Summary: AdvaMed applauds the House AI Task Force for calling on CMS to create payment pathways for AI-enabled devices. The report stresses proper reimbursement, data protection, and standards development to foster AI innovation in healthcare. AdvaMed remains engaged with policymakers, supporting collaborative efforts that ensure patient access to transformative medtech solutions.

Key Takeaways:

  • The House AI Task Force’s recommendations emphasize new, formalized reimbursement structures for AI-enabled devices to support broader clinical adoption and patient benefits.
  • AdvaMed is committed to working with government agencies and policymakers, advocating for data access, responsible AI use, and industry standards for medical device innovation.

AdvaMed, the Medtech Association, commended the House of Representatives’ bipartisan Task Force on Artificial Intelligence for urging the Centers for Medicare & Medicaid Services (CMS) to develop a formalized payment pathway for AI-enabled medical devices. AI-enabled medical devices are FDA-cleared and produce clinical information to aid in patient diagnosis or treatment.

AdvaMed agrees with the Task Force suggestion that the Department of Commerce and other government agencies can learn more about AI risk mitigations through collaboration with the Food and Drug Administration (FDA) and the Department of Health & Human Services (HHS). AdvaMed stands ready to work with policymakers and the FDA to develop improved guidance for AI-enabled devices in the post-market space, as suggested in the report.

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Importance of Adequate Reimbursement Pathways

The Task Force highlights AI-enabled medical devices, stating, “Considering that AI tools streamline these practices and reduce time spent on services, current payment mechanisms cannot adequately reimburse these tools. Certainly, there will be no ‘one size fits all’ reimbursement policy for every AI technology, and developing appropriate payment mechanisms requires recognition of varying kinds of technology and clinical settings. For example, many AI technologies may fit into existing benefit categories or facility fees. Congress should continue to evaluate emerging technologies to ensure Medicare benefits adequately recognize appropriate AI-related medical technologies.”

Focus on Data Access and Standards

The report went on to highlight the importance of data access, stating, “Policymakers could also develop or expand high-quality data access mechanisms that ensure the protection of patient data,” citing industry standards as a key path toward that goal. AdvaMed, which was recently accredited by the American National Standards Institute to develop industry standards for medical device innovation, looks forward to working alongside policymakers to enact policies that facilitate access to data and support standards development.

Task Force Panel Participation

Dr. Taha Kass-Hout, global chief science and technology officer, GE HealthCare, and chair of the AdvaMed Digital Health Tech board of directors, participated in an AI Task Force Panel examining Healthcare Applications. Each of the 15 AI Task Force Panels helped inform the report.

“We thank these House lawmakers for their leadership and commitment to improving patient access to innovative medical devices,” said Scott Whitaker, president and CEO of AdvaMed. “We look forward to continuing to work with CMS, patients, and policymakers to establish sensible, efficient Medicare coverage and reimbursement policies.”