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.

ASNC, ACC ask US government not to tariff radiopharmaceuticals
The two groups stressed that tariffs would likely impact patient care.
Tariffs will have a significant impact on the nuclear imaging supply chain in the US
"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.
U.S. iodine contrast supply may not be subject to proposed 25% tariffs
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.
Tariffs not enough to make Siemens Healthineers move production or raise prices—yet
The imaging manufacturer expects to spend between $227 million and $340 million on tariff mitigation efforts, leaders said Wednesday.
Answering key follow-up questions after the FDA approved TAVR in asymptomatic patients
The approval of certain TAVR valves to be used in asymptomatic patients is expected to make a significant impact on patient care going forward.

5 key takeaways from new ACC/AHA aortic disease guidelines

The new guidance, published in the Journal of the American College of Cardiology, covers a variety of topics, including thoracic aortic disease, peripheral artery disease, shared decision-making and cardiac imaging.

Cardiologists, electrophysiologists ‘disappointed’ in final 2023 Medicare Physician Fee Schedule

The American College of Cardiology and Heart Rhythm Society issued a joint statement soon after CMS published its final rule for the 2023 Medicare Physician Fee Schedule. The groups warned that the final rule could threaten patient access to high-quality care.

Providers face ‘ominous reality’ of payment cuts as CMS finalizes 2023 Physician Fee Schedule

Physicians are now bracing for payment cuts after the Centers for Medicare and Medicaid Services (CMS) published its final rule for the 2023 Physician Fee Schedule.

Regulatory Roundup: FDA approves new heart failure therapy, clears an interventional device and much more

The FDA has been busy this month. Review some of the biggest FDA-related stories of October, including big news from scPharmaceuticals, Abiomed, Bristol Myers Squibb and MedAlliance, in our monthly roundup.

CMS assigns new code and payment rate for automated CCTA coronary plaque assessment

CMS stated the code would have an assigned payment rate of $900-$1,000. It became effective starting on October 1, 2022.

American College of Cardiology shares expert analysis on treating ASCVD patients with multiple chronic conditions

The new guidance document was designed to help cardiologists and other clinicians deliver the best care possible when treating ASCVD patients who present with additional conditions that need to be considered.

FDA announces new recall of blood pressure medication due to potential cancer risk

Patients impacted by this recall are advised to speak with a physician about how to proceed.

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.

Around the web

Health Imaging

Tariffs will have a significant impact on the nuclear imaging supply chain in the US

"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.

Radiology Business

U.S. iodine contrast supply may not be subject to proposed 25% tariffs

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.