AB 941: Clinics: licensure and regulation: exemption.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2015-10-05
Existing law provides for the regulation and licensure of clinics, as defined, by the State Department of Public Health. Under existing law, specified types of clinics are exempted from these licensing provisions, including a clinic that is conducted, maintained, or operated by a federally recognized Indian tribe and is located on land recognized as tribal land by the federal government.
This bill would expand that exemption to also include a clinic conducted, maintained, or operated by a federally recognized Indian tribe under a contract with the United States pursuant to federal law, without regard to the location of the clinic, except that if the clinic chooses to apply to the department for a state facility license, then the department would retain authority to regulate that clinic as a primary care clinic.
This bill would incorporate additional changes to Section 1206 of the Health and Safety Code proposed by AB 1130 that would become operative if this bill and AB 1130 are chaptered and this bill is chaptered last.
Existing law provides for the regulation and licensure of clinics, as defined, by the State Department of Public Health. Under existing law, specified types of clinics are exempted from these licensing provisions, including a clinic that is conducted, maintained, or operated by a federally recognized Indian tribe and is located on land recognized as tribal land by the federal government.
This bill would expand that exemption to also include a clinic conducted, maintained, or operated by a federally recognized Indian tribe under a contract with the United States pursuant to federal law, without regard to the location of the clinic, except that if the clinic chooses to apply to the department for a state facility license, then the department would retain authority to regulate that clinic as a primary care clinic.
This bill would incorporate additional changes to Section 1206 of the Health and Safety Code proposed by AB 1130 that would become operative if this bill and AB 1130 are chaptered and this bill is chaptered last.
Existing law provides for the regulation and licensure of clinics, as defined, by the State Department of Public Health. Under existing law, specified types of clinics are exempted from these licensing provisions, including a clinic that is conducted, maintained, or operated by a federally recognized Indian tribe and is located on land recognized as tribal land by the federal government.
This bill would expand that exemption to also include a clinic conducted, maintained, or operated by a federally recognized Indian tribe under a contract with the United States pursuant to federal law, without regard to the location of the clinic, except that if the clinic chooses to apply to the department for a state facility license, then the department would retain authority to regulate that clinic as a primary care clinic.
This bill would incorporate additional changes to Section 1206 of the Health and Safety Code proposed by AB 1130 that would become operative if this bill and AB 1130 are chaptered and this bill is chaptered last.
Existing law provides for the regulation and licensure of clinics, as defined, by the State Department of Public Health. Under existing law, specified types of clinics are exempted from these licensing provisions, including a clinic that is conducted, maintained, or operated by a federally recognized Indian tribe and is located on land recognized as tribal land by the federal government.
This bill would expand that exemption to also include a clinic conducted, maintained, or operated by a federally recognized Indian tribe under a contract with the United States pursuant to federal law, without regard to the location of the clinic. clinic, except that if the clinic chooses to apply to the department for a state facility license, then the department would retain authority to regulate that clinic as a primary care clinic.
Existing law provides for the regulation and licensure of clinics, as defined, by the State Department of Public Health. Under existing law, specified types of clinics are exempted from these licensing provisions, including a clinic that is conducted, maintained, or operated by a federally recognized Indian tribe and is located on land recognized as tribal land by the federal government.
This bill would expand that exemption to also include a federally recognized Indian tribe under a contract with the United States pursuant to federal law, without regard to the location of the clinic.
This chapter does not apply to the following:
(a)Except with respect to the option provided with regard to surgical clinics in paragraph (1) of subdivision (b) of Section 1204 and, further, with respect to specialty clinics specified in paragraph (2) of subdivision (b) of Section 1204, any place or establishment owned or leased and operated as a clinic or office by one or more licensed health care practitioners and used as an office for the practice of their profession, within the scope of their license, regardless of the name used publicly to identify the place or establishment.
(b)Any clinic directly conducted, maintained, or operated by the United States or by any of its departments, officers, or agencies, and any primary care clinic specified in subdivision (a) of Section 1204 that is directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city. Nothing in this subdivision precludes the state department from adopting regulations that utilize clinic licensing standards as eligibility criteria for participation in programs funded wholly or partially under Title XVIII or XIX of the federal Social Security Act.
(c)(1)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, that is located on land recognized as tribal land by the federal government.
(2)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act (Public Law 93-638), regardless of the location of the clinic, except that if the clinic chooses to apply to the State Department of Public Health for a state facility license, then the State Department of Public Health will retain authority to regulate that clinic as a primary care clinic as defined by subdivision (a) of Section 1204.
(d)Clinics conducted, operated, or maintained as outpatient departments of hospitals.
(e)Any facility licensed as a health facility under Chapter 2 (commencing with Section 1250).
(f)Any freestanding clinical or pathological laboratory licensed under Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code.
(g)A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art.
(h)A clinic that is operated by a primary care community or free clinic and that is operated on separate premises from the licensed clinic and is only open for limited services of no more than 20 hours a week. An intermittent clinic as described in this subdivision shall, however, meet all other requirements of law, including administrative regulations and requirements, pertaining to fire and life safety.
(i)The offices of physicians in group practice who provide a preponderance of their services to members of a comprehensive group practice prepayment health care service plan subject to Chapter 2.2 (commencing with Section 1340).
(j)Student health centers operated by public institutions of higher education.
(k)Nonprofit speech and hearing centers, as defined in Section 1201.5. Any nonprofit speech and hearing clinic desiring an exemption under this subdivision shall make application therefor to the director, who shall grant the exemption to any facility meeting the criteria of Section 1201.5. Notwithstanding the licensure exemption contained in this subdivision, a nonprofit speech and hearing center shall be deemed to be an organized outpatient clinic for purposes of qualifying for reimbursement as a rehabilitation center under the Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code).
(l)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, that conducts medical research and health education and provides health care to its patients through a group of 40 or more physicians and surgeons, who are independent contractors representing not less than 10 board-certified specialties, and not less than two-thirds of whom practice on a full-time basis at the clinic.
(m)Any clinic, limited to in vivo diagnostic services by magnetic resonance imaging functions or radiological services under the direct and immediate supervision of a physician and surgeon who is licensed to practice in California. This shall not be construed to permit cardiac catheterization or any treatment modality in these clinics.
(n)A clinic operated by an employer or jointly by two or more employers for their employees only, or by a group of employees, or jointly by employees and employers, without profit to the operators thereof or to any other person, for the prevention and treatment of accidental injuries to, and the care of the health of, the employees comprising the group.
(o)A community mental health center, as defined in Section 5601.5 of the Welfare and Institutions Code.
(p)(1)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, as an entity organized and operated exclusively for scientific and charitable purposes and that satisfied all of the following requirements on or before January 1, 2005:
(A)Commenced conducting medical research on or before January 1, 1982, and continues to conduct medical research.
(B)Conducted research in, among other areas, prostatic cancer, cardiovascular disease, electronic neural prosthetic devices, biological effects and medical uses of lasers, and human magnetic resonance imaging and spectroscopy.
(C)Sponsored publication of at least 200 medical research articles in peer-reviewed publications.
(D)Received grants and contracts from the National Institutes of Health.
(E)Held and licensed patents on medical technology.
(F)Received charitable contributions and bequests totaling at least five million dollars ($5,000,000).
(G)Provides health care services to patients only:
(i)In conjunction with research being conducted on procedures or applications not approved or only partially approved for payment (I) under the Medicare program pursuant to Section 1359y(a)(1)(A) of Title 42 of the United States Code, or (II) by a health care service plan registered under Chapter 2.2 (commencing with Section 1340), or a disability insurer regulated under Chapter 1 (commencing with Section 10110) of Part 2 of Division 2 of the Insurance Code; provided that services may be provided by the clinic for an additional period of up to three years following the approvals, but only to the extent necessary to maintain clinical expertise in the procedure or application for purposes of actively providing training in the procedure or application for physicians and surgeons unrelated to the clinic.
(ii)Through physicians and surgeons who, in the aggregate, devote no more than 30 percent of their professional time for the entity operating the clinic, on an annual basis, to direct patient care activities for which charges for professional services are paid.
(H)Makes available to the public the general results of its research activities on at least an annual basis, subject to good faith protection of proprietary rights in its intellectual property.
(I)Is a freestanding clinic, whose operations under this subdivision are not conducted in conjunction with any affiliated or associated health clinic or facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as affiliated only if it directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, a clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as associated only if more than 20 percent of the directors or trustees of the clinic are also the directors or trustees of any individual clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). Any activity by a clinic under this subdivision in connection with an affiliated or associated entity shall fully comply with the requirements of this subdivision. This subparagraph shall not apply to agreements between a clinic and any entity for purposes of coordinating medical research.
(2)By January 1, 2007, and every five years thereafter, the Legislature shall receive a report from each clinic meeting the criteria of this subdivision and any other interested party concerning the operation of the clinics activities. The report shall include, but not be limited to, an evaluation of how the clinic impacted competition in the relevant health care market, and a detailed description of the clinics research results and the level of acceptance by the payer community of the procedures performed at the clinic. The report shall also include a description of procedures performed both in clinics governed by this subdivision and those performed in other settings. The cost of preparing the reports shall be borne by the clinics that are required to submit them to the Legislature pursuant to this paragraph.
SEC. 1.5.Section 1206 of the Health and Safety Code is amended to read:1206.This chapter does not apply to the following:
(a)Except with respect to the option provided with regard to surgical clinics in paragraph (1) of subdivision (b) of Section 1204 and, further, with respect to specialty clinics specified in paragraph (2) of subdivision (b) of Section 1204, any place or establishment owned or leased and operated as a clinic or office by one or more licensed health care practitioners and used as an office for the practice of their profession, within the scope of their license, regardless of the name used publicly to identify the place or establishment.
(b)Any clinic directly conducted, maintained, or operated by the United States or by any of its departments, officers, or agencies, and any primary care clinic specified in subdivision (a) of Section 1204 that is directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city. Nothing in this subdivision precludes the state department from adopting regulations that utilize clinic licensing standards as eligibility criteria for participation in programs funded wholly or partially under Title XVIII or XIX of the federal Social Security Act.
(c)(1)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, that is located on land recognized as tribal land by the federal government.
(2)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act (Public Law 93-638), regardless of the location of the clinic, except that if the clinic chooses to apply to the State Department of Public Health for a state facility license, then the State Department of Public Health will retain authority to regulate that clinic as a primary care clinic as defined by subdivision (a) of Section 1204.
(d)Clinics conducted, operated, or maintained as outpatient departments of hospitals.
(e)Any facility licensed as a health facility under Chapter 2 (commencing with Section 1250).
(f)Any freestanding clinical or pathological laboratory licensed under Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code.
(g)A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art.
(h)A clinic that is operated by a primary care community or free clinic and that is operated on separate premises from the licensed clinic and is only open for limited services of no more than 30 hours a week. An intermittent clinic as described in this subdivision shall, however, meet all other requirements of law, including administrative regulations and requirements, pertaining to fire and life safety.
(i)The offices of physicians in group practice who provide a preponderance of their services to members of a comprehensive group practice prepayment health care service plan subject to Chapter 2.2 (commencing with Section 1340).
(j)Student health centers operated by public institutions of higher education.
(k)Nonprofit speech and hearing centers, as defined in Section 1201.5. Any nonprofit speech and hearing clinic desiring an exemption under this subdivision shall make application therefor to the director, who shall grant the exemption to any facility meeting the criteria of Section 1201.5. Notwithstanding the licensure exemption contained in this subdivision, a nonprofit speech and hearing center shall be deemed to be an organized outpatient clinic for purposes of qualifying for reimbursement as a rehabilitation center under the Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code).
(l)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, that conducts medical research and health education and provides health care to its patients through a group of 40 or more physicians and surgeons, who are independent contractors representing not less than 10 board-certified specialties, and not less than two-thirds of whom practice on a full-time basis at the clinic.
(m)Any clinic, limited to in vivo diagnostic services by magnetic resonance imaging functions or radiological services under the direct and immediate supervision of a physician and surgeon who is licensed to practice in California. This shall not be construed to permit cardiac catheterization or any treatment modality in these clinics.
(n)A clinic operated by an employer or jointly by two or more employers for their employees only, or by a group of employees, or jointly by employees and employers, without profit to the operators thereof or to any other person, for the prevention and treatment of accidental injuries to, and the care of the health of, the employees comprising the group.
(o)A community mental health center, as defined in Section 5667 of the Welfare and Institutions Code.
(p)(1)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, as an entity organized and operated exclusively for scientific and charitable purposes and that satisfied all of the following requirements on or before January 1, 2005:
(A)Commenced conducting medical research on or before January 1, 1982, and continues to conduct medical research.
(B)Conducted research in, among other areas, prostatic cancer, cardiovascular disease, electronic neural prosthetic devices, biological effects and medical uses of lasers, and human magnetic resonance imaging and spectroscopy.
(C)Sponsored publication of at least 200 medical research articles in peer-reviewed publications.
(D)Received grants and contracts from the National Institutes of Health.
(E)Held and licensed patents on medical technology.
(F)Received charitable contributions and bequests totaling at least five million dollars ($5,000,000).
(G)Provides health care services to patients only:
(i)In conjunction with research being conducted on procedures or applications not approved or only partially approved for payment (I) under the Medicare program pursuant to Section 1359y(a)(1)(A) of Title 42 of the United States Code, or (II) by a health care service plan registered under Chapter 2.2 (commencing with Section 1340), or a disability insurer regulated under Chapter 1 (commencing with Section 10110) of Part 2 of Division 2 of the Insurance Code; provided that services may be provided by the clinic for an additional period of up to three years following the approvals, but only to the extent necessary to maintain clinical expertise in the procedure or application for purposes of actively providing training in the procedure or application for physicians and surgeons unrelated to the clinic.
(ii)Through physicians and surgeons who, in the aggregate, devote no more than 30 percent of their professional time for the entity operating the clinic, on an annual basis, to direct patient care activities for which charges for professional services are paid.
(H)Makes available to the public the general results of its research activities on at least an annual basis, subject to good faith protection of proprietary rights in its intellectual property.
(I)Is a freestanding clinic, whose operations under this subdivision are not conducted in conjunction with any affiliated or associated health clinic or facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as affiliated only if it directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, a clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as associated only if more than 20 percent of the directors or trustees of the clinic are also the directors or trustees of any individual clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). Any activity by a clinic under this subdivision in connection with an affiliated or associated entity shall fully comply with the requirements of this subdivision. This subparagraph shall not apply to agreements between a clinic and any entity for purposes of coordinating medical research.
(2)By January 1, 2007, and every five years thereafter, the Legislature shall receive a report from each clinic meeting the criteria of this subdivision and any other interested party concerning the operation of the clinics activities. The report shall include, but not be limited to, an evaluation of how the clinic impacted competition in the relevant health care market, and a detailed description of the clinics research results and the level of acceptance by the payer community of the procedures performed at the clinic. The report shall also include a description of procedures performed both in clinics governed by this subdivision and those performed in other settings. The cost of preparing the reports shall be borne by the clinics that are required to submit them to the Legislature pursuant to this paragraph.
SEC. 2.Section 1.5 of this bill incorporates amendments to Section 1206 of the Health and Safety Code proposed by both this bill and Assembly Bill 1130. It shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2016, (2) each bill amends Section 1206 of the Health and Safety Code, and (3) this bill is enacted after Assembly Bill 1130, in which case Section 1 of this bill shall not become operative.
This chapter does not apply to the following:
(a)Except with respect to the option provided with regard to surgical clinics in paragraph (1) of subdivision (b) of Section 1204 and, further, with respect to specialty clinics specified in paragraph (2) of subdivision (b) of Section 1204, any place or establishment owned or leased and operated as a clinic or office by one or more licensed health care practitioners and used as an office for the practice of their profession, within the scope of their license, regardless of the name used publicly to identify the place or establishment.
(b)Any clinic directly conducted, maintained, or operated by the United States or by any of its departments, officers, or agencies, and any primary care clinic specified in subdivision (a) of Section 1204 that is directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city. Nothing in this subdivision precludes the state department from adopting regulations that utilize clinic licensing standards as eligibility criteria for participation in programs funded wholly or partially under Title XVIII or XIX of the federal Social Security Act.
(c)(1)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, that is located on land recognized as tribal land by the federal government.
(2)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act (Public Law 93-638), regardless of the location of the clinic, except that if the clinic chooses to apply to the State Department of Public Health for a state facility license, then the State Department of Public Health will retain authority to regulate that clinic as a primary care clinic as defined by subdivision (a) of Section 1204.
(d)Clinics conducted, operated, or maintained as outpatient departments of hospitals.
(e)Any facility licensed as a health facility under Chapter 2 (commencing with Section 1250).
(f)Any freestanding clinical or pathological laboratory licensed under Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code.
(g)A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art.
(h)A clinic that is operated by a primary care community or free clinic and that is operated on separate premises from the licensed clinic and is only open for limited services of no more than 20 hours a week. An intermittent clinic as described in this subdivision shall, however, meet all other requirements of law, including administrative regulations and requirements, pertaining to fire and life safety.
(i)The offices of physicians in group practice who provide a preponderance of their services to members of a comprehensive group practice prepayment health care service plan subject to Chapter 2.2 (commencing with Section 1340).
(j)Student health centers operated by public institutions of higher education.
(k)Nonprofit speech and hearing centers, as defined in Section 1201.5. Any nonprofit speech and hearing clinic desiring an exemption under this subdivision shall make application therefor to the director, who shall grant the exemption to any facility meeting the criteria of Section 1201.5. Notwithstanding the licensure exemption contained in this subdivision, a nonprofit speech and hearing center shall be deemed to be an organized outpatient clinic for purposes of qualifying for reimbursement as a rehabilitation center under the Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code).
(l)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, that conducts medical research and health education and provides health care to its patients through a group of 40 or more physicians and surgeons, who are independent contractors representing not less than 10 board-certified specialties, and not less than two-thirds of whom practice on a full-time basis at the clinic.
(m)Any clinic, limited to in vivo diagnostic services by magnetic resonance imaging functions or radiological services under the direct and immediate supervision of a physician and surgeon who is licensed to practice in California. This shall not be construed to permit cardiac catheterization or any treatment modality in these clinics.
(n)A clinic operated by an employer or jointly by two or more employers for their employees only, or by a group of employees, or jointly by employees and employers, without profit to the operators thereof or to any other person, for the prevention and treatment of accidental injuries to, and the care of the health of, the employees comprising the group.
(o)A community mental health center, as defined in Section 5601.5 of the Welfare and Institutions Code.
(p)(1)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, as an entity organized and operated exclusively for scientific and charitable purposes and that satisfied all of the following requirements on or before January 1, 2005:
(A)Commenced conducting medical research on or before January 1, 1982, and continues to conduct medical research.
(B)Conducted research in, among other areas, prostatic cancer, cardiovascular disease, electronic neural prosthetic devices, biological effects and medical uses of lasers, and human magnetic resonance imaging and spectroscopy.
(C)Sponsored publication of at least 200 medical research articles in peer-reviewed publications.
(D)Received grants and contracts from the National Institutes of Health.
(E)Held and licensed patents on medical technology.
(F)Received charitable contributions and bequests totaling at least five million dollars ($5,000,000).
(G)Provides health care services to patients only:
(i)In conjunction with research being conducted on procedures or applications not approved or only partially approved for payment (I) under the Medicare program pursuant to Section 1359y(a)(1)(A) of Title 42 of the United States Code, or (II) by a health care service plan registered under Chapter 2.2 (commencing with Section 1340), or a disability insurer regulated under Chapter 1 (commencing with Section 10110) of Part 2 of Division 2 of the Insurance Code; provided that services may be provided by the clinic for an additional period of up to three years following the approvals, but only to the extent necessary to maintain clinical expertise in the procedure or application for purposes of actively providing training in the procedure or application for physicians and surgeons unrelated to the clinic.
(ii)Through physicians and surgeons who, in the aggregate, devote no more than 30 percent of their professional time for the entity operating the clinic, on an annual basis, to direct patient care activities for which charges for professional services are paid.
(H)Makes available to the public the general results of its research activities on at least an annual basis, subject to good faith protection of proprietary rights in its intellectual property.
(I)Is a freestanding clinic, whose operations under this subdivision are not conducted in conjunction with any affiliated or associated health clinic or facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as affiliated only if it directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, a clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as associated only if more than 20 percent of the directors or trustees of the clinic are also the directors or trustees of any individual clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). Any activity by a clinic under this subdivision in connection with an affiliated or associated entity shall fully comply with the requirements of this subdivision. This subparagraph shall not apply to agreements between a clinic and any entity for purposes of coordinating medical research.
(2)By January 1, 2007, and every five years thereafter, the Legislature shall receive a report from each clinic meeting the criteria of this subdivision and any other interested party concerning the operation of the clinics activities. The report shall include, but not be limited to, an evaluation of how the clinic impacted competition in the relevant health care market, and a detailed description of the clinics research results and the level of acceptance by the payer community of the procedures performed at the clinic. The report shall also include a description of procedures performed both in clinics governed by this subdivision and those performed in other settings. The cost of preparing the reports shall be borne by the clinics that are required to submit them to the Legislature pursuant to this paragraph.
SEC. 1.5.Section 1206 of the Health and Safety Code is amended to read:1206.This chapter does not apply to the following:
(a)Except with respect to the option provided with regard to surgical clinics in paragraph (1) of subdivision (b) of Section 1204 and, further, with respect to specialty clinics specified in paragraph (2) of subdivision (b) of Section 1204, any place or establishment owned or leased and operated as a clinic or office by one or more licensed health care practitioners and used as an office for the practice of their profession, within the scope of their license, regardless of the name used publicly to identify the place or establishment.
(b)Any clinic directly conducted, maintained, or operated by the United States or by any of its departments, officers, or agencies, and any primary care clinic specified in subdivision (a) of Section 1204 that is directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city. Nothing in this subdivision precludes the state department from adopting regulations that utilize clinic licensing standards as eligibility criteria for participation in programs funded wholly or partially under Title XVIII or XIX of the federal Social Security Act.
(c)(1)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, that is located on land recognized as tribal land by the federal government.
(2)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act (Public Law 93-638), regardless of the location of the clinic, except that if the clinic chooses to apply to the State Department of Public Health for a state facility license, then the State Department of Public Health will retain authority to regulate that clinic as a primary care clinic as defined by subdivision (a) of Section 1204.
(d)Clinics conducted, operated, or maintained as outpatient departments of hospitals.
(e)Any facility licensed as a health facility under Chapter 2 (commencing with Section 1250).
(f)Any freestanding clinical or pathological laboratory licensed under Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code.
(g)A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art.
(h)A clinic that is operated by a primary care community or free clinic and that is operated on separate premises from the licensed clinic and is only open for limited services of no more than 30 hours a week. An intermittent clinic as described in this subdivision shall, however, meet all other requirements of law, including administrative regulations and requirements, pertaining to fire and life safety.
(i)The offices of physicians in group practice who provide a preponderance of their services to members of a comprehensive group practice prepayment health care service plan subject to Chapter 2.2 (commencing with Section 1340).
(j)Student health centers operated by public institutions of higher education.
(k)Nonprofit speech and hearing centers, as defined in Section 1201.5. Any nonprofit speech and hearing clinic desiring an exemption under this subdivision shall make application therefor to the director, who shall grant the exemption to any facility meeting the criteria of Section 1201.5. Notwithstanding the licensure exemption contained in this subdivision, a nonprofit speech and hearing center shall be deemed to be an organized outpatient clinic for purposes of qualifying for reimbursement as a rehabilitation center under the Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code).
(l)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, that conducts medical research and health education and provides health care to its patients through a group of 40 or more physicians and surgeons, who are independent contractors representing not less than 10 board-certified specialties, and not less than two-thirds of whom practice on a full-time basis at the clinic.
(m)Any clinic, limited to in vivo diagnostic services by magnetic resonance imaging functions or radiological services under the direct and immediate supervision of a physician and surgeon who is licensed to practice in California. This shall not be construed to permit cardiac catheterization or any treatment modality in these clinics.
(n)A clinic operated by an employer or jointly by two or more employers for their employees only, or by a group of employees, or jointly by employees and employers, without profit to the operators thereof or to any other person, for the prevention and treatment of accidental injuries to, and the care of the health of, the employees comprising the group.
(o)A community mental health center, as defined in Section 5667 of the Welfare and Institutions Code.
(p)(1)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, as an entity organized and operated exclusively for scientific and charitable purposes and that satisfied all of the following requirements on or before January 1, 2005:
(A)Commenced conducting medical research on or before January 1, 1982, and continues to conduct medical research.
(B)Conducted research in, among other areas, prostatic cancer, cardiovascular disease, electronic neural prosthetic devices, biological effects and medical uses of lasers, and human magnetic resonance imaging and spectroscopy.
(C)Sponsored publication of at least 200 medical research articles in peer-reviewed publications.
(D)Received grants and contracts from the National Institutes of Health.
(E)Held and licensed patents on medical technology.
(F)Received charitable contributions and bequests totaling at least five million dollars ($5,000,000).
(G)Provides health care services to patients only:
(i)In conjunction with research being conducted on procedures or applications not approved or only partially approved for payment (I) under the Medicare program pursuant to Section 1359y(a)(1)(A) of Title 42 of the United States Code, or (II) by a health care service plan registered under Chapter 2.2 (commencing with Section 1340), or a disability insurer regulated under Chapter 1 (commencing with Section 10110) of Part 2 of Division 2 of the Insurance Code; provided that services may be provided by the clinic for an additional period of up to three years following the approvals, but only to the extent necessary to maintain clinical expertise in the procedure or application for purposes of actively providing training in the procedure or application for physicians and surgeons unrelated to the clinic.
(ii)Through physicians and surgeons who, in the aggregate, devote no more than 30 percent of their professional time for the entity operating the clinic, on an annual basis, to direct patient care activities for which charges for professional services are paid.
(H)Makes available to the public the general results of its research activities on at least an annual basis, subject to good faith protection of proprietary rights in its intellectual property.
(I)Is a freestanding clinic, whose operations under this subdivision are not conducted in conjunction with any affiliated or associated health clinic or facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as affiliated only if it directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, a clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as associated only if more than 20 percent of the directors or trustees of the clinic are also the directors or trustees of any individual clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). Any activity by a clinic under this subdivision in connection with an affiliated or associated entity shall fully comply with the requirements of this subdivision. This subparagraph shall not apply to agreements between a clinic and any entity for purposes of coordinating medical research.
(2)By January 1, 2007, and every five years thereafter, the Legislature shall receive a report from each clinic meeting the criteria of this subdivision and any other interested party concerning the operation of the clinics activities. The report shall include, but not be limited to, an evaluation of how the clinic impacted competition in the relevant health care market, and a detailed description of the clinics research results and the level of acceptance by the payer community of the procedures performed at the clinic. The report shall also include a description of procedures performed both in clinics governed by this subdivision and those performed in other settings. The cost of preparing the reports shall be borne by the clinics that are required to submit them to the Legislature pursuant to this paragraph.
SEC. 2.Section 1.5 of this bill incorporates amendments to Section 1206 of the Health and Safety Code proposed by both this bill and Assembly Bill 1130. It shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2016, (2) each bill amends Section 1206 of the Health and Safety Code, and (3) this bill is enacted after Assembly Bill 1130, in which case Section 1 of this bill shall not become operative.
This chapter does not apply to the following:
(a)Except with respect to the option provided with regard to surgical clinics in paragraph (1) of subdivision (b) of Section 1204 and, further, with respect to specialty clinics specified in paragraph (2) of subdivision (b) of Section 1204, any place or establishment owned or leased and operated as a clinic or office by one or more licensed health care practitioners and used as an office for the practice of their profession, within the scope of their license, regardless of the name used publicly to identify the place or establishment.
(b)Any clinic directly conducted, maintained, or operated by the United States or by any of its departments, officers, or agencies, and any primary care clinic specified in subdivision (a) of Section 1204 that is directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city. Nothing in this subdivision precludes the state department from adopting regulations that utilize clinic licensing standards as eligibility criteria for participation in programs funded wholly or partially under Title XVIII or XIX of the federal Social Security Act.
(c)(1)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, that is located on land recognized as tribal land by the federal government.
(2)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act (Public Law 93-638), regardless of the location of the clinic, except that if the clinic chooses to apply to the State Department of Public Health for a state facility license, then the State Department of Public Health will retain authority to regulate that clinic as a primary care clinic as defined by subdivision (a) of Section 1204.
(d)Clinics conducted, operated, or maintained as outpatient departments of hospitals.
(e)Any facility licensed as a health facility under Chapter 2 (commencing with Section 1250).
(f)Any freestanding clinical or pathological laboratory licensed under Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code.
(g)A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art.
(h)A clinic that is operated by a primary care community or free clinic and that is operated on separate premises from the licensed clinic and is only open for limited services of no more than 20 hours a week. An intermittent clinic as described in this subdivision shall, however, meet all other requirements of law, including administrative regulations and requirements, pertaining to fire and life safety.
(i)The offices of physicians in group practice who provide a preponderance of their services to members of a comprehensive group practice prepayment health care service plan subject to Chapter 2.2 (commencing with Section 1340).
(j)Student health centers operated by public institutions of higher education.
(k)Nonprofit speech and hearing centers, as defined in Section 1201.5. Any nonprofit speech and hearing clinic desiring an exemption under this subdivision shall make application therefor to the director, who shall grant the exemption to any facility meeting the criteria of Section 1201.5. Notwithstanding the licensure exemption contained in this subdivision, a nonprofit speech and hearing center shall be deemed to be an organized outpatient clinic for purposes of qualifying for reimbursement as a rehabilitation center under the Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code).
(l)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, that conducts medical research and health education and provides health care to its patients through a group of 40 or more physicians and surgeons, who are independent contractors representing not less than 10 board-certified specialties, and not less than two-thirds of whom practice on a full-time basis at the clinic.
(m)Any clinic, limited to in vivo diagnostic services by magnetic resonance imaging functions or radiological services under the direct and immediate supervision of a physician and surgeon who is licensed to practice in California. This shall not be construed to permit cardiac catheterization or any treatment modality in these clinics.
(n)A clinic operated by an employer or jointly by two or more employers for their employees only, or by a group of employees, or jointly by employees and employers, without profit to the operators thereof or to any other person, for the prevention and treatment of accidental injuries to, and the care of the health of, the employees comprising the group.
(o)A community mental health center, as defined in Section 5601.5 of the Welfare and Institutions Code.
(p)(1)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, as an entity organized and operated exclusively for scientific and charitable purposes and that satisfied all of the following requirements on or before January 1, 2005:
(A)Commenced conducting medical research on or before January 1, 1982, and continues to conduct medical research.
(B)Conducted research in, among other areas, prostatic cancer, cardiovascular disease, electronic neural prosthetic devices, biological effects and medical uses of lasers, and human magnetic resonance imaging and spectroscopy.
(C)Sponsored publication of at least 200 medical research articles in peer-reviewed publications.
(D)Received grants and contracts from the National Institutes of Health.
(E)Held and licensed patents on medical technology.
(F)Received charitable contributions and bequests totaling at least five million dollars ($5,000,000).
(G)Provides health care services to patients only:
(i)In conjunction with research being conducted on procedures or applications not approved or only partially approved for payment (I) under the Medicare program pursuant to Section 1359y(a)(1)(A) of Title 42 of the United States Code, or (II) by a health care service plan registered under Chapter 2.2 (commencing with Section 1340), or a disability insurer regulated under Chapter 1 (commencing with Section 10110) of Part 2 of Division 2 of the Insurance Code; provided that services may be provided by the clinic for an additional period of up to three years following the approvals, but only to the extent necessary to maintain clinical expertise in the procedure or application for purposes of actively providing training in the procedure or application for physicians and surgeons unrelated to the clinic.
(ii)Through physicians and surgeons who, in the aggregate, devote no more than 30 percent of their professional time for the entity operating the clinic, on an annual basis, to direct patient care activities for which charges for professional services are paid.
(H)Makes available to the public the general results of its research activities on at least an annual basis, subject to good faith protection of proprietary rights in its intellectual property.
(I)Is a freestanding clinic, whose operations under this subdivision are not conducted in conjunction with any affiliated or associated health clinic or facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as affiliated only if it directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, a clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as associated only if more than 20 percent of the directors or trustees of the clinic are also the directors or trustees of any individual clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). Any activity by a clinic under this subdivision in connection with an affiliated or associated entity shall fully comply with the requirements of this subdivision. This subparagraph shall not apply to agreements between a clinic and any entity for purposes of coordinating medical research.
(2)By January 1, 2007, and every five years thereafter, the Legislature shall receive a report from each clinic meeting the criteria of this subdivision and any other interested party concerning the operation of the clinics activities. The report shall include, but not be limited to, an evaluation of how the clinic impacted competition in the relevant health care market, and a detailed description of the clinics research results and the level of acceptance by the payer community of the procedures performed at the clinic. The report shall also include a description of procedures performed both in clinics governed by this subdivision and those performed in other settings. The cost of preparing the reports shall be borne by the clinics that are required to submit them to the Legislature pursuant to this paragraph.
SEC. 1.5.Section 1206 of the Health and Safety Code is amended to read:1206.This chapter does not apply to the following:
(a)Except with respect to the option provided with regard to surgical clinics in paragraph (1) of subdivision (b) of Section 1204 and, further, with respect to specialty clinics specified in paragraph (2) of subdivision (b) of Section 1204, any place or establishment owned or leased and operated as a clinic or office by one or more licensed health care practitioners and used as an office for the practice of their profession, within the scope of their license, regardless of the name used publicly to identify the place or establishment.
(b)Any clinic directly conducted, maintained, or operated by the United States or by any of its departments, officers, or agencies, and any primary care clinic specified in subdivision (a) of Section 1204 that is directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city. Nothing in this subdivision precludes the state department from adopting regulations that utilize clinic licensing standards as eligibility criteria for participation in programs funded wholly or partially under Title XVIII or XIX of the federal Social Security Act.
(c)(1)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1601 1603 of Title 25 of the United States Code, that is located on land recognized as tribal land by the federal government.
(2)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act (Public Law 93-638), regardless of the location of the clinic, except that if the clinic chooses to apply to the State Department of Public Health for a state facility license, then the State Department of Public Health will retain authority to regulate that clinic as a primary care clinic as defined by subdivision (a) of Section 1204.
(d)Clinics conducted, operated, or maintained as outpatient departments of hospitals.
(e)Any facility licensed as a health facility under Chapter 2 (commencing with Section 1250).
(f)Any freestanding clinical or pathological laboratory licensed under Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code.
(g)A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art.
(h)A clinic that is operated by a primary care community or free clinic and that is operated on separate premises from the licensed clinic and is only open for limited services of no more than 20 30 hours a week. An intermittent clinic as described in this subdivision shall, however, meet all other requirements of law, including administrative regulations and requirements, pertaining to fire and life safety.
(i)The offices of physicians in group practice who provide a preponderance of their services to members of a comprehensive group practice prepayment health care service plan subject to Chapter 2.2 (commencing with Section 1340).
(j)Student health centers operated by public institutions of higher education.
(k)Nonprofit speech and hearing centers, as defined in Section 1201.5. Any nonprofit speech and hearing clinic desiring an exemption under this subdivision shall make application therefor to the director, who shall grant the exemption to any facility meeting the criteria of Section 1201.5. Notwithstanding the licensure exemption contained in this subdivision, a nonprofit speech and hearing center shall be deemed to be an organized outpatient clinic for purposes of qualifying for reimbursement as a rehabilitation center under the Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code).
(l)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, that conducts medical research and health education and provides health care to its patients through a group of 40 or more physicians and surgeons, who are independent contractors representing not less than 10 board-certified specialties, and not less than two-thirds of whom practice on a full-time basis at the clinic.
(m)Any clinic, limited to in vivo diagnostic services by magnetic resonance imaging functions or radiological services under the direct and immediate supervision of a physician and surgeon who is licensed to practice in California. This shall not be construed to permit cardiac catheterization or any treatment modality in these clinics.
(n)A clinic operated by an employer or jointly by two or more employers for their employees only, or by a group of employees, or jointly by employees and employers, without profit to the operators thereof or to any other person, for the prevention and treatment of accidental injuries to, and the care of the health of, the employees comprising the group.
(o)A community mental health center, as defined in Section 5601.5 5667 of the Welfare and Institutions Code.
(p)(1)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, as an entity organized and operated exclusively for scientific and charitable purposes and that satisfied all of the following requirements on or before January 1, 2005:
(A)Commenced conducting medical research on or before January 1, 1982, and continues to conduct medical research.
(B)Conducted research in, among other areas, prostatic cancer, cardiovascular disease, electronic neural prosthetic devices, biological effects and medical uses of lasers, and human magnetic resonance imaging and spectroscopy.
(C)Sponsored publication of at least 200 medical research articles in peer-reviewed publications.
(D)Received grants and contracts from the National Institutes of Health.
(E)Held and licensed patents on medical technology.
(F)Received charitable contributions and bequests totaling at least five million dollars ($5,000,000).
(G)Provides health care services to patients only:
(i)In conjunction with research being conducted on procedures or applications not approved or only partially approved for payment (I) under the Medicare program pursuant to Section 1359y(a)(1)(A) of Title 42 of the United States Code, or (II) by a health care service plan registered under Chapter 2.2 (commencing with Section 1340), or a disability insurer regulated under Chapter 1 (commencing with Section 10110) of Part 2 of Division 2 of the Insurance Code; provided that services may be provided by the clinic for an additional period of up to three years following the approvals, but only to the extent necessary to maintain clinical expertise in the procedure or application for purposes of actively providing training in the procedure or application for physicians and surgeons unrelated to the clinic.
(ii)Through physicians and surgeons who, in the aggregate, devote no more than 30 percent of their professional time for the entity operating the clinic, on an annual basis, to direct patient care activities for which charges for professional services are paid.
(H)Makes available to the public the general results of its research activities on at least an annual basis, subject to good faith protection of proprietary rights in its intellectual property.
(I)Is a freestanding clinic, whose operations under this subdivision are not conducted in conjunction with any affiliated or associated health clinic or facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as affiliated only if it directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, a clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as associated only if more than 20 percent of the directors or trustees of the clinic are also the directors or trustees of any individual clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). Any activity by a clinic under this subdivision in connection with an affiliated or associated entity shall fully comply with the requirements of this subdivision. This subparagraph shall not apply to agreements between a clinic and any entity for purposes of coordinating medical research.
(2)By January 1, 2007, and every five years thereafter, the Legislature shall receive a report from each clinic meeting the criteria of this subdivision and any other interested party concerning the operation of the clinics activities. The report shall include, but not be limited to, an evaluation of how the clinic impacted competition in the relevant health care market, and a detailed description of the clinics research results and the level of acceptance by the payer community of the procedures performed at the clinic. The report shall also include a description of procedures performed both in clinics governed by this subdivision and those performed in other settings. The cost of preparing the reports shall be borne by the clinics that are required to submit them to the Legislature pursuant to this paragraph.
SEC. 2.Section 1.5 of this bill incorporates amendments to Section 1206 of the Health and Safety Code proposed by both this bill and Assembly Bill 1130. It shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2016, (2) each bill amends Section 1206 of the Health and Safety Code, and (3) this bill is enacted after Assembly Bill 1130, in which case Section 1 of this bill shall not become operative.
This chapter does not apply to the following:
(a)Except with respect to the option provided with regard to surgical clinics in paragraph (1) of subdivision (b) of Section 1204 and, further, with respect to specialty clinics specified in paragraph (2) of subdivision (b) of Section 1204, any place or establishment owned or leased and operated as a clinic or office by one or more licensed health care practitioners and used as an office for the practice of their profession, within the scope of their license, regardless of the name used publicly to identify the place or establishment.
(b)Any clinic directly conducted, maintained, or operated by the United States or by any of its departments, officers, or agencies, and any primary care clinic specified in subdivision (a) of Section 1204 that is directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city. Nothing in this subdivision precludes the state department from adopting regulations that utilize clinic licensing standards as eligibility criteria for participation in programs funded wholly or partially under Title XVIII or XIX of the federal Social Security Act.
(c)(1)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, that is located on land recognized as tribal land by the federal government.
(2)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act (Public Law 93-638), regardless of the location of the clinic. clinic, except that if the clinic chooses to apply to the State Department of Public Health for a state facility license, then the State Department of Public Health will retain authority to regulate that clinic as a primary care clinic as defined by subdivision (a) of Section 1204.
(d)Clinics conducted, operated, or maintained as outpatient departments of hospitals.
(e)Any facility licensed as a health facility under Chapter 2 (commencing with Section 1250).
(f)Any freestanding clinical or pathological laboratory licensed under Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code.
(g)A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art.
(h)A clinic that is operated by a primary care community or free clinic and that is operated on separate premises from the licensed clinic and is only open for limited services of no more than 20 hours a week. An intermittent clinic as described in this subdivision shall, however, meet all other requirements of law, including administrative regulations and requirements, pertaining to fire and life safety.
(i)The offices of physicians in group practice who provide a preponderance of their services to members of a comprehensive group practice prepayment health care service plan subject to Chapter 2.2 (commencing with Section 1340).
(j)Student health centers operated by public institutions of higher education.
(k)Nonprofit speech and hearing centers, as defined in Section 1201.5. Any nonprofit speech and hearing clinic desiring an exemption under this subdivision shall make application therefor to the director, who shall grant the exemption to any facility meeting the criteria of Section 1201.5. Notwithstanding the licensure exemption contained in this subdivision, a nonprofit speech and hearing center shall be deemed to be an organized outpatient clinic for purposes of qualifying for reimbursement as a rehabilitation center under the Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code).
(l)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, that conducts medical research and health education and provides health care to its patients through a group of 40 or more physicians and surgeons, who are independent contractors representing not less than 10 board-certified specialties, and not less than two-thirds of whom practice on a full-time basis at the clinic.
(m)Any clinic, limited to in vivo diagnostic services by magnetic resonance imaging functions or radiological services under the direct and immediate supervision of a physician and surgeon who is licensed to practice in California. This shall not be construed to permit cardiac catheterization or any treatment modality in these clinics.
(n)A clinic operated by an employer or jointly by two or more employers for their employees only, or by a group of employees, or jointly by employees and employers, without profit to the operators thereof or to any other person, for the prevention and treatment of accidental injuries to, and the care of the health of, the employees comprising the group.
(o)A community mental health center, as defined in Section 5601.5 of the Welfare and Institutions Code.
(p)(1)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, as an entity organized and operated exclusively for scientific and charitable purposes and that satisfied all of the following requirements on or before January 1, 2005:
(A)Commenced conducting medical research on or before January 1, 1982, and continues to conduct medical research.
(B)Conducted research in, among other areas, prostatic cancer, cardiovascular disease, electronic neural prosthetic devices, biological effects and medical uses of lasers, and human magnetic resonance imaging and spectroscopy.
(C)Sponsored publication of at least 200 medical research articles in peer-reviewed publications.
(D)Received grants and contracts from the National Institutes of Health.
(E)Held and licensed patents on medical technology.
(F)Received charitable contributions and bequests totaling at least five million dollars ($5,000,000).
(G)Provides health care services to patients only:
(i)In conjunction with research being conducted on procedures or applications not approved or only partially approved for payment (I) under the Medicare program pursuant to Section 1359y(a)(1)(A) of Title 42 of the United States Code, or (II) by a health care service plan registered under Chapter 2.2 (commencing with Section 1340), or a disability insurer regulated under Chapter 1 (commencing with Section 10110) of Part 2 of Division 2 of the Insurance Code; provided that services may be provided by the clinic for an additional period of up to three years following the approvals, but only to the extent necessary to maintain clinical expertise in the procedure or application for purposes of actively providing training in the procedure or application for physicians and surgeons unrelated to the clinic.
(ii)Through physicians and surgeons who, in the aggregate, devote no more than 30 percent of their professional time for the entity operating the clinic, on an annual basis, to direct patient care activities for which charges for professional services are paid.
(H)Makes available to the public the general results of its research activities on at least an annual basis, subject to good faith protection of proprietary rights in its intellectual property.
(I)Is a freestanding clinic, whose operations under this subdivision are not conducted in conjunction with any affiliated or associated health clinic or facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as affiliated only if it directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, a clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as associated only if more than 20 percent of the directors or trustees of the clinic are also the directors or trustees of any individual clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). Any activity by a clinic under this subdivision in connection with an affiliated or associated entity shall fully comply with the requirements of this subdivision. This subparagraph shall not apply to agreements between a clinic and any entity for purposes of coordinating medical research.
(2)By January 1, 2007, and every five years thereafter, the Legislature shall receive a report from each clinic meeting the criteria of this subdivision and any other interested party concerning the operation of the clinics activities. The report shall include, but not be limited to, an evaluation of how the clinic impacted competition in the relevant health care market, and a detailed description of the clinics research results and the level of acceptance by the payer community of the procedures performed at the clinic. The report shall also include a description of procedures performed both in clinics governed by this subdivision and those performed in other settings. The cost of preparing the reports shall be borne by the clinics that are required to submit them to the Legislature pursuant to this paragraph.
This chapter does not apply to the following:
(a)Except with respect to the option provided with regard to surgical clinics in paragraph (1) of subdivision (b) of Section 1204 and, further, with respect to specialty clinics specified in paragraph (2) of subdivision (b) of Section 1204, any place or establishment owned or leased and operated as a clinic or office by one or more licensed health care practitioners and used as an office for the practice of their profession, within the scope of their license, regardless of the name used publicly to identify the place or establishment.
(b)Any clinic directly conducted, maintained, or operated by the United States or by any of its departments, officers, or agencies, and any primary care clinic specified in subdivision (a) of Section 1204 that is directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city. Nothing in this subdivision precludes the state department from adopting regulations that utilize clinic licensing standards as eligibility criteria for participation in programs funded wholly or partially under Title XVIII or XIX of the federal Social Security Act.
(c)(1)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1601 1603 of Title 25 of the United States Code, that is located on land recognized as tribal land by the federal government.
(2)Any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in Section 450 or 1603 of Title 25 of the United States Code, under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act (Public Law 93-638), regardless of the location of the clinic.
(d)Clinics conducted, operated, or maintained as outpatient departments of hospitals.
(e)Any facility licensed as a health facility under Chapter 2 (commencing with Section 1250).
(f)Any freestanding clinical or pathological laboratory licensed under Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code.
(g)A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art.
(h)A clinic that is operated by a primary care community or free clinic and that is operated on separate premises from the licensed clinic and is only open for limited services of no more than 20 hours a week. An intermittent clinic as described in this subdivision shall, however, meet all other requirements of law, including administrative regulations and requirements, pertaining to fire and life safety.
(i)The offices of physicians in group practice who provide a preponderance of their services to members of a comprehensive group practice prepayment health care service plan subject to Chapter 2.2 (commencing with Section 1340).
(j)Student health centers operated by public institutions of higher education.
(k)Nonprofit speech and hearing centers, as defined in Section 1201.5. Any nonprofit speech and hearing clinic desiring an exemption under this subdivision shall make application therefor to the director, who shall grant the exemption to any facility meeting the criteria of Section 1201.5. Notwithstanding the licensure exemption contained in this subdivision, a nonprofit speech and hearing center shall be deemed to be an organized outpatient clinic for purposes of qualifying for reimbursement as a rehabilitation center under the Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code).
(l)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, that conducts medical research and health education and provides health care to its patients through a group of 40 or more physicians and surgeons, who are independent contractors representing not less than 10 board-certified specialties, and not less than two-thirds of whom practice on a full-time basis at the clinic.
(m)Any clinic, limited to in vivo diagnostic services by magnetic resonance imaging functions or radiological services under the direct and immediate supervision of a physician and surgeon who is licensed to practice in California. This shall not be construed to permit cardiac catheterization or any treatment modality in these clinics.
(n)A clinic operated by an employer or jointly by two or more employers for their employees only, or by a group of employees, or jointly by employees and employers, without profit to the operators thereof or to any other person, for the prevention and treatment of accidental injuries to, and the care of the health of, the employees comprising the group.
(o)A community mental health center, as defined in Section 5601.5 of the Welfare and Institutions Code.
(p)(1)A clinic operated by a nonprofit corporation exempt from federal income taxation under paragraph (3) of subsection (c) of Section 501 of the Internal Revenue Code of 1954, as amended, or a statutory successor thereof, as an entity organized and operated exclusively for scientific and charitable purposes and that satisfied all of the following requirements on or before January 1, 2005:
(A)Commenced conducting medical research on or before January 1, 1982, and continues to conduct medical research.
(B)Conducted research in, among other areas, prostatic cancer, cardiovascular disease, electronic neural prosthetic devices, biological effects and medical uses of lasers, and human magnetic resonance imaging and spectroscopy.
(C)Sponsored publication of at least 200 medical research articles in peer-reviewed publications.
(D)Received grants and contracts from the National Institutes of Health.
(E)Held and licensed patents on medical technology.
(F)Received charitable contributions and bequests totaling at least five million dollars ($5,000,000).
(G)Provides health care services to patients only:
(i)In conjunction with research being conducted on procedures or applications not approved or only partially approved for payment (I) under the Medicare program pursuant to Section 1359y(a)(1)(A) of Title 42 of the United States Code, or (II) by a health care service plan registered under Chapter 2.2 (commencing with Section 1340), or a disability insurer regulated under Chapter 1 (commencing with Section 10110) of Part 2 of Division 2 of the Insurance Code; provided that services may be provided by the clinic for an additional period of up to three years following the approvals, but only to the extent necessary to maintain clinical expertise in the procedure or application for purposes of actively providing training in the procedure or application for physicians and surgeons unrelated to the clinic.
(ii)Through physicians and surgeons who, in the aggregate, devote no more than 30 percent of their professional time for the entity operating the clinic, on an annual basis, to direct patient care activities for which charges for professional services are paid.
(H)Makes available to the public the general results of its research activities on at least an annual basis, subject to good faith protection of proprietary rights in its intellectual property.
(I)Is a freestanding clinic, whose operations under this subdivision are not conducted in conjunction with any affiliated or associated health clinic or facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as affiliated only if it directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, a clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). For purposes of this subparagraph, a freestanding clinic is defined as associated only if more than 20 percent of the directors or trustees of the clinic are also the directors or trustees of any individual clinic or health facility defined under this division, except a clinic exempt from licensure under subdivision (m). Any activity by a clinic under this subdivision in connection with an affiliated or associated entity shall fully comply with the requirements of this subdivision. This subparagraph shall not apply to agreements between a clinic and any entity for purposes of coordinating medical research.
(2)By January 1, 2007, and every five years thereafter, the Legislature shall receive a report from each clinic meeting the criteria of this subdivision and any other interested party concerning the operation of the clinics activities. The report shall include, but not be limited to, an evaluation of how the clinic impacted competition in the relevant health care market, and a detailed description of the clinics research results and the level of acceptance by the payer community of the procedures performed at the clinic. The report shall also include a description of procedures performed both in clinics governed by this subdivision and those performed in other settings. The cost of preparing the reports shall be borne by the clinics that are required to submit them to the Legislature pursuant to this paragraph.
|
Date
|
Status
|
|---|---|
| Jul 8, 2015 | In committee: Hearing postponed by committee. |
| Oct 5, 2015 | Chaptered by Secretary of State - Chapter 502, Statutes of 2015. |
| Oct 5, 2015 | Approved by the Governor. |
| Sep 15, 2015 | Enrolled and presented to the Governor at 4 p.m. |
| Sep 2, 2015 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 79. Noes 0.). |
| Sep 2, 2015 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 79. Noes 0. Page 2773.). |
| Aug 31, 2015 | Read third time. Passed. Ordered to the Assembly. (Ayes 39. Noes 0. Page 2306.). |
| Aug 31, 2015 | Read third time. Passed. Ordered to the Assembly. |
| Aug 31, 2015 | In Assembly. Concurrence in Senate amendments pending. May be considered on or after September 2 pursuant to Assembly Rule 77. |
| Aug 27, 2015 | Read second time. Ordered to third reading. |
| Aug 26, 2015 | Read third time and amended. Ordered to second reading. |
| Aug 18, 2015 | Read second time and amended. Ordered to third reading. |
| Aug 17, 2015 | From committee: Be placed on second reading file pursuant to Senate Rule 28.8 and be amended. |
| Feb 26, 2015 | Read first time. To print. |
| Jun 29, 2015 | In committee: Hearing postponed by committee. |
| Jun 25, 2015 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 8. Noes 0.) (June 24). Re-referred to Com. on APPR. |
| May 21, 2015 | Referred to Com. on HEALTH. |
| May 11, 2015 | Read third time. Passed. Ordered to the Senate. (Ayes 77. Noes 0. Page 1386.) |
| May 11, 2015 | Read third time. Passed. Ordered to the Senate. |
| May 11, 2015 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 7, 2015 | Read second time. Ordered to third reading. |
| May 6, 2015 | From committee: Do pass. (Ayes 16. Noes 0.) (May 6). |
| Apr 29, 2015 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 19. Noes 0.) (April 28). Re-referred to Com. on APPR. |
| Apr 21, 2015 | In committee: Hearing postponed by committee. |
| Mar 19, 2015 | Referred to Com. on HEALTH. |
| Feb 27, 2015 | From printer. May be heard in committee March 29. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Sep 2, 2015 | AB 941 WOOD Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Aug 31, 2015 | Assembly 3rd Reading AB941 Wood By Hernandez | Senate Floor |
Passed |
|
| Jun 24, 2015 | Do pass, but first be re-referred to the Committee on [Appropriations] | Senate Standing Committee on Health |
Passed |
|
| May 11, 2015 | AB 941 WOOD Assembly Third Reading | Assembly Floor |
Passed |
|
| May 6, 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 Health |
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
|
|---|---|---|
| American Nurses Association | ** Against | Aug 31, 2015 |
| Big Valley Band of Pomo Indians | ** Support | Aug 31, 2015 |
| Blue Lake Rancheria | ** Support | Aug 31, 2015 |
| California Labor Federation, Afl-Cio | * Indeterminate | Apr 28, 2015 |
| California Nurses Association | ** Against | Jun 24, 2015 |
| California Pan-Ethnic Health Network | ** Support | Aug 31, 2015 |
| California Primary Care Association | ** Support | Aug 31, 2015 |
| California Rural Indian Health Board | ** Support | Aug 31, 2015 |
| Chapa-De Indian Health Program | ** Support | Aug 31, 2015 |
| Cloverdale Rancheria | ** Support | Aug 31, 2015 |
| Feather River Tribal Health | ** Support | Aug 31, 2015 |
| Greenville Rancheria | ** Support | Aug 31, 2015 |
| Indian Health Council | ** Support | Aug 31, 2015 |
| Karuk Tribe | ** Support | Aug 31, 2015 |
| Kashia Band of Pomo Indians | ** Support | Aug 31, 2015 |
| Lake County Tribal Health Consortium | ** Support | Aug 31, 2015 |
| Latino Coalition for a Healthy California | ** Support | Aug 31, 2015 |
| Manchester-Point Arena Band of Pomo Indians | ** Support | Aug 31, 2015 |
| Northern Valley Indian Health | ** Support | Aug 31, 2015 |
| Pit River Health Service | ** Support | Aug 31, 2015 |
| Pit River Tribe | ** Support | Apr 28, 2015 |
| Redding Rancheria Tribal Health Center | ** Support | Aug 31, 2015 |
| Resighini Rancheria | ** Support | Aug 31, 2015 |
| Riverside-San Bernardino County Indian Health System | ** Support | Aug 31, 2015 |
| Santa Ynez Tribal Health Clinic | ** Support | Aug 31, 2015 |
| Service Employees International Union California | * Indeterminate | Apr 28, 2015 |
| Sherwood Valley Band of Pomo Indians | ** Support | Aug 31, 2015 |
| Smith River Rancheria | ** Support | Aug 31, 2015 |
| Sonoma County Indian Health Project | ** Support | Aug 31, 2015 |
| Southern Indian Health Council | ** Support | Aug 31, 2015 |
| Toiyabe Indian Health Project | ** Support | Aug 31, 2015 |
| Tule River Indian Health Center | ** Support | Aug 31, 2015 |
| Twenty-Nine Palms Band Of Mission Indians | ** Support | Aug 31, 2015 |
| United Indian Health Services | ** Support | Aug 31, 2015 |
| Warner Mountain Indian Health Clinic | ** Support | Aug 31, 2015 |
| Yurok Tribe | ** Support | Aug 31, 2015 |
AB 941
Page 2
CONCURRENCE IN SENATE AMENDMENTS
AB 941
(Wood)
As Amended August 26, 2015
Majority vote
ASSEMBLY: |
77-0 |
(May 11, 2015) |
SENATE: |
38-0 |
(August 31, 2015) |
Original Committee Reference: HEALTH
SUMMARY: Exempts clinics operated by a tribe or tribal organization, regardless of location, from obtaining a license from the Department of Public Health (DPH), and requires, to qualify for the exemption, the clinic operate under a contract with the United States pursuant to the Indian Self Determination and Education Assistance Act.
The Senate amendments clarify that clinics operated by a tribe or tribal organization may apply for a license from DPH should they choose to do so, and incorporate additional changes to Health and Safety Code Section 1206 proposed by AB 1130 that would become operative if this bill and AB 1130 are chaptered and this bill is chaptered last.
FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS: According to the author, the majority of California tribal health clinics (tribal clinics) are located in rural areas of the state and oftentimes, it is challenging to meet unmet needs when providing healthcare services over large geographic areas. Tribal clinics cannot always establish new clinics on Indian land, as oftentimes, the Indian land in question is not available in an area where many tribal clinic patients may reside. This results in opening new tribal clinics on non-Indian land in order to provide adequate access of care to patients. The author notes, tribal clinics may only place new sites within the federal statutorily defined service areas based on the population of the tribal communities they serve. The federal, tribal, and state standards requirements have to be met in order to create a new tribal clinic; and these standards are comprehensive and coherent. When abiding by the federal, tribal, and state standards, the administrative process becomes very duplicative when applying for a license to operate a tribal clinic on non-Indian land. The author concludes, this bill will streamline the state clinic licensing exemptions and exempt tribal clinics on non-Indian land from DPH's state facility license.
Background. There are approximately 1,000 primary care clinics currently licensed in California. In order to obtain a license, a primary care clinic must submit an application and fee to DPH and pass an initial licensure survey conducted by DPH. Clinics exempt from state licensing do have to apply to the Department of Health Care Services (DHCS) if they want to enroll as a Medi-Cal provider. DHCS has a specific application process for exempt clinics, including obtaining a certification by DPH or a specified nonprofit entity that inspects the clinics and ensures they meet minimum requirements.
Tribal Health Services. The Indian Health Service (IHS) oversees health programs over portions of the state. By federal law, the area is limited to the 38 counties with American Indian trust lands, generally meaning a reservation or rancheria. Within the included counties there is a service population of approximately 130,000 eligible American Indians. The IHS divides their service area in California into smaller administrative units called services units. These services units have responsibility for planning, managing, and evaluating the health programs in its jurisdiction. They are focused on a specific geographic area and are usually centered on a single federal reservation. It is within these services units that a tribe or consortium of tribes can operate clinics under contract with the federal government. Although the clinics are established to provide services to specified American Indians they are open to all. The proportion of non-Indians using these clinics varies dramatically. In some smaller rural areas without many health care facilities, the proportion of non-Indians can be quite significant accounting for about half the patients seen. In other clinics, Indians comprise the overwhelming majority. According to the California Rural Indian Health Board, of the 30 existing tribal health clinics in the state, this bill will apply to approximately five. All IHS-funded health care is tied to American Indian and Alaska Native user populations. In California there are eight urban Indian clinics in cities. The exemption proposed by this bill would not apply to them, and their funding and federal statutory authority is distinct and separate from the funding and authority for tribal health programs.
Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0001851
AB 941
Page 6
|
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 |
THIRD READING
Bill No: AB 941
Amended: 8/26/15 in Senate
SENATE HEALTH COMMITTEE: 8-0, 6/24/15
AYES: Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan, Roth, Wolk
NO VOTE RECORDED: Hall
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 77-0, 5/11/15 - See last page for vote
SUBJECT: Clinics: licensure and regulation: exemption
SOURCE: California Rural Indian Health Board
DIGEST: This bill exempts from licensure and regulation by the Department of Public Health any clinic operated by a federally recognized Indian tribe under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act, regardless of the location of the clinic.
Senate Floor Amendments of 8/26/15 incorporate provisions from AB 1130 (Gray) in order to avoid chaptering-out problems.
Existing federal law:
Establishes the Indian Health Service (IHS), which is charged with providing federal health services to American Indians and Alaska Natives who are members of 566 federally recognized tribes across the United States.
Establishes the Indian Self-Determination and Education Assistance Act (ISDEAA), which was enacted to ensure “effective and meaningful participation by the Indian people in the planning, conduct, and administration” of federal services and programs provided to members of tribes, including health care. Under ISDEAA, tribes have the option to exercise their sovereignty by either assuming from IHS the administration and operation of providing health care themselves (through contracts), or to continue to receive health care through the IHS-administered, direct-care health system.
Specifies areas in which tribes are permitted to contract with IHS to provide health care services under ISDEAA, known as “contract health service delivery areas.” California is a contract health service delivery area, except for the following 20 excluded counties: Alameda, Contra Costa, Los Angeles, Marin, Orange, Sacramento, San Francisco, San Mateo, Santa Clara, Kern, Merced, Monterey, Napa, San Benito, San Joaquin, San Luis Obispo, Santa Cruz, Solano, Stanislaus, and Ventura.
Existing state law:
Exempts various types of clinics from licensure and regulation by the Department of Public Health (DPH), including clinics operated by a federally recognized Indian tribe or tribal organization, as defined, that are located on land recognized as tribal land by the federal government. Among the other types of clinics exempt from licensure by DPH are the following:
Any establishment that is owned and operated as a clinic by one or more licensed health care practitioners and used as an office for the practice of their profession, with the exception of surgical clinics and specialty clinics;
Clinics operated as outpatient departments of hospitals;
A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art;
An intermittent clinic that is open for no more than 20 hours per week, and that is operated by a licensed primary care clinic; and,
Student health centers operated by public institutions of higher education.
Exempts a health care practitioner that is licensed in any other state, and who is employed by a tribal health program, from any requirement to be licensed in California with respect to acts authorized under the person’s license in another state, where the tribal health program performs services under the ISDEAA.
Establishes within the Department of Health Care Services the Indian Health Program, which is charged to improve the health status of American Indians living in urban, rural, and reservation or rancheria communities throughout California.
This bill exempts from licensure and regulation by DPH any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in federal law, under a contract with the United States pursuant to ISDEAA, as specified, regardless of the location of the clinic, except that if the clinic chooses to apply to DPH for a license, then DPH retains the authority to regulate that clinic.
Comments
Author’s statement. According to the author, many Native American tribes operate their own health programs for their members on the reservation, but often times many tribal members live off the reservation. Due to the geographic nature of the North Coast, many members off the reservation have a difficult time accessing health care. In order to better serve these members, tribal groups have opened new tribal health clinics off the reservation to expand health care services to their tribal members. However, opening a tribal clinic off the reservation is a very burdensome process. One cumbersome application in the process is the state facility license within DPH, which is known to be time-consuming, costly, and includes duplicative paperwork. Tribal clinics are already required to be licensed under the federal government and IHS, which already cover the same requirements that DPH’s state facility license seeks to regulate. By streamlining the facility licensing process, tribal clinics would be able to focus more time to providing quality health care to tribal and non-tribal members off the reservation.
Background on ISDEAA and tribal health services in California. In 1975, the ISDEAA was signed into law. The ISDEAA reaffirmed congressional support of the nation-to-nation relationship between the United States and each Tribal nation. The ISDEAA was enacted to ensure “effective and meaningful participation by the Indian people in the planning, conduct, and administration” of federal services and programs provided to the tribes and their members. Under the ISDEAA, tribes and tribal organizations have the option to either (a) administer programs and services the IHS would otherwise provide (referred to as Title I Self-Determination Contracting) or (b) assume control over health care programs and services that the IHS would otherwise provide (referred to as Title V Self-Governance Compacting). These options are not exclusive; tribes may choose to combine them based on their individual needs and circumstances.
According to IHS, California is home to the largest population of American Indians/Alaska Natives in the country. According to the 2010 Census, California’s Indian population was 362,801. California is home to 107 federally recognized tribes. The California Rural Indian Health Board (CRIHB), the sponsor of this bill, reports that there are approximately 34 clinics operated by tribal health programs in California: 13 of these clinics are off tribal land and are currently licensed by DPH, while 21 clinics are either on tribal land or meet one of the other licensure exemptions (for example, affiliation with an institution of higher education that offers a health profession education program). All of these tribal health programs are provided in “contract health service delivery areas,” which are federally designated areas that are located in counties that contain, or are adjacent to, tribal land. Separate from these tribal health programs in contract areas, IHS funds eight “urban health programs” that operate under a separate provision of federal law, intended to offer services to Indians located in urban areas. This bill does not affect urban tribal health programs, as this bill is limited to clinics in contract areas (typically more rural).
While the primary purpose of tribal health programs is to provide federally required health care to tribal members, these programs can, if they choose, treat non-tribal members. This is true regardless of whether the clinic is located on or off tribal land. These clinics, again regardless of where they are located, are permitted to seek reimbursement from Medicare and Medi-Cal, though they have to be certified by the Centers for Medicare and Medicaid Services (CMS) in order to bill these programs. CRIHB reports that almost all tribal clinics in California are CMS-certified.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
California Rural Indian Health Board (source)
Big Valley Band of Pomo Indians
Blue Lake Rancheria
California Pan-Ethnic Health Network
California Primary Care Association
Chapa-De Indian Health Program
Cloverdale Rancheria
Feather River Tribal Health
Greenville Rancheria
Indian Health Council
Karuk Tribe
Kashia Band of Pomo Indians
Lake County Tribal Health Consortium
Latino Coalition for a Healthy California
Manchester-Point Arena Band of Pomo Indians
Northern Valley Indian Health
Pit River Health Service
Redding Rancheria Tribal Health Center
Resighini Rancheria
Riverside-San Bernardino County Indian Health System
Santa Ynez Tribal Health Clinic
Sherwood Valley Band of Pomo Indians
Smith River Rancheria
Sonoma County Indian Health Project
Southern Indian Health Council
Toiyabe Indian Health Project
Tule River Indian Health Center
Twenty-Nine Palms Band of Mission Indians
United Indian Health Services
Warner Mountain Indian Health Clinic
Yurok Tribe
OPPOSITION: (Verified 8/27/15)
American Nurses Association/California
ARGUMENTS IN SUPPORT: This bill is sponsored by CRIHB, and supported by numerous tribal health programs. CRIHB states that this bill creates a much-needed single standard for clinic licensure for federal Tribal Health Program sites. According to CRIHB, regardless of where a tribal health program is located, it is required to adhere to all federal IHS operating requirements in order to maintain its status as a federal contractor. CRIHB states that tribal health programs are committed to maintaining high standards of corporate conduct and are audited annually. CRIHB points out that there are currently more than 15 state licensing exemptions for various types of health clinics in California. According to CRIHB, if a tribal health program is located on Indian land or has a working partnership with an institution of higher learning, it is exempt from state licensure, but if it is not located on Indian land or does not have an affiliation with an institution of higher learning, it must be licensed as a primary care clinic. CRIHB states that the multiple tribal health licensing standards create undue administrative challenges, confusion, and burden for tribal health programs in their mission of providing federally contracted health services. The Riverside-San Bernardino County Indian Health System, in its support letter, described delays in getting its two clinics licensed, and having to undergo an unnecessary comprehensive audit that resulted in a great deal of cost to its organization. The California Primary Care Association states in support that this bill is a simple yet effective way for tribal health organizations to meet the unique healthcare needs of the communities they serve in a culturally competent, accessible manner.
ARGUMENTS IN OPPOSITION: This bill is opposed by the American Nurses Association/California (ANAC). ANAC states that it opposes this bill because it will exclude tribal health clinics from California licensing and safety provisions outside of federally designated tribal lands, and that without licensing, clinics would not have to comply with state building or state professional standards which assure minimal protections for employees working in clinics that may or may not be tribal members.
ASSEMBLY FLOOR: 77-0, 5/11/15
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, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Low, Maienschein, Mathis, Mayes, 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
NO VOTE RECORDED: Harper, Lopez, Atkins
Prepared by: Vince Marchand / HEALTH /
8/28/15 8:48:28
AB 941
Page 6
|
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 |
THIRD READING
Bill No: AB 941
Amended: 8/18/15 in Senate
SENATE HEALTH COMMITTEE: 8-0, 6/24/15
AYES: Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan, Roth, Wolk
NO VOTE RECORDED: Hall
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 77-0, 5/11/15 - See last page for vote
SUBJECT: Clinics: licensure and regulation: exemption
SOURCE: California Rural Indian Health Board
DIGEST: This bill exempts from licensure and regulation by the Department of Public Health any clinic operated by a federally recognized Indian tribe under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act, regardless of the location of the clinic.
Existing federal law:
Establishes the Indian Health Service (IHS), which is charged with providing federal health services to American Indians and Alaska Natives who are members of 566 federally recognized Tribes across the United States.
Establishes the Indian Self-Determination and Education Assistance Act (ISDEAA), which was enacted to ensure “effective and meaningful participation by the Indian people in the planning, conduct, and administration” of federal services and programs provided to members of Tribes, including health care. Under ISDEAA, Tribes have the option to exercise their sovereignty by either assuming from IHS the administration and operation of providing health care themselves (through contracts), or to continue to receive health care through the IHS-administered, direct-care health system.
Specifies areas in which tribes are permitted to contract with IHS to provide health care services under ISDEAA, known as “contract health service delivery areas.” California is a contract health service delivery area, except for the following 20 excluded counties: Alameda, Contra Costa, Los Angeles, Marin, Orange, Sacramento, San Francisco, San Mateo, Santa Clara, Kern, Merced, Monterey, Napa, San Benito, San Joaquin, San Luis Obispo, Santa Cruz, Solano, Stanislaus, and Ventura.
Existing state law:
Exempts various types of clinics from licensure and regulation by the Department of Public Health (DPH), including clinics operated by a federally recognized Indian tribe or tribal organization, as defined, that are located on land recognized as tribal land by the federal government. Among the other types of clinics exempt from licensure by DPH are the following:
Any establishment that is owned and operated as a clinic by one or more licensed health care practitioners and used as an office for the practice of their profession, with the exception of surgical clinics and specialty clinics;
Clinics operated as outpatient departments of hospitals;
A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art;
An intermittent clinic that is open for no more than 20 hours per week, and that is operated by a licensed primary care clinic; and,
Student health centers operated by public institutions of higher education.
Exempts a health care practitioner that is licensed in any other state, and who is employed by a tribal health program, from any requirement to be licensed in California with respect to acts authorized under the person’s license in another state, where the tribal health program performs services under the ISDEAA.
Establishes within the Department of Health Care Services the Indian Health Program, which is charged to improve the health status of American Indians living in urban, rural, and reservation or rancheria communities throughout California.
This bill exempts from licensure and regulation by DPH any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in federal law, under a contract with the United States pursuant to ISDEAA, as specified, regardless of the location of the clinic, except that if the clinic chooses to apply to DPH for a license, then DPH retains the authority to regulate that clinic.
Comments
Author’s statement. According to the author, many Native American tribes operate their own health programs for their members on the reservation, but often times many tribal members live off the reservation. Due to the geographic nature of the North Coast, many members off the reservation have a difficult time accessing health care. In order to better serve these members, tribal groups have opened new tribal health clinics off the reservation to expand health care services to their tribal members. However, opening a tribal clinic off the reservation is a very burdensome process. One cumbersome application in the process is the state facility license within DPH, which is known to be time-consuming, costly, and includes duplicative paperwork. Tribal clinics are already required to be licensed under the federal government and IHS, which already cover the same requirements that DPH’s state facility license seeks to regulate. By streamlining the facility licensing process, tribal clinics would be able to focus more time to providing quality health care to tribal and non-tribal members off the reservation.
Background on ISDEAA and tribal health services in California. In 1975, the ISDEAA was signed into law. The ISDEAA reaffirmed congressional support of the nation-to-nation relationship between the United States and each Tribal nation. The ISDEAA was enacted to ensure “effective and meaningful participation by the Indian people in the planning, conduct, and administration” of federal services and programs provided to the Tribes and their members. Under the ISDEAA, Tribes and Tribal Organizations have the option to either (a) administer programs and services the IHS would otherwise provide (referred to as Title I Self-Determination Contracting) or (b) assume control over health care programs and services that the IHS would otherwise provide (referred to as Title V Self-Governance Compacting). These options are not exclusive; Tribes may choose to combine them based on their individual needs and circumstances.
According to IHS, California is home to the largest population of American Indians/Alaska Natives in the country. According to the 2010 Census, California’s Indian population was 362,801. California is home to 107 federally recognized tribes. The California Rural Indian Health Board (CRIHB), the sponsor of this bill, reports that there are approximately 34 clinics operated by tribal health programs in California: 13 of these clinics are off tribal land and are currently licensed by DPH, while 21 clinics are either on tribal land or meet one of the other licensure exemptions (for example, affiliation with an institution of higher education that offers a health profession education program). All of these tribal health programs are provided in “contract health service delivery areas,” which are federally designated areas that are located in counties that contain, or are adjacent to, tribal land. Separate from these tribal health programs in contract areas, IHS funds eight “urban health programs” that operate under a separate provision of federal law, intended to offer services to Indians located in urban areas. This bill does not affect urban tribal health programs, as this bill is limited to clinics in contract areas (typically more rural).
While the primary purpose of tribal health programs is to provide federally required health care to tribal members, these programs can, if they choose, treat non-tribal members. This is true regardless of whether the clinic is located on or off tribal land. These clinics, again regardless of where they are located, are permitted to seek reimbursement from Medicare and Medi-Cal, though they have to be certified by the Centers for Medicare and Medicaid Services (CMS) in order to bill these programs. CRIHB reports that almost all tribal clinics in California are CMS-certified.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
California Rural Indian Health Board (source)
Big Valley Band of Pomo Indians
California Pan-Ethnic Health Network
California Primary Care Association
Chapa-De Indian Health Program
Cloverdale Rancheria
Feather River Tribal Health
Greenville Rancheria
Karuk Tribe
Lake County Tribal Health Consortium
Latino Coalition for a Healthy California
Manchester-Point Arena Band of Pomo Indians
Pit River Health Service
Redding Rancheria Tribal Health Center
Riverside-San Bernardino County Indian Health System
Santa Ynez Tribal Health Clinic
Sherwood Valley Band of Pomo Indians
Smith River Rancheria
Sonoma County Indian Health Project
Southern Indian Health Council
Toiyabe Indian Health Project
Tule River Indian Health Center
Twenty-Nine Palms Band of Mission Indians
United Indian Health Services
Warner Mountain Indian Health Clinic
Yurok Tribe
OPPOSITION: (Verified 8/18/15)
American Nurses Association/California
ARGUMENTS IN SUPPORT: This bill is sponsored by CRIHB, and supported by numerous tribal health programs. CRIHB states that this bill creates a much-needed single standard for clinic licensure for federal Tribal Health Program sites. According to CRIHB, regardless of where a tribal health program is located, it is required to adhere to all federal IHS operating requirements in order to maintain its status as a federal contractor. CRIHB states that tribal health programs are committed to maintaining high standards of corporate conduct and are audited annually. CRIHB points out that there are currently more than fifteen state licensing exemptions for various types of health clinics in California. According to CRIHB, if a tribal health program is located on Indian land or has a working partnership with an institution of higher learning, it is exempt from state licensure, but if it is not located on Indian land or does not have an affiliation with an institution of higher learning, it must be licensed as a primary care clinic. CRIHB states that the multiple tribal health licensing standards create undue administrative challenges, confusion, and burden for tribal health programs in their mission of providing federally contracted health services. The Riverside-San Bernardino County Indian Health System, in its support letter, described delays in getting its two clinics licensed, and having to undergo an unnecessary comprehensive audit that resulted in a great deal of cost to its organization. The California Primary Care Association states in support that this bill is a simple yet effective way for tribal health organizations to meet the unique healthcare needs of the communities they serve in a culturally competent, accessible manner.
ARGUMENTS IN OPPOSITION: This bill is opposed by the American Nurses Association/California (ANAC). ANAC states that it opposes this bill because it will exclude tribal health clinics from California licensing and safety provisions outside of federally designated tribal lands, and that without licensing, clinics would not have to comply with state building or state professional standards which assure minimal protections for employees working in clinics that may or may not be tribal members.
ASSEMBLY FLOOR: 77-0, 5/11/15
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, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Low, Maienschein, Mathis, Mayes, 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
NO VOTE RECORDED: Harper, Lopez, Atkins
Prepared by: Vince Marchand / HEALTH /
8/20/15 13:57:05
**** END ****
AB 941 (Wood) Page 6 of 6
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 941
AUTHOR: |
Wood |
||
VERSION: |
February 26, 2015 |
||
HEARING DATE: |
June 24, 2015 |
|
|
CONSULTANT: |
Vince Marchand |
||
SUBJECT: Clinics: licensure and regulation: exemption
SUMMARY:
Exempts from licensure and regulation by the Department of Public Health any clinic operated by a federally recognized Indian tribe under a contract with the United States pursuant to the Indian Self-Determination and Education Assistance Act, regardless of the location of the clinic.
Existing state law:
Licenses and regulates clinics, including primary care clinics and specialty clinics, by the Department of Public Health (DPH).
Exempts various types of clinics from licensure and regulation by DPH, including clinics operated by a federally recognized Indian tribe or tribal organization, as defined, that are located on land recognized as tribal land by the federal government. Among the other types of clinics exempt from licensure by DPH are the following:
Any establishment that is owned and operated as a clinic by one or more licensed health care practitioners and used as an office for the practice of their profession, with the exception of surgical clinics and specialty clinics;
Clinics operated as outpatient departments of hospitals;
A clinic operated by, or affiliated with, any institution of learning that teaches a recognized healing art and is approved by the state board or commission vested with responsibility for regulation of the practice of that healing art;
An intermittent clinic that is open for no more than 20 hours per week, and that is operated by a licensed primary care clinic; and,
Student health centers operated by public institutions of higher education.
Exempts a health care practitioner that is licensed in any other state, and who is employed by a tribal health program, from any requirement to be licensed in California with respect to acts authorized under the person’s license in another state, where the tribal health program performs services under the Indian Self-Determination and Education Assistance Act.
Establishes within the Department of Health Care Services (DHCS) the Indian Health Program (IHP), which is charged to improve the health status of American Indians living in urban, rural, and reservation or rancheria communities throughout California.
Existing federal law:
Establishes the Indian Health Service (IHS), which is charged with providing federal health services to American Indians and Alaska Natives who are members of 566 federally recognized Tribes across the United States.
Establishes the Indian Self-Determination and Education Assistance Act (ISDEAA), which was enacted to ensure “effective and meaningful participation by the Indian people in the planning, conduct, and administration” of federal services and programs provided to members of Tribes, including health care. Under ISDEAA, Tribes have the option to exercise their sovereignty by either assuming from IHS the administration and operation of providing health care themselves (through contracts), or to continue to receive health care through the IHS-administered, direct-care health system.
Specifies areas in which tribes are permitted to contract with IHS to provide health care services under ISDEAA, known as “contract health service delivery areas.” California is a contract health service delivery area, except for the following 20 excluded counties: Alameda, Contra Costa, Los Angeles, Marin, Orange, Sacramento, San Francisco, San Mateo, Santa Clara, Kern, Merced, Monterey, Napa, San Benito, San Joaquin, San Luis Obispo, Santa Cruz, Solano, Stanislaus, and Ventura.
This bill: Exempts from licensure and regulation by DPH any clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization, as defined in federal law, under a contract with the United States pursuant to ISDEAA, as specified, regardless of the location of the clinic.
FISCAL EFFECT:
According to the Assembly Appropriations Committee, this bill will result in minor annual revenue loss to DPH, to the extent tribal clinics no longer pay approximately $700 per facility in licensing fees. DPH oversight workload will be reduced commensurately with any reduction in licensure fees.
PRIOR VOTES:
Assembly Floor: |
77 - 0 |
Assembly Appropriations Committee: |
16 - 0 |
Assembly Health Committee: |
19 - 0 |
COMMENTS:
Author’s statement. According to the author, many Native American tribes operate their own health programs for their members on the reservation, but often times many tribal members live off the reservation. Due to the geographic nature of the North Coast, many members off the reservation have a difficult time accessing health care. In order to better serve these members, tribal groups have opened new tribal health clinics off the reservation to expand health care services to their tribal members. However, opening a tribal clinic off the reservation is a very burdensome process. One cumbersome application in the process is the state facility license within DPH, which is known to be time-consuming, costly, and includes duplicative paperwork. Tribal clinics are already required to be licensed under the federal government and Indian Health Services, which already cover the same requirements that DPH’s state facility license seeks to regulate. By streamlining the facility licensing process, tribal clinics would be able to focus more time to providing quality health care to tribal and non-tribal members off the reservation.
Background on ISDEAA and tribal health services in California. In 1975, the ISDEAA was signed into law. The ISDEAA reaffirmed congressional support of the nation-to-nation relationship between the United States and each Tribal nation. The ISDEAA was enacted to ensure “effective and meaningful participation by the Indian people in the planning, conduct, and administration” of federal services and programs provided to the Tribes and their members. Under the ISDEAA, Tribes and Tribal Organizations have the option to either (1) administer programs and services the IHS would otherwise provide (referred to as Title I Self-Determination Contracting) or (2) assume control over health care programs and services that the IHS would otherwise provide (referred to as Title V Self-Governance Compacting). These options are not exclusive; Tribes may choose to combine them based on their individual needs and circumstances.
According to IHS, California is home to the largest population of American Indians/Alaska Natives in the country. According to the 2010 Census, California’s Indian population was 362,801. California is home to 107 federally recognized tribes. The California Rural Indian Health Board (CRIHB), the sponsor of this bill, reports that there are approximately 34 clinics operated by tribal health programs in California: 13 of these clinics are off tribal land and are currently licensed by DPH, while 21 clinics are either on tribal land or meet one of the other licensure exemptions (for example, affiliation with an institution of higher education that offers a health profession education program). All of these tribal health programs are provided in “contract health service delivery areas,” which are federally designated areas that are located in counties that contain, or are adjacent to, tribal land. Separate from these tribal health programs in contract areas, IHS funds eight “urban health programs” that operate under a separate provision of federal law, intended to offer services to Indians located in urban areas. This bill would not affect urban tribal health programs, as this bill is limited to clinics in contract areas (typically more rural).
While the primary purpose of tribal health programs is to provide federally required health care to tribal members, these programs can, if they choose, treat non-tribal members. This is true regardless of whether the clinic is located on or off tribal land. These clinics, again regardless of where they are located, are permitted to seek reimbursement from Medicare and Medi-Cal, though they have to be certified by the Centers for Medicare and Medicaid Services (CMS) in order to bill these programs. CRIHB reports that almost all tribal clinics in California are CMS-certified.
Background on DHCS’ Indian Health Program. Within DHCS is the IHP, which is directed to improve the health status of American Indians living in California. The IHP provides technical assistance and training to American Indian health clinics, and also coordinates with similar programs of the federal government, other state, and voluntary programs, and conducts studies on the health and health services available to American Indians and their families in California. Additionally, IHP administers the American Indian Infant Health Initiative, and manages a Tribal Emergency Preparedness program via an inter-agency agreement with DPH’s Emergency Preparedness Office. According to DHCS, highlights of IHP’s activities include training and technical assistance via site visits, webinars, and phone consultation to clinics on quality assurance/improvement, infection control, licensing and certification issues, program development, billing, and accreditation.
Related legislation. AB 1130 (Gray), would expand the licensure exemption for intermittent clinics that are operated by licensed clinics on separate premises by permitting these intermittent clinics to be open for up to 30 hours per week, instead of only 20 hours per week. AB 1130 is currently pending in this committee.
Prior legislation. AB 2264 (Levine, 2014), was substantially similar to this bill. AB 2264 was amended to address a different subject matter.
AB 1896 (Chesbro, Chapter 119, Statutes of 2012), exempted a health care practitioner that is licensed in any other state, and who is employed by a tribal health program, from any requirement to be licensed in California with respect to acts authorized under the person’s license in another state, where the tribal health program performs services under the ISDEAA.
Support. This bill is sponsored by CRIHB, and supported by numerous tribal health programs. CRIHB states that this bill would create a much-needed single standard for clinic licensure for federal Tribal Health Program sites. According to CRIHB, regardless of where a tribal health program is located, it is required to adhere to all federal Indian Health Service operating requirements in order to maintain its status as a federal contractor. CRIHB states that tribal health programs are committed to maintaining high standards of corporate conduct and are audited annually. CRIHB points out that there are currently more than fifteen state licensing exemptions for various types of health clinics in California. According to CRIHB, if a tribal health program is located on Indian land or has a working partnership with an institution of higher learning, it is exempt from state licensure, but if it is not located on Indian land or does not have an affiliation with an institution of higher learning, it must be licensed as a primary care clinic. CRIHB states that the multiple tribal health licensing standards create undue administrative challenges, confusion, and burden for tribal health programs in their mission of providing federally contracted health services. The Riverside-San Bernardino County Indian Health System, in its support letter, described delays in getting its two clinics licensed, and having to undergo an unnecessary comprehensive audit that resulted in a great deal of cost to its organization. The California Primary Care Association states in support that this bill is a simple yet effective way for tribal health organizations to meet the unique healthcare needs of the communities they serve in a culturally competent, accessible manner.
Opposition. This bill is opposed by the California Nurses Association (CNA) and the American Nurses Association/California (ANAC). CNA states that exemptions from state law generally exist because of federally recognized sovereignty in which agreements with respect to health services provided on federally designated tribal lands, or reservations, are managed by IHS. According to CNA, exempting tribal clinics not on tribal lands from licensing requirements creates disparity between requirements for clinics operated by IHS and clinics operated by other providers, even though they may be serving the same population. CNA states that tribal clinics see any patient who presents for care, and can bill Medicare and Medi-Cal for healthcare services provided to both tribal and non-tribal members alike. CNA states that California regulatory standards provide a level of patient safety that exceeds federal standards with regard to staffing and worker protections, and the process of clinic licensure assures a level of care that is consistent throughout California. ANAC states that it opposes this bill because it will exclude tribal health clinics from California licensing and safety provisions outside of federally designated tribal lands, and that without licensing, clinics would not have to comply with state building or state professional standards which assure minimal protections for employees working in clinics that may or may not be tribal members.
Letter of concern. The California State Council of the Service Employees International Union (SEIU California), in a letter of concern, states that under current law, in recognition of tribal sovereignty, tribal clinics are exempt from state facilities licensure when operated on tribal land. SEIU California notes that this bill would essentially treat tribal clinics the same, whether they were operated on, or off of tribal lands. SEIU California states that it is concerned that these clinics would be open to any Californian, not just members of the tribe and their families, and as such, patients may have a reasonable expectation that all state and federal licensure and certification standards have been applied, when in fact they would not have. SEIU California states that it would be willing to support an exemption from state licensure if this were a closed system of clinics, open only to members of the tribe and their relatives, consistent with exemptions for other facilities run by governmental entities, such as the Veteran’s Administration facilities.
Different oversight standards. Under this bill, a tribal health program may operate a clinic, without obtaining licensure from DPH, anywhere in the state, as long as it is in one of the 38 counties that are not excluded. While the author and sponsors point out that the majority of these counties are in rural areas, there are some eligible counties that include significant urban centers, such as San Diego County. California law already permits tribal health programs, whether located on or off tribal land, to hire health care professionals who are licensed in any state. This could lead to a potential situation in which a non-tribal member walks into a tribal clinic, which could be in a relatively urban area, and not have recourse to the two sources of oversight most typically associated with a clinic: either DPH for a facility-based complaint, or a California professional licensing board for a complaint regarding an individual doctor or nurse. To be sure, the ability to hire a health care professional licensed in another state is already the law for all tribal clinics, regardless of their location. Additionally, CRIHB points out there are multiple sources of oversight of tribal health clinics, ranging from internal complaint procedures through the tribal health program itself or the tribal government that sanctions the clinic, to the complaint procedure governed by IHS. However, for non-tribal members unaccustomed to the IHS system, the complaint process will not be typical of the way it is handled in licensed clinics.
SUPPORT AND OPPOSITION:
Support: California Rural Indian Health Board (sponsor)
Big Valley Band of Pomo Indians
California Pan-Ethnic Health Network
California Primary Care Association
Chapa-De Indian Health Program
Cloverdale Rancheria
Feather River Tribal Health
Greenville Rancheria
Karuk Tribe
Lake County Tribal Health Consortium
Latino Coalition for a Healthy California
Manchester-Point Arena Band of Pomo Indians
Pit River Health Service
Redding Rancheria Tribal Health Center
Riverside-San Bernardino County Indian Health System
Santa Ynez Tribal Health Clinic
Sherwood Valley Band of Pomo Indians
Smith River Rancheria
Sonoma County Indian Health Project
Southern Indian Health Council
Toiyabe Indian Health Project
Tule River Indian Health Center
Twenty-Nine Palms Band of Mission Indians
United Indian Health Services
Warner Mountain Indian Health Clinic
Yurok Tribe
Oppose: American Nurses Association/California
California Nurses Association
-- END --
AB 941
Page 2
ASSEMBLY THIRD READING
AB 941
(Wood)
As Introduced February 26, 2015
Majority vote
Committee |
Votes |
Ayes |
Noes |
Health |
19-0 |
Bonta, Maienschein, Bonilla, Burke, Chávez, Chiu, Gomez, Gonzalez, Roger Hernández, Lackey, Nazarian, Patterson, Ridley-Thomas, Rodriguez, Santiago, Steinorth, Thurmond, Waldron, Wood |
|
Appropriations |
16-0 |
Gomez, Bigelow, Bloom, Bonta, Calderon, Chang, Daly, Eggman, Eduardo Garcia, Holden, Jones, Quirk, Rendon, Wagner, Weber, Wood |
|
SUMMARY: Exempts clinics operated by a tribe or tribal organization, regardless of location, from obtaining a license from the Department of Public Health (DPH), and requires, to qualify for the exemption, the clinic operate under a contract with the United States pursuant to the Indian Self Determination and Education Assistance Act.
FISCAL EFFECT: According to the Assembly Appropriations Committee, minor annual revenue loss to DPH, to the extent tribal clinics no longer pay approximately $700 per facility in licensing fees. DPH oversight workload will be reduced commensurately with any reduction in licensure fees.
COMMENTS: According to the author, the majority of California tribal health clinics (tribal clinics) are located in rural areas of the state and oftentimes, it is challenging to meet unmet needs when providing healthcare services over large geographic areas. Tribal clinics cannot always establish new clinics on Indian land, as oftentimes, the Indian land in question is not available in an area where many tribal clinic patients may reside. This results in opening new tribal clinics on non-Indian land in order to provide adequate access of care to patients. The author notes, tribal clinics may only place new sites within the federal statutorily defined service areas based on the population of the tribal communities they serve. The federal, tribal, and state standards requirements have to be met in order to create a new tribal clinic; and these standards are comprehensive and coherent. When abiding by the federal, tribal, and state standards, the administrative process becomes very duplicative when applying for a license to operate a tribal clinic on non-Indian land. The author concludes, this bill will streamline the state clinic licensing exemptions and exempt tribal clinics on non-Indian land from DPH's state facility license.
Background. There are approximately 1,000 primary care clinics currently licensed in California. In order to obtain a license, a primary care clinic must submit an application and fee to DPH and pass an initial licensure survey conducted by DPH. Clinics exempt from state licensing do have to apply to the Department of Health Care Services (DHCS) if they want to enroll as a Medi-Cal provider. DHCS has a specific application process for exempt clinics, including obtaining a certification by DPH or a specified nonprofit entity that inspects the clinics and ensures they meet minimum requirements.
Tribal Health Services. The Indian Health Service (IHS) oversees health programs over portions of the state. By federal law, the area is limited to the 38 counties with American Indian trust lands, generally meaning a reservation or rancheria. Within the included counties there is a service population of approximately 130,000 eligible American Indians. The IHS divides their service area in California into smaller administrative units called services units. These services units have responsibility for planning, managing, and evaluating the health programs in its jurisdiction. They are focused on a specific geographic area and are usually centered on a single federal reservation. It is within these services units that a tribe or consortium of tribes can operate clinics under contract with the federal government. Although the clinics are established to provide services to specified American Indians they are open to all. The proportion of non-Indians using these clinics varies dramatically. In some smaller rural areas without many health care facilities, the proportion of non-Indians can be quite significant accounting for about half the patients seen. In other clinics, Indians comprise the overwhelming majority. According to the California Rural Indian Health Board, of the 30 existing tribal health clinics in the state, this bill will apply to approximately five. All IHS-funded health care is tied to American Indian and Alaska Native user populations. In California there are eight urban Indian clinics in cities. The exemption proposed by this bill would not apply to them, and their funding and federal statutory authority is distinct and separate from the funding and authority for tribal health programs.
Support. The California Rural Indian Health Board, Inc., numerous Tribes and Rancherias, and the California Pan-Ethnic Health Network support this bill stating it will create a much needed single standard for clinic licensure for federal Tribal Health Programs (THP). Supporter's note, regardless of where a THP is located, it is required to adhere to all federal IHS operating requirements in order to maintain its status as a federal contractor. Supporters also contend the THPs' governing bodies have established compliance services that detect, prevent, and appropriately respond to violations of law or company policy, and many THPs are accredited by the Accreditation Association for Ambulatory Health Care or the Joint Commission on Accreditation of Health Care Organizations.
Opposition. The California Nurses Association (CNA) is opposed to this bill because it will exclude Tribal Health Clinics from California licensing and safety provisions outside of federally designated tribal lands. CNA notes, without licensing, clinics would not have to comply with state building or state professional standards which assure minimal protections for employees working in clinics who may or may not be tribal members. CNA concludes the exemption proposed by this bill does not assure any state minimum standards of care for tribal clinics operating within California but not on tribal land.
Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0000355
AB 941
Page 1
Date of Hearing: May 6, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
AB 941
(Wood) – As Introduced February 26, 2015
Policy Committee: |
Health |
Vote: |
19 - 0 |
|
|
|
|
|
|
|
|
Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill exempts a clinic conducted, maintained, or operated by a federally recognized Indian tribe or tribal organization from licensure as a clinic by the California Department of Public Health (CDPH).
FISCAL EFFECT:
Minor annual revenue loss to DPH, to the extent tribal clinics no longer pay approximately $700 per facility in licensing fees per facility. DPH oversight workload will be reduced commensurately with any reduction in licensure fees.
COMMENTS:
Purpose. According to the author, this bill creates a single licensing standard for tribe-operated clinics, by clarifying the exemption from clinic licensing in existing law for clinics operated by federally recognized tribes applies to clinics that are not located within Indian country. The author notes when tribe-operated health programs operate a clinic on federal Indian trust land or in affiliation with an institution of higher learning they are exempt from licensure. However, other clinics tribes operate must be licensed.
Support. This bill is supported by numerous tribes, Latino Coalition for a Healthy California, the California Primary Care Association, and several other organizations.
Opposition. The California Nurses Association (CNA) opposes this bill, noting without licensing, clinics would not have to comply with state building or state professional standards which assure minimal protections for employees working in clinics who may or may not be tribal members. CNA believes the exemption proposed by this bill does not assure any minimum standards of care for tribal clinics operating within California but not on tribal land.
Previous Legislation. AB 2264 (Levine) of 2014, was substantially similar to this bill. AB 2264 was amended to address entirely different subject matter.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
AB 941
Page 5
Date of Hearing: April 28, 2015
ASSEMBLY COMMITTEE ON HEALTH
Rob Bonta, Chair
AB 941
(Wood) – As Introduced February 26, 2015
SUBJECT: Clinics: licensure and regulation: exemption.
SUMMARY: Exempts clinics operated by a tribe or tribal organization, regardless of location, from obtaining a license from the Department of Public Health (DPH), and requires, to qualify for the exemption, the clinic operate under a contract with the United States pursuant to the Indian Self Determination and Education Assistance Act (ISDEAA).
EXISTING STATE LAW:
Requires clinics to be licensed by DPH. Provides for exemptions from these licensing requirements for certain types of clinics, including federally operated clinics, local government primary care clinics, clinics affiliated with an institution of higher learning, clinics conducted as outpatient departments of hospitals, and community or free clinics.
Exempts from the clinic licensing requirement, clinics operated by a federally recognized Indian tribe or tribal organization on land recognized as tribal land by the federal government.
Authorizes DPH to take various types of enforcement actions against a primary care clinic that has violated state law or regulation, including imposing fines, sanctions, civil or criminal penalties, and suspension or revocation of the clinic's license.
Requires a provider to apply to the Department of Health Care Services (DHCS) to obtain approval for participating in the Medi-Cal program and to apply and obtain DHCS approval for enrollment. Specifies extensive application requirements.
Requires clinics to meet specified standards and be approved for operation by DPH prior to obtaining a Medi-Cal provider number or providing services.
Creates within DPH the Indian Health Program whose mission is to improve the health status of American Indians living in urban, rural, and reservation or rancheria communities in California.
Specifies that nothing prohibits DPH from adopting regulations that utilize clinic licensing standards as eligibility criteria for participation in programs funded wholly or partially under Title XVII or XIX of the federal Social Security Act (i.e., Medicaid).
Allows a person who is licensed as a health care practitioner in any other state and is employed by a tribal health program to be exempt from any licensing requirement with respect to acts authorized under the person's license where the tribal health program performs the services described in the contract or compact of the tribal health program under the ISDEAA.
EXISTING FEDERAL LAW:
Allows the federal government to contract with federally recognized tribes for health services within the California contract health service delivery area. Excludes from the California area the Counties of Alameda, Contra Costa, Los Angeles, Marin, Orange, Sacramento, San Francisco, San Mateo, Santa Clara, Kern, Merced, Monterey, Napa, San Benito, San Joaquin, San Luis Obispo, Santa Cruz, Solano, Stanislaus, and Ventura.
Includes under The Patient Protection and Affordable Care Act (ACA) provisions for health care services provided to Indians through Tribal Health Programs. The ACA indicates that professionals who are employed by tribal health programs shall be considered exempt from the licensing requirements of the state in which the tribal health program performs services under the ISDEAA.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.
COMMENTS:
PURPOSE OF THIS BILL. According to the author, the majority of California tribal health clinics (tribal clinics) are located in rural areas of the state and oftentimes, it is challenging to meet unmet needs when providing healthcare services over large geographic areas. Tribal clinics cannot always establish new clinics on Indian land, as oftentimes, the Indian land in question is not available in an area where many tribal clinic patients may reside. This results in opening new tribal clinics on non-Indian land in order to provide adequate access of care to patients.
The author notes, tribal clinics may only place new sites within the federal statutorily defined service areas based on the population of the tribal communities they serve. The federal, tribal, and state standards requirements have to be met in order to create a new tribal clinic; and these standards are comprehensive and coherent.
When abiding by the federal, tribal, and state standards, the administrative process becomes very duplicative when applying for a license to operate a tribal clinic on non-Indian land. The author concludes, this bill will streamline the state clinic licensing exemptions and exempt tribal clinics on non-Indian land from DPH's state facility license.
BACKGROUND. There are approximately 1,000 primary care clinics currently licensed in California. In order to obtain a license, a primary care clinic must submit an application and fee to DPH and pass an initial licensure survey conducted by DPH. Upon receipt of a completed application for a clinic license, DPH has up to 100 days to either grant or deny the license. Existing law requires DPH to issue a provisional license, good for six months from the date of issuance, to a clinic that has not been previously licensed. DPH is required to inspect the clinic within 30 days prior to the termination of the provisional license, and, if the clinic meets all licensure requirements, issue a regular license. Clinics that do not meet the requirements for licensure, but make progress toward meeting the requirements, may have their provisional license renewed by DPH for another six months.
Clinics exempt from state licensing do have to apply to DHCS if they want to enroll as a Medi-Cal provider. DHCS has a specific application process for exempt clinics, including obtaining a certification by DPH or a specified nonprofit entity that inspects the clinics and ensures they meet minimum requirements.
TRIBAL HEALTH SERVICES. The federal government has a major role in providing health care services to American Indians. The federal government’s obligation began with the terms of many treaties where the federal government promised health care as one of the conditions of these treaties. Over time the obligation has endured, but the means for carrying it out has undergone significant change. A landmark change occurred when the Snyder Act was passed in 1921 which better defined the federal responsibility, consolidated various programs, and assigned responsibility to the Bureau of Indian Affairs. Their responsibilities were later transferred to the forerunner of today’s Department of Health and Human Services and administered by the newly created Indian Health Service (IHS). Another significant change came with the enactment in 1975 of the Indian Self-Determination and Education Act (Public Law 93-638). Enactment of this law marked the beginning of a period when the tribes began taking more responsibility and a direct role in providing health services. Health services may still be provided by the IHS but as an alternative they can be provided by a contracting tribe, a program which has grown markedly over the years.
The IHS provides health services to members of federally recognized tribes and other eligible Indians, as specified. The health services have been described as universal eligibility but have limited availability, a further factor in the tribes taking more responsibility for the direct provision of services. The IHS oversees health programs over portions of the state. By federal law, the area is limited to the 38 counties with American Indian trust lands, generally meaning a reservation or rancheria. Within the included counties there is a service population of approximately 130,000 eligible American Indians. The IHS divides their service area in California into smaller administrative units called services units. These services units have responsibility for planning, managing, and evaluating the health programs in its jurisdiction. They are focused on a specific geographic area and are usually centered on a single federal reservation. It is within these services units that a tribe or consortium of tribes can operate clinics under contract with the federal government.
Although the clinics are established to provide services to specified American Indians they are open to all. The proportion of non-Indians using these clinics varies dramatically. In some smaller rural areas without many health care facilities, the proportion of non-Indians can be quite significant accounting for about half the patients seen. In other clinics, Indians comprise the overwhelming majority.
According to the California Rural Indian Health Board, of the 30 existing tribal health clinics in the state, this bill will apply to approximately five. All IHS-funded health care is tied to American Indian and Alaska Native user populations. In California there are eight urban Indian clinics in cities. The exemption proposed by this bill would not apply to them, and their funding and federal statutory authority is distinct and separate from the funding and authority for tribal health programs.
SUPPORT. The California Rural Indian Health Board, Inc. (CRIHB), numerous Tribes and Rancherias, and the California Pan-Ethnic Health Network support this bill stating it will create a much needed single standard for clinic licensure for federal Tribal Health Programs (THP). Supporter's note, regardless of where a THP is located, it is required to adhere to all federal IHS operating requirements in order to maintain its status as a federal contractor. Supporters also contend the THPs' governing bodies have established compliance services that detect, prevent, and appropriately respond to violations of law or company policy, and many THPs are accredited by the Accreditation Association for Ambulatory Health Care or the Joint Commission on Accreditation of Health Care Organizations.
The California Primary Care Association (CPCA) supports this bill noting that American Indians face unique health challenges, from having the highest rates of asthma, diabetes, and heart disease among any ethnic group to experiencing persistent barriers to health care and insurance. CPCA also states American Indian peoples also suffer from a scarcity of resources and data on a broad range of health topics, from obesity to cancer survival to suicide and mental health issues. They also note that California has the largest population of elderly American Indians of any state, which will likely increase the need for culturally sensitive healthcare services, like those provided by tribal health clinics.
OPPOSITION. The California Nurses Association (CNA) is opposed to this bill because it will exclude Tribal Health Clinics from California licensing and safety provisions outside of federally designated tribal lands. CNA notes, without licensing, clinics would not have to comply with state building or state professional standards which assure minimal protections for employees working in clinics who may or may not be tribal members. CNA states while the Social Security Act generally prohibits payment to any Federal agency, an exception is provided for IHS/Tribally owned and operated facilities, and the enactment of Medicare, Medicaid, and State Children's Health Insurance Program Benefits Improvement and Protection Act expanded payment for Medicare services provided in IHS/tribally owned and operated facilities. In short, CNA contends, tribal clinics are able to bill for Medicare reimbursement just as any other clinic in California, and exemptions from state law exist because of federally recognized sovereignty in which agreements with respect to health services provided on federally designated tribal lands, or reservations are managed by IHS. CNA concludes the exemption proposed by this bill does not assure any state minimum standards of care for tribal clinics operating within California but not on tribal land.
RELATED LEGISLATION. SB 396 (Hill) allows ambulatory surgical clinics which are Medicare certified to have the option of being licensed by DPH and also clarifies that they are deemed to be licensed if they are already Medicare certified. SB 396 passed the Senate Business & Professions Committee on April 20, 2015 with a vote of 9-0 and is pending hearing in the Senate Health Committee.
PREVIOUS LEGISLATION.
AB 2264 (Levine) of 2014, was substantially similar to this bill. AB 2264 was amended to address entirely different subject matter.
AB 1896 (Chesbro), Chapter 119, Statutes of 2012, aligns California law with provisions of federal law which exempt a health care practitioner licensed in any state who practices as part of the tribal health program from the licensure requirements of the state in which the tribal health program is located.
POLICY COMMENT. This bill could result in clinics in very similar situations being subject to different regulations. A clinic operated by a recognized tribe and located off a reservation currently can hire health care providers who are not licensed in California, and should this bill pass, would not have to obtain a license from DPH. Another clinic operated by another entity and not on a reservation would have to hire health care providers licensed in California and obtain a license, creating a potentially inequitable situation and leading to possible confusion for consumers. One way to address this situation would be to repeal the current exemption allowing tribal clinics to hire providers without a California license.
REGISTERED SUPPORT / OPPOSITION:
Support
Big Valley Band of Pomo Indians
Blue Lake Rancheria
California
Pan-Ethnic Health Network
California Primary Care
Association
California Rural Indian Health Board, Inc.
Chapa-De
Indian Health Program, Inc.
Cloverdale Rancheria
Greenville
Rancheria
Karuk Tribe
Kashia Band of Pomo Indians
Latino
Coalition for a Healthy California
Northern Valley Indian
Health
Pit River Tribe
Resighini Rancheria
Riverside-San
Bernardino County Indian Health System
Smith River
Rancheria
Toiyabe Indian Health Project
Tule River Indian
Health Center, Inc.
United Indian Health Services, Inc.
Warner
Mountain Indian Health Clinic
Yurok Tribe
Opposition
California Nurses Association
Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097
Discussed in Hearing
Assembly Floor
Senate Floor
Senate Standing Committee on Health
Assembly Floor
Assembly Standing Committee on Appropriations
Assembly Standing Committee on Health
Bill Author
Bill Co-Author(s):