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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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.

layoffs staff cuts termination workforce

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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DEA proposes restricting some telemedicine prescriptions

The proposed rules specifically narrow the prescribing of controlled substances via telemedicine for patients who have not been seen in person.

FDA authorizes first at-home flu and COVID-19 test

The test specifically can detect and differentiate between influenza A and B and the SARS-Cov-2 virus that causes COVID-19.

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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.