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.

FDA highlights risks of evaluating blood pressure with unauthorized medical devices
The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated.
Healthcare AI today: Another angle on AI regulation, move fast but don’t break things, WISeR in the real world, more
Getting healthcare AI to fulfill its destiny—can we call it that now?—will require ‘scenario-based’ consideration of every use case.
Repeat imaging rates higher when scans are interpreted by nurse practitioners, physician assistants
The finding is based on an analysis of nearly 1.4 million office-based imaging claims, conducted by the Harvey L. Neiman Health Policy Institute.
Members of Congress condemn Medicare model targeting ‘wasteful’ interventional radiology services
“It is not an exaggeration to say that the requirement of prior authorization for traditional Medicare services will kill seniors,” says Rep. Mark Pocan, D-Wis.
Referrers frequently failing to recommend patients for key interventional radiology procedure
An analysis of nearly 272,000 uterine fibroid healthcare encounters shows that only about 4% of women underwent uterine fibroid embolization, a minimally invasive IR treatment option.

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

FDA highlights risks of evaluating blood pressure with unauthorized medical devices

Healthcare AI today: Another angle on AI regulation, move fast but don’t break things, WISeR in the real world, more

Repeat imaging rates higher when scans are interpreted by nurse practitioners, physician assistants

Members of Congress condemn Medicare model targeting ‘wasteful’ interventional radiology services

Referrers frequently failing to recommend patients for key interventional radiology procedure