Bill Text: CA SB524 | 2023-2024 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Pharmacists: furnishing prescription medications.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Failed) 2024-02-01 - Returned to Secretary of Senate pursuant to Joint Rule 56. [SB524 Detail]

Download: California-2023-SB524-Amended.html

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Amended  IN  Senate  March 20, 2023

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Senate Bill

No. 524

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Introduced by Senator Caballero

February 14, 2023

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An act to amend Section 4052 of the Business and Professions Sections 4052 and 4052.4 of, and to add Section 4052.04 to, the Business and Professions Code, and to amend Section 14132.968 of the Welfare and Institutions Code, relating to healing arts.

LEGISLATIVE COUNSEL'S DIGEST

SB 524, as amended, Caballero. The Pharmacy Law. Pharmacists: testing and treatment.

(1) Existing law, the Pharmacy Law, provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy in the Department of Consumer Affairs. A violation of the Pharmacy Law is a crime. Existing law generally authorizes a pharmacist to dispense or furnish drugs only pursuant to a valid prescription, with prescribed exceptions. Existing law authorizes a pharmacist or a pharmacy to perform skin puncture in the course of performing routine patient assessment procedures, as defined, or in the course of performing prescribed clinical laboratory tests or examinations. Under existing law, the definition of “routine patient assessment procedures” includes clinical laboratory tests that are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) and specified regulations adopted pursuant to the CLIA. Existing law also authorizes a pharmacist to perform any aspect of a test approved or authorized by the United States Food and Drug Administration (FDA) that is classified as waived pursuant to the CLIA, under specified conditions.

This bill, with respect to the conditional performance of tests approved or authorized by the FDA and classified as waived pursuant to the CLIA, would instead authorize a pharmacist to order, perform, and report those tests. The bill would authorize a pharmacist to furnish prescription medications that are furnished pursuant to the result from a test performed by the pharmacist that is used to guide diagnosis or clinical decisionmaking, as specified. The bill would require a pharmacist, in providing these patient care services, to utilize specified evidence-based clinical guidelines or other clinically recognized recommendations. The bill would require the pharmacist to document, to the extent possible, the testing services provided, as well as the prescription medications furnished, to the patient pursuant to the test result, in the patient’s record in the record system maintained by the pharmacy. Because a violation of these requirements would be a crime, the bill would impose a state-mandated local program.

(2) 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 ordering, performing, and reporting any test approved or authorized by the FDA that is classified as waived pursuant to the CLIA, as authorized by existing law, that is used to guide diagnosis or clinical decisionmaking. The bill would also expand the schedule of benefits to include furnishing prescriptions pursuant to the result from a test, as authorized by the bill’s provisions, that is used to guide diagnosis or clinical decisionmaking.

(3) 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.

The Pharmacy Law establishes the California State Board of Pharmacy to administer its provisions and authorizes a pharmacist to, among other things, perform certain procedures or functions in a licensed health care facility, as specified.

This bill would make a nonsubstantive change to that provision.

Digest Key

Vote: MAJORITY   Appropriation: NO   Fiscal Committee: NOYES   Local Program: NOYES  

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Bill Text

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 do all of the following:

(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 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) Prescription medications that are furnished pursuant to the result from a test as authorized by Section 4052.4 that is used to guide diagnosis or clinical decisionmaking.

(iv)

(v) HIV preexposure prophylaxis, as authorized by Section 4052.02.

(v)

(vi) HIV postexposure prophylaxis, as authorized by Section 4052.03.

(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.

(13) Initiate, adjust, or discontinue drug therapy for a patient under a collaborative practice agreement with any health care provider with prescriptive authority. The collaborative practice agreement may be between a single or multiple pharmacists and a single or multiple health care providers with prescriptive authority.

(14) Provide medication-assisted treatment pursuant to a state protocol, to the extent authorized by federal law.

(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 4052.04 is added to the Business and Professions Code, to read:

4052.04.

 (a) Notwithstanding any other law, a pharmacist may furnish prescriptions pursuant to the result from a test, as authorized by Section 4052.4, that is used to guide diagnosis or clinical decisionmaking.

(b) A pharmacist shall utilize the most recent relevant and appropriate evidence-based clinical guidelines published by the federal Centers for Disease Control and Prevention or the Infectious Diseases Society of America, or other clinically recognized recommendations, in providing these patient care services.

(c) The pharmacist shall document, to the extent possible, the testing services provided, as well as the prescription medications furnished, to the patient pursuant to the test result, in the patient’s record in the record system maintained by the pharmacy. The pharmacist shall maintain records of prescription medications furnished to each patient.

SEC. 3.

 Section 4052.4 of the Business and Professions Code is amended to read:

4052.4.

 (a) Notwithstanding Section 2038 or any other provision of law, a pharmacist may perform skin puncture in the course of performing routine patient assessment procedures or in the course of performing any procedure authorized under Section 1206.5 or 1206.6. For purposes of this section, “routine patient assessment procedures” means: (a) procedures that a patient could, with or without a prescription, perform for themselves, or (b) clinical laboratory tests that are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, as authorized by paragraph (11) of subdivision (a) of Section 1206.5 or Section 1206.6. A pharmacist performing these functions shall report the results obtained from a test to the patient and any physician designated by the patient. A pharmacist may furnish prescriptions pursuant to the result from a routine patient assessment procedure, as authorized by this section, used to guide diagnosis or clinical decisionmaking. Any pharmacist who performs the service authorized by this section shall not be in violation of Section 2052.

(b) A pharmacist may perform any aspect of any FDA-approved or -authorized test order, perform, and report any test approved or authorized by the United States Food and Drug Administration that is classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, under all of the following conditions:

(1) The test meets the criteria in subparagraph (A) or (B) and does not require the use of specimens collected by vaginal swab, venipuncture, or the collection of seminal fluid.

(A) The test is used to detect or screen for any of the following illnesses, conditions, or diseases:

(i) SARS-CoV-2 or other respiratory illness, condition or disease.

(ii) Mononucleosis.

(iii) Sexually transmitted infection.

(iv) Strep throat.

(v) Anemia.

(vi) Cardiovasular health.

(vii) Conjunctivitis.

(viii) Urinary tract infection.

(ix) Liver and kidney function or infection.

(x) Thyroid function.

(xi) Substance use disorder.

(xii) Diabetes.

(B) Other tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration and approved by the board by regulation, in conjunction with the Medical Board of California and Laboratory Field Services in the State Department of Public Health.

(2) The pharmacist completes the testing in a pharmacy laboratory that is appropriately licensed in California as a laboratory pursuant to Section 1265, unless otherwise authorized in law.

(3) The pharmacist has completed necessary training as specified in the pharmacy’s policies and procedures maintained pursuant to subdivision (b) of Section 4119.10, and that allows the pharmacist to demonstrate sufficient knowledge of the illness, condition, or disease being tested, as applicable.

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, except for medication therapy management (MTM) pharmacist services as described in Section 14132.969.

(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, as authorized in Section 4052.02 of the Business and Professions Code, limited to no more than a 60-day supply of preexposure prophylaxis to a single patient once every two years.

(G) Initiating and furnishing postexposure prophylaxis, as authorized in Section 4052.03 of the Business and Professions Code.

(H) Providing MTM pharmacist services in conjunction with the dispensing of qualified specialty drugs, as described in Section 14132.969.

(I) Ordering, performing, and reporting any test approved or authorized by the United States Food and Drug Administration that is classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, as authorized by Section 4052.4 of the Business and Professions Code, that is used to guide diagnosis or clinical decisionmaking.

(J) Furnishing prescriptions pursuant to the result from a test, as authorized by Section 4052.4 of the Business and Professions Code, that is used to guide diagnosis or clinical decisionmaking.

(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. 5.

 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.

SECTION 1.Section 4052 of the Business and Professions Code is amended to read:

4052.

(a)Notwithstanding any other law, a pharmacist may do all of the following:

(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 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, as authorized by Section 4052.02.

(v)HIV postexposure prophylaxis, as authorized by Section 4052.03.

(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.

(13)Initiate, adjust, or discontinue drug therapy for a patient under a collaborative practice agreement with any health care provider with prescriptive authority. The collaborative practice agreement may be between a single or multiple pharmacists and a single or multiple health care providers with prescriptive authority.

(14)Provide medication-assisted treatment pursuant to a state protocol, to the extent authorized by federal law.

(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.