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.

American College of Radiology expects volume of ‘dangerous’ scope-expansion bills to grow in 2024

This year alone, ACR has tracked more than 100 proposed policies relating to radiologic scope-of-practice expansion, spanning 30 states.

Physicians fight to end ban on doc-owned hospitals while AHA advocates for status quo

A proposal to end the moratorium on new POHs was among several policies discussed at a House Energy & Commerce Committee hearing Oct. 19.

Edwards Lifesciences gains CE mark approval for Evoque transcatheter tricuspid valve replacement (TTVR) system

Edwards gains CE mark approval for new tricuspid valve replacement device

The approval represents a significant moment in the treatment of structural heart disease. Edwards will share updated data on the device at TCT 2023 in San Francisco.

Poll of Medicare beneficiaries shows ‘overwhelming’ opposition to cutting radiologist pay

More than three-quarters of those reached said they disagree with reducing reimbursement to rads under the 2024 fee schedule, RBMA and MITA reported Thursday.

Money court lawsuit judge ruling scales of justice

UnitedHealthcare owes Radiology Partners affiliate $153.5M in underpayment dispute, arbitration panel rules

The preliminary award includes $134M in underpayment damages, $9M in prejudgment interest, and $2.2M in attorney fees, arbitrators confirmed.

CMS changes coverage policy for carotid stenting to make it more widely available

A group of interventional cardiologists, neurologists and vascular surgeons successfully petitioned Medicare to change its coverage determination for carotid stenting procedures.

M&A mergers and acquisitions business deal

FTC wants to hear from physicians about their experiences with private equity

Chair Lina M. Khan spoke about the topic during the closing keynote at the American College of Emergency Physicians’ annual meeting in Philadelphia.

artificial intelligence money finance acquisition

Number of FDA-cleared AI imaging tools expected to skyrocket by 2035, backed by $30B in funding

During the past seven years, the availability of such products has continued to grow, with medical imaging accounting for 85% of digital health’s venture capital funding.

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