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

Summary Reviewer 1

An 81-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/27/18. 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 prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic count may add to these statistics. DecisionDx-Melanoma testing is a 31-gene assay of an individuals melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami and colleagues reported on 217 cases with good correlation between prognosis and DecisionDx-Melanoma class, in patients undergoing sentinel node sampling. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear if the assay can be used to make clinical decisions. Therefore, DecisionDx-Melanoma testing performed on 2/27/18 was not likely to have been superior over 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 3

A 32-year-old female enrollee has requested reimbursement for the Prometheus Anser ADA testing performed on 4/10/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that the Prometheus Anser ADA test is a quantitative measurement of serum adalimumab (ADA) and anti-ADA antibodies. Some evidence exists that low serum levels of adalimumab and/or the presence of antibodies to adalimumab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. However, in a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. Moreover, the reasons for therapeutic failures remain unclear. While there have been testimonials, there are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment (Steenholdt, et al; Nanda, et al). Accordingly, the Prometheus Anser ADA testing performed on 4/10/16 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: Medical Necessity
Decision: Overturned

Summary Reviewer 


An 86-year-old male enrollee has requested authorization and coverage for Sovaldi and Daklinza. The Health Insurer has denied this request indicating that the requested medications are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that according to 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. The guidelines state that patients with cirrhosis are high priority for treatment. According to the guidelines, this patient is interferon-ineligible due to thrombocytopenia. The guidelines recommend that cirrhotic treatment-naive patients with genotype 3 hepatitis C should be treated with Sovaldi and Daklinza (with or without ribavirin) for 24 weeks. This is based partially on the results of the ALLY-3 study, which demonstrated poor cure rates (only 58%) after 12 weeks of therapy (Nelson, et al). For patients with renal failure, the guidelines cite data showing that daclatasvir is an appropriate medication due to lack of substantial renal excretion (Nelson, et al). Data supporting the safety and efficacy of full-dose (400 mg) daily sofosbuvir in end-stage renal disease or hemodialysis with genotype 1a hepatitis C has been published (Nazario, et al). In addition, the guidelines cite study data reporting that delay in treatment may result in decreased survival (Jezequel, et al). For these reasons, the requested treatment with Daklinza and Sovaldi is medically necessary for the treatment of this patients hepatitis C infection. Therefore, the requested medications are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/06/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities.  This has been shown to be most useful in the evaluation of dense breasts.  In this patients case, her breasts were described as dense.  It is specifically those patients who have dense breasts that can benefit most from breast tomosynthesis.  The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor.  Thus, digital breast tomosynthesis performed on 7/06/16 was likely to have been more efficacious than other methods of evaluating this patient.  Based upon the information set forth above, the service 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: Upheld

Summary Reviewer 2

A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen. 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 this patient has an early stage melanoma. The National Comprehensive Cancer Network guidelines do not support the services at issue in this clinical setting, as routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical trial. The medical evidence does not support the services at issue in this clinical setting. In sum, DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen was not likely to have been of greater benefit than other available modalities for 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 1

A 61-year-old male enrollee has requested authorization and coverage for Tykerb. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested medication in this patients case. In the setting of metastatic breast cancer to brain, there has been interest in using Tykerb because of its purported better entry into the central nervous system. In the setting of breast cancer, there may be some advantage with combining Tykerb with chemotherapy such as Xeloda. However, the benefit of Tykerb alone is not established. Additionally, one cannot necessarily analogize treatment of salivary gland cancer with that of breast cancer. Therefore, Tykerb is not likely to be more efficacious than other available treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3
A 58-year-old male has requested authorization and coverage for proton beam therapy (77499). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees right tonsillar cancer. The physician reviewer found that currently, there is a lack of clinical data in the medical literature to suggest that treatment with proton beam therapy offers a clinical benefit compared to conventional radiation therapy techniques for tumors of the head and neck area. In the majority of cases, the standard approach to treat this malignancy is with standard photon techniques using intensity modulated radiation therapy. A recent comparative analysis by Sio and colleagues found no significant difference in symptom burden in the acute and chronic phases of treatment with proton beam therapy when compared to photon therapy for head and neck cancer. Consensus group guidelines do not support the use of proton therapy in this setting. There is a lack of level I evidence to support the use of proton therapy for the treatment of head and neck cancer. Thus, the superior efficacy of the requested proton beam therapy (77499) has not been established in this patients case. 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 2

A 41-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/26/20. 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 various (mostly retrospective) studies of prognostic gene expression profiling (GEP) testing suggest its role as an independent predictor of worse outcome, although not superior to Breslow thickness or sentinel lymph node status. It remains unclear whether this GEP profile is reliably predictive of outcome across the risk spectrum of melanoma. Prospective validation studies are required to more accurately define the clinical utility of molecular testing prior to widespread implementation of GEP for prognostication of cutaneous melanoma, and in particular to determine its role in guiding surveillance imaging, sentinel lymph node biopsy, and adjuvant treatment decisions. Existing and emerging GEP platforms and other prognostic techniques should also be compared with optimized contemporary multivariable phenotypic models. This patient has a good prognosis based on pathological findings and has not yet had a wide local excision. Therefore, DecisionDx-Melanoma testing performed on 5/26/20 was not likely to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 52-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the current medical evidence has not established the superior efficacy of the requested services.  There is a lack of randomized controlled trials comparing the LINX procedure with Nissen fundoplication or other surgical anti-reflux procedures.  Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval. The currently available peer-reviewed literature does not definitively support the conclusion that the LINX procedure is more likely to be beneficial in this case than standard treatment, surgical fundoplication.  Therefore, the requested LINX procedure is not likely to be of greater benefit than other treatment options.  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 3


An 18-year-old male has requested reimbursement for Anser IFX testing performed on 7/09/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions.  In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment.  The reasons for therapeutic failures remain unclear.  Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment.  However, there are few well-controlled clinical trials to confirm that use of the Anser IFX testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment.  The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results.  Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement.  It has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established.  Thus, Anser IFX testing performed on 7/09/15 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: Upheld

Summary Reviewer 3

A 48-year-old female enrollee has requested reimbursement for electroretinography performed on 8/17/18. 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 diabetic retinopathy is a clinical diagnosis that is based on findings of the anterior segment and dilated fundoscopic examination. Signs of non-proliferative diabetic retinopathy include retinal dot blot hemorrhages, microaneurysms and macular edema. There are ancillary tests that aid in the diagnosis, including fluorescein angiography and optical coherence tomography.  Electroretinography is a diagnostic test used to detect and quantify electrical activity given off by retinal cells to a light stimulus.  It is often used in diagnosis of retinal dystrophies, such as retinitis pigmentosa, Stargardts disease, and acquired conditions, such as retinal toxicity from long-term Plaquenil use.  Electroretinography is not commonly utilized in the diagnosis of diabetic retinopathy.  It can give additional information regarding overall health of the various components of the retina, but is not used to diagnose or guide management. The medical evidence does not support the services at issue in this clinical setting. Thus, electroretinography performed on 8/17/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 50-year-old male enrollee has requested reimbursement for Guardant360 testing performed on 8/31/18. 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 there is sufficient support for the services at issue in this clinical setting. Adenocarcinoma of the lung should be evaluated for specific molecular abnormalities, such as EGFR, ALK, ROS-1 and PDL-1. These have clear therapeutic implications, and such testing is done preferentially on tissue sampling. If this is not possible or not safe, plasma cell-free DNA testing (Guardant assay) is a reasonable alternative. The services at issue were likely to have been of clinical benefit in this patients case. Therefore, Guardant360 testing performed on 8/31/18 was likely to have been more effective than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1
A 42-year-old female enrollee has requested reimbursement for the Ova 1 test performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees risk for ovarian cancer.  The physician reviewer found that Ovarian cancer usually presents at advanced stages since considerable tumor growth can occur without symptoms. At this juncture, ideal screening tests have not been determined and studies are in progress. The CA 125 serum test is sensitive but can also be elevated in other nonmalignant conditions. This patients provider noted that this was possible in the patients case and warranted further information with the Ova 1 assay before recommending surgery or another diagnostic procedure. The Ova 1 test is a multivariate proteomic test that analyzes five proteins that are differentially expressed in ovarian cancer. The expression levels are fed into a proprietary algorithm that generates an ovarian malignancy risk index score. The test was approved by the U.S. Food and Drug Administration (FDA) for use in women who are considering surgery for complex adnexal masses based on findings in clinical studies (Kozak, et al). The sensitivity for ovarian cancer detection was 80.8% for pre-menopausal women and 91.3% for post-menopausal women. The negative predictive value for pre-menopausal women was 93.1%. These findings constitute good evidence supporting the Ova 1 testing for use in this patients clinical situation and suggest that it was likely to be more beneficial for evaluation of the patients medical condition than any available standard 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: Overturned

Summary Reviewer 1

A 48-year-old female enrollee has requested authorization and coverage for reconstructive lymphedema surgeries and one (1) inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. At issue is whether the requested services are likely to be more beneficial for treatment of the enrolleeas condition than any available standard therapy. The physician reviewer found that transplantation of lymph nodes with a blood supply is termed vascularized lymph node transfer (VLNT). This procedure involves harvesting a lymph node or several lymph nodes along with their vascular supply from a donor site and transferring this vascularized tissue to the affected extremity as a free tissue transfer. A microsurgical anastomosis is performed between the blood vessels of the lymph node flap and the recipient site vessels, thus establishing blood flow to the lymph node flap. While both lymphaticovenous anastomosis and VLNT have been demonstrated to be effective in the treatment of lymphedema, the provider plans to combine both procedures in a three-part surgery over three consecutive days. Chen and colleagues conducted a pilot series of combined VLNT and lymphaticovenous anastomosis for lower extremity lymphedema compared with VLNT alone. The authors reported, aAt one year follow up, the VLNT and lymphaticovenous anastomosis group scored a greater circumference reduction rate at all levels in comparison to the VLNT group. Nevertheless, no statistically significant difference was found.a Treatment combination of VLA and VLNT at the same procedure appears to be investigational at this time. Therefore, reconstructive lymphedema surgeries and one (1) inpatient bed day are not likely to be more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 44-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/18/16.  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 that 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 3/18/16 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: Experimental
Decision: Upheld

Summary Reviewer 3

A 52-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene expression testing performed on 11/01/18. 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 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 a 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 DecisionDx-Melanoma gene expression testing has not made it part of routine analysis after sentinel lymph node biopsy. There has 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. Thus, DecisionDx-Melanoma gene expression testing performed on 11/01/18 was not likely to have been more beneficial than other methods of evaluating this patient.