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Sue Darcey
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Latest From Sue Darcey
Physicians Failing To Disclose Supplier, POD Arrangements Fuel Kickback Concerns, Senators Say
US Senate Finance Committee leaders say some physicians may have failed to disclose their physician-ownership interests in entities that offer medical supplies to the physician’s own practice, as required under the Physician Payment Sunshine Act. The legislators on March 19 prodded the Health and Human Services' Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) to take a closer look into these arrangements.
FDA Focusing More On Safety Of Device Biomaterials, Attorney Warns
Device-makers will have to take a more proactive approach to understanding the safety of biomaterials they use for their implanted devices, and how these materials might affect patients during post-market use, industry attorney Michele Buenafe of Morgan Lewis & Bockius LLP told Medtech Insight in a March 18 interview.
FDA Will Hold Advisory Panel Meeting In Fall On Metal Implant Reactivity
US FDA Commissioner Scott Gottlieb and device center director Jeffrey Shuren reminded the public on March 15 that materials in devices – including metals in orthopedic products and defibrillators – can cause reactions in some patients. They said the agency needs to do "more work” on patient responses to metal implants and other biomaterials, and announced an FDA advisory panel meeting this fall on reactions to metals.
AdvaMed Pins Hopes For Device Tax Repeal On 10 Senate Democrats, But Could Lose House Support
A coalition of 27 Senators – including 10 Democrats led by Amy Klobuchar, D-Minn. – on March 7 co-sponsored a bill to permanently repeal the device tax. AdvaMed says support of additional Democrats on this year’s bill should persuade Senate leaders to bring S. 692 to the floor for a vote, or it could be attached to other, "must pass"’ legislation. But the bill’s approval in the Democratic-controlled House is uncertain. Sixty-five of 283 “yes,” voters – mostly GOP – favoring tax repeal in the last session, are no longer in office.
HHS Secretary Azar Takes Heat At Budget Hearing
HHS Secretary Alex Azar was pressed on issues tied to the Affordable Care Act and the recently proposed FY 2020 budget at a March 12 congressional hearing.
NCI Director And Former Dx Start-Up Founder Sharpless Will Helm FDA
After a week of speculation as to who will succeed US FDA Commissioner Scott Gottlieb when he steps down next month, Health and Human Services Secretary Alex Azar announced during a congressional hearing that National Cancer Institute Director Ned Sharpless will step in as acting commissioner. One note of medtech interest in Sharpless' bio: he was a co-founder of a diagnostics company.