Bill Text: CA SB159 | 2019-2020 | Regular Session | Amended
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: HIV: preexposure and postexposure prophylaxis.
Spectrum: Moderate Partisan Bill (Democrat 6-1)
Status: (Passed) 2019-10-07 - Chaptered by Secretary of State. Chapter 532, Statutes of 2019. [SB159 Detail]
Download: California-2019-SB159-Amended.html
prexposure HIV preexposure prophylaxis and postexposure prophylaxis in accordance with this section.
Bill Title: HIV: preexposure and postexposure prophylaxis.
Spectrum: Moderate Partisan Bill (Democrat 6-1)
Status: (Passed) 2019-10-07 - Chaptered by Secretary of State. Chapter 532, Statutes of 2019. [SB159 Detail]
Download: California-2019-SB159-Amended.html
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Amended
IN
Senate
April 01, 2019 |
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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) (Coauthor: Assembly Member Chiu) |
January 23, 2019 |
An act 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, 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 initiate and furnish preexposure prophylaxis and postexposure prophylaxis if a prophylaxis, in specified
amounts, if the pharmacist completes a training program approved by the board, board and complies with specified requirements, such as assessing a patient and providing a patient with counseling and tests, and provides these if those services can be provided in a private and sanitary location. 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. Because a willful violation of these provisions 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.
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YESBill Text
The people of the State of California do enact as follows:
SECTION 1.
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(b) Before furnishing preexposure prophylaxis or postexposure prophylaxis to a patient, a pharmacist shall complete a training program approved by the board that addresses on
the use of preexposure prophylaxis and postexposure prophylaxis. The board shall consult with the California Pharmacists Association and the Office of AIDS, within the State Department of Public Health, on training programs that are appropriate to meet the requirements of this subdivision.
(c) A pharmacist may furnish an initial course of preexposure prophylaxis as determined by the federal Centers for Disease Control and Prevention guidelines if the
pharmacist completes all of the following:
(1) Screens the patient for human immunodeficiency virus (HIV) and Provides HIV testing and confirms a negative test result or determines that the patient has recently received a negative HIV test within the last seven days. result consistent with the most recent guidelines from the federal Centers for
Disease Control and Prevention. If the patient tests positive for HIV infection, the pharmacist or person administering the test shall inform the patient that there are numerous treatment options available and identify followup testing and care that may be recommended, including contact information for medical and psychological services.
(2) Provides counseling to the patient, including a side effect assessment, patient on the ongoing use of preexposure prophylaxis consistent with the most recent guidelines from the federal Centers for Disease Control and Prevention, which may include education about side effects of the medication
effects, safety during pregnancy and breastfeeding, adherence to recommended dosing, and the importance of adhering to the drug regimen, timely testing and treatment, as applicable, for HIV and sexually transmitted diseases, behavioral risk reduction support, and pregnancy testing. HIV, renal function, hepatitis B, hepatitis C, sexually transmitted diseases, and pregnancy for individuals of child-bearing capacity.
(3)Advises the patient on current guidelines and recommendations by the federal Centers for Disease Control and Prevention regarding ongoing use of the medication.
(4)
(3) Documents the services provided by the pharmacist in the patient’s health record.
(5)
(4) 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 a
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 for health care services. regarding ongoing care for preexposure prophylaxis.
(d) A pharmacist may refill a prescription pursuant to this section if, prior to refilling the prescription, the pharmacist completes all of the following:
(1) Ensures the patient is clinically eligible for use of preexposure prophylaxis consistent with the most recent guidelines from the federal Centers for Disease Control and Prevention, which may include providing or determining the patient has received 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.
(2) Documents the services provided by the pharmacist in the patient’s health record.
(3) 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.
(d)
(e) A pharmacist may furnish a complete course or 30-day supply of postexposure prophylaxis if the pharmacist completes all of the following:
(1) Screens the patient for HIV
and determines the exposure meets the clinical criteria for use consideration of postexposure prophylaxis consistent with the most recent guidelines from the federal Centers for Disease Control and Prevention.
(2) Provides HIV testing or determines the patient is willing to receive an HIV test undergo HIV testing consistent with the most recent guidelines from the federal Centers for Disease Control and Prevention.
(3) Provides counseling to the patient on the use of the medication postexposure prophylaxis consistent with the most recent guidelines from the federal Centers for Disease Control and Prevention, including which may include education about side effects of the medication, effects, safety
during pregnancy and breastfeeding, adherence to recommended dosing, and the importance of adhering to the
drug regimen and testing timely testing and treatment, as applicable, for HIV and sexually transmitted diseases.
(4) 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 a 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 for health care services.
regarding followup care for postexposure prophylaxis.
(e)
(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 and the Medical Board of California.
(f)A pharmacist who provides
(g) Notwithstanding any other law, a pharmacist is not required to provide the counseling, assessments, or tests, as
prescribed in this section, shall ensure that these services are provided in a private and sanitary location, without interruption by others, and the pharmacist shall not be interrupted tests specified in subdivision (c), (d), or (e) if the pharmacist cannot conduct the counseling, assessments, or tests at a location that is sufficiently private to permit the pharmacist to comply with the federal Health Insurance Portability and Accountability Act and applicable state law governing the privacy of medical information, meets the sanitation standards under applicable law governing pharmacy practice, and allows the pharmacist to provide the services without being interrupted by others or called away
to perform other duties.
(g)
(h) The board and the Medical Board of California are each authorized to ensure compliance with this section. Each board is specifically charged with enforcing this section with respect to its respective licensees.
(h)
(i) The board may adopt emergency regulations to establish necessary procedures or protocols. These emergency regulations shall be developed
in accordance with the most current guidelines from the federal Centers for Disease Control and Prevention. 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. The emergency regulations authorized by this subdivision are exempt from review by the Office of Administrative Law. The emergency regulations authorized by this subdivision shall be submitted to the Office of Administrative Law for filing with the Secretary of State and shall remain in effect until the earlier of 180 days following their effective date or the effective date of regulations adopted pursuant to Section 4005.
(i)
(j) This section does not limit a pharmacist’s scope of practice described in Section 4052.2.
SEC. 2.
Section 1342.74 is added to the Health and Safety Code, immediately following Section 1342.73, to read:1342.74.
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.SEC. 3.
Section 10123.1933 is added to the Insurance Code, immediately following Section 10123.1932, to read:10123.1933.
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.SEC. 4.
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.
