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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Teva settles with DOJ for $450M to resolve latest price fixing allegations

The world's largest generic drug manufacturer allegedly paid charities kickbacks to cover patient co-pays in an effort to inflate the price tag of its multiple sclerosis treatment.

pharmaceutical drug approval process

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. 

artificial intelligence in cardiology

FDA grants AI-powered ECG screening tool for aortic stenosis its breakthrough device designation

The FDA clearly sees significant potential in this new screening software from New York-based AccurKardia.

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AMA, physician groups file amicus brief with Supreme Court in ‘ghost gun’ case

The groups are urging the Supreme Court to uphold a lower court ruling in Garland v. VanDerStok that permits the ATF to regulate firearms made from part kits. 

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CMS proposes rule to combat gray market health insurance scams

The agency has received an increasing number of complaints from patients enrolled in a low-value health plan without their knowledge. If finalized, a new rule would empower CMS to ban brokers from the ACA marketplace. 

Monitoring acute heart patients at home linked to considerable cost savings

The new report could go on to help guide decisions made by CMS and hospital leadership teams for years to come.

Medtronic's MiniMed 780 (left) and 670 (right) insulin pumps in FDA recall

FDA rules Medtronic’s insulin pump issues a Class I recall due to safety risks

Some of Medtronic's 600 and 700 series MiniMed insulin pumps are experiencing significant battery issues when dropped, bumped or impacted in any way. This has been linked to reports of health issues in more than 180 patients.

U.S. News & World Report children’s hospitals cardiology heart surgery

SCAI urges lawmakers to improve cardiac care access for children

The Accelerating Kids' Access to Care Act would expand Medicaid access for pediatric patients so that it covers interventional cardiologists outside of their home states.

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Around the web

Cardiovascular Business
Payment cuts and beyond: Key takeaways for cardiologists from the 2025 Medicare Physician Fee Schedule

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

AI in Healthcare
A modest proposal to rally AI regulators around a simple game plan

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

Cardiovascular Business
FDA commissioner urges clinicians to join fight against medical misinformation

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

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