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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CVS Health announces $10.6B acquisition of Oak Street Health

CVS generic drugs twice as likely to be recalled over safety concerns, investigation finds

CVS generics have been linked to more than 15 manufacturers cited for producing allegedly contaminated drugs.

Coalition seeks to simplify prior authorizations and improve Medicare Advantage coverage

More than 380 organizations have expressed support for the bipartisan Improving Seniors’ Timely Access to Care Act, which unanimously passed a House vote in 2022.

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Cardiologist-supported prior authorization reform reintroduced in Congress

The Improving Seniors’ Timely Access to Care Act has been considered by Congress multiple times, getting closer than ever in 2023. Will 2024 be the year it finally lands on the president's desk?

AMA wants insurers to be accountable when prior authorization harms patients

The American Medical Association (AMA) House of Delegates this week approved two policies aimed at increasing insurer accountability and transparency amid an explosion of prior authorization requirements.

FDA announces recall of Medline endotracheal tubes after three injuries

The Medline Sub-G endotracheal tubes with subglottic suction are defective and known to tear, potentially leading to serious injury or death.

The American Medical Association (AMA) House of Delegates today elected Bobby Mukkamala, MD, an otolaryngologist from Flint, Michigan, as president-elect of the AMA for the 2025-2026 term. Mukkamala will be inaugurated as AMA president in June 2025. Photo courtesy of the AMA

AMA elects new president heavily involved in Flint water contamination response

The American Medical Association (AMA) House of Delegates elected a new president and numerous other positions.

CityMD agrees to $12M settlement over alleged COVID claims fraud

The company cooperated with a DoJ investigation into COVID-19 tests being erroneously billed to the federal government.

physician tracking patient data and reporting on outcomes

Q&A: Cardiologist Karen Joynt Maddox on why new healthcare policies are not improving outcomes

Healthcare's ongoing shift toward value-based care is a good thing, Joynt Maddox explained, but its implementation has been far from ideal. She also discussed population health, the pandemic, health disparities and the rising influence of private equity investments.

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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.