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. 

Radiology should work with certified health records—not against them

Radiologists should understand the importance of using certified electronic health record (EHR) technology—now more than ever with the opening of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)’s first reporting period.

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As Policies Evolve, Practice Leadership Must Remain Active

As research director of a policy think tank dedicated to medical imaging, I’m frequently asked how radiologists—and their practices—will fit into the broader healthcare landscape once the current tumultuous healthcare environment evolves into stable equilibrium. Of course, whether we do see a stable equilibrium is a questionable assumption in itself, but it doesn’t hurt to put on our futurist hats and explore how this may look for radiology. 

FDA approves first digital pathology system for diagnostic use

Royal Phillips has received U.S. Food and Drug Administration (FDA) clearance for its IntelliSite Pathology Solution, a pathology image creation and management system. Its currently the only digital pathology system cleared for primary diagnostic use, an important milestone in the burgeoning field.

USPSTF changes 2012 recommendation on PSA testing

Blood testing for prostate cancer now has a passing grade—the U.S. Preventative Services Task Force (USPSTF) has changed its tune on prostate-specific antigen (PSA) screening, upgrading the recommendation that some men undergo to a “C” grade.  

Legislation could modernize FDA regulations on imaging devices, contrast

Imaging advocacy groups have lined up to support a bill providing medical imaging device and contrast drug manufacturers a clear regulatory pathway, speeding the bench-to-bedside transition.

EU reconsiders pulling gadolinium contrast agents from market

The European Medicines Agency (EMA) will re-examine its decision to pull several gadolinium contrast agents from the European single market following requests from gadolinium producers.

PSA screening not recommended by USPSTF

When first introduced in the 1990s, blood tests for prostate-specific-antigens were hailed as the cheap, non-invasive screening men had needed for years. While the rate of prostate cancer rose sharply, that was expected—a more effective screening test meant more cancers were diagnosed.

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Imaging growth leveling off due to reimbursement cuts, changes in ordering

The dramatic growth in imaging utilization experienced at the beginning of the millennium has mostly leveled off, according to a study published in Health Affairs, primarily due to major cuts to reimbursement and more careful ordering of noninvasive exams.

Around the web

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.

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