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

Summary Reviewer 2


A 53-year-old female enrollee has requested reimbursement for the homocysteine testing performed on 3/9/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees peripheral neuropathy. The physician reviewer found that Homocysteine level testing is supported in cases of anemia and bleeding disorders. This testing may also be used to characterize etiology of B12 deficiency. However, homocysteine level testing lacks data supporting its utility as a standard test in the evaluation of peripheral neuropathy. Wile and Toth noted that homocysteine testing is not supported in routine testing for peripheral neuropathy but may be used in diabetic neuropathy. All told, the homocysteine testing performed on 3/9/16 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 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: Upheld

Summary Reviewer 1

A 56-year-old female enrollee has requested reimbursement for gene test (Breast Cancer Index) performed on 1/6/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who had a history of breast cancer. The physician reviewer found that patients with early stage disease typically undergo primary surgery (lumpectomy or mastectomy) to the affected breast and regional lymph nodes with or without radiation therapy. Adjuvant therapy may be offered based on primary tumor characteristics which include: tumor size, grade, number of involved lymph nodes, the status of the hormone receptors and expression of the HER2 receptor. The Breast Cancer Index (BCI) test is a validated test that can predict the likelihood of benefit from extended endocrine therapy; prognostic for the risk of late distant recurrence in N0 and N1 patients. It is a test intended for use in patient diagnosed with estrogen receptor positive, lymph node negative or lymph node positive (1 to 3) early stage invasive breast cancer. The published studies validating or evaluating the use of the BCI resulted in a change in treatment plan in 26% of cases in which endocrine therapy was being considered. Based on National Comprehensive Cancer Network guidelines, patients with tumor characteristics as demonstrated by this patient, T2N0 ER/PR positive and HER2 negative, invasive breast cancer, 21 gene reverse transcription polymerase chain reaction (RT-PCR) testing should be conducted. The risk of recurrence score should guide the use of adjuvant endocrine therapy and/or chemotherapy. Although the Breast Cancer Index test has been validated, it is not considered in the current standard guidelines. The studies available indicate that it has similar ability to detect low and high risk of recurrence and that it has resulted in a change in clinical practice. However, there is a lack of long term follow up data of its use in this clinical setting. As such, the services at issue were not likely to be more effective than the standard options available for evaluation of this patients medical condition.  
Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer  
The patient is a 21-year-old female with chronic urticarial eruption and severe atopic dermatitis. The 
patient has requested authorization and coverage for Dupixent. The Health Insurer has denied this request 
and reported that the requested medication is not medically necessary for the treatment of this patient. 
This denial is the subject of this appeal and determination. The physician reviewer found that the 
submitted documentation supports the medical necessity of the requested medication. The U.S. Food and 
Drug Administration (FDA) approves the use of Dupixent for the treatment of severe atopic dermatitis. In 
this case, the patient has failed numerous medications, including topical and systemic medications, and is 
currently being treated with Dupixent. In this clinical setting, the requested medication is medically 
indicated.  Therefore,  Dupixent  is  medically  necessary  for  the  treatment  of  this  patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 40-year-old female enrollee has requested reimbursement for the Genecept Assay provided by Genomind, Inc. on 2/24/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. The physician reviewer found that the records provided for review do not specify the type of medications, dosage, length of time, and outcome for this patient. It was not mentioned if the patient was tried on different classes of antidepressants or concomitantly, or if augmentation strategies were attempted. There is no evidence in the records provided that electroconvulsive therapy (ECT) was discussed with the patient. Per community standard, ECT would be the next likely consideration in a patient with treatment refractory depression. Currently, ECT remains the most powerful treatment modality for patients with treatment resistant depression, with a proven track record of higher frequency of response and remission in these cases. Studies have shown that clinically useful predictors in genetic testing are scarce for antidepressant therapy, with results being inconsistent. At best, studies have shown that there is only marginal clinical association between enzyme system variants and drug metabolism, efficacy, and tolerability in the treatment of depression. In addition, there is a lack of large randomized trials supporting its use. The existing studies have also indicated that there was no significant correlation between either genotypes or medication serum concentration and response treatment. Current evidence does not support the use of genotyping when choosing an antidepressant, and even less is understood about its use in the treatment of anxiety disorders. Genetic testing lacks evidence based research to show its effective use in guiding the provider towards choosing a medication regimen. All told, the Genecept Assay provided by Genomind, Inc. on 2/24/16 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: Upheld

Summary Reviewer 2


A 50-year-old female has requested authorization and coverage for sacroiliac joint fusion.  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 the submitted documentation fails to demonstrate the superior efficacy of the requested services.  This patients history supports a diagnosis of complex regional lumbosacral pain syndrome with multiple pain generators.  Her history suggests likely pain generation from intervertebral disc and facet joints.  The reliance of steroid local injection into the sacroiliac joint is not sufficient to localize pain generation from the sacroiliac joint in the face of multifactorial chronic pain.  Many patients experiencing chronic inflammation at the sacroiliac joint have minimal symptoms.  The study by Wise and colleagues is a prospective cohort study with limited number of patients.   The study is not blinded as to procedure and is vulnerable to selection bias, evaluation bias and placebo effect.  In the article by Schoell and colleagues, the authors identified 469 patients who had undergone minimally invasive sacroiliac fusion between 2007 and 2014.  Overall complication rates were 13.2% at 90 days after surgery and 16.4% at six months after surgery.  The authors concluded that minimally invasive sacroiliac joint fusion could possibly carry higher risks of complications than had been previously stated.  In sum, the requested sacroiliac joint fusion is not likely to be more efficacious than other treatment options.  Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment 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 64-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that there are several clinical publications for safety and efficacy of proton beam radiation for prostate cancer. However, there is a lack of randomized trials demonstrating superior clinical outcome of proton beam for prostate cancer over commonly used intensity modulated radiation therapy (IMRT). Most providers have recommended additional study on the long-term safety and efficacy of protons compared with photons before adopting protons as a viable treatment option for prostate cancer. The National Comprehensive Cancer Network (NCCN) guideline state that proton beam therapy for primary treatment of prostate cancer should only be performed within the context of a prospective clinical trial or within prospective registries. Given these findings, the requested proton beam radiation therapy is not 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 requested services are not likely to be more beneficial for treatment 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 30-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 6/16/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease. The physician reviewer found in this case, the patient has Crohns disease and was started on Remicade in February 2014. Several months post Remicade treatment he had recurrent symptoms of diarrhea despite adequate response initially on Remicade. Due to the multitude of management options once a patient has no response to Remicade and the fact that Remicade has a wide array of adverse effects, it is important for the treating provider to have a roadmap of the nature of the patients clinical course. ADA testing provides important and significant management implications, and was clinically indicated in this case. Based upon the information set forth above, the testing at issue was 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: Upheld

Summary Reviewer 3

A 24-year-old male enrollee has requested reimbursement for services provided from 5/10/15 through 8/05/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health conditions. The physician reviewer found there is substantial literature to support the use of cognitive behavioral therapy for the patients symptoms.  However, the literature for wilderness adventure therapy programs is not robust in relation to treating these issues.  The majority of the literature on the wilderness adventure therapy programs is for children and adolescents.  In this patients case, it is not clear that less restrictive resources were not available or appropriate for the patients needs. The documentation does not support failure of outpatient therapy, intensive outpatient therapy, partial hospital program therapy or cognitive behavioral therapy.  Based on the records, it is not clear that the services provided would have been more beneficial than typical evidence-based treatments for the patients anxiety issues as well as his functional issues due to his anxiety. The patient also had social skills and language deficits that were a main focus of treatment. The documentation does not support failures of community-based services and evidence based treatments, such as cognitive behavioral therapy, which is a mainstay for anxiety and social anxiety symptom treatment.  Behavioral health therapy should be started in the least restrictive and most similar to home-type environment available. This is due to the fact that skills learned in therapy will generalize better to a home-type environment. Skills learned in an artificial environment are known to not generalize as well as those learned in a home-type environment.  In this patients case, he could have safely been treated in a less restrictive setting.  Thus, services provided from 5/10/15 through 8/05/15 were not likely to have been superior over other treatment alternatives in this patients case.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
A 59-year-old female insured has requested authorization and coverage for Rinvoq 45 mg tablets 
(30 tablets every 30 days). The Health Insurer has denied this request indicating that the requested 
medication is considered investigational for the treatment of the insured's Chron's disease. 
The physician reviewer found that the medical literature has established Rinvoq as a safe and 
effective treatment option for patients with Crohn's disease. In one study by Sandborn and 
colleagues involving patients with Crohn's disease, Rinvoq demonstrated a significant increase in 
efficacy for all doses tested as compared with placebo, with the efficacy maintained for one year. 
Rinvoq is also U.S. Food and Drug Administration (FDA) approved for the treatment of patients 
with Crohn's disease. A recent study of high-dose, 45 mg Rinvoq demonstrated safety findings 
consistent with previous studies, with no new safety risks observed (Sandborn, et al.). In this case, 
the patient presents with a history of Crohn's disease. The patient has tried and failed treatment 
with standard biologic therapy agents such as budesonide, high-dose infliximab with azathioprine, 
and high-dose Stelara with azathioprine. Without an effective treatment, the patient is at risk for 
complications including stricture, fistula, and a need for surgery or hospitalization. Rinvoq is FDA-
approved and supported by the medical literature for the treatment of patients with Crohn's disease. 
Given these findings, the requested Rinvoq 45 mg tablets (30 tablets every 30 days) are likely to 
be more beneficial for the treatment of the patients condition than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


The parent of a 14-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 2/24/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition.The physician reviewer found checking infliximab levels and antibodies has been demonstrated to be helpful in guiding clinical decision making when there is concern for a loss of response to infliximab. However, in this case, the patient was apparently in remission at the time of testing, with labs drawn to proactively monitor infliximab levels and antibodies. While this approach is being studied, there is not yet robust evidence that it will improve clinical outcomes. Vaughn and colleagues performed a retrospective observational study of proactive monitoring of infliximab troughs and antibodies. The authors found that among the 48 patients with proactive monitoring, the likelihood of remaining on infliximab (presumably due to sustained response) was higher than for controls. While this approach is certainly promising, and may well become standard of care in future, at this point it is not the standard of care. Therefore, the Anser IFX diagnostic testing performed on 2/24/15 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: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 42-year-old female enrollee has requested authorization and coverage for Aimovig 140 mg dose, two auto-injections. 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 Aimovig has been approved by the U.S. Food and Drug Administration for migraine headache.  This patient has failed numerous first-line therapies for headache. More recently, she has demonstrated benefit with Aimovig. There is sufficient medical evidence supporting the use of Aimovig for patients with chronic headache. It would not be in this patients best interest to be required to discontinue Aimovig in favor of another medication (Botox) which may have possible side effects for this patient. Continued use of Aimovig is medically reasonable and indicated in this case. Therefore, Aimovig 140 mg dose, two auto-injectors are medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 62-year-old female enrollee has requested reimbursement for ChemoFX assay performed on 5/08/15. 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 in vitro drug testing on patients tumor cells prior to applying chemotherapy is an appealing idea, but it is difficult to put into clinical use.  The most thorough evaluation of these technologies was performed by the American Society of Clinical Oncology in 2004.  In their review of this technology, the panel concluded that such in vitro drug testing should be limited to clinical trials.  There is a lack of support for the services at issue in this clinical setting.  Therefore, ChemoFx assay performed on 5/08/15 was not likely to have been more effective than other methods of evaluation.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

The patient is a 64-year-old male who has been diagnosed with melanoma. The patient has requested reimbursement for unlisted multianalyte assay with algorithmic analysis performed on 12/18/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that the National Comprehensive Cancer Network guidelines state, aCommercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established.a This patient has an early stage melanoma without adverse pathologic features. There is a lack of support for the services at issue in this clinical setting. Therefore, unlisted multianalyte assay with algorithmic analysis performed on 12/18/19 was not medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2 
 
A 62-year-old male enrollee has requested authorization and coverage for proton beam therapy. 
The  Health  Insurer  has  denied  this  request  and  reported  that  the  requested  service  is 
investigational for the treatment of the enrollees prostate cancer. The physician reviewer found 
that there is a lack of evidence in current medical literature to suggest that treatment with proton 
therapy is associated with a clinical benefit when compared to standard treatment. There are no 
comparative randomized studies validating the efficacy of proton therapy as compared to 
standard treatment with photons. There is insufficient clinical data to discern whether treatment 
with proton beam radiation offers a clinical benefit compared to conventional radiation therapy 
techniques in the treatment of prostate cancer. In a multi-institutional analysis of 1,850 patients 
with low or intermediate risk prostate cancer that compared groups receiving hypofractionated 
radiation  proton  therapy  and  intensity  modulated  radiation  therapy  (IMRT)  with  photons, 
Vapiwala and colleagues  found no significant difference in gastrointestinal or genitourinary 
toxicities between the two treatments. Further, the authors found no difference in disease 
control between the two modalities. The American Society of Radiation Oncology (ASTRO) states,  Proton beam therapy for primary treatment of prostate cancer should only be performed within 
the context of a prospective clinical trial or registry. ASTRO further notes that the comparative 
efficacy evidence of proton beam therapy with other prostate cancer treatments is still being 
developed, and thus the role of proton beam therapy for localized prostate cancer within the 
current availability of treatment options remains unclear. The National Comprehensive Cancer 
Network (NCCN) guidelines for the treatment of prostate cancer note no clear benefit of proton 
therapy over standard treatment with photons and IMRT. Therefore, proton beam therapy is not 
likely to be more beneficial for treatment of the patients condition than any available standard 
therapy.