Section 1367.41 Of Article 5. Standards From California Health And Safety Code >> Division 2. >> Chapter 2.2. >> Article 5.
1367.41
. (a) Commencing January 1, 2017, a health care service plan
shall maintain a pharmacy and therapeutics committee that shall be
responsible for developing, maintaining, and overseeing any drug
formulary list. If the plan delegates responsibility for the
formulary to any entity, the obligation of the plan to comply with
this chapter shall not be waived.
(b) The pharmacy and therapeutics committee board membership shall
conform with both of the following:
(1) Represent a sufficient number of clinical specialties to
adequately meet the needs of enrollees.
(2) Consist of a majority of individuals who are practicing
physicians, practicing pharmacists, and other practicing health
professionals who are licensed to prescribe drugs.
(c) Members of the board shall abstain from voting on any issue in
which the member has a conflict of interest with respect to the
issuer or a pharmaceutical manufacturer.
(d) At least 20 percent of the board membership shall not have a
conflict of interest with respect to the issuer or any pharmaceutical
manufacturer.
(e) The pharmacy and therapeutics committee shall meet at least
quarterly and shall maintain written documentation of the rationale
for its decisions regarding the development of, or revisions to, the
formulary drug list.
(f) The pharmacy and therapeutics committee shall do all of the
following:
(1) Develop and document procedures to ensure appropriate drug
review and inclusion.
(2) Base clinical decisions on the strength of the scientific
evidence and standards of practice, including assessing peer-reviewed
medical literature, pharmacoeconomic studies, outcomes research
data, and other related information.
(3) Consider the therapeutic advantages of drugs in terms of
safety and efficacy when selecting formulary drugs.
(4) Review policies that guide exceptions and other utilization
management processes, including drug utilization review, quantity
limits, and therapeutic interchange.
(5) Evaluate and analyze treatment protocols and procedures
related to the plan's formulary at least annually.
(6) Review and approve all clinical prior authorization criteria,
step therapy protocols, and quantity limit restrictions applied to
each covered drug.
(7) Review new United States Food and Drug Administration-approved
drugs and new uses for existing drugs.
(8) Ensure that the plan's formulary drug list or lists cover a
range of drugs across a broad distribution of therapeutic categories
and classes and recommended drug treatment regimens that treat all
disease states and do not discourage enrollment by any group of
enrollees.
(9) Ensure that the plan's formulary drug list or lists provide
appropriate access to drugs that are included in broadly accepted
treatment guidelines and that are indicative of general best
practices at the time.
(g) This section shall be interpreted consistent with federal
guidance issued under paragraph (3) of subdivision (a) of Section
156.122 of Title 45 of the Code of Federal Regulations. This section
shall apply to the individual, small group, and large group markets.