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. 

Stark Law Kickback Erlanger

Pharmacy fined $39M for fraud after 7-day trial

Florida-based Assured RX was found to be complicit in billing a Connecticut health plan $10M, sending kickbacks to co-conspirators who formerly worked for the state. 

Q&A: Medicaid evolving to meet the mental health and material needs of patients

The former Medicaid Director of Texas, Gary Jessee, tells HealthExec that state healthcare programs are raising the bar for care access and quality, even for patients covered by commercial plans. 

the words "FDA recall" on a board

FDA issues Class I update on robotic arms due to risk of fire

A protective coating on Jaco Assistive Robotic Arms from Kinova could become damaged, leading to exposed metal causing an electrical fire when it comes into contact with a powered wheelchair.

Smith Medical FDA issues BLU tracheostomy tubes FDA recall

FDA issues Class I recall on tracheostomy tubes after 12 injuries

The Smiths Medical BLUSelect and related products have a manufacturing defect and must be removed from stocks immediately. 

MGMA's Anders Gilberg discusses concerns on Medicare physician fee schedule

MGMA concerned by 2025 Medicare Physician Fee Schedule

The Medical Group Management Association (MGMA) Senior Vice of Government Affairs, Anders Gilberg, explains MGMA’s 28-page letter to CMS on issues with the proposed 2025 Medicare Physician Fee Schedule.
 

microsoft building

Microsoft: Ransomware hit nearly 400 healthcare entities this year—a 300% rise since 2015

A study from Microsoft on the impact of ransomware found unaffected nearby hospitals see a rise in stroke and cardiac arrest cases, in addition to an influx of patients. 

UnitedHealth Group - 2

Feds make it official: Change data breach was the largest in healthcare history, impacting 100M

Updated reporting from HHS shows UnitedHealth Group's estimate that roughly one-third of people in the U.S. would be affected was correct. 

phenylephrine FDA

FDA approves first RSV vaccine for adults

Pfizer's Abrysvo vaccine can now be prescribed to all adults 18 and older at high risk for severe RSV complications, including pregnant women. 

Around the web

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

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