Bill Text: CA AB425 | 2023-2024 | Regular Session | Introduced

California Assembly Bill 425

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

Bill Title: Medi-Cal: pharmacogenomic testing.

Spectrum: Bipartisan Bill

Status: (Passed) 2023-10-07 - Chaptered by Secretary of State - Chapter 329, Statutes of 2023. [AB425 Detail]

Download: California-2023-AB425-Introduced.html

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Assembly Bill

No. 425

Introduced by Assembly Member Alvarez
(Coauthors: Assembly Members Aguiar-Curry and Rodriguez)

February 06, 2023

An act to add Section 14132.08 to the Welfare and Institutions Code, relating to Medi-Cal.

LEGISLATIVE COUNSEL'S DIGEST

AB 425, as introduced, Alvarez. Medi-Cal: pharmacogenomic testing.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law sets forth a schedule of covered benefits under the Medi-Cal program.

This bill, the Pharmacogenomics Advancing Total Health for All Act (PATH for All Act), subject to an appropriation, would add pharmacogenomic testing as a covered benefit under Medi-Cal, as specified. The bill would define pharmacogenomic testing as laboratory genetic testing, by a laboratory with specified licensing, accreditation, and certification, to identify how a person’s genetics may impact the efficacy, toxicity, and safety of medications. The bill would cover the benefit under Medi-Cal if a medication, as defined, is being considered for use, or is already being administered, and is approved for use, in treating a Medi-Cal beneficiary’s condition and is known to have a gene-drug or drug-drug-gene interaction that has been demonstrated to be clinically actionable, as specified, if the test is ordered by an enrolled Medi-Cal clinician or pharmacist.

The bill would authorize the department to implement the above-described provisions through all-county or plan letters, or similar instructions, until the department promulgates regulations. The bill would also make related legislative findings.

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

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

SECTION 1.

The Legislature finds and declares all of the following:

(a) This act is intended to benefit the total health, including mental and physical health, of Medi-Cal beneficiaries by using available, evidence-based technologies to assess how an individual’s genetics impact their metabolism of a variety of medications.

(b) The Legislature seeks to curb the opioid crisis in California, which is exacerbated by genetic changes in individuals that create unintended “high” feelings or no pain relief, prompting increases in opioid dependency.

(c) Through equitable access with unobstructed coverage, the safety and efficacy of medications will improve and lead to progress in health equity as well as reduction of adverse drug events, opioid dependency, emergency department visits, and hospital admissions.

(d) It is the intent of the Legislature that, with the passage of the coverage described in Section 14132.08 of the Welfare and Institutions Code as added by this act, and with any future funding appropriated for implementing that coverage, the Medi-Cal program will realize a net savings of approximately fifty-nine million one hundred thousand dollars ($59,100,000) in the first year of implementation and approximately one hundred ten million dollars ($110,000,000) in savings annually thereafter.

SEC. 2.

Section 14132.08 is added to the Welfare and Institutions Code, to read:

14132.08.

(a) This section shall be known, and may be cited, as the Pharmacogenomics Advancing Total Health for All Act (PATH for All Act).

(b) Pharmacogenomic testing shall be a covered Medi-Cal benefit, without prior authorization or treatment authorization request, pursuant to this section.

(c) Pharmacogenomic testing shall be covered under the Medi-Cal program if a medication is being considered for use, or is already being administered, and is approved for use, in treating a Medi-Cal beneficiary’s condition and is known to have a gene-drug or drug-drug-gene interaction that has been demonstrated to be clinically actionable, as defined by the United States Food and Drug Administration or by the Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for Level A, A/B, or B, if the test is ordered by an enrolled Medi-Cal clinician or pharmacist pursuant to paragraph (12) of subdivision (a) of Section 4052 of the Business and Professions Code.

(d) (1) Medi-Cal reimbursement for pharmacogenomic testing is subject to the use of only one Current Procedural Terminology (CPT) code, or only one Healthcare Common Procedure Coding System (HCPCS) code, for the test. Each individual gene of a panel test shall not be billed with multiple CPT or HCPCS codes.

(2) Sample collection for purposes of performing pharmacogenomic testing may be completed at home, within a pharmacy, or at a health facility. The location of sample collection shall not impact Medi-Cal reimbursement for pharmacogenomic testing.

(e) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement this section by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions, until the department promulgates regulations.

(f) This section shall become operative upon an appropriation by the Legislature for the express purpose of implementing this section.

(g) For purposes of this section, the following definitions apply:

(1) “Medication” means medication prescribed for any condition, including, but not limited to, behavioral or mental health, oncology, hematology, pain management, infectious disease, urology, reproductive or sexual health, neurology, gastroenterology, or cardiovascular diseases.

(2) “Pharmacogenomics” means the evaluation of how a person’s genes affect how the person responds to medications. Pharmacogenomics enables the selection of drugs and doses best suited to reduce toxicity and adverse drug events, including treatment failures, severe harm, or even death.

(3) “Pharmacogenomic testing” means laboratory genetic testing, including, but not limited to, a panel test, by a California-licensed laboratory with accreditation by the College of American Pathologists (CAP) or another accrediting agency approved by the federal Centers for Medicare and Medicaid Services (CMS) and a valid CLIA certificate to identify how a person’s genetics may impact the efficacy, toxicity, and safety of medications.