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AB-1060 Health care coverage: naloxone hydrochloride. (2023-2024)

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Date Published: 09/18/2023 09:00 PM
AB1060:v94#DOCUMENT

Enrolled  September 18, 2023
Passed  IN  Senate  September 12, 2023
Passed  IN  Assembly  September 13, 2023
Amended  IN  Senate  September 08, 2023
Amended  IN  Senate  September 01, 2023
Amended  IN  Senate  June 12, 2023
Amended  IN  Assembly  March 16, 2023

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Assembly Bill
No. 1060

Introduced by Assembly Member Ortega
(Coauthors: Assembly Members Arambula, Haney, Schiavo, and Zbur)
(Coauthors: Senators Dodd, Durazo, and Wahab)

February 15, 2023

An act to add and repeal Section 1374.198 of the Health and Safety Code, to add and repeal Section 10127.22 of the Insurance Code, and to add and repeal Section 14132.37 of the Welfare and Institutions Code, relating to opioids.


LEGISLATIVE COUNSEL'S DIGEST


AB 1060, Ortega. Health care coverage: naloxone hydrochloride.
Existing law sets forth various programs relating to opioid overdose prevention and treatment, including, among others, standing orders for the distribution of an opioid antagonist, a naloxone grant program, and a grant program to reduce fentanyl overdoses and use throughout the state.
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. Under existing law, the pharmacist service of furnishing naloxone hydrochloride is a covered Medi-Cal benefit. The Medi-Cal program also covers certain medications to treat opioid use disorders as part of narcotic treatment program services, or as part of medication-assisted treatment services within the Drug Medi-Cal Treatment Program, as specified.
Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of the act a crime. Existing law provides for the regulation of health insurers by the Department of Insurance.
This bill would make legislative findings relating to the United States Food and Drug Administration (FDA) approving a certain naloxone hydrochloride nasal spray for nonprescription use.
Under the bill, prescription or nonprescription naloxone hydrochloride or another drug approved by the FDA for the complete or partial reversal of an opioid overdose would be a covered benefit under the Medi-Cal program. The bill would require a health care service plan contract or health insurance policy that provides coverage for prescription drugs and that is issued, amended, delivered, or renewed on or after January 1, 2025, to cover prescription and nonprescription naloxone hydrochloride and all other drugs or products approved by the FDA for the complete or partial reversal of an opioid overdose. The bill would prohibit a health care service plan contract or health insurance policy that provides coverage for prescription drugs from imposing any cost-sharing requirements for that coverage exceeding $10 per package of medication, as specified, would require point-of-sale coverage for over-the-counter, FDA-approved naloxone hydrochloride or another FDA-approved drug or product for the complete or partial reversal of an opioid overdose at in-network pharmacies, and would prohibit a high deductible health plan from imposing cost sharing, as specified. The bill would repeal these provisions on January 1, 2030.
Because a willful violation of these provisions by a health care service plan 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.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

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


SECTION 1.

 The Legislature finds and declares all of the following:
(a) According to the United States Food and Drug Administration (FDA), naloxone hydrochloride is a medicine that can counter overdose effects when administered timely and that can help to reduce opioid overdose deaths.
(b) In November 2022, the FDA issued a Federal Register notice with a preliminary assessment of the safety and effectiveness of certain naloxone hydrochloride drug products for nonprescription use, in order to facilitate the development and approval of those products, including through a potential switch from prescription status to nonprescription status.
(c) In February 2023, an advisory committee to the FDA voted unanimously in favor of making Narcan, a naloxone hydrochloride nasal spray, available over the counter.
(d) In March 2023, the FDA approved Narcan for nonprescription use.
(e) The California Overdose Surveillance Dashboard, administered by the State Department of Public Health, contains the following data applicable to the state for 2021:
(1) Seven thousand one hundred seventy-five deaths were documented as relating to an opioid overdose. Of those deaths, 5,961 were documented as relating to a fentanyl overdose.
(2) Eight hundred forty-six deaths were associated with an opioid-related overdose for persons 24 years of age or younger. Of those deaths, 801 were associated with a fentanyl-related overdose.
(3) Twenty-one thousand sixteen emergency department (ED) visits were documented as relating to an opioid overdose. Of those ED visits, 5,644 were associated with a fentanyl-related overdose.

SEC. 2.

 Section 1374.198 is added to the Health and Safety Code, immediately following Section 1374.197, to read:

1374.198.
 (a) A health care service plan contract that provides coverage for prescription drugs and that is issued, amended, delivered, or renewed on or after January 1, 2025, shall cover prescription and nonprescription naloxone hydrochloride and all other drugs or products approved by the United States Food and Drug Administration (FDA) for the complete or partial reversal of an opioid overdose.
(b) A health care service plan contract that provides coverage for prescription drugs shall not impose any cost-sharing requirements, including a copayment, coinsurance, or deductible, for coverage provided pursuant to this section exceeding ten dollars ($10) per package of naloxone hydrochloride or another drug approved by the FDA for the complete or partial reversal of an opioid overdose.
(c) (1) If a health care service plan maintains a drug formulary grouped into tiers, the copayment of not more than ten dollars ($10) pursuant to subdivision (b) shall apply only to naloxone hydrochloride or another product approved by the FDA for the complete or partial reversal of an opioid overdose that is in Tier 1 or Tier 2 or that is provided over-the-counter at an in-network pharmacy.
(2) A health care service plan that maintains a drug formulary grouped into tiers shall include, for each of the plan’s formularies, in Tiers 1 and 2 combined, at least two drugs or products approved by the FDA for the complete or partial reversal of an opioid overdose.
(d) (1) Point-of-sale coverage for over-the-counter, FDA-approved naloxone hydrochloride or another drug or product approved by the FDA for over-the-counter complete or partial reversal of an opioid overdose shall be provided at in-network pharmacies.
(2) A health care service plan contract may impose a limit on the quantity of over-the-counter, FDA-approved naloxone hydrochloride covered if a reasonable limit is established by the department in coordination with the Department of Insurance.
(3) For purposes of this section, ”point-of-sale” means the ability to charge only the applicable cost sharing amount for an over-the-counter, FDA-approved opioid reversal or partial reversal drug or product at the time of purchase.
(e) If a health care service plan contract is a “high deductible health plan” under the definition set forth in Section 223(c)(2) of Title 26 of the United States Code, the contract shall not impose cost sharing as specified in this section, unless not applying cost sharing would conflict with federal requirements for high deductible health plans.
(f) This section does not limit the provisions of Sections 1342.7, 1342.73, 1367.206, 1367.24, 1367.241, and 1367.244 with respect to prescription naloxone hydrochloride or another product approved by the FDA for the complete or partial reversal of an opioid overdose.
(g) Coverage provided pursuant to this section shall be provided consistent with guidance issued by the FDA in connection with drugs or products approved by the FDA for the complete or partial reversal of an opioid overdose.
(h) A health care service plan contract that provides coverage for prescription drugs pursuant to this section may require an enrollee to obtain naloxone hydrochloride or another drug or product approved by the FDA for the complete or partial reversal of an opioid overdose from a network provider, consistent with this chapter.
(i) This section does not apply to Medi-Cal managed care plans contracting with the State Department of Health Care Services pursuant to Chapter 7 (commencing with Section 14000), Chapter 8 (commencing with Section 14200), or Chapter 8.75 (commencing with Section 14590) of Part 3 of Division 9 of the Welfare and Institutions Code, to the extent that the services described in this section are excluded from coverage under the contract between the Medi-Cal managed care plans and the State Department of Health Care Services.
(j) The director may issue guidance to health care service plans regarding compliance with this section. This guidance shall not be subject to the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). The department shall consult with the Department of Insurance in issuing the guidance specified in this subdivision.
(k) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.

SEC. 3.

 Section 10127.22 is added to the Insurance Code, immediately following Section 10127.20, to read:

10127.22.
 (a) A health insurance policy that provides coverage for prescription drugs and that is issued, amended, delivered, or renewed on or after January 1, 2025, shall cover prescription and nonprescription naloxone hydrochloride and all other drugs or products approved by the United States Food and Drug Administration (FDA) for the complete or partial reversal of an opioid overdose.
(b) A health insurance policy that provides coverage for prescription drugs shall not impose any cost-sharing requirements, including a copayment, coinsurance, or deductible, for coverage provided pursuant to this section exceeding ten dollars ($10) per package of naloxone hydrochloride or another drug approved by the FDA for the complete or partial reversal of an opioid overdose.
(c) (1) If a health insurer maintains a drug formulary grouped into tiers, the copayment of not more than ten dollars ($10) pursuant to subdivision (b) shall apply only to naloxone hydrochloride or another product approved by the FDA for the complete or partial reversal of an opioid overdose that is in Tier 1 or Tier 2 or that is provided over-the-counter at an in-network pharmacy.
(2) A health insurer that maintains a drug formulary grouped into tiers shall include, for each of the insurer’s formularies, in Tiers 1 and 2 combined, at least two drugs or products approved by the FDA for the complete or partial reversal of an opioid overdose.
(d) (1) Point-of-sale coverage for over-the-counter, FDA-approved naloxone hydrochloride or another drug or product approved by the FDA for over-the-counter complete or partial reversal of an opioid overdose shall be provided at in-network pharmacies.
(2) A health insurance policy may impose a limit on the quantity of over-the-counter, FDA-approved naloxone hydrochloride covered if a reasonable limit is established by the department in coordination with the Department of Managed Health Care.
(3) For purposes of this section, ”point-of-sale” means the ability to charge only the applicable cost sharing amount for an over-the-counter, FDA-approved opioid reversal or partial reversal drug or product at the time of purchase.
(e) If a health insurance policy is a “high deductible health plan” under the definition set forth in Section 223(c)(2) of Title 26 of the United States Code, the policy shall not impose cost sharing as specified in this section, unless not applying cost sharing would conflict with federal requirements for high deductible health plans.
(f) This section does not limit the provisions of Sections 10123.191, 10123.193, 10123.1932, 10123.197, and 10123.201 with respect to prescription naloxone hydrochloride or another product approved by the FDA for the complete or partial reversal of an opioid overdose.
(g) Coverage provided pursuant to this section shall be provided consistent with guidance issued by the FDA in connection with drugs or products approved by the FDA for the complete or partial reversal of an opioid overdose.
(h) A health insurance policy that provides coverage for prescription drugs pursuant to this section may require an insured to obtain naloxone hydrochloride or another drug or product approved by the FDA for the complete or partial reversal of an opioid overdose from a network provider, consistent with this chapter.
(i) The commissioner may issue guidance to insurers regarding compliance with this section. This guidance shall not be subject to the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). The department shall consult with the Department of Managed Health Care in issuing the guidance specified in this subdivision.
(j) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.

SEC. 4.

 Section 14132.37 is added to the Welfare and Institutions Code, immediately following Section 14132.36, to read:

14132.37.
 (a) Prescription or nonprescription naloxone hydrochloride or another drug approved by the United States Food and Drug Administration for the complete or partial reversal of an opioid overdose shall be a covered benefit under the Medi-Cal program.
(b) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.

SEC. 5.

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