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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Surprise active shooter drill at children’s psychiatric hospital results in $13M for victims

The Michigan Department of Health and Human Services failed to notify staff and law enforcement that a simulation at the state-run facility was taking place, resulting in chaos. 

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CMS contractor takes $1.2M loss after data breach, DOJ lawsuit

Federal Data Solutions allegedly failed to encrypt screenshots of patient data, stored on a server being paid for with Medicare funds.

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Farawave Nav ablation catheter for the treatment of paroxysmal atrial fibrillation (AFib) and FDA clearance for its new Faraview software

Boston Scientific scores 2 key FDA approvals for PFA mapping technology

The two newly approved technologies are used together to help visualize cardiac ablation procedures performed with Boston Scientific’s Farapulse pulsed field ablation system.

Boston Scientific Obsidio instructions updated

4 deaths prompt updated instructions for embolic agent used in IR procedures

The Obsidio Conformable Embolic is routinely used for vascular embolization procedures.

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New Category I CPT codes announced for treating heart failure with implantable Barostim device

Baroreflex activation therapy with the Barostim device from CVRx has received new CPT codes from the American Medical Association. The codes go into effect in January 2026.

FDA announces recall of Boston Scientific's Obsidio Conformable Embolic

Boston Scientific updates instructions for recalled embolic agent linked to multiple deaths

The premixed embolic agent is designed to embolize hypervascular tumors and occlude blood flow in a patient's peripheral blood vessels. It was recalled in April due to safety concerns.

Bipartisan group of 233 House members call for Medicare reform

In a letter, the undersigned asked Congress to halt cuts to Medicare reimbursement and enact a permanent system to adjust rates to inflation. 

Wartime powers enacted to address nationwide IV fluid shortage

The Biden Administration has invoked parts of the Defense Production Act to address shortages that stem from Hurricane Helene damaging a Baxter production facility in North Carolina.