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.

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.
Former CEO of Unite Us tapped as CMS’ Medicaid and CHIP lead
Dan Brillman, the former CEO and co-founder of coordinated care support service Unite Us, has left his position for a role in the Centers for Medicare & Medicaid Services, where he will be responsible for overseeing the federal government's safety net healthcare programs.

Under new legislation, Medicare would cover radiology assistants’ services in all settings

Absent passage of HR 3657, the profession is “in peril,” with RAs losing their jobs and left unable to practice to the full extent of their training, advocates said.

Microsoft notches antitrust approval for nearly $20B acquisition of radiology vendor Nuance

The two tech giants have now cleared a key hurdle to completing their merger, company officials revealed recently.

FDA approves first commercially available PSMA PET imaging agent for prostate cancer

Pylarify is a F 18-labeled, prostate-specific membrane antigen targeted PET agent used to pinpoint suspected metastasis or recurrence of the disease.

4 ways radiology practices can strengthen their price transparency strategy while outshining competitors

Most nonhospital-based groups fall outside of the new CMS rule, but there’s still an opportunity to adopt this mindset and attract new customers, experts wrote recently.

Breast imaging center sees certification expire after ignoring ACR’s mammography requests

This is the FDA's second mammography warning in two days, with both centers going weeks without performing mandatory quality-control tests.

ACO accountable care coordination shared savings

Radiologist participation in Medicare ACOs is surging, and late comers must take notice

Rad involvement in these value-minded care-coordination efforts leapt threefold, preparing members of the specialty to take on downside risk while strengthening bonds with hospital partners.

Delaying rule to fast-track breakthrough devices only ‘kicks the can down the road,' imaging advocate says

CMS recently postponed the go-live date of the Medicare Coverage Innovative Technology rule for the second time.

FDA issues final guidance for assessing medical device safety, compatibility in MRI rooms

The 32-page document covers everything from implanted devices to those fastened or carried by patients, such as external insulin pumps and pulse oximeters.

Policy & Regulations

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

Former CEO of Unite Us tapped as CMS’ Medicaid and CHIP lead