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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California State Capitol Sacramento

Newsom vetoes bill to regulate private equity transactions in healthcare

Assembly Bill 3129 would have given the California Attorney General oversight of all private equity investments or purchases involving a healthcare entity. Gov. Gavin Newsom argued that a similar regulatory framework is already in place. 

FDA announces recall of Pfizer's fast-tracked sickle cell drug

The drugmaker is voluntarily withdrawing Oxbryta from the market due to a higher-than-acceptable risk of death.

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Public health coalition wins lawsuit against EPA for lack of fluoride oversight

A federal judge in California ruled existing evidence of the negative effects of fluoride in drinking water warrants an investigation and potential action from the Environmental Protection Agency. 

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Cardiology groups cheer new bill that would improve access to Medicare claims data

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

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Walmart workers sue over tobacco fees levied for health plan trust

The class action lawsuit argues employees cannot escape the fees even after they stop using tobacco, a violation of labor regulations.  

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HHS awards $75M for addiction and maternal health services in rural areas

The funds will be used to expand services and improve the financial stability of existing healthcare organizations located in underserved regions of the South. 

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FDA announces Class I recall for compounding inlets due to risk of death

Baxter’s disposable inlets for automated compounding systems could pose a serious risk to patients if not properly inspected before use.

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Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

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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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