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 announces recall of biopsy device after 14 injuries and 1 death

The voluntary recall pertains to the ViziShot 2 FLEX from Olympus, which is used with ultrasound-guidance to help diagnose and stage lung cancer. 

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Cigna will cover CT imaging artificial intelligence software nationwide

The Bloomfield, Connecticut-based payer has committed to covering plaque analysis software offered by several competing vendors including Heartflow. 

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Medical marijuana company sued after 1M records leaked online

Ohio Medical Alliance, which operates in six states to help individuals obtain medical marijuana cards, is facing a class action lawsuit after a cybersecurity researcher discovered a 323 GB trove of patient data online.

Anders Gilberg, MGA, Senior Vice President, Government Affairs at Medical Group Management Association (MGMA), said the rapid fire changes in healthcare policy under the Trump administration has been a whirlwind with a mix of reactions by stakeholders to policies based on reality and and also perception of possible impacts. #MGMA

MGMA weighs in on Washington’s political turmoil, Medicaid cuts and healthcare policy uncertainty

“It’s been a whirlwind,” Anders Gilberg, senior vice president of government affairs at MGMA, told HealthExec. “Rarely do we have an administration come in and do so much in such a short period of time.”

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Healthcare AI today: major breast screening AI trial, AI’s appetite for data, AI prior auth: wise and WISeR, more

CMS is prepping to pilot AI for prior authorization of Medicare claims in six states. Critics say the Trump Administration is acting hypocritically.

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Controversial Medicare cost-cutting initiative may kill seniors, radiology society warns

The Society of Interventional Radiology on Monday formally announced its opposition to the Wasteful and Inappropriate Service Reduction (or “WISeR”) Model. 
 

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Experts call for greater scrutiny around conflicts of interest between radiologists, AI developers

"Manufacturers of radiology devices may be less likely to disclose payments because many fall outside current reporting requirements," researchers write in JAMA. 

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CMS grants pass-through payment status for new prostate imaging agent Gozellix

This enables separate reimbursement for the radionuclide diagnostic agent under the Hospital Outpatient Prospective Payment System, manufacturer Telix says.