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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HHS awards $75M for addiction and maternal health services in rural areas

The funds will be used to expand services and improve the financial stability of existing healthcare organizations located in underserved regions of the South. 

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FDA announces Class I recall for compounding inlets due to risk of death

Baxter’s disposable inlets for automated compounding systems could pose a serious risk to patients if not properly inspected before use.

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Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

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Q&A: Healthcare attorney skeptical of California’s new private equity regulation

AB 3129 grants the Attorney General of California oversight of private equity transactions in healthcare. An attorney with Holland & Knight is concerned about the unintended consequences of the proposed law. 

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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Foreign nurses face immigration barriers amid U.S. healthcare staffing shortages

Immigration attorney Kathleen Campbell Walker, JD, explains the barriers foreign nurses face when immigrating to the U.S. and the need for policy changes that could help solve the growing healthcare staffing shortage.

 

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FTC sues PBMs and GPOs for insulin price collusion

In a statement announcing its lawsuit, the FTC said Caremark, Optum RX and Express Scripts benefit from manufacturer rebates and ignore lower-costing drugs as a way to artificially increase prices. 

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FTC sues drug middlemen over insulin prices, puts others on notice

The FTC alleges that pharmacy benefit managers have set up a system where they get rich, while patients are forced to pay rising insulin costs. The agency also called out drug manufacturers such as Eli Lilly, Sanofi and Novo Nordisk, saying their own actions have raised serious concerns.

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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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