Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pancreatic cancer.
Treatment: Radiation therapy.
The insurer denied coverage for radiation therapy. 
The denial is overturned. 

This is a male patient who has a history of moderately differentiated pancreatic head adenocarcinoma. According to the patient's medical record, this patient has a diagnosis of a recurrent pancreatic carcinoma involving local disease recurrence primarily in the pancreatic bed/prior treatment field. The patient is to be considered for radiation treatment, including proton beam radiation therapy (PBRT). The patient's treating physician is considering delivery of an ablative dose to the tumor mass.  

As per literature review, proton radiation is generally accepted as medically necessary for the following conditions: (1) intracranial arteriovenous malformations (AVMs); (2) Ocular tumors, including intraocular/uveal melanoma (includes the iris, ciliary body and choroid); or (3) Skull-based tumors (e.g., chordomas or chondrosarcomas). Other clinical situations considered as group one, medically necessary include re-irradiation cancers where cumulative critical structure dose would exceed tolerance dose. The National Comprehensive Cancer Network (NCCN) Guidelines version 5.2020 for Biliary/Hepatic Cancers describes appropriate radiation techniques as intensity-modulated radiation therapy (IMRT) photons or other conformal techniques, including proton therapy. The guidelines indicate that for proton beam therapy achieving highly conformal dose distributions is especially important for patients whose tumors require highly conformal accuracy to spare normal critical structures/anatomy. The liver/biliary/pancreas share the same anatomical region/concerns thus the extrapolation of biliary issues for the biliary/pancreatic region. Proton beam therapy is also to be used to treat patients with the most challenging disease, for which other radiation therapy options are not felt to be safe. In this case, this patient falls into the aforementioned category. 

Regarding medical necessity, the proton therapy for group one tumors may be considered a standard of medical practice. It may be safe and effective and may be considered more effective than standard photon therapy for this patient's condition. The patient's treating physician has indicated that for a photon plan, they are concerned with tolerances of multiple structures, including the liver, small bowel, kidneys, stomach, and spinal cord.  The medical records submitted for review provide evidence that the proton plan can attain a dose to these organs within acceptable limits, better than the photon plan, while providing a significant dose to the tumor regions. This will reduce short term toxicity and reduce significant long-term side-effects. The proton plan is essentially the best modality that will allow this patient to be safely treated. It is an appropriate level of service that can be safely provided.  For these reasons, included from the clinical information provided, the NCCN and the America Society for Therapeutic Radiology & Oncology (ASTRO) guidelines, the proton beam therapy for this patient with a recurrent pancreatic adenocarcinoma, is considered medically necessary for this patient. 

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

The carrier's denial of coverage for radiation therapy for pancreatic cancer should be overturned. The medical necessity is substantiated.