Persius/hicric huggingface dataset:
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1


A 50-year-old female enrollee has requested reimbursement for CPT codes 84999 (unlisted chemistry procedure, Oncotype DX colon cancer assay) and 88342 (immunohistochemistry of immunohistochemistry, per specimen, initial single antibody stain procedure) performed on 6/17/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer.The physician reviewer found the current medical evidence has not demonstrated the superior efficacy of the services at issue.  Oncotype DX colon cancer assay has been shown to have prognostic value, but to date has not shown that predictive benefit of standard chemotherapies.  National Comprehensive Cancer Network guidelines state that there are insufficient data to recommend the use of multigene assays, such as the Oncotype DX colon cancer assay, to determine adjuvant therapy.  Mismatch repair (MMR) status was stable for this patient.  However, given ulceration on final pathology of her colon tumor and abdominal abscess at presentation, most experts would lean toward chemotherapy for this patient given these risk factors.  Based on the available data, CPT codes 84999 and 88342 performed on 6/17/16 were 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 Overturned

Summary Reviewer 2


A 50-year-old female enrollee has requested reimbursement for CPT codes 84999 (unlisted chemistry procedure, Oncotype DX colon cancer assay) and 88342 (immunohistochemistry of immunohistochemistry, per specimen, initial single antibody stain procedure) performed on 6/17/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found that it is clear that adjuvant chemotherapy is of benefit to patients with stage III (node positive) colon cancer.  However, it is much more controversial as to the usefulness of adjuvant chemotherapy in stage II colon cancer, as in this patients case.  Most oncologists make this decision based on specific pathologic and clinical features in an individual.  Among those features that predict for a higher risk of recurrence are poorly differentiated histology, lymphovascular invasion, presentation with obstruction or perforation, or a T4 tumor.  Of these features, only the fact that it was a T4 tumor is applicable here, suggesting the possible need for adjuvant chemotherapy.  Oncotype DX colon cancer assay is a 12-gene panel that appears to predict the risk of recurrence in both stage III and stage II colon cancer, which goes beyond the pathologic features noted above.  There is sufficient support for the services at issue in this clinical setting, with only one bad feature (that is a T4 tumor), wherein the decision about adjuvant chemotherapy is difficult.  Therefore, CPT codes 84999 and 88342 performed on 6/17/16 were likely to have been superior over other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were likely to be 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: Insurer Denial Overturned

Summary Reviewer 3


A 50-year-old female enrollee has requested reimbursement for CPT codes 84999 (unlisted chemistry procedure, Oncotype DX colon cancer assay) and 88342 (immunohistochemistry of immunohistochemistry, per specimen, initial single antibody stain procedure) performed on 6/17/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found is sufficient support for the services at issue in this clinical setting.  The medical evidence shows that adjuvant chemotherapy confers a survival advantage for patients with stage III colorectal cancer, but not for those with stage II disease.  Meta-analyses have not shown any survival advantage for 5-FU/leucovorin treatment in stage II patients. The reasons for this conclusion are complex.  Stage II patients do well after surgery alone so that the magnitude of the survival benefit conferred by adjuvant chemotherapy is small; and, randomized clinical trials to date have had too few stage II patients to discern a statistically significant advantage.  Therefore, subset analyses to identify those patients with prognostic features that may predict for chemotherapy benefit have been analyzed.  For example, oncologists consider adjuvant treatment for those stage II patients with T4 disease, obstructing lesions, and other biomarkers.  The Oncotype DX colon cancer assay has been validated independently as being an excellent prognostic indicator.  The medical evidence for the test is sufficient to allow its use to estimate the risk of recurrence for stage II patients when incorporated with other tests such as standard pathology and microsatellite instability testing.  Thus, CPT codes 84999 and 88342 performed on 6/17/16 were 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 likely to be 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: Insurer Denial Overturned

Summary Reviewer 1

A 59-year-old male enrollee has requested reimbursement for gene testing performed on 3/9/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15 % of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Miller, et al). The Afirma Thyroid FNA Analysis utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries.  Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures (Duick et al). For the reasons provided above, the services at issue were 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 services at issue were likely to be 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: Insurer Denial Overturned

Summary Reviewer 2


A 59-year-old male enrollee has requested reimbursement for gene testing performed on 3/9/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that gene testing performed on 3/9/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. In this case, the initial biopsy report was determined to be indeterminate. The Afirma testing showed a suspicious lesion, which was a determining factor in delineating the further course of action to assess whether a surgical procedure was warranted. Afirma testing is considered standard protocol on fine needle aspirations performed on thyroid nodules. In sum, the testing at issue was 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 services at issue were likely to be 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: Insurer Denial Overturned

Summary Reviewer 3


A 59-year-old male enrollee has requested reimbursement for gene testing performed on 3/9/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the Afirma gene expression classifier testing performed on 3/9/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The biopsy result was consistent with follicular neoplasm. The median risk of malignancy on follicular neoplasm lesions is 15-30% (Cibas, et al). The Bethesda System recommends a second fine needle aspiration when the cytopathology is consistent with follicular neoplasm. The 2015 American Thyroid Associations guidelines state Diagnostic surgical excision is the long-established standard of care for the management of [follicular neoplasm/suspicious for follicular neoplasm] FN/SFN cytology nodules. However, after consideration of clinical and sonographic features, molecular testing may be used to supplement malignancy risk assessment data in lieu of proceeding directly with surgery. Informed patient preference and feasibility should be considered in clinical decision-making (Haugen, et al).  Fine needle aspiration with molecular testing is considered standard of care in this clinical setting. When the genetic test is suspicious for malignancy, the risk of malignancy increases to 40%, therefore surgery is recommended. However, the risk of malignancy decreases to less than 6% with benign findings by genetic testing (Haugen, et al; Alexander, et al). The test was important for the medical decision making to proceed with surgery (Alexander, et al). A benign results would have prevented unnecessary surgery. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

The parent of a four-year-old female enrollee has requested authorization and coverage for genetic testing. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that Ataxia is an uncommon finding in children with a large number of causes. Genetic etiology can often be identified, particularly in those with early age of onset, family history of ataxia, or consanguineous parents. In this childs case, the very early age of onset indicated a high probability of an underlying genetic cause. Studies of whole exome sequencing (WES), which is more comprehensive than the panel requested here, have shown rates of identification of underlying genetic etiology ranging from 21% to 69%, depending on age and family history of those included. The rate of positive WES in 21% of adults with ataxia suggests a significant likelihood of finding a diagnosis for this child, either by panel test or by WES. Many authors currently recommend WES either as a follow-up test to non-diagnostic ataxia panel genetic testing, or as an initial molecular test due to its comprehensiveness. Specific treatments do exist for some hereditary ataxias, and more clinical trials and therapies are anticipated, increasing the benefits of confirming a molecular diagnosis. The current medical evidence supports genetic testing in this clinical setting. Therefore, the requested genetic testing is medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 66-year-old female enrollee has requested authorization and coverage for gene testing provided on 12/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the medical evidence does not support the superior efficacy of the services at issue in this clinical setting. The medical evidence shows that survival rates for melanoma vary based on the depth of invasion of the primary tumor. Based on the medical record provided the patients stage was a T3, and as such, a stage II. Stage II has an increased risk of recurrence. Multiple analyses have demonstrated that survival/prognosis is dependent upon tumor thickness, age at diagnosis, location of primary, presence of ulceration, mitotic rate, lymph node involvement, and growth pattern. Genomic and proteomic expression profiling has been under investigation, but the role in standard therapy has not been clearly outlined. DecisionDX melanoma is a commercial gene expression profile test which has been developed for patients with local (stage I and II) or locoregional (stage III) cutaneous melanoma. The most recent assessment was to determine the impact on clinical practice and therefore did not or was not able to discuss the impact on patient outcome. The National Comprehensive Cancer Network (NCCN) guidelines indicate that for stage II melanoma, wide excision be pursued with sentinel lymph node evaluation if the tumor is greater than 0.75 mm in thickness. For stage IIA, clinical trial or observation is recommended whereas for stage IIB or IIC, in addition to those options, interferon alpha should also be considered. There are no current recommendations to undergo genomic or proteomic analysis to assess risk or assess benefit of adjuvant therapy.  Based on the review of the current guidelines, it is unclear that the addition DecisionDX melanoma improved this patients overall care plan since the role in clinical care is still undergoing investigation. In sum, the gene test performed on 12/28/15 was not likely to have been superior to the available options in the evaluation of this patients medical condition.Therefore, for the reasons stated above, the services at issue were not likely to have been 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 66-year-old female enrollee has requested authorization and coverage for gene testing provided on 12/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that a commercial gene expression profile test (DecisionDX-Melanoma) has been developed in patients with stage I and II cutaneous melanoma. However, there are no definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials according to published data available. Per the National Comprehensive Cancer Network (NCCN) guidelines, while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate benign from malignant neoplasms, or melanomas at low versus high risk for metastasis, routine (baseline) genetic testing of primary cutaneous melanomas (before or following SLNB) is not recommended outside of a clinical study (trial).  In sum, gene testing performed on 12/28/15, was not likely to have been more beneficial than any available standard of care in evaluating this patient. 
Therefore, for the reasons stated above, the services at issue were not likely to have been 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 66-year-old female enrollee has requested authorization and coverage for gene testing provided on 12/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the 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 they suggest 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 test for melanoma has not been made a 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 very novel and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. This was also the consensus opinion of the National Comprehensive Cancer Network (NCCN) guidelines. Accordingly, the gene test performed on 12/28/15 was not likely to have been more effective than the standard methods of evaluating this patient.
Therefore, for the reasons stated above, the services at issue were not likely to have been 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 Upheld

Summary Reviewer 

A 28-year-old male enrollee has requested authorization and coverage for Genium x 3 (military grade) microprocessor K3 knee. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of this patient. The physician reviewer found that the current medical evidence does not support the requested device in this clinical setting. The requested device, a microprocessor-controlled prosthetic knee, is not of proven marginal clinical benefit over a conventional prosthetic knee without microprocessor control. The contention that this type of device affords significant functional benefits is largely anecdotal or industry-generated/supported. A clinical trial by Meier and colleagues showed higher performance with a passive prosthetic knee (Mauch SNS) versus the microprocessor-controlled C-Leg. The authors postulated that a simpler knee joint could perform better than a microprocessor-aided prosthetic knee on soft or uneven surfaces because users have a more expedient and direct impact on the knees behavior over a microprocessor-aided knee. More recent high-grade literature establishing a clinically significant functional improvement using this technology has not been published. Therefore, the requested Genium x 3 (military grade) microprocessor K3 knee is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1


A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/29/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the medical evidence supports the services at issue in this patients case.  Breast tomosynthesis allows radiologists to separate dense glandular elements from underlying architectural distortion.  In this case, the use of breast tomosynthesis helped to characterize the initial lesion as suspicious and allowed the radiologist to evaluate the remainder of the right breast for a potential synchronous mass as well as clearing the left breast.  The use of breast tomosynthesis has resulted in a decrease in callbacks and increase in detection of small cancers in screening populations.  Thus, the inclusion of breast tomosynthesis in the diagnostic mammogram of 7/29/15 was likely of more benefit to the patient than if she had a two-dimensional study alone.  Based upon the information set forth above, the services at issue were likely to be 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: Insurer Denial Overturned

Summary Reviewer 2

A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/29/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the medical literature supports the services at issue in this clinical setting.  Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues reported that integrated two-dimensional and three-dimensional mammography improve breast cancer detection and has the potential to reduce false positive recalls.  In sum, the literature supports the use of breast tomosynthesis over conventional mammogram due to improved cancer detection rate.  Therefore, breast tomosynthesis performed on 7/29/15 was likely to have been of greater benefit than other modalities.  Based upon the information set forth above, the services at issue were likely to be 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: Insurer Denial Overturned

Summary Reviewer 3


A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/29/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities.  This has been shown to be most useful in the evaluation of dense breasts.  In this patients case, the original mammogram performed on 7/21/15 was done as a screening study, so that it is not unreasonable for the images to have been interpreted after the patient left the facility.  To recall the patient for additional images once a suspicious abnormality is detected is typical and appropriate.  However, it is not reasonable to repeat another tomosynthesis after only eight days.  While the first breast tomosynthesis was warranted due to the heterogeneously dense nature of her breasts and the asymmetry, the records do not establish the need for the second breast tomosynthesis.  Therefore, the breast tomosynthesis performed on 7/29/15 was not likely to have been more effective than other methods of evaluation.  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.