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.

ASNC calls on members to fight 57% Medicare cut for cardiac amyloid imaging
Jamieson M. Bourque, MD, MHS, president-elect of the American Society of Nuclear Cardiology, shared the group's concerns with Cardiovascular Business. “This is going to have a highly negative impact," he said.
Society of Interventional Radiology shares guidance on offering new image-guided service
IRs can play a key role in kidney care using a novel, nonsurgical approach that deploys catheters and imaging guidance to create a fistula in the arm for dialysis access.
FDA issues recall of intraoperative imaging system due to safety risks
The system enables surgeons to intraoperatively illuminate cancerous tissue in the breast cavity during lumpectomy surgery.
Radiology Business Management Association strongly urges Medicare to withdraw controversial doc pay ‘efficiency adjustment’
The federal payment program first proposed this 2.5%, across-the-board cut for physician services in July, exempting most time-based healthcare offerings.
Lawmakers urge Trump administration to fix No Surprises Act problems plaguing radiology
Five years after Congress passed the landmark law, shortcomings persist, which are potentially hampering patients and physicians, House leaders contend.

Edwards Lifesciences Corporation has shared new one-year data on the safety and effectiveness of its Evoque transcatheter tricuspid valve replacement (TTVR) system among patients with tricuspid regurgitation (TR)

CMS approves Medicare coverage for transcatheter tricuspid valve replacement

CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.

FDA approves new prostate cancer imaging agent with extended shelf life

The new product from Telix paves the way for increased access at clinics where prostate PET may not have been available in the past.

Bard Peripheral Vascular Rotarex Atherectomy System recall

Safety update: FDA announces Class I recall due to atherectomy devices breaking during use

The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

Healthcare AI newswatch: California AI hoping, the jagged AI frontier, agents bumping off bots, more

California has moved assertively to legislate guardrails around AI in healthcare. Will other states follow?

Next-generation AI agents are headed for healthcare. What will they do once they get here?

Healthcare AI agents can be classified as one of four models. In increasing order of autonomy and clinical integration, these are: foundation, assistant, partner and pioneer.

FDA issues two serious patient safety alerts

The notices are unrelated, but both require that clinicians adhere to a set of updated use instructions. One patient died as a result of injury.

Changes to practice-expense RVU component could spell ‘detrimental consequences’ for radiology

Radiology experts are warning that reimbursements for certain imaging services are not enough to cover expenses, putting specialists in a precarious position.

FDA announces Class I recall on defective ports used for vein access

There have been two reported injuries linked to the Smiths Medical ProPort Plastic Implantable Ports, many of which are subject to an immediate recall.

Policy & Regulations

ASNC calls on members to fight 57% Medicare cut for cardiac amyloid imaging

Society of Interventional Radiology shares guidance on offering new image-guided service

FDA issues recall of intraoperative imaging system due to safety risks

Radiology Business Management Association strongly urges Medicare to withdraw controversial doc pay ‘efficiency adjustment’

Lawmakers urge Trump administration to fix No Surprises Act problems plaguing radiology