November 12, 2024
The Centers for Medicare and Medicaid Services (CMS) released an unpublished final rule Nov. 1 that updates Medicare payment policies for hospitals under the Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center Payment System and Quality Reporting Program for calendar year (CY) 2025. The final rule is scheduled for publication in the Federal Register on Nov. 27. CMS also released an accompanying fact sheet.
In the final rule, CMS will increase all payment rates under the OPPS hospital outpatient department fee schedule by 2.9% based on the most recent updated cost reports and claims data available. The final rule includes several provisions of interest to the blood and biotherapies community. AABB has summarized these sections below.
Effective Oct. 1, CMS introduced HCPCS code P9027 for red blood cells that are leukoreduced and stored in a deoxygenated state to prevent oxidative damage. This code addresses products that use a two-stage process to maintain a low oxygen environment during storage.
Because P9027 was created after the CY 2025 OPPS proposed rule, it was assigned to APC 9541 (with status indicator "R" for Blood and Blood Products) through Change Request 13784. The interim payment rate is set at $493.01, crosswalked to existing blood product code P9035. CMS is accepting public comments on this rate.
To ensure adequate reimbursement for cell and gene therapies used as primary treatments, CMS is revising its comprehensive ambulatory payment classification (C-APC) policy for 2025 and beyond. This update, supported by AABB, excludes certain cell and gene therapies from being packaged under the C-APC framework if they serve as standalone therapies rather than as ancillary or supportive services. Newly assigned HCPCS codes for cell and gene therapies that are not adjunctive to a primary C-APC service will also be added to the C-APC exclusion list.
CMS has determined that separate or packaged payment for CAR T-cell collection and processing procedures (CPT codes 38225, 38226 and 38227) is not warranted, as these steps are part of the manufacturing process for the final product. Instead, these CPT codes will remain reportable to CMS for tracking purposes.
Meanwhile, CMS has finalized a payment designation (status indicator "S") for CAR T-cell administration (CPT code 38228), making this procedure eligible for separate reimbursement under OPPS in 2025.
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