Bill Text

Bill Information

PDF |Add To My Favorites |Track Bill | print page

SB-159 HIV: preexposure and postexposure prophylaxis.(2019-2020)

SHARE THIS:share this bill in Facebookshare this bill in Twitter
Date Published: 05/17/2019 01:12 PM
SB159:v94#DOCUMENT

Amended  IN  Senate  May 17, 2019
Amended  IN  Senate  April 30, 2019
Amended  IN  Senate  April 11, 2019
Amended  IN  Senate  April 01, 2019
Amended  IN  Senate  February 27, 2019

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Senate Bill No. 159


Introduced by Senator Wiener
(Principal coauthors: Assembly Members Gipson and Gloria)
(Coauthors: Senators Glazer and Stone)
(Coauthor: Assembly Member Chiu)

January 23, 2019


An act to amend Section 4052 of, and to add Section 4052.02 to, the Business and Professions Code, to add Section 1342.74 to the Health and Safety Code, to add Section 10123.1933 to the Insurance Code, and to amend Section 14132.968 of the Welfare and Institutions Code, relating to HIV prevention.


LEGISLATIVE COUNSEL'S DIGEST


SB 159, as amended, Wiener. HIV: preexposure and postexposure prophylaxis.
Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy, Pharmacy and makes a violation of these requirements a crime. Existing law generally authorizes a pharmacist to dispense or furnish drugs only pursuant to a valid prescription, except as provided, such as furnishing emergency contraceptives, hormonal contraceptives, and naloxone hydrochloride, pursuant to standardized procedures.
This bill would authorize a pharmacist to furnish preexposure prophylaxis and postexposure prophylaxis, in specified amounts, if the pharmacist completes a training program approved by the board and complies with specified requirements, such as assessing a patient and providing a patient with counseling and tests. Because a violation of these requirements would be a crime, this bill would impose a state-mandated local program.
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services pursuant to a schedule of benefits, including pharmacist services, which are subject to approval by the federal Centers for Medicare and Medicaid Services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions.
This bill would expand the Medi-Cal schedule of benefits to include preexposure prophylaxis and postexposure prophylaxis as pharmacist services.
Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of the act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. Existing law authorizes health care service plans and health insurers that cover prescription drugs to utilize reasonable medical management practices, including prior authorization and step therapy, consistent with applicable law. For combination antiretroviral drug treatments medically necessary for the prevention of AIDS/HIV, existing law prohibits plans and insurers, until January 1, 2023, from having utilization management policies or procedures that rely on a multitablet drug regimen instead of a single-tablet drug regimen, except as specified.
This bill would additionally prohibit plans and insurers from subjecting those drug treatments, including preexposure prophylaxis or postexposure prophylaxis, to prior authorization or step therapy. The bill would also prohibit plans and insurers from prohibiting, or allowing a pharmacy benefit manager to prohibit, a pharmacy provider from providing preexposure prophylaxis or postexposure prophylaxis. Because a willful violation of these provisions by a health care service plan would be a crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

The people of the State of California do enact as follows:


SECTION 1.

 Section 4052 of the Business and Professions Code is amended to read:

4052.
 (a) Notwithstanding any other law, a pharmacist may:
(1) Furnish a reasonable quantity of compounded drug product to a prescriber for office use by the prescriber.
(2) Transmit a valid prescription to another pharmacist.
(3) Administer drugs and biological products that have been ordered by a prescriber.
(4) Perform procedures or functions in a licensed health care facility as authorized by Section 4052.1.
(5) Perform procedures or functions as part of the care provided by a health care facility, a licensed home health agency, a licensed clinic in which there is a physician oversight, a provider who contracts with a licensed health care service plan with regard to the care or services provided to the enrollees of that health care service plan, or a physician, as authorized by Section 4052.2.
(6) Perform procedures or functions as authorized by Section 4052.6.
(7) Manufacture, measure, fit to the patient, or sell and repair dangerous devices, or furnish instructions to the patient or the patient’s representative concerning the use of those devices.
(8) Provide consultation, training, and education to patients about drug therapy, disease management, and disease prevention.
(9) Provide professional information, including clinical or pharmacological information, advice, or consultation to other health care professionals, and participate in multidisciplinary review of patient progress, including appropriate access to medical records.
(10) Furnish the medications described in subparagraph (A) in accordance with subparagraph (B):
(A) (i) Emergency contraception drug therapy and self-administered hormonal contraceptives, as authorized by Section 4052.3.
(ii) Nicotine replacement products, as authorized by Section 4052.9.
(iii) Prescription medications not requiring a diagnosis that are recommended by the federal Centers for Disease Control and Prevention for individuals traveling outside of the United States.
(iv) HIV preexposure prophylaxis and postexposure prophylaxis, as authorized by Section 4052.02.
(B) The pharmacist shall notify the patient’s primary care provider of any drugs or devices furnished to the patient, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs or devices furnished and advise the patient to consult a physician of the patient’s choice.
(11) Administer immunizations pursuant to a protocol with a prescriber.
(12) Order and interpret tests for the purpose of monitoring and managing the efficacy and toxicity of drug therapies. A pharmacist who orders and interprets tests pursuant to this paragraph shall ensure that the ordering of those tests is done in coordination with the patient’s primary care provider or diagnosing prescriber, as appropriate, including promptly transmitting written notification to the patient’s diagnosing prescriber or entering the appropriate information in a patient record system shared with the prescriber, when available and as permitted by that prescriber.
(b) A pharmacist who is authorized to issue an order to initiate or adjust a controlled substance therapy pursuant to this section shall personally register with the federal Drug Enforcement Administration.
(c) This section does not affect the applicable requirements of law relating to either of the following:
(1) Maintaining the confidentiality of medical records.
(2) The licensing of a health care facility.

SEC. 2.

 Section 4052.02 is added to the Business and Professions Code, to read:

4052.02.
 (a) Notwithstanding any other law, a pharmacist may initiate and furnish HIV preexposure prophylaxis and postexposure prophylaxis in accordance with this section.
(b) For purposes of this section, the following definitions apply:
(1) “Preexposure prophylaxis” means a fixed-dose combination of tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg), or another drug or drug combination that meets the same clinical eligibility recommendations provided in CDC guidelines.
(2) “Postexposure prophylaxis” means either of the following:
(A) Tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg), taken once daily, in combination with either raltegravir (400 mg), taken twice daily, or dolutegravir (50 mg), taken once daily.
(B) Tenofovir disoproxil fumarate (TDF) (300 mg) and emtricitabine (FTC) (200 mg), taken once daily, in combination with darunavir (800 mg) and ritonavir (100 mg), taken once daily.
(3) “CDC guidelines” means either of the following publications by the federal Centers for Disease Control and Prevention:
(A) “2017 Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update: A Clinical Practice Guideline.”
(B) “Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV – United States, 2016.”
(c) Before furnishing preexposure prophylaxis or postexposure prophylaxis to a patient, a pharmacist shall complete a training program approved by the board on the use of preexposure prophylaxis and postexposure prophylaxis. The board shall consult with the California Pharmacists Association and relevant stakeholders, including, but not limited to, the Office of AIDS, within the State Department of Public Health, on training programs that are appropriate to meet the requirements of this subdivision.
(d) A pharmacist may furnish a 30-day supply of preexposure prophylaxis if all of the following conditions are met:
(1) The patient is HIV negative, as documented by a negative HIV test result obtained within the previous seven days from an HIV antigen/antibody test or antibody-only test, test or from a rapid, point-of-care fingerstick blood test approved by the federal Food and Drug Administration. If the patient does not provide evidence of a negative HIV test in accordance with this paragraph, the pharmacist shall order an HIV test. If the test results are not transmitted directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist’s satisfaction. If the patient tests positive for HIV infection, the pharmacist or person administering the test shall direct the patient to a primary care provider and provide a list of providers and clinics in the region.
(2) The patient does not report any signs or symptoms of acute HIV infection on a self-reported checklist of acute HIV infection signs and symptoms.
(3) The patient does not report taking any contraindicated medications.
(4) The pharmacist provides counseling to the patient on the ongoing use of preexposure prophylaxis, which may include education about side effects, safety during pregnancy and breastfeeding, adherence to recommended dosing, and the importance of timely testing and treatment, as applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted diseases, and pregnancy for individuals of child-bearing capacity. The pharmacist shall notify the patient that the patient must be seen by a primary care provider to receive subsequent prescriptions for preexposure prophylaxis and that a pharmacist may not furnish a 30-day supply of preexposure prophylaxis to a single patient more than once every two years.
(5) The patient reports having normal kidney function, and the pharmacist orders a test to measure kidney function. The patient shall provide contact information for the patient and sign an agreement to stop taking preexposure prophylaxis if laboratory results indicate that the patient should not take preexposure prophylaxis. The pharmacist shall contact the patient if laboratory results indicate that the patient should not take preexposure prophylaxis.
(6) The pharmacist documents, to the extent possible, the services provided by the pharmacist in the patient’s health record. The pharmacist shall maintain records of preexposure prophylaxis furnished to each patient.
(7) The pharmacist does not furnish a 30-day supply of preexposure prophylaxis to a single patient more than once every two years, unless directed otherwise by a prescriber.
(8) The pharmacist notifies the patient’s primary care provider that the pharmacist completed the requirements specified in this subdivision. If the patient does not have a primary care provider, or refuses consent to notify the patient’s primary care provider, the pharmacist shall provide the patient a list of physicians and surgeons, clinics, or other health care service providers to contact regarding ongoing care for preexposure prophylaxis.
(e) A pharmacist may furnish a complete course of postexposure prophylaxis if all of the following conditions are met:
(1) The pharmacist screens the patient and determines the exposure occurred within the previous 72 hours and the patient otherwise meets the clinical criteria for postexposure prophylaxis consistent with CDC guidelines.
(2) The pharmacist provides HIV testing or determines the patient is willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo HIV testing but is otherwise eligible for postexposure prophylaxis under this section, the pharmacist may furnish postexposure prophylaxis.
(3) The pharmacist provides counseling to the patient on the use of postexposure prophylaxis consistent with CDC guidelines, which may include education about side effects, safety during pregnancy and breastfeeding, adherence to recommended dosing, and the importance of timely testing and treatment, as applicable, for HIV and sexually transmitted diseases.
(4) The pharmacist notifies the patient’s primary care provider of the postexposure prophylaxis treatment. If the patient does not have a primary care provider, or refuses consent to notify the patient’s primary care provider, the pharmacist shall provide the patient a list of physicians and surgeons, clinics, or other health care service providers to contact regarding followup care for postexposure prophylaxis.
(5) The pharmacist does not furnish postexposure prophylaxis to a single individual more than two times in a calendar year.
(f) A pharmacist initiating or furnishing preexposure prophylaxis or postexposure prophylaxis shall not permit the person to whom the drug is furnished to waive the consultation required by the board.
(g) The board, by July 1, 2020, shall adopt emergency regulations to implement this section in accordance with CDC guidelines. The adoption of regulations pursuant to this subdivision shall be deemed to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare.

SEC. 3.

 Section 1342.74 is added to the Health and Safety Code, immediately following Section 1342.73, to read:

1342.74.
 (a) Notwithstanding Section 1342.71, a health care service plan shall not subject combination antiretroviral drug treatments that are medically necessary for the prevention of AIDS/HIV, including preexposure prophylaxis or postexposure prophylaxis, to prior authorization or step therapy.
(b) Notwithstanding any other law, a health care service plan shall not prohibit, or permit a delegated pharmacy benefit manager to prohibit, a pharmacy provider from dispensing preexposure prophylaxis or postexposure prophylaxis.
(c) This section does not require a health care service plan to cover preexposure prophylaxis or postexposure prophylaxis by a pharmacist at an out-of-network pharmacy, unless the health care service plan has an out-of-network pharmacy benefit.

SEC. 4.

 Section 10123.1933 is added to the Insurance Code, immediately following Section 10123.1932, to read:

10123.1933.
 (a) Notwithstanding Section 10123.201, a health insurer shall not subject combination antiretroviral drug treatments that are medically necessary for the prevention of AIDS/HIV, including preexposure prophylaxis or postexposure prophylaxis, to prior authorization or step therapy.
(b) Notwithstanding any other law, a health insurer shall not prohibit, or permit a contracted pharmacy benefit manager to prohibit, a pharmacist from dispensing preexposure prophylaxis or postexposure prophylaxis.

SEC. 5.

 Section 14132.968 of the Welfare and Institutions Code is amended to read:

14132.968.
 (a) (1) Pharmacist services are a benefit under the Medi-Cal program, subject to approval by the federal Centers for Medicare and Medicaid Services.
(2) The department shall establish a fee schedule for the list of pharmacist services.
(3) The rate of reimbursement for pharmacist services shall be at 85 percent of the fee schedule for physician services under the Medi-Cal program.
(b) (1) The following services are covered pharmacist services that may be provided to a Medi-Cal beneficiary:
(A) Furnishing travel medications, as authorized in clause (3) of subparagraph (A) of paragraph (10) of subdivision (a) of Section 4052 of the Business and Professions Code.
(B) Furnishing naloxone hydrochloride, as authorized in Section 4052.01 of the Business and Professions Code.
(C) Furnishing self-administered hormonal contraception, as authorized in subdivision (a) of Section 4052.3 of the Business and Professions Code.
(D) Initiating and administering immunizations, as authorized in Section 4052.8 of the Business and Professions Code.
(E) Providing tobacco cessation counseling and furnishing nicotine replacement therapy, as authorized in Section 4052.9 of the Business and Professions Code.
(F) Initiating and furnishing preexposure prophylaxis and postexposure prophylaxis, as authorized in Section 4052.02 of the Business and Professions Code.
(2) Covered pharmacist services shall be subject to department protocols and utilization controls.
(c) A pharmacist shall be enrolled as an ordering, referring, and prescribing provider under the Medi-Cal program prior to rendering a pharmacist service that is submitted by a Medi-Cal pharmacy provider for reimbursement pursuant to this section.
(d) (1) The director shall seek any necessary federal approvals to implement this section. This section shall not be implemented until the necessary federal approvals are obtained and shall be implemented only to the extent that federal financial participation is available.
(2) This section neither restricts nor prohibits any services currently provided by pharmacists as authorized by law, including, but not limited to, this chapter, or the Medicaid state plan.
(e) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement, interpret, or make specific this section, and any applicable federal waivers and state plan amendments, by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions, without taking regulatory action. By July 1, 2021, the department shall adopt regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. Commencing July 1, 2017, the department shall provide a status report to the Legislature on a semiannual basis, in compliance with Section 9795 of the Government Code, until regulations have been adopted.

SEC. 6.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.