Bill Text: CA SB838 | 2021-2022 | Regular Session | Chaptered
Bill Title: Health care: prescription drugs.
Spectrum: Partisan Bill (Democrat 2-0)
Status: (Passed) 2022-09-27 - Chaptered by Secretary of State. Chapter 603, Statutes of 2022. [SB838 Detail]
Download: California-2021-SB838-Chaptered.html
Senate Bill
No. 838
CHAPTER 603
An act to amend Sections 127692 and 127693 of, and to add Section 127694.1 to, the Health and Safety Code, relating to health care.
[
Approved by
Governor
September 27, 2022.
Filed with
Secretary of State
September 27, 2022.
]
LEGISLATIVE COUNSEL'S DIGEST
SB 838, Pan.
Health care: prescription drugs.
Existing law, the California Affordable Drug Manufacturing Act of 2020, requires the California Health and Human Services Agency (CHHSA) to enter into partnerships, in consultation with other state departments as necessary to, among other things, increase patient access to affordable drugs. Existing law requires CHHSA to enter into such partnerships to produce or distribute at least one form of insulin, if a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in savings.
Existing law, for the purposes of implementing the California Affordable Drug Manufacturing Act of 2020, until December 31, 2027, permits CHHSA and its departments to enter into exclusive or nonexclusive contracts on a bid or negotiated basis.
This bill would require CHHSA to establish metrics to measure progress and efficiency, and remedies in the case those metrics
are not met, and include those metrics and remedies in any contract entered into pursuant to these provisions. The bill would eliminate the viability requirement for the manufacturing of insulin pursuant to these provisions and would require any partnership, among other things, to consider guaranteeing priority access to insulin supply for the state.
This bill would require, upon appropriation by the Legislature, the development of a California-based manufacturing facility for insulin with the intent of creating high-skill, high-paying jobs within the state.
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NOBill Text
The people of the State of California do enact as follows:
SECTION 1.
Section 127692 of the Health and Safety Code is amended to read:127692.
(a) The California Health and Human Services Agency (CHHSA) or its departments shall enter into partnerships, consistent with subdivision (b) of Section 127693, in consultation with other state departments as necessary, to increase competition, lower prices, and address shortages in the market for generic prescription drugs, to reduce the cost of prescription drugs for public and private purchasers, taxpayers, and consumers, and to increase patient access to affordable drugs.(b) Until December 31, 2027, for purposes of implementing this chapter, CHHSA and its departments, including the Department of Health Care Access and Information, may enter into exclusive or nonexclusive contracts on a bid or negotiated basis. Contracts entered into or amended pursuant to
this section are exempt from Chapter 6 (commencing with Section 14825) of Part 5.5 of Division 3 of Title 2 of the Government Code and Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code, and are exempt from the review or approval of any division of the Department of General Services. CHHSA shall establish initial and ongoing metrics to measure progress and efficiency, and remedies in the case those metrics are not met, and shall include those metrics and remedies in any partnership contract entered into pursuant to this section.
(c) CHHSA shall have the ability to hire staff to oversee and project-manage the partnerships for manufacturing or distribution of generic prescription drugs, contingent upon an appropriation by the Legislature for this purpose.
(d) It is the Legislature’s intent that any partnership contract entered into pursuant to subdivision (b) is a partnership intended to create a California-branded label for generic drugs. It is further the Legislature’s intent that any manufacturing that is done under this section is intended to benefit the residents of this state by ensuring adequate supplies and access to generic prescription drugs and lowering health care costs through savings to public health care programs and private health insurance coverage.
SEC. 2.
Section 127693 of the Health and Safety Code is amended to read:127693.
(a) CHHSA shall enter into partnerships resulting in the production or distribution of generic prescription drugs, with the intent that these drugs be made widely available to public and private purchasers, providers and suppliers as defined in subdivision (b) of Section 1367.50, and pharmacies as defined in Section 4037 of the Business and Professions Code, as appropriate. The generic prescription drugs shall be produced or distributed by a drug company or generic drug manufacturer that is registered with the United States Food and Drug Administration.(b) (1) CHHSA shall only enter into partnerships pursuant to subdivision (a) to produce a generic prescription drug
at a price that results in savings, targets failures in the market for generic drugs, and improves patient access to affordable medications.
(2) For top drugs identified pursuant to the criteria listed in paragraph (5), CHHSA shall determine if viable pathways exist for partnerships to manufacture or distribute generic prescription drugs by examining the relevant legal, market, policy, and regulatory factors.
(3) CHHSA shall consider the following, if applicable, when setting the price of the generic prescription drug:
(A) United States Food and Drug Administration user fees.
(B) Abbreviated new drug application acquisition costs amortized over a five-year
period.
(C) Mandatory rebates.
(D) Total contracting and production costs for the drug, including a reasonable amount for administrative, operating, and rate-of-return expenses of the drug company or generic drug manufacturer.
(E) Research and development costs attributed to the drug over a five-year period.
(F) Other initial start-up costs amortized over a five-year period.
(4) Each drug shall be made available to providers, patients, and purchasers at a transparent price and without rebates, other than federally required rebates.
(5) CHHSA shall prioritize the selection of generic prescription drugs that have the greatest impact on lowering drug costs to patients, increasing competition and addressing shortages in the prescription drug market, improving public health, or reducing the cost of prescription drugs to public and private purchasers.
(c) (1) In identifying generic prescription drugs to be produced, CHHSA shall consider the report produced by the Department of Managed Health Care pursuant to subdivision (b) of Section 1367.243, the report produced by the Department of Insurance pursuant to subdivision (b) of Section 10123.205 of the Insurance Code, and pharmacy spending data from Medi-Cal and other entities for which the state pays the cost of generic prescription drugs.
(2) The partnerships entered into pursuant to subdivision (a) shall include the production of at least one form of insulin made available at production and dispensing costs, if one does not already exist in the market. Dispensing costs may include related expenses such as transportation, distribution, and market operations. Any partnership shall also consider:
(A) Guaranteeing priority access to insulin supply for the state.
(B) Guaranteeing the manufacture of at least four high-priority drugs for California, as identified pursuant to paragraph (5) of subdivision (b).
(C) Creating a state brand identifying biosimilar insulin and generic
prescription drugs sold in California under this section.
(3) CHHSA shall prioritize drugs for chronic and high-cost conditions, and shall consider prioritizing those that can be delivered through mail order.
(d) CHHSA shall consult with all of the following public and private purchasers, as appropriate, to develop a list of generic prescription drugs to be manufactured or distributed through
partnerships:
(1) The Public Employees’ Retirement System, the State Department of Health Care Services, the California Health Benefit Exchange (Covered California), the State Department of Public Health, the Department of General Services, and the Department of Corrections and Rehabilitation, or the entities acting on behalf of each of those state purchasers.
(2) Licensed health care service plans.
(3) Health insurers holding a valid outstanding certificate of authority from the Insurance Commissioner.
(4) Hospitals.
(e) Before effectuating a partnership pursuant to this section, CHHSA shall consider the volume of each generic prescription drug over a multiyear period to support a market for a lower cost generic prescription drug, if volume is an important factor in driving down the cost of the drug. For partnerships involving procurement, CHHSA shall determine minimum thresholds for procurement of an entity’s expected volume of a targeted drug from the company or manufacturer over a multiyear period. In making advance commitments, CHHSA may
consult with the Statewide Pharmaceutical Program and the California Pharmaceutical Collaborative.
(f) The listed entities in paragraphs (2) to (5), inclusive, of subdivision (d) shall not be required to purchase prescription drugs from CHHSA or entities that contract or partner with CHHSA pursuant to this chapter.
(g) CHHSA shall not be required to consult with every entity listed in paragraphs (2) to (5), inclusive, of subdivision (d), so long as purchaser engagement includes a reasonable representation from these groups.
(h) Any partnership entered into pursuant to this section shall include representation and involvement with the governance of the contractor
entity.
