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

A 46-year-old male enrollee has requested hyperbaric oxygen therapy for treatment of his post-traumatic stress disorder and history of traumatic brain injury.  Findings:  The physician reviewer found that the medical literature reveals a lack of randomized, well-controlled and adequately powered exploratory and confirmatory studies regarding the application of hyperbaric oxygen therapy in the setting of traumatic brain injury. While a study reported by Harch and colleagues suggests potential for the modality, the findings were based on a proof of concept study which was neither randomized nor controlled in its design.  Further, the pathophysiology of the study group was based on blast exposure, not acceleration/deceleration axonal injury typical of high-velocity blunt head trauma common to a vehicular accident.  A review by Bennett and colleagues concluded that the routine use of hyperbaric oxygen therapy cannot be justified, and additional study is needed. This aligns with the Veterans Administration/Department of Defense (VA/DoD) Clinical Practice Guideline which states: Novel therapy (hyperbaric oxygen, nutritional supplements) modalities in the management of concussion/mTBI are being explored in the field as potential treatment approaches. It is the recommendation of the Working Group that interventions which lack sufficient empirical support should occur only under the auspices of an IRB reviewed protocol. In terms of the patients PTSD, it does not appear he has failed evidence-based interventions shown to impart durable treatment gains for this condition. Treatments such as cognitive processing therapy and prolonged exposure have exceptional 10-year follow up data and represent first-line treatments for PTSD.  Hyperbaric oxygen therapy is not mentioned in the VA/DoD Clinical Practice Guideline as an accepted therapy for PTSD. Moreover, a literature search failed to reveal well-designed studies supporting the use of hyperbaric oxygen therapy in patients with PTSD. In sum, at this time there is a lack of scientific evidence demonstrating hyperbaric oxygen therapy is efficacious for the treatment of traumatic brain injury and/or PTSD. In the absence of adequate confirmatory evidence of the favorable effects of hyperbaric oxygen therapy in this setting, the medically necessity of the requested therapy not been established.
Appeal type: Medical Necessity
Decision: Upheld

The patient is a 37-year-old female with relapsing-remitting multiple sclerosis (MS).  She did not receive disease-modifying therapy during pregnancy or immediately following delivery. The patient was treated with IVIG in the postpartum period as a preventative therapy to avoid relapse of her MS. The patient is requesting reimbursement for the IVIG therapy. The Health Plan has denied her request based upon a determination that the therapy was not medically necessary.The American Academy of Neurology Therapeutics Assessment Committee guidelines do not support the application of IVIG therapy in relapsing-remitting MS. Although there have been several small studies suggesting IVIG therapy reduces the rate of MS relapse in the postpartum period, these studies were primarily retrospective and open label. Further studies are necessary to establish the efficacy of IVIG therapy in this clinical context. Therefore, I have determined the therapy at issue was not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

A 60-year-old male has requested approval for a past lumbar artificial disc replacement at L3-4 and L4-5 for treatment of his degenerative disc disease.  Findings:  Three physician reviewers found that the patient is has a history of severe right leg sciatica as well as low back pain. He has been treated with multiple therapies including epidurals, nerve root blocks, acupuncture, physical therapy, massage and medications, all without lasting relief. On neurological testing, he has 4+/5 strength in the right iliopsoas, tibialis anterior and extensor hallucis longus (EHL) but 5/5 elsewhere. His sensation is intact in both lower extremities. A discogram was unable to determine his primary pain generator. A post discogram computed tomography (CT) demonstrated multilevel disc and facet degenerative changes without significant central canal stenosis. An electromyography (EMG) was consistent with a right L4 radiculopathy with ongoing denervation. The patient underwent artificial disc replacement surgery at L3-4 and L4-5. The ProDisc-L total disc replacement was approved by the FDA in 2006 for spinal arthroplasty in patients with degenerative disc disease. This approval was based on a non-inferiority rather than superiority study comparing 162 randomized patients treated with ProDisc-L and 80 control patients. The main conclusions of the study were that at 24 months, the overall incidence of adverse events, number of device-related adverse events, and the overall success rate of the ProDisc-L group was no worse than that of the control group. In a case series published in a peer-reviewed journal, Shim and colleagues followed 24 patients for greater than three years and concluded that the facet joint of the index level and the disc at the adjacent level showed an aggravation of the degenerative process in a significant number of patients (32% and 28.6%, respectively), raising concerns of possible late consequences of total disc replacement, especially regarding facet arthrosis and adjacent segment disease. Given the lack of well designed studies with long-term outcome data supporting the superiority of the procedure under review, the surgery at issue was not likely to be more beneficial for treatment of the patients medical condition than any available alternative therapy.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested skilled nursing facility services for treatment of the enrollees lateral tibial plateau compression fracture and a strain of the patellar ligament. Findings: The physician reviewer found that Tibial plateau fractures are complicated injuries, each requiring an individualized initial approach whether surgical or nonsurgical. These fractures can result in significant functional impairments.  The focus of early rehabilitation efforts should be an early range of motion with special attention to full knee extension.  In this patients case, the patient had been in the rehabilitation setting for approximately a month and a half.  She had made no progress with transfers or mobility.  Even if she had been on non-weight-bearing restrictions of one lower limb, some progress with transfers should have been possible.  No progress has been documented even with liberalization of her weight-bearing status to weight-bearing as tolerated.  The records indicate that the patients obesity and diminished functional capacity are precluding meaningful progress with rehabilitation before knee replacement surgery as well.  Further care could have been provided in a less intensive setting of care.  Continued inpatient care would constitute custodial level care.  All told, skilled nursing facility services were not and are not medically indicated for the treatment of this patient.Final Result: The reviewers determined that the services at issue were not and 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: Experimental/Investigational
Decision: Upheld

A 47-year-old female enrollee has requested authorization and coverage for positron emission tomography (PET) scans every nine weeks. The Health Plan has denied this request indicating that the requested diagnostic imaging is considered investigational for evaluation of the enrollees stage IV lung cancer. Findings:  Two physician reviewers found that the patient was diagnosed with stage IV non-small cell lung cancer (NSCLC) 5 years ago. There was tissue confirmation, and the patient had brain metastases. She has been treated with chemotherapy, and is currently on a regimen of pemetrexed administered every three weeks.  According to the patients physician, the patient is in complete remission, with no evidence of recurrent disease. Multiple recent PET scans have been reported as not showing evidence of tumor.  An MRI of the brain dated reported brain lesions that were felt to be less conspicuous. The issue in this appeal is whether PET scans at intervals of every nine weeks are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Based on the kinetics of tumor development, obtaining frequent follow-up imaging studies is often not diagnostically or clinically useful. For example, in the case of this patient, she reportedly has no signs of tumor in her chest/abdomen/pelvis. In order to obtain useful information on a follow-up study, there must be sufficient time for the tumor to present itself. A further issue is that detecting a tumor earlier, before it becomes clinically apparent, often does not necessarily alter the course of disease. The National Comprehensive Cancer Network (NCCN) has developed guidelines for when to best obtain follow-up studies for surveillance. Their current recommendation for NSCLC Stages I-IV for patients with no evidence of clinical/radiographic disease (NED) is to obtain a history and physical and chest CT +/- contrast every 6 to 12 months for 2 years and then a history and physical and a non-contrast-enhanced chest CT annually. Specifically, PET is not indicated for routine follow-up. (NCCN Guidelines). Alberts indicates that in lung cancer patients following curative intent therapy, the use of blood tests, PET scanning, sputum cytology, tumor markers, and fluorescence bronchoscopy is not currently recommended for surveillance. In sum, the peer-reviewed medical literature does not demonstrate that the use of frequent PET scans is recommended in the surveillance of NSCLC.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 53-year-old female with a recent diagnosis of Churg-Strauss syndrome following a history of asthma. She presented in December 2005 with weight loss, leg weakness, pulmonary infiltrates on imaging studies, elevated p-anca, elevated IgE, elevated ESR, and nerve conduction/EMG studies documenting mononeuritis multiplex, producing a multifocal polyneuropathy.  She was treated appropriately with high-dose steroids and cyclophosphamide, but had an inadequate response.She was next treated with a course of IVIG with dramatic benefit, but when the effects wore off her leg pain again prevented her from walking. Her rheumatologist then recommended a course of five more treatments with IVIG, but the Health Plan has denied authorization for the treatment on the basis that IVIG has not been shown to be effective for the patients diagnosis.The patient has a history and findings most consistent with Churg-Strauss vasculitis, and is being managed by an experienced rheumatologist. This illness can be difficult to control, as many patients do not respond adequately to what was once the standard regimen of steroids and cyclophosphamide. As a result, the medical literature has noted reports of various other methods of primary or adjunctive treatment of this illness. As the submitted literature indicates, the most reliably effective intervention has involved repeated courses of IVIG.It is clear that the addition of IVIG to the regimen of steroids and cyclophosphamide for the treatment of Churg-Strauss vasculitis has produced more beneficial responses with greater durability, and the use of IVIG is now considered standard of care in patients failing to respond adequately to previous treatment with steroids and cyclophosphamide. In addition, this patients multifocal polyneuropathy is, in itself, a recognized indication for IVIG.In conclusion, the use of IVIG for the treatment of Churg-Strauss vasculitis in patients with inadequate response to steroids and cyclophosphamide is within the standard of care and is not considered investigational. Therefore, I have determined the requested therapy is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 15-year-old male who has been diagnosed with Perthes disease and adolescent avascular necrosis. After discussing treatment options with the patients providers, the patients family decided to pursue the distraction procedure (external fixation) to treat the disorder. On 11/25/03, the patient underwent application of external fixation to the right hemipelvis and femur for hip joint distraction, which was performed by an out-of-plan provider. On 4/26/04, the patient returned to the out-of-plan provider for an arthrogram, external fixation removal, percutaneous adductor tenotomy and hip injection of growth hormone. A request has been made for reimbursement for the services at issue. The Health Plan has denied the request on the basis that the services at issue were not medically necessary.The patient is a 15-year-old male with Perthes disease and adolescent avascular necrosis. Standard surgical therapy for patients in the patients age group results in mixed outcomes. Furthermore, conservative management was not likely to be of benefit to the patient. The distraction procedure is a medically reasonable and appropriate option for patients such as this patient. Since the distraction procedure is only available at a few centers throughout the country, it was medically necessary for the patient to receive the treatment from an out-of-plan provider. However, follow-up care including external fixation removal could have been performed by an in-plan physician. There is no evidence that the patients in-plan physician did not have sufficient expertise to provide follow-up care. As such, the follow-up services at issue were not medically indicated for treatment of the patients condition.Based upon the information set forth above, I have determined that although distraction surgery was medically necessary for treatment of the patients medical condition, it was not medically necessary for the patient to receive follow-up care from the patients out-of-plan provider. Therefore, the Health Plans denial should be partially overturned.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a one-year-old female enrollee has requested general anesthesia in a hospital or surgery center setting for treatment of the enrollees dental caries requiring pulpectomy.  Findings:  The physician reviewer found that coverage for general anesthesia in a hospital or surgery center setting is medically necessary for the patients dependent dental services. The patient has severe disease requiring extensive dental surgery. The patient is a one-year-old without fully developed oropharyngeal reflexes to protect the airway. General anesthesia provides a safe and effective setting for the dental surgery. General anesthesia also provides a controlled setting in which the patients airway is protected from excessive secretions and aspiration which can potentially put the patient at risk for respiratory distress. Dial and colleagues performed a retrospective review on sedation of 301 pediatric patients undergoing various procedures. The authors tested the hypothesis that the need to attain immobility during pediatric sedation for procedures determines the depth of sedation, which cannot always be predicted. They reported that pediatric sedation results in four categories of immobility. Complete immobility during painful and invasive procedures is associated with a higher incidence of adverse events. The depth of sedation required to achieve immobility varies from patient to patient. Thus, granting a limited sedation authority (i.e. conscious sedation only) to providers is of limited practical value. In this patients case, conscious sedation in a non-surgical setting for a dental procedure that requires stability and immobility is not ideal or safe in a one-year-old patient. Cote and colleagues performed a critical incident analysis to determine the factors that contribute to adverse sedation events in children undergoing procedures. The authors identified several features associated with adverse sedation events and poor outcome. Specifically, adverse outcomes and inadequate resuscitation were more often associated with a non-hospital based facility setting. Inadequate physiologic monitoring was another major factor contributing to poor outcome in all venues of non-hospital based settings. Consistent with these findings, the requested authorization and coverage for general anesthesia in a hospital or surgery center has been demonstrated to be medically necessary for treatment of the patients medical condition.
Appeal type: Medical Necessity
Decision: Upheld

A 64-year-old female enrollee requested authorization and coverage for total knee replacement surgery. The health plan has denied this request indicating that the requested surgery is not medically necessary for treatment of the enrollees osteoarthritis. One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer upheld the health plans denial on the basis that the requested procedure is not medically necessary.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 54-year-old female with multiple medical problems who was treated for arteriosclerotic cardiovascular disease with stent placement in August 2005. She is anti-coagulated with aspirin and Plavix.  The patient now has an infected tooth with a draining fistula requiring urgent surgical treatment. This procedure would typically be carried out in an oral surgery office.  The patients oral surgeon however believes that she remains at risk for MI and stent occlusion and has requested authorization to perform the procedure under general anesthesia in a hospital operating room. The Health Plan denied authorization based upon a determination that the requested services are not medically necessary.The standard of care dictates the avoidance of elective oral surgery and ambulatory in-office general anesthesia or drip sedation for at least 6 months after stent placement when possible.  This patient has an acute condition and surgical intervention cannot be delayed.  There does not appear to be any dispute on that issue.  It is the judgment of her treating oral surgeon that the risks related to IV sedation or general anesthesia with oral surgery carried out in the office setting, are unacceptable at this time.  I concur that this procedure should be carried out in a hospital setting with IV sedation or general anesthesia and appropriate cardiac and vital sign monitoring. Treatment facilities for stent occlusion or MI should be immediately available. Although the risk for cardiac complications maybe small, a treatment risk remains in this American Surgical Association (ASA) class II or class III patient and the risks associated with treatment in an oral surgery office are significant enough to contraindicate an office procedure at this time.Based upon the information set forth above, I have determined the requested services are 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: An enrollee has requested reimbursement for the Oncotype DX Prostate Cancer Assay. Once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features such as the grade of tumor and prostate specific antigen (PSA) level. According to the National Cancer Institutes Physicians Data Query, most clinical variables have not been analyzed in prospective clinical trials. Despite their utility, Gleason score and PSA are imperfect predictors. The Oncotype DX Prostate Cancer Assay is a gene expression analysis of target genes in the biopsy specimen that generates a genomic prostate score (GPS). A validation study was presented at the American Urological Association Meeting in 2013 involving 395 patients. The GPS identified patients that had very low risk disease that could be followed rather than referred for surgery. Thus, the test aided decision-making for the next treatment step. Given this support, the Oncotype DX Prostate Cancer Assay provided was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. One reviewer found that the Oncotype DX Prostate Cancer Assay provided was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: Two of the three reviewers determined that the service at issue was 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:  One reviewer is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. One Reviewer is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing.  One Reviewer is board certified in internal medicine and medical oncology and is actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

A 46-year-old female has requested additional chiropractic services for treatment of her back and shoulder pain.  Findings:  The physician reviewer found that the proposed treatment is not medically necessary for this patients medical condition given the lack of proven benefit of chiropractic manipulation on clinical course or outcomes in the setting of chronic neck, shoulder, or back pain (Ernst; Johnston, et al). In the medical literature, Ernst concluded, that the notion that chiropractic or massage are effective interventions for pain control has not been demonstrated convincingly through rigorous clinical trials. In 2008, Bronfort and colleagues did not report significant, sustained benefit to spinal manipulation and mobilization over other conservative management. More recent high-grade studies establishing the clinical efficacy of these interventions have not been published. Overall, there is insufficient data to establish that this intervention delays or prevents the need for clinically appropriate surgical interventions. All told, no significant marginal benefit is expected with the proposed treatment over an independent exercise program balanced with judicious rest, as well as self-applied palliative modalities. Although the patient remains symptomatic, the proposed chiropractic therapy is not reasonably expected to provide significant clinical benefit and is not medically necessary.