Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for transcatheter mitral valve leaflet repair, using the MitraClip Delivery System. Transcutaneous mitral valve repair is supported for patients with: chronic moderate-to-severe or severe mitral regurgitation; severely symptomatic heart failure despite medical therapy; favorable anatomy for the repair procedure; reasonable life expectancy; and prohibitive surgical risk due to comorbidities. This patient presents with a history of cardiomyopathy with severe mitral regurgitation and prior history of stroke radiation pneumonitis and fibrosis. The patient was not found to be a good candidate for surgery given her comorbid conditions. Due to her symptomatic mitral regurgitation and contraindication to open surgery, it is reasonable to repair the mitral valve percutaneously. Therefore, the transcatheter mitral valve leaflet repair, using the MitraClip Delivery System is likely to be more beneficial for treatment of this patients medical condition than any available standard therapy.Findings:  Three physician reviewers found the transcatheter mitral valve leaflet repair, using the MitraClip Delivery System is likely to be more beneficial for treatment of this patients medical condition than any available standard therapy.Final Result: The reviewers determined that the transcatheter mitral valve leaflet repair, using the MitraClip Delivery System is likely to be more beneficial for treatment of this patients medical condition than any available standard therapy.Credentials/Qualifications: Physician reviewer 1 is board certified in surgery with subspecialty certification in thoracic surgery and is actively practicing. Physician reviewer 2 is board certified in cardiovascular disease with subspecialty certification in interventional cardiology and is actively practicing. Physician reviewer 3 is board certified in internal medicine with subspecialty certifications in cardiovascular disease and interventional cardiology 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 Thick-It. The documentation provided for review reports that this patient has significant debility consistent with common manifestations of Pallister-Killian syndrome, including dysphagia and aspiration. He has been stabilized on Thick-It with Pediasure without documented recurrent aspiration pneumonia despite finding of aspiration with unthickened liquids on imaging in the past. While thickeners can decrease the risk of aspiration and pneumonia in patients with dysphagia, various thickeners have negative effects including increased viscosity resulting in increased residue or decreased palatability or treatment compliance, which are not an issue when the patient uses an alternative thickener. In this case, Thick-It has been demonstrated to be effective and without adverse effects that may occur if the supplement is switched to a less effective alternative. For these reasons, Thick-It is supported as medically necessary for the treatment of this patients dysphagia.Final Result: The reviewer determined that the requested dietary supplement 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: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for whole exome genetic testing (CPT 81416 x 2 and CPT 81415 x 1). Findings:  The physician reviewer found that whole exome sequencing is a comprehensive test which identifies changes in a patients DNA that are causative or related to their medical concerns. Sequencing the exome is an effective method of analyzing a patients DNA to discover the genetic cause of diseases or disabilities. Whole exome sequencing is a diagnostic test with high sensitivity and specificity. In a recent study by Soden and colleagues, 100 families with 119 children affected by neurodevelopmental disorders received diagnostic whole genome sequencing, or whole exome sequencing. Of the patients tested, 45% received a molecular diagnoses leading to a change in the clinical care or impression of the pathophysiology in 49% of newly diagnosed families. Moreover, the use of whole exome sequencing has been endorsed by the American College of Medical Genetics and Genomics for use in this clinical setting. In this case, prior genetic studies have failed to reveal a unifying molecular diagnosis to guide treatment and surveillance strategies. For these reasons, the requested whole exome genetic testing (CPT 81416 x 2 and CPT 81415 x 1) is likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy.One reviewer found that whole exome genetic testing (CPT 81416 x 2 and CPT 81415 x 1) is not likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy.Final Result: Two of the three reviewers determined that the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications:  One reviewer is board certified in pediatrics with subspecialty certification in genetics and is actively practicing. One Reviewer is board certified in pediatrics with subspecialty certifications in neurodevelopmental behavioral pediatrics and genetics and is actively practicing.  One Reviewer is board certified in pediatrics with subspecialty certifications in genetics and clinical biochemical genetics and is actively practicing.  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: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient is a female who requested authorization and coverage of Orencia ClickJect autoinjector. The Health Plan has denied the request for authorization and coverage of the medication Orencia ClickJect, indicating that Enbrel and Xeljanz or Xeljanz XR should be trialed before Orencia ClickJect. The U.S. Food & Drug Administration (the FDA) has approved abatacept (Orencia) for the treatment of patients with moderately to severely active RA who have had an inadequate response to one or more disease modifying anti-rheumatic drugs or tumor necrosis factor inhibitors (TNFi). (package insert; and Med Lett Drugs Ther).  Two Cochrane system reviews from 2009 and 2010 indicate that abatacept appears to be safe and efficacious. This medication appears to be most effective in certain subsets of RA patients. One subset includes patients with active RA who are resistant to either methotrexate (MTX) or the combination of MTX and anti-TNF agents. Another subset includes MTX-naive patients with early RA and poor prognostic indicators. These factors include patients who were methotrexate-naive and seropositive for rheumatoid factor, anti-cyclic citrullinated protein type 2, or both, and who had radiographic evidence of joint erosions.  In this case, the patient has a history of seronegative RA, positive ANA, Lyme disease, and GI issues. Given the patients GI issues, Xeljanz would not be recommended. The patient has failed treatment with two TNFi medications, Simponi and Humira. Given her Lyme disease, a TNFi would not be a preferred agent and Enbrel would not be recommended. The medical literature does not discuss the use of anti-TNF agents in patients with autoantibodies associated with lupus. The package insert recommends against the use of anti-TNF agents in patients with these autoantibodies. Orencia ClickJect does not have this concern or warning. Under these circumstances, Orencia ClickJect is medically necessary to treat 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 allergy and immunology, and internal medicine, with subspecialty 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: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A enollee has requested authorization and coverage for a non-invasive electrical bone growth stimulator. The Health Plan has denied this request indicating the requested device is not medically necessary for treatment of the patients right foot pain. Review of the submitted documentation does not support the medical necessity of the requested non-invasive electrical bone growth stimulator. The patient underwent magnetic resonance imaging (MRI) of a painful right foot. The MRI revealed an intrinsic, non-displaced, irregular fracture at the proximal segment of the right hallux tibial sesamoid. The study was reviewed with the patient, and a non-invasive electrical bone stimulator was recommended. The patient has requested coverage for a non-invasive electrical bone growth stimulator. The Health Plan has denied this request and reported that the requested device is not medically necessary for the treatment of this patient. The Centers for Medicare and Medicaid Services indicates that a non-invasive electrical osteogenesis stimulator is covered only if any of the following criteria are met: (1) nonunion of a long bone fracture defined by radiographic evidence that includes two sets of x-rays with multiple views, 90 days apart, confirming fracture healing has ceased for 3 or more months before starting treatment with the osteogenesis stimulator, or (2) failed fusion of a joint, other than in the spine, where a minimum of 9 months has elapsed since the last surgery, or congenital pseudoarthrosis. Bone growth stimulators are authorized for use on a long bone fracture. In this case, the MRI of the patients foot showed a fracture of the tibial sesamoid bone. This patients provider has recommended a non-invasive bone growth stimulator for the tibial sesamoid fracture. The tibial sesamoid is a small bone below the first metatarsal head and is not considered a long bone. The medical evidence does not support the requested device in this clinical setting. Therefore, the requested non-invasive electrical bone growth stimulator is not medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested device 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 podiatric medicine and is actively practicing. The reviewer is an expert in the treatment of the patients 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 genetic array genome testing. Studies show polycythemia vera is a condition where autonomous production of red cells proceeds in an unfettered manner. If not appropriately treated, polycythemia vera may result in serious vascular thrombotic consequences. The expected erythrocytosis in this condition may be masked in patients who are iron deficient. In such cases, when iron is replenished, the hematocrit will rise into the polycythemic range. The provider in this patients case recommended the JAK2 assay to assist in appropriate diagnosis and treatment. The clinic notes indicate the patients hemoglobin reached 16.8 g/dL at one stage, which supports an indication for testing, since guidelines suggest consideration for polycythemia vera in males with hemoglobin levels above 16.5 g/dL. Given these findings, the genetic array genome testing was likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy. Findings:  Three physician reviewers found the genetic array genome testing was likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy.Final Result: The reviewers determined that the genetic array genome testing was likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in internal medicine with sub-specialty certification 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 the medication Otezla for his diagnosis of plaque psoriasis. The Health Plan has denied this request, indicating that the requested services were not medically necessary for treatment of the patients medical condition. Psoriasis has a high negative impact on the quality of life, especially in patients moderately or severely affected by the disease. The long-term use of traditional systemic therapies is frequently unacceptable because of renal, hepatic, pulmonary toxicity and limited efficacy. Over the past several years, the use of anti-tumor necrosis factor biologic therapies for the treatment of moderate to severe psoriasis has been a major clinical and research focus. Despite several difficulties with documenting risks, some systemic treatments for psoriasis have been linked with an increased risk of selected cancers. In addition, patients treated with anti-TNF (Tumor Necrosis Factor) drugs may develop adverse events such as infections, acute infusion and injection reactions, autoimmunity and cardiovascular effects. It has been well-documented that therapies of psoriasis with injectable biologics increase the risk for malignancy and infection, mandating prior testing for tuberculosis. Apremilast (brand name Otezla), an oral PDE4 inhibitor, provides a novel therapeutic option for the treatment of patients with moderate to severe plaque psoriasis. Its effects on cyclic adenosine monophosphateregulated intracellular signaling, gene expression, and subsequent protein levels allow apremilast to modulate the immune responses that cause the inflammation associated with psoriasis. In this case, the patient has chronic plaque psoriasis that requires systemic treatment. The anti-TNF drugs recommended by the Health Plan can increase the risk for malignancy. Otezla is approved by the U.S. Food and Drug Administration (FDA) for treatments of such patients, and it has worked well for this patient. Final Result: The reviewer determined that the medical evidence supports Otezla in this clinical setting. Therefore, the requested medication, Otezla, is medically necessary for the treatment of the patients medical condition.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 been treated for chronic pain for several years. She has been treated with physical therapy, nerve blocks, acupuncture, and medication therapy. The patient has undergone multiple surgical interventions. The records noted that she is status post lysis of adhesions. She has had some response to hormone replacement and requires chronic narcotic use for pain control. The patient has requested authorization and coverage for deep excision laparoscopic surgery. The Health Plan has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.The submitted documentation fails to demonstrate the medical necessity of the requested services.  This patient has undergone multiple prior surgeries without benefit. There is no indication that a repeat surgery will provide benefit for the patients pain. There is literature describing the use of excision in areas categorized as deep excision as well as the lateral pelvis.  The role of laparoscopy for diagnosis is well substantiated, as is the role of excision for endometriosis. There is a lack of literature to support the use of repeated laparoscopy or surgical intervention in the setting of chronic pelvic pain. In this case, the records do not demonstrate that further surgical exploration is warranted. Pathology from surgery did not document endometriosis. The records noted microscopic endometriosis. Therefore, the requested deep excision laparoscopic surgery is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested services are 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 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: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A enrollee has requested reimbursement for gene panel testing. Per the American College of Obstetricians and Gynecologists (ACOG), expanded carrier screening does not replace previous risk-based screening recommendations. All patients who are considering pregnancy or are already pregnant, regardless of screening strategy and ethnicity, should be offered carrier screening for cystic fibrosis and spinal muscular atrophy . However, expanded carrier screening panel testing using next generation sequencing technology is not currently considered within the standard of care. There is a paucity of evidence in the peer-reviewed literature from large, randomized trials or high-quality prospective observational trials supporting the clinical utility and impact on patient management of expanded carrier screening panels using next generation sequencing. Moreover, these panels have significant limitations, including increased false positives and variants of unknown significance. Specific screening may be indicated based on a patients family history or specific ethnicity. However, this patients records do not include clinical documentation of any family history or ethnic risk factors. For these reasons, the gene panel testing was likely to be more beneficial for evaluation of this patients medical condition than available standard therapy, while others were not likely to be more beneficial for evaluation of this patients medical condition than available standard therapy.One reviewer found that the gene panel testing was not likely to be more beneficial for evaluation of this patients medical condition than available standard therapy.Final Result: Two of the three reviewers determined that a portion of the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be partially overturned.Credentials/Qualifications:  One reviewer is board certified in obstetrics and gynecology and is actively practicing. One Reviewer is board certified in obstetrics and gynecology and is actively practicing.  One Reviewer is board certified in obstetrics and gynecology and is actively practicing.  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: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollees parent has requested reimbursement for leukocyte histamine release testing measures the amount of histamine released in vitro. Allergen extracts are added to the peripheral blood leukocytes of the patient being tested. Histamine is normally released as a consequence of the interaction of allergen with cell-bound immunoglobulin E (IgE) antibodies. If a patient is hypersensitive to a specific antigen, the leukocytes will release the histamine in vitro. However, there is a lack of peer-reviewed medical literature to support the clinical utility of this testing for diagnosis of this patients medical condition. The current standard of care to diagnose an autoimmune type of chronic urticaria, as suspected in this patient, includes a test measuring the presence of autoantibodies against the receptor to the constant region of IgE on mast cells and basophils. For these reasons, the leukocyte histamine release testing was not likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy.Findings:  Three physician reviewers found the leukocyte histamine release testing was not likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy.Final Result: The reviewers determined that the leukocyte histamine release testing was not likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in dermatology 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.