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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Specialized lung AI tool cleared for U.S. sales

A popular marketer of handheld ultrasound devices has won FDA approval for an AI-enabled B-line quantification tool for use with patients suspected of having compromised lung function.

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Illumina ordered to divest Grail

The agency, which is charged with preventing fraud, deception and unfair business practices, said Illumina’s acquisition of Grail would stifle competition and innovation in the U.S. market for life-saving cancer tests.

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CMS finalizes 2024 MA payment rule with rate bump

According to CMS, MA plans will see an average payment increase of 3.32% from 2023 to 2024, worth approximately $13.8 billion in increases for next year.

FDA turns up sterility issues at eye drop facility linked to deaths, vision loss

The FDA has found a drug-resistant bacteria at an eye drop manufacturing facility linked to severe infections and even a few deaths.

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Affordable Care Act dealt a blow in new judgment

The Affordable Care Act (ACA) was dealt a major blow after a federal judge ruled that employers don’t have to cover certain preventive services, including PReP, which prevents HIV.

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UnitedHealthcare to cut back on prior authorization paperwork

UnitedHealthcare announced it would remove 20% of its current prior authorizations starting with the third quarter of this year. 

 

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FDA approves OTC Narcan for the first time

The medication can reverse an opioid overdose and is a critical, life-saving product now able to be sold directly to consumers in places like pharmacies, convenience stores, grocers, gas stations and online, the FDA said.

 

Congress aims to crack down on ‘zombie drug’

Xylazine is a sedative intended for animals such as horses and cattle, but it is increasingly being found mixed with strong opioids such as fentanyl.

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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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