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. 

Rapt drug trial halted

FDA halts Rapt drug trial after patient complication

Shares in the drugmaker took a hit after a case of liver failure in one study participant resulted in regulators putting an immediate pause on further dosing or enrollment in the trials. 

FDA announces recall of more than 50,000 infusion pumps

Smiths Medical says providers should double check that Medfusion Model 4000 pumps have had their software properly updated, after reports that earlier versions of the device software could cause harm.

American Society of Nuclear Cardiology (ASNC) 2024 President Lawrence Phillips, MD, FASNC, director of nuclear cardiology and medical director for outpatient cardiology at NYU Langone Health, explains ASNC’s advocacy efforts for Medicare payments and reform.

ASNC president advocates for Medicare reimbursement reform

Lawrence Phillips, MD, president of the American Society of Nuclear Cardiology, said that U.S. physicians are growing more and more frustrated by Medicare policies.

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CDC: Updated COVID jab significantly reduces odds of infection

The latest COVID-19 vaccine began entering recipients’ bodies last September. Now comes early CDC data supporting the formulation’s general effectiveness.

Cardinal Health recalls some Monoject syringes

The company’s “Cardinal Health”-branded Monoject syringes, released in June 2023, were manufactured by a different contractor and differed slightly in dimensions from the “Covidien”-branded syringes, which could put patients at risk.

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CMS steps up its game on value-based care communications

The Centers for Medicare & Medicaid Services has launched a website breaking down the basics of value-based care. The site is suitable for educating healthcare consumers and professionals alike.

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Philips halting sleep apnea device sales amid FDA consent decree

The deal aims to resolve concerns over the company's breathing device division after complaints and a controversial recall brought the attention of government watchdogs.
 

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Cardiologists speak out about reimbursement cuts, say Congress ‘left clinicians holding the bag’

When Congress passed its latest continuing resolution to avoid a government shutdown, it provided no relief for cardiologists and other physicians impacted by ongoing Medicare reimbursement cuts. The American College of Cardiology responded to this development with yet another plea for change. 

Around the web

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.

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. 

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.