Hogan Lovells Posts Summary: AI and Reimbursement Today and Tomorrow

 Recently, Hogan Lovells held a workshop on cutting edge issues in reimbursement, including AI.   Luckily, they've posted a detailed summary for those who couldn't attend.  Find it here:

https://www.hoganlovells.com/en/publications/ai-summit-panelists-offer-tips-for-obtaining-reimbursement-for-innovative-health-care-technology

It's part of their fourth annual AI Health Law & Policy summit.

Speakers included:

• Victoria Wallace, Partner
• Anitra Graves, CMS / FCSO
• Richard Frank MD, in his role as AMA CPT digital medicine co-chair
• David Reich MD, Mt Sinai Health System
  
• Clark Daniel, Heartflow Govt Relations

Read Hogan Lovell's full summary at the link above.

On the topic of AI and reimbursement, that's one of 5 points raised by Jonathan Blum in a new essay about modernizing CMS.

###

AI CORNER

A mini-summary by AI (Chat GPT)

As AI-enabled medical technologies surge forward, the reimbursement landscape is struggling to keep pace. At a recent summit, Hogan Lovells' Victoria Wallace laid out the challenge: Medicare reimbursement is governed by decades-old legislation that never envisioned artificial intelligence. CMS lacks a defined benefit category for AI, and sponsors must wedge cutting-edge tools into outdated regulatory frameworks.

Dr. Anitra Graves, a key Medicare contractor medical director, described efforts to build a CMS taxonomy for autonomous technologies—essential groundwork for future pricing and coverage. But many questions remain, including how to value the complexity of algorithms versus the data they analyze.

Heartflow’s Clark Daniel and Mount Sinai’s Dr. David Reich added real-world insight: from the battles to secure appropriate coding and payer acceptance, to the necessity of embedding AI into clinical workflows. Reich emphasized that AI won’t replace physicians, but those who adopt it will outpace those who don’t.

Representing an AMA committee, Dr. Richard Frank highlighted how CPT coding and regulatory validation must align. A major update to CPT guidance is underway, aiming to define algorithm-specific codes. For now, the message is clear: reimbursement for AI is still a moving target—and stakeholder input is critical.

ACLA POSTS: LDT RULE is DEAD

 According to ACLA, the HHS has let pass its 60-day deadline to lodge notice-of-appeal regarding the FDA LDT Rule.  The Notice of Appeal would have kept alive the case which otherwise terminated with the Texas judge's ruling 60 days ago.  O quote the ACLA below; see the original link for ongoing community commentary.

https://www.linkedin.com/feed/update/urn:li:activity:7334443741191057408/

ACLA writes,

The U.S. Department of Health and Human Services (HHS) declined to appeal the landmark ruling issued on March 31, 2025 by the U.S. District Court for the Eastern District of Texas that vacated the final rule seeking to regulate laboratory developed tests (LDTs) issued by the FDA, confirming that laboratory developed testing services are not “medical devices” subject to FDA’s regulatory oversight. The FDA had until May 30 to file its appeal.

The Court held that the FDA lacks authority to regulate LDTs. These testing services are not mass-produced devices introduced into interstate commerce, but rather diagnostic services developed and performed by laboratory professionals. Congress has never granted the FDA jurisdiction over such services, which are regulated under the Clinical Laboratory Improvement Act (CLIA) by the Centers for Medicare & Medicaid Services (CMS).

This ruling affirms what ACLA has long maintained: the FDA may not regulate laboratory developed testing services as medical devices. FDA’s rule would have resulted in reduced patient access to innovative tests that improve and save lives. Laboratory testing services provide patients and physicians with vital diagnostic information to inform clinical care, advance precision medicine, contribute to the discovery of novel therapeutics, identify rare diseases, and lead the fight against emerging pathogens.

ACLA members remain committed to the highest standards of quality and to ensuring patients benefit from timely, accurate, and accessible testing. ACLA represents the nation’s leading clinical laboratories, and all ACLA member clinical laboratories are fully accredited by the College of American Pathologists (CAP). We look forward to continued collaboration with policymakers to support patients, innovation, and America’s clinical laboratories.