Persius/imr-appeals huggingface dataset:
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 44-year-old male enrollee has requested reimbursement for DecisionDX-Melanoma assay rendered on 2/1/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees malignant melanoma. The physician reviewer found that the medical research indicates that melanoma is a cancer that is curable in its earliest stages. There is very little data on the DecisionDX test for melanoma. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision but they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. Castle Biosciences which developed and markets the test states that it has been validated prospectively. These data are not published and not available for review. As such, this test is very novel and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. This was also the consensus opinion of the National Comprehensive Cancer Network guidelines. In sum, DecisionDX-Melanoma assay rendered on 2/1/16 was not medically necessary for the evaluation of this patients cancer. Therefore, based on the stated reasons above, the services at issue were not medically necessary for evaluation of the patient. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 67-year-old male enrollee has requested reimbursement for clonoSEQ assay test performed on 9/13/20. 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 current medical evidence has not established the superior efficacy of the services at issue. The assay has been shown to be useful in determining MRD in several types of hematologic malignancies. However, it has not been shown to be clinically beneficial in decision making for mantle cell lymphoma. The oncologist who saw him in September 2020 commented on a clinical trial looking at whether clonoSEQ would be useful in this situation, but there is no clear data yet as to its usefulness. Therefore, clonoSEQ assay test performed on 9/13/20 was not likely to have been more beneficial for the evaluation of the patient than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 57-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1b.  The physician reviewer found that according to the most recent 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, regardless of fibrosis, should be treated except those with life expectancy less than 12 months due to non-liver-related comorbid conditions. Patients who have failed treatment with peginterferon and ribavirin are recommended to be re-treated with daily Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). This patient should not be considered a failure of Sovaldi/ribavirin as he did not complete that therapy. Further, resistance to the medication due to prior use is not a concern. In the COSMOS trial, sofosbuvir resistance was not observed (Lawitz, et al). Based on published evidence of safety and efficacy in the published literature, and clinical guidelines, the requested treatment with Harvoni for 12 weeks is supported as medically necessary for treatment of this patients hepatitis C virus infection. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
A 74-year-old male enrollee has requested reimbursement for laboratory testing provided on 
10/12/20. The Health Insurer has denied this request and reported that the services at issue 
were investigational for the evaluation of the enrollees medical condition. The physician 
reviewer found that local treatment for primary uveal melanoma is effective in preventing local 
recurrence in over 95 percent of cases, yet up to 50 percent of patients are at risk for 
metastatic disease. The high risk of metastatic disease is thought to be due to a propensity for 
early micrometastasis followed by a variable latency period prior to the emergence of overt 
metastatic disease. Gene expression profiling (GEP) has been shown to be superior to 
chromosomal markers, as well as clinical and histopathological prognostic factors, for defining 
groups at high risk for the development of metastatic disease. Using primary uveal melanoma 
samples obtained by fine needle biopsy, GEP classifies tumors as having low (class 1) or high 
(class 2) metastatic potential depending on the expression of 12 discriminating genes and three 
control genes. This profile test has been validated a prospective multicenter study and is a 
standard of care and now recommended by the National Comprehensive Cancer Network 
guidelines. Therefore, laboratory testing provided on 10/12/20 was likely to have been more 
beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 41-year-old female enrollee has requested reimbursement for a dopamine transporter single-photon emission computed tomography (DAT-SPECT) scan performed on 9/17/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of tremor. The physician reviewer found that the current medical evidence supports the services at issue in this clinical setting.  The patient presented with tremor and posture elements that raised question of a movement disorder condition.  There is sufficient support for DAT-SPECT scan in this case, as it could help confirm a diagnosis and provide treatment guidance given the clinical diagnosis was not clear regarding the type of movement disorder.  Thus, DAT-SPECT scan performed on 9/17/15 was likely to have been of greater benefit than other methods of evaluating this patient.  Based upon the information set forth above, 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: Upheld

Summary Reviewer 3


A 45-year-old male enrollee has requested authorization and coverage for hybrid artificial disc replacement at L4-5 and fusion at L5-S1 (CPT codes 22558, 22851, 22585, 22845, 20930, 63090, 63091 and 77003). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. The physician reviewer found the request for hybrid artificial disc replacement at L4-5 and fusion at L5-S1 (CPT codes 22558, 22851, 22585, 22845, 20930, 63090, 63091 and 77003) are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. According to the North American Spine Society guidelines, lumbar artificial disc replacement is indicated as an alternative to lumbar fusion for patients with discogenic low back pain with advanced single level disease. In this case, the patient has multi-level degenerative disc disease confirmed on imaging. As such, the requested services have not been established as 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 not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 52-year-old female enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there are insufficient high quality clinical outcomes reported to allow one to make definitive conclusions regarding the relative safety and efficacy of proton beam radiation for the management of this patients esophageal cancer, as compared to standard of care photon-based radiotherapy.  The American Society for Radiation Oncology (ASTRO) Model Policy for proton radiation does not support its use for thoracic malignancies (including esophageal cancer) outside the setting of a clinical trial. Proton beam radiation has the potential to reduce lower dose radiation exposure to surrounding normal tissues, but it remains to be seen as to whether such reduction in low dose is associated with clinically meaningful improvements in outcomes. Therefore, proton beam therapy is not likely to be more beneficial than other available treatment options.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 1/26/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this patients case.  According to Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues noted integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls.  In sum, breast tomosynthesis performed on 1/26/16 was likely to have been of greater benefit than other methods of evaluation.  Based upon the information set forth above, 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: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 29-year-old female enrollee has requested reimbursement and prospective authorization and coverage for eating disorder residential treatment center services provided from 4/09/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based, objective instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. In terms of risk of harm, the records support a score of 1 due to a lack of current suicidal ideation. With regards to functional status, the records support a score of 2 due to some difficulty meeting obligations but overall ability to maintain meaningful relationships. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 2 due to stable medical issues and no substance use. With regards to level of stress of the recovery environment, the records support a score of 2 due to some performance pressure at work and leave from work. In terms of level of support of the recovery environment, the records support a score of 2 due to positive relationship with family but some struggles with her relationship with her mother. With regards to treatment and recovery history, the records support a score of 3 due to successful recent residential treatment with significant weight gain but incomplete resolution of eating disorder symptoms. In terms of engagement and recovery status, the records support a score of 2 due to good cooperation in treatment and insight into the need for treatment. Thus, the patient has a composite score of 14. This score of correlates with a high intensity community-based services. Therefore, eating disorder residential treatment center services provided from 4/09/19 forward were not and are not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 52-year-old female enrollee has requested reimbursement for the risk of ovarian malignancy algorithm (ROMA) test provided on 6/22/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees irregular menstrual bleeding and ovarian cyst. The physician reviewer found that ovarian cancer screening includes evaluation of symptomatology, ultrasound and tumor marker levels to assess an individual patients risk. CA-125 is the gold standard tumor marker. Although new tests have been developed to predict a patients risk, the data is conflicting. Emerging literature recommends the ROMA test as a useful component in evaluating patients with ovarian/adnexal masses. The ROMA test is especially useful for its negative predictive value. Moore and colleagues noted that the ROMA test detected 94% of the women with an invasive epithelial ovarian cancer and 85% of the women with early-stage epithelial ovarian cancer in the initial validation trial. For this patient, a CA-125 of 36 in a perimenopausal female would likely be considered negative by most providers. However, the provider recommended a ROMA test for confirmation. In this clinical setting, repeating the CA-125 level alone without the addition of the HE-4 would have been sufficient to determine whether the patient was at an elevated risk for ovarian cancer. Thus, the ROMA test provided on 6/22/15 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, 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: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 44-year-old male enrollee has requested authorization and coverage MRI of the left shoulder. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that according to the American College of Radiology, the initial appropriate imaging study in the evaluation of atraumatic shoulder pain is radiography. Radiographs can evaluate for the presence of unsuspected fracture or dislocation, osteoarthritis or calcific tendinitis, among other pathology. If radiographs are negative or inconclusive, and rotator cuff pathology is suspected, then shoulder MRI is generally appropriate. MRI can accurately demonstrate rotator cuff tendinosis or full thickness tear as well as labral pathology. MRI can also aid in the diagnosis of extra-articular osseous or soft tissue findings that may contribute to shoulder impingement symptomatology. In this case, the patient had radiographs, which were negative, followed by physical therapy. His pain has persisted. His provider suspects rotator cuff pathology. The medical evidence supports the requested services in this clinical setting. Therefore, MRI of the left shoulder is medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 49-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma assay provided on 2/14/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that melanoma staging is characterized by the American Joint Committee on Cancer (AJCC) system that defines cutaneous melanoma stages 0-IV. While the majority of clinical stage I patients will be disease-free at five years, some stage I patients will develop advanced disease. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin examinations and clinical examination. In contrast, patients diagnosed with stage III melanoma receive complete lymph node dissection, active surveillance measures and often, referral to medical oncology for adjuvant medical therapy and clinical trial participation. DecisionDx-Melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as Class 1 consistent with a low risk of metastasis or Class 2 suggestive of a high risk of metastasis. One peer-reviewed publication indicated that there was a statistically significant association of a Class 1 signature by DecisionDx-Melanoma assay for primary dermal melanoma (PDM), whereas cutaneous metastatic melanoma (CMM) were more frequently Class 2 (Sidiropoulos, et al). The authors concluded that the melanoma prognostic assay may be a useful tool for distinguishing PDM from CMM. According to the results of analysis of this patients melanoma performed with DecisionDx-Melanoma assay, the tumor was classified as Class 1 with a low risk of near-term (within five years) metastatic disease. Therefore, DecisionDx-Melanoma signature may be an independent predictor of metastasis risk. However, there is a lack of peer-reviewed published studies confirming this hypothesis. Accordingly, the DecisionDx-Melanoma assay performed on 2/14/17 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: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 30-year-old female enrollee has requested authorization and coverage for Ocrevus injection, 300/10 mL. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees multiple sclerosis. The physician reviewer found that the submitted records fail to demonstrate the medical necessity of the requested medication.  The records document that the patient is unable to tolerate Copaxone. Based on this patients side effect profile to Copaxone, Glatopa will cause similar side effect issues. The study by Kappos and colleagues compared Rebif to Ocrevus and demonstrated a relative reduction in new enhancing lesions achieved by Ocrevus.  However, there is no evidence of superiority of Ocrevus compared to the Health Insurers alternative Gilenya in comparative studies. Since the proposed treatment has not been demonstrated to be superior to all of the offered preferred agents, the medical necessity of the requested medication has not been established. All told, Ocrevus injection, 300/10 mL is not medically necessary for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 39-year-old male enrollee has requested authorization and coverage for Stelara (ustekinumab). The Health Insurer has denied this request indicating that the requested medication is investigational for treatment of the enrollees medical condition. The physician reviewer found that the advent of anti-tumor necrosis factor (TNF) therapy has been a major advance in the medical management of Crohns disease. However, a significant proportion of patients with Crohns disease do not respond adequately to treatment with these agents. Primary and secondary nonresponse to anti-TNF therapy represents a common clinical challenge, and highlights the need for the development of additional medication options for Crohns disease.  Ustekinumab is a fully human immunoglobulin G1 monoclonal antibody, which blocks activity of IL-12 and IL-23 through binding the p40 subunit. Relative to the use of ustekinumab in Crohns disease, Sandborn and colleagues demonstrated in a randomized, placebo-controlled study of 526 subjects that Patients with moderate-to-severe Crohns disease that was resistant to TNF antagonists had an increased rate of response to induction with ustekinumab, as compared with placebo. Patients with an initial response to ustekinumab had significantly increased rates of response and remission with ustekinumab as maintenance therapy. Furthermore, Kopylov and colleagues cohort of 38 patients with severe anti-TNF resistant Crohns disease, an initial clinical response to subcutaneous ustekinumab was observed in 73.7% of the patients. In addition, the initial response was successfully maintained in the majority of patients for up to 12 months. Finally, Stelara was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in 2009, and later approved for the treatment of active psoriatic arthritis in 2013. The drug holds considerable promise in non-pregnant Crohns disease patients, and appears to be one of the remaining few treatment options available to the patient at this time. Given the above, Stelara is likely to be more beneficial for treatment of the patients Crohns disease than available standard therapy. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.