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 alerts public to Medtronic device recall after 33 injuries

An urgent device recall has been issued on Bravo CF, a line of pH capsules that are placed in the esophagus to aid in understanding the effects of acid reflux. Due to a dangerous manufacturing error, certain lots of the devices must be quarantined immediately.

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Major health insurers agree to reduce prior authorization burden for imaging and other services

AHIP, the industry’s largest lobbying group, made the commitment Monday alongside over 50 payers including UnitedHealthcare and the BCBS Association. 

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Report: Medicaid cuts could force hundreds of rural hospitals to close their doors

A report from the Chartis Center for Rural Health warns that many hospitals in rural communities are at risk of closure if Medicaid cuts pass through Congress and are enacted by President Donald Trump. According to the analysis, women and newborns will disproportionately lose access to care. 

FDA issues Class I recall on GE Carestations due to ventilation issue

The issue stems from a mode on the ventilation systems malfunctioning. Although no devices need to be removed from care settings, some will require repair.

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FDA issues emergency recall on resuscitation systems due to failure code

A specific model of AutoPulse resuscitation system manufactured by Zoll is prone to a failure code that could result in inadequate chest compressions being administered to patients. The affected kits must be removed from the supply chain immediately.

Suman Tandon, MD, FASNC, a cardiac imager at St. Francis Hospital and Heart Center, in Rosyln, New York, and an American Society of Nuclear Cardiology (ASNC) representative to the American Medical Association (AMA) House of Delegates (HOD), explains ASNC's concerns about artificial intelligence being used to automatically deny prior authorizations and prevent patients from accessing care.

ASNC and AMA push back against AI prior authorization denials

Suman Tandon, MD, a representative of the American Society of Nuclear Cardiology, explains her organization's concerns about artificial intelligence being used to automatically deny prior authorizations and prevent patients from accessing care.

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Physicians speak out against payers’ growing use of AI to deny imaging requests

Heart imaging specialists contend that the deployment of artificial intelligence "is making the issue of prior authorization worse, not better."

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CVS sued over alleged ‘political manipulation’ through mass text messages

A class-action lawsuit claims CVS Health sent text messages to customers and patients, inciting fear over a PBM regulation up for vote in Louisiana. Plaintiffs allege the incident violates state data privacy and political communication laws.

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