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. 

Rapt drug trial halted

FDA halts Rapt drug trial after patient complication

Shares in the drugmaker took a hit after a case of liver failure in one study participant resulted in regulators putting an immediate pause on further dosing or enrollment in the trials. 

wheelchair

Prominent radiology practice accused of refusing imaging services to wheelchair user

The dispute dates to August, when Suzanne Garraffa first contacted Connecticut-based Jefferson Radiology seeking X-rays. 

Video of Patricia Keegan, NP, Emory, explains value of the ACC TVT NCDR registry for TAVR and why it is important from both a quality monitoring standpoint and for attracting patients to your program.

Data registries have been a huge success for U.S. structural heart programs

ACC/STS National Cardiovascular Data Registry metrics reporting for TAVR is important for marketing and care quality, explains Patricia Keegan, NP, with the Emory Heart and Vascular Center.

doctor telehealth computer screen

American College of Radiology asks CMS to permanently allow remote supervision of diagnostic tests

The Centers for Medicare & Medicaid Services started allowing this perk in 2020 amid the pandemic, but it is slated to go away by the end of 2024. 

artificial intelligence regulation legislation

Physician congressman hopes to address ‘appalling’ inaction on Medicare pay fix by March

Rep. Larry Bucshon, MD, R-Ind, spoke during the American Medical Association’s National Advocacy Conference, which took place from Feb. 12-14 in Washington. 
 

FDA announces recall of more than 50,000 infusion pumps

Smiths Medical says providers should double check that Medfusion Model 4000 pumps have had their software properly updated, after reports that earlier versions of the device software could cause harm.

doctor looking at CLTI patient's leg

FDA grants bioresorbable scaffold system its breakthrough device designation to treat infrapopliteal lesions

The new drug-eluting device was designed to provide both stability and flexibility to patients presenting with below-the-knee lesions.  

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Outpatient imaging provider attempts to capitalize on closure of 2 local hospitals

Smart Scan Medical Imaging has sought to attract customers impacted by the news, noting the institutions were seeing 400 patients per month.