Appeal type: Medical necessity
Decision: Overturned

Diagnosis: left breast tumor.

Treatment proton radiation therapy (PBT, left breast, 25 fractions).

The insurer denied coverage for proton radiation therapy (PBT, left breast, 25 fractions).

The denial is overturned.

This is the case of a female patient diagnosed with left breast tumor 2/3 (T2/T3 [size of tumor]) node (N) 1 invasive ductal carcinoma (IDC). The patient was in the office for an evaluation of newly diagnosed left breast cancer. The patient was due to finish chemotherapy and presented for surgical evaluation. The patient was estrogen receptor (ER) negative and progesterone receptor (PR) negative. She was also human epidermal growth factor receptor 2 (HER2) negative. The provider and the patient discussed the treatment of triple negative breast cancers (TNBCs). The mass was no longer palpable and therefore the provider opined the patient had an excellent clinical response by imaging as well and would be an appropriate candidate for breast conservation given her negative genetic testing. The patient had questions about proton radiation therapy and was to undergo a consultation. The patient signed a consent form to be part of a research study. The request was received for proton beam radiation therapy (PBRT).

The National Comprehensive Cancer Network (NCCN) Guideline's for Breast Cancer describes appropriate postoperative radiation as intensity-modulated radiation therapy (IMRT) photons or other conformal techniques, including proton therapy. 

The American Society for Radiation Oncology (ASTRO) Report on Emerging Technologies indicates the proton beam therapy for breast cancer, while not necessarily a standard of care currently, may be considered in appropriate situations. The 2017, June update indicates that for sites other than those listed above, there is a continued need for clinical evidence development and comparative effective analysis for appropriate use of proton beam therapy for these various disease sites. This update also indicates that proton beam would be considered necessary in situations where proton beam therapy does offer a clinical advantage over that of well-planned photon-based therapy. A Group 1 indication is listed as cases where re-irradiation with photons will have cumulative critical structure dose exceed tolerance dose. 

The photon plan comparison does show that the photon plan is unacceptable. The tolerances for the organs listed, including lung and heart are shown to be exceeded. The proton plan will be the better modality that will allow this patient to be safely treated. The patient is young and has a significant life expectancy, so minimizing dose to surrounding tissues is critically important. The photon plan is shown to be unacceptable. It is not an appropriate level of service that can be safely provided, compared to protons.  For their complexity, protons are shown to add a clinically significant benefit over photons for this patient. For these reason, included from the clinical information provided, the NCCN and ASTRO guidelines, given that the patient can be better treated with a proton plan that will reduce normal tissue dosing, proton beam therapy for this patient with breast cancer, a treatment plan utilizing proton therapy is medically necessary.

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

The proton radiation therapy (proton beam therapy, left breast, 25 fractions) is considered medically necessary for this patient.

The insurer's denial of coverage for proton radiation therapy (proton beam therapy, left breast, 25 fractions) is reversed. Medical necessity is substantiated.