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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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. 

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. 

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House leaders reveal ‘major’ healthcare bill that includes radiologist-opposed Imaging Services Price Transparency Act

The rule would establish a list of “at least 50” shoppable radiology exams for which providers must publicly disclose pricing on their websites.

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Philips will pay $479M to settle class-action lawsuit stemming from product recall

The Amsterdam-based imaging industry giant emphasized that the agreement “does not include or constitute any admission of liability, wrongdoing or fault.” 

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Implementing structured radiology reporting via O-RADS boosts patient, referrer satisfaction

One key finding, experts noted, is that the Ovarian-Adnexal Reporting and Data System had little impact on patients' ability to interpret reports. 

Techsomed VisAble.IO 3D Ablation Assessment view

FDA clears AI software for aiding interventional radiologists during image-guided procedures

Israel-based developer Techsomed said its VisAble.IO product can increase treatment precision by helping physicians confirm ablation zones. 

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Inflation-adjusted Medicare pay in radiology has decreased by $2.8B since 2005

This occurred during a period when radiologists took on an increasing workload, with relative value units leaping 13.1% during the 16-year study period. 

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Around the web

Cardiovascular Business
Global shortage of nuclear imaging isotopes may be over

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

Cardiovascular Business
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

Cardiovascular Business
GE HealthCare moves PET/CT scanner production to United States

The all-in-one Omni Legend PET/CT scanner is now being manufactured in a new production facility in Waukesha, Wisconsin.