Annapolis, MD / July 30, 2026 – RadSite™, a leading accreditation organization promoting quality-based imaging practices, has published a new Clinical Coverage Guideline for Breast Cone Beam Computed Tomography (Breast CBCT). Developed with input from industry experts and reviewed by RadSite’s CBCT Standards Committee, the guideline is informed by clinical evidence and technical information provided by Koning. It establishes criteria for the appropriate clinical use and medical necessity of this compression-free, three-dimensional breast imaging technology.  

Breast CBCT produces three-dimensional images of the breast while the patient is positioned prone, without breast compression. The new guideline provides a framework for ordering clinicians, imaging facilities, payer medical directors, and utilization management reviewers to determine when Breast CBCT is medically necessary. 

The guideline states that Breast CBCT may be appropriate for diagnostic or treatment-planning use when standard imaging, such as mammography or ultrasound, is inconclusive or technically limited. It also identifies Breast CBCT as a potential alternative for patients who need three-dimensional assessment but cannot undergo breast MRI because of severe claustrophobia, a contraindication to gadolinium-based contrast agents, or MRI-incompatible implanted devices. 

Clinical data reviewed in the guideline support the diagnostic performance of Breast CBCT. A 2024 meta-analysis cited in the guideline, for example, found that contrast-enhanced Breast CBCT had a pooled sensitivity of 92%, compared with 77% for standard mammography, while showing similar specificity.  

The guideline also summarizes the Category III CPT codes used to report unilateral and bilateral Breast CBCT studies. These codes identify the services but do not guarantee coverage or reimbursement. 

“This guideline is an important milestone in standardizing and expanding access to high-quality advanced breast imaging,” said Garry Carneal, JD, RadSite’s President and CEO. “By defining clear diagnostic pathways—especially for complex cases or situations where breast MRI is not feasible—we are helping clinicians and payers more easily incorporate true 3D imaging into clinical decision-making, ultimately improving patient care, comfort, and safety.”  

“We are pleased to see Breast CBCT recognized through these rigorous clinical criteria,” said Richard Reaven, MD, Co-CMO, Koning Health. “For years, patients have had limited options as an alternative to the discomfort of compression. This innovative new choice should be a welcome addition in the fight against breast cancer. The Koning Breast CT system delivers isotropic, high-resolution 3D views of breast tissue at a radiation dose comparable to multi-view mammography, providing another option for resolving complex diagnostic questions and supporting precise treatment planning.”  

“The guideline translates the available clinical evidence into practical criteria that clinicians, imaging facilities, and payers can use when considering Breast CBCT,” said Adam Powell, PhD, Co-Chair, RadSite’s CBCT Standards Committee and President, Payer+Provider Syndicate. “Facilities offering Breast CBCT should also consider RadSite accreditation, which assesses technical proficiency, documentation, and dose management protocols.”  

Individual copies of the Clinical Coverage Guideline: Breast Cone Beam Computed Tomography (Breast CBCT) are available for non-commercial download. Click here. This publication is for informational purposes only and does not constitute medical advice, a substitute for professional clinical judgment, or a guarantee of reimbursement.   

RadSite also hosted a complimentary webinar on this topic in June, entitled “Breast Cone Beam CT: Emerging Clinical Applications and the Development of Guidelines.” To view the webinar on the RadSite YouTube channel, click here.   

RadSite has earned a reputation for providing an innovative and cost-effective choice for accreditation. RadSite offers six accreditation programs, with an Ultrasound Accreditation Program under development:    

• CT Accreditation 

• MRI Accreditation 

• Nuclear Medicine and PET Accreditation  

• Dental CBCT Accreditation 

• Medical CBCT Accreditation  

• Remote Scanning Accreditation 

To learn more about RadSite, visit www.radsitequality.com.  

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About RadSite™ (www.RadSiteQuality.com) 

Founded in 2005, RadSite promotes quality-based practices for imaging systems across the United States and its territories. Today, RadSite offers six accreditation programs, including CT accreditation, MRI accreditation, Nuclear Medicine and PET accreditation, Dental CBCT accreditation, Medical CBCT accreditation, and Remote Scanning accreditation. RadSite is recognized by the Centers for Medicare & Medicaid Services as an official accreditation organization under the Medicare Improvements for Patients and Providers Act of 2008. It is also recognized by more than 350 payers and has accredited more than 2,000 imaging systems. RadSite’s programs help assess, track, and report imaging trends to enhance imaging procedures and outcomes. The organization also offers educational programs, publishes issue briefs, and underwrites research on a complimentary basis to raise awareness of safety issues and promote best practices. RadSite is governed by an independent advisory board and committee system that is open to a broad range of volunteers to ensure transparency and accountability. To learn more, contact us at 443-440-6007 or info@radsitequality.com.