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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Cardiology ranked No. 2 among all specialties with 122 FDA-cleared AI models

Only radiology is associated with more FDA-cleared AI algorithms than cardiology, according to new federal data. 

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Kaiser Permanente unloading $3.5B in private equity stakes

Citing sources familiar with the matter, the Wall Street Journal reported that Kaiser Permanente is working with Jefferies Financial Group to find secondary buyers.

lex Sandhu, MD, MS, assistant professor of cardiovascular medicine, Stanford University, and cardiologist at the Palo Alto VA. He spoke in the business of cardiology sessions at ACC 2024 and explained how Medicare reimbursements will be moving toward a value based payment model by 2030. #ACC #ACC24 #ACC2024 #CMS #reimbersements #Medicare

How the shift to value-based reimbursements could transform cardiology

"I think we really need our cardiologist community to understand the changes that are happening with value-based payment," one expert tells Cardiovascular Business. 

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Six hospital groups urge UnitedHealth to take responsibility for Change Healthcare hack notifications

In a public letter, the groups are urging UnitedHealth Group to announce a timeline for notifying patients about what personal data was stolen in the breach of Change Healthcare's systems.

Ohio doctor gets 7 years in prison for violating Controlled Substances Act

The Department of Justice said Thomas Romando, MD, illegally prescribed over 137,000 pills to nine patients over a five-year period.

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UPMC settles $38M whistleblower lawsuit for Medicare fraud

Surgeons at the health system were accused of performing unnecessary procedures and receiving bonuses as kickbacks. UPMC does not admit wrongdoing.

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FDA announces new recall of delivery catheters after patient’s death

The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.

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FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls

The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible. 

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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.