AABB Urges CMS to Hold Off on Proposed Payment Changes for Software Analyses

AABB urged the Centers for Medicare and Medicaid Services (CMS) to not finalize proposed changes to the payment classification of software as a medical service (SaMS) analyses performed on laboratory tests. The proposal is part of the agency’s proposed rule for the 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System.

In comments to CMS Administrator Mehmet Oz, MD, AABB expressed concern that moving SaMS analyses from the Clinical Laboratory Fee Schedule (CLFS) to the Hospital Outpatient Prospective Payment System (OPPS) could shift costs to beneficiaries and providers. The Association also noted that CMS is separately examining laboratories’ use of software algorithms and artificial intelligence through proposed changes to the 2027 Physician Fee Schedule and a request for information on the Clinical Laboratory Improvement Amendments (CLIA). The Association said revising the payment classification of SaMS analyses before CMS completes its CLIA inquiry could result in a payment framework that does not reflect stakeholder feedback or align with the agency’s regulations.

AABB also encouraged CMS to work with the laboratory community to better understand the clinical, operational and regulatory considerations associated with SaMS analyses before changing payment policies. The Association emphasized that long-term payment approaches should reflect the complexities of algorithmic technologies in laboratory medicine while supporting access to innovative care.