Dive Brief:
- Advamed said it supports the efforts of a bipartisan group of senators who are pushing to establish a formalized payment pathway for algorithm-based healthcare services.
- The four senators wrote to the Centers for Medicare and Medicaid Services last week to urge the agency to consider policies and processes that make payments predictable in its upcoming rulemaking cycle.
- The CMS currently covers medical devices that rely on artificial intelligence or machine learning on a case-by-case basis, the senators said. That approach creates “an inherent barrier” to the use of algorithm-based devices, they argued.
Dive Insight:
Medical device developers are using AI and ML to try to improve diagnosis and treatment. The Food and Drug Administration has authorized 882 AI/ML devices as of May 13. The CMS provides payment for “a limited number” of the devices, according to the senators’ Thursday letter, and assesses coverage on a case-by-case basis.
The senators wrote to CMS Administrator Chiquita Brooks-LaSure to propose a different approach to covering the devices that will “ensure future innovation” and protect access for Medicare beneficiaries. The approach is intended to support investment by making payment more predictable.
Specifically, the senators want the CMS to codify in regulation the software-as-a-service payment policy that the agency set out in its 2023 Medicare Hospital Outpatient Prospective Payment Systems final rule. The senators see the policy as a way “to provide stability and certainty moving forward.”
The lawmakers also asked Brooks-LaSure to consider tailoring the new technology ambulatory payment classification requirements and policies to the “unique aspects” of algorithm-based healthcare services. The CMS created the system for services or procedures that are “truly new” and significant enough to have a unique code, but according to the senators, it fails to reflect how algorithms may be used.
Advamed welcomed the senators’ intervention. Scott Whitaker, president and CEO of the trade group, said in a statement that manufacturers need “a formalized Medicare reimbursement pathway” to ensure patients access AI-enabled clinical technology.
