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. 

prior authorization claim deny denial insurance insurer payer Medicare Advantage

Members of Congress condemn Medicare model targeting ‘wasteful’ interventional radiology services

“It is not an exaggeration to say that the requirement of prior authorization for traditional Medicare services will kill seniors,” says Rep. Mark Pocan, D-Wis. 

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Referrers frequently failing to recommend patients for key interventional radiology procedure

An analysis of nearly 272,000 uterine fibroid healthcare encounters shows that only about 4% of women underwent uterine fibroid embolization, a minimally invasive IR treatment option. 

UnitedHealthcare

WSJ: UnitedHealth seeks meeting with Trump as part of lobbying effort

The Wall Street Journal said that President Donald Trump has yet to meet with company representatives. However, UnitedHealth CEO Stephen Hemsley reportedly met with members of the administration in Washington.

Joysticks recalled after power wheelchairs move on their own, injuring a patient

The U.S. Food and Drug Administration announced a recall of Mo-Vis BVBA joysticks after a faulty firmware version was linked to the malfunction. Users will need to have their devices upgraded.

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Terrorism charges dropped against Mangione in UnitedHealthcare CEO killing

Luigi Mangione still faces nine counts in New York stemming from the alleged murder of Brian Thompson. Additionally, he faces a federal murder indictment that carries the possibility of the death penalty.

MGMA's Anders Gilberg says Congress needs to act soon to preserve access to telemedicine programs.

MGMA: Congress needs to act soon to preserve access to telemedicine programs

Congress needs to act soon to extend telemedicine services that were greatly expanded under COVID provisions, or they will expire by October. Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains concerns raised by doctors and lawmakers.

 

Corstasis Therapeutics bumetanide nasal spray Enbumyst

FDA approves nasal spray for edema associated with congestive heart failure

The newly approved intranasal loop diuretic can also be used to treat edema in patients with liver and kidney disease.

All medical device products in Europe need to obtain the Conformité Européenne mark (European Conformity, or CE mark) regulatory approval. This is based on minimal safety requirements and is needed to be sold in the EU.

Cardiologists lead charge for medical device approvals in Europe to be more rigorous

There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that.