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

Summary Reviewer 3

A 50-year-old female enrollee has requested reimbursement for breast tomosynthesis imaging performed on 2/10/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented for her annual breast examination. The physician reviewer found that Tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as CT scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. In recent years, there have been several studies that have supported the use of breast tomosynthesis as a more accurate study than routine screening mammography.  As Skaane concludes, in a study including 12,631 examinations, 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.   In this particular patient, she has breasts that have been described as extremely dense.  It is specifically those patients who have dense breasts that can benefit most from tomosynthesis.  The ability to separate out the overlapping structures better enables the possibility of demonstrating an otherwise occult tumor. In sum, breast tomosynthesis imaging performed on 2/10/17 was likely to have been more effective than the other methods for the evaluation of this patients medical condition. Based upon the information set forth above, the service at issue was likely to be more beneficial for the evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 22-year-old female enrollee has requested reimbursement for the blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the patient is a 22-year-old female with stenotic ileocolonic and perianal Crohns disease diagnosed in 2012. She has been maintained on Remicade therapy since 2012, with doses varying from 5 mg/kg every eight weeks to 10 mg/kg every four weeks. Remission was achieved in January 2013. Per the office note dated 3/2/16, the patient was experiencing no gastrointestinal symptoms, had no active perianal disease or bleeding, and stools were formed and 1-2 per day in the setting of a normal C-reactive protein. On 4/28/16 Prometheus Anser IFX testing showed detectable serum infliximab (8.7 ug/mL, reference <1.0) and undetectable antibodies to infliximab (<3.1 U/mL). The patient has requested reimbursement for blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request as investigational. The blood testing (Prometheus Anser IFX) performed on 4/26/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. The American Gastroenterological Association (AGA) guideline recommendations on therapeutic drug monitoring in patients with inflammatory bowel disease acknowledged that there exists no defined cut-offs by which to judge low versus high titer anti-drug antibodies. In this case, the provided records do not support that the patients Crohns disease was symptomatically active at the time of the Prometheus Anser IFX testing. As such, the testing at issue 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 22-year-old female enrollee has requested reimbursement for the blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the patient is a 22-year-old female with Crohns disease and ileocolonic disease with a stenotic ileocecal valve. The patient also has a history of perianal disease. The patient is maintained on infliximab monotherapy. On 3/2/16, the patient reported feeling well. However, her fecal calprotectin was elevated at 288 and recent magnetic resonance enterography demonstrated increasing disease activity. There was concern that the patients infliximab levels were inadequate. The patient underwent Prometheus Anser IFX on 4/26/16 and results demonstrated detectable levels of infliximab (8.7) and undetectable levels of antibody. The patient has requested reimbursement for blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request as investigational. This case highlights exactly why infliximab level measurement is often not helpful clinically and there is very low evidence for its use to guide clinical management. The records demonstrate that the patient has good trough level of infliximab and no antibodies. However, the patient has active disease so the decision was made to increase the dose of infliximab. In this clinical setting, even without Prometheus Anser IFX testing the same clinical decision would have been made. For the reasons provided, the blood testing (Prometheus Anser IFX) performed on 4/26/16 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 22-year-old female enrollee has requested reimbursement for the blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the patient is a 22-year-old female with Crohns disease diagnosed in 2012. Per the progress note dated 3/2/16, the patient has a stenotic ileocolonic valve and perianal disease. She has been treated with 6-mercaptopurine, Remicade combination therapy, and then Remicade monotherapy at 10 mg/kg every four weeks and then 5 mg/kg every eight weeks with clinical response and remission. She was noted to have fecal calprotectin at 288 and normal C-reactive protein with elevated erythrocyte sedimentation rate. The patient reported to having one to two formed bowel movements per day with no bleeding, urgency, abdominal pain, fever, chills, or active perianal disease. On that date, erythrocyte sedimentation rate was slightly elevated and fecal calprotectin was suggestive of active disease. The provider recommended Anser IFX, colonoscopy and magnetic resonance enterography to assess disease activity. Anser IFX on 4/26/16 showed Remicade level of 8.7 ug/mL and lack of anti-Remicade antibodies. Magnetic resonance enterography showed active disease and led to Remicade dosage increase. The patient has requested reimbursement for blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request as investigational. Prometheus Anser IFX has not definitively demonstrated efficacy for the management of Crohns disease. The presence of antibodies alone does not necessarily result in reactions to infliximab or loss of response to infliximab, nor have threshold levels been established (Steenholdt, et al). Furthermore, studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response (Vande Casteele, et al; Nanda, et al). In sum, the medical literature reports contradictory outcomes with the use of use of Prometheus Anser IFX and lacks high-quality controlled studies to define drug level or antibody level thresholds requiring action, compare clinical strategies such as dose increase or change in medication based on those thresholds. For these reasons, the blood testing (Prometheus Anser IFX) performed on 4/26/16 was not likely to be more beneficial for treatment of the enrollees 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: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 


A 61-year-old female enrollee has requested reimbursement for Nuvigil provided from 1/1/15 through 8/1/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees circadian rhythm disorder, shift work type. The physician reviewer found that Nuvigil has been provided to this patient for circadian rhythm disorder, shift work type. This medication has shown efficacy and has an indication for this condition (Czeisler, et al; Morgenthaler, et al). However, this patients records do not support a diagnosis of shift work sleep disorder. Further, there is no reference to any other condition such as narcolepsy or treated obstructive sleep apnea which may support an indication for Nuvigil. Given this lack of information, the Nuvigil provided to this patient from 1/1/15 through 8/1/15 was not medically necessary.  Consistent with these findings, the medication 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: Insurer Denial Upheld

Summary Reviewer 

A 60-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 3/29/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. 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. The medical evidence does not support the services at issue in this clinical setting. Thus, DecisionDx-Melanoma testing performed on 3/29/18 was not medically necessary for the evaluation 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: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1


A 62-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that 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, by separating the various layers of breast tissue, one can better detect abnormalities. This patient has breasts that have been described as extremely dense. It is the patients with dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 8/9/16 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 service at issue was 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 62-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that Tomosynthesis was approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2011. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography, the American College of Radiology (ACR) urged the technique be removed from the investigational category due to the advantages this new tomographic technique brings to radiologists interpreting mammograms. This technique often allows radiologists to separate dense glandular elements from underlying masses and architectural distortion resulting in a decrease in callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to this patient than had her exam been done with two-dimensional imaging alone. Accordingly, the breast tomosynthesis that was performed on 8/9/16 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 service at issue was 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 62-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that there is a lack of peer-reviewed literature that supports the use of three-dimensional breast tomosynthesis compared to currently available techniques, especially in a patient without an increased risk of breast cancer. Although breast tomosynthesis may be a promising technique, its clinical efficacy is yet to be substantiated in peer-reviewed literature. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 8/9/16 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 service 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 1

A 63-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 3/08/19. 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 the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is unknown if the DecisionDx-Melanoma assay can be used to make clinical decisions. Thus, DecisionDx-Melanoma testing provided on 3/08/19 was not likely to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 63-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 3/08/19. 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 the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is unknown if the DecisionDx-Melanoma assay can be used to make clinical decisions. Thus, DecisionDx-Melanoma testing provided on 3/08/19 was not likely to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 63-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 3/08/19. 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 the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is unknown if the DecisionDx-Melanoma assay can be used to make clinical decisions. Thus, DecisionDx-Melanoma testing provided on 3/08/19 was not likely to have been more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

A 28-year-old male enrollee has requested reimbursement for substance use inpatient detoxification provided from 7/27/17 through 8/08/17 and residential treatment provided from 8/09/17 through 9/11/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that regarding the request for residential services, on step-down, the patients vital signs were stable. He showed no post-acute withdrawal symptoms on admission to residential treatment. This is inconsistent with staffs report of ongoing post-acute symptoms which one would see in the acute phase of opioid withdrawal. As noted above, there were no emotional, behavioral, cognitive, or impulsive issues requiring a 24/7 structured setting. He was not suicidal or homicidal. There was no evidence of any psychotic thought process, mania, or any other condition which would preclude treatment on an ambulatory basis. Standard of practice in the community is medication assisted treatment, which he had previously received. Thus, substance use inpatient detoxification provided from 7/27/17 through 8/08/17 and residential treatment provided from 8/09/17 through 9/11/17 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

The parent of a 14-year-old male enrollee has requested authorization and coverage for Norditropin Flexpro 15 mg/1.5. 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. This patient was already between the 5th and 10th percentile before starting treatment. His growth velocity had already started to improve before the start of growth hormone therapy, suggesting that he might have constitutional delay of growth and puberty, and ultimately started to have pubertal growth spurt. There is no clear documentation of Tanner staging for the patient. It seems there was period of slow growth in 2019, which could be due to pre-pubertal slow down, which is a normal physiological phenomenon. His height/growth potential was always maintained, as the predicted adult height has been either in range or above the range of his target height. Therefore, Norditropin FlexPro 15 mg/1.5 is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. 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 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 DecisionDx-Melanoma testing 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. Therefore, DecisionDx-Melanoma testing performed on 11/21/19 was not likely to have been more beneficial than other available standard therapy.