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

Summary Reviewer 1


A 30-year-old female enrollee has requested authorization and coverage for cervical total disc replacement surgery and one day inpatient services. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees neck pain.   The physician reviewer found that the U.S. Food and Drug Administration (FDA) has required a seven year post approval study to determine the long-term safety and effectiveness of the Mobi-C device. That study is ongoing and has yet to be reported. Despite the findings by Davis and colleagues at four-year follow-up, cervical artificial disc replacement is not indicated for symptomatic multi-level disease, especially in patients with multilevel degenerative disc disease. This patient has ill defined, vague upper extremity symptoms not representative of a cervical radiculopathy with matching dermatomal and myotomal symptoms and findings (Corey and Comeau). She is noted to have a cervical myelopathy, but there is a lack of substantiating symptoms and findings of increased tone, spasticity, gait disturbance, bowel or bladder problems, hyperreflexia, or pathologic reflexes. Further, there is no correlation on imaging with her clinical examination. She has no symptoms or signs substantiating the C4-5 or the C5-6 level as her pain generator and her pain generator has not been identified. She has annular tears at C3-4, C4-5, C5-6, and C6-7. Disc protrusion of 1 or 2 mm is not clinically significant and her cord shadow is normal. There is no significant compression or deviation of her cord. All told, the use of two level Mobi-C total disc replacement and one day inpatient services for this patient is not likely to be more beneficial than standard treatment alternatives. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 28-year-old male enrollee has requested reimbursement for Foundation One gene test performed on 4/7/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with malignant peripheral nerve sheath tumor (MPNST). The physician reviewer found that MPNST are aggressive neoplasms of Schwann cells that are associated with neurofibromatosis (NF) type I but may also present sporadically. They may respond to the regimen noted here but eventually become chemotherapy resistant and fatal (Kroep, et al). In this patients case, he had exhausted the standard care options and is in need of therapy. There is molecular genetic evidence that supports a role for epidermal growth factor receptor (EGFR) signaling in MPNST. Direct blockade of EGFR signaling by tyrosine kinase inhibitors induces growth arrest and inhibition of metastases (Du, et al). This targeted therapy may offer some clinical benefit to this patient. Recently, a clinical study directly compared the use of targeted agents with conventional chemotherapy approaches. A study of 86 patients where the progression-free survival on regimen selected by molecular profiling was compared to progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage (Von Hoff, et al). This trial has very significant results for patients with stage IV tumors.  Invariably, this patient will be offered something off-label or a phase I/II clinical trial, but the results from molecular profiling offers a rational selection of the next regimen. Thus, the submission of his tissue for analysis to FoundationOne on 4/7/15, in an effort to guide next steps in his treatment, was likely to have been more beneficial than conventional therapies. Based upon the information set forth above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 11/27/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.  The physician reviewer found that this patient was diagnosed with endometrial cancer. The patient had a hysterectomy and salpingo-oophorectomy and the final pathology showed an endometrial adenocarcinoma. A portion of the tumor tissue was submitted for FoundationOne CDX testing. The test performed microsatellite assessment, tumor mutational burden, as well as an analysis of mutations in over 400 known tumor suppressor and oncogenes. Endometrial cancers have been analyzed in depth, and the current pathology work-up recommends detailed molecular analysis. The current medical evidence supports the services at issue in this clinical setting. Therefore, FoundationOne CDx testing performed on 11/27/20 was likely to have been more beneficial than other available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The parent of an 11-year-old female enrollee has requested authorization and coverage for Nutropin growth hormone (GH) therapy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees short stature and ulcerative colitis.  The physician reviewer found that according to the Pediatric Endocrinology Society guidelines, a trial of GH therapy should be approved for children with otherwise unexplained short stature who pass GH stimulation tests but who meet most of the following criteria: (1) height more than 2.25 SDs below the mean for age or more than two SDs below the mid-parental height percentile; (2) growth velocity less than 25th percentile for bone age; (3) bone age more than two SDs below the mean for age; (4) low serum IGF-1 and/or IGFBP-3; and/or (5) other clinical features suggestive of GH deficiency. This patient meets most of these criteria. The patients pre-treatment height was more than two SDs below the mean for age and gender. In addition, her pre-treatment growth velocity was poor and all other causes of short stature were ruled out. The patients inflammatory bowel disease has been stable and she was not receiving any steroid treatment. All told, her adult predicted height of 56-59 inches supports treatment with GH therapy based on current U.S. Food and Drug Administration (FDA) standards for treatment of idiopathic short stature. Thus, the requested Nutropin GH therapy is medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 59-year-old female who presented in September 2019 for a routine examination. The patient has requested reimbursement for vitamin D screening test (CPT 82306) performed on 11/16/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the patient. The physician reviewer found that the U.S. Preventative Services Task Force recommends against universal screening for vitamin D deficiency. The American Association of Clinical Endocrinologists and American College of Endocrinology recommend screening only in patients who present with known risk factors that include: malnutrition, sedentary lifestyle, limited sun exposure, obesity, dark skin, age greater than or equal to 65, conditions causing gastrointestinal malabsorption, including short bowel syndrome, pancreatitis, iniammatory bowel disease, amyloidosis, celiac sprue, and bariatric surgery, liver disease or failure, renal insuiciency or nephrotic syndrome, cystic fibrosis, and medications that alter vitamin D metabolism, including anticonvulsants and glucocorticoids. Vitamin D insufficiency appears to be common among patients who are taking medications that accelerate the metabolism of vitamin D, hospitalized on a general medical service, institutionalized, and in patients who have limited sun exposure, osteoporosis, or malabsorption. Most patients with vitamin D deficiency are asymptomatic. Prolonged, severe vitamin D deficiency causes secondary hyperparathyroidism, which leads to phosphaturia, demineralization of bones, and when prolonged, osteomalacia. Symptoms may include bone pain and tenderness, muscle weakness, fracture, and difficulty walking. In this case, the patient was diagnosed with vitamin D insufficiency in February 2016. Thus, the laboratory test was not for screening but monitoring of a known deficiency condition, and was therefore appropriate. In sum, vitamin D screening test (CPT 82306) performed on 11/16/19 was medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3 
The parent of a one-year-old female enrollee has requested authorization and coverage for a whole 
genome test. The Health Insurer has denied this request and reported that the requested service is 
investigational for the enrollees of the enrollees ataxia. The Health Insurer indicated that the 
requested  service  is  investigational  for  the  evaluation  of  the  enrollees  medical  condition. 
Therefore, the Health Insurer has denied coverage for the requested service. At issue is whether a 
whole genome test is likely to be more beneficial for evaluation of the enrollee's condition than 
any available standard therapy. The physician reviewer found that Renaud and colleagues explain, 
AFP is a biomarker of several autosomal recessive cerebellar ataxias (ARCAs), especially ataxia 
telangiectasia (AT) and ataxia with oculomotor apraxia (AOA) type 2 (AOA2). AT typically 
presents with progressive gait and truncal ataxia with onset between the ages one and four years. 
Nystagmus,  dysphagia,  and  elevations  in  serum  concentrations  of  AFP  are  also  commonly 
observed in AT. Sequencing and deletion/duplication analysis of the causative gene in AT, ATM, 
is available. Alternatively, multigene hereditary ataxia panels that include AT, AOA2, and other 
hereditary ataxias are also available. In this case, the patient had an onset of symptoms after turning 
one, presenting with progressive ataxia, nystagmus, dysphagia, and an elevated AFP level. The 
records noted that AT was the primary consideration by the clinical geneticist at an evaluation of 
the patient. The records do not reflect that single gene or multigene panel testing for the hereditary 
ataxias were undertaken. In this case, whole genome sequencing is not likely to be more beneficial 
than the available standard targeted gene testing of ATM or a multigene hereditary ataxia panel. 
Therefore, a whole genome test is not likely to be more beneficial for evaluation of the patients 
condition than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 20-year-old male enrollee has requested authorization and coverage for inpatient admission for lidocaine infusions for seven days. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees orthostatic headache. The physician reviewer found the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. This patient is diagnosed with chronic migraine and new daily persistent headache. He has already had treatment with a couple of therapeutic preventative interventions without benefit. There are multiple treatments that have not yet been explored, and are generally considered first-line for the preventative therapy of chronic migraine.  These include Topamax, which is the only oral medicine that has adequate evidence as a preventive for chronic migraine, as well as Botox, which is the only U.S. Food and Drug Administration (FDA) indicated treatment for chronic migraine. Botox has adequate success rates with minimal side effects. Intravenous lidocaine has some evidence for headache conditions (Matharu, et al). However, the data regarding its use for chronic migraine is mixed and weak. There are no specific treatments indicated for new daily persistent headache, which is typically treated based on the phenomenology of the primary headache disorder that otherwise resembles, such as migraine. As standard treatments have not yet been pursued, and there are several standard treatments that have proven effectiveness, inpatient treatment with intravenous lidocaine is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 33-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg tablets 60/30 days. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollee/s medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. This patient has failed alternatives, including multiple anti-tumor necrosis factor (TNF) medications. Xeljanz has a different mechanism of action than anti-TNF therapies and Entyvio. Xeljanz is U.S. Food and Drug Administration (FDA) approved (at up to 10 mg twice daily, with lower dosage for several factors) for the treatment of ulcerative colitis, and has proven to be effective in a double-blind, placebo-controlled trial of patients with moderate-severe ulcerative colitis. In this patient with severe disease and failure of multiple biologic medications of different classes, Xeljanz is medically indicated. Therefore, Xeljanz 5 mg tablets, 60 per 30 days are medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 33-year-old female enrollee has requested reimbursement for DecisionDX melanoma gene expression profiling assay.  The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees malignant melanoma.   The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue.  In this clinical setting, at least a 95% five-year survival and an 88% ten-year survival is predicted based on staging described by Balch and mitotic index.  DecisionDX is a study of 31 genes in the melanoma cells.  It then classifies that particular melanoma as either Class 1 (97% disease-free rate at five years) versus Class 2 (31% disease-free rate at five years).  Per the medical evidence, there is good correlation between prognosis and DecisionDX classification.  However, it is not clear how DecisionDX data compares to the ten-year data of the Balch determinations, and whether it can be used in clinical practice.  This is significant in this patients case given her pathologic findings and excellent prognosis.  This assay was not expected to be of clinical benefit in this case.  All told, DecisionDX melanoma gene expression profiling assay was not medically indicated for the treatment of this patient.  Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 58-year-old male enrollee has requested reimbursement for an aflibercept injection, J0178 performed on 2/23/15. The Health Insurer has denied this request indicating that the service at issue was not medically necessary for treatment of the enrollees cystoid macular edema. The physician reviewer found the submitted documentation fails to establish the medical necessity of the service at issue. Eylea has shown promising results in treatment of macular edema in cases of diabetic retinopathy and central retinal vein occlusion. However, the medical literature has not yet demonstrated that Eylea has any application in post-cataract surgery cystoid macular edema. As such, the aflibercept injection, J0178 performed on 2/23/15 was not clinically indicated in this patients case. For the reasons provided, the service at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 46-year-old female who has been diagnosed with both psoriatic arthritis and granuloma annulare. She has tried nonsteroidal anti-inflammatory drugs (NSAIDs), without any relief. The physician reviewer found that there is sufficient support for the requested medication in this clinical setting. Humira has been approved by the U.S. Food and Drug Administration for the treatment of psoriatic arthritis for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active disease. The approval was based on results of clinical trials that showed marked improvement in skin condition. 
Granuloma annulare (GA) is a non-infectious chronic granulomatous dermatosis characterized by annular papules. The response to various treatments, such as topical and intralesional corticosteroids, topical tacrolimus, dapsone, isotretinoin, etretinate or hydroxychloroquine, is usually unsatisfactory. Recently, tumor necrosis factor (TNF)-a inhibitors have been reported to improve GA. Adalimumab (Humira) is an agent that binds to membrane-bound and soluble TNF-a, showing great promise in treating recalcitrant GA. Min and Lebwohl sought to evaluate adalimumabs efficacy in treating GA. They identified seven patients with physician-verified GA who were treated with adalimumab. All patients GA Investigator Global Assessment scores improved by 2 or greater. The authors found significant improvements in body surface area, erythema, and induration (average improvements by 87%, 88%, and 95%, respectively). Adverse events were minimal. Taken together, FDA approval for psoriatic arthritis and published results for GA indicate that adalimumab could be an effective and well-tolerated treatment for both psoriatic arthritis and GA. The patient has already demonstrated efficacy of such treatment. Therefore, Humira is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 52-year-old male enrollee has requested reimbursement and prospective authorization and coverage for elotuzumab (Empliciti) from 1/4/17 through 7/3/17. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees myeloma. The physician reviewer found that Empliciti is a monoclonal antibody targeted on a glycoprotein present on myeloma cells. Empliciti has been approved by the U.S. Food and Drug Administration (FDA) for use with lenalidomide and dexamethasone (Gormley, et al). There are currently multiple studies exploring the usefulness of this drug in various combinations and at different stages in the treatment of myeloma. However, there is a lack of data that adding Empliciti to this patients treatment as part of a clinical trial is likely to be more beneficial than participation in the clinical trial without Empliciti. The patient has already been treated with Empliciti with progression of the disease. Therefore, treatment with Empliciti from 1/4/17 through 7/3/17 was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the medication at issue was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 63-year-old male enrollee has requested authorization and coverage for stereotactic body radiotherapy (SBRT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees liver cancer. The physician reviewer found SBRT is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The patient presents with a long history of oligometastatic disease from a diagnosis of colon cancer. The peer-reviewed literature demonstrates that aggressive local therapy in the form of stereotactic body radiation can be beneficial for patients with oligometastatic disease (Palma, et al; Hanna and Landau). In addition, the National Comprehensive Cancer Network (NCCN) guidelines state that SBRT can be utilized in the management of liver metastases from colon cancer. Therefore, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 52-year-old female enrollee has requested reimbursement for hospital stay from 4/17/14 through 4/19/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee who presented with chest pain. The physician reviewer found that the patient is a 52-year-old female with a history of hyperlipidemia and hypertension.   Due to chest discomfort, a chest computed tomography (CT) angiogram was performed on 4/16/14. The study reported no evidence of pericardial effusion, pulmonary embolism or aortic pathology.  A note dated 4/17/14 documented one week of chest pain, worse with inspiration. A coronary angiogram had recently been performed at another hospital and reported only 20-30% proximal left anterior descending coronary disease. She presented on 4/17/14 with persistent chest pain, a normal cardiovascular physical examination and lateral precordial ST depression and T wave inversions on electrocardiogram.  She was placed on telemetry and observation.  Both troponin I and creatine kinase (CK) were normal.  The patient was discharged on 4/19/14.  The Health Plan denied coverage for the hospital admission from 4/17/14 through 4/19/14. This denial is the subject of this appeal and determination.Based on the records, this patient presented with some coronary risk and chest pain that does not sound anginal (worse with inspiration and some foods).  An evaluation reported a normal chest CT angiogram and an essentially normal coronary angiogram (20% stenosis). In addition, initial serum cardiac biomarkers were also normal. In this circumstance of persistent nonanginal quality chest pain and a negative evaluation, the hospital admission, from 4/17/16 through 4/19/16 was not medically necessary. Further evaluation and management could have been safely provided at a lower level of care. Therefore, for the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.