Amended IN Senate April 17, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 512Introduced by Senator HernandezFebruary 16, 2017 An act to amend Section 14000 of the Welfare and Institutions Code, relating to Medi-Cal. add Chapter 8.4 (commencing with Section 1744) to Division 2 of the Health and Safety Code, relating to health and care facilities.LEGISLATIVE COUNSEL'S DIGESTSB 512, as amended, Hernandez. Medi-Cal. Health and care facilities: stem cell clinics.Existing law provides for the licensure and regulation of clinics by the State Department of Public Health. A violation of those provisions is a misdemeanor. Existing law provides that certain types of specialty clinics, including surgical clinics, as defined, are eligible for licensure. Existing law excludes from the definition of surgical clinic any place or establishment owned or leased and operated as a clinic or office by one or more physicians or dentists in individual or group practice, provided, however, that physicians or dentists may, at their option, apply for licensure.This bill would require a stem cell clinic, as defined, to post on site conspicuously in the entrance of the clinic and in at least one additional area where the clients wait to receive services, and to include in any print and digital advertising materials, a specified notice regarding the provision of stem cell therapies.Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, and under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law provides that it is the intent of the Legislature to provide, to the extent practicable, for health care for those aged and other individuals who lack sufficient annual income to meet the costs of health care, and whose other assets are so limited that their application toward the costs of care would jeopardize the individuals or familys future minimum self-maintenance and security.This bill would make technical, nonsubstantive changes to this statement of legislative intent.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Chapter 8.4 (commencing with Section 1744) is added to Division 2 of the Health and Safety Code, to read: CHAPTER 8.4. Stem Cell Clinics1744. (a) A stem cell clinic shall post on site, and shall include in any print and digital advertising materials, including Internet Web sites, the following notice in English:THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This facility is not licensed as a medical facility by the State of California and performs procedures utilizing stem cells that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a procedure utilizing stem cells at this facility.(b) The notice shall be disclosed in the following manner:(1) The onsite notice shall be at least eight and one-half inches by 11 inches and written in no less than 48-point type. The notice shall be posted conspicuously in the entrance of the clinic and in at least one additional area where clients wait to receive services.(2) The notice in any advertising materials shall be clear and conspicuous. For purposes of this subdivision, clear and conspicuous means in larger point type than the surrounding text, or in contrasting type, font, or color to the surrounding text of the same size, or set off from the surrounding text of the same size by symbols or other marks that call attention to the language.(c) This section does not apply to a stem cell clinic that has obtained approval for an investigation new drug or a regenerative medicine advanced therapy application from the United States Food and Drug Administration for the use of a stem cell therapy.(d) For purposes of this section, and except as provided for in subdivision (d), stem cell clinic means an unlicensed facility that is operated as a clinic or office by one or more providers licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, where non-FDA-approved stem cell therapies are provided and that satisfies one or more of the following:(1) The facility markets therapies using harvested stem cells from adipose, bone marrow, cord blood, amniotic, or placenta tissue to replace or repair a patients cells or tissues.(2) The facility markets therapies that deliver stem cells through blood or transplanted directly into damaged tissue.SECTION 1.Section 14000 of the Welfare and Institutions Code is amended to read:14000.(a)The purpose of this chapter is to afford to qualifying individuals health care and related remedial or preventive services, including related social services that are necessary for those receiving health care under this chapter. (b)The intent of the Legislature is to provide, to the extent practicable, through the provisions of this chapter, for health care for those aged and other individuals, including family members, who lack sufficient annual income to meet the costs of health care and whose other assets are so limited that their application toward the costs of that care would jeopardize the individuals or familys future minimum self-maintenance and security. It is intended that whenever possible and feasible:(1)The means employed shall allow, to the extent practicable, an eligible individual to secure health care in the same manner employed by the public generally, and without discrimination or segregation, based purely on his or her economic disability. The means employed shall include an emphasis on efforts to arrange and encourage access to health care through enrollment in organized, managed care plans of the type available to the general public.(2)The benefits available under this chapter shall not duplicate those provided under other federal or state laws or under other contractual or legal entitlements of the individual or individuals receiving them.(3)In the administration of this chapter and in establishing the means to be used to provide access to health care to individuals eligible under this chapter, the department shall emphasize and take advantage of both the efficient organization and ready accessibility and availability of health care facilities and resources through enrollment in managed health care plans and new and innovative fee-for-service managed health care plan approaches to the delivery of health care services.
Amended IN Senate April 17, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 512Introduced by Senator HernandezFebruary 16, 2017 An act to amend Section 14000 of the Welfare and Institutions Code, relating to Medi-Cal. add Chapter 8.4 (commencing with Section 1744) to Division 2 of the Health and Safety Code, relating to health and care facilities.LEGISLATIVE COUNSEL'S DIGESTSB 512, as amended, Hernandez. Medi-Cal. Health and care facilities: stem cell clinics.Existing law provides for the licensure and regulation of clinics by the State Department of Public Health. A violation of those provisions is a misdemeanor. Existing law provides that certain types of specialty clinics, including surgical clinics, as defined, are eligible for licensure. Existing law excludes from the definition of surgical clinic any place or establishment owned or leased and operated as a clinic or office by one or more physicians or dentists in individual or group practice, provided, however, that physicians or dentists may, at their option, apply for licensure.This bill would require a stem cell clinic, as defined, to post on site conspicuously in the entrance of the clinic and in at least one additional area where the clients wait to receive services, and to include in any print and digital advertising materials, a specified notice regarding the provision of stem cell therapies.Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, and under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law provides that it is the intent of the Legislature to provide, to the extent practicable, for health care for those aged and other individuals who lack sufficient annual income to meet the costs of health care, and whose other assets are so limited that their application toward the costs of care would jeopardize the individuals or familys future minimum self-maintenance and security.This bill would make technical, nonsubstantive changes to this statement of legislative intent.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO
Amended IN Senate April 17, 2017
Amended IN Senate April 17, 2017
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION
Senate Bill No. 512
Introduced by Senator HernandezFebruary 16, 2017
Introduced by Senator Hernandez
February 16, 2017
An act to amend Section 14000 of the Welfare and Institutions Code, relating to Medi-Cal. add Chapter 8.4 (commencing with Section 1744) to Division 2 of the Health and Safety Code, relating to health and care facilities.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
SB 512, as amended, Hernandez. Medi-Cal. Health and care facilities: stem cell clinics.
Existing law provides for the licensure and regulation of clinics by the State Department of Public Health. A violation of those provisions is a misdemeanor. Existing law provides that certain types of specialty clinics, including surgical clinics, as defined, are eligible for licensure. Existing law excludes from the definition of surgical clinic any place or establishment owned or leased and operated as a clinic or office by one or more physicians or dentists in individual or group practice, provided, however, that physicians or dentists may, at their option, apply for licensure.This bill would require a stem cell clinic, as defined, to post on site conspicuously in the entrance of the clinic and in at least one additional area where the clients wait to receive services, and to include in any print and digital advertising materials, a specified notice regarding the provision of stem cell therapies.Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, and under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law provides that it is the intent of the Legislature to provide, to the extent practicable, for health care for those aged and other individuals who lack sufficient annual income to meet the costs of health care, and whose other assets are so limited that their application toward the costs of care would jeopardize the individuals or familys future minimum self-maintenance and security.This bill would make technical, nonsubstantive changes to this statement of legislative intent.
Existing law provides for the licensure and regulation of clinics by the State Department of Public Health. A violation of those provisions is a misdemeanor. Existing law provides that certain types of specialty clinics, including surgical clinics, as defined, are eligible for licensure. Existing law excludes from the definition of surgical clinic any place or establishment owned or leased and operated as a clinic or office by one or more physicians or dentists in individual or group practice, provided, however, that physicians or dentists may, at their option, apply for licensure.
This bill would require a stem cell clinic, as defined, to post on site conspicuously in the entrance of the clinic and in at least one additional area where the clients wait to receive services, and to include in any print and digital advertising materials, a specified notice regarding the provision of stem cell therapies.
Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, and under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law provides that it is the intent of the Legislature to provide, to the extent practicable, for health care for those aged and other individuals who lack sufficient annual income to meet the costs of health care, and whose other assets are so limited that their application toward the costs of care would jeopardize the individuals or familys future minimum self-maintenance and security.
This bill would make technical, nonsubstantive changes to this statement of legislative intent.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Chapter 8.4 (commencing with Section 1744) is added to Division 2 of the Health and Safety Code, to read: CHAPTER 8.4. Stem Cell Clinics1744. (a) A stem cell clinic shall post on site, and shall include in any print and digital advertising materials, including Internet Web sites, the following notice in English:THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This facility is not licensed as a medical facility by the State of California and performs procedures utilizing stem cells that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a procedure utilizing stem cells at this facility.(b) The notice shall be disclosed in the following manner:(1) The onsite notice shall be at least eight and one-half inches by 11 inches and written in no less than 48-point type. The notice shall be posted conspicuously in the entrance of the clinic and in at least one additional area where clients wait to receive services.(2) The notice in any advertising materials shall be clear and conspicuous. For purposes of this subdivision, clear and conspicuous means in larger point type than the surrounding text, or in contrasting type, font, or color to the surrounding text of the same size, or set off from the surrounding text of the same size by symbols or other marks that call attention to the language.(c) This section does not apply to a stem cell clinic that has obtained approval for an investigation new drug or a regenerative medicine advanced therapy application from the United States Food and Drug Administration for the use of a stem cell therapy.(d) For purposes of this section, and except as provided for in subdivision (d), stem cell clinic means an unlicensed facility that is operated as a clinic or office by one or more providers licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, where non-FDA-approved stem cell therapies are provided and that satisfies one or more of the following:(1) The facility markets therapies using harvested stem cells from adipose, bone marrow, cord blood, amniotic, or placenta tissue to replace or repair a patients cells or tissues.(2) The facility markets therapies that deliver stem cells through blood or transplanted directly into damaged tissue.SECTION 1.Section 14000 of the Welfare and Institutions Code is amended to read:14000.(a)The purpose of this chapter is to afford to qualifying individuals health care and related remedial or preventive services, including related social services that are necessary for those receiving health care under this chapter. (b)The intent of the Legislature is to provide, to the extent practicable, through the provisions of this chapter, for health care for those aged and other individuals, including family members, who lack sufficient annual income to meet the costs of health care and whose other assets are so limited that their application toward the costs of that care would jeopardize the individuals or familys future minimum self-maintenance and security. It is intended that whenever possible and feasible:(1)The means employed shall allow, to the extent practicable, an eligible individual to secure health care in the same manner employed by the public generally, and without discrimination or segregation, based purely on his or her economic disability. The means employed shall include an emphasis on efforts to arrange and encourage access to health care through enrollment in organized, managed care plans of the type available to the general public.(2)The benefits available under this chapter shall not duplicate those provided under other federal or state laws or under other contractual or legal entitlements of the individual or individuals receiving them.(3)In the administration of this chapter and in establishing the means to be used to provide access to health care to individuals eligible under this chapter, the department shall emphasize and take advantage of both the efficient organization and ready accessibility and availability of health care facilities and resources through enrollment in managed health care plans and new and innovative fee-for-service managed health care plan approaches to the delivery of health care services.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Chapter 8.4 (commencing with Section 1744) is added to Division 2 of the Health and Safety Code, to read: CHAPTER 8.4. Stem Cell Clinics1744. (a) A stem cell clinic shall post on site, and shall include in any print and digital advertising materials, including Internet Web sites, the following notice in English:THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This facility is not licensed as a medical facility by the State of California and performs procedures utilizing stem cells that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a procedure utilizing stem cells at this facility.(b) The notice shall be disclosed in the following manner:(1) The onsite notice shall be at least eight and one-half inches by 11 inches and written in no less than 48-point type. The notice shall be posted conspicuously in the entrance of the clinic and in at least one additional area where clients wait to receive services.(2) The notice in any advertising materials shall be clear and conspicuous. For purposes of this subdivision, clear and conspicuous means in larger point type than the surrounding text, or in contrasting type, font, or color to the surrounding text of the same size, or set off from the surrounding text of the same size by symbols or other marks that call attention to the language.(c) This section does not apply to a stem cell clinic that has obtained approval for an investigation new drug or a regenerative medicine advanced therapy application from the United States Food and Drug Administration for the use of a stem cell therapy.(d) For purposes of this section, and except as provided for in subdivision (d), stem cell clinic means an unlicensed facility that is operated as a clinic or office by one or more providers licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, where non-FDA-approved stem cell therapies are provided and that satisfies one or more of the following:(1) The facility markets therapies using harvested stem cells from adipose, bone marrow, cord blood, amniotic, or placenta tissue to replace or repair a patients cells or tissues.(2) The facility markets therapies that deliver stem cells through blood or transplanted directly into damaged tissue.
SECTION 1. Chapter 8.4 (commencing with Section 1744) is added to Division 2 of the Health and Safety Code, to read:
### SECTION 1.
CHAPTER 8.4. Stem Cell Clinics1744. (a) A stem cell clinic shall post on site, and shall include in any print and digital advertising materials, including Internet Web sites, the following notice in English:THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This facility is not licensed as a medical facility by the State of California and performs procedures utilizing stem cells that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a procedure utilizing stem cells at this facility.(b) The notice shall be disclosed in the following manner:(1) The onsite notice shall be at least eight and one-half inches by 11 inches and written in no less than 48-point type. The notice shall be posted conspicuously in the entrance of the clinic and in at least one additional area where clients wait to receive services.(2) The notice in any advertising materials shall be clear and conspicuous. For purposes of this subdivision, clear and conspicuous means in larger point type than the surrounding text, or in contrasting type, font, or color to the surrounding text of the same size, or set off from the surrounding text of the same size by symbols or other marks that call attention to the language.(c) This section does not apply to a stem cell clinic that has obtained approval for an investigation new drug or a regenerative medicine advanced therapy application from the United States Food and Drug Administration for the use of a stem cell therapy.(d) For purposes of this section, and except as provided for in subdivision (d), stem cell clinic means an unlicensed facility that is operated as a clinic or office by one or more providers licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, where non-FDA-approved stem cell therapies are provided and that satisfies one or more of the following:(1) The facility markets therapies using harvested stem cells from adipose, bone marrow, cord blood, amniotic, or placenta tissue to replace or repair a patients cells or tissues.(2) The facility markets therapies that deliver stem cells through blood or transplanted directly into damaged tissue.
CHAPTER 8.4. Stem Cell Clinics1744. (a) A stem cell clinic shall post on site, and shall include in any print and digital advertising materials, including Internet Web sites, the following notice in English:THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This facility is not licensed as a medical facility by the State of California and performs procedures utilizing stem cells that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a procedure utilizing stem cells at this facility.(b) The notice shall be disclosed in the following manner:(1) The onsite notice shall be at least eight and one-half inches by 11 inches and written in no less than 48-point type. The notice shall be posted conspicuously in the entrance of the clinic and in at least one additional area where clients wait to receive services.(2) The notice in any advertising materials shall be clear and conspicuous. For purposes of this subdivision, clear and conspicuous means in larger point type than the surrounding text, or in contrasting type, font, or color to the surrounding text of the same size, or set off from the surrounding text of the same size by symbols or other marks that call attention to the language.(c) This section does not apply to a stem cell clinic that has obtained approval for an investigation new drug or a regenerative medicine advanced therapy application from the United States Food and Drug Administration for the use of a stem cell therapy.(d) For purposes of this section, and except as provided for in subdivision (d), stem cell clinic means an unlicensed facility that is operated as a clinic or office by one or more providers licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, where non-FDA-approved stem cell therapies are provided and that satisfies one or more of the following:(1) The facility markets therapies using harvested stem cells from adipose, bone marrow, cord blood, amniotic, or placenta tissue to replace or repair a patients cells or tissues.(2) The facility markets therapies that deliver stem cells through blood or transplanted directly into damaged tissue.
CHAPTER 8.4. Stem Cell Clinics
CHAPTER 8.4. Stem Cell Clinics
1744. (a) A stem cell clinic shall post on site, and shall include in any print and digital advertising materials, including Internet Web sites, the following notice in English:THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This facility is not licensed as a medical facility by the State of California and performs procedures utilizing stem cells that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a procedure utilizing stem cells at this facility.(b) The notice shall be disclosed in the following manner:(1) The onsite notice shall be at least eight and one-half inches by 11 inches and written in no less than 48-point type. The notice shall be posted conspicuously in the entrance of the clinic and in at least one additional area where clients wait to receive services.(2) The notice in any advertising materials shall be clear and conspicuous. For purposes of this subdivision, clear and conspicuous means in larger point type than the surrounding text, or in contrasting type, font, or color to the surrounding text of the same size, or set off from the surrounding text of the same size by symbols or other marks that call attention to the language.(c) This section does not apply to a stem cell clinic that has obtained approval for an investigation new drug or a regenerative medicine advanced therapy application from the United States Food and Drug Administration for the use of a stem cell therapy.(d) For purposes of this section, and except as provided for in subdivision (d), stem cell clinic means an unlicensed facility that is operated as a clinic or office by one or more providers licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, where non-FDA-approved stem cell therapies are provided and that satisfies one or more of the following:(1) The facility markets therapies using harvested stem cells from adipose, bone marrow, cord blood, amniotic, or placenta tissue to replace or repair a patients cells or tissues.(2) The facility markets therapies that deliver stem cells through blood or transplanted directly into damaged tissue.
1744. (a) A stem cell clinic shall post on site, and shall include in any print and digital advertising materials, including Internet Web sites, the following notice in English:
THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This facility is not licensed as a medical facility by the State of California and performs procedures utilizing stem cells that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a procedure utilizing stem cells at this facility.
(b) The notice shall be disclosed in the following manner:
(1) The onsite notice shall be at least eight and one-half inches by 11 inches and written in no less than 48-point type. The notice shall be posted conspicuously in the entrance of the clinic and in at least one additional area where clients wait to receive services.
(2) The notice in any advertising materials shall be clear and conspicuous. For purposes of this subdivision, clear and conspicuous means in larger point type than the surrounding text, or in contrasting type, font, or color to the surrounding text of the same size, or set off from the surrounding text of the same size by symbols or other marks that call attention to the language.
(c) This section does not apply to a stem cell clinic that has obtained approval for an investigation new drug or a regenerative medicine advanced therapy application from the United States Food and Drug Administration for the use of a stem cell therapy.
(d) For purposes of this section, and except as provided for in subdivision (d), stem cell clinic means an unlicensed facility that is operated as a clinic or office by one or more providers licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, where non-FDA-approved stem cell therapies are provided and that satisfies one or more of the following:
(1) The facility markets therapies using harvested stem cells from adipose, bone marrow, cord blood, amniotic, or placenta tissue to replace or repair a patients cells or tissues.
(2) The facility markets therapies that deliver stem cells through blood or transplanted directly into damaged tissue.
(a)The purpose of this chapter is to afford to qualifying individuals health care and related remedial or preventive services, including related social services that are necessary for those receiving health care under this chapter.
(b)The intent of the Legislature is to provide, to the extent practicable, through the provisions of this chapter, for health care for those aged and other individuals, including family members, who lack sufficient annual income to meet the costs of health care and whose other assets are so limited that their application toward the costs of that care would jeopardize the individuals or familys future minimum self-maintenance and security. It is intended that whenever possible and feasible:
(1)The means employed shall allow, to the extent practicable, an eligible individual to secure health care in the same manner employed by the public generally, and without discrimination or segregation, based purely on his or her economic disability. The means employed shall include an emphasis on efforts to arrange and encourage access to health care through enrollment in organized, managed care plans of the type available to the general public.
(2)The benefits available under this chapter shall not duplicate those provided under other federal or state laws or under other contractual or legal entitlements of the individual or individuals receiving them.
(3)In the administration of this chapter and in establishing the means to be used to provide access to health care to individuals eligible under this chapter, the department shall emphasize and take advantage of both the efficient organization and ready accessibility and availability of health care facilities and resources through enrollment in managed health care plans and new and innovative fee-for-service managed health care plan approaches to the delivery of health care services.