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. 

Novartis sues FDA over ‘unlawful’ approval of generic heart failure drug

The drugmaker argues that the FDA's recent approval of a generic version of Entresto should not be allowed for multiple reasons. Novartis sent multiple requests to the agency hoping to stop the approval, but the FDA denied each one. 

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Radiology Partners leader urges physicians to turn their Medicare ire toward Congress

Despite raging inflation and rising staff costs, the conversion factor is the lowest it’s been since 1993, Richard Heller, MD, MBA, wrote for MedPage Today. 

Stark Law Kickback Erlanger

DOJ suing health system in alleged kickback scheme

Three years after a pair of former hospital C-suite executives blew the whistle on their own institution, the U.S. Department of Justice has acted on the complaint.

Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system

Abbott says some FreeStyle Libre 3 sensors need replacement—patients should discontinue use

The new medical device correction only includes a select number of devices. Abbott said they produce inaccurate readings, putting patient health at risk. 

The Teleflex Ringer Perfusion Balloon Catheter has been approved by the FDA for PCI.

FDA clears perfusion balloon catheter for complex PCI cases

The newly cleared device includes a rapid-exchange catheter and a helical balloon that takes the shape of a hollow cylinder when inflated.

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Radiologists urge Congress to quash bill that would ‘inappropriately’ grant pharmacists more authority

The Equitable Community Access to Pharmacist Services Act would allow Medicare to reimburse for certain pharmacist-administered tests, treatments and vaccinations. 

AMA survey: Prior authorization causes many patients to abandon care, raises healthcare costs

Prior authorization is frustrating to clinicians, but a new survey from the American Medical Association shows it also frustrates patients to the point of abandoning care. The survey showed many more insights regarding PA impact on care.

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What might reimbursements for proposed MRI safety CPT codes look like?

Prior to the final proposal’s release, the American College of Radiology reached out to CMS to offer its recommendations on payment rates for five out of the six the new codes.