Persius/hicric huggingface dataset:
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 11/27/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.  The physician reviewer found that the use of next generation sequencing or molecular profiling is recommended by the National Comprehensive Cancer Network guidelines for patients with endometrial cancer. To date, molecular analysis of endometrial carcinoma has identified four clinically significant molecular subgroups with differing clinical prognoses: POLE mutations, microsatellite instability-high (MSI-H), copy number low, and copy number high. Ancillary studies for POLE mutations, mismatch repair (MMR)/MSI, and aberrant p53 expression are encouraged to complement morphologic assessment of histologic tumor type. Molecular analysis can help classify difficult cases and provide future therapeutic targets. Molecular targets can help distinguish the patientas eligibility for immunotherapy. Next generation sequencing such as with FoundationOne CDx can help identify therapeutic options both on and off of clinical trials and is a standard of care for patients with advanced endometrial cancer. Therefore, FoundationOne CDx testing performed on 11/27/20 was likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 11/27/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.  The physician reviewer found that FoundationOne assay is one of many multi-genomic assays used in the hope of identifying a target at which a specific chemotherapeutic agent can be aimed. Thus far, there is a lack of convincing evidence that choosing an agent by such an assay is reliably beneficial or better than choosing an agent in more conventional ways. A randomized study by Le Tourneau failed to demonstrate benefit from such use of an assay-directed therapy. The percentage of patients who will benefit from such an approach appears to be quite small. One use of Foundation One assay is to identify tumors that are microsatellite unstable, and/or with high tumor mutational burden. Such tumors are sensitive to treatment with Keytruda. In this case, there was a previous FoundationOne assay in 2015 that indeed did identify the tumor cells as fitting into this category. There was no need to repeat the FoundationOne assay in 2020. Therefore, FoundationOne CDx testing performed on 11/27/20 was not likely to be more beneficial than other available standard therapy.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 


A 62-year-old male enrollee has requested has requested authorization and coverage for Sovaldi. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found that according to the joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. Re-treatment is supported by the presence of diabetes mellitus, which is associated with rapid progression of fibrosis per the guidelines. In patients who have failed an NS5A inhibitor such as Harvoni, testing for NS3 and NS5A resistance-associated variants is recommended. In patients with both NS3 and NS5A resistance-associated variants, retreatment is recommended with Sovaldi, Zepatier, and ribavirin for 12 weeks, based on a 100% cure rate in the C-SWIFT study using this regimen (Lawitz, et al). The guidelines cite data showing decreased survival with delay in therapy (Jezequel, et al). For these reasons, the requested treatment with Sovaldi, to be used with Zepatier and ribavirin for 12 weeks is medically necessary for the treatment of this patients hepatitis C infection. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

A 60-year-old female enrollee has requested reimbursement for laboratory testing performed on 7/29/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that molecular diagnostic studies in non-small cell lung cancer (NSCLC) are considered a standard of care. Numerous gene alterations have been identified that impact therapy selection. The National Comprehensive Cancer Network strongly advises broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with NSCLC. Testing of lung cancer specimens for these alterations is important for identification of potentially efficacious targeted therapies, as well as avoidance of therapies unlikely to provide clinical benefit. This patient has received two prior lines of therapy, limiting treatment choices. The use of next generation sequencing panels helps broaden the potential treatments available. Therefore, laboratory testing performed on 7/29/18 was medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 38-year-old female enrollee has requested authorization and coverage for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee. The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees osteochondral defect. The physician reviewer found the peer-reviewed literature demonstrates that autologous chondrocyte implantation of the talus yields improvement in all parameters tested with enduring long-term results in patients who have failed previous surgery for osteochondral lesions of the talus. In this case, the patient has undergone multiple surgeries on the cystic osteochondral lesion of the talus with persistent severe pain. Significant limitation is documented in activities of daily living, work activities, and recreational pursuits. Detailed evidence of long-term reasonable and/or comprehensive non-operative and operative treatment and failure has been submitted. There is imaging evidence of an osteochondral defect of the medial talar dome, measuring 9 x 9 x 8 mm. Autologous chondrocyte implantation of the talus is supported by a significant volume of literature for patients who have failed previous surgery for osteochondral lesions of the talus. Therefore, the request for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee, is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 38-year-old female enrollee has requested authorization and coverage for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee. The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees osteochondral defect. The physician reviewer found autologous Autologous chondrocyte implantation techniques require a two-stage procedure, the first for chondrocyte harvest and the second for implantation in a periosteum-covered or matrix-induced form after in vivo culture expansion. The transplantation of chondrocyte-like cells into the defect will result in hyaline-like repair tissue. The medical literature demonstrates that autologous chondrocyte implantation is usually successful in relieving pain in the presence of a large osteochondral defect with minimal degenerative change in the remaining joint. In this case, the patient presents with a large osteochondral lesion of the talus and has failed multiple surgical procedures with continuing pain. Based on the support in the peer-reviewed literature, the request for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

A 38-year-old female enrollee has requested authorization and coverage for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee. The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees osteochondral defect. The physician reviewer found the request for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Autologous chondrocyte implantation is a joint sparing/joint salvaging reconstructive procedure. The ankle joint is a complex joint with both dorsiflexion plantar flexion and rotational motion. Attempts to develop total ankle arthroplasty devices has been limited in meeting the design challenges posed by this joint. Kwak and colleagues reported on the long-term outcomes of patients who underwent autologous chondrocyte implantation of the talus after failed marrow stimulation techniques for osteochondral lesions of the talus. The authors concluded that autologous chondrocyte implantation of the talus yielded improvement in clinical parameters and was beneficial with enduring long term results in patients who had failed prior surgeries. Given the support in the peer-reviewed literature, the he requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1
A 61-year-old female enrollee has requested reimbursement for the molecular profiling lab testing performed on 1/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic carcinoma of unknown primary site. The physician reviewer found thatalthough it is important to determine the tissue of origin so that the proper therapy could be applied, in this case, there were numerous tests ordered piecemeal with no specific rationale. In retrospective studies, molecular profiling based on gene expression has been demonstrated to be highly accurate in determining the tissue of origin (Bender and Erlander). The Pathwork Tissue of Origin test is similar to the test provided in this case, but is strongly supported by a large multicenter clinical trial (Monzon, et al). All told, there was more conventional testing to adequately evaluate this patients CUP and the additional molecular profiling lab testing performed on 1/23/15 was not likely to be more beneficial for evaluation of the patients medical condition than any the available standard tests. Based upon the information set forth above, I have determined the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2
A 61-year-old female enrollee has requested reimbursement for the molecular profiling lab testing performed on 1/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic carcinoma of unknown primary site. The physician reviewer found that in the peer-reviewed medical literature, Weiss and colleagues noted that their study demonstrated a role for molecular studies in carcinoma of unknown primary, although the precise clinical indication requires further study. The current National Comprehensive Cancer Network (NCCN) guidelines state the clinical benefit of molecular assays remains to be determined. Finally, this patients records suggest the presence of a signet ring carcinoma of gastrointestinal origin, for which standard treatment is FOLFOX or FOLFIRI. Given these findings, the molecular profiling lab testing performed on 1/23/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 61-year-old female enrollee has requested reimbursement for the molecular profiling lab testing performed on 1/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic carcinoma of unknown primary site. The physician reviewer found that the determination of a patients primary site of an adenocarcinoma is of clinical importance in determining the most likely treatment to be efficacious. The use of genetic markers is likely to indicate the most likely primary site, and also to help guide treatment determinations (Weiss, et al; Hainsworth, et al). For these reasons, the molecular profiling lab testing performed on 1/23/15 was likely to be of greater clinical benefit than standard available testing. Based upon the information set forth above, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 47-year-old male enrollee has requested reimbursement for the Oncotype Dx Colon Cancer Assay provided on 2/14/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectosigmoid cancer. The physician reviewer found that in the peer-reviewed medical literature, there is adequate data demonstrating the benefit from adjuvant chemotherapy in patients with stage III colon cancer. However, it remains controversial whether adjuvant chemotherapy has a role in treating patients with stage II colon cancer. Currently, the decision to treat with adjuvant chemotherapy focuses on the specific features of the cancer such as high grade pathology, lymphovascular invasion, or the presence of obstruction or perforation. In this patients case, none of these features were present. The Oncotype DX Colon Cancer Assay is a 12-gene panel that aims to help predict the risk of recurrence in stage II patients and guide the need for adjuvant chemotherapy. However, there is a paucity of support in the clinical studies showing that use of the Oncotype DX results in superior health outcomes when compared to the standard of care. For these reasons, the Oncotype DX Colon Cancer Assay provided on 2/14/18 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 47-year-old male enrollee has requested reimbursement for the Oncotype Dx Colon Cancer Assay provided on 2/14/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectosigmoid cancer. The physician reviewer found that the Oncotype DX test uses a reverse transcriptase polymerase chain reaction assay for 12 genes in an algorithm that can be used to help predict recurrence (OConnell, et al; Gray, et al). Despite this support, it has not been established whether adjuvant chemotherapy can obviate recurrence risk. Overall, the current data does not support use of the Oncotype DX as a predictive marker for response to adjuvant treatment (Benson and Hamilton; Gray, et al). As such, the National Comprehensive Cancer Network (NCCN) guidelines state that there are insufficient data to recommend use of multi-gene assay panels to determine adjuvant therapy. All told, the Oncotype DX Colon Cancer Assay provided on 2/14/18 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 47-year-old male enrollee has requested reimbursement for the Oncotype Dx Colon Cancer Assay provided on 2/14/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectosigmoid cancer. The physician reviewer found that it has not been established in the medical literature whether molecular markers are useful in treatment decisions and prognosis in patients with colon cancer. While an assay may have the ability to help estimate a patients risk of recurrence, whether such increased risk can be overcome by adjuvant chemotherapy remains unclear. In addition, the National Comprehensive Cancer Network (NCCN) guidelines state that there are insufficient data to recommend the use of multi-gene assays, such as the Oncotype DX assay, to determine adjuvant therapy. Thus, the Oncotype DX Colon Cancer Assay provided on 2/14/18 was not likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 41-year-old male enrollee has requested authorization and coverage for a spine procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the Intracept procedure is a minimally invasive procedure of intraosseous basivertebral nerve ablation for treatment of chronic low back pain of vertebrogenic origin with Modic Type 1 or 2 vertebral endplate changes. Khalil and colleagues performed a randomized controlled trial comparing the effectiveness of radiofrequency ablation of the basivertebral nerve to standard care for the treatment of chronic low back pain. A total of 140 patients were involved in this study. The selection criteria included chronic low back pain for at least six months, and evidence of severe degenerative disc disease with Modic Type 1 or 2 endplate changes. Half the patients received the radiofrequency ablation of the basivertebral nerve and the other half received standard care. The minimally invasive radiofrequency ablation of the basivertebral nerve group showed significant improvement in pain and functional improvement at the three-month evaluation. This randomized controlled trial showed the safety and efficacy of the Intracept procedure for patients with vertebrogenic low back pain with Modic Type 1 and 2 endplate changes. This patient has vertebrogenic pain with Modic type 2 changes at L3-4 and L4-5. He has chronic low back pain over six months in duration with failed standard treatment. As such, he is a good candidate for the Intracept procedure. Therefore, the requested spine procedure is likely to be more beneficial for the treatment of the patientas medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 41-year-old male enrollee has requested authorization and coverage for a spine procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is evidence-based support for this procedure. In this case, the patient has chronic low back pain that has not responded to at least six months of conservative care. The patient has had multiple treatments, including lumbar epidural steroid injections, medial branch blocks, aquatic therapy, massage therapy, home exercise program, stretching, cryotherapy, transforaminal epidural steroid injection, chiropractic manipulation and medication management. There are also Type II Modic changes in the lumbar spine at the L3-4 and L4-5 levels. There is sufficient evidence-based support for the requested services. There has been sufficient, documented, detailed, comprehensive and reasonable treatment provided prior to this request. Therefore, the requested spine procedure is likely to be more beneficial for the treatment of the patientas medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

A 41-year-old male enrollee has requested authorization and coverage for a spine procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the medical literature supported the Intracept procedure in this setting. The current modalities for these patients is either fusion or artificial disc replacement. Intracept procedure offers a far less invasive outpatient procedure, avoiding either fusion and or artificial disc replacement, while maintaining the structural integrity of the spine. Based on evidence-based literature, patients have been shown to have significant improvements in pain following the Intracept procedure. Therefore, the requested spine procedure is likely to be more beneficial for the treatment of the patientas medical condition than any available standard therapy.