Anal Rectal 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 positron emission tomography with computed tomography (PET/CT). According to the American College of Radiology (ACR) recommendations, there is a specific role for PET/CT in the restaging of patients with colorectal cancer. Per the ACR guidelines, PET/CT can demonstrate functional uptake at an early stage when morphologic changes have not yet occurred, and these uptake values can help determine a patient’s response to treatment. In this case, the results of the PET/CT are likely to establish an indication for additional resection of metastases versus ablation with proton therapy, or by interventional radiology.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for Erbitux (cetuximab) 800 mg infusions every 14 days. The records document that this patient presents with metastatic poorly differentiated squamous cell anal carcinoma status post 5FU with mitomycin, radiation therapy, carboplatin with paclitaxel, and an anti-CTLA and anti-PD2 monoclonal antibody. The provider reports that the patient demonstrated progression on these therapeutic regimens. Treatment with FOLFIRI with Erbitux has yielded a significant response with an interval decrease in the size of multiple hepatic masses compatible with improving hepatic metastatic disease. Erbitux is an anti-EGFR antibody that has been found to be beneficial in certain cancers.

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.

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 anal rectal, then check the rights and deadlines that apply to your plan.