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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Medicare Money dollar payment reimbursement

Medicare negotiates lower price for 10 vital drugs, saving seniors $1.5B

The move will save the Medicare $6 billion in just one year, an announcement from the Biden administration said.

private equity corporatization business consolidation

Steward sells physician group to private equity firm for $245M

Stewardship Health, a group represented by 3,500 doctors, will be sold to Rural Healthcare Group, owned by private equity firm Kinderhook Industries.

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Patient risks persist for insulin pump caught in Class I recall

A software update for the pump's mobile app was expected to fix ongoing battery issues, but the problem remains. 

Artificial intelligence sign in the United Imaging booth. The Chinese company wants to break into the U.S. market and has a massive booth footprint at RSNA 2023. This included a section for its own AI development division. Photo by Dave Fornell #RSNA

FDA on track to clear 1,000+ clinical AI algorithms by end of the year

As of July 2024, the FDA reports it has cleared 950 AI algorithms to aid in direct clinical decision making.

Dana Smetherman, MD, ACR CEO, explains AUC may be better than prior authorizations.

ACR CEO discusses solution to fight burdensome prior authorizations in medical imaging

Dana Smetherman, MD, MBA, outlines a possible remedy for the growing number of these roadblocks in the specialty. 

MDMA Ecstasy

FDA rejects ‘ecstasy’ as treatment for PTSD

The agency has asked for an additional phase 3 study before it considers another application from manufacturer Lykos.

Recor Medical's Paradise Ultrasound Renal Denervation System

CMS increases inpatient payment for Recor Medical, Medtronic renal denervation systems

Physicians using the Paradise Ultrasound Renal Denervation system from Recor Medical or Symplicity Spyral Renal Denervation system from Medtronic will soon be eligible for a much more significant reimbursement when treating Medicare patients in an inpatient setting. 

FDA approves epinephrine nasal spray for anaphylaxis

The Neffy nasal spray was shown to be as effective as injectables in four studies on 175 adults.

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.