Amended  IN  Assembly  June 29, 2023
Amended  IN  Senate  April 18, 2023
Amended  IN  Senate  March 08, 2023

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Senate Bill
No. 70

Introduced by Senator Wiener

January 09, 2023

An act to amend Sections 1367.21 and 1367.22 of the Health and Safety Code, and to amend Section 10123.195 of, and to add Section 10123.190 to, the Insurance Code, relating to health care coverage.


LEGISLATIVE COUNSEL'S DIGEST


SB 70, as amended, Wiener. Prescription drug coverage.
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. Existing law generally authorizes a health care service plan or health insurer to use utilization review, under which a licensed physician or a licensed health care professional who is competent to evaluate specific clinical issues may approve, modify, delay, or deny requests for health care services based on medical necessity. Existing law prohibits a health care service plan contract that covers prescription drug benefits or a specified health insurance policy from limiting or excluding coverage for a drug on the basis that the drug is prescribed for a use that is different from the use for which it was approved by the federal Food and Drug Administration if specified conditions are met. Existing law also prohibits a health care service plan that covers prescription drug benefits from limiting or excluding coverage for a drug that was previously approved for coverage if an enrollee continues to be prescribed that drug, as specified.
This bill would additionally prohibit limiting or excluding coverage of a drug, dose of a drug, or dosage form of a drug that is prescribed for off-label use if the drug has been previously covered for a chronic condition or cancer, as specified, regardless of whether or not the drug, dose, or dosage form is on the plan’s or insurer’s formulary. The bill would prohibit a health care service plan contract or health insurance policy from requiring additional cost sharing not already imposed for a drug that was previously approved for coverage. 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.

 Section 1367.21 of the Health and Safety Code is amended to read:

1367.21.
 (a) A health care service plan contract that covers prescription drug benefits shall not be issued, amended, delivered, or renewed in this state if the plan limits or excludes coverage for a drug on the basis that the drug is prescribed for a use that is different from the use for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), if all of the following conditions have been met:
(1) The drug is approved by the FDA.
(2) One of the following is true:
(A) The drug is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition.
(B) The drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the plan formulary. If the drug is not on the plan formulary, the participating subscriber’s request shall be considered pursuant to the process required by Section 1367.24.
(3) The drug has been recognized for treatment of that condition by any of the following:
(A) The American Hospital Formulary Service’s Drug Information.
(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:
(i) The Elsevier Gold Standard’s Clinical Pharmacology.
(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.
(iii) The Thomson Micromedex DrugDex.
(C) Two articles from major peer-reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal.
(b) A health care service plan contract that covers prescription drug benefits shall not be issued, amended, delivered, or renewed in this state if the plan limits or excludes coverage for a drug, dose of a drug, or dosage form of a drug on the basis that the drug, dose of a drug, or dosage form is prescribed for a use, dose, or dosage form that is different from the use, dose, or dosage form for which the drug has been approved for marketing by the FDA if all of the following conditions have been met:
(1) The drug is approved by the FDA.
(2) One of the following is true:
(A) The drug, dose, or dosage form is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition.
(B) The drug, dose, or dosage form is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition and the drug, dose, or dosage form is medically necessary to treat that condition.
(3) The drug has been recognized for treatment of that condition by any of the following:
(A) The American Hospital Formulary Service’s Drug Information.
(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:
(i) The Elsevier Gold Standard’s Clinical Pharmacology.
(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.
(iii) The Thomson Micromedex DrugDex.
(C) Two articles from major peer-reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal.
(4) The drug has been previously covered pursuant to Section 1367.22 for a chronic condition or cancer.
(c) It shall be the responsibility of the participating prescriber to submit to the plan documentation supporting compliance with the requirements of subdivisions (a) and (b), if requested by the plan.
(d) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug, subject to the conditions of the contract.
(e) For purposes of this section, “life-threatening” means either or both of the following:
(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.
(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.
(f) For purposes of this section, “chronic and seriously debilitating” means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.
(g) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the plan.
(h) This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.
(i) If a plan denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under Section 1370.4.
(j) Health care service plan contracts for the delivery of Medi-Cal services under the Waxman-Duffy Prepaid Health Plan Act (Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code) are exempt from the requirements of this section.

SEC. 2.

 Section 1367.22 of the Health and Safety Code is amended to read:

1367.22.
 (a)  A health care service plan contract, issued, amended, or renewed on or after July 1, 1999, that covers prescription drug benefits shall not limit or exclude coverage, or require additional cost sharing not already imposed, for a drug, dose of a drug, or dosage form for an enrollee if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee and the plan’s prescribing provider continues to prescribe the drug for the medical condition, provided that the drug, dose of the drug, or dosage form is appropriately prescribed and is considered safe and effective for treating the enrollee’s medical condition. This section does not preclude the prescribing provider from prescribing another drug covered by the plan that is medically appropriate for the enrollee, and does not prohibit generic drug substitutions as authorized by Section 4073 of the Business and Professions Code. For purposes of this section, a prescribing provider shall include a provider authorized to write a prescription, pursuant to subdivision (a) of Section 4059 of the Business and Professions Code, to treat a medical condition of an enrollee.
(b) This section shall not be construed to restrict or impair the application of any other provision of this chapter, including, but not limited to, Section 1367, which includes among its requirements that plans furnish services in a manner providing continuity of care and demonstrate that medical decisions are rendered by qualified medical providers unhindered by fiscal and administrative management. With respect to cost sharing, this shall not be construed to affect application of a deductible or coinsurance, or cost-sharing changes associated with contract changes at renewal. If the change of dosage or dosage form results in coverage of a drug in a higher tier, the plan may charge additional cost sharing associated with that tier.
(c) This section does not prohibit a health care service plan from charging a subscriber or enrollee a copayment or a deductible for prescription drug benefits or from setting forth, by contract, limitations on maximum coverage of prescription drug benefits, provided that the copayments, deductibles, or limitations are reported to, and held unobjectionable by, the director and set forth to the subscriber or enrollee pursuant to the disclosure provisions of Section 1363.
(d) This section applies to a prescription drug that is prescribed off-label in accordance with Section 1367.21.

SEC. 3.

 Section 10123.190 is added to the Insurance Code, to read:

10123.190.
 (a) A health insurance policy that covers prescription drugs that is issued, amended, or renewed on or after January 1, 2024, shall not limit or exclude coverage, or require authorization or additional cost sharing for a drug, dosage of a drug, or dosage form of a drug if the insurer had previously approved coverage of the drug for a health condition, and a participating provider continues to prescribe the drug for the condition, if the drug, dosage, or dosage form of the drug was prescribed appropriately and is considered safe and effective for an insured’s health condition under current generally accepted standards of care. With respect to cost sharing, this shall not be construed to affect application of a deductible or coinsurance, or cost-sharing changes associated with policy changes at renewal. If the change of dosage or dosage form results in coverage of a drug in a higher tier, the insurer may charge additional cost sharing associated with that tier.
(b) A prescription drug is prescribed appropriately if a provider is authorized to prescribe or furnish the drug within the provider’s scope of practice. This section does not preclude a participating provider from prescribing or furnishing another drug that is clinically appropriate for an insured or prohibit generic drug substitution as authorized by Section 4073 of the Business and Professions Code.
(c) This section applies to a prescription drug that was prescribed off-label, including in accordance with Section 10123.195. This section does not apply to a Medicare supplement policy or a specialized health insurance policy that covers only dental or vision benefits.
(d) The commissioner may promulgate regulations 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) to implement and enforce this section. In addition to any other remedies that are available to the commissioner for a violation of this code, the commissioner may enforce this section pursuant to Chapter 4.5 (commencing with Section 11400) or Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. This subdivision does not impair or restrict the commissioner’s authority pursuant to another provision of this code or the Administrative Procedure Act.

SEC. 4.

 Section 10123.195 of the Insurance Code is amended to read:

10123.195.
 (a) An individual or group health insurance policy issued, delivered, or renewed in this state, or a certificate of group insurance issued, delivered, or renewed in this state pursuant to a master group policy issued, delivered, or renewed in another state, that directly or indirectly covers prescription drugs shall not limit or exclude coverage for a drug on the basis that the drug is prescribed for a use that is different from the use for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), if all of the following conditions have been met:
(1) The drug is approved by the FDA or is legally marketed without FDA approval.
(2) One of the following is true:
(A) The drug is prescribed by a contracting licensed health care professional for the treatment of a life-threatening condition.
(B) The drug is prescribed by a contracting licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the insurer’s formulary, if any. If the drug is not on the insurer’s formulary, the participating prescriber’s request shall be considered pursuant to the process required by Section 10123.191.
(3) The drug has been recognized for treatment of that condition by any of the following:
(A) The American Hospital Formulary Service’s Drug Information.
(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:
(i) The Elsevier Gold Standard’s Clinical Pharmacology.
(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.
(iii) The Thomson Micromedex DrugDex.
(C) Two articles from major peer-reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal.
(b) An individual or group health insurance policy issued, delivered, or renewed in this state, or a certificate of group insurance issued, delivered, or renewed in this state pursuant to a master group policy issued, delivered, or renewed in another state, that directly or indirectly covers prescription drugs shall not limit or exclude coverage for a drug, dose of a drug, or dosage form of a drug on the basis that the drug, dose of a drug, or dosage form is prescribed for a use, dose, or dosage form that is different from the use, dose, or dosage form for which the drug has been approved for marketing by the FDA if all of the following conditions have been met:
(1) The drug is approved by the FDA or is legally marketed without FDA approval.
(2) One of the following is true:
(A) The drug, dose, or dosage form is prescribed by a contracting licensed health care professional for the treatment of a life-threatening condition or health condition as provided by Section 10123.1961.
(B) The drug, dose, or dosage form is prescribed by a contracting licensed health care professional for the treatment of a chronic and seriously debilitating health condition and the drug, dose, or dosage form is clinically appropriate to treat that condition. If the prescription drug is not covered or not covered off-label, then clinical appropriateness shall be determined solely in accordance with paragraph (3).
(3) The drug has been recognized for treatment of that condition by any of the following:
(A) The American Hospital Formulary Service’s Drug Information.
(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:
(i) The Elsevier Gold Standard’s Clinical Pharmacology.
(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.
(iii) The Thomson Micromedex DrugDex.
(C) Two articles from major peer-reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal.
(4) The In the case of the dose or dosage form of the drug, the drug has been previously covered pursuant to Section 10123.190 for a chronic condition or cancer.
(c) It shall be the responsibility of the contracting prescriber to submit to the insurer documentation supporting compliance with the requirements of subdivisions (a) and (b), if requested by the insurer. With respect to a request for coverage of a prescription drug pursuant to Section 10123.191, it shall be the responsibility of the health insurer to determine whether or not this section applies to the request, and to request any additional or omitted information that is needed to make a coverage determination pursuant to the request under the requirements of this section and Section 10123.191.
(d) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug.
(e) For purposes of this section, “life-threatening” means either or both of the following:
(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.
(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.
(f) For purposes of this section, “chronic and seriously debilitating” means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.
(g) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the insurer.
(h) This section shall not apply to a policy of insurance that covers health care expenses and that is issued outside of California to an employer whose principal place of business and majority of employees are located outside of California.
(i) If an insurer denies coverage pursuant to this section on the basis that off-label use of a prescription drug is experimental, investigational, or not clinically appropriate, or for any other reason, that decision is subject to review under the Independent Medical Review System of Article 3.5 (commencing with Section 10169).
(j) This section is not applicable to vision-only, dental-only, or Medicare supplement insurance policies.
(k) The commissioner may promulgate regulations 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) to implement and enforce this section. In addition to any other remedies that are available to the commissioner for a violation of this code, the commissioner may enforce this section pursuant to Chapter 4.5 (commencing with Section 11400) or Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. This subdivision does not impair or restrict the commissioner’s authority pursuant to another provision of this code or the Administrative Procedure Act.

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.