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. 

FDA announces new Class I recall of drainage systems after 26 injuries

According to the agency, using these devices “may cause serious injuries or death.”

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Feds seeking public comment on private equity healthcare spending sprees

A joint announcement from the DOJ, FTC and HHS asks for providers, patients or other industry experts to share their experiences with private equity transactions, including those not typically subject to antitrust review by law.

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Industry Watcher’s Digest

Buzzworthy developments of the past few days.

Dexcom, a global healthcare technology company based out of San Diego, has received U.S. Food and Drug Administration (FDA) clearance for Stelo, a wearable glucose biosensor that can be obtained without a prescription.

FDA clears first over-the-counter wearable device for continuous glucose monitoring

The newly cleared device is worn on the back of the arm and sends data directly to the user's smartphone. 

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Feds launch inquiry to assess private equity’s impact on healthcare

The Federal Trade Commission, Department of Justice, and Health and Human Services want to learn more about corporations’ “increasing control” of the field. 

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S&P expects Radiology Partners to generate positive free cash flow for 1st time in years

The country's largest imaging group spent more than it was collecting in both 2022 and 2023, but the ratings agency believes it may be turning a corner. 

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HHS responds to physician concerns raised after Change Healthcare cyberattack

The department is urging managed care plans to relax prior authorization requirements during the outage and instructing MACs to accept paper claims. 

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Southwestern state to forgive $2B in medical debt for 1M residents

A February analysis showed more than 11 million Americans owe healthcare providers between $1,001 and $10,000. Another 3 million owe more than $10K.