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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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. 

FDA announces another recall for surgical devices over safety concerns—7 new injuries reported

Maquet Cardiovascular, a subsidiary of Getinge, is recalling two of its endoscopic vessel harvesting devices due to issues with different pieces bending, peeling or detaching during use. Some of the company's other EVH devices were recently involved in a separate recall for similar reasons. 

Anthem

Q&A: Vulnerable patients hit hardest by anesthesia reimbursement cuts

Tracy Young, CRNA, vice president at the American Association of Nurse Anesthesiology, details the ongoing fight between providers and insurers over how anesthesiologists get paid. 

Around the web

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns. 

One product is being pulled from the market, and the other is receiving updated instructions for use.

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology?