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 proposes major shift to COVID vaccine schedule

Under the new proposal, the FDA would conduct an assessment of prevalent strains circulating each year, likely beginning around June, with the aim of new vaccines being ready by September. 

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Uninsured rate dropped during COVID-19 pandemic

The uninsured rate in the United States saw a drop from 11.1% in 2019 to 10.5% in 2021, according to a new report from the Department of Health and Human Services (HHS).

Animal testing no longer required for all new drugs approved by FDA

The bill was first introduced by Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) in the Senate, and it was approved unanimously.

COVID-19 PHE extended to mid-April

The renewal comes as the country is facing another wave of COVID-19 infections, this time from a new variant identified as XBB.1.5.

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Cardiologists push for a more diverse, inclusive healthcare workforce

A recent roundtable discussion focused on how today's healthcare leaders can "begin to dismantle the systems that perpetuate inequities in medicine and build new systems that promote diversity, equity and inclusive excellence."

FDA announces recall of adrenaline lots

Spectrum Laboratory Products is voluntarily recalling the lots after customer complaints found the adrenaline to be discolored.

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HHS to release first wave of drugs up for price negotiations Sept. 1

HHS is moving forward with drug price negotiations afforded to CMS under the Inflation Reduction Act.

FDA approves new Alzheimer’s disease drug

The U.S. Food and Drug Administration (FDA) approved a new drug treatment for Alzheimer’s disease, Leqembi (lecanemab).

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Around the web

Cardiovascular Business
Cardiology groups cheer new bill that would improve access to Medicare claims data

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. 

Cardiovascular Business
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.

Cardiovascular Business
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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