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

Nature of Statutory Criteria/Case Summary:  An enrollee has requested or Xeljanz for treatment of her atopic dermatitis.   Findings:  Three physician reviewers found that atopic dermatitis is a common itchy inflammatory skin disease characterized by immune activation, marked epidermal hyperplasia, and defective barrier function, reflecting underlying alterations in keratinocyte differentiation. The disease may be associated with significant morbidity, particularly when complicated by secondary infection. Frequent disruption of sleep is common, and emotional stress associated with the illness can have a significant impact on quality of life for patients and families. Much effort has recently been placed on the development of new treatment strategies for this increasingly common illness. Treatment of atopic dermatitis usually starts with topical agents, such as corticosteroids as well as phototherapy. Skin inflammation in atopic dermatitis results from inherited and acquired insults to the skin barrier, and agents that normalize the skin barrier reduce the dependence on topical steroids. Tacrolimus ointment and pimecrolimus cream are the topical calcineurin inhibitor approved for clinical use and has been demonstrated to be safe and effective in the treatment of patients with atopic dermatitis.  Xeljanz is U.S. Food and Drug Administration (FDA) approved for the treatment of moderate to severe rheumatoid arthritis. In this patient, there is a lack of documentation that standard immunosuppressant medications such as cyclosporine and ultraviolet A (UVA) have been used for treatment. Further, there is no evidence that this patient has been diagnosed with rheumatoid arthritis. Additional studies should confirm Xeljanz efficacy in atopic dermatitis before it can be recommended for treatment of atopic dermatitis patients. Thus, the requested Xeljanz is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Final Result: Three reviewers determined that the requested medication is 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 dermatology 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 gene panel testing for evaluation of the enrollees astrocytoma. Findings:  Two physician reviewers found that the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Li-Fraumeni syndrome is an inherited autosomal dominant disorder that is manifested by a wide range of malignancies that appear at an unusually early age. Li-Fraumeni syndrome is also known as the sarcoma, breast, leukemia, and adrenal gland (SBLA) cancer syndrome. This cancer predisposition syndrome is inherited as an autosomal dominant disorder and is associated with abnormalities in the tumor protein p53 gene (TP53). Several case reports have suggested that radiation-induced cancers are more common in patients with Li-Fraumeni syndrome and preclinical studies have provided additional evidence in support of this relationship. Thus, radiation therapy is generally avoided as a component in the management of these patients whenever possible. The differential diagnosis includes other inherited cancer syndromes in patients whose presentation suggests Li-Fraumeni syndrome such as BRCA1 and 2 mutations and Lynch syndrome (there are a number of genes involved in the repair of DNA mismatch errors, including M1H1, MSH2, MSH6, PMS1, and PMS2). The recent introduction of multi-gene testing for hereditary forms of cancer has rapidly altered the clinical approach to testing at-risk patients and their families. Based on next-generation sequencing technology, these tests simultaneously analyze a set of genes that are associated with a specific family cancer phenotype or multiple phenotypes. When more than one gene can explain an inherited cancer syndrome, then multi-gene testing may be indicated. As such, multi-gene panel testing was clinically indicated for this patient. Final Result: The reviewers determined that the testing 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: Reviewers 1, 2 and 3 are board certified in internal medicine with sub-specialty certification in medical oncology 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

The parent of a 7-year-old male enrollee has requested occupational therapy services twice per week for 60 minutes per visit for treatment of the enrollees autism.  Findings:  The physician reviewer found that occupational therapy for this patient with fine motor deficits and decreased adaptive functioning is medically necessary. The therapy is indicated when deficits exist in functional skills or occupational performance as well as in areas of self-maintenance and ADLs (Filipek, et al). The goal is to enable the patient to participate in ADLs of self care including dressing, bathing, and toileting and to help the patient develop skills such as posture and coordination (Fazliglu and Baran). Overall, the evidence based research offers strong positive data in support of occupational therapists using comprehensive, individualized analysis of a patients performance to develop intervention strategies. The literature also advocates the use of family-centered interdisciplinary approaches. Based on the documentation provided, the patients OT regimen has included sensory integration techniques. Sensory integration intervention appears to enhance a patients ability to modulate behavior and participate in social interaction(Case-Smith and Arbesman). However, the authors cautioned that findings are inconclusive at this time, as classic sensory integration approaches have minimal research evidence. All told, the use of sensory integration techniques is not a standard treatment modality for patients with autism. As such, I have determined that OT for the patients fine motor and adaptive deficits was and is clinically indicated and necessary for this patient. However, the literature does not support the efficacy of OT for sensory processing in autism; therefore, the portion of the patients OT focused on sensory integration techniques was not and is not medically necessary.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee requested transcranial magnetic stimulation (TMS) for treatment of his depression, obsessive compulsive disorder (OCD), and anxiety.   Findings:  The physician reviewer found that the records indicate that this patients depression is treatment resistant since multiple antidepressants and augmentation strategies have not successfully brought on remission. The medical literature reported that TMS had a moderate effect on treatment resistant depression. Moreover, TMS has been approved by the U.S. Food and Drug Administration (FDA) for patients with treatment resistant major depressive disorder. Thus, TMS is supported as medically necessary for treatment of this patients medical condition.Final Result: The reviewer determined that the requested therapy 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 psychiatry 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 43-year-old male enrollee has requested for Rozerem 8mg for treatment of his insomnia. Findings:  The physician reviewer found that ramelteon is a non-addictive FDA approved medication for insomnia.  It generates clinical effect usually within 60 minutes by selectively binding to and stimulating central melatonin receptors.  Melatonin can improve sleep latency, total sleep time and quality of sleep, but it has a particular affinity for maintaining circadian rhythms and promoting a healthy sleep-wake cycle.  In clinical practice, common alternatives to ramelteon include eszopiclone and zolpidem.  The documentation provided fails to demonstrate the medical necessity of ramelteon in this particular case. There is no documentation in the records provided that  any of these are present in this case. Therefore, the requested medication is not medically necessary.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for OxyContin, Roxicodone, Ativan, and clonazepam and palliative care for treatment of the enrollees human immunodeficiency virus (HIV), idiopathic peripheral autonomic neuropathy, and chronic pain syndrome. Findings:  The physician reviewer found that the patient is on an extremely high dose opioid and benzodiazepine regimen. Further, the patient has a documented failed urine screen from October 2016 with positive findings for multiple non-prescribed agents. Additionally, the patient does not have a medical condition that at this time qualifies him for palliative care. Given the above findings of extremely high dose opioids with two concurrent benzodiazepines medications and a failed urine screen, the above requested OxyContin, Roxicodone, Ativan, and clonazepam and palliative care are not medically necessary. Final Result: The reviewer determined that the requested medications and 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 anesthesiology with sub-specialty certification in pain medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 55-year-old female who has been diagnosed with osteoporosis. A dual-energy x-ray absorptiometry (DEXA) scan showed a spine L1-4 T-score of -3.0, a left femoral neck T-score of -2.5, and a right femoral neck T-score of -2.5. A couple years later, a DEXA scan showed a spine L1-4 score of -2.4, a left femoral neck T-score of -2.3 and a right femoral neck score of -2.5. Another DEXA scan was taken a year after, showing a spine L1-4 T-score of -2.6, a right femoral neck T-score of -2.3 and a left femoral neck T-score of -2.4. Records also noted that the patient had a history of breast cancer that was treated with tamoxifen for several years. The patient had received treatment with Zometa for three years and discontinued therapy approximately 1.5 to two years ago. The provider noted the patient had been treated with zoledronic acid, without improvement in her bone density. The patient has requested authorization and coverage for Prolia. The Health Plan denied the request and reported the requested medication is not medically necessary for the treatment of this patient. At issue in this case is whether Prolia is medically necessary for the treatment of the patients medical condition. Prolia is indicated for the treatment of osteoporosis in postmenopausal women who are at high risk of bone fracture. The medical evidence supports the requested medication in this clinical setting. Therefore, Prolia 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 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: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Zepatier 50/100 mg one tablet by mouth for 16 weeks and Ribasphere 200 mg three tablets by mouth every morning and two tablets every evening for 16 weeks for treatment of the enrollees hepatitis C virus. Findings:  The physician reviewer found that according to the recent 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. This recommendation applies to all patients, regardless of fibrosis stage. The guidelines recommend that treatment naive genotype 1a patients should be treated with regimens including Zepatier with ribavirin for 16 weeks when NS5A resistance is present. These guideline recommendations are based on clinical trial results showing a 58% cure rate with Zepatier for a duration of 12 weeks (as requested) when NS5A resistance is present. When NS5A resistance is present, Zepatier and ribavirin for 16 weeks is recommended by the guidelines, based on a 100% cure rate in the C-EDGE TE trial.  In this case, the patient has the M28 mutation, which is associated with reduced effectiveness of Zepatier unless ribavirin is used and treatment is extended to 16 weeks. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, treatment of hepatitis C is medically indicated in this patients case. Therefore, the requested treatment with Zepatier 50/100 mg one tablet by mouth for 16 week and Ribasphere 200 mg three tablets by mouth every morning and two tablets every evening for 16 weeks to treat hepatitis C is supported as medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested medications 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 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: The patient has requested authorization and coverage for Vascepa 1 gm capsules. The U.S. Food and Drug Administration (FDA) approves the use of Vascepa for the management of elevated triglyceride levels and established cardiovascular disease, elevated triglyceride levels with diabetes and two or more additional risk factors for cardiovascular disease, or severe hypertriglyceridemia. In this case, the documentation does not reflect a history of symptomatic coronary artery disease or diabetes, and she has only moderate elevation of triglycerides. In this clinical setting, statin therapy is recommended. Therefore, Vascepa 1 gm capsules are not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in cardiovascular 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: Overturned

A 59-year-old female enrollee has requested Lipitor 20 mg for treatment of her hyperlipidemia.  Findings:  The physician reviewer found that with reference to the current medical literature regarding the use of statins in patients without known or symptomatic heart disease for primary prevention, Lipitor has been extensively studied in the primary and secondary prevention of cardiovascular events. In addition, some studies suggest that Lipitor may offer some clinical advantages over various other statins (Arca and Gaspardone). In the principal primary prevention study, Sever and colleagues reported on the ASCOT-LLA (Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm) study. The researchers found that Lipitor reduced the relative risk of primary coronary heart disease (CHD) events by 36% compared with placebo in patients with hypertension at median follow-up of 3.3 years. In addition, substantial published data confirm the secondary preventive benefits of Lipitor in various clinical settings (Arca and Gaspardone). As this patients hyperlipidemia has been adequately managed with Lipitor and the medication is supported as beneficial in the scientific data, its use has been established as medically necessary for treatment of this patients condition.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested tramadol for treatment of the enrollees restless leg syndrome.  The physician reviewer found that based on the available medical literature, the use of tramadol is not considered the standard of care to manage this patients medical condition. Further, there is a lack of controlled studies supporting the safety and efficacy of the long-term use of tramadol for restless leg syndrome. As noted by Zhang and colleagues, long-term studies and more evidence of head-to-head comparisons of pramipexole with other dopamine agonists, anticonvulsants, and levodopa are needed. All told, the requested tramadol is not supported as medically necessary for treatment of this patients restless leg syndrome. 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 with sub-specialty certification in neuromuscular medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An has requested reimbursement for 10 transcranial magnetic stimulation (TMS) sessions for treatment of her major depressive disorder. Findings:  The physician reviewer found that Transcranial Magnetic Stimulation is a novel, noninvasive, neuro-stimulatory intervention endorsed by the American Psychiatric Association for the treatment of acute phase depression in the adult population.  A typical treatment course of transcranial magnetic stimulation consists of 30 to 40 sessions spanning four to six weeks.   At this time, there is a lack of adequately powered, controlled studies showing the benefit of longer courses of transcranial magnetic stimulation therapy.  The medical literature does not support a reasonable expectation that additional transcranial magnetic stimulation therapy would have improved the patients condition or prevented a more serious episode of illness.  Further, there is a lack of evidence in the literature to suggest that the patients marginal improvement was more than likely due to the additional transcranial magnetic stimulation sessions.  Finally, it appears that the patient was neither prescribed antidepressant medication nor active in psychotherapy, which represent trusted first-line interventions in the treatment armamentarium for major depressive disorder. Final Result: The reviewer determined that the services at issue were 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 psychiatry 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 55-year-old male enrollee has requested kyphoplasty or vertebroplasty for treatment of his compression fracture. Findings:  Three physician reviewers found the requested services are not likely to be of greater benefit than other treatment options.  This patient has chronic back pain and was found to have a wedged vertebra on an x-ray at the time of his trauma.  Subsequently, an MRI did not show any bright signal in that vertebral body and this was deemed a chronic and not acute finding.  There is a lack of support for the requested services in this clinical setting.  The indications for kyphoplasty include acute osteoporotic compression fractures, painful vertebral fractures due to malignancy or painful hemangiomas.  The submitted records do not demonstrate these findings.  Additionally, there is a lack of support for the requested vertebroplasty in this patients case.  Thus, the requested kyphoplasty and/or vertebroplasty are not likely to be more effective than other option for the treatment of this patient.