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.

ACR wants Medicare to add more radiology measures in MIPS quality pay program

Radiology advocates believe the value-based payment program needs more measures to support radiologists in meeting performance requirements.

Radiology societies, all 50 state medical associations push Medicare pay fix

A total of 80 healthcare organizations signed the message, sent to leaders in the U.S. House and Senate on Feb. 10.

Gottlieb: Let’s not slap the label ‘medical device’ on AI software that only helps clinicians make care decisions

Standing FDA guidance reflects concern over physicians deferring to AI-aided CDS recommendations when pressed for time or uncertain of their own judgments. Is that stance outdated?

Benzodiazepine use before heart surgery: Should it be embraced or restricted?

Benzodiazepines are administered before a majority of cardiac surgeries to lower the risk of intraoperative awareness. At the same time, however, recent studies have suggested they increase the risk of postoperative delirium.

A graphic released by the AMA showing that cumulative Medicare payment cuts to physicians between 2001-2025 has resulted in a 33% cuts, which medical societies and numerous physicians in Congress says is not sustainable without Medicare patients losing access to care.

Congressional bill could reverse Medicare cuts and increase physician pay

A bill in Congress would reverse the 2025 Medicare cuts and increase physician pay, but a March deadline looms to make this happen.

ACR wants radiology prioritized in Senate bill to boost number of residency slots

Members of Congress introduced the bipartisan legislation in December, hoping to help hospitals train more physicians amid workforce shortages

Pennsylvania, South Carolina propose requiring insurers to cover breast MRI, ultrasound

Gaps in coverage result in individuals paying anywhere from $234 for a follow-up diagnostic mammogram to over $1,000 for a breast MRI, Komen estimates.

Report: Incoming Trump executive order to eliminate ‘thousands’ of jobs at HHS

According to coverage in the Wall Street Journal, leadership at HHS has been told to rank probationary workers as the Trump Administration prepares to announce cuts. The White House denies the claim.

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