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. 

FDA temporarily approves importation of a second foreign-labeled iodinated contrast media

Bracco Diagnostics, Inc has been given the go ahead by the U.S. Food and Drug Administration to temporarily import Iomeron (iomeprol injection) into the U.S. market amid the ongoing iodinated contrast media shortage. 

contrast shortage

Generic, FDA approved contrast agent set to hit the market in wake of nationwide shortage

On July 18 Fresenius Kabi announced that they are rolling out a line of generic contrast media products, starting immediately with Iodixanol Injection USP. 

insurance payer payment insurer

Providers ask for higher payments in OPPS proposed rule

The proposed payment increase of 2.7% doesn't make up for sequestration cuts, inflation, and other factors hitting hospitals, medical groups say. 

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Autoimmune patients caught in crossfire of Supreme Court's Roe decision

Some patients with certain autoimmune diseases are finding it difficult to obtain their prescriptions for methotrexate as a result of changing abortion care laws.

Contrast shortage update: FDA opens door for U.S. providers to order foreign-labeled Bayer contrast media

Per Bayer’s communications, the contrast agent is manufactured at the same site in Berlin, Germany as the Ultravist that is intended for U.S. markets, but due to its intended distribution abroad it lacks current FDA-approved labeling. 

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Imaging-based COVID study finds blood clots twice as likely with infection vs. vaccination

A retrospective analysis of cross-sectional venograms shows only 4.5% of a teaching hospital’s COVID-vaccinated patients had a clotting condition in early 2021. Meanwhile the rate for the unvaccinated was 10.1%.

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Cardiologists applaud new research on social/structural determinants of health among heart patients

The American Heart Association and Association of Black Cardiologists announced the winners of a six-month data challenge, describing health equity as "one of the most pressing areas in healthcare.”

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3D mammography may shake ‘routine’ out of architectural distortion surgery

When counseling patients with architectural distortion on digital breast tomosynthesis (DBT) but no signs of malignancy on biopsy, mammographers should raise imaging alone as a sound option for surveillance.