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. 

Malissa Wood, MD. explains why Mass General created a program to combat racism and health equity.

Why health equity is important in cardiology

Malissa Wood, MD, associate chief of cardiology for diversity and equity at Massachusetts General Hospital, explains the role of health equity in cardiovascular care and what her health system is doing to address it. 

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How the Mark Cuban prescription drug playbook could save taxpayers billions

A new analysis reveals that insurers could put between $228 million and $2.15 billion back in taxpayers’ pockets by purchasing a series of generic oncology medications at the same prices obtained by the Mark Cuban Cost Plus Drug Company.

megaphone bullhorn speak announcement

Radiology societies issue ‘call to action’ against looming threat to physician offices’ financial viability

ACR, SIR, ASTRO and others are concerned about about forthcoming cuts in the Medicare Physician Fee Schedule that will impact specialties with high equipment costs.  

The Wattson temporary pacing guidewire from Teleflex

FDA clears new guidewire used for valve delivery and ventricular pacing during TAVR, BAV procedures

The device, now on display at TVT 2023 in Phoenix, is scheduled to begin hitting the market in the months ahead. 

American College of Radiology, nuclear medicine society urge CMS to fix years-old billing code mistakes

SNMMI and ACR are pushing the agency to make modifications retroactive, so specialists can still claim lost revenues impacted by the error. 

Zio AT mobile cardiac telemetry device

FDA warning letter: iRhythm committed multiple violations, failed to report patient deaths in time

“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”

Avatar Medical virtual reality imaging

Startup scores FDA clearance for virtual reality tool that creates patient avatars via CT, MR images

Avatar Medical said its VR solution can serve as an aid in pre-operative planning or for use during procedures. 

Merck Januvia Janumet Steglujan Nitroso-STG-19 (NTTP) type 2 diabetes

Merck sues US government over Medicare's drug price negotiation liberties, calls program a 'sham'

Merck believes the Inflation Reduction Act-launched effort “coerces” manufacturers to enter into agreements to sell their top products at a fraction of their actual value.