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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Harvoni for 12 weeks for treatment of the enrollees hepatitis C virus. Findings:  The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. The guidelines recommend that non-cirrhotic treatment-naive genotype 1 patients should be treated with Harvoni for 12 weeks. These recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA)-approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage. Zepatier for 12 weeks is also a recommended regimen, without a requirement for NS5A resistance testing in genotype 1b, and the guidelines recommend either Harvoni or Zepatier as acceptable therapy. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. Given the lack of documentation showing that Zepatier has been authorized for this patient, treatment with Harvoni for 12 weeks is medically necessary for the treatment of this patients hepatitis C infection. 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 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: Experimental/Investigational
Decision: Upheld

A 61-year-old female enrollee has requested Rituxan therapy for the treatment of her Polyarteritis Nodosa (systemic vasculitis). Findings:  Three physician reviewers found that Rituximab is appropriate in cases in which there is clear evidence of continuing active necrotizing vasculitis despite treatment with virtually all other conventional agents. There is significant case-report evidence of the effectiveness of rituximab in treating ANCA associated vasculitides, and less substantial, but still meaningful evidence of its effect in treating PAN. In the case of this patient, the submitted records do not present evidence that the requested rituximab treatment is appropriate, as the patients current diagnosis and degree of disease activity are not substantiated in the medical documentation provided.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for blood testing (lipoprotein) for evaluation of the enrollees hyperthyroidism. Findings:  Three physician reviewers found that based on the documentation provided for review, the patient underwent advanced lipoprotein testing including lipid sub-fractionation. Current guidelines currently do not recommend routine performance of specialized tests in the context of assessing coronary risk. Treatment change or addition 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. In addition, even though results of some of these specialized tests may be abnormal and considered independent risk markers for coronary disease, there is a lack of controlled trials that demonstrate outcome benefits by treating routinely obtained abnormal results. Therefore, the blood testing (lipoprotein) was not likely to be more beneficial for evaluation of the patients medical condition than available standard therapy. Final Result: The reviewers determined that the testing at issue was 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 physician reviewers 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for treatment of his hepatitis C virus. Findings: The physician reviewer found that according to the joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. The guidelines recommend that treatment-naive genotype 1 patients should be treated with Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA)-approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, the requested treatment with Harvoni for 12 weeks is medically necessary for the treatment of this patients hepatitis C infection.  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 physician 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

The parent of a four-year-old male enrollee has requested an augmentative and alternative communication device for the treatment of the enrollees autism. Findings:  Two physician reviewers found that a child must be able to understand and express language in order for an AAC device to be helpful (Rhea Paul). As such, the Health Plan criterion requiring that the patient have comprehension and expression of language equivalent at least to that of a five-year-old is appropriate and consistent with the standard of care. Based on this patients age and developmental delays, he does not meet this criterion. Furthermore, as the Health Plan indicates, a patient should complete two years of therapy without improvement before being considered for an AAC device. In the case of this patient, the submitted evidence demonstrates the patient has been experiencing modest improvement and does not appear to have plateaued. All told, the patient is not an appropriate candidate for an AAC device at this time.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:The parent of an enrollee has requested authorization and coverage for Avastin/Bevacizumab infusion therapy services.Recurrent respiratory papillomatosis (RRP) is an airway neoplasm which is caused by human papillomavirus types 6 and 11. RRP is the most common benign neoplasm of the larynx among children and the second most frequent cause of childhood hoarseness. After changes in voice, stridor is the second most common symptom, first inspiratory and then biphasic. Less common presenting symptoms include chronic cough, recurrent pneumonia, failure to thrive, dyspnea, dysphagia, or acute respiratory distress, especially in infants with an upper respiratory tract infection. Often misdiagnosed, RRP may result in severe airway obstruction and death due to delayed diagnosis. Despite its mostly benign nature, RRP may cause significant morbidity and mortality because of its unpredictable clinical course and especially its tendency, albeit infrequent, for malignant transformation. Hence, treating RRP is an absolute medical necessity and can be life-saving.Bevacizumab has been shown to be effective in small clinical trial and case series. Bevacizumab acts by selectively binding circulating vascular endothelial growth factor (VEGF), thereby inhibiting the binding of VEGF to its cell surface receptors. This inhibition leads to a reduction in microvascular growth of tumor blood vessels and thus limits the blood supply to tumor tissues. Vascular endothelial growth factor-A (VEGF-A) is known to play an important role in the angiogenic response essential for tumor growth in a variety of human and experimental tumors. VEGF-A may play a role in the pathogenesis of recurrent respiratory papillomatosis (RRP). Many pediatric case series have demonstrated rapid response to the bevacizumab and with recurrence free survival. Furthermore, frequent debridement in the airway can cause other secondary issues such as tracheomalacia and broncopleural fistula. Treatment with bevacizumab can help patients avoid such complications in the airway. In this case, this pediatric patient has a diagnosis of RRP and has required regular surgical debridement for recurrent papillomae. The medical literature supports the use of bevacizumab to treat RRP under these circumstances. Accordingly, the requested Avastin/Bevacizumab infusion therapy services are medically necessary to treat the patients medical condition.Final Result: The reviewer determined that the requested medication is medically necessary to treat the patient's medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in pediatrics, with subspecialty certification in pediatric pulmonology, 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 three-month-old male enrollee has requested brand Daptacel T-dap vaccine for treatment of the enrollees unremarkable medical history.  Findings:  The physician reviewer found that based upon the current medical literature, there is a lack of evidence demonstrating that this patient should receive the requested brand Daptacel instead of Infanrix. The media has been fraught with concerns regarding the presence of aluminum in some vaccines. There are discussion about the amount of aluminum in injectables and the effects on children. Those at most risk for aluminum toxicity are extremely premature infants and those with inadequate kidney function. However, there is little information in the literature about the effects of aluminum in vaccines.  Daptacel contains 330mcg per dose, and Infanrix contains 625mcg per dose.  The amount of aluminum adjuvant in Infanrix is considered to be safe. The literature does not support the use of one vaccine over another in a healthy infant.  All told, the requested brand Daptacel T-dap vaccine is not medically indicated in this patients case.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested authorization and coverage for Trulicity 0.75 ng.0.5 pen injector. Findings:  The physician reviewer found that the American Diabetes Association (ADA) support the additional of a second oral agent, a glucagon-like peptide 1 receptor agonist, or basal insulin if noninsulin monotherapy at maximum tolerated dose does not achieve or maintain the A1C target after three months. Trulicity is a glucagon-like peptide 1 (GLP-1) receptor agonist (GLP-1RA). It is one of the noninsulin agents in the algorithm for the pharmacological treatment of diabetes. The combination of insulin plus a GLP-1RA has been used for a long time to address the metabolic defects of diabetes. Many studies document the efficacy of the combination of basal insulin plus a GLP-1RA for use in this clinical setting. Studies noted that GLP-1 analog and basal insulin combination treatment can enable achievement of the ideal trifecta in diabetic treatment: robust glycaemic control with no increased hypoglycaemia or weight gain. This combination is thus a potential therapeutic strategy that could improve the management of patients with type 2 diabetes. This patient has been trying to control her diabetes for many years. The patient has a documented contraindication to metformin with reported an adverse effects. Experts in diabetes management know that pioglitazone and insulin are responsible for weight gain, which was the case here, and fluid retention. Sulfonylureas are not very effective in a patient already on short acting insulin and can cause hypoglycemia. The addition of Trulicity to the basal insulin regimen is the best choice for this patient that has uncontrolled diabetes, obesity, and risk of hypoglycemia. Thus, the Trulicity 0.75 mg/0.5 pen injector to the current regimen is medically necessary for the treatment of this patients diabetes. 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: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Harvoni 90-400 mg tablets for 12 weeks for treatment of the enrollees chronic hepatitis C virus genotype 1a. Findings:  The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. The guidelines recommend that treatment-naive genotype 1a patients should be treated with Harvoni for 12 weeks. These recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage. The AASLD and IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, the requested treatment with Harvoni 90-400 mg daily for 12 weeks is supported as medically necessary for the treatment of this patients hepatitis C infection. 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 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 patient has requested authorization and coverage for magnetic resonance imaging (MRI) of the eye, face, and neck before and after contrast. An addendum states that there was slight irregularity of the distal left optic nerve on one slice. The recommendation was for an ophthalmology examination and if clinically indicated, an MRI of the orbits with and without contrast. The provider diagnosed the patient with positional vertigo and found no objective evidence of organic visual disturbance. Specifically, the provider stated there was no clinical indication for MRI of the orbits. Detailed historical and physical examination revealed no sign of parasitic infection related to the orbits and no evidence of optic neuritis. The clinical examination conducted by ophthalmology stated that there was no indication for MRI of the orbits. Therefore, the requested MRI of the eye, face, and neck before and after contrast is not medically necessary for this patient. Final Result: The reviewer determined that the requested services are 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 diagnostic radiology 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

Nature of Statutory Criteria/Case Summary:An enrollee has requested authorization and coverage for Vemlidy for treatment of the enrollees hepatitis B virus.Findings:  The physician reviewer found that the guidelines for the treatment of hepatitis B from the American Association for the Study of Liver Disease (AASLD) recommend entecavir and tenofovir compared with alternatives for the treatment of chronic hepatitis B. Entecavir has failed due to resistance. In comparison with tenofovir disoproxil fumarate, Vemlidy formulation of tenofovir is effective for hepatitis B, but is associated with fewer side effects, including osteopenia and renal disease. Final Result: The reviewers 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 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

A 53-year-old female enrollee has requested an MRI of the breast for an evaluation of her breast cancer. Findings:  The physician reviewer found that there were suspicious (though probably benign) lesions seen on routine ultrasound in the breast, which had previously been diagnosed with cancer. The MRI was apparently used to further define the necessity of biopsy. The MRI could not preclude malignancy and therefore a biopsy was recommended. The difficult issue is whether this lesion should have been biopsied just on the basis of the ultrasound, making the MRI unnecessary. Certainly MRI has been used in this type of situation and indeed in the article by Orel, et al. there is discussion of such situations. While MRI is not definitive (as there are false negatives), taking into account all of the clinical factors, the use of an MRI here does appear to have been a medically reasonable and appropriate attempt to avoid biopsy and as such, was necessary in this case.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for an increase of Applied Behavior Analysis (ABA) hours from 96 hours per month to 103 hours per month going forward. Findings:  The physician reviewer found that ouncil of Autism Service Providers (CASP) guidelines recommend service provision of 25 hours or less of Applied Behavior Analysis (ABA) services for individuals who need treatment only for a limited number of key functional skills. Papatola and Lustig define medically necessary ABA services as, (a) required to meet the essential health needs of the patient; (b) consistent with the diagnosis of the condition for which they are required; (c) consistent in type, frequency, and duration of treatment with scientifically based guidelines as determined by medical research; (d) required for purposes other than the convenience of the provider or the comfort of the patient; and (e) rendered in the least intensive setting that is appropriate for the delivery of health care.In this case, the ABA service provider is targeting 24 goals, in addition to 3 challenging behaviors (and 3 additional behaviors with the caregivers). With 27 active goals being addressed, the requested increase of ABA hours will allow each program to be addressed for approximately 12 to 15 minutes each day. Given the breadth of treatment that the patient is receiving, the requested increase of ABA hours from 96 hours per month to 103 hours per month is warranted. Accordingly, an increase of Applied Behavior Analysis (ABA) hours from 96 hours per month to 103 hours per month going forward is medically necessary for the patients medical condition.Final Result: The reviewer determined that the requested services are medically necessary for the patient's medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is a licensed psychologist who is a board certified behavior analyst 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 patient is a 43-year-old female with asthma who has requested authorization for a portable nebulizer. The patient apparently did not tolerate metered dose inhalers having had an adverse reaction possibly because of the propellant. The patient is seeking a portable nebulizer because she is concerned about asthma exacerbations and not being able to utilize her standard, plug-in nebulizer. The Health Plan has denied the patients request.The information submitted does not demonstrate a portable nebulizer is necessary. Prior to consideration of a portable nebulizer there needs to be further information documenting the patients inability to utilize a metered dose inhaler. The patient needs to be re-evaluated by her treating provider to assist in determining the best treatment options for the patient. Because of the lack of documentation demonstrating the need for a portable nebulizer, I have determined the requested equipment is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.