Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Metastatic cholangiocarcinoma; intrahepatic bile duct stage IV (intravenous), gallbladder stage IV (4)

Treatment radiation therapy for bile duct cancer: Phase 1: 25 fractions of proton beam therapy (PBT), Phase 2: 8 fractions of proton beam therapy; image-guided radiation therapy (IGRT)

The insurer denied coverage for radiation therapy for bile duct cancer: Phase 1: 25 fractions of proton beam therapy (PBT), Phase 2: 8 fractions of proton beam therapy; image-guided radiation therapy (IGRT).

The denial is overturned.

This patient has been diagnosed with metastatic cholangiocarcinoma; intrahepatic bile duct stage IV, gallbladder stage IV with prior treatment to include chemotherapy.  She has been recommended to be treated with proton beam therapy to avoid damaging her kidneys, spinal cord, remaining healthy liver, and bowel.  The documentation indicated she was initially diagnosed with direct extension into the liver.  Portal/peripancreatic metastatic nodal disease with metastasis to pancreas.  She has complaints of abdominal pain which has progressively worsened and was seen recently for evaluation regarding radiation therapy. It has been recommended that she be treated with proton beam therapy.

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). All other clinical situations are generally either medically unnecessary or investigational. National Comprehensive Cancer Network (NCCN) Guidelines version 5.2021 for Hepatobiliary Cancers describes appropriate postoperative radiation as intensity modulated radiation therapy (IMRT) photons or other conformal techniques, including proton therapy. This update indicates that for proton beam therapy achieving highly conformal dose distributions is especially important for patients whose primary tumors cannot be adequately treated with 3D (three-dimensional), IMRT or stereotactic body radiation therapy (SBRT) photon plans for good performance patients. Proton beam therapy is to be used to treat patients with the most challenging disease, for which other radiation therapy (RT) options are not felt to be safe to provide reasonable benefit. The guidelines further indicate that there are a few randomized and single institution reports and systemic comparisons demonstrating safety and efficacy of proton beam therapy in the above-mentioned specific clinical scenarios. This patient falls into the category described above. She has disease, located in a specific anatomical area such as an area surrounded by tissues with low radiation tolerances that requires extremely specific and conformal dosing. 

With a comparison IMRT vs Proton plan showing specific tissue constraints where the photon plan fails to protect normal tissue and the proton plan does meet the constraints provided, then a comparison can be done, and it is reasonable and necessary to allow the use of protons. The information and material provided are specific enough to make a comparison. With this comparison, protons are shown to be an appropriate level of service that can be safely provided, better than a photon plan for protecting critical structures. For these reasons, included from the clinical information provided, the NCCN and American Society for Radiation Oncology (ASTRO) guidelines, proton beam therapy, for this patient with an advanced cholangiocarcinoma with an indication for post-operative radiation, treatment of her current disease is shown to be medical necessary.

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

The insurer's denial of coverage for radiation therapy for bile duct cancer: Phase 1: 25 fractions of proton beam therapy (PBT), Phase 2: 8 fractions of proton beam therapy; image-guided radiation therapy (IGRT) is overturned. Medical Necessity is substantiated.