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

Summary Reviewer 3

A 55-year-old male enrollee has requested authorization and coverage for the LINX lower esophageal sphincter augmentation device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than Nissen fundoplication or other surgical anti-reflux procedures. One evidence review concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined (Sheu and Rattner). Another best-evidence review concluded that long-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval (Bauer, et al). The currently available peer-reviewed literature does not support the conclusion that LINX is more likely to be beneficial in this case than standard treatment including surgical fundoplication (Sheu, et al; Ganz, et al). American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). For these reasons, the requested LINX lower esophageal sphincter augmentation device is not 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 procedure is 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: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 63-year-old female enrollee has requested reimbursement for inpatient hospitalization services provided from 3/19/18 through 3/20/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees low back pain. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. Inpatient care is necessary when the patients signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Her pain was controlled with oral medications, and there was no indication for significant neurologic compromise or infection. All told, inpatient hospitalization services provided from 3/19/18 through 3/20/18 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2
The parent of a three-year-old female enrollee has requested authorization and coverage for homocysteine, Factor V Leiden, and methylene tetrahydrofolate reductase (MTHFR), testing performed on 6/4/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee whose parent was diagnosed with idiopathic venous embolism and was positive for the MTHFR mutation and Factor V Leiden deficiency. The physician reviewer found that according to the records, the services at issue were not likely to have been beneficial to this patient. The patients mother tested negative for the FVL mutation. As such, testing the patient, who was asymptomatic, was not indicated. Further, the patients mother was the only person in the family with thrombosis and she tested negative for this mutation. Though the patients mother has had blood clots at an early age and in unusual places, the patient herself is not reported to have thrombosis. The American College of Medical Genetics (ACGM) has a practice guideline regarding genotyping of MTHFR. Studies of MTHFR have been plentiful and have focused on a wide variety of conditions, including vascular disease, neural tube defects, mental illness, autism, and cancer, to name a few. However, after a comprehensive review, ACMG found that there is insufficient evidence for the clinical utility of MTHFR polymorphism testing. The ACMG guidelines do not recommend testing for MTHFR.  In this patients case, the records do not support that this test provided any clinical utility. All told, homocysteine, FVL, and MTHFR testing performed on 6/4/16 was not likely to have been more effective than other standard modalities for the evaluation of this patient. Therefore, for the reasons stated 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 26-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/15/19. 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 prognosis of cutaneous melanoma has classically been determined by the staging system spelled out by Balch. Mitotic index is thought to add a bit to these statistics. DecisionDx-Melanoma testing is an assay of the molecular and genetic changes in an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not known if DecisionDx-Melanoma data can be used to make clinical decisions, such as whether to do a sentinel node or not. Therefore, DecisionDx-Melanoma testing performed on 4/15/19 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2 
A 31-year-old female has requested reimbursement for lab tests that measure the levels of 
medication, adalimumab (ADA) performed on 8/1/22. The Health Insurer has denied this request 
indicating that the testing at issue was considered investigational for evaluation of the insureds 
ulcerative colitis. The physician reviewer found that on review of the current medical literature, 
there is insufficient clinical data provided to support the ADA drug levels and antibody testing 
performed in this patients evaluation and treatment. The records do not demonstrate that the ADA 
testing was recommended to evaluate the patient to confirm dosing or due to suspected failure of 
medication. In the setting of suspected drug failure, additional testing such as stool cultures should 
also be performed to rule-out other potential causes of the patients disease flare. A recent meta-
analysis  concluded  that,  Routine  proactive  therapeutic  drug  monitoring  to  target  biologic 
concentration to specific thresholds, regardless of disease activity, did not offer clinical benefit in 
patients with inflammatory bowel disease treated with TNF-alpha antagonists in randomized 
controlled trials conducted to date (Nguyen, et al.). All told, the lab tests that measure the levels 
of medication, ADA performed on 8/1/22 were not likely to be more beneficial for evaluation of 
the patients medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 45-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation of the knee. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees knee pain. The physician reviewer found that the surfaces of the bones in the knee are covered with hyaline articular cartilage, a very smooth, frictionless surface allowing movement in the joint and acting as a shock absorber. In this case, the documentation shows significant loss of the articular cartilage of the patellofemoral joint. Articular cartilage has very little capacity for self-repair, so damage may be permanent. Various methods have been used to try to repair cartilage. Autologous chondrocyte implantation involves laboratory culture of cartilage-producing cells from the knee and then implanting them into the defect. Studies have revealed that the results with autologous chondrocyte implantation are superior to microfracture. When combined with a patellofemoral stabilization procedure, it is effective in relieving pain and promoting healing of articular defects of the patellofemoral joint. The medical evidence supports the requested services in this clinical setting. In sum, autologous chondrocyte implantation of the knee is likely to be more effective than other treatment options. 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: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 53-year-old female enrollee has requested 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 hepatitis C virus. The physician reviewer found 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 life expectancy less than 12 months due to non-liver-related conditions. This applies regardless of the fibrosis stage.  In treatment-naive genotype 3 patients, therapy is recommended with Sovaldi and Daklinza for 12 weeks. This is based on the ALLY-3 study, which showed a cure rate of 97% (Nelson, et al; Hezode, et al). Delay in treatment may result in decreased survival (Jezequel, et al). For these reasons, treatment with Sovaldi and Daklinza 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: Upheld

Summary Reviewer 3


A 48-year-old female enrollee has requested reimbursement for lab testing (Factor V Leiden genetic testing) provided on 12/16/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support in the peer-reviewed literature for the Factor V Leiden genetic testing performed in this clinical setting. In this case, the patient does not have a personal history of venous thromboembolism (VTE). Moreover, the testing at issue is not the standard of care as it is not supported for population testing. The position statement by the North American Menopause Society (NAMS) states Women with a previous history of VTE, obese women, or women who possess a Factor V Leiden mutation are at increased risk of VTE with HT use. However NAMS does not recommend Factor V Leiden population testing such as in this case, with no indication for testing by medical or family history. 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 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 2/25/17. 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 osteoporosis.  The physician reviewer found that osteoporosis is a condition of thinning of the bones which leads to increased risk of fracture. It  is defined by the World Health Organization (WHO) as a bone mineral density of 2.5 standard deviations or more below the mean peak bone mass (average of young, healthy adults) as measured by dual-energy x-ray absorptiometry (DEXA). Bone mineral density (BMD) assessment, via DEXA, is still the criterion standard for evaluation and diagnosis of osteoporosis.  However, because changes in bone mass and density in response to antiresorptive therapy account for only a small portion of the predicted fracture risk reduction, markers of bone turnover may be a useful adjunct in monitoring of osteoporotic patients treated with antiresorptive agents. The medical evidence suggests that biochemical markers could be useful in making therapeutic decisions because, in general, the higher the bone remodeling and bone loss rates, the greater the concentration of bone biochemical markers in blood or urine. There is sufficient support for the services at issue in this clinical setting. All told, laboratory testing (collagen crosslink testing) performed on 2/25/17 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.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 29-year-old female enrollee has requested authorization and coverage for compound medication of sirolimus cream 1%. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has Klippel Trenaunay syndrome. The physician reviewer found that Klippel Trenaunay syndrome is characterized by the triad of cutaneous capillary malformations, asymmetrical disturbed growth of soft tissues and/or bone, and venous and lymphatic malformations. Recent publications emphasize the potential interest of sirolimus, an inhibitor of mammalian target of rapamycin (mTOR) activity, as a treatment option for cutaneous vascular malformations and PIK3CA-related overgrowth spectrum (PROS). Sirolimus has been used successfully with a good safety profile. The requested medication is an appropriate medical treatment for bleeding induced by venous and lymphatic malformation associated with Klippel Trenaunay syndrome. Thus, compound medication of sirolimus cream 1% is likely to be more efficacious than other treatment options. 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.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

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 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 DecisionDx-Melanoma testing 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. 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: Overturned

Summary Reviewer 1
A 38-year-old female enrollee has requested authorization and coverage for Humira 40 mg weekly.  The Health Insurer has denied this request indicating that the requested medication dosage is considered investigational for treatment of the enrollees ulcerative colitis. The physician reviewer found that anti-tumor necrosis factor agents, such as Humira and Remicade, have demonstrated efficacy for induction and maintenance of remission in patients with moderate to severe inflammatory bowel disease, but the response is not universal. More than one-third of patients do not respond to induction therapy (primary nonresponse) and even among initial responders, the response wanes over time, sometimes resulting in disease exacerbation. Relative to this patients desire to conceive, after week 20 of pregnancy, chimeric antibodies cross the placenta. However, the consequence of having anti-tumor necrosis factor in a neonate has not been studied until recently. Recent population-based data find that there is no increased risk for birth defects. According to the most recent practice guideline, pregnant women receiving maintenance therapy should continue therapy, and the decision to stop after week 20 is individualized. Because this patient is in remission, there is no need to stop now, nor is there significant concern for an increased risk of an adverse pregnancy outcome. Pregnancy desire is not a contraindication to anti-tumor necrosis factor treatment. If a mother is not treated through her pregnancy, she runs the risk of disease activity, which will be detrimental to her health and her pregnancy. Evidence supports the safety and efficacy of anti-tumor necrosis therapy before and during pregnancy and should not delay the decision to start or optimize therapy. In this patients case, Humira 40 mg weekly is likely to be of greater benefit than other available treatment options. Based upon the information set forth above, the requested medication dosage 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: Overturned

Summary Reviewer 3


A 41-year-old male enrollee has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found the LINX device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The LINX device, which is U.S. Food and Drug Administration (FDA) approved, is laparoscopically implanted around the esophagus at the esophagogastric junction to mechanically augment the function of the lower esophageal sphincter (LES) for the treatment of GERD. LINX has shown efficacy up to four years in the reduction of the amount of pathologic esophageal acid exposure (Lipham, et al). A multi-institutional, non-randomized, prospective case series of 100 patients by Ganz and colleagues evaluated patients before and after sphincter augmentation with a magnetic device. The authors found exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Based on the minimal invasive nature of the procedure, documented safety and efficacy data in multiple studies, and FDA approval, the 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: Upheld

Summary Reviewer 2

A 62-year-old male enrollee has requested reimbursement for the Life Vest provided from 6/10/15 through 7/10/15. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees dilated cardiomyopathy. The physician reviewer found that placement of a prophylactic defibrillator is not recommended until a period of time after myocardial infarction has elapsed, where continued severe left ventricular dysfunction is documented to persist in spite of appropriate treatment (Russo, et al). Placement of a prophylactic defibrillator (wearable or implantable) before this time has not been demonstrated to improve patient outcomes. Studies assessing the efficacy of prophylactic defibrillators early after diagnosis of myocardial infarction and reduced ejection fraction of 35% or less before ventricular function has had a chance to recover have not demonstrated improved outcome (Steinbeck, et al). A prophylactic wearable external defibrillator is indicated only if accepted criteria for an implantable defibrillator are met and an implantable defibrillator could not be placed, needed to be significantly delayed or required explantation. Therefore, the Life Vest provided from 6/10/15 through 7/10/15 has not been demonstrated by scientific literature as likely to have been more beneficial in treating this patients medical condition than standard alternatives. Based upon the information set forth above, I have determined the device at issue was 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: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 57-year-old female enrollee has requested reimbursement for myocardial perfusion imaging test performed on 1/31/20. 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 the patient has some chest/epigastric symptoms and mild hypertension. Her baseline EKG is described as abnormal as well. The planned orthopedic surgery with general anesthesia would be considered an intermediate risk surgical procedure in terms of cardiac complications. She has some risk factors for coronary artery disease and an inability to exert herself enough to determine reasonable functional capacity due to knee arthritis, so the assessment of functional capacity as a risk marker is not possible in this situation. In addition, she is not asymptomatic, as she has some epigastric discomfort symptoms as well as a baseline abnormal EKG, and the description and presentation of angina pectoris can be more often atypical in women as well. Based on these preoperative factors, her limited mobility (impairing an assessment of her functional capacity) and her epigastric symptoms, a pharmacologic nuclear stress test was reasonable and medically indicated to assess cardiac risk in this patient prior to the planned orthopedic surgery. Therefore, the myocardial perfusion imaging test performed on 1/31/20 was medically necessary for the evaluation of this patient.