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. 

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Radiology Business Management Association warns CMS that specialty is reaching a ‘tipping point’

“After 16 straight years of cuts to radiology this is an unsustainable environment in medicine,” RBMA Executive Director Bob Still wrote to the agency.

Industry Watcher’s Digest

Buzzworthy developments of the past few days.

FDA approves LimFlow System for Transcatheter Arterialization of Deep Veins for CLTI

FDA approves new minimally invasive CLTI treatment for ‘no-option’ patients at risk of amputation

The new device, the first of its kind to gain FDA approval, was designed for patients who have no other endovascular or surgical options available to them.

U.S. News & World Report children’s hospitals cardiology heart surgery

Study unearths high rates of incidental findings on pediatric CT scans for trauma

About 10% of these cases required immediate or urgent action, researchers detailed in Clinical Imaging

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FDA aiming to modernize 510(k) process that many radiology devices must go through

The administration also is accepting comments on the draft guidelines and plans to host a webinar on Oct. 26. 

Medtronic faces lawsuit for sharing data of customers who used the InPen smartphone app

Medtronic faces class-action lawsuit after patient data shared with Google, other third-party sites

The complaint describes Medtronic's actions as “immoral, unethical, oppressive and unscrupulous.”

Imaging advocacy group hopes to counteract ‘dangerous care delays and denials’ in PET payment

The American Society of Nuclear Cardiology is pushing payers to more consistently and correctly cover medically necessary scans without prior authorization. 

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CMS kick-starts key piece of IDR process under surprise billing law

The federal agency first announced the move Tuesday, noting that it pertains to single and bundled payment disputes submitted on or before Aug. 3.