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. 

Employee parking lot is a sea of mud and storm debris at the the Baxter North Cove facility. Photo by Aerial Lens.

Baxter begins importing IV supplies as 86% of providers report shortages

Hurricane Helene severely damaged Baxter's plant near Asheville, North Carolina, leading to a nationwide shortage of IV fluid bags. 

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Conspiracy at Chicago safety net hospital leads to fourth indictment

Three executives at Loretta Hospital were allegedly receiving cash bribes from a local businessman who operated medical supply companies.

HeartFlow Plaque Analysis

CMS updates Medicare coverage for AI-powered coronary plaque assessments

The new policy goes into effect in November, improving Medicare coverage for a technology that has rapidly gained momentum in recent years.

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Teva settles with DOJ for $450M to resolve latest price fixing allegations

The world's largest generic drug manufacturer allegedly paid charities kickbacks to cover patient co-pays in an effort to inflate the price tag of its multiple sclerosis treatment.

pharmaceutical drug approval process

FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

artificial intelligence in cardiology

FDA grants AI-powered ECG screening tool for aortic stenosis its breakthrough device designation

The FDA clearly sees significant potential in this new screening software from New York-based AccurKardia.

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AMA, physician groups file amicus brief with Supreme Court in ‘ghost gun’ case

The groups are urging the Supreme Court to uphold a lower court ruling in Garland v. VanDerStok that permits the ATF to regulate firearms made from part kits. 

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CMS proposes rule to combat gray market health insurance scams

The agency has received an increasing number of complaints from patients enrolled in a low-value health plan without their knowledge. If finalized, a new rule would empower CMS to ban brokers from the ACA marketplace. 

Around the web

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.