Cell and Gene Therapy (CGT) Access Model - Years 1 & 2

The Cell and Gene Therapy (CGT) Access Model aims to improve the lives of people living with rare and severe diseases by increasing access to potentially transformative treatments. It is a multi-year, voluntary model for states and manufacturers to test whether a CMS-led approach to developing and administering outcomes-based agreements (OBAs) for cell and gene therapies increases Medicaid beneficiaries’ access to innovative treatment, improves their health outcomes, and reduces health care costs and burden to state Medicaid programs. The initial focus of the model is on access to gene therapy treatments for people living with sickle cell disease, a genetic blood disorder.

To support implementation of the CGT Access Model, including increasing access to the state-selected Model drugs. Funds will support personnel costs for both the state and a CBO partner, allow both the state and CBO to implement the CGT Access Model, and allow the CBO to provide increased beneficiary and provider education and training, referrals, and direct wraparound services and supports, including the infrastructure to implement them, that address access barriers on the patient journey to increase access to the Model drugs. Funds also will support research conducted by a university partner, described below, that will inform implementation of the Model in Illinois, including assessing access for beneficiaries with SCD and assessing the effectiveness of various wraparound services and supports. The CBO wraparound services and supports will be adjusted over the course of the Model based on the research findings to maximize beneficiary access and most effectively address the access barriers of beneficiaries with SCD. Illinois Department of Healthcare and Family Services will provide subawards to selected CBOs to implement support services for Cell and Gene Therapy Model participants in Years 1 & 2.

If you have any questions regarding the application process, please contact Clare Fisher at: Email: clare.c.fisher@illinois.gov Phone: 312-610-0186

Federal funds were received by HFS as a State Medicaid Agency. HFS will partner with an Illinois community-based organization that serves individuals living with sickle cell disease - the Sickle Cell Disease Association of Illinois. Organization must have the capacity to provide educational materials and care coordination services related to CGT Access Model and the treatment of sickle cell disease.

The Cell and Gene Therapy Access Model beneficiaries are Medicaid-eligible individuals with sickle cell disease.

Registration and pre-qualification through the Grant Accountability and Transparency Act (GATA) Grantee Portal, www.grants.illinois.gov/portal.

Pre-Registration: An entity may not apply for a grant until the entity has registered and pre-qualified through the Grant Accountability and Transparency Act (GATA) Grantee Portal, www.grants.illinois.gov/portal. Registration and pre-qualification are required annually. Pre-Qualification: During pre-qualification, verifications are performed including a check of federal SAM.gov Exclusion List and status on the Illinois Stop Payment List. The Grantee Portal alerts the entity of “qualified” status or informs how to remediate a negative verification(e.g., missing UEI- Unique Entity Identifier assigned insam.gov, not in good standing with the Secretary of State). Inclusion on the SAM.gov Exclusion List cannot be remediated. Eligible Applicants: HFS will only accept applications from legally recognized organizational entities; applications from individual persons will not be considered. Only organizations based within Illinois (including local chapters of national organizations) are eligible to compete for these funds.

Program specific page will be added to https://hfs.illinois.gov/.

Illinois Department of Healthcare and Family Services Michael Welton Interim Project Director Directors Office Office: (312) 636-8019 Email: michael.welton@illinois.gov