Bill Text: CA SB1452 | 2019-2020 | Regular Session | Amended


Bill Title: Biological products.

Spectrum: Partisan Bill (Republican 1-0)

Status: (Introduced - Dead) 2020-05-11 - Re-referred to Com. on HEALTH. [SB1452 Detail]

Download: California-2019-SB1452-Amended.html

Amended  IN  Senate  April 17, 2020
Amended  IN  Senate  March 25, 2020

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Senate Bill
No. 1452


Introduced by Senator Morrell

February 21, 2020


An act to add Section 1342.715 to the Health and Safety Code, and to add Section 10123.1935 to the Insurance Code, relating to health care coverage.


LEGISLATIVE COUNSEL'S DIGEST


SB 1452, as amended, Morrell. Biological products.
Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, and makes a willful violation of the act a crime. Existing law also provides for the regulation of health insurers by the Insurance Commissioner. Existing law requires a health care service plan contract or a health insurance policy that provides coverage for outpatient prescription drugs to cover medically necessary prescription drugs, including nonformulary drugs determined to be medically necessary, and authorizes a health care service plan or health insurer to utilize formulary, prior authorization, step therapy, or other reasonable medical management practices in the provision of outpatient prescription drug coverage.

This bill would require a

With respect to a health care service plan contract or health insurance policy issued, amended, or renewed on or after January 1, 2021, to include coverage for any biological product or biosimilar, as defined, if the health care service plan contract or health insurance policy provides for medical or prescription drug benefits and coverage for any biological product or biosimilar. that provides coverage for biological products or their respective biosimilars, as defined, this bill would prohibit a health care service plan or health insurer from determining which manufacturer’s biological products or their respective biosimilars are to be used when medically necessary biological products or their respective biosimilars are prescribed. The bill would prohibit a health care service plan or health insurer that is subject to this provision from determining requiring prior authorization or step therapy to limit which manufacturer’s biological product or biosimilar is to be a physician-administered biological product when a medically necessary biological product or biosimilar is prescribed. products or their respective biosimilars are to be administered by a physician or clinician to an enrollee or insured.
By imposing new requirements on a health care service plan, the willful violation of which is a crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

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


SECTION 1.

 Section 1342.715 is added to the Health and Safety Code, immediately following Section 1342.71, to read:

1342.715.
 (a) A If a health care service plan contract, including a specialized health care service plan contract, issued, amended, or renewed on or after January 1, 2021, shall provide coverage for any biological product or biosimilar if that health care service plan contract provides for both of the following: provides coverage for biological products or their respective biosimilars as a medical benefit, that health care service plan shall not determine which manufacturer’s biological products or their respective biosimilars are to be used when medically necessary biological products or their respective biosimilars are prescribed. This prohibition applies to physician- or clinician-administered biological products or their respective biosimilars.

(1)Medical or prescription drug benefits.

(2)Coverage for any biological product or biosimilar.

(b) A health care service plan subject to this section shall not determine which manufacturer’s biological product or biosimilar is to be a physician-administered biological product when a medically necessary biological product or biosimilar is prescribed. This prohibition applies to any biological product or biosimilar covered under either an enrollee’s outpatient prescription drug benefit or their medical benefit. require prior authorization or step therapy to limit which manufacturer’s biological products or their respective biosimilars are to be administered by a physician or clinician to an enrollee.
(c) For purposes of this section, the following definitions apply:
(1) “Biological product” products” has the same meaning as that term is “biological product,” as defined under Section 262(i)(1) of Title 42 of the United States Code.
(2) “Biosimilar” “Biosimilars” has the same meaning as that term is “biosimilar,” as defined under Section 262(i)(2) of Title 42 of the United States Code.
(3) “Physician-administered biological product” means a biological product or biosimilar that is “Physician- or clinician-administered biological products or their respective biosimilars” means biological products or biosimilars that are administered by a health care provider in a provider’s office, or clinician in a hospital, clinic, infusion center, their office, or other health care facility setting.

SEC. 2.

 Section 10123.1935 is added to the Insurance Code, immediately following Section 10123.1933, to read:

10123.1935.
 (a) A If a health insurance policy, including a specialized health insurance policy, issued, amended, or renewed on or after January 1, 2021, shall provide coverage for any biological product or biosimilar if that health insurance policy provides for both of the following: provides coverage for biological products or their respective biosimilars as a medical benefit, the health insurer shall not determine which manufacturer’s biological products or their respective biosimilars are to be used when medically necessary biological products or their respective biosimilars are prescribed. This prohibition applies to physician- or clinician-administered biological products or their respective biosimilars.

(1)Medical or prescription drug benefits.

(2)Coverage for any biological product or biosimilar.

(b) A health insurer subject to this section shall not determine which manufacturer’s biological product or biosimilar is to be a physician-administered biological product when a medically necessary biological product or biosimilar is prescribed. This prohibition applies to any biological product or biosimilar covered under either an insured’s outpatient prescription drug benefit or their medical benefit. require prior authorization or step therapy to limit which manufacturer’s biological products or their respective biosimilars are to be administered by a physician or clinician to an insured.
(c) For purposes of this section, the following definitions apply:
(1) “Biological product” products” has the same meaning as that term is “biological product,” as defined under Section 262(i)(1) of Title 42 of the United States Code.
(2) “Biosimilar” “Biosimilars” has the same meaning as that term is “biosimilar,” as defined under Section 262(i)(2) of Title 42 of the United States Code.
(3) “Physician-administered biological product” means a biological product or biosimilar that is “Physician- or clinician-administered biological products or their respective biosimilars” means biological products or biosimilars that are administered by a health care provider in a provider’s office, or clinician in a hospital, clinic, infusion center, their office, or other health care facility setting.

SEC. 3.

 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.
feedback