Cell and Gene Therapy (CGT) Access Model

 

The Cell & Gene Therapy Access Model is a voluntary model intended to improve the lives of Medicaid beneficiaries living with rare and severe diseases by increasing access to cell and gene therapies, which are potentially transformative treatments. Cell and gene therapies have high upfront costs but have the potential to reduce health care spending over time by addressing the underlying causes of disease, reducing the severity of illness, and reducing health care utilization. Initially, the Model will focus on access to gene therapy treatments for people living with sickle cell disease, a genetic blood disorder that disproportionately affects Black Americans. Under the Model, the Center for Medicare and Medicaid Services (CMS) will form a partnership between CMS, pharmaceutical manufacturers (hereinafter, Manufacturers) of CGTs, and States, wherein they agree upon an outcomes-based agreement (OBA) that will include discounted prices for the therapies, a uniform access policy for all eligible beneficiaries in participating States, and rebates to States if the therapies do not perform as expected in the Model population. The Model seeks to test whether a CMS-led approach to negotiating and administering outcomes-based agreements (OBAs) for CGTs, while addressing a broad range of access barriers will improve beneficiary access and health outcomes, and reduce health care costs. Assistance Listing goals: Provide States with funding to support Model implementation and optional partnerships with community-based organizations. Provide States with funding if they achieve milestones associated with improving equitable access to gene therapy for SCD and promoting multi-disciplinary, comprehensive care that address access barriers.

Active 93.885 Centers For Medicare and Medicaid Services, Department of Health and Human Services B - Project Grants Not applicable. Section 1115A of the Social Security Act (the Act) establishes CMMI to test innovative health care payment and service delivery models that have the potential to lower Medicare, Medicaid, and CHIP spending while maintaining or improving the quality of beneficiaries’ care., Title Social Security Act, Section 1115A, The Secretary shall, consistent with the criteria set out in 42 U.S.C. 1315a(b)(2), consider whether to select for testing by the Innovation Center new health care payment and delivery models that would lower drug costs and promote access to innovative drug therapies for beneficiaries enrolled in the Medicare and Medicaid programs, including models that may lead to lower cost-sharing for commonly used drugs and support value-based payment that promotes high-quality care. The Secretary shall, not later than 90 days after the date of this order, submit a report to the Assistant to the President for Domestic Policy enumerating and describing any models that the Secretary has selected. The report shall also include the Secretary’s plan and timeline to test any such models. Following the submission of the report, the Secretary shall take appropriate actions to test any health care payment and delivery models discussed in the report., Title #14087 Executive Order on Lowering Prescription Drug Prices for Americans The Centers for Medicare & Medicaid Services (CMS) is seeking applications from State Medicaid Agencies from any state, the District of Columbia, and any U.S. territory that participates in the Medicaid Drug Rebate Program (MDRP) (hereinafter, "States") for optional funding under the Cell & Gene Therapy Access Model (the CGT Model or "the Model"). To be considered for funding under this NOFO, the State must: o Submit the State RFA application at the same time as, or before, submitting a NOFO application o Participate in the Model by applying to the Cell and Gene Therapy Model State Request for Application (RFA) by no later than February 28, 2025 and signing a State Agreement with CMS o Apply to this NOFO by no later than February 28, 2025 To be eligible for gene therapy to treat sickle cell disease as part of this model, a person must: o Have a documented medical diagnosis for sickle cell disease. o Be enrolled in Medicaid or CHIP (if applicable) in a state participating in the model at time of therapy. o Beneficiaries for whom Medicaid is the primary payer. o Receive a gene therapy from a participating manufacturer. o Meet standardized prior authorization criteria established through the OBAs. Not applicable. Preapplication coordination is not applicable. 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. Interested applicants will submit their applications via grants.gov. All qualified applications will be forwarded to a merit review committee. The results of the merit review of the applications by qualified experts will be used to advise the CMS approving official. In making these decisions, the CMS approving official will take into consideration recommendations of the review panel. Notification is made in writing by a Notice of Award (NoA). Application deadline will be stated in the published Notice of Funding Opportunity on Grants.gov. Application review period will take 90-120 days. Not applicable. Not applicable. To be determined. Cooperative Agreement funding will support the following activities: • Required and optional implementation activities • Partnerships with Community-Based Organizations • Milestone Funding to states that achieve performance milestones Not applicable. Not applicable. Recipients are required to maintain grant accounting records 3 years after the date they submit the final Federal Financial Report. If any litigation, claim, negotiation, audit or other action involving the award has been started before the expiration of the 3-year period, the records shall be retained until completion of the action and resolution of all issues which arise from it, or until the end of the regular 3-year period, whichever is later. Statutory formula is not applicable to this assistance listing.

Matching requirements are not applicable to this assistance listing.

MOE requirements are not applicable to this assistance listing. The estimated period of performance is approximately 10.5 years Method of awarding/releasing assistance: Recipients drawdown funds, as necessary, from the Payment Management System (PMS). PMS is the centralized web-based payment system for HHS awards. Recipients can draw down at any frequency dependent on their needs/internal processes. None/Not specified. Melissa Majerol
7500 Security Boulevard
Baltimore, MD 21244 USA
melissa.majerol@cms.hhs.gov
Phone: 410-786-6593

Caroline Horrow
7500 Security Blvd
Windsor Mill, MD 21244 USA
Caroline.Horrow@cms.hhs.gov
Phone: 667-414-0611 https://www.cms.gov/priorities/innovation/innovation-models/cgt 75-0522-0-1-551 (Cooperative Agreements) FY 23$0.00; FY 24 est $0.00; FY 25 est $4,000,000.00; FY 22 - CMS will make a maximum of $9.5M available to each awardee participating in the CGT Access Model, which will consist of implementation funding and/or milestone funding. States that apply for, and are awarded, funding under the Model will enter into a Cooperative Agreement with CMS, that will begin as early as June or July 2025 and conclude on December 31, 2025. Not applicable. Not applicable.