Cell and Gene Therapy (CGT) Access Model
Program Funding
Annual program obligations reported to SAM.gov.
Program Objective
The Cell and Gene Therapy (CGT) Access Model aims to improve the lives of people with Medicaid 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. Manufacturers and state participants joined the model through a Request for Application (RFA) process. States begin participation between January 2025 and January 2026.
The Notice of Funding Opportunity (NOFO) announced the opportunity to apply for Cooperative Agreement funding to support states’ participation in the CGT Access Model. Cooperative Agreement funding is intended to support state model implementation activities and to support states that take steps to improve equitable access to gene therapy and multi-disciplinary, comprehensive care in conjunction with the model test.
Eligibility
Eligible Applicants
- State
- U.S. Territory Government
- U.S. State Government
Eligible applicants are States, the District of Columbia, and any U.S. Territory participating in the Medicaid Drug Rebate Program (MDRP). Eligible applicants must:
• Apply to the State Request for Applications (RFA) by no later than March 14, 2025
• Apply to the Notice of Funding Opportunity (NOFO) by no later than March 14, 2025
• Sign a State Agreement with CMS by no later than June 1, 2025
How to Apply
Award Procedure
Awards will be made through Cooperative Agreements. Recipients can draw down at any frequency dependent on their needs/internal processes.
Application review period will take 90-120 days.
Program details & compliance
Description
• Cell and gene therapies can transform the lives of people living with rare and severe diseases that are hard to treat, but gaining access to these potentially life-changing treatments is difficult because they can cost millions of dollars.
• The CGT Access Model supports outcomes-based agreements between states and manufacturers that will provide treatments within a framework that lowers prices for states and ties payment to outcomes.
• By increasing access to transformative therapies, this model aims to improve the poor health outcomes and low life expectancy associated with rare and severe diseases like sickle cell disease, as well as make it easier for states to pay for cell and gene therapies.
• The model underscores CMS’ commitment to accelerating access to innovative therapies, improving patient health, and tying payment to outcomes.
• Through a Cooperative Agreement award, Implementation Funding will be available to states to support required and optional model implementation activities. Additionally, Milestone Funding will be available to States that successfully complete research projects related to increasing equitable access to sickle cell disease (SCD) gene therapy and promoting multi-disciplinary, comprehensive care for beneficiaries with SCD who are considering or receiving SCD gene therapy. Up to $9.55 million in Cooperative Agreement award funding is anticipated to be available to each selected award recipient over the course of up to 10 years and 5 months (August 1, 2025 – December 31, 2035).
Mission Categories
Primary: General Health and Medical
Use of Funds
Allowed Uses
Cooperative Agreement funding includes two distinct types of financial support: Implementation Funding and Milestone Funding. Implementation Funding is designed to support required and optional model activities that involve staff/contractor time and infrastructure costs, including partnerships with community-based organizations. Milestone Funding is designed to support states that successfully complete research projects related to increasing equitable access to SCD gene therapy and promoting multi-disciplinary, comprehensive care for beneficiaries with SCD who are considering or receiving SCD gene therapy.
Restrictions
CMS prohibits the use of Cooperative Agreement funding to reimburse pre-award costs or to supplant existing state, local, tribal, or private funding of state costs.
For a full list of all the applicable limitations on the use of funds, please review Sections D6 and F2 of the NOFO. These sections provide comprehensive guidelines to ensure the funds are used appropriately and in alignment with the overall objectives of the CGT Access Model.
Required Documentation
2 CFR 200, Subpart E - Cost Principles applies to this program.
Reporting & Compliance
Applicable 2 CFR 200 Subparts
- Subpart B — General Provisions
- Subpart C — Pre-Federal Award Requirements
- Subpart D — Post-Federal Award Requirements
- Subpart F — Audit Requirements