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

Summary Reviewer 1

The patient is a 55-year-old female with a history of rheumatoid arthritis. On 8/18/16, she was being treated with methotrexate, prednisone and Xeljanz.  Per the records, Xeljanz had improved her symptoms, but she was having more frequent outbreaks of herpes.  During the past month, she had experienced pain in her right elbow, worse back pain, left ankle pain/stiffness and weight gain.  The records noted that the patient has responded to Remicade in the past, although this was discontinued due to cost. The patients provider recommended retrying Remicade, but the provider reported concerns given the long period of abstinence. The provider recommended Prometheus Anser IFX testing.  The Health Insurer has denied reimbursement for Prometheus Anser IFX testing performed on 8/19/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient.
The anti-tumor necrosis factor agents have been noted to be associated with an increasing amount of autoantibodies resulting in an increased risk of infusion reactions, a reduced response to medications, and the need for increasing dose adjustments. Up to about 50% of patients treated with infliximab develop these antibodies, and those patients with high antibodies have been found to have a higher risk of infusion reactions. In this patients case, based on the records from 8/18/16, there was evidence of active rheumatoid arthritis and intolerance of Xeljanz.  She has tolerated Remicade in the past, with no reactions, and other anti-tumor necrosis factor agents were stopped due to ineffectiveness or cost.  There is a lack of evidence to support that Remicade would be ineffective or possibly harmful.  Remicade was stopped in the past due to cost, not medical issues. At this time, the role of this testing is still being determined. As such, the medical records and the current medical literature fail to support that Prometheus Anser IFX testing performed on 8/19/16 was 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

The patient is a 55-year-old female with a history of rheumatoid arthritis manifested by synovitis of the small and large joints and fatigue. On 8/18/16, the records noted that she had been treated with Remicade, methotrexate and Xeljanz. The documentation indicated that the patient had responded to Remicade in the past, but this was discontinued due to cost.  The provider reported reluctance to resume Remicade due to concern for infusion reaction. The provider ordered Prometheus Anser IFX testing.  The Health Insurer has denied reimbursement for Prometheus Anser IFX testing performed on 8/19/16.  Per the Health Insurer, the services at issue were investigational for the evaluation of this patient.  The current medical evidence does not support the services at issue in this patients case.  Prometheus Anser IFX testing can measure antibodies to Remicade (infliximab). However, there is a lack of peer-reviewed, evidence-based medical literature to support the use of Prometheus Anser IFX testing in the management of rheumatoid arthritis. Additionally, the available medical records do not adequately document the providers rationale for the request of this test.  All told, the superior effectiveness of Prometheus Anser IFX testing performed on 8/19/16 has not been established. 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

The patient is a 55-year-old female with rheumatoid arthritis who has failed multiple therapies. These therapies have included Actemra, Simponi, Orencia, Humira and recently Xeljanz. The patient did not tolerate Arava. On 8/18/16, the records noted that the patient had been on Remicade in the past, and this medication was both tolerated and effective. The provider ordered Prometheus Anser IFX testing to determine if antibodies had been formed against infliximab (Remicade) due to prior therapy with Remicade and to determine if this would be a suitable next therapy. The Health Insurer has denied reimbursement for Prometheus Anser IFX testing performed on 8/19/16.  Per the Health Insurer, the services at issue were investigational for the evaluation of this patient.  There is a lack of support for Prometheus Anser IFX testing in this patients case.  The services at issue are not standard of care prior to starting patients on Remicade, even if they have been on it before.  There is a lack of literature to support that testing of these antibodies changes the overall outcome or prognosis. Additionally, antibodies to anti-tumor necrosis factor agents can occur any time during therapy, but most often occur at the beginning of therapy and may be transient. Patients with anti-tumor necrosis factor antibodies do not necessarily always demonstrate a lack of response to therapy. Therefore, there is no one-to-one correlation between antibody formation and presence and failure to respond to Remicade.  Thus, Prometheus Anser IFX testing performed on 8/19/16 was not likely to be 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: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1


A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 4/29/15. 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 there is some support for the services at issue in this clinical setting.  Singh and colleagues discussed therapeutic drug monitoring (TDM) in children and young adults with inflammatory bowel disease (IBD).  According to the paper by Singh and colleagues, The clinical value of TDM [therapeutic drug monitoring] is increasingly being recognized, with the growing body of evidence linking serum anti-TNF drug and ADA concentrations to clinical outcomes in IBD. The knowledge of these results provides insight into the etiology of loss of response and enables therapy to be optimized for an individual patient.  Per the submitted documentation, Prometheus IFX testing performed on 4/29/15 was likely to have been more efficacious 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 Upheld

Summary Reviewer 2


A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 4/29/15. 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 testing in dispute was ordered to direct the use of infliximab in this patient with Crohns disease.  However, the use of this testing to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response.  In sum, Prometheus Anser IFX testing performed on 4/29/15 was not likely to have been of greater benefit 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.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3


A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 4/29/15. 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 there is a lack of support for the services at issue in this clinical setting.  Some evidence exists that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures.  Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear.  Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment.  However, there are few well-controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment.  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. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement.  It has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established.  Thus, the superior efficacy of Prometheus Anser IFX testing performed on 4/29/15 has not been established.  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 

The patient is a 52-year-old male who had a history of a stage IIB (T4N0) colon adenocarcinoma diagnosed in 2017. He was treated with adjuvant chemotherapy and was noted to have no mutations. The physician reviewer found that as a standard of care, metastatic colon cancers should be tested for KRAS, NRAS, BRAF, HER2, and microsatellite instability (MSI) or mismatch repair (MMR) testing. Per the National Comprehensive Cancer Network guidelines, these can be done individually or as part of next-generation sequencing (NGS). NGS panels have the ability to pick up rare and actionable mutations and fusions. Universal genetic testing is recommended on all colon cancer tumors, and NGS allows for initial screening with MSI testing. NGS offers the advantage of identifying markers known to have targeted therapy as well as potential clinical trials. This patient has metastatic colon cancer that is recurrent. Although his initial tumor did not have any mutations, the panel has expanded since he was diagnosed, and recurrences can develop new mutations. The
medical evidence supports the services at issue in this clinical setting. Therefore, CPT codes 81202, 91275, 81292, 81298, 81301, 81311, 81321, 81404, 81406 XU x 2 and 81479 XU x 4 performed on 5/12/19 were medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1


A 44-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/18/16.  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 that according to 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 noted integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls.  In sum, breast tomosynthesis performed on 3/18/16 was likely to have been of greater benefit than other methods of evaluation.  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 44-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/18/16.  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 that 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.  However, in this patients case, there were no problems to be resolved.  The patient did not have dense breasts, a mass, palpable lumps, or suspicious calcifications.  In this clinical setting, a routine mammogram would have been sufficient.  Digital breast tomosynthesis has not been shown to provide significant increased value in patients who do not have dense tissue that could obscure an abnormality. Therefore, breast tomosynthesis performed on 3/18/16 was not likely to have been of greater benefit than other modalities for 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 3


A 44-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/18/16.  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 that there is sufficient support for digital breast tomosynthesis for the evaluation of patients for breast cancer screening. Digital breast tomosynthesis provides advantages to radiologists interpreting mammograms. This tomographic method often enables the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks, increase in accuracy and increase in detection of small cancers. For this reason, the addition of digital breast tomosynthesis to the usual two dimensional protocol was likely of greater benefit to the patient than had the examination been performed using two dimensional imaging 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 1

A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/14/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts.The physician reviewer found that there is evidence based support for the service at issue in this clinical setting. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in callbacks and biopsies and an increase in detection of small cancers when compared to two dimensional imaging alone. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. Therefore, the addition of digital breast tomosynthesis, to the usual two dimensional protocol was likely to be more effective than had the patients examination been performed using two dimensional imaging alone. 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 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/14/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts. The physician reviewer found that 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 state that integrated two dimensional and three dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Therefore, the medical literature supports the use of digital breast tomosynthesis over conventional mammogram due to improved cancer detection rate. As such, digital breast tomosynthesis performed on 7/14/16 was likely to have been superior to other methods of evaluating this patient. 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 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/14/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts. The physician reviewer found that 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 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, her breasts were described as borderline heterogeneously dense.  It is specifically those patients who have dense breasts that can benefit most from breast tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor.  Thus, digital breast tomosynthesis performed on 7/14/16 was likely to have been more efficacious than other methods of evaluating this patient. 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: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

The patient is a 26-year-old female with a history of an intensive care unit admission for alcoholic ketoacidosis. She had a history of depression and anxiety with poor compliance with medication. The physician reviewer found that based on the records, this patient met American Society of Addiction Medicine (ASAM) criteria for sub-acute substance abuse rehabilitation (ASAM 3.5) provided from 6/20/21 through 7/18/21. The ASAM criteria focuses on six dimensions to determine the appropriate level of care. 

For dimension 1, acute intoxication or withdrawal potential, the patient had several episodes of withdrawal and experienced alcoholic ketoacidosis, alcohol hepatocyte injury, macrocytic anemia and physical withdrawal. After discharge from the inpatient hospital, she was stable enough to receive further medical detoxification at the level 3.5 residential treatment level of care.

For dimension 2, biomedical conditions, the patientas medical problems as cited in dimension 1 were stable enough to be treated at the 3.5 level of care.

For dimension 3, emotional, behavioral, or cognitive conditions, the patient had a history of anxiety and depression and had difficulty complying with medication on an outpatient basis. Her co-occurring anxiety and depression and need for supervision of medications meets ASAM 3.5 level of care criteria.

For dimension 4, readiness to change, the patient was ambivalent about residential treatment and thought it was ajust what her family wanteda, showing low insight and poor judgment and supporting the need for further structured treatment to enhance her willingness to change.

For dimension 5, relapse, continued use, continued problem potential, the patient had tried stopping on her own several times and had developed serious medical problems which could worsen and be potentially fatal outside of a structured 24-hour monitored treatment setting.  

For dimension 6, recovery environment, the patientas family works in the wine business and she would have been exposed to continuous use had she been discharged to her motheras home. The patient had no support for sobriety at her home in Colorado. She met 3.5 level of care on dimension 6.

Accordingly, sub-acute substance abuse rehabilitation (ASAM 3.5) provided from 6/20/21 through 7/18/21 was medically necessary for the treatment of this patient
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

A 59-year-old female enrollee has requested reimbursement for Avastin provided from 5/27/15 through 8/4/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees metastatic colorectal carcinoma. The physician reviewer found that in this case, chemotherapy is being used in the neoadjuvant setting. There is limited data on neoadjuvant chemotherapy since most patients in this clinical setting typically present with inoperable advanced disease. Neoadjuvant treatment is a medically reasonable approach in a patient with limited stage disease that is potentially operable (Assifi, et al; Andriulli, et al). The best chemotherapy options include gemcitabine or oxaliplatin or cisplatin combined with fluoropyrimidines, gemcitabine with Abraxane, gemcitabine with erlotinib, and gemcitabine with docetaxel and capecitabine (Ghosn, et al). In addition, Avastin did improve progression-free survival when combined with erlotinib and gemcitabine (Van Cutsem, et al). All told, there is adequate data supporting the medical necessity of the Avastin provided to this patient from 5/27/15 through 8/4/15. 
Consistent with these findings, the medication at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.