Today's Law As Amended


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SB-521 Drug manufacturers: value-based arrangement.(2021-2022)



As Amends the Law Today


SECTION 1.

 Section 14105.3 of the Welfare and Institutions Code is amended to read:

14105.3.
 (a) The department is considered to be  the purchaser, but not the dispenser or distributor, of prescribed drugs under the Medi-Cal program for the purpose of enabling the department to obtain from manufacturers of prescribed drugs the most favorable price for those drugs furnished by one or more manufacturers, based upon the large quantity of the drugs purchased under the Medi-Cal program, and to enable the department, notwithstanding any other provision of state  law, to obtain from the manufacturers discounts, rebates, or refunds based on the quantities purchased under the program, insofar as may be permissible  to the extent permitted  under federal law. Nothing in this  This  section shall not  interfere with usual and customary distribution practices in the drug industry.
(b) The department may enter into exclusive or nonexclusive contracts on a bid or negotiated basis with manufacturers, distributors, dispensers, or suppliers of appliances, durable medical equipment, medical supplies, and other product-type health care services and with laboratories for clinical laboratory services for the purpose of obtaining the most favorable prices to the state and to assure adequate quality of the product or service. Except as provided in subdivision (f), this subdivision shall not apply to prescribed drugs dispensed by pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2 of the Business and Professions Code.
(c) Notwithstanding subdivision (b), the department may shall  not enter into a contract with a clinical laboratory unless the clinical laboratory operates in conformity with Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code and the regulations adopted thereunder, and  Code,  Section 263a of Title 42 of the United States Code Code,  and the regulations adopted thereunder. pursuant to those provisions. 
(d) (1)  The department shall contract with manufacturers of single-source drugs on a negotiated basis, and with manufacturers of multisource drugs on a bid or negotiated basis.
(2) (A) Notwithstanding any other law, the department may enter into a written value-based arrangement with drug manufacturers based on outcome data or other metrics, as determined by the department and the drug manufacturers, pursuant to those contracts.
(B) A value-based arrangement may include, but is not limited to, a rebate, discount, price reduction, contribution, risk sharing, reimbursement, payment deferral, installment payment, guarantee, shared savings payment, withhold, bonus, or patient care.
(C) (i) To ensure that the health needs of Medi-Cal beneficiaries are met in a way that is consistent with this chapter, a value-based arrangement negotiated and entered into by the department with a manufacturer pursuant to this subdivision shall meet the drug evaluation criteria set forth in Section 14105.39 of this code and Section 51313.6 of Title 22 of the California Code of Regulations.
(ii) The department shall incorporate terms and conditions in a value-based arrangement that address the frequency and duration of payments, tracking and measurement of patient outcomes, if applicable, and verification of drug utilization as a measure of patient access to the drug.
(D) On or before July 1, 2022, the department shall report to the Legislature on how value-based arrangements may be implemented in the Medi-Cal program, including its recommendations for doing so. The report shall be submitted in compliance with Section 9795 of the Government Code.
(e) In order to  To  ensure and improve access by Medi-Cal beneficiaries to both  hearing aid appliances and provider services, and to ensure that the state obtains the most favorable prices, the department, by June 30, 2008, shall enter into exclusive or nonexclusive contracts, on a bid or negotiated basis, for purchasing hearing aid appliances.
(f) In order to  To  provide specialized care in the distribution of specialized drugs, including blood factors and immunizations,  as identified by the department and that include, but are not limited to, blood factors and immunizations,  department,  the department may enter into contracts with providers licensed to dispense dangerous drugs or devices pursuant to Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code, for programs that qualify for federal funding pursuant to the Medicaid state plan, plan  or waivers, and the programs authorized by Article 5 (commencing with Section 123800) of Chapter 3 of Part 2 of, and Article 1 (commencing with Section 125125) of Chapter 2 of Part 5 of, Division 106 of the Health and Safety Code, in accordance with this subdivision.
(1) The department shall, for  For  purposes of ensuring proper patient care, the department shall  consult current standards of practice when executing a provider contract.
(2) The department shall, for  For  purposes of ensuring quality of care to people with unique conditions requiring specialty drugs, the department shall  contract with a nonexclusive number of providers that meet the needs of the affected population, covers all geographic regions in California, and reflects the distribution of the specialty drug in the community. The department may use a single provider in if  the event the  product manufacturer designates a sole-source delivery mechanism. The department shall consult with interested parties and appropriate stakeholders in implementing this section with respect to all of the following:
(A) Notifying stakeholder representatives of the potential inclusion or exclusion of drugs in the specialty pharmacy program.
(B) Allowing for written input regarding on  the potential inclusion or exclusion of drugs into the specialty pharmacy program.
(C) Scheduling at least one public meeting regarding on  the potential inclusion or exclusion of drugs into the specialty pharmacy program.
(D) Obtaining a recommendation from the Medi-Cal Drug Utilization Review Advisory Committee, established pursuant to Section 1927 of the federal Social Security Act (42 U.S.C. Sec. 1396r-8), on the inclusion or exclusion of drugs into the specialty pharmacy program distribution based on clinical best practices related to each drug considered.
(3) For purposes of this subdivision, the definition of  “blood factors” has the same meaning as that term is defined in Section 14105.86.
(4) The department shall make every reasonable effort to ensure all medically necessary clotting factor therapies are available for the treatment of people with bleeding disorders.
(g) The department may contract with an intermediary to establish provider contracts pursuant to this section for programs that qualify for federal funding pursuant to the Medicaid state plan, plan  or waivers, and the programs authorized by Article 5 (commencing with Section 123800) of Chapter 3 of Part 2 of, and Article 1 (commencing with Section 125125) of Chapter 2 of Part 5 of, Division 106 of the Health and Safety Code.
(h) In carrying out contracting activity for this or any section associated with the Medi-Cal list of contract drugs, notwithstanding Section 19130 of the Government Code, the department may contract, either directly or through the fiscal intermediary, for pharmacy consultant staff necessary to accomplish the contracting process or treatment authorization request reviews. The fiscal intermediary contract, including any contract amendment, system change pursuant to a change order, and project or systems development notice shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code and any policies, procedures, or regulations authorized by these provisions.
(i) In order to  To  achieve maximum cost savings, the Legislature hereby determines that an expedited contract process for contracts under this section is necessary. Therefore, contracts under this section shall be exempt from Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of the Public Contract Code.
(j) For purposes of implementing the contracting provisions specified in this section, the department shall do all of the following:
(1) Ensure adequate access for Medi-Cal patients to quality laboratory testing services in the geographic regions of the state where contracting occurs.
(2) Consult with the statewide association of clinical laboratories and other appropriate stakeholders on the implementation of the contracting provisions specified in this section to ensure maximum access for Medi-Cal patients consistent with the savings targets projected by the 2002–03 budget conference committee for clinical laboratory services provided under the Medi-Cal program.
(3) Consider which types of laboratories are appropriate for implementing the contracting provisions specified in this section, including independent laboratories, outreach laboratory programs of hospital-based laboratories, clinic laboratories, physician office laboratories, and group practice laboratories.