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.

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately
The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.
Why all heart patients should be vaccinated against the flu, COVID-19, RSV
The American College of Cardiology has shared new recommendations highlighting the protective benefits of a variety of vaccines. The new guidance also examines how to speak with patients who are hesitant to be vaccinated.
Medicare has denied $16M worth of radiology artificial intelligence claims
The federal payment program first started paying for AI in 2018 and has denied about 53% of claims (or 53,857) submitted by radiologists since then, experts detail in JACR.
Members of Congress propose tapping foreign-born physicians to relieve radiology workforce shortages
Lawmakers in both chambers have reintroduced the Healthcare Workforce Resilience Act, touting support from the American Hospital Association and several physician societies.
Medicare opts not to make CT radiation-related quality measure mandatory in 2027
The measure evaluates the proportion of scans that exceed certain thresholds for image noise or radiation dose across 18 categories.

Hospital to pay $24.3M over TAVR allegations

According to a whistleblower, Cape Cod Hospital performed hundreds of TAVR procedures without following specific government requirements.

The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.

FDA clears advanced AI model for predicting heart failure risk

The new algorithm from Implicity evaluates implantable device data and monitors patients for changes that suggest they could experience severe heart failure symptoms in the near future. It was designed to alert clinicians up to weeks in advance.

Prior authorization a ‘major contributor’ to radiologists’ mounting administrative burdens, ACR tells Congress

Amid specialist shortages and imaging backlogs, members of the U.S. Senate are seeking ways to ease the stress endured by physicians.

noncompete contract clause employment pen sign

Maryland enacts sweeping ban on noncompetes for all healthcare professionals

The new law will ban noncompetes in the state for all healthcare workers who provide care, including veterinarians and veterinary technicians.

Cardiologists examine how residual TR after transcatheter tricuspid valve repair impacts survival

Researchers tracked data from more than 600 patients, noting that heart teams may want to reconsider how they classify residual TR after treatment.

Atraverse Medical Hotwire radiofrequency (RF) guidewire

Medical device startup gains FDA clearance for new RF guidewire, raises $12.5M

Atraverse Medical, a San Diego-based medical device company founded in 2022, designed the guidewire to give physicians as much freedom as possible while treating heart patients.

Industry Watcher’s Digest

Buzzworthy developments of the past few days.

Radvocates applaud bipartisan bill that would end decade-long decline in Medicare reimbursement

The Radiation Oncology Case Rate Value-Based Program Act of 2024 would build on the shelved RO Model and save the federal payment program $200M.

Policy & Regulations

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

Why all heart patients should be vaccinated against the flu, COVID-19, RSV

Medicare has denied $16M worth of radiology artificial intelligence claims

Members of Congress propose tapping foreign-born physicians to relieve radiology workforce shortages

Medicare opts not to make CT radiation-related quality measure mandatory in 2027