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 announces coverage decision for new Alzheimer's drugs

The agency indicated that, in order for such drugs to be covered, patients with Medicare Part B must be enrolled in registries that collect real-world data on the treatment’s effectiveness. 

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Cardiology groups issue statement on bullying, harassment and discrimination within the specialty

Bullying and other inappropriate workplace behaviors have been linked to an increased risk of errors and worse patient outcomes. 

Sam Jones, MD, explains why CMS reduced payments for EP ablation and how it will negatively impact electrophysiology. #HRS #HRS2023 #EPeeps #EPlab #Medicare

Making sense of the huge Medicare reimbursement cuts in electrophysiology

Samuel Jones, MD, examines the large reimbursement reductions in cardiac ablations and what the impact might be on access to care in EP labs.

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Integra poised to take $60 million hit following voluntary recall of devices manufactured at Boston facility

Production of Integra’s SurgiMend, PriMatrix, Revize and TissueMend products has been temporarily halted due to the recalls, although the company said it has not received any customer complaints. 

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FDA approval of several impactful drugs could be delayed if US defaults on debt

The FDA’s process of reviewing and approving drugs and devices could be put on hold, if lawmakers fail to reach a deal related to the debt ceiling.

biden administration artificial intelligence

White House spotlights 3 newly added items on AI to-do list

The Biden Administration has refreshed its efforts to encourage AI innovation while mitigating AI risks.

Federal Trade Commission issues warning to health companies about the misuse of consumer data

The new policy statement warns that any inaccurate or misleading claims to consumers about how their data is collected and used will be considered a violation of the FTC Act.

money maze payment reimbursement

'Forced to jump through hoops': Commercial insurers are making life harder for physicians

Although commercial payors do offer better reimbursement rates, their lack of timeliness in making payments is negatively impacting hospitals.

Around the web

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. 

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

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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