FY25 IPPS Proposed Rule Comments Urge a Robust NTAP for All CGTs

As more transformative cell and gene therapies come to market, ASGCT continues to advocate for appropriate Medicare reimbursement policies to support patient access. Most recently, the Society submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the FY2025 Inpatient Prospective Payment System (IPPS) Proposed Rule. 

ASGCT supports CMS’ proposal to increase the NTAP percentage for gene therapies used to treat sickle cell disease. Last year, the Food and Drug Administration (FDA) approved two new sickle cell therapies for use in patients. Moving forward, sickle cell disease patients will finally be able to experience some relief from pain crises and other serious complications that come with the disease. The Society also urges CMS to further enhance the New Technology Add-on Payment (NTAP) as it pertains to other CGTs. This add on payment is critical to ensuring Medicare coverage of novel cell and gene therapies during the initial period when they come to market. Specifically, comments recommended establishing multiple NTAP application windows per year, increasing the NTAP payment cap to 100% of therapy costs, and ensuring products receive the full 3 years of NTAP eligibility. 

ASGCT also expressed concerns about previous CMS policy changes that could restrict NTAP eligibility for future products by moving up FDA marketing authorization deadlines. ASGCT appreciated CMS's proposal to start the NTAP "newness" period on October 1 instead of April 1. As in previous comments, ASGCT emphasized that imposing tighter timelines could delay patient access as manufacturers rush to meet application cutoffs. 

 ASGCT continues to advocate for CMS to explore innovative, alternative payment models for cell and gene therapies that provide more long-term predictability beyond the NTAP period. Comments cautioned against policies that could distort the MS-DRG 018 weights intended for CAR-T therapies by incorporating other immunotherapies. The Society also supports transparency on potential new models from the Center for Medicare and Medicaid Innovation to support these novel therapies. 

With so many groundbreaking cell and gene therapy products in the pipeline, ASGCT remains committed to partnering with CMS, policymakers, and other patient advocacy organizations to modernize the Medicare reimbursement landscape. Ensuring timely and adequate payment is critical to translating remarkable scientific advances into real-world patient access and improved outcomes. 

Margarita Valdez Martínez is ASGCT's Chief Advocacy Officer.

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