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.

Medicare and FDA propose granting rapid coverage for breakthrough radiology devices
The two agencies on April 23 announced the rollout of the Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway.
Radiology groups endorse bill to exempt physicians from $100,000 visa fee
ACR, ASNR and over 40 other organizations shared their support for the Healthcare Workforce Act in a letter to lawmakers written April 15.
'Sterility failures' prompt FDA to threaten radiopharmaceutical producer with disciplinary action
Multiple issues that could raise the risk of product contamination were discovered during an inspection, according to an FDA warning letter.
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.
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.

Medicare and FDA propose granting rapid coverage for breakthrough radiology devices

The two agencies on April 23 announced the rollout of the Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway.

congress money legislation lawmaker bill senate house senator representative

Radiology groups endorse bill to exempt physicians from $100,000 visa fee

ACR, ASNR and over 40 other organizations shared their support for the Healthcare Workforce Act in a letter to lawmakers written April 15.

'Sterility failures' prompt FDA to threaten radiopharmaceutical producer with disciplinary action

Multiple issues that could raise the risk of product contamination were discovered during an inspection, according to an FDA warning letter.

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.

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.

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.