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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The Millipede 088 Access Catheter. Image courtesy of Perfuze. FDA clearance.

Regulatory Roundup: FDA clears 2 new solutions, declines to approve omecamtiv mecarbil for HFrEF

Read our monthly recap of FDA-related news items from the world of cardiovascular medicine. 

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‘Tremendous setback’: Imaging advocate blasts CMS decision on Alzheimer’s care

The Medical Imaging & Technology Alliance challenged Medicare's limited coverage for beta-amyloid PET, used to help identify those at risk.

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2021 Medicare policy changes dragged down radiologist pay, new study confirms

Specialties that provided fewer E/M services, such as radiology and general surgery, saw the largest declines, experts wrote in JAMA. 

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DEA proposes restricting some telemedicine prescriptions

The proposed rules specifically narrow the prescribing of controlled substances via telemedicine for patients who have not been seen in person.

Abbott and the U.S. Food and Drug Administration (FDA) are warning healthcare providers about the potential risk of early structural valve deterioration (SVD) with Abbott’s line of Trifecta bioprosthetic heart valves. This includes the original Trifecta valve and the Trifecta GT, which are both designed to treat disease, damaged or malfunctioning aortic heart valves.

FDA warns that early deterioration is possible with Abbott’s Trifecta heart valves

Early SVD has been reported in these devices, particularly three to four years after implantation. According to the FDA, this has resulted in surgical replacement procedures and transcatheter valve-in-valve interventions. In some cases, the patient died.

FDA authorizes first at-home flu and COVID-19 test

The test specifically can detect and differentiate between influenza A and B and the SARS-Cov-2 virus that causes COVID-19.

New ransomware threat with ties to Russia targets healthcare providers

The "prolific" ransomware group Clop is associated with Russia and has managed to breach some major healthcare systems.

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Proposed bills in several states would bolster coverage for breast imaging services

The Susan G. Komen organization has lobbied for the proposals and recently touted them in a series of separate announcements. 

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