(a) (1) A manufacturer of a new single-source drug may request inclusion of its drug on the list of contract drugs pursuant to Section 14105.33 provided all of the following conditions are met:
(A) The request is made within 12 months of approval for marketing by the federal Food and Drug Administration.
(B) The manufacturer agrees to negotiate a contract with the department to provide the drug at the manufacturer’s best price.
(C) (i) The manufacturer provides the department with necessary information, as specified by the department, in the request.
(ii) Notwithstanding clause (i), either of the following may be submitted by the manufacturer in lieu of the Summary Basis of Approval prepared by the federal Food and Drug Administration for that drug:
(I) The federal Food and Drug Administration’s approval or approvable letter for the drug and federal Food and Drug Administration’s approved labeling.
(II) The federal Food and Drug Administration’s medical officers’ and pharmacologists’ reviews and the federal Food and Drug Administration’s approved labeling.
(D) The department had concluded contracting for the therapeutic category in which the drug is included prior to approval of the drug by the federal Food and Drug Administration.
(2) Within 90 days from receipt of the request, the department shall evaluate the request using the criteria identified in subdivision (d), and shall submit the drug to the Medi-Cal Contract Drug Advisory Committee.
(b) Any petition for the addition to or deletion of a drug to the Medi-Cal drug formulary submitted prior to July 31, 1990, shall be deemed to be denied. A manufacturer who has submitted a petition deemed denied may request inclusion of that drug on the list of contract drugs provided all of the following conditions are met:
(1) The manufacturer agrees to negotiate for a contract with the department to provide the drug at the manufacturer’s best price.
(2) The manufacturer provides the department with necessary information, as specified by the department, in the request.
(3) The manufacturer submits the request to the department prior to October 1, 1990.
(c) (1) To ensure that the health needs of Medi-Cal beneficiaries are met consistent with the intent of this chapter, the department shall, when evaluating a decision to execute a contract, and when evaluating drugs for retention on, addition to, or deletion from, the list of contract drugs, use all of the following criteria:
(A) The safety of the drug.
(B) The effectiveness of the drug.
(C) The essential need for the drug.
(D) The potential for misuse of the drug.
(E) The cost of the drug.
(2) The deficiency of a drug when measured by one of these criteria may be sufficient to support a decision that the drug should not be added or retained, or should be deleted from the list. However, the superiority of a drug under one criterion may be sufficient to warrant the addition or retention of the drug, notwithstanding a deficiency in another criterion.
(d) (1) A manufacturer of single-source drugs denied a contract pursuant to this section or Section 14105.33 or 14105.37, may file an appeal of that decision with the director within 30 calendar days of the department’s written decision.
(2) Within 30 calendar days of the manufacturer’s appeal, the director shall request a recommendation regarding the appeal from the Medi-Cal Contract Drug Advisory Committee. The committee shall provide its recommendation in writing, within 30 calendar days of the director’s request.
(3) The director shall issue a final decision on the appeal within 30 calendar days of the recommendation.
(e) Deletions made to the list of contract drugs, including those made pursuant to Section 14105.37, shall become effective no sooner than 30 days after publication of the changes in provider bulletins.
(f) A manufacturer of a drug deleted from, or not added to, the list of contract drugs may request inclusion of the drug on the list of preferred prior authorization drugs that is hereby established as a subset of the list of contract drugs. To ensure that the health needs of Medi-Cal beneficiaries are met, the department shall evaluate the request pursuant to subdivision (c). The department shall give preference for prior authorization drugs based on the medical need or continuing care of the beneficiary. The department may contract with manufacturers of drugs on the list of preferred prior authorization drugs. Contracts executed pursuant to this subdivision are subject to Section 14105.33.
(g) Changes made to the list of contract drugs under this or any other section are exempt from the requirements of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340), Chapter 4 (commencing with Section 11370), and Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code), and shall not be subject to the review and approval of the Office of Administrative Law.
(Amended by Stats. 2002, Ch. 1161, Sec. 63. Effective September 30, 2002.)