Persius/imr-appeals huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Upheld

A 45-year-old female enrollee has requested cervical total disc arthroplasty (artificial disc) for treatment of her parasthesias with moderate to severe central spinal stenosis.  Findings:  Two physician reviewers found that there is an increasing interest in spinal arthroplasty as an alternative to fusion in conjunction with cervical discectomy. However, there are currently no comparative studies of artificial disc replacement with other treatment modalities besides fusion. In addition, the durability of this procedure is unknown, which is important based on the age of most patients who fit the current criteria for treatment. Further, there is limited data in terms of mechanical failure and aseptic loosening. There is also limited evidence as to the long-term effect on index-level facet arthrosis and/or adjacent level degeneration. Moreover, the devices utilized in artificial disc appear to yield results equal to or only incrementally better than fusion for the same indications (Resnick and Watters). Finally, the consequences of failure of an implant in close proximity to the spinal cord, the esophagus, and the trachea are of concern. The available peer-reviewed medical literature suggests that an analysis of these types of questions will take from five to 10 years. The suggested surgery is a three-level construct, yet the literature review shows greater than two levels to be contraindicated. Given the lack of scientific data demonstrating improved health outcomes with artificial disc replacement in the spine, the requested cervical total disc arthroplasty (artificial disc) is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has chronic migraines. The patient has previously tried and failed topiramate, beta-blocker, Botox, and nortriptyline. Her current medications include Amerge, butalbital, and Microgestin FE. The patient discontinued taking butalbital due to a concern for possible medication overuse headache. The patient has completed a migraine disability assessment (MIDAS) and a headache diary, which documents she has 14-15 headache days a month. Her provider recommended erenumab (Aimovig). The Health Plan has denied the request for Aimovig, indicating the patient has medication overuse headache, and that the requested medication is only for use with migraines. In the analysis of patients in the clinical trials of Aimovig, data shows that there is statistically significant efficacy in patients with acute medication overuse headache. Additional studies on calcitonin gene-related peptide (CGRP) monoclonal antibodies included patients with medication overuse headache in the trials for Aimovig. The authors found that the efficacy was as good as, or better than, in patients who did not have medication overuse headache. This patient has high-frequency episodic migraine/chronic migraine. She has been treated with more than four preventive agents, including beta-blockers, Topamax, and Effexor, which were not successful. The records indicate the patient has been tried and failed on Botox. A CGRP monoclonal antibody, such as Aimovig is appropriate for this patient given her frequent migraines, which have persisted despite treatment with multiple preventative medications. Therefore, the request for Aimovig is medically necessary for treatment of this patients chronic migraines. 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: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for multilevel spinal fusion surgery. This patient presents status post L4-L5 anterior lumbar interbody fusion with posterior spinal fusion and decompression at L5-S1. She initially did well following surgery, but records indicate that she reported a return of symptoms. Conservative treatment in the postoperative period included medications, activity modification, bracing, and physical therapy, without benefit. She reports constant severe pain with significant functional limitations in activities of daily living and inability to work. However, current evidence-based criteria have not been met. There is no documentation that the decompression surgery has failed at the L5-S1 level. There is no current documentation from the spine surgeon relative to physical findings with corroborating postoperative imaging evidence of residual spinal stenosis, severe degenerative disc disease, and/or nerve root compromise at the L5-S1 level. There is no radiographic evidence of L5-S1 spondylolisthesis or spinal segmental instability on flexion and extension x-rays. There is no discussion supporting the need for wide decompression that would result in temporary intraoperative instability and necessitate fusion. There is no clear documentation that the patient has failed a comprehensive attempt at postoperative rehabilitation. Therefore, the requested multilevel spinal fusion surgery is not medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested services are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in 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

A 57-year-old male enrollee has requested a Walk-Aid device (including electronic leads) for the treatment of his medical condition following cerebrovascular accident. Findings:  The physician reviewer found that in general, post-CVA foot drop/hemiparesis is managed with either a plastic molded ankle-foot-orthosis (AFO) or double-metal upright AFO, depending on various clinical factors. In certain instances, however, post-CVA patients may have significantly improved gait mechanics with use of a functional electric stimulation (FES) unit (like the Walk-Aid) when compared with a standard AFO (Ring, et al. and Hausdorff, et al.). This can only be determined through a detailed gait assessment, typically performed by a skilled physical therapist. When this is found to be the case, an FES unit is medically justified. In this case, no formal gait analysis or evaluation has been provided, nor is there specific objective documentation of the benefits of the Walk-Aid over conventional therapy, such as the AFO.
Appeal type: Experimental/Investigational
Decision: Upheld

A 28-year-old male enrollee has requested a magnetic resonance spectroscopy (MRS) for an evaluation of his traumatic brain injury. Findings:  Three physician reviewers found that this patient had a serious brain injury nearly five years ago with significant physical recovery and residual mild cognitive changes. The literature shows that MRS may in the future give better insight into prognostic factors for recovery from acute traumatic brain injury. In this patients case, there is no information submitted to suggest that MRS would be beneficial in clarifying the diagnosis, that clinical decision-making would be altered by MRS findings or that MRS results would guide treatment decisions. Additionally, there is no evidence in the literature or the clinical record that MRS will provide meaningful prognostic information years after traumatic brain injury.
Appeal type: Experimental/Investigational
Decision: Overturned

A 54-year-old male enrollee has requested intensity modulated radiation therapy (IMRT) for treatment of his prostate cancer. Findings:  Three physician reviewers found that intensity modulated radiation therapy is a radiation planning and delivery tool available to the radiation oncologist to better shape the radiation dose distribution, and therefore minimize the dose to normal structures. Intensity modulated radiation therapy is a tool that clinicians can use when there is concern about sparing normal tissues from high dose exposure.  Tomotherapy is a form of intensity modulated radiation therapy which uses helical delivery of MV radiation with a hydraulically controlled collimator to achieve modulation of the beam.  Intensity modulated radiation therapy (and tomotherapy) employ inverse planning, using input dose volume constraints, and an inverse planning algorithm which maximizes a plans adherence to these constraints.  Intensity modulated radiation therapy for post-prostatectomy can be considered a standard approach to treat the prostate bed.  Intensity modulated radiation therapy allows relative sparing of the bowel and bladder.  In this patients case, there is seminal vesicle involvement. Thus, the treatment field will likely be much larger, creating concern about rectal and bladder doses.  Intensity modulated radiation therapy can be considered medically necessary to reduce dose to surrounding critical structures of bowel and bladder, particularly in this patient with positive margins and original bulky tumor.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Epclusa 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. Per the guidelines, Epclusa is recommended as a first-line regimen for non-cirrhotic genotype 3 patients, regardless of prior treatment. This is based on trials including ASTRAL-3, which showed a high cure rate of 98%. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, Epclusa is medically necessary for treatment of the 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: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary:   An enrollee has requested the wearable cardiac defibrillator (Zoll LifeVest) for treatment of her medical condition.  Findings:  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. The peer reviewed literature does not support a benefit or improved outcome as compared to standard medical therapy with deployment of the LifeVest in this clinical setting. All told, the wearable cardiac defibrillator (Zoll LifeVest) was not likely to be more beneficial for treatment of the patients medical condition than other standard therapies. Final Result: Three reviewers determined that the services at issue were 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 reviewers are board certified in internal medicine with sub-specialty certification in cardiovascular disease 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: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the sacroiliac joint fusion for treatment of the enrollees sacroiliitis. Findings:  Two physician reviewers found that the SI joint fusion was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In the medical literature, one study showed that minimally invasive SI joint fusion using triangular titanium implants was more effective than nonsurgical management at one year in relieving pain, improving function, and improving quality of life in patients with SI joint dysfunction caused by degenerative sacroiliitis or SI joint disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment. The International Society for Advancement of Spine Surgery (ISASS) policy statement for minimally invasive SI joint fusion provide specific indications for surgery. The criteria includes: significant SI joint pain or significant limitations in activities of daily living because of SI joint pain; SI joint pain confirmed by at least three positive SI joint provocative tests; confirmation of the SI joint as a pain generator with at least 75% decrease in pain following fluoroscopically guided diagnostic intra-articular SI joint block in the immediate post-injection period; failure to respond to at least six months of non-surgical treatment including medications, rest, physical therapy, and SI joint steroid injection or rhizotomy; and, additional or alternative diagnoses that could be responsible for the patients ongoing pain or disability have been clearly considered, investigated and ruled-out. In this case, the patient presented with chronic and function-limiting left hip and buttock pain radiating into the left lower extremity that progressively worsened over a one year period. Her pain was described as constant, severe and debilitating. Clinical exam findings documented five positive SI joint provocative signs. Imaging demonstrated SI joint spondylosis. A positive SI joint diagnostic injection was documented with 100% pain relief in the immediate post injection period. Detailed evidence of at least six months of conservative therapy was documented. Alternative diagnoses of L4-5 disc pathology were investigated, considered and ruled out at the primary source of pain and disability. Final Result: Two reviewers determined that the procedure at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications: All three physician reviewers 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: The parent of an enrollee has requested authorization and coverage for Norditropin flexpro 5 mg/1.5 mL pen for treatment of the enrollee, who has symptoms of growth hormone deficiency. Findings: The physician reviewer found that the patient has short stature, poor growth velocity, low growth factors, and delay in bone age. He has a congenital morphological abnormality of his pituitary gland known to be associated with GH deficiency, and he has evidence of another pituitary hormone deficiency, central adrenal insufficiency. The patient meets standard criteria for classic GH deficiency, and it is medically necessary for him to receive GH therapy until epiphyseal fusion. The patient does not require formal provocative GH testing to diagnose GH deficiency in the setting of poor growth, a morphological abnormality of the pituitary gland, and biochemical testing supporting 2 pituitary hormone deficiencies. 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 pediatrics with sub-specialty certification in pediatric endocrinology 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 37-year-old female enrollee requested morphine (7-9), Percocet tablets (7-9), Soma (3-4), and Ativan (0-4) daily for medical treatment of her chronic pain.  Findings:  The physician reviewer found that morphine (7-9), Percocet tablets (7-9), Soma (3-4), and Ativan (0-4) daily is not medically necessary. The patient does not have a history of malignancy. The opioid dosing regimen is only indicated for malignant pain.  The current standard of care for chronic pain associated is treatment in a multidisciplinary practice to include physical therapy, massage therapy, behavioral therapy, and injections to help reduce pain (Fishman).  Baron and MacDonald reported that high dose and short acting opiates might contribute to pain sensitization via opioid-induced hyperalgesia, decreasing patient pain threshold, and potentially masking resolution of a preexisting pain condition.  In this retrospective study, the majority of patients undergoing detoxification of high dose opiates for chronic pain reported a significant decrease in pain at the end of the study, further supporting the theory of opioid-induced hyperalgesia.  In addition, long-term opiates are more likely to cause adverse outcomes.  Ballantyne and Mao reported that prolonged use of high dose opiates might induce tolerance and abnormal pain sensitivity. It is in the patients best interest to wean off opioids and start in a multidisciplinary program.  Consistent with these findings, the requested medications are not medically necessary for treatment of this patients chronic pain.
Appeal type: Medical Necessity
Decision: Upheld

A 64-year-old male enrollee requested morphine sulfate 200 mg extended release (ER) (six times per day) for medical treatment of the enrollees chronic pain.  Findings:  The physician reviewer found that the request for morphine sulfate 200 mg ER (six times per day), is not medically necessary. The patient has non-malignant chronic pain, which will often worsen or recur as a result of opioid rebound.  Baron and colleagues reported that high dose opiates might contribute to pain sensitization via opioid-induced hyperalgesia, decreasing patient pain threshold and potentially masking resolution of a preexisting pain condition. In this retrospective study, the majority of patients undergoing detoxification of high dose opiates for chronic pain reported a significant decrease in pain at the end of the study, further supporting the theory of opioid-induced hyperalgesia. It would therefore, be in the best interest of the patient to wean down or off all opiates and participate in adjunctive therapy including non-narcotic medications, physical therapy, massage therapy, or cognitive behavioral therapy, in order to address the chronic pain.  Based on the documentation submitted for review and the peer-reviewed literature cited above, the requested medication is not medically necessary for treatment of the patients medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patients parent has requested authorization and coverage for in-home nursing services up to 12 hours per day. Home health care aims to provide patients with chronic conditions comprehensive health care within a nurturing home environment. Providers are tasked with maximizing the capabilities of the patient and minimizing the effects of the disabilities. Children with special needs frequently require equipment at home to allow for safe and effective care. Such equipment may facilitate feeding and eating, toileting, bathing, safe sleeping, and mobility, as well as opportunities to achieve functional skills. This patient has a number of skilled nursing needs as a result of her congenital anomalies. She requires 24-hour care due to her inability to protect her airway and severe feeding problems. She currently receives all nutrition via the gastrostomy tube due to an inability to tolerate small amounts of formula. She requires intermittent feedings during the day with a feeding pump and continuous feedings at night. She is at risk for aspiration because of poor airway clearance, pooling of secretions, and gastroesophageal reflux. She is also at risk for skin breakdown secondary to atopic dermatitis, requiring meticulous skin care. The patients family has been trained in her care. However, requiring the patients family to provide her care 24-hours per day without skilled nursing assistance would place the patient at risk for complications. Given these findings, the requested in-home nursing services up to 12 hours per day, are medically necessary and appropriate for treatment of this patients medical condition.Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in pediatrics with subspecialty certification in pediatric critical care 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.