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. 

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Hospital CEO files lawsuit after losing job over naked art exhibition

According to the former executive, he was barely involved in planning the offsite fundraiser. The hospital declined to comment. 

Video of Denise Garris, ASE regulatory consultant and principal of the Korris Group, explaining how reimbursements from insurance andMedicare work to pay or cardiac ultrasound exams. #ASE #ASE360 #ASE23 #ASE2023 #healthcarereimbursment

Understanding reimbursements and coding for echocardiography

"I think everyone would agree that the current fee-for-service model is not working appropriately and there needs to be a fix," regulatory consultant Denise Garris explained in a new interview. 

FDA shares update on heart devices linked to multiple recalls and patient deaths

The devices, designed to provide temporary support to a patient's left ventricle, have been associated with a long list of issues in recent months. 

Governors urge Congress to act now on medication shortages, supply chain insecurities

Eleven GOP governors joined together to call for a more transparent drug manufacturing supply chain.

gold card

AHA shares support of new prior authorization reform in letter to Congress

The American Hospital Association believes the Gold Card Act could help healthcare providers throughout the country avoid "dangerous delays." 

Former Mayo Clinic researcher gets 18 years in prison for supporting ISIS

The man vowed to conduct "lone wolf" attacks in support of the terrorist group ISIS.

Doctor patient with masks

Should masks still be required at hospitals? Physicians push for a nuanced approach in face of uncertainty

A team of physicians examined the question of continued masking, urging healthcare leaders to work together in a new commentary in Annals of Internal Medicine.

Recor Medical's Paradise Ultrasound Renal Denervation System

FDA panel votes in favor of Recor Medical renal denervation system

A few members of the panel did question the device's efficacy and long-term durability. The FDA will now use these findings to make its final decision related to the system's approval. 

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.