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.

FDA clears and grants breakthrough status for radiology triage tool from Annalise.ai

The Sydney, Australia-based vendor said its solution enables both passive and active notifications for suspected obstructive hydrocephalus.

Radiology groups urge CMS to retool the flawed Merit-based Incentive Payment System

Leaders with ACR, the RBMA and Radiology Partners all have recently written about concerning aspects of the quality-focused Medicare payment program.

FDA announces recall of Abbott neurostimulation devices after MRI-related issues lead to 73 injuries

The new recall, which includes more than 155,000 implantable pulse generators, is due to ongoing issues with the devices being unable to exit MRI mode and return to normal use.

ACR, others push for imaging-agent pay fix as House leaders plan hearing on topic

The House Energy and Commerce Committee announced Tuesday that it will hold a hearing to discuss the FIND Act.

Video of Denise Garris, ASE regulatory consultant and principal of the Korris Group, explaining how reimbursements from insurance andMedicare work to pay or cardiac ultrasound exams. #ASE #ASE360 #ASE23 #ASE2023 #healthcarereimbursment

Understanding reimbursements and coding for echocardiography

"I think everyone would agree that the current fee-for-service model is not working appropriately and there needs to be a fix," regulatory consultant Denise Garris explained in a new interview.

Radiology Business Management Association warns CMS that specialty is reaching a ‘tipping point’

“After 16 straight years of cuts to radiology this is an unsustainable environment in medicine,” RBMA Executive Director Bob Still wrote to the agency.

Industry Watcher’s Digest

Buzzworthy developments of the past few days.

FDA approves LimFlow System for Transcatheter Arterialization of Deep Veins for CLTI

FDA approves new minimally invasive CLTI treatment for ‘no-option’ patients at risk of amputation

The new device, the first of its kind to gain FDA approval, was designed for patients who have no other endovascular or surgical options available to them.

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