Value AD
CAN BE
ALTERNATIVE
INVESTMENT
Cell and Gene Therapy (CGT) Access Model
CMS-2P2-25-001
CGTModel@cms.hhs.gov
Funding Opportunity Number: CMS-2P2-25-001
Opportunity Category: Discretionary
Expected Number of Awards: 52
CFDA Number(s): 93.885 -- Cell and Gene Therapy (CGT) Access Model
Cost Sharing or Matching Requirement: No
Posted Date: Jun 12, 2024 12:00:00 AM EDT
Closing Date: N/A
Estimated Total Program Funding: 95000000
Eligible Applicants: State governments
Additional Information on Eligibility: Eligible applicants are States, the District of Columbia, and any U.S. Territory participating in the Medicaid Drug Rebate Program (MDRP).
Description:
This Notice of Funding Opportunity (NOFO) announces the opportunity to apply for Cooperative Agreement funding to support States’ participation in the Cell and Gene Therapy (CGT) Access Model (the CGT Access Model or “the Model”). Eligible applicants are States, the District of Columbia, and any U.S. territory that participates in the Medicaid Drug Rebate Program (MDRP). A maximum of $9.55 million may be awarded to each Recipient, depending on the number of States that apply for funding, pending availability of funds.
The CGT Access Model is an 11-year voluntary model that tests whether a CMS-led approach to developing and administering outcomes-based agreements (OBAs) for cell and gene therapies (CGTs) improves Medicaid beneficiary access to innovative treatment, improves health outcomes for Medicaid beneficiaries, and reduces health care expenditures. Within this Model, CMS will negotiate standard Key Terms of an OBA directly with manufacturers of gene therapies approved or licensed by the U.S. Food & Drug Administration (FDA) for the treatment of sickle cell disease (SCD). The negotiated Key Terms will be disclosed to all States in December 2024. After the Key Terms have been disclosed, States (1) may apply to participate in the Model in response to the State Request for Applications (RFA) and (2) may apply for Cooperative Agreement funding in response to this NOFO.
Cooperative Agreement funding is intended to support State Model implementation activities and to reward States that take steps to improve equitable access to gene therapy and multi-disciplinary, comprehensive care in conjunction with the model test.
To be considered for Cooperative Agreement funding, a State must apply to both the State RFA and this NOFO. Up to $9.55 million in Cooperative Agreement award funding will be available to each selected award recipient over the course of up to 10.5 years. The Cooperative Agreement and the Model will conclude no later than December 31, 2035.
