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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Carestream Health agrees to sell healthcare IT business to Philips

Carestream Health has signed an agreement to sell its healthcare information systems (HCIS) business to Royal Philips, the company announced Thursday, March 7. The deal is expected to close in the second half of this year.

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Brexit ‘likely’ to delay delivery of drugs used to detect, treat cancer

The upcoming vote on whether the U.K. will leave the European Union has prompted the Royal College of Radiologists (RCR) to warn doctors of a potential delay in receiving drugs used to detect and treat cancer, the BBC reported.

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Study: Medicaid expansion boosted colon cancer screening, survival in Kentucky

"The takeaway here is that screening does matter, and the expansion of Medicaid has increased usage of colon cancer screening for many Kentuckians who otherwise wouldn't have had access," wrote authors of a Feb. 22 study published in the Journal of the American College of Surgeons.

ACR urges radiologists to help avoid massive ultrasound reimbursement cuts from CMS

The American College of Radiology (ACR) is urging the radiology community and other medical professionals to help the ACR get rid of $112 million in cuts to Medicare ultrasound reimbursement by sending invoices to the ACR that reflect the actual cost to purchase ultrasound equipment, according to a recent ACR news release. 

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New recommendations suggest all breast cancer patients get genetic testing

The new American Society of Breast Surgeons' recommendations are based on a comprehensive review of the most impactful evidence in modern literature, data and national guidelines.

 

 

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FDA updates guidance on exemption of certain medical devices from 510(k) requirements

This exemption of certain unclassified medical devices from 510(k) requirements aims to achieve two goals: decrease regulatory burdens on the medical device industry and reduce costs required to comply with federal regulations, while allowing patients continued access to medical devices.

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Erlanger Health System’s stroke program in danger after contract dispute with radiology group

A contract dispute between Chattanooga, Tennessee-based Erlanger Health System and Tennessee Interventional and Imaging Associates (TIAA) is threatening to upend the hospital’s premiere stroke program, according to documents obtained by the Times Free Press.

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FDA posts final guidance on 'least burdensome’ approach for medical device regulation

“Applying the least burdensome approach means gathering the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time,” according to the agency. 

Around the web

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

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.

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.