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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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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Biden administration urges Supreme Court to uphold ACA mandate requiring cost-free cancer screenings

A recent "mixed bag" ruling from the Fifth Circuit Court of Appeals threw the mandate into question, potentially jeopardizing imaging services for millions of Americans. 

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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. 

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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