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. 

Zio AT mobile cardiac telemetry device

FDA warning letter: iRhythm committed multiple violations, failed to report patient deaths in time

“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”

Avatar Medical virtual reality imaging

Startup scores FDA clearance for virtual reality tool that creates patient avatars via CT, MR images

Avatar Medical said its VR solution can serve as an aid in pre-operative planning or for use during procedures. 

Merck Januvia Janumet Steglujan Nitroso-STG-19 (NTTP) type 2 diabetes

Merck sues US government over Medicare's drug price negotiation liberties, calls program a 'sham'

Merck believes the Inflation Reduction Act-launched effort “coerces” manufacturers to enter into agreements to sell their top products at a fraction of their actual value.

physician money payments dollars

Incorrect place-of-service codes resulted in Medicare overpayments totaling in the millions

The audit revealed that Medicare overpaid by approximately $22.5 million due to incorrect place-of-service coding completed by practitioners.  

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Federal bill would require more transparency from private equity-backed physician practices

H.R. 3561 also would apply to groups owned by physicians, hospitals, insurers, or venture capital firms, who could face fines of $2M for failing to comply. 

‘It was killing some of these radiology departments’: State grapples with long licensing delays

Some rad techs have waited upward of four months to receive their credentials, with it taking days prior to COVID.

FDA clears GE HealthCare MRI tool that can cut scan times by up to 83%

Sonic DL is powered by deep learning technology and targeted for use in cardiac MRI, the company said Monday.

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Will PET imaging be covered alongside new Alzheimer's drugs? CMS dodges topic in new coverage decision

The recent CMS coverage determination did not make any mention of beta-amyloid PET imaging that is necessary for both diagnosing Alzheimer’s and monitoring the effectiveness of related treatments.