Persius/hicric huggingface dataset:
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

A 57-year-old female enrollee has requested authorization and coverage for Venclexta 100 mg, 240 for 30 days. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. Venclexta is U.S. Food and Drug Administration (FDA) approved for use in acute myeloid leukemia and chronic lymphocytic leukemia. It is not FDA approved for use in multiple myeloma or supported for off-label use in major drug compendia. Studies show promise, but these are phase I studies which show better efficacy in translocation t(11;14) and in combination with bortezomib and dexamethasone. In this patients case, she is requesting this medication in combination with carfilzomib, which is the subject of actively recruiting clinical trials. There is a lack of support for the requested medication in this clinical setting. Thus, Venclexta 100 mg tablets, 240 for 30 days are not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 


A 55-year-old female enrollee has requested authorization and coverage for Viekira Pak. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the requested medication. According to the American Association for the Study of Liver Diseases (AASLD) recommendations for treating hepatitis C, Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Denying treatment for patients with early stage hepatitis C is not supported by the peer-reviewed literature. Thus, the recommendation is not deny patients treatment if they have early stage disease, but to provide treatment to avoid complications from advanced disease, including liver failure and extrahepatic complications. In addition, the AASLD/IDSA guidelines state that high priority for treatment owing to high risk for complications include patients with fibrosis (Metavir F2). This patient has a Metavir score of F2. Furthermore, AASLD/IDSA guidelines recommend Viekira Pak, a daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) for 12 weeks for patients with hepatitis C genotype 1 in whom prior treatment with peg-interferon and ribavirin has failed. For the reasons provided, 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: Insurer Denial Overturned

Summary Reviewer 

The patient is a 23-year-old male with a lifelong history of nasal obstruction that was refractory to prolonged topical nasal steroid spray. In a letter dated 3/05/20, the provider noted that the patient was found to have a left septal deviation, bilateral inferior turbinate hypertrophy, and bilateral alar collapse with dynamic obstruction of the internal and external nasal valve with inspiration. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue in this clinical setting. The patient had nasal obstruction that was found to be due to septal deviation, turbinate hypertrophy, and alar collapse. He underwent a septoplasty, turbinate reduction, and alar batten grafts. Reconstruction of the nasal valve is essential in improving nasal breathing. Performing the septoplasty and turbinate reduction alone would not have improved the patientas breathing given the valve collapse was present. Therefore, CPT 30465 performed on 12/18/19 was medically necessary for the treatment of this patient.
The California reconstructive surgery statute requires health insurers to cover reconstructive surgeries, defined as surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function; (2) To create a normal appearance, to the extent possible. In this patientas case, the records support that an abnormal structure of the body. The
patient had weak cartilage on the sides of the nostrils. This abnormal structure of the body is likely congenital. The services at issue were performed in order to improve function. Therefore, CPT 30465 performed on 12/18/19 was reconstructive in nature.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by the applying the staging system spelled out by Balch. Mitotic index may add to these statistics. DecisionDx-Melanoma assay is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma based on the risk of metastasis over five years. Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma assay classification, in patients undergoing sentinel lymph node biopsy. At this time, it is not clear how the five-year data from DecisionDx-Melanoma assay compares to the ten-year data from Balch. It is also not clear if one can use the assay to make clinical decisions. Therefore, DecisionDx-Melanoma assay provided on 3/21/18 was not likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha.  The data on the DecisionDx-Melanoma assay has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. In sum, DecisionDx-Melanoma assay provided on 3/21/18 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines indicate while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of the services at issue were not likely to have altered treatment and surveillance recommendations. Thus, DecisionDx-Melanoma assay provided on 3/21/18 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

A 61-year-old enrollee has requested authorization and coverage for clobetasol ointment. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested medication in this clinical setting. This patient has been diagnosed with lichen sclerosus et atrophicus involving the genital skin. Lichen sclerosus et atrophicus is a chronic inflammatory condition. If left untreated, this can lead to squamous cell carcinoma. Treatment with ultrapotent topical steroids is recommended to reduce inflammation. Clobetasol ointment is an ultrapotent topical steroid commonly used for the treatment of lichen sclerosus et atrophicus. Therefore, clobetasol ointment is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 


The parent of a 10-month-old female enrollee has requested reimbursement for a cranial remolding orthosis provided on 7/19/17. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees severe brachycephaly. The physician reviewer found that since the back to sleep approach was recommended by the American Academy of Pediatrics in 1994, there has been an increase in the incidence of positional plagiocephaly in infants (Trachtenberg, et al). One review of 15 studies on the treatment of positional plagiocephaly in infants and concluded that there is a fairly substantive body of nonrandomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet in comparison with conservative therapy, especially if the deformity is severe, provided that helmet therapy is applied during the appropriate period of infancy (Tamber, et al). The authors also noted that in general, infants with a more severe presenting deformity and infants who are helmeted early in infancy tend to have more significant correction (and even normalization) of head shape. Roby and colleagues evaluated 1045 teenagers born after the introduction of the back to sleep recommendation and found persistent plagiocephaly in only 1.1% and brachycephaly in 1%, compared with the estimates of 20-48% incidence in infants, suggesting that positional plagiocephaly may self-correct over time. Given that the Congress of Neurological Surgeons recommends cranial orthosis treatment for infants with persistent moderate to severe plagiocephaly after a course of conservative treatment, the DOC Band device at issue was indicated for treatment of this patients medical condition (Tamber, et al). A trial of repositioning had occurred, and she was documented as having severe brachycephaly with a cephalic index of 101.5, which was more than six standard deviations from the mean. Thus, the cranial remolding orthosis provided on 7/19/17 was medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the device at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 41-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested services in this clinical setting. This patient has been diagnosed with sacroiliac joint dysfunction. The records document physical examination findings which localize his symptoms to the sacroiliac joint. However, these findings are nonspecific in the presence of chronic low back pain. There are no objective imaging or laboratory findings to indicate the presence of sacroiliac joint infection, tumor, sacroiliitis due to spondyloarthropathy, or posttraumatic arthritis. Although the North American Spine Society does note some evidence supporting sacroiliac fusion for sacroiliac joint-mediated pain, the quality of evidence is low. Further research is recommended at this time. Therefore, the requested sacroiliac joint fusion is not likely to be more effective than other treatment options.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 41-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient presents status post L4-S1 lumbar laminectomy and fusion with persistent severe and debilitating bilateral sacroiliac joint pain. Significant functional limitations are documented in activities of daily living. Clinical examination findings have documented five positive provocative sacroiliac joint maneuvers, including flexion, abduction and external rotation (FABER) test, compression, thigh thrust, Gaenslens, and distraction, consistent with reported imaging evidence of degenerative changes of the sacroiliac joints. Detailed evidence of a long-term nonoperative treatment protocol trial and failure has been submitted. He has had over 75% temporary pain relief with sacroiliac joint injections, confirming the sacroiliac joints as the pain generator. There is no evidence of lumbar spine post-surgical hardware complications or significant neural compression that could be responsible for this patients ongoing pain and disability. The current medical evidence supports sacroiliac joint fusion in this patients case. In sum, the requested sacroiliac joint fusion is likely to be superior over other available treatment options.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

A 41-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that Sacroiliac joint degeneration is a common cause of chronic low back pain which is underdiagnosed. Minimally invasive fusion procedures have demonstrated successful pain relief for these individuals. Recent medical literature has documented two-year follow-up of these procedures demonstrating meaningful clinical improvement and maintained pain relief as well as evidence of a solid fusion on imaging studies. The article by Duhon and colleagues discussed long-term results from a prospective multicenter clinical trial. The authors noted minimally invasive sacroiliac joint fusion using triangular titanium implants showed marked improvements in pain, disability and quality of life at two years. Imaging showed that bone apposition to implants was common, but radiographic evidence of intra-articular fusion within the joint may take more than one year in many patients.  This case illustrates the difficulty encountered in making an accurate diagnosis of chronic low back pain that does not respond to the usual conservative measures. In the absence of evidence of neural compression on the magnetic resonance imaging scan and in the presence of clinical findings of sacroiliac pain which is relieved by injecting the sacroiliac joint, the requested procedure of sacroiliac fusion using the minimally invasive technique is likely to be beneficial for this patient. Thus, the requested sacroiliac joint fusion is likely to be more effective than other treatment options.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1


A 40-year-old female enrollee has requested reimbursement for the Genecept Assay provided by Genomind, Inc. on 2/24/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. The physician reviewer found that in this patients clinical scenario, there is a lack of clinical data provided to support an indication for genetic testing. Notably absent was documentation of the longitudinal illness burden and extent of impairment, family history, psychosocial stressors and medical comorbidities. Moreover, the provider did not include specific information regarding prior interventions used to treat the patients depression. Without the review of the specific type, setting and duration of psychotherapies, the treatment parameters and outcome of the TMS therapy, or the selection, dosing and length of previous psychotropic medication trials, it cannot be determined that the patient had exhausted standard treatments available to treat her condition. Given these findings, the Genecept Assay provided by Genomind, Inc. on 2/24/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2


A 40-year-old female enrollee has requested reimbursement for the Genecept Assay provided by Genomind, Inc. on 2/24/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. The physician reviewer found that based on the review of the submitted documentation, Genecept Assay provided by Genomind, Inc. on 2/24/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Pharmacogenetic testing in psychiatry is a newly evolving field but large randomized controlled trials are needed to further substantiate the utility of genetic testing in this clinical setting. A review of the available literature regarding pharmacogenetic testing suggests that it has been studied that to the extent that genetic factors are associated with the efficacy, tolerability, and safety of different drugs, pharmacogenetic tests may be used to personalize medication treatments for an individual patient. However, pharmacogenetic tests, such as the Genecept Assay, have a lack of evidence to support their clinical validity or utility. Overall, there is a lack of large randomized controlled trials that conclude the efficacy of pharmacogenetic testing in psychiatry. For these reasons, the Genecept Assay provided by Genomind, Inc. on 2/24/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3


A 40-year-old female enrollee has requested reimbursement for the Genecept Assay provided by Genomind, Inc. on 2/24/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. The physician reviewer found that the records provided for review do not specify the type of medications, dosage, length of time, and outcome for this patient. It was not mentioned if the patient was tried on different classes of antidepressants or concomitantly, or if augmentation strategies were attempted. There is no evidence in the records provided that electroconvulsive therapy (ECT) was discussed with the patient. Per community standard, ECT would be the next likely consideration in a patient with treatment refractory depression. Currently, ECT remains the most powerful treatment modality for patients with treatment resistant depression, with a proven track record of higher frequency of response and remission in these cases. Studies have shown that clinically useful predictors in genetic testing are scarce for antidepressant therapy, with results being inconsistent. At best, studies have shown that there is only marginal clinical association between enzyme system variants and drug metabolism, efficacy, and tolerability in the treatment of depression. In addition, there is a lack of large randomized trials supporting its use. The existing studies have also indicated that there was no significant correlation between either genotypes or medication serum concentration and response treatment. Current evidence does not support the use of genotyping when choosing an antidepressant, and even less is understood about its use in the treatment of anxiety disorders. Genetic testing lacks evidence based research to show its effective use in guiding the provider towards choosing a medication regimen. All told, the Genecept Assay provided by Genomind, Inc. on 2/24/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.