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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Change Healthcare faces second ransom as cybercriminals leak stolen data

A new hacker group is claiming credit for the data breach, first reported in February. Change Healthcare has already paid criminals a $22 million ransom.

Healthcare systems set up at the ACC.24 career fair in hopes of filling open positions, including a large and growing number of general cardiologist positions. Photo by Dave Fornell #ACC24 #ACC2024

The growing shortage or general cardiologists and recruiting crisis in rural America

There is a rapidly growing shortage in general cardiologists and for positions in rural areas, numerous healthcare system recruiters set up at the ACC reported.

CMS proposed rule would boost Medicare inpatient rates by 2.6%

CMS has issued a proposed rule that would result in a net increase of 2.6% to the Medicare inpatient prospective payment system rate for fiscal year 2025, a raise that hospital trade groups say doesn’t go far enough.

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Payments to FDA advisory panel questioned

A recent investigation from KFF Health News about payments to members of an FDA panel evaluating an Abbott Laboratories cardiac device is raising eyebrows.

CMS drug price negotiations

Drug price dialogues represent ‘an opportunity for CMS to clarify negotiation policies and their potential impact for the future’

CMS must ensure transparency, clarity and predictability by providing detailed guidance on comparator drug selection and the evaluation of evidence, according to a group of D.C.-based health policy researchers.

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FDA announces recall of more than 300,000 catheter kits after 10 injuries, 1 death

This recall is due to reports of “increased resistance” when using the devices. There have been 194 customer complaints about the issue so far. 

Medicaid still leads gov in payment errors but showing improvement

Medicaid’s $50 billion in improper payments was the highest total for a single program—but it was also the most improved government program, cutting about $30 billion from its 2022 improper payments total. 

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CNN highlights potential ‘seismic shift’ for FDA dual mandate due to Supreme Court abortion case

An expansion in access to mifepristone for telehealth patients is at risk before the Supreme Court. What does this mean for the FDA approvals process?

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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.