AABB Urges CMS to Keep Software Analyses on Laboratory Fee Schedule

AABB urged the Centers for Medicare and Medicaid Services (CMS) not to finalize a proposal to move software as a medical service (SaMS) analyses performed on laboratory tests from the Clinical Laboratory Fee Schedule (CLFS) to the Physician Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System. In comments on the proposed 2027 PFS rule, AABB said these analyses should remain on the CLFS while CMS works with the laboratory community to develop a durable payment framework.

In a letter to CMS Administrator Mehmet Oz, MD, AABB said changing the payment framework for SaMS analyses before CMS completes its CLIA request for information risks creating an approach that is misaligned with stakeholder feedback and the agency’s own regulations. The Association said SaMS analyses do not fit the PFS resource-based methodology and that any future payment approach should account for costs such as clinical validation, performance monitoring, cybersecurity and oversight by qualified laboratory personnel. Moving the services would subject them to budget neutrality and beneficiary cost-sharing, potentially shifting costs to beneficiaries and providers.

AABB also responded to a request for information in the rule on duplicate testing and interoperability. The Association asked CMS to distinguish repeat testing from duplicate testing, noting that repeat testing in transfusion medicine and biotherapies often occurs within hours or minutes and may be required by professional standards or federal regulation. Clinical necessity, rather than the interval between tests, should determine whether testing is duplicative, AABB said. The Association also noted that Medicare already recognizes medically necessary repeat testing through modifier 91.

On interoperability, AABB said laboratories cannot address the issue in isolation and that mandates without implementation resources could add burden without corresponding clinical benefit. The Association pointed to patients with sickle cell disease, whose alloantibodies can become undetectable over time, as an example of why longitudinal transfusion history is important. AABB said interoperability must preserve that history rather than individual results alone.