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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ACA medical device tax carries price tag of $665M

The study in the latest edition of Research Policy, looking at the 2.3 percent excise tax imposed on medical devices in 2013, found it significantly reduced research and development investment, sales revenue, gross margins and earnings since ACA implementation in 2013.

FDA approves AI software to detect wrist fractures

The Food and Drug Administration (FDA) gave software company Imagen permission to market its artificial intelligence (AI) diagnostic system OsteoDetect.

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Anthem, Colorado hospitals butt heads over imaging policy

Health insurance giant Anthem implemented its controversial imaging policy in Colorado last fall which has limited CT and MRI coverage for the nearly one in five patients with private insurance in the state, according to a Denver Post report. Some experts question the motivation of the move.

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Second opinions after breast imaging are worth the time, resources

For patients without a breast cancer diagnosis, receiving second-opinion interpretations of breast imaging exams relieve anxiety while reducing patient morbidity and healthcare costs, according to a study published May 19 in the Journal of the American College of Radiology.

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FDA releases finalized Clinical Trial Imaging Endpoint Process Standards

The FDA released a finalized industry guidance April 27 that will help sponsors optimize the quality of imaging data obtained in clinical trials that support approval of drugs and biological products.

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Jefferson Health, AHRA exec on medical device tariffs and the ‘commoditization’ of imaging

Chris Tomlinson, VP of enterprise radiology at Jefferson Health and finance chair at the Association for Medical Imaging Management (AHRA), spoke with HealthImaging about these issues—and why the "commoditization” of imaging may be at the heart of the problem.

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FDA's Gottlieb: AI-based imaging device submissions expected to increase in coming years

FDA Commissioner Scott Gottlieb, MD, said his administration is working on an updated “new regulatory framework” to promote the use of artificial intelligence (AI) in healthcare, and he expects medical imaging to be at the forefront of AI-based healthcare devices, according to a report published by The Hill.

Samsung announces commitment to lower dose exposure within its digital radiography suite

Samsung has announced a growth vision centered on improving the quality and safety of patient care through a commitment to lower radiation across its innovative suite of medical imaging products.

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Around the web

Cardiovascular Business
Positron partners with Upbeat Cardiology Solutions to improve cardiac PET/CT access

Positron, a New York-based nuclear imaging company, will now provide Upbeat Cardiology Solutions with advanced PET/CT systems and services. 

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.