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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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. 

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Social media ads led 200K patients to unwittingly drop their insurance

Users on Facebook and Snapchat clicked on ads promising free cash, only to find out their health plan changed.

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AMA study shows four pharmacy benefit managers control 70% of the market

The study from the American Medical Association is based on data from commercial and Medicare Part D plans. The analysis found market share for PBMs is heavily concentrated, leading to higher drug costs. 

Around the web

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

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

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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