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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FDA approves first rapid-acting insulin biosimilar for diabetes

Sanofi's Merilog is a new biosimilar substitute for Novo Nordisk’s NovoLog. It can be used to treat adult and pediatric patients with type 1 and type 2 diabetes.

Biosense Webster, part of Johnson & Johnson MedTech, shared updated data on its Varipulse pulsed field ablation (PFA) system at AF Symposium 2024 in Boston,

Johnson & Johnson resumes PFA rollout after stopping to review safety concerns

Johnson & Johnson MedTech has resumed the U.S. rollout of its Varipulse PFA system, sharing new warnings to help physicians. 

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Veterans with heart disease often receive better care through VA than they would elsewhere

Military veterans face an increased risk of cardiovascular disease, making it especially important to ensure they receive high-quality care.

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FDA announces new recall of Johnson & Johnson heart pumps over safety concerns

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.” 

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Cardiologists recommend AVR for asymptomatic severe AS—TAVR and surgery both viable options

A trio of leading voices in cardiology reviewed years of data while considering their proposal. The choice between TAVR and SAVR, they added, should be made on a case-by-case basis.

ACC Vice President Christopher Kramer, MD, FACC, offers an update on the creation of a new cardiovascular board.

Final decision on the creation of a new cardiovascular board expected soon

U.S. cardiology groups have worked together to propose the creation of a new American Board of Cardiovascular Medicine for certifying cardiologists. Now, after many months of waiting, a final decision is expected by the end of February. 

The impact of Trump tariffs on iodine contrast media costs

GE HealthCare said the price of iodine contrast increased by more than 200% between 2017 to 2023. Will new Chinese tariffs drive costs even higher?

ACC President Cathie Biga explains the American College of Cardiology advocacy efforts in Washington D.C. in 2025.

ACC president details key advocacy efforts in cardiology

American College of Cardiology President Cathie Biga, MSN, says Medicare payment reform remains a top priority going forward. Site-neutral payments and improved access to PAD screening are two other issues close to the ACC's heart. 

Around the web

"Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by additional tariffs,” SNMMI President Cathy Cutler, PhD, wrote in a letter to the U.S. Department of Commerce this week.

If President Trump initiates a 25% tariff against pharmaceuticals imported from Ireland, it might impact the price for X-ray iodine contrast agents in the U.S. depending what rules are put in place.