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

Nature of Statutory Criteria/Case Summary: The parents of an enrollee have requested reimbursement for the laboratory allergy testing services provided by Foundation Labs on 4/21/20. Findings:  The physician reviewer found that Bernstein and colleagues state that testing for the most common allergenic foods usually detects most suspected food hypersensitivity, although more tests may be required depending on the clinical situation. Many clinicians test with a limited panel of commonly allergenic foods when food allergy is suspected and there is no clear-cut history of symptoms occurring after exposure to specific foods. Exhaustive testing to the 200 or so foods available for skin or specific immunoglobulin E (IgE) testing in patients presenting with anaphylactic reactions is rarely indicated. The primary tools available to evaluate patients adverse reactions to foods include history (including diet records), physical examination, prick/puncture skin tests, serum tests for food specific IgE antibodies, trial elimination diets, and oral food challenges. The general aims of diagnosis are to determine if food is causing the disorder under evaluation and, if so, to identify specific causal food(s). A proper diagnosis will allow the patient to receive instructions regarding avoidance of problematic food. The current literature and Allergy Practice Parameter Guidelines that address immunoglobulin G (IgG) diagnostic testing, which includes IgG food sensitivity and IgG subclass testing, notes that neither of these tests are considered clinically useful, relevant, or a valid method for evaluating for food allergy or food intolerance that may be contributing to an allergic condition. In this case, the superior efficacy of the services at issue has not been established. There is a lack of published peer-reviewed literature, scientific evidence, or professional standard guidelines supporting the safety and efficacy of Tolerance Induction Program. Therefore, the laboratory allergy testing services provided by Foundation Labs on 4/21/20 was not likely to have been more beneficial for evaluation of the patients condition than any available standard therapy.Findings: Three out of three physician reviewers found that the laboratory allergy testing services provided by Foundation Labs on 4/21/20 were not likely to have been more beneficial for the enrollee than any available standard therapy.Final Result: The reviewers determined that the requested services were not likely to be more beneficial than any available standard method of evaluation for the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewers 1, 2, and 3 are board certified in allergy and immunology and is actively practicing. The reviewers are experts in the treatment of the
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for bilateral mammoplasty. Findings:  The physician reviewer found that World Professional Association for Transgender Health (WPATH) Standards of Care (SOC) acknowledges that in the treatment of the male-to-female patient, surgical procedures in the treatment of gender dysphoria may include breast/chest surgery: augmentation mammoplasty (implants/lipofilling) (Coleman, et al.). The WPATH also states that augmentation mammoplasty is  understood to be medically necessary for the treatment of the diagnosed condition. For this patient, the providers have documented that the patient is committed to feminine transformation as evidenced by hormone therapy and gender confirmation surgery. The patient meets the WPATH criteria for gender dysphoria and indication for mammoplasty based upon clinical documentation of persistent gender dysphoria. Moreover, the requested mammoplasty is in accordance with the generally accepted standards of mental health and substance use disorder care, clinically appropriate in terms of type, frequency, extent, site, and duration, and not primarily for the convenience of the patient or provider. Given these findings, the requested bilateral mammoplasty  is medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in psychiatry with expertise in transgender health and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Tazverik 200 mg tablets. This patient presents with a history of clival chordoma that has progressed despite treatment with resection and re-resection, proton beam radiation therapy, afatinib, and nivolumab plus relatlimab. The patients provider has recommended treatment with Tazverik. The U.S. Food and Drug Administration (FDA) has not approved Tazverik for the treatment of clival chordoma, which is a bone sarcoma. Tazverik has been approved by the FDA for epithelioid sarcoma, which is a type of soft tissue sarcoma. The National Comprehensive Cancer Network (NCCN) and major drug compendia do not recommend treatment of bone sarcoma with Tazverik. Currently, the utility of Tazverik in chordoma is limited to pediatric phase I data. On review of the medical literature, there is a lack of clinical studies demonstrating that Tazverik is safe and effective for the treatment of clival chordoma. Therefore, the requested Tazverik 200 mg tablets are not medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in internal medicine with subspecialty certifications in medical oncology and hematology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Xeljanz oral tablet. Sandborn and colleagues found that patients with moderately to severely active ulcerative colitis treated with tofacitinib were more likely to have clinical response and remission than those receiving a placebo. Rogler notes that Janus kinase (JAK) inhibitors constitute a promising new class of drugs for the treatment of Crohns disease. In this case, the patient has severe fistulizing and stricturing Crohns disease complicated by perianal abscess. As he has failed all major classes of therapy and guideline-recommended biologic alternatives for the treatment of Crohns disease, strict adherence to guidelines would result in uncontrolled disease with potentially severe clinical consequences. In this clinical setting, treatment with Xeljanz may help this patient avoid complications, including fistula, disease flare, stricture, hospitalization, and need for surgery, and is medically indicated. Therefore, Xeljanz oral tablet is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary:  An enrollee has requested authorization and coverage for Opdivo (nivolumab) 240 mg every two weeks.Nivolumab is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of oligodendrogliomas. Moreover, nivolumab use for oligodendrogliomas is not supported by major drug compendia. Alternatively, pembrolizumab is approved by the FDA for tumor mutational burden-high tumors. The National Cancer Institute (NCI) conducted a study evaluating the effectiveness of nivolumab in cancer patients, However, the NCI study did not include any brain tumors and only included 42 patients overall. Additionally, the use of nivolumab is not supported by the National Comprehensive Cancer Network (NCCN) Guidelines or the medical literature. Therefore, Opdivo (nivolumab) 240 mg every two weeks is not medically necessary for the treatment of the patients medical condition. 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 medical oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for Fentanyl transdermal system, 100 mcg, 15 patches per month (Please note: ten patches per month have been approved by the Health Plan.). On determining when to initiate or continue opioids for chronic pain, Dowell and colleagues report, Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.  The Federation of State Medical Boards (FSMB) states, Continuation, modification or termination of opioid therapy for pain is contingent on the clinicians evaluation of (1) evidence of the patients progress toward treatment objectives and (2) the absence of substantial risks or adverse events, such as signs of substance use disorder and/or diversion. Further, the FSMB strongly recommends prescribers use opioid therapy for chronic pain that is not cancer-related, or part of palliative care or end-of-life care, only when non-opioid and non-pharmacological options have not been effective. In this case, the patient has a history of chronic pain in the thoracic spine and hip, treated with one Fentanyl patch every 48 hours, totaling 15 patches per month. The records do not document any aberrant or drug seeking behavior, irregular Controlled Substance Utilization Review and Evaluation System (CURES) reports, or inconsistent urine drug screens. The provider notes that the patients current medication regimen is allows the patient to perform activities of daily living and work full time. Given that this patient is being treated in a manner consistent with current medical literature, the requested medication is medically indicated. Therefore, Fentanyl transdermal system, 100 mcg, 15 patches per month (Please note: ten patches per month have been approved by the Health Plan.), were and are medically necessary for the treatment of this patient.Final Result: The reviewer determined that the medication at issue was and is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in anesthesiology with sub-specialty certification in pain medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a Sprint peripheral nerve stimulation (PNS)  system. In an evaluation on the efficacy of PNS of the medial branch nerves to treat chronic axial back pain after failed attempts to manage the symptoms with a radiofrequency ablation, researchers noted that at two months after PNS, a majority of participants reported clinically significant reductions of 50% or greater in average pain intensity along with clinically significant improvements in functional outcomes. The authors reported that five months after PNS, 93% of the participants reported clinically meaningful improvement in one or more outcome measures, and a majority experienced clinically meaningful improvements in pain intensity, disability, and pain interference. In a study on the efficacy of PNS to treat chronic low back pain, one study reported no serious or unanticipated adverse events in patients twelve months after PNS treatment. In this case, visit notes report that the patient has chronic low back pain and has tried a wide spectrum of standard treatments, including lumbar facet joint injections, nonsteroidal anti-inflammatory drugs (NSAIDs), opioid analgesics, transcutaneous electrical nerve stimulation (TENS) unit, and physical therapy. In this clinical setting, current medical literature supports the superiority of the requested service for sustained relief over standard conservative treatment. Therefore, a Sprint PNS system is likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested Sprint peripheral nerve stimulation (PNS)  system is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested service is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in anesthesiology with sub-specialty certification in pain medicine 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for 10 physical therapy sessions. Recovery following shoulder surgery may be prolonged. Gutierrez-Espinoza and colleagues note that supervised physical therapy and home-based progressive shoulder strengthening and stretching exercises for the rotator cuff and scapular muscles are equally effective in patients with subacromial impingement syndrome treated conservatively. Thomson and colleagues report that a systematic review of postoperative rehabilitation recommendations following rotator cuff surgery include exercise therapy, continuous passive motion machines, and aquatic therapy, however, no one rehabilitation protocol was found to be superior to another. The authors further note that the findings of this review suggest that following rotator cuff repair, patients should expect improvement in pain, range of motion, and function. As range of motion and strength are restored and the patient becomes accustomed to the exercises, the program can be transitioned to an independent program, which is a viable and acceptable alternative to formal therapy, unless there are specific documented factors that would preclude an independent program. In this case, the patient is receiving postoperative physical therapy for her left shoulder. She reports various persistent symptoms such as stiffness and weakness at the left shoulder. However, the records do not document impairments or other factors that would preclude transition to an independent exercise program. Further formal physical therapy in this case would not be expected to favorably impact the patients course or outcomes in a clinically significant manner beyond independent exercise, self-applied modalities, and the passage of time. In this clinical setting, given that long-term skilled physical therapy, including supervised exercises and formal passive therapies such as manual therapy, is not generally of proven marginal benefit over an appropriate independent program, the requested services are not medically indicated. Therefore, 10 physical therapy sessions are 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 physical medicine and rehabilitation and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary:  An enrollee has requested authorization and coverage for total left knee arthroplasty.A study by Roemer and Colleagues assessed structural progression in knees with no or mild radiographic osteoarthritis that underwent knee replacement during a five-year period. The study found that more than half of the knees with no or mild radiographic osteoarthritis before knee replacement progressed to severe radiographic osteoarthritis during four years of follow-up. Additionally, worsening pain status may contribute to knee replacement in knees with no or mild radiographic osteoarthritis. In this case, the patient presented with bilateral knee pain that she feels is getting worse. There is moderate, generalized tenderness about the lateral and medial aspect as well as patellofemoral joint of the right knee and lateral and medial joint line as well as patellofemoral joint of the left knee. There is mild swelling and crepitus noted bilaterally. The patients current pain levels are reported to be eight to ten out of ten. There is functional impairment affecting the activities of daily living, and there is documentation of failed conservative treatment. Further, x-rays of the left knee show radiographic evidence of worsening medial joint space narrowing in the left knee. Therefore, the requested total left knee arthroplasty is medically necessary for the treatment of the patients medical condition.Final Result: The reviewer determined that the requested service 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 orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for modafinil 100 mg tablets. Consistent with data reported by the American Academy of Sleep Medicine (AASM), the U.S. Food and Drug Administration (FDA) has approved modafinil for the treatment OSA patients who have sleepiness despite effective CPAP treatment and lack any other identifiable cause for their sleepiness. This patient has a history of OSA that has partially responded to CPAP use. However, the patient has continued to report daytime sleepiness with use of CPAP. The patient did reportedly experience improvement in her daytime sleepiness with modafinil. Given these findings, the requested modafinil 100 mg tablets are medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with subspecialty certification in sleep medicine 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for genetic testing provided by Guardant Health Inc. Current National Comprehensive Cancer Network (NCCN) guidelines suggest that certain molecular studies should be performed in the evaluation of colon cancer, including testing for HER2, KRAS, NRAS, and BRAF. Sholl and colleagues note that while liquid biopsy, such as the Guardant360 assay, in a patient population with a genomically defined solid tumor may potentially be clinically useful, it currently does not supersede conventional pretreatment tissue diagnosis of lung cancer. Sohal and colleagues note that systematic studies evaluating the clinical benefit of tumor genomic profiling are lacking. In this case, the patient underwent a pathology panel which did not result in treatment possibilities. It is unclear why a reanalysis with the Guarand360 assay was performed. The service at issue was unlikely to result in other possible targets for treatment, given that the use of multi-gene assays has not been shown to be of sufficient clinical benefit. Therefore, the genetic testing provided by Guardant Health Inc. was not likely to have been more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the genetic testing provided by Guardant Health Inc. at issue was not likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the service at issue was not likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1 and 3 are board certified in internal medicine with sub-specialty certifications in medical oncology and in hematology and are actively practicing. Physician reviewer 2 is board certified in internal medicine with sub-specialty certification in medical oncology 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.