AABB, ASFA Urge CMS to Reconsider Reimbursement Policy for CAR T-Cell Therapy

AABB and the American Society for Apheresis (ASFA) urged the Centers for Medicare and Medicaid Services (CMS) to reconsider its proposal to bundle the payments for services involved in the manufacture of chimeric antigen receptor (CAR) T-cell products.

In the agency’s proposed calendar year 2026 Physician Fee Schedule (PFS), CMS proposes to include payment for tissue procurement and processing steps (CPT 38225, 38266, 38227) into the payment for the CAR-T product (CPT 38228). AABB and ASFA cautioned that bundling these services undermines the complexity of care, diminishes physician work valuation and could discourage providers from engaging in such intensive, life-saving therapies.

If CMS finalizes the bundling policy, AABB and ASFA requested clear and actionable guidance for reimbursement when the CAR-T product is ultimately not administered. They also asked CMS to refrain from extending this bundling policy to other autologous cell-based therapies or gene therapies, warning that doing so could further undervalue critical laboratory and physician work across emerging therapeutic modalities.