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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Novavax NVX-CoV2373 COVID-19 vaccine myocarditis

COVID-19 public health emergency to end in May

"If the PHE were suddenly terminated, it would sow confusion and chaos into this critical wind-down," the White House said.

Doctor gets prison time for operating pill mill

A Pennsylvania physician sold medically unnecessary prescriptions for oxycodone and other controlled substances to about 120 individuals from 2016 to 2020.

Mahurkar Acute Dual Lumen High-Flow Hemodialysis Catheter

FDA announces recall of hemodialysis catheters due to risk of leaks, adverse outcomes

“The use of the defective catheter may cause serious adverse health outcomes, including bleeding or the need for surgical removal and replacement of the affected catheter,” according to an FDA advisory.

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Record-breaking number of Americans enrolled in health insurance for 2023

A record-breaking 16.3 million people signed up for health insurance coverage on the Affordable Care Act marketplace during the latest open enrollment period.

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Justice Dept. takes down ransomware group targeting hospitals

The group targeted 1,500 victims in over 80 countries and received more than $100M since June 2021.

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Majority of Americans believe healthcare is a government responsibility

More than half of Americans (57%) believe healthcare should be ensured by the federal government, according to a recent poll from Gallup.

FDA proposes major shift to COVID vaccine schedule

Under the new proposal, the FDA would conduct an assessment of prevalent strains circulating each year, likely beginning around June, with the aim of new vaccines being ready by September. 

insurance payer payment insurer

Uninsured rate dropped during COVID-19 pandemic

The uninsured rate in the United States saw a drop from 11.1% in 2019 to 10.5% in 2021, according to a new report from the Department of Health and Human Services (HHS).

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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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