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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Mavyret 100-40 mg for eight weeks. The submitted documentation supports the medical necessity of the requested medication regimen. According to the most 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. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. The guidelines recommend that non-cirrhotic treatment-naive genotype 1a patients should be treated with Mavyret 100-40 mg for eight weeks. These recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration approved for all patients with chronic hepatitis C, genotype 1 regardless of fibrosis stage. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, Mavyret 100-40 mg for eight weeks is medically necessary for this patient.Final Result: The reviewer determined that the requested medication regimen is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty 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: Overturned

The patient is a 36-year-old male with a body mass index (BMI) of 59.3. The patient has multiple comorbidities including sleep apnea. The patient reports multiple failed attempts at diets, all of which have resulted in weight regain. The patients provider has recommended the patient undergo gastric bypass with duodenal switch. The Health Plan indicates the long-term safety and efficacy of the procedure has not been established.The patient is an appropriate candidate for surgical intervention to treat his morbid obesity. There is more than substantial data in the literature to support the use of duodenal switch to accomplish this goal. Consequently, duodenal switch is an accepted and medically necessary procedure for this patients medical condition. Therefore, I have determined that the requested procedure is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

A 48-year-old male enrollee has requested left-sided C5-6 minimally invasive laminoforaminotomy with decompression of the nerve root for the treatment of his left arm and shoulder pain. Findings:  The physician reviewer found that the objective of minimally invasive spinal surgery is to achieve the clinical outcomes attainable with conventional open surgery, while minimizing the risk of treatment-related injury. Multiple new technologies including microsurgery, laser technology, endoscopy, and video and image guidance systems have paved the way for these procedures. At the present time, until better scientific evidence is available, minimally invasive laminectomy and foraminotomy should be regarded as research techniques. The patients underlying pathology is the cervical disc bulge at C5-6 as well as the disc-osteophyte complex. These problems will be satisfactorily addressed by the anterior fusion proposed by the in-Plan provider. There is no need for an out-of-Plan referral for the treatment of the patients spinal stenosis and degenerative disc disease.
Appeal type: Experimental/Investigational
Decision: Upheld

An enrollee has requested authorization and coverage for hydrogel spacer (SpaceOAR). Researchers found that although there are data suggesting positive clinical outcomes, there are a number of severe and debilitating complications recently reported in proximity to gel injection. The authors highlighted the need for additional study on the potential complications associated with SpaceOAR including acute pulmonary embolism, severe anaphylaxis, prostatic abscess and sepsis among others. This patient presents with a diagnosis of adenocarcinoma of the prostate. There is a lack of adequate data to support SpaceOAR use as safe and effective in this clinical setting. Therefore, the requested hydrogel spacer (SpaceOAR) for use during an upcoming prostate procedure is not 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 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: Physician reviewers 1, 2, and 3 are board certified in urology 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: Upheld

A 55-year-old male enrollee has requested insertion of an AxiaLIF spine fixation device for the treatment of his upper and lower back pain. Findings:  The physician reviewer found that spine fusion is an accepted surgical treatment in appropriate situations involving instability of the spine. In this case, there is no documentation of such a situation. The MRI report indicates that there had been no change in the five-year interval since the prior study, and the recent x-ray noted no abnormal motion. The AxiaLIF procedure for L5-S1 fusion utilizes an approach through the presacral space for introduction of the internal fixation and graft, thereby avoiding several critical structures at risk in other approaches to that joint. Although early reports have been encouraging, experience with it has been limited, complication rates are not known, and long-term results are not available.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 50-year-old perimenopausal female found to have primary hyperparathyroidism in 2001. She has had two unsuccessful neck surgeries suggesting the likelihood of a substantial mediastinal adenocarcinoma. She has many symptoms, which are disabling. Her symptom complex has both usual (nausea and fatigue), and unusual (bone pain and anxiety) components. The patient has received the drug Sensipar, approved by the Food and Drug Administration for treatment of secondary hyperparathy, with normalization of her calcium and resolution of her symptoms. The Health Plan has determined that Sensipar is not medically necessary for treatment of the patients medical condition.Review of the submitted evidence indicates the patient has had two unsuccessful neck explorations. The neck is where 90 percent of primary hyperparathyroid causing adenomas are found. The mediasternum is the next most common site. Thus, further surgery would involve major chest surgery including the splitting of the sternum. Morbidity, short- and long-term, of surgery is substantial and mortality though infrequent is not inconsequential.The evidence for benefit of Sensipar in treatment of secondary hyperparathy is compelling and the limited data currently available for primary hyperparathy is equally impressive. The drug appears to be effective and safe for at least moderate lengths of use. Chronic primary hyperparathy is not a benign disease, especially in menopausal women with significant long-term risk of ulcer disease, hypertension, nephrolithasis, and osteoporosis with fractures.Therefore, in weighing the risk/benefit ratio of Sensipar versus surgery or no additional treatment, it appears treatment with Sensipar is the optimal choice. As such, I have determined that the requested medication is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

A 58-year-old female enrollee has requested a Flexitouch System (multi-chamber programmable lymphedema pump) for the treatment of her lymphedema. Findings:  The physician reviewer found that genital and truncal swelling in patients with lymphedema are often associated with standard pumps which treat only the limb and apply static pressures. The provider indicated that he specifically prescribed a Flexitouch System for this patient because the patient had failed treatment with a standard pump and the Flexitouch System has the ability to treat her right lower extremity and truncal/genital lymphedema. Although the published medical literature regarding treatment of lymphedema in a situation such as this is limited, the rationale for use of the Flexitouch System in this particular case is well-supported by the patients provider.  The patient has clearly failed treatment with a standard lymphedema pump. The continued use of a standard pump is contraindicated for this patient as the device was ineffective and resulted in clinical problems of very notable concern. The patient has had documented improvement with the use of the Flexitouch System as evidenced by decreased swelling in her lower extremity.
Appeal type: Experimental/Investigational
Decision: Overturned

A 64-year-old female enrollee has requested bilateral breast magnetic resonance imaging (MRI) for evaluation of the her family history of breast cancer. Findings:  Two physician reviewers found that in this patients case, the requested bilateral breast MRI is likely to be more efficacious than other methods of evaluation.  Per the submitted records, she has a family history of breast cancer and heterogeneously dense breast tissue on mammography.  Due to her positive family history, this patient has an increased lifetime risk of breast cancer, and MRI is the most sensitive means with which to diagnose early breast cancer.  The heterogeneously dense breast tissue on mammography limits the utility of mammography.  All told, the requested bilateral breast MRI is likely to be of greater benefit than other modalities for evaluating this patient.
Appeal type: Experimental/Investigational
Decision: Overturned

A 73-year-old female enrollee has requested a positron emission tomography (PET) scan for evaluation of her  primary central nervous system lymphoma. Findings:  Three physician reviewers found that in this patients case, the requested services are likely to be more efficacious than other available modalities.  The current medical evidence supports the requested PET scan in this clinical setting.  Mohile and colleagues reported that fluorodeoxyglucose (FDG)-PET may disclose higher rates of concomitant systemic disease at primary central nervous system lymphoma diagnosis.  Kawai and colleagues noted pretreatment and post-treatment (18)F-FDG uptake values may have a prognostic value in patients with primary central nervous system lymphoma.  All told, the requested PET scan is likely to be superior over other methods of evaluating this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the DecisionDx-Melanoma Assay. Findings:  Three physician reviewers found that the DecisionDx-Melanoma Assay tests the tissue genetics of the melanoma to help stratify whether a melanoma is high risk for metastasis. The DecisionDx-Melanoma Assay test has shown some accuracy in thin melanomas. However, there is a lack of scientific evidence permitting conclusions concerning the effect of this test on health outcomes. The test is not considered routine standard of care and is not recommended by the National Comprehensive Cancer Network (NCCN) guidelines. Overall, there is a lack of published data to support its routine use. Since this test has not been demonstrated to provide a benefit more than established tests, the DecisionDx-Melanoma Assay provided was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: 2 of 3 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: All three physician reviewers are board certified in dermatology 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: Experimental/Investigational
Decision: Upheld

The parent of an 18-year-old male enrollee has requested for Avastin (bevacizumab) and Tarceva (erlotinib) for treatment of his metastatic hepatocellular carcinoma. Findings:  Three physician reviewers found that Hepatocellular carcinoma is a cancer that is generally resistant to conventional chemotherapy. This has led to a great deal of interest in using the newer drugs, particularly the anti-angiogenic agents. Nexavar (sorafenib) has been approved for use in this disease. This approval was based on a placebo-controlled trial of approximately 600 patients. This trial demonstrated a significantly better overall median survival time and time to progression in the sorafenib-treated group. Submitted with this appeal was the relevant reported trial of erlotinib (Tarceva) with bevacizumab (Avastin). The Thomas trial looked at such treatment in 29 patients, and did demonstrate responses, though there was no firm conclusion as to real clinical efficacy. There have also been other trials, with small numbers of patients, suggesting activity of either Tarceva or Avastin when used as a single agent.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Saxenda solution pen-injector 18 mg/3 mL. Gadde and colleagues note that obesity remains a continuing global health concern. The authors further note that while lifestyle modification is recommended as the cornerstone of obesity management, as many patients do not achieve long-lasting benefits due to difficulty with adherence as well as physiological and neurohormonal adaptation of the body in response to weight loss, there are currently multiple pharmacologic therapies which are available for weight management. Knudsen and Lau report that glucagon-like peptide-1 (GLP-1) analogs, such as Saxenda, improve glycemic control, reduce body weight, and decrease cardiovascular risk. Cornell notes that GLP-1 receptor agonists have an established efficacy and safety profile. These medications promote weight loss by reducing appetite and energy intake and delaying gastric emptying. Given that current medical literature supports the use of the Saxenda in promoting weight loss and the low likelihood of health risks associated with this medication, the requested medication is medically indicated. Therefore, Saxenda solution pen-injector 18 mg/3 mL 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 endocrinology, diabetes, and metabolism 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 parent of a 15-year-old female enrollee has requested for Procrit for treatment of the enrollees Friedreichs ataxia. Findings:  The physician reviewer found that Procrit increases the intracellular levels of frataxin, the missing protein in Friedreichs ataxia, and it reduces programmed cell death (apoptosis). The open label study of Boesch and colleagues is the first to show increased levels of frataxin in tissues of patients treated with Procrit.
Appeal type: Medical Necessity
Decision: Overturned

The patient has requested authorization and coverage for a power wheelchair with seat elevator and power standing feature. In the peer-reviewed medical literature, colleagues noted that power wheelchairs can have a positive impact on user well-being, self-esteem, pain, activity and participation. The records provided for review document that the patient has undergone a wheelchair evaluation by a rehabilitation medicine specialist. That provider has determined that a power wheelchair with seat elevator and standing feature is medically necessary. The patients current power wheelchair is seven years old and the patient has demonstrated his ability to use the wheelchair safely in this historical period. The patient underwent a face-to-face wheelchair evaluation. The providers assessment of the patients condition is congenital quadriplegia, right swan neck deformities, contractures of the right elbow, wrists, and knee, hearing impairment, and chronic low back, hips, knee pain. He indicates that he has arthritis in his hips and transfers hurt his hips especially to the stander. The stander is reported as difficult to access and he indicates that a standing wheelchair (sit-stand electric feature) would help eliminate this. He also reports that the patients pain is improved with standing, which is worse when sitting all day. At the end of the evaluation, he states that his new power chair should also have a retractable joystick on the left, head rest adjustable and removable for access, trunk supports, abductor pad, anterior tilt to help with transfers, elevating leg rests for pressure relief and positioning of joints and back, solid back, elevating seating seat for ADL independence. The providers evaluation and findings are consistent with the recommendations in the current medical literature. All told, the requested power wheelchair with seat elevator and power standing feature is medically necessary for treatment of this patient.Final Result: The reviewer determined that the requested equipment 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 physical medicine and rehabilitation and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for shoe inserts for her diagnosed plantar fasciitis. Findings: The physician reviewer found that the submitted documentation demonstrates the medical necessity for the requested equipment in this clinical setting.  In this particular case, it is well documented that this patient has a diagnosis of painful heels with plantar fasciitis. The patient is noted to complain of painful heels with a past medical history of left heel fracture. It is standard of care to treat plantar fasciitis with conservative treatment options including stretching, icing, anti-inflammatory medicine, and custom functional orthotics. Custom functional orthotics have been standard of care treatment for plantar fasciitis for several years. The medical studies have shown that orthotics improve abnormal biomechanics of the foot which tend to cause plantar fasciitis. For the reasons mentioned above, the requested shoe inserts are medically reasonable and necessary to treat this patients medical condition.Final Result: The reviewer determined that the requested equipment 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 podiatry 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

A 62-year-old female enrollee has requested a full body positron emission tomography (PET) scan for evaluation of her Merkel cell carcinoma. Findings:  Three physician reviewers found that Merkel cell carcinoma is an exceptionally rare tumor originating from a specialized cell in the dermis. A review of the medical literature suggests that this tumor has a very high propensity for relapse and lymphovascular invasion. Allen and colleagues conducted a large case series in which 43% of patients developed distant metastasis and the pathologic presence of tumor in regional lymph nodes was an important prognostic variable for survival. Since there are so few cases in the world, large phase II or phase III clinical trials demonstrating the utility of PET/CT cannot reasonably be expected. Nevertheless, considering what is known about Merkel cell carcinoma, it is detectable by PET as it is hypermetabolic. It has also been observed that more aggressive radiotherapy translates into better locoregional control and prolonged survival. This patients recurrence was detectable by PET/CT and therefore, she should be followed closely with this diagnostic procedure. Early therapy could be employed to eradicate her disease and her treatment plan should be guided by the findings on PET/CT.