Health and Safety Code section 1367.21
(a)
No health care service plan contract which covers prescription drug benefits shall 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), provided that all of the following conditions have been met:(1)
The drug is approved by the FDA.(2)
(A)The drug is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition; or(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.(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)
It shall be the responsibility of the participating prescriber to submit to the plan documentation supporting compliance with the requirements of subdivision (a), if requested by the plan.(c)
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.(d)
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.(e)
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.(f)
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.(g)
Nothing in this section shall be construed to 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.(h)
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.(i)
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.
Source:
Section 1367.21, https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=1367.21. (accessed Apr. 24, 2025).