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 approves first cellular therapy to treat type 1 diabetes

The new therapy, made from the pancreatic cells of deceased donors, is designed to help adult type 1 diabetes with severe hypoglycemia go a year or longer without needing to take insulin. 

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Former Johnson & Johnson sales rep indicted for defrauding hospital out of hundreds of thousands of dollars

The sales representative is alleged to have falsely documented his sales numbers on invoices submitted to the hospital’s billing department in addition to interfering with their sterilization processes, according to the DOJ.

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Moderna's updated COVID vaccine now awaits FDA authorization

"We have been working diligently for months to build ample supply, with doses ready to ship in time for the fall vaccination season in the Northern Hemisphere,” Moderna's CEO said in the announcement.

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Bristol Myers Squibb joins others suing US government over portions of the Inflation Reduction Act

The Drug Price Negotiation Program already has changed how the company considers the development of future oncology programs and medications. 

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USPSTF now recommends screening all adults for anxiety disorders

This is the first time that the task force has recommended screening for anxiety disorders in an asymptomatic adult population.

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Millions of Americans have 'unnecessarily' lost Medicaid coverage since April

Many did not lose coverage because they were deemed ineligible during the redetermination process, but due to procedural reasons, such as not completing required paperwork.

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American Medical Association to advise on the use of AI in medicine

The goal is to inform users on how to best utilize AI tools while also practicing caution, as many are still in their early stages of deployment and can pose risks. 

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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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

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. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

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.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

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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