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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Lawyer: Court decision over website trackers has ‘zero impact on patient privacy’

The U.S. Department of Health and Human Services has opted not to appeal a federal court decision that partially repealed the agency’s ban on website trackers.

abortion law ban pregnancy dobbs

Planned Parenthood sues Missouri over Medicaid defunding

Despite abortions being effectively banned in the state, a law that passed in May banned Medicaid funds from going to any organization that provides abortions in any state.

Insulet Corporation, a Massachusetts-based medical device company focused on diabetes technology, announced that its Omnipod 5 Automated Insulin Delivery System is now cleared by the U.S. Food and Drug Administration (FDA) to manage type 2 diabetes (T2D).

FDA clears first automated insulin pump for type 2 diabetes

Insulet's Omnipod 5 Automated Insulin Delivery System was already cleared to help patients manage type 1 diabetes. 

Medicare coverage for weight loss drug semaglutide could cost up to $145B per year

Medications that target obesity are not typically covered by Medicare. When the FDA approved semaglutide as a way to treat certain cardiovascular risks, however, CMS said Medicare coverage was on the table. 

Immigration attorney Kathleen Campbell Walker explains how can immigration help solve the healthcare staffing shortages.

Immigration barriers prevent solution to healthcare staffing shortages

Kathleen Campbell Walker, JD, immigration practice attorney, and past president of the American Immigration Lawyers Association (AILA), explains the barriers to global physician mobility amid growing shortages.

SCAI calls on interventional cardiologists to tell Washington to reverse physician pay cuts

Congress is considering two bills that would prevent or mitigate the Medicare physician payment cuts that went into effect in January 2024, and the Society for Cardiovascular Angiography and Interventions is urging members write their Congressmen.

The U.S. Food and Drug Administration (FDA) has announced that Defibtech, a Nihon Kohden company, is recalling its RMU-2000 ARM XR Chest Compression Device due to significant safety concerns. This is a Class I recall, which means the FDA believes using the device “may cause serious injury or death.”

Automated chest compression device recalled after patient death

Regulators emphasized that these devices should not be used due to significant safety risks. 

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CMS has received 12,000 complaints over No Surprises Act noncompliance—most were valid

In total, 10,300 complaints were made against providers and air ambulance services. The rest were for surprise bills from insurance plans.

Around the web

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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