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 dosage escalation of Entyvio 300 mg IV infusion to every four weeks. The request to continue Entyvio 300 mg every four weeks is supported as medically necessary for the treatment of this patients Crohns disease. In two randomized placebo-controlled trials, which supported U.S. Food and Drug Administration (FDA) approval, Entyvio was part of a study protocol for patients who had not achieved remission despite six weeks of treatment and continued Entyvio every four weeks rather than every eight weeks. The American Gastroenterological Association (AGA) indicated that for patients with Crohns disease, Entyvio every four weeks resulted in remission in over 36% of patients after one year. In addition, studies have shown that insufficient Entyvio dosing can result in uncontrolled disease and related complications. Per the American College of Gastroenterology (ACG) guidelines for the treatment of Crohns disease, patients with continued symptoms should have their medication dose adjusted in order to attempt to optimize therapy. For this patient, continued treatment with dose intensification is appropriate for infusion every four weeks. The patient has severe Crohns disease given history of surgery including an ileocecal anastomosis. Since the patients disease was uncontrolled on colonoscopy while on Entyvio, a dose decrease, discontinuation, or change to an alternative would place the patient at risk for complications of uncontrolled disease. For these reasons, the requested dosage escalation of Entyvio 300 mg IV infusion to every four weeks is medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested medication dosage 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 subspecialty 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: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Humira. Current medical literature supports the requested Humira to be used as dual biologic therapy with Stelara for the treatment of this patients Crohns disease. The patients disease is severe and complicated by fistula. The patient has failed treatment with multiple primary therapeutic medication classes recommended by guidelines for the treatment of Crohns disease. In addition, the patient is already on dose-escalated Stelara. Several studies have assessed the use of dual biologic therapy including Stelara. In this case, the patient demonstrated improvement on Stelara, although colonoscopy showed ongoing inflammation and he has reported ongoing symptoms. A continuation of current therapy could result in additional complications of uncontrolled disease and the patients alternative options are limited. In this clinical setting, the requested therapy with Humira in combination with high-dose Stelara is appropriate for the treatment of this patients Crohns disease. Therefore, the requested Humira is medically necessary for 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 subspecialty 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: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Fiasp 20 units per day and Tresiba 12-14 units per day. Type 1 diabetes is a chronic autoimmune disease characterized by insulin deficiency and resultant hyperglycemia. Although insulin remains the mainstay of therapy, new insulin analogues with varying onsets and durations of action are widely available. Optimal glycemic control requires multiple-dose insulin regimens that mimic physiological insulin release, with basal insulin for overnight and between-meal control, plus bolus doses of rapid-acting insulin analogues to cover ingested carbohydrate loads and treat hyperglycemia. To optimize glycemic control, new insulin options have been introduced for routine patient use. Basal insulin analogs with longer duration, such as Tresiba, have demonstrated efficacy in maintaining metabolic control without hypoglycemia, especially during the night. Likewise, new ultra-rapid prandial insulin analogs, such as Fiasp, have led to better postprandial glycemic control reducing hyperglycemia in the early post-prandial phase. This patient requires approximately 12 to 14 units of Tresiba and 20 units of Fiasp per day in order to optimize her glycemic control for her type 1 diabetes. The provider reports that the patient has been treated with Fiasp 4-6 units per meal and Tresiba 12 units per day with Farxiga 5 mg per day with reasonable control of her diabetes. Given these findings, the requested Fiasp 20 units per day and Tresiba 12-14 units per day are medically necessary for 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 subspecialty 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: Upheld Decision of Health Plan

Findings:  The physician reviewer found that The patient has requested authorization and coverage for intravenous immunoglobulin (IVIG) Gammagard. Small fiber polyneuropathy has various underlying causes including associations with systemic autoimmune conditions. As noted in the medical literature, IVIG is considered a first-line treatment for patients with immune-mediated neuropathies such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy. In a retrospective study by Liu and colleagues, 55 patients with objectively confirmed small fiber polyneuropathy attributed to autoimmunity were treated with IVIG for more than three months. The authors concluded that the results provide Class IV evidence demonstrating that IVIG is safe and effective for well-selected small fiber polyneuropathy patients with apparent autoimmune causality. In this case, the patient has small fiber neuropathy. Based on the study by Liu and colleagues, IVIG may be beneficial in patients with small fiber neuropathy secondary to an autoimmune disorder. However, the records provided for review do not include evidence of an autoimmune cause for this patients small fiber neuropathy. Based on the study by Geerts and colleagues, IVIG had no significant effect in patients with idiopathic small fiber neuropathy. Given these findings, the requested IVIG Gammagard 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.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Orthovisc injections in both knees. An exhaustive review of the current medical literature pertaining to viscosupplementation reveals mixed results. Evidence from eight systematic reviews and six randomized controlled trials indicates that although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not known as to which individuals will benefit. Different studies have tried mixing hyaluronic acid with corticosteroids, platelet-rich plasma, and other agents to make it more effective. 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, there is a history of good results from prior Orthovisc injections. There is sufficient support for the requested services in this clinical setting. Therefore, Orthovisc injections in both knees are medically necessary for the 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollees parent has requested authorization and coverage for Xeljanz 5 mg twice daily. The treatment of patients with alopecia areata is largely based on provider preference as there is lack of standard therapies approved by the U.S. Food and Drug Administration (FDA) for this indication. This patients provider has recommended treatment with Xeljanz, which is a JAK inhibitor. In addition, per clinical notes reviewed from the provider, the patient has tried and failed treatment with topical steroids, intralesional Kenalog, topical anthralin, topical tofacitinib, and topical minoxidil. There are several large case series reported in the literature demonstrating improvement of alopecia with Xeljanz treatment (Ibrahim, et al.; Liu, et al.). Since this patients morphea is currently controlled, continued treatment with methotrexate is not indicated. Considering that the patient has failed treatment with topical steroids, treatment with Xeljanz is appropriate. Therefore, the requested Xeljanz 5 mg twice daily is 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 requested Xeljanz 5 mg twice daily is 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 medication is 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 dermatology and is actively practicing. Physician reviewer 2 is board certified in dermatology and is actively practicing. Physician reviewer 3 is board certified in dermatology 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

Findings:  The physician reviewer found that An enrollee has requested reimbursement for Panzyga intravenous immunoglobulin (IVIG) 1 gm/kg over one day every two weeks. McGrath and colleagues noted that although corticosteroids are considered first-line therapy for anti-synthetase syndrome, IVIG is increasingly being used as initial therapy in patients with immune-mediating necrotizing myopathy. Kocoloski and colleagues reported that IVIG was associated with marked improvement in immune-mediated necrotizing myopathy patients, with 85% of patients meeting clinically significant response endpoints. Moreover, the authors found a substantial reduction in dose of prednisone required in patients treated with IVIG at six months. This patient was previously treated with IVIG with good results. The patient has also undergone treatment with multiple therapies without adequate response including methotrexate, hydrochloroquine, and rituximab. The patient was retreated with IVIG with a change in the administration. The medical literature supports treatment with IVIG as administered in this case to manage the patients anti-synthetase syndrome. Accordingly, Panzyga IVIG 1 gm/kg over one day every two weeks 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 Panzyga IVIG 1 gm/kg over one day every two weeks 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.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for Femring 0.05 mg/24 hour vaginal ring. As noted in the medical literature, postmenopausal female patients should be treated for their symptoms. HRT in the form of estrogen and progesterone is the most studied form with ample data on its advantages and disadvantages. The preferred form of estrogen is 17 beta-estradiol, which is structurally identical to the main estrogen produced by the ovary, and this is the estrogen contained in Femring. In this case, the patients provider reports that the benefits of using HRT outweigh the risks of discontinuation. The provider reported concern over the patients significant mood deterioration without Femring treatment. The provider also noted that the patient has been treated with other formulations with a variety of adverse side effects. Per the North American Menopause Society (NAMS) recommendations, although some data suggest that HRT should be discontinued at the age of 60 to decrease cardiovascular risk, this recommendation may be modified when appropriate, as in the case of this patients vasomotor symptoms. For these reasons, Femring 0.05 mg/24 hour vaginal ring was and is medically necessary for treatment of this patient. Final Result: The reviewer determined that the medication at issue was and 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 obstetrics and gynecology 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 patients parent has requested authorization and coverage for Dupixent. Findings: The U.S. Food and Drug Administration (FDA) approves the use of Dupixent, an interleukin-4 receptor alpha antagonist, for the treatment of patients aged six years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. One study notes that moderate-to-severe atopic dermatitis is defined as involving over ten percent of 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. Another study notes 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 is not recommended for younger children. 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 provider reports that the patient has moderate-to-severe atopic dermatitis affecting over ten percent of his BSA. The patient had tried and failed topical steroids including betamethasone, tacrolimus, Eucrisa, Opzelura, and prednisone, a systemic steroid. In this clinical setting, the requested medication is medically indicated. Therefore, Dupixent 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: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Talicia. Findings: Based on the available records reviewed, the requested treatment with Talicia is not medically necessary for treatment of this patient. There is a lack of documentation of attempt and failure of a first-line therapeutic regimen as recommended by American College of Gastroenterology (ACG) and American Gastroenterological Association (AGA) guidelines with a proton pump inhibitor with clarithromycin and metronidazole or regimen with a proton pump inhibitor with levofloxacin, bismuth, and metronidazole. Additionally, these guidelines recommend penicillin allergy testing in certain cases, as a negative penicillin allergy test allows multiple amoxicillin regimens to be considered. A rifabutin-based salvage regimen with Talicia, as requested in this case, is supported for patients after other treatment failures. Since this patient has not reportedly attempted and failed first-line therapy, the medical literature and guidelines do not support treatment with Talicia. Therefore, the requested Talicia 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 internal medicine with subspecialty 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: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Besremi injections. The U.S. Food and Drug Administration (FDA) describes Besremi, ropeginterferon alfa-2b, as an interferon alpha-2b that is indicated for the treatment of adults with polycythemia vera. In a Phase III, randomized controlled trial, Gisslinger and colleagues reported that ropeginterferon alfa-2b was effective in inducing hematological responses that continued to increase over time with improved responses compared with hydroxyurea at 36 months. The authors concluded that considering the high and durable hematological and molecular responses and its good tolerability, ropeginterferon alfa-2b offers a safe long-term treatment option with features distinct from hydroxyurea. Given that current medical literature supports the use of Besremi in this clinical setting without requiring the failure of prior therapy, the requested services are medically indicated. Therefore, Besremi injections are medically necessary for the 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 internal medicine with sub-specialty certifications in medical oncology and in hematology 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 Entresto. Findings: The records provided for review document that this patient presents with a history of sudden cardiac death and sustained ventricular tachycardia. The patient has been treated with an implantable cardioverter defibrillator (ICD) as well as medical therapy with losartan and metoprolol. The patients provider has recommended a change in medications from losartan to Entresto. In the medical literature, a study noted that the PARADIGM-HF study demonstrated benefits of treatment with Entresto to be consistent across a broad range of heart failure subgroups, including patients with clinically stable heart failure, as in this patients case. The authors found that Entresto improved patients quality of life and longevity as well as reduced hospital admissions. The authors concluded that Entresto has been shown to reduce the risk of cardiovascular death or heart failure hospitalization and improve symptoms among patients with chronic heart failure with reduced ejection fraction compared to enalapril, the gold standard angiotensin-converting enzyme inhibitor. The findings of the PARADIGM-HF study support the efficacy of treatment with Entresto for this patient given her history of sudden cardiac death and sustained ventricular tachycardia. For these reasons, the requested Entresto is medically necessary for 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 subspecialty certification in cardiology 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.