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.

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately
The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.
Why all heart patients should be vaccinated against the flu, COVID-19, RSV
The American College of Cardiology has shared new recommendations highlighting the protective benefits of a variety of vaccines. The new guidance also examines how to speak with patients who are hesitant to be vaccinated.
Medicare has denied $16M worth of radiology artificial intelligence claims
The federal payment program first started paying for AI in 2018 and has denied about 53% of claims (or 53,857) submitted by radiologists since then, experts detail in JACR.
Members of Congress propose tapping foreign-born physicians to relieve radiology workforce shortages
Lawmakers in both chambers have reintroduced the Healthcare Workforce Resilience Act, touting support from the American Hospital Association and several physician societies.
Medicare opts not to make CT radiation-related quality measure mandatory in 2027
The measure evaluates the proportion of scans that exceed certain thresholds for image noise or radiation dose across 18 categories.

Medical societies representing radiology, emergency medicine and anesthesiology blast new NSA guidance

“Our organizations are strongly opposed to this newest guidance, which further broadens the already significant discretion health plans had," RBMA and others wrote Oct. 9.

Inmate, prison guard stuck to MRI machine at unregulated site

The incident happened at a SimonMed location in Arizona after staff failed to remove a waist shackle from the inmate.

An RSNA attendee undergoes an MRI brain scan on the expo floor using the Hyperfine Swoop head MRI system. It is self-shields with a low field 0.064 T. It uses a standard wall power outlet and can be wheeled through a standard 34-inch wide door frame. It weighs 1,400 pounds. Imaging sequences include T1, T2, FLAIR, and DWI (with ADC map) and its operational controls are all directed on an iPad interface. #RSNA #RSNA22

FDA clears new artificial intelligence capabilities for portable MRI scanner

This is the eighth clearance in the past three years for Hyperfine's Swoop system, company officials said Monday.

Lab owner confesses to $359M fraud involving COVID tests

A married couple operating a lab in California admit to billing Medicare for unnecessary rapid COVID tests.

Patisiran, marketed under the name Onpattro

FDA chooses not to approve patisiran for treating ATTR cardiomyopathy

The announcement came just weeks after an FDA subcommittee voted in favor of approval.

What is CKM syndrome? American Heart Association outlines how to identify and manage a dangerous new condition

The American Heart Association has developed an updated strategy for the prevention and management of cardiovascular disease. A newly defined health condition, cardiovascular-kidney-metabolic syndrome, sits at the center of that strategy.

ACR, coalition of nearly 50 provider groups urge Congress to quash controversial code update

According to CMS estimates, the code would be responsible for 90% of the overall budget neutrality reduction tied to the conversion factor, advocates noted.

Feds finally relaunch IDR under No Surprises Act following radiologist concern

“This announcement is a step in the right direction," the Radiology Business Management Association said on Friday.

Policy & Regulations

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

Why all heart patients should be vaccinated against the flu, COVID-19, RSV

Medicare has denied $16M worth of radiology artificial intelligence claims

Members of Congress propose tapping foreign-born physicians to relieve radiology workforce shortages

Medicare opts not to make CT radiation-related quality measure mandatory in 2027