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

A 53-year-old female enrollee has requested Bioness L300 (functional electrical stimulation walking device) for treatment of her multiple sclerosis with foot drop. Findings:  The physician reviewer found that the submitted documentation fails to establish the medical necessity of the requested equipment. Functional electrical stimulation devices may be useful in the treatment of significant foot drop due to upper motor neuron disorders of the brain and spinal cord including stroke, spinal cord injury, and multiple sclerosis. In this case, the patient has multiple sclerosis with right foot drop. The patient was evaluated and an 8-week gait training therapy program was planned. However, the documentation submitted for review indicates that the patient did not attend the follow-up physical therapy appointments. Therefore, it would be reasonable to consider a trial of the Bioness if after an adequate trial of physical therapy has been completed. Based upon the documentation submitted for review and the peer-reviewed literature cited above, the medical necessity of the requested equipment has not been established in this clinical setting.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Strensiq (asfotase alpha) 80 mg/0.8 mL vials = 9.6 mL (12 vials) x 28 days, and Strensiq (asfotase alpha) 80 mg/0.45 mL vials = 5.4 mL (12 vials) x 28 days. Findings:  The physician reviewer found that submitted documentation does not support the medical necessity of the requested medication, which is used to stabilize skeletal abnormalities, and is not indicated for chronic pain. The records did not demonstrate clinical signs and/or symptoms of hypophosphatasia, such as skeletal deformities or juvenile onset, or a diagnosis confirmed by the presence of a known pathological mutation in the ALPL gene, or of skeletal abnormalities demonstrated on radiographic imaging. In this case, while the patient has chronic pain, the records do not document a history of juvenile onset or of recurrent fracture. Therefore, Strensiq (asfotase alpha) 80 mg/0.8 mL vials = 9.6 mL (12 vials) x 28 days, and Strensiq (asfotase alpha) 80 mg/0.45 mL vials = 5.4 mL (12 vials) x 28 days are not medically necessary for the treatment of this patientFinal 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 with sub-specialty certification in rheumatology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Remicade intravenous infusion. The Health Plan has denied this request indicating that the medication at issue was considered investigational for treatment of the enrollees ulcerative colitis. Findings:  There is support in the medical literature for the medication at issue in this clinical setting. Until recently, the main goals in the treatment of UC were to temper the symptoms, such as diarrhea, pain, and weight loss, by using mesalazine and steroids. With newer medications, such as immunomodulators (thiopurines) and the biologics-providing blockade of tumor necrosis factor (TNF), the goals of the therapy in UC have changed to long-term remission and mucosal healing. The first available anti-TNF therapy in UC included infusion therapy with infliximab every few weeks.  The studies have shown that the anti-tumor necrosis factor- agents infliximab and adalimumab have been used in large-scale clinical trials and are currently widely used in the treatment of inflammatory bowel disease patients, such as in this patient Moreover, the studies have also shown that,   early treatment of Crohns disease with immunomodulators and anti-TNF agents leads to a superior clinical outcome, including healing of the mucosa, compared with standard therapy alone. Accordingly, based on the medical literature, the medication at issue was likely to have been more effective than the available standard therapy for treatment of this patients medical condition.Final Result: Two of the three reviewers have determined that the medication 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 reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for assay of lipoprotein (a) for evaluation of the enrollees lipoprotein level. Findings:  The physician reviewers found that while some providers advocate use of the advanced lipoprotein analysis, this testing has not been recommended by standard guidelines from the American College of Cardiology (ACC). Rather the ACC guidelines recommend use of standard risk factor analysis and standard lipid panels. All told, the assay of lipoprotein (a) was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: Two of three 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: Physician reviewer number one, two, and three are board certified in internal medicine with sub-specialty certification in cardiovascular disease and 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 56-year-old female has requested an increase of Actiq 1200 mcg to five times daily for treatment of her pain.  Findings:  The physician reviewer found that a dosage of Actiq 1200 mcg five times per day is not indicated for any medical condition except for cancer pain associated with a limited life expectancy. Presently, the maximum recommended dose on label for Actiq at all concentrations in the treatment of chronic pain is four units per day. The patients request for Actiq 1200 mcg five times per day exceeds the dose recommended for chronic pain.  In addition, a dose higher than the maximum recommended dose may lead to unwanted risks and side effects, and could prove to be lethal. High dose opioids may contribute to pain sensitization via opioid-induced hyperalgesia, decreasing a patients pain threshold and potentially masking resolution of a pre-existing pain condition (Baron and colleagues). In this retrospective study, the majority of patients undergoing detoxification of high dose opioids for chronic pain reported a significant decrease in pain at the end of the study, further supporting the theory of opioid-induced hyperalgesia. High dose opioids may also cause adverse outcomes and therefore the patients requested authorization for an increase in Actiq 1200 mcg to five times per day is not indicated. Ballantyne and colleagues found that prolonged use of high dose opioids may induce tolerance, abnormal pain sensitivity, and hormonal effects. The aim of current guidelines is to protect patients from the adverse effects of opioid therapy. Increasing Actiq 1200 mcg to five times per day is not clinically indicated for this patient.
Appeal type: Medical Necessity
Decision: Upheld

The parents of a three-year-old female enrollee requested authorization and coverage of occupational therapy for treatment of sensory modulation disorder.  The health plan denied the enrollees request indicating that occupational therapy 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 requested occupational therapy is not medically necessary.
Appeal type: Medical Necessity
Decision: Upheld

A 48-year-old female enrollee has requested authorization and coverage for Mohs micrographic surgery for treatment of the enrollee, who has a history of skin cancer. Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services in this patients case.  Mohs micrographic surgery is not medically indicated at this time, given that the lesion in question has not been evaluated and is not a biopsy-proven skin cancer.  Once a diagnosis is made by a dermatologist, appropriate treatment may or may not include surgical intervention.  Given her history of skin cancer, the patient requires routine evaluation by a dermatologist.  However, appropriate services are available in-network.  All told, the requested Mohs micrographic surgery is not medically indicated in this clinical setting.
Appeal type: Medical Necessity
Decision: Upheld

The patient is a 71-year-old female who sustained a spinal cord injury approximately four years ago and now has central pain syndrome. Standard pain medications have either failed to provide relief or caused intolerable side effects. Her pain is currently managed with transdermal fentanyl and Actiq for breakthrough pain. Her request for authorization of the Actiq was denied by the Health Plan based upon a determination that the medication is not medically necessary.Actiq is currently approved by the FDA for the management of cancer-related breakthrough pain. The medication has not been approved for the management of central pain syndrome.  The use of Actiq in this context is not medically indicated and is not consistent with the community standard of care. Therefore, I have determined the requested medication is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

A 48-year-old female enrollee has requested Provigil for the treatment of her fatigue secondary to multiple sclerosis. Findings:  The physician reviewer found that this patient has a diagnosis of relapsing-remitting multiple sclerosis (RRMS) with severe fatigue, a common and disabling condition in this patient population. She has reportedly tried other medications for this condition but experienced excessive negative side-effects. Provigil has apparently been beneficial and tolerated in the past, resulting in an improved quality of life. A thorough literature review demonstrates that Provigil is commonly used for RRMS-related fatigue, and can be of benefit. In this patients clinical situation, Provigil is reasonable and appropriate for treatment of her RRMS-related fatigue, and should be covered.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for services with a specialist who is a certified Lyme literate medical director (LLMD) and/or a member of the International Lyme and Associated Diseases Society (ILADS). This patient reportedly had a Lyme antibody, which is not the diagnostic standard for Lyme disease. The standard approach is to obtain a Lyme antibody then western blot for confirmation. However, this patients records do not include a confirmatory western blot. In addition, the diagnosis and treatment of Lyme disease could be treated with any board certified infectious disease specialist. The treatments including doxycycline and cephalosporins are routine for infectious disease specialists. Given these findings, the requested services with a specialist who is a certified Lyme literate medical director (LLMD) and/or a member of the International Lyme and Associated Diseases Society (ILADS) are not supported as medically necessary for evaluation and treatment of this patients medical condition. Final Result: The reviewer determined that the requested services are not medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in infectious disease and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

A 53-year-old male has requested an iBot Mobility System for his mobility.  Findings:  The physician reviewer found that the records provided are not supportive of the patients need for the iBot Mobility System to perform mobility-related ADLs. The patient has a long history of spinal cord injury and is currently using a POV. Modification to the living space is the appropriate means of gaining access to higher-level cabinets, etc. Additionally, the iBot Mobility System is still investigational at this time, and long-term outcomes have not been established.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Aimovig 140 mg/mL auto injector. Aimovig (erenumab) is a calcitonin gene-related peptide receptor antagonist approved by the U.S. Food and Drug Administration for the preventive treatment of migraine in adults. The recommended dosage is 70 mg once monthly, with some patients benefitting from a dosage of 140 mg once monthly. As an injectable preventive therapy, erenumab does not require slow dose escalation, provides a rapid onset of therapeutic benefits, and demonstrates favorable tolerability among patients. Researchers found that in patients with chronic migraines, erenumab 70 mg and 140 mg reduced the number of monthly migraine days with a safety profile similar to placebo. The American Headache Society (AHS) indications for treatment with erenumab include a diagnosis of chronic migraines and an inability to tolerate, or an inadequate response to, preventive medications such as topiramate, divalproex sodium/valproate sodium, or amitriptyline. In this case, the patient has a history of chronic migraines that have not responded to multiple oral preventative medications, including Topamax, Depakote, and Elavil. She has found Aimovig effective in decreasing the frequency of migraines in the past. Therefore, Aimovig 140 mg/mL auto injector is medically necessary for the treatment of 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 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

A 48-year-old female enrollee has requested for surgery to remove a ruptured breast implant for treatment of her ruptured saline implant.  Findings:  The physician reviewer found that there is no documentation in the record to indicate a prior history of breast cancer or that the implants were placed for reasons of cancer reconstruction. There is also no documentation of a loss of functioning as a result of the ruptured implant. The implant adds contour to the breast mound but the functionality of the mammary tissue is not altered. There are articles which discuss the fact that saline implants can deflate but no complications other than asymmetry are cited. A retrospective study by Gabriel and colleagues showed that 24% of women with breast implants had complications resulting in a reoperation during the first five years after implantation (silicone and saline implants were studied together). According to this study, about 1 in 3 women who sought breast implants for reconstruction needed a reoperation within five years, and about 1 in 8 women getting breast implants for augmentation needed a reoperation within five years.
Appeal type: Medical Necessity
Decision: Upheld

A 61-year-old female enrollee requested modafinil for medical treatment of her multiple sclerosis (MS) related fatigue.  Findings:  The physician reviewer found that MS related fatigue is not an indication for Provigil. The patient does not have an FDA approved indication for the use of Provigil. The use of Provigil for the treatment of fatigue for patients with MS is not the standard of care and is not medically necessary for this patient. Based on the medical literature cited above and the documentation submitted for review, the request for modafinil is not medically necessary for treatment of the patients medical condition.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Cerefolin NAC. Findings:  The physician reviewer found that Cerefolin NAC contains L-methylfolate (as Metafolin) 5.6 mg, methylcobalamin 2 mg, and N-acetylcysteine 600 mg. Cerefolin NAC has been approved by the U.S. Food and Drug Administration (FDA) for the treatment or prevention of vitamin deficiencies as a medical food. However, Cerefolin NAC has not been approved for the treatment of mild cognitive impairment, primary progressive aphasia, or memory loss. Overall, there is a lack of data in the peer-reviewed medical literature demonstrating that treatment with Cerefolin in patients with primary progressive aphasia results in improved health outcomes. There are case reports about use of Cerefolin in mild cognitive impairment, but no randomized and controlled studies. All told, the requested Cerefolin NAC is not medically necessary for treatment of this patients medical condition. 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 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 Harvoni for 12 weeks for treatment of his hepatitis C.  Findings:  The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions.  This applies regardless of fibrosis stage or viral load.  Per the guidelines, Harvoni for 12 weeks is medically appropriate in this clinical setting.  However, the guidelines also support treatment with Viekira Pak/ribavirin in this patients case.  Based on the provided records, there are no contraindications to Viekira Pak/ribavirin in this case.  Given that the Health Plans alternative of Viekira Pak is appropriate, the requested treatment with Harvoni for 12 weeks is not medically indicated 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 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for left gonadal vein embolization procedure (CPT code 37241). This patient has clinical findings and imaging studies suggestive of pelvic congestion syndrome. There is limited data regarding the standard of care or optimal strategy to manage this diagnosis. For women with pelvic congestion syndrome, invasive treatment is an appropriate option. Case reports have shown the benefit of this procedure although these studies are difficult to compare due to varying diagnostic criteria and techniques for treatment. Despite these limitations, the reported technical and clinical success rates of ovarian vein embolization is up to 100%, with 53% of patients reporting no pelvic pain and 47% noting a reduction in pelvic pain at one-year follow-up. Gonadal vein embolization is safe, well tolerated, and allows for a minimally invasive approach. Given this support, the requested left gonadal vein embolization procedure (CPT code 37241) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings:  Three of the three physician reviewers found the requested left gonadal vein embolization procedure (CPT code 37241) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in obstetrics and gynecology 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.