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

Summary Reviewer 1


A 42-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 1/19/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.  The physician reviewer found that the breast tomosynthesis performed on 1/19/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. 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 it brings radiologists interpreting mammograms especially in women with dense breast tissue such as in this case. This tomographic method often allows the reader to separate dense glandular elements from underlying mass and architectural distortion resulting in a decrease in biopsies and callbacks and increase in diagnostic accuracy and detection of small cancers compared to two-dimensional (2D) imaging alone. Thus, the addition of tomosynthesis was likely of greater benefit to the patient than had her exam been done with 2D imaging only. 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: Overturned

Summary Reviewer 2

A 32-year-old female enrollee has requested authorization and coverage for Gamunex-C. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the medical evidence supports the requested medication in this clinical setting. Schofield and Chemali noted, Immunoglobulin therapy has been used increasingly with significant efficacy in the treatment of patients with disabling autoimmune forms of dysautonomia, which are most often small fiber (autonomic and/or sensory) polyneuropathies. De Greef and colleagues noted that, Small fiber neuropathy is the most common cause of neuropathic pain in peripheral neuropathies. Patients experience excruciating pain, and currently available anti-neuropathic and other pain drugs do not relieve the pain substantially. Several open-label studies have suggested an immunological basis in small fiber neuropathy and have reported efficacy of treatment with intravenous immunoglobulin. Gamunex-C is an appropriate treatment in this patients case. All told, Gamunex-C is likely to be more beneficial than other available treatment options.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 58-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/10/15.  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 current medical evidence supports the services at issue in this clinical setting.  Breast tomosynthesis allows providers to differentiate dense glandular elements from underlying architectural distortion which in turn has been associated with a decrease in callbacks and increase in detection of small cancers.  The medical literature supports the breast tomosynthesis in this patients case.  Thus, the addition of tomosynthesis to the usual two-dimensional imaging protocol was likely of more benefit for the patient than had the examination been done with the two-dimensional technique 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: Upheld

Summary Reviewer 2


A 22-year-old male has requested reimbursement for Prometheus Anser IFX testing performed on 8/30/15.  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 submitted records fail to demonstrate the superior effectiveness of the services at issue.  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 IFX 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.  Therefore, Prometheus Anser IFX testing performed on 8/30/15 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: Upheld

Summary Reviewer 2 
 
A 61-year-old female enrollee has requested reimbursement for laboratory testing performed on 
11/29/19. The Health Insurer has denied this request and reported that the services at issue were 
investigational for the evaluation of the enrollees medical condition. The physician reviewer 
found that this patient was recently diagnosed with advanced non-small cell lung cancer. Even if 
stage IV or advanced disease is present in non-small lung cancer, therapy targeted to EGFR 
mutations  with  erlotinib  results  in  prolonged  survival  when  compared  with  standard 
chemotherapy regimens.  The mutational landscape of non-small cell lung cancer has significantly 
expanded in the past two to three years to encompass gain of function in multiple oncogenes 
with major prognostic and therapeutic consequences. It is generally accepted that the panel of  mutations that was analyzed in the patient using the Guardant 360 test is for mutually exclusive 
somatic driver mutations. Generally, KRAS, TP53, and BRAF are also included in these panels and 
are informative. The NCCN does not promote brand name products such as Guardant 360 and so 
the specific test is not mentioned but comprehensive mutational testing is mentioned and 
recommended. Therefore, laboratory testing performed on 11/29/19 was likely to have been 
more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 45-year-old female enrollee has requested reimbursement for FoundationOne gene testing performed on 3/26/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees adenosarcoma of the cervix.        The physician reviewer found this patient has a rare uterine sarcoma that has not been extensively studied. A study of 86 patients where the progression-free survival on regimen selected by molecular profiling was compared to progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage (Von Hoff, et al). This trial has very significant results for patients with stage IV tumors.  The results from molecular profiling offer a rational selection of the next regimen. This patient has a rare form of cancer and she has exhausted conventional therapies for treatment.  Thus, the submission of her tissue for analysis to FoundationOne, in an effort to guide next steps in her treatment, was likely more beneficial than conventional therapies. 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: Upheld

Summary Reviewer 2

A 47-year-old male enrollee has requested reimbursement for the Oncotype Dx Colon Cancer Assay provided on 2/14/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectosigmoid cancer. The physician reviewer found that the Oncotype DX test uses a reverse transcriptase polymerase chain reaction assay for 12 genes in an algorithm that can be used to help predict recurrence (OConnell, et al; Gray, et al). Despite this support, it has not been established whether adjuvant chemotherapy can obviate recurrence risk. Overall, the current data does not support use of the Oncotype DX as a predictive marker for response to adjuvant treatment (Benson and Hamilton; Gray, et al). As such, the National Comprehensive Cancer Network (NCCN) guidelines state that there are insufficient data to recommend use of multi-gene assay panels to determine adjuvant therapy. All told, the Oncotype DX Colon Cancer Assay provided on 2/14/18 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: Overturned

Summary Reviewer 2 
 
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx TM 
comprehensive genomic profiling test performed on 1/26/21. The Health Insurer has denied 
this request and reported that the services at issue were investigational for the evaluation of 
the enrollees medical condition. The physician reviewer found that there is sufficient support 
for the services at issue in this setting. Many patients with metastatic breast cancer encounter 
off-label therapies that may be supported by medical evidence. Von Hoff and colleagues 
performed a study of 86 patients. The progression-free survival on regimen selected by 
molecular profiling was compared to progression-free survival on the last chemotherapy 
regimen. The authors noted that the regimen selected by molecular profiling offered a 27% 
survival advantage. This trial has very significant results for patients with stage IV tumors. This 
patient may be offered something off-label or a phase I/II clinical trial. The results from 
molecular profiling offer a rational selection of the next regimen. More recent data on breast 
cancer also supports the use of FoundationOne testing. The National Comprehensive Cancer 
Network guidelines also support a role for mutational analysis. Therefore, FoundationOne CDx 
TM comprehensive genomic profiling test performed on 1/26/21 was likely to have been more 
beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 20-year-old female enrollee has requested reimbursement for Anser IFX diagnostic test performed on 2/8/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees chronic ulcerative pancolitis. The physician reviewer found that there is a lack of properly conducted, prospective, controlled trials showing a benefit of the services at issue over routine tests. Monitoring patients on infliximab with measurement of infliximab levels and antibodies to infliximab continues to be an area of intense investigation. The Anser IFX test categorizes drug levels as high or low and antibody levels as high or low. However, this algorithmic approach has not been validated using prospectively controlled data. Their value as a random test to assess levels in a clinically stable patient on maintenance therapy, such as in this patients case, has yet to be established in prospective controlled trials. Therefore, the Anser IFX diagnostic test administered on 2/8/16 was not likely to have been more beneficial than any available standard therapy for the evaluation of this patients medical condition. Based upon the information set forth 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: Upheld

Summary Reviewer 

The patient is a 58-year-old male. He presented to the emergency department on 8/18/20 with lower abdominal pain, nausea, and chills for two days, as well as constipation with no bowel movement for days. The patient has requested reimbursement for inpatient hospital level of care provided from 8/18/20 through 8/21/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. In patients with uncomplicated diverticulitis, outpatient management or observation is the standard of care. The safety and efficacy of outpatient management of acute uncomplicated diverticulitis has been demonstrated. A systematic review of the literature underscored this [4]. The observation level of care can be appropriate over outpatient care when there is a possible microperforation. In this case, there was a locule of free air, which suggested microperforation, leukocytosis on presentation, and distended abdomen with ileus and ongoing lack of bowel movements on the day after presentation. However, there was no protracted fever or hypotension to suggest that antibiotics were ineffective. The patient improved on intravenous antibiotics and was appropriately discharged on oral antibiotics. His diet was gradually advanced as he started having bowel movements on the night after presentation. No other cause for the inpatient level of care, such as peritonitis, toxic megacolon, bowel obstruction, sepsis, abscess, fistula, or other complication, was documented. Therefore, inpatient hospital level of care provided from 8/18/20 through 8/21/20 was not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 24-year-old female enrollee has requested authorization and coverage for intensity modulated radiation therapy (IMRT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.  The physician reviewer found that the goal for the treatment of Hodgkins disease in young adults is to eradicate the disease to minimize the risks of late effects secondary to therapy. The late effects of treatment have become more apparent with increased survival of Hodgkins patients. IMRT is superior to three-dimensional conformal radiation therapy (3D-CRT) for patients with bulky mediastinal disease. This is because IMRT allows a more conformal dose of radiation to mediastinal disease while at the same time delivering a lower dose to adjacent sensitive organs such as heart and lungs. The National Comprehensive Cancer Network (NCCN) Hodgkins lymphoma guidelines state Advanced radiation therapy (RT) technologies such as IMRT, breath hold or respiratory gating, image guided RT or proton therapy may offer significant and clinically relevant advantages in specific instances to spare important [organs at risk] OAR such as the heart (including coronary arteries, valves and left ventricles), and decrease the risk for late normal tissue damage while still achieving the primary goal of local tumor control. In this case, IMRT will be more beneficial treatment to avoid long-term complications in this young patient who has a very high chance of cure. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2
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 the digital mammography screening has been proven to decrease mortality related to breast cancer. Standard or two dimensional (2-D) mammography has significant limitations, namely obscuration of cancers within areas of overlapping or dense tissue, as well as false positive recalls due to overlapping breast tissue, which must be confirmed with additional imaging. Digital breast tomosynthesis addresses both of these issues as it increases the cancer detection rate. It does this by allowing the radiologist to scan through slices of breast tissue rather than seeing the breast tissue superimposed on itself. This technology is especially beneficial in patients with dense breast tissue, where the mammogram is already limited in the detection of cancer. According to the American College of Radiology position statement on breast tomosynthesis, it specifically states: To be clear: tomosynthesis is no longer investigational. Tomosynthesis has been shown to improve key screening parameters compared to digital mammography. As digital breast tomosynthesis has been proven to increase cancer detection in the screening setting, as well as decrease false positive recall rates, this patient would benefit from breast cancer screening utilizing tomosynthesis. As such, current medical literature supports that this modality is superior to standard 2-D mammography. Therefore, in this case, breast tomosynthesis imaging performed on 2/10/17 was likely to have been more beneficial for the evaluation of the patients condition than the available standard imaging.  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: Upheld

Summary Reviewer 3


A 32-year-old female enrollee has requested reimbursement for the gene testing performed on 8/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees behavioral health condition. The physician reviewer found that despite its promise, pharmacogenetics is not yet ready for mainstream clinical application. The American Psychiatric Association (APA) does not endorse such testing in its current clinical practice guidelines. In this case, the documentation submitted for review failed to show the patients longitudinal illness burden and extent of impairment at the time of testing, including family history, psychosocial stressors, substance use disorders and medical comorbidities. In addition, there was no mention of prior interventions used to treat panic, depression and excessive worry. Without the review of the specific type, setting and duration of psychotherapies, or, the selection, dosing and length of previous psychotropic medication trials, it cannot be inferred that the patient had exhausted standard treatments available to treat her condition. In sum, considering the relevant peer-reviewed literature and current practice standards, it is not possible to assert with any degree of confidence that the disputed gene test yielded information that significantly influenced treatment decisions, improved the patients condition, prevented a more serious episode of illness or reduced morbidity. Thus, the gene testing performed on 8/11/16 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: Experimental
Decision: Overturned

Summary Reviewer 3


The parent of a four-year-old female enrollee has requested reimbursement for chromosomal microarray (CMA) genetic testing performed on 9/16/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation the enrollees developmental delays. The physician reviewer found that CMA is recommended by the American College of Medical Genetics (ACMG) as a first-tier test for patients with developmental delay, intellectual disability, and/or multiple congenital anomalies (Manning, et al). Increasing numbers of patients have been found to have underlying copy number variations. As such, copy number variations on CMA may inform about possible other complications and medical risks, some of which can be screened for and treated. WS is caused by microdeletion of chromosome 7q11.23. Features of WS include cardiovascular disease, most commonly peripheral pulmonary stenosis or supravalvular aortic stenosis, distinctive facies, joint laxity, intellectual disability with specific cognitive profile and unique personality characteristics, slow growth abnormalities, and calcium abnormalities including hypercalcemia and hypercalciuria. This is an important diagnosis to make as cardiac, renal, and endocrine evaluation and ongoing care are necessary. Accordingly, the CMA genetic testing performed on 9/16/15 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 testing 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.