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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Two Florida women sentenced to prison for falsifying clinical records

Two women in Florida have been sentenced to prison for their roles in a conspiracy to falsify clinical trial data.

Sutter Health to pay $13M in settlement over improper billing

The healthcare provider allegedly billed for toxicology tests performed by outside labs for government health programs. 

 

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FDA, DOJ go after e-cigarette companies for breaking the law

“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” one FDA official said. 

 

Claire Ernst, director of government affairs, Medical Group Management Association (MGMA), explains the list of priorities for the association. These include staving off the large, planned 2023 Medicare reimbursement cuts, fighting for continuation of reimbursements for telehealth, and revamping prior authorizations.

VIDEO: MGMA explains why the COVID-19 public health emergency extension is critical

Claire Ernst, director of government affairs for the Medical Group Management Association, talked to us about why extending the federal COVID-19 health emergency was so important for healthcare providers.

Left, HeartFlow's RoadMap analysis enables cardiac CT readers to identify stenoses in the major coronary arteries. The AI provides visualization and quantification of the location and severity of anatomic narrowings. Right image, HeartFlow's Plaque Analysis AI algorithm automates assessment of coronary plaque characteristics and volume on CCTA exams to greatly reduce the time it takes to manually assess and quantify these features.

HeartFlow gains FDA clearance for 2 new AI-powered imaging assessments

The solutions, Plaque Analysis and RoadMap Analysis, both use coronary CT angiography to provide clinicians with a noninvasive look at patients who present with coronary artery disease and face a heightened myocardial infarction risk.

Walmart to sell OTC hearing aids

Retail giant Walmart is now offering over-the-counter hearing aids for the first time ever to U.S. customers 18 and older.

overnight night shift attending radiologist burnout

Cardiologists explain why career flexibility is needed to thrive in today’s challenging work environment

A new policy statement from the American College of Cardiology highlights the importance of career flexibility—including the ability to change hours or work responsibilities when necessary—for cardiologists of all ages. 

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CMS extends bundled payments to 2025

Instead of concluding Dec. 31, 2023, the Bundled Payments for Care Improvement Advanced (BPCI Advanced) Model is scheduled to end Dec. 31, 2025.

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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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