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. 

Chicago - Circa May 2018: Blue Cross Blue Shield headquarters signage and logo.

Blue Cross Blue Shield of New York sued over ‘ghost networks’

Thousands of patients have filed a class-action lawsuit against the insurer for issuing directories of providers who were out-of-network and did not take BCBS health plans. 

artificial intelligence partnership on AI global cooperation

Partnership on AI valiantly trying to wrap arms around the world

It’s going to take a multinational effort for the global AI community—such as it is—to avoid the emergence of a “fragmented AI landscape.” 

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Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

child in shock from noise trauma

Surprise active shooter drill at children’s psychiatric hospital results in $13M for victims

The Michigan Department of Health and Human Services failed to notify staff and law enforcement that a simulation at the state-run facility was taking place, resulting in chaos. 

DOJ U.S. Department of Justice HQ

CMS contractor takes $1.2M loss after data breach, DOJ lawsuit

Federal Data Solutions allegedly failed to encrypt screenshots of patient data, stored on a server being paid for with Medicare funds.

Bipartisan group of 233 House members call for Medicare reform

In a letter, the undersigned asked Congress to halt cuts to Medicare reimbursement and enact a permanent system to adjust rates to inflation. 

Wartime powers enacted to address nationwide IV fluid shortage

The Biden Administration has invoked parts of the Defense Production Act to address shortages that stem from Hurricane Helene damaging a Baxter production facility in North Carolina. 

HeartFlow Plaque Analysis Example

New Category I CPT code issued for AI-enabled coronary plaque analysis software

The news comes just days after CMS confirmed these technologies would start receiving expanded Medicare coverage in November. HeartFlow and other AI vendors have already shared their excitement over the decision. 

Around the web

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.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

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