SB 464: Healing arts: self-reporting tools.
- Session Year: 2015-2016
- House: Senate
- Latest Version Date: 2015-09-30
The Medical Practice Act provides for licensure and regulation of physicians and surgeons by the Medical Board of California, and authorizes a physician and surgeon to, among other things, use drugs or devices in or upon human beings. The Medical Practice Act makes it unprofessional conduct for a physician and surgeon to prescribe, dispense, or furnish dangerous drugs without an appropriate prior examination and medical indication. The act prohibits, with specified exceptions, a person or entity from prescribing, dispensing, or furnishing, or causing to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices on the Internet for delivery to a person in California without an appropriate prior examination and medical indication.
The Nursing Practice Act provides for the licensure and regulation of registered nurses, including nurse practitioners and certified nurse-midwives, by the Board of Registered Nursing within the Department of Consumer Affairs. The Nursing Practice Act authorizes a registered nurse to dispense self-administered hormonal contraceptives, as specified, in accordance with standardized procedures, including demonstration of competency in providing the appropriate prior examination comprised of checking blood pressure, weight, and patient and family health history, including medications taken by the patient. The Nursing Practice Act also authorizes certified nurse-midwives and nurse practitioners to furnish or order drugs or devices, as specified.
The Physician Assistant Practice Act provides for the licensure and regulation of physician assistants by the Physician Assistant Board within the jurisdiction of the Medical Board of California, and authorizes a physician assistant to administer or provide medication to a patient or to transmit a drug order, as specified.
The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy within the Department of Consumer Affairs, and authorizes a pharmacist to furnish self-administered hormonal contraceptives in accordance with standardized procedures and protocols. The Pharmacy Law requires the standardized procedures and protocols to require a patient to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives, as specified.
This bill, notwithstanding any other law, would authorize a physician and surgeon, a registered nurse acting in accordance with the authority of the Nursing Practice Act, a certified nurse-midwife acting within the scope of specified existing law relating to nurse-midwives, a nurse practitioner acting within the scope of specified existing law relating to nurse practitioners, a physician assistant acting within the scope of specified existing law relating to physician assistants, or a pharmacist acting within the scope of a specified existing law relating to pharmacists to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, to prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient. The bill would authorize blood pressure, weight, height, and patient health history to be self-reported using the self-screening tool.
The Medical Practice Act provides for licensure and regulation of physicians and surgeons by the Medical Board of California, and authorizes a physician and surgeon to, among other things, use drugs or devices in or upon human beings. The Medical Practice Act makes it unprofessional conduct for a physician and surgeon to prescribe, dispense, or furnish dangerous drugs without an appropriate prior examination and medical indication. The act prohibits, with specified exceptions, a person or entity from prescribing, dispensing, or furnishing, or causing to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices on the Internet for delivery to a person in California without an appropriate prior examination and medical indication.
The Nursing Practice Act provides for the licensure and regulation of registered nurses, including nurse practitioners and certified nurse-midwives, by the Board of Registered Nursing within the Department of Consumer Affairs. The Nursing Practice Act authorizes a registered nurse to dispense self-administered hormonal contraceptives, as specified, in accordance with standardized procedures, including demonstration of competency in providing the appropriate prior examination comprised of checking blood pressure, weight, and patient and family health history, including medications taken by the patient. The Nursing Practice Act also authorizes certified nurse-midwives and nurse practitioners to furnish or order drugs or devices, as specified.
The Physician Assistant Practice Act provides for the licensure and regulation of physician assistants by the Physician Assistant Board within the jurisdiction of the Medical Board of California, and authorizes a physician assistant to administer or provide medication to a patient or to transmit a drug order, as specified.
The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy within the Department of Consumer Affairs, and authorizes a pharmacist to furnish self-administered hormonal contraceptives in accordance with standardized procedures and protocols. The Pharmacy Law requires the standardized procedures and protocols to require a patient to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives, as specified.
This bill, notwithstanding any other law, would authorize a physician and surgeon, a registered nurse acting in accordance with the authority of the Nursing Practice Act, a certified nurse-midwife acting within the scope of specified existing law relating to nurse-midwives, a nurse practitioner acting within the scope of specified existing law relating to nurse practitioners, a physician assistant acting within the scope of specified existing law relating to physician assistants, or a pharmacist acting within the scope of a specified existing law relating to pharmacists to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, to prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient. The bill would authorize blood pressure, weight, height, and patient health history to be self-reported using the self-screening tool.
The Medical Practice Act provides for licensure and regulation of physicians and surgeons by the Medical Board of California, and authorizes a physician and surgeon to, among other things, use drugs or devices in or upon human beings. The Medical Practice Act makes it unprofessional conduct for a physician and surgeon to prescribe, dispense, or furnish dangerous drugs without an appropriate prior examination and medical indication. The act prohibits, with specified exceptions, a person or entity from prescribing, dispensing, or furnishing, or causing to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices on the Internet for delivery to a person in California without an appropriate prior examination and medical indication.
The Nursing Practice Act provides for the licensure and regulation of registered nurses, including nurse practitioners and certified nurse-midwives, by the Board of Registered Nursing within the Department of Consumer Affairs. The Nursing Practice Act authorizes a registered nurse to dispense self-administered hormonal contraceptives, as specified, in accordance with standardized procedures, including demonstration of competency in providing the appropriate prior examination comprised of checking blood pressure, weight, and patient and family health history, including medications taken by the patient. The Nursing Practice Act also authorizes certified nurse-midwives and nurse practitioners to furnish or order drugs or devices, as specified.
The Physician Assistant Practice Act provides for the licensure and regulation of physician assistants by the Physician Assistant Board within the jurisdiction of the Medical Board of California, and authorizes a physician assistant to administer or provide medication to a patient or to transmit a drug order, as specified.
The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy within the Department of Consumer Affairs, and authorizes a pharmacist to furnish self-administered hormonal contraceptives in accordance with standardized procedures and protocols. The Pharmacy Law requires the standardized procedures and protocols to require a patient to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives, as specified.
This bill, notwithstanding any other law, would authorize the board to consider the use of self-reporting tools by licensees, as that use may be allowed by law. a physician and surgeon, a registered nurse acting in accordance with the authority of the Nursing Practice Act, a certified nurse-midwife acting within the scope of specified existing law relating to nurse-midwives, a nurse practitioner acting within the scope of specified existing law relating to nurse practitioners, a physician assistant acting within the scope of specified existing law relating to physician assistants, or a pharmacist acting within the scope of a specified existing law relating to pharmacists to use a self screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient. The bill would authorize blood pressure, weight, height, and patient health history to be self-reported using the self-screening tool.
The Medical Practice Act provides for licensure and regulation of physicians and surgeons by the Medical Board of California, and authorizes a physician and surgeon to, among other things, use drugs or devices in or upon human beings. The act prohibits, with specified exceptions, a person or entity from prescribing, dispensing, or furnishing, or causing to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices on the Internet for delivery to a person in California without an appropriate prior examination and medical indication.
This bill would authorize the board to consider the use of self-reporting tools by licensees, as that use may be allowed by law.
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid Program provisions. Existing law, the federal Patient Protection and Affordable Care Act (PPACA), requires each state to establish an American Health Benefit Exchange that facilitates the purchase of qualified health plans by qualified individuals and qualified small employers, and meets certain other requirements. Existing law creates the California Health Benefit Exchange for the purpose of facilitating the enrollment of qualified individuals and qualified small employers in qualified health plans as required under PPACA. Existing law requires the department, in collaboration with the exchange, to prepare reports that include specified information about the enrollment process for insurance affordability programs, and to make those reports public on at least a quarterly basis, for the purpose of informing specified entities about the enrollment process for those programs.
This bill would make technical, nonsubstantive changes to the latter provision.
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid Program provisions. Existing law, the federal Patient Protection and Affordable Care Act (PPACA), requires each state to establish an American Health Benefit Exchange that facilitates the purchase of qualified health plans by qualified individuals and qualified small employers, and meets certain other requirements. Existing law creates the California Health Benefit Exchange for the purpose of facilitating the enrollment of qualified individuals and qualified small employers in qualified health plans as required under PPACA. Existing law requires the department, in collaboration with the exchange, to prepare reports that include specified information about the enrollment process for insurance affordability programs, and to make those reports public on at least a quarterly basis, for the purpose of informing specified entities about the enrollment process for those programs.
This bill would make technical, nonsubstantive changes to the latter provision.
Notwithstanding any other law, a physician and surgeon, a registered nurse acting in accordance with Section 2725.2, a certified nurse-midwife acting within the scope of Section 2746.51, a nurse practitioner acting within the scope of Section 2836.1, a physician assistant acting within the scope of Section 3502.1, and a pharmacist acting within the scope of Section 4052.3 may use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient. Blood pressure, weight, height, and patient health history may be self-reported using the self-screening tool that identifies patient risk factors.
Notwithstanding any other law, a physician and surgeon, a registered nurse acting in accordance with Section 2725.2, a certified nurse-midwife acting within the scope of Section 2746.51, a nurse practitioner acting within the scope of Section 2836.1, a physician assistant acting within the scope of Section 3502.1, and a pharmacist acting within the scope of Section 4052.3 may use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient. Blood pressure, weight, height, and patient health history may be self-reported using the self-screening tool that identifies patient risk factors.
Notwithstanding any other law, a physician and surgeon, a registered nurse acting in accordance with Section 2725.2, a certified nurse-midwife acting within the scope of Section 2746.51, a nurse practitioner acting within the scope of Section 2836.1, a physician assistant acting within the scope of Section 3502.1, and a pharmacist acting within the scope of Section 4052.3 may use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient. Blood pressure, weight, height, and patient health history may be self-reported using the self-screening tool that identifies patient risk factors.
SECTION 1.Section 2242.1 of the Business and Professions Code is amended to read:2242.1.(a)No person or entity may prescribe, dispense, or furnish, or cause to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices, as defined in Section 4022, on the Internet for delivery to any person in this state, without an appropriate prior examination and medical indication, except as authorized by Section 2242.
(b)Notwithstanding any other provision of law, a violation of this section may subject the person or entity that has committed the violation to either a fine of up to twenty-five thousand dollars ($25,000) per occurrence pursuant to a citation issued by the board or a civil penalty of twenty-five thousand dollars ($25,000) per occurrence.
(c)The Attorney General may bring an action to enforce this section and to collect the fines or civil penalties authorized by subdivision (b).
(d)For notifications made on and after January 1, 2002, the Franchise Tax Board, upon notification by the Attorney General or the board of a final judgment in an action brought under this section, shall subtract the amount of the fine or awarded civil penalties from any tax refunds or lottery winnings due to the person who is a defendant in the action using the offset authority under Section 12419.5 of the Government Code, as delegated by the Controller, and the processes as established by the Franchise Tax Board for this purpose. That amount shall be forwarded to the board for deposit in the Contingent Fund of the Medical Board of California.
(e)If the person or entity that is the subject of an action brought pursuant to this section is not a resident of this state, a violation of this section shall, if applicable, be reported to the persons or entitys appropriate professional licensing authority.
(f)Nothing in this section shall prohibit the board from commencing a disciplinary action against a physician and surgeon pursuant to Section 2242.
(g)The board may consider the use of self-screening tools by a licensee, as that use may be allowed by law.
(a)No person or entity may prescribe, dispense, or furnish, or cause to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices, as defined in Section 4022, on the Internet for delivery to any person in this state, without an appropriate prior examination and medical indication, except as authorized by Section 2242.
(b)Notwithstanding any other provision of law, a violation of this section may subject the person or entity that has committed the violation to either a fine of up to twenty-five thousand dollars ($25,000) per occurrence pursuant to a citation issued by the board or a civil penalty of twenty-five thousand dollars ($25,000) per occurrence.
(c)The Attorney General may bring an action to enforce this section and to collect the fines or civil penalties authorized by subdivision (b).
(d)For notifications made on and after January 1, 2002, the Franchise Tax Board, upon notification by the Attorney General or the board of a final judgment in an action brought under this section, shall subtract the amount of the fine or awarded civil penalties from any tax refunds or lottery winnings due to the person who is a defendant in the action using the offset authority under Section 12419.5 of the Government Code, as delegated by the Controller, and the processes as established by the Franchise Tax Board for this purpose. That amount shall be forwarded to the board for deposit in the Contingent Fund of the Medical Board of California.
(e)If the person or entity that is the subject of an action brought pursuant to this section is not a resident of this state, a violation of this section shall, if applicable, be reported to the persons or entitys appropriate professional licensing authority.
(f)Nothing in this section shall prohibit the board from commencing a disciplinary action against a physician and surgeon pursuant to Section 2242.
(g)The board may consider the use of self-screening tools by a licensee, as that use may be allowed by law.
SECTION 1.Section 14102.5 of the Welfare and Institutions Code is amended to read:14102.5.(a)The department shall, in collaboration with the Exchange, the counties, consumer advocates, and the Statewide Automated Welfare System consortia, develop and prepare one or more reports that shall be issued on at least a quarterly basis and shall be made public within 30 days following the end of each quarter, for the purpose of informing the California Health and Human Services Agency, the Exchange, the Legislature, and the public about the enrollment process for insurance affordability programs. The reports shall comply with federal reporting requirements and shall, at a minimum, include the following information, to be derived from, as appropriate depending on the data element, CalHEERS, MEDS, or the Statewide Automated Welfare System:
(1)For applications received for insurance affordability programs through any venue, all of the following:
(A)The number of applications received through each venue.
(B)The number of applicants included on those applications.
(C)Applicant demographics, including, but not limited to, gender, age, race, ethnicity, and primary language.
(D)The disposition of applications, including all of the following:
(i)The number of eligibility determinations that resulted in an approval for coverage.
(ii)The program or programs for which the individuals in clause (i) were determined eligible.
(iii)The number of applications that were denied for any coverage and the reason or reasons for the denials.
(E)The number of days for eligibility determinations to be completed.
(2)With regard to health plan selection, all of the following:
(A)The health plans that are selected by applicants enrolled in an insurance affordability program, reported by the program.
(B)The number of Medi-Cal enrollees who do not select a health plan but are defaulted into a plan.
(3)For annual redeterminations conducted for beneficiaries, all of the following:
(A)The number of redeterminations processed.
(B)The number of redeterminations that resulted in continued eligibility for the same insurance affordability program.
(C)The number of redeterminations that resulted in a change in eligibility to a different insurance affordability program.
(D)The number of redeterminations that resulted in a finding of ineligibility for any program and the reason or reasons for the findings of ineligibility.
(E)The number of days for redeterminations to be completed.
(4)With regard to disenrollments not related to a redetermination of eligibility, all of the following:
(A)The number of beneficiary disenrollments.
(B)The reasons for the disenrollments.
(C)The number of disenrollments that are caused by an individual disenrolling from one insurance affordability program and enrolling into another.
(5)The number of applications for insurance affordability programs that were filed with the help of an assister or navigator.
(6)The total number of grievances and appeals filed by applicants and enrollees regarding eligibility for insurance affordability programs, the basis for the grievance, and the outcomes of the appeals.
(b)The department shall collect the information necessary for these reports and develop these reports using data obtained from the Statewide Automated Welfare System, CalHEERS, MEDS, and any other appropriate state information management systems.
(c)For purposes of this section, the following definitions shall apply:
(1)CalHEERS means the California Healthcare Eligibility, Enrollment, and Retention System developed under Section 15926.
(2)Exchange means the California Health Benefit Exchange established pursuant to Title 22 (commencing with Section 100500) of the Government Code.
(3)Statewide Automated Welfare System means the system developed pursuant to Section 10823.
(4)MEDS means the Medi-Cal Eligibility Data System that is maintained by the department.
(d)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department, without taking any further regulatory action, shall implement, interpret, or make specific this section by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions until the time regulations are adopted. Thereafter, the department shall adopt regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Beginning six months after the effective date of this section, and notwithstanding Section 10231.5 of the Government Code, the department shall provide a status report to the Legislature on a semiannual basis until regulations have been adopted.
(e)This section shall become operative on January 1, 2014.
(a)The department shall, in collaboration with the Exchange, the counties, consumer advocates, and the Statewide Automated Welfare System consortia, develop and prepare one or more reports that shall be issued on at least a quarterly basis and shall be made publicly available public within 30 days following the end of each quarter, for the purpose of informing the California Health and Human Services Agency, the Exchange, the Legislature, and the public about the enrollment process for all insurance affordability programs. The reports shall comply with federal reporting requirements and shall, at a minimum, include the following information, to be derived from, as appropriate depending on the data element, CalHEERS, MEDS, or the Statewide Automated Welfare System:
(1)For applications received for insurance affordability programs through any venue, all of the following:
(A)The number of applications received through each venue.
(B)The number of applicants included on those applications.
(C)Applicant demographics, including, but not limited to, gender, age, race, ethnicity, and primary language.
(D)The disposition of applications, including all of the following:
(i)The number of eligibility determinations that resulted in an approval for coverage.
(ii)The program or programs for which the individuals in clause (i) were determined eligible.
(iii)The number of applications that were denied for any coverage and the reason or reasons for the denials.
(E)The number of days for eligibility determinations to be completed.
(2)With regard to health plan selection, all of the following:
(A)The health plans that are selected by applicants enrolled in an insurance affordability program, reported by the program.
(B)The number of Medi-Cal enrollees who do not select a health plan but are defaulted into a plan.
(3)For annual redeterminations conducted for beneficiaries, all of the following:
(A)The number of redeterminations processed.
(B)The number of redeterminations that resulted in continued eligibility for the same insurance affordability program.
(C)The number of redeterminations that resulted in a change in eligibility to a different insurance affordability program.
(D)The number of redeterminations that resulted in a finding of ineligibility for any program and the reason or reasons for the findings of ineligibility.
(E)The number of days for redeterminations to be completed.
(4)With regard to disenrollments not related to a redetermination of eligibility, all of the following:
(A)The number of beneficiary disenrollments.
(B)The reasons for the disenrollments.
(C)The number of disenrollments that are caused by an individual disenrolling from one insurance affordability program and enrolling into another.
(5)The number of applications for insurance affordability programs that were filed with the help of an assister or navigator.
(6)The total number of grievances and appeals filed by applicants and enrollees regarding eligibility for insurance affordability programs, the basis for the grievance, and the outcomes of the appeals.
(b)The department shall collect the information necessary for these reports and develop these reports using data obtained from the Statewide Automated Welfare System, CalHEERS, MEDS, and any other appropriate state information management systems.
(c)For purposes of this section, the following definitions shall apply:
(1)CalHEERS means the California Healthcare Eligibility, Enrollment, and Retention System developed under Section 15926.
(2)Exchange means the California Health Benefit Exchange established pursuant to Title 22 (commencing with Section 100500) of the Government Code.
(3)Statewide Automated Welfare System means the system developed pursuant to Section 10823.
(4)MEDS means the Medi-Cal Eligibility Data System that is maintained by the department.
(d)Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department, without taking any further regulatory action, shall implement, interpret, or make specific this section by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions until the time regulations are adopted. Thereafter, the department shall adopt regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Beginning six months after the effective date of this section, and notwithstanding Section 10231.5 of the Government Code, the department shall provide a status report to the Legislature on a semiannual basis until regulations have been adopted.
(e)This section shall become operative on January 1, 2014.
|
Date
|
Status
|
|---|---|
| Jul 16, 2015 | Read second time. Ordered to third reading. |
| Sep 30, 2015 | Chaptered by Secretary of State. Chapter 387, Statutes of 2015. |
| Sep 30, 2015 | Approved by the Governor. |
| Sep 1, 2015 | Enrolled and presented to the Governor at 4:30 p.m. |
| Aug 31, 2015 | Assembly amendments concurred in. (Ayes 29. Noes 5.) Ordered to engrossing and enrolling. |
| Aug 31, 2015 | Assembly amendments concurred in. (Ayes 29. Noes 5. Page 2270.) Ordered to engrossing and enrolling. |
| Aug 27, 2015 | From committee: That the Assembly amendments be concurred in. (Ayes 8. Noes 0.) |
| Aug 27, 2015 | From committee: That the Assembly amendments be concurred in. (Ayes 8. Noes 0. Page 2235.) |
| Aug 26, 2015 | Set for hearing August 27. |
| Aug 24, 2015 | Re-referred to Com. on RLS. pursuant to Senate Rule 29.10(d). |
| Aug 24, 2015 | Re-referred to Com. on B., P. & E.D. pursuant to Senate Rule 29.10. |
| Aug 24, 2015 | Re-referred to Com. on B., P. & E.D. pursuant to Senate Rule 29.10(d). |
| Aug 24, 2015 | From committee: Be re-referred to Com. on B., P. & E.D. pursuant to Senate Rule 29.10(d). (Ayes 5. Noes 0. Page 2161.) Re-referred to Com. on B., P. & E.D. |
| Aug 20, 2015 | Read third time. Passed. (Ayes 73. Noes 1. Page 2530.) Ordered to the Senate. |
| Aug 20, 2015 | Read third time. Passed. Ordered to the Senate. |
| Aug 20, 2015 | In Senate. Concurrence in Assembly amendments pending. |
| Feb 25, 2015 | Introduced. Read first time. To Com. on RLS. for assignment. To print. |
| Jul 15, 2015 | From committee: Do pass. (Ayes 15. Noes 1.) (July 15). |
| Jun 30, 2015 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 14. Noes 0.) (June 30). Re-referred to Com. on APPR. |
| May 22, 2015 | Referred to Com. on B. & P. |
| May 22, 2015 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on B. & P. |
| May 11, 2015 | Read third time. Passed. (Ayes 27. Noes 2.) Ordered to the Assembly. |
| May 11, 2015 | Read third time. Passed. (Ayes 27. Noes 2. Page 952.) Ordered to the Assembly. |
| May 11, 2015 | In Assembly. Read first time. Held at Desk. |
| May 5, 2015 | Read second time. Ordered to third reading. |
| May 4, 2015 | From committee: Do pass. (Ayes 8. Noes 0.) (May 4). |
| May 4, 2015 | From committee: Do pass. (Ayes 8. Noes 0. Page 885.) (May 4). |
| Apr 29, 2015 | Set for hearing May 4. |
| Apr 27, 2015 | Re-referred to Com. on B., P. & E.D. |
| Apr 27, 2015 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on RLS. |
| Mar 5, 2015 | Referred to Com. on RLS. |
| Feb 26, 2015 | From printer. May be acted upon on or after March 28. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 31, 2015 | Unfinished Business SB464 Hernandez Concurrence | Senate Floor |
Passed |
|
| Aug 27, 2015 | That the Assembly amendments be concurred in | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
|
| Aug 20, 2015 | SB 464 Hernandez Senate Third Reading By WOOD | Assembly Floor |
Passed |
|
| Jul 15, 2015 | Do pass. | Assembly Standing Committee on Appropriations |
Passed |
|
| Jun 30, 2015 | Do pass and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Business and Professions |
Passed |
|
| May 11, 2015 | Senate 3rd Reading SB464 Hernandez | Senate Floor |
Passed |
|
| May 4, 2015 | Do pass | Senate Standing Committee on Business, Professions and Economic Development |
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
|
|---|---|---|
| California Academy Of Family Physicians | * Support | Jun 30, 2015 |
| California Catholic Conference | ** Against | Aug 31, 2015 |
| California Letter Association | * Support | Jun 30, 2015 |
| California Medical Association, Inc. | ** Support | Aug 31, 2015 |
| California Nurses Association | ** Against | Aug 31, 2015 |
| California Primary Care Association | ** Support | Aug 31, 2015 |
| California Right to Life Committee, Inc. | ** Against | Aug 31, 2015 |
| Icebreaker Health | ** Support | Aug 31, 2015 |
| NARAL Pro-Choice California | ** Support | Aug 31, 2015 |
| Planned Parenthood Action Fund of the Pacific Southwest | ** Support | Aug 31, 2015 |
| Planned Parenthood Advocacy Project Los Angeles County | ** Support | Aug 31, 2015 |
| Planned Parenthood Affiliates Of California | ** Support | Aug 31, 2015 |
| Planned Parenthood Mar Monte | ** Support | Aug 31, 2015 |
| Planned Parenthood Northern California Action Fund | ** Support | Aug 31, 2015 |
| Planned Parenthood Pasadena and San Gabriel Valley | ** Support | Aug 31, 2015 |
| University of California Davis | * Support | Jun 30, 2015 |
| University of California, Davis | * Support | Jun 30, 2015 |
SB 464
Page 6
|
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 |
UNFINISHED BUSINESS
Bill No: SB 464
Amended: 5/22/15
PRIOR SENATE VOTES NOT RELEVANT
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 8-0, 8/27/15
(pursuant to Senate Rule 29.10)
AYES: Hill, Berryhill, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski
NO VOTE RECORDED: Bates
ASSEMBLY FLOOR: 73-1, 8/20/15 - See last page for vote
SUBJECT: Healing arts: self-reporting tools
SOURCE: Planned Parenthood Affiliates of California
DIGEST: This bill permits a physician, registered nurse (RN), certified nurse-midwife (CNM), nurse practitioner (NP), physician assistant (PA), and pharmacist to use a self-screening tool to aid the prescription of self-administered hormonal contraceptives.
Assembly Amendments delete the contents of the bill and replace it with the current version.
Existing law:
Prohibits a person or entity from prescribing, dispensing, or furnishing, or causing to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices on the Internet for delivery to any person in this state, without an appropriate prior examination and medical indication, except as specified. (BPC § 2242.1)
Authorizes a RN to dispense a self-administered hormonal contraceptive (SAHC) in accordance with standardized procedures, which shall include demonstration of competency in providing the appropriate prior examination comprised of checking blood pressure, weight, and patient and family health history, including medications taken by the patient. The appropriate prior examination shall be consistent with the evidence-based practice guidelines adopted by the federal Centers for Disease Control and Prevention (CDC) in conjunction with the United States Medical Eligibility Criteria for Contraceptive Use (USMEC). (BPC § 2725.2)
Authorizes a pharmacist to furnish SAHC in accordance with standardized procedures developed and approved by both the Board of Pharmacy (BOP) and the Medical Board of California (MBC) in consultation with other entities, as specified, and requires that the protocol mandate the use of a patient self-screening tool to identify risk factors for the use of SAHC, based on current USMEC developed by the federal CDC. (BPC § 4052.3)
This
bill:
Authorizes a physician, RN, CNM, NP, PA, and pharmacist to use a self-screening tool that will identify patient risk factors for the use of SAHC by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, SAHC to the patient.
Permits blood pressure, weight, height, and patient health history to be self-reported using the self-screening tool.
Background
Telehealth and Self-Screening Tools. Current law defines telehealth as “the mode of delivering health care services and public health via information and communication technologies to facilitate the diagnosis, consultation, treatment, education, care management, and self-management of a patient’s health care while the patient is at the originating site and the health care provider is at a distant site.” Telehealth is neither a distinct technology nor a type of care; it is the remote provision of healthcare services according to the same professional standards governing in-person care.
Telehealth may be facilitated by many mediums, including telephone, videoconferencing, store-and-forward technology, and increasingly, by mobile devices connected to the Internet.
A self-screening tool is not defined in law; it is any instrument by which an individual reports health information. BOP is developing a paper checklist as its self-screening tool, and there exist mobile apps that record consumers’ answers in response to online prompts that are also considered self-screening tools.
Requirements for Prescribing SAHC. Current law authorizes a physician, RN, CNM, NP, PA, or a pharmacist to prescribe, furnish, or dispense SAHC. However, current laws and regulations are not specific as to the exact protocols required for each licensee to provide SAHC to patients.
Physician: An appropriate prior examination is mandated by law prior to a physician prescribing a SAHC. However, an in-person examination is not required and a physician is expected to use his or her professional judgment in determining the appropriate standard of care for each patient.
RN, CNM, NP, PA: These licensees are required to furnish or dispense SAHC pursuant to standardized procedures, which are the legal mechanism for non-physicians to perform functions which would otherwise be considered the practice of medicine, including prescribing drugs. 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. These licensees are also required to conduct an appropriate prior examination before dispensing or furnishing SAHC on the Internet for delivery to any person in this state, but what constitutes an appropriate prior examination is undefined.
As part of their standardized procedures for dispensing SAHC, RNs are required to demonstrate competency in providing an appropriate prior examination, which is comprised of checking blood pressure, weight, and collecting patient and family health history. Current law further states that the appropriate prior examination by a RN shall be consistent with the evidence-based practice guidelines adopted by the CDC.
The CDC recommended in their June 14, 2013 Morbidity and Mortality Weekly Report that, “among healthy women, few examinations or tests are needed before initiation of combined hormonal contraceptives.” They recommend that blood pressure be measured and that weight and body mass may be useful for monitoring SAHC use over time. However, nothing in the CDC recommendation states that a RN must measure blood pressure and weight for each patient prior to furnishing SAHC, and it is reasonable to infer that an accurate self-reporting of the same information would yield the necessary information.
Pharmacist: Pharmacists may furnish SAHC in accordance with standardized procedures developed and approved by the BOP and MBC. These standardized procedures have not yet been adopted, but the law states they must include a patient self-screening tool to identify risk factors based on the same CDC guidelines as required by RN protocols. The initial regulations formalizing the standardized procedures approved by the MBC and BOP required that the pharmacist also measure a patient’s seated blood pressure, in addition to the information collected by the self-screening tool. However, at the July 29, 2015 BOP meeting, the BOP voted to modify the protocol so that a pharmacist may accept self-reported blood pressure at his or her discretion. This modification must now be approved by the MBC.
This bill acknowledges the need for patient health information, including blood pressure and weight, to appropriately recommend a SAHC, but permits practitioners to rely on information provided by the patient, rather than measured by the practitioner.
Self-Reported Health Metrics and Safety of SAHC. Accepting self-reported medical information for SAHC is supported by numerous medical reports and journals because of the nature of the drugs themselves, effective self-screening, and the greater risks of unintended pregnancies.
For example, the American College of Obstetricians and Gynecologists (ACOG) advocated for over-the-counter availability of SAHCs in 2014, noting that the primary risk associated with SAHC, venous thromboembolism (blood clots) is “extremely low,” and that women can self-screen for contraindications. Further, the risk of blood clots due to SAHC is lower than the same risk of clotting in pregnancy. A 2014 article in the American Journal of Obstetrics and Gynecology reported on a study indicating that on average, there is a low prevalence of medical contraindications in women of reproductive age overall, so there is a very small portion of the population for whom information on a self-screening tool is truly vital.
This bill aims to clarify that existing and potential telehealth providers operate in accordance with current law by stating that practitioners who are currently authorized to provide SAHC may do so by relying on self-reported health information.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
According to the Assembly Appropriations analysis, this bill will have negligible costs to affected professional licensing boards within the Department of Consumer Affairs.
Planned Parenthood Affiliates of California (source)
California Medical Association
California Primary Care Association
Community Action Fund of Planned Parenthood of Orange and San Bernardino Counties
Icebreaker Health
NARAL Pro-Choice California
Planned Parenthood Action Fund of Santa Barbara, Ventura and San Luis Obispo Counties
Planned Parenthood Action Fund of the Pacific Southwest
Planned Parenthood Advocacy Project Los Angeles County
Planned Parenthood Mar Monte
Planned Parenthood Northern California Action Fund
Planned Parenthood Pasadena and San Gabriel Valley
Numerous individuals.
OPPOSITION: (Verified 8/27/15)
California Catholic Conference
California Nurses Association
California Right to Life Committee, Inc.
ARGUMENTS IN SUPPORT: “Planned Parenthood supports efforts to better serve our patients through the development and expansion of telehealth services. Telehealth is a safe, effective delivery system that expands access to health care for people who otherwise would have to travel a long distance to see a provider.
“SB 464 seeks to help improve preventive health services by increasing access to services in rural communities through the utilization of telemedicine by allowing patients to provide information to a health provider through a self-screening tool, including family history, blood pressure, or weight. As technology advances, telehealth will include models where patients communicate directly with a distant provider and are not physically present in a provider’s office.”
ARGUMENTS IN OPPOSITION: The California Catholic Conference writes in opposition, “Young girls, and other minors under the age of 18, would be able to receive contraceptives … without an actual medical exam and without the consent of their parent(s) or guardian(s). Further, without any oversight, these dangerous drugs could easily get into the wrong hands of human traffickers or the hands of young people.”
ASSEMBLY FLOOR: 73-1, 8/20/15
AYES: Achadjian, Alejo, Baker, Bigelow, Bloom, Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Weber, Wilk, Williams, Wood, Atkins
NOES: Gallagher
NO VOTE RECORDED: Travis Allen, Brough, Chu, Harper, Patterson, Waldron
Prepared by: Sarah Huchel / B., P. & E.D. / (916) 651-4104, Sarah Huchel / B., P. & E.D. / (916) 651-4104
8/28/15 15:24:23
SB 464
Page 2
SENATE THIRD READING
SB 464
(Hernandez)
As Amended May 22, 2015
Majority vote
SENATE VOTE: 27-2
Committee |
Votes |
Ayes |
Noes |
Business & Professions |
14-0 |
Bonilla, Jones, Baker, Bloom, Campos, Chang, Dodd, Eggman, Gatto, Holden, Mullin, Ting, Wilk, Wood |
|
Appropriations |
15-1 |
Gomez, Bigelow, Bloom, Bonta, Calderon, Chang, Daly, Eggman, Eduardo Garcia, Jones, Quirk, Rendon, Wagner, Weber, Wood |
Gallagher |
SUMMARY: Authorizes a physician, a registered nurse (RN), a certified nurse-midwife (CNM), a nurse practitioner (NP), a physician assistant (PA), or a pharmacist, in accordance with existing law for each practitioner, to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient. Specifically, this bill:
Authorizes six types of healing arts licensees to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient.
Authorizes the patient to self-report blood pressure, weight, height, and patient health history with the self-screening tool that identifies patient risk factors.
This bill includes the following licensees:
Physician and surgeons;
RNs acting in accordance with Business and Professions Code (BPC) Section 2725.2;
CNMs acting within the scope of BPC Section 2746.51;
NPs acting within the scope of BPC Section 2836.1;
PAs acting within the scope of BPC Section 3502.1; and,
Pharmacists acting within the scope of BPC Section 4052.3.
FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill will have negligible costs to affected professional licensing boards within the Department of Consumer Affairs.
COMMENTS:
Purpose. This bill is sponsored by Planned Parenthood Affiliates of California. According to the author, "In California, about half of all pregnancies are unintended. Women with unintended pregnancies are less likely to receive prenatal care, and health outcomes are worse for both mother and baby. According to a 2015 study by the Guttmacher Institute, the annual public cost of unintended pregnancies in California is more than $1.75 billion. Hormonal contraception has been proven safe and effective at preventing pregnancy, and the American College of Obstetricians and Gynecologists recently recommended that women should self-screen for contraindications using checklists to increase their access to hormonal contraceptives. Existing law is not clear as to whether self-screening tools can be used to transmit relevant medical and family history information from a patient to her provider for the purposes of accessing hormonal contraception. Enabling the use of self-screening tools will allow health care providers to make greater use of existing and developing technology, and will increase access to oral contraception for all women."
Background. Existing law already allows the six healing arts licensees included in this bill to provide self-administered hormonal contraceptives to patients through varying mechanisms:
Physicians are required to perform an appropriate prior examination.
PAs must be authorized by a supervising physician through a delegation of services agreement and perform an appropriate prior examination.
The NPs, CNMs, and RNs must follow Standardized Protocols and Procedures (SPPs) developed with a supervising physician and perform an appropriate prior examination.
Pharmacists must follow SPPs developed with an authorized prescriber, which require a patient to use a self-screening tool to screen for counter-indications, and must refer the patient to a primary care provider or clinic after denial or provision of the drug.
This bill simply clarifies that the practitioners may use a self-screening tool that allows a patient to self-report information.
Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001300
Date of Hearing: July 15, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
SB 464
(Hernandez) – As Amended May 22, 2015
Policy Committee: |
Business and Professions |
Vote: |
14 - 0 |
|
|
|
|
|
|
|
|
Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill clarifies health care practitioners can use patient self-screening tools that will identify patient risk factors for the use of self-administered hormonal contraceptives, for purposes of furnishing self-administered hormonal contraceptives to the patient.
FISCAL EFFECT:
Negligible costs to affected professional licensing boards within the Department of Consumer Affairs.
COMMENTS:
Purpose. According to the author, hormonal contraception has been proven safe and effective at preventing pregnancy, and the American College of Obstetricians and Gynecologists recently recommended that women should self-screen for contraindications using a checklist, in order to increase their access to hormonal contraceptives. The author further states existing law is unclear as to whether self-screening tools can be used to transmit relevant medical and family history information from a patient to her provider. The author believes enabling the use of self-screening tools will allow healthcare providers to make greater use of existing and developing technology, and will increase access to oral contraception. This bill is sponsored by Planned Parenthood Affiliates of California.
Background. Health care professionals specified in this bill, including a physician, a registered nurse (RN), a certified nurse-midwife (CNM), a nurse practitioner (NP), a physician assistant (PA), or a pharmacist are allowed to furnish self-administered hormonal contraceptives in accordance with existing law for each practitioner. In order to screen patients to ensure hormonal contraceptives are appropriate, certain data elements must be collected. This bill simply clarifies it is acceptable to collect this data from patient self-screening tools, for purposes of furnishing self-administered hormonal contraceptives.
Prior Legislation. SB 493 (Hernandez), Chapter 469, Statutes of 2013, among other things, authorized a pharmacist to furnish self-administered hormonal contraception in accordance with standardized procedures and protocols, which require the patient to use a self-screening tool to identify patient risk factors for contraceptives.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
SB 464
Page 7
Date of Hearing: June 30, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
SB 464
(Hernandez) – As Amended May 22, 2015
SENATE VOTE: 27-2
SUBJECT: Healing arts: self-reporting tools.
SUMMARY: Authorizes a physician, a registered nurse (RN), a certified nurse-midwife (CNM), a nurse practitioner (NP), a physician assistant (PA), or a pharmacist, in accordance with existing law for each practitioner, to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient.
EXISTING LAW:
Defines “dangerous drug” or “dangerous device” as any drug or device unsafe for self-use in humans or animals, and includes the following: (Business and Professions Code (BPC) § 4022)
Any drug that bears the legend: “Caution: federal law prohibits dispensing without prescription,” “Rx only,” or words of similar import.
Any device that bears the statement: “Caution: federal law restricts this device to sale by or on the order of a ____,” “Rx only,” or words of similar import, the blank to be filled in with the designation of the practitioner licensed to use or order use of the device.
Any other drug or device that by federal or state law can be lawfully dispensed only on prescription or furnished pursuant to BPC § 4006.
Makes it unprofessional conduct for a physician and surgeon to prescribe, dispense, or furnish dangerous drugs without an appropriate prior examination and medical indication, with exceptions. (BPC § 2242)
Makes it unlawful for a person or entity to prescribe, dispense, or furnish, or cause to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices, as defined in BPC § 4022, on the Internet for delivery to any person in this state, without an appropriate prior examination and medical indication, except as authorized by BPC § 2242. (BPC § 2242.1)
Authorizes a registered nurse (RN) to dispense self-administered hormonal contraceptives, as specified. The RN must follow standardized procedures and protocols (SPPs), including demonstrating competency in providing the appropriate prior examination comprised of checking blood pressure, weight, patient history and medication taken, and family health history. The appropriate prior examination shall be consistent with the evidence-based practice guidelines adopted by the federal Centers for Disease Control and Prevention (CDC) in conjunction with the United States Medical Eligibility Criteria (US MEC) for Contraceptive Use. (BPC § 2725.2)
Authorizes a certified nurse-midwife (CNM) to furnish or order drugs or devices, including controlled substance in accordance with SPPs, as specified. (BPC § 2746.51)
Authorizes a nurse practitioner (NP) to furnish or order drugs or devices, including controlled substance in accordance with SPPs, as specified. (BPC § 2836.1)
Authorizes a physician assistant (PA) to administer or provide medication to a patient or to transmit a drug order in accordance with the PA’s delegated services agreement (DSA), as specified. (BPC § 3502.1)
Authorizes a pharmacist to furnish self-administered hormonal contraceptives in accordance with SPPs. The SPPS must require a patient to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives, based on the current US MEC for Contraceptive Use developed by the CDC. (BPC § 4052.3)
Defines “telehealth” as the mode of delivering health care services and public health via information and communication technologies to facilitate the diagnosis, consultation, treatment, education, care management, and self-management of a patient’s health care while the patient is at the originating site and the health care provider is at a distant site. States that telehealth facilitates patient self-management and caregiver support for patients and includes real-time interactions and the transmission of patient medical information.
(BPC § 2290.5(a)(6))Requires a health care provider initiating the use of telehealth to inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health. The consent must be documented. (BPC § 2290.5(b))
THIS BILL:
Authorizes six types of healing arts licensees to use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives by a patient, and, after an appropriate prior examination, prescribe, furnish, or dispense, as applicable, self-administered hormonal contraceptives to the patient.
Authorizes the patient to self-report blood pressure, weight, height, and patient health history with the self-screening tool that identifies patient risk factors.
This bill includes the following licensees:
Physician and surgeons;
RNs acting in accordance with BPC § 2725.2;
CNMs acting within the scope of BPC § 2746.51;
NPs acting within the scope of BPC § 2836.1;
PAs acting within the scope of BPC § 3502.1; and,
Pharmacists acting within the scope of BPC § 4052.3.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by Planned Parenthood Affiliates of California. According to the author, “In California, about half of all pregnancies are unintended. Women with unintended pregnancies are less likely to receive prenatal care, and health outcomes are worse for both mother and baby. According to a 2015 study by the Guttmacher Institute, the annual public cost of unintended pregnancies in California is more than $1.75 billion. Hormonal contraception has been proven safe and effective at preventing pregnancy, and the American College of Obstetricians and Gynecologists recently recommended that women should self-screen for contraindications using checklists to increase their access to hormonal contraceptives. Existing law is not clear as to whether self-screening tools can be used to transmit relevant medical and family history information from a patient to her provider for the purposes of accessing hormonal contraception. Enabling the use of self-screening tools will allow health care providers to make greater use of existing and developing technology, and will increase access to oral contraception for all women.”
Background. Existing law allows the six healing arts licensees included in this bill to provide self-administered hormonal contraceptives to patients through varying mechanisms:
Physicians are required to perform an appropriate prior examination.
PAs must be authorized by a supervising physician through a DSA and perform an appropriate prior examination.
The NPs, CNMs, and RNs must follow SPPs developed with a supervising physician and perform an appropriate prior examination.
Pharmacists must follow SPPs developed with an authorized prescriber, which require a patient to use a self-screening tool to screen for counter-indications, and must refer the patient to a primary care provider or clinic after denial or provision of the drug.
Every provider besides a pharmacist is required to perform an appropriate prior exam. However, existing law does not specifically define an appropriate prior exam. According to the Medical Board of California (MBC), a physician has complete authority to determine what type of prior exam would be appropriate, so long as the exam fits the standard of care for the patient.
The standard of care is an objective test used to determine the quality of the services a physician is expected to provide. According to the 2013 MBC Expert Reviewer Guidelines, the standard of care means “the level of skill, knowledge and care in diagnosis and treatment ordinarily possessed and exercised by another reasonably careful and prudent physician in the same or similar circumstances.” The standard is objective because it takes into account current, medically-acceptable behavior, not an individual physician’s subjective opinion.
Therefore, an appropriate exam is what would be considered acceptable for the particular patient, based on current evidence and practices. As a result, under existing law, a physician could determine that, given the patient’s prior medical history and situation, an appropriate prior examination would be to require a patient to fill out a questionnaire, if similarly situated physicians would do the same. Other possible appropriate prior exams could range from blood pressure checks to full physical exams, depending on what the physician believed was needed to ensure the patient’s medical need, safety, and the efficacy of the drug.
Prior Exams by Non-Physicians. An appropriate prior examination differs for PAs and nurses because they must follow written guidelines developed with a supervising physician or entity. The guidelines will be based on the standard of care for varying types of patients and situations. For PAs, the written guidelines are called DSAs, which include a formulary. For nurses, they are called SPPs. Because PAs and nurses must follow the guidelines, they are limited to a prior examination that adheres to the guidelines.
PAs, CNMs, and NPs and the supervising physician have broad discretion in determining drug prescribing guidelines. RNs, however, have specific requirements for the prior examination for providing hormonal contraceptives. For instance, the SPPs must require RNs to demonstrate competency in providing the appropriate prior examination comprised of checking blood pressure, weight, and patient and family health history, including medications taken by the patient.
While the SPP must require that RNs demonstrates “competency” in providing an appropriate prior exam that consists of checking various patient health measures, the actual type of prior exam that is appropriate is not defined. Existing law only specifies that an appropriate prior examination must be consistent with the evidence-based practice guidelines adopted by the CDC in conjunction with the US MEC.
The CDC’s US MEC is a set of recommendations on who can safely use contraceptives (essentially a list of risk factors). It is unclear which evidence-based practice guidelines the language refers to, but it may refer to the US MEC companion document adopted by the CDC, the U.S. Selected Practice Recommendations for Contraceptive Use (US SPR), which is discussed in the next section.
Finally, pharmacists (besides advanced practice pharmacists) are different from the other providers because their scope of practice does not ordinarily permit them to perform an appropriate prior exam to the same extent as the other practitioners. Instead, existing law requires them to operate under SPPs that require them to use a self-screening tool that is consistent with the CDC’s US MEC.
Self-Screening Tools. The sponsors argue that it is not clear that a provider may have a patient self-report data using a self-screening tool to provide self-administered hormonal contraception. Therefore, this bill aims to clarify that a provider may do so.
Existing law does not define “self-screening tool.” However, according to the federal National Institutes of Health (NIH), screenings are medical tests that look for indications or risk factors for a particular condition. A self-screening tool would be a tool that a patient uses to alert a provider of those conditions. For instance, filling out a medical history form could be a type of self-screening tool.
For contraceptives, the screening tool would identify risk factors in a patient that would suggest which contraceptives may not be safe for the patient to take. That is why pharmacists are required to use a self-screening tool instead of performing an appropriate prior exam. Pharmacists ask the patient to use a screening tool in order to screen the patient for the risk factors identified in the US MEC for a particular form of contraception.
For physicians, nurses, and PAs, the standard of care for self-administered hormonal contraceptives could allow for a self-screening tool. For example, according to the CDC’s US SPR (noted above), the companion document to the US MEC, some forms of hormonal contraceptives need minimal or no initial examinations. The US SPR is a set of evidence-based practice recommendations on how a provider should use the US MEC risk factors. The CDC adapted both documents for U.S. practices from the recommendations of the World Health Organization (WHO).
According to the US SPR recommendations, self-administered hormonal contraceptives are generally safe and effective and require minimal examinations. The only recommended initial examination for combined hormonal contraceptives is a blood pressure test. However, women with limited access to healthcare can take the measure in a nonclinical setting (such as a pharmacy) and self-report the data to a provider. For progestin-only pills, there are no initial exams that would make taking the pill safer or more effective. For all contraceptives, body weight is never needed for an initial prescription.
Therefore, the standard of care for starting hormonal oral contraceptives requires very little examination and testing. As a result, existing law could allow a physician to determine that an appropriate prior examination for a combined oral contraceptive prescription is a self-screening tool that reported blood pressure data from the patient to the physician.
Further, existing law already requires RN SPPs to be consistent with the evidence-based practice guidelines adopted by the CDC in conjunction with the US MEC, which may be the CDC’s US SPR. If so, a set of RN SPPs could potentially allow a RN provide progestin-only pills after a brief phone consultation without taking any measurements, where the consultation is considered the prior examination. The defining factors are the standard of care (US MEC) and the adequacy of the screening tool as a prior examination, which this bill does not address.
Internet and Phone Applications for Self-Reporting. According to the sponsors, this bill will allow providers to prescribe self-administered hormonal contraceptives through phone and internet applications (mobile apps) that are used as self-screening tools. However, because self-reporting through self-screening tools is already permitted, there is currently no prohibition against the use of a mobile app for that purpose. Existing law allows internet prescribing for direct delivery after an appropriate examination and medical indication. It also permits the use of telehealth after written consent.
The reason for the explicit requirement for internet prescribing, which is duplicative of the regular prescription requirements, is due to the fear of online pharmacies illegally providing dangerous drugs to patients without medical need. In 2004, the MBC issued an action report that stated, “Internet prescribing is illegal when a legitimate physician-patient relationship does not exist. Some physicians have attempted to legitimize their Internet prescribing by engaging in the review of questionnaires, which Internet users will complete, although there is no way to confirm the patient is reporting accurate or truthful information.”
“In-person examinations not only enhance the opportunity to confirm if a patient needs the identified medication or to rule out other medical conditions, but ensures the patient is advised of alternative treatment options and is aware of potential side effects. For some patients, certain drugs are contraindicated and serious injury, including death, can follow.”
However, at the time, the MBC cited drugs like Vicodin and Viagra being sold at discounted prices without a doctor-patient relationship. However, drugs like Vicodin are prone to abuse and additional screening is important in those situations (see DEA Schedule II-III categorization). In addition, drugs like Viagra have many risk factors and are counter-indicated for many medications.
On the other hand, the efficacy for hormonal contraceptives is well-known and accepted, and the risk factors are minimal. Therefore, the standard of care would require a more stringent prior exam for a scheduled drug like Vicodin than it would for hormonal contraceptives. While in-person examinations would be useful in many situations, the law does not require it. Further, technology and internet security have progressed in the eleven years since the MBC report. Therefore, internet prescribing and the use of mobile applications as a self-screening tool are already allowed if the appropriate prior examination was performed.
Other States. Oregon H 2879, of this legislative session, would permit pharmacists to prescribe hormonal contraceptive patches and self-administered oral hormonal contraceptives.
Prior Related Legislation. SB 493 (Hernandez), Chapter 469, Statutes of 2013, among other things, authorized a pharmacist to furnish self-administered hormonal contraception in accordance with SPPs that require the patient to use a self-screening tool to identify patient risk factors for the contraceptives.
ARGUMENTS IN SUPPORT:
Planned Parenthood Affiliates of California (sponsors) write in support, “[this bill] seeks to help improve preventive health services by increasing access to services in rural communities through the utilization of telemedicine by allowing patients to provide information to a health provider through a self-screening tool, including family history, blood pressure, or weight. As technology advances, telehealth will include models where patients communicate directly with a distant provider and are not physically present in a provider’s office.”
ARGUMENTS IN OPPOSITION:
The Union of American Physicians and Dentists writes in opposition, “[this bill] provides for no “prescribing” safeguards, and disperses oversight across several State Boards. State lawmakers have an obligation to enact legislation, which places patient safety as a number one priority.”
POLICY ISSUE FOR CONSIDERATION:
Because the use of a self-screening tool for the purposes of providing contraceptives is already permitted, the Committee may wish to consider the necessity of this bill.
REGISTERED SUPPORT:
Planned Parenthood Affiliates of California (sponsor)
California Primary Care Association
California Women’s Law Center
Icebreaker Health
Planned Parenthood Los Angeles
Planned Parenthood Mar Monte
Planned Parenthood Northern California
Planned Parenthood Orange and San Bernardino Counties
Planned Parenthood Pasadena and San Gabriel Valley
Planned Parenthood Santa Barbara, Ventura, & San Luis Obispo Counties
Five MDs
REGISTERED OPPOSITION:
Union of American Physicians and Dentists
Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301
SB 464
Page 5
|
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 |
THIRD READING
Bill No: SB 464
Amended: 4/27/15
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 8-0, 5/4/15
AYES: Hill, Bates, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski
NO VOTE RECORDED: Berryhill
SUBJECT: Healing arts: self-reporting tools
DIGEST: This bill authorizes the Medical Board of California to consider the use of self-screening tools by a licensee, as that use may be allowed by law.
Existing federal law:
Authorizes the Federal Food and Drug Administration (FDA) to regulate drugs and medical devices. (Title 21 United States Code (USC) § 301 et seq.)
Defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them.
Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. (21 USC § 201(h))
Existing state law:
Establishes the Medical Board of California (Board) to administer the Medical Practice Act (Act). (Business and Professions Code (BPC) §§ 2001 and 2004)
Prohibits any person or entity from prescribing, dispensing, or furnishing dangerous drugs or dangerous devices on the Internet for delivery to any person in California without an appropriate prior examination and medical indication, except as specified.
Defines “dangerous drug” or “dangerous device” as any drug or device unsafe for self-use in humans or animals, and includes the following:
Any drug that bears the legend: “Caution: federal law prohibits dispensing without prescription,” “Rx only,” or words of similar import.
Any device that bears the statement: “Caution: federal law restricts this device to sale by or on the order of a ____,” “Rx only,” or words of similar import, the blank to be filled in with the designation of the practitioner licensed to use or order use of the device.
This
bill authorizes the Board to consider the use of self-screening tools
by a licensee, as that use may be allowed by law.
Background
According to the Author’s office, “This bill will expand access to health care through the use of new and innovative technology that will connect patients with their health care provider more efficiently and cost effectively. This bill will promote the use of self-screening tools to allow a patient to communicate important information to their provider when appropriate. Using these tools in mobile and web-based technologies will increase the use of telehealth in all communities -- rural, urban, and suburban and in underserved areas.”
The Author further states that, “Existing law is not clear as to whether self-screening tools can be used to transmit relevant medical and family history information from a patient to his or her provider. Enabling the use of self-screening tools, when appropriate, will allow providers to make greater use of existing and developing technology to provide health care through synchronous and asynchronous telehealth. For example, the American College of Obstetricians and Gynecologists recently recommended that women should self-screen for contraindications using checklists to increase their access to extremely safe hormonal contraceptives. This, in turn, could help reduce the very high levels of unintended pregnancies experienced in California and the rest of the country. Self-screening tools would all be developed by the appropriate providers, used under their direction and with a patient’s consent.”
Medical Self-Screening Applications.
The FDA is responsible for protecting the public health by assuring that foods (with certain exceptions) are safe, wholesome, sanitary, and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.
In September 2013, the FDA issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices.
The FDA stated that it intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers, but rather focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.
Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.
Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes.
Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.
The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.
Medical Board of California.
The MBC administers the Act, which does not speak specifically to the particular use of medical devices, but ensures that overall safety of a physician’s practice. This bill authorizes the MBC to consider the use of self-screening tools by a licensee.
FISCAL EFFECT: Appropriation: No Fiscal Com.: No Local: No
Community Action Fund of Planned Parenthood of Orange and San Bernardino Counties
Icebreaker Health
NARAL Pro-Choice
Planned Parenthood Action Fund of the Pacific Southwest
Planned Parenthood Action Fund of Santa Barbara, Ventura and San Luis Obispo Counties
Planned Parenthood Advocacy Project Los Angeles
Planned Parenthood Mar Monte
Planned Parenthood Pasadena and San Gabriel Valley
None received
ARGUMENTS IN SUPPORT: Icebreaker Health writes, “Self-screening tools and use of self-reported biometrics are increasingly being utilized by the healthcare system. Medical professionals have long accepted self-reporting of important elements of the patient’s health-related history – personal health history, smoking history, current medication lists, alcohol use, family medical history, etc. Such self-reported data points are an important source of information for medical professionals, especially when interacting with new patients. The advent of technology now also allows health professionals to utilize self-screening tools to collect biometrics for elements such as self-monitored blood pressure and histories, and self-monitored glucose and histories. These provide valuable information that can be used to provide appropriate care for patients.
“Given this, Icebreaker Health respectfully requests your Aye vote for SB 464.”
Prepared by: Sarah Huchel / B., P. & E.D. / (916) 651-4104
5/6/15 16:49:47
**** END ****
SB 464 (Hernandez) Page 3 of 3
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: SB 464 Hearing Date: May 4, 2015
Author: |
Hernandez |
||
Version: |
April 27, 2015 |
||
Urgency: |
No |
Fiscal: |
No |
Consultant: |
Sarah Huchel |
||
Subject: Healing arts: self-reporting tools.
SUMMARY: Authorizes the Medical Board of California to consider the use of self-screening tools by a licensee, as that use may be allowed by law.
Existing federal law:
Authorizes the Federal Food and Drug Administration to regulate drugs and medical devices. (Title 21 United States Code (USC) § 301 et seq.)
Defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them.
Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. (21 USC § 201(h))
Existing law:
Establishes the Medical Board of California (Board) to administer the Medical Practice Act (Act). (Business and Professions Code (BPC) §§ 2001 and 2004)
Prohibits any person or entity from prescribing, dispensing, or furnishing dangerous drugs or dangerous devices on the Internet for delivery to any person in California without an appropriate prior examination and medical indication, except as specified.
Defines “dangerous drug” or “dangerous device” as any drug or device unsafe for self-use in humans or animals, and includes the following:
Any drug that bears the legend: “Caution: federal law prohibits dispensing without prescription,” “Rx only,” or words of similar import.
Any device that bears the statement: “Caution: federal law restricts this device to sale by or on the order of a ____,” “Rx only,” or words of similar import, the blank to be filled in with the designation of the practitioner licensed to use or order use of the device.
This
bill authorizes the Board to consider the use of self-screening
tools by a licensee, as that use may be allowed by law.
FISCAL EFFECT:
This bill has been keyed “nonfiscal” by Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by the Author. According to the Author’s office, “This bill will expand access to health care through the use of new and innovative technology that will connect patients with their health care provider more efficiently and cost effectively. This bill will promote the use of self-screening tools to allow a patient to communicate important information to their provider when appropriate. Using these tools in mobile and web-based technologies will increase the use of telehealth in all communities -- rural, urban, and suburban and in underserved areas.”
The Author further states that, “Existing law is not clear as to whether self-screening tools can be used to transmit relevant medical and family history information from a patient to his or her provider. Enabling the use of self-screening tools, when appropriate, will allow providers to make greater use of existing and developing technology to provide health care through synchronous and asynchronous telehealth. For example, the American College of Obstetricians and Gynecologists recently recommended that women should self-screen for contraindications using checklists to increase their access to extremely safe hormonal contraceptives. This, in turn, could help reduce the very high levels of unintended pregnancies experienced in California and the rest of the country. Self-screening tools would all be developed by the appropriate providers, used under their direction and with a patient’s consent.”
Medical Self-Screening Applications. The FDA is responsible for protecting the public health by assuring that foods (with certain exceptions) are safe, wholesome, sanitary, and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.
In September 2013, the FDA issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices.
The FDA stated that it intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers, but rather focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.
Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.
Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes.
Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.
The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.
Medical Board of California. The MBC administers the Act, which does not speak specifically to the particular use of medical devices, but ensures that overall safety of a physician’s practice. This bill authorizes the MBC to consider the use of self-screening tools by a licensee.
SUPPORT AND OPPOSITION:
Support: None on file as of April 29, 2015.
Opposition: None
on file as of April 29, 2015.
-- END --
Bill Author
Bill Co-Author(s):