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. 

physician tracking patient data and reporting on outcomes

American College of Radiology updates imaging appropriateness criteria with 8 new topics

ACR is adding new entries covering scenarios such as brain tumors, inflammatory ear disease, and lung cancer staging after therapy. 

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. 

Heart Rhythm Society launches new group focused on EP advocacy

The new organization, Heart Rhythm Advocates, will urge federal policymakers to pass legislation and support actions that have a positive impact on the future of electrophysiology.

EARLY TAVR investigator Philippe Généreux, MD, announced his team’s findings in front of a packed audience at TCT 2024.

Treating asymptomatic aortic stenosis with TAVR linked to significant benefits

Attendees cheered as lead investigator Philippe Généreux, MD, shared his team's findings at TCT 2024. “A major reset in our approach to severe asymptomatic AS is now warranted,” one veteran cardiologist said about the data. “The concept of watchful waiting is no longer appropriate."

BioZorb 3D bioabsorbable marker Hologic

FDA warns against use of Hologic breast care device after nearly 200 adverse events

The alert pertains to the BioZorb and BioZorb LP markers, implanted in soft tissue to indicate the site for radiographic procedures. 

The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.

5 of 7 Medicare Administrative Contractors approve payment for imaging AI software

Providers have the potential to earn a Medicare payment of $950 if the software is deployed in medically appropriate scenarios.  

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.