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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A graphic released by the AMA showing that cumulative Medicare payment cuts to physicians between 2001-2025 has resulted in a 33% cuts, which medical societies and numerous physicians in Congress says is not sustainable without Medicare patients losing access to care.

Congressional bill could reverse Medicare cuts and increase physician pay

A bill in Congress would reverse the 2025 Medicare cuts and increase physician pay, but a March deadline looms to make this happen.

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Report: Incoming Trump executive order to eliminate ‘thousands’ of jobs at HHS

According to coverage in the Wall Street Journal, leadership at HHS has been told to rank probationary workers as the Trump Administration prepares to announce cuts. The White House denies the claim. 

the words "FDA recall" on a board

FDA announces recall of dangerous arterial catheters

While there have been no reported injuries, a manufacturing error involving debris contamination could potentially kill a patient.

The U.S. Food and Drug Administration (FDA) has shared a new warning about ongoing safety issues with atherectomy devices sold and distributed by Bard Peripheral Vascular, an Arizona-based subsidiary of Becton, Dickinson and Company (BD). The warning includes multiple models of Bard Peripheral Vascular’s Rotarex Atherectomy System, which is designed to target high-risk plaques and blood clots in the peripheral arteries by rotating at a high speed.

FDA warns that atherectomy devices are breaking during use—30 serious injuries, 4 deaths reported

More than 100 incidents have been reported so far. The FDA is still evaluating this issue, but the agency wanted to raise awareness as quickly as possible.

healthcare executives

Healthcare systems are proceeding apace with GenAI—and learning as they go

Last summer more than 40% of 121 hospital executives surveyed said their organization had already realized a decent ROI in generative AI. However, a C-suite slice of nearly the same size said it was too soon to know for sure. 

U.S. Department of Health and Human Services (HHS) HQ

HHS offers update on comms pause as rapid policy shifts continue

A spokesperson told HealthExec that "several types of external communications" are no longer subject to any pause, including urgent public health alerts. 

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FDA announces emergency recall of oxygen concentrators after spontaneous fires

There have been no injuries. However, due to the serious risk of death, the devices manufactured by Jiangsu Jumao X-Care Medical Equipment must be removed from the market immediately. 

Elon Musk Neuralink

Musk’s DOGE granted access to CMS records in search of ‘big money fraud’

The pseudo-government organization led by billionaire Elon Musk has been given read-only access to payment, contract and staffing records at the agency. 

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Around the web

Radiology Business
FDA announces recall of Medtronic interventional radiology devices after 17 injuries, 4 deaths

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

AI in Healthcare
What federal regulators can learn from the states about AI oversight

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? 

Cardiovascular Business
Boston Scientific enters renal denervation market with acquisition worth up to $540M

Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN technology.