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

The parents of a nine-year-old male enrollee have requested  for speech therapy for treatment of his language disorder. Findings:  The physician reviewer found that this patient has been diagnosed with autism and has communication delays. Speech therapy is a frequently indicated treatment for autism.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Saxenda 3 mg/0.5 ml (18 mg/3 ml) pen injector. Findings:  The physician reviewer found that The medical literature supports the requested medication in this clinical setting.  Saxenda has been approved by the U.S. Food and Drug Administration (FDA) for treatment of obesity. The medication is approved as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30 or greater.  The medication may also be appropriate as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.  The patient has been diagnosed with morbid obesity, type 2 diabetes and dyslipidemia. Saxenda (liraglutide) is approved for the treatment of adults with BMI of at least 30 kg/m2 or a BMI of 27 kg/m2 if they had treated or untreated dyslipidemia, hypertension or prediabetes and was effective in weight loss in subjects without type 2 diabetes. While the documentation notes that the patient has not tried the formulary alternatives (sympathomimetic agents), there is not enough long term data on the safety of these drugs. Sympathomimetic drugs are not recommended for obesity management because of their potential side effects and short duration of use. This patient has a BMI greater than 57 kg/m2. As such, the requested authorization and coverage for Saxenda 3 mg/0.5 ml (18 mg/3 ml) pen injector is medically necessary for treatment of the patients medical condition.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 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: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested gene tests (CPT 81225, 81226, 81227, 81355, and 81401 for evaluation of his hypertension.   Three physician reviewers found that based on the records provided, the patient presented to his provider with some coronary risk given his diagnosis of hypertension but no documented symptoms or objective findings to suggest active coronary disease. In this circumstance, primary prevention guidelines for the management of cardiac risk and dyslipidemia have been established, are periodically updated by expert committees and are endorsed by several national organizations including the Expert Panel on Detection, Evaluation, and Treatment of High Blood Pressure in Adults. These guidelines currently do not recommend routine performance of specialized tests in the context of assessing coronary risk including lipoprotein-associated phosholipase A2 (Lp-PLA2), sub-classifications of LDL, HDL subclasses, lipoprotein (a), C-reactive protein, high sensitivity C-reactive protein, insulin, fibrinogen, homocysteine, Factor V Leiden mutation, Factor II mutation and other genetic testing for mutations that increase the risk for thrombosis and cardiovascular disease. In addition, treatment changes based on the results of screening with these specialized tests has not been shown to improve cardiac outcome incremental to that achievable by treatment based on standard risk factor profiling and basic lipid analysis. Thus, the gene tests (CPT 81225, 81226, 81227, 81355, and 81401) were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: Three reviewers determined that the services at issue were 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:  All three reviewers are board certified in internal medicine with sub-All three 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

The parent of a five-year-old female enrollee requested the medication Tarceva for medical treatment of the enrollees neurofibromatosis type 1 with extensive metastatic peripheral nerve sheath tumor.  Findings:  Two physician reviewers found that the requested medication is likely to be of greater benefit than other treatment alternatives.  This patient has a rare malignancy, and because the disease is rare, there is not an evidence base upon which to make firm, data-based management decisions.  Per the current medical evidence, there is biologic rationale for the proposed therapy.  This patients tumor is EGFR positive, and there are preclinical data that suggest EGFR positive tumors might respond to targeted therapy.  As this patient has exhausted standard therapies, the requested medication Tarceva is likely to be more efficacious than other alternatives.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the removal of tissue from the breasts performed for treatment of the enrollees gynecomastia. Findings:  The physician reviewer found that review of the submitted documentation and relevant literature fails to demonstrate the medical necessity of the procedure at issue. The patients pain and discomfort is not adequately supported in the medical documentation as likely due to distention and tightness from hypertrophied breast. In addition, the patients grade of gynecomastia is not adequately defined and photographs were not provided for review. The records do not demonstrate a concern for possible malignancy based on examination detail and other results. Other possible causes had not been sufficiently evaluated, including relevant laboratory studies and endocrine work-up. Therefore, the removal of tissue from the breasts performed has not been established as medically necessary for treatment of the patients. Final Result: The reviewers determined that the procedure at issue was not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one is board certified in plastic 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: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for the medication Botox for treatment of her headache disorder.Findings: Three physician reviewers found that the documentation submitted for review fail to indicate several diagnostic criteria important in the classification of chronic migraine as well as any history of treatment of her headache disorder with associated success or failure.  As per the International Headache Society Classification for Headache Disorders, chronic migraine is defined as occurring greater than 15 days per month for greater than three months, headache not attributable to another disorder, at least two characteristics of unilateral, pulsatile, moderate to severe in intensity, or aggravation by or causing avoidance of routine physical activity. Additionally, there must be one characteristic of nausea and/or vomiting, photophobia and phonophobia. Botox is a tool in the management of chronic migraine which has shown effectiveness in the PREEMPT trials.  However, there were significant criticisms of their outcomes including absolute gain of headache free days, primary efficacy end point of PREEMPT 2, which was only 2.3 days on average over a 28 week period, high placebo effect, and the trials enrolled a majority of subjects with concomitant medication overuse headache possibly confounding the results.  In a study by Mathew and Jaffri, they compared Topamax, Botox, and placebo in a double blind study where the authors concluded OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of chronic migraine. In a study performed by Cady and colleagues, the study also failed to show statistical significance between group differences for efficacy variables, such as reduction in pain intensity and reduction in analgesic doses in Botox versus topiramate. The evidence available and the limitations in the PREEMPT trials suggest that Botox is no better than standard available therapy.  Additionally, there is insufficient documentation to support this patient has met criteria for chronic migraine. There is also a lack of documentation to support that this patient has attempted and failed other drug classes, which may be equally as effective. For these reasons, the medication Botox was not and is not likely to be more effective than the standard methods for the treatment of this patients medical condition.Final Result: Three reviewers determined that the medication at issue was not and is 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 reviewers are board certified in neurology 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 32-year-old male enrollee has requested for a Le Fort I procedure for treatment of his jaw deformity. Findings:  The physician reviewer found that he has an anterior open bite, with no overlap of anterior teeth and a posterior cross bite.  As result of this, he has difficulty with mastication. The orthognathic surgery proposed consisting of a Le Fort I procedure is well-established.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for sildenafil 20 mg twice per day (BID), 60 per month for more than 12 months or indefinitely for treatment of her pulmonary hypertension and mixed connective tissue disease. Findings:  The physician reviewer found that the requested duration of sildenafil is not medically necessary for treatment of the patients medical condition. The Health Plan has authorized sildenafil 20 mg BID, 60 per month with 11 refills. The patient is seeking approval of sildenafil beyond 12 months or indefinitely. Approval of sildenafil beyond one year is not clinically indicated. The standard of care requires periodic follow-up evaluation of the patients symptoms in order to determine if continued treatment with sildenafil is appropriate. The patient will need to be evaluated for disease progression as measured by pulmonary function testing and spirometer. Final Result: The reviewer determined that the requested duration of 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 sub-specialty certification in rheumatology 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

A 50-year-old male enrollee has requested artificial disc replacement surgery (ProDisc) for treatment of his cervical radiculopathy.  Findings:  Three physician reviewers found that at this time, there is currently insufficient data to adequately assess the performance of total disc replacement. There is a lack of evidence indicating that disc replacement reliably, reproducibly, and over long periods of time fulfills the three primary aims of clinical efficacy, continued motion, and few adjacent segment degenerative problems. Total disc replacement has been associated with a high rate of re-operations, and the potential problems that may occur with longer follow-up have not been fully documented.  In this clinical scenario, standard procedure would be a single-level anterior cervical discectomy and fusion.  The safety and efficacy of a total disc arthroplasty in this setting has not been established.  There is a lack of truly blinded studies establishing the effectiveness of the requested procedure. Thus, the requested artificial disc replacement is not likely to be more beneficial than other available treatment options.
Appeal type: Experimental/Investigational
Decision: Upheld

A 38-year-old female enrollee has requested cyclophosphamide for the treatment of her systemic scleroderma. Findings:  Two physician reviewers found that this patient has scleroderma which is becoming more severe. She is quite ill and there are no guidelines for treatment in this particular setting. It is stated in the literature that Cytoxan for one year may be of some help in treating the lung disease associated with scleroderma. However, the patient has already received Cytoxan. In addition, there is no evidence that Cytoxan can improve the gastrointestinal involvement. All told, there is inadequate evidence that additional use of Cytoxan is likely to be efficacious in this setting.
Appeal type: Medical Necessity
Decision: Overturned

The patient has requested authorization and coverage for Saxenda or Wegovey. Mancini and De Melo describe liraglutide as a glucagon-like peptide 1 (GLP-1) receptor agonist that has emerged as an effective therapy for type 2 diabetes and obesity. The authors further note that as an adjunct to a reduced-calorie diet and increased physical activity, treatment with liraglutide 3.0 mg may provide statistically significant and clinically meaningful weight loss. Nuffer and Trujillo note that obesity treatment guidelines recommend the use of pharmacologic therapy in adults who have a BMI of 30 or higher. Given this patients history of obesity and as obesity may lead to the development of comorbidities such as diabetes and hypertension, the requested medication Saxenda is medically indicated. Therefore, Saxenda is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

The parent of a 13-year-old male enrollee has requested Increlex therapy for the treatment of the enrollees IGF-1 deficiency and short stature. Findings:  The physician reviewer found that the patients mid-parental height is 67.5. Given the patients height of 55 at a bone age between 11 and 1112 years, his predicted adult height should be 67.2 to 68.4 as assessed by the G & P Hand Atlas for average boys. Thus, with his delay in sexual maturation, he should attain his target height without intervention.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Otezla for treatment of her medical condition.  Findings:  The physician reviewer found that this patient presents with history of moderate to severe plaque psoriasis. She has been treated with topical steroids and Xtrac laser therapy without improvement. However, there is no documentation of the patient having been treated with methotrexate, cyclosporine, etanercept (Enbrel), or Humira. The patient does not have a documented contraindication or intolerance to any of these medications. Kutlubay and colleagues reported that cyclosporine is indicated for patients with severe plaque psoriasis. Prinz and colleagues noted that Enbrel offers a rapid and sustained response, flexibility of dosing, maintenance of response after dose reduction or interruption, and efficacy against non-skin manifestations such as psoriatic arthritis. All told, the requested Otezla is not medically necessary as she has not tried and failed or shown intolerance or contraindication to the preferred formulary medications.  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 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

A 63-year-old female enrollee requested authorization and coverage of continued physical therapy for the treatment of back and neck pain.  The Health Plan denied the enrollees request indicating that the requested treatment is not medically necessary.One physician reviewer performed a medical necessity Independent Medical Review.  The physician reviewer upheld the health plans denial on the basis that the requested services are not medically necessary for treatment of the patients medical condition.
Appeal type: Medical Necessity
Decision: Overturned

A 61-year-old female enrollee has requested Sovaldi and ribavirin for treatment of her hepatitis C. Findings:  The physician reviewer found that the submitted documentation establishes the medical necessity of the requested medications. Prior to the introduction of Sovaldi, treatment options for interferon ineligible HCV patients have been very limited. Compared to previously conventional agents, Sovaldi provides improved efficacy and tolerability, oral route of administration, and a shortened treatment duration requirement. For patients with HCV genotype 1 infection who cannot take interferon, the use of Sovaldi plus ribavirin may be considered as an alternative (Osinusi, et al). In addition, the joint treatment guidelines of the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommend the proposed regimen of daily Sovaldi and weight-based ribavirin for the retreatment of HCV genotype 1 infection in this clinical setting. In sum, based on the medical records submitted for review and the medical literature cited above, the patients request for Sovaldi and ribavirin is medically necessary. Therefore, the medical necessity of the requested medications has been established in this clinical setting.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Xifaxan (550 mg three times a day for 14 days with two refills). The records provided for review document that this patient has irritable bowel syndrome, diarrhea-predominant (IBS-D) and gastroesophageal reflux disease (GERD). The patient reportedly experienced symptomatic improvement with Xifaxan. Her provider has recommended a repeat course of treatment with Xifaxan. Per Pimentel and colleagues, Xifaxan has been demonstrated to be safe and effective for the treatment of IBS-D. The U.S. Food and Drug Administration (FDA) has approved Xifaxan for the treatment of IBS-D with repeat courses if needed, and the medication has proven safe and effective in randomized placebo-controlled trials for IBS-D (Schoenfeld, et al.). In the TARGET-3 trial, over 1,000 patients with IBS were treated with Xifaxan 550 mg three times daily with significant symptomatic improvement (Lembo, et al.). The American College of Gastroenterology (ACG) guidelines for the treatment of irritable bowel syndrome state that Xifaxan is an effective medication (Ford, et al.). In this case, the patient experienced a satisfactory response to Xifaxan, with recurrence of symptoms. Xifaxan has been demonstrated to be effective with repeat treatment courses. For these reasons, the requested Xifaxan (550 mg three times a day for 14 days with two refills) is supported as 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: Upheld

The parent of a 17-year-old male enrollee has requested residential treatment services for the treatment of the enrollees substance abuse and major depression. Findings:  The physician reviewer found that this young man has a history of polysubstance abuse, difficulty with anger management and acting out, and depression. His admission was his first attempt at residential treatment. There was no documentation of any prior psychiatric evaluation or substance abuse treatment or failure of prior outpatient treatment before the first visit. There was no documentation of trials of psychotherapy or medication for the depression. Upon admission, the patient initially was somewhat resistant to treatment but then became more engaged in the process. The patient had progressed through some stages of treatment involving working on his relationships with his family, and the documentation suggests the patient was expecting to return home with his family in early July following their visit. The documentation at that time showed progress in regulation of mood and compliance. However, there was little documentation of targeted treatment of the patients substance abuse, or its relation to his other problems. The Plan stated that the patients condition was such that continued outpatient treatment was appropriate. I concur with the Plans assessment. This indicates that the patient was able to regulate and improve his behavior when motivated. Following the Plans denial, the patient became more hostile and uncooperative. He expressed anger at having been left there. Subsequently the patient did not respond well to treatment. He was subsequently removed from treatment by his parents. There is no evidence to support that residential treatment beyond the last authorized date of service was medically necessary for this patient.