Appeal type: Medical Necessity
Decision: Overturned

Findings:  The physician reviewer found that The patient has requested authorization and coverage for proton beam therapy. Proton beam has unique properties compared to standard photon or x-ray beam in its ability to deposit radiation doses. The use of proton beams potentially results in fewer areas of low scattered radiation dose as fewer proton beams may be used to achieve a dose distribution similar to standard photon beams, potentially resulting in less radiation exposure to critical organs. The use of proton beams in treating the chest wall and mediastinum is well-studied. The National Comprehensive Cancer Network (NCCN) guidelines support the use of proton beams in the chest region when a reduction in dose to organs at risk is required that cannot be achieved by other radiation techniques.  The amount of radiation dose exposure is particularly important in this patients case as the patient is considered a young adult so the long-term sequelae of radiation dose are magnified. The primary organs at risk in treating the chest wall region are the adjacent heart and lung. The rate of secondary lung cancers, pneumonitis, and major coronary events is correlated with the amount of radiation exposure to these organs. There is maturing data showing exceptional heart- and lung- sparing effects with proton beam therapy. Choi and colleagues report that proton therapy represents a precision radiotherapy technology that limits the normal tissue exposure to unnecessary radiation dose not only to uninvolved breast tissue but also the underlying thoracic organs including the heart and lungs. Braunstein and Cahlon note that proton radiotherapy confers significant dosimetric advantages in the treatment of malignancies that arise adjacent to critical radiosensitive structures. The properties of proton beam allow for a steep dose gradient, meaning that there is a rapid fall-off of dose outside of the intended target. There is also a dose-dependent risk to the nearby exposed organs. Higher radiation dose exposure to the heart and lung results in a higher risk of late lung and cardiac related morbidities. Proton beam therapy can achieve high dose homogeneity, thus reducing hot spots of dose deposits to nearby organs and significantly decreasing the risk of late complications. This is particularly important in this patient given the young age and relatively high lifetime risk of a secondary malignancy. In this case, a comparison treatment plan showed a mean heart dose of 4.7 Gy with the proton plan, and a mean heart dose of 16.8 Gy with a standard x-ray plan. The acceptable mean cardiac dose limit under Quantitative Analysis of Normal Tissue Effects in the Clinic (QUANTEC) guidelines is under five Gy. Given that the treating radiation oncologist is unable to achieve an acceptable cardiac dose constraint without utilizing proton beam in this setting, and as proton beam therapy is indicated for this patient to avoid cardiac toxicity and to reduce the risk of secondary malignancy, the requested services are medically indicated. Therefore, proton beam therapy is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.