Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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Report: UnitedHealth under investigation by DOJ for Medicare Advantage upcoding

According to the Wall Street Journal, federal authorities are probing claims that the insurer billed health programs for billions of dollars in undelivered patient care. 

FDA approves first therapy for very rare lipid storage disorder

Ctexli (chenodiol) can now be prescribed to patients with cerebrotendinous xanthomatosis, a condition caused by a genetic mutation that leads to cholesterol buildup around vital organs. 

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Radiology societies demand moratorium on enforcement of ‘concerning’ Medicare decision

Societies representing neuro, interventional and spine radiologists are concerned 3 MACs do not understand the nuances of a key minimally invasive pain procedure. 

FDA announces Class I recall of Boston Scientific pacemakers—replacement may be necessary

These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced. 

FDA ends semaglutide shortage, closing the door on compounded Wegovy, Ozempic

The years-long shortage of Wegovy and Ozempic, two popular prescription-only semaglutide injections, is officially over. 

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American Heart Association highlights importance of NIH as battle over Trump funding cuts continues

“Now more than ever, we must recognize that our country’s leadership in groundbreaking medical research spurs scientific innovation, improves public health and creates new innovations that save and improve lives nationwide,” Joseph C. Wu, MD, PhD, explained in a statement. 

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Healthcare AI newswatch: Trump-era AI regs, AI sign language, AI dentistry, more

The Trump administration will probably play to type when it comes to regulating AI. 

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Imaging industry lobbying group criticizes FDA staffing cuts

The list reportedly included the agency's head of medical device safety and 10 of the 40 staffers tasked with reviewing imaging devices.