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

Nature of Statutory Criteria/Case Summary:  An enrollee has requested authorization and coverage for Aimovig.Aimovig (erenumab) is a calcitonin gene-related peptide (CGRP) approved for episodic and chronic migraine. CGRP monoclonal antibodies (mAbs) are biologic agents that have demonstrated efficacy, safety, and tolerability for the preventive treatment of episodic and chronic migraine in phase 2 and phase 3 randomized, placebo-controlled trials. Erenumab can be administered every four or 12 weeks by subcutaneous injection and does not require dose titration. Erenumab may achieve rapid treatment effects over days to weeks and is effective in patients who have failed prior preventive treatment, as well as in those on concurrent oral preventive treatments. The lack of need for slow dose escalation, the rapid onset of therapeutic benefits, and the favorable tolerability profiles are advantages of injectable therapies. In 2018, the American Headache Society (AHS) position statement noted that treatment with anti-CGRP mAbs is indicated when all of the following are met: there is a diagnosis of International Classification of Headache Disorders third edition (ICHD-3) migraine with or without aura. Additionally, the patient must demonstrate an inability to tolerate (due to side effects) or inadequate response to a six-week trial of at least two of the following: topiramate, divalproex sodium/valproate sodium (Depakote), beta-blocker (metoprolol, propranolol, timolol, atenolol, nadolol), tricyclic antidepressant (amitriptyline, nortriptyline), and/or serotonin-norepinephrine reuptake inhibitor (venlafaxine, duloxetine). Alternatively, the patient may demonstrate an inability to tolerate or inadequate response to a minimum of two quarterly injection (six months) of onabotulinumtoxinA. In this case, the patient has a history of chronic migraines. However, there is no documentation in the record of failure of other oral preventive medications. The patient does not fit AHS criteria for initiation of CGRP monoclonal antibody therapy. For these reasons, Aimovig is not medically necessary for the treatment of the patients medical condition.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in neurology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested authorization and coverage for a real time remote heart monitor. Findings:  Two of the three physician reviewers found that in this patients case, the records note a reported transient ischemic attack of uncertain cause with a suspicion of possible transient atrial fibrillation. In this circumstance, evaluation for transient atrial fibrillation should be sufficiently performed using a combination of serial Holter monitoring and data obtained from an implantable loop recorder, both of which already have been provided to the patient. Real-time remote cardiac telemetry is not indicated since the patient already has implantation of an implantable loop recorder that should be able to sufficiently detect transient atrial fibrillation. Therefore, the requested real time remote heart monitor is not likely to be superior over other methods of evaluating this patient. Final Result: The reviewers determined that the requested device is not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in internal medicine with sub-specialty certification in cardiovascular disease and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

A 52-year-old male requested reimbursement coverage for residential treatment services provided from a specific date and forward for treatment of his cocaine dependence and major depression. Findings:  The physician reviewer found that modern psychiatric practice is aimed at treating individuals in the least restrictive setting to consolidate treatment gains and foster autonomy, resilience, and mental wellness.  Due to multiple factors and unique considerations, determination of the appropriate level of care for patients with substance dependence is a challenging endeavor.  Clinical guidelines and patient placement criteria have been developed to assist with the determination process.  In this patients case, his substance abuse dominated social and family dynamics.  Further, he currently lacks a harmonious living environment and social supports to facilitate recovery.  Therapeutically, the patient has not yet consolidated the treatment gains needed to succeed in a community setting.  Although he is described as motivated to participate in treatment, he remains at a high risk for relapse.  Additionally, there is a high risk that continued drug use will exacerbate his major depressive disorder to the extent that treatment in a less restrictive level of care cannot be safely provided at this time.  In this clinical setting, residential treatment services provided from the date in question and forward were and are medically indicated.  It is reasonable to anticipate up to a four-week residential placement before pursuing a transition to less restrictive setting, such as partial hospital or intensive outpatient programming.
Appeal type: Experimental/Investigational
Decision: Overturned

A 24-year-old female enrollee requested the MiniMed 530G with Enlite (E0784, A9276, and A9277 for medical treatment of the enrollees type 1 diabetes.   Findings:  Two physician reviewers found that according to American Association for Clinical Endocrinologists (AACE) guidelines, insulin pump therapy with continuous glucose monitor systems are indicated in patients with type 1 or type 2 diabetes mellitus who need to reestablish blood glucose control. These devices enable switching from conventional insulin injections to pump therapy, and manage sustained elevations of glycosylated hemoglobin, unstable blood glucose levels with large glycemic fluctuations, as well as respond to episodes of hypoglycemic unawareness and frequent or severe nocturnal hypoglycemia. This patient has long-standing type 1 diabetes mellitus and has unstable blood glucose levels with large glycemic fluctuations and wide fluctuations in preprandial blood sugars as well as hypoglycemia. Given this support, the MiniMed 530G with Enlite (E0784, A9276, and A9277) is likely to be more beneficial for treatment of this patients medical condition than any available standard therapy.
Appeal type: Experimental/Investigational
Decision: Upheld

A 44-year-old female enrollee has requested for total disc replacement for treatment of her severe stenosis at C5-6.  Findings:  Three physician reviewers found that published reports of randomized trials with longer term follow-up suggest that artificial disc replacement may be beneficial, but the percentages of patients receiving 4-year and 5-year follow-up are exceedingly low and call into question the validity of the findings (Burkus, et al). For this reason, the FDA required a post-approval study with 5-7 year follow-up to determine long-term health outcomes and these studies are ongoing. With regard to this particular patient, she has multi-level cervical disease and the manufacturer specifically states that arthroplasty is not indicated for patients with more than single level disease. Given the lack of methodologically sound studies producing reliable and reproducible data supporting the long-term outcomes of total disc replacement, the requested surgery is not likely to be more beneficial for this patient than standard therapies.
Appeal type: Medical Necessity
Decision: Overturned

A 53-year-old male enrollee has requested for Rituxan therapy for treatment of his progressive renal failure. Findings:  The physician reviewer found that there is data to suggest that Rituxan may be effective in membranoproliferative glomerulonephritis associated with Type 2 cryoglobulinemia, which is the predominant type of HCV-related glomerulonephritis. It is medically appropriate and reasonable that a trial of Rituxan be tried in this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the cooling device for treatment of the enrollees medical condition status post anterior cruciate ligament (ACL) reconstruction surgery. Findings:  Two physician reviewers found that this patients provider recommended a commercial cold compression unit (VascuTherm2) for post-operative use following knee arthroscopy for degenerative meniscal tearing. However, there is a lack of scientific evidence demonstrating that such devices improve outcomes following such surgery and the devices are not included in any evidence based treatment guidelines. Some studies have suggested short-term pain relief, but no effect on long-term outcomes, while other studies have reported no benefit at all. Risk of DVT and pulmonary embolism is low following arthroscopic partial meniscectomy. Cooling is frequently recommended after surgery, but can be accomplished with available materials such as bags of ice. In the peer-reviewed medical literature, the authors noted that the potential benefits of cryotherapy on blood loss, postoperative pain, and range of motion may be too small to justify its use, and the quality of the evidence was very low or low for all main outcomes. Based on the available scientific evidence, the cooling device provided was not more likely to be more beneficial for treatment of this patients post-operative medical condition than more standard treatment such as a compressive bandage and cooling with bags of ice. Final Result: The reviewers determined that the device at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: All three physician reviewers are board certified in orthopedic surgery and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

A female enrollee requested Qsymia for medical treatment of her obesity.   Findings:  The physician reviewer found that the U.S. Food and Drug Administration (FDA) has approved Qsymia for treatment of patients with a BMI of 35 or greater. This patients records document a BMI that is 34.99; she has complications of obesity as well as arthritis and has made documented efforts to lose weight. As this patients medical condition currently includes neuromuscular complications from obesity, the requested Qsymia is supported as medically necessary for treatment of this patients medical condition.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Spectracell Micronutrient testing. while tiredness is a frequent complaint in primary care, extensive investigations are only warranted in case of specific findings from the history or clinical examination and that attention should instead be focused on depression and psychosocial problems. Clinicians assessing for cognitive impairment should use a brief, validated cognitive assessment instrument in addition to eliciting patient and informant history regarding cognitive concerns. Chronic fatigue syndrome (CFS) is heterogeneous in presentation without diagnostic indicators, therefore, in health care encounters, insight must be gained from the patient's perspective. A clinical approach to the management of bloating and abdominal distension includes a physical examination and basic diagnostic tests, such as complete blood count, celiac serology, abdominal x-ray, and a breath test. In this case, the documentation does not reflect an evaluation for pathological etiologies for the patients symptoms. Given that current medical literature does not support the use of testing for vitamin and nutrient deficiencies in the setting of chronic pain, fatigue, bloating, and cognitive deficits, the requested service is not medically indicated. Therefore, Spectracell Micronutrient testing is not medically necessary for the evaluation of this patient.Final Result: The reviewer determined that the requested service is not medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

A 58-year-old male enrollee has requested acupuncture treatment for treatment of his left foot and hand pain, and sleeping difficulties. Findings:  The physician reviewer found that though there is a lack of high-quality randomized controlled trials, acupuncture is one of the most utilized tools in the world for the treatment of pain and many other illnesses. However, there is compelling evidence in smaller studies, anecdotal evidence, and retrospective studies supporting the use of acupuncture as a low risk and high reward tool on the continuum of treating chronic pain from both myofascial and OA pain generators. Overall, acupuncture is not known to be effective with only 1 visit, and the requested number of sessions are well within the standard range for therapy of myofascial pain and OA mediated pain. Therefore, the patient should be approved for a trial of acupuncture therapy.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Synvisc One injection for the left knee. Findings:  The physician reviewer found that Evidence from systematic reviews and randomized controlled trials indicate that although viscosupplementation may relieve knee pain in some patients with osteoarthritis, data has not established which patients will benefit. Guidelines from the American Academy of Orthopedic Surgeons (AAOS) indicate that the data on safety and efficacy of viscosupplementation remain inconclusive. As such, the AAOS does not currently recommend viscosupplementation as routine treatment for osteoarthritis of the knees. Viscosupplementation is reserved for patients with a history of lasting benefit from prior injections and in cases where the remaining options are limited. In this case, the patient has a history of continuing long-term benefit from viscosupplementation using Synvisc One injections of the left knee every six months. In addition, the patient has failed treatment with non-steroidal anti-inflammatory drugs (NSAIDs), cortisone injections, bracing, and physical therapy. For these reasons, the requested Synvisc One injection for the left knee is medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

A 51-year-old female enrollee has requested botulinum toxin A (Botox) injections for treatment of her cervical dystonia.  Findings:  Three physician reviewers found that this patients medical records support that the patient has cervical dystonia, and has been well managed for years with Botox therapy. Cervical dystonia is characterized by involuntary movements, spasms, pain, and altered mobility. Botox is beneficial for these symptoms, and is considered first-line therapy in the literature. In addition, the FDA states that Botox is indicated for treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain. Botox is therefore likely to continue to provide this patient with an improved health outcome beyond that expected with standard therapies.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Gammaplex 60 gm/10% IV, to be administered 30 gm daily for 2 days, every 4 weeks for 12 months.The submitted documentation does not support that the requested medication is medically necessary. The hyper-IgE syndrome (HIES) is a primary immunodeficiency characterized by infections of the lung and skin, elevated serum IgE, and involvement of the soft and bony tissues. In this case, the diagnosis of hyper IgE syndrome is not verified. Although the patient does have evidence of elevated IgE at 1164, this alone is not diagnostic of hyper IgE syndrome, as this finding can be associated with many other clinical conditions. There is no documentation that the patient has had recurrent sinopulmonary infections or skin abscesses in the submitted records. In addition to the necessary clinical and laboratory findings, the identification of a genetic defect through molecular testing is necessary to confirm a diagnosis of hyper IgE syndrome, and this has not been documented to have been performed for the patient. Furthermore, the laboratory data in regard to Epstein-Barr virus (EBV) and Human Herpesvirus 6 (HHV-6) demonstrates prior infection or exposure through positive IgG values, which is common in the general population. There is no evidence of active or acute infection clinically or objectively. In addition, the use of intravenous immune globulin (IVIG) has not been shown to provide significant benefit to hyper IgE syndrome patients, except in those with lowered immunoglobulin levels or significantly lowered vaccine responses to protein and/or polysaccharide antigens, which medical records do not reveal to be the case in this patient. Accordingly, the requested Gammaplex 60 gm/10% IV, to be administered 30 gm daily for 2 days, every 4 weeks for 12 months is not medically necessary to treat the patients medical condition.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in both internal medicine and allergy and immunology, and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

An enrollee has requested authorization and coverage for individual mental health therapy, two times a month for the next twelve months. In cases such as this, an evidence-based, objective, instrument such as the American Association of Community Psychiatrists Level of Care Utilization System is indispensable in determining the necessary level of care for adults. The patients composite score is consistent with low intensity community based services. The level of care analysis indicates that meeting two times a month is a reasonable frequency and within the standard of care. Furthermore, the patient is placed at risk for further decompensation, including poor blood sugar control, without treatment of her depression and grief. Under these circumstances, individual mental health therapy, two times a month for the next twelve months, is medically necessary for treatment of the patients medical condition.Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in psychiatry and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

A 44-year-old female enrollee has requested for Botox injections every three months for treatment of her chronic daily headaches. Findings:  Three physician reviewers found that the patient has been documented to have tried multiple standard preventives, as well as alternative treatments like acupuncture, without adequate relief.  Botox treatment has been tried and has been of benefit.  Large phase III studies of Botox for treatment of individuals with chronic migraine, not on other preventives, treated with 155-195 Units, show definitive clinical and statistical benefit in reduction in of headache days in comparison to placebo. A responder rate (at least a 50% improvement in headache days) of nearly 70% was seen in patients treated with Botox. Thus, there is adequate evidence that Botox is more beneficial than placebo, and is clinically beneficial in the majority of patients.  The phase III trials of Botox for chronic migraine have shown higher responder rates than is seen in management of episodic migraine with standard oral preventives, suggesting that Botox may in fact be more effective than standard preventives even in individuals who have not tried and failed standard therapies.
Appeal type: Medical Necessity
Decision: Overturned

A 59-year-old female enrollee requested authorization and coverage of a referral to a dermatologist for the removal of a sebaceous cyst.  The health plan denied the enrollees request indicating that the requested referral is not medically necessary.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer overturned the health plans denial on the basis that the requested referral is medically necessary.