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Centers for Medicare & Medicaid Services
CMS Announces Release of the State RFA for the CGT Access Model

Today, the Centers for Medicare & Medicaid Services (CMS) announced the release of the State Request for Applications (RFA) for the Cell and Gene Therapy (CGT) Access Model, announced in January 2024, which will initially focus on gene therapies for sickle cell disease [ https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmNtcy5nb3YvbmV3c3Jvb20vcHJlc3MtcmVsZWFzZXMvYmlkZW4taGFycmlzLWFkbWluaXN0cmF0aW9uLWFubm91bmNlcy1hY3Rpb24taW5jcmVhc2UtYWNjZXNzLXNpY2tsZS1jZWxsLWRpc2Vhc2UtdHJlYXRtZW50cyIsImJ1bGxldGluX2lkIjoiMjAyNDAzMDcuOTE0MjMwMzEifQ.3AOAzxouJjo0J2_cHLXzlJidVWWoPH0-wL2tp_T1pVs/s/1113586784/br/238377214666-l ]. The CGT Access Model aims to improve the lives of people with Medicaid living with rare and severe diseases by increasing their access to potentially life-changing treatments. The model will test whether a CMS-led approach to developing and administering outcomes-based agreements (OBAs) for cell and gene therapies improves Medicaid beneficiaries’ health outcomes, broadens access to innovative treatment, and reduces health care expenditures.

The State RFA [ https://www.cms.gov/files/document/cgt-model-rfa.pdf ] is available on the model webpage [ https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmNtcy5nb3YvcHJpb3JpdGllcy9pbm5vdmF0aW9uL2lubm92YXRpb24tbW9kZWxzL2NndCIsImJ1bGxldGluX2lkIjoiMjAyNDAzMDcuOTE0MjMwMzEifQ.EIGCEVjpOQeid3aAV8lmWQoWLsd1f8ZrpaeKP1re8nE/s/1113586784/br/238377214666-l ] and is open to all states, the District of Columbia, and all U.S. territories participating in the Medicaid Drug Rebate Program. Participation in the Cell and Gene Therapy (CGT) Access Model will be voluntary for both manufacturers and states. States may submit applications to participate in the model after the negotiated Key Terms are communicated to all states in December 2024. The application portal will be open from December 2024 to February 28, 2025. View the State RFA factsheet [ https://www.cms.gov/files/document/cgt-model-rfa-fact-sheet.pdf ] for additional details.

More information about the model can be found on the model webpage [ https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmNtcy5nb3YvcHJpb3JpdGllcy9pbm5vdmF0aW9uL2lubm92YXRpb24tbW9kZWxzL2NndCIsImJ1bGxldGluX2lkIjoiMjAyNDAzMDcuOTE0MjMwMzEifQ.yxsZo99GNGl5hPay_e15R8TcRJynEfyAtouV_GSCkyY/s/1113586784/br/238377214666-l ] and in the CGT Access Model press release [ https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDQsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmNtcy5nb3YvbmV3c3Jvb20vcHJlc3MtcmVsZWFzZXMvYmlkZW4taGFycmlzLWFkbWluaXN0cmF0aW9uLWFubm91bmNlcy1hY3Rpb24taW5jcmVhc2UtYWNjZXNzLXNpY2tsZS1jZWxsLWRpc2Vhc2UtdHJlYXRtZW50cyIsImJ1bGxldGluX2lkIjoiMjAyNDAzMDcuOTE0MjMwMzEifQ.xvHMjeyGn6W5bUnLfaLfqiLmpcVXXjKFt2-CFLSvQ00/s/1113586784/br/238377214666-l ]. For updates on the model, please register for the model listserv [ https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDUsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vcHVibGljLmdvdmRlbGl2ZXJ5LmNvbS9hY2NvdW50cy9VU0NNUy9zdWJzY3JpYmVyL25ldz90b3BpY19pZD1VU0NNU18xMzE3MiIsImJ1bGxldGluX2lkIjoiMjAyNDAzMDcuOTE0MjMwMzEifQ.1ou_k9HSsk_crBv9pHTc5WuvFPp-cUPr-q_gf9MFW7Q/s/1113586784/br/238377214666-l ].

Questions about the model can be submitted to CGTModel@cms.hhs.gov [ https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDYsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHA6Ly9saW5rLmVtYWlsLmR5bmVjdC5uZXQvbGluay5waHAiLCJidWxsZXRpbl9pZCI6IjIwMjQwMzA3LjkxNDIzMDMxIn0.umGzwYuEOYQFboDnAJOqoQXNdpWII_AZmVybt1OfEfA/s/1113586784/br/238377214666-l ].

 

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