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

A 60-year-old male enrollee has requested repeat epidural injection for treatment of his back pain.  Findings:  The physician reviewer found that the requested repeat epidural injection is not medically necessary for management of this patients medical condition based on the records provided for review. The peer-reviewed medical literature does not provide evidence for a repeat epidural steroid injection in treating the patients medical condition. Novack and Nemeth performed a literature review to determine the current evidence to construct guidelines for the frequency and timing of epidural steroid injections, to help determine what sort of responses should occur to repeat an injection, and to outline specific research needs in these areas. The authors reported there was limited evidence to support guidelines for frequency and timing of epidural steroid injections or to help define what constitutes the appropriate partial response to trigger a repeat injection. Abdi and colleagues performed a systematic review utilizing the criteria established by the Agency for Healthcare Research and Quality (AHRQ) for evaluation of randomized and non-randomized trials as well as the criteria of Cochrane Musculoskeletal Review group for randomized trials. The authors found that there was moderate evidence for interlaminar epidural injections in the cervical spine, but only limited evidence in the lumbar spine, for long-term relief. This patient indicated that he did not experience long-term relief for greater than three months, or demonstrate reduced use of medications and adjunctive therapy such as physical therapy, heat and ice, with the first epidural steroid injection. Therefore, the requested repeat epidural steroid is not 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 reimbursement for FoundationOne testing. Findings:  FoundationOne is a molecular assay that explores the mutations of an individuals cancer cells. The hope is that the assay will identify a specific mutation or target which would guide the provider as to which chemotherapeutic agent would be useful. At this time, there is a lack of convincing evidence that the assay adds to the decision-making ability or yields a result that is reliably clinically beneficial. A randomized trial did not demonstrate a significant clinical benefit from choosing therapy based on molecular targets versus by the providers clinical judgment. Also, finding a mutation does not guarantee that a treatment directed at that mutation will produce a clinically meaningful response. Therefore, FoundationOne testing was not likely to have been of greater benefit than other methods of evaluating this patient. Final Result: Two of the three physician reviewers found 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: 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested a 12 week course of Harvoni for treatment of her chronic hepatitis C virus genotype 1a. Findings:  Three physician reviewers found that as per the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) guidelines, all patients with chronic active hepatitis C are eligible for treatment and should be treated with U.S. Food and Drug Administration (FDA) approved antiviral therapy regardless of fibrosis score. Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and is expected to benefit nearly all chronically infected patients. The fixed dose combination ledipasvir-sofosbuvir (Harvoni) is FDA approved for the treatment of chronic hepatitis C genotype 1 in both treatment-naive and treatment-experienced patients. Given this support, the requested 12 week course of Harvoni is medically necessary for treatment of this patients hepatitis C virus. Final Result: Three 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: 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.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Tecfidera Capsule DR 240 mg for treatment of the enrollees multiple sclerosis (MS). Findings:  The physician reviewer found that there are 14 available U.S. Food and Drug Administration (FDA) approved therapies for the treatment of relapsing MS. There are similarities, but also major differences as far as mechanism of action, route and frequency of administration, tolerability, safety, and efficacy. Making a decision on MS therapy is a joint decision-making process in order to find the best medication for each patient based on many factors including age, stage of disease, risk tolerance, and co-morbidities. Tecfidera has been approved by the FDA as a first-line MS therapy. While there are a lack of quality head to head studies, Tecfidera is generally recognized to be more effective than the platform agents such as Extavia and Copaxone, and less effective than the highly active agents such as Tysabri, Ocrevus, and Lemtrada. In this case, the provider indicates that because the patient does not want to use injections an oral agent has been recommended. Given that Tecfidera capsule DR 240 mg has been approved as a first-line MS therapy, it is a reasonable treatment for relapsing MS and as such is medically necessary for treatment of this patients relapsing MS. 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 neurology 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: An enrollee has requested authorization and coverage for Intracept Nerve Ablation System and destruction of intraosseous basivertebral nerve. The guideline published by International Society for the Advancement of Spine Surgery (ISASS) concluded that the intraosseous basivertebral nerve ablation for the treatment of chronic low back pain is a treatment option that has supporting Level 1 evidence for patients with clinical and radiologic findings supporting a vertebrogenic source of back pain. Moreover, the Intracept Nerve Ablation System has been demonstrated to be safe and effective in two randomized controlled clinical trials that showed statistically significant pain scores and functional improvements over a two-year period. This patients clinical and radiologic findings of Modic type 1 changes at L4 support a vertebrogenic cause of back pain. The patient has not experienced relief from comprehensive and multimodal treatment options. Extending his fusion would not provide symptomatic relief, as the records do not report substantial relief with prior fusion. Radiofrequency ablation of the intraosseous basivertebral nerve is likely to provide functional relief for this patient, especially given that etiology of his axial back pain is likely vertebrogenic. All told, the requested Intracept Nerve Ablation System and destruction of intraosseous basivertebral nerve is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings:  Two of the three physician reviewers found the requested Intracept Nerve Ablation System and destruction of intraosseous basivertebral nerve 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 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: Physician reviewers 1, 2, and 3 are board certified in anesthesiology with subspecialty certification in pain management 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: Experimental/Investigational
Decision: Upheld

A 60-year-old female enrollee has requested for Erbitux (cetuximab) in combination with Camptosar (CPT-11 or irinotecan) for treatment of her recurrent progressive metastatic adenocarcinoma.   Findings:  Two physician reviewers found that cetuximab is one of a newer class of drugs, which has been approved for use in metastatic colon cancer as well as head and neck cancer, when used with radiation therapy. Submitted with this appeal were data from a few clinical trials. One of them demonstrated that when cetuximab is added to chemotherapy, as first line therapy of metastatic lung cancer, there was an approximately one-month increase in median survival, which was not statistically significant. There is not convincing data that when cetuximab is used in combination (i.e., with irinotecan) beyond first line therapy, that there is any statistically significant benefit.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for autonomic neuropathy assessment (cardiovascular testing with head-up tilt, the Valsalva maneuver, deep breathing, thermoregulatory sweat test, and quantitative sudomotor axon reflex test). The diagnosis of autonomic neuropathy in young patients, particularly in the setting of diabetes, is characterized by orthostatic hypotension, exercise intolerance, gastroparesis, diarrhea, constipation, and urinary incontinence. While this patient does not carry a diagnosis of diabetes type 1, she does have multiple neurologic and psychiatric diagnoses. From the history and records from her providers, the patients psychiatric diagnoses outweigh neurologic diagnoses in terms of clinical importance and interference with her ability to perform activities of daily living. The lack of objective findings on examination and laboratory evaluations has not pointed to a known neurologic disease. Thus, these findings do not substantiate the noted clinical diagnosis. Based on these findings, the requested autonomic neuropathy assessment (cardiovascular testing with head-up tilt, the Valsalva maneuver, deep breathing, thermoregulatory sweat test, and quantitative sudomotor axon reflex test) are not medically necessary for evaluation of the patients medical condition.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 neurology with special qualification in child neurology 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 49-year-old female enrollee has requested artificial disc replacement for treatment of her degenerative disc disease.  Findings:  Three physician reviewers found that although the artificial disc is currently being investigated for single level disc replacement in the treatment of degenerative disc disease in the lumbar spine, there is no evidence supporting the safety and efficacy of a two-level disc replacement. Current data for single level disc replacement demonstrates that the majority of the procedures may be  successful in the short term, however the long-term outcomes are unknown and complications may be severe.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement for a LifeVest wearable cardioverter defibrillator (CPT code K0606). This patient sustained a non-ST elevation myocardial infarction (NSTEMI) with a troponin of 33 and a left ventricle ejection fraction (LVEF) of 20%. In this clinical circumstance, there is potential for recovery of left ventricular function over time with medical therapy. There was no documented indication for immediate placement of a defibrillator such as sustained or inducible ventricular tachycardia, unexplained syncope, or aborted sudden cardiac arrest. Placement of a prophylactic defibrillator is not recommended until at least 90 days have elapsed with continued left ventricular dysfunction demonstrated by an LVEF less than 35% despite appropriate treatment. A prophylactic wearable external defibrillator is indicated when accepted criteria for an implantable defibrillator were met and an implantable defibrillator could not be placed, needed to be significantly delayed, or required explantation. Placement of a prophylactic defibrillator before this time has elapsed has not been associated with improved patient outcomes. For these reasons, the LifeVest wearable cardioverter defibrillator (CPT code K0606) was not medically necessary for treatment of this patient. Final Result: The reviewer determined that the device at issue was 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 certification in cardiovascular disease 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

The parent of a 17-year-old female enrollee has requested  the subtalar arthroereisis (CPT 28725) for treatment of the enrollees ankle and foot deformity.  Findings:  Two physician reviewers found that subtalar arthroereisis has been used as an isolated procedure in a subset of patients with symptomatic recalcitrant adult and pediatric flatfoot deformity and is also a component of a more comprehensive surgical procedure. As noted by Schon, subtalar arthroereisis as an adjunct procedure may offer relief for patients with mild and more severe variance of posterior tibial tendon dysfunction. However, the biomechanics of the implant function have not been fully evaluated in prospective, randomized, controlled trials. Several retrospective case series report significant improvement in pain and function when subtalar arthroereisis is used as a component of reconstructive ankle and foot surgery (Needleman). It should be noted that despite the promising preliminary results, the author reported an overall complication rate of 46% with surgical removal of 39% of the implants due to sinus tarsi pain. Consistent with the American College of Foot and Ankle Surgeons practice guidelines, the long-term outcomes of subtalar arthroereisis in the flatfoot patient has not been established (Harris, et al). Given the lack of reliable scientific data demonstrating the long-term safety and efficacy of the procedure at issue, the Health Plans denial was appropriate, as more standard therapeutic alternatives may have been more beneficial for treatment of this patients medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for vest airway clearance system for treatment of the enrollee who was diagnosed with recurrent acute lower respiratory infection.Findings:  Three physician reviewers found that the patient had a diagnosis of mild upper lobe bronchiectasis and multiple pulmonary nodules. The patient has been treated with the Acapella device. The patients pulmonary function tests were normal and stable. Diffusion capacity per alveolar volume was also normal. Total lung capacity was normal. Oxygen (O2) saturation on room air at rest was 98% and with exertion to a heart rate of 151 per minute, the O2 saturation on room air was 95%. Her chest was clear. There was no ground glass lesions. The computed tomography scan of the chest did not have bronchiectasis of the lingula or right middle lobe. The provider recommended a vest airway clearance system for the treatment of this patients symptoms. The medical literature has not shown the superior efficacy of the device at issue in this clinical setting. The vest airway clearance system is a high frequency chest wall device for chest physical therapy.  It has been studied most frequently in patients with cystic fibrosis where daily chest physical therapy is generally accepted and deemed medically necessary.  The sputum in patients with cystic fibrosis is abnormal and the patients frequently have pulmonary infections with progressive decrease in pulmonary function.  However, there has been no documented superiority of the vest over routine chest physical therapy in any disease entity where the long term end point of the prospective clinical trial is a clinically significant outcome endpoint such as:  fewer hospitalizations for pulmonary infections, decrease in length of stay of a hospitalization or decrease in the progression of pulmonary disease.  The medical evidence appear to support that the vest is a convenience. There is a lack of randomized, controlled, clinical trials to prove efficacy and safety of the device at issue in this patients case. This patient does not have a diagnosis of cystic fibrosis or a neuromuscular condition affecting respiration. Final Result: Three reviewers determined that the device at issue was 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 physician reviewers are board certified in internal medicine with sub-specialty certification in pulmonary 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: Experimental/Investigational
Decision: Upheld

A 47-year-old female enrollee requested authorization and coverage of minimally invasive total hip replacement surgery. The Health Plan denied the request indicating that the requested procedure is considered experimental for treatment of the enrollees osteoarthritis.Three physician reviewers performed an experimental/investigational Independent Medical Review. All three physician reviewers concluded that the requested procedure is not likely to be more beneficial for treatment of the enrollee's medical condition than any available standard therapy. Because all three physician reviewers concluded that the requested procedure is not likely to be more beneficial for treatment of the enrollee's medical condition than any available standard therapy, the Health Plans denial has been upheld.
Appeal type: Medical Necessity
Decision: Overturned

Standard Review A transgender male enrollee has requested authorization and coverage for a hysterectomy. The Health Plan has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees gender dysphoria. Credentials/Qualifications: The reviewer is 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. Nature of Statutory Criteria/Case Summary: There is support in the literature for the requested procedure in this clinical setting. For patients with gender dysphoria, treatment options range, but can include hormonal therapy, gender conforming surgery and appropriate screenings based on assigned sex at birth. The medical literature indicates that gender reassignment surgery is considered essential for the wellbeing of transgender patients. This patient has well documented gender dysphoria.  He has been living in the gender role that conforms to his gender identity. The records also reflect that he has been placed on hormone therapy and has undergone a double mastectomy. This patient was evaluated by multiple specialists to prepare him for the next step towards his gender conforming surgery. While the records also indicate that this patient has been on opioid therapy for treatment of his chronic kidney stones and low back pain, his opioid therapy is not a contraindication to the requested surgery. An evaluation noted that this patient had no clear evidence of substance use disorder from the history provided by the patient, in addition to a partial review of the medical record. Moreover, the documentation provided did not indicate that a detoxification referral/recommendation was made for this patient. As such, this patients opioid therapy is not a contraindication to the requested gender conforming hysterectomy. Instead, this patients record reflects that he has met the requirements recommended by World Professional Association for Transgender Health. Therefore, the requested hysterectomy is medically necessary for the treatment of this patient's gender dysphoria.  Final Result: The reviewer determined that the requested procedure is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.
Appeal type: Experimental/Investigational
Decision: Upheld

The treating provider of a 58-year-old female enrollee requested authorization and coverage for thalidomide for treatment of the enrollees cancer.  The health plan has denied this request indicating that the requested treatment is considered experimental for treatment of the enrollees medical condition.Three physician reviewers performed an experimental/investigational Independent Medical Review.  Because two of the three physician reviewers concluded that the requested therapy is not likely to be more beneficial for treatment of the enrollee's condition than any available standard therapy, the health plans denial was upheld.
Appeal type: Medical Necessity
Decision: Overturned

The parent of an 18-year-old male enrollee has requested for Xopenex for treatment of his cystic fibrosis. Findings:  The physician reviewer found that the bronchodilators are in the same class as albuterol. Xopenex is associated with less tachycardia and tremulousness.