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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CMS cites 'newly published evidence' in postponement of PET coverage decision

Prior to the Dec. 15 announcement, CMS had released a different statement in June informing the public that they were reconsidering the amount of PET scans that Alzheimer’s patients undergoing monoclonal antibody treatment can receive.

Lack of transparency in AI research limits reproducibility, renders work 'worthless'

A recent analysis found that a significant amount of studies do not provide information pertaining to their raw data, source code or model. As a result, up to 97% of these studies do not produce systems that are fit to be used in real-world clinical scenarios. 

FDA adds diabetes medicine to drug shortage list

A diabetes treatment drug, Mounjaro, has been added to the Food and Drug Administration’s (FDA) list of drug shortages.

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ACR recommendations result in 15-fold increase in breast MRI eligibility among cancer survivors

Prior to 2018, it was recommended that women at higher-than-average risk undergo supplemental breast MRI screening only if they had a personal history of breast cancer in addition to carrying a hereditary breast cancer gene mutation.

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Chicago physician indicted in $9.5M healthcare fraud conspiracy

Benjamin T. Toh, of Chicago faces up to 10 years in prison and a $250,000 fine.

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World’s leading cardiology groups say it is time to rethink RCTs

The American College of Cardiology, American Heart Association, European Society of Cardiology and World Heart Federation all collaborated on a joint statement aimed at updating the rules and regulations associated with randomized clinical trials

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Biden’s winter preparedness plan includes more free COVID-19 tests

The Biden administration plans to make more free, at-home COVID-19 tests available to Americans as part of its newly announced winter preparedness plan.

Regulatory hurdles cleared by MedCognetics, Novartis

The Dallas-based company says its product incorporates bias-busting algorithms that overcome the lack of diverse populations available for model training.