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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Incorrect place-of-service codes resulted in Medicare overpayments totaling in the millions

The audit revealed that Medicare overpaid by approximately $22.5 million due to incorrect place-of-service coding completed by practitioners.  

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Nearing a ‘breaking point’: Cardiologists support legislation designed to mitigate Medicare cuts to office-based services

These latest cuts could be a "breaking point" for physicians, according to a new letter to lawmakers. 

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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.

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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.

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

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.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

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. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

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.