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

The patient is a 54-year-old woman with a long-standing history of gastroesophageal reflux disease (GERD) who has not had satisfactory relief with standard medical treatment including PPI medications. She describes chronic pain, inability to sleep, frequent regurgitation, and chronic heartburn. She is said to have endoscopic evidence of erosive esophagitis on endoscopy. The patient has apparently made lifestyle changes such as elevating the head of her bed and avoiding foods known to worsen reflux without satisfactory resolution of symptoms. The patient has consulted a provider who has recommended an endoscopic plication procedure as a superior alternative to conventional surgical techniques for control of the patients symptoms. The Health Plan has denied coverage for the requested procedure on the basis it is not medically necessary for treatment of the patients medical condition.Conventional therapy for GERD is based on a stepped approach. The first approach to treatment is generally life-style modification including measures such as weight loss, which this patient has already adopted. The second approach is based on anti-secretory medications, which reduce gastric acid secretion and exposure of the esophageal epithelium to acid. For those patients who fail these measures, surgical control with fundoplication is the standard treatment accepted by the medical community.The endoscopic plication procedure (i.e., the Plicator procedure) is a less invasive alternative to fundoplication. The Plicator procedure has been described in numerous pre-clinical studies and in a recent case series report. The series reported on 64 treated patients with mild esophagitis (grade 1 or 2). A majority of patients experienced improved quality of life and decreased use of PPI medication over six months. A minority had normalization of acid exposure. This was not a randomized trial and no long-term results or comparison to surgical therapy was made. In the case of this patient (unlike those in the study), she has severe ulcerative esophagitis (grade IV). To date, there is no evidence demonstrating the Plicator procedure is superior to conventional therapy for patients such as this patient, and since this patient clearly would have been excluded from the above referenced study, there is no indication that she would have obtained substantial benefit over the short-term. Furthermore, although the Plicator device has been approved by the Food and Drug Administration, the Plicator procedure has not been accepted by the medical community or proven in randomized, long-term trials against conventional therapy. As such, I have determined the requested procedure is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

The mother of an 11 year-old male enrollee has requested IVIG for treatment of pediatric autoimmune neuropsychiatric disorder associated with streptococcus (PANDAS).  Findings:  Two physician reviewers found that the symptomatology described in the available information does not fit all the diagnostic criteria for PANDAS. There is no evidence presented that this patients disorder is linked to a previous or current streptoccal infection. Furthermore, IVIG is still considered investigational for treatment of PANDAS. At the present time, the National Institute of Mental Health recommends this therapy only as part of a research protocol.  Side effects are also a concern with IVIG.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for cervical/thoracic interlaminar epidural steroid injection for treatment of the enrollees neck pain. Findings:  The physician reviewer found that the request for cervical/thoracic interlaminar epidural steroid injection is not medically necessary for treatment of the patients medical condition. Researchers conducted a multicenter, randomized, comparative-effectiveness study comparing epidural steroid injections, conservative treatment, or combination treatment for cervical radicular pain. For the primary outcome measure, no significant differences were found between treatments, although combination therapy provided better improvement than stand-alone treatment on some measures. Whereas these results suggest an interdisciplinary approach to neck pain may improve outcomes, confirmatory studies are needed. In this case, the patient presented with neck pain and stiffness. There is no documentation of radicular pain in a dermatomal distribution, numbness or tingling. Functional difficulty is documented in activities of daily living. Clinical examination findings do not demonstrate radiculopathy or nerve root compression, correlated to imaging findings of C4-C7 degenerative disc disease. Prior physical therapy has been reported in prior year without lasting benefit. Prior epidural steroid injection in early this year provided two months of significant relief. There is no rationale presented to support the medical necessity of cervical epidural steroid injection for neck pain in the absence of signs/symptoms and clinical findings of radiculopathy. Final Result: The reviewer determined that the requested service 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 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: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for reduction mammaplasty. Findings:  The physician reviewer found that Women with increased breast size experience symptoms such as pain in the neck, shoulders and lumbar spine, headache, intertrigo in the inframammary fold, difficulty in performing daily activities, paresthesia in the hands (due to weight on the anterior chest wall and compression of the brachial plexus), difficulty in exercising, low self-esteem, and body dissatisfaction. The American Society of Plastic Surgeons (ASPS) recommends reduction mammaplasty authorization based on documentation of the severity of the symptoms of macromastia and impact on health-related quality of life with at least two of the following signs. Per the ASPS guidelines, this patient does not meet the criteria for reduction mammaplasty. The patient complains of low back, shoulder, and neck pain, and intertrigo. However, shoulder grooving is not demonstrated in the photographs provided for review. In addition, there is a lack of evidence that the patients intertrigo has been unresponsive to medical management. Furthermore, there is no report of chronic breast pain due to weight of the breasts, thoracic kyphosis, upper extremity paresthesia, headache, or congenital breast deformity. In the absence of fewer than two ASPS quality of life signs, the requested reduction mammaplasty is not medically necessary for treatment of this patient. The California reconstructive surgery statute requires health insurers to cover reconstructive surgeries, defined as surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: to improve function; or to create a normal appearance, to the extent possible. This patient has significant breast ptosis without significant breast hypertrophy. Based on the available documentation, a reduction mammaplasty would not improve the patients function. Moreover, the patients appearance is within the wide range of normal for female breasts and the requested mammaplasty would not provide a more than minimal improvement in the patients appearance. Therefore, the requested reduction mammaplasty is not reconstructive in nature for this patient. Final Result: The reviewer determined that the requested services are not medically necessary or reconstructive in nature for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in plastic 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: Upheld

A 46-year-old male enrollee has requested for a power scooter for treatment of his multilevel degenerative disc disease and arthritis in the feet.  Findings:  The physician reviewer found that the standard of care indicates that a power mobility device should be utilized only if a patient is unable to effectively use a gait-aid or non-powered mobility devices, such as a wheelchair. The use of a power mobility device carries with it the substantial risk of iatrogenic deconditioning, which can cause a profound cycle of inactivity, weakness, and immobility. A power scooter is therefore only necessary when a patient is unable to ambulate in the community or otherwise with a less restricted device. This patients medical records do not include an evaluation establishing this type of mobility related deficit. Therefore, the medical necessity of a power scooter is not supported as clinically reasonable or medically necessary for treatment of this patients medical condition.
Appeal type: Medical Necessity
Decision: Overturned

A 56-year-old female enrollee requested authorization and coverage of weekly therapy visits with twice-weekly visits as needed. The Health Plan denied the request indicating that the requested services are not medically necessary for treatment of the enrollees depression.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer overturned the Health Plans denial on the basis that the requested services are medically necessary.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Saxenda. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patients obesity. The submitted documentation does not support the medical necessity of the requested medication. Saxenda is approved for the treatment of obesity. It is used in adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index greater than 30 kg/m2 or greater than 27 kg/m2 in the presence of at least one weight-related comorbid condition, including hypertension, type II diabetes mellitus, and/or dyslipidemia. Initial management of individuals who would benefit from weight loss is a comprehensive lifestyle intervention consisting of a combination of diet, exercise, and behavioral modification. Per the medical evidence, patients who would benefit from weight loss should receive counseling on diet, exercise, and goals for weight loss. When a patient with an initial body mass index greater than 30 kg/m2 or a body mass index of 27 kg/m2 with comorbidities, such as hypertension or diabetes mellitus, has failed to achieve weight loss goals through diet and exercise alone, a pharmacologic therapy is suggested. In this case, the documentation does not support that the patient has failed treatment with counseling, calorie restriction, and increased physical activity to achieve weight loss goals. Additionally, the requested non-formulary drug, Saxenda, would not be more effective than the Health Plans formulary drugs, phentermine, benzphetamine, diethylpropion, and phendimetrazine.  There is a lack of studies that demonstrate that Saxenda is more effective than the listed formulary drugs. Therefore, Saxenda 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 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

An 18-year-old male enrollee has requested for artificial disc replacement surgery for treatment of his L5-S1 fracture, degenerative disc disease, and central disc herniation at L4-5.  Findings:  Three physician reviewers found that the ProDisc total disc replacement was approved by the FDA in 2006 for use in patients with one-level disease. Although early results have been encouraging, further study with follow-up over the long-term is still in progress (Berg, et al). Randomized controlled trials of high quality with long-term follow-up are needed to evaluate the safety and effectiveness of total disc replacement (van den Eerenbeemt, et al). Currently, it is not possible to draw conclusions regarding any benefits in motion preservation or complications over the long-term, and further study is needed (Delamarter, et al). The situation concerning hybrid constructs, such as was used in this case, is also unclear. Although results in some studies have been encouraging, the combination of these techniques increases the likelihood of complications, and the outcomes over time are not well delineated (Bertagnoli, et al). Consistent with these findings, the surgery at issue was not likely to be more beneficial for treatment of this patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for lidocaine patches. Findings: Lidocaine patches provide topical anesthesia to the area that they are placed. In this particular case, the patient demonstrated prior pain relief with the use of the lidocaine patch. Multiple studies demonstrate that lidocaine patches are effective in alleviating a patients neuropathic pain caused by chronic regional pain syndrome. The documentation reviewed supports that this patient presents with complex regional pain syndrome (CRPS) affecting the foot. The provider reports that the patient has been treated with lidocaine patches in the past, which helped alleviate a good portion of her neuropathic pain. The patient is also being treated with Lyrica. On 2/25/20, the provider recommended continued use of lidocaine patches to be applied to the foot daily for three months. Therefore, the requested lidocaine patches are medically necessary for 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 a licensed D.P.M., board certified in podiatry, 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 62-year-old female enrollee has requested bilateral breast reduction for the treatment of her breast, upper back, and neck pain. Findings: The physician reviewer found that the submitted clinical evidence does not establish that the requested procedure is reconstructive in nature. Breast reduction surgery removes excess breast fat, glandular tissue and skin to achieve a breast size in proportion with a patients body and to alleviate discomfort associated with overly large breasts. While the submitted photographs show a female with large pendulous breasts, the patients condition is not considered an abnormal structure of the body. There is no evidence of breast asymmetry or disease or infection affecting the breast tissue. The patients breasts are not excessively large so as to constitute an abnormal structure caused by a congenital defect, developmental abnormality, trauma, infection, tumor or disease. Therefore, the proposed procedure does not meet the definition of reconstructive surgery as defined by California law. As for the medical necessity of the procedure, while a number of photos document shoulder grooves, the photos do not document intertrigo, skin ulcerations or rashes. The patient appears to have scars around the areola in a standard inverted T-pattern, consistent with prior breast surgery. The photos do not support the patients contention that her breasts are causing her back, neck, and shoulder pain. The proposed reduction of breast tissue in the amount of 300 grams would reduce the patients breast volume, but would not make a functional difference in terms of reducing her symptomatology, due to the small volume of removal. Furthermore, there is lack of documentation of workup of the etiology of the back, neck and shoulder pain, with no evidence of an orthopedic evaluation, physical therapy evaluation, diagnosis or conservative treatments with failure of those conservative treatments.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for proton beam therapy. Proton beam therapy for treatment of early stages of prostate cancer was introduced as a possible means to reduce side effects and increase the effectiveness of radiation treatment in patients with cancer. However, there is a paucity of controlled randomized studies demonstrating clinical improvement with proton beam therapy over patients treated with routine intensity modulated radiation therapy (IMRT) in this clinical setting. Researchers reported that their findings on early proton beam therapy have shown mixed results when compared with routine intensity-modulated radiation therapy. This patient presented with an elevated prostate specific antigen (PSA) of 5.2. He underwent biopsy, which revealed Gleason score 3+3=6 and Gleason score 3+4=7 adenocarcinoma of the prostate from both sides of the prostate gland. Based on the available documentation, there is a lack of comparative superiority with proton beam therapy in lieu of IMRT for treatment of this patients prostate cancer. Therefore, the requested proton beam therapy is not medically necessary for 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 urology 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 34-year-old female requested authorization and coverage of Fobi-pouch gastric bypass surgery.  The enrollees health plan denied the request indicating the requested surgery is not medically necessary.One physician reviewer performed a medical necessity Independent Medical Review.  The physician reviewer upheld the health plans denial on the basis that the Fobi-pouch surgery is not medically necessary because the Roux-en-Y gastric bypass surgery is the standard of care.
Appeal type: Medical Necessity
Decision: Overturned

A 63-year-old male enrollee requested Harvoni for medical treatment of his chronic hepatitis C genotype 1b.  Findings:  Two physician reviewers found that given this patients advanced stage disease with evidence of cirrhosis, the requested Harvoni is supported as medically necessary. In addition, the U.S. Food and Drug Administration (FDA) recommend treatment for patients with advanced stage of disease. Per the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA), successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Consistent with these findings, the requested Harvoni is medically necessary for treatment of this patients advanced stage chronic hepatitis C virus with cirrhosis.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Assay testing. Findings:  Three physician reviewers found that the National Comprehensive Cancer Network (NCCN) guidelines indicate that genetic testing such as the DecisionDx-Melanoma Gene Assay should not be used outside of a clinical trial setting. The use of this type of testing is not considered to be standard of care in the evaluation of this patients melanoma. Moreover, the DecisionDx-Melanoma Assay is not expected to impact the treatment or outcome of this patients melanoma. All told, the DecisionDx-Melanoma Assay provided was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: 2 of 3 reviewers determined that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: All three physician reviewers are board certified in 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.
Appeal type: Medical Necessity
Decision: Upheld

A 58-year-old female enrollee has requested cancer treatment clinical trial (CB 10-01-02: A Phase II, Open-Label Evaluation of the Safety & Efficacy of CB-10-01, Transgenic Lymphocyte Immunization (TLI) against Telomerase, as Adjuvant Therapy in Subjects with Stage III Melanoma) for the treatment of her malignant melanoma. Findings:  The physician reviewer found that there is no data available regarding the efficacy or superiority of the proposed clinical trial as compared to interferon in the treatment of stage III melanoma. In the absence of any data from which to conclude transgenic lymphocyte immunization against telomerase is likely to be effective in this setting, the medical necessity of the proposed clinical trial has not been established.