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. 

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.

Study ranks US health system dead last among wealthy nations

Low rankings for accessibility and outcomes earned the country the overall lowest ranking in an analysis of healthcare systems across 10 nations.

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Landmark opioid trial in Baltimore set to begin; Johnson & Johnson settles to avoid jury

Six companies have settled with the city for as total of over $402M. Two remaining defendants, McKesson and AmerisourceBergen, will test their luck in court.

Coalition of 86 healthcare groups calls for change to Affordable Care Act rule

In a letter to Congress, the groups are urging lawmakers to support HR 9001 and lift the ban on physician-run hospitals.

FDA issues recall on infusion pump parts due to risk of uncontrollable drug flow

Due to a risk of fatal overdose, the recall is labeled as the most serious of its type. While no patients have died, two have reportedly been injured. 

Around the web

Compensation for heart specialists continues to climb. What does this say about cardiology as a whole? Could private equity's rising influence bring about change? We spoke to MedAxiom CEO Jerry Blackwell, MD, MBA, a veteran cardiologist himself, to learn more.

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. 

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.”