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QUALITY REIMBURSEMENT RY 2028 DRAFT POLICY COMMENT DUE DATE CHANGE TO DECEMBER 2, 2025
NOTICE IS HEREBY GIVEN THAT THE COMMENT DUE DATE ON THE QUALITY BASED REIMBURSEMENT RY 2028 DRAFT POLICY ISSUED TO THE PUBLIC ON NOVEMBER 7, 2025 HAS BEEN CHANGED. THE COMMENT DUE DATE OF NOVEMBER 21, 2025 SPECIFIED IN THE DRAFT POLICY INITIALLY HAS BEEN CHANGED TO DECEMBER 2, 2025.
In 2024, the Centers for Medicare and Medicaid Services (CMS) announced a new model, under the Center for Medicare and Medicaid Innovation (CMMI), to aid in the treatment of sickle cell disease (SCD). The model is the Cell and Gene Therapy Access Model (Model). The purpose of this Model is to expand access to gene therapy for SCD, provide access to critical supports and services, and cover ancillary services and, for interested participants, fertility preservation services.
CMS, on States behalf, negotiated key terms of an outcomes-based agreement (OBA) with two manufacturers of gene therapies for SCD. The two manufacturers are Vertex Pharmaceuticals, Incorporated for CASGEVY™ and Genetix Biotherapeutics for LYFGENIA™. Facilities go through an application process with each manufacturer to become an authorized or qualified treatment center (A/QTC). Maryland Medicaid applied to participate in the Model and was accepted in the Spring of 2025. Maryland Medicaid's participation in the Model will begin on January 1, 2026. As part of this innovative model, reimbursement to the A/QTCs for the medications CASGEVY™ and LYFGENIA™ will be at no less than the actual acquisition cost (AAC) of the gene therapies. For Maryland Medicaid, these two medications are not subject to the public payer differential.
CMS, on States behalf, negotiated key terms of an outcomes-based agreement (OBA) with two manufacturers of gene therapies for SCD. The two manufacturers are Vertex Pharmaceuticals, Incorporated for CASGEVY™ and Genetix Biotherapeutics for LYFGENIA™. Facilities go through an application process with each manufacturer to become an authorized or qualified treatment center (A/QTC).
Maryland Medicaid applied to participate in the Model and was accepted in the Spring of 2025. Maryland Medicaid's participation in the Model will begin on January 1, 2026. As part of this innovative model, reimbursement to the A/QTCs for the medications CASGEVY™ and LYFGENIA™ will be at no less than the actual acquisition cost (AAC) of the gene therapies. For Maryland Medicaid, these two medications are not subject to the public payer differential.
