Existing law authorizes a person to perform an analysis of samples to test for SARS-CoV-2 in a clinical laboratory or a city, county, or city and county public health laboratory if they meet the requirements under specified federal regulations for high complexity testing.

This bill would repeal these provisions as of July 1, 2028.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy to license and regulate pharmacists. A violation of these requirements is a crime. Existing law authorizes a pharmacist, among other things, to administer drugs and biological products that have been ordered by a prescriber.

This bill, until January 1, 2025, would authorize a pharmacist to furnish COVID-19 oral therapeutics, as defined, following a positive test for SARS-CoV-2, the virus that causes COVID-19, as specified. Among other things, the bill would require a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to these provisions, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years. Because a violation of these requirements would be a crime, the bill would impose a state-mandated local program.

Existing law, the California Uniform Controlled Substances Act, regulates the distribution and use of controlled substances, as defined. Existing law authorizes specified individuals, when acting under the direction of a physician and surgeon, to administer a narcotic controlled substance orally in the treatment of a person with substance use disorder for addiction to a controlled substance.

This bill would instead authorize the above-described individuals to administer a narcotic controlled substance in the treatment of a person with substance use disorder for addiction to a controlled substance.

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.

This bill would declare that it is to take effect immediately as an urgency statute.

Existing law authorizes a person to perform an analysis of samples to test for SARS-CoV-2 in a clinical laboratory or a city, county, or city and county public health laboratory if they meet the requirements under specified federal regulations for high complexity testing.

This bill would repeal these provisions as of July 1, 2028.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy to license and regulate pharmacists. A violation of these requirements is a crime. Existing law authorizes a pharmacist, among other things, to administer drugs and biological products that have been ordered by a prescriber.

This bill, until January 1, 2025, would authorize a pharmacist to furnish COVID-19 oral therapeutics, as defined, following a positive test for SARS-CoV-2, the virus that causes COVID-19, as specified. Among other things, the bill would require a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to these provisions, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years. Because a violation of these requirements would be a crime, the bill would impose a state-mandated local program.

Existing law, the California Uniform Controlled Substances Act, regulates the distribution and use of controlled substances, as defined. Existing law authorizes specified individuals, when acting under the direction of a physician and surgeon, to administer a narcotic controlled substance orally in the treatment of a person with substance use disorder for addiction to a controlled substance.

This bill would instead authorize the above-described individuals to administer a narcotic controlled substance in the treatment of a person with substance use disorder for addiction to a controlled substance.

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.

This bill would declare that it is to take effect immediately as an urgency statute.

Existing law authorizes a person to perform an analysis of samples to test for SARS-CoV-2 in a clinical laboratory or a city, county, or city and county public health laboratory if they meet the requirements under specified federal regulations for high complexity testing.

This bill would repeal these provisions as of July 1, 2028.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy to license and regulate pharmacists. A violation of these requirements is a crime. Existing law authorizes a pharmacist, among other things, to administer drugs and biological products that have been ordered by a prescriber.

This bill, until January 1, 2025, would authorize a pharmacist to furnish COVID-19 oral therapeutics, as defined, following a positive test for SARS-CoV-2, the virus that causes COVID-19, as specified. Among other things, the bill would require a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to these provisions, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years. Because a violation of these requirements would be a crime, the 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.

This bill would declare that it is to take effect immediately as an urgency statute.

Existing law authorizes a person to perform an analysis of samples to test for SARS-CoV-2 in a clinical laboratory or a city, county, or city and county public health laboratory if they meet the requirements under specified federal regulations for high complexity testing.

This bill would repeal these provisions as of July 1, 2028.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy to license and regulate pharmacists. A violation of these requirements is a crime. Existing law authorizes a pharmacist, among other things, to administer drugs and biological products that have been ordered by a prescriber.

This bill, until January 1, 2025, would authorize a pharmacist to furnish COVID-19 oral therapeutics, as defined, following a positive test for SARS-CoV-2, the virus that causes COVID-19, as specified. Among other things, the bill would require a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to these provisions, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years. Because a violation of these requirements would be a crime, the 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.

The Pharmacy Law establishes the California State Board of Pharmacy (board) to license and regulate pharmacists. Existing law authorizes a pharmacist to furnish an opioid antagonist approved by the federal Food and Drug Administration (FDA), in accordance with standardized procedures or protocols developed and approved by the board and the Medical Board of California, in consultation with other entities, as specified. Existing law authorizes the board to adopt emergency regulations, exempt from review by the Office of Administrative Law, to establish the standardized procedures or protocols. Existing law makes the emergency regulations effective until the earlier of either 180 days following their effective date, or the effective date of regulations adopted by both the board and the Medical Board of California, in consultation with other entities, as specified.

This bill would recast the provision regarding the authority of the board to adopt emergency regulations to specify that the board may adopt emergency regulations to establish the standardized procedures or protocols, and adopt emergency regulations that amend existing regulations, to address any opioid antagonist that receives approval by the FDA.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 1341

Author:(Berman)

As Amended Ver:August 23, 2023

2/3 vote. Urgency

SUMMARY

Authorizes pharmacists to continue furnishing COVID-19 oral therapeutics to patients who test positive for SARS-CoV-2, without a prior prescription, until January 1, 2025.

Senate Amendments

1. Replace the requirement that pharmacists utilize guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations with a requirement that pharmacists utilize guidelines published by the federal Food and Drug Administration.
2. Strike the word "orally" from a pharmacist's existing authority to administer treatments for substance use disorder under the direction of a physician and surgeon.

COMMENTS

COVID-19 Pandemic. On March 4, 2020, Governor Gavin Newsom proclaimed a State of Emergency as a result of the impacts of the COVID-19 public health crisis. On March 12, 2020, the Governor issued an executive order that directed residents to follow public health directives and guidance, including to cancel large non-essential gatherings that do not meet certain state criteria. On March 19, 2020, the Governor formally issued a statewide "stay at home order," directing Californians to only leave the house to provide or obtain specified essential services. Subsequent guidance from the State Public Health Officer expressly exempted from that order various professionals regulated by the Department of Consumer Affairs (DCA).

On March 30, 2020, Governor Newsom announced an initiative to "expand California's health care workforce and recruit health care professionals to address the COVID-19 surge" and signed Executive Order N-39-20. This executive order established a waiver request process under the DCA and included other provisions authorizing the waiver of licensing, certification, and credentialing requirements for health care providers. This waiver process constituted a delegation of the Governor's existing authority under the California Emergency Services Act to make, amend, and rescind orders and regulations necessary to respond to a declared emergency.

Approximately 74 further executive orders were issued to waive or revise various laws to advance the state's pandemic response. Over the course of the pandemic, approximately 596 EO provisions were effectuated, with 27 still in effect as of October 2022. Dozens of additional waivers have been issued for licensing programs under the DCA. The majority of these waivers have since expired, and a number were permanently codified through the enactment of legislation.

COVID-19 Therapeutics. The FDA has authorized two oral antiviral pills for the treatment of mild-to-moderate COVID-19. Paxlovid, developed by Pfizer, is a combination formulation of two protease inhibitor medications: nirmatrelvir and ritonavirhas. Molnupiravir, developed by Merck & Co., is sold under the brand name Lagevrio. Both therapeutics have been shown to prevent hospitalization or death in high-risk patients with mild to moderate COVID-19.

As antiviral therapeutics for COVID-19 became available at the beginning of 2022, the CDPH and other public health entities have pushed to make those treatments accessible, particularly to high-risk patients. Therapeutics have been made free to all Californians, including the uninsured. COVID-19 therapeutics are most effective when taken within days of a patient developing symptoms, so beginning treatment immediately upon receipt of a positive test is the most efficacious way of prevent a patient's condition from becoming more severe.

Despite the effectiveness and wide availability of COVID-19 therapeutics, it was reported in 2022 that the antiviral medications were being underutilized, particularly within low-income communities and communities of color. The CDPH issued a health advisory for California healthcare providers urging a low threshold to prescribe COVID-19 therapeutics. The Governor repeatedly stated that his objective was to "remedy ongoing inequities in therapeutics access."

In May 2022, the CDPH announced that it was upgrading 146 existing testing sites to "Test to Treat" locations where individuals could be seen by a provider and receive a prescription for oral antiviral therapeutics immediately upon testing positive for COVID-19. This initiative was launched as a partnership with OptumServe, a company with existing contracts with the state to provide vaccination and testing site services. The state's program aligned with the Biden Administration's national Test to Treat initiative in the National COVID-19 Preparedness Plan.

On September 14, 2021, the Secretary of the federal Department of Health and Human Services, Xavier Becerra, issued a declaration authorizing pharmacists to independently order and administer any COVID-19 therapeutic in compliance with FDA authorization. On July 6, 2022, the FDA announced that it had revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients. This authority was effectuated in California through a waiver issued by the Director of DCA, which waived any provisions of law prohibiting a pharmacist from independently initiating and furnishing Paxlovid consistent with the EUA.

The EUAs for both Paxlovid and Lagevrio are expected to remain in effect until the FDA completes its full approval of these therapeutics. This full approval is expected to occur sometime this summer, at which point it is believed that pharmacists will only remain authorized to furnish the drugs directly to patients until the federal stockpile established during the EUA has expired. This bill will preserve the ability of pharmacists in California to continue furnishing these drugs directly to patients after the federal authorization has ended, until January 1, 2025.

Clinical Laboratory Testing Requirements. Federal and state laws regulate clinical laboratory testing on human specimens for diagnostic or assessment purposes. The purpose of clinical laboratory regulation is to ensure patients who undergo diagnostic testing receive accurate and timely results. Inaccurate or delayed results may prevent a patient from receiving the proper level or type of care.

To that end, all clinical laboratories and tests must comply with requirements under CLIA. CLIA establishes the minimum standards under federal law but allows states to establish more stringent requirements. Under CLIA, laboratory tests are classified based on the complexity of the laboratory tests performed. In general, the more complicated the test, the stricter the requirements relating to the test, including the requirements for training and licensing of the laboratory personnel performing the test.

There are two types of tests used to detect SARS-CoV-2, the virus that causes COVID-19. The first type is diagnostic tests, which will reveal if an individual has an active coronavirus infection; diagnostic tests include both antigen tests (which detect the presence of certain viral proteins) and molecular tests (which detect viral genetic material). The second type of COVID-19 test is antibody tests, which use a blood sample to detect antibodies that could reveal either an active or a previous infection. Tests for SARS-CoV-2 have been deemed CLIA-waived for the duration of the federal emergency declaration through the FDA's EUA.

On March 12, 2020, Governor Newsom issued Executive Order N-25-20, which substantially broadened the available workforce for individuals to perform analysis of COVID-19 tests. Because California requirements are considered more restrictive than the federal regulations, laboratories utilizing the waiver were able to utilize professionals who meet federal standards but who would not currently qualify under Section 1206.5. This increased capacity was essential to California's robust response to the COVID-19 pandemic through the proliferation of testing options.

When Governor Newsom announced that California's State of Emergency would be terminated on February 28, 2023, he requested statutory changes to ensure "the continued ability of laboratory workers to solely process COVID-19 tests." Subsequently, Assembly Bill 269 (Berman) was enacted to continue the waiver of state requirements for individuals analyzing COVID-19 tests who meet the federal requirements for high complexity testing. During the expedited legislative process for that bill, the author made commitments to stakeholders that he would add sunset dates to these provisions in another vehicle introduced following enactment of the urgency legislation. This will would fulfill that promise by adding a July 1, 2028 sunset date to the relevant provisions of Assembly Bill 269.

According to the Author

"Throughout the pandemic, California has relied on pharmacy professionals to expand access to testing, immunization, and treatment for COVID-19. While much of the state and national pandemic response is currently winding down, it remains essential that patients be able to start receiving effective therapeutics like Paxlovid immediately upon testing positive for the virus. AB 1341 will extend the preexisting authority of licensed pharmacists to furnish COVID-19 oral therapeutics without a prescription until January 1, 2025."

Arguments in Support

The California Community Pharmacy Coalition (CCPC) supports this bill, writing: "For many Californians, especially those living in rural communities, access to health care is limited. A 2018 study found that on average, driving to a hospital in a rural community takes 17 minutes – a distance that is often too far for those in need of care. However, approximately 90% of Californians live within five miles of a pharmacy. Because of this proximity, pharmacies have become many patients' primary connection to health care. This was highlighted during the COVID-19 Pandemic and continues to be a reality for millions of Californians." The CCPC states that "because it will increase healthcare access for Californians and ensure effective testing and treatment for COVID-19, the California Community Pharmacy Coalition is in strong support of AB 1341."

Arguments in Opposition

None on file.

FISCAL COMMENTS

According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.

VOTES:

ASM BUSINESS AND PROFESSIONS: 18-0-1

YES: Berman, Flora, Alanis, Alvarez, Bains, Bonta, Chen, Dixon, Gipson, Grayson, Irwin, Jackson, Lee, Lowenthal, McKinnor, Stephanie Nguyen, Joe Patterson, Ting

ABS, ABST OR NV: McCarty

ASM APPROPRIATIONS: 14-0-2

YES: Holden, Megan Dahle, Calderon, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Robert Rivas, Sanchez, Weber, Wilson

ABS, ABST OR NV: Bryan, Pellerin

ASSEMBLY FLOOR: 79-0-1

YES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones- Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

ABS, ABST OR NV: Jim Patterson

SENATE FLOOR: 39-0-1

YES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ABS, ABST OR NV: Padilla

UPDATED

VERSION: August 23, 2023

CONSULTANT: Robert Sumner / B. & P. / (916) 319-3301 FN: 0001790

 THIRD READING  

Bill No: AB 1341

Author: Berman (D)

Amended: 8/23/23 in Senate

Vote: 27 - Urgency

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 13-0, 6/5/23

AYES: Roth, Nguyen, Alvarado-Gil, Archuleta, Ashby, Becker, Dodd, Eggman, Glazer, Niello, Smallwood-Cuevas, Wahab, Wilk

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 79-0, 4/27/23 (Consent) - See last page for vote

SUBJECT: Public health: COVID-19: testing and dispensing sites: oral therapeutics

SOURCE: Author

DIGEST:

This bill adds a sunset date of July 1, 2028 to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments (CLIA) for high complexity testing, as specified. Authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, as specified, until January 1, 2025. This bill also requires a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years.

Senate Floor Amendments of 8/23/23 make technical and clarifying changes.

ANALYSIS:

Existing federal law:

1. Establishes CLIA under federal law, which regulates clinical laboratories that perform tests on human specimens and sets standards for facility administration, personnel qualifications and quality control. These standards apply to all settings, including commercial, hospital or physician office laboratories. (Code of Federal Regulations (CFR) Title 42 § 493)
2. Defines CLIA waived tests as simple laboratory examinations and procedures that are approved by the Food and Drug Administration (FDA) for home use, employ methodologies that are simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly. (CFR Title 42 § 493)

Existing state law:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the California Department of Public Health (CDPH), with specified exceptions. (Business and Professions Code (BPC) § 1200-1327)
2. Makes various definitions for the purposes of state regulation of clinical laboratories.
3. States that no person shall perform clinical laboratory tests or examinations classified as of high complexity under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, where the test is performed by a specified individual. (BPC § 1206.5(c) and Health and Safety Code (HSC) § 101150)
4. Requires any city or county public health laboratory, as specified, be approved by CDPH and comply with the requirements of CLIA, as specified. (HSC § 101160)
5. Prohibits a prescriber from dispensing drugs or dangerous devices to patients in the prescriber’s office or place of practice unless specified conditions are met, where relevant business and professions boards share enforcement authority with the Board of Pharmacy (BOP), as specified, where other requirements and exceptions are qualified, as specified. (BPC § 4170 et seq.)
6. Permits a pharmacist or a clinic licensed and acting under specified authority to, in good faith, furnish a dangerous drug or dangerous device in reasonable quantities without a prescription during a federal, state, or local emergency, to further the health and safety of the public. (BPC § 4062 (a))

This bill adds a sunset date of July 1, 2028 to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the CLIA for high complexity testing, as specified. Authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, as specified, until January 1, 2025. This bill also requires a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years.

Background

1. Federal and State Regulation for Clinical Laboratory Testing. A facility that performs laboratory tests on human specimens for diagnosis or assessment must be certified under CLIA. CLIA certification requirements vary depending on the complexity of the laboratory tests performed.

Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director. The FDA determines the complexity of CLIA laboratory tests. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process. While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements.

1. Additional Authority In Response To the COVID-19 Pandemic. In the wake of the COVID-19 pandemic, federal and state governments expedited certain processes and waived certain requirements to protect the health and safety of the public. At the federal level, this meant providing emergency use authorizations for COVID-19 tests and vaccines.

In 2020, California undertook similar efforts to combat the COVID-19 pandemic. In March 2020, the Governor issued Executive Order N-25-20 (EO) to suspend statutes and regulations in support of the state’s pandemic response efforts. One part of the EO states:

“The certification and licensure requirements of California Code of Regulations, Title 17, section 1079 and Business and Professions Code section 1206.5 are suspended as to all persons who meet the requirements under the Clinical Laboratory Improvement Amendments of section 353 of the Public Health Service Act for high complexity testing and who are performing analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory.”

Therefore, anyone who meets the CLIA requirements for high complexity testing can perform analyses of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory. Professionals who are able to perform these tests due to the waiver include a physician, podiatrist, dentist, naturopathic doctor, person licensed to engage in clinical laboratory practice or to direct a clinical lab, physician assistant, perfusionist, respiratory care practitioner, medical assistant, pharmacist, naturopathic assistant, licensed optometrist, other health care personnel providing direct patient care, any other person performing non-diagnostic testing, as specified. This expansion of professionals allowed for the increased staff required to support California through the COVID-19 pandemic.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Assembly Committee on Appropriations, the fiscal impact of this bill is minor and absorbable costs to the Board of Pharmacy.

SUPPORT: (Verified 8/23/23)

Board of Pharmacy

California Chronic Care Coalition
California Community Pharmacy Coalition

California Pharmacists Association
County Health Executives Association of California

Miora

OPPOSITION: (Verified 8/23/23)

None received

ARGUMENTS IN SUPPORT: According to the Board of Pharmacy, “Pharmacists have been safely providing these services and an extension of the authority is appropriate to ensure continued access to care.” Other supporters argue that allowing those who test positive for COVID can access effective therapeutics in a timely and convenient manner remains important.

ASSEMBLY FLOOR: 79-0, 4/27/23

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NO VOTE RECORDED: Jim Patterson

Prepared by: Dana Shaker / B., P. & E.D. /

8/25/23 13:44:32

**** END ****

 THIRD READING  

Bill No: AB 1341

Author: Berman (D)

Amended: 3/29/23 in Assembly

Vote: 27 - Urgency

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 13-0, 6/5/23

AYES: Roth, Nguyen, Alvarado-Gil, Archuleta, Ashby, Becker, Dodd, Eggman, Glazer, Niello, Smallwood-Cuevas, Wahab, Wilk

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 79-0, 4/27/23 (Consent) - See last page for vote

SUBJECT: Public health: COVID-19: testing and dispensing sites: oral therapeutics

SOURCE: Author

DIGEST:

This bill adds a sunset date of July 1, 2028, to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments (CLIA) for high complexity testing, as specified. This bill authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, as specified, until January 1, 2025. This bill also requires a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for three years.

ANALYSIS:

Existing federal law:

1. Establishes CLIA under federal law, which regulates clinical laboratories that perform tests on human specimens and sets standards for facility administration, personnel qualifications and quality control. These standards apply to all settings, including commercial, hospital or physician office laboratories. (Code of Federal Regulations (CFR) Title 42 § 493)
2. Defines CLIA waived tests as simple laboratory examinations and procedures that are approved by the Food and Drug Administration (FDA) for home use, employ methodologies that are simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly. (CFR Title 42 § 493)

Existing state law:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by CDPH, with specified exceptions. (Business and Professions Code (BPC) § 1200-1327)
2. Makes various definitions for the purposes of state regulation of clinical laboratories
3. States that no person shall perform clinical laboratory tests or examinations classified as of high complexity under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, where the test is performed by a specified individual. (BPC § 1206.5(c) and Health and Safety Code (HSC) § 101150)
4. Requires any city or county public health laboratory, as specified, be approved by CDPH and comply with the requirements of CLIA, as specified. (HSC § 101160)
5. Prohibits a prescriber from dispensing drugs or dangerous devices to patients in the prescriber’s office or place of practice unless specified conditions are met, where relevant business and professions boards share enforcement authority with the Board of Pharmacy (BOP), as specified, where other requirements and exceptions are qualified, as specified. (BPC § 4170 et seq.)
6. Permits a pharmacist or a clinic licensed and acting under specified authority to, in good faith, furnish a dangerous drug or dangerous device in reasonable quantities without a prescription during a federal, state, or local emergency, to further the health and safety of the public. (BPC § 4062 (a))

This bill:

1. Adds a sunset date of July 1, 2028, to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under CLIA for high complexity testing, as specified.
2. Authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, as specified, until January 1, 2025.
3. Requires a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for three years.

Background

Federal and State Regulation for Clinical Laboratory Testing. A facility that performs laboratory tests on human specimens for diagnosis or assessment must be certified under CLIA. CLIA certification requirements vary depending on the complexity of the laboratory tests performed.

Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director. The FDA determines the complexity of CLIA laboratory tests. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process. While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements.

Additional Authority In Response To the COVID-19 Pandemic. In the wake of the COVID-19 pandemic, federal and state governments expedited certain processes and waived certain requirements to protect the health and safety of the public. At the federal level, this meant providing emergency use authorizations for COVID-19 tests and vaccines.

In 2020, California undertook similar efforts to combat the COVID-19 pandemic. In March 2020, the Governor issued Executive Order N-25-20 (EO) to suspend statutes and regulations in support of the state’s pandemic response efforts. One part of the EO states:

The certification and licensure requirements of California Code of Regulations, Title 17, section 1079 and Business and Professions Code section 1206.5 are suspended as to all persons who meet the requirements under the Clinical Laboratory Improvement Amendments of section 353 of the Public Health Service Act for high complexity testing and who are performing analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory.

Therefore, anyone who meets the CLIA requirements for high complexity testing can perform analyses of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory. Professionals who are able to perform these tests due to the waiver include a physician, podiatrist, dentist, naturopathic doctor, person licensed to engage in clinical laboratory practice or to direct a clinical lab, physician assistant, perfusionist, respiratory care practitioner, medical assistant, pharmacist, naturopathic assistant, licensed optometrist, other health care personnel providing direct patient care, any other person performing non-diagnostic testing, as specified. This expansion of professionals allowed for the increased staff required to support California through the COVID-19 pandemic.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

SUPPORT: (Verified 6/26/23)

Board of Pharmacy

California Chronic Care Coalition

California Community Pharmacy Coalition

California Pharmacists Association

County Health Executives Association of California

MiOra

OPPOSITION: (Verified 6/26/23)

None received

ARGUMENTS IN SUPPORT: According to the Board of Pharmacy, “Pharmacists have been safely providing these services and an extension of the authority is appropriate to ensure continued access to care.” Other supporters argue that allowing those who test positive for COVID can access effective therapeutics in a timely and convenient manner remains important.

ASSEMBLY FLOOR: 79-0, 4/27/23

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NO VOTE RECORDED: Jim Patterson

Prepared by: Dana Shaker / B., P. & E.D. /

6/28/23 10:41:49

**** END ****

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Richard Roth, Chair

2023 - 2024 Regular

Bill No: Hearing Date: June 5, 2023

Subject:

SUMMARY:

Adds a sunset date of July 1, 2028 to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments (CLIA) for high complexity testing, as specified. Authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, as specified, until January 1, 2025. Requires a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years.

Existing law:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by CDPH, with specified exceptions. (Business and Professions Code (BPC) § 1200-1327)
2. Defines, for purposes of state regulation of clinical laboratories, the following:
3. “CLIA” to mean the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L. 100-578) and the regulations adopted thereunder by the federal Health Care Financing Administration and effective on January 1, 1994, or any later date, when adopted in California pursuant to subdivision (b) of Section 1208. (BPC § 1202.5(a))
4. “Clinical laboratory” to mean any place used, or any establishment or institution organized or operated, for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. That application may include any means that applies the clinical laboratory sciences. (BPC § 1206(a)(8))
5. Prohibits a person from performing a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as described in Section 1209, including, but not limited to, documentation by the laboratory director of the adequacy of the qualifications and competency of the personnel, and the test is performed by specified personnel. (BPC § 1206.5(a))
6. Authorizes a person to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory or a city, county, or city and county public health laboratory if they meet certain requirements. (BPC § 1206.7)
7. Authorizes an entity contracted with and approved by the California Department of Public Health (CDPH) to operate a designated COVID-19 testing and dispensing site to acquire, dispense, and store COVID-19 oral therapeutics, as defined, at or from a designated site, until January 1, 2024. (Health and Safety Code (HSC) § 101161)
8. States that no person shall perform clinical laboratory tests or examinations classified as of high complexity under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, where the test is performed by one of the following:
9. a licensed physician and surgeon holding an M.D. or D.O. degree;
10. a licensed podiatrist or a licensed dentist, as specified;
11. a person licensed to engage in clinical laboratory practice or to direct a clinical laboratory, as specified;
12. a person who supports a public health laboratory in the examination of specimens from suspected cases of infections and environmental diseases, that may include milk products, waters, and the environment, as specified;
13. a licensed physician assistant, as specified;
14. a perfusionist, as specified;
15. a respiratory care practitioner, as specified;
16. a person performing nuclear medicine technology, as specified;
17. a person if performing blood gas analysis, as specified;
18. any other person within a physician office laboratory if the test is performed under the onsite supervision of the patient’s physician and surgeon or a podiatrist who will: 1) ensure that the person is performing test methods as required for accurate and reliable tests; and 2) have personal knowledge of the results of clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory. (BPC § 1206.5(c) and Health and Safety Code (HSC) § 101150)
19. Requires any city or county public health laboratory, as specified, be approved by CDPH and comply with the requirements of CLIA, as specified. (HSC § 101160)
20. Prohibits a prescriber from dispensing drugs or dangerous devices to patients in the prescriber’s office or place of practice unless specified conditions are met, where relevant business and professions boards share enforcement authority with the Board of Pharmacy (BOP), as specified, where other requirements and exceptions are qualified, as specified. (BPC § 4170 et seq.)
21. Permits a pharmacist or a clinic licensed and acting under specified authority to, in good faith, furnish a dangerous drug or dangerous device in reasonable quantities without a prescription during a federal, state, or local emergency, to further the health and safety of the public. (BPC § 4062 (a))

Existing Federal Law:

1. Establishes CLIA under federal law, which regulates clinical laboratories that perform tests on human specimens and sets standards for facility administration, personnel qualifications and quality control. These standards apply to all settings, including commercial, hospital or physician office laboratories. (Code of Federal Regulations (CFR) Title 42 § 493)
2. Defines CLIA waived tests as simple laboratory examinations and procedures that are approved by the Food and Drug Administration (FDA) for home use, employ methodologies that are simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly. (CFR Title 42 § 493)

This bill:

1. Adds a sunset date of July 1, 2028 to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments (CLIA) for high complexity testing, as specified.
2. Permits pharmacists to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2.
3. Requires a pharmacist to utilize relevant and appropriate evidence-based clinical guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations in providing these patient care services before furnishing a COVID-19 oral therapeutic.
4. Requires a pharmacist who furnishes COVID-19 oral therapeutics to notify the patient’s primary care provider, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. States that if the patient does not have a primary care provider, the pharmacist will provide the patient with a written record of the drugs furnished and advise the patient to consult a physician of the patient’s choice.
5. Requires a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished, as well as information regarding any testing services provided, in the patient’s record in the record system maintained by the pharmacy. States the records shall be maintained for three years and shall be available for inspection by all properly authorized personnel of the board.
6. Defines “COVID-19 oral therapeutics” in this context to mean drugs that are approved or authorized by the United States Food and Drug Administration for the treatment of COVID-19 and administered orally.
7. Repeals this section on January 1, 2025.
8. States this act is an urgency measure necessary in order to ensure the continued ability of pharmacists to furnish COVID-19 oral therapeutics to patients who test positive for SARS-CoV-2 at a pharmacy without delaying treatment.

FISCAL EFFECT:

This bill is keyed fiscal. According to the Assembly Committee on Appropriations, the fiscal impact of this bill is “Minor and absorbable costs to the Board of Pharmacy.”

COMMENTS:

1. Purpose. The Author is the Sponsor of this bill. According to the Author, “Throughout the pandemic, California has relied on pharmacy professionals to expand access to testing, immunization, and treatment for COVID-19. While much of the state and national pandemic response is currently winding down, it remains essential that patients be able to start receiving effective therapeutics like Paxlovid immediately upon testing positive for the virus. AB 1341 will extend the preexisting authority of licensed pharmacists to furnish COVID-19 oral therapeutics without a prescription until January 1, 2025.”
2. Background.

Federal and State Regulation for Clinical Laboratory Testing. A facility that performs laboratory tests on human specimens for diagnosis or assessment must be certified under CLIA. CLIA certification requirements vary depending on the complexity of the laboratory tests performed.

Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director. The FDA determines the complexity of CLIA laboratory tests. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process. While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements.

Drug Dispensing. Current law prohibits a prescriber from dispensing drugs or dangerous devices to patients in the prescriber’s office or place of practice without specified conditions being met. These conditions include the following:

• The dangerous drugs or dangerous devices are dispensed to the prescriber’s own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant.
• The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient.
• The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons.
• The prescriber fulfills all of the labeling requirements imposed upon pharmacists, all of the specified recordkeeping requirements and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers.
• The prescriber does not use a dispensing device unless the prescriber personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded, as specified.
• The prescriber, before dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy.
• The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patient’s choice.
• A certified nurse-midwife who functions pursuant to a standardized procedure or protocol as specified, a nurse practitioner who functions pursuant to a standardized procedure as specified, or protocol, a physician assistant who functions as specified, or a naturopathic doctor who functions as specified, may hand to a patient of the supervising physician and surgeon a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist.

“Prescriber” here refers to a person who holds a physician’s and surgeon’s certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, a certificate to practice podiatry, or a certificate to practice as a nurse practitioner practicing, as specified, and who is duly registered by the Medical Board of California, the Osteopathic Medical Board of California, the California State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, the Podiatric Medical Board of California, or the Board of Registered Nursing.

Additional Authority In Response To the COVID-19 Pandemic. In the wake of the COVID-19 pandemic, federal and state governments expedited certain processes and waived certain requirements to protect the health and safety of the public. At the federal level, this meant providing emergency use authorizations for COVID-19 tests and vaccines.

In 2020, California undertook similar efforts to combat the COVID-19 pandemic. In March 2020, the Governor issued Executive Order N-25-20 (EO) to suspend statutes and regulations in support of the state’s pandemic response efforts. One part of the EO states:

“The certification and licensure requirements of California Code of Regulations, Title 17, section 1079 and Business and Professions Code section 1206.5 are suspended as to all persons who meet the requirements under the Clinical Laboratory Improvement Amendments of section 353 of the Public Health Service Act for high complexity testing and who are performing analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory.”

Therefore, anyone who meets the CLIA requirements for high complexity testing can perform analyses of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory. Professionals who are able to perform these tests due to the waiver include a physician, podiatrist, dentist, naturopathic doctor, person licensed to engage in clinical laboratory practice or to direct a clinical lab, physician assistant, perfusionist, respiratory care practitioner, medical assistant, pharmacist, naturopathic assistant, licensed optometrist, other health care personnel providing direct patient care, any other person performing non-diagnostic testing, as specified. This expansion of professionals allowed for the increased staff required to support California through the COVID-19 pandemic.

AB 269. Earlier this year, AB 269 (Berman, Chapter 1, Statutes of 2023) authorized a person to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory or a city, county, or city and county public health laboratory if they meet certain requirements, without a sunset date. This bill adds a January 1, 2028 sunset date for these provisions.

1. Related Legislation. AB 524 (Caballero, 2023) would authorize a pharmacist to furnish medications to treat various diseases and conditions based on the results of a federal Food and Drug Administration approved test the pharmacist ordered, performed, or reported. (Status: This bill was held under submission in the Senate Committee on Appropriations.)
2. Arguments in Support. According to the Board of Pharmacy, “Pharmacists have been safely providing these services and an extension of the authority is appropriate to ensure continued access to care.”

California Chronic Care Coalition writes in support: “While the Covid-19 pandemic shed light on the inequities within our health care system, including severe access limitations for many of California’s most underserved communities, it also highlighted the important role that pharmacists can play in bridging the access gap. We strongly believe that pharmacists are a crucial component of California’s health care delivery system, serving as a critical access point for their communities. Thankfully, while it appears that the worst of the Covid-19 pandemic is behind us, it remains essential that patients who test positive for the virus can access effective therapeutics in a timely and convenient manner. Therefore, extending the preexisting authority of licensed pharmacists to furnish Covid-19 oral therapeutics without a prescription until January 1, 2025, will be an important component of our continued fight to curtail the spread of the Covid virus.”

California Community Pharmacy Coalition states that “Although certain federal authorizations remain in place up until October 1, 2024, pharmacies in California are concerned that pharmacists and pharmacy technicians will no longer be able to respond to the COVID-19 pandemic by providing treatment options to patients. AB 1341 will address this problem by continuing COVID treatment beyond the federal waiver expiration date.”

County Health Executives Association of California notes that “COVID-19 therapeutics help to prevent or treat eligible non-hospital patients who have tested positive for COVID-19 and can improve outcomes, reduce stress on healthcare facilities, and even save lives. AB 1341 would also allow a pharmacist to furnish COVID-19 oral therapeutics after a positive COVID-19 test as long as they utilize relevant and appropriate clinical guidelines, notify the patient’s primary care physician or recommend they see a physician, and document the kind and amounts of therapeutics they furnish. This continued flexibility beyond the end of California’s State of Emergency Declaration on the COVID-19 pandemic, until January 1, 2025, will support continued access for Californians to COVID-19 treatment.”

SUPPORT AND OPPOSITION:

Support:

Board of Pharmacy

California Chronic Care Coalition
California Community Pharmacy Coalition

California Pharmacists Association
County Health Executives Association of California

Miora

Opposition:

None received

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Richard Roth, Chair

2023 - 2024 Regular

Bill No: AB 1341 Hearing Date: June 5, 2023

Subject: Public health: COVID-19: testing and dispensing sites: oral therapeutics

SUMMARY:

Adds a sunset date of July 1, 2028 to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments (CLIA) for high complexity testing, as specified. Authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, as specified, until January 1, 2025. Requires a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years.

Existing law:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by CDPH, with specified exceptions. (Business and Professions Code (BPC) § 1200-1327)
2. Defines, for purposes of state regulation of clinical laboratories, the following:
3. “CLIA” to mean the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L. 100-578) and the regulations adopted thereunder by the federal Health Care Financing Administration and effective on January 1, 1994, or any later date, when adopted in California pursuant to subdivision (b) of Section 1208. (BPC § 1202.5(a))
4. “Clinical laboratory” to mean any place used, or any establishment or institution organized or operated, for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. That application may include any means that applies the clinical laboratory sciences. (BPC § 1206(a)(8))
5. Prohibits a person from performing a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as described in Section 1209, including, but not limited to, documentation by the laboratory director of the adequacy of the qualifications and competency of the personnel, and the test is performed by specified personnel. (BPC § 1206.5(a))
6. Authorizes a person to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory or a city, county, or city and county public health laboratory if they meet certain requirements. (BPC § 1206.7)
7. Authorizes an entity contracted with and approved by the California Department of Public Health (CDPH) to operate a designated COVID-19 testing and dispensing site to acquire, dispense, and store COVID-19 oral therapeutics, as defined, at or from a designated site, until January 1, 2024. (Health and Safety Code (HSC) § 101161)
8. States that no person shall perform clinical laboratory tests or examinations classified as of high complexity under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, where the test is performed by one of the following:
9. a licensed physician and surgeon holding an M.D. or D.O. degree;
10. a licensed podiatrist or a licensed dentist, as specified;
11. a person licensed to engage in clinical laboratory practice or to direct a clinical laboratory, as specified;
12. a person who supports a public health laboratory in the examination of specimens from suspected cases of infections and environmental diseases, that may include milk products, waters, and the environment, as specified;
13. a licensed physician assistant, as specified;
14. a perfusionist, as specified;
15. a respiratory care practitioner, as specified;
16. a person performing nuclear medicine technology, as specified;
17. a person if performing blood gas analysis, as specified;
18. any other person within a physician office laboratory if the test is performed under the onsite supervision of the patient’s physician and surgeon or a podiatrist who will: 1) ensure that the person is performing test methods as required for accurate and reliable tests; and 2) have personal knowledge of the results of clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory. (BPC § 1206.5(c) and Health and Safety Code (HSC) § 101150)
19. Requires any city or county public health laboratory, as specified, be approved by CDPH and comply with the requirements of CLIA, as specified. (HSC § 101160)
20. Prohibits a prescriber from dispensing drugs or dangerous devices to patients in the prescriber’s office or place of practice unless specified conditions are met, where relevant business and professions boards share enforcement authority with the Board of Pharmacy (BOP), as specified, where other requirements and exceptions are qualified, as specified. (BPC § 4170 et seq.)
21. Permits a pharmacist or a clinic licensed and acting under specified authority to, in good faith, furnish a dangerous drug or dangerous device in reasonable quantities without a prescription during a federal, state, or local emergency, to further the health and safety of the public. (BPC § 4062 (a))

Existing Federal Law:

1. Establishes CLIA under federal law, which regulates clinical laboratories that perform tests on human specimens and sets standards for facility administration, personnel qualifications and quality control. These standards apply to all settings, including commercial, hospital or physician office laboratories. (Code of Federal Regulations (CFR) Title 42 § 493)
2. Defines CLIA waived tests as simple laboratory examinations and procedures that are approved by the Food and Drug Administration (FDA) for home use, employ methodologies that are simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly. (CFR Title 42 § 493)

This bill:

1. Adds a sunset date of July 1, 2028 to the current provision that a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments (CLIA) for high complexity testing, as specified.
2. Permits pharmacists to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2.
3. Requires a pharmacist to utilize relevant and appropriate evidence-based clinical guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations in providing these patient care services before furnishing a COVID-19 oral therapeutic.
4. Requires a pharmacist who furnishes COVID-19 oral therapeutics to notify the patient’s primary care provider, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. States that if the patient does not have a primary care provider, the pharmacist will provide the patient with a written record of the drugs furnished and advise the patient to consult a physician of the patient’s choice.
5. Requires a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished, as well as information regarding any testing services provided, in the patient’s record in the record system maintained by the pharmacy. States the records shall be maintained for three years and shall be available for inspection by all properly authorized personnel of the board.
6. Defines “COVID-19 oral therapeutics” in this context to mean drugs that are approved or authorized by the United States Food and Drug Administration for the treatment of COVID-19 and administered orally.
7. Repeals this section on January 1, 2025.
8. States this act is an urgency measure necessary in order to ensure the continued ability of pharmacists to furnish COVID-19 oral therapeutics to patients who test positive for SARS-CoV-2 at a pharmacy without delaying treatment.

FISCAL EFFECT:

This bill is keyed fiscal. According to the Assembly Committee on Appropriations, the fiscal impact of this bill is “Minor and absorbable costs to the Board of Pharmacy.”

COMMENTS:

1. Purpose. The Author is the Sponsor of this bill. According to the Author, “Throughout the pandemic, California has relied on pharmacy professionals to expand access to testing, immunization, and treatment for COVID-19. While much of the state and national pandemic response is currently winding down, it remains essential that patients be able to start receiving effective therapeutics like Paxlovid immediately upon testing positive for the virus. AB 1341 will extend the preexisting authority of licensed pharmacists to furnish COVID-19 oral therapeutics without a prescription until January 1, 2025.”
2. Background.

Federal and State Regulation for Clinical Laboratory Testing. A facility that performs laboratory tests on human specimens for diagnosis or assessment must be certified under CLIA. CLIA certification requirements vary depending on the complexity of the laboratory tests performed.

Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director. The FDA determines the complexity of CLIA laboratory tests. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process. While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements.

Drug Dispensing. Current law prohibits a prescriber from dispensing drugs or dangerous devices to patients in the prescriber’s office or place of practice without specified conditions being met. These conditions include the following:

• The dangerous drugs or dangerous devices are dispensed to the prescriber’s own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant.
• The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient.
• The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons.
• The prescriber fulfills all of the labeling requirements imposed upon pharmacists, all of the specified recordkeeping requirements and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers.
• The prescriber does not use a dispensing device unless the prescriber personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded, as specified.
• The prescriber, before dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy.
• The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patient’s choice.
• A certified nurse-midwife who functions pursuant to a standardized procedure or protocol as specified, a nurse practitioner who functions pursuant to a standardized procedure as specified, or protocol, a physician assistant who functions as specified, or a naturopathic doctor who functions as specified, may hand to a patient of the supervising physician and surgeon a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist.

“Prescriber” here refers to a person who holds a physician’s and surgeon’s certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, a certificate to practice podiatry, or a certificate to practice as a nurse practitioner practicing, as specified, and who is duly registered by the Medical Board of California, the Osteopathic Medical Board of California, the California State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, the Podiatric Medical Board of California, or the Board of Registered Nursing.

Additional Authority In Response To the COVID-19 Pandemic. In the wake of the COVID-19 pandemic, federal and state governments expedited certain processes and waived certain requirements to protect the health and safety of the public. At the federal level, this meant providing emergency use authorizations for COVID-19 tests and vaccines.

In 2020, California undertook similar efforts to combat the COVID-19 pandemic. In March 2020, the Governor issued Executive Order N-25-20 (EO) to suspend statutes and regulations in support of the state’s pandemic response efforts. One part of the EO states:

“The certification and licensure requirements of California Code of Regulations, Title 17, section 1079 and Business and Professions Code section 1206.5 are suspended as to all persons who meet the requirements under the Clinical Laboratory Improvement Amendments of section 353 of the Public Health Service Act for high complexity testing and who are performing analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory.”

Therefore, anyone who meets the CLIA requirements for high complexity testing can perform analyses of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory. Professionals who are able to perform these tests due to the waiver include a physician, podiatrist, dentist, naturopathic doctor, person licensed to engage in clinical laboratory practice or to direct a clinical lab, physician assistant, perfusionist, respiratory care practitioner, medical assistant, pharmacist, naturopathic assistant, licensed optometrist, other health care personnel providing direct patient care, any other person performing non-diagnostic testing, as specified. This expansion of professionals allowed for the increased staff required to support California through the COVID-19 pandemic.

AB 269. Earlier this year, AB 269 (Berman, Chapter 1, Statutes of 2023) authorized a person to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory or a city, county, or city and county public health laboratory if they meet certain requirements, without a sunset date. This bill adds a January 1, 2028 sunset date for these provisions.

1. Related Legislation. AB 524 (Caballero, 2023) would authorize a pharmacist to furnish medications to treat various diseases and conditions based on the results of a federal Food and Drug Administration (FDA) test the pharmacist ordered, performed, or reported. (Status: This bill was held under submission in the Senate Committee on Appropriations.)
2. Arguments in Support.

California Chronic Care Coalition writes in support: “While the Covid-19 pandemic shed light on the inequities within our health care system, including severe access limitations for many of California’s most underserved communities, it also highlighted the important role that pharmacists can play in bridging the access gap. We strongly believe that pharmacists are a crucial component of California’s health care delivery system, serving as a critical access point for their communities.

Thankfully, while it appears that the worst of the Covid-19 pandemic is behind us, it remains essential that patients who test positive for the virus can access effective therapeutics in a timely and convenient manner. Therefore, extending the preexisting authority of licensed pharmacists to furnish Covid-19 oral therapeutics without a prescription until January 1, 2025, will be an important component of our continued fight to curtail the spread of the Covid virus.”

California Community Pharmacy Coalition writes in support: “For many Californians, especially those living in rural communities, access to health care is limited. A 2018 study found that on average, driving to a hospital in a rural community takes 17 minutes – a distance that is often too far for those in need of care. However, approximately 90% of Californians live within five miles of a pharmacy. Because of this proximity, pharmacies have become many patients’ primary connection to health care. This was highlighted during the COVID-19 Pandemic and continues to be a reality for millions of Californians.

The California State of Emergency related to COVID-19 expired on February 28, 2023. Although certain federal authorizations remain in place up until October 1, 2024, pharmacies in California are concerned that pharmacists and pharmacy technicians will no longer be able to respond to the COVID-19 pandemic by providing treatment options to patients. AB 1341 will address this problem by continuing COVID treatment beyond the federal waiver expiration date.”

County Health Executives Association of California (CHEAC) writes in support: “COVID-19 therapeutics help to prevent or treat eligible non-hospital patients who have tested positive for COVID-19 and can improve outcomes, reduce stress on healthcare facilities, and even save lives. AB 1341 would also allow a pharmacist to furnish COVID-19 oral therapeutics after a positive COVID-19 test as long as they utilize relevant and appropriate clinical guidelines, notify the patient’s primary care physician or recommend they see a physician, and document the kind and amounts of therapeutics they furnish. This continued flexibility beyond the end of California’s State of Emergency Declaration on the COVID-19 pandemic, until January 1, 2025, will support continued access for Californians to COVID-19 treatment.”

SUPPORT AND OPPOSITION:

Support:

California Chronic Care Coalition
California Community Pharmacy Coalition
County Health Executives Association of California (CHEAC)

Opposition:

None received.

-- END --

Date of Hearing: April 19, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

ABPCA Bill Id:AB 1341

Author:(Berman) – As Amended Ver:March 29, 2023

Urgency: Yes State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill authorizes pharmacists to continue furnishing COVID-19 oral therapeutics, without a prior prescription, to patients who test positive for SARS-CoV-2, until January 1, 2025. To ensure the continued ability of pharmacists to furnish COVID-19 oral therapeutics as, specified, this bill goes into effect immediately. This bill also repeals, on July 1, 2028, a recent expansion of the classifications of professionals authorized to test samples for SARS-CoV-2.

FISCAL EFFECT:

Minor and absorbable costs to the Board of Pharmacy.

COMMENTS:

1. Purpose. This bill is sponsored by the author. According to the author:

Throughout the pandemic, California has relied on pharmacy professionals to expand access to testing, immunization, and treatment for COVID-19. While much of the state and national pandemic response is currently winding down, it remains essential that patients be able to start receiving effective therapeutics like Paxlovid immediately upon testing positive for the virus. [This bill] will extend the preexisting authority of licensed pharmacists to furnish COVID-19 oral therapeutics without a prescription until January 1, 2025.

1. COVID-19 Therapeutics. The federal Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for two oral antiviral therapies, Paxlovid and Lagevrio, for treatment of mild-to-moderate COVID-19. COVID-19 therapeutics are most effective when taken within days of a patient developing symptoms, so beginning treatment immediately upon receipt of a positive test is the most efficacious way to prevent a patient’s condition from becoming more severe. These therapeutics are available to all Californians, including the uninsured, free of charge.

Despite the effectiveness and wide availability of COVID-19 therapeutics, the medications were being underutilized, particularly in low-income communities and communities of color. The Department of Public Health (DPH) issued a health advisory for California healthcare providers, urging a low threshold to prescribe COVID-19 therapeutics. In May 2022, DPH announced it was upgrading 146 existing COVID-19 testing sites to “Test to Treat” locations, where individuals could be seen by a provider and receive a prescription for oral antiviral therapeutics immediately upon testing positive for COVID-19.

The EUAs for both Paxlovid and Lagevrio are expected to remain in effect until the FDA completes its full approval of these therapeutics. This bill preserves the ability of pharmacists to continue furnishing these drugs directly to patients until January 1, 2025.

1. SARS-CoV-2 Testing Expansion. AB 269 (Berman) Chapter 1, Statutes of 2023, authorized additional health care workers, including physicians, podiatrists, dentists, naturopathic doctors, persons licensed to engage in clinical laboratory practice or direct a clinical lab, physician assistants, perfusionists, respiratory care practitioners, medical assistants, pharmacists, naturopathic assistants, licensed optometrists, other health care personnel providing direct patient care, and any other person performing non-diagnostic testing, as specified, in any certified public health laboratory or licensed clinical laboratory. This expansion of professionals allowed for the increased staff required to support California through the COVID-19 pandemic. This bill sunsets the expansion of authorized testing personnel.
2. Related Legislation. SB 524 (Caballero), of the current legislative session, authorizes a pharmacist to furnish prescription medications pursuant to the result from a test performed by the pharmacist that is used to guide diagnosis or clinical decision making. SB 524 is pending in the Senate Committee on Business, Professions and Economic Development.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing:

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Marc Berman, Chair

ABPCA Bill Id:AB 1341

Author:(Berman) – As Amended Ver:March 16, 2023

SUBJECT: Public health: COVID-19: testing and dispensing sites: oral therapeutics.

SUMMARY: Authorizes pharmacists to continue furnishing COVID-19 oral therapeutics to patients who test positive for SARS-CoV-2, without a prior prescription, until January 1, 2025.

EXISTING LAW:

1. Establishes the California State Board of Pharmacy (BOP) to administer and enforce the Pharmacy Law, comprised of seven pharmacists and six public members. (BPC § 4002)
2. Defines “furnish” as supplying by any means, by sale or otherwise. (BPC § 4026)
3. Defines “dispense” as the furnishing of drugs or devices upon a prescription from a physician, nurse practitioner, dentist, optometrist, podiatrist, veterinarian, or naturopathic doctor acting within the scope of their practice. (BPC § 4024)
4. Defines “pharmacist” as a natural person to whom a license has been issued by the BOP which is required for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription. (BPC § 4036; BPC § 4051)
5. Declares pharmacy practice to be “a dynamic, patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes” and that “pharmacy practice is continually evolving to include more sophisticated and comprehensive patient care activities.” (BPC § 4050)
6. Authorizes a pharmacist to do all of the following, among other permissible activities, as part of their scope of practice:
   1. Provide consultation, training, and education to patients about drug therapy, disease management, and disease prevention.
   2. 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.
   3. Order and interpret tests for the purpose of monitoring and managing the efficacy and toxicity of drug therapies in coordination with the patient’s provider or prescriber.
   4. Administer immunizations pursuant to a protocol with a prescriber.
   5. Furnish emergency contraception drug therapy, self-administered hormonal contraceptives, HIV preexposure and postexposure prophylaxis, and nicotine replacement products, subject to specified requirements.
   6. Administer drugs and biological products that have been ordered by a prescriber.

(BPC § 4052)

1. Authorizes a pharmacist to furnish an approved opioid antagonist in accordance with standardized procedures or protocols developed and approved by the BOP and the Medical Board of California, in consultation with stakeholders. (BPC § 4052.01)
2. Authorizes an entity contracted with and approved by the Department of Public Health to operate a designated COVID-19 testing and dispensing site to acquire, dispense, and store COVID-19 oral therapeutics at or from a designated site. (BPC § 4176)
3. Allows a person who meets the federal CLIA requirements for high complexity testing to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in either a clinical laboratory or a city or county public health laboratory. (BPC § 1206.7; Health and Safety Code § 101161)

THIS BILL:

1. Authorizes a pharmacist to furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, the virus that causes COVID-19.
2. Requires a pharmacist to utilize relevant and appropriate evidence-based clinical guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations in providing these patient care services prior to furnishing COVID-19 oral therapeutics.
3. Requires a pharmacist who furnishes COVID-19 oral therapeutics to notify the patient’s primary care provider, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider.
4. Requires a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished, as well as information regarding any testing services provided, in the patient’s record in the record system maintained by the pharmacy for three years.
5. Defines “COVID-19 oral therapeutics” as drugs that are approved or authorized by the United States Food and Drug Administration (FDA) for the treatment of COVID-19 and administered orally.
6. Subjects each of the above provisions to a repeal date of January 1, 2025.
7. Adds a repeal date of July 1, 2028 to provisions of existing law currently allowing persons who meets CLIA requirements for high complexity testing to perform an analysis of samples to test for COVID-19 in either a clinical laboratory or public health laboratory.

FISCAL EFFECT: Unknown; this bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

Purpose. This bill is sponsored by the author. According to the author:

“Throughout the pandemic, California has relied on pharmacy professionals to expand access to testing, immunization, and treatment for COVID-19. While much of the state and national pandemic response is currently winding down, it remains essential that patients be able to start receiving effective therapeutics like Paxlovid immediately upon testing positive for the virus. AB 1341 will extend the preexisting authority of licensed pharmacists to furnish COVID-19 oral therapeutics without a prescription until January 1, 2025.”

Background.

COVID-19 Pandemic. On March 4, 2020, Governor Gavin Newsom proclaimed a State of Emergency as a result of the impacts of the COVID-19 public health crisis. On March 12, 2020, the Governor issued an executive order that directed residents to follow public health directives and guidance, including to cancel large non-essential gatherings that do not meet certain state criteria. On March 19, 2020, the Governor formally issued a statewide “stay at home order,” directing Californians to only leave the house to provide or obtain specified essential services. Subsequent guidance from the State Public Health Officer expressly exempted from that order various professionals regulated by the Department of Consumer Affairs (DCA).

On March 30, 2020, Governor Newsom announced an initiative to “expand California’s health care workforce and recruit health care professionals to address the COVID-19 surge” and signed Executive Order N-39-20. This executive order established a waiver request process under the DCA and included other provisions authorizing the waiver of licensing, certification, and credentialing requirements for health care providers. This waiver process constituted a delegation of the Governor’s existing authority under the California Emergency Services Act (EMSA) to make, amend, and rescind orders and regulations necessary to respond to a declared emergency.

Approximately 74 further executive orders were issued to waive or revise various laws to advance the state’s pandemic response. Over the course of the pandemic, approximately 596 EO provisions were effectuated, with 27 still in effect as of October 2022. Dozens of additional waivers have been issued for licensing programs under the DCA. The majority of these waivers have since expired, and a number were permanently codified through the enactment of legislation.

COVID-19 Therapeutics. The FDA has authorized two oral antiviral pills for the treatment of mild-to-moderate COVID-19. Paxlovid, developed by Pfizer, is a combination formulation of two protease inhibitor medications: nirmatrelvir and ritonavirhas. Molnupiravir, developed by Merck & Co., is sold under the brand name Lagevrio. Both therapeutics have been shown to prevent hospitalization or death in high-risk patients with mild to moderate COVID-19.

As antiviral therapeutics for COVID-19 became available at the beginning of 2022, the CDPH and other public health entities have pushed to make those treatments accessible, particularly to high-risk patients. Therapeutics have been made free to all Californians, including the uninsured. COVID-19 therapeutics are most effective when taken within days of a patient developing symptoms, so beginning treatment immediately upon receipt of a positive test is the most efficacious way of prevent a patient’s condition from becoming more severe.

Despite the effectiveness and wide availability of COVID-19 therapeutics, it was reported in 2022 that the antiviral medications were being underutilized, particularly within low-income communities and communities of color. The CDPH issued a health advisory for California healthcare providers urging a low threshold to prescribe COVID-19 therapeutics. The Governor repeatedly stated that his objective was to “remedy ongoing inequities in therapeutics access.”

In May 2022, the CDPH announced that it was upgrading 146 existing testing sites to “Test to Treat” locations where individuals could be seen by a provider and receive a prescription for oral antiviral therapeutics immediately upon testing positive for COVID-19. This initiative was launched as a partnership with OptumServe, a company with existing contracts with the state to provide vaccination and testing site services. The state’s program aligned with the Biden Administration’s national Test to Treat initiative in the National COVID-19 Preparedness Plan.

On September 14, 2021, the Secretary of the federal Department of Health and Human Services, Xavier Becerra, issued a declaration authorizing pharmacists to independently order and administer any COVID-19 therapeutic in compliance with FDA authorization. On July 6, 2022, the FDA announced that it had revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients. This authority was effectuated in California through a waiver issued by the Director of DCA, which waived any provisions of law prohibiting a pharmacist from independently initiating and furnishing Paxlovid consistent with the EUA.

The EUAs for both Paxlovid and Lagevrio are expected to remain in effect until the FDA completes its full approval of these therapeutics. This full approval is expected to occur sometime this summer, at which point it is believed that pharmacists will only remain authorized to furnish the drugs directly to patients until the federal stockpile established during the EUA has expired. This bill will preserve the ability of pharmacists in California to continue furnishing these drugs directly to patients after the federal authorization has ended, until January 1, 2025.

Clinical Laboratory Testing Requirements. Federal and state laws regulate clinical laboratory testing on human specimens for diagnostic or assessment purposes. The purpose of clinical laboratory regulation is to ensure patients who undergo diagnostic testing receive accurate and timely results. Inaccurate or delayed results may prevent a patient from receiving the proper level or type of care.

To that end, all clinical laboratories and tests must comply with requirements under CLIA. CLIA establishes the minimum standards under federal law but allows states to establish more stringent requirements. Under CLIA, laboratory tests are classified based on the complexity of the laboratory tests performed. In general, the more complicated the test, the stricter the requirements relating to the test, including the requirements for training and licensing of the laboratory personnel performing the test.

There are two types of tests used to detect SARS-CoV-2, the virus that causes COVID-19. The first type is diagnostic tests, which will reveal if an individual has an active coronavirus infection; diagnostic tests include both antigen tests (which detect the presence of certain viral proteins) and molecular tests (which detect viral genetic material). The second type of COVID-19 test is antibody tests, which use a blood sample to detect antibodies that could reveal either an active or a previous infection. Tests for SARS-CoV-2 have been deemed CLIA-waived for the duration of the federal emergency declaration through the FDA’s EUA.

On March 12, 2020, Governor Newsom issued Executive Order N-25-20, which substantially broadened the available workforce for individuals to perform analysis of COVID-19 tests. Because California requirements are considered more restrictive than the federal regulations, laboratories utilizing the waiver were able to utilize professionals who meet federal standards but who would not currently qualify under Section 1206.5. This increased capacity was essential to California’s robust response to the COVID-19 pandemic through the proliferation of testing options.

When Governor Newsom announced that California’s State of Emergency would be terminated on February 28, 2023, he requested statutory changes to ensure “the continued ability of laboratory workers to solely process COVID-19 tests.” Subsequently, Assembly Bill 269 (Berman) was enacted to continue the waiver of state requirements for individuals analyzing COVID-19 tests who meet the federal requirements for high complexity testing. During the expedited legislative process for that bill, the author made commitments to stakeholders that he would add sunset dates to these provisions in another vehicle introduced following enactment of the urgency legislation. This will would fulfill that promise by adding a July 1, 2028 sunset date to the relevant provisions of Assembly Bill 269.

Current Related Legislation. SB 524 (Caballero) 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. This bill is pending referral in the Senate Committee on Rules.

Prior Related Legislation. AB 269 (Berman, Chapter 1, Statutes of 2023) authorizes a person who meets the CLIA requirements for high complexity testing to perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in either a clinical laboratory or a city or county public health laboratory.

ARGUMENTS IN SUPPORT:

The California Community Pharmacy Coalition (CCPC) supports this bill, writing: “For many Californians, especially those living in rural communities, access to health care is limited. A 2018 study found that on average, driving to a hospital in a rural community takes 17 minutes – a distance that is often too far for those in need of care. However, approximately 90% of Californians live within five miles of a pharmacy. Because of this proximity, pharmacies have become many patients’ primary connection to health care. This was highlighted during the COVID-19 Pandemic and continues to be a reality for millions of Californians.” The CCPC states that “because it will increase healthcare access for Californians and ensure effective testing and treatment for COVID-19, the California Community Pharmacy Coalition is in strong support of AB 1341.”

The County Health Executives Association of California also supports this bill, writing: “COVID-19 therapeutics help to prevent or treat eligible non-hospital patients who have tested positive for COVID-19 and can improve outcomes, reduce stress on healthcare facilities, and even save lives. AB 1341 would also allow a pharmacist to furnish COVID-19 oral therapeutics after a positive COVID-19 test as long as they utilize relevant and appropriate clinical guidelines, notify the patient’s primary care physician or recommend they see a physician, and document the kind and amounts of therapeutics they furnish. This continued flexibility beyond the end of California’s State of Emergency Declaration on the COVID-19 pandemic, until January 1, 2025, will support continued access for Californians to COVID-19 treatment.”

ARGUMENTS IN OPPOSITION:

None on file.

AMENDMENTS:

To ensure that pharmacists retain the authority to independently furnish COVID-19 oral therapeutics once federal authorization ends, an urgency clause should be added to this bill so that its provisions may go into effect immediately.

REGISTERED SUPPORT:

California Community Pharmacy Coalition
County Health Executives Association of California

REGISTERED OPPOSITION:

None on file.

Analysis Prepared by: Robert Sumner / B. & P. / (916) 319-3301