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. 

emergency physician doctor

How long will we accept patients languishing in the ER as normal? (asks a firsthand witness to ‘boarding’ who’s also a distinguished journalist and an erstwhile ER doctor)

Boarding is hospital-speak for when patients get left in the emergency department, typically on gurneys or in wheelchairs, for many hours—sometimes days—because no inpatient beds are available. 

U.S. FDA Sign

FDA, CMS unveil rapid Medicare coverage pathway for critical medical devices

Prior to the new “RAPID” program announced on Thursday, it could take a year or more for Breakthrough-designated medical devices to earn approval for Medicare coverage. Now regulators say that timeline could be reduced to as little as two months.

 The U.S. Food and Drug Administration (FDA) has granted market clearance for Biotronik's Acticor Sky and Rivacor Sky implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The new technology will be launches at the Heart Rhythm Society (HRS) annual meeting this week. #HRS2026

FDA approves 2 implantable heart devices from Biotronik

These devices were built to provide better patient data and improve clinician workflows. They will be on display at Heart Rhythm 2026 in Chicago. 

approval regulations checkmark doctor

Trump administration moves to speed up Medicare coverage for breakthrough cardiology devices

CMS and the FDA say the goal is to improve patient access to medical devices that address an unmet need.

Clinic selling electrical stimulation pain relief pays $380K to resolve fraud allegations

The U.S. Department of Justice said Wisconsin-based Apple Clinic and its owner Michael Johnson, MD, were using a combination of nerve density testing, vitamin injections and electrical stimulation to alleviate pain, billing Medicare for these medically unnecessary services. 

FDA clears Philips Rembra platform

FDA clears Philips' CT platform that streamlines and coordinates workflows

The product expands the capabilities of computed tomography within both diagnostic and radiation therapy settings, improving coordination between care teams. 

doctor patient elderly check up hospital

Heart failure experts agree: HFmrEF should not be ignored

Data on the treatment and management of HFmrEF are limited, but a new scientific statement from the Heart Failure Society of America highlights how important it is to take this condition seriously.

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Radiologists collect $90M in research funding from imaging industry, with overall share of pie falling

Altogether, members of the specialty collected nearly 5,800 of these payments in 2024, from sources such as pharmaceutical companies and imaging device manufacturers.