TITLE 4:

PHARMACEUTICALS, MEDICAL SUPPLIES, TECHNOLOGY, DURABLE EQUIPMENT, AND COST CONTAINMENT

Section 400:

The Secretary in consultation with CA Professional and Technical Advisory Council shall create a permanent California Pharmaceutical, Medical Supplies, Assistive Equipment, Regulatory Task Force, that shall interface with the organized public health, public and private university research communities, and scientific research incubator organizations, as possible, to provide data-based recommendations to the CALTCHA Board for the establishment and updating of a CALTCHA pharmaceutical and supplies formulary. The Board retains the final authority to set the formulary. The Task Force shall monitor negotiations between the Board and the pharmaceutical industry to ensure standardized costs and supply of prescription therapeutics, and vetted supplements and complementary drugs and preparations, assistive and durable medical equipment, surgical equipment, and medical supplies, to ensure product effectiveness and safety and monitor the propriety of industry pricing and market practices. The Task Force shall guide the Board's budgeting to ensure full equitable access to medications and supplies across marginalized and poor populations in California. The Task Force shall identify and preserve patents and intellectual property rights for therapeutic products and equipment developed using the State's research and development funds appropriated for those purposes. The Task Force shall monitor and supervise the following:

400.1. Technical research and innovations within the State

400.2. Costs of all accommodation and assistive medical and durable equipment

400.3. Costs of medical supplies

400.4. Costs of prescription and non-prescription drugs

400.5. Costs of medical robotics and digital surgical and dental equipment

400.6. Costs of pharmaceutical, medical supplies, technology, and durable equipment used in other countries with single-payer or universal healthcare systems

400.7. The distribution and availability of medications, supplies, and equipment between institutional and non-institutional clinical settings to ensure racial and ethnic equity in access of them.

Section 401: CALTCHA Prescription Drug and Medical Supply Formulary

401.1.The CALTCHA Board shall establish a prescription drug and medical supplies formulary system beginning with a professional model, then improving upon the Veterans Administration (VA) system. The formulary shall reflect best but flexible practices in prescribing and provide economies of scale in bulk purchases. It shall discourage the use of ineffective, duplicated, dangerous, highly addictive, or excessively costly medications when better alternatives are available.

401.2. Promotion of the use of generics: The approved formulary shall preferentially promote the use of generic medications or publicly manufactured and licensed ones but allow the use of the brand name and off-formulary medications with consideration to cost and effectiveness. The Board, in consultation with organized medical and pharmacy professional associations, the Prescription Medications Regulatory Task Force, and local public health officers shall have the authority to define the formulary and the system of supervised access to non-formulary medications and supplies.

401.2.1 Off-formula medications shall not be covered by CALTCHA

401.3. . Document and publish, quarterly, any history of manufacturer abuses, evidence of excess pricing, and prior penalties for fraud or other criminal behavior as a consideration in negotiating purchases or patent rights. CALTCHA shall have the authority to fund and obtain patent rights where California pharmaceutical corporation abuses or pricing place a danger or limitation on user access.

401.4. Formulary Updates and Petition Rights: The formulary shall be updated annually. Clinicians, patients, experts, and or public members may petition their County Health Officer or the Board to add pharmaceuticals and other products to the formulary or to remove ineffective or dangerous items from it.

Section 402: Payment For Prescription Medications, Medical Supplies, And Medically Necessary Rehabilitation Engineering, Accommodation and Assistive Device Equipment

402.1.The prices to be paid each year under this Act for covered pharmaceuticals, medical supplies, and medically necessary assistive equipment shall be negotiated with manufacturers biannually by the program.

402.2. Non-state pharmaceutical benefit management entities shall be strictly excluded and prohibited from participation in any way in the formulary, price negotiation, or transactions

402.3. . All CA pharmaceutical and medical product and negotiated purchase prices shall be referenced to the goal of being equal to or below those established by the Federal Veterans Administration system's practices.