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.

FDA clears new AI-enabled coronary plaque analysis software
Circle Cardiovascular Imaging, a Canadian medtech company, received the key approval for its cvi42 | Plaque platform.
Consolidation may be driving radiologists away from practicing as generalists
Radiologists who experienced a practice closure are more likely to operate as subspecialists afterward, according to new Neiman research.
FDA warns Philips after issues arise at multiple manufacturing facilities
Meanwhile, the Amsterdam-based imaging giant said it has already taken action to begin correcting these issues.
FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus
The company is working to commercialize MK-6240, a radiodiagnostic that targets tau protein tangles—a “key hallmark of several neurodegenerative diseases.”
Medicare now covers renal denervation for patients with uncontrolled hypertension
This decision expands access to renal denervation to many more patients throughout the United States. Recor Medical and Medtronic both gained FDA approval for their RDN systems in 2023, and other vendors are actively developing their own treatment options.

Tens of thousands of radiologists and other docs align in opposing surprise-billing provision

Meanwhile, the nation's largest payer trade group voiced its support, believing the rule will encourage more physicians to join health plan networks.

Radiology stakeholders want White House intervention to prevent ‘disastrous’ payment changes in 2022

Physicians face "draconian" Medicare cuts that could stifle cancer care in 2022, the American College of Radiology, ASTRO, Siemens and others wrote to President Biden recently.

Feds drop surprise-billing rule, prompting fears new dispute-resolution process will tip scales in insurers’ favor

Radiology advocates believe the regulation will lead to sizable payment cuts in imaging and reduce patients' access to care, regardless of their insurer.

healthcare value value-based care money dollar

ACR Association offers up $225,000 to help local radiologists fight nonphysician scope-of-practice gains

Possible uses could include advertising, grassroots campaigns or engaging a political strategist, with applications due by Oct. 31, the college announced recently.

‘A troublesome trend’: Top imaging groups slam insurer-directed test substitution policies

Advocates say payers' push for single first-line imaging tests for all patients isn't backed by evidence and may cause harm.

FDA authorizes first AI-based software used to spot prostate cancer

The tool helps pathologists spot areas of interest on biopsy images and is designed to be used as an assistant.

Hundreds of radiologists flood feds with pleas to avoid massive Medicare pay cuts

ACR members have sent more than 1,300 emails to members of Congress, imploring them to quash a controversial change that would dramatically cut doc pay.

Imaging advocates blast CMS repeal of rule granting faster Medicare coverage for breakthrough devices

Those in support of the MCIT proposal called the administration's decision a "major setback" in efforts to bring innovation to seniors sooner.

Policy & Regulations

FDA clears new AI-enabled coronary plaque analysis software

Consolidation may be driving radiologists away from practicing as generalists

FDA warns Philips after issues arise at multiple manufacturing facilities

FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus

Medicare now covers renal denervation for patients with uncontrolled hypertension