ARTICLE SUMMARY:
In this week’s Pathways Picks: CMS trims procedure payments in the name of efficiency, reimburses ADHD digital therapeutics, and approves real-world renal denervation study; FDA looks to cardio and AI advisory panels; China revamps and harmonizes GMP standards; South Korea invests in device innovation; EU forms new combo product group; and more.
Medicare Picks
Efficiency cuts, real-world renal denervation, CGM letter:
Medicare cuts in the name of efficiencies. CMS followed through with plans to enact a 2.5% “efficiency adjustment” in 2026 to payments for established surgical and interventional services in its final Physician Fee Schedule (PFS) rule, issued October 31. The policy undercuts work and time estimates assigned to many services by physician surveys to account for natural efficiencies gained, although it exempts “time-based” services, like office visits, to help equalize primary care with specialist work. However, impacted clinical groups argue the across-the-board cuts are counterproductive and will limit access to advanced care. The adjustment is “unprecedented and arbitrary,” said Srihari Naidu, MD, president of the Society for Cardiovascular Angiography and Interventions (SCAI), who says the group will be taking its argument to Congress to reverse the cuts. In response to pushback from SCAI and other societies, CMS agreed in its final rule to exempt newly created codes from the cuts, acknowledging they would have yet to accrue efficiencies. The agency also finalized plans to reduce the work values for services performed by physicians in hospitals and ambulatory surgical centers compared to “nonfacility” settings like physician offices. These and the efficiency cuts are counterbalanced by statutory increases in the factors used to calculate all physician payments. In net, physicians in cardiology, radiology, and other device-heavy specialty areas will be subject to somewhere in the range of single-digit percentage cuts to small increases in service payments next year.