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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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. 

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FDA flags defective packaging of Exactech shoulder joint devices

Equinoxe Shoulder System joint replacement devices have shipped in bags missing a crucial oxygen barrier, potentially putting patients at risk.

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Around the web

Cardiovascular Business
Cardiology groups cheer new bill that would improve access to Medicare claims data

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

Cardiovascular Business
Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Cardiovascular Business
Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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