AB 1306: Healing arts: certified nurse-midwives: scope of practice.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2016-06-30
(1)Existing law, the Nursing Practice Act, provides for the licensure and regulation of the practice of nursing by the Board of Registered Nursing and authorizes the board to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the board or the equivalent of those educational standards. The act makes the violation of any of its provisions a misdemeanor punishable upon conviction by imprisonment in the county jail for not less than 10 days nor more than one year, or by a fine of not less than $20 nor more than $1,000, or by both that fine and imprisonment.
This bill would additionally require an applicant for a certificate to practice nurse-midwifery to provide evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board. The bill would also require the board to create and appoint a Nurse-Midwifery Advisory Committee consisting of certified nurse-midwives in good standing with experience in hospital settings, alternative birth settings, and home settings, a nurse-midwife educator, as specified, 2 qualified physicians, and a consumer of midwifery care. This The bill would require the committee to consist of a majority of certified nurse-midwives and would require the committee to make recommendations to the board on all matters related to nurse-midwifery practice, education, disciplinary actions, standards of care, and other matters specified by the board, and would require the committee to meet regularly, but at least twice a year. This bill would prohibit corporations and other artificial legal entities from having professional rights, privileges, or powers under the act, except as specified. The bill would authorize specified entities to employ a certified nurse-midwife and charge for professional services rendered by that certified nurse-midwife, as provided.
(2)The act authorizes a certified nurse-midwife, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn, and provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal.
This bill would delete those provisions and would instead authorize a certified nurse-midwife to manage a full range of gynecological and obstetric care services for women from adolescence beyond menopause, as provided. The bill would authorize a certified nurse-midwife to practice under that gynecological and obstetric care services authorization without supervision of a physician and surgeon in certain settings, including, but not limited to, a home setting, as specified. This The bill would prohibit entities described in those specified settings from interfering with, controlling, or otherwise directing the professional judgment of such a certified nurse-midwife, as specified. The bill would declare that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the client and the resources of the medical personnel available in the setting of care, and would provide that the practice of nurse-midwifery emphasizes informed consent, preventive care, and early detection and referral of complications to a physician and surgeon.
(3)The act authorizes a certified nurse-midwife to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the certified nurse-midwifes educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified.
This bill would delete the requirement that drugs or devices are furnished or ordered in accordance with standardized procedures and protocols. The bill would authorize a certified nurse-midwife to furnish and order drugs or devices in connection with care rendered in a home, and would authorize a certified nurse-midwife to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and that are consistent with nurse-midwifery education preparation.
(4)The act also authorizes a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center, if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon.
This bill would also authorize a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a home, and would delete all requirements that those procedures be performed pursuant to protocols developed and approved by the supervising physician and surgeon. The bill would require a certified nurse-midwife to provide emergency care to a patient during times when a physician and surgeon is unavailable.
This bill would provide that a consultative relationship between a certified nurse-midwife and a physician and surgeon by it self itself is not a basis for finding the physician and surgeon liable for any acts or omissions on the part of the certified nurse-midwife. The bill would also update cross-references as needed.
(5)Because the act makes a violation of any of its provisions a misdemeanor, this bill would expand the scope of an existing crime and therefore this bill would impose a state-mandated local program.
(6)Existing law provides prescribed protection against retaliation for health care practitioners who advocate for appropriate health care for their patients. Existing law defines health care practitioner for those purposes to mean a person who engages in acts that are the subject of licensure or regulation under specific law or initiative act and who is either a licentiate, as defined, a party to a contract with a payer whose decision, policy, or practice is subject to such advocacy, or an individual designated in a contract with a payer whose decision, policy, or practice is subject to such advocacy, where the individual is granted the right to appeal denials of payment or authorization for treatment under the contract.
This bill would expand that protection against retaliation to certified nurse-midwives.
(6)
(7)Existing law prohibits a licensee, as defined, from referring a person for laboratory, diagnostic, nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the licensee or his or her immediate family has a financial interest with the person or entity that receives the referral, and makes a violation of that prohibition punishable as a misdemeanor. Under existing law, the Medical Board of California is required to review the facts and circumstances of any conviction for violating the prohibition, and to take appropriate disciplinary action if the licensee has committed unprofessional conduct. Existing law provides that, among other exceptions, this prohibition does not apply to a licensee who refers a person to a health facility if specified conditions are met.
This bill would include a certified nurse-midwife under the definition of a licensee, which would expand the scope of an existing crime and therefore impose a state-mandated local program. The bill would require the Board of Registered Nursing to review the facts and circumstances of any conviction of a certified nurse-midwife for violating that prohibition, and would require the board to take appropriate disciplinary action if the certified nurse-midwife has committed unprofessional conduct. The bill would additionally authorize a licensee to refer a person to a licensed alternative birth center, as defined, or a nationally accredited alternative birth center.
(7)
(8)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
(1)Existing law, the Nursing Practice Act, provides for the licensure and regulation of the practice of nursing by the Board of Registered Nursing and authorizes the board to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the board or the equivalent of those educational standards. The act makes the violation of any of its provisions a misdemeanor punishable upon conviction by imprisonment in the county jail for not less than 10 days nor more than one year, or by a fine of not less than $20 nor more than $1,000, or by both that fine and imprisonment.
This bill would additionally require an applicant for a certificate to practice nurse-midwifery to provide evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board. This The bill would also require the board to create and appoint a Nurse-Midwifery Advisory Council Committee consisting of certified nurse-midwives in good standing with experience in hospital settings, alternative birth settings, and home settings, a nurse-midwife educator, as specified, 2 qualified physicians, and a consumer of midwifery care. This bill would require the council committee to consist of a majority of certified nurse-midwives and would require the council committee to make recommendations to the board on all matters related to nurse-midwifery practice, education, disciplinary actions, standards of care, and other matters specified by the board, and would require the council committee to meet regularly, but at least twice a year. This bill would prohibit corporations and other artificial legal entities from having professional rights, privileges, or powers under the act, except as specified. The bill would authorize specified entities to employ a certified nurse-midwife and charge for professional services rendered by that certified nurse-midwife, as provided.
(2)The act authorizes a certified nurse-midwife, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn, and provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal.
This bill would delete those provisions and would instead authorize a certified nurse-midwife to manage a full range of gynecological and obstetric care services for women from adolescence beyond menopause, as provided. The bill would authorize a certified nurse-midwife to practice in specified certain settings, including, but not limited to, a home setting. setting, as specified. This bill would declare that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the client and the resources of the medical personnel available in the setting of care, and would provide that the practice of nurse-midwifery emphasizes informed consent, preventive care, and early detection and referral of complications to a physician and surgeon.
(3)The act authorizes a certified nurse-midwife to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the certified nurse-midwifes educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified.
This bill would delete the requirement that drugs or devices are furnished or ordered in accordance with standardized procedures and protocols. The bill would authorize a certified nurse-midwife to furnish and order drugs or devices in connection with care rendered in a home, and would authorize a certified nurse-midwife to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and that are consistent with nurse-midwifery education preparation.
(4)The act also authorizes a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center, if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon.
This bill would also authorize a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a home, and would delete all requirements that those procedures be performed pursuant to protocols developed and approved by the supervising physician and surgeon. The bill would require a certified nurse-midwife to provide emergency care to a patient during times when a physician and surgeon is unavailable.
This bill would provide that a consultative relationship between a certified nurse-midwife and a physician and surgeon by it self is not a basis for finding the physician and surgeon liable for any acts or omissions on the part of the certified nurse-midwife. The bill would also update cross-references as needed.
(5)Because the act makes a violation of any of its provisions a misdemeanor, this bill would expand the scope of an existing crime and therefore this bill would impose a state-mandated local program.
(6)Existing law prohibits a licensee, as defined, from referring a person for laboratory, diagnostic, nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the licensee or his or her immediate family has a financial interest with the person or entity that receives the referral, and makes a violation of that prohibition punishable as a misdemeanor. Under existing law, the Medical Board of California is required to review the facts and circumstances of any conviction for violating the prohibition, and to take appropriate disciplinary action if the licensee has committed unprofessional conduct. Existing law provides that, among other exceptions, this prohibition does not apply to a licensee who refers a person to a health facility if specified conditions are met.
This bill would include a certified nurse-midwife under the definition of a licensee, which would expand the scope of an existing crime and therefore impose a state-mandated local program. The bill would require the Board of Registered Nursing to review the facts and circumstances of any conviction of a certified nurse-midwife for violating that prohibition, and would require the board to take appropriate disciplinary action if the certified nurse-midwife has committed unprofessional conduct. The bill would additionally authorize a licensee to refer a person to a licensed alternative birth center, as defined, or a nationally accredited alternative birth center.
(7)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
(1)Existing law, the Nursing Practice Act, provides for the licensure and regulation of the practice of nursing by the Board of Registered Nursing and authorizes the board to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the board or the equivalent of those educational standards. The act makes the violation of any of its provisions a misdemeanor punishable upon conviction by imprisonment in the county jail for not less than 10 days nor more than one year, or by a fine of not less than $20 nor more than $1,000, or by both that fine and imprisonment.
This bill would additionally require an applicant for a certificate to practice nurse-midwifery to provide evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board. This bill would also require the board to create and appoint a Nurse-Midwifery Advisory Council consisting of certified nurse-midwives in good standing with experience in hospital and nonhospital practice settings, alternative birth settings, and home settings, a nurse-midwife educator, as specified, and a consumer of midwifery care. This bill would require the council to consist of a majority of certified nurse-midwives and would require the council to make recommendations to the board on all matters related to nurse-midwifery practice, education, disciplinary actions, standards of care, and other matters specified by the board, and would require the council to meet regularly, but at least twice a year. This bill would also prohibit corporations and other artificial legal entities from having professional rights, privileges, or powers under the act, except as specified. The bill would authorize specified entities to employ a certified nurse-midwife and charge for professional services rendered by that certified nurse-midwife, as provided.
(2)The act authorizes a certified nurse-midwife, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn, and provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal.
This bill would delete those provisions and would instead authorize a certified nurse-midwife to manage a full range of primary health gynecological and obstetric care services for women from adolescence beyond menopause, including, but not limited to, gynecologic and family planning services. as provided. The bill would authorize a certified nurse-midwife to practice in all specified settings, including, but not limited to, a home setting. This bill would declare that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the client and the resources of the medical personnel available in the setting of care, and would provide that the practice of nurse-midwifery emphasizes informed consent, preventive care, and early detection and referral of complications to a physician and surgeon. This bill would authorize a certified nurse-midwife to provide peripartum care in an out-of-hospital setting to low-risk women with uncomplicated singleton-term pregnancies who are expected to have uncomplicated birth.
(3)The act authorizes a certified nurse-midwife to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the certified nurse-midwifes educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified.
This bill would delete the requirement that drugs or devices are furnished or ordered in accordance with standardized procedures and protocols. The bill would authorize a certified nurse-midwife to furnish and order drugs or devices in connection with care rendered in a home, and would authorize a certified nurse-midwife to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and that are consistent with nurse-midwifery education preparation.
(4)The act also authorizes a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center, if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon.
This bill would also authorize a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a home, and would delete all requirements that those procedures be performed pursuant to protocols developed and approved by the supervising physician and surgeon. The bill would require a certified nurse-midwife to provide emergency care to a patient during times when a physician and surgeon is unavailable.
This bill would provide that a consultative relationship between a certified nurse-midwife and a physician and surgeon by it self is not a basis for finding the physician and surgeon liable for any acts or omissions on the part of the certified nurse-midwife. The bill would also update cross-references as needed.
(5)Because the act makes a violation of any of its provisions a misdemeanor, this bill would expand the scope of an existing crime and therefore this bill would impose a state-mandated local program.
(6)Existing law prohibits a licensee, as defined, from referring a person for laboratory, diagnostic, nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the licensee or his or her immediate family has a financial interest with the person or entity that receives the referral, and makes a violation of that prohibition punishable as a misdemeanor. Under existing law law, the Medical Board of California is required to review the facts and circumstances of any conviction for violating the prohibition, and to take appropriate disciplinary action if the licensee has committed unprofessional conduct. Existing law provides that, among other exceptions, this prohibition does not apply to a licensee who refers a person to a health facility if specified conditions are met.
This bill would include a certified nurse-midwife under the definition of a licensee, which would expand the scope of an existing crime and therefore impose a state-mandated local program. The bill would also require the Board of Registered Nursing to review the facts and circumstances of any conviction of a certified nurse-midwife for violating that prohibition, and would require the board to take appropriate disciplinary action if the certified nurse-midwife has committed unprofessional conduct. The bill would additionally authorize a licensee to refer a person to a licensed alternative birth center, as defined, or a nationally accredited alternative birth center.
(7)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
(1)Existing law, the Nursing Practice Act, provides for the licensure and regulation of the practice of nursing by the Board of Registered Nursing and authorizes the board to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the board or the equivalent of those educational standards. The act makes the violation of any of its provisions a misdemeanor punishable upon conviction by imprisonment in the county jail for not less than 10 days nor more than one year, or by a fine of not less than $20 nor more than $1,000, or by both that fine and imprisonment.
This bill would additionally require an applicant for a certificate to practice nurse-midwifery to provide evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board. This bill would also require the board to create and appoint a Nurse-Midwifery Advisory Council consisting of certified nurse-midwives in good standing with experience in hospital and nonhospital practice settings, a nurse-midwife educator, as specified, and a consumer of midwifery care. This bill would require the council to make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters specified by the board, and would require the council to meet regularly, but at least twice a year. This bill would also prohibit corporations and other artificial legal entities from having professional rights, privileges, or powers under the act, except as specified.
(2)The act authorizes a certified nurse-midwife, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn, and provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal.
This bill would delete those provisions and would instead authorize a certified nurse-midwife to manage a full range of primary health care services for women from adolescence beyond menopause, including, but not limited to, gynecologic and family planning services. The bill would authorize a certified nurse-midwife to practice in all settings, including, but not limited to, a home. This bill would declare that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the client and the resources of the medical personnel available in the setting of care, and would provide that the practice of nurse-midwifery emphasizes informed consent, preventive care care, and early detection and referral of complications to a physician and surgeon. This bill would authorize a certified nurse-midwife to provide peripartum care in an out-of-hospital setting to low-risk women with uncomplicated singleton-term pregnancies who are expected to have uncomplicated birth.
(3)The act authorizes a certified nurse-midwife to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the certified nurse-midwifes educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified.
This bill would delete the requirement that drugs or devices are furnished or ordered in accordance with standardized procedures and protocols. The bill would authorize a certified nurse-midwife to furnish and order drugs or devices in connection with care rendered in a home, and would authorize a certified nurse-midwife to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and that are consistent with nurse-midwifery education preparation.
(4)The act also authorizes a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center, if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon.
This bill would also authorize a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a patients home, and would delete all requirements that those procedures be performed pursuant to protocols developed and approved by the supervising physician and surgeon. The bill would require a certified nurse-midwife to provide emergency care to a patient during times when a physician and surgeon is unavailable.
This bill would provide that a consultative relationship between a certified nurse-midwife and a physician and surgeon by it self is not a basis for finding the physician and surgeon liable for any acts or omissions on the part of the certified nurse-midwife. The bill would also update cross-references as needed.
(5)Because the act makes a violation of any of its provisions a misdemeanor, this bill would expand the scope of an existing crime and therefore this bill would impose a state-mandated local program.
The
(6)Existing law prohibits a licensee, as defined, from referring a person for laboratory, diagnostic, nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the licensee or his or her immediate family has a financial interest with the person or entity that receives the referral, and makes a violation of that prohibition punishable as a misdemeanor. Under existing law the Medical Board of California is required to review the facts and circumstances of any conviction for violating the prohibition, and to take appropriate disciplinary action if the licensee has committed unprofessional conduct.
This bill would include a certified nurse-midwife under the definition of a licensee, which would expand the scope of an existing crime and therefore impose a state-mandated local program. The bill would also require the Board of Registered Nursing to review the facts and circumstances of any conviction of a certified nurse-midwife for violating that prohibition, and would require the board to take appropriate disciplinary action if the certified nurse-midwife has committed unprofessional conduct.
(7)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
(1)Existing law, the Nursing Practice Act, provides for the licensure and regulation of the practice of nursing by the Board of Registered Nursing and authorizes the board to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the board or the equivalent of those educational standards. The act makes the violation of any of its provisions a misdemeanor punishable upon conviction by imprisonment in the county jail for not less than 10 days nor more than one year, or by a fine of not less than $20 nor more than $1,000, or by both that fine and imprisonment.
This bill would additionally require an applicant for a certificate to practice nurse-midwifery to provide evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board. This bill would also require the board to create and appoint a Nurse-Midwifery Advisory Council consisting of certified nurse-midwives in good standing with experience in hospital and nonhospital practice settings, a nurse-midwife educator, as specified, and a consumer of midwifery care. This bill would require the council to make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters specified by the board, and would require the council to meet regularly, but at least twice a year.
(2)The act authorizes a certified nurse-midwife, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn, and provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal.
This bill would delete those provisions and would instead authorize a certified nurse-midwife to manage a full range of primary health care services for women from adolescence beyond menopause, including, but not limited to, gynecologic and family planning services. The bill would authorize a certified nurse-midwife to practice in all settings, including, but not limited to, a home. This bill would declare that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the client and the resources of the medical personnel available in the setting of care, and would provide that the practice of nurse-midwifery emphasizes informed consent, preventive care and early detection and referral of complications to a physician and surgeon. This bill would authorize a certified nurse-midwife to provide peripartum care in an out-of-hospital setting to low-risk women with uncomplicated singleton-term pregnancies who are expected to have uncomplicated birth.
(3)The act authorizes a certified nurse-midwife to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the certified nurse-midwifes educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified.
This bill would delete the requirement that drugs or devices are furnished or ordered in accordance with standardized procedures and protocols. The bill would authorize a certified nurse-midwife to furnish and order drugs or devices in connection with care rendered in a home, and would authorize a certified nurse-midwife to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and that are consistent with nurse-midwifery education preparation.
(4)The act also authorizes a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center, if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon.
This bill would also authorize a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a patients home, and would delete all requirements that those procedures be performed pursuant to protocols developed and approved by the supervising physician and surgeon. The bill would require a certified nurse-midwife to provide emergency care to a patient during times when a physician and surgeon is unavailable.
This bill would provide that a consultative relationship between a certified nurse-midwife and a physician and surgeon by it self is not a basis for finding the physician and surgeon liable for any acts or omissions on the part of the certified nurse-midwife. The bill would also update cross-references as needed.
(5)Because the act makes a violation of any of its provisions a misdemeanor, this bill would expand the scope of an existing crime and therefore this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
(a)The purpose of this section is to provide protection against retaliation for health care practitioners who advocate for appropriate health care for their patients pursuant to Wickline v. State of California 192 Cal. App. 3d 1630.
(b)It is the public policy of the State of California that a health care practitioner be encouraged to advocate for appropriate health care for his or her patients. For purposes of this section, to advocate for appropriate health care means to appeal a payers decision to deny payment for a service pursuant to the reasonable grievance or appeal procedure established by a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff and governing body, or payer, or to protest a decision, policy, or practice that the health care practitioner, consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care, reasonably believes impairs the health care practitioners ability to provide appropriate health care to his or her patients.
(c)The application and rendering by any individual, partnership, corporation, or other organization of a decision to terminate an employment or other contractual relationship with or otherwise penalize a health care practitioner principally for advocating for appropriate health care consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care violates the public policy of this state.
(d)This section shall not be construed to prohibit a payer from making a determination not to pay for a particular medical treatment or service, or the services of a type of health care practitioner, or to prohibit a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff, hospital governing body acting pursuant to Section 809.05, or payer from enforcing reasonable peer review or utilization review protocols or determining whether a health care practitioner has complied with those protocols.
(e)(1)Except as provided in paragraph (2), appropriate health care in a hospital licensed pursuant to Section 1250 of the Health and Safety Code shall be defined by the appropriate hospital committee and approved by the hospital medical staff and the governing body, consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care.
(2)To the extent the issue is under the jurisdiction of the medical staff and its committees, appropriate health care in a hospital licensed pursuant to Section 1250 of the Health and Safety Code shall be defined by the hospital medical staff and approved by the governing body, consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care.
(f)Nothing in this section shall be construed to prohibit the governing body of a hospital from taking disciplinary actions against a health care practitioner as authorized by Sections 809.05, 809.4, and 809.5.
(g)Nothing in this section shall be construed to prohibit the appropriate licensing authority from taking disciplinary actions against a health care practitioner.
(h)For purposes of this section, health care practitioner means either a person who is described in subdivision (f) of Section 900 and who is either (1) a licentiate as defined in Section 805, or (2) a party to a contract with a payer whose decision, policy, or practice is subject to the advocacy described in subdivision (b), or (3) an individual designated in a contract with a payer whose decision, policy, or practice is subject to the advocacy described in subdivision (b), where the individual is granted the right to appeal denials of payment or authorization for treatment under the contract. contract, or a person who is described in Section 2746.2.
(i)Nothing in this section shall be construed to revise or expand the scope of practice of any health care practitioner, or to revise or expand the types of health care practitioners who are authorized to obtain medical staff privileges or to submit claims for reimbursement to payers.
(j)The protections afforded health care practitioners by this section shall be in addition to the protections available under any other law of this state.
SECTION 1.SEC. 2.Section 650.01 of the Business and Professions Code is amended to read:650.01.(a)Notwithstanding Section 650, or any other law, it is unlawful for a licensee to refer a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the licensee or his or her immediate family has a financial interest with the person or in the entity that receives the referral.
(b)For purposes of this section and Section 650.02, the following shall apply:
(1)Diagnostic imaging includes, but is not limited to, all X-ray, computed axial tomography, magnetic resonance imaging nuclear medicine, positron emission tomography, mammography, and ultrasound goods and services.
(2)A financial interest includes, but is not limited to, any type of ownership interest, debt, loan, lease, compensation, remuneration, discount, rebate, refund, dividend, distribution, subsidy, or other form of direct or indirect payment, whether in money or otherwise, between a licensee and a person or entity to whom the licensee refers a person for a good or service specified in subdivision (a). A financial interest also exists if there is an indirect financial relationship between a licensee and the referral recipient including, but not limited to, an arrangement whereby a licensee has an ownership interest in an entity that leases property to the referral recipient. Any financial interest transferred by a licensee to any person or entity or otherwise established in any person or entity for the purpose of avoiding the prohibition of this section shall be deemed a financial interest of the licensee. For purposes of this paragraph, direct or indirect payment shall not include a royalty or consulting fee received by a physician and surgeon who has completed a recognized residency training program in orthopedics from a manufacturer or distributor as a result of his or her research and development of medical devices and techniques for that manufacturer or distributor. For purposes of this paragraph, consulting fees means those fees paid by the manufacturer or distributor to a physician and surgeon who has completed a recognized residency training program in orthopedics only for his or her ongoing services in making refinements to his or her medical devices or techniques marketed or distributed by the manufacturer or distributor, if the manufacturer or distributor does not own or control the facility to which the physician is referring the patient. A financial interest shall not include the receipt of capitation payments or other fixed amounts that are prepaid in exchange for a promise of a licensee to provide specified health care services to specified beneficiaries. A financial interest shall not include the receipt of remuneration by a medical director of a hospice, as defined in Section 1746 of the Health and Safety Code, for specified services if the arrangement is set out in writing, and specifies all services to be provided by the medical director, the term of the arrangement is for at least one year, and the compensation to be paid over the term of the arrangement is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between parties.
(3)For the purposes of this section, immediate family includes the spouse and children of the licensee, the parents of the licensee, and the spouses of the children of the licensee.
(4)Licensee means a physician as defined in Section 3209.3 of the Labor Code, and a certified nurse-midwife as defined in Article 2.5 (commencing with Section 2746) of Chapter 6 of Division 2 of the Business and Professions Code.
(5)Licensees office means either of the following:
(A)An office of a licensee in solo practice.
(B)An office in which services or goods are personally provided by the licensee or by employees in that office, or personally by independent contractors in that office, in accordance with other provisions of law. Employees and independent contractors shall be licensed or certified when licensure or certification is required by law.
(6)Office of a group practice means an office or offices in which two or more licensees are legally organized as a partnership, professional corporation, or not-for-profit corporation, licensed pursuant to subdivision (a) of Section 1204 of the Health and Safety Code, for which all of the following apply:
(A)Each licensee who is a member of the group provides substantially the full range of services that the licensee routinely provides, including medical care, consultation, diagnosis, or treatment through the joint use of shared office space, facilities, equipment, and personnel.
(B)Substantially all of the services of the licensees who are members of the group are provided through the group and are billed in the name of the group and amounts so received are treated as receipts of the group, except in the case of a multispecialty clinic, as defined in subdivision (l) of Section 1206 of the Health and Safety Code, physician services are billed in the name of the multispecialty clinic and amounts so received are treated as receipts of the multispecialty clinic.
(C)The overhead expenses of, and the income from, the practice are distributed in accordance with methods previously determined by members of the group.
(c)It is unlawful for a licensee to enter into an arrangement or scheme, such as a cross-referral arrangement, that the licensee knows, or should know, has a principal purpose of ensuring referrals by the licensee to a particular entity that, if the licensee directly made referrals to that entity, would be in violation of this section.
(d)No claim for payment shall be presented by an entity to any individual, third party payer, or other entity for a good or service furnished pursuant to a referral prohibited under this section.
(e)No insurer, self-insurer, or other payer shall pay a charge or lien for any good or service resulting from a referral in violation of this section.
(f)A licensee who refers a person to, or seeks consultation from, an organization in which the licensee has a financial interest, other than as prohibited by subdivision (a), shall disclose the financial interest to the patient, or the parent or legal guardian of the patient, in writing, at the time of the referral or request for consultation.
(1)If a referral, billing, or other solicitation is between one or more licensees who contract with a multispecialty clinic pursuant to subdivision (l) of Section 1206 of the Health and Safety Code or who conduct their practice as members of the same professional corporation or partnership, and the services are rendered on the same physical premises, or under the same professional corporation or partnership name, the requirements of this subdivision may be met by posting a conspicuous disclosure statement at the registration area or by providing a patient with a written disclosure statement.
(2)If a licensee is under contract with the Department of Corrections or the California Youth Authority, and the patient is an inmate or parolee of either respective department, the requirements of this subdivision shall be satisfied by disclosing financial interests to either the Department of Corrections or the California Youth Authority.
(g)A violation of subdivision (a) shall be a misdemeanor. In the case of a licensee who is a physician, the Medical Board of California shall review the facts and circumstances of any conviction pursuant to subdivision (a) and take appropriate disciplinary action if the licensee has committed unprofessional conduct. In the case of a licensee who is a certified nurse-midwife, the Board of Registered Nursing shall review the facts and circumstances of any conviction pursuant to subdivision (a) and take appropriate disciplinary action if the licensee has committed unprofessional conduct. Violations of this section may also be subject to civil penalties of up to five thousand dollars ($5,000) for each offense, which may be enforced by the Insurance Commissioner, Attorney General, or a district attorney. A violation of subdivision (c), (d), or (e) is a public offense and is punishable upon conviction by a fine not exceeding fifteen thousand dollars ($15,000) for each violation and appropriate disciplinary action, including revocation of professional licensure, by the Medical Board of California, the Board of Registered Nursing, or other appropriate governmental agency.
(h)This section shall not apply to referrals for services that are described in and covered by Sections 139.3 and 139.31 of the Labor Code.
(i)This section shall become operative on January 1, 1995.
SEC. 2.SEC. 3.Section 650.02 of the Business and Professions Code is amended to read:650.02.The prohibition of Section 650.01 shall not apply to or restrict any of the following:
(a)A licensee may refer a patient for a good or service otherwise prohibited by subdivision (a) of Section 650.01 if the licensees regular practice is located where there is no alternative provider of the service within either 25 miles or 40 minutes traveling time, via the shortest route on a paved road. If an alternative provider commences furnishing the good or service for which a patient was referred pursuant to this subdivision, the licensee shall cease referrals under this subdivision within six months of the time at which the licensee knew or should have known that the alternative provider is furnishing the good or service. A licensee who refers to or seeks consultation from an organization in which the licensee has a financial interest under this subdivision shall disclose this interest to the patient or the patients parents or legal guardian in writing at the time of referral.
(b)A licensee, when the licensee or his or her immediate family has one or more of the following arrangements with another licensee, a person, or an entity, is not prohibited from referring a patient to the licensee, person, or entity because of the arrangement:
(1)A loan between a licensee and the recipient of the referral, if the loan has commercially reasonable terms, bears interest at the prime rate or a higher rate that does not constitute usury, is adequately secured, and the loan terms are not affected by either partys referral of any person or the volume of services provided by either party.
(2)A lease of space or equipment between a licensee and the recipient of the referral, if the lease is written, has commercially reasonable terms, has a fixed periodic rent payment, has a term of one year or more, and the lease payments are not affected by either partys referral of any person or the volume of services provided by either party.
(3)Ownership of corporate investment securities, including shares, bonds, or other debt instruments that may be purchased on terms generally available to the public and that are traded on a licensed securities exchange or NASDAQ, do not base profit distributions or other transfers of value on the licensees referral of persons to the corporation, do not have a separate class or accounting for any persons or for any licensees who may refer persons to the corporation, and are in a corporation that had, at the end of the corporations most recent fiscal year, or on average during the previous three fiscal years, stockholder equity exceeding seventy-five million dollars ($75,000,000).
(4)Ownership of shares in a regulated investment company as defined in Section 851(a) of the federal Internal Revenue Code, if the company had, at the end of the companys most recent fiscal year, or on average during the previous three fiscal years, total assets exceeding seventy-five million dollars ($75,000,000).
(5)A one-time sale or transfer of a practice or property or other financial interest between a licensee and the recipient of the referral if the sale or transfer is for commercially reasonable terms and the consideration is not affected by either partys referral of any person or the volume of services provided by either party.
(6)A personal services arrangement between a licensee or an immediate family member of the licensee and the recipient of the referral if the arrangement meets all of the following requirements:
(A)It is set out in writing and is signed by the parties.
(B)It specifies all of the services to be provided by the licensee or an immediate family member of the licensee.
(C)The aggregate services contracted for do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement.
(D)A person who is referred by a licensee or an immediate family member of the licensee is informed in writing of the personal services arrangement that includes information on where a person may go to file a complaint against the licensee or the immediate family member of the licensee.
(E)The term of the arrangement is for at least one year.
(F)The compensation to be paid over the term of the arrangement is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties.
(G)The services to be performed under the arrangement do not involve the counseling or promotion of a business arrangement or other activity that violates any state or federal law.
(c)(1)A licensee may refer a person to a health facility, as defined in Section 1250 of the Health and Safety Code, a licensed alternative birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, or to any facility, or nationally accredited alternative birth center, owned or leased by a health facility, if the recipient of the referral does not compensate the licensee for the patient referral, and any equipment lease arrangement between the licensee and the referral recipient complies with the requirements of paragraph (2) of subdivision (b).
(2)Nothing shall preclude this subdivision from applying to a licensee solely because the licensee has an ownership or leasehold interest in an entire health facility or an entity that owns or leases an entire health facility.
(3)A licensee may refer a person to a health facility for any service classified as an emergency under subdivision (a) or (b) of Section 1317.1 of the Health and Safety Code.
(4)A licensee may refer a person to any organization that owns or leases a health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 of the Health and Safety Code if the licensee is not compensated for the patient referral, the licensee does not receive any payment from the recipient of the referral that is based or determined on the number or value of any patient referrals, and any equipment lease arrangement between the licensee and the referral recipient complies with the requirements of paragraph (2) of subdivision (b). For purposes of this paragraph, the ownership may be through stock or membership, and may be represented by a parent holding company that solely owns or controls both the health facility organization and the affiliated organization.
(d)A licensee may refer a person to a nonprofit corporation that provides physician services pursuant to subdivision (l) of Section 1206 of the Health and Safety Code if the nonprofit corporation is controlled through membership by one or more health facilities or health facility systems and the amount of compensation or other transfer of funds from the health facility or nonprofit corporation to the licensee is fixed annually, except for adjustments caused by physicians joining or leaving the groups during the year, and is not based on the number of persons utilizing goods or services specified in Section 650.01.
(e)A licensee compensated or employed by a university may refer a person for a physician service, to any facility owned or operated by the university, or to another licensee employed by the university, provided that the facility or university does not compensate the referring licensee for the patient referral. In the case of a facility that is totally or partially owned by an entity other than the university, but that is staffed by university physicians, those physicians may not refer patients to the facility if the facility compensates the referring physicians for those referrals.
(f)The prohibition of Section 650.01 shall not apply to any service for a specific patient that is performed within, or goods that are supplied by, a licensees office, or the office of a group practice. Further, the provisions of Section 650.01 shall not alter, limit, or expand a licensees ability to deliver, or to direct or supervise the delivery of, in-office goods or services according to the laws, rules, and regulations governing his or her scope of practice.
(g)The prohibition of Section 650.01 shall not apply to cardiac rehabilitation services provided by a licensee or by a suitably trained individual under the direct or general supervision of a licensee, if the services are provided to patients meeting the criteria for Medicare reimbursement for the services.
(h)The prohibition of Section 650.01 shall not apply if a licensee is in the office of a group practice and refers a person for services or goods specified in Section 650.01 to a multispecialty clinic, as defined in subdivision (l) of Section 1206 of the Health and Safety Code.
(i)The prohibition of Section 650.01 shall not apply to health care services provided to an enrollee of a health care service plan licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).
(j)The prohibition of Section 650.01 shall not apply to a request by a pathologist for clinical diagnostic laboratory tests and pathological examination services, a request by a radiologist for diagnostic radiology services, or a request by a radiation oncologist for radiation therapy if those services are furnished by, or under the supervision of, the pathologist, radiologist, or radiation oncologist pursuant to a consultation requested by another physician.
(k)This section shall not apply to referrals for services that are described in and covered by Sections 139.3 and 139.31 of the Labor Code.
(l)This section shall become operative on January 1, 1995.
SEC. 3.SEC. 4.Section 2725.1 of the Business and Professions Code is amended to read:2725.1.(a)Notwithstanding any other law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon or an order by a certified nurse-midwife, nurse practitioner, or physician assistant issued pursuant to Section 2746.51, 2836.1, or 3502.1, respectively, if the registered nurse is functioning within a licensed primary care clinic as defined in subdivision (a) of Section 1204 of, or within a clinic as defined in subdivision (b), (c), (h), or (j) of Section 1206 of, the Health and Safety Code.
(b)No clinic shall employ a registered nurse to perform dispensing duties exclusively. No registered nurse shall dispense drugs in a pharmacy, keep a pharmacy, open shop, or drugstore for the retailing of drugs or poisons. No registered nurse shall compound drugs. Dispensing of drugs by a registered nurse, except a certified nurse-midwife who functions pursuant to Section 2746.51 or a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, shall not include substances included in the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code). Nothing in this section shall exempt a clinic from the provisions of Article 13 (commencing with Section 4180) of Chapter 9.
(c)This section shall not be construed to limit any other authority granted to a certified nurse-midwife pursuant to Article 2.5 (commencing with Section 2746), to a nurse practitioner pursuant to Article 8 (commencing with Section 2834), or to a physician assistant pursuant to Chapter 7.7 (commencing with Section 3500).
(d)This section shall not be construed to affect the sites or types of health care facilities at which drugs or devices are authorized to be dispensed pursuant to Chapter 9 (commencing with Section 4000).
SEC. 4.SEC. 5.Section 2746.2 of the Business and Professions Code is amended to read:2746.2.(a)Each applicant shall show by evidence satisfactory to the board that he or she has met the educational standards established by the board or has at least the equivalent thereof, including evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board.
(b)The board shall create and appoint a Nurse-Midwifery Advisory Committee consisting of certified nurse-midwives in good standing with experience in hospital settings, alternative birth center settings, and home settings, a nurse-midwife educator who has demonstrated familiarity with educational standards in the delivery of maternal-child health care, a consumer of midwifery care, and at least two qualified physicians, including an obstetrician that has experience working with nurse-midwives. The committee membership shall consist of a majority of certified nurse-midwives and shall make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters as specified by the board. The committee shall meet regularly, but at least twice a year.
(c)Corporations and other artificial legal entities shall have no professional rights, privileges, or powers. However, the Board of Registered Nursing may in its discretion, after such investigation and review of such documentary evidence as it may require, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic.
(d)Notwithstanding subdivision (c), the following entities may employ a certified nurse-midwife and charge for professional services rendered by a certified nurse-midwife; however, the entity shall not interfere with, control, or otherwise direct the professional judgment of a certified nurse-midwife:
(1)A clinic operated under subdivision (h) or (p) of Section 1206 of the Health and Safety Code.
(2)A hospital owned and operated by a health care district pursuant to Division 23 (commencing with Section 32000) of the Health and Safety Code.
(3)A clinic operated primarily for the purpose of medical education or nursing education by a public or private nonprofit university medical school, which is approved by the Medical Board or the Osteopathic Medical Board of California, provided the certified nurse-midwife holds an academic appointment on the faculty of the university, including, but not limited to, the University of California medical schools and hospitals.
(4)A licensed alternative birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, or a nationally accredited alternative birth center owned or operated by a nursing corporation, as defined in Section 2775 of the Business and Professions Code.
(5)A health facility described in Section 1250 of the Health and Safety Code if the certified-nurse midwife is practicing under the supervision of a physician and surgeon.
(6)A clinic operated under subdivision (a) of Section 1204 of the Health and Safety code.
(e)As used in this section, supervision shall not be construed to require the physical presence of a supervising physician and surgeon. A facility described in paragraphs (1) to (4), inclusive, of subdivision (d) that employs a certified-nurse midwife shall not require supervision by a physician and surgeon of the certified-nurse midwife.
SEC. 5.SEC. 6.Section 2746.5 of the Business and Professions Code is amended to read:2746.5.(a)The certificate to practice nurse-midwifery authorizes the holder to manage a full range of primary gynecological and obstetric care services for women from adolescence to beyond menopause, consistent with the Core Competencies for Basic Midwifery practice promulgated by the American College of Nurse-Midwives, or its successor national professional organization, as approved by the board. These services include, but are not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, immediate care of the newborn, and treatment of male partners for sexually transmitted infections, utilizing consultation, collaboration, or referral to appropriate levels of health care services, as indicated.
(b)A certified nurse-midwife may practice under this section without supervision of a physician and surgeon in the following settings:
(1)A licensed clinic as described in Chapter 1 (commencing with Section 1200) of Division 2 of the Health and Safety Code.
(2)A facility as described in Chapter 2 (commencing with Section 1250) of Division 2 of the Health and Safety Code.
(3)A facility as described in Chapter 2.5 (commencing with Section 1440) of Division 2 of the Health and Safety Code.
(4)A medical group practice, including a professional medical corporation, a medical partnership, a medical foundation exempt from licensure pursuant to Section 1206 of the Health and Safety Code, or another lawfully organized group of physicians that delivers, furnishes, or otherwise arranges for or provides health care services.
(5)A licensed alternative birth center, as described in Section 1204 of the Health and Safety Code, or nationally accredited birth center.
(6)A nursing corporation, as defined in Section 2775 of the Business and Professions Code.
(7)A home setting.
(A)Except as provided in subparagraph (B), a certified nurse-midwife shall only attend during normal, low-risk pregnancy and childbirth in the home setting when all of the following conditions apply:
(i)There is the absence of all of the following:
(I)Any preexisting maternal disease or condition creating risks beyond that of a normal, low-risk pregnancy or birth, as defined in the American College of Nurse-Midwives standard-setting documents and any future changes to those documents.
(II)Disease arising from or during the pregnancy creating risks beyond that of a normal, low-risk pregnancy or birth, as defined in the American College of Nurse-Midwives standard-setting documents and any future changes to those documents.
(III)Prior caesarean delivery.
(ii)There is a singleton fetus.
(iii)There is cephalic presentation at the onset of labor.
(iv)The gestational age of the fetus is greater than 370/7 weeks and less than 420/7 completed weeks of pregnancy at the onset of labor.
(v)Labor is spontaneous or induced in an outpatient setting.
(B)If a potential certified nurse-midwife client meets the conditions specified in subclauses (I) and (II) of clause (i) and clauses (ii) to (v), inclusive, of subparagraph (A), but fails to meet the condition specified in subclause (III) of clause (i) of subparagraph (A), and the woman still desires to be a client of the certified nurse-midwife, the certified nurse-midwife shall provide the woman with a referral for an examination by a physician and surgeon trained in obstetrics and gynecology. A certified nurse-midwife may assist the woman in pregnancy and childbirth only if an examination by a physician and surgeon trained in obstetrics and gynecology is obtained and, based upon review of the clients medical file, the certified nurse-midwife determines that the risk factors presented by the womans condition do not increase the womans risk beyond that of a normal, low-risk pregnancy and birth. The certified nurse-midwife may continue care of the client during a reasonable interval between the referral and the initial appointment with the physician and surgeon.
(c)An entity described in subdivision (b) shall not interfere with, control, or otherwise direct the professional judgment of a certified nurse-midwife functioning pursuant to this section in a manner prohibited by Section 510 or any other law.
(c)
(d)As used in this chapter, the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the patient and the resources and medical personnel available in the setting of care. The practice of nurse-midwifery care emphasizes informed consent, preventive care, and early detection and referral of complications to physicians and surgeons. While practicing in a hospital setting, the certified nurse-midwife shall collaboratively care for women with more complex health needs.
(d)
(e)A certified nurse-midwife practicing under subdivision (a) shall be subject to all credentialing and quality standards held by the facility in which he or she practices. The peer review body shall include nurse-midwives as part of the peer review body that reviews nurse-midwives. The peer review body of that facility shall impose standards that ensure quality and patient safety in their facility. The standards shall be approved by the relevant governing body unless found by a court to be arbitrary and capricious.
(e)
(f)The practice of nurse-midwifery does not include the assisting of childbirth by any forcible or mechanical means or the performance of a version.
(f)
(g)A certified nurse-midwife is not authorized to practice medicine and surgery by the provisions of this chapter.
(g)
(h)Any regulations promulgated by a state department that affect the scope of practice of a certified nurse-midwife shall be developed in consultation with the board and the Nurse-Midwifery Advisory Committee.
SEC. 6.SEC. 7.Section 2746.51 of the Business and Professions Code is amended to read:2746.51.(a)Neither this chapter nor any other law shall be construed to prohibit a certified nurse-midwife from furnishing or ordering drugs or devices, including controlled substances classified in Schedule II, III, IV, or V under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code), when the drugs or devices are furnished or ordered related to the provision of any of the following:
(1)Family planning services, as defined in Section 14503 of the Welfare and Institutions Code.
(2)Routine health care or perinatal care, as defined in subdivision (d) of Section 123485 of the Health and Safety Code.
(3)Care rendered, consistent with the certified nurse-midwifes educational preparation or for which clinical competency has been established and maintained, to persons within a facility specified in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the Health and Safety Code, a clinic as specified in Section 1204 of the Health and Safety Code, a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code, a licensed birth center as defined in Section 1204.3 of the Health and Safety Code, or a special hospital specified as a maternity hospital in subdivision (f) of Section 1250 of the Health and Safety Code.
(4)Care rendered in a home pursuant to subdivision (a) of Section 2746.5.
(b)(1)The furnishing or ordering of drugs or devices by a certified nurse-midwife is conditional on the issuance by the board of a number to the applicant who has successfully completed the requirements of paragraph (2). The number shall be included on all transmittals of orders for drugs or devices by the certified nurse-midwife. The board shall maintain a list of the certified nurse-midwives that it has certified pursuant to this paragraph and the number it has issued to each one. The board shall make the list available to the California State Board of Pharmacy upon its request. Every certified nurse-midwife who is authorized pursuant to this section to furnish or issue a drug order for a controlled substance shall register with the United States Drug Enforcement Administration.
(2)The board has certified in accordance with paragraph (1) that the certified nurse-midwife has satisfactorily completed a course in pharmacology covering the drugs or devices to be furnished or ordered under this section. The board shall establish the requirements for satisfactory completion of this paragraph.
(3)Certified nurse-midwives who are certified by the board and hold an active furnishing number, who are currently authorized to furnish Schedule II controlled substances, and who are registered with the United States Drug Enforcement Administration shall provide documentation of continuing education specific to the use of Schedule II controlled substances in settings other than a hospital based on standards developed by the board.
(c)Drugs or devices furnished or ordered by a certified nurse-midwife may include Schedule II controlled substances under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code) when the drugs and devices are furnished or ordered in accordance with requirements referenced in paragraphs (1) to (3), inclusive, of subdivision (b). In a nonhospital setting, a Schedule II controlled substance shall be furnished by a certified nurse-midwife only during labor and delivery and only after a consultation with a physician and surgeon.
(d)Furnishing of drugs or devices by a certified nurse-midwife means the act of making a pharmaceutical agent or agents available to the patient.
(e)Drug order or order for purposes of this section means an order for medication or for a drug or device that is dispensed to or for an ultimate user, issued by a certified nurse-midwife as an individual practitioner, within the meaning of Section 1306.03 of Title 21 of the Code of Federal Regulations. Notwithstanding any other law, (1) a drug order issued pursuant to this section shall be treated in the same manner as a prescription of a physician; (2) all references to prescription in this code and the Health and Safety Code shall include drug orders issued by certified nurse-midwives; and (3) the signature of a certified nurse-midwife on a drug order issued in accordance with this section shall be deemed to be the signature of a prescriber for purposes of this code and the Health and Safety Code.
(f)A certified nurse-midwife is authorized to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and consistent with nurse-midwifery education preparation.
SEC. 7.SEC. 8.Section 2746.52 of the Business and Professions Code is amended to read:2746.52.(a)Notwithstanding Section 2746.5, the certificate to practice nurse-midwifery authorizes the holder to perform and repair episiotomies, and to repair first-degree and second-degree lacerations of the perineum, in a licensed acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, in a licensed alternate birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, or a nationally accredited birth center, and in a home pursuant to paragraph (7) of subdivision (b) of Section 2746.5.
(b)The certified nurse-midwife performing and repairing first-degree and second-degree lacerations of the perineum shall do both of the following:
(1)Ensure that all complications are referred to a physician and surgeon immediately.
(2)Ensure immediate care of patients who are in need of care beyond the scope of practice of the certified nurse-midwife, or provide emergency care for times when a physician and surgeon is not available.
SEC. 8.SEC. 9.Section 2746.6 is added to the Business and Professions Code, to read:2746.6.A consultative relationship between a certified nurse-midwife and a physician and surgeon shall not, by itself, provide the basis for finding a physician and surgeon liable for any act or omission of the certified nurse-midwife.
SEC. 9.SEC. 10.Section 4061 of the Business and Professions Code is amended to read:4061.(a)A manufacturers sales representative shall not distribute any dangerous drug or dangerous device as a complimentary sample without the written request of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7. However, a certified nurse-midwife who functions pursuant to Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to a protocol described in Section 3502.1, or a naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, may sign for the request and receipt of complimentary samples of a dangerous drug or dangerous device that has been identified in the standardized procedure, protocol, or practice agreement. Standardized procedures, protocols, and practice agreements shall include specific approval by a physician. A review process, consistent with the requirements of Section 2725, 3502.1, or 3640.5, of the complimentary samples requested and received by a nurse practitioner, certified nurse-midwife, physician assistant, or naturopathic doctor, shall be defined within the standardized procedure, protocol, or practice agreement.
(b)Each written request shall contain the names and addresses of the supplier and the requester, the name and quantity of the specific dangerous drug desired, the name of the certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor, if applicable, receiving the samples pursuant to this section, the date of receipt, and the name and quantity of the dangerous drugs or dangerous devices provided. These records shall be preserved by the supplier with the records required by Section 4059.
(c)Nothing in this section is intended to expand the scope of practice of a certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor.
SEC. 10.Section 4076 of the Business and Professions Code is amended to read:4076.(a)A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)Except when the prescriber or the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturers trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturers trade name or the commonly used name or the principal active ingredients.
(2)The directions for the use of the drug.
(3)The name of the patient or patients.
(4)The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)The date of issue.
(6)The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)The strength of the drug or drugs dispensed.
(8)The quantity of the drug or drugs dispensed.
(9)The expiration date of the effectiveness of the drug dispensed.
(10)The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)(A)Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)Prescriptions dispensed by a veterinarian.
(ii)An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)Dispensed medications for which no physical description exists in any commercially available database.
(B)This paragraph applies to outpatient pharmacies only.
(C)The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice.
SEC. 11.Section 4076 of the Business and Professions Code is amended to read:4076.(a)A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)Except when the prescriber or the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturers trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturers trade name or the commonly used name or the principal active ingredients.
(2)The directions for the use of the drug.
(3)The name of the patient or patients.
(4)The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)The date of issue.
(6)The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)The strength of the drug or drugs dispensed.
(8)The quantity of the drug or drugs dispensed.
(9)The expiration date of the effectiveness of the drug dispensed.
(10)The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)(A)Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)Prescriptions dispensed by a veterinarian.
(ii)An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)Dispensed medications for which no physical description exists in any commercially available database.
(B)This paragraph applies to outpatient pharmacies only.
(C)The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice.
(e)A pharmacist shall use professional judgment to provide a patient with directions for use that enhance the patients understanding of those directions, consistent with the prescribers instructions.
SEC. 11.SEC. 12.Section 4170 of the Business and Professions Code is amended to read:4170.(a)A prescriber shall not dispense drugs or dangerous devices to patients in his or her office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant.
(2)The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient.
(3)The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons.
(4)The prescriber fulfills all of the labeling requirements imposed upon pharmacists by Section 4076, all of the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers.
(5)The prescriber does not use a dispensing device unless he or she personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded in accordance with paragraph (4).
(6)The prescriber, prior to dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy.
(7)The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patients choice.
(8)A certified nurse-midwife who functions pursuant to Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to Section 3502.1, or a naturopathic doctor who functions pursuant to Section 3640.5, may hand to a patient of the supervising physician and surgeon, if applicable, a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist.
(b)The Medical Board of California, the State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, the Veterinary Medical Board, and the Physician Assistant Committee shall have authority with the California State Board of Pharmacy to ensure compliance with this section, and those boards are specifically charged with the enforcement of this chapter with respect to their respective licensees.
(c)Prescriber, as used in this section, means a person, who holds a physicians and surgeons certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, or a certificate to practice podiatry, and who is duly registered by the Medical Board of California, the State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, or the Board of Osteopathic Examiners of this state.
SEC. 12.SEC. 13.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)Notwithstanding Section 650, or any other law, it is unlawful for a licensee to refer a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the licensee or his or her immediate family has a financial interest with the person or in the entity that receives the referral.
(b)For purposes of this section and Section 650.02, the following shall apply:
(1)Diagnostic imaging includes, but is not limited to, all X-ray, computed axial tomography, magnetic resonance imaging nuclear medicine, positron emission tomography, mammography, and ultrasound goods and services.
(2)A financial interest includes, but is not limited to, any type of ownership interest, debt, loan, lease, compensation, remuneration, discount, rebate, refund, dividend, distribution, subsidy, or other form of direct or indirect payment, whether in money or otherwise, between a licensee and a person or entity to whom the licensee refers a person for a good or service specified in subdivision (a). A financial interest also exists if there is an indirect financial relationship between a licensee and the referral recipient including, but not limited to, an arrangement whereby a licensee has an ownership interest in an entity that leases property to the referral recipient. Any financial interest transferred by a licensee to any person or entity or otherwise established in any person or entity for the purpose of avoiding the prohibition of this section shall be deemed a financial interest of the licensee. For purposes of this paragraph, direct or indirect payment shall not include a royalty or consulting fee received by a physician and surgeon who has completed a recognized residency training program in orthopedics from a manufacturer or distributor as a result of his or her research and development of medical devices and techniques for that manufacturer or distributor. For purposes of this paragraph, consulting fees means those fees paid by the manufacturer or distributor to a physician and surgeon who has completed a recognized residency training program in orthopedics only for his or her ongoing services in making refinements to his or her medical devices or techniques marketed or distributed by the manufacturer or distributor, if the manufacturer or distributor does not own or control the facility to which the physician is referring the patient. A financial interest shall not include the receipt of capitation payments or other fixed amounts that are prepaid in exchange for a promise of a licensee to provide specified health care services to specified beneficiaries. A financial interest shall not include the receipt of remuneration by a medical director of a hospice, as defined in Section 1746 of the Health and Safety Code, for specified services if the arrangement is set out in writing, and specifies all services to be provided by the medical director, the term of the arrangement is for at least one year, and the compensation to be paid over the term of the arrangement is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between parties.
(3)For the purposes of this section, immediate family includes the spouse and children of the licensee, the parents of the licensee, and the spouses of the children of the licensee.
(4)Licensee means a physician as defined in Section 3209.3 of the Labor Code, and a certified nurse-midwife as defined in Article 2.5 (commencing with Section 2746) of Chapter 6 of Division 2 of the Business and Professions Code.
(5)Licensees office means either of the following:
(A)An office of a licensee in solo practice.
(B)An office in which services or goods are personally provided by the licensee or by employees in that office, or personally by independent contractors in that office, in accordance with other provisions of law. Employees and independent contractors shall be licensed or certified when licensure or certification is required by law.
(6)Office of a group practice means an office or offices in which two or more licensees are legally organized as a partnership, professional corporation, or not-for-profit corporation, licensed pursuant to subdivision (a) of Section 1204 of the Health and Safety Code, for which all of the following apply:
(A)Each licensee who is a member of the group provides substantially the full range of services that the licensee routinely provides, including medical care, consultation, diagnosis, or treatment through the joint use of shared office space, facilities, equipment, and personnel.
(B)Substantially all of the services of the licensees who are members of the group are provided through the group and are billed in the name of the group and amounts so received are treated as receipts of the group, except in the case of a multispecialty clinic, as defined in subdivision (l) of Section 1206 of the Health and Safety Code, physician services are billed in the name of the multispecialty clinic and amounts so received are treated as receipts of the multispecialty clinic.
(C)The overhead expenses of, and the income from, the practice are distributed in accordance with methods previously determined by members of the group.
(c)It is unlawful for a licensee to enter into an arrangement or scheme, such as a cross-referral arrangement, that the licensee knows, or should know, has a principal purpose of ensuring referrals by the licensee to a particular entity that, if the licensee directly made referrals to that entity, would be in violation of this section.
(d)No claim for payment shall be presented by an entity to any individual, third party payer, or other entity for a good or service furnished pursuant to a referral prohibited under this section.
(e)No insurer, self-insurer, or other payer shall pay a charge or lien for any good or service resulting from a referral in violation of this section.
(f)A licensee who refers a person to, or seeks consultation from, an organization in which the licensee has a financial interest, other than as prohibited by subdivision (a), shall disclose the financial interest to the patient, or the parent or legal guardian of the patient, in writing, at the time of the referral or request for consultation.
(1)If a referral, billing, or other solicitation is between one or more licensees who contract with a multispecialty clinic pursuant to subdivision (l) of Section 1206 of the Health and Safety Code or who conduct their practice as members of the same professional corporation or partnership, and the services are rendered on the same physical premises, or under the same professional corporation or partnership name, the requirements of this subdivision may be met by posting a conspicuous disclosure statement at the registration area or by providing a patient with a written disclosure statement.
(2)If a licensee is under contract with the Department of Corrections or the California Youth Authority, and the patient is an inmate or parolee of either respective department, the requirements of this subdivision shall be satisfied by disclosing financial interests to either the Department of Corrections or the California Youth Authority.
(g)A violation of subdivision (a) shall be a misdemeanor. In the case of a licensee who is a physician, the Medical Board of California shall review the facts and circumstances of any conviction pursuant to subdivision (a) and take appropriate disciplinary action if the licensee has committed unprofessional conduct. In the case of a licensee who is a certified nurse-midwife, the Board of Registered Nursing shall review the facts and circumstances of any conviction pursuant to subdivision (a) and take appropriate disciplinary action if the licensee has committed unprofessional conduct. Violations of this section may also be subject to civil penalties of up to five thousand dollars ($5,000) for each offense, which may be enforced by the Insurance Commissioner, Attorney General, or a district attorney. A violation of subdivision (c), (d), or (e) is a public offense and is punishable upon conviction by a fine not exceeding fifteen thousand dollars ($15,000) for each violation and appropriate disciplinary action, including revocation of professional licensure, by the Medical Board of California, the Board of Registered Nursing, or other appropriate governmental agency.
(h)This section shall not apply to referrals for services that are described in and covered by Sections 139.3 and 139.31 of the Labor Code.
(i)This section shall become operative on January 1, 1995.
SEC. 2.Section 650.02 of the Business and Professions Code is amended to read:650.02.The prohibition of Section 650.01 shall not apply to or restrict any of the following:
(a)A licensee may refer a patient for a good or service otherwise prohibited by subdivision (a) of Section 650.01 if the licensees regular practice is located where there is no alternative provider of the service within either 25 miles or 40 minutes traveling time, via the shortest route on a paved road. If an alternative provider commences furnishing the good or service for which a patient was referred pursuant to this subdivision, the licensee shall cease referrals under this subdivision within six months of the time at which the licensee knew or should have known that the alternative provider is furnishing the good or service. A licensee who refers to or seeks consultation from an organization in which the licensee has a financial interest under this subdivision shall disclose this interest to the patient or the patients parents or legal guardian in writing at the time of referral.
(b)A licensee, when the licensee or his or her immediate family has one or more of the following arrangements with another licensee, a person, or an entity, is not prohibited from referring a patient to the licensee, person, or entity because of the arrangement:
(1)A loan between a licensee and the recipient of the referral, if the loan has commercially reasonable terms, bears interest at the prime rate or a higher rate that does not constitute usury, is adequately secured, and the loan terms are not affected by either partys referral of any person or the volume of services provided by either party.
(2)A lease of space or equipment between a licensee and the recipient of the referral, if the lease is written, has commercially reasonable terms, has a fixed periodic rent payment, has a term of one year or more, and the lease payments are not affected by either partys referral of any person or the volume of services provided by either party.
(3)Ownership of corporate investment securities, including shares, bonds, or other debt instruments that may be purchased on terms generally available to the public and that are traded on a licensed securities exchange or NASDAQ, do not base profit distributions or other transfers of value on the licensees referral of persons to the corporation, do not have a separate class or accounting for any persons or for any licensees who may refer persons to the corporation, and are in a corporation that had, at the end of the corporations most recent fiscal year, or on average during the previous three fiscal years, stockholder equity exceeding seventy-five million dollars ($75,000,000).
(4)Ownership of shares in a regulated investment company as defined in Section 851(a) of the federal Internal Revenue Code, if the company had, at the end of the companys most recent fiscal year, or on average during the previous three fiscal years, total assets exceeding seventy-five million dollars ($75,000,000).
(5)A one-time sale or transfer of a practice or property or other financial interest between a licensee and the recipient of the referral if the sale or transfer is for commercially reasonable terms and the consideration is not affected by either partys referral of any person or the volume of services provided by either party.
(6)A personal services arrangement between a licensee or an immediate family member of the licensee and the recipient of the referral if the arrangement meets all of the following requirements:
(A)It is set out in writing and is signed by the parties.
(B)It specifies all of the services to be provided by the licensee or an immediate family member of the licensee.
(C)The aggregate services contracted for do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement.
(D)A person who is referred by a licensee or an immediate family member of the licensee is informed in writing of the personal services arrangement that includes information on where a person may go to file a complaint against the licensee or the immediate family member of the licensee.
(E)The term of the arrangement is for at least one year.
(F)The compensation to be paid over the term of the arrangement is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties.
(G)The services to be performed under the arrangement do not involve the counseling or promotion of a business arrangement or other activity that violates any state or federal law.
(c)(1)A licensee may refer a person to a health facility, as defined in Section 1250 of the Health and Safety Code, a licensed alternative birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, or to any facility, or nationally accredited alternative birth center, owned or leased by a health facility, if the recipient of the referral does not compensate the licensee for the patient referral, and any equipment lease arrangement between the licensee and the referral recipient complies with the requirements of paragraph (2) of subdivision (b).
(2)Nothing shall preclude this subdivision from applying to a licensee solely because the licensee has an ownership or leasehold interest in an entire health facility or an entity that owns or leases an entire health facility.
(3)A licensee may refer a person to a health facility for any service classified as an emergency under subdivision (a) or (b) of Section 1317.1 of the Health and Safety Code.
(4)A licensee may refer a person to any organization that owns or leases a health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 of the Health and Safety Code if the licensee is not compensated for the patient referral, the licensee does not receive any payment from the recipient of the referral that is based or determined on the number or value of any patient referrals, and any equipment lease arrangement between the licensee and the referral recipient complies with the requirements of paragraph (2) of subdivision (b). For purposes of this paragraph, the ownership may be through stock or membership, and may be represented by a parent holding company that solely owns or controls both the health facility organization and the affiliated organization.
(d)A licensee may refer a person to a nonprofit corporation that provides physician services pursuant to subdivision (l) of Section 1206 of the Health and Safety Code if the nonprofit corporation is controlled through membership by one or more health facilities or health facility systems and the amount of compensation or other transfer of funds from the health facility or nonprofit corporation to the licensee is fixed annually, except for adjustments caused by physicians joining or leaving the groups during the year, and is not based on the number of persons utilizing goods or services specified in Section 650.01.
(e)A licensee compensated or employed by a university may refer a person for a physician service, to any facility owned or operated by the university, or to another licensee employed by the university, provided that the facility or university does not compensate the referring licensee for the patient referral. In the case of a facility that is totally or partially owned by an entity other than the university, but that is staffed by university physicians, those physicians may not refer patients to the facility if the facility compensates the referring physicians for those referrals.
(f)The prohibition of Section 650.01 shall not apply to any service for a specific patient that is performed within, or goods that are supplied by, a licensees office, or the office of a group practice. Further, the provisions of Section 650.01 shall not alter, limit, or expand a licensees ability to deliver, or to direct or supervise the delivery of, in-office goods or services according to the laws, rules, and regulations governing his or her scope of practice.
(g)The prohibition of Section 650.01 shall not apply to cardiac rehabilitation services provided by a licensee or by a suitably trained individual under the direct or general supervision of a licensee, if the services are provided to patients meeting the criteria for Medicare reimbursement for the services.
(h)The prohibition of Section 650.01 shall not apply if a licensee is in the office of a group practice and refers a person for services or goods specified in Section 650.01 to a multispecialty clinic, as defined in subdivision (l) of Section 1206 of the Health and Safety Code.
(i)The prohibition of Section 650.01 shall not apply to health care services provided to an enrollee of a health care service plan licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).
(j)The prohibition of Section 650.01 shall not apply to a request by a pathologist for clinical diagnostic laboratory tests and pathological examination services, a request by a radiologist for diagnostic radiology services, or a request by a radiation oncologist for radiation therapy if those services are furnished by, or under the supervision of, the pathologist, radiologist, or radiation oncologist pursuant to a consultation requested by another physician.
(k)This section shall not apply to referrals for services that are described in and covered by Sections 139.3 and 139.31 of the Labor Code.
(l)This section shall become operative on January 1, 1995.
SEC. 3.Section 2725.1 of the Business and Professions Code is amended to read:2725.1.(a)Notwithstanding any other law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon or an order by a certified nurse-midwife, nurse practitioner, or physician assistant issued pursuant to Section 2746.51, 2836.1, or 3502.1, respectively, if the registered nurse is functioning within a licensed primary care clinic as defined in subdivision (a) of Section 1204 of, or within a clinic as defined in subdivision (b), (c), (h), or (j) of Section 1206 of, the Health and Safety Code.
(b)No clinic shall employ a registered nurse to perform dispensing duties exclusively. No registered nurse shall dispense drugs in a pharmacy, keep a pharmacy, open shop, or drugstore for the retailing of drugs or poisons. No registered nurse shall compound drugs. Dispensing of drugs by a registered nurse, except a certified nurse-midwife who functions pursuant to Section 2746.51 or a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, shall not include substances included in the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code). Nothing in this section shall exempt a clinic from the provisions of Article 13 (commencing with Section 4180) of Chapter 9.
(c)This section shall not be construed to limit any other authority granted to a certified nurse-midwife pursuant to Article 2.5 (commencing with Section 2746), to a nurse practitioner pursuant to Article 8 (commencing with Section 2834), or to a physician assistant pursuant to Chapter 7.7 (commencing with Section 3500).
(d)This section shall not be construed to affect the sites or types of health care facilities at which drugs or devices are authorized to be dispensed pursuant to Chapter 9 (commencing with Section 4000).
SEC. 4.Section 2746.2 of the Business and Professions Code is amended to read:2746.2.(a)Each applicant shall show by evidence satisfactory to the board that he or she has met the educational standards established by the board or has at least the equivalent thereof, including evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board.
(b)The board shall create and appoint a Nurse-Midwifery Advisory Council Committee consisting of certified nurse-midwives in good standing with experience in hospital settings, alternative birth center settings, and home settings, a nurse-midwife educator who has demonstrated familiarity with educational standards in the delivery of maternal-child health care, a consumer of midwifery care, and at least two qualified physicians appointed by the Medical Board of California, physicians, including an obstetrician that has experience working with nurse-midwives. The council committee membership shall consist of a majority of certified nurse-midwives and shall make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters as specified by the board. The council committee shall meet regularly, but at least twice a year.
(c)Corporations and other artificial legal entities shall have no professional rights, privileges, or powers. However, the Board of Registered Nursing may in its discretion, after such investigation and review of such documentary evidence as it may require, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic.
(d)Notwithstanding subdivision (c), the following entities may employ a certified nurse-midwife and charge for professional services rendered by a certified nurse-midwife; however, the entity shall not interfere with, control, or otherwise direct the professional judgment of a certified nurse-midwife:
(1)A clinic operated under subdivision (h) or (p) of Section 1206 of the Health and Safety Code.
(2)A hospital owned and operated by a health care district pursuant to Division 23 (commencing with Section 32000) of the Health and Safety Code.
(3)A clinic operated primarily for the purpose of medical education or nursing education by a public or private nonprofit university medical school, which is approved by the Medical Board or the Osteopathic Medical Board of California, provided the certified nurse-midwife holds an academic appointment on the faculty of the university, including, but not limited to, the University of California medical schools and hospitals.
(4)A licensed alternative birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, or a nationally accredited alternative birth center owned or operated by a nursing corporation, as defined in Section 2775 of the Business and Professions Code.
(5)A health facility described in Section 1250 of the Health and Safety Code if the certified-nurse midwife is practicing under the supervision of a physician and surgeon.
(6)A clinic operated under subdivision (a) of Section 1204 of the Health and Safety code.
(e)As used in this section, supervision shall not be construed to require the physical presence of a supervising physician and surgeon. A facility described in paragraphs (1) to (4), inclusive, of subdivision (d) that employs a certified-nurse midwife shall not require supervision by a physician and surgeon of the certified-nurse midwife.
SEC. 5.Section 2746.5 of the Business and Professions Code is amended to read:2746.5.(a)The certificate to practice nurse-midwifery authorizes the holder to manage a full range of primary gynecological and obstetric care services for women from adolescence to beyond menopause, consistent with the Core Competencies for Basic Midwifery practice promulgated by the American College of Nurse-Midwives, or its successor national professional organization, as approved by the board. These services include, but are not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, immediate care of the newborn, and treatment of male partners for sexually transmitted infections, utilizing consultation, collaboration, or referral to appropriate levels of health care services, as indicated.
(b)A certified nurse-midwife may practice in the following settings:
(1)A licensed clinic as described in Chapter 1 (commencing with Section 1200) of Division 2 of the Health and Safety Code.
(2)A facility as described in Chapter 2 (commencing with Section 1250) of Division 2 of the Health and Safety Code.
(3)A facility as described in Chapter 2.5 (commencing with Section 1440) of Division 2 of the Health and Safety Code.
(4)A medical group practice, including a professional medical corporation, a medical partnership, a medical foundation exempt from licensure pursuant to Section 1206 of the Health and Safety Code, or another lawfully organized group of physicians that delivers, furnishes, or otherwise arranges for or provides health care services.
(5)A licensed alternative birth center, as described in Section 1204 of the Health and Safety Code, or nationally accredited birth center.
(6)A nursing corporation, as defined in Section 2775 of the Business and Professions Code.
(7)A home setting.
(A)Except as provided in subparagraph (B) of this paragraph, (B), a certified nurse-midwife shall assist only attend during normal, low-risk pregnancy and childbirth in the home setting only when all of the following conditions apply:
(i)There is the absence of all of the following:
(I)Any preexisting maternal disease or condition likely to complicate the pregnancy. creating risks beyond that of a normal, low-risk pregnancy or birth, as defined in the American College of Nurse-Midwives standard-setting documents and any future changes to those documents.
(II)Disease arising from or during the pregnancy likely to cause significant maternal and/or fetal compromise. creating risks beyond that of a normal, low-risk pregnancy or birth, as defined in the American College of Nurse-Midwives standard-setting documents and any future changes to those documents.
(III)Prior caesarean delivery.
(ii)There is a singleton fetus.
(iii)There is cephalic presentation at the onset of labor.
(iv)The gestational age of the fetus is greater than 370/7 weeks and less than 420/7 completed weeks of pregnancy at the onset of labor.
(v)Labor is spontaneous or induced in an outpatient setting.
(B)If a potential certified nurse-midwife client meets the conditions specified in subclauses (I) and (II) of clause (i) and clauses (ii) to (v), inclusive, of subparagraph (A), but fails to meet the conditions condition specified in subclause (III) of clause (i) of subparagraph (A), and the woman still desires to be a client of the certified nurse-midwife, the certified nurse-midwife shall consult with provide the woman with a referral for an examination by a physician and surgeon trained in obstetrics and gynecology. A certified nurse-midwife may assist the woman in pregnancy and childbirth only if an examination by a physician and surgeon trained in obstetrics and gynecology is consulted and the physician and surgeon who performed the consultation determines that the risk factors presented by her disease or condition are not likely to significantly affect the course of pregnancy and childbirth. obtained and, based upon review of the clients medical file, the certified nurse-midwife determines that the risk factors presented by the womans condition do not increase the womans risk beyond that of a normal, low-risk pregnancy and birth. The certified nurse-midwife may continue care of the client during a reasonable interval between the referral and the initial appointment with the physician and surgeon.
(c)As used in this chapter, the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the patient and the resources and medical personnel available in the setting of care. The practice of nurse-midwifery care emphasizes informed consent, preventive care, and early detection and referral of complications to physicians and surgeons. While practicing in a hospital setting, the certified nurse-midwife shall collaboratively care for women with more complex health needs.
(d)A certified nurse-midwife practicing under subdivision (a) shall be subject to all credentialing and quality standards held by the facility in which he or she practices. The peer review body shall include nurse-midwives as part of the peer review body that reviews nurse-midwives. The peer review body of that facility shall impose standards that assure ensure quality and patient safety in their facility. The standards shall be approved by the relevant governing body unless found by a court to be arbitrary and capricious.
(e)The practice of nurse-midwifery does not include the assisting of childbirth by any forcible, forcible or mechanical means, nor means or the performance of any version of those means. a version.
(f)A certified nurse-midwife is not authorized to practice medicine and surgery by the provisions of this chapter.
(g)Any regulations promulgated by a state department that affect the scope of practice of a certified nurse-midwife shall be developed in consultation with the board and the Nurse-Midwifery Advisory Council. Committee.
SEC. 6.Section 2746.51 of the Business and Professions Code is amended to read:2746.51.(a)Neither this chapter nor any other law shall be construed to prohibit a certified nurse-midwife from furnishing or ordering drugs or devices, including controlled substances classified in Schedule II, III, IV, or V under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code), when the drugs or devices are furnished or ordered related to the provision of any of the following:
(1)Family planning services, as defined in Section 14503 of the Welfare and Institutions Code.
(2)Routine health care or perinatal care, as defined in subdivision (d) of Section 123485 of the Health and Safety Code.
(3)Care rendered, consistent with the certified nurse-midwifes educational preparation or for which clinical competency has been established and maintained, to persons within a facility specified in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the Health and Safety Code, a clinic as specified in Section 1204 of the Health and Safety Code, a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code, a licensed birth center as defined in Section 1204.3 of the Health and Safety Code, or a special hospital specified as a maternity hospital in subdivision (f) of Section 1250 of the Health and Safety Code.
(4)Care rendered in a home pursuant to subdivision (a) of Section 2746.5.
(b)(1)The furnishing or ordering of drugs or devices by a certified nurse-midwife is conditional on the issuance by the board of a number to the applicant who has successfully completed the requirements of paragraph (2). The number shall be included on all transmittals of orders for drugs or devices by the certified nurse-midwife. The board shall maintain a list of the certified nurse-midwives that it has certified pursuant to this paragraph and the number it has issued to each one. The board shall make the list available to the California State Board of Pharmacy upon its request. Every certified nurse-midwife who is authorized pursuant to this section to furnish or issue a drug order for a controlled substance shall register with the United States Drug Enforcement Administration.
(2)The board has certified in accordance with paragraph (1) that the certified nurse-midwife has satisfactorily completed a course in pharmacology covering the drugs or devices to be furnished or ordered under this section. The board shall establish the requirements for satisfactory completion of this paragraph.
(3)Certified nurse-midwives who are certified by the board and hold an active furnishing number, who are currently authorized to furnish Schedule II controlled substances, and who are registered with the United States Drug Enforcement Administration shall provide documentation of continuing education specific to the use of Schedule II controlled substances in settings other than a hospital based on standards developed by the board.
(c)Drugs or devices furnished or ordered by a certified nurse-midwife may include Schedule II controlled substances under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code) when the drugs and devices are furnished or ordered in accordance with requirements referenced in paragraphs (1) to (3), inclusive, of subdivision (b). In a nonhospital setting, a Schedule II controlled substance shall be furnished by a certified nurse-midwife only during labor and delivery and only after a consultation with a physician and surgeon.
(d)Furnishing of drugs or devices by a certified nurse-midwife means the act of making a pharmaceutical agent or agents available to the patient.
(e)Drug order or order for purposes of this section means an order for medication or for a drug or device that is dispensed to or for an ultimate user, issued by a certified nurse-midwife as an individual practitioner, within the meaning of Section 1306.03 of Title 21 of the Code of Federal Regulations. Notwithstanding any other law, (1) a drug order issued pursuant to this section shall be treated in the same manner as a prescription of a physician; (2) all references to prescription in this code and the Health and Safety Code shall include drug orders issued by certified nurse-midwives; and (3) the signature of a certified nurse-midwife on a drug order issued in accordance with this section shall be deemed to be the signature of a prescriber for purposes of this code and the Health and Safety Code.
(f)A certified nurse-midwife is authorized to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and consistent with nurse-midwifery education preparation.
SEC. 7.Section 2746.52 of the Business and Professions Code is amended to read:2746.52.(a)Notwithstanding Section 2746.5, the certificate to practice nurse-midwifery authorizes the holder to perform and repair episiotomies, and to repair first-degree and second-degree lacerations of the perineum, in a licensed acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, in a licensed alternate birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, or a nationally accredited birth center, and in a home pursuant to paragraph (7) of subdivision (b) of Section 2746.5.
(b)The certified nurse-midwife performing and repairing first-degree and second-degree lacerations of the perineum shall do both of the following:
(1)Ensure that all complications are referred to a physician and surgeon immediately.
(2)Ensure immediate care of patients who are in need of care beyond the scope of practice of the certified nurse-midwife, or provide emergency care for times when a physician and surgeon is not available.
SEC. 8.Section 2746.6 is added to the Business and Professions Code, to read:2746.6.A consultative relationship between a certified nurse-midwife and a physician and surgeon shall not, by itself, provide the basis for finding a physician and surgeon liable for any act or omission of the certified nurse-midwife.
SEC. 9.Section 4061 of the Business and Professions Code is amended to read:4061.(a)A manufacturers sales representative shall not distribute any dangerous drug or dangerous device as a complimentary sample without the written request of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7. However, a certified nurse-midwife who functions pursuant to Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to a protocol described in Section 3502.1, or a naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, may sign for the request and receipt of complimentary samples of a dangerous drug or dangerous device that has been identified in the standardized procedure, protocol, or practice agreement. Standardized procedures, protocols, and practice agreements shall include specific approval by a physician. A review process, consistent with the requirements of Section 2725, 3502.1, or 3640.5, of the complimentary samples requested and received by a nurse practitioner, certified nurse-midwife, physician assistant, or naturopathic doctor, shall be defined within the standardized procedure, protocol, or practice agreement.
(b)Each written request shall contain the names and addresses of the supplier and the requester, the name and quantity of the specific dangerous drug desired, the name of the certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor, if applicable, receiving the samples pursuant to this section, the date of receipt, and the name and quantity of the dangerous drugs or dangerous devices provided. These records shall be preserved by the supplier with the records required by Section 4059.
(c)Nothing in this section is intended to expand the scope of practice of a certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor.
SEC. 10.Section 4076 of the Business and Professions Code is amended to read:4076.(a)A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)Except when the prescriber or the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturers trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturers trade name or the commonly used name or the principal active ingredients.
(2)The directions for the use of the drug.
(3)The name of the patient or patients.
(4)The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)The date of issue.
(6)The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)The strength of the drug or drugs dispensed.
(8)The quantity of the drug or drugs dispensed.
(9)The expiration date of the effectiveness of the drug dispensed.
(10)The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)(A)Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)Prescriptions dispensed by a veterinarian.
(ii)An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)Dispensed medications for which no physical description exists in any commercially available database.
(B)This paragraph applies to outpatient pharmacies only.
(C)The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice.
SEC. 11.Section 4170 of the Business and Professions Code is amended to read:4170.(a)A prescriber shall not dispense drugs or dangerous devices to patients in his or her office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant.
(2)The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient.
(3)The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons.
(4)The prescriber fulfills all of the labeling requirements imposed upon pharmacists by Section 4076, all of the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers.
(5)The prescriber does not use a dispensing device unless he or she personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded in accordance with paragraph (4).
(6)The prescriber, prior to dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy.
(7)The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patients choice.
(8)A certified nurse-midwife who functions pursuant to Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to Section 3502.1, or a naturopathic doctor who functions pursuant to Section 3640.5, may hand to a patient of the supervising physician and surgeon, if applicable, a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist.
(b)The Medical Board of California, the State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, the Veterinary Medical Board, and the Physician Assistant Committee shall have authority with the California State Board of Pharmacy to ensure compliance with this section, and those boards are specifically charged with the enforcement of this chapter with respect to their respective licensees.
(c)Prescriber, as used in this section, means a person, who holds a physicians and surgeons certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, or a certificate to practice podiatry, and who is duly registered by the Medical Board of California, the State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, or the Board of Osteopathic Examiners of this state.
SEC. 12.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)Notwithstanding Section 650, or any other law, it is unlawful for a licensee to refer a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the licensee or his or her immediate family has a financial interest with the person or in the entity that receives the referral.
(b)For purposes of this section and Section 650.02, the following shall apply:
(1)Diagnostic imaging includes, but is not limited to, all X-ray, computed axial tomography, magnetic resonance imaging nuclear medicine, positron emission tomography, mammography, and ultrasound goods and services.
(2)A financial interest includes, but is not limited to, any type of ownership interest, debt, loan, lease, compensation, remuneration, discount, rebate, refund, dividend, distribution, subsidy, or other form of direct or indirect payment, whether in money or otherwise, between a licensee and a person or entity to whom the licensee refers a person for a good or service specified in subdivision (a). A financial interest also exists if there is an indirect financial relationship between a licensee and the referral recipient including, but not limited to, an arrangement whereby a licensee has an ownership interest in an entity that leases property to the referral recipient. Any financial interest transferred by a licensee to any person or entity or otherwise established in any person or entity for the purpose of avoiding the prohibition of this section shall be deemed a financial interest of the licensee. For purposes of this paragraph, direct or indirect payment shall not include a royalty or consulting fee received by a physician and surgeon who has completed a recognized residency training program in orthopedics from a manufacturer or distributor as a result of his or her research and development of medical devices and techniques for that manufacturer or distributor. For purposes of this paragraph, consulting fees means those fees paid by the manufacturer or distributor to a physician and surgeon who has completed a recognized residency training program in orthopedics only for his or her ongoing services in making refinements to his or her medical devices or techniques marketed or distributed by the manufacturer or distributor, if the manufacturer or distributor does not own or control the facility to which the physician is referring the patient. A financial interest shall not include the receipt of capitation payments or other fixed amounts that are prepaid in exchange for a promise of a licensee to provide specified health care services to specified beneficiaries. A financial interest shall not include the receipt of remuneration by a medical director of a hospice, as defined in Section 1746 of the Health and Safety Code, for specified services if the arrangement is set out in writing, and specifies all services to be provided by the medical director, the term of the arrangement is for at least one year, and the compensation to be paid over the term of the arrangement is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between parties.
(3)For the purposes of this section, immediate family includes the spouse and children of the licensee, the parents of the licensee, and the spouses of the children of the licensee.
(4)Licensee means a physician as defined in Section 3209.3 of the Labor Code, and a certified nurse-midwife as defined in Article 2.5 (commencing with Section 2746) of Chapter 6 of Division 2 of the Business and Professions Code.
(5)Licensees office means either of the following:
(A)An office of a licensee in solo practice.
(B)An office in which services or goods are personally provided by the licensee or by employees in that office, or personally by independent contractors in that office, in accordance with other provisions of law. Employees and independent contractors shall be licensed or certified when licensure or certification is required by law.
(6)Office of a group practice means an office or offices in which two or more licensees are legally organized as a partnership, professional corporation, or not-for-profit corporation, licensed pursuant to subdivision (a) of Section 1204 of the Health and Safety Code, for which all of the following apply:
(A)Each licensee who is a member of the group provides substantially the full range of services that the licensee routinely provides, including medical care, consultation, diagnosis, or treatment through the joint use of shared office space, facilities, equipment, and personnel.
(B)Substantially all of the services of the licensees who are members of the group are provided through the group and are billed in the name of the group and amounts so received are treated as receipts of the group, except in the case of a multispecialty clinic, as defined in subdivision (l) of Section 1206 of the Health and Safety Code, physician services are billed in the name of the multispecialty clinic and amounts so received are treated as receipts of the multispecialty clinic.
(C)The overhead expenses of, and the income from, the practice are distributed in accordance with methods previously determined by members of the group.
(c)It is unlawful for a licensee to enter into an arrangement or scheme, such as a cross-referral arrangement, that the licensee knows, or should know, has a principal purpose of ensuring referrals by the licensee to a particular entity that, if the licensee directly made referrals to that entity, would be in violation of this section.
(d)No claim for payment shall be presented by an entity to any individual, third party payer, or other entity for a good or service furnished pursuant to a referral prohibited under this section.
(e)No insurer, self-insurer, or other payer shall pay a charge or lien for any good or service resulting from a referral in violation of this section.
(f)A licensee who refers a person to, or seeks consultation from, an organization in which the licensee has a financial interest, other than as prohibited by subdivision (a), shall disclose the financial interest to the patient, or the parent or legal guardian of the patient, in writing, at the time of the referral or request for consultation.
(1)If a referral, billing, or other solicitation is between one or more licensees who contract with a multispecialty clinic pursuant to subdivision (l) of Section 1206 of the Health and Safety Code or who conduct their practice as members of the same professional corporation or partnership, and the services are rendered on the same physical premises, or under the same professional corporation or partnership name, the requirements of this subdivision may be met by posting a conspicuous disclosure statement at the registration area or by providing a patient with a written disclosure statement.
(2)If a licensee is under contract with the Department of Corrections or the California Youth Authority, and the patient is an inmate or parolee of either respective department, the requirements of this subdivision shall be satisfied by disclosing financial interests to either the Department of Corrections or the California Youth Authority.
(g)A violation of subdivision (a) shall be a misdemeanor. In the case of a licensee who is a physician, the Medical Board of California shall review the facts and circumstances of any conviction pursuant to subdivision (a) and take appropriate disciplinary action if the licensee has committed unprofessional conduct. In the case of a licensee who is a certified nurse-midwife, the Board of Registered Nursing shall review the facts and circumstances of any conviction pursuant to subdivision (a) and take appropriate disciplinary action if the licensee has committed unprofessional conduct. Violations of this section may also be subject to civil penalties of up to five thousand dollars ($5,000) for each offense, which may be enforced by the Insurance Commissioner, Attorney General, or a district attorney. A violation of subdivision (c), (d), or (e) is a public offense and is punishable upon conviction by a fine not exceeding fifteen thousand dollars ($15,000) for each violation and appropriate disciplinary action, including revocation of professional licensure, by the Medical Board of California, the Board of Registered Nursing, or other appropriate governmental agency.
(h)This section shall not apply to referrals for services that are described in and covered by Sections 139.3 and 139.31 of the Labor Code.
(i)This section shall become operative on January 1, 1995.
SEC. 2.Section 650.02 of the Business and Professions Code is amended to read:650.02.The prohibition of Section 650.01 shall not apply to or restrict any of the following:
(a)A licensee may refer a patient for a good or service otherwise prohibited by subdivision (a) of Section 650.01 if the licensees regular practice is located where there is no alternative provider of the service within either 25 miles or 40 minutes traveling time, via the shortest route on a paved road. If an alternative provider commences furnishing the good or service for which a patient was referred pursuant to this subdivision, the licensee shall cease referrals under this subdivision within six months of the time at which the licensee knew or should have known that the alternative provider is furnishing the good or service. A licensee who refers to or seeks consultation from an organization in which the licensee has a financial interest under this subdivision shall disclose this interest to the patient or the patients parents or legal guardian in writing at the time of referral.
(b)A licensee, when the licensee or his or her immediate family has one or more of the following arrangements with another licensee, a person, or an entity, is not prohibited from referring a patient to the licensee, person, or entity because of the arrangement:
(1)A loan between a licensee and the recipient of the referral, if the loan has commercially reasonable terms, bears interest at the prime rate or a higher rate that does not constitute usury, is adequately secured, and the loan terms are not affected by either partys referral of any person or the volume of services provided by either party.
(2)A lease of space or equipment between a licensee and the recipient of the referral, if the lease is written, has commercially reasonable terms, has a fixed periodic rent payment, has a term of one year or more, and the lease payments are not affected by either partys referral of any person or the volume of services provided by either party.
(3)Ownership of corporate investment securities, including shares, bonds, or other debt instruments that may be purchased on terms generally available to the public and that are traded on a licensed securities exchange or NASDAQ, do not base profit distributions or other transfers of value on the licensees referral of persons to the corporation, do not have a separate class or accounting for any persons or for any licensees who may refer persons to the corporation, and are in a corporation that had, at the end of the corporations most recent fiscal year, or on average during the previous three fiscal years, stockholder equity exceeding seventy-five million dollars ($75,000,000).
(4)Ownership of shares in a regulated investment company as defined in Section 851(a) of the federal Internal Revenue Code, if the company had, at the end of the companys most recent fiscal year, or on average during the previous three fiscal years, total assets exceeding seventy-five million dollars ($75,000,000).
(5)A one-time sale or transfer of a practice or property or other financial interest between a licensee and the recipient of the referral if the sale or transfer is for commercially reasonable terms and the consideration is not affected by either partys referral of any person or the volume of services provided by either party.
(6)A personal services arrangement between a licensee or an immediate family member of the licensee and the recipient of the referral if the arrangement meets all of the following requirements:
(A)It is set out in writing and is signed by the parties.
(B)It specifies all of the services to be provided by the licensee or an immediate family member of the licensee.
(C)The aggregate services contracted for do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement.
(D)A person who is referred by a licensee or an immediate family member of the licensee is informed in writing of the personal services arrangement that includes information on where a person may go to file a complaint against the licensee or the immediate family member of the licensee.
(E)The term of the arrangement is for at least one year.
(F)The compensation to be paid over the term of the arrangement is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties.
(G)The services to be performed under the arrangement do not involve the counseling or promotion of a business arrangement or other activity that violates any state or federal law.
(c)(1)A licensee may refer a person to a health facility, as defined in Section 1250 of the Health and Safety Code, a licensed alternative birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, or to any facility, or nationally accredited alternative birth center, owned or leased by a health facility, if the recipient of the referral does not compensate the licensee for the patient referral, and any equipment lease arrangement between the licensee and the referral recipient complies with the requirements of paragraph (2) of subdivision (b).
(2)Nothing shall preclude this subdivision from applying to a licensee solely because the licensee has an ownership or leasehold interest in an entire health facility or an entity that owns or leases an entire health facility.
(3)A licensee may refer a person to a health facility for any service classified as an emergency under subdivision (a) or (b) of Section 1317.1 of the Health and Safety Code.
(4)A licensee may refer a person to any organization that owns or leases a health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 of the Health and Safety Code if the licensee is not compensated for the patient referral, the licensee does not receive any payment from the recipient of the referral that is based or determined on the number or value of any patient referrals, and any equipment lease arrangement between the licensee and the referral recipient complies with the requirements of paragraph (2) of subdivision (b). For purposes of this paragraph, the ownership may be through stock or membership, and may be represented by a parent holding company that solely owns or controls both the health facility organization and the affiliated organization.
(d)A licensee may refer a person to a nonprofit corporation that provides physician services pursuant to subdivision (l) of Section 1206 of the Health and Safety Code if the nonprofit corporation is controlled through membership by one or more health facilities or health facility systems and the amount of compensation or other transfer of funds from the health facility or nonprofit corporation to the licensee is fixed annually, except for adjustments caused by physicians joining or leaving the groups during the year, and is not based on the number of persons utilizing goods or services specified in Section 650.01.
(e)A licensee compensated or employed by a university may refer a person for a physician service, to any facility owned or operated by the university, or to another licensee employed by the university, provided that the facility or university does not compensate the referring licensee for the patient referral. In the case of a facility that is totally or partially owned by an entity other than the university, but that is staffed by university physicians, those physicians may not refer patients to the facility if the facility compensates the referring physicians for those referrals.
(f)The prohibition of Section 650.01 shall not apply to any service for a specific patient that is performed within, or goods that are supplied by, a licensees office, or the office of a group practice. Further, the provisions of Section 650.01 shall not alter, limit, or expand a licensees ability to deliver, or to direct or supervise the delivery of, in-office goods or services according to the laws, rules, and regulations governing his or her scope of practice.
(g)The prohibition of Section 650.01 shall not apply to cardiac rehabilitation services provided by a licensee or by a suitably trained individual under the direct or general supervision of a licensee, if the services are provided to patients meeting the criteria for Medicare reimbursement for the services.
(h)The prohibition of Section 650.01 shall not apply if a licensee is in the office of a group practice and refers a person for services or goods specified in Section 650.01 to a multispecialty clinic, as defined in subdivision (l) of Section 1206 of the Health and Safety Code.
(i)The prohibition of Section 650.01 shall not apply to health care services provided to an enrollee of a health care service plan licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).
(j)The prohibition of Section 650.01 shall not apply to a request by a pathologist for clinical diagnostic laboratory tests and pathological examination services, a request by a radiologist for diagnostic radiology services, or a request by a radiation oncologist for radiation therapy if those services are furnished by, or under the supervision of, the pathologist, radiologist, or radiation oncologist pursuant to a consultation requested by another physician.
(k)This section shall not apply to referrals for services that are described in and covered by Sections 139.3 and 139.31 of the Labor Code.
(l)This section shall become operative on January 1, 1995.
SEC. 2.SEC. 3.Section 2725.1 of the Business and Professions Code is amended to read:2725.1.(a)Notwithstanding any other law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon or an order by a certified nurse-midwife, nurse practitioner, or physician assistant issued pursuant to Section 2746.51, 2836.1, or 3502.1, respectively, if the registered nurse is functioning within a licensed primary care clinic as defined in subdivision (a) of Section 1204 of, or within a clinic as defined in subdivision (b), (c), (h), or (j) of Section 1206 of, the Health and Safety Code.
(b)No clinic shall employ a registered nurse to perform dispensing duties exclusively. No registered nurse shall dispense drugs in a pharmacy, keep a pharmacy, open shop, or drugstore for the retailing of drugs or poisons. No registered nurse shall compound drugs. Dispensing of drugs by a registered nurse, except a certified nurse-midwife who functions pursuant to Section 2746.51 or a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, shall not include substances included in the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code). Nothing in this section shall exempt a clinic from the provisions of Article 13 (commencing with Section 4180) of Chapter 9.
(c)This section shall not be construed to limit any other authority granted to a certified nurse-midwife pursuant to Article 2.5 (commencing with Section 2746), to a nurse practitioner pursuant to Article 8 (commencing with Section 2834), or to a physician assistant pursuant to Chapter 7.7 (commencing with Section 3500).
(d)This section shall not be construed to affect the sites or types of health care facilities at which drugs or devices are authorized to be dispensed pursuant to Chapter 9 (commencing with Section 4000).
SEC. 3.SEC. 4.Section 2746.2 of the Business and Professions Code is amended to read:2746.2.(a)Each applicant shall show by evidence satisfactory to the board that he or she has met the educational standards established by the board or has at least the equivalent thereof, including evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board.
(b)The board shall create and appoint a Nurse-Midwifery Advisory Council consisting of certified nurse-midwives in good standing with experience in hospital and nonhospital practice settings, settings, alternative birth center settings, and home settings, a nurse-midwife educator who has demonstrated familiarity with consumer needs, collegial practice and accompanied liability, and related educational standards in the delivery of maternal-child health care, and a consumer of midwifery care. care, and at least two qualified physicians appointed by the Medical Board of California, including an obstetrician that has experience working with nurse-midwives. The council membership shall consist of a majority of certified nurse-midwives and shall make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters as specified by the board. The council shall meet regularly, but at least twice a year.
(c)Corporations and other artificial legal entities shall have no professional rights, privileges, or powers. However, the Board of Registered Nursing may in its discretion, after such investigation and review of such documentary evidence as it may require, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic.
(d)Notwithstanding subdivision (c), the following entities may employ a certified nurse-midwife and charge for professional services rendered by a certified nurse-midwife; however, the entity shall not interfere with, control, or otherwise direct the professional judgment of a certified nurse-midwife:
(1)A clinic operated under subdivision (p) of Section 1206 of the Health and Safety Code.
(2)A hospital owned and operated by a health care district pursuant to Division 23 (commencing with Section 32000) of the Health and Safety Code.
(3)A clinic operated primarily for the purpose of medical education or nursing education by a public or private nonprofit university medical school, which is approved by the Medical Board or the Osteopathic Medical Board of California, provided the certified nurse-midwife holds an academic appointment on the faculty of the university, including, but not limited to, the University of California medical schools and hospitals.
(4)A licensed alternative birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, or a nationally accredited alternative birth center owned or operated by a nursing corporation, as defined in Section 2775 of the Business and Professions Code.
SEC. 4.SEC. 5.Section 2746.5 of the Business and Professions Code is amended to read:2746.5.(a)The certificate to practice nurse-midwifery authorizes the holder to manage a full range of primary health gynecological and obstetric care services for women from adolescence to beyond menopause. menopause, consistent with the Core Competencies for Basic Midwifery practice promulgated by the American College of Nurse-Midwives, or its successor national professional organization, as approved by the board. These services include, but are not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, immediate care of the newborn, and treatment of male partners for sexually transmitted infections. A certified nurse-midwife is authorized to practice in all settings, including, but not limited to, private practice, clinics, hospitals, birth centers, and homes. infections, utilizing consultation, collaboration, or referral to appropriate levels of health care services, as indicated.
(b)A certified nurse-midwife may practice in the following settings:
(b)
(1)A licensed clinic as described in Chapter 1 (commencing with Section 1200) of Division 2 of the Health and Safety Code.
(2)A facility as described in Chapter 2 (commencing with Section 1250) of Division 2 of the Health and Safety Code.
(3)A facility as described in Chapter 2.5 (commencing with Section 1440) of Division 2 of the Health and Safety Code.
(4)A medical group practice, including a professional medical corporation, a medical partnership, a medical foundation exempt from licensure pursuant to Section 1206 of the Health and Safety Code, or another lawfully organized group of physicians that delivers, furnishes, or otherwise arranges for or provides health care services.
(5)A licensed alternative birth center, as described in Section 1204 of the Health and Safety Code, or nationally accredited birth center.
(6)A nursing corporation, as defined in Section 2775 of the Business and Professions Code.
(7)A home setting.
(A)Except as provided in subparagraph (B) of this paragraph, a certified nurse-midwife shall assist during pregnancy and childbirth in the home setting only when all of the following conditions apply:
(i)There is the absence of all of the following:
(I)Any preexisting maternal disease or condition likely to complicate the pregnancy.
(II)Disease arising from the pregnancy likely to cause significant maternal and/or fetal compromise.
(III)Prior caesarean delivery.
(ii)There is a singleton fetus.
(iii)There is cephalic presentation at the onset of labor.
(iv)The gestational age of the fetus is greater than 370/7 weeks and less than 420/7 completed weeks of pregnancy at the onset of labor.
(v)Labor is spontaneous or induced in an outpatient setting.
(B)If a potential certified nurse-midwife client meets the conditions specified in clauses (ii) to (v), inclusive, of subparagraph (A), but fails to meet the conditions specified in clause (i) of subparagraph (A), and the woman still desires to be a client of the certified nurse-midwife, the certified nurse-midwife shall consult with a physician and surgeon trained in obstetrics and gynecology. A certified nurse-midwife may assist the woman in pregnancy and childbirth only if a physician and surgeon trained in obstetrics and gynecology is consulted and the physician and surgeon who performed the consultation determines that the risk factors presented by her disease or condition are not likely to significantly affect the course of pregnancy and childbirth.
(c)As used in this chapter, the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the patient and the resources and medical personnel available in the setting of care. When providing peripartum care in out-of-hospital settings, the certified nurse-midwife shall only provide care to low-risk women with uncomplicated singleton-term pregnancies who are expected to have an uncomplicated birth. The practice of nurse-midwifery care emphasizes informed consent, preventive care, and early detection and referral of complications to physicians and surgeons. While practicing in a hospital setting, the certified nurse-midwife shall collaboratively care for women with more complex health needs.
(d)A certified nurse-midwife practicing under subdivision (a) shall be subject to all credentialing and quality standards held by the facility in which he or she practices. The peer review body shall include nurse-midwives as part of the peer review body that reviews nurse-midwives. The peer review body of that facility shall impose standards that assure quality and patient safety in their facility. The standards shall be approved by the relevant governing body unless found by a court to be arbitrary and capricious.
(c)
(e)The practice of nurse-midwifery does not include the assisting of childbirth by any forcible, or mechanical means, nor the performance of any version of those means.
(f)A certified nurse-midwife is not authorized to practice medicine and surgery by the provisions of this chapter.
(d)
(g)Any regulations promulgated by a state department that affect the scope of practice of a certified nurse-midwife shall be developed in consultation with the board and the Nurse-Midwifery Advisory Council.
SEC. 5.SEC. 6.Section 2746.51 of the Business and Professions Code is amended to read:2746.51.(a)Neither this chapter nor any other law shall be construed to prohibit a certified nurse-midwife from furnishing or ordering drugs or devices, including controlled substances classified in Schedule II, III, IV, or V under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code), when the drugs or devices are furnished or ordered related to the provision of any of the following:
(1)Family planning services, as defined in Section 14503 of the Welfare and Institutions Code.
(2)Routine health care or perinatal care, as defined in subdivision (d) of Section 123485 of the Health and Safety Code.
(3)Care rendered, consistent with the certified nurse-midwifes educational preparation or for which clinical competency has been established and maintained, to persons within a facility specified in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the Health and Safety Code, a clinic as specified in Section 1204 of the Health and Safety Code, a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code, a licensed birth center as defined in Section 1204.3 of the Health and Safety Code, or a special hospital specified as a maternity hospital in subdivision (f) of Section 1250 of the Health and Safety Code.
(4)Care rendered in a home pursuant to subdivision (a) of Section 2746.5.
(b)(1)The furnishing or ordering of drugs or devices by a certified nurse-midwife is conditional on the issuance by the board of a number to the applicant who has successfully completed the requirements of paragraph (2). The number shall be included on all transmittals of orders for drugs or devices by the certified nurse-midwife. The board shall maintain a list of the certified nurse-midwives that it has certified pursuant to this paragraph and the number it has issued to each one. The board shall make the list available to the California State Board of Pharmacy upon its request. Every certified nurse-midwife who is authorized pursuant to this section to furnish or issue a drug order for a controlled substance shall register with the United States Drug Enforcement Administration.
(2)The board has certified in accordance with paragraph (1) that the certified nurse-midwife has satisfactorily completed a course in pharmacology covering the drugs or devices to be furnished or ordered under this section. The board shall establish the requirements for satisfactory completion of this paragraph.
(3)Certified nurse-midwives who are certified by the board and hold an active furnishing number, who are currently authorized to furnish Schedule II controlled substances, and who are registered with the United States Drug Enforcement Administration shall provide documentation of continuing education specific to the use of Schedule II controlled substances in settings other than a hospital based on standards developed by the board.
(c)Drugs or devices furnished or ordered by a certified nurse-midwife may include Schedule II controlled substances under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code) when the drugs and devices are furnished or ordered in accordance with requirements referenced in paragraphs (1) to (3), inclusive, of subdivision (b). In a nonhospital setting, a Schedule II controlled substance shall be furnished by a certified nurse-midwife only during labor and delivery and only after a consultation with a physician and surgeon.
(d)Furnishing of drugs or devices by a certified nurse-midwife means the act of making a pharmaceutical agent or agents available to the patient.
(e)Drug order or order for purposes of this section means an order for medication or for a drug or device that is dispensed to or for an ultimate user, issued by a certified nurse-midwife as an individual practitioner, within the meaning of Section 1306.03 of Title 21 of the Code of Federal Regulations. Notwithstanding any other law, (1) a drug order issued pursuant to this section shall be treated in the same manner as a prescription of a physician; (2) all references to prescription in this code and the Health and Safety Code shall include drug orders issued by certified nurse-midwives; and (3) the signature of a certified nurse-midwife on a drug order issued in accordance with this section shall be deemed to be the signature of a prescriber for purposes of this code and the Health and Safety Code.
(f)A certified nurse-midwife is authorized to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and consistent with nurse-midwifery education preparation.
SEC. 6.SEC. 7.Section 2746.52 of the Business and Professions Code is amended to read:2746.52.(a)Notwithstanding Section 2746.5, the certificate to practice nurse-midwifery authorizes the holder to perform and repair episiotomies, and to repair first-degree and second-degree lacerations of the perineum, in a licensed acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, in a licensed alternate birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, or a nationally accredited birth center, and in a home pursuant to subdivision (a) paragraph (7) of subdivision (b) of Section 2746.5.
(b)The certified nurse-midwife performing and repairing first-degree and second-degree lacerations of the perineum shall do both of the following:
(1)Ensure that all complications are referred to a physician and surgeon immediately.
(2)Ensure immediate care of patients who are in need of care beyond the scope of practice of the certified nurse-midwife, or provide emergency care for times when a physician and surgeon is not available.
SEC. 7.SEC. 8.Section 2746.6 is added to the Business and Professions Code, to read:2746.6.A consultative relationship between a certified nurse-midwife and a physician and surgeon shall not, by it self, itself, provide the basis for finding a physician and surgeon liable for any act or omission of the certified nurse-midwife.
SEC. 8.SEC. 9.Section 4061 of the Business and Professions Code is amended to read:4061.(a)A manufacturers sales representative shall not distribute any dangerous drug or dangerous device as a complimentary sample without the written request of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7. However, a certified nurse-midwife who functions pursuant to Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to a protocol described in Section 3502.1, or a naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, may sign for the request and receipt of complimentary samples of a dangerous drug or dangerous device that has been identified in the standardized procedure, protocol, or practice agreement. Standardized procedures, protocols, and practice agreements shall include specific approval by a physician. A review process, consistent with the requirements of Section 2725, 3502.1, or 3640.5, of the complimentary samples requested and received by a nurse practitioner, certified nurse-midwife, physician assistant, or naturopathic doctor, shall be defined within the standardized procedure, protocol, or practice agreement.
(b)Each written request shall contain the names and addresses of the supplier and the requester, the name and quantity of the specific dangerous drug desired, the name of the certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor, if applicable, receiving the samples pursuant to this section, the date of receipt, and the name and quantity of the dangerous drugs or dangerous devices provided. These records shall be preserved by the supplier with the records required by Section 4059.
(c)Nothing in this section is intended to expand the scope of practice of a certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor.
SEC. 9.SEC. 10.Section 4076 of the Business and Professions Code is amended to read:4076.(a)A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)Except when the prescriber or the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturers trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturers trade name or the commonly used name or the principal active ingredients.
(2)The directions for the use of the drug.
(3)The name of the patient or patients.
(4)The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)The date of issue.
(6)The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)The strength of the drug or drugs dispensed.
(8)The quantity of the drug or drugs dispensed.
(9)The expiration date of the effectiveness of the drug dispensed.
(10)The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)(A)Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)Prescriptions dispensed by a veterinarian.
(ii)An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)Dispensed medications for which no physical description exists in any commercially available database.
(B)This paragraph applies to outpatient pharmacies only.
(C)The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice.
SEC. 10.SEC. 11.Section 4170 of the Business and Professions Code is amended to read:4170.(a)A prescriber shall not dispense drugs or dangerous devices to patients in his or her office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant.
(2)The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient.
(3)The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons.
(4)The prescriber fulfills all of the labeling requirements imposed upon pharmacists by Section 4076, all of the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers.
(5)The prescriber does not use a dispensing device unless he or she personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded in accordance with paragraph (4).
(6)The prescriber, prior to dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy.
(7)The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patients choice.
(8)A certified nurse-midwife who functions pursuant to Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to Section 3502.1, or a naturopathic doctor who functions pursuant to Section 3640.5, may hand to a patient of the supervising physician and surgeon, if applicable, a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist.
(b)The Medical Board of California, the State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, the Veterinary Medical Board, and the Physician Assistant Committee shall have authority with the California State Board of Pharmacy to ensure compliance with this section, and those boards are specifically charged with the enforcement of this chapter with respect to their respective licensees.
(c)Prescriber, as used in this section, means a person, who holds a physicians and surgeons certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, or a certificate to practice podiatry, and who is duly registered by the Medical Board of California, the State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, or the Board of Osteopathic Examiners of this state.
SEC. 11.SEC. 12.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)Notwithstanding Section 650, or any other provision of law, it is unlawful for a licensee to refer a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the licensee or his or her immediate family has a financial interest with the person or in the entity that receives the referral.
(b)For purposes of this section and Section 650.02, the following shall apply:
(1)Diagnostic imaging includes, but is not limited to, all X-ray, computed axial tomography, magnetic resonance imaging nuclear medicine, positron emission tomography, mammography, and ultrasound goods and services.
(2)A financial interest includes, but is not limited to, any type of ownership interest, debt, loan, lease, compensation, remuneration, discount, rebate, refund, dividend, distribution, subsidy, or other form of direct or indirect payment, whether in money or otherwise, between a licensee and a person or entity to whom the licensee refers a person for a good or service specified in subdivision (a). A financial interest also exists if there is an indirect financial relationship between a licensee and the referral recipient including, but not limited to, an arrangement whereby a licensee has an ownership interest in an entity that leases property to the referral recipient. Any financial interest transferred by a licensee to any person or entity or otherwise established in any person or entity for the purpose of avoiding the prohibition of this section shall be deemed a financial interest of the licensee. For purposes of this paragraph, direct or indirect payment shall not include a royalty or consulting fee received by a physician and surgeon who has completed a recognized residency training program in orthopedics from a manufacturer or distributor as a result of his or her research and development of medical devices and techniques for that manufacturer or distributor. For purposes of this paragraph, consulting fees means those fees paid by the manufacturer or distributor to a physician and surgeon who has completed a recognized residency training program in orthopedics only for his or her ongoing services in making refinements to his or her medical devices or techniques marketed or distributed by the manufacturer or distributor, if the manufacturer or distributor does not own or control the facility to which the physician is referring the patient. A financial interest shall not include the receipt of capitation payments or other fixed amounts that are prepaid in exchange for a promise of a licensee to provide specified health care services to specified beneficiaries. A financial interest shall not include the receipt of remuneration by a medical director of a hospice, as defined in Section 1746 of the Health and Safety Code, for specified services if the arrangement is set out in writing, and specifies all services to be provided by the medical director, the term of the arrangement is for at least one year, and the compensation to be paid over the term of the arrangement is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between parties.
(3)For the purposes of this section, immediate family includes the spouse and children of the licensee, the parents of the licensee, and the spouses of the children of the licensee.
(4)Licensee means a physician as defined in Section 3209.3 of the Labor Code. Code, and a certified nurse-midwife as defined in Article 2.5 (commencing with Section 2746) of Chapter 6 of Division 2 of the Business and Professions Code.
(5)Licensees office means either of the following:
(A)An office of a licensee in solo practice.
(B)An office in which services or goods are personally provided by the licensee or by employees in that office, or personally by independent contractors in that office, in accordance with other provisions of law. Employees and independent contractors shall be licensed or certified when licensure or certification is required by law.
(6)Office of a group practice means an office or offices in which two or more licensees are legally organized as a partnership, professional corporation, or not-for-profit corporation, licensed pursuant to subdivision (a) of Section 1204 of the Health and Safety Code, for which all of the following apply:
(A)Each licensee who is a member of the group provides substantially the full range of services that the licensee routinely provides, including medical care, consultation, diagnosis, or treatment through the joint use of shared office space, facilities, equipment, and personnel.
(B)Substantially all of the services of the licensees who are members of the group are provided through the group and are billed in the name of the group and amounts so received are treated as receipts of the group, except in the case of a multispecialty clinic, as defined in subdivision (l) of Section 1206 of the Health and Safety Code, physician services are billed in the name of the multispecialty clinic and amounts so received are treated as receipts of the multispecialty clinic.
(C)The overhead expenses of, and the income from, the practice are distributed in accordance with methods previously determined by members of the group.
(c)It is unlawful for a licensee to enter into an arrangement or scheme, such as a cross-referral arrangement, that the licensee knows, or should know, has a principal purpose of ensuring referrals by the licensee to a particular entity that, if the licensee directly made referrals to that entity, would be in violation of this section.
(d)No claim for payment shall be presented by an entity to any individual, third party payer, or other entity for a good or service furnished pursuant to a referral prohibited under this section.
(e)No insurer, self-insurer, or other payer shall pay a charge or lien for any good or service resulting from a referral in violation of this section.
(f)A licensee who refers a person to, or seeks consultation from, an organization in which the licensee has a financial interest, other than as prohibited by subdivision (a), shall disclose the financial interest to the patient, or the parent or legal guardian of the patient, in writing, at the time of the referral or request for consultation.
(1)If a referral, billing, or other solicitation is between one or more licensees who contract with a multispecialty clinic pursuant to subdivision (l) of Section 1206 of the Health and Safety Code or who conduct their practice as members of the same professional corporation or partnership, and the services are rendered on the same physical premises, or under the same professional corporation or partnership name, the requirements of this subdivision may be met by posting a conspicuous disclosure statement at the registration area or by providing a patient with a written disclosure statement.
(2)If a licensee is under contract with the Department of Corrections or the California Youth Authority, and the patient is an inmate or parolee of either respective department, the requirements of this subdivision shall be satisfied by disclosing financial interests to either the Department of Corrections or the California Youth Authority.
(g)A violation of subdivision (a) shall be a misdemeanor. The In the case of a licensee who is a physician, the Medical Board of California shall review the facts and circumstances of any conviction pursuant to subdivision (a) and take appropriate disciplinary action if the licensee has committed unprofessional conduct. In the case of a licensee who is a certified nurse-midwife, the Board of Registered Nursing shall review the facts and circumstances of any conviction pursuant to subdivision (a) and take appropriate disciplinary action if the licensee has committed unprofessional conduct. Violations of this section may also be subject to civil penalties of up to five thousand dollars ($5,000) for each offense, which may be enforced by the Insurance Commissioner, Attorney General, or a district attorney. A violation of subdivision (c), (d), or (e) is a public offense and is punishable upon conviction by a fine not exceeding fifteen thousand dollars ($15,000) for each violation and appropriate disciplinary action, including revocation of professional licensure, by the Medical Board of California California, the Board of Registered Nursing, or other appropriate governmental agency.
(h)This section shall not apply to referrals for services that are described in and covered by Sections 139.3 and 139.31 of the Labor Code.
(i)This section shall become operative on January 1, 1995.
SECTION 1.SEC. 2.Section 2725.1 of the Business and Professions Code is amended to read:2725.1.(a)Notwithstanding any other law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon or an order by a certified nurse-midwife, nurse practitioner, or physician assistant issued pursuant to Section 2746.51, 2836.1, or 3502.1, respectively, if the registered nurse is functioning within a licensed primary care clinic as defined in subdivision (a) of Section 1204 of, or within a clinic as defined in subdivision (b), (c), (h), or (j) of Section 1206 of, the Health and Safety Code.
(b)No clinic shall employ a registered nurse to perform dispensing duties exclusively. No registered nurse shall dispense drugs in a pharmacy, keep a pharmacy, open shop, or drugstore for the retailing of drugs or poisons. No registered nurse shall compound drugs. Dispensing of drugs by a registered nurse, except a certified nurse-midwife who functions pursuant to Section 2746.51 or a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, shall not include substances included in the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code). Nothing in this section shall exempt a clinic from the provisions of Article 13 (commencing with Section 4180) of Chapter 9.
(c)This section shall not be construed to limit any other authority granted to a certified nurse-midwife pursuant to Article 2.5 (commencing with Section 2746), to a nurse practitioner pursuant to Article 8 (commencing with Section 2834), or to a physician assistant pursuant to Chapter 7.7 (commencing with Section 3500).
(d)This section shall not be construed to affect the sites or types of health care facilities at which drugs or devices are authorized to be dispensed pursuant to Chapter 9 (commencing with Section 4000).
SEC. 2.SEC. 3.Section 2746.2 of the Business and Professions Code is amended to read:2746.2.(a)Each applicant shall show by evidence satisfactory to the board that he or she has met the educational standards established by the board or has at least the equivalent thereof, including evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board.
(b)The board shall create and appoint a Nurse-Midwifery Advisory Council consisting of certified nurse-midwives in good standing with experience in hospital and nonhospital practice settings, a nurse-midwife educator who has demonstrated familiarity with consumer needs, collegial practice and accompanied liability, and related educational standards in the delivery of maternal-child health care, and a consumer of midwifery care. The council shall make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters as specified by the board. The council shall meet regularly, but at least twice a year.
(c)Corporations and other artificial legal entities shall have no professional rights, privileges, or powers. However, the Board of Registered Nursing may in its discretion, after such investigation and review of such documentary evidence as it may require, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic.
SEC. 3.SEC. 4.Section 2746.5 of the Business and Professions Code is amended to read:2746.5.(a)The certificate to practice nurse-midwifery authorizes the holder to manage a full range of primary health care services for women from adolescence to beyond menopause. These services include, but are not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, immediate care of the newborn, and treatment of male partners for sexually transmitted infections. A certified nurse-midwife is authorized to practice in all settings, including, but not limited to, private practice, clinics, hospitals, birth centers, and homes.
(b)As used in this chapter, the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the patient and the resources and medical personnel available in the setting of care. When providing peripartum care in out-of-hospital settings, the certified nurse-midwife shall only provide care to low-risk women with uncomplicated singleton-term pregnancies who are expected to have an uncomplicated birth. The practice of nurse-midwifery care emphasizes informed consent, preventive care, and early detection and referral of complications to physicians and surgeons. While practicing in a hospital setting, the certified nurse-midwife shall collaboratively care for women with more complex health needs.
(c)A certified nurse-midwife is not authorized to practice medicine and surgery by the provisions of this chapter.
(d)Any regulations promulgated by a state department that affect the scope of practice of a certified nurse-midwife shall be developed in consultation with the board.
SEC. 4.SEC. 5.Section 2746.51 of the Business and Professions Code is amended to read:2746.51.(a)Neither this chapter nor any other law shall be construed to prohibit a certified nurse-midwife from furnishing or ordering drugs or devices, including controlled substances classified in Schedule II, III, IV, or V under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code), when the drugs or devices are furnished or ordered related to the provision of any of the following:
(1)Family planning services, as defined in Section 14503 of the Welfare and Institutions Code.
(2)Routine health care or perinatal care, as defined in subdivision (d) of Section 123485 of the Health and Safety Code.
(3)Care rendered, consistent with the certified nurse-midwifes educational preparation or for which clinical competency has been established and maintained, to persons within a facility specified in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the Health and Safety Code, a clinic as specified in Section 1204 of the Health and Safety Code, a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code, a licensed birth center as defined in Section 1204.3 of the Health and Safety Code, or a special hospital specified as a maternity hospital in subdivision (f) of Section 1250 of the Health and Safety Code.
(4)Care rendered in a home pursuant to subdivision (a) of Section 2746.5.
(b)(1)The furnishing or ordering of drugs or devices by a certified nurse-midwife is conditional on the issuance by the board of a number to the applicant who has successfully completed the requirements of paragraph (2). The number shall be included on all transmittals of orders for drugs or devices by the certified nurse-midwife. The board shall maintain a list of the certified nurse-midwives that it has certified pursuant to this paragraph and the number it has issued to each one. The board shall make the list available to the California State Board of Pharmacy upon its request. Every certified nurse-midwife who is authorized pursuant to this section to furnish or issue a drug order for a controlled substance shall register with the United States Drug Enforcement Administration.
(2)The board has certified in accordance with paragraph (1) that the certified nurse-midwife has satisfactorily completed a course in pharmacology covering the drugs or devices to be furnished or ordered under this section. The board shall establish the requirements for satisfactory completion of this paragraph.
(3)Certified nurse-midwives who are certified by the board and hold an active furnishing number, who are currently authorized to furnish Schedule II controlled substances, and who are registered with the United States Drug Enforcement Administration shall provide documentation of continuing education specific to the use of Schedule II controlled substances in settings other than a hospital based on standards developed by the board.
(c)Drugs or devices furnished or ordered by a certified nurse-midwife may include Schedule II controlled substances under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code) when the drugs and devices are furnished or ordered in accordance with requirements referenced in paragraphs (1) to (3), inclusive, of subdivision (b).
(d)Furnishing of drugs or devices by a certified nurse-midwife means the act of making a pharmaceutical agent or agents available to the patient.
(e)Drug order or order for purposes of this section means an order for medication or for a drug or device that is dispensed to or for an ultimate user, issued by a certified nurse-midwife as an individual practitioner, within the meaning of Section 1306.03 of Title 21 of the Code of Federal Regulations. Notwithstanding any other law, (1) a drug order issued pursuant to this section shall be treated in the same manner as a prescription of a physician; (2) all references to prescription in this code and the Health and Safety Code shall include drug orders issued by certified nurse-midwives; and (3) the signature of a certified nurse-midwife on a drug order issued in accordance with this section shall be deemed to be the signature of a prescriber for purposes of this code and the Health and Safety Code.
(f)A certified nurse-midwife is authorized to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and consistent with nurse-midwifery education preparation.
SEC. 5.SEC. 6.Section 2746.52 of the Business and Professions Code is amended to read:2746.52.(a)Notwithstanding Section 2746.5, the certificate to practice nurse-midwifery authorizes the holder to perform and repair episiotomies, and to repair first-degree and second-degree lacerations of the perineum, in a licensed acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, in a licensed alternate birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, and in a home pursuant to subdivision (a) of Section 2746.5.
(b)The certified nurse-midwife performing and repairing first-degree and second-degree lacerations of the perineum shall do both of the following:
(1)Ensure that all complications are referred to a physician and surgeon immediately.
(2)Ensure immediate care of patients who are in need of care beyond the scope of practice of the certified nurse midwife, nurse-midwife, or provide emergency care for times when a physician and surgeon is not available.
SEC. 6.SEC. 7.Section 2746.6 is added to the Business and Professions Code, to read:2746.6.A consultative relationship between a certified nurse-midwife and a physician and surgeon shall not, by it self, provide the basis for finding a physician and surgeon liable for any act or omission of the certified nurse-midwife.
SEC. 7.SEC. 8.Section 4061 of the Business and Professions Code is amended to read:4061.(a)A manufacturers sales representative shall not distribute any dangerous drug or dangerous device as a complimentary sample without the written request of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7. However, a certified nurse-midwife who functions pursuant to Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to a protocol described in Section 3502.1, or a naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, may sign for the request and receipt of complimentary samples of a dangerous drug or dangerous device that has been identified in the standardized procedure, protocol, or practice agreement. Standardized procedures, protocols, and practice agreements shall include specific approval by a physician. A review process, consistent with the requirements of Section 2725, 3502.1, or 3640.5, of the complimentary samples requested and received by a nurse practitioner, certified nurse-midwife, physician assistant, or naturopathic doctor, shall be defined within the standardized procedure, protocol, or practice agreement.
(b)Each written request shall contain the names and addresses of the supplier and the requester, the name and quantity of the specific dangerous drug desired, the name of the certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor, if applicable, receiving the samples pursuant to this section, the date of receipt, and the name and quantity of the dangerous drugs or dangerous devices provided. These records shall be preserved by the supplier with the records required by Section 4059.
(c)Nothing in this section is intended to expand the scope of practice of a certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor.
SEC. 8.SEC. 9.Section 4076 of the Business and Professions Code is amended to read:4076.(a)A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)Except when the prescriber or the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturers trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturers trade name or the commonly used name or the principal active ingredients.
(2)The directions for the use of the drug.
(3)The name of the patient or patients.
(4)The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)The date of issue.
(6)The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)The strength of the drug or drugs dispensed.
(8)The quantity of the drug or drugs dispensed.
(9)The expiration date of the effectiveness of the drug dispensed.
(10)The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)(A)Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)Prescriptions dispensed by a veterinarian.
(ii)An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)Dispensed medications for which no physical description exists in any commercially available database.
(B)This paragraph applies to outpatient pharmacies only.
(C)The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice.
SEC. 9.SEC. 10.Section 4170 of the Business and Professions Code is amended to read:4170.(a)A prescriber shall not dispense drugs or dangerous devices to patients in his or her office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant.
(2)The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient.
(3)The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons.
(4)The prescriber fulfills all of the labeling requirements imposed upon pharmacists by Section 4076, all of the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers.
(5)The prescriber does not use a dispensing device unless he or she personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded in accordance with paragraph (4).
(6)The prescriber, prior to dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy.
(7)The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patients choice.
(8)A certified nurse-midwife who functions pursuant to Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to Section 3502.1, or a naturopathic doctor who functions pursuant to Section 3640.5, may hand to a patient of the supervising physician and surgeon a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist.
(b)The Medical Board of California, the State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, the Veterinary Medical Board, and the Physician Assistant Committee shall have authority with the California State Board of Pharmacy to ensure compliance with this section, and those boards are specifically charged with the enforcement of this chapter with respect to their respective licensees.
(c)Prescriber, as used in this section, means a person, who holds a physicians and surgeons certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, or a certificate to practice podiatry, and who is duly registered by the Medical Board of California, the State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, or the Board of Osteopathic Examiners of this state.
SEC. 10.SEC. 11.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)Notwithstanding any other provision of law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon or an order by a certified nurse-midwife, nurse practitioner, or physician assistant issued pursuant to Section 2746.51, 2836.1, or 3502.1, respectively, if the registered nurse is functioning within a licensed primary care clinic as defined in subdivision (a) of Section 1204 of, or within a clinic as defined in subdivision (b), (c), (h), or (j) of Section 1206 of, the Health and Safety Code.
(b)No clinic shall employ a registered nurse to perform dispensing duties exclusively. No registered nurse shall dispense drugs in a pharmacy, keep a pharmacy, open shop, or drugstore for the retailing of drugs or poisons. No registered nurse shall compound drugs. Dispensing of drugs by a registered nurse, except a certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51 or a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, shall not include substances included in the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code). Nothing in this section shall exempt a clinic from the provisions of Article 13 (commencing with Section 4180) of Chapter 9.
(c)Nothing in this This section shall not be construed to limit any other authority granted to a certified nurse-midwife pursuant to Article 2.5 (commencing with Section 2746), to a nurse practitioner pursuant to Article 8 (commencing with Section 2834), or to a physician assistant pursuant to Chapter 7.7 (commencing with Section 3500).
(d)Nothing in this This section shall not be construed to affect the sites or types of health care facilities at which drugs or devices are authorized to be dispensed pursuant to Chapter 9 (commencing with Section 4000).
SEC. 2.Section 2746.2 of the Business and Professions Code is amended to read:2746.2.(a)Each applicant shall show by evidence satisfactory to the board that he or she has met the educational standards established by the board or has at least the equivalent thereof. The board is authorized to appoint a committee of qualified physicians and nurses, including, but not limited to, obstetricians and nurse-midwives, to develop the necessary standards relating to educational requirements, ratios of nurse-midwives to supervising physicians, and associated matters. thereof, including evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board.
(b)The board shall create and appoint a Nurse-Midwifery Advisory Council consisting of certified nurse-midwives in good standing with experience in hospital and nonhospital practice settings, a nurse-midwife educator who has demonstrated familiarity with consumer needs, collegial practice and accompanied liability, and related educational standards in the delivery of maternal-child health care, and a consumer of midwifery care. The council shall make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters as specified by the board. The council shall meet regularly, but at least twice a year.
SEC. 3.Section 2746.5 of the Business and Professions Code is amended to read:2746.5.(a)The certificate to practice nurse-midwifery authorizes the holder, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn. holder to manage a full range of primary health care services for women from adolescence to beyond menopause. These services include, but are not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, immediate care of the newborn, and treatment of male partners for sexually transmitted infections. A certified nurse-midwife is authorized to practice in all settings, including, but not limited to, private practice, clinics, hospitals, birth centers, and homes.
(b)As used in this chapter, the practice of nurse-midwifery constitutes the furthering or undertaking by any certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal. All complications shall be referred to a physician immediately. The practice of nurse-midwifery does not include the assisting of childbirth by any artificial, forcible, or mechanical means, nor the performance of any version. within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the patient and the resources and medical personnel available in the setting of care. When providing peripartum care in out-of-hospital settings, the certified nurse-midwife shall only provide care to low-risk women with uncomplicated singleton-term pregnancies who are expected to have an uncomplicated birth. The practice of nurse-midwifery care emphasizes informed consent, preventive care, and early detection and referral of complications to physicians and surgeons. While practicing in a hospital setting, the certified nurse-midwife shall collaboratively care for women with more complex health needs.
(c)As used in this article, supervision shall not be construed to require the physical presence of the supervising physician.
(d)
(c)A certified nurse-midwife is not authorized to practice medicine and surgery by the provisions of this chapter.
(e)
(d)Any regulations promulgated by a state department that affect the scope of practice of a certified nurse-midwife shall be developed in consultation with the board.
SEC. 4.Section 2746.51 of the Business and Professions Code is amended to read:2746.51.(a)Neither this chapter nor any other provision of law shall be construed to prohibit a certified nurse-midwife from furnishing or ordering drugs or devices, including controlled substances classified in Schedule II, III, IV, or V under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code), when all of the following apply:
(1)The the drugs or devices are furnished or ordered incidentally related to the provision of any of the following:
(A)
(1)Family planning services, as defined in Section 14503 of the Welfare and Institutions Code.
(B)
(2)Routine health care or perinatal care, as defined in subdivision (d) of Section 123485 of the Health and Safety Code.
(C)
(3)Care rendered, consistent with the certified nurse-midwifes educational preparation or for which clinical competency has been established and maintained, to persons within a facility specified in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the Health and Safety Code, a clinic as specified in Section 1204 of the Health and Safety Code, a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code, a licensed birth center as defined in Section 1204.3 of the Health and Safety Code, or a special hospital specified as a maternity hospital in subdivision (f) of Section 1250 of the Health and Safety Code.
(4)Care rendered in a home pursuant to subdivision (a) of Section 2746.5.
(2)The drugs or devices are furnished or ordered by a certified nurse-midwife in accordance with standardized procedures or protocols. For purposes of this section, standardized procedure means a document, including protocols, developed and approved by the supervising physician and surgeon, the certified nurse-midwife, and the facility administrator or his or her designee. The standardized procedure covering the furnishing or ordering of drugs or devices shall specify all of the following:
(A)Which certified nurse-midwife may furnish or order drugs or devices.
(B)Which drugs or devices may be furnished or ordered and under what circumstances.
(C)The extent of physician and surgeon supervision.
(D)The method of periodic review of the certified nurse-midwifes competence, including peer review, and review of the provisions of the standardized procedure.
(3)If Schedule II or III controlled substances, as defined in Sections 11055 and 11056 of the Health and Safety Code, are furnished or ordered by a certified nurse-midwife, the controlled substances shall be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician and surgeon. For Schedule II controlled substance protocols, the provision for furnishing the Schedule II controlled substance shall address the diagnosis of the illness, injury, or condition for which the Schedule II controlled substance is to be furnished.
(4)The furnishing or ordering of drugs or devices by a certified nurse-midwife occurs under physician and surgeon supervision. For purposes of this section, no physician and surgeon shall supervise more than four certified nurse-midwives at one time. Physician and surgeon supervision shall not be construed to require the physical presence of the physician, but does include all of the following:
(A)Collaboration on the development of the standardized procedure or protocol.
(B)Approval of the standardized procedure or protocol.
(C)Availability by telephonic contact at the time of patient examination by the certified nurse-midwife.
(b)(1)The furnishing or ordering of drugs or devices by a certified nurse-midwife is conditional on the issuance by the board of a number to the applicant who has successfully completed the requirements of paragraph (2). The number shall be included on all transmittals of orders for drugs or devices by the certified nurse-midwife. The board shall maintain a list of the certified nurse-midwives that it has certified pursuant to this paragraph and the number it has issued to each one. The board shall make the list available to the California State Board of Pharmacy upon its request. Every certified nurse-midwife who is authorized pursuant to this section to furnish or issue a drug order for a controlled substance shall register with the United States Drug Enforcement Administration.
(2)The board has certified in accordance with paragraph (1) that the certified nurse-midwife has satisfactorily completed a course in pharmacology covering the drugs or devices to be furnished or ordered under this section. The board shall establish the requirements for satisfactory completion of this paragraph.
(3)A physician and surgeon may determine the extent of supervision necessary pursuant to this section in the furnishing or ordering of drugs and devices.
(4)A copy of the standardized procedure or protocol relating to the furnishing or ordering of controlled substances by a certified nurse-midwife shall be provided upon request to any licensed pharmacist who is uncertain of the authority of the certified nurse-midwife to perform these functions.
(5)
(3)Certified nurse-midwives who are certified by the board and hold an active furnishing number, who are currently authorized through standardized procedures or protocols to furnish Schedule II controlled substances, and who are registered with the United States Drug Enforcement Administration shall provide documentation of continuing education specific to the use of Schedule II controlled substances in settings other than a hospital based on standards developed by the board.
(c)Drugs or devices furnished or ordered by a certified nurse-midwife may include Schedule II controlled substances under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code) under the following conditions:
(1)The when the drugs and devices are furnished or ordered in accordance with requirements referenced in paragraphs (2) to (4), inclusive, of subdivision (a) and in paragraphs (1) to (3), inclusive, of subdivision (b).
(2)When Schedule II controlled substances, as defined in Section 11055 of the Health and Safety Code, are furnished or ordered by a certified nurse-midwife, the controlled substances shall be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician and surgeon.
(d)Furnishing of drugs or devices by a certified nurse-midwife means the act of making a pharmaceutical agent or agents available to the patient in strict accordance with a standardized procedure or protocol. Use of the term furnishing in this section shall include the following: patient.
(1)The ordering of a drug or device in accordance with the standardized procedure or protocol.
(2)Transmitting an order of a supervising physician and surgeon.
(e)Drug order or order for purposes of this section means an order for medication or for a drug or device that is dispensed to or for an ultimate user, issued by a certified nurse-midwife as an individual practitioner, within the meaning of Section 1306.03 of Title 21 of the Code of Federal Regulations. Notwithstanding any other provision of law, (1) a drug order issued pursuant to this section shall be treated in the same manner as a prescription of the supervising a physician; (2) all references to prescription in this code and the Health and Safety Code shall include drug orders issued by certified nurse-midwives; and (3) the signature of a certified nurse-midwife on a drug order issued in accordance with this section shall be deemed to be the signature of a prescriber for purposes of this code and the Health and Safety Code.
(f)A certified nurse-midwife is authorized to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and consistent with nurse-midwifery education preparation.
SEC. 5.Section 2746.52 of the Business and Professions Code is amended to read:2746.52.(a)Notwithstanding Section 2746.5, the certificate to practice nurse-midwifery authorizes the holder to perform and repair episiotomies, and to repair first-degree and second-degree lacerations of the perineum, in a licensed acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, and in a licensed alternate birth center, as defined in paragraph (4) of subdivision (b) of Section 1204 of the Health and Safety Code, but only if all of the following conditions are met: and in a home pursuant to subdivision (a) of Section 2746.5.
(a)The supervising physician and surgeon and any backup physician and surgeon is credentialed to perform obstetrical care in the facility.
(b)The episiotomies are performed pursuant to protocols developed and approved by all of the following:
(1)The supervising physician and surgeon.
(2)The certified nurse-midwife.
(3)The director of the obstetrics department or the director of the family practice department, or both, if a physician and surgeon in the obstetrics department or the family practice department is a supervising physician and surgeon, or an equivalent person if there is no specifically identified obstetrics department or family practice department.
(4)The interdisciplinary practices committee, if applicable.
(5)The facility administrator or his or her designee.
(c)
(b)The protocols, and the procedures which shall be developed pursuant to the protocols, shall relate to the performance and repair of episiotomies and the repair of certified nurse-midwife performing and repairing first-degree and second-degree lacerations of the perineum, and perineum shall do all both of the following:
(1)Ensure that all complications are referred to a physician and surgeon immediately.
(2)Ensure immediate care of patients who are in need of care beyond the scope of practice of the certified nurse midwife, or provide emergency care for times when the supervising a physician and surgeon is not on the premises. available.
(3)Establish the number of certified nursemidwives that a supervising physician and surgeon may supervise.
SEC. 6.Section 2746.6 is added to the Business and Professions Code, to read:2746.6.A consultative relationship between a certified nurse-midwife and a physician and surgeon shall not, by it self, provide the basis for finding a physician and surgeon liable for any act or omission of the certified nurse-midwife.
SEC. 7.Section 4061 of the Business and Professions Code is amended to read:4061.(a)No A manufacturers sales representative shall not distribute any dangerous drug or dangerous device as a complimentary sample without the written request of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7. However, a certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to a protocol described in Section 3502.1, or a naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, may sign for the request and receipt of complimentary samples of a dangerous drug or dangerous device that has been identified in the standardized procedure, protocol, or practice agreement. Standardized procedures, protocols, and practice agreements shall include specific approval by a physician. A review process, consistent with the requirements of Section 2725, 3502.1, or 3640.5, of the complimentary samples requested and received by a nurse practitioner, certified nurse-midwife, physician assistant, or naturopathic doctor, shall be defined within the standardized procedure, protocol, or practice agreement.
(b)Each written request shall contain the names and addresses of the supplier and the requester, the name and quantity of the specific dangerous drug desired, the name of the certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor, if applicable, receiving the samples pursuant to this section, the date of receipt, and the name and quantity of the dangerous drugs or dangerous devices provided. These records shall be preserved by the supplier with the records required by Section 4059.
(c)Nothing in this section is intended to expand the scope of practice of a certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor.
SEC. 8.Section 4076 of the Business and Professions Code is amended to read:4076.(a)A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)Except when the prescriber or the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturers trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturers trade name or the commonly used name or the principal active ingredients.
(2)The directions for the use of the drug.
(3)The name of the patient or patients.
(4)The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)The date of issue.
(6)The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)The strength of the drug or drugs dispensed.
(8)The quantity of the drug or drugs dispensed.
(9)The expiration date of the effectiveness of the drug dispensed.
(10)The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)(A)Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)Prescriptions dispensed by a veterinarian.
(ii)An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)Dispensed medications for which no physical description exists in any commercially available database.
(B)This paragraph applies to outpatient pharmacies only.
(C)The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice.
SEC. 9.Section 4170 of the Business and Professions Code is amended to read:4170.(a)No A prescriber shall not dispense drugs or dangerous devices to patients in his or her office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant.
(2)The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient.
(3)The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons.
(4)The prescriber fulfills all of the labeling requirements imposed upon pharmacists by Section 4076, all of the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers.
(5)The prescriber does not use a dispensing device unless he or she personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded in accordance with paragraph (4).
(6)The prescriber, prior to dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy.
(7)The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patients choice.
(8)A certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to Section 3502.1, or a naturopathic doctor who functions pursuant to Section 3640.5, may hand to a patient of the supervising physician and surgeon a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist.
(b)The Medical Board of California, the State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, the Veterinary Medical Board, and the Physician Assistant Committee shall have authority with the California State Board of Pharmacy to ensure compliance with this section, and those boards are specifically charged with the enforcement of this chapter with respect to their respective licensees.
(c)Prescriber, as used in this section, means a person, who holds a physicians and surgeons certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, or a certificate to practice podiatry, and who is duly registered by the Medical Board of California, the State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, or the Board of Osteopathic Examiners of this state.
SEC. 10.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
|
Date
|
Status
|
|---|---|
| Jun 18, 2015 | Referred to Com. on B., P. & E.D. |
| Aug 31, 2016 | Assembly refused to concur in Senate amendments. |
| Aug 30, 2016 | Read third time. Passed. Ordered to the Assembly. (Ayes 22. Noes 9. Page 5519.). |
| Aug 30, 2016 | Read third time. Passed. Ordered to the Assembly. |
| Aug 30, 2016 | In Assembly. Concurrence in Senate amendments pending. |
| Aug 2, 2016 | Read second time. Ordered to third reading. |
| Aug 1, 2016 | From committee: Be placed on second reading file pursuant to Senate Rule 28.8. |
| Jun 30, 2016 | Read second time and amended. Re-referred to Com. on APPR. |
| Jun 29, 2016 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 7. Noes 0.) (June 27). |
| Jun 20, 2016 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on B., P. & E.D. |
| Jul 13, 2015 | In committee: Set, second hearing. Testimony taken. Further hearing to be set. |
| Jul 6, 2015 | In committee: Set, first hearing. Hearing canceled at the request of author. |
| Jul 1, 2015 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on B., P. & E.D. |
| Feb 27, 2015 | Introduced. To print. |
| Jun 3, 2015 | Read third time. Passed. Ordered to the Senate. (Ayes 78. Noes 1. Page 1839.) |
| Jun 3, 2015 | Read third time. Passed. Ordered to the Senate. |
| Jun 3, 2015 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 28, 2015 | Read third time and amended. Ordered to third reading. (Page 1624.) |
| May 28, 2015 | Read third time and amended. Ordered to third reading. |
| May 14, 2015 | Read second time. Ordered to third reading. |
| May 13, 2015 | From committee: Do pass. (Ayes 15. Noes 2.) (May 13). |
| May 6, 2015 | In committee: Set, first hearing. Hearing canceled at the request of author. |
| Apr 29, 2015 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 14. Noes 0.) (April 28). Re-referred to Com. on APPR. |
| Mar 23, 2015 | Referred to Com. on B. & P. |
| Mar 2, 2015 | Read first time. |
| Mar 1, 2015 | From printer. May be heard in committee March 31. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 31, 2016 | AB 1306 BURKE Concurrence in Senate Amendments | Assembly Floor |
Failed |
|
| Aug 30, 2016 | Assembly 3rd Reading AB1306 Burke By Hill | Senate Floor |
Passed |
|
| Jun 27, 2016 | Do pass as amended, but first amend, and re-refer to the Committee on [Appropriations] | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
|
| Jun 3, 2015 | AB 1306 BURKE Assembly Third Reading | Assembly Floor |
Passed |
|
| May 13, 2015 | Do pass. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 28, 2015 | Do pass and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Business and Professions |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| AARP | ** Support | Aug 30, 2016 |
| American Association of Birth Centers | ** Support | Aug 30, 2016 |
| American College of Nurse-Midwives | ** Support | Aug 30, 2016 |
| American Congress of Obstetricians and Gynecologists | * Indeterminate | Jun 27, 2016 |
| American Nurses Association | ** Support | Aug 30, 2016 |
| Association of California Healthcare Districts | ** Support | Aug 30, 2016 |
| Beach Cities Midwifery | * Support | Jul 13, 2015 |
| Beach Cities Midwifery & Women's Health Care | ** Support | Aug 30, 2016 |
| Beachside Birth Center | ** Support | Aug 30, 2016 |
| Best Start Birth Center | * Support | Jul 13, 2015 |
| Birth and Postpartum Doula | * Support | Jul 13, 2015 |
| black women for wellness | ** Support | Aug 30, 2016 |
| California Academy Of Family Physicians | * Indeterminate | Jun 27, 2016 |
| California Association for Nurse Practitioners | ** Support | Aug 30, 2016 |
| California Association of Midwives | ** Support | Aug 30, 2016 |
| California Association of Nurse and Ethicist | * Indeterminate | Jun 27, 2016 |
| California Association of Nurse Anesthetics | * Support | Apr 28, 2015 |
| California Association of Nurse Anesthetists | ** Support | Jul 13, 2015 |
| California Birth Center Association | * Support | Jul 13, 2015 |
| California Hospital Association | ** Support | Aug 30, 2016 |
| California Medical Association, Inc. | ** Against | Aug 30, 2016 |
| California Nurse Midwives Association | ** Support | Aug 30, 2016 |
| Center Davis | * Indeterminate | Jul 13, 2015 |
| Certidied Nurse-midwife | * Support | Jul 13, 2015 |
| Certified Nurse-Midwife | * Support | Jul 13, 2015 |
| Certiied Nurse-Midwife | * Support | Jul 13, 2015 |
| County of Santa Cruz Board of Supervisors | ** Support | Aug 30, 2016 |
| Ellison Wilson Advocacy | * Indeterminate | Jun 27, 2016 |
| Inland Midwife Service | ** Support | Aug 30, 2016 |
| Los Gatos | * Indeterminate | Jul 13, 2015 |
| Maternal and Child Health Access | ** Support | Aug 30, 2016 |
| Medical Board of California | ** Against | Aug 30, 2016 |
| Obstetrician-Gynecologist | * Support | Jul 13, 2015 |
| Palo Alto Medical Foundation | * Indeterminate | Jul 13, 2015 |
| Palo Alto Medical Foundation, Santa Cruz | * Support | Jul 13, 2015 |
| Professionals | ** Support | Aug 30, 2016 |
| South Coast Midwifery & Women's Healthcare, Inc. | ** Support | Aug 30, 2016 |
| Sutter Health | * Indeterminate | Jun 27, 2016 |
| Sutter Hospital | * Indeterminate | Jun 27, 2016 |
| Union of Health Care | ** Support | Aug 30, 2016 |
| United Nurses Associations of California | ** Support | Aug 30, 2016 |
| Yolo County | * Indeterminate | Jun 27, 2016 |
CONCURRENCE IN SENATE AMENDMENTS
CSA1 Bill Id:AB 1306
Author:(Burke)
As Amended Ver:June 30, 2016
Majority vote
ASSEMBLY: | 78-1 | (June 3, 2015) | SENATE: | 22-9 | (August 30, 2016) |
Original Committee Reference: B. & P.
SUMMARY: Removes the physician supervision requirement for certified nurse midwives (CNMs), allowing CNMs to manage a full range of primary gynecological and obstetric health services. Specifically, this bill:
- Prohibits a CNM from referring a patient for services if the CNM has a financial interest in the referral.
- Requires an applicant for a certificate to practice nurse-midwifery to provide evidence of current advanced level national certification by a certifying body that meets standards established and approved by the Board of Registered Nursing (BRN).
- Requires the BRN to create and appoint a Nurse-Midwifery Advisory Committee (committee) consisting of CNMs in good standing with experience in hospital and nonhospital practice settings, a nurse-midwife educator, two qualified physicians, as specified, and a consumer of midwifery care.
- Requires the committee to consist of a majority of nurse-midwives and to make recommendations to the BRN on all matters related to nurse-midwifery practice, education, disciplinary actions, standards of care, and other matters specified by the BRN, and would require the council to meet regularly, but at least twice a year.
- Authorizes a CNM to manage a full range of primary gynecological and obstetric care services for women from adolescence beyond menopause, including, but not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, immediate care of the newborn, and treatment of male partners for sexually transmitted infections, utilizing consultation, collaboration, or referral to appropriate levels of health care services, as specified.
- Authorizes a CNM to practice without supervision of a physician and surgeon in the following settings:
- A licensed clinic as described in Health and Safety Code Division 2 Chapter 1 (commencing with Section 1200).
- A facility as described in Health and Safety Code Division 2 Chapter 2 (commencing with Section 1250).
- A facility as described in Health and Safety Code Division 2 Chapter 2.5 (commencing with Section 1440).
- A medical group practice, including a professional medical corporation, a medical partnership, a medical foundation exempt from licensure pursuant to Health and Safety Code Section 1206, or another lawfully organized group of physicians that delivers, furnishes, or otherwise arranges for or provides health care services.
- A licensed alternative birth center, as described in Health and Safety Code Section 1204, or nationally accredited birth center.
- A nursing corporation, as defined in Business and Professions Code Section 2775.
- A home setting, except as specified.
- Prohibits an entity which employs a CNM from not interfering with, controlling, or otherwise directing the professional judgment of a CNM, as specified.
- Makes a CNM practicing without physician and surgeon supervision subject to all credentialing and quality standards held by the facility in which the CNM practices. Specifies that the peer review body shall include CNMs as part of the peer review body that reviews CNMs. Requires the peer review body of that facility to impose standards that ensure quality and patient safety in their facility. Specifies that the standards shall be approved by the relevant governing body unless found by a court to be arbitrary and capricious.
- Provides that the practice of nurse-midwifery does not include the assisting of childbirth by any forcible or mechanical means or the performance of a version.
- Declares that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the client and the resources of the medical personnel available in the setting of care, and provides that the practice of nurse-midwifery emphasizes informed consent, preventive care and early detection and referral of complications to a physician and surgeon.
- Requires a CNM while practicing in a hospital setting to collaboratively care for women with more complex health needs.
- Deletes the requirement that drugs or devices are furnished or ordered in accordance with standardized procedures and protocols.
- Provides that, in a nonhospital setting, a Schedule II controlled substance shall be furnished by a CNM only during labor and delivery and only after a consultation with a physician and surgeon.
- Authorizes a CNM to furnish and order drugs or devices in connection with care rendered in a home.
- Authorizes a CNM to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a CNM and that are consistent with nurse-midwifery education preparation.
- Deletes the requirement that, in order for a CNM to perform and repair episiotomies and to repair first-degree and second degree lacerations of the perineum, the procedures must be performed pursuant to protocols developed and approved by a supervising physician and surgeon. Further authorizes a CNM to perform the procedures in a patient's home.
- Indicates that a consultative relationship between a CNM and a physician and surgeon by itself is not a basis for finding the physician and surgeon liable for any acts or omissions on the part of the CNM.
- Makes conforming changes.
The Senate amendments:
- Change the name of the Nurse-Midwifery Advisory Council to the Nurse-Midwifery Advisory Committee.
- Change the composition of the committee and changed the requirements of the committee members.
- Delete the provisions prohibiting corporations and other artificial legal entities from practicing mid-wifery.
- Specify that CNMs must practice consistent with the Competencies for Basic Midwifery practice promulgated by the American College of Nurse-Midwives, or its successor national professional organization, as approved by the BRN.
- Amend the CNM scope of practice to mean managing "a full range of primary gynecological and obstetric care" rather than "a full range of primary health care services."
- Specify the settings in which a CNM may practice without physician and surgeon supervision.
- Further specify the conditions under which a CNM may provide peripartum care in a home without physician and surgeon supervision.
- Provide that the entities under which a CNM might practice may not interfere with, control, or otherwise direct the professional judgment of a CNM.
- Add the self-referral prohibition.
- Add additional conforming and technical changes.
FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS:
Purpose. This bill is sponsored by the California Nurse Midwives Association. According to the author, "AB 1306 creates a level of parity in the law between [Licensed Midwives] and CNMs by removing the physician supervision requirements for CNMs, allowing them to practice independently within their scope of practice. If signed into law, CNMs will be able to provide a full range of services for women in all settings, furnish and order prescription drugs, supplies, and devices, order, obtain, and administer diagnostic tests, and receive reports.
"Most pregnancies and births are completely normal physiologic events. When permitted to work to the full extent of their education and experience, CNMs can expertly manage more births in California. Untethering CNMs from physician supervision requirements will increase access to primary health care services for thousands of women in both urban and rural areas."
Background. Midwifery is the care of childrearing women during pregnancy, labor and birth and during the postpartum period. Midwifery services are offered by CNMs, who are regulated by the BRN and Licensed Midwives (LMs) who are regulated by the Medical Board of California (MBC). While both CNMs and NMs practice midwifery, there are differences in their education requirements, practice settings and supervision requirements.
Education. CNMs are licensed registered nurses with a certificate to practice midwifery, have acquired additional training in the field of obstetrics and are certified by the American College of Nurse Midwives.
LMs have completed a three-year postsecondary education program in an accredited midwifery school approved by the Medical Board or via the Challenge Mechanism. The Challenge Mechanism is an approved midwifery education program which allows students to obtain credit by examination for previous midwifery education and clinical experience.
Practice Settings. LMs can practice in home, birth centers and clinics. CNMs can practice in the same settings, but, unlike LMs, they can also practice in hospital settings. In 2012, CNMs attended approximately 8.5% of all births in California – the majority of which took place in a hospital and 1365 were in free-standing birth centers. It is estimated that 90% of all CNM attended births take place in a hospital setting.
CNM care is a federally mandated Medicaid benefit. According to the Centers for Disease Control, in 2012, 30% of CNM attended births in California were Medicaid, 65% were private pay and 2% were self-pay.
Physician Supervision. In California, LMs are permitted to practice without the supervision of a physician. However, despite the fact that many states allow CNMs to practice independently, California is one of six states that still requires physician supervision of CNMs. California law specifies that the supervision shall not be construed to require the physical presence of the physician. It also requires that in order for a CNM to prescribe medication, a physician needs to be telephonically available.
According to the author, although the supervision requirement tethers CNMs to practice only where a physician can supervise, it does not consist of actual oversight of health care delivery, inspection or review of charts, co-signature on prescriptions, direct care of the patient or evaluation of CNM patients at any point during pregnancy or well-woman care.
Changes to CNMs' Scope of Practice. If this measure is enacted, a number of changes to the scope of practice for a CNM and authorization for a CNMs independent practice would be made. These include:
- Management of a full range of primary gynecological and obstetric care services for women from adolescence beyond menopause, including, but not limited to, primary care and gynecologic and family planning services.
- A CNM would no longer be required to adhere to standardized procedures and protocols when:
- Furnishing drugs or devices in connection with care rendered in a home;
- Procuring supplies and devices;
- Ordering, obtaining, and administering drugs and diagnostic tests;
- Ordering laboratory and diagnostic testing;
- Receiving reports that are necessary to his or her practice as a CNM;
- Performing and repairing episiotomies and to repair first-degree and second degree lacerations of the perineum in a patient's home; and,
- Providing emergency care to a patient during times when a physician and surgeon is unavailable.
ARGUMENTS IN SUPPORT:
The California Nurse Midwives Association (sponsor) writes in their letter of support, "AB 1306 provides no new authority for CNMs than they currently provide. It ensures they can practice as they currently do without physician supervision. …CNM attended births have documented excellent maternity care outcomes. …The excellent outcomes consistently achieved by nurse-midwives are the result of the midwifery model of care, not state-mandated relationships with physicians."
The California Association for Nurse Practitioners supports the bill and writes, "With the addition of millions of individuals to California's healthcare system due to ACA [Affordable Care Act] implementation, more healthcare providers are crucial to ensure quality, timely access to care. …AB 1306 will assist in addressing this problem by allowing nurse-midwives to work collaboratively with physicians to provide women's health care services across the state, including pregnancy and delivery care."
Access Women's Health Justice, Beach Cities Midwifery & Women's Health Care, Beachside Birth Center, California Association of Nurse Anesthetists, Yes2Kollege Education Resources, and the Women's Community Clinic, all similarly write in their support letters, "Physician collaboration is and has always been a hallmark of nurse-midwifery care and AB 1306 will not change that. …According to ACOG [American Congress of Obstetricians and Gynecologists], California is facing a workforce shortage of women's health care providers. …AB 1306 will not change the way that nurse-midwives currently practice and will not change the high quality of care provided by nurse-midwives."
ARGUMENTS IN OPPOSITION:
The California Medical Association (CMA) opposes the bill and writes, "The CMA believes that AB 1306 allows certified nurse midwives to independently engage in the practice of medicine and lacks several important patient protection statutes that include, but are not limited to: 1) the corporate practice of medicine, 2) self-referral and anti-kickback prohibitions, 3) standard of care and 4) prescribing oversight."
POLICY ISSUES FOR CONSIDERATION:
Examination Requirement. As highlighted by the opposition, this bill would authorize a CNM to work independently, without the supervision of a physician, and perform primary care services within the scope of gynecology. As such, the author may wish to amend the bill to include a requirement for an examination that would take place at the conclusion of the CNM's residency. This examination should include criteria similar to the United States Medical Licensing Examination, Step 3 which medical residents are required to take in order to show competency in practicing as an independent and unsupervised medical professional.
Corporate Practice of Medicine (CPM). The CPM is defined as any involvement of corporations in medicine. The CPM may also be defined more narrowly, for example, as the employment of a physician by a lay-controlled corporation that sells the services of the physician for a profit or provides the physician's services to its employees free of charge. The CPM now most commonly refers to the employment of physicians by hospitals, but is also still used to refer to employment of physicians by for-profit and non-profit corporate entities and government (see Business and Professions Code Section 2400).
Cross Collaboration Between Advisory Councils. This bill would impact the practice of CNMs. It would also create a Nurse Midwives Advisory Committee within the BRN. The MBC has a similar committee, the MBC Midwifery Advisory Council, which vets issues germane to the practice of midwifery. As such, it may be fruitful to require cross collaboration between the two committees as the practice of midwifery falls within the scope of practice for both CNMs and LMs.
Analysis Prepared by: Le Ondra Clark Harvey Ph.D. / B. & P. / (916) 319-3301 FN: 0003867
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB |
THIRD READING
Bill No: AB 1306
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 7-0, 6/27/16
AYES: Hill, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski
NO VOTE RECORDED: Bates, Gaines
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 78-1, 6/3/15 - See last page for vote
SOURCE: California Nurse Midwives Association
DIGEST: This bill removes physician supervision requirements for a Certified Nurse Midwife (CNM) as specified, modifies practice parameters, establishes a Nurse-Midwifery Advisory Committee (Committee) within the Board of Registered Nursing (BRN), and protects against retaliation for CNMs who advocate for appropriate health care for their patients, as specified, among other changes.
Existing law:
- The Nursing Practice Act provides for the licensure and regulation of the practice of nursing by the BRN and authorizes the BRN to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the BRN. (Business and Professions Code (BPC) §§ 2700 et seq.)
- Authorizes a CNM, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn. (BPC § 2746.5 (a))
- Provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal.
(BPC § 2746.5 (b)) - Authorizes a CNM to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the CNM's educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified. (BPC §§ 2746.51 et seq.)
- Authorizes the BRN to appoint a Nurse-Midwifery Committee of qualified physicians and nurses, including, but not limited to, obstetricians and nurse-midwives, to develop the necessary standards relating to educational requirements, ratios of nurse-midwives to supervising physicians, and associated matters. (BPC § 2746.2)Authorizes a CNM to furnish or order drugs or devices, including Schedule II-V controlled substances, pursuant to physician supervision, standardized procedures and protocols, and other conditions, as specified. (BPC § 2746.51)
This bill:
- Extends protections against retaliation to CNMs who advocate for patients’ appropriate health care.
- Prohibits CNMs from referring a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the CNM or his or her immediate family has a financial interest with the person or in the entity that receives the referral.
- States that, notwithstanding the prohibition on referrals, a CNM may refer a person to a licensed alternative birth center or to a nationally accredited alternative birth center, among other facilities, if the recipient of the referral does not compensate the CNM for the patient referral, and any equipment lease arrangement between the licensee and the referral recipient complies with specified requirements.
- Requires an applicant to acquire an advanced level national certification by a certifying body that meets standards established and approved by the BRN for certification as a nurse midwife.
- Requires the BRN to create the Committee to make recommendations to the BRN on all matters related to nurse-midwifery practice, education, and other matters as specified by the BRN.
- Requires the Committee to meet regularly, but at least twice per year.
- Specifies that the Committee shall consist of:
- A majority of CNMs in good standing with experience in hospital settings, alternative birth center settings, and home settings.
- A nurse-midwife educator who has demonstrated familiarity with educational standards in the delivery of maternal-child health care.
- A consumer of midwifery care.
- At least two qualified physicians, including an obstetrician that has experience working with nurse-midwives.
- Authorizes a CNM to manage a full range of primary gynecological and obstetric care services for women from adolescence to beyond menopause, consistent with the Core Competencies for Basic Midwifery practice promulgated by the American College of Nurse-Midwives, or its successor national professional organization, as approved by the BRN. These services include, but are not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, and treatment of male partners for sexually transmitted infections, utilizing consultation, collaboration, or referral to appropriate levels of health care services, as indicated.
- Authorizes a CNM to practice without supervision of a physician and surgeon in the following settings, and specifies that such entities shall not interfere with, control, or otherwise direct the professional judgment of a CNM, as specified:
- A licensed clinic, as specified.
- A facility, as specified,
- A medical group practice, including a professional medical corporation; a medical partnership; a medical foundation exempt from licensure, as specified; or another lawfully organized group of physicians that delivers, furnishes, or otherwise arranges for or provides health care services.
- A licensed alternative birth center, as specified, or nationally accredited birth center.
- A nursing corporation, as specified.
- A home setting.
- Limits a CNM to attend during a normal, low-risk pregnancy and childbirth in the home setting when all the following conditions apply:
- There is the absence of all of the following:
- Any preexisting maternal disease or condition creating risks beyond that of a normal, low-risk pregnancy or birth, as defined in the American College of Nurse-Midwives’ standard-setting documents and any future changes to those documents.
- Disease arising from or during the pregnancy creating risks beyond that of a normal, low-risk pregnancy or birth, as defined in the American College of Nurse-Midwives’ standard-setting documents and any future changes to those documents.
- Prior caesarean delivery.
- There is a singleton fetus.
- There is cephalic presentation at the onset of labor.
- The gestational age of the fetus is greater than 37 weeks 0/7 days and less than 42 weeks 0/7 days completed weeks of pregnancy at the onset of labor.
- Labor is spontaneous or induced in an outpatient setting.
- There is the absence of all of the following:
- States that if a potential CNM client meets the conditions specified in clauses (b) to (e) above, but fails to meet the conditions specified in (a) and the woman still desires to be a client of the CNM, the CNM shall provide the woman with a referral for an examination by a physician and surgeon trained in obstetrics and gynecology. A CNM may assist the woman in pregnancy and childbirth only if an examination by a physician and surgeon trained in obstetrics and gynecology is obtained and, based upon review of the client’s medical file, the CNM determines that the risk factors presented by the woman’s condition do not increase the woman’s risk beyond that of a normal, low-risk pregnancy and birth. The CNM may continue care of the client during a reasonable interval between the referral and the initial appointment with the physician and surgeon.
- States that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the patient and the resources and medical personnel available in the setting of care. It also emphasizes informed consent, preventive care, and early detection and referral of complications to physicians and surgeons. While practicing in a hospital setting, the CNM shall collaboratively care for women with more complex health needs.
- Requires a CNM to be subject to all credentialing and quality standards held by the facility in which he or she practices. The peer review body shall include nurse-midwives as part of the peer review body that reviews nurse-midwives. The peer review body of that facility shall impose standards that assure quality and patient safety in their facility. The standards shall be approved by the relevant governing body unless found by a court to be arbitrary and capricious.
- States that the practice of nurse-midwifery does not include the assisting of childbirth by any forcible or mechanical means or the performance of a version.
- Requires any regulations promulgated by a state department that affect the scope of practice of a CNM to be developed in consultation with the Committee.
- Prohibits any other law from being construed to prohibit a CNM from furnishing or ordering drugs or devices, including controlled substances classified in Schedule II, III, IV, or V under the California Uniform Controlled Substances Act, when the drugs or devices are furnished or ordered related to the provision of any of the following:
- Family planning services.
- Routine health care or perinatal care.
- Care rendered, consistent with the CNM’s educational preparation or for which clinical competency has been established and maintained, to persons within specified facilities.
- Care rendered in a home, as specified.
- Deletes references to standardized procedures and protocols and physician supervision for the furnishing of drugs and devices by CNMs, except that in a nonhospital setting, a Schedule II controlled substance shall be furnished by a CNM only during labor and delivery and only after a consultation with a physician and surgeon.
- Authorizes a CNM to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a CNM and consistent with nurse-midwifery education preparation.
- Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second-degree lacerations of the perineum in a nationally accredited birth center and in a home, as specified.
- States that a consultative relationship between a CNM and a physician and surgeon shall not, by itself, provide the basis for finding a physician and surgeon liable for any act or omission of the CNM.
- Makes clarifying and technical amendments.
Background
Certified Nurse Midwives (CNMs). CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. The nurse - midwifery certificate also authorizes the CNM to attend cases of normal childbirth, as well as immediate care for the newborn. Current law requires a CNM be licensed as a registered nurse and graduate from an approved program in nurse-midwifery. There are 1,271 CNMs in California.
A CNM may furnish drugs and devices after completing at least six months of physician supervised experience in the furnishing of drugs and devices and a course in pharmacology. “Furnishing” is the ordering of a drug or device in accordance with standardized procedure or protocol.
Standardized procedures are policies and protocols developed by a health facility or organized health care system, with input from administrators and health professionals, which establish parameters for medical care. Protocols are a part of standardized procedures and are designed to describe the steps of medical care for given patient situations. Protocols are developed in consultation with a supervising physician.
CNMs as Independent Practitioners. According to the U.S. Library of Medicine, CNMs are well positioned as primary care practitioners. “Many studies over the past 20 to 30 years have shown that [CNMs] can manage most perinatal (including prenatal, delivery, and postpartum) care. They are also qualified to deliver most family planning and gynecological needs of women of all ages.” Echoing this sentiment, the Center for the Health Professions at the University of California at San Francisco (UCSF) states that research generally confirms that care provided by CNMs is at least as safe as that from physicians and costs less.
However, current laws and regulations hamper the ability of CNMs to practice to the full extent of their training, limiting their potential impact. The dean of the UCSF School of Nursing, Kathleen Dracup, states “Primary care delivery has changed dramatically in the past 50 years, and for the better; we are living longer and more comfortably, and [advance practice nurses] are often the people who have provided the primary care in partnership with primary care doctors. If regulations around nurse practitioners and midwives are updated and outdated views of primary care change, that will provide one very promising pathway toward effective health care reform.”
CNMs have demonstrated an ability to play a key role in the delivery of primary healthcare to Californians, and this bill will release them to practice independently, enabling many more individuals to access needed care.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
California Nurse Midwives Association (source)
AARP
American Association of Birth Centers
American College of Nurse-Midwives
American Nurses Association/California
Association of California Healthcare Districts
Beach Cities Midwifery & Women’s Health Care
Beachside Birth Center
Black Women for Wellness
California Association for Nurse Practitioners
California Association of Midwives
California Association of Nurse Anesthetists, Inc.
California Hospital Association
Center on Reproductive Rights and Justice at the University of California, Berkeley School of Law
County of Santa Cruz Board of Supervisors
Inland Midwife Service
Maternal and Child Health Access
Numerous individuals
South Coast Midwifery & Women’s Healthcare, Inc.
United Nurses Associations of California/Union of Health Care Professionals
California Medical Association
Medical Board of California
ARGUMENTS IN SUPPORT: Writing in support of the bill, the California Association of Midwives, Maternal and Child Health Access (MCHA), Black Women for Wellness, the County of Santa Cruz Board of Supervisors, South Coast Midwifery & Women’s Healthcare, Inc., Beach Cities Midwifery & Women’s Health Care, Beachside Birth Center, the American Association of Birth Centers, AARP, the California Association of Nurse Anesthetists, Inland Midwife Service, and the Center on Reproductive Rights and Justice at the University of California, Berkeley School of Law state that AB 1306 separates the practice of nurse-midwives from physician practice, creating an opportunity for expansion of women’s health care services within their current scope of practice. These organizations state, “California is one of six remaining states to include physician supervision language, language which contradicts national and international standards. AB 1306 will not change the high quality of care provided by nurse-midwives nor the way that nurse-midwives currently practice. Removing state-mandated supervision would allow the nurse-midwife to partner collaboratively with physicians, expanding options beyond working as a physician’s employee. AB 1306 would directly and positively affect the California health care system by providing for improved physician and nurse-midwife collaboration and greater innovation in health care delivery.”
ARGUMENTS IN OPPOSITION: The California Medical Association (CMA) writes, “Since February 2015, the CMA has engaged in a productive stakeholder process with the author and the sponsors of AB 1306. This process resulted in collaboration and compromise by all those involved. Even though this bill reverses decades of California law that ensured high quality health care through physician supervision of allied health professionals, CMA adopted a neutral position because the bill contained provisions that helped ensure that CNMs could only practice independently in highly integrated settings such as acute care hospitals and clinics and that independently practicing CNMs are subject [to] the same patient and consumer protection laws that apply to practicing physicians. The latest amendments taken in Senate Business [Professions and Economic Development] Committee deleted the Corporate Practice of Medicine (CPM) bar language, which is a key component of these consumer protection measures.
“….the CMA believes that AB 1306 will likely result in increased cost[s] in our healthcare system. A University of Maryland Division of General Internal Medicine study called, “A Comparison of resource utilization in nurse practitioners and physicians, concluded that in a primary care setting, nurse practitioners may utilize more health care resources than physicians. The study compared health care resource utilization for adult patients assigned to a nurse practitioner with that for patients assigned to a resident or attending physicians. The reason for the disparity is that lower trained practitioners are less sure about their initial [diagnoses] and therefore order more tests and referrals than higher trained physicians.”
ASSEMBLY FLOOR: 78-1, 6/3/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
NOES: Beth Gaines
NO VOTE RECORDED: Mayes
8/3/16 18:06:32
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 1306 Hearing Date: June 27, 2016
Author: | Burke | ||
Version: |
| ||
Urgency: | Fiscal: | ||
Consultant: | |||
Subject: Healing arts: certified nurse-midwives: scope of practice
SUMMARY:
Removes certain physician supervision requirements for a Certified Nurse Midwife (CNM), increases educational requirements, modifies practice parameters, establishes a Nurse-Midwifery Advisory Committee within the Board of Registered Nursing (BRN), and subjects certified nurse midwives to the ban on the corporate practice of medicine, as specified, among other changes.
Existing law:
- The Nursing Practice Act provides for the licensure and regulation of the practice of nursing by the BRN and authorizes the BRN to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the BRN. (Business and Professions Code (BPC) §§ 2700 et seq.)
- Authorizes a CNM, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn. (BPC § 2746.5 (a))
- Provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal.
(BPC § 2746.5 (b)) - States that physician “supervision” shall not be construed to require the physical presence of the supervising physician. (BPC § 2746.5 (c))
- Authorizes a CNM to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the CNM's educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified. (BPC §§ 2746.51 et seq.)
- Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon. (BPC § 2746.52)
- Authorizes the BRN to appoint a Nurse-Midwifery Committee of qualified physicians and nurses, including, but not limited to, obstetricians and nurse-midwives, to develop the necessary standards relating to educational requirements, ratios of nurse-midwives to supervising physicians, and associated matters. (BPC § 2746.2)
- Authorizes a CNM to furnish or order drugs or devices, including Schedule II-V controlled substances, pursuant to physician supervision, standardized procedures and protocols, and other conditions, as specified. (BPC § 2746.51)
- Prohibits a physician from referring a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the physician or his or her immediate family has a financial interest with the person or in the entity that receives the referral. (BPC § 650.01)
- Requires a physician and surgeon’s certificate to practice medicine. (BPC § 2052)
- States that corporations and other artificial legal entities shall have no professional rights, privileges, or powers. Provides that the Medical Board of California (MBC) may in its discretion, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic. (BPC § 2400)
- Establishes exceptions to the ban on the corporate practice medicine, thereby allowing certain types of facilities to employ physicians. (BPC § 2401)
- Establishes the following protections against retaliation for health care practitioners who advocate for appropriate health care for their patients pursuant to Wickline v. State of California (192 Cal. App. 3d 1630): (BPC § 510)
- It is the public policy of the State of California that a health care practitioner be encouraged to advocate for appropriate health care for his or her patients. For purposes of this section, “to advocate for appropriate health care” means to appeal a payer’s decision to deny payment for a service pursuant to the reasonable grievance or appeal procedure established by a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff and governing body, or payer, or to protest a decision, policy, or practice that the health care practitioner, consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care, reasonably believes impairs the health care practitioner’s ability to provide appropriate health care to his or her patients.
- The application and rendering by any individual, partnership, corporation, or other organization of a decision to terminate an employment or other contractual relationship with or otherwise penalize a health care practitioner principally for advocating for appropriate health care consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care violates the public policy of this state.
- This law shall not be construed to prohibit a payer from making a determination not to pay for a particular medical treatment or service, or the services of a type of health care practitioner, or to prohibit a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff, hospital governing body, or payer from enforcing reasonable peer review or utilization review protocols or determining whether a health care practitioner has complied with those protocols.
This bill:
- Prohibits CNMs from referring a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the CNM or his or her immediate family has a financial interest with the person or in the entity that receives the referral.
- States that, notwithstanding the prohibition on referrals, a CNM may refer a person to a licensed alternative birth center or to a nationally accredited alternative birth center, among other facilities.
- Requires an applicant to acquire an advanced level national certification by a certifying body that meets standards established and approved by the BRN for certification as a nurse midwife.
- Requires the BRN to create and a Nurse-Midwifery Advisory Committee (Committee). States that the Committee shall make recommendations to the BRN on all matters related to nurse-midwifery practice, education, and other matters as specified by the BRN.
- Requires the Committee to meet regularly, but at least twice per year.
- Specifies that the Committee shall consist of:
- A majority of CNMs in good standing with experience in hospital settings, alternative birth center settings, and home settings.
- A nurse-midwife educator who has demonstrated familiarity with educational standards in the delivery of maternal-child health care.
- A consumer of midwifery care.
- At least two qualified physicians, including an obstetrician that has experience working with nurse-midwives.
- Prohibits corporations and other artificial legal entities from having any professional rights, privileges, or powers. However, the BRN may in its discretion, after such investigation and review of such documentary evidence as it may require, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for
professional services rendered patients is made by any such institution, foundation, or clinic. - Permits the following entities to employ a CNM and charge for professional services rendered by a CNM; however, the entity shall not interfere with, control, or otherwise direct the professional judgment of a CNM:
- A clinic operated by a nonprofit corporation as an entity organized and operated exclusively for scientific and charitable purposes.
- A hospital owned and operated by a health care district.
- A clinic operated primarily for the purpose of medical education or nursing education by a public or private nonprofit university medical school, which is approved by the MBC or the Osteopathic Medical Board of California, provided the CNM holds an academic appointment on the faculty of the university, including, but not limited to, the University of California medical schools and hospitals.
- A licensed alternative birth center, as specified, or a nationally accredited alternative birth center owned or operated by a nursing corporation, as specified.
- A health facility, as specified, if the CNM is practicing under the supervision of a physician and surgeon.
- A clinic, as specified.
- States that, for purposes of Item #8) above, that supervision shall not be construed to require the physical presence of a supervising physician and surgeon. States that a facility that employs a CNM shall not require supervision by a physician and surgeon of the CNM.
- Deletes references in current law to supervision by a physician and surgeon.
- Authorizes a CNM to manage a full range of primary gynecological and obstetric care services for women from adolescence to beyond menopause, consistent with the Core Competencies for Basic Midwifery practice promulgated by the American College of Nurse-Midwives, or its successor national professional organization, as approved by the BRN. These services include, but are not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, and treatment of male partners for sexually transmitted infections, utilizing consultation, collaboration, or referral to appropriate levels of health care services, as indicated.
- Authorizes permissible settings in which a CNM may practice, including the home, but a CNM may only attend during normal, low-risk pregnancy and childbirth when the following conditions apply:
- There is the absence of all of the following:
- Any preexisting maternal disease or condition creating risks beyond that of a normal, low-risk pregnancy or birth, as defined in the American College of Nurse-Midwives’ standard-setting documents and any future changes to those documents.
- Disease arising from or during the pregnancy creating risks beyond that of a normal, low-risk pregnancy or birth, as defined in the American College of Nurse-Midwives’ standard-setting documents and any future changes to those documents.
- Prior caesarean delivery.
- There is a singleton fetus.
- There is cephalic presentation at the onset of labor.
- The gestational age of the fetus is greater than 37 weeks 0/7 days and less than
42 weeks 0/7 days completed weeks of pregnancy at the onset of labor. - Labor is spontaneous or induced in an outpatient setting.
- There is the absence of all of the following:
- States that if a potential CNM client meets the conditions specified in clauses (b) to (e) above, but fails to meet the conditions specified in (a) and the woman still desires to be a client of the CNM, the CNM shall provide the woman with a referral for an examination by a physician and surgeon trained in obstetrics and gynecology. A CNM may assist the woman in pregnancy and childbirth only if an examination by a physician and surgeon trained in obstetrics and gynecology is obtained and, based upon review of the client’s medical file, the CNM determines that the risk factors presented by the woman’s condition do not increase the woman’s risk beyond that of a normal, low-risk pregnancy and birth. The CNM may continue care of the client during a reasonable interval between the referral and the initial appointment with the physician and surgeon.
- States that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the patient and the resources and medical personnel available in the setting of care. It also emphasizes informed consent, preventive care, and early detection and referral of complications to physicians and surgeons. While practicing in a hospital setting, the CNM shall collaboratively care for women with more complex health needs.
- Requires a CNM to be subject to all credentialing and quality standards held by the facility in which he or she practices. The peer review body shall include nurse-midwives as part of the peer review body that reviews nurse-midwives. The peer review body of that facility shall impose standards that assure quality and patient safety in their facility. The standards shall be approved by the relevant governing body unless found by a court to be arbitrary and capricious.
- Requires any regulations promulgated by a state department that affect the scope of practice of a CNM to be developed in consultation with the Committee.
- Deletes references to standardized procedures and protocols and physician supervision for the furnishing of drugs and devices by CNMs, except that in a nonhospital setting, a Schedule II controlled substance shall be furnished by a CNM only during labor and delivery and only after a consultation with a physician and surgeon.
- Authorizes a CNM to furnish or order drugs or devices related to the provision of care rendered in a home, as specified.
- Authorizes a CNM to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a CNM and consistent with nurse-midwifery education preparation.
- Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second-degree lacerations of the perineum in a home, as specified.
- States that a consultative relationship between a CNM and a physician and surgeon shall not, by itself, provide the basis for finding a physician and surgeon liable for any act or omission of the CNM.
- Makes clarifying and technical amendments.
FISCAL EFFECT:
This bill has been keyed “fiscal” by Legislative Counsel. According to the Assembly Appropriations Committee analysis dated May 13, 2015, this bill will result in minor costs to the BRN Fund for advisory committee meetings. The analysis notes that the potential impact on BRN enforcement costs resulting from the bill is unclear, but will likely be minor, as removing the requirement for supervision does not significantly change the practice of midwifery.
COMMENTS:
- Purpose. This bill is sponsored by the California Nurse Midwives Association. According to the Author’s office, “Approximately 1,200 CNMs are licensed in California by the BRN to practice midwifery – the care of childbearing women during pregnancy, labor and birth, and during the postpartum period. While most states allow CNMs to practice independently, California is one of only six states that require physician supervision of CNMs.
“California law requires a CNM to practice under the supervision of a physician, but specifies that the supervision requirement shall not be construed to require the physical presence of the physician. Although the supervision requirement tethers CNMs to practice only where a physician can supervise, it does not consist of actual oversight of health care delivery, inspection or review of charts, co-signatures on prescriptions, direct care of the patient, or evaluation of CNM patients at any point during pregnancy or well-woman care. In communities without obstetricians/ gynecologists, the supervision requirement limits access to care for women, even when a CNM is available to provide care.
“In 2013, the Legislature removed physician supervision of licensed midwives (LMs) AB 1308 , Bonilla, Chapter 665, Statutes of 2013). CNMs are required to have a higher level of education and training than LMs in order to qualify for licensure (licensed as a registered nurse and graduate of a Board-approved nurse-midwifery program), and yet are still subject to physician supervision to practice.
“AB 1306 allows CNMs to practice to the full extent of the education and training, without physician supervision. The bill keeps their existing scope of practice in place and aligns their education and practice requirements with national standards. In addition, the bill includes consumer protections to guard against kickbacks and self-referrals, as well as additional structure for CNMs serving patients in home and birth center settings.”
- CNMs. CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. The nurse - midwifery certificate also authorizes the CNM to attend cases of normal childbirth, as well as immediate care for the newborn. Current law requires a CNM be licensed as a registered nurse and graduate from an approved program in nurse-midwifery. There are 1,271 CNMs in California.
A CNM may furnish drugs and devices after completing at least six months of physician supervised experience in the furnishing of drugs and devices and a course in pharmacology. “Furnishing” is the ordering of a drug or device in accordance with standardized procedure or protocol.
Standardized procedures are policies and protocols developed by a health facility or organized health care system, with input from administrators and health professionals, which establish parameters for medical care. Protocols are a part of standardized procedures and are designed to describe the steps of medical care for given patient situations. Protocols are developed in consultation with a supervising physician.
This bill would remove the requirements of physician supervision and largely remove the restrictions on the independent furnishing of drugs and devices by CNMs.
- CNMs as Independent Practitioners. According to the U.S. Library of Medicine, CNMs are well positioned as primary care practitioners. “Many studies over the past 20 to 30 years have shown that [CNMs] can manage most perinatal (including prenatal, delivery, and postpartum) care. They are also qualified to deliver most family planning and gynecological needs of women of all ages.” Echoing this sentiment, the Center for the Health Professions at the University of California at San Francisco (UCSF) states that research generally confirms that care provided by CNMs is at least as safe as that from physicians and costs less.
However, current laws and regulations hamper the ability of CNMs to practice to the full extent of their training, limiting their potential impact. The dean of the UCSF School of Nursing, Kathleen Dracup, states “Primary care delivery has changed dramatically in the past 50 years, and for the better; we are living longer and more comfortably, and [advance practice nurses] are often the people who have provided the primary care in partnership with primary care doctors. If regulations around nurse practitioners and midwives are updated and outdated views of primary care change, that will provide one very promising pathway toward effective health care reform.”
CNMs have demonstrated an ability to play a key role in the delivery of primary healthcare to Californians, and this bill will release them to practice independently, enabling many more individuals to access needed care.
- Ban on the Corporate Practice of Medicine (CPM). This bill subjects CNMs to the ban on CPM, which previously has only been applied to physicians. CPM is usually referred to in the context of a prohibition, banning hospitals from employing physicians. The ban on CPM evolved in the early 20th century when mining companies had to hire physicians directly to provide care for their employees in remote areas. However, problems arose when physicians' loyalty to the mining companies conflicted with patients' needs. Eventually, physicians, courts, and legislatures prohibited CPM in an effort to preserve physicians' autonomy and improve patient care.
Over the years, various state and federal statutes have weakened the CPM prohibition. According to a 2007 report issued by the California Research Bureau, “California’s CPM doctrine has been defined largely through lawsuits and Attorney General opinions over decades, and then riddled by HMO and other legislation; its power and meaning are now inconsistent…. Although some non-profit clinics may employ physicians, California applies the CPM doctrine to most other entities.... Teaching hospitals may employ physicians, but other hospitals, including most public and non-profit hospitals, may not employ physicians. Professional medical corporations are expressly permitted to engage in the practice of medicine, and may employ physicians. [However, t]hese medical corporations may operate on a for-profit basis, although the profit motive was one of the original rationales of the CPM prohibition.” Indeed, the greatest cost pressures typically come from health insurers, and not the facilities themselves.
The following entities may currently employ physicians:
- A clinic operated primarily of the purpose of medical education by a public or private nonprofit university medical school.
- A clinic operated by a nonprofit corporation as an entity organized and operated exclusively for scientific and charitable purposes.
- A narcotic treatment program.
- A hospital owned and operated by a licensed charitable organization that offers only pediatric subspecialty care, as specified.
- A health maintenance organization (HMO).
California is one of only five remaining states that adhere to some form of the ban. The American Medical Association, historically the driving force behind the CPM prohibition, no longer views physician employment as a violation of medical ethics and has removed the doctrine from its ethical code.
- The Changing Healthcare Employment Landscape. The nationwide trend in healthcare is toward direct employment. According to a 2011 survey from the consulting firm Accenture:
“U.S. physicians continue to sell their private practices and seek employment with healthcare systems, according to a new survey from Accenture. As physicians migrate from private practice to larger health systems, the new landscape will require healthcare information technology (IT), medical device manufacturers, pharmaceutical companies and payers to revise their business models and offerings. At the same time, hospitals will need to determine how to retain and recruit the correct mix of physicians, especially in high-growth service lines, including cardiovascular care, orthopedics, cancer care and radiology. Patients will increasingly move to large health systems, as opposed to the current trend of visiting doctors in private, small practice settings.
“’Health reform is challenging the entire system to deliver improved care through insight driven health,’ said Kristin Ficery, senior executive, Accenture Health. ‘We see an increasing number of physicians leaving private practice to join hospital systems, which will force all stakeholders to revise and refine their business models, product offerings and service strategies.’”
Benefits to employment include:
- Relief from administrative responsibilities, especially those relating to insurance billing.
- Malpractice insurance.
- Greater access and support for healthcare IT tools, facilities, and medical equipment.
- A predictable work week.
- Economic stability.
These realities are the same facing CNMs, who are currently employed by hospitals and other facilities. CNMs would be unable to continue to realize the benefits of employment in many facilities according to the terms of this bill.
- Impact on Health Care Access. The potential impact of the ban on CPM for CNMs is not only on those currently employed; it will affect future employment opportunities for CNMs and consumers’ access to care.
California currently has a physician shortage. As of 2013, just 16 of California's 58 counties had the federal government's recommended supply of primary care physicians, with the Inland Empire and the San Joaquin Valley facing the worst shortages. In addition, nearly 30 percent of the state's doctors are nearing retirement age, the highest percentage in the nation, according to the Association of American Medical Colleges. There are not enough physicians in training, and certainly not enough physicians planning to specialize in primary care, to backfill this deficit.
If this bill only contained the elimination of the physician supervision requirement, it would likely result in the increased employment by hospitals and clinics of CNMs, given their versatility: CNMs can provide a wide range of services in a variety of settings, and facilities would no longer have to struggle to find physicians willing to supervise them. Particularly for rural hospitals and other areas where it is challenging to attract physicians, employing CNMs would be a desirable option for expanding hospitals’ and clinics’ ability to meet basic community needs.
However, restricting the employment opportunities for these practice types by including their services in the ban on CPM will necessarily limit healthcare access to those individuals who would otherwise receive their care.
- The Need for Equity in the Workplace Between CNMs and Physicians. Supporters of the CPM ban argue that it is necessary for equity in the workforce to subject any profession that becomes independent of physician supervision to be subject to the same business constraints as physicians.
This does not appear to be a valid argument in consideration of the following: - Physicians and CNMs have very different practice scopes. CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. The nurse - midwifery certificate also authorizes the CNM to attend cases of normal childbirth on his or her own responsibility, as well as immediate care for the newborn. CNM care includes preventative measures and the detection of abnormal conditions in mother and child, but CNMs cannot assist childbirth by any artificial, forcible, or mechanical means. CNMs are not authorized to perform surgery, although this bill will allow them to perform and repair episiotomies and first-degree and second-degree lacerations of the perineum in a home, as specified.
Obstetrician-gynecologists (OB/GYN) are physicians who possess special knowledge, skills and professional capability in the medical and surgical care of the female reproductive system and associated disorders. OB/GYNs are necessary for abnormal cases of pregnancy, advanced conditions, and surgeries. Resident education in obstetrics-gynecology must include four years of accredited, clinically-oriented graduate medical education, which must be focused on reproductive health care and ambulatory primary health care for women, including health maintenance, disease prevention, diagnosis, treatment, consultation, and referral.
There will always be a need for OB/GYNs, and while there will be some practice overlap in the provision of basic care, the professions are not, nor will they be, interchangeable.
- Physicians still have control of medical staffing decisions at hospitals and may not have incentives to hire physician extenders like CNMs. Current law requires that hospitals have a dual structure – an administrative governing body which oversees the hospital operations, and a medical staff which provides medical services and is generally responsible for ensuring that its members provide appropriate medical care to patients at the hospital.
In order to practice at a hospital, a physician must be granted privileges by the medical staff. To the extent that CNMs may provide some overlapping functions with OB/GYNs, hospitals may prefer to hire some CNMs in addition to OB/GYNs to handle cases of normal childbirth and provision of primary care. Because this bill would revoke employment by hospitals by CNMs, CNMs would have to apply for staff privileges from physicians. Given the nature of their overlapping scopes, it is likely that medical staff would be reluctant to replace or supplement OB/GYNs with CNMs.
- Arguments in Support. Writing in support of the bill, the California Association of Midwives, Maternal and Child Health Access (MCHA), Black Women for Wellness, the County of Santa Cruz Board of Supervisors, South Coast Midwifery & Women’s Healthcare, Inc., Beach Cities Midwifery & Women’s Health Care, Beachside Birth Center, the American Association of Birth Centers, AARP, the California Association of Nurse Anesthetists, Inland Midwife Service, and the Center on Reproductive Rights and Justice at the University of California, Berkeley School of Law state,
AB 1306 separates the practice of nurse-midwives from physician practice, creating an opportunity for expansion of women’s health care services within their current scope of practice. These organizations state that “California is one of six remaining states to include physician supervision language, language which contradicts national and international standards. AB 1306 will not change the high quality of care provided by nurse-midwives nor the way that nurse-midwives currently practice. Removing state-mandated supervision would allow the nurse-midwife to partner collaboratively with physicians, expanding options beyond working as a physician’s employee. AB 1306 would directly and positively affect the California health care system by providing for improved physician and nurse-midwife collaboration and greater innovation in health care delivery.”
The American College of Nurse-Midwives (ACNM) states, “California nurse-midwives are highly trained providers who earn graduate degrees and are trained in the disciplines of midwifery and nursing. AB 1306 would require all nurse-midwives to pass a national certification examination to demonstrate mastery of ACNM’s core competencies, which meet or exceed national recommendations for midwifery care, as a condition of licensure. Safe, quality health care can best be provided to women and their infants when policymakers permit CNMs to provide independent midwifery care within their scope of practice.”
The American Nurses Association/California, the California Association for Nurse Practitioners, the United Nurses Associations of California/Union of Health Care Professionals, and the California Nurse Midwife Association (CNMA) state that a CNM is an advanced practice nurse who is educated in Master’s Degree programs accredited by the American Commission on Midwifery Education through the US Department of Education and have a higher level of education and training than Licensed Midwives. According to these organizations, “with the increasing number of Californians insured under Covered California and the Affordable Care Act, there is a growing shortage of providers to meet the demand for primary care services. This bill untethers CNMs from physician supervision requirements to promote the expansion of primary health care access for thousands of women. In addition, the bill eliminated barriers that physicians encounter from malpractice carriers that prohibit them from supervising CNMs due to fears of vicarious liability.”
- Arguments in Opposition. The California Hospital Association, Ridgecrest Regional Hospital, Henry Mayo Newhall Hospital, San Gorgonio Memorial Hospital, San Benito Health Care District, Community Hospital of the Monterey Peninsula, Lompoc Valley Medical Center, Sutter Health, Sharp Healthcare, Watsonville Community Hospital, Natividad Medical Center, St. Helena Hospital Napa Valley, Mammoth Hospital, Coalinga Regional Medical Center, Ceders-Sinai, Lodi Health, El Camino Hospital, Adventist Health, and Loma Linda University Health state that their opposition is in response to the amendment that subjects CNMs to the ban on the corporate practice of medicine. These organizations state, “This corporate practice ban would prevent CNMs from being employed by hospitals, professional corporations, and most other employers that would like to make CNMs available to their patient population. The current ban in AB 1306 is more restrictive than provisions that exist for physicians. This restriction is an unnecessary and unreasonable barrier for employment of CNMs and hinders access to care for California women.”
The Medical Board of California has taken an oppose unless amended position, stating, “This bill does not have the same clear guidance and restrictions on what types of patients that [CNMs] can accept and does not clearly delineate when a patient should be transferred to a physician or require a physician consult for higher risk patients. Because this bill does not currently include parameters on independent CNM practice that would ensure consumer protection, the Board is opposed to this bill unless it is amended to address these concerns.”
The California Association of Clinical Nurse Specialists CACNS) writes, “While CACNS lauds this effort for CNMs to achieve full practice authority, the acceptance of amendments that will include the CPM ban will limit opportunities for Californians to access nurse midwifery services by placing undue restrictions on employment opportunities for CNMs…. Acceptance of the amendments for the CPM ban also assumes that CNMs practice Medicine. All nurses, regardless of role, practice Nursing. CNMs are educated and trained by nurses. Core competencies, scope, and standards of practice were created by and for CNMs, not physicians. The national certification exam was created by and for CNMs. CNMs have their own nursing science. Lastly, CNMs are licensed as nurses, not physicians. These fundamental distinctions are important to recognize since the CPM ban applies to the practice of Medicine….
“If the authors are willing to remove the employment components of the CPM ban and leave intact the spirit of the CPM ban that focuses on the prohibition of non-clinical corporations in the practice of nursing, then CACNS would be happy to reconsider our position on the bill.”
- Related Legislation. SB 323 (Hernandez) of 2015, would authorize a nurse practitioner who holds a national certification to practice without physician supervision in specified settings. (Status: This bill is pending reconsideration in the Assembly Business and Professions Committee.)
- Prior Related Legislation. SB 1308 (Bonilla, Chapter 665, Statutes of 2013) authorized a midwife to directly obtain supplies and devices, obtain and administer drugs and diagnostic tests, order testing and receive reports that are necessary to his/her practice of midwifery and consistent with his/her scope of practice; expanded the disclosures required to be made by a midwife to a prospective client to include the specific procedures that warrant consultation with a physician and surgeon; and made other correcting and conforming changes.
SB 1950 (Figueroa, Chapter 1085, Statutes of 2002) required the MBC to adopt regulations defining the appropriate standard of care and level of supervision required for the practice of midwifery.
SB 1479 (Figueroa, Chapter 303, Statutes of 2000) expanded the disclosures required to be given by licensed midwives and also required midwives to register birth certificates for home births.
SB 350 (Killea, Chapter 1280, Statutes of 1993) enacted the Licensed Midwifery Practice Act of 1993 to provide for the licensing and regulation of non-nurse and non-physician assistant midwives by the MBC.
SUPPORT AND OPPOSITION:
Support:
California Nurse Midwives Association (Sponsor)
Association of California Healthcare Districts
AARP
(7/1/15 version):
American Association of Birth Centers
American College of Nurse-Midwives
American Nurses Association/California
Beach Cities Midwifery & Women’s Health Care
Beachside Birth Center
Black Women for Wellness
California Association of Midwives
California Association of Nurse Anesthetists
Center on Reproductive Rights and Justice at the University of California, Berkeley
School of Law
County of Santa Cruz Board of Supervisors
Inland Midwife Service
Maternal and Child Health Access
South Coast Midwifery & Women’s Healthcare, Inc.
United Nurses Associations of California/Union of Health Care Professionals
Numerous individuals
Opposition:
Adventist Health
California Association for Nurse Practitioners
California Hospital Association
Sutter Health
(7/1/15 version):
California Association of Clinical Nurse Specialists
California Hospital Association
Ceders-Sinai
Coalinga Regional Medical Center
Community Hospital of the Monterey Peninsula
Corona Regional Medical Center
El Camino Hospital
Henry Mayo Newhall Hospital
Lodi Health
Loma Linda University Health
Lompoc Valley Medical Center
Mammoth Hospital
Medical Board of California
Natividad Medical Center
Ridgecrest Regional Hospital
San Antonio Regional Hospital
San Benito Health Care District
San Gorgonio Memorial Hospital
Sharp Healthcare
St. Helena Hospital Napa Valley
Watsonville Community Hospital
-- END --
AB 1306 (Burke) Page 15 of 15
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 1306 Hearing Date: July 13, 2015
Author: |
Burke |
||
Version: |
July 1, 2015 Amended |
||
Urgency: |
No |
Fiscal: |
Yes |
Consultant: |
Sarah Huchel |
||
Subject: Healing arts: certified nurse-midwives: scope of practice.
SUMMARY:
Removes physician supervision requirements for a Certified Nurse Midwife, increases educational requirements, establishes a Nurse-Midwifery Advisory Council within the Board of Registered Nursing, and subjects certified nurse midwives to the ban on the corporate practice of medicine, among other changes.
Existing law:
The Nursing Practice Act provides for the licensure and regulation of the practice of nursing by the Board of Registered Nursing (BRN) and authorizes the BRN to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the BRN. (Business and Professions Code (BPC) §§ 2700 et seq.)
Authorizes a Certified Nurse Midwife (CNM), under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn. (BPC § 2746.5 (a))
Provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal.
(BPC § 2746.5 (b))States that physician “supervision” shall not be construed to require the physical presence of the supervising physician. (BPC § 2746.5 (c))
Authorizes a CNM to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the CNM's educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified. (BPC §§ 2746.51 et seq.)
Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon. (BPC § 2746.52)
Authorizes the BRN to appoint a Nurse-Midwifery Committee of qualified physicians and nurses, including, but not limited to, obstetricians and nurse-midwives, to develop the necessary standards relating to educational requirements, ratios of nurse-midwives to supervising physicians, and associated matters. (BPC § 2746.2)
Authorizes a CNM to furnish or order drugs or devices, including Schedule II-V controlled substances, pursuant to physician supervision, standardized procedures and protocols, and other conditions, as specified. (BPC § 2746.51)
Prohibits a physician from referring a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the physician or his or her immediate family has a financial interest with the person or in the entity that receives the referral. (BPC § 650.01)
Requires a physician and surgeon’s certificate to practice medicine. (BPC § 2052)
States that corporations and other artificial legal entities shall have no professional rights, privileges, or powers. Provides that the Medical Board of California (MBC) may in its discretion, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic. (BPC § 2400)
Establishes exceptions to the ban on the corporate practice medicine, thereby allowing certain types of facilities to employ physicians. (BPC § 2401)
Establishes the following protections against retaliation for health care practitioners who advocate for appropriate health care for their patients pursuant to Wickline v. State of California (192 Cal. App. 3d 1630):
It is the public policy of the State of California that a health care practitioner be encouraged to advocate for appropriate health care for his or her patients. For purposes of this section, “to advocate for appropriate health care” means to appeal a payer’s decision to deny payment for a service pursuant to the reasonable grievance or appeal procedure established by a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff and governing body, or payer, or to protest a decision, policy, or practice that the health care practitioner, consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care, reasonably believes impairs the health care practitioner’s ability to provide appropriate health care to his or her patients.
The application and rendering by any individual, partnership, corporation, or other organization of a decision to terminate an employment or other contractual relationship with or otherwise penalize a health care practitioner principally for advocating for appropriate health care consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care violates the public policy of this state.
This law shall not be construed to prohibit a payer from making a determination not to pay for a particular medical treatment or service, or the services of a type of health care practitioner, or to prohibit a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff, hospital governing body, or payer from enforcing reasonable peer review or utilization review protocols or determining whether a health care practitioner has complied with those protocols. (BPC § 510)
This
bill:
Prohibits CNMs from referring a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the CNM or his or her immediate family has a financial interest with the person or in the entity that receives the referral.
States that, notwithstanding the prohibition on referrals, a CNM may refer a person to a licensed alternative birth center or to a nationally accredited alternative birth center, among other facilities.
Requires an applicant to acquire an advanced level national certification by a certifying body that meets standards established and approved by the BRN for certification as a nurse midwife.
Deletes the authorization for the BRN to appoint a Nurse-Midwifery Committee, and instead requires the BRN to create and appoint, with assistance from the MBC, a Nurse-Midwifery Advisory Council (Council). States that the Council shall make recommendations to the BRN on all matters related to nurse-midwifery practice, education, and other matters as specified by the BRN.
Requires the Council to meet regularly, but at least twice per year.
Specifies that the Council shall consist of:
A majority of CNMs in good standing with experience in hospital settings, alternative birth center settings, and home settings.
A nurse-midwife educator who has demonstrated familiarity with educational standards in the delivery of maternal-child health care.
A consumer of midwifery care.
At least two qualified physicians appointed by the MBC, including an obstetrician that has experience working with nurse-midwives.
Prohibits corporations and other artificial legal entities from having any professional rights, privileges, or powers. However, the BRN may in its discretion, after such investigation and review of such documentary evidence as it may require, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic.
Permits the following entities to employ a CNM and charge for professional services rendered by a CNM; however, the entity shall not interfere with, control, or otherwise direct the professional judgment of a certified nurse-midwife:
A clinic operated by a nonprofit corporation as an entity organized and operated exclusively for scientific and charitable purposes.
A hospital owned and operated by a health care district.
A clinic operated primarily for the purpose of medical education or nursing education by a public or private nonprofit university medical school, which is approved by the MBC or the Osteopathic Medical Board of California, provided the CNM holds an academic appointment on the faculty of the university, including, but not limited to, the University of California medical schools and hospitals.
A licensed alternative birth center, as specified, or a nationally accredited alternative birth center owned or operated by a nursing corporation, as specified.
Deletes references in current law to supervision by a physician and surgeon.
Authorizes a CNM to manage a full range of primary gynecological and obstetric care services for women from adolescence to beyond menopause, consistent with the Core Competencies for Basic Midwifery practice promulgated by the American College of Nurse-Midwives, or its successor national professional organization, as approved by the BRN. These services include, but are not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, and treatment of male partners for sexually transmitted infections, utilizing consultation, collaboration, or referral to appropriate levels of health care services, as indicated.
Authorizes permissible settings in which a CNM may practice, including the home, but only when the following conditions apply:
There is the absence of all of the following:
Any preexisting maternal disease or condition likely to complicate the pregnancy.
Disease arising from the pregnancy likely to cause significant maternal and/or fetal compromise.
Prior caesarean delivery.
There is a singleton fetus.
There is cephalic presentation at the onset of labor.
The gestational age of the fetus is greater than 37 weeks 0/7 days and less than
42 weeks 0/7 days completed weeks of pregnancy at the onset of labor.
Labor is spontaneous or induced in an outpatient setting.
States that if a potential CNM client meets the conditions specified in clauses (b) to (e) above, but fails to meet the conditions specified in (a) and the woman still desires to be a client of the CNM, the CNM shall consult with a physician and surgeon trained in obstetrics and gynecology. A CNM may assist the woman in pregnancy and childbirth only if a physician and surgeon trained in obstetrics and gynecology is consulted and the physician and surgeon who performed the consultation determines that the risk factors presented by her disease or condition are not likely to significantly affect the course of pregnancy and childbirth.
States that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the patient and the resources and medical personnel available in the setting of care. It also emphasizes informed consent, preventive care, and early detection and referral of complications to physicians and surgeons. While practicing in a hospital setting, the certified nurse-midwife shall collaboratively care for women with more complex health needs.
Requires a CNM to be subject to all credentialing and quality standards held by the facility in which he or she practices. The peer review body shall include nurse-midwives as part of the peer review body that reviews nurse-midwives. The peer review body of that facility shall impose standards that assure quality and patient safety in their facility. The standards shall be approved by the relevant governing body unless found by a court to be arbitrary and capricious.
Requires any regulations promulgated by a state department that affect the scope of practice of a CNM to be developed in consultation with the Council.
Deletes references to standardized procedures and protocols and physician supervision for the furnishing of drugs and devices by CNMs, except that in a nonhospital setting, a Schedule II controlled substance shall be furnished by a CNM only during labor and delivery and only after a consultation with a physician and surgeon.
Authorizes a CNM to furnish or order drugs or devices related to the provision of care rendered in a home, as specified.
Authorizes a CNM to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a CNM and consistent with nurse-midwifery education preparation.
Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second-degree lacerations of the perineum in a home, as specified.
States that a consultative relationship between a CNM and a physician and surgeon shall not, by itself, provide the basis for finding a physician and surgeon liable for any act or omission of the CNM.
Makes clarifying and technical amendments.
FISCAL EFFECT:
This bill has been keyed “fiscal” by Legislative Counsel. According to the Assembly Appropriations Committee analysis dated May 13, 2015, this bill will result in minor costs to the BRN Fund for advisory council meetings. The analysis notes that the potential impact on BRN enforcement costs resulting from the bill is unclear, but will likely be minor, as removing the requirement for supervision does not significantly change the practice of midwifery.
COMMENTS:
Purpose. This bill is sponsored by the California Nurse Midwives Association. According to the Author’s office, “Approximately 1,200 CNMs are licensed in California by the BRN to practice midwifery – the care of childbearing women during pregnancy, labor and birth, and during the postpartum period. While most states allow CNMs to practice independently, California is one of only six states that require physician supervision of CNMs.
“California law requires a CNM to practice under the supervision of a physician, but specifies that the supervision requirement shall not be construed to require the physical presence of the physician. Although the supervision requirement tethers CNMs to practice only where a physician can supervise, it does not consist of actual oversight of health care delivery, inspection or review of charts, co-signatures on prescriptions, direct care of the patient, or evaluation of CNM patients at any point during pregnancy or well-woman care. In communities without obstetricians/ gynecologists, the supervision requirement limits access to care for women, even when a CNM is available to provide care.
“In 2013, the Legislature removed physician supervision of licensed midwives (LMs) (AB 1308, Bonilla, Chapter 665, Statutes of 2013). CNMs are required to have a higher level of education and training than LMs in order to qualify for licensure (licensed as a registered nurse and graduate of a Board-approved nurse-midwifery program), and yet are still subject to physician supervision to practice.
“AB 1306 allows CNMs to practice to the full extent of the education and training, without physician supervision. The bill keeps their existing scope of practice in place and aligns their education and practice requirements with national standards. In addition, the bill includes consumer protections to guard against kickbacks and self-referrals, as well as additional structure for CNMs serving patients in home and birth center settings.”
CNMs. CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. The nurse - midwifery certificate also authorizes the CNM to attend cases of normal childbirth, as well as immediate care for the newborn. Current law requires a CNM be licensed as a registered nurse and graduate from an approved program in nurse-midwifery. There are 1,271 CNMs in California.
A CNM may furnish drugs and devices after completing at least six months of physician supervised experience in the furnishing of drugs and devices and a course in pharmacology. “Furnishing” is the ordering of a drug or device in accordance with standardized procedure or protocol.
Standardized procedures are policies and protocols developed by a health facility or organized health care system, with input from administrators and health professionals, which establish parameters for medical care. Protocols are a part of standardized procedures and are designed to describe the steps of medical care for given patient situations. Protocols are developed in consultation with a supervising physician.
This bill would remove the requirements of physician supervision and largely remove the restrictions on the independent furnishing of drugs and devices by CNMs.
CNMs as Independent Practitioners. According to the U.S. Library of Medicine, CNMs are well positioned as primary care practitioners. “Many studies over the past 20 to 30 years have shown that [CNMs] can manage most perinatal (including prenatal, delivery, and postpartum) care. They are also qualified to deliver most family planning and gynecological needs of women of all ages.” Echoing this sentiment, the Center for the Health Professions at the University of California at San Francisco (UCSF) states that research generally confirms that care provided by CNMs is at least as safe as that from physicians and costs less.
However, current laws and regulations hamper the ability of CNMs to practice to the full extent of their training, limiting their potential impact. The dean of the UCSF School of Nursing, Kathleen Dracup, states “Primary care delivery has changed dramatically in the past 50 years, and for the better; we are living longer and more comfortably, and [advance practice nurses] are often the people who have provided the primary care in partnership with primary care doctors. If regulations around nurse practitioners and midwives are updated and outdated views of primary care change, that will provide one very promising pathway toward effective health care reform.”
CNMs have demonstrated an ability to play a key role in the delivery of primary healthcare to Californians, and this bill will release them to practice independently, enabling many more individuals to access needed care.
Ban on the Corporate Practice of Medicine (CPM). This bill subjects CNMs to the ban on CPM, which previously has only been applied to physicians. CPM is usually referred to in the context of a prohibition, banning hospitals from employing physicians. The ban on CPM evolved in the early 20th century when mining companies had to hire physicians directly to provide care for their employees in remote areas. However, problems arose when physicians' loyalty to the mining companies conflicted with patients' needs. Eventually, physicians, courts, and legislatures prohibited CPM in an effort to preserve physicians' autonomy and improve patient care.
Over the years, various state and federal statutes have weakened the CPM prohibition. According to a 2007 report issued by the California Research Bureau, “California’s CPM doctrine has been defined largely through lawsuits and Attorney General opinions over decades, and then riddled by HMO and other legislation; its power and meaning are now inconsistent…. Although some non-profit clinics may employ physicians, California applies the CPM doctrine to most other entities.... Teaching hospitals may employ physicians, but other hospitals, including most public and non-profit hospitals, may not employ physicians. Professional medical corporations are expressly permitted to engage in the practice of medicine, and may employ physicians. [However, t]hese medical corporations may operate on a for-profit basis, although the profit motive was one of the original rationales of the CPM prohibition.” Indeed, the greatest cost pressures typically come from health insurers, and not the facilities themselves.
The following entities may currently employ physicians:
A clinic operated primarily of the purpose of medical education by a public or private nonprofit university medical school.
A clinic operated by a nonprofit corporation as an entity organized and operated exclusively for scientific and charitable purposes.
A narcotic treatment program.
A hospital owned and operated by a licensed charitable organization that offers only pediatric subspecialty care, as specified.
A health maintenance organization (HMO).
California is one of only five remaining states that adhere to some form of the ban. The American Medical Association, historically the driving force behind the CPM prohibition, no longer views physician employment as a violation of medical ethics and has removed the doctrine from its ethical code.
The Changing Healthcare Employment Landscape. The nationwide trend in healthcare is toward direct employment. According to a 2011 survey from the consulting firm Accenture:
“U.S. physicians continue to sell their private practices and seek employment with healthcare systems, according to a new survey from Accenture. As physicians migrate from private practice to larger health systems, the new landscape will require healthcare information technology (IT), medical device manufacturers, pharmaceutical companies and payers to revise their business models and offerings. At the same time, hospitals will need to determine how to retain and recruit the correct mix of physicians, especially in high-growth service lines, including cardiovascular care, orthopedics, cancer care and radiology. Patients will increasingly move to large health systems, as opposed to the current trend of visiting doctors in private, small practice settings.
“’Health reform is challenging the entire system to deliver
improved care through insight driven health,’ said Kristin
Ficery, senior executive, Accenture Health. ‘We see an
increasing number of physicians leaving private practice to join
hospital systems, which will force all stakeholders to revise and
refine their business models, product offerings and service
strategies.’”
Benefits to employment include:
Relief from administrative responsibilities, especially those relating to insurance billing.
Malpractice insurance.
Greater access and support for healthcare IT tools, facilities, and medical equipment.
A predictable work week.
Economic stability.
These realities are the same facing CNMs, who are currently employed by hospitals and other facilities. CNMs would be unable to continue to realize the benefits of employment in many facilities according to the terms of this bill.
Impact on Health Care Access. The potential impact of the ban on CPM for CNMs is not only on those currently employed; it will affect future employment opportunities for CNMs and consumers’ access to care.
California currently has a physician shortage. As of 2013, just 16 of California's 58 counties had the federal government's recommended supply of primary care physicians, with the Inland Empire and the San Joaquin Valley facing the worst shortages. In addition, nearly 30 percent of the state's doctors are nearing retirement age, the highest percentage in the nation, according to the Association of American Medical Colleges. There are not enough physicians in training, and certainly not enough physicians planning to specialize in primary care, to backfill this deficit.
If this bill only contained the elimination of the physician supervision requirement, it would likely result in the increased employment by hospitals and clinics of CNMs, given their versatility: CNMs can provide a wide range of services in a variety of settings, and facilities would no longer have to struggle to find physicians willing to supervise them. Particularly for rural hospitals and other areas where it is challenging to attract physicians, employing CNMs would be a desirable option for expanding hospitals’ and clinics’ ability to meet basic community needs.
However, restricting the employment opportunities for these practice types by including their services in the ban on CPM will necessarily limit healthcare access to those individuals who would otherwise receive their care.
The Need for Equity in the Workplace Between CNMs and Physicians. Supporters of the CPM ban argue that it is necessary for equity in the workforce to subject any profession that becomes independent of physician supervision to be subject to the same business constraints as physicians.
This does not appear to be a valid argument in consideration of the following:
Physicians and CNMs have very different practice scopes. CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. The nurse - midwifery certificate also authorizes the CNM to attend cases of normal childbirth on his or her own responsibility, as well as immediate care for the newborn. CNM care includes preventative measures and the detection of abnormal conditions in mother and child, but CNMs cannot assist childbirth by any artificial, forcible, or mechanical means. CNMs are not authorized to perform surgery, although this bill will allow them to perform and repair episiotomies and first-degree and second-degree lacerations of the perineum in a home, as specified.
Obstetrician-gynecologists (OB/GYN) are physicians who possess special knowledge, skills and professional capability in the medical and surgical care of the female reproductive system and associated disorders. OB/GYNs are necessary for abnormal cases of pregnancy, advanced conditions, and surgeries. Resident education in obstetrics-gynecology must include four years of accredited, clinically-oriented graduate medical education, which must be focused on reproductive health care and ambulatory primary health care for women, including health maintenance, disease prevention, diagnosis, treatment, consultation, and referral.
There will always be a need for OB/GYNs, and while there will be some practice overlap in the provision of basic care, the professions are not, nor will they be, interchangeable.
Physicians still have control of medical staffing decisions at hospitals and may not have incentives to hire physician extenders like CNMs.
Current law requires that hospitals have a dual structure – an administrative governing body which oversees the hospital operations, and a medical staff which provides medical services and is generally responsible for ensuring that its members provide appropriate medical care to patients at the hospital.
In order to practice at a hospital, a physician must be granted privileges by the medical staff. To the extent that CNMs may provide some overlapping functions with OB/GYNs, hospitals may prefer to hire some CNMs in addition to OB/GYNs to handle cases of normal childbirth and provision of primary care. Because this bill would revoke employment by hospitals by CNMs, CNMs would have to apply for staff privileges from physicians. Given the nature of their overlapping scopes, it is likely that medical staff would be reluctant to replace or supplement OB/GYNs with CNMs.
Arguments in Support. Writing in support of the bill, the California Association of Midwives, Maternal and Child Health Access (MCHA), Black Women for Wellness, the County of Santa Cruz Board of Supervisors, South Coast Midwifery & Women’s Healthcare, Inc., Beach Cities Midwifery & Women’s Health Care, Beachside Birth Center, the American Association of Birth Centers, AARP, the California Association of Nurse Anesthetists, Inland Midwife Service, and the Center on Reproductive Rights and Justice at the University of California, Berkeley School of Law state,
AB 1306 separates the practice of nurse-midwives from physician practice, creating an opportunity for expansion of women’s health care services within their current scope of practice. These organizations state that “California is one of six remaining states to include physician supervision language, language which contradicts national and international standards. AB 1306 will not change the high quality of care provided by nurse-midwives nor the way that nurse-midwives currently practice. Removing state-mandated supervision would allow the nurse-midwife to partner collaboratively with physicians, expanding options beyond working as a physician’s employee. AB 1306 would directly and positively affect the California health care system by providing for improved physician and nurse-midwife collaboration and greater innovation in health care delivery.”
The American College of Nurse-Midwives (ACNM) states, “California nurse-midwives are highly trained providers who earn graduate degrees and are trained in the disciplines of midwifery and nursing. AB 1306 would require all nurse-midwives to pass a national certification examination to demonstrate mastery of ACNM’s core competencies, which meet or exceed national recommendations for midwifery care, as a condition of licensure. Safe, quality health care can best be provided to women and their infants when policymakers permit CNMs to provide independent midwifery care within their scope of practice.”
The American Nurses Association/California, the California Association for Nurse Practitioners, the United Nurses Associations of California/Union of Health Care Professionals, and the California Nurse Midwife Association (CNMA) state that a CNM is an advanced practice nurse who is educated in Master’s Degree programs accredited by the American Commission on Midwifery Education through the US Department of Education and have a higher level of education and training than Licensed Midwives. According to these organizations, “with the increasing number of Californians insured under Covered California and the Affordable Care Act, there is a growing shortage of providers to meet the demand for primary care services. This bill untethers CNMs from physician supervision requirements to promote the expansion of primary health care access for thousands of women. In addition, the bill eliminated barriers that physicians encounter from malpractice carriers that prohibit them from supervising CNMs due to fears of vicarious liability.”
Arguments in Opposition. The California Hospital Association, Ridgecrest Regional Hospital, Henry Mayo Newhall Hospital, San Gorgonio Memorial Hospital, San Benito Health Care District, Community Hospital of the Monterey Peninsula, Lompoc Valley Medical Center, Sutter Health, Sharp Healthcare, Watsonville Community Hospital, Natividad Medical Center, St. Helena Hospital Napa Valley, Mammoth Hospital, Coalinga Regional Medical Center, Ceders-Sinai, Lodi Health, El Camino Hospital, Adventist Health, and Loma Linda University Health state that their opposition is in response to the amendment that subjects CNMs to the ban on the corporate practice of medicine. These organizations state, “This corporate practice ban would prevent CNMs from being employed by hospitals, professional corporations, and most other employers that would like to make CNMs available to their patient population. The current ban in AB 1306 is more restrictive than provisions that exist for physicians. This restriction is an unnecessary and unreasonable barrier for employment of CNMs and hinders access to care for California women.”
The Medical Board of California has taken an oppose unless amended position, stating, “This bill does not have the same clear guidance and restrictions on what types of patients that [CNMs] can accept and does not clearly delineate when a patient should be transferred to a physician or require a physician consult for higher risk patients. Because this bill does not currently include parameters on independent CNM practice that would ensure consumer protection, the Board is opposed to this bill unless it is amended to address these concerns.”
The California Association of Clinical Nurse Specialists CACNS) writes, “While CACNS lauds this effort for CNMs to achieve full practice authority, the acceptance of amendments that will include the CPM ban will limit opportunities for Californians to access nurse midwifery services by placing undue restrictions on employment opportunities for CNMs…. Acceptance of the amendments for the CPM ban also assumes that CNMs practice Medicine. All nurses, regardless of role, practice Nursing. CNMs are educated and trained by nurses. Core competencies, scope, and standards of practice were created by and for CNMs, not physicians. The national certification exam was created by and for CNMs. CNMs have their own nursing science. Lastly, CNMs are licensed as nurses, not physicians. These fundamental distinctions are important to recognize since the CPM ban applies to the practice of Medicine….
“If the authors are willing to remove the employment components of the CPM ban and leave intact the spirit of the CPM ban that focuses on the prohibition of non-clinical corporations in the practice of nursing, then CACNS would be happy to reconsider our position on the bill.”
Related Legislation This Year. SB 323 (Hernandez) of 2015, would authorize a nurse practitioner who holds a national certification to practice without physician supervision in specified settings. (Status: This bill is pending reconsideration in the Assembly Business and Professions Committee.)
Prior Related Legislation. SB 1308 (Bonilla, Chapter 665, Statutes of 2013) authorized a midwife to directly obtain supplies and devices, obtain and administer drugs and diagnostic tests, order testing and receive reports that are necessary to his/her practice of midwifery and consistent with his/her scope of practice; expanded the disclosures required to be made by a midwife to a prospective client to include the specific procedures that warrant consultation with a physician and surgeon; and made other correcting and conforming changes.
SB 1950 (Figueroa, Chapter 1085, Statutes of 2002) required
the MBC to adopt regulations defining the appropriate standard of
care and level of supervision required for the practice of
midwifery.
SB 1479 (Figueroa, Chapter 303, Statutes
of 2000) expanded the disclosures required to be given by licensed
midwives and also required midwives to register birth certificates
for home births.
SB 350 (Killea, Chapter 1280,
Statutes of 1993) enacted the Licensed Midwifery Practice Act of 1993
to provide for the licensing and regulation of non-nurse and
non-physician assistant midwives by the MBC.
Suggested Amendments.
Expand Exemptions to the Ban on CPM for CNMs. Until a more comprehensive debate on the merits of the ban on CPM as it relates to all health professions is undertaken, it is recommended that exemptions for nonprofit clinics and hospitals be added to this bill to ensure the provision of basic healthcare services to underserved individuals. The exemption for nonprofit entities would avoid the conflict of interest that detractors argue is inherent in a for-profit, non-medical employer situation.
On page 14, between lines 16 and 17, insert:
“A clinic operated under subdivision (a) of Section 1204 of the Health and Safety Code”
On page 14, between lines 21 and 22, insert:
“A nonprofit hospital, as defined in Section 129405 of the Health and Safety Code”
Remove References to the Medical Board of California. This bill deletes the authorization for the BRN to appoint a Nurse-Midwifery Committee, and instead requires the BRN to create and appoint a Nurse-Midwifery Advisory Council, at least two members of which would be qualified physicians appointed by the MBC, including an obstetrician that has experience working with nurse-midwives.
There is no precedent for DCA boards to have appointment authority over the composition of another board’s committee. BRN is capable of appointing physician members to the Council proposed in this bill and as such, language referencing a MBC appointment should be removed.
On page 13, line 36, strike “appointed by the Medical Board of California”
Technical Amendments Regarding Home Birth Conditions. The following language would provide greater semantic clarity to the circumstances in which a CNM may attend a home birth.
On page 15, line 39, strike “likely” and add “with the potential”
On page 15, line 40, add “or birth” after pregnancy.
On page 16, line 1, after “from” add “or during,” strike “likely” and add “with the potential”
On page 16, line 2, strike “significant”
On page 16, line 6, after “is” add “equal to or” and replace “370/7” with “37 0/7”
On page 16, line 7, add a space between “42” and “0/7”
Other Technical Amendments: The following amendments correct consistency and drafting concerns:
On page 17, line 5, delete the comma after “forcible”
On page 15, line 6, delete “of those means”
On page 12, line 32, after “1204 of” add “or within an alternative birth center as defined in subdivision (b)(4) of Section 1204 of,”
On page 14, line 24, after Board, add “of California”
On page 14, line 25, after “of California,” add “or the Board of Registered Nursing”
On page 14, line 28, after “schools” add “, nursing schools,”
SUPPORT AND OPPOSITION:
Support:
California Nurse Midwives Association (Sponsor)
American Association of Birth Centers
American College of Nurse-Midwives
American Nurses Association/California
Beach Cities Midwifery & Women’s Health Care
Beachside Birth Center
Black Women for Wellness
California Association of Midwives
California Association of Nurse Anesthetists
Center on Reproductive Rights and Justice at the University of California, Berkeley
School of Law
County of Santa Cruz Board of Supervisors
Inland Midwife Service
Maternal and Child Health Access
South Coast Midwifery & Women’s Healthcare, Inc.
United Nurses Associations of California/Union of Health Care Professionals
Numerous individuals
Opposition:
AARP
Adventist Health
Association of California Healthcare Districts
California Association of Clinical Nurse Specialists
California Association for Nurse Practitioners
California Hospital Association
Ceders-Sinai
Coalinga Regional Medical Center
Community Hospital of the Monterey Peninsula
Corona Regional Medical Center
El Camino Hospital
Henry Mayo Newhall Hospital
Lodi Health
Loma Linda University Health
Lompoc Valley Medical Center
Mammoth Hospital
Medical Board of California
Natividad Medical Center
Ridgecrest Regional Hospital
San Antonio Regional Hospital
San Benito Health Care District
San Gorgonio Memorial Hospital
Sharp Healthcare
St. Helena Hospital Napa Valley
Sutter Health
Watsonville Community Hospital
-- END --
AB 1306 (Burke) Page 15 of 15
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 1306 Hearing Date: July 6, 2015
Author: |
Burke |
||
Version: |
July 1, 2015 Click here to enter text. |
||
Urgency: |
No |
Fiscal: |
Yes |
Consultant: |
Sarah Huchel |
||
Subject: Healing arts: certified nurse-midwives: scope of practice
SUMMARY:
Removes physician supervision requirements for a Certified Nurse Midwife (CNM), increases educational requirements, establishes a Nurse-Midwifery Advisory Council within the Board of Registered Nursing (BRN), and subjects CNMs to the ban on the corporate practice of medicine, among other changes.
Existing law:
The Nursing Practice Act, provides for the licensure and regulation of the practice of nursing by the Board of Registered Nursing (BRN), within the Department of Consumer Affairs (DCA), and authorizes the BRN to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the BRN or the equivalent of those educational standards. (Business and Professions Code (BPC) §§ 2700 et seq.)
Authorizes a CNM, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn. (BPC § 2746.5 (a))
Provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal. (BPC § 2746.5 (b))
States that physician “supervision” shall not be construed to require the physical presence of the supervising physician. (BPC § 2746.5 (c))
Authorizes a CNM to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the CNM's educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified. (BPC § 2746.51 et seq.)
Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center, if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon. (BPC § 2746.52)
Authorizes the BRN to appoint a Nurse-Midwifery Committee of qualified physicians and nurses, including, but not limited to, obstetricians and nurse-midwives, to develop the necessary standards relating to educational requirements, ratios of nurse-midwives to supervising physicians, and associated matters. (BPC § 2746.2)
Authorizes a CNM to furnish or order drugs or devices, including Schedule II-V controlled substances, pursuant to physician supervision, standardized procedures and protocols, and other conditions, as specified. (BPC § 2746.51)
Prohibits a physician from referring a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the physician or his or her immediate family has a financial interest with the person or in the entity that receives the referral. (BPC § 650.01)
Requires a physician and surgeon’s certificate to practice medicine. (BPC § 2052)
States that corporations and other artificial legal entities shall have no professional rights, privileges, or powers. Provides that the Medical Board of California (MBC) may in its discretion, after such investigation and review of such documentary evidence as it may require, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic. (BPC § 2400)
Establishes exceptions to the ban on the corporate practice medicine, thereby allowing certain types of facilities to employ physicians. (BPC § 2401)
Establishes the following protections against retaliation for health care practitioners who advocate for appropriate health care for their patients pursuant to Wickline v. State of California (192 Cal. App. 3d 1630):
It is the public policy of the State of California that a health care practitioner be encouraged to advocate for appropriate health care for his or her patients. For purposes of this section, “to advocate for appropriate health care” means to appeal a payer’s decision to deny payment for a service pursuant to the reasonable grievance or appeal procedure established by a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff and governing body, or payer, or to protest a decision, policy, or practice that the health care practitioner, consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care, reasonably believes impairs the health care practitioner’s ability to provide appropriate health care to his or her patients.
The application and rendering by any individual, partnership, corporation, or other organization of a decision to terminate an employment or other contractual relationship with or otherwise penalize a health care practitioner principally for advocating for appropriate health care consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care violates the public policy of this state.
This law shall not be construed to prohibit a payer from making a determination not to pay for a particular medical treatment or service, or the services of a type of health care practitioner, or to prohibit a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff, hospital governing body, or payer from enforcing reasonable peer review or utilization review protocols or determining whether a health care practitioner has complied with those protocols. (BPC § 510)
This
bill:
Subjects CNMs to the prohibition on referring a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the CNM or his or her immediate family has a financial interest with the person or in the entity that receives the referral.
States that, notwithstanding the prohibition on referrals, a CNM may refer a person to a licensed alternative birth center or to a nationally accredited alternative birth center, among other facilities.
Requires an applicant to acquire an advanced level national certification by a certifying body that meets standards established and approved by the BRN for certification as a nurse midwife.
Deletes the authorization for the BRN to appoint a Nurse-Midwifery Committee, and instead requires the BRN to create and appoint, with assistance from the MBC, a Nurse-Midwifery Advisory Council (Council). States that the Council shall make recommendations to the BRN on all matters related to nurse-midwifery practice, education, and other matters as specified by the BRN.
Requires the Council to meet regularly, but at least twice a year.
Specifies that the Council shall consist of:
Majority of CNMs in good standing with experience in hospital settings, alternative birth center settings, and home settings.
A nurse-midwife educator who has demonstrated familiarity with educational standards in the delivery of maternal-child health care.
A consumer of midwifery care.
At least two qualified physicians appointed by the MBC, including an obstetrician that has experience working with nurse-midwives.
Prohibits corporations and other artificial legal entities from having any professional rights, privileges, or powers. However, the BRN may in its discretion, after such investigation and review of such documentary evidence as it may require, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic.
Permits the following entities to employ a CNM and charge for professional services rendered by a CNM; however, the entity shall not interfere with, control, or otherwise direct the professional judgment of a certified nurse-midwife:
A nonprofit clinic.
A hospital owned and operated by a health care district.
A clinic operated primarily for the purpose of medical education or nursing education by a public or private nonprofit university medical school, which is approved by the MBC the Osteopathic Medical Board of California, provided the CNM holds an academic appointment on the faculty of the university, including, but not limited to, the University of California medical schools and hospitals.
A licensed alternative birth center, as specified, or a nationally accredited alternative birth center owned or operated by a nursing corporation, as specified.
Deletes references in current law to supervision by a physician and surgeon.
Authorizes a CNM to manage a full range of primary gynecological and obstetric care services for women from adolescence to beyond menopause, consistent with the Core Competencies for Basic Midwifery practice promulgated by the American College of Nurse-Midwives, or its successor national professional organization, as approved by the BRN. These services include, but are not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, and treatment of male partners for sexually transmitted infections, utilizing consultation, collaboration, or referral to appropriate levels of health care services, as indicated.
Authorizes permissible settings in which a CNM may practice, including the home, but only when the following conditions apply:
There is the absence of all of the following:
Any preexisting maternal disease or condition likely to complicate the pregnancy.
Disease arising from the pregnancy likely to cause significant maternal and/or fetal compromise.
Prior caesarean delivery.
There is a singleton fetus.
There is cephalic presentation at the onset of labor.
The gestational age of the fetus is greater than 370/7 weeks and less than 420/7 completed weeks of pregnancy at the onset of labor.
Labor is spontaneous or induced in an outpatient setting.
States that if a potential CNM client meets the conditions specified in clauses (b) – (e) above, but fails to meet the conditions specified in (a) and the woman still desires to be a client of the CNM, the CNM shall consult with a physician and surgeon trained in obstetrics and gynecology. A CNM may assist the woman in pregnancy and childbirth only if a physician and surgeon trained in obstetrics and gynecology is consulted and the physician and surgeon who performed the consultation determines that the risk factors presented by her disease or condition are not likely to significantly affect the course of pregnancy and childbirth.
States that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the patient and the resources and medical personnel available in the setting of care. It also emphasizes informed consent, preventive care, and early detection and referral of complications to physicians and surgeons. While practicing in a hospital setting, the certified nurse-midwife shall collaboratively care for women with more complex health needs.
Requires a CNM to be subject to all credentialing and quality standards held by the facility in which he or she practices. The peer review body shall include nurse-midwives as part of the peer review body that reviews nurse-midwives. The peer review body of that facility shall impose standards that assure quality and patient safety in their facility. The standards shall be approved by the relevant governing body unless found by a court to be arbitrary and capricious.
Requires any regulations promulgated by a state department that affect the scope of practice of a CNM to be developed in consultation with the Council.
Deletes references to standardized procedures and protocols and physician supervision for the furnishing of drugs and devices by CNMs, except that, in a nonhospital setting, a Schedule II controlled substance shall be furnished by a CNM only during labor and delivery and only after a consultation with a physician and surgeon.
Authorizes a CNM to furnish or order drugs or devices related to the provision of care rendered in a home, as specified.
Authorizes a CNM to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a CNM and consistent with nurse-midwifery education preparation.
Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second-degree lacerations of the perineum in a home, as specified.
States that a consultative relationship between a CNM and a physician and surgeon shall not, by itself, provide the basis for finding a physician and surgeon liable for any act or omission of the CNM.
Makes clarifying and technical amendments.
FISCAL EFFECT:
This bill has been keyed “fiscal” by Legislative Counsel. According to the Assembly Appropriations Committee analysis dated May 13, 2015, this bill will result in minor costs to the BRN Fund for advisory council meetings. The analysis notes that the potential impact on BRN enforcement costs resulting from the bill is unclear, but will likely be minor, as removing the requirement for supervision does not significantly change the practice of midwifery.
COMMENTS:
Purpose. This bill is sponsored by the California Nurse Midwives Association. According to the Author’s office, “Approximately 1,200 CNMs are licensed in California by the BRN to practice midwifery – the care of childbearing women during pregnancy, labor and birth, and during the postpartum period. While most states allow CNMs to practice independently, California is one of only six states that require physician supervision of CNMs.
“California law requires a CNM to practice under the supervision of a physician, but specifies that the supervision requirement shall not be construed to require the physical presence of the physician. Although the supervision requirement tethers CNMs to practice only where a physician can supervise, it does not consist of actual oversight of health care delivery, inspection or review of charts, co-signatures on prescriptions, direct care of the patient, or evaluation of CNM patients at any point during pregnancy or well-woman care. In communities without obstetricians/gynecologists, the supervision requirement limits access to care for women, even when a CNM is available to provide care.
“In 2013, the Legislature removed physician supervision of licensed midwives (LMs) (AB 1308, Bonilla, Chapter 665, Statutes of 2013). CNMs are required to have a higher level of education and training than LMs in order to qualify for licensure (licensed as a registered nurse and graduate of a Board-approved nurse-midwifery program), and yet are still subject to physician supervision to practice.
“AB 1306 allows CNMs to practice to the full extent of the education and training, without physician supervision. The bill keeps their existing scope of practice in place and aligns their education and practice requirements with national standards. In addition, the bill includes consumer protections to guard against kickbacks and self-referrals, as well as additional structure for CNMs serving patients in home and birth center settings.”
CNMs. CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. The nurse - midwifery certificate also authorizes the CNM to attend cases of normal childbirth, as well as immediate care for the newborn. Current law requires CNM be licensed as a registered nurse and graduate from an approved program in nurse-midwifery. There are 1,271 CNMs in California.
A CNM may furnish drugs and devices after certification that he or she has completed at least six months of physician and surgeon supervised experience in the furnishing of drugs and devices and a course in pharmacology. “Furnishing” is the ordering of a drug or device in accordance with standardized procedure or protocol.
Standardized procedures are defined as policies and protocols developed by a health facility or organized health care system, with input from administrators and health professionals, which establish parameters for medical care. Protocols are a part of standardized procedures and are designed to describe the steps of medical care for given patient situations. Protocols are developed in consultation with a supervising physician. “Supervision” requires telephonic availability but not the physical presence of the physician.
This bill would remove the requirements of physician supervision and largely remove the restrictions on the independent furnishing of drugs and devices by CNMs.
CNMs as Independent Practitioners. According to the U.S. Library of Medicine, CNMs are well positioned as independent primary care practitioners. “[CNMs] have improved primary health care services for women in rural and inner-city areas. The National Institute of Medicine has recommended that [CNMs] be given a larger role in delivering women's health care.
“Many studies over the past 20 to 30 years have shown that [CNMs] can manage most perinatal (including prenatal, delivery, and postpartum) care. They are also qualified to deliver most family planning and gynecological needs of women of all ages. Some may check and manage common adult illnesses, as well.”
In addition, a 2015 article in the peer-reviewed Journal of Midwifery & Women’s Health, “Midwives as Primary Care Providers for Women,” conclude that “Midwives certified by the American Midwifery Certification Board are prepared to provide primary care to women from menarche across the lifespan and to well newborns to 28 days using consultation, collaboration, and referral to other providers as needed.”
Ban on the Corporate Practice of Medicine (CPM). This bill subjects CNMs to the ban on CPM, which previously has only been applied to physicians. The corporate practice of medicine (CPM) is usually referred to in the context of a prohibition, banning hospitals from employing physicians. The ban on CPM evolved in the early 20th century when mining companies had to hire physicians directly to provide care for their employees in remote areas. However, problems arose when physicians' loyalty to the mining companies conflicted with patients' needs. Eventually, physicians, courts, and legislatures prohibited CPM in an effort to preserve physicians' autonomy and improve patient care.
Over the years, various state and federal statutes have left the CPM prohibition substantially weakened and largely nonsensical. According to a 2007 report issued by the California Research Bureau, “California’s CPM doctrine has been defined largely through lawsuits and Attorney General opinions over decades, and then riddled by HMO and other legislation; its power and meaning are now inconsistent…. Although some non-profit clinics may employ physicians, California applies the CPM doctrine to most other entities. Non-profit associations may employ physicians under specific circumstances and non-profit corporations may employ physicians in clinics meeting specific requirements. Teaching hospitals may employ physicians, but other hospitals, including most public and non-profit hospitals, may not employ physicians. Professional medical corporations are expressly permitted to engage in the practice of medicine, and may employ physicians. [However, t]hese medical corporations may operate on a for-profit basis, although the profit motive was one of the original rationales of the CPM prohibition.” Indeed, the greatest cost pressures typically come from health insurers, and not the facilities themselves.
The following entities may currently employ physicians:
A clinic operated primarily of the purpose of medical education by a public or private nonprofit university medical school.
A clinic operated by a nonprofit corporation as an entity organized and operated exclusively for scientific and charitable purposes.
A narcotic treatment program.
A hospital owned and operated by a health care district.
A hospital owned and operated by a licensed charitable organization, that offers only pediatric subspecialty care, as specified.
California is one of only five remaining states that adhere to some form of the ban. The American Medical Association, historically the driving force behind the CPM prohibition, no longer views physician employment per se as a violation of medical ethics and has removed the doctrine from its ethical code.
The Changing Healthcare Employment Landscape. California’s ban on CPM is becoming a hindrance to efficiency and the state’s competitiveness in a rapidly changing healthcare environment. Extending an outdated ban on employment to an expanding and vital class of health care providers will not benefit consumers or the professionals themselves. According to a 2011 survey from the consulting firm Accenture:
“U.S. physicians continue to sell their private practices and seek employment with healthcare systems, according to a new survey from Accenture. As physicians migrate from private practice to larger health systems, the new landscape will require healthcare information technology (IT), medical device manufacturers, pharmaceutical companies and payers to revise their business models and offerings. At the same time, hospitals will need to determine how to retain and recruit the correct mix of physicians, especially in high-growth service lines, including cardiovascular care, orthopedics, cancer care and radiology. Patients will increasingly move to large health systems, as opposed to the current trend of visiting doctors in private, small practice settings.
“The rate of independent physicians being employed by health systems will grow by an annual five percent over three years. By 2013, less than one-third of physicians are expected to remain truly independent.
“’Health reform is challenging the entire system to deliver improved care through insight driven health,’ said Kristin Ficery, senior executive, Accenture Health. ‘We see an increasing number of physicians leaving private practice to join hospital systems, which will force all stakeholders to revise and refine their business models, product offerings and service strategies.’
“According to the survey, physicians are increasingly attracted to the benefits offered by hospital-based employment opportunities. These benefits include:
Relief from administrative responsibilities.
Greater access to leading-edge healthcare IT tools, facilities and equipment.
A more manageable work week.
Stability in a business environment made uncertain by developments such as payment reforms.”
These realities are the same facing CNMs, who are currently employed by hospitals and other facilities. CNMs would be unable to continue to realize the benefits of employment should this measure pass.
Health Care Access. The potential impact of the ban on CPM for CNMs is not only on those currently employed; it will affect future employment opportunities that will be lost as the result of it.
The elimination of the physician supervision requirement for CNMs, standing on its own, would likely result in the increased employment by hospitals and clinics of CNMs, given their versatility: CNMs can provide a wide range of services in a variety of settings, and hospitals would no longer have to struggle to find physicians willing to supervise them. Particularly for rural hospitals and other areas where it is challenging to attract physicians, employing CNMs would be a desirable option for expanding hospitals’ and clinics’ ability to meet basic community needs.
California’s CPM Equality Argument. Supporters of the CPM ban argue that it is necessary for equity in the workforce to subject any profession that becomes independent of physician supervision to be subject to the same business constraints as physicians. This is not a valid argument because the professions are not on equal footing.
Physicians and CNMs have very different practice scopes. CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. The nurse - midwifery certificate also authorizes the CNM to attend cases of normal childbirth on his or her own responsibility, as well as immediate care for the newborn. CNM care includes preventative measures and the detection of abnormal conditions in mother and child, but CNMs cannot assist childbirth by any artificial, forcible, or mechanical means. CNMs are not authorized to perform surgery, although this bill will allow them to perform and repair episiotomies and first-degree and second-degree lacerations of the perineum in a home, as specified.
Obstetrician-gynecologists (OB/GYN) are physicians who possess special knowledge, skills and professional capability in the medical and surgical care of the female reproductive system and associated disorders. OB/GYNs are necessary for abnormal cases of pregnancy, advanced conditions, and surgeries. Resident education in obstetrics-gynecology must include four years of accredited, clinically-oriented graduate medical education, which must be focused on reproductive health care and ambulatory primary health care for women, including health maintenance, disease prevention, diagnosis, treatment, consultation, and referral.
There will always be a need for OB/GYNs, and while there will be some practice overlap, the professions are not, nor will they be according to the terms of this bill, interchangeable.
Physicians still have control of medical staffing decisions at hospitals and may not have incentives to hire physician extenders like CNMs.
Current law requires that hospitals have a dual structure – an administrative governing body, which oversees the hospital operations, and a medical staff, which provides medical services and is generally responsible for ensuring that its members provide appropriate medical care to patients at the hospital.
In order to practice at a hospital, a physician must be granted privileges by the medical staff. To the extent that CNMs may provide some overlapping functions with OB/GYNs, hospitals may prefer to hire some CNMs in addition to OB/GYNs to handle cases of normal childbirth and provision of primary care. Because this bill would revoke employment by hospitals by CNMs, CNMs would have to apply for staff privileges from physicians. Given the nature of their overlapping scopes, it is likely that medical staff would be reluctant to replace or supplement OB/GYNs with CNMs.
Additional Means of Protecting Medical Decision Making. In tandem with the exceptions made to the ban on CPM, California has enacted legislation sharply limiting actual and potential corporate control over physicians.
The Knox-Keene Act, which regulates health maintenance organizations (HMOs), subjects HMOs to the following requirements:
Capitated payment agreements or shared-risk arrangements must not be tied to specific medical decisions.
Health plans must furnish medical services in a manner providing continuity of care.
Health plans must provide ready referral to other providers when good professional practice requires it.
All services must be readily available, and to the extent feasible, readily accessible, to all enrollees.
Health plans must assure that medical decisions are made by qualified medical providers, without influence of fiscal or administrative management.
Multiple sections in California statute and regulation ensure the primacy of an individual’s professional medical decision-making, including this broad statute contained in BPC § 501:
“It is the public policy of the State of California that a health care practitioner be encouraged to advocate for appropriate health care for his or her patients. For purposes of this section, ‘to advocate for appropriate health care’ means to appeal a payer’s decision to deny payment for a service pursuant to the reasonable grievance or appeal procedure established by a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff and governing body, or payer, or to protest a decision, policy, or practice that the health care practitioner, consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care, reasonably believes impairs the health care practitioner’s ability to provide appropriate health care to his or her patients.”
These and similar provisions make the uneven doctrine of CPM largely unnecessary.
Arguments in Support. Writing in support of the bill, the California Association of Midwives, Maternal and Child Health Access (MCHA), Black Women for Wellness, the County of Santa Cruz Board of Supervisors, South Coast Midwifery & Women’s Healthcare, Inc., Beach Cities Midwifery & Women’s Health Care, Beachside Birth Center, the American Association of Birth Centers, AARP, the California Association of Nurse Anesthetists, Inland Midwife Service, and the Center on Reproductive Rights and Justice at the University of California, Berkley School of Law state, AB 1306 separates the practice of nurse-midwives from physician practice, creating an opportunity for expansion of women’s health care services within their current scope of practice. These organizations state that “California is one of six remaining states to include physician supervision language, language which contradicts national and international standards. AB 1306 will not change the high quality of care provided by nurse-midwives nor the way that nurse-midwives currently practice. Removing state-mandated supervision would allow the nurse-midwife to partner collaboratively with physicians, expanding options beyond working as a physician’s employee. AB 1306 would directly and positively affect the California health care system by providing for improved physician and nurse-midwife collaboration and greater innovation in health care delivery.”
The American College of Nurse-Midwives (ACNM) states, “California nurse-midwives are highly trained providers who earn graduate degrees and are trained in the disciplines of midwifery and nursing. AB 1306 would require all nurse-midwives to pass a national certification examination to demonstrate mastery of ACNM’s core competencies, which meet or exceed national recommendations for midwifery care, as a condition of licensure. Safe, quality health care can best be provided to women and their infants when policymakers permit CNMs to provide independent midwifery care within their scope of practice.”
The American Nurses Association/California, the California Association for Nurse Practitioners, the United Nurses Associations of California/Union of Health Care Professionals, and the California Nurse Midwife Association (CNMA) state that a CNM is an advanced practice nurse who is educated in Master’s Degree programs accredited by the American Commission on Midwifery Education through the US Department of Education and have a higher level of education and training than Licensed Midwives. According to these organizations, “with the increasing number of Californians insured under Covered California and the Affordable Care Act, there is a growing shortage of providers to meet the demand for primary care services. This bill untethers CNMs from physician supervision requirements to promote the expansion of primary health care access for thousands of women. In addition, the bill eliminated barriers that physicians encounter from malpractice carriers that prohibit them from supervising CNMs due to fears of vicarious liability.”
Arguments in Opposition. The California Hospital Association, Ridgecrest Regional Hospital, Henry Mayo Newhall Hospital, San Gorgonio Memorial Hospital, San Benito Health Care District, Community Hospital of the Monterey Peninsula, Lompoc Valley Medical Center, Sutter Health, Sharp Healthcare, Watsonville Community Hospital, Natividad Medical Center, St. Helena Hospital Napa Valley, Mammoth Hospital, Coalinga Regional Medical Center, Ceders-Sinai, Lodi Health, El Camino Hospital, Adventist Health, and Loma Linda University Health state that their opposition is in response to the amendment that subjects CNMs to the ban on the corporate practice of medicine. These organizations state, “This corporate practice ban would prevent CNMs from being employed by hospitals, professional corporations, and most other employers that would like to make CNMs available to their patient population. The current ban in AB 1306 is more restrictive than provisions that exist for physicians. This restriction is an unnecessary and unreasonable barrier for employment of CNMs and hinders access to care for California women.”
The Medical Board of California has taken an oppose unless amended position, stating, “This bill does not have the same clear guidance and restrictions on what types of patients that [CNMs] can accept and does not clearly delineate when a patient should be transferred to a physician or require a physician consult for higher risk patients. Because this bill does not currently include parameters on independent CNM practice that would ensure consumer protection, the Board is opposed to this bill unless it is amended to address these concerns.”
Related Legislation This Year. SB 323 (Hernandez) of 2015, would authorize a nurse practitioner who holds a national certification to practice without physician supervision in specified settings. (Status: This bill is pending reconsideration in the Assembly Business and Professions Committee).
Prior Related Legislation. SB 1308 (Bonilla, Chapter 665, Statutes of 2013) authorized a midwife to directly obtain supplies and devices, obtain and administer drugs and diagnostic tests, order testing and receive reports that are necessary to his/her practice of midwifery and consistent with his/her scope of practice; expanded the disclosures required to be made by a midwife to a prospective client to include the specific procedures that warrant consultation with a physician and surgeon; and made other correcting and conforming changes. This bill included no CPM provisions.
SB 1950 (Figueroa, Chapter 1085, Statutes of 2002) required
the MBC to adopt regulations defining the appropriate standard of
care and level of supervision required for the practice of
midwifery.
SB 1479 (Figueroa, Chapter 303, Statutes
of 2000) expanded the disclosures required to be given by licensed
midwives and also required midwives to register birth certificates
for home births.
SB 350 (Killea, Chapter 1280,
Statutes of 1993) enacted the Licensed Midwifery Practice Act of 1993
to provide for the licensing and regulation of non-nurse and
non-physician assistant midwives by the MBC.
Suggested Amendments.
Strike references to the ban on CPM. The ban on CPM has outlived its usefulness and extending it to another class of healthcare professionals does not further the interests of California consumers or CNMs.
On page 14, strike lines 3 -34.
To provide additional protections against any corporate influence on medical judgment, insert the following on page 16, after line 21:
“(c) No entity in (b) shall interfere with, control, or otherwise direct the professional judgment of a certified nurse midwife in a manner prohibited by Section 510 or of any other provision of law.”
Remove references to the Medical Board of California. This bill deletes the authorization for the BRN to appoint a Nurse-Midwifery Committee, and instead requires the BRN to create and appoint a Nurse-Midwifery Advisory Council, at least two members of which would be qualified physicians appointed by the MBC, including an obstetrician that has experience working with nurse-midwives.
There is no precedent for DCA boards to have appointment authority over the composition of another board’s committee. BRN is capable of appointing physician members to the Council proposed in this bill and as such, language referencing a MBC appointment should be removed.
On page 13, line 36, strike “appointed by the Medical Board of California”
Amendments regarding home birth conditions. The following language would provide greater semantic clarity to the circumstances in which a CNM may attend a home birth.
On page 15, line 39, strike “likely” and add “with the potential”
On page 15, line 40, add “or birth” after pregnancy.
On page 16, line 1, after “from” add “or during,” strike “likely” and add “with the potential”
On page 16, line 2, strike “significant”
On page 16, line 6, after “is” add “equal to or” and replace “370/7” with “37/7”
On page 16, line 7, add a space between “42” and “0/7”
SUPPORT AND OPPOSITION:
Support:
California Nurse Midwives Association (Sponsor)
AARP
American Association of Birth Centers
American College of Nurse-Midwives
American Nurses Association/California
Beach Cities Midwifery & Women’s Health Care
Beachside Birth Center
Black Women for Wellness
California Association of Midwives
California Association of Nurse Anesthetists
California Association for Nurse Practitioners
Center on Reproductive Rights and Justice at the University of California, Berkley School of Law
County of Santa Cruz Board of Supervisors
Inland Midwife Service
Maternal and Child Health Access
South Coast Midwifery & Women’s Healthcare, Inc.
United Nurses Associations of California/Union of Health Care Professionals
Numerous individuals
Opposition:
Adventist Health
California Hospital Association
Ceders-Sinai
Coalinga Regional Medical Center
Community Hospital of the Monterey Peninsula
El Camino Hospital
Henry Mayo Newhall Hospital
Lodi Health
Loma Linda University Health
Lompoc Valley Medical Center
Mammoth Hospital
Medical Board of California
Natividad Medical Center
Ridgecrest Regional Hospital
San Benito Health Care District
San Gorgonio Memorial Hospital
Sharp Healthcare
St. Helena Hospital Napa Valley
Sutter Health
Watsonville Community Hospital
-- END --
AB 1306 (Burke) Page 15 of 15
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 1306 Hearing Date: July 6, 2015
Author: |
Burke |
||
Version: |
July 1, 2015 Click here to enter text. |
||
Urgency: |
No |
Fiscal: |
Yes |
Consultant: |
Sarah Huchel |
||
Subject: Healing arts: certified nurse-midwives: scope of practice
SUMMARY:
Removes physician supervision requirements for a Certified Nurse Midwife (CNM), increases educational requirements, establishes a Nurse-Midwifery Advisory Council within the Board of Registered Nursing (BRN), and subjects CNMs to the ban on the corporate practice of medicine, among other changes.
Existing law:
The Nursing Practice Act, provides for the licensure and regulation of the practice of nursing by the Board of Registered Nursing (BRN), within the Department of Consumer Affairs (DCA), and authorizes the BRN to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the BRN or the equivalent of those educational standards. (Business and Professions Code (BPC) §§ 2700 et seq.)
Authorizes a CNM, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn. (BPC § 2746.5 (a))
Provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal. (BPC § 2746.5 (b))
States that physician “supervision” shall not be construed to require the physical presence of the supervising physician. (BPC § 2746.5 (c))
Authorizes a CNM to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the CNM's educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified. (BPC § 2746.51 et seq.)
Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center, if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon. (BPC § 2746.52)
Authorizes the BRN to appoint a Nurse-Midwifery Committee of qualified physicians and nurses, including, but not limited to, obstetricians and nurse-midwives, to develop the necessary standards relating to educational requirements, ratios of nurse-midwives to supervising physicians, and associated matters. (BPC § 2746.2)
Authorizes a CNM to furnish or order drugs or devices, including Schedule II-V controlled substances, pursuant to physician supervision, standardized procedures and protocols, and other conditions, as specified. (BPC § 2746.51)
Prohibits a physician from referring a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the physician or his or her immediate family has a financial interest with the person or in the entity that receives the referral. (BPC § 650.01)
Requires a physician and surgeon’s certificate to practice medicine. (BPC § 2052)
States that corporations and other artificial legal entities shall have no professional rights, privileges, or powers. Provides that the Medical Board of California (MBC) may in its discretion, after such investigation and review of such documentary evidence as it may require, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic. (BPC § 2400)
Establishes exceptions to the ban on the corporate practice medicine, thereby allowing certain types of facilities to employ physicians. (BPC § 2401)
Establishes the following protections against retaliation for health care practitioners who advocate for appropriate health care for their patients pursuant to Wickline v. State of California (192 Cal. App. 3d 1630):
It is the public policy of the State of California that a health care practitioner be encouraged to advocate for appropriate health care for his or her patients. For purposes of this section, “to advocate for appropriate health care” means to appeal a payer’s decision to deny payment for a service pursuant to the reasonable grievance or appeal procedure established by a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff and governing body, or payer, or to protest a decision, policy, or practice that the health care practitioner, consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care, reasonably believes impairs the health care practitioner’s ability to provide appropriate health care to his or her patients.
The application and rendering by any individual, partnership, corporation, or other organization of a decision to terminate an employment or other contractual relationship with or otherwise penalize a health care practitioner principally for advocating for appropriate health care consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care violates the public policy of this state.
This law shall not be construed to prohibit a payer from making a determination not to pay for a particular medical treatment or service, or the services of a type of health care practitioner, or to prohibit a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff, hospital governing body, or payer from enforcing reasonable peer review or utilization review protocols or determining whether a health care practitioner has complied with those protocols. (BPC § 510)
This
bill:
Subjects CNMs to the prohibition on referring a person for laboratory, diagnostic nuclear medicine, radiation oncology, physical therapy, physical rehabilitation, psychometric testing, home infusion therapy, or diagnostic imaging goods or services if the CNM or his or her immediate family has a financial interest with the person or in the entity that receives the referral.
States that, notwithstanding the prohibition on referrals, a CNM may refer a person to a licensed alternative birth center or to a nationally accredited alternative birth center, among other facilities.
Requires an applicant to acquire an advanced level national certification by a certifying body that meets standards established and approved by the BRN for certification as a nurse midwife.
Deletes the authorization for the BRN to appoint a Nurse-Midwifery Committee, and instead requires the BRN to create and appoint, with assistance from the MBC, a Nurse-Midwifery Advisory Council (Council). States that the Council shall make recommendations to the BRN on all matters related to nurse-midwifery practice, education, and other matters as specified by the BRN.
Requires the Council to meet regularly, but at least twice a year.
Specifies that the Council shall consist of:
Majority of CNMs in good standing with experience in hospital settings, alternative birth center settings, and home settings.
A nurse-midwife educator who has demonstrated familiarity with educational standards in the delivery of maternal-child health care.
A consumer of midwifery care.
At least two qualified physicians appointed by the MBC, including an obstetrician that has experience working with nurse-midwives.
Prohibits corporations and other artificial legal entities from having any professional rights, privileges, or powers. However, the BRN may in its discretion, after such investigation and review of such documentary evidence as it may require, and under regulations adopted by it, grant approval of the employment of licensees on a salary basis by licensed charitable institutions, foundations, or clinics, if no charge for professional services rendered patients is made by any such institution, foundation, or clinic.
Permits the following entities to employ a CNM and charge for professional services rendered by a CNM; however, the entity shall not interfere with, control, or otherwise direct the professional judgment of a certified nurse-midwife:
A nonprofit clinic.
A hospital owned and operated by a health care district.
A clinic operated primarily for the purpose of medical education or nursing education by a public or private nonprofit university medical school, which is approved by the MBC the Osteopathic Medical Board of California, provided the CNM holds an academic appointment on the faculty of the university, including, but not limited to, the University of California medical schools and hospitals.
A licensed alternative birth center, as specified, or a nationally accredited alternative birth center owned or operated by a nursing corporation, as specified.
Deletes references in current law to supervision by a physician and surgeon.
Authorizes a CNM to manage a full range of primary gynecological and obstetric care services for women from adolescence to beyond menopause, consistent with the Core Competencies for Basic Midwifery practice promulgated by the American College of Nurse-Midwives, or its successor national professional organization, as approved by the BRN. These services include, but are not limited to, primary health care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth, and the postpartum period, and treatment of male partners for sexually transmitted infections, utilizing consultation, collaboration, or referral to appropriate levels of health care services, as indicated.
Authorizes permissible settings in which a CNM may practice, including the home, but only when the following conditions apply:
There is the absence of all of the following:
Any preexisting maternal disease or condition likely to complicate the pregnancy.
Disease arising from the pregnancy likely to cause significant maternal and/or fetal compromise.
Prior caesarean delivery.
There is a singleton fetus.
There is cephalic presentation at the onset of labor.
The gestational age of the fetus is greater than 370/7 weeks and less than 420/7 completed weeks of pregnancy at the onset of labor.
Labor is spontaneous or induced in an outpatient setting.
States that if a potential CNM client meets the conditions specified in clauses (b) – (e) above, but fails to meet the conditions specified in (a) and the woman still desires to be a client of the CNM, the CNM shall consult with a physician and surgeon trained in obstetrics and gynecology. A CNM may assist the woman in pregnancy and childbirth only if a physician and surgeon trained in obstetrics and gynecology is consulted and the physician and surgeon who performed the consultation determines that the risk factors presented by her disease or condition are not likely to significantly affect the course of pregnancy and childbirth.
States that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the patient and the resources and medical personnel available in the setting of care. It also emphasizes informed consent, preventive care, and early detection and referral of complications to physicians and surgeons. While practicing in a hospital setting, the certified nurse-midwife shall collaboratively care for women with more complex health needs.
Requires a CNM to be subject to all credentialing and quality standards held by the facility in which he or she practices. The peer review body shall include nurse-midwives as part of the peer review body that reviews nurse-midwives. The peer review body of that facility shall impose standards that assure quality and patient safety in their facility. The standards shall be approved by the relevant governing body unless found by a court to be arbitrary and capricious.
Requires any regulations promulgated by a state department that affect the scope of practice of a CNM to be developed in consultation with the Council.
Deletes references to standardized procedures and protocols and physician supervision for the furnishing of drugs and devices by CNMs, except that, in a nonhospital setting, a Schedule II controlled substance shall be furnished by a CNM only during labor and delivery and only after a consultation with a physician and surgeon.
Authorizes a CNM to furnish or order drugs or devices related to the provision of care rendered in a home, as specified.
Authorizes a CNM to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a CNM and consistent with nurse-midwifery education preparation.
Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second-degree lacerations of the perineum in a home, as specified.
States that a consultative relationship between a CNM and a physician and surgeon shall not, by itself, provide the basis for finding a physician and surgeon liable for any act or omission of the CNM.
Makes clarifying and technical amendments.
FISCAL EFFECT:
This bill has been keyed “fiscal” by Legislative Counsel. According to the Assembly Appropriations Committee analysis dated May 13, 2015, this bill will result in minor costs to the BRN Fund for advisory council meetings. The analysis notes that the potential impact on BRN enforcement costs resulting from the bill is unclear, but will likely be minor, as removing the requirement for supervision does not significantly change the practice of midwifery.
COMMENTS:
Purpose. This bill is sponsored by the California Nurse Midwives Association. According to the Author’s office, “Approximately 1,200 CNMs are licensed in California by the BRN to practice midwifery – the care of childbearing women during pregnancy, labor and birth, and during the postpartum period. While most states allow CNMs to practice independently, California is one of only six states that require physician supervision of CNMs.
“California law requires a CNM to practice under the supervision of a physician, but specifies that the supervision requirement shall not be construed to require the physical presence of the physician. Although the supervision requirement tethers CNMs to practice only where a physician can supervise, it does not consist of actual oversight of health care delivery, inspection or review of charts, co-signatures on prescriptions, direct care of the patient, or evaluation of CNM patients at any point during pregnancy or well-woman care. In communities without obstetricians/gynecologists, the supervision requirement limits access to care for women, even when a CNM is available to provide care.
“In 2013, the Legislature removed physician supervision of licensed midwives (LMs) (AB 1308, Bonilla, Chapter 665, Statutes of 2013). CNMs are required to have a higher level of education and training than LMs in order to qualify for licensure (licensed as a registered nurse and graduate of a Board-approved nurse-midwifery program), and yet are still subject to physician supervision to practice.
“AB 1306 allows CNMs to practice to the full extent of the education and training, without physician supervision. The bill keeps their existing scope of practice in place and aligns their education and practice requirements with national standards. In addition, the bill includes consumer protections to guard against kickbacks and self-referrals, as well as additional structure for CNMs serving patients in home and birth center settings.”
CNMs. CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. The nurse - midwifery certificate also authorizes the CNM to attend cases of normal childbirth, as well as immediate care for the newborn. Current law requires CNM be licensed as a registered nurse and graduate from an approved program in nurse-midwifery. There are 1,271 CNMs in California.
A CNM may furnish drugs and devices after certification that he or she has completed at least six months of physician and surgeon supervised experience in the furnishing of drugs and devices and a course in pharmacology. “Furnishing” is the ordering of a drug or device in accordance with standardized procedure or protocol.
Standardized procedures are defined as policies and protocols developed by a health facility or organized health care system, with input from administrators and health professionals, which establish parameters for medical care. Protocols are a part of standardized procedures and are designed to describe the steps of medical care for given patient situations. Protocols are developed in consultation with a supervising physician. “Supervision” requires telephonic availability but not the physical presence of the physician.
This bill would remove the requirements of physician supervision and largely remove the restrictions on the independent furnishing of drugs and devices by CNMs.
CNMs as Independent Practitioners. According to the U.S. Library of Medicine, CNMs are well positioned as independent primary care practitioners. “[CNMs] have improved primary health care services for women in rural and inner-city areas. The National Institute of Medicine has recommended that [CNMs] be given a larger role in delivering women's health care.
“Many studies over the past 20 to 30 years have shown that [CNMs] can manage most perinatal (including prenatal, delivery, and postpartum) care. They are also qualified to deliver most family planning and gynecological needs of women of all ages. Some may check and manage common adult illnesses, as well.”
In addition, a 2015 article in the peer-reviewed Journal of Midwifery & Women’s Health, “Midwives as Primary Care Providers for Women,” conclude that “Midwives certified by the American Midwifery Certification Board are prepared to provide primary care to women from menarche across the lifespan and to well newborns to 28 days using consultation, collaboration, and referral to other providers as needed.”
Ban on the Corporate Practice of Medicine (CPM). This bill subjects CNMs to the ban on CPM, which previously has only been applied to physicians. The corporate practice of medicine (CPM) is usually referred to in the context of a prohibition, banning hospitals from employing physicians. The ban on CPM evolved in the early 20th century when mining companies had to hire physicians directly to provide care for their employees in remote areas. However, problems arose when physicians' loyalty to the mining companies conflicted with patients' needs. Eventually, physicians, courts, and legislatures prohibited CPM in an effort to preserve physicians' autonomy and improve patient care.
Over the years, various state and federal statutes have left the CPM prohibition substantially weakened and largely nonsensical. According to a 2007 report issued by the California Research Bureau, “California’s CPM doctrine has been defined largely through lawsuits and Attorney General opinions over decades, and then riddled by HMO and other legislation; its power and meaning are now inconsistent…. Although some non-profit clinics may employ physicians, California applies the CPM doctrine to most other entities. Non-profit associations may employ physicians under specific circumstances and non-profit corporations may employ physicians in clinics meeting specific requirements. Teaching hospitals may employ physicians, but other hospitals, including most public and non-profit hospitals, may not employ physicians. Professional medical corporations are expressly permitted to engage in the practice of medicine, and may employ physicians. [However, t]hese medical corporations may operate on a for-profit basis, although the profit motive was one of the original rationales of the CPM prohibition.” Indeed, the greatest cost pressures typically come from health insurers, and not the facilities themselves.
The following entities may currently employ physicians:
A clinic operated primarily of the purpose of medical education by a public or private nonprofit university medical school.
A clinic operated by a nonprofit corporation as an entity organized and operated exclusively for scientific and charitable purposes.
A narcotic treatment program.
A hospital owned and operated by a health care district.
A hospital owned and operated by a licensed charitable organization, that offers only pediatric subspecialty care, as specified.
California is one of only five remaining states that adhere to some form of the ban. The American Medical Association, historically the driving force behind the CPM prohibition, no longer views physician employment per se as a violation of medical ethics and has removed the doctrine from its ethical code.
The Changing Healthcare Employment Landscape. California’s ban on CPM is becoming a hindrance to efficiency and the state’s competitiveness in a rapidly changing healthcare environment. Extending an outdated ban on employment to an expanding and vital class of health care providers will not benefit consumers or the professionals themselves. According to a 2011 survey from the consulting firm Accenture:
“U.S. physicians continue to sell their private practices and seek employment with healthcare systems, according to a new survey from Accenture. As physicians migrate from private practice to larger health systems, the new landscape will require healthcare information technology (IT), medical device manufacturers, pharmaceutical companies and payers to revise their business models and offerings. At the same time, hospitals will need to determine how to retain and recruit the correct mix of physicians, especially in high-growth service lines, including cardiovascular care, orthopedics, cancer care and radiology. Patients will increasingly move to large health systems, as opposed to the current trend of visiting doctors in private, small practice settings.
“The rate of independent physicians being employed by health systems will grow by an annual five percent over three years. By 2013, less than one-third of physicians are expected to remain truly independent.
“’Health reform is challenging the entire system to deliver improved care through insight driven health,’ said Kristin Ficery, senior executive, Accenture Health. ‘We see an increasing number of physicians leaving private practice to join hospital systems, which will force all stakeholders to revise and refine their business models, product offerings and service strategies.’
“According to the survey, physicians are increasingly attracted to the benefits offered by hospital-based employment opportunities. These benefits include:
Relief from administrative responsibilities.
Greater access to leading-edge healthcare IT tools, facilities and equipment.
A more manageable work week.
Stability in a business environment made uncertain by developments such as payment reforms.”
These realities are the same facing CNMs, who are currently employed by hospitals and other facilities. CNMs would be unable to continue to realize the benefits of employment should this measure pass.
Health Care Access. The potential impact of the ban on CPM for CNMs is not only on those currently employed; it will affect future employment opportunities that will be lost as the result of it.
The elimination of the physician supervision requirement for CNMs, standing on its own, would likely result in the increased employment by hospitals and clinics of CNMs, given their versatility: CNMs can provide a wide range of services in a variety of settings, and hospitals would no longer have to struggle to find physicians willing to supervise them. Particularly for rural hospitals and other areas where it is challenging to attract physicians, employing CNMs would be a desirable option for expanding hospitals’ and clinics’ ability to meet basic community needs.
California’s CPM Equality Argument. Supporters of the CPM ban argue that it is necessary for equity in the workforce to subject any profession that becomes independent of physician supervision to be subject to the same business constraints as physicians. This is not a valid argument because the professions are not on equal footing.
Physicians and CNMs have very different practice scopes. CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. The nurse - midwifery certificate also authorizes the CNM to attend cases of normal childbirth on his or her own responsibility, as well as immediate care for the newborn. CNM care includes preventative measures and the detection of abnormal conditions in mother and child, but CNMs cannot assist childbirth by any artificial, forcible, or mechanical means. CNMs are not authorized to perform surgery, although this bill will allow them to perform and repair episiotomies and first-degree and second-degree lacerations of the perineum in a home, as specified.
Obstetrician-gynecologists (OB/GYN) are physicians who possess special knowledge, skills and professional capability in the medical and surgical care of the female reproductive system and associated disorders. OB/GYNs are necessary for abnormal cases of pregnancy, advanced conditions, and surgeries. Resident education in obstetrics-gynecology must include four years of accredited, clinically-oriented graduate medical education, which must be focused on reproductive health care and ambulatory primary health care for women, including health maintenance, disease prevention, diagnosis, treatment, consultation, and referral.
There will always be a need for OB/GYNs, and while there will be some practice overlap, the professions are not, nor will they be according to the terms of this bill, interchangeable.
Physicians still have control of medical staffing decisions at hospitals and may not have incentives to hire physician extenders like CNMs.
Current law requires that hospitals have a dual structure – an administrative governing body, which oversees the hospital operations, and a medical staff, which provides medical services and is generally responsible for ensuring that its members provide appropriate medical care to patients at the hospital.
In order to practice at a hospital, a physician must be granted privileges by the medical staff. To the extent that CNMs may provide some overlapping functions with OB/GYNs, hospitals may prefer to hire some CNMs in addition to OB/GYNs to handle cases of normal childbirth and provision of primary care. Because this bill would revoke employment by hospitals by CNMs, CNMs would have to apply for staff privileges from physicians. Given the nature of their overlapping scopes, it is likely that medical staff would be reluctant to replace or supplement OB/GYNs with CNMs.
Additional Means of Protecting Medical Decision Making. In tandem with the exceptions made to the ban on CPM, California has enacted legislation sharply limiting actual and potential corporate control over physicians.
The Knox-Keene Act, which regulates health maintenance organizations (HMOs), subjects HMOs to the following requirements:
Capitated payment agreements or shared-risk arrangements must not be tied to specific medical decisions.
Health plans must furnish medical services in a manner providing continuity of care.
Health plans must provide ready referral to other providers when good professional practice requires it.
All services must be readily available, and to the extent feasible, readily accessible, to all enrollees.
Health plans must assure that medical decisions are made by qualified medical providers, without influence of fiscal or administrative management.
Multiple sections in California statute and regulation ensure the primacy of an individual’s professional medical decision-making, including this broad statute contained in BPC § 501:
“It is the public policy of the State of California that a health care practitioner be encouraged to advocate for appropriate health care for his or her patients. For purposes of this section, ‘to advocate for appropriate health care’ means to appeal a payer’s decision to deny payment for a service pursuant to the reasonable grievance or appeal procedure established by a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff and governing body, or payer, or to protest a decision, policy, or practice that the health care practitioner, consistent with that degree of learning and skill ordinarily possessed by reputable health care practitioners with the same license or certification and practicing according to the applicable legal standard of care, reasonably believes impairs the health care practitioner’s ability to provide appropriate health care to his or her patients.”
These and similar provisions make the uneven doctrine of CPM largely unnecessary.
Arguments in Support. Writing in support of the bill, the California Association of Midwives, Maternal and Child Health Access (MCHA), Black Women for Wellness, the County of Santa Cruz Board of Supervisors, South Coast Midwifery & Women’s Healthcare, Inc., Beach Cities Midwifery & Women’s Health Care, Beachside Birth Center, the American Association of Birth Centers, AARP, the California Association of Nurse Anesthetists, Inland Midwife Service, and the Center on Reproductive Rights and Justice at the University of California, Berkley School of Law state, AB 1306 separates the practice of nurse-midwives from physician practice, creating an opportunity for expansion of women’s health care services within their current scope of practice. These organizations state that “California is one of six remaining states to include physician supervision language, language which contradicts national and international standards. AB 1306 will not change the high quality of care provided by nurse-midwives nor the way that nurse-midwives currently practice. Removing state-mandated supervision would allow the nurse-midwife to partner collaboratively with physicians, expanding options beyond working as a physician’s employee. AB 1306 would directly and positively affect the California health care system by providing for improved physician and nurse-midwife collaboration and greater innovation in health care delivery.”
The American College of Nurse-Midwives (ACNM) states, “California nurse-midwives are highly trained providers who earn graduate degrees and are trained in the disciplines of midwifery and nursing. AB 1306 would require all nurse-midwives to pass a national certification examination to demonstrate mastery of ACNM’s core competencies, which meet or exceed national recommendations for midwifery care, as a condition of licensure. Safe, quality health care can best be provided to women and their infants when policymakers permit CNMs to provide independent midwifery care within their scope of practice.”
The American Nurses Association/California, the California Association for Nurse Practitioners, the United Nurses Associations of California/Union of Health Care Professionals, and the California Nurse Midwife Association (CNMA) state that a CNM is an advanced practice nurse who is educated in Master’s Degree programs accredited by the American Commission on Midwifery Education through the US Department of Education and have a higher level of education and training than Licensed Midwives. According to these organizations, “with the increasing number of Californians insured under Covered California and the Affordable Care Act, there is a growing shortage of providers to meet the demand for primary care services. This bill untethers CNMs from physician supervision requirements to promote the expansion of primary health care access for thousands of women. In addition, the bill eliminated barriers that physicians encounter from malpractice carriers that prohibit them from supervising CNMs due to fears of vicarious liability.”
Arguments in Opposition. The California Hospital Association, Ridgecrest Regional Hospital, Henry Mayo Newhall Hospital, San Gorgonio Memorial Hospital, San Benito Health Care District, Community Hospital of the Monterey Peninsula, Lompoc Valley Medical Center, Sutter Health, Sharp Healthcare, Watsonville Community Hospital, Natividad Medical Center, St. Helena Hospital Napa Valley, Mammoth Hospital, Coalinga Regional Medical Center, Ceders-Sinai, Lodi Health, El Camino Hospital, Adventist Health, and Loma Linda University Health state that their opposition is in response to the amendment that subjects CNMs to the ban on the corporate practice of medicine. These organizations state, “This corporate practice ban would prevent CNMs from being employed by hospitals, professional corporations, and most other employers that would like to make CNMs available to their patient population. The current ban in AB 1306 is more restrictive than provisions that exist for physicians. This restriction is an unnecessary and unreasonable barrier for employment of CNMs and hinders access to care for California women.”
The Medical Board of California has taken an oppose unless amended position, stating, “This bill does not have the same clear guidance and restrictions on what types of patients that [CNMs] can accept and does not clearly delineate when a patient should be transferred to a physician or require a physician consult for higher risk patients. Because this bill does not currently include parameters on independent CNM practice that would ensure consumer protection, the Board is opposed to this bill unless it is amended to address these concerns.”
Related Legislation This Year. SB 323 (Hernandez) of 2015, would authorize a nurse practitioner who holds a national certification to practice without physician supervision in specified settings. (Status: This bill is pending reconsideration in the Assembly Business and Professions Committee).
Prior Related Legislation. SB 1308 (Bonilla, Chapter 665, Statutes of 2013) authorized a midwife to directly obtain supplies and devices, obtain and administer drugs and diagnostic tests, order testing and receive reports that are necessary to his/her practice of midwifery and consistent with his/her scope of practice; expanded the disclosures required to be made by a midwife to a prospective client to include the specific procedures that warrant consultation with a physician and surgeon; and made other correcting and conforming changes. This bill included no CPM provisions.
SB 1950 (Figueroa, Chapter 1085, Statutes of 2002) required
the MBC to adopt regulations defining the appropriate standard of
care and level of supervision required for the practice of
midwifery.
SB 1479 (Figueroa, Chapter 303, Statutes
of 2000) expanded the disclosures required to be given by licensed
midwives and also required midwives to register birth certificates
for home births.
SB 350 (Killea, Chapter 1280,
Statutes of 1993) enacted the Licensed Midwifery Practice Act of 1993
to provide for the licensing and regulation of non-nurse and
non-physician assistant midwives by the MBC.
Suggested Amendments.
Strike references to the ban on CPM. The ban on CPM has outlived its usefulness and extending it to another class of healthcare professionals does not further the interests of California consumers or CNMs.
On page 14, strike lines 3 -34.
To provide additional protections against any corporate influence on medical judgment, insert the following on page 16, after line 21:
“(c) No entity in (b) shall interfere with, control, or otherwise direct the professional judgment of a certified nurse midwife in a manner prohibited by Section 510 or of any other provision of law.”
Remove references to the Medical Board of California. This bill deletes the authorization for the BRN to appoint a Nurse-Midwifery Committee, and instead requires the BRN to create and appoint a Nurse-Midwifery Advisory Council, at least two members of which would be qualified physicians appointed by the MBC, including an obstetrician that has experience working with nurse-midwives.
There is no precedent for DCA boards to have appointment authority over the composition of another board’s committee. BRN is capable of appointing physician members to the Council proposed in this bill and as such, language referencing a MBC appointment should be removed.
On page 13, line 36, strike “appointed by the Medical Board of California”
Amendments regarding home birth conditions. The following language would provide greater semantic clarity to the circumstances in which a CNM may attend a home birth.
On page 15, line 39, strike “likely” and add “with the potential”
On page 15, line 40, add “or birth” after pregnancy.
On page 16, line 1, after “from” add “or during,” strike “likely” and add “with the potential”
On page 16, line 2, strike “significant”
On page 16, line 6, after “is” add “equal to or” and replace “370/7” with “37/7”
On page 16, line 7, add a space between “42” and “0/7”
SUPPORT AND OPPOSITION:
Support:
California Nurse Midwives Association (Sponsor)
AARP
American Association of Birth Centers
American College of Nurse-Midwives
American Nurses Association/California
Beach Cities Midwifery & Women’s Health Care
Beachside Birth Center
Black Women for Wellness
California Association of Midwives
California Association of Nurse Anesthetists
California Association for Nurse Practitioners
Center on Reproductive Rights and Justice at the University of California, Berkley School of Law
County of Santa Cruz Board of Supervisors
Inland Midwife Service
Maternal and Child Health Access
South Coast Midwifery & Women’s Healthcare, Inc.
United Nurses Associations of California/Union of Health Care Professionals
Numerous individuals
Opposition:
Adventist Health
California Hospital Association
Ceders-Sinai
Coalinga Regional Medical Center
Community Hospital of the Monterey Peninsula
El Camino Hospital
Henry Mayo Newhall Hospital
Lodi Health
Loma Linda University Health
Lompoc Valley Medical Center
Mammoth Hospital
Medical Board of California
Natividad Medical Center
Ridgecrest Regional Hospital
San Benito Health Care District
San Gorgonio Memorial Hospital
Sharp Healthcare
St. Helena Hospital Napa Valley
Sutter Health
Watsonville Community Hospital
-- END --
AB 1306
Page 5
ASSEMBLY THIRD READING
AB 1306
(Burke)
As Amended May 28, 2015
Majority vote
Committee |
Votes |
Ayes |
Noes |
Business & Professions |
14-0 |
Bonilla, Jones, Baker, Bloom, Burke, Chang, Dodd, Eggman, Gatto, Holden, Mullin, Ting, Wilk, Wood |
|
Appropriations |
15-2 |
Gomez, Bloom, Bonta, Calderon, Chang, Daly, Eggman, Gallagher, Eduardo Garcia, Holden, Jones, Quirk, Rendon, Weber, Wood |
Bigelow, Wagner |
SUMMARY: Removes the physician supervision requirement for certified nurse midwives (CNMs) allowing them to manage a full range of primary health services, perform peripartum care, provide emergency care when a physician is not present and perform and repair episiotomies in all practice settings. Specifically, this bill:
Requires an applicant for a certificate to practice nurse-midwifery to provide evidence of current advanced level national certification by a certifying body that meets standards established and approved by the Board of Registered Nursing (BRN).
Requires the BRN to create and appoint a Nurse-Midwifery Advisory Council (Council) consisting of CNM in good standing with experience in hospital and nonhospital practice settings, a nurse-midwife educator, as specified, and a consumer of midwifery care.
Requires the Council to make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters specified by the board, and would require the Council to meet regularly, but at least twice a year.
Authorizes a CNM to manage a full range of primary health care services for women from adolescence beyond menopause, including, but not limited to, gynecologic and family planning services.
Authorizes a CNM to practice in all settings, including, but not limited to, a home.
Declares that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the client and the resources of the medical personnel available in the setting of care, and would provide that the practice of nurse-midwifery emphasizes informed consent, preventive care and early detection and referral of complications to a physician and surgeon.
Authorizes a CNM to provide peripartum care in an out-of-hospital setting to low-risk women with uncomplicated singleton-term pregnancies who are expected to have uncomplicated birth.
Deletes the requirement that drugs or devices are furnished or ordered in accordance with standardized procedures and protocols.
Authorizes a CNM to furnish and order drugs or devices in connection with care rendered in a home, and would authorize a CNM to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a CNM and that are consistent with nurse-midwifery education preparation.
Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second degree lacerations of the perineum in a patient's home, and deletes all requirements that those procedures be performed pursuant to protocols developed and approved by the supervising physician and surgeon.
Requires a CNM to provide emergency care to a patient during times when a physician and surgeon are unavailable.
Indicates that a consultative relationship between a CNM and a physician and surgeon by itself is not a basis for finding the physician and surgeon liable for any acts or omissions on the part of the CNM.
Extends the definition of "licensee" to include a CNM.
Specifies that the Medical Board of California (MBC) shall take appropriate disciplinary action if the physician commits a misdemeanor.
Indicates that the BRN shall take appropriate disciplinary action if the CNM committed unprofessional conduct.
Indicates that the BRN may revoke a CNM's license if they refer a patient for services if the licensee or immediate family of the licensee has a financial interest with the person that receives the referral.
Makes other clarifying and technical changes.
FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill will result in minor costs to the BRN Fund for advisory council meetings. Costs for enforcement are unknown, but estimated to be minor.
COMMENTS:
Purpose. This bill is sponsored by the California Nurse Midwives Association. According to the author, "AB 1306 creates a level of parity in the law between [Licensed Midwives] and CNMs by removing the physician supervision requirements for CNMs, allowing them to practice independently within their scope of practice. If signed into law, CNMs will be able to provide a full range of services for women in all settings, furnish and order prescription drugs, supplies, and devices, order, obtain, and administer diagnostic tests, and receive reports.
Most pregnancies and births are completely normal physiologic events. When permitted to work to the full extent of their education and experience, CNMs can expertly manage more births in California. Untethering CNMs from physician supervision requirements will increase access to primary health care services for thousands of women in both urban and rural areas."
Background. Midwifery is the care of childrearing women during pregnancy, labor and birth and during the postpartum period. Midwifery services are offered by CNMs, who are regulated by the BRN and Licensed Midwives (LMs) who are regulated by the MBC. While both CNMs and Nurse Midwives (NMs) practice midwifery, there are differences in their education requirements, practice settings and supervision requirements.
Education. CNMs are licensed registered nurses with a certificate to practice midwifery, have acquired additional training in the field of obstetrics and are certified by the American College of Nurse Midwives.
LMs have completed a three-year postsecondary education program in an accredited midwifery school approved by the Medical Board or via the Challenge Mechanism. The Challenge Mechanism is an approved midwifery education program which allows students to obtain credit by examination for previous midwifery education and clinical experience.
Practice Settings. LMs can practice in home, birth centers and clinics. CNMs can practice in the same settings, but, unlike LMs, they can also practice in hospital settings. In 2012, CNMs attended approximately 8.5% of all births in California – the majority of which took place in a hospital and 1,365 were in free-standing birth centers. It is estimated that 90% of all CNM attended births take place in a hospital setting.
CNM care is a federally mandated Medicaid benefit. According to the Centers for Disease Control and Prevention, in 2012, 30% of CNM attended births in California were Medicaid, 65% were private pay and 2% were self-pay.
Physician Supervision. In California, LMs are permitted to practice without the supervision of a physician. However, despite the fact that many states allow CNMs to practice independently, California is one of six states that still requires physician supervision of CNMs. California law specifies that the supervision shall not be construed to require the physical presence of the physician. It also requires that in order for a CNM to prescribe medication, a physician needs to be telephonically available.
According to the author, although the supervision requirement tethers CNMs to practice only where a physician can supervise, it does not consist of actual oversight of health care delivery, inspection or review of charts, co-signature on prescriptions, direct care of the patient or evaluation of CNM patients at any point during pregnancy or well-woman care.
Changes to CNMs Scope of Practice. If this measure is enacted, a number of changes to the scope of practice for a CNM and authorization for a CNMs independent practice would be made. These include:
Management of a full range of primary health care services for women from adolescence beyond menopause, including, but not limited to, gynecologic and family planning services.
Practice in all settings, including, but not limited to, a home.
Authorization to provide peripartum care in an out-of-hospital setting to low-risk women with uncomplicated singleton-term pregnancies who are expected to have an uncomplicated birth.
A CNM would no longer be required to adhere to standardized procedures and protocols when:
Furnishing drugs or devices in connection with care rendered in a home;
Procuring supplies and devices;
Ordering, obtaining, and administering drugs and diagnostic tests;
Ordering laboratory and diagnostic testing;
Receiving reports that are necessary to his or her practice as a CNM;
Performing and repairing episiotomies and to repair first-degree and second degree lacerations of the perineum in a patient’s home; and,
Providing emergency care to a patient during times when a physician and surgeon is unavailable.
Arguments in Support:
The California Nurse Midwives Association (sponsor) writes in their letter of support, "AB 1306 provides no new authority for CNMs than they currently provide. It ensures they can practice as they currently do without physician supervision… CNM attended births have documented excellent maternity care outcomes… The excellent outcomes consistently achieved by nurse-midwives are the result of the midwifery model of care, not state-mandated relationships with physicians."
The California Association for Nurse Practitioners supports this bill and writes, "With the addition of millions of individuals to California's healthcare system due to ACA [Affordable Care Act] implementation, more healthcare providers are crucial to ensure quality, timely access to care… AB 1306 will assist in addressing this problem by allowing nurse-midwives to work collaboratively with physicians to provide women’s health care services across the state, including pregnancy and delivery care."
Access Women's Health Justice, Beach Cities Midwifery & Women's Health Care, Beachside Birth Center, California Association of Nurse Anesthetists, Yes2Kollege Education Resources, and the Women's Community Clinic, all similarly write in their support letters, "Physician collaboration is and has always been a hallmark of nurse-midwifery care and AB 1306 will not change that… According to ACOG, California is facing a workforce shortage of women's health care providers… AB 1306 will not change the way that nurse-midwives currently practice and will not change the high quality of care provided by nurse-midwives."
Arguments in Opposition:
The California Medical Association (CMA) opposes this bill and writes, "The CMA believes that AB 1306 allows certified nurse midwives to independently engage in the practice of medicine and lacks several important patient protection statutes that include, but are not limited to: 1) the corporate practice of medicine, 2) self-referral and anti-kickback prohibitions, 3) standard of care and 4) prescribing oversight."
Policy Issues for Consideration:
Examination Requirement. As highlighted by the opposition, this bill would authorize a CNM to work independently, without the supervision of a physician, and perform primary care services including gynecology. As such, the author may wish to amend this bill to include a requirement for an examination that would take place at the conclusion of the CNM's residency. This examination should include criteria similar to the United States Medical Licensing Examination, Step 3 which medical residents are required to take in order to show competency in practicing as an independent and unsupervised medical professional.
Corporate Practice of Medicine (CPM). The CPM is defined as any involvement of corporations in medicine. The CPM may also be defined more narrowly, for example, as the employment of a physician by a lay-controlled corporation that sells the services of the physician for a profit or provides the physician's services to its employees free of charge. The CPM now most commonly refers to the employment of physicians by hospitals, but is also still used to refer to employment of physicians by for-profit and non-profit corporate entities and government (see Business and Professions Code Section 2400).
This bill does not include a provision that prohibits the CPM. As such, the author should consider amending this bill to include language that explicitly prohibits the CPM considering that the provisions of this bill would allow CNMs to act as a primary care physicians. The addition of this language would serve as an important patient protection measure.
Cross Collaboration Between Advisory Councils. This bill would impact the practice of CNMs. It would also create a Nurse Midwives Advisory Council within the BRN. The MBC has a similar committee, the MBC Midwifery Advisory Council, which vets issues germane to the practice of midwifery. As such, it may be fruitful to require cross collaboration between the two committees as the practice of midwifery falls within the scope of practice for both CNMs and LMs.
Self-referrals. Another patient protection measure that is not included in this bill is specific language that addresses self-referrals. California law contains prohibitions against self-referral in the Physician Ownership and Referral Act of 1993 (PORA) which applies to healthcare licensees. Under PORA, a "financial interest" includes direct or indirect compensation. This means that a physician should not have a stock ownership in the entity to which the physician is referring in order for PORA to apply (see Business and Professions Code Section 650.01).
The author should include language in this bill that references these sections of law to ensure that the CNMs financial interests are not involved in the provision of medical care to patients.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P./ (916) 319-3301 FN: 0000634
AB 1306
Page 5
ASSEMBLY THIRD READING
AB 1306
(Burke)
As Introduced February 27, 2015
Majority vote
Committee |
Votes |
Ayes |
Noes |
Business & Professions |
14-0 |
Bonilla, Jones, Baker, Bloom, Burke, Chang, Dodd, Eggman, Gatto, Holden, Mullin, Ting, Wilk, Wood |
|
Appropriations |
15-2 |
Gomez, Bloom, Bonta, Calderon, Chang, Daly, Eggman, Gallagher, Eduardo Garcia, Holden, Jones, Quirk, Rendon, Weber, Wood |
Bigelow, Wagner |
SUMMARY: Removes the physician supervision requirement for certified nurse midwives (CNMs) allowing them to manage a full range of primary health services, perform peripartum care, provide emergency care when a physician is not present and perform and repair episiotomies in all practice settings. Specifically, this bill:
Requires an applicant for a certificate to practice nurse-midwifery to provide evidence of current advanced level national certification by a certifying body that meets standards established and approved by the Board of Registered Nursing (BRN).
Requires the BRN to create and appoint a Nurse-Midwifery Advisory Council (Council) consisting of CNM in good standing with experience in hospital and nonhospital practice settings, a nurse-midwife educator, as specified, and a consumer of midwifery care.
Requires the Council to make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters specified by the board, and would require the Council to meet regularly, but at least twice a year.
Authorizes a certified nurse-midwife to manage a full range of primary health care services for women from adolescence beyond menopause, including, but not limited to, gynecologic and family planning services.
Authorizes a certified nurse-midwife to practice in all settings, including, but not limited to, a home.
Declares that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the client and the resources of the medical personnel available in the setting of care, and would provide that the practice of nurse-midwifery emphasizes informed consent, preventive care and early detection and referral of complications to a physician and surgeon.
Authorizes a certified nurse-midwife to provide peripartum care in an out-of-hospital setting to low-risk women with uncomplicated singleton-term pregnancies who are expected to have uncomplicated birth.
Deletes the requirement that drugs or devices are furnished or ordered in accordance with standardized procedures and protocols.
Authorizes a certified nurse-midwife to furnish and order drugs or devices in connection with care rendered in a home, and would authorize a certified nurse-midwife to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a CNM and that are consistent with nurse-midwifery education preparation.
Authorizes a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and second degree lacerations of the perineum in a patient’s home, and deletes all requirements that those procedures be performed pursuant to protocols developed and approved by the supervising physician and surgeon.
Requires a certified nurse-midwife to provide emergency care to a patient during times when a physician and surgeon is unavailable.
Indicates that a consultative relationship between a CNM and a physician and surgeon by itself is not a basis for finding the physician and surgeon liable for any acts or omissions on the part of the CNM.
FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill will result in minor costs to the BRN Fund for advisory council meetings. Costs for enforcement are unknown, but estimated to be minor.
COMMENTS:
Purpose. This bill is sponsored by the California Nurse Midwives Association. According to the author, "AB 1306 creates a level of parity in the law between [Licensed Midwives] and CNMs by removing the physician supervision requirements for CNMs, allowing them to practice independently within their scope of practice. If signed into law, CNMs will be able to provide a full range of services for women in all settings, furnish and order prescription drugs, supplies, and devices, order, obtain, and administer diagnostic tests, and receive reports.
Most pregnancies and births are completely normal physiologic events. When permitted to work to the full extent of their education and experience, CNMs can expertly manage more births in California. Untethering CNMs from physician supervision requirements will increase access to primary health care services for thousands of women in both urban and rural areas."
Background. Midwifery is the care of childrearing women during pregnancy, labor and birth and during the postpartum period. Midwifery services are offered by CNMs, who are regulated by the BRN and Licensed Midwives (LMs) who are regulated by the Medical Board of California (MBC). While both CNMs and NMs practice midwifery, there are differences in their education requirements, practice settings and supervision requirements.
Education. CNMs are licensed registered nurses with a certificate to practice midwifery, have acquired additional training in the field of obstetrics and are certified by the American College of Nurse Midwives.
LMs have completed a three-year postsecondary education program in an accredited midwifery school approved by the Medical Board or via the Challenge Mechanism. The Challenge Mechanism is an approved midwifery education program which allows students to obtain credit by examination for previous midwifery education and clinical experience.
Practice Settings. LMs can practice in home, birth centers and clinics. CNMs can practice in the same settings, but, unlike LMs, they can also practice in hospital settings. In 2012, CNMs attended approximately 8.5% of all births in California – the majority of which took place in a hospital and 1,365 were in free-standing birth centers. It is estimated that 90% of all CNM attended births take place in a hospital setting.
CNM care is a federally mandated Medicaid benefit. According to the Centers for Disease Control, in 2012, 30% of CNM attended births in California were Medicaid, 65% were private pay and 2% were self-pay.
Physician Supervision. In California, LMs are permitted to practice without the supervision of a physician. However, despite the fact that many states allow CNMs to practice independently, California is one of six states that still requires physician supervision of CNMs. California law specifies that the supervision shall not be construed to require the physical presence of the physician. It also requires that in order for a CNM to prescribe medication, a physician needs to be telephonically available.
According to the author, although the supervision requirement tethers CNMs to practice only where a physician can supervise, it does not consist of actual oversight of health care delivery, inspection or review of charts, co-signature on prescriptions, direct care of the patient or evaluation of CNM patients at any point during pregnancy or well-woman care.
Changes to CNMs Scope of Practice. If this measure is enacted, a number of changes to the scope of practice for a CNM and authorization for a CNMs independent practice would be made. These include:
Management of a full range of primary health care services for women from adolescence beyond menopause, including, but not limited to, gynecologic and family planning services.
Practice in all settings, including, but not limited to, a home.
Authorization to provide peripartum care in an out-of-hospital setting to low-risk women with uncomplicated singleton-term pregnancies who are expected to have an uncomplicated birth.
A CNM would no longer be required to adhere to standardized procedures and protocols when:
Furnishing drugs or devices in connection with care rendered in a home;
Procuring supplies and devices;
Ordering, obtaining, and administering drugs and diagnostic tests;
Ordering laboratory and diagnostic testing;
Receiving reports that are necessary to his or her practice as a CNM;
Performing and repairing episiotomies and to repair first-degree and second degree lacerations of the perineum in a patient’s home; and,
Providing emergency care to a patient during times when a physician and surgeon is unavailable.
Arguments in Support:
The California Nurse Midwives Association (sponsor) writes in their letter of support, "AB 1306 provides no new authority for CNMs than they currently provide. It ensures they can practice as they currently do without physician supervision… CNM attended births have documented excellent maternity care outcomes… The excellent outcomes consistently achieved by nurse-midwives are the result of the midwifery model of care, not state-mandated relationships with physicians."
The California Association for Nurse Practitioners supports this bill and writes, "With the addition of millions of individuals to California's healthcare system due to ACA [Affordable Care Act] implementation, more healthcare providers are crucial to ensure quality, timely access to care… AB 1306 will assist in addressing this problem by allowing nurse-midwives to work collaboratively with physicians to provide women’s health care services across the state, including pregnancy and delivery care."
Access Women’s Health Justice, Beach Cities Midwifery & Women's Health Care, Beachside Birth Center, California Association of Nurse Anesthetists, Yes2Kollege Education Resources, and the Women's Community Clinic, all similarly write in their support letters, "Physician collaboration is and has always been a hallmark of nurse-midwifery care and AB 1306 will not change that… According to ACOG, California is facing a workforce shortage of women’s health care providers… AB 1306 will not change the way that nurse-midwives currently practice and will not change the high quality of care provided by nurse-midwives."
Arguments in Opposition:
The California Medical Association opposes this bill and writes, "The CMA believes that AB 1306 allows certified nurse midwives to independently engage in the practice of medicine and lacks several important patient protection statutes that include, but are not limited to: 1) the corporate practice of medicine, 2) self-referral and anti-kickback prohibitions, 3) standard of care and 4) prescribing oversight."
Policy Issues for Consideration:
Examination Requirement. As highlighted by the opposition, this bill would authorize a CNM to work independently, without the supervision of a physician, and perform primary care services including gynecology. As such, the author may wish to amend this bill to include a requirement for an examination that would take place at the conclusion of the CNM's residency. This examination should include criteria similar to the United States Medical Licensing Examination, Step 3 which medical residents are required to take in order to show competency in practicing as an independent and unsupervised medical professional.
Corporate Practice of Medicine (CPM). The CPM is defined as any involvement of corporations in medicine. The CPM may also be defined more narrowly, for example, as the employment of a physician by a lay-controlled corporation that sells the services of the physician for a profit or provides the physician’s services to its employees free of charge. The CPM now most commonly refers to the employment of physicians by hospitals, but is also still used to refer to employment of physicians by for-profit and non-profit corporate entities and government (see Business and Professions Code Section 2400).
This bill does not include a provision that prohibits the CPM. As such, the author should consider amending this bill to include language that explicitly prohibits the CPM considering that the provisions of this bill would allow CNMs to act as a primary care physicians. The addition of this language would serve as an important patient protection measure.
Cross Collaboration Between Advisory Councils. This bill would impact the practice of CNMs. It would also create a Nurse Midwives Advisory Council within the BRN. The MBC has a similar committee, the MBC Midwifery Advisory Council, which vets issues germane to the practice of midwifery. As such, it may be fruitful to require cross collaboration between the two committees as the practice of midwifery falls within the scope of practice for both CNMs and LMs.
Self-referrals. Another patient protection measure that is not included in this bill is specific language that addresses self-referrals. California law contains prohibitions against self-referral in the Physician Ownership and Referral Act of 1993 (PORA) which applies to healthcare licensees. Under PORA, a "financial interest" includes direct or indirect compensation. This means that a physician should not have a stock ownership in the entity to which the physician is referring in order for PORA to apply (see Business and Professions Code Section 650.01).
The author should include language in this bill that references these sections of law to ensure that the CNMs financial interests are not involved in the provision of medical care to patients.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301 FN: 0000414
AB 1306
Page 2
Date of Hearing: May 13, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
AB 1306
(Burke) – As Introduced February 27, 2015
Policy Committee: |
Business and Professions |
Vote: |
14 - 0 |
|
|
|
|
|
|
|
|
Urgency: No State Mandated Local Program: Yes Reimbursable: No
SUMMARY:
This bill removes the physician supervision requirement for certified nurse midwives (CNMs) and some related requirements, such as the requirement to dispense drugs pursuant to a standardized procedure or protocol. It also requires the Board of Registered Nursing (BRN) to convene a Nurse-Midwifery Advisory Council and hold, at minimum, two meetings yearly.
FISCAL EFFECT:
Minor costs to the BRN Fund for advisory council meetings.
Potential impact on BRN enforcement costs is unclear, but will likely be minor, as removing the requirement for supervision does not significantly change the practice of midwifery.
COMMENTS:
Purpose. According to the author, this bill creates parity in the law between licensed midwives and CNMs by removing the physician supervision requirements for CNMs, allowing them to practice independently within their scope of practice. If signed into law, CNMs will be able to provide a full range of services for women in all settings. This bill is sponsored by the California Nurse Midwives Association.
Background. Midwifery is the care of childrearing women during pregnancy, labor and birth and during the postpartum period. Midwifery services are offered by CNMs, who are regulated by the BRN and Licensed Midwives (LMs) who are regulated by the Medical Board of California (MBC). While both CNMs and LMs practice midwifery, there are differences in their education requirements, practice settings and supervision requirements. Generally CNMs have a higher level of education and training than LMs. LMs can practice in home, birth centers and clinics. CNMs can practice in the same settings, but, unlike LMs, they can also practice in hospital settings.
Prior Related Legislation. AB 1308 (Bonilla), Chapter 665, Statutes of 2013, removed physician supervision requirements for licensed midwives.
Opposition. The California Medical Association (CMA) opposes the bill unless amended to include additional protections related to the corporate practice of medicine, self-referral and anti-kickback prohibitions, standards of care and prescribing oversight.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
AB 1306
Page 2
Date of Hearing: May 6, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
AB 1306
(Burke) – As Introduced February 27, 2015
Policy Committee: |
Business and Professions |
Vote: |
14 - 0 |
|
|
|
|
|
|
|
|
Urgency: No State Mandated Local Program: Yes Reimbursable: No
SUMMARY:
This bill removes the physician supervision requirement for certified nurse midwives (CNMs) and some related requirements, such as the requirement to dispense drugs pursuant to a standardized procedure or protocol. It also requires the Board of Registered Nursing (BRN) to convene a Nurse-Midwifery Advisory Council and hold, at minimum, two meetings yearly.
FISCAL EFFECT:
Minor costs to the BRN Fund for advisory council meetings.
Potential impact on BRN enforcement costs is unclear, but will likely be minor, as removing the requirement for supervision does not significantly change the practice of midwifery.
COMMENTS:
Purpose. According to the author, this bill creates parity in the law between licensed midwives and CNMs by removing the physician supervision requirements for CNMs, allowing them to practice independently within their scope of practice. If signed into law, CNMs will be able to provide a full range of services for women in all settings. This bill is sponsored by the California Nurse Midwives Association.
Background. Midwifery is the care of childrearing women during pregnancy, labor and birth and during the postpartum period. Midwifery services are offered by CNMs, who are regulated by the BRN and Licensed Midwives (LMs) who are regulated by the Medical Board of California (MBC). While both CNMs and LMs practice midwifery, there are differences in their education requirements, practice settings and supervision requirements. Generally CNMs have a higher level of education and training than LMs. LMs can practice in home, birth centers and clinics. CNMs can practice in the same settings, but, unlike LMs, they can also practice in hospital settings.
Prior Related Legislation. AB 1308 (Bonilla), Chapter 665, Statutes of 2013, removed physician supervision requirements for licensed midwives.
Opposition. The California Medical Association (CMA) opposes the bill unless amended to include additional protections related to the corporate practice of medicine, self-referral and anti-kickback prohibitions, standards of care and prescribing oversight.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
AB 1306
Page 6
Date of Hearing: April 28, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 1306
(Burke) – As Introduced February 27, 2015
SUBJECT: Healing arts: certified nurse-midwives: scope of practice.
SUMMARY: Removes the physician supervision requirement for certified nurse midwives (CNMs) allowing them to manage a full range of primary health services, perform peripartum care, provide emergency care when a physician is not present and perform and repair episiotomies in all practice settings.
EXISTING LAW:
The Nursing Practice Act, provides for the licensure and regulation of the practice of nursing by the Board of Registered Nursing (BRN), within the Department of Consumer Affairs, and authorizes the board to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the board or the equivalent of those educational standards. (Business and Professions Code (BPC) § 2700 et seq.)
Authorizes a CNM, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn. (BPC § 2746.5 (a))
Provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal. (BPC § 2746.5 (b))
Authorizes a CNM to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the CNM's educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified. (BPC § 2746.51 et seq.)
Authorizes a CNM to perform and repair episiotomies and to repair first-degree and second degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center, if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon. (BPC § 2746.52)
THIS BILL:
Requires an applicant for a certificate to practice nurse-midwifery to provide evidence of current advanced level national certification by a certifying body that meets standards established and approved by the BRN.
Requires the BRN to create and appoint a Nurse-Midwifery Advisory Council (Council) consisting of CNM in good standing with experience in hospital and nonhospital practice settings, a nurse-midwife educator, as specified, and a consumer of midwifery care.
Requires the council to make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters specified by the board, and would require the council to meet regularly, but at least twice a year.
Authorizes a certified nurse-midwife to manage a full range of primary health care services for women from adolescence beyond menopause, including, but not limited to, gynecologic and family planning services.
Authorizes a certified nurse-midwife to practice in all settings, including, but not limited to, a home.
Declares that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the client and the resources of the medical personnel available in the setting of care, and would provide that the practice of nurse-midwifery emphasizes informed consent, preventive care and early detection and referral of complications to a physician and surgeon.
Authorizes a certified nurse-midwife to provide peripartum care in an out-of-hospital setting to low-risk women with uncomplicated singleton-term pregnancies who are expected to have uncomplicated birth.
Deletes the requirement that drugs or devices are furnished or ordered in accordance with standardized procedures and protocols.
Authorizes a certified nurse-midwife to furnish and order drugs or devices in connection with care rendered in a home, and would authorize a certified nurse-midwife to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a CNM and that are consistent with nurse-midwifery education preparation.
Authorizes a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and second degree lacerations of the perineum in a patient’s home, and deletes all requirements that those procedures be performed pursuant to protocols developed and approved by the supervising physician and surgeon.
Requires a certified nurse-midwife to provide emergency care to a patient during times when a physician and surgeon is unavailable.
Indicates that a consultative relationship between a CNM and a physician and surgeon by itself is not a basis for finding the physician and surgeon liable for any acts or omissions on the part of the CNM.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by the California Nurse Midwives Association. According to the author, “AB 1306 creates a level of parity in the law between [Licensed Midwives] and CNMs by removing the physician supervision requirements for CNMs, allowing them to practice independently within their scope of practice. If signed into law, CNMs will be able to provide a full range of services for women in all settings, furnish and order prescription drugs, supplies, and devices, order, obtain, and administer diagnostic tests, and receive reports.
Most pregnancies and births are completely normal physiologic events. When permitted to work to the full extent of their education and experience, CNMs can expertly manage more births in California. Untethering CNMs from physician supervision requirements will increase access to primary health care services for thousands of women in both urban and rural areas.”
Background. Midwifery is the care of childrearing women during pregnancy, labor and birth and during the postpartum period. Midwifery services are offered by CNMs, who are regulated by the BRN and Licensed Midwives (LMs) who are regulated by the Medical Board of California (MBC). While both CNMs and NMs practice midwifery, there are differences in their education requirements, practice settings and supervision requirements.
Education. CNMs are licensed registered nurses with a certificate to practice midwifery, have acquired additional training in the field of obstetrics and are certified by the American College of Nurse Midwives.
LMs have completed a three-year postsecondary education program in an accredited midwifery school approved by the Medical Board or via the Challenge Mechanism. The Challenge Mechanism is an approved midwifery education program which allows students to obtain credit by examination for previous midwifery education and clinical experience.
Practice Settings. LMs can practice in home, birth centers and clinics. CNMs can practice in the same settings, but, unlike LMs, they can also practice in hospital settings. In 2012, CNMs attended approximately 8.5 percent of all births in California – the majority of which took place in a hospital and 1365 were in free-standing birth centers. It is estimated that ninety percent of all CNM attended births take place in a hospital setting.
CNM care is a federally mandated Medicaid benefit. According to the Centers for Disease Control, in 2012, 30 percent of CNM attended births in California were Medicaid, 65 percent were private pay and 2 percent were self-pay.
Physician Supervision. In California, LMs are permitted to practice without the supervision of a physician. However, despite the fact that many states allow CNMs to practice independently, California is one of six states that still requires physician supervision of CNMs. California law specifies that the supervision shall not be construed to require the physical presence of the physician. It also requires that in order for a CNM to prescribe medication, a physician needs to be telephonically available.
According to the author, although the supervision requirement tethers CNMs to practice only where a physician can supervise, it does not consist of actual oversight of health care delivery, inspection or review of charts, co-signature on prescriptions, direct care of the patient or evaluation of CNM patients at any point during pregnancy or well-woman care.
Changes to CNMs Scope of Practice. If this measure is enacted, a number of changes to the scope of practice for a CNM and authorization for a CNMs independent practice would be made. These include:
Management of a full range of primary health care services for women from adolescence beyond menopause, including, but not limited to, gynecologic and family planning services.
Practice in all settings, including, but not limited to, a home.
Authorization to provide peripartum care in an out-of-hospital setting to low-risk women with uncomplicated singleton-term pregnancies who are expected to have an uncomplicated birth.
A CNM would no longer be required to adhere to standardized procedures and protocols when:
furnishing drugs or devices in connection with care rendered in a home;
procuring supplies and devices;
ordering, obtaining, and administering drugs and diagnostic tests;
ordering laboratory and diagnostic testing;
receiving reports that are necessary to his or her practice as a CNM;
performing and repairing episiotomies and to repair first-degree and second degree lacerations of the perineum in a patient’s home; and,
providing emergency care to a patient during times when a physician and surgeon is unavailable.
Prior Related Legislation. AB 1308 (Bonilla), Chapter 665, Statutes of 2013, removed physician supervision requirements for licensed midwives.
SB 1950 (Figueroa), Chapter 1085, Statutes of 2002, required the MBC
to adopt regulations defining the appropriate standard of care and
level of supervision required for the practice of midwifery.
SB
1479 (Figueroa), Chapter 303, Statutes of 2000, expanded the
disclosures required to be given by licensed midwives and also
required midwives to register birth certificates for home births.
SB
350 (Killea), Chapter 1280, Statutes of 1993, enacted the Licensed
Midwifery Practice Act of 1993 to provide for the licensing and
regulation of non-nurse and non-physician assistant midwives by the
MBC.
ARGUMENTS IN SUPPORT:
The California Nurse Midwives Association (sponsor) writes in their letter of support, “AB 1306 provides no new authority for CNMs than they currently provide. It ensures they can practice as they currently do without physician supervision…CNM attended births have documented excellent maternity care outcomes…The excellent outcomes consistently achieved by nurse-midwives are the result of the midwifery model of care, not state-mandated relationships with physicians.”
The California Association for Nurse Practitioners supports the bill and writes, “With the addition of millions of individuals to California’s healthcare system due to ACA implementation, more healthcare providers are crucial to ensure quality, timely access to care…AB 1306 will assist in addressing this problem by allowing nurse-midwives to work collaboratively with physicians to provide women’s health care services across the state, including pregnancy and delivery care.”
Access Women’s Health Justice, Beach Cities Midwifery & Women’s Health Care, Beachside Birth Center, California Association of Nurse Anesthetists, Yes2Kollege Education Resources, and the Women’s Community Clinic, all similarly write in their support letters, “Physician collaboration is and has always been a hallmark of nurse-midwifery care and AB 1306 will not change that…According to ACOG, California is facing a workforce shortage of women’s health care providers…AB 1306 will not change the way that nurse-midwives currently practice and will not change the high quality of care provided by nurse-midwives.”
ARGUMENTS IN OPPOSITION:
The California Medical Association opposes the bill and writes, “The CMA believes that AB 1306 allows certified nurse midwives to independently engage in the practice of medicine and lacks several important patient protection statutes that include, but are not limited to: 1) the corporate practice of medicine, 2) self-referral and anti-kickback prohibitions, 3) standard of care and 4) prescribing oversight.”
POLICY ISSUES FOR CONSIDERATION:
Examination Requirement. As highlighted by the opposition, this bill would authorize a CNM to work independently, without the supervision of a physician, and perform primary care services including gynecology. As such, the author may wish to amend the bill to include a requirement for an examination that would take place at the conclusion of the CNM’s residency. This examination should include criteria similar to the United States Medical Licensing Examination, Step 3 which medical residents are required to take in order to show competency in practicing as an independent and unsupervised medical professional.
Corporate Practice of Medicine (CPM). The CPM is defined as any involvement of corporations in medicine. The CPM may also be defined more narrowly, for example, as the employment of a physician by a lay-controlled corporation that sells the services of the physician for a profit or provides the physician’s services to its employees free of charge. The CPM now most commonly refers to the employment of physicians by hospitals, but is also still used to refer to employment of physicians by for-profit and non-profit corporate entities and government (see BPC § 2400).
This bill does not include a provision that prohibits the CPM. As such, the author should consider amending the bill to include language that explicitly prohibits the CPM considering that the provisions of the bill would allow CNMs to act as a primary care physicians. The addition of this language would serve as an important patient protection measure.
Cross Collaboration Between Advisory Councils. This bill would impact the practice of CNMs. It would also create a Nurse Midwives Advisory Council within the BRN. The MBC has a similar committee, the MBC Midwifery Advisory Council, which vets issues germane to the practice of midwifery. As such, it may be fruitful to require cross collaboration between the two committees as the practice of midwifery falls within the scope of practice for both CNMs and LMs.
Self-referrals. Another patient protection measure that is not included in the bill is specific language that addresses self-referrals. California law contains prohibitions against self-referral in the Physician Ownership and Referral Act of 1993 (PORA) which applies to healthcare licensees. Under PORA, a “financial interest” includes direct or indirect compensation. This means that a physician should not have a stock ownership in the entity to which the physician is referring in order for PORA to apply (see BPC § 650.01).
The author should include language in the bill that references these sections of law to ensure that the CNMs financial interests are not involved in the provision of medical care to patients.
REGISTERED SUPPORT:
California Nurse Midwives Association (sponsor)
AARP
Access Women’s Health Justice
American Association of Birth Centers
American Nurses Association California
Association of California Healthcare Districts
Beachside Birth Center
Beach Cities Midwifery & Women’s Health Care
California Association of Nurse Anesthetists
California Association for Nurse Practitioners
Maternal and Child Health Access
Women’s Community Clinic
Yes2Kollege Education Resources Inc.
Over 50 individuals
REGISTERED OPPOSITION:
California Medical Association
1 individual
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301
Discussed in Hearing
Assembly Floor
Senate Floor
Senate Standing Committee on Business, Professions and Economic Development
Senate Standing Committee on Business, Professions and Economic Development
Assembly Floor
Assembly Floor
Assembly Standing Committee on Appropriations
Assembly Standing Committee on Business and Professions
Bill Author
Bill Co-Author(s):