Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Prostate Cancer
Treatment: 44 units Intensity Modulated Radiation Therapy (IMRT); 44 units Image-Guided Radiation Therapy (IGRT)
The insurer denied the 44 units Intensity Modulated Radiation Therapy (IMRT); 44 units Image-Guided Radiation Therapy (IGRT)
The denial is overturned.

The patient is a male with a diagnosis of unfavorable intermediate-risk prostate cancer. Gleason score of seven and prostate specific antigen (PSA) of 6.8.  Definitive therapy was recommended and a total of 44 fractions of intensity modulated radiation therapy (IMRT) / image-guided radiation therapy (IGRT) was requested.

The prior denial reason was that the hypofractionated regimen is medically necessary and that only 28 fractions of radiation treatment were authorized. The request is for 44 fractions of radiation and the reason for the appeal is that standard fractionation regimen for prostate cancer is considered one of the standard radiation regimens for prostate cancer.

Yes, the proposed 44 fractions of intensity modulated radiation therapy (IMRT) / image-guided radiation therapy (IGRT) are medically necessary.
There are several peer-review literatures that showed that intensity modulated radiation therapy (IMRT) is as effective, and safer compared to conventional conformal radiation therapy for the treatment of prostate cancer.  

In a study, a comparison was made for 1,100 patients with prostate cancer treated with three-dimensional (3-D) conformal or intensity modulated radiation therapy (IMRT).  The authors concluded that "treatment with IMRT ( intensity modulated radiation therapy) significantly decreased the incidence of late grade-2 rectal toxicity," and concluded that "IMRT ( intensity modulated radiation therapy)  is associated with minimal rectal and bladder toxicity, and, hence, represents the treatment delivery approach with the most favorable risk-to-benefit ratio."  

In terms of the fractionation regimen, according to the National Comprehensive Cancer Network (NCCN) Guideline, standard fractionation with a total of 37 to 45 fractions is considered one of the standard regimens for the definitive treatment of intermediate risk prostate cancer.

Image guided radiotherapy (IGRT) is a method of tumor localization during the delivery of radiation therapy.  This procedure is performed during the actual radiation therapy delivery session.  It is a technique used to compensate for the movement of the tumor and/or patient during radiation therapy.  It provides accurate and objective monitoring of the patient's alignment and motion as well as the tumor's position.  The information from image guided radiotherapy (IGRT) is used to adjust the patient's position for optimal radiation dosing to the target area while sparing adjacent healthy tissue or organs.  Image guided radiotherapy (IGRT) is typically used in patients with tumors located near or within critical structures and/or in tissues with setup variations.  Image guided radiotherapy (IGRT) is considered medically necessary per Medicare when intensity modulated radiation therapy (IMRT) is being utilized.  

The requested intensity modulated radiation therapy (IMRT) / image guided radiotherapy (IGRT) of 44 fractions, therefore, is medically necessary.

Standard fractionation of up to 45 fractions is considered the standard of care for the treatment of prostate cancer.  This dose regimen is supported by National Comprehensive Cancer Network (NCCN), the American Society for Clinical Oncology (ASCO) and the American Society for Radiation Oncology (ASTRO), and is currently one of the standard regimens.  The requested intensity modulated radiation therapy (IMRT) for 44 fractions, therefore, is medically necessary.