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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Chicago - Circa May 2018: Blue Cross Blue Shield headquarters signage and logo.

Blue Cross settles largest healthcare antitrust case in history for $2.8B

The settlement also includes an agreement for operational changes at all of the insurer's 33 independent partners.

The iCardio.ai EchoMeasure AI software to automate measurements for cardiac echo imaging. It was FDA cleared in October 2024.

FDA approves AI startup’s new software for echo assessments

iCardio.ai, co-founded by a cardiologist, is part of the Cedars-Sinai Accelerator program. The startup has already announced new partnerships with Viz.ai, Abbott and others in the cardiac health space. 

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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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business
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. 

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