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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VA first to cover new ALZ drug

A new Alzheimer’s disease drug, Leqembi (lecanemab), will be covered by the Veterans Affairs for some patients, making the VA the first insurer to cover the drug.

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Pfizer to acquire Seagen for $43B

“Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen’s antibody-drug conjugate technology with the scale and strength of Pfizer’s capabilities and expertise," says Pfizer Chairman and CEO Albert Bourla, PhD.

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Former CEO indicted for fake medical device implanted in patients

Laura Perryman, the former chief of Florida-based Stimwave, allegedly created a non-functioning “dummy device” that was used to treat patients suffering from chronic pain.

Oversight Committee launches investigation into pharmacy benefit managers

CVS Caremark, Express Scripts and OptumRx have been asked to provide documents, communications and information related to their practices.

FDA seeking upwards of $7B for 2024

The Food and Drug Administration has put in for a $7.2 billion chunk of the $6.9 trillion federal budget for fiscal year 2024 that President Joe Biden proposed March 9.

Biden’s budget: Extend Medicare solvency through higher taxes on rich, more drug price changes

Biden says his proposals are an extension of what he has already accomplished to reduce the deficit and lower healthcare spending.

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Akorn Pharmaceuticals shuts down, lays off all employees

In a sudden "shock," Akorn Pharmaceuticals is closing all U.S. sites and laying off its entire workforce after failing to find a potential buyer.

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FTC fines BetterHelp $7.8M, says the company 'betrayed' users for profit

BetterHelp is in hot water after the Federal Trade Commission slapped the online counseling service company with a $7.8 million fine and a proposed ban from sharing consumers’ health data.

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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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