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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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.

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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.

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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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Lab owner gets 27 years in prison for $463M Medicare fraud scheme

According to the U.S. Department of Justice, LabSolutions took advantage of patients using a telemarketing scheme, with its owner personally pocketing millions in kickbacks.

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FDA warning letter details quality concerns, violations at Integra facility

The facility in question is responsible for producing collagen-based medical devices primarily used in wound care, soft tissue repair and complex reconstruction surgeries. 

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Around the web

Cardiovascular Business
Cardiology groups cheer new bill that would improve access to Medicare claims data

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

Cardiovascular Business
Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Cardiovascular Business
Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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