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. 

Erin R. Stevens, CNMT, NCT, director of nuclear medicine at Oregon Heart Center, said training physicians for what is needed in cardiac PET documentation is key for preventing issues with prior authorizations. ASNC photo

Good documentation is the key to cardiac PET prior authorizations

Knowing what, exactly, is needed in cardiac PET documentation is one of the best ways to limit prior authorization issues.

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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State Supreme Court ruling holds hospitals accountable for mistakes made by independently contracted radiologists

Washington becomes one of a select few where attorneys can also go after a hospital that hired outside physicians, joining South Carolina, Michigan, Maryland and Iowa

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.