Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Angiosarcoma of the left breast. 
Treatment: Proton Beam Therapy. 

The insurer denied coverage for Proton Beam Therapy. 

The denial is overturned. 

The treating provider has diagnosed the patient with a history of angiosarcoma of the left breast, status post left total mastectomy (pT2 (pathologically organ-confined) with negative margins), anxiety, and depression. The patient is currently pregnant and is status post (s/p) doxorubicin chemotherapy. The patient is now referred for adjuvant radiation therapy for her breast cancer; the request is for Initial Phase: 25 fractions (treatment sessions) of proton beam therapy (PBT) and boost phase: five (5) fractions of PBT, which is under review. 

This is a young adult who is currently pregnant with angiosarcoma of the left breast s/p left mastectomy, pT2 with negative margins, s/p doxorubicin chemotherapy, and now is referred for adjuvant radiation therapy. There is literature and organizational support for the requested service(s). 

There are several reasons why proton therapy is clinically justified for the treatment of this patient: 

First, per NCCN (National Comprehensive Cancer Network) guidelines for soft tissue sarcoma (NCCN Guidelines Version 1.2023 Soft Tissue Sarcoma) state, "When external beam radiation therapy (EBRT) is used, sophisticated treatment planning with intensity-modulated radiation therapy (IMRT) and/or protons should be used to improve the therapeutic ratio." 

This is because successful treatment of a sarcoma requires high doses of radiation (60 Gy (gray) units), which is often limited by surrounding critical tissues (Kraybill et al 2010), such as heart and lung. 

The accepted practice is to limit the lung dose to less than (<)30% (percent), which was achieved with proton therapy (left lung 18.1%) vs. (versus) 32.2% with intensity-modulated radiation therapy (IMRT)/photons, and additionally the accepted mean heart dose (Dmean) is less than 7Gy which was achieved with proton therapy (0.5Gy) vs. 9.6 Gy with IMRT/photons. Clinical studies also associate increasing heart Dmean dose to increased risk of cardiac morbidity, particularly when the heart Dmean is greater than 3.3 Gy (Beaton et al 2019, Darby et al 2013). 

Second, per the American Society of Radiation Oncology (ASTRO) model policy for proton therapy would consider proton therapy to the breast/chest wall to be group 2 and states, "Radiation therapy for patients treated under the coverage with evidence development (CED) paradigm should be covered by the insurance carrier as long as the patient is enrolled in either an Institutional review boards (IRB)-approved clinical trial or in a multi-institutional patient registry adhering to Medicare requirements for CED." 

Further, being that the patient is a young adult with angiosarcoma, clinically she likely has an underlying cancer predisposition and therefore methods of radiation delivery that would minimize normal tissue exposure (such as proton therapy) would reduce the risk of a second malignancy. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Radiation Therapy for Breast Cancer; Description: Initial Phase: 25 fractions (treatment sessions) of Proton Beam Therapy. Boost Phase: 5 fractions of Proton Beam Therapy. Image Guided Radiation Therapy for initial and boost phase is substantiated.