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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FDA announces recall of infusion pumps after thousands of complaints, 1 death

InfuTronix has received 3,698 complaints related to device failures of its Halo Ambulatory Infusion system and other Nimbus pumps.

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Cardiology groups share key update: ABMS seeking feedback on proposed Board of Cardiovascular Medicine

Five of the largest U.S. medical societies focused on cardiovascular health are one step closer to seeing their paradigm-shifting proposal become a reality.

FDA announces recall of more than 2 million catheter parts, citing serious health risks

Fresenius Medical Care is issuing a recall on 2,192,535 catheter extensions and adapters used in patients with acute and chronic kidney disease.

noncompete contract clause employment pen sign

Cardiologists, thoracic surgeons applaud FTC’s ban of most noncompete clauses

The Society for Cardiovascular Angiography & Interventions and Society of Thoracic Surgeons have both shared statements in support of the ban, which is already being challenged in court. The American Hospital Association, meanwhile, opposes the policy shift, saying it “errs by seeking to create a one-size-fits-all rule”

Which healthcare entities will be affected by ban on noncompetes? Look to business practices, not tax status

The new rule will give healthcare workers more options, but are non-profit hospitals exempt from the law?

Alison Bailey, MD, FACC, chief of cardiology, Centennial Heart at Parkridge Medical Center, and a physician director of cardiovascular disease for HCA Healthcare. She was the co-chair of a four-part series on the business of cardiology sessions at ACC 2024. She explains why ACC chose to concentrate on business. #ACC #ACC24 #ACC2024 #Cardiologybusiness

Why the business side of cardiology was a key focus at ACC.24

Alison Bailey, MD, co-chair of the business of cardiology sessions at ACC.24, emphasized that reimbursement cuts can have a long-term negative impact on patient. 

Hackers were inside Change Healthcare’s systems 9 days before attack

UnitedHealth Group confirms hackers have personal data on “a substantial proportion of people in America."

Joint replacements recalled after FDA safety warning

The FDA initially made the complaint in January. Exactech has agreed to recall products at risk of chemical oxidation as a result of faulty packaging.

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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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