Drugs

Court Threatens ‘Practice of Medicine’ Defense: Attorneys

A Cooley Alert says a recent 4th Circuit Court of Appeals decision in a Medicare fraud case may embolden the government to reject the “practice of medicine” defense whenever a healthcare practitioner uses an approved or cleared medical device for off-label uses, under the theory that any device that violates the Federal Food, Drug, and Cosmetic Act is not “legally marketed.” The alert says the case involved an ENT doctor who was convicted of a $4.7 million four-year Medicare fraud scheme involving repeated use of surgical devices that FDA approved for only a single use.

The doctor reportedly reused the Entellus XprESS device in balloon sinuplasty surgery for which she billed Medicare for the cost of a new device for each surgery. The alert says the doctor charged Medicare more than $46 million for balloon sinuplasty surgery and at one point was the nation’s leading Medicare biller for the procedure.

“During the first Trump administration,” the report says, “the Department of Justice (DoJ) brought record-breaking criminal charges and recoveries for healthcare fraud. Now, with newfound vigor in the wake of [the Circuit Court decision], we expect DoJ and FDA under the second Trump administration to continue aggressively prosecuting fraud involving medical devices by supplementing long-standing enforcement mechanisms with additional charges under Section 301(k).”

The attorneys say the decision is the second federal appellate ruling, and the first since the Supreme Court’s decision ending deference to agency legal interpretations, to endorse the government’s expansive reading of Section 301(k), which criminalizes certain actions involving regulated products.

“Industry participants can expect close scrutiny by federal and state enforcers over the use of allegedly adulterated medical devices to perpetuate healthcare fraud,” the alert concludes.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome