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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Palbociclib, 125 mg daily for 21 days, then off for seven days. Finn and colleagues describe Palbociclib as an oral, small-molecule inhibitor of cyclin-dependent kinases (CDKs) 4 and 6. The authors further note that the addition of Palbociclib to letrozole in a phase 2 study significantly improved progression-free survival in women with advanced estrogen receptor-positive and HER2-negative breast cancer. Lee and Ho note that there is emerging data that CDK4 and CDK6 may be effective in metastatic ovarian cancer and reported on a case study in which a patient continued to respond at 30 months to the use of Palbociclib after multiple lines of cytotoxic chemotherapy and hormonal therapy. In this case, the patient has exhausted standard therapies, and current medical literature supports the safety of the requested medication. Therefore, Palbociclib, 125 mg daily for 21 days, then off for seven days, is likely to be more beneficial for treatment of the patient's condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested medication 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 medication is 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 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi for treatment of his hepatitis C virus. Findings:  The physician reviewer found that according to the 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 (less than 12 months) due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per guidelines, treatment-naive genotype 2 patients should be treated with Sovaldi and ribavirin for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA)-approved for all patients with chronic hepatitis C genotype 2 regardless of fibrosis stage (Zeuzem, et al; Lawitz, et al; Jacobson, et al). The AASLD/IDSA guidelines do not recommend any other regimens for ribavirin-eligible genotype 2 patients. It is known that chemotherapy can cause an acute exacerbation of hepatitis C, underscoring the importance of expedient curative treatment in this case (Sagnelli, et al). The guidelines also cite data showing increased survival with earlier treatment (Jezequel, et al). For these reasons, treatment with Sovaldi is medically necessary for the treatment of this 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: Medical Necessity
Decision: Upheld

A 53-year-old female enrollee has requested a Bioness NESS L300 functional electric stimulator for the treatment of her myelomeningocele. Findings:  The physician reviewer found that the Bioness device has been recommended in this case to allow for greater knee flexion during gait. However, the Bioness device has not been approved for this indication. There is no peer-reviewed scientific literature documenting the efficacy of the Bioness device in this particular setting.  The device has not been prescribed for its FDA-approved use, which is for the treatment of foot drop. This patients gait dysfunction can be adequately addressed through the use of a traditional static AFO combined with muscle exercises. All told, the medical necessity of the Bioness device has not been established in this setting.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage of Copaxone 40 mg/mL injections three times per week for treatment of the enrollees multiple sclerosis. Findings:  The physician reviewer found that the submitted documentation does not support the medical necessity of the requested medication in this clinical setting. Multiple sclerosis (MS) is a progressive immune disease affecting the central nervous system (CNS), causing neurological dysfunction. MS is considered to be one of the most common neurological immunologic diseases. Multifocal inflammation of the CNS characterizes the disease and causes impaired nerve conduction, which is what causes the many different symptoms of MS. The most common form of MS is the relapsing and remitting subtype, which clinically refers to episodes of new or worsening functioning with MRI correlation and periods of clinical stability.  MS is not a curable pathology but currently, there are several therapies that can manage the disease. Copaxone is an analog of myelin basic protein (MBP), which is thought to be involved in MS. Over the 20-year history of glatiramer acetate the medication has been compared with other medications as well as with alternative dosing. Trials involving different dosing regimens have largely produced similar results of similar efficacy and tolerability. While there is some support in the medical literature as to the benefits of glatiramer acetate for treatment of MS in some patients, therapy of Copaxone 40 mg injection, three times weekly, has not been effective in treating this patients medical condition. The record supports new symptoms of incontinence, sensory disturbances, and weakness despite ongoing therapy with this regimen. Moreover, elevated liver enzymes are reported in the patients history while on current therapy. 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Mavyret 100-40 mg for eight weeks. Findings:  The physician reviewer found that, 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 3 patients should be treated with Mavyret for eight weeks. These recommendations apply 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 the treatment of 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 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

A 43-year-old female enrollee has requested for continued acupuncture for treatment of her fibromyalgia. Findings:  The physician reviewer found that although there are notations showing a decrease in some symptoms, continued improvement is not demonstrated in the medical records. Unfortunately, there are notations showing flare-ups shortly after the reduction of symptoms. There does not appear to be any sustained continued improvement.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient is a 52-year-old male with symptoms of edema, fatigue, aches/pains, and cramps in the lower extremities. Findings:  The physician reviewer found that an ultrasound performed showed reflux of over 1000 ms in the greater saphenous vein (GSV) of the right and left legs, and a refluxing perforator vein in the right and left legs. The ankle brachial indices, pulse volume recording, and arterial ultrasound performed were all normal. The patient was prescribed compression stockings. On ------ the patient reported continued symptoms of edema, fatigue, and bulging veins. A repeat venous ultrasound of the legs showed the same findings as the study on -------. The patient has requested coverage for endovenous ablation therapy of incompetent veins right and left. The Health Plan denied the request and reported the requested services are not medically necessary for the treatment of this patient. At issue is whether endovenous ablation therapy of incompetent veins right and left is medically necessary for the treatment of the patients medical condition. This patient had clinical symptoms consistent with venous hypertension of the lower extremities, including cramping and aching. The clinical work-up documented the absence of arterial disease and the presence of venous insufficiency as the cause of symptoms. There was no evidence of chronic deep vein insufficiency or thrombosis. Therefore, the clinical indications for superficial lower extremity vein ablation were met.  The records noted superficial venous insufficiency and a duplex scan documenting reflux greater than 0.5 seconds. Per the medical evidence, endovenous thermal ablations are safe and effective and are recommended for treatment of saphenous incompetence. Medical literature supports providing endovenous ablation for symptomatic venous insufficiency with documentation of reflux, as this patients medical history supports. Therefore, the requested endovenous ablation therapy of incompetent veins right and left is medically necessary for the treatment of this patient. 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 general 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: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for bioimpedance spectroscopy. Measurements of arm circumference and arm volume are common ways to identify lymphedema at an early stage following treatment for breast cancer. Bioimpedance spectroscopy is a newer method of determining whether a patient may develop lymphedema. Given these findings, the bioimpedance spectroscopy services were not and are not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. One reviewer found that the bioimpedance spectroscopy services were and are 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 services at issue were not and are 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: One reviewer is board certified in radiation oncology and is actively practicing. One Reviewer is board certified in radiation oncology and is actively practicing.  One Reviewer is board certified in radiation 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: Experimental/Investigational
Decision: Upheld

A 60-year-old male has requested cervical total disc arthroplasty using ProDisc-C Cervical Artificial Disc for treatment of his neck and left arm pain.   Findings:  Three physician reviewers found that the patient presents with chronic neck pain and left upper extremity pain. His physical examination shows motor and reflex findings within normal limits. A magnetic resonance imaging (MRI) demonstrated a disc osteophyte complex at C5-6 of 2mm with narrowing and stenosis at left C5-6 foramen. He has not had improvement with recent physical therapy. Flexion and extension x-rays have been ordered. His surgeon advised artificial disc replacement/nucleus replacement with ProDisc-C due to concern of potential adjacent segment failure with a fusion. The long-term safety and effectiveness of ProDisc-C has not been established. There are some promising studies. However, these studies are of small numbers with short-term follow-up. The FDA has required a Post Approval Study to determine the long-term safety and effectiveness of ProDisc-C. This study has not been concluded nor reported. Boselie and colleagues noted that, use of these disc prostheses should be limited to clinical trials. Results are too early given absence of truly long-term results.` Similarly, Madigan and colleagues noted, nucleus replacement and motion sparing technology are too new to have demonstrated long term data regarding their efficacy.`
Appeal type: Medical Necessity
Decision: Overturned

A 48-year-old female enrollee has requested magnetic resonance imaging (MRI) of the breast for an evaluation of her breast condition. Findings:  The physician reviewer found that there are several indications for MRI of the breast, which include a determination of the pre-operative extent of cancer, post-operative extent of residual cancer, extent of lobular cancer, identification of an occult primary cancer with positive axillary lymph nodes, screening of high risk patients, and problem solving. An indication for non-malignant disease is the evaluation of breast implants. High risk patients are those with a personal or family history of breast cancer or a genetic predisposition for breast cancer such as a BRCA 1 or BRCA 2 gene. High risk patients also include those with biopsy proven atypia, lobular carcinoma in situ, radial scar or prior mantle radiation. Based on her family and medical history, this patient is at high risk for breast cancer.
Appeal type: Medical Necessity
Decision: Upheld

A 46-year-old female enrollee has requested a pelvic ultrasound for evaluation of her pelvic pain.  Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested diagnostic procedure in this patients case.  The current medical evidence does not support the requested pelvic ultrasound in this clinical setting.  Per the medical records, there are no abnormal pelvic examination findings which could be further elucidated by an ultrasound.  She has no uterus, adnexal masses, or free fluid.  This patient has sources of pain that have been identified, including a possible left lower quadrant hernia.  She has also been evaluated with an MRI of the pelvis which showed normal findings.  All told, the requested pelvic ultrasound is not medically indicated for the evaluation of this patient.
Appeal type: Medical Necessity
Decision: Overturned

A 37-year-old female enrollee has requested for a continuous glucose monitoring system for treatment of her severe hypoglycemia. Findings:  The physician reviewer found that continuous glucose monitoring systems can be used to detect low blood glucose levels in advance of the patient developing neuroglycopenic symptoms. Additionally, in patients with severe hypoglycemic unawareness, who have diabetes mellitus and use insulin, continuous glucose monitoring helps patients to avoid low blood glucose levels. Although this device is not specifically approved for use in patients who are post gastric bypass, this patient continues to experience neuroglycopenic symptoms as a result of severely low blood glucose levels. Due to the debilitating effects of this patients uncontrolled hypoglycemia, it is medically necessary that this patient utilize a continuous glucose monitor to aid in controlling her disease.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Tysabri for treatment of her multiple sclerosis (MS). Findings:  The physician reviewer found that clinically it is reasonable to treat aggressive presentation of MS with more potent therapies, and this is now acknowledged in the Tysabri prescribing information. Tysabri is no longer indicated only for failure of other MS treatments. Also, per the prescribing information, Tysabri is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis. While research indicates that Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML) for some patients, for this patient the risk is offset by the benefit that Tysabri may bring in the treatment of her medical condition. For these reasons, initiating and continuing treatment with Tysabri was and is clinically appropriate and medically necessary for this patient.  Final Result: The reviewer determined that the medication at issue was and 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 Repatha SureClick 140 mg/mL pen injector for treatment of the enrollees medical condition.  Findings:  The physician reviewer found that based on the records provided, the patient is with hyperlipidemia but no documented coronary disease and no documented familial hypercholesterolemia. Familial hypercholesterolemia usually manifests by a combination of physical exam findings and low-density lipoprotein cholesterol (LDL) levels that are at minimum above 180 mg/dl. None of the above is documented in the medical records provided for review. Repatha (evolocumab) is a PCSK9 inhibitor approved only for patients with heterozygous familial hypercholesterolemia or for patients with documented atherosclerotic heart disease who require additional lowering of LDL. In this case, the patient does not fit either of those criteria. In addition, PCSK9 inhibitors have not been studied in other patient populations such as this patient. Also current guidelines that are endorsed by several national organizations do not recommend the use of PCSK9 inhibitors in this primary prevention setting.  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 male enrollee requested for AndroGel for medical treatment his hypogonadism. Findings:  The physician reviewer found that low testosterone can lead to complications such as reduced libido, erectile dysfunction, reduced muscle mass and strength, increased adiposity, osteoporosis/low bone mass, depressed mood and fatigue (Dandona and Rosenberg). This treatment should therefore help to prevent potential complications from untreated hypogonadism.  All told, the requested AndroGel is medically necessary for treatment of this patients medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Magnetic Resonance Imaging (MRI) of the left and right breast. The submitted documentation supports that the requested services are medically necessary. Contrast enhanced breast MRI is a highly sensitive (greater than 90%) examination which has clear indications and can identify abnormalities that are occult on mammography and ultrasound. The indications for breast MRI include high risk screening, new diagnosis of breast cancer to evaluate for additional sites of disease, patients with positive margins after lumpectomy, evaluation of response to chemotherapy prior to surgery, evaluation for breast cancer recurrence, and evaluation of metastatic cancer of an unknown primary source. According to the American College of Radiology, MRI may be used when mammographic/sonographic findings are inconclusive or in the setting of complex breast augmentation cases in which mammography is difficult.In this case, due to the patient's history of multiple, extensive post-operative complications, as well as in the setting of silicone implants, breast MRI is recommended for screening due to the inability to adequately asse with extensive sc ss the breast tissue mammographically. Because the patient has had multiple prior surgeries ar tissue, the breast tissue would not be well visualized due to the inability to compress the breast tissue. Under these circumstances, magnetic resonance imaging (MRI) of the left and right breast is medically necessary for the 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 diagnostic radiology 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.