Persius/hicric huggingface dataset:
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Dupixent pen 300 mg/2 mL. The U.S. Food and Drug Administration (FDA) approves the use of Dupixent, an interleukin-4 receptor alpha antagonist, for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies. Boguniewicz and colleagues note that moderate-to-severe atopic dermatitis is defined as involving over 10% of body surface area (BSA) and/or involvement of highly visible areas or those that are important for function such as the hands, neck, face, and genitals, and significantly impaired quality of life. Seigels and colleagues note that the data supporting the safety and efficacy of the use of dupilumab (brand name Dupixent) in moderate-to-severe atopic dermatitis is substantial. Systemic cyclosporine is contraindicated in those with hypertension and kidney impairment, is immunosuppressive and associated with increased infection risk, and cannot be used long term due to these toxicities. In this case, the patient has hypertension and thus cyclosporine is not indicated. The use of methotrexate, an immunosuppressive, has been associated with increased hospitalization if a patient is infected with COVID-19, and immunosuppressives such as methotrexate, mycophenolate, azathioprine, and cyclosporine may reduce the response to vaccination. In this case, the patient has moderate-severe atopic dermatitis with 20% BSA involvement and has failed light treatment, Protopic, fluocinonide, ketoconazole, and triamcinolone acetonide. In this clinical setting, the use of the requested medication is medically indicated. Therefore, Dupixent 300 mg/2 mL pen is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is 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 dermatology 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Foundation One CDxTM comprehensive genomic profiling test (F1CDx). Molecular and biomarker testing has become an integral part the management of non-small cell lung cancer (NSCLC) as multiple targetable mutations help to inform on prognosis and direct therapy. Foundation One CDx comprehensive genomic profiling test can help identify these mutations. Guidelines by the National Comprehensive Cancer Network Guidelines (NCCN), American Society of Clinical Oncology (ASCO), and European Society for Medical Oncology (ESMO) for the management of NSCLC all recommend molecular and biomarker testing in this clinical setting. The U.S. Food and Drug Administration (FDA) lists NSCLC as an indication for F1CDx testing. Therefore, F1CDx was likely to have been more beneficial for evaluation of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the F1CDx at issue was likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the service at issue was likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in internal medicine with sub-specialty certifications in medical oncology 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Fasenra. The U.S. Food and Drug Administration (FDA) approves the use of Fasenra for the management of severe asthma in adults with an eosinophilic phenotype. The Global Initiative for Asthma (GINA) strategy for asthma management and prevention reports that benralizumab may be used to treat adult patients with severe eosinophilic asthma that is uncontrolled on standard therapies. In this case, the patient has an eosinophilic phenotype based on an elevated peripheral eosinophil count of 817. His asthma is inadequately controlled on standard therapy comprising of Breztri, a long-acting beta2-adrenergic agonist (LABA), dexamethasone, a synthetic adrenocortical steroid, and Jardiance. In this clinical setting, the requested medication is medically indicated for the management of the patients eosinophilic asthma. Therefore, Fasenra is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is 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 internal medicine with sub-specialty certification in pulmonary disease 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The enrollee has requested reimbursement and prospective authorization and coverage for hyperbaric oxygen therapy (HBOT). The patient has reported sudden hearing loss on 1/20/22. The patients provider recommended treatment with HBOT. However, the evidence in the medical literature supporting treatment of sudden hearing loss with HBOT remains limited. Hosokawa and colleagues evaluated the outcomes and prognostic factors in patients who presented with idiopathic sudden sensorineural (SSNHL) hearing loss. The authors reported that in patients who failed to respond to treatment with systemic steroids, HBOT provided small improvements in patients who were unresponsive to initial therapy. Overall, the authors reported a 9.6% chance of definitive improvement with HBOT. Pezzoli and colleagues noted a benefit with HBOT only in patients who started treatment within the first four weeks after onset of symptoms. The records document that this patient was started on HBOT seven weeks after onset of hearing loss. The peer-reviewed medical literature has not demonstrated the efficacy of HBOT more than four weeks after initial onset of symptoms. Given these findings, the 30 treatments of HBOT was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings: Two of the three physician reviewers found the 30 treatments of HBOT was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the services at issue were not and are 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: Physician reviewer 1 is board certified in otolaryngology and is actively practicing. Physician reviewer 2 is board certified in otolaryngology and is actively practicing. Physician reviewer 3 is board certified in otolaryngology and is 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: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for 15 stereotactic beam radiation therapy (SBRT) treatments. The National Comprehensive Cancer Network (NCCN) guidelines on the management of lung cancer endorse the routine use of local therapy in patients with EGFR mutated lung cancer who have oligoprogression. In a phase 3 study in patients with EGFR metastatic lung cancer, Wang and colleagues demonstrated a benefit from consolidative radiotherapy to sites of involvement in patients with metastatic disease. In this case, the patient has a single site of progressive disease without other sites of progression or development of distant metastases. Given that the patient meets criteria for oligoprogression, the patient is likely to benefit from local radiation to sites of involvement. Therefore, 15 SBRT treatments are likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested 15 SBRT treatments are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are in radiation oncology 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: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for DME - Volara System and supplies. Findings:  The physician reviewer found that Lee and colleagues report that patients with bronchiectasis experience chronic cough and sputum production and require the prescription of airway clearance techniques. Mucus clearance programs are the mainstay of treatment of bronchiectasis. While the Volara System assists in mucus clearance, there is insufficient evidence to support the use of the Volara System over alternative standard mucus clearance programs including those combining flutter valves, hypertonic saline, nebulizer bronchodilators, and/or vest therapy. Per the medical evidence, airway clearance systems such as the Volara System appear comparable to other airway clearance techniques, including vest therapy. Whether prescribed within a stable clinical state or during an acute exacerbation, there is insufficient evidence to support the Volara System as more beneficial than other available standard therapies. Therefore, DME - Volara System and supplies are not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested DME - Volara System and supplies are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested device and supplies are 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: Physician reviewers 1 and 2 are board certified in internal medicine with sub-specialty certification in pulmonary disease and in critical care medicine and are actively practicing. Physician reviewer 3 is board certified in internal medicine with sub-specialty certification in pulmonary disease and is 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for topical testosterone therapy. Shin and Park report that according to recent guidelines by the International Society for the Study of Aging Male (ISSAM), the European Association of Urology (EAU), the European Society of Endocrinology (ESE), the European Academy of Andrology (EAA), and the American Association of Urology (AUA), a total testosterone of 250 to 350 ng/dL is the proper threshold value to define low testosterone. Signs and symptoms suggestive of testosterone deficiency may include erectile dysfunction, loss of libido, fatigue, and decreased physical performance. Bhasin and colleagues note that the Endocrine Society clinical practice guideline on testosterone therapy in men with hypogonadism recommends that when clinicians institute testosterone therapy, the aim is to achieve testosterone concentrations in the mid-normal range during treatment. Mid-normal range testosterone level values are approximately 450 ng/dL. In this case, the patient has symptoms suggestive of testosterone deficiency, with laboratory testing results showing testosterone levels not yet at the appropriate therapeutic level at the mid-normal range and reports an improvement in symptoms with testosterone therapy. In this clinical setting, given that the patient continues to experience symptoms at the current testosterone level, the requested medication is medically indicated. Therefore, topical testosterone therapy is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is 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 urology 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Monovisc injection in the left knee. Findings: Per the medical literature, although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not known as to which individuals will benefit. The current evidence is limited, and guidelines from organizations such as the American Academy of Orthopedic Surgeons indicate that the evidence is not conclusive. In light of the foregoing, viscosupplementation can only be recommended in individuals with a history of lasting benefit from prior injections, and in carefully selected cases where everything else has been tried, and the options are limited. In this case, the patient has a history of post-traumatic osteoarthritis of the left knee. The patient has tried and failed other conservative measures including physical therapy, bracing, and Voltaren gel, with the alternative being a total knee arthroplasty. Given the patients limited options and based on the current medical literature, the requested service is medically indicated. Therefore, Monovisc injection in the left knee is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested service is 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for proton beam radiation therapy (66 Gy in 33 treatments). The use of proton beam radiotherapy in this patient with head and neck cancer can provide for more conformal radiotherapy compared to standard treatment with photons and may reduce the dose to critical organs at risk to toxicity (Baxi, et al.). In this case, the providers comparative planning shows significant decreases in the oral cavity dose and mandible dose with protons compared to standard treatment with photons. The reduction in radiation dose to these structures was expected to be associated with reduced long-term toxicities compared to treatment with photons (Leeman, et al.). Furthermore, the current guidelines also suggest that proton therapy can be considered in this patient population to reduce the potential for exposure to toxicities associated with treatment. Given this support, the proton beam radiation therapy (66 Gy in 33 treatments) was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings: Three of the three physician reviewers found the proton beam radiation therapy (66 Gy in 33 treatments) was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Final Result: The reviewers determined that the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer 1 is board certified in radiation oncology and is actively practicing. Physician reviewer 2 is board certified in radiation oncology and is actively practicing. Physician reviewer 3 is board certified in radiation oncology and is 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Stelara 90 mg/mL syringe to every four (4) weeks. Current medical literature supports dose escalation of Stelara to 90 mg every four weeks in this case. The mechanism of Stelara (ustekinumab) is entirely different than that of anti-tumor necrosis factor (TNF) medications, which the patient has failed. Ustekinumab has been demonstrated to be safe and effective for induction and maintenance of remission in patients with moderate to severe Crohns disease that was resistant to anti-TNF therapy. In a study of patients with anti-TNF resistant Crohns disease, Kopylov and colleagues observed an initial clinical response to subcutaneous ustekinumab in 73.7% of the patients. The study showed dosing at 90 mg every four weeks was used frequently to address inadequate disease control, and a large proportion of patients were able to maintain response with dose escalation to 90 mg every four weeks. Multiple studies have shown that a majority of patients in whom Stelara dosing every eight weeks failed to control symptoms responded to dosing every four weeks. In this case, the patient has disease symptoms consistent with active disease while taking Stelara every eight weeks. While a Stelara level of at least 4.5 ug/mL is associated with effective disease control, laboratory testing results reported a low Stelara level of 0.3 ug/mL. Continuation of dosing at every eight weeks or discontinuation of Stelara may result in loss of disease control, with complications such as fistula, stricture, bowel obstruction, flare, hospitalization, need for surgery, or other complications. Therefore, Stelara 90 mg/mL syringe to every four (4) weeks is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication regimen is 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 internal medicine with sub-specialty certification in gastroenterology 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: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Emgality 120 mg/mL syringe. In this case, the patient has a history of chronic migraines. The patients provider has recommended continued treatment with Emgality given the improvement in the frequency of the patients migraines. Per the American Headache Society (AHS), a patients records should document failure of oral preventative medications to support an indication for a calcitonin gene-related peptide (CGRP) monoclonal antibody agent such as Emgality. Every chronic migraine treatment plan should include both prophylactic treatment of reduction of headache days and severity and as-needed treatment of exacerbations. Current evidence-based prophylactic medications for episodic migraine include topiramate, gabapentin, tizanidine, fluoxetine, amitriptyline, and valproate. CGRP monoclonal antibodies 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, placebocontrolled trials. Emgality is an injectable preventive therapy approved for episodic and chronic migraine. Per the U.S. Food and Drug Administration (FDA), Emgality is a monoclonal antibody targeting CGRP. Overall, this patients records do not adequately document trials of oral preventative medications to meet the AHS criteria for treatment with Emgality. Therefore, the requested Emgality 120 mg/mL syringe is not medically necessary for treatment of this patient.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.