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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Boston Scientific pacemakers recalled again—software update now available

The new Class I recall, which includes more than 1.4 million devices, is related to an issue first announced back in 2024. Updating the software should address the issue going forward, though some patients may still require an early replacement. 

Medicare Advantage

Lawmakers introduce bipartisan bill to speed up prior authorization in Medicare Advantage

Several healthcare stakeholders have voiced their support for the effort, including the Medical Group Management Association. 

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Current political climate having 'detrimental' effect on radiology research, survey says

Published in Clinical Imaging, the responses indicate that Trump administration policies have made it more difficult to acquire funding and collaborate with other researchers. 

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FTC shuts down alleged health insurance fraud scheme involving the sale of low-quality plans

The owners of several telemarketing companies, along with the organizations themselves, have been named as defendants in a federal lawsuit. The Federal Trade Commission alleges that the group would sell bundled services as supposed “PPO” plans, leaving patients to discover that services were not covered. 

Example of a RF burn from an MRI scan where a sedated patient's identification bracelet was touching their skin during an exam. Image courtesy of RSNA. https://pubs.rsna.org/doi/10.1148/radiol.09090637

FDA: CVS and MediHoney wound gels recalled after 14 serious injuries

The wound and burn gels are manufactured by Integra LifeSciences. Defective packaging could cause the sterile barrier to fail, exposing the gels to pathogens. Due to the risk of severe infections, all recalled products must be removed from where they are used and sold. 

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5 reasons not to (solely) blame insurance companies for what ails US healthcare

As this midterm-election year barrels toward decision day, health insurers continue taking punches from both political parties. The piling-on might be as unfair as it is understandable.  

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Medicare and FDA propose granting rapid coverage for breakthrough radiology devices

The two agencies on April 23 announced the rollout of the Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway. 

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Radiology groups endorse bill to exempt physicians from $100,000 visa fee

ACR, ASNR and over 40 other organizations shared their support for the Healthcare Workforce Act in a letter to lawmakers written April 15.