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

Nature of Statutory Criteria/Case Summary:  An enrollee has requested authorization and coverage for vedolizumab (Entyvio), 1 mg injection  Findings:  The physician reviewer found that Lichtenstein and colleagues, for patients with moderately to severely active Crohns disease and objective evidence of active disease, anti-integrin therapy (with vedolizumab) with or without an immunomodulator is more effective than placebo and should be considered to be used for induction of symptomatic remission in patients with Crohns disease. Moreover, vedolizumab should be used for maintenance of remission of vedolizumab-induced remission of Crohns disease. Additionally, several studies have assessed the use of Stelara with Entyvio, including both used at dosing every four weeks. In aggregate, no significant safety issues were attributed to dual biologic therapy, and the therapy was broadly successful in improving response in patients who had failed biologic therapy. In this case, the patient had improvement on Stelara with Entyvio, although a colonoscopy showed ongoing inflammation (ulceration in the ileum and rectum). Therefore, a discontinuation or decrease in dose of either Entyvio or Stelara could result in additional complications of uncontrolled disease, flare, hospitalization, need for surgery, fistula, and stricture. The patients alternative options are limited. Therefore, vedolizumab (Entyvio), 1 mg injection is medically necessary for the treatment of the patients medical condition.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in 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

Nature of Statutory Criteria/Case Summary:  An enrollee has requested a power mobility device for treatment of the enrollee, who has been diagnosed with multiple sclerosis.  Findings:  The physician reviewer found that this patient has multiple sclerosis.  The records do not establish that the patient is unable to propel an optimally-fitted manual wheelchair.  Overall, the records do not demonstrate that the patients basic mobility-related activities of daily living could not be accomplished with a walker with a seat or a manual wheelchair.  Physical activity is generally encouraged for all persons, regardless of any underlying health conditions that may exist, including multiple sclerosis.  Exercise has been shown to improve fatigue, mobility and quality of life in the setting of multiple sclerosis.  The use of a walker or manual wheelchair would promote physical activity while accomplishing mobility-related activities of daily living.  All told, the requested power mobility device is not medically indicated for the treatment of this patient.  Final Result: The reviewer determined that the requested equipment 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 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: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for allergy injections. Allergy shots may be indicated for persistent symptoms on a seasonal and/or perennial basis for patients with an inadequate or partial response to environmental control and medications. In this case, the medical records do not demonstrate a failure to respond to the new medication regimen, cetirizine and Flonase. The records do not establish that allergen immunotherapy is warranted at this time. As noted by colleagues, the immunotherapy build-up schedule (also called updosing, induction, or the dose-increase phase) entails administration of gradually increasing doses during a period of approximately. In conventional schedules a single dose increase is given on each visit, and the visit frequency can vary from one to three times a week. The authors noted that the maintenance phase begins when the effective therapeutic dose is reached. Once the maintenance dose is reached, the intervals between allergy injections are increased. The dose generally is the same with each injection, although modifications can be made based on several variablesthe intervals between maintenance immunotherapy injections generally range from four to eight weeks for venom and every two to four weeks for inhalant allergens but can be advanced as tolerated if clinical efficacy is maintained. In this patients case, the request is for weekly allergen immunotherapy during the maintenance phase, which is in excess of the current recommendations. As such, the request for allergy injections is not medically necessary.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 allergy and immunology 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

The patient is a 62-year-old female with a prior history of hyperplastic polyps seen on sigmoidoscopy in 1999 and 2002. She is now requesting a colonoscopy for colorectal neoplasia screening. The Health Plan has denied this request because the patient is not considered at high risk. In the alternative, the Health Plan has recommended a repeat sigmoidoscopy in 2007.The Health Plans denial should be overturned. Although colonoscopy is invasive, it is the best means of determining whether neoplasia exists and whether there is future risk. Furthermore, the clinical evidence demonstrates the patient requires a full colon screening. Sigmoidoscopy alone is not effective in decreasing proximal colon neoplasia risk and is inadequate for evaluating a normal risk individual who still has a 5% lifetime risk of developing colorectal cancer. Therefore, because this patient requires full colon screening, I have determined the requested colonoscopy is medically necessary for evaluation of the patients medical condition. The Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

A female enrollee requested ribavirin 400 mg and sofosbuvir (Sovaldi) 400 mg for medical treatment of the enrollees hepatitis C virus genotype 2b. Findings:  Two physician reviewers found thatp per the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) treatment guidelines, the recommended regimen for treatment experienced patients with hepatitis C virus genotype 2 is daily sofosbuvir 400 mg and weight-based ribavirin for 12 weeks. In addition, the guidelines cite three clinical trials demonstrating the safety and effectiveness of this medication regimen in patients with genotype 2 hepatitis C. Based on the provided records, published evidence of safety and efficacy in the published literature and clinical guidelines, the requested ribavirin 400 mg and sofosbuvir (Sovaldi) 400 mg should be approved as medically necessary for treatment of this patients medical hepatitis C virus.
Appeal type: Medical Necessity
Decision: Upheld

A 64-year-old male enrollee has requested medications such as Arimidex, clomiphene, tamoxifen or danazol and laboratory work to monitor high estrogen levels and low testosterone levels for evaluation and treatment of his medical condition. Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medications and testing.  According to American Association of Clinical Endocrinologists guidelines, male hypogonadism is diagnosed when there is a pretreatment level of testosterone less than 300.  Generally, hypogonadism is treated using testosterone replacement or gonadotropin therapy when fertility is an issue.  In this patients case, the records do not document a pretreatment testosterone level less than 300.  There is a lack of randomized prospective studies demonstrating the efficacy or safety of Arimidex, clomiphene, tamoxifen or danazol in the treatment of male hypogonadism.  The current medical evidence does not support the requested medications in this clinical setting.  Additionally, since there is no documentation of low testosterone levels, laboratory work to monitor for low testosterone and high estrogen is not medically indicated.  All told, the requested medications and testing are not medically indicated for the evaluation and treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 52-year-old woman with a long history of allergic asthma. She has been receiving monthly treatment with Xolair.  The patients provider reports the patient had a decreased need for albuterol and improved spirometry while using Xolair.  The patient experiences adverse side effects from Advair. Spirometry from September 2005 demonstrates an FEV-1 65% of predicted and an FEF 35% of predicted.  Continued use of Xolair has been recommended for treatment of the patients asthma. The Health Plan has denied coverage for the requested medication indicating it is not medically necessary for treatment of the patients medical condition.Review of the submitted clinical records indicates Xolair is medically indicated for the patient. She has allergic asthma with a low FEV, (57% in July 2005 was 57%, and 65% in September 2005, which is diagnostic of severe airway obstruction). Additionally, her previous response to Xolair therapy at 150 mg SQ every 4 weeks was documented in January 2005, April 2005 and September 2005. There is a note indicating good response on Xolair. Although this response is not necessarily reflected in her FEV, it is reflected in reduction in serious adverse events such as urgent care visits, severe exacerbations and hospitalizations. Furthermore, the patients IqE of 55 is within the recommended treatment range. Moreover, the submitted records indicate maximum therapy with oral steroid use. The patient has documented intolerance to inhaled corticosteroids.For these reasons, I have determined the requested medication is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for the matrix-induced autologous chondrocyte implantation (MACI) procedure. There is current peer-reviewed evidence that (MACI) is safe and effective for treatment of full thickness cartilage defects in the knee. The U.S. Food and Drug Administration (FDA) indications for MACI states that this autologous cellularized scaffold product is appropriate for the repair of symptomatic, full thickness cartilage defects of the knee, with or without bone involvement. In the medical literature, colleagues performed a systematic review that showed statistically significant improvements in patients undergoing MACI alone, and MACI combined with osteotomy, for patellofemoral chondral defects. This patients condition is severe and disabling. She reports significant locking and catching sensations. She is status post bilateral knee arthroscopy, debridement, chondroplasty, and synovectomy. She is not a candidate for total knee replacement due to her young age. She is not a candidate for osteochondral autograft or allograft transplant or microfracture surgery based on the size of chondral lesions. Given these findings, the requested MACI procedure is likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy.Findings:  Two of three physician reviewers found the requested MACI procedure is likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested MACI procedure is likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy.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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni 90/400 mg treatment of the enrollees hepatitis C virus. Findings: The physician reviewer found that according to the joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. The guidelines recommend that non-cirrhotic treatment-naive genotype 1 patients should be treated with Harvoni for 12 weeks. These recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA)-approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage . AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, the requested treatment with Harvoni 90/400 mg for 12 weeks is supported as medically necessary for the treatment of this patients hepatitis C infection.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

A female enrollee requested a sleep study, polysomnogram, for medical evaluation of her medical condition.  Findings:  The physician reviewer found that there is no documentation of hypersomnia, and hypersomnia is a cornerstone for a diagnosis of sleep apnea.  There is no Epworth Sleepiness score noted.  Patients with anxiety and depression frequently have sleep onset insomnia and this does not substantiate the medical necessity for a sleep study.  There is a lack of support for the requested services in this clinical setting.  All told, the requested sleep study, polysomnogram is not medically indicated for the evaluation of this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

A 67-year-old male enrollee has requested for cognitive rehabilitation therapy for treatment of his Alzheimers disease. Findings:  Two physician reviewers found that studies of cognitive rehabilitation for acquired brain injury show varied results and have varied trial designs.  Available literature regarding the efficacy of treatment for Alzheimers disease endorses use of anticholinergic medications and memantine, and suggests that maintaining physical activity and cognitively stimulating activities may reduce the rate of decline in Alzheimers disease. A study of reality orientation therapy suggested that once trained, benefits were maintained by continuation of reality orientation therapy by the caregiver.  All told, there is not substantial evidence to show that cognitive rehabilitation therapy is effective in treatment of this patients condition.
Appeal type: Medical Necessity
Decision: Overturned

A 55-year-old female enrollee has requested residential level treatment for chemical dependency for the treatment of her opiate abuse. Findings:  The physician reviewer found that this patient had a significant opiate addiction and was using large doses of prescribed analgesics. She had an uneventful detoxification. Given the severity of the patients opiate addiction for chronic pain, ongoing care beyond detoxification treatment was required to prevent rapid relapse. She required education and support to learn alternative strategies to deal with her pain. This could not be done at a lower level of care given her chronic history of daily opiate abuse. Substance abuse guidelines suggest that mere detoxification treatment for a short period is often inadequate to begin to guide a patient to abstinence, particularly when there is a prior history of significant drug abuse earlier in life and when chronic pain is an issue. Comorbid depression also increases the chance of relapse. Residential level treatment for chemical dependency provided was medically indicated.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a four-year-old male enrollee has requested participation in the UCLA Early Childhood partial hospitalization program (PHP) for treatment of the enrollees autism.  Findings:  The physician reviewer found that given the severe functional impairment, aggression and tantrums, this young patient requires the structure, monitoring and medical/psychological interventions available in a PHP. Applying the guidelines published by the American Academy of Child and Adolescent Psychiatry (AACAP), it is likely that this patient with the delineated serious behavioral issues would experience escalation at a level of care lower than PHP. Moreover, the Child and Adolescent Level of Care Utilization System (CALOCUS) recommendations and community standards suggest treatment at the least restrictive level of care possible. For this patient, whose aggressive behaviors have markedly decreased since beginning treatment at the current facility, the PHP level of care is the least restrictive level of services at which he can be safely and effectively treated. Since the records show improvement, yet continued safety concerns with aggressive behavior and prolonged tantrums, the PHP services at issue have been demonstrated to be medically appropriate.
Appeal type: Medical Necessity
Decision: Overturned

A 58-year-old male enrollee has requested for Lyrica for treatment of his peripheral neuropathy. Findings:  The physician reviewer found that the patient has painful neuropathy due to immunosuppressant medications. The mechanism of the neuropathy is different than in diabetic or post-herpetic neuropathies, but the mechanism of pain transmission and the symptoms are the same.  Therefore, the management of these neuropathies is similar, and agents such as membrane stabilizers and antiepileptic medications are useful and efficacious for the management of the over activity associated with the affected nerves.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Epclusa tablet 400-100 mg for 12 weeks for treatment of the enrollees hepatitis C virus. Findings:  The physician reviewer found that according to joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with life expectancy less than 12 months due to non-liver-related conditions. This applies in all cases, regardless of fibrosis stage. In this case, there is imaging evidence of cirrhosis. Per the guidelines, Epclusa for 12 weeks is recommended as a first line regimen for treatment naive genotype 3 patients. This is based on the ASTRAL-3 trial for Epclusa, which showed a high cure rate of 98%. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. Final Result: The reviewer determined that the requested medication regimen is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

The parents of an 11-year-old male enrollee requested authorization and coverage of a magnetoencephalography for evaluation of the enrollees medical condition. The Health Plan denied the request indicating that the requested magnetoencephalography (MEG) is considered experimental for evaluation of the enrollees partial complex seizures.Three physician reviewers performed an experimental/investigational Independent Medical Review. Two physician reviewers concluded that the requested MEG is likely to be more beneficial for the evaluation of the enrollees medical condition than any available standard therapy. One physician reviewer concluded that the requested MEG is not likely to be more beneficial for the evaluation of the enrollees medical condition than any available standard therapy. Because two of the three physician reviewers determined that the requested MEG is likely to be more beneficial for the evaluation of the enrollees medical condition than any available standard therapy, the Health Plans denial has been overturned.