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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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. 

The Texas State Capital building in Austin where 140 scope creep bills were defeated in 2024 by the Texas medical Association.

Texas legislature held ground in face of scope of practice expansion bills

The AMA applauded the Texas Medical Association for defeating dozens of scope of practice creep bills in the Texas legislature this year.

Bharath Krishnamurthy, a director of Health Policy and Analytics at the American Hospital Association (AHA), explains the financial impact of the growing healthcare staffing shortage.

Healthcare staffing shortages leading to financial instability

Bharath Krishnamurthy, a director of health policy and analytics at the American Hospital Association, explains the financial impact of current healthcare staffing shortages.

Novartis sues FDA over ‘unlawful’ approval of generic heart failure drug

The drugmaker argues that the FDA's recent approval of a generic version of Entresto should not be allowed for multiple reasons. Novartis sent multiple requests to the agency hoping to stop the approval, but the FDA denied each one. 

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Around the web

Cardiovascular Business
Cardiology groups cheer new bill that would improve access to Medicare claims data

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. 

Cardiovascular Business
Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

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

Cardiovascular Business
Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

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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