Zebra Medical Gets AI (Non Human) Screening Code for Vertebral Fractures; CMS Classes as Non Payable

Zebra Medical got a code for FDA-cleared vertebral fracture screening without human intervention on CT scans.  (Films and patients are flagged for human review).  The code was passed at the February 2021 meeting, meaning it was published around July 1 in final form and with final code number, for use January 1, 2022.

In July 2021 proposals, CMS proposed to class with "New Proposed" pricing (NP) with status E1 (not payable for Medicare.)  It would be not payable on the theory that there is a bone density screening benefit for osteoporosis, but there is not a specific screening benefit just for non human AI VFX screening.

BACKGROUND

Code made a splash in the radiology trade journals.

Just Links:

https://www.businesswire.com/news/home/20210707005601/en/Zebra-Med-Announces-the-American-Medical-Associations-AMA-Issuance-of-the-Category-III-CPT%C2%AE-Code-for-VCF-Detection-from-CT-scans-for-Population-Health

https://www.healthimaging.com/topics/ai-emerging-technologies/radiology-ai-cpt-code-approved-ama-zebra-medical

https://www.auntminnie.com/index.aspx?sec=ser&sub=def&pag=dis&ItemID=132954

https://axisimagingnews.com/radiology-products/radiology-software/ai-machine-learning/ama-issues-category-iii-cpt-code-for-vcf-detection-from-ct-scans-for-population-health

https://info.hapusa.com/blog-0/hcpcs-code-for-billing-artificial-intelligence-is-announced

FROM AUNT MINNIE LINK

July 19, 2021

Officially added on July 1 and set to take effect on January 1, 2022, the new category III code -- 0691T -- would apply to the use of AI for automated analysis of existing CT studies for vertebral fracture(s), including assessment of bone density when performed, data preparation, interpretation, and reporting.

Dr. Melissa Chen.

The code was approved by the AMA after representatives from the RSNA, American College of Radiology (ACR), the American Roentgen Ray Society (ARRS), and the Association of University Radiologists initially proposed the code in a presentation at the AMA CPT Editorial Panel meeting in February. 

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Similarly

https://www.theimagingwire.com/2021/07/12/imaging-in-h1-ai-code-going-corporate/

he American Medical Association issued the first imaging AI CPT codes on July 1st, including Category III codes for incidental vertebral fracture detection and quantitative ultrasound characterization, allowing clinics to start billing for these applications in January 2022 and potentially leading to the first AI reimbursements (the new AI codes are on page 3).

• The VCF AI Code – Highlighted among the AMA’s CPT update is a new code (0691T) for using AI to automatically analyze existing chest CTs to detect vertebral fractures, potentially paving the way for AI-based population health osteoporosis programs. This CPT code represents quite a milestone for AI (it’s the first radiology-specific AI code) and for Zebra Medical Vision, which is the only company with an FDA/CE-cleared product for population-scale incidental VCF detection.

• Ultrasound AI Codes – The AMA also issued a pair of CPT codes for quantitative ultrasound tissue characterization, which can be used in conjunction or separately from existing ultrasound exam codes (0690T w/ other US exam codes, 0689T separately). These codes could also represent a major step for key ultrasound exams (e.g. breast, thyroid) and ultrasound AI decision support players (e.g. Koios Medical).

FDA Documentation here   as K192901

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192901.pdf

Category is 21 CFR 892.2080, Radiological computer assisted prioritization software

The category descriptor is pretty detailed:

https://www.law.cornell.edu/cfr/text/21/892.2080

Radiological computer aided triage and notification software.

Trade on FDA

https://www.businesswire.com/news/home/20200518005487/en/Zebra-Medical-Vision-Secures-its-5th-FDA-Clearance-Making-Its-Vertebral-Compression-Fractures-AI-Solution-Available-in-the-U.S.

Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.