Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cancer
Treatment: Radiation Therapy (Proton Beam)
The insurer denied: Radiation Therapy (Proton Beam)
The denial is overturned.

The patient is an adult male with stage pT2N0M0 (stage 2, no nodal involvement, no metastases) 5.1 centimeters high grade synovial sarcoma of the right thigh status post resection. Proton beam therapy is being requested to deliver adjuvant treatment to right thigh surgical area.

The requested proton beam therapy is medically necessary.

Proton radiation therapy has been used for treatment of tumors that require highly conformal radiation therapy due to the location of tumor in close proximity to critical structures such as bladder, rectum, femur, as in this patient's case. Proton beams with their superior ability to precisely conform radiation dose distribution around an irregularly shaped target as in this patient's case enable delivery of high dose of radiation to the tumor precisely with maximum sparing of these normal tissues. Therefore, the requested proton beam therapy will increase tumor control probability and minimize normal tissue complications. The 2022 ASTRO (American Society for Radiation Oncology) Model Policy on Proton Beam Therapy (PBT) (1) states that PBT (proton beam therapy) is considered reasonable in instances where sparing the surrounding normal tissue is of added clinical benefit to the patient and cannot be adequately achieved with photon-based radiation therapy. Examples of such an advantage include, but are not limited to, the following:
1) The target volume is near one or more critical structures and a steep dose gradient outside the target must be achieved to avoid exceeding the tolerance dose to the critical structure(s), which 
would portend a higher risk of toxicity.
2) A proton-based technique would decrease the probability of clinically meaningful normal tissue toxicity by lowering an integral dose-based metric and/or organ at risk dose volume constraint associated with toxicity.
3) The same or an immediately adjacent area has been previously irradiated, and the dose distribution within the patient must be sculpted to avoid exceeding the cumulative tolerance dose of nearby normal tissue.

Based on the medical necessity requirements and published clinical data that meet the selection criteria above, disease sites that frequently support the use of proton beam therapy include the following:
Group 1 indication: GENERAL: Benign or malignant tumors or hematologic malignancies in children aged 21 years and younger treated with curative intent and occasionally palliative intent treatment of childhood tumors when at least one of the three criteria noted above under "indications for coverage" apply. Benign or malignant tumors or hematologic malignancies in the adolescent/young adult (AYA) population aged 22 years to 39 years treated with curative intent when at least one of the three criteria noted above apply.
This adult patient and the requested proton beam therapy for curative treatment of stage T2N0M0 (stage 2, no nodal involvement, no metastases) high grade synovial sarcoma is consistent with Group 1 indication of the 2022 ASTRO (American Society for Radiation Oncology) Model Policy on Proton Beam Therapy (PBT). Therefore, the requested proton beam therapy is medically necessary.