AdvaMed has a new posting on Linked In, highlighting a recent panel in which HHS leadership voiced a commitment to Breakthrough Device coverage.
Find the posting here, including a video clip:
Here's part of what AdvaMed writes:
- When the FDA deems breakthrough medtech safe and effective, there shouldn’t be duplicative, years-long reviews that delay patient access to lifesaving innovations.
- In a recent FOX interview, Dr. Makary shared that [FDA] and Dr. Mehmet Oz are working on “a way Medicare can pay for something the second the FDA approves a breakthrough device, so they don’t have to go through their own repeat, duplicative approval process for a year.”
- This effort aligns with the recent introduction of bipartisan legislation by U.S. Senators Todd Young (R-Ind.) and Alex Padilla (D-Calif.) aimed at improving this process and expediting coverage for FDA-designated breakthrough medical technologies. House legislation is expected soon. If enacted, this reform will accelerate patient access, improve efficiency, and ensure smarter use of taxpayer dollars.
I've pointed out as far back as March that AdvaMed has strongly supported HHS appointments like Dr. Oz:
...Whereas AMA, JAMA, NEJM, etc, have been consistently highly negative about the administration. NEJM, etc, have gotten "vaguely threatening prosecutor's letters." AMA got a pay cut for physicians. This week's news is that RFK Jr would like to block NIH from publishing in journals like JAMA and NEJM.
