Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for digital breast tomosynthesis that were performed for the evaluation of the enrollee, who presented for breast examination. Findings: Two physician reviewers found that the patient was asymptomatic with respect to her breasts.  She had a prior left breast biopsy. She underwent a routine screening mammogram consisting of a three dimensional tomosynthesis study with synthetically reconstructed two dimensional views. Those images were compared to prior.  In one image there was an area of asymmetry noted in the left breast.  In addition, there was a nodular area noted in the retroareolar area of the right breast.  Following that screening study, it was recommended that the patient return for additional imaging.  The patients breasts were described as heterogeneously dense. Subsequently, she returned and had a repeat set of compression images including an additional tomosynthesis study. Those repeat images did not reveal an abnormality on the left. The prior suspected abnormality was felt to represent a summation artifact.  However, the nodule on the right persisted, and the patient then had a directed hand-held sonogram of the right breast.  The sonogram demonstrated a solid nodule, and a biopsy of that nodule was recommended.  The patient requested reimbursement for both tomosynthesis studies performed. However, the Health Plan denied reimbursement noting that the digital breast tomosynthesis portions of the examinations were investigational for evaluation of this patient. Breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts.  In this particular patient, there are multiple indications for one of the tomosynthesis studies.  On the basis of her heterogeneously dense breasts, one can justify tomosynthesis.  It is specifically those patients who have dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. In addition, the asymmetry and the nodule are further justifiable indications for tomosynthesis.  Furthermore, it is reasonable and appropriate to recall the patient for additional imaging after the screening study detected the abnormalities.  The ability to better characterize the nodule and/or possibly exclude it as a lesion is useful information. Considering the density, the nodule, and the asymmetry, the initial tomosynthesis performed was likely more effective over the standard options available for the evaluation of this patient.  However, the subsequent tomosynthesis performed was not likely to have been more effective than the standard procedures available. There is a lack of support to justify a repeat tomosynthesis after only a two week interval from her last tomosynthesis study. In sum, the initial digital breast tomosynthesis performed was likely to have been superior over the standard options available for the evaluation of this patient but the subsequent digital tomosynthesis was not. Final Result: The reviewers determined that the services at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be partially overturned. Credentials/Qualifications: The physician reviewers are board certified in diagnostic radiology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.