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. 

Donald J. Trump 2024

Trump signs executive order to withdraw U.S. from the World Health Organization

The President made good on a campaign promise to leave the international health agency, after attempting to do so when he last held office in 2020. 

Vintage neon drug sign at the Walgreens pharmacy on Canal Street in downtown New Orleans.

DOJ sues Walgreens for allegedly filling ‘millions’ of illegal prescriptions

Walgreens filed a countersuit, accusing the federal government of failing to take down prescribers acting unlawfully. 

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Another insurer sues CMS over star ratings, citing contractor error

Alignment Health is accusing CMS and a third-party contractor of surveying Spanish-speaking members in English and using an "arbitrary" calculation method to reduce the ratings of Medicare Advantage plans.

money maze payment reimbursement

Biden chooses semaglutide for next round of Medicare price negotiations—Trump gets final say

The final list also included diabetes drugs sold by Boehringer Ingelheim and Merck. The first round of drug price negotiations reduced the Medicare prices for 10 popular drugs by up to 79%. 

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DEA wants to permanently anchor some COVID-era prescription regulations

The Drug Enforcement Administration is proposing the adoption of some COVID-era prescription practices around certain controlled substances. The agency published a framework to guide any such changes Jan. 17. 

Stephen Browning, FDA assistant director for hemodynamic and heart failure diagnostics, explains the FDA perspectives and regulatory pathways for AI-enabled cardiovascular devices at TCT 2024.

FDA regulator examines AI's growing influence in cardiology

Stephen Browning, the FDA's assistant director of hemodynamics and heart failure diagnostics, spoke with Cardiovascular Business about the agency's perspective on AI-enabled cardiovascular devices and many other topics.

Healthcare salaries and compensation

FTC, DOJ and HHS release report warning of private equity consolidation in healthcare

The agencies said private equity firms are rolling up healthcare sectors through serialized purchases that fly under the radar of regulators, creating an unsustainable level of consolidation. 

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Report highlights flaws in FDA rapid approval of Alzheimer drug

A new report from the Office of the Inspector General found the FDA failed to properly record meetings with drug manufacturers, ultimately approving drugs later shown to have safety and efficacy issues. 

Around the web

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.” 

The FDA recently cleared the company's cable-free, credit card-sized heart monitor that produces 12-lead ECGs.

If 25% tariffs go into effect, it could have a big impact on the cost of medical imaging and radiotherapy systems, with many manufacturing facilities in Mexico.