Prescription drug coverage: dose adjustments., the official text

An act to add Section 1367.225 to the Health and Safety Code, and to add Section 10123.1934 to the Insurance Code, relating to health care coverage.

LEGISLATIVE COUNSEL'S DIGEST

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 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 authorize an enrollee’s or insured’s treating provider to request, and would require that they be granted, the authority to adjust the dose or frequency of a drug to meet the specific medical needs of the enrollee or insured without prior authorization if specified conditions are met. 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.

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

SECTION 1.
Section 1367.225 is added to the Health and Safety Code, to read:
1367.225.
(a) An enrollee’s treating provider may request, and shall be granted, the authority to adjust the dose or frequency of a drug to meet the specific medical needs of the enrollee without prior authorization or subsequent utilization management if all of the following conditions are met:
(1) The drug previously had been approved for coverage by the plan for an enrollee’s chronic medical condition or cancer treatment and the enrollee’s treating provider continues to prescribe the drug for the enrollee’s chronic medical condition or cancer treatment.
(2) The drug is not an opioid or a scheduled controlled substance.
(3) The dose has not been adjusted more than two times without prior authorization.
(4) If the adjusted dose or frequency is for an off-label use, two articles from major peer-reviewed medical journals have presented data supporting the proposed off-label use as generally safe and effective as described in subparagraph (C) of paragraph (3) of subdivision (a) of Section 1367.21.
(b) This section does not apply to a Medi-Cal managed care plan 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 14591) of Part 3 of Division 9 of the Welfare and Institutions Code.

SEC. 2.
Section 10123.1934 is added to the Insurance Code, to read:
10123.1934.
An insured’s treating provider may request, and shall be granted, the authority to adjust the dose or frequency of a drug to meet the specific medical needs of the insured without prior authorization or subsequent utilization management if all of the following conditions are met:
(a) The drug previously had been approved for coverage by the insurer for an insured’s chronic medical condition or cancer treatment and the insured’s treating provider continues to prescribe the drug for the insured’s chronic medical condition or cancer treatment.
(b) The drug is not an opioid or a scheduled controlled substance.
(c) The dose has not been adjusted more than two times without prior authorization.
(d) If the adjusted dose or frequency is for an off-label use, two articles from major peer-reviewed medical journals have presented data supporting the proposed off-label use as generally safe and effective as described in subparagraph (C) of paragraph (3) of subdivision (a) of Section 10123.195.

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.