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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artificial intelligence healthcare providers legal

3 AI to-do’s for legally aware healthcare providers

Healthcare providers might be the most underrated of all AI stakeholders. Never mind that close to half of 200 CEOs surveyed believe healthcare is the field in which AI is likely to make the most transformative contribution.

Medtronic has received FDA approval for its IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

FDA says treating PAD with paclitaxel-coated devices does not increase mortality risk

After warning healthcare providers about a heightened risk of mortality back in 2019, the FDA has now updated its stance on the use of these devices. 

brain money alzheimer dementia

Coverage is now available for new Alzheimer's drug

In a July 6 announcement, CMS shared that coverage is officially available for Leqembi for those who meet certain criteria.

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President Biden cracks down on short-term health plans, calls them 'junk insurance'

The proposed rule would require that short-term plans are truly short-term and are active for just three months.

Cost of healthcare expected to increase by 7% in 2024

The estimated increase is driven by multiple factors, including labor shortages, provider contract negotiations and rising drug prices.

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CMS slated to introduce nearly 400 new CPT codes in October

The upcoming changes include a total of 395 new codes, 25 deletions and 13 revisions.

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SEC nails former Pfizer employee for insider trading ahead of COVID drug announcement

The senior statistician purchased short-term stock options, including some that expired the next day, after allegedly being made aware of Paxlovid’s success in clinical trials ahead of a public announcement.

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American Medical Association slams Supreme Court ruling on affirmative action, saying it 'undermines decades of progress'

"Diversity is vital to healthcare, and this court ruling deals a serious blow to our goal of increasing medical career opportunities for historically marginalized and minoritized people."

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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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