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

Summary Reviewer 1

A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing for bacterial vaginosis provided on 5/09/19. 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 there is insufficient support for vaginitis panel testing using polymerase chain reaction (PCR) technology. This testing offers no proven benefit over standard culture in symptomatic women. Furthermore, there is a lack of evidence on the clinical utility and impact of PCR testing for vaginitis. There is a lack of studies showing that this testing leads to better patient management decisions and/or better health outcomes. Studies of diagnostic accuracy alone are inadequate, especially because most symptomatic women can be diagnosed with a standard work-up and/or a trial of empiric therapy. Therefore, PCR testing for bacterial vaginosis performed on 5/09/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

The patient is a 63-year-old male with a history of urothelial cancer. He presented with gross hematuria when a large 17 cm soft tissue mass was found in the distal left ureter. He started with neoadjuvant chemotherapy with gemcitabine and cisplatin for four cycles with some response. A cystoscopy showed a T1 transitional cell carcinoma of the bladder. He underwent a transurethral resection. A left abdominal lymph node was sampled and was positive for metastatic disease. A sample of his tumor was sent to Foundation Medicine for FoundationOne mutational analysis. The patient is requesting reimbursement for the FoundationOne gene testing (CPT codes 81201, 81235 and 81321) performed on 5/4/16. The Health Insurer has denied this request as investigational. Metastatic bladder cancer has a poor prognosis. One standard regimen for advanced bladder cancer is methotrexate, vincristine, doxorubicin, and cisplatin (MVAC). This regimen is toxic with many patients requiring hospitalization due to myelosuppression or mucositis. Therefore, not all patients are suitable. One regimen that stands out is that of gemcitabine/cisplatin which was equivalent to MVAC in one clinical trial. Some complete responses were seen with this regimen (von der Maase, et al). According to the National Cancer Institutes Physicians Data Query, gemcitabine/cisplatin is a reasonable alternative for those patients that may not tolerate MVAC. In this case, the patient was tried on MVAC and his tumor showed a poor response. A study by Von Hoff and colleagues 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. This trial has very significant results for patients with stage IV tumors. As such, the results from molecular profiling offer a rational selection of the next regimen. Therefore, the FoundationOne gene testing (CPT codes 81201, 81235 and 81321) performed on 5/4/16 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 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.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 61-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/02/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. 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 states 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. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma. This test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy. Therefore, DecisionDx-Melanoma test performed on 10/02/18 was not medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 60-year-old male enrollee has requested authorization and coverage for nerve stimulator implant. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has obstructive sleep apnea. Drug-induced sleep endoscopy showed no concentric collapse at the palate or tongue base. The patient has not been able to tolerate continuous positive airway pressure (CPAP) therapy. The Inspire device has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of obstructive sleep apnea. At this time, this patient is not a candidate for the Inspire device given his body mass index is greater than 32 and outside of FDA criteria. Very small studies have included patients with a body mass index greater than 32, but the number of the patients and data at this point in time is not adequate to consider standard. Therefore, the requested nerve stimulator implant is not likely to be superior over other treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 46-year-old female enrollee has requested reimbursement for Botox injections provided on 7/8/15 and 11/6/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees medical condition.  The physician reviewer found review of the submitted documentation and relevant literature supports the use of Botox injections in this clinical setting. The patient has chronic migraine and has failed at least two medications from the same class. Moreover, the patient had reported benefit with Botox. Botox is standard therapy for treatment of chronic migraine, and has been shown to be as effective or more effective, than medications available to treat chronic migraine. In addition, Botox is U.S. Food and Drug Administration (FDA) approved for the treatment of chronic migraine. For the reasons provided, the Botox injections at issue were likely to be more beneficial for treatment 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 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 1


A 35-year-old female enrollee has requested reimbursement for NxGen MDx Universal panel and Harmony Prenatal test provided on 11/12/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for treatment of the enrollees pregnancy.] The physician reviewer found that the Harmony Prenatal cell-free DNA testing provided on 11/12/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Cell-free fetal DNA testing is an accepted approach to aneuploidy screening in high risk individuals (Devers, et al). In this case, the patient had increased risk based on her age of 35 at the expected time of delivery. However, the NxGen MDx Universal panel provided on 11/12/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Genetic carrier screening with NxGen MDx Universal panel is not recommended without a family history or ethnic background placing a patient at increased risk for the screened genetic disorders. According to Grody and colleagues, the standard of care for prenatal/preconception population carrier screening for common single-gene autosomal recessive disorders (such as cystic fibrosis and spinal muscular atrophy) and a panel of single-gene autosomal recessive conditions specifically for the Ashkenazi Jewish population. The patients records do not document a family history or ethnic background to support the NxGen MDx Universal panel. Based upon the information set forth above, a portion of 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 partially overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3 
A 59-year-old male enrollee has requested authorization and coverage for deep brain stimulation. 
The Health Insurer has denied this request and reported that the requested service is investigational 
for the treatment of the enrollees Parkinsons disease. The physician reviewer found that the 
standard therapies available for patients with Parkinsons disease depend on a number of factors 
including whether the patient has been newly diagnosed, whether the patient has tried standard 
medication therapies such as carbidopa/levodopa, what type of responses the patient demonstrates 
to oral medication therapies, and the duration of treatment with medications. In this case the patient 
is not newly diagnosed, has tried standard oral medication therapies with  considerable and 
intolerable side-effects, had less favorable and escalating medication dosages leading to unwanted 
side-effects following initial good response to medications, and has been on a medication regimen 
for ten years. In this clinical setting, DBS represents the only standard therapy option for this 
patient following the trial and failure of standard oral medication therapies. Therefore, deep brain 
stimulation is likely to be more beneficial for treatment of the patients condition than any available 
standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

The parent of a one-year-old male enrollee has requested authorization and coverage for Olumiant
1 mg tablet. The Health Insurer has denied this request and reported that the requested medication
is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the current medical evidence supports the requested medication in this clinical setting. Aicardi-
GoutiA res Syndrome (AGS) is recognized as a Type 1 interferonopathy, which leads to
autoimmune-mediated inflammation. Uncontrolled autoimmune inflammation results in a wide
range of disease manifestations with the central nervous system (CNS), in particular, being
affected. This is an important point to make, because any conventional FDA-approved medicine
that treats CNS disease, including all available antiepileptic medications, does not address the
underlying disease processes in AGS. In this patientas case, Olumiant therapy offers the chance
for a marked reduction in AGS-associated morbidity. Therefore, Olumiant 1 mg tablet is likely to
be more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 47-year-old female enrollee has requested reimbursement for DecisionDX-UM assay performed on 5/09/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ocular melanoma. The physician reviewer found that the DecisionDX is a study of 15 to 31 genes in a patients melanoma cells.  It has been used to classify the individuals melanoma as having either a high or low risk of metastasis.  It is controversial in cutaneous melanoma as to whether it has additional value when added to the usual pathologic prognostic factors.  However, it is particularly useful in the analysis of uveal melanoma and has been validated in several studies.  Specifically, a Class 1 category carries with it a less than 20% chance of metastasis, whereas Class 2 has a greater than 70% chance of metastasis.  This testing has become a standard in many ocular cancer centers.  Its clinical value lies in determining the need for intense surveillance, and possibly to assist in the decision as to adjuvant therapy.  Therefore, DecisionDX-UM assay performed on 5/09/16 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 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 authorization and coverage for vestibular stenosis repair. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee, who has a history of nasal congestion and obstruction. The physician reviewer found that there is sufficient support for the requested services in this case. This patient has lateral nasal wall collapse from lower lateral cartilage weakness. The images appear to show significant collapse. The Latera implant is a U.S. Food and Drug Administration (FDA) approved device which has been used successfully for lateral nasal wall collapse. In sum, vestibular stenosis repair is likely to be more effective than other treatment options. 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: Medical Necessity
Decision: Overturned

Summary Reviewer 

An 18-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment provided from 2/20/20 through 3/05/20. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the Child and Adolescent Level of Care Utilization System (CALOCUS) provides a framework for determining the clinically appropriate level of care for a child or adolescent in mental health treatment. In this case, CALOCUS, rather than the adult Level of Care Utilization System (LOCUS) was used, despite the patient being age 18, due to her developmental level, dependence on her family, and family involvement in her care. In addition, the residential treatment center she attended was a treatment center designed for adolescents. With regard to risk of harm, the records support a score of 4. The patient had a serious risk of harm, due to two prior serious suicide attempts, and a recent pattern of excessive substance use. In terms of functional impairment, the records support a score of 4. The patient had serious functional impairment due to conflict with her family and refusal to leave the house prior to admission to the residential treatment center. With regard to comorbidity, the records support a score of 4. The patient had uncontrolled substance use. In terms of level of stress of the recovery environment, the records support a score of 2. The patient had a mildly stressful environment due to expectations for performance at home or school that create discomfort. With regard to environmental support, the records support a score of 2. The patient had a supportive environment due to her parents active participation in treatment. In terms of resiliency and response to treatment, the records support a score of 4. The patient had poor resiliency and/or response to treatment. With regard to treatment acceptance and engagement, the records support a score of 2. The patient actively participated in treatment and was motivated for change. Thus, the patient has a composite score of 22. Due to her risk of harm, the patient qualified for medically monitored residence-based services. The combination of depression, anxiety, past suicidality, family conflict, and substance use, as well as lack of response to prior outpatient treatment, placed the patient at high risk. Therefore, mental health residential treatment provided from 2/20/20 through 3/05/20 was medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 28-year-old male enrollee has requested reimbursement for Prometheus Anser ADA diagnostic test performed on 12/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
 The physician reviewer found that monitoring patients on adalimumab with measurement of adalimumab levels and antibodies to adalimumab continues to be an area of interest in the inflammatory bowel disease community. In general, adalimumab levels correlate inversely with disease activity. However, there is a lack controlled data which has identified the optimal drug level and so, the issue remains speculative. This patients level was in the normal range despite the fact that he was having an active flare/progression of disease, highlighting the limitation of the test. Using the Anser ADA, one can set up a hypothetical table categorizing drug levels as high or low and antibody levels as high or low. In theory, one could use this table to determine whether to dose increase or switch to a biologic agent with a different mechanism of action. Unfortunately, this hypothetical benefit is not supported by high quality medical evidence. In sum, Prometheus Anser ADA diagnostic test performed on 12/30/15 was not likely to be more effective than standard options of therapy, like empiric dose titration. Therefore, for the reasons stated 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 3 
 
A 54-year-old female enrollee has requested reimbursement for advanced lipoprotein testing 
performed on 4/15/22. 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 current medical literature does not demonstrate that advanced lipoprotein 
testing adds significant actionable information to what is already known from a basic fasting lipid 
profile.  There  is  a  lack  of  randomized  trials  showing  that  therapies  to  correct  any  novel 
lipoprotein abnormalities, such as lipoprotein(a), have any effect on cardiovascular outcomes 
such as myocardial infarction, stroke, or death. In this clinical setting, there is insufficient 
evidence to support the use of the service at issue. Therefore, advanced lipoprotein testing 
performed on 4/15/22 was not likely to have been more beneficial for evaluation of the patients 
condition than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3 
 
A 27-year-old female enrollee has requested authorization and coverage for E1399 durable 
medical equipment RT300 FES arm therapy system. The Health Insurer has denied this request 
and reported that the requested device is investigational for the treatment of the enrollees 
medical condition. The physician reviewer found that there is support for the requested device 
in  this  clinical  setting.  Zheng  and  colleagues  demonstrated  significant  shortened  time  of 
improving upper extremity function in early-phase stroke in the treatment group compared to 
the control group. Shimodozono and colleagues conducted a randomized controlled pilot study 
that demonstrated neuromuscular electrical stimulation demonstrated greater improvement 
compared to a conventional arm rehabilitation program for post-stroke hemiplegia. There are 
many significant health consequences that can occur with untreated spastic hemiplegia and the 
neurodeficits described by the patients provider, including severe spasticity with contracture. 
Avoiding this issue will take daily treatment. There is documented improvement in the patients 
function with the RT300 FES therapy system. The documentation indicates that occupational 
therapy without functional electrical stimulation was most likely inadequate. Therefore, the 
requested for E1399 durable medical equipment RT300 FES arm therapy system is likely to be 
more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 33-year-old female enrollee has requested reimbursement for the assistant at surgery for the pelvic examination under anesthesia and the laparoscopic aspiration of a cavity or cyst with biopsy performed on 3/15/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees malignant neoplasm peritoneum and retroperitoneum. The physician reviewer found that based on the available records, there is a lack of documentation to establish the requirement for the services of the assistant at surgery during the procedure performed on 3/15/18. This procedure is the standard, recommended procedure for evaluation of a patient in this clinical setting. The operation was staffed by an attending surgeon, a resident, and a physician assistant. However, there is no documentation regarding the procedure was complex and required an assistant at surgery. The records do not report which portions of the case which were staffed by the resident or the physician assistant. All told, the assistant at surgery for the pelvic examination under anesthesia and the laparoscopic aspiration of a cavity or cyst with biopsy performed on 3/15/18 was not medically necessary for evaluation of this patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.