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. 

RSNA Board member Richard Heller, MD, explains issues with Medicare reinburements and the No Surprises Act and Congressional actions that may fix both.

Key Medicare reimbursement and No Surprises Act updates from RSNA 2024

Richard Heller III, MD, RSNA board member and senior VP of policy at Radiology Partners, offers an overview of policies in Congress that are directly impacting imaging.
 

Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey Type 1 dissections when malperfusion occurs. This HDE ensures select patients can be treated with the device before the FDA makes its final approval decision.

First surgical device of its kind granted key FDA exemption

This update helps ensure Artivion's AMDS Hybrid Prosthesis can be used to treat high-risk patients as the FDA makes its final approval decision. The news came as Artivion works to bounce back from a cybersecurity attack that occurred in November.

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Radiologists sound alarm with state bill to more than double cap on malpractice damages

Radiology advocates have rallied against the measure, worried it could “threaten the stability” of the state’s healthcare system, ACR reported. 

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Industry Watcher’s Digest

The FDA has finalized its recommendations for getting AI-equipped medical devices approved. 

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Providers, payers share actionable experiences involving healthcare AI

A large venture capital firm focused on supporting early-stage healthtech companies has a tip for AI startups targeting the healthcare sector.

Anthem

Anthem BCBS reverses course on anesthesia time limits

After announcing it would place time limits on reimbursement for the time a patient is under anesthesia, Anthem Blue Cross Blue Shield has now denied it ever intended to make the change. 

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Interventional cardiology’s first Match Day celebrated as a ‘historic achievement’

This was a moment years in the making for interventional cardiology. A total of 164 training programs participated, and 94% of applicants secured a position. 

FDA issues Class I recall on insulin syringes due to risk of death

A line of syringes manufactured by Cardinal Health may fail to properly inject insulin when used with needleless IV connectors.