Proposed Changes to Medicare Payment Policies Could Impact Cell and Gene Therapies

Payment for Cell and Gene Therapies

On July 14 and 15, 2025 the Centers for Medicare & Medicaid Services (CMS) published two proposed rules that could potentially impact payment for cell and gene therapies under the Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical (ASC) Center Payment System, respectively.

In short:

CMS proposes that the costs of preparatory procedures for tissue procurement needed to manufacture autologous cell-based immunotherapy or gene therapy be included in the product payment. Starting January 1, 2026, any such procedures paid for by the manufacturer should be factored into the calculated Average Sales Price (ASP). 

CMS also proposes a list of cell and gene therapy products that are intended to be separately paid in the hospital outpatient department, as well as proposal to continue the APC assignment for LUXTURNA.  

Get 4Front’s summary report:

If you would like a copy of our report on Medicare’s proposed changes related to cell and gene therapy products, please contact Alyssa Foster at afoster@4frontsp.com.