Persius/imr-appeals huggingface dataset:
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 53-year-old female enrollee has requested reimbursement for gene testing performed on 7/5/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees bilateral thyroid nodules. The physician reviewer found that the gene testing performed on 7/5/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. In this case, the patient presented with bilateral thyroid nodules. The dominant nodule on the lower right lobe measuring 1.6 cm in largest diameter showed suspicious features in the thyroid ultrasound. The cytopathology of the 1.6 cm thyroid nodule was consistent with follicular neoplasm. The other nodule showed benign cytopathology. The American Thyroid Associations guidelines state that for follicular neoplasm nodules, molecular testing may be used to supplement malignancy risk assessment data in lieu of proceeding directly with surgery. Informed patient preference and feasibility should be considered in clinical decision-making (Haugen, et al). If the genetic test is suspicious, the risk of malignancy increases to 40% (Haugen, et al; Alexander, et al). However, the risk of malignancy decreases to less than 6% with benign findings by genetic testing (Haugen, et al; Alexander, et al). The test is therefore beneficial for the medical decision making. In this case, the result of the gene expression classifier was suspicious for malignancy. This result was helpful to direct subsequent management and a hemithythyroidectomy was recommended. All told, genetic testing was appropriate, in line with current specialty standards and 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 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: Overturned

Summary Reviewer 1

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 per the National Comprehensive Cancer Network guidelines, aEarly referral for high-dose therapy with stem cell rescue is advisable for planning purposes.a Achievement of minimal residual disease (MRD) negativity is associated with improved clinical response. The amount of MRD also guides eligibility for autologous transplant and clinical trials. Multiple studies currently recruiting for mantle cell lymphoma require measurement of MRD to determine eligibility for enrollment. There is sufficient evidence for the services at issue in this clinical setting. Therefore, clonoSEQ assay test performed on 9/13/20 was 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 


The parent of a 17-year-old female enrollee has requested reimbursement for residential treatment center services provided from 10/16/15 through 5/31/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the RTC services provided from 10/16/15 through 5/31/16 was medically necessary for treatment of the patients medical condition. Based on the documentation provided for review, the stress of the patients family was continuing to trigger most of her symptoms, including depression, suicidal thoughts, disordered eating pattern and PTSD. It was an essential component of this patients therapy that she be removed from the home and provided a safe, structured and supportive environment 24-hours per day. Only by being removed from the home could she begin to work on her own issues in individual and group therapy. During this time, family therapy continued allowing her to very slowly develop a relationship with her parent, with whom she would live after discharge. Given the above, the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 48-year-old female has requested reimbursement for genotyping for CYP2D6 polymorphism performed on 7/10/14.  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 there is a lack of evidence supporting the services at issue in this clinical setting.  The National Comprehensive Cancer Network does not recommend routine testing for CYP2D6 genotype in women being considered for tamoxifen therapy.  This issue has been retrospectively examined in a postmenopausal population of women, in which investigators found no difference in outcome according to CYP2D6 genotype.  Moreover, the superior benefit of this screening in premenopausal women has not been established.   Per the medical evidence, the superior efficacy of genotyping for CYP2D6 polymorphism performed on 7/10/14 has not been demonstrated.  Based upon the information set forth above, 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: Overturned

Summary Reviewer 3

A 63-year-old male enrollee has requested reimbursement for the wearable cardioverter defibrillator provided on 11/5/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found that the wearable cardioverter defibrillator (LifeVest) was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In this case, the placement of a wearable cardioverter defibrillator was clinically indicated as the patient presented with underlying COPD and a new diagnosis of severe symptomatic congestive heart failure, and LV dysfunction. There is scientific literature of large case series, prospective registries, and from expert opinion supporting the services at issue. In this particular clinical situation, the patient had a severely depressed ejection fraction and needed further aggressive ongoing medical treatment of both congestive heart failure and COPD, which further delayed the planned cardiac mitral and aortic valve replacement surgery. All told, the wearable cardioverter defibrillator was indicated in this particular short-term clinical situation with support in the medical literature, until both the planned surgical and medical treatments for congestive heart failure could be optimized and the LV function could be reassessed. Based upon the information set forth above, the services at issue were 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: Overturned

Summary Reviewer 1

A 59-year-old female enrollee has requested reimbursement for the Veracyte Afirma genetic testing provided on 12/3/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule.  The physician reviewer found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Miller, et al). A newer test, the Afirma Thyroid FNA Analysis from Veracyte utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures (Duick, et al). Based on these findings, the Veracyte Afirma genetic testing performed on 12/3/14 was 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 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 1

The parent of a four-year-old male enrollee has requested reimbursement for the polymerase chain reaction (PCR) testing and homocysteine testing performed on 6/4/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk for methylenetetrahydrofolate (MTHFR), Factor V Leiden, and homocysteine mutations. The physician reviewer found that in the evaluation of thrombophilia, providers frequently conduct MTHFR polymorphism testing, as it has been hypothesized that reduced enzyme activity of MTHFR leads to hyperhomocysteinemia which results in an increased risk for venous thromboembolism, coronary heart disease, and recurrent pregnancy loss. According to the American College of Medical Genetics and Genomics, recent meta-analyses have disproven an association between hyperhomocysteinemia and risk for coronary heart disease and between MTHFR polymorphism status and risk for venous thromboembolism (Hickey, et al). These findings have led the American College of Medical Genetics and Genomics to state that there is growing evidence that MTHFR polymorphism testing has minimal clinical utility and, therefore should not be ordered as a part of a routine evaluation for thrombophilia (Hickey, et al). For these reasons, the American Congress of Obstetricians and Gynecologists does not recommend the measurement of homocysteine or MTHFR polymorphisms in the evaluation of the etiology of venous thromboembolism (Lockwood, et al). In this case, the mother of the patient was found to have a homozygous A1298C mutation in MTHFR. However, it does not appear that this finding alone accounts for mothers recurrent deep venous thromboses during pregnancy. Moreover, the testing performed in this patient is not supported in the current peer-reviewed medical literature. All told, the PCR testing and homocysteine testing performed on 6/4/16 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: Upheld

Summary Reviewer 1

A 52-year-old male enrollee has requested reimbursement for optical endomicroscopy performed on 5/30/18. 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 Confocal laser endomicroscopy (CLE) is based upon the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. The laser is focused at a specific depth, and only light reflected back from that plane is refocused and able to pass through the pinhole confocal aperture. As a result, scattered light from above and below the plane of interest is not detected, increasing spacial resolution. The area being examined is scanned in the horizontal and vertical planes, and an image is reconstructed. In this manner, microscopic imaging of biological tissue in vivo is possible due to the high lateral resolution of confocal imaging. Since CLE relies upon tissue fluorescence, intravenous and/or topically applied contrast agents are required. The current medical evidence has not demonstrated the superior efficacy of the services at issue in this clinical setting. At this time, the standard of care is to base management decisions on actual biopsy specimens. Therefore, optical endomicroscopy performed on 5/30/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. 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 this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha.  The data on the DecisionDx-Melanoma assay has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. In sum, DecisionDx-Melanoma assay provided on 3/21/18 was not 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 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: Overturned

Summary Reviewer 2

A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 6/01/15.  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 in this patients case, the services at issue were likely to have been more effective than other available modalities.  The addition of the technique has gained worldwide popularity among radiologists due to an associated decrease in callbacks and increase in detection of small cancers.  Tomosynthesis helps in the elimination of confusing overlapping glandular tissue particularly in dense and heterogeneously dense breast tissue, which in turn allows for a more definitive assessment of the breast parenchyma.  Thus, digital breast tomosynthesis performed on 6/01/15 was likely to have been more beneficial 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: Experimental
Decision: Upheld

Summary Reviewer 2

A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the services at issue. The treatment of this patient would not change based on the results of this testing. There is a lack of scientific evidence permitting conclusions concerning the effect of this test on health outcomes. The test is not considered routine standard of care. There is a paucity of published data to support its routine use currently. At this time, there is a need for clinical trials to determine the utility of the results of the test to effect health outcomes. In sum, DecisionDx-Melanoma testing performed on 2/20/18 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, 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: Upheld

Summary Reviewer 1

A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees autoimmune hearing loss. The physician reviewer found that autoimmune inner ear disease is sensorineural hearing loss, caused by an abnormal immune system response. The clinical expression of immune-mediated inner ear disease typically benefits from steroid and immunosuppressive therapy. There are no standardized diagnostic criteria or reliable diagnostic tests for the diagnosis of autoimmune inner ear disease. The diagnosis is based on exclusion. The safety and efficacy of intratympanically injected golimumab for patients with autoimmune inner ear disease was evaluated by Derebery and colleagues. While the study was limited, there were no serious adverse events. There is support for the medication at issue for the treatment of this patient who is no longer responsive to Imuran, Atabrine, or azulfidine. Thus, J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward was and is likely to be more efficacious than other treatment options. Based upon the information set forth above, the medication at issue was and 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.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 44-year-old female enrollee has requested reimbursement for BRCA testing performed on 3/17/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk of cancer.  The physician reviewer found that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Screening patients with no personal history of breast cancer is indicated when an individual has a family history of one or more of the following: a blood relative with a known mutation in a gene that increases cancer risk, a blood relative with two or more primary breast cancers, two or more relatives with breast cancer on the same side of the family with at least one diagnosed before age 50, a blood relative with ovarian cancer, a close blood relative with breast cancer before age 45, a blood relative with male breast cancer or anyone of Ashkenazi Jewish ancestry with breast, ovarian, or pancreatic cancer at any age. The patient does not meet criteria for the BRCA testing performed on 3/17/16. 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: Overturned

Summary Reviewer 1

A 59-year-old female enrollee has requested reimbursement for HCMNext Reflex-Ambry genetic test performed on 10/2/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollee, who has a history of hypertrophic cardiomyopathy. The physician reviewer found that based on the records provided the patient has been diagnosed with hypertrophic cardiomyopathy by echocardiography. The patient also has a 22-year-old son.  In this circumstance, the use of genetic testing in the proband (patient) is supported in the medical literature in order to determine the presence of any gene defect that may be then tested for in the son and other family members who may be at risk.  If a gene mutation known to cause hypertrophic cardiomyopathy is identified in the proband, then this can be used as definitive screening of family members without the need for serial testing with less accurate imaging tests such as serial echocardiography or cardiac magnetic resonance imaging. Current guidelines recommend genetic screening of a proband with hypertrophic cardiomyopathy. As such, HCMNext Reflex-Ambry Genetics test on 10/2/17 was likely to have been more beneficial than the standard options available for evaluating this patient.

Based upon the information set forth above, the testing at issue was 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: Overturned

Summary Reviewer 3

A 66-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 8/10/17.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung adenocarcinoma. The physician reviewer found that the therapy of advanced non-small cell lung cancer has been revolutionized by the finding of epidermal growth factor receptor (EGFR) mutations in certain adenocarcinomas. The mutations are more common in those who have never smoked.  Even if stage IV disease is present, therapy targeted to EGFR with erlotinib results in prolonged survival when compared with standard chemotherapy regimens. The mutational landscape of non-small cell lung cancer has significantly expanded in the past two to three years to encompass gain of function in multiple oncogenes with major prognostic and therapeutic consequences. Patients on targeted therapy may develop resistance to erlotinib, and this may be appreciated at the genetic level by recognition of new mutations or amplifications in parallel signal transduction pathways. The Guardant360 test is a liquid biopsy that analyzes patient plasma for mutations in a panel of 70 genes. Von Hoff and colleagues performed a clinical study directly comparing the use of targeted agents with conventional chemotherapy approaches. The study involved 86 patients, and the progression-free survival on regimen selected by molecular profiling was compared to the progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. This trial has significant results for patients with stage IV tumors. In this patients case, the results from molecular profiling may offer a rational selection of the next regimen. Thus, Guardant360 testing performed on 8/10/17 was likely to have been superior over 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.