ARTICLE SUMMARY:
In this week’s Pathways Picks: AdvaMed weighs in on CMS competitive bidding proposals and a federal Anti-Kickback Statute case; AI hearing on Capitol Hill; Japan drafts home-use software guide; guidance developments from South Korea, Singapore, and Canada; and a regulatory reliance agreement between Brazil and Mexico.
US Picks
Industry pushes back in Medicare, legal spheres:
Medicare bidding plans misguided? Device industry advocates say CMS’ recent proposals to expand the scope of competitive bidding for durable medical equipment (DME) and make other reforms to the program will restrain patient access and technology innovation. The Medicare agency rolled out plans in July as part of its 2026 Home Health payment proposed rule to add new products, including urological, tracheostomy, and ostomy supplies and continuous glucose monitors (CGMs), to its DME competitive bidding program, principally to lower costs and reduce fraud among equipment suppliers. AdvaMed sent a letter to CMS August 28 detailing all the ways the proposals will not accomplish those goals. “CMS presents the DME Competitive Bidding Program (CBP) as a tool to reduce Medicare expenditures for durable medical equipment (DME) and to remove fraudulent DME suppliers from the Medicare program,” writes Carol Blackford, who runs payment and healthcare delivery policy for the trade group. “Unfortunately, a poorly designed competitive bidding program will have the opposite effect.” Blackford notes the market for the proposed products is already intensely competitive and artificially reducing payment rates with bidding will reduce innovation and drive the highest-quality suppliers from the program. AdvaMed also expressed dismay with proposals to change the status of CGMs to require long-term rentals and servicing/refurbishing from suppliers that might not align with patient needs or FDA labeling. CMS has implemented DME competitive bidding as an alternative to the DME fee schedule in fits and starts over the past 15 years, but it is currently in a gap period, and CMS has yet to announce when new bidding will commence.
