CMS Finalizes 2026 Medicare PFS Rule, Updates Biotherapies Payment Policies

The Centers for Medicare and Medicaid Services (CMS) published the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) final rule on Tuesday, updating payment rates and policies for physicians and other health care professionals under Medicare Part B.

The CY 2026 final rule includes several provisions of interest to the blood and biotherapies community.

Cell and Gene Therapy Payments

CMS finalized its decision to continue the existing bundled payment policy for chimeric antigen receptor (CAR) T-cell therapies and extend it to autologous cell-based immunotherapy and gene therapy products. Under this policy, preparatory procedures for patient-specific cell or tissue procurement required for manufacture are included in the product payment rather than reimbursed separately.

In its proposed rule, CMS had also suggested that, beginning Jan. 1, 2026, manufacturer-paid preparatory procedures for tissue procurement be included in the calculation of the manufacturer’s average sales price (ASP). However, in the final rule, the agency did not finalize this proposal.

Instead, CMS stated that manufacturer-paid preparatory services may continue to qualify as bona fide service fees (BFSF), and therefore be excluded from ASP calculations, when they meet the four-part test outlined in 42 CFR 414.802.

AABB previously joined other organizations in urging CMS to recognize CAR T-cell and related biotherapies as distinct clinical services and to establish separate reimbursement policies to reflect their complexity.

Therapeutic Apheresis

CMS also considered a revaluation of current procedural terminology (CPT) code 36514 (therapeutic apheresis; plasma exchange), citing feedback that current labor and equipment inputs undervalue therapeutic apheresis nurses’ wages and the cost of cell separator systems. After reviewing the submission and public comments, CMS determined that it lacked sufficient information to consider the code potentially misvalued and will maintain existing inputs, including the standard 50% equipment utilization rate.