Rectal Cancer denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement for proton beam radiation therapy. The utilization of proton beam therapy in rectal cancer is an area of debate. Proton beam radiation therapy has unique properties compared to standard photon or X-ray beam radiation therapies in its ability to deposit radiation dose. Oftentimes, fewer proton beams can be used to achieve a dose distribution similar to that of standard photon beams. This potentially results in fewer areas of scattered low radiation dose. The primary organs at risk in treating the rectum are the adjacent normal bowel tissue, the nearby bladder, and genitalia. The rate of radiation-induced toxicity to the bowel and bladder is correlated with the amount of radiation exposure to these organs. There is maturing data showing improved normal tissue sparing with proton beam therapy.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for intensity modulated radiation therapy (IMRT). IMRT is frequently utilized to treat certain body sites when normal tissue dose constraints cannot be met by other radiation techniques. IMRT is also utilized if patient anatomy makes it difficult to safely treat using 3D conformal radiation technique (3D-CRT). When treating the rectum, the nearby critical organs that need to be monitored are the bowel, bladder, and anal verge. IMRT is very frequently utilized to treat the region of the pelvis to improve dose sparing given the very close proximity of critical organs in that region. IMRT is currently utilized and strongly indicated in settings where severe toxicities would result if normal tissue constraints cannot be met by photon beam.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested reimbursement and prospective authorization and coverage for chemotherapy regimen consisting of Opdivo administered every three weeks in combination with Yervoy administered every six weeks for a total of four cycles.For the neoadjuvant treatment of a clinical T3N0 rectal cancer that is microsatellite stable (MSS) and tumor mutational burden (TMB) low, the combination of Opdivo and Yervoy is not supported by the current medical literature and guidelines. The National Comprehensive Cancer Network (NCCN) Guidelines reserve this combination for deficient mismatch repair (MMR)/microsatellite instability-high (MSI-H) or POLE/POLD1 mutation with ultra-hypermutated phenotype, consistent with a TMB greater than 50.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for proton beam radiation therapy. Proton therapy is a highly targeted form of radiation treatment that has been shown to be effective in treating certain types of cancer, such as pediatric brain tumors. However, there is a paucity of data in the peer-reviewed medical literature supporting an indication for proton beam radiation therapy instead of photon beam radiation in the treatment of patients with rectal cancer. Per the National Comprehensive Cancer Network (NCCN) guidelines, photon beam radiation is the recommended approach for radiation therapy in the management of patients with rectal cancer. Furthermore, there is a paucity of published randomized phase 3 studies that support the use of proton beam radiation for patients with rectal cancer.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving rectal cancer, then check the rights and deadlines that apply to your plan.