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.

DOJ unveils West Coast ‘Strike Force’ as new tactic used to tackle healthcare fraud
Federal authorities said the shift to regional “Strike Force” models have been shown to be successful, with 6,200 defendants prosecuted nationwide. The DOJ said this latest unit will take a special interest in Northern California.
Atrium Health looking to scoop up smaller nonprofit health system in $2B deal
WakeMed, a three-hospital system in the North Carolina capital region of Raleigh, would become part of Advocate Health, Atrium’s parent company, if the deal goes through. Advocate is one of the largest not-for-profit health systems in the U.S.
FDA moves to restrict compounded versions of popular GLP-1 weight loss drugs
The agency said it is seeking to exclude semaglutide, tirzepatide and liraglutide from the 503B program based on a lack of clinical evidence. Unless there’s a shortage, the pharmaceuticals would be barred from being compounded by third-parties for the purpose of treating diabetes or obesity. The FDA is seeking public comment on the proposal.
FDA announces recall on insulin pump pods after leaks cause 29 serious injuries
Some Omnipod 5 devices, manufactured by Insulet, are subject to the Class I recall. The products with the defect must be removed from where they are used or sold to ensure safety, as lower-than-expected insulin doses could have potentially lethal repercussions.
5-point call goes out for action against ‘one of the most urgent and complex socioeconomic challenges of our time’
U.S. healthcare is in the throes of an affordability crisis. The good news is that healthcare leaders have all the evidence, tools and expertise needed to keep the predicament from becoming a plight. Can they marshal the will to wield those weapons toward that end?

UnitedHealthcare sues Radiology Partners again, claiming mega practice ‘weaponized’ surprise billing protections

Rad Partners "firmly" denied the allegations, which mirror a similar complaint from Aetna, contending it plans to "vigorously defend against these claims" in court.

Federal update would help imaging centers, rad practices qualify for small business loans

The Small Business Administration will raise receipts-based standards for 263 industries including imaging, allowing more to apply for financing.

FDA shares concerns about new imaging agent, sinking shares for radiopharma firm Telix

The company is seeking approval for TLX250-CDx (brand name Zircaix), a novel PET (positron emission tomography) product geared toward kidney cancer.

FDA announces recall of Integra applicators due to sanitation risk

Multiple lots of extended tip applicators from Integra LifeSciences could put patients at risk of serious infection, prompting the FDA to designate the recall as Class I.

Recent fraud cases suggest ‘fake nursing’ has become a troubling career path

A new report reveals that states are keeping databases on “imposter nurses” to slow what could be a growing trend of unlicensed individuals holding nursing positions at hospitals nationwide.

Compact multifunctional PET scanner receives clearance in the US

The system was built with patients in mind, and its compact design has the potential to expand access to the modality where it may have previously been lacking.

Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.

Medtronic receives updated FDA approval for redo TAVR

The company also launched a new clinical trial designed to follow redo TAVR patients who present with symptomatic bioprosthetic valve failure for up to five years.

CDC director, chief medical officer ousted as RFK shakes up agency

CDC Director Susan Monarez, PhD, was less than a month into her role, having been confirmed by the U.S. Senate on July 30. Her lawyers said the staffing shakeup was a result of HHS Secretary Robert F. Kennedy Jr. “weaponizing public health for political gain.”

Policy & Regulations

DOJ unveils West Coast ‘Strike Force’ as new tactic used to tackle healthcare fraud

Atrium Health looking to scoop up smaller nonprofit health system in $2B deal

FDA moves to restrict compounded versions of popular GLP-1 weight loss drugs

FDA announces recall on insulin pump pods after leaks cause 29 serious injuries

5-point call goes out for action against ‘one of the most urgent and complex socioeconomic challenges of our time’