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. 

SCAI outlines broken Medicaid reimbursement model for congenital heart disease

SCAI says many children and adults living with congenital heart disease are being left behind by a payment system that does not adequately value their care.

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Radiology groups urge Congress to extend premium tax credits, protect physician practices

Numerous medical trade groups including the American College of Radiology and American Society of Neuroradiology recently wrote to Senate and House leaders on this issue. 

Evinacumab-dgnb is sold by Regeneron under the brand name Evkeeza

FDA approves treatment of rare genetic disorder in children as young as 1 year old

Evinacumab-dgnb, sold by Regeneron under the brand name Evkeeza, can now be used to treat homozygous familial hypercholesterolemia in much younger patients.

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Radiology groups urge Trump administration to exempt docs from $100,000 visa fee

The White House first issued the presidential proclamation on Sept. 19 with the stated goal of restricting certain nonimmigrants’ access to the U.S. 

Department of Commerce launches investigation into imaging device imports, with potential for new tariffs

Authorities are seeking to determine the impact on national security of importing CT scanners, MRI machines, X-ray apparatuses and other radiologic equipment. 

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Trump’s Commerce Department floats new medical device tariffs to ‘protect national security’

The U.S. Department of Commerce is investigating domestic medical product manufacturing, as well as imports, to gauge how "state-sponsored overproduction" is impacting supply chain security. 

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Fewer than 30% of FDA-cleared AI devices share key safety, adverse event info prior to approval

A new analysis is prompting questions regarding how rigorously many of the AI-enabled tools approved by the U.S. Food and Drug Administration are evaluated prior to their clearance. 

U.S. considering new tariffs for heart valves, imaging equipment and other medical devices

The Department of Commerce is seeking more information about how current trade policies are impacting the U.S. medtech industry. The investigation could lead to the creation of new tariffs. Public comments are being accepted until Oct. 17, and the findings will be presented to President Donald Trump.