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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Recor Medical's Paradise Ultrasound Renal Denervation System

CMS increases inpatient payment for Recor Medical, Medtronic renal denervation systems

Physicians using the Paradise Ultrasound Renal Denervation system from Recor Medical or Symplicity Spyral Renal Denervation system from Medtronic will soon be eligible for a much more significant reimbursement when treating Medicare patients in an inpatient setting. 

FDA approves epinephrine nasal spray for anaphylaxis

The Neffy nasal spray was shown to be as effective as injectables in four studies on 175 adults.

private equity corporatization business consolidation

Private equity linked to 23% of healthcare bankruptcies in 2024

A new report from the Private Equity Stakeholder Project (PESP) found bankruptcies in healthcare continue to follow private equity buyouts.

Cardiologist Ami B. Bhatt, MD, a digital health specialist and longtime member of the American College of Cardiology (ACC), will serve as the Digital Health Advisory Committee's very first chair.

Cardiologist to chair new FDA advisory committee focused on AI, other digital health technologies

The Digital Health Advisory Committee is tasked with providing perspective and recommendations on a wide variety of topics. These insights will then help the FDA draft new policies and make other important decisions.

Dan Blumenthal, MD, MBA, chief quality officer at the Cardiovascular Associates of America, and a cardiologist at Massachusetts General Hospital, spoke at the Heart Rhythm Society (HRS) 2024 meeting business sessions on how changes in Medicare payments will impact electrophysiology and cardiology more broadly.

What cardiologists should expect as U.S. healthcare payment models evolve

Cardiologist Dan Blumenthal, MD, MBA, explains how changes in Medicare payments will greatly impact cardiology in the years ahead. In just a few short years, the business side of cardiology could look substantially different than it does today. 

Novo Nordisk withdraws FDA application to expand use of weight loss drug

The Danish pharmaceutical company said it will resubmit its application in 2025 to have Wegovy approved for use in heart failure patients.

ACA premiums expected to rise 7% in 2025, report finds

A survey from KFF survey found the spike in cost will be mitigated by subsidies. However, the number of uninsured Americans could rise.

Bharath Krishnamurthy, a director of health policy and analytics at the American Hospital Association (AHA), factors that are leading to instability the U.S. healthcare system. #AHA #AmericanHospitalAssociation #CMS #Healthcare

Challenges to the financial stability of the American healthcare system

Bharath Krishnamurthy, director of health policy and analytics, American Hospital Association, explains factors leading to the economic instability of the U.S. healthcare system. 

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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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