Elevidys
Sarepta Therapeutics, Inc. announced Monday evening, July 21, 2015, that they are voluntarily and temporarily pausing the shipment of their gene therapy, Elevidys® (delandistrogene moxeparvovec-rokl; SRP-9001) for Duchenne muscular dystrophy in the US. This pause will allow Sarepta and the US Food and Drug Administration (FDA) to complete the safety labeling supplement process. This announcement follows two teenage boys who passed away after receiving the gene therapy, and a third death of a fifty-year-old man who was a participant in a clinical trial for a therapy developed on a similar platform.
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Cell and Gene Therapy Access Model
On July 16, 2025, CMS announced the list of 35 states and territories that are participating in the Cell and Gene Therapy Access Model which represents approximately 84% of Medicaid beneficiaries with sickle cell disease (SCD). The Model has several key elements including CMS-negotiated outcomes-based contracts with manufacturers, developed with input from state Medicaid agencies, patients, and providers and expanding access to gene therapy for sickle cell disease. In addition, the Model provides support services including fertility preservation services, travel expenses, case management, and behavioral health services. The following states and territories are participating in the CGT Access Model: Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, and Wisconsin, as well as the District of Columbia and Puerto Rico.
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Cell and Gene Therapy (CGT) Access Model | CMS
CMS Expands Access to Lifesaving Gene Therapies Through Innovative State Agreements | HHS.gov
Proposed Skin Substitute Changes for 2026
Skin substitutes have been reimbursed like biologicals, each with its own unique billing code and payment limit, which has led to million-dollar claims. According to Medicare claims data, Part B spending for these products rose from $252 million in 2019 to more than $10 billion in 2024, a nearly forty-fold increase. For calendar year (CY) 2026, CMS is proposing to shift the payment of skin substitute products from biologic to incident-to supplies, and to group and pay for these products based on relevant product characteristics with a single payment rate. According to the proposed CY 2026 Physician Fee Schedule (page 1200), under this proposal, which assumes a single rate of approximately $125.38 for CY 2026, there would be an estimated savings of $9.4 billion.
Article by Kathy Clark, RN, BSN, CMCN, RIT, Vice President, Director of Managed Care. For more information about how this may affect your plan, please contact your Summit ReSources care specialist.