Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for intraoperative radiation therapy (IORT). Under the National Comprehensive Cancer Network (NCCN) guidelines for the management for breast cancer, it is standard for patients to undergo adjuvant radiation therapy after a lumpectomy as part of their treatment program. Most commonly, this radiation therapy is given post-surgery over the course of one to several weeks. It may be given with a variety of treatment modalities such as external beam or interstitial brachytherapy. There are established consensus guidelines by the American Brachytherapy Society and recommendations by which help determine suitable patients for this technique as well guide dosing regimens. Some patients and providers prefer IORT because the indicated radiation therapy may be completed on the operating table in one session, thus eliminating the need for multiple trips afterward. Numerous prospective and retrospective studies have been performed to determine disease recurrence outcomes following IORT. Abo-Madyan and colleagues reported results demonstrating the non-inferiority of IORT compared to standard postoperative external beam treatment. There are also similar disease control rates and cosmetic outcomes between IORT and standard external beam treatment. However, there is a great heterogeneity in the IORT techniques. One primary drawback of IORT is a lack of dosimetric planning during its administration. Dosimetric planning involves the patient returning to the radiation oncology clinic after surgery to undergo three-dimensional (3D) mapping of the breast so that dose calculations and targeting can be performed prior to starting radiation therapy. The radiation oncologist would then also have available the complete surgical pathology report after surgery, which guides treatment. For example, if there is unexpected tumor involvement within the lymph nodes or if the disease is more extensive than originally imaged, then the radiation therapy plans may be modified. This is only possible when radiation therapy is given after surgery. With IORT, as the radiation is delivered to the cavity that was just vacated by the surgeon, there is no pathologic data such as lymph node involvement and surgical margin status is yet available. In many cases, patients receiving IORT end up requiring further radiation treatment after surgery anyway due to adverse findings on the pathology report. Valente and colleagues report higher recurrence rates in some patients treated with IORT. While IORT is an active area of study and there is data suggesting that in the future it may achieve similar long-term disease control outcomes as standard postoperative external beam treatment, there is currently a paucity of data showing better outcomes in this clinical setting. Therefore, IORT is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested IORT is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested service is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in radiation oncology 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.