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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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. 

Recor Medical's Paradise Ultrasound Renal Denervation System

Momentum continues for renal denervation as CMS considers national Medicare coverage

CMS is accepting public comments on the topic for a period of 30 days. Recor Medical and Medtronic have both shared statements in support of the potential policy shift.

4 ways HHS plans to help shape a national strategy for healthcare AI

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.

Around the web

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. 

Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.