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

Summary Reviewer 

A 52-year-old male enrollee has requested authorization and coverage for Vascepa. 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 the submitted documentation supports the medical necessity of the requested medication. This patient has established coronary artery disease and is at significantly higher cardiovascular event risk at his age due to his elevated calcium score. He has been maximized previously for his hyperlipidemia and hypertriglyceridemia with diet, high dose statin medication and Lovaza, with marked improvement in his lipid profile. Although eicosapentaenoic acids have been shown to possibly have effects on cardiovascular risk previously, the most recent data specifically on the preparation Lovaza, while effective at lowering triglyceride level, has not been shown to affect cardiovascular risk or freedom from cardiovascular events in the recent ASCEND trial. Most recently, the specific icosapent ethyl preparation, Vascepa, has been shown to lower both triglyceride levels and decrease cardiovascular events in high risk patients with either known coronary artery disease or diabetes mellitus. Given that this patient is already on triglyceride lowering therapy and has known established coronary artery disease, it is appropriate that he be on lipid lowering therapy that has been clinically shown to decrease his cardiovascular risk. Vascepa is medically indicated in this specific, high-risk clinical circumstance. Therefore, Vascepa is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 64-year-old female enrollee has requested reimbursement for FoundationOne test performed on 1/19/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found that the medical literature has not established if molecular markers are useful in treatment determination as predictive markers and prognosis other than for KRAS, NRAS, and BRAF mutation testing and microsatellite instability (MSI) or mismatch repair (MMR) testing. This is supported by both the National Comprehensive Cancer Network (NCCN) guidelines and American Society of Clinical Oncology (ASCO). Although preliminary data from some clinical studies have fueled excitement about the value and utility of these studies, their execution has also provoked many questions about the best way to approach complicating factors such as tumor heterogeneity and the choice of which genetic mutations to target. To date it is unclear if molecular profiling is beneficial in identifying potential targets for treatment or if targets are identified whether or not targeted treatment is beneficial. In this patients case, there were other chemotherapy options available for adjuvant therapy including treatment with irinotecan. All told, the use of FoundationOne testing on 1/19/17 was not likely to have been of greater benefit than any other available standard therapy for evaluating this patients medical condition. 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 62-year-old male enrollee has requested reimbursement for the Life Vest provided on 1/20/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees paroxysmal atrial flutter and atrial fibrillation with rapid ventricular response.   The physician reviewer found that based on the records provided, the patient has newly recognized severely depressed LV ejection fraction due to a non-ischemic cardiomyopathy possibly tachycardia mediated. In this circumstance, there is potential for recovery of LV function with medical therapy and atrial flutter ablation. Thus, there was no indication for immediate placement of a defibrillator such as sustained or inducible ventricular tachycardia, syncope or aborted sudden cardiac arrest. Placement of a prophylactic defibrillator is not recommended until at least 90 days have elapsed with continued LV dysfunction with an ejection fraction 35% or less is documented to persist in spite of appropriate treatment (Russo, et al).  A prophylactic defibrillator (wearable or implantable) before this time has passed has not been demonstrated to improve outcome (Hohnloser, et al). At this time, prophylactic wearable external defibrillator would be indicated only if accepted criteria for an implantable defibrillator were met and an implantable defibrillator could not be placed, needed to be significantly delayed or required explantation. For these reasons, the use of the Life Vest provided on 1/20/14 was 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, 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: Experimental
Decision: Upheld

Summary Reviewer 3

A 53-year-old female enrollee has requested authorization and coverage for a transcatheter aortic valve replacement (TAVR). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the requested services. TAVR is indicated for patients with symptomatic severe aortic valve stenosis and either intermediate or high surgical risk for open aortic valve replacement surgery. This patient would be considered low surgical risk by the information provided. Although recent data has evaluated lower risk patients for TAVR, they have generally excluded patients with bicuspid aortic valves such as with this patient, they required higher baseline gradients for eligibility compared to this patient, and there is no long-term follow-up beyond one year. Therefore, the requested TAVR is not likely to be more beneficial than other available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 38-year-old male enrollee has requested reimbursement for Truvada 200/300 mg, 30 tablets for 30 days, provided on 10/03/17. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollee, who had a potential exposure to human immunodeficiency virus (HIV). The physician reviewer found that the current medical evidence supports a portion of the medication at issue. The records document that the patient was exposed to HIV infected blood. Recommendations from Centers for Disease Control and Prevention and the U.S. Public Health Service note 28 days of treatment is recommended in this setting.  Thus, Truvada 200/300 mg, 28 tablets was medically indicated. There is a lack of support for the quantity provided in this patients case. In sum, Truvada 200/300 mg, 28 tablets, was medically necessary for the treatment of this patient. Therefore, a portion of the medication at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


An 18-year-old female enrollee has requested reimbursement for the gene testing performed on 9/1/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. The physician reviewer found that in general, the practice of pharmacogenetics, or the tailoring of a medication regimen based on an individual patients genetic organization, may become a valuable tool in the treatment armamentarium for those plagued with psychiatric illness. However, despite its promise, pharmacogenetics is not yet ready for routine clinical application as the relatively small, short-term studies to date have not been replicated on a larger scale. In addition, the American Psychiatric Association (APA) did not endorse such testing per current clinical practice guidelines. In this case, there was no clinical data provided to support genetic testing. Notably absent was the documentation of the longitudinal illness burden and extent of impairment at the time, family history, developmental history, social history, psychosocial stressors and medical comorbidities. In sum, considering the relevant peer-reviewed literature and current practice standards, it is not possible to assert with any degree of confidence that the disputed gene test yielded information that significantly influenced treatment decisions, improved the patients condition, prevented a more serious episode of illness or reduced morbidity. Thus, the genetic testing performed on 9/1/16 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 56-year-old female enrollee has requested reimbursement for a blood test performed on 11/24/18. 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 a lack of support for the services at issue in this clinical setting. The choice of test used to diagnose Helicobacter pylori depends on whether a patient requires an upper endoscopy for evaluation of symptoms or surveillance. Endoscopy is not indicated solely for the purpose of establishing Helicobacter pylori status. In patients who do not require endoscopic evaluation, initial diagnosis of Helicobacter pylori should be made with a test for active infection (stool antigen or urea breath test). The urea breath test and stool antigen assay both have high sensitivity and specificity for identifying active Helicobacter pylori infection. Serology has low sensitivity and specificity for Helicobacter pylori and cannot differentiate between active and past infection. Therefore, the blood test performed on 11/24/18 was not likely to have been more effective than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

The parent of an 11-year-old female enrollee has requested reimbursement for the FirstStep PLUS test provided on 11/23/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees severe attention deficit hyperactivity disorder (ADHD) and developmental delays. The physician reviewer found that array-based comparative genomic hybridization or chromosomal microarray (CMA) has become the standard of care to evaluate children with developmental delay, intellectual disability, autism spectrum disorders or congenital anomalies. This patient meets the criteria established for CMA use given the documentation of intellectual disability. In addition, the patients positive family history provides additional support for this testing. In the medical literature, Henderson and colleagues reported that 12.7% of patients meeting referral criteria had a pathogenic copy number variant identified on microarray, and that half of those results influenced management including pharmacological treatment, cancer-related screening or exclusion of screening, identifying contraindications, and referrals for further evaluation. Riggs and colleagues demonstrated that 7% of microarray results impact clinical management, a rate which is similar to other genetic tests. Data have now emerged showing that actionable findings from CMA justify its use. All told, the FirstStep PLUS test provided on 11/23/16 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, 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: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 29-year-old female enrollee has requested reimbursement and prospective authorization and coverage for OxyContin 20 mg three times per day from 2/9/18 forward. The Health Insurer has denied this request indicating that the medication dosage at issue was not and is not medically necessary for treatment of the enrollee who has been assessed with chronic pain syndrome. The physician reviewer found that the medical literature states that dose escalation is not a long-term plan but a short-term plan for the treatment of tolerance. In the documentation available for review, there were no objective treatment goals for pain and function noted for the requested medication. In addition, several requirements for opioid prescribing have not been documented to be performed. Therefore, the need to use them as the primary medication treatment strategy for pain has not been established (Chou, et al). The Centers for Disease Control and Prevention (CDC) states that when starting opioid therapy for chronic pain, providers should prescribe immediate release opioids instead of extended release/long-acting (ER/LA) opioids. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, and should carefully reassess evidence of individual benefits and risks when considering increasing dosage to 50 or more morphine milligram equivalents (MME) per day, and should avoid increasing dosage to 90 or more MME per day or carefully justify a decision to titrate dosage to 90 or more MME per day. In this case, the patient was recently taking 135 MME per day. However, there is no submitted evidence based rationale given by the provider to support the potential long-term consequences with the continual increase in opioids. Risk and benefit analysis must be performed to justify the requested level of 90 MME per day. It is also reasonable to consider alternatives to opioids. Moreover, pure mu agonists are not considered evidence based treatments for fibromyalgia and the adverse effects of opioids in fibromyalgia patients are unknown. In addition, the submitted records do not mention the completion of behavior therapy despite much research to support its use. For all of these reasons, reimbursement and prospective authorization and coverage for OxyContin 20 mg three times per day from 2/9/18 forward has not been demonstrated as medically necessary for treatment of the patients medical condition. Therefore, based on the reasons stated above, the medication dosage at issue was not and is not medically necessary for the treatment of this patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 51-year-old female has requested reimbursement for destruction by neurolytic agent (CPT codes 64635 and 64636) performed on 12/02/13 and 12/23/13.  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 the records indicate that the patient underwent cooled radiofrequency lesioning.  Of note, cooled radiofrequency lesioning is a newer technology that does not have the same peer-reviewed evidence of duration and efficacy as conventional radiofrequency lesioning.  Although the current literature on cooled radiofrequency lesioning is promising, more extensive studies need to be conducted against the standard approach.  Therefore, the services at issue performed on 12/02/13 and 12/23/13 were not likely to be of greater benefit than other treatment alternatives.  Based upon the information set forth above, the services at issue were 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: Overturned

Summary Reviewer 2
The parent of a 16-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) testing performed on 4/26/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for the enrollees dysmorphic facies and postural and kinetic tremor. The physician reviewer found that CGH, also referred to as CMA, is a well-established first-line genetic test for individuals with developmental delays and autism spectrum disorders according to the American Academy of Pediatrics (AAP), the American College of Medical Genetics (ACMG), the American College of Neurology (AAN) and the Child Neurology Society (CNS) (Schaefer et al; Moeschler et al; Shevell, et al; Shen et al). CMA technology has been shown to provide clinically actionable information. In this case, the patient presented with kinetic tremor. The clinical utility of CMA in the evaluation of seizure concerns is also well established. Olson and colleagues evaluated 805 patients with epilepsy/seizures using CMA technology. The authors found that in at least 40 cases (5%), the epilepsy phenotype was explained by a [copy number variant] CNV, including 29 patients with epilepsy-associated syndromes and 11 with likely disease-associated CNVs involving epilepsy genes or hotspots. Copy number abnormalities were found to play an important role in patients with epilepsy. The authors concluded that because the diagnostic yield of CMA for epilepsy patients is similar to the yield in autism spectrum disorders and in prenatal diagnosis, for which published guidelines recommend testing with CMA, we recommend the implementation of CMA in the evaluation of unexplained epilepsy. For these reasons, CGH testing performed on 4/26/16 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, 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: Upheld

Summary Reviewer 2


A 41-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/02/15. 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 the current medical evidence does not support the services at issue in this clinical setting.  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 has 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 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.  In sum, Anser IFX testing performed on 4/02/15 was not likely to have been superior over other 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: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 56-year-old male enrollee has requested reimbursement for inpatient hospital stay provided from 6/23/18 through 6/25/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The patient was injured in an accident and presented to the emergency department with shortness of breath and chest/rib pain.  He denied loss of consciousness, and the initial imaging did not show any acute central nervous system bleeding. He was treated in the emergency department with intravenous fluids and pain medications. At the time of admission, his vital signs were stable with normal oxygen saturation.  Imaging showed a fractured rib without any significant complications.  The inpatient admission was not medically necessary for this patient. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Therefore, inpatient hospital stay from 6/23/18 through 6/25/18 was not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 64-year-old female has requested reimbursement for vedolizumab infusions provided on 5/03/19 and 6/28/19. The Health Insurer has denied this request and reported that the medication at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has been diagnosed with ulcerative colitis. The U.S. Food and Drug Administration has approved vedolizumab for induction of remission and maintenance of remission in moderate to severe ulcerative colitis. The patient was previously treated with Humira, but had side effects, including hair loss. The patient was started on vedolizumab and received infusions on 5/03/19 and 6/28/19. In this patients case, there are no progress notes or other information from the provider documenting that vedolizumab was working. There is insufficient documentation of benefit for the continued use of this medication. All told, vedolizumab infusions provided on 5/03/19 and 6/28/19 were not likely to have been more beneficial than other methods of evaluating this patient.