Senators Debate Adding Unique Device IDs To Claims Forms
This article was originally published in The Gray Sheet
Sen. Patty Murray floated, and then withdrew, an amendment to require that Unique Device Identifiers be added to insurance claims forms. She plans to raise the matter on the Senate floor. Both CMS and Sen. Orrin Hatch, who heads the Senate Finance Committee with jurisdiction over Medicare, have reservations about the idea.
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The acting head of the Center for Medicare and Medicaid Services has signaled his agency's plan to support the effort to get UDIs incorporated as a standard element of insurance claims by signing a letter jointly with the FDA commissioner. Previously, CMS had worried about the move due to the significant system upgrades that hospitals and payers will need to make to support UDIs in claims.
The Senate HELP Committee voted March 9 in favor of a breakthrough device provision, watered down from a version approved in the House last year. Other bills voted out of committee include a combination products reform measure, the digital-health focused MEDTECH Act, and four others. Senators are still debating whether NIH and FDA should get additional funds to cover the cost of the bills, which will be wrapped up into a broader package before Senate floor debate.
Senate HELP Ranking Member Sen. Patty Murray in a staff report criticizes FDA and manufacturers for reacting slowly to duodenoscope contamination incidents in 2013. The report says FDA needs a more robust device surveillance system and calls for more attention to 510(k) modification policies. Murray is a key partner in ongoing Senate work to produce a so-called "medical innovation" bill.