10123.201.
(a) A policy of health insurance that covers outpatient prescription drugs shall cover medically necessary drugs. The policy may provide for step therapy and prior authorization consistent with Section 1342.7 of the Health and Safety Code and any regulations adopted pursuant to that section.(b) (1) Commencing January 1, 2017, an insurer shall maintain a pharmacy and therapeutics committee that shall be responsible for developing, maintaining, and overseeing any drug formulary list. If the insurer delegates responsibility for the formulary to any entity, the obligation of the insurer to comply with this part shall not be waived.
(2) The pharmacy and therapeutics committee board membership shall conform with both of the following:
(A) Represent a sufficient number of clinical specialties to adequately meet the needs of insureds.
(B) Consist of a majority of individuals who are practicing physicians, practicing pharmacists, and other practicing health professionals who are licensed to prescribe drugs.
(3) 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.
(4) At least 20 percent of the board membership shall not have a
conflict of interest with respect to the issuer or any pharmaceutical manufacturer.
(5) 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.
(6) The pharmacy and therapeutics committee shall do all of the following:
(A) Develop and document procedures to ensure appropriate drug review and inclusion.
(B) 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.
(C) Consider the therapeutic advantages of drugs in terms of safety and efficacy when selecting formulary drugs.
(D) Review policies that guide exceptions and other utilization management processes, including drug utilization review, quantity limits, and therapeutic interchange.
(E) Evaluate and analyze treatment protocols and procedures related to the insurer’s formulary at least annually.
(F) Review and approve all clinical prior authorization criteria, step therapy protocols, and quantity limit restrictions applied to each covered drug.
(G) Review new
United States Food and Drug Administration-approved drugs and new uses for existing drugs.
(H) Ensure the insurer’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 does not discourage enrollment by any group of insureds.
(I) Ensure the insurer’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.
(7) This subdivision 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 subdivision shall apply to the individual, small group, and large group markets.
(c) (1) A health insurer may impose prior authorization requirements on prescription drug benefits, consistent with the requirements of this part.
(2) (A) If there is more than one drug that is appropriate for the treatment of a medical condition, a health insurer may require step therapy.
(B) A step therapy exception shall be expeditiously granted if the healthcare health care
provider submits justification and supporting clinical documentation, if needed, to support the health care provider’s statement that any of the following are met:
(i) The required prescription drug is contraindicated or will likely cause an adverse reaction or physical or mental harm to the insured.
(ii) The insured’s provider expects the required prescription drug to be ineffective based on the known clinical characteristics of the insured and the known characteristics and history of the prescription drug regimen.
(iii) The insured has tried the required prescription drug, or another prescription drug in the same pharmacologic class or with the same mechanism of action, while covered by their
current or previous health insurance policy or health benefit plan contract or Medicaid, and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event. The health insurer may require the submission of completed documentation demonstrating that the insured has tried the required prescription drug before it was discontinued.
(iv) The required prescription drug is not in the best interest of the insured, based on medical necessity because the required drug is expected to cause any of the following:
(I) Worsen a comorbid condition of the insured.
(II) Decrease the insured’s ability to maintain a reasonable functional ability in performing daily activities.
(III) Be a significant barrier to the insured’s adherence to or compliance with the insured’s plan of care.
(v) The insured is stable on a prescription drug selected by their health care provider for the medical condition under consideration while covered by their current or previous health insurance policy or health care service plan contract or Medicaid.
(D) This section does not prohibit either of the following:
(i) An insurer, health benefit plan, or utilization review organization from requiring an insured to try an AB-rated generic equivalent or interchangeable biological product before providing coverage for the equivalent branded prescription drug.
(ii) A health care provider from prescribing a prescription drug that is determined to be medically appropriate.
(3) An insurer shall provide coverage for the medically necessary dosage and quantity of the drug prescribed for the treatment of a medical condition consistent with professionally recognized standards of practice.
(4) For plan years commencing on or after January 1, 2017, an insurer that provides essential health benefits shall allow an insured to access prescription drug benefits at an in-network retail pharmacy unless the prescription drug is subject to restricted distribution by the United States Food and Drug Administration or requires special handling, provider coordination, or patient education
that cannot be provided by a retail pharmacy. A nongrandfathered individual or small group health insurer may charge an insured a different cost sharing for obtaining a covered drug at a retail pharmacy, but all cost sharing shall count toward the policy’s annual limitation on cost sharing consistent with Section 10112.28.
(d) An insured or the insured’s designee, guardian, primary care physician, or health care provider may file an appeal of a prior authorization or the denial of a step therapy exception request. A health insurer shall designate a clinical peer to review appeals, because these appeals pertain to medical or clinical matters and an appeal shall be reviewed by an appropriate health care professional. A clinical peer reviewing an appeal shall not have had any involvement in the initial determination that is the subject of the
appeal.
(e) Every health insurer that provides prescription drug benefits shall maintain all of the following information, which shall be made available to the commissioner upon request:
(1) The complete drug formulary or formularies of the insurer, if the insurer maintains a formulary, including a list of the prescription drugs on the formulary of the insurer by major therapeutic category with an indication of whether any drugs are preferred over other drugs.
(2) Records developed by the pharmacy and therapeutics committee of the insurer, or by others responsible for developing, modifying, and overseeing formularies, including medical groups, individual practice associations, and contracting pharmaceutical benefit
management companies, used to guide the drugs prescribed for the insureds of the insurer, that fully describe the reasoning behind formulary decisions.
(3) Any insurer arrangements with prescribing providers, medical groups, individual practice associations, pharmacists, contracting pharmaceutical benefit management companies, or other entities that are associated with activities of the insurer to encourage formulary compliance or otherwise manage prescription drug benefits.
(f)The health insurer or utilization review organization shall
report, the following information to the department annually, in a manner and format prescribed by the department, including, but not limited to, any of the following:
(1)The number of step therapy exception requests and prior authorization requests received.
(2)The type of health care providers or the medical specialties of the health care providers submitting requests.
(3)The number of step therapy exception
requests that were initially denied and the reasons for the denials.
(4)The number of step therapy exception requests that were initially approved.
(5)The number of step therapy exception denials that were reversed by an internal appeal or an external review.
(6)The medical conditions for which patients are granted
exceptions due to the likelihood that switching from the prescription drug will likely cause an adverse reaction or physical or mental harm to the insured.
(g)
(f) If an insurer provides prescription drug benefits, the commissioner shall, as part of its market conduct examination, review the performance of the insurer in providing those benefits, including, but not limited to, a review of the procedures and information maintained pursuant to this section, and describe the performance of the insurer as part of its report issued as part of its market conduct examination.
(h)
(g) The commissioner shall not publicly disclose any information reviewed pursuant to this section that is determined by the commissioner to be confidential pursuant to state law.
(i)
(h) For purposes of this section, the following definitions shall apply:
(1) “Authorization” means approval by the health insurer to provide payment for the prescription drug.
(2) “Clinical peer” means a health care professional who is in the same profession and the same or similar specialty as the health care provider who typically manages the medical condition, procedures, or treatment under review.
(3) “Step therapy” means a type of protocol that specifies the sequence in which different prescription drugs for a given medical condition and medically appropriate for a particular patient are to be prescribed.
(4) “Step therapy exception” means the exception to the step therapy process and the determination of whether the exception will be granted, taking into consideration the insured’s needs and medical circumstances, along with the professional judgment of the insured’s
provider.
(5) “Utilization review organization” means an entity that conducts utilization review, other than a health insurer performing its own utilization review.
(j)
(i) Nonformulary prescription drugs shall include any drug for which an insured’s copayment or out-of-pocket costs are different than the copayment for a formulary prescription drug, except as otherwise provided by law or regulation.
(k)
(j) This section does not affect an insured’s or policyholder’s eligibility to submit a complaint to the department for review or to apply to the department for an independent medical review under Article 3.5 (commencing with Section 10169).
(l)
(k) This section does not restrict or impair the application of any other provision of this part.