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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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.

Dana Smetherman, MD, explains the ACR take on the growing radiology staffing shortage.

Radiology workforce shortage a major concern for the American College of Radiology

Dana H. Smetherman, MD, MBA, CEO of the ACR, discusses the reasons behind the worsening shortage of radiologists, along with possible solutions. 

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Federal court strikes down FTC ban on noncompete contracts

On Tuesday, a federal court in Texas ruled the Federal Trade Commission overstepped its statutory authority in issuing the ban. It’s been officially halted, pending appeal.

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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.