Health & Saf. Code, § 125290.75

Treatments and Cures Accessibility and Affordability Working Group

(a) Membership

The Treatments and Cures Accessibility and Affordability Working Group shall have 17 members, nominated by the chairperson or vice chairperson and approved by the board, as follows:

(1) Five members of the ICOC (the governing board), with at least two of those members drawn from the appointments made pursuant to paragraph (3), (4), (5), or (6) of subdivision (a) of Section 125290.20.

(2) An individual who has private sector experience in innovative therapy medical coverage terms, qualifications, and the process for reimbursement, including, if possible, experience with coverage negotiations with private insurers, health management organizations, or corporate self-insurance health plans.

(3) An expert or a highly knowledgeable individual with experience in federal therapy coverage, qualifications, and process for reimbursement, including, if possible, experience with the federal Centers for Medicare and Medicaid Services.

(4) An expert or a highly knowledgeable individual with experience in California’s public insurance program (Covered California), coverage, qualifications, and the process for reimbursement of innovative therapies.

(5) Two representatives from hospitals in California that are participating in stem cell clinical trials or that are treating patients with federal Food and Drug Administration approved stem cell or genetic therapies.

(6) A representative from a philanthropic organization who has experience assisting patients with clinical trial access and affordability or with access to, and the affordability of, innovative therapies.

(7) Two representatives from patient advocacy organizations who have technical expertise or experience in coverage, qualifications, and the process for reimbursement of innovative therapies.

(8) A health care economist with experience in advising or negotiating with private insurers, government insurers, or corporate self-insurance programs on coverage for innovative therapies or human trials, including experience in assisting hospitals and clinics in covering financial gaps in coverage of the direct and indirect costs of innovative therapies.

(9) A patient navigator with training and experience helping patients obtain financial support from private insurers, public support, or nonprofit support, and helping patients obtain social service support to facilitate their participation in federal Food and Drug Administration approved human trials or their qualification for access and financial assistance for innovative therapies.

(10) The chairperson and vice chairperson of the governing board.

(b) Functions

The Treatments and Cures Accessibility and Affordability Working Group shall have the following functions:

(1) Examine, develop, and assist with the implementation of financial models to enhance the accessibility and affordability of treatments and cures arising from institute-funded research for Californians and to enhance access to clinical trials, including reimbursement alternatives for patient-qualified costs to help achieve the objective that reimbursement covers patient expenses, including, but not limited to, medical expenses, lodging, meals, and travel for research participants and their caregivers.

(2) Recommend to the governing board policies and programs to help Californians obtain access to human clinical trials and to make treatments and cures arising from institute-funded research available to California patients throughout California.

(3) Recommend to the governing board policies and programs to help Californians afford to participate in human clinical trials and to make treatments and cures arising from institute-funded research affordable to California patients, regardless of their financial means.

(4) Work with the Alpha Stem Cell Clinics and Community Care Centers of Excellence and other California health care institutions, and health care payors, including private insurers, government programs, and foundations, to develop model programs and coverage models to promote the access and affordability of treatments and cures arising from institute-funded research for California patients, regardless of their financial means, or the disease, injury, or health condition from which they suffer.

(5) Advise the governing board regarding the coverage criteria and the process for reimbursement of innovative therapies and cures arising from institute-funded research and made available to patients through publicly or privately funded programs in California with the goal of expanding access and affordability.