Persius/imr-appeals huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the FoundationOne gene test received for the evaluation of the enrollees metastatic low grade mucinous appendiceal adenocarcinomaFindings:  Three physician reviewers found that the patient was diagnosed with a metastatic low grade mucinous appendiceal adenocarcinoma. Per the January 2015 pathology report, multiple abdominal tumors were noted as consistent with a low grade mucinous carcinoma peritonei. Appendectomy was consistent with a low grade mucinous neoplasm. A clinic note reports that the patient presented 10 weeks status post palliative debulking surgery, distal gastrectomy with Billroth II gastrojejunostomy, small bowel resection, total splenectomy, cholecystectomy, appendectomy, complete peritonectomy right hemidiaphragm, and abdominal wall resection with excision of tumor of sigmoid colon.  Appendix cancer is a rare cancer. The prognosis and treatment is closely associated with histologic characteristics. Histologic types include mucinous, intestinal/colonic type, and signet ring. These tumors also have been characterized by their mitotic rate. Signet ring cell types and poorly differentiated/high grade have been associated with poorer prognosis. Prognostic features currently appear to be based on histologic and not specific genomic or proteomic profiles. The role of adjuvant chemotherapy is unknown due to the rarity of the disease. There are currently no standard guidelines, and the use of systemic therapy is extrapolated from colon adenocarcinoma guidelines. Commonly, the types with high-grade features/signet ring will undergo adjuvant fluorouracil based therapy after surgery. From the pathology report, the primary site of disease was the appendix and therefore molecular profiling would not be needed to clarify this. Current therapeutic options are not clearly outlined and therefore it is unclear of what utility the molecular profile would provide in determining treatment options. Final Result: Three reviewers determined that the testing was not likely to have been 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 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

A 27-year-old female enrollee requested authorization and coverage for bilateral breast resection of lateral tissue. 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 overturned the health plans denial on the basis that the requested procedure is medically necessary for treatment of the patients medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested cervical total disc arthroplasty for treatment of his medical condition.  Two physician reviewers found that the submitted documentation fails to demonstrate the superior efficacy of the requested services.  There are general concerns regarding cervical artificial disc replacement.  Studies of longer duration are needed to assess the longer term potential complications of a methyl methacrylate arthroplasty within the cervical spine.  It is known that the metal to methyl methacrylate bearing surface will be exposed to the wear mechanisms of abrasion, adhesion, fatigue and third body wear.  A continuing particulate load of these particles will occur.  The patients specific response will be influenced by the response of the immune system, but it is known that there is a universal giant cell reaction and chronic inflammation in response to wear debris.  Additionally, it remains controversial whether motion at the replaced intervertebral disc will be maintained over time.  The question of whether total disc arthroplasty as compared to arthrodesis will be beneficial in terms of adjacent segment degeneration remains controversial both by reason of gradual loss of motion at the arthroplasty index site and by the possibility that adjacent segment degeneration is an expression of a progressive disease process rather than a complication of arthrodesis itself.  All told, the requested cervical total disc arthroplasty is not likely to be of greater benefit than other treatment options.   Final Result: Two reviewers determined that the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications: All three reviewers are board certified in orthopedic surgery and are 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: Upheld

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with Crohns disease and axial spondyloarthropathy. The provider noted the patient has tried and failed treatment with Remicade, Humira, and Cimzia. She underwent laparoscopic ileocolic resection with creation of an end-ileostomy and drainage of a perianal access. The patient was taking Stelara 90 mg every four weeks. The patient reported her current ankylosing spondylitis symptoms were acceptable. The patient has requested authorization and coverage for Rinvoq extended release 15 mg tablet. The Health Plan denied the request and reported the requested medication is not medically necessary for the treatment of this patient. At issue in this case is whether Rinvoq extended release 15 mg tablet is medically necessary for the treatment of the patients medical condition. Serhal and Edwards reported that upadacitinib is U.S. Food and Drug Administration (FDA) approved for the treatment of rheumatoid arthritis. Axial spondyloarthropathy includes both sacroiliitis and spinal arthropathy. Ward and colleagues did not include upadacitinib as a treatment option for axial spondyloarthropathy. In this case, the patient was diagnosed with Crohns disease with axial spondyloarthropathy. The patient has tried and failed Remicade, Humira, and Cimzia; however, there are no details provided regarding the duration of therapy and compliance with these medications. The medical evidence does not support the requested medication in this clinical setting. Therefore, upadacitinib (Rinvoq) extended release 15 mg tablet is not medically necessary for 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 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: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested psychiatric residential treatment center services for treatment of the enrollees behavioral health condition. Findings: The physician reviewer found that the residential treatment center services provided were initially medically necessary for treatment of the patients medical condition, but not thereafter. The patient was not a danger to herself or others. She was not engaged in treatment, had cravings, and had made the statement that she would return to drinking, representing a risk given her level of defensiveness and lack of insight and judgment at that point in her treatment. Family therapy was in the early stages as well, again, given the patients lack of engagement in the therapeutic processes. At this point in time returning her to her environment may in fact have undermined treatment as she had not yet begun to develop interest or coping strategies. The patient still required residential level of care. However, she was showing the development of coping strategies and engagement in treatment, both individually and in family therapy. She was utilizing mechanisms such as walking to discharge anxiety and had been working on her accountability letter. Thus, subsequently she could have continued treatment at a lower level of care. Given the above, a portion of services at issue were medically necessary for treatment of the patients medical condition.Final Result: The reviewer determined that a portion of the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned.Credentials/Qualifications: The reviewer is board certified in psychiatry 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

Nature of Statutory Criteria/Case Summary: A represented minor enrollee has requested reimbursement and prospective authorization and coverage for intrapulmonary percussive ventilation (IPV) system. Findings:  The physician reviewer found that there have been few long-term studies that compare the home use of IPV devices with other means of airway clearance for patients with cystic fibrosis. There are various means of airway clearance used in cystic fibrosis. However, the medical literature does not appear to indicate one modalitys superiority over another. Instead, the efficacy and preference for a specific treatment modality is best provided by the individual patient. The data seems to suggest the type of equipment used for treating patients diagnosed with cystic fibrosis depends on the ability and preference of the individual patient. In this patients case, the patient, his parents and the treating provider, all report improved lung function since the patient had started using IPV. Accordingly, the IPV system was and is likely to be of greater benefit in treating this patients medical condition when compared to available standard therapy.Final Result: All three reviewers determined the equipment at issue was and is likely to be more beneficial for treating 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 and pediatric critical care and is actively practicing. Two reviewers are board certified in pediatrics and are 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

Nature of Statutory Criteria/Case Summary:  The parent of an enrollee has requested one hour per week of additional speech therapy for treatment of the enrollees medical condition. Findings:  The physician reviewer found that review of the submitted documentation and medical literature demonstrates the medical necessity of the requested services. Speech therapy is medically necessary to address the medical condition of autism spectrum disorder. After the age of five there are slower and fewer gains made in speech. There is evidence that speech services can lead to long term benefits on functional outcome from autism spectrum disorder (Kasari, et al). The study by Kasari and colleagues included children who received speech therapy twice per week in addition to school services. In this case, at least one hour per week in addition to the school related services are indicated for this patient. For the reasons stated, one hour per week of additional speech therapy services are medically necessary in this clinical setting. 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 pediatrics with sub-specialty certification in developmental and behavioral pediatrics 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 24-year-old male enrollee requested substance abuse partial hospitalization program (PHP) services for treatment of his substance abuse.  Findings:  The physician reviewer found that the services at issue were not and are not medically necessary for treatment of the patients medical condition. This patient had completed detoxification and was not at risk for withdrawals. He denied suicidal/homicidal ideation, plan, or intent. There was no evidence that he represented a danger to himself or others. He was medically stable and his depression was safely being managed with medications. The patient has undergone multiple prior treatments, apparently without significant impact upon his substance abuse behavior. There is a lack of evidence demonstrating that he has worked on the development of coping skills throughout all of his prior treatments. In this clinical setting, outpatient treatment, such as daily 12-step meetings and the support of a sponsor is likely to be beneficial.
Appeal type: Experimental/Investigational
Decision: Upheld

An enrollee has requested authorization and coverage for an interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion. There is a paucity of prospective randomized controlled clinical trials demonstrating improved patient health outcomes with use of an interspinous process stabilization or distraction device. Researchers concluded on their retrospective study of 1,108 patients that the ultimate failure rate requiring additional surgery was 9.6%. The authors noted that the reasons for revision, which always involved removal of the original implant, were acute worsening of low-back pain or lack of improvement, recurrence of symptoms after an initial good outcome, and implant dislocation. In this patients case, there is no documented spinal instability. There is no need for a spinal stabilization device. There is no medical indication for the device in this case. All told, the requested interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion is not likely to be more beneficial for treatment of the patient's medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in orthopedic surgery 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: Upheld

Nature of Statutory Criteria/Case Summary: A enrollee has requested authorization and coverage for Jublia solution. Findings:  The physician reviewer found that the submitted documentation does not support the medical necessity of Jublia solution. The records do not demonstrate the patient has failed treatment with oral terbinafine. The patient reports a history of prior treatment with Harvoni for hepatitis C.  The medical records provided do not document that the patient continues to have active hepatitis C virus. As Harvoni treatment is highly effective in the treatment of hepatitis C virus, the patient may no longer have active disease. In the absence of documentation demonstrating active hepatitis C virus or other contraindication to the use of terbinafine, the medical necessity of Jublia solution has not been established. 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 sub-specialty certification 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

Nature of Statutory Criteria/Case Summary:   An enrollee has requested anesthesia services during a colonoscopy for treatment of his medical condition.  Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue.  The patient had a low American Society of Anesthesiologists (ASA) preoperative physical status classification score. Intravenous sedation performed by a non-anesthesiologist and non-certified registered nurse anesthetist is well-supported in both clinical practice and in the research given a low preoperative physical status classification score.  The current medical evidence does not support the services at issue in this clinical setting.  All told, anesthesia services provided during a colonoscopy were not medically indicated for the treatment of this patient. Final Result: The reviewer determined that the services at issue were 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 anesthesiology 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

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Amitiza (lubiprostone). The American Gastroenterological Association (AGA) guidelines on the medical management of opioid-induced constipation states, The panel favored use of a combination of at least two types of laxatives before escalating therapy, and also that scheduled use of laxatives (versus use as needed) is required before determining whether alternative opioid-induced constipation therapy is necessary. Further, the guidelines do not specifically recommend the use of Amitiza, stating, The AGA makes no recommendation for the use of lubiprostone in the treatment of opioid-induced constipation, due to an evidence gap.  In this case, given the records do not document the patient has failed first-line treatment with a laxative regimen, and based on available guidelines on the treatment of opioid-induced constipation, the requested medication is not medically indicated. Therefore, Amitiza (lubiprostone) is not medically necessary for the 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 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

Nature of Statutory Criteria/Case Summary:   An enrollee has requested tumor necrosis factor antagonists testing for evaluation of her medical condition.   Findings:  Three physician reviewers found that there is a lack of support for the services at issue in this clinical setting.  Some evidence exists that low serum levels of adalimumab and/or the presence of antibodies to adalimumab may play a role in primary or secondary response failures.  Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions.  In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment.  The reasons for therapeutic failures remain unclear.  Some evidence exists that low serum levels of adalimumab or the presence of adalimumab antibodies has an adverse effect on the clinical outcome of a patients response to treatment.  However, there are few well-controlled clinical trials to confirm that use of the testing in dispute leads to improved patient outcomes or quality of life as opposed to the standard method of treatment.  The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement.  It has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established.  All told,  tumor necrosis factor antagonists testing was not likely to have been superior over other methods of evaluating this patient.   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-specialty certification in gastroenterology and are 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.