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 2 new MR-guided breast biopsy tools
The tools were developed with both patients and providers in mind and were designed to streamline the entire procedural process.
FDA clears MiniMed’s screenless, smartphone-controlled insulin pump
Just weeks after separating from Medtronic and going public, MiniMed secured FDA clearance for its next-generation insulin pump technology.
EP advocacy group details 6 key policy issues
The Heart Rhythm Society's advocacy arm is monitoring such issues as prior authorization, outpatient payment policies and cancelled research funding.
FDA issues emergency alert on surgical stapler reloads after 1 death, 4 injuries
The problem is limited to surgical stapler reloads used by the da Vinci robot, specifically those manufactured by Intuitive Surgical. The FDA said it’s currently investigating why the reloads are leaving incomplete line formations. For now, they need to be pulled from all patient care settings.
MGMA outlines path and pitfalls in CMS 2030 value-based care push
The Center for Medicare and Medicaid Innovation (CMMI) has tested nearly 40 APMs, of which only two turned out to be successful, which does not bode well for meeting a 2030 deadline to transition to value-based payments.

MR-guided breast biopsy tools from Mammotome nab FDA clearance.

FDA clears 2 new MR-guided breast biopsy tools

The tools were developed with both patients and providers in mind and were designed to streamline the entire procedural process.

FDA clears MiniMed’s screenless, smartphone-controlled insulin pump

Just weeks after separating from Medtronic and going public, MiniMed secured FDA clearance for its next-generation insulin pump technology.

EP advocacy group details 6 key policy issues

The Heart Rhythm Society's advocacy arm is monitoring such issues as prior authorization, outpatient payment policies and cancelled research funding.

FDA issues emergency alert on surgical stapler reloads after 1 death, 4 injuries

The problem is limited to surgical stapler reloads used by the da Vinci robot, specifically those manufactured by Intuitive Surgical. The FDA said it’s currently investigating why the reloads are leaving incomplete line formations. For now, they need to be pulled from all patient care settings.

Video interview with Anders Gilberg, MGA, senior vice president, government affairs at Medical Group Management Association (MGMA), explains various value-based payment models the Centers for Medicare and Medicaid Services (CMS) is experimenting with, but notes out or more than 30 models, only two have actually saved Medicare money.

MGMA outlines path and pitfalls in CMS 2030 value-based care push

The Center for Medicare and Medicaid Innovation (CMMI) has tested nearly 40 APMs, of which only two turned out to be successful, which does not bode well for meeting a 2030 deadline to transition to value-based payments.

FDA approves JenaValve TAVR system for aortic regurgitation

The Trilogy Transcatheter Heart Valve System is the first TAVR device approved by the FDA to treat severe aortic regurgitation. Until now, interventional cardiologists have had to settle for the off-label use of TAVR valves built for treating aortic stenosis.

Bipartisan bill would exempt radiologists from new $100,000 visa fee

The bill is endorsed by the American Medical Association, American Hospital Association and numerous others in the industry.

Insurer and business lobbying interests kill supplemental breast imaging bill in 1 state

Earlier this year, Kansas lawmakers introduced Senate Bill 409, seeking to close insurance gaps for women who need follow-up scans after screening mammography.