AIM Act Touted As One Solution To Device Reimbursement Woes
This article was originally published in The Gray Sheet
The Accelerating Innovation in Medicine Act, introduced last year with some bipartisan support, was touted at the latest House 21st Century Cures hearing as a self-pay path for seniors to get access to newly-approved devices not yet covered under Medicare, and to give manufacturers time to collect needed data to support reimbursement.
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But the April 29 updated draft of the broad-based House reform package for medical innovation is missing some significant items floated earlier this year, including a Medicare breakthrough device program, a revamp of diagnostics regulations and device supply-chain security reform.
A significant new addition to the legislative proposal would double the number of people that could be treated per year with a humanitarian device exemption product from 4,000 to 8,000.
Device industry advocates have a lot of reading to do. There are more than two dozen provisions with relevance to the medtech sector, many aimed at smoothing the way for product approvals and reimbursement, in a 21st Century Cures discussion draft unveiled by the House Energy and Commerce panel Jan. 27. The initial proposal does not have bipartisan support.
Device Consortium Addresses Barriers To Early U.S. Feasibility Studies, MDIC’s Murray Tells Congress
Medical Device Innovation Consortium President and CEO Bill Murray testified about MDIC and FDA’s plans to promote early feasibility studies of products in the U.S., rather than abroad, at a recent House Energy and Commerce panel hearing.