HHS Watchdog Blesses Proposed Gift Card Giveaway To Encourage Test Returns
A proposal that would give some patients gift cards in exchange for returning a screening test sample would not violate anti-kickback law because it doesn’t encourage medically unnecessary services, HHS-OIG says.
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Parallel Review Progress: FDA Approves, CMS Assesses Cologuard Cancer Test
CMS opened a national coverage determination for Exact Sciences Cologuard, the first stool-based colorectal cancer screening test on the same day FDA approved the test. This is the first simultaneous approval/coverage determination under FDA and CMS’ joint parallel review program.
News We’re Watching: Disease X Act, Abiomed Recall, TAVR AI Cleared
This week, the bipartisan Disease X Act for pandemic preparedness was introduced in the US House of Representatives; Abiomed Impella pumps were the subject of a class I recall; Dasi Simulations and Endologix landed FDA clearances; and the FDA warned against the use of Getinge/Maquet Oxygenators.
FDA Tweaks Q-Sub Meeting Guidance
The revised guidance document clarifies the Q-submission meeting process, alternate ways sponsors may obtain FDA feedback, and more.