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

Summary Reviewer 


A 58-year-old female enrollee has requested reimbursement for the radiofrequency lesioning performed on 7/7/16 and 7/21/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees thoracic and lumbar degenerative disc disease and facet arthropathy. The physician reviewer found that the literature states that a diagnostic medial branch block is supposed to be done prior to radiofrequency ablation and should include use of a pain diary for the day to verify when the local anesthetic wore off, using either solely lidocaine or bupivacaine, without sedation (Derby, et al). In the documentation available for review, the provider does not document a pain diary for the medial branch block done prior to the previous radiofrequency ablation. Further, the records do not document a steroid injection has been performed, which may provide the patient with identical relief without the increased risks associated with radiofrequency ablation (Manchikanti, et al). Finally, the medical records from the prior ablation are not submitted to demonstrate the patient obtained 50% relief, with increased functional benefit from baseline, and decrease in perceived pain from baseline. For these reasons, radiofrequency lesioning performed on 7/7/16 and 7/21/16, were not medically necessary for treatment of the patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 51-year-old female has requested reimbursement for human epididymis protein 4 (HE4) testing.  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 evaluation of the symptomatic patient with pelvic/adnexal mass includes physical examination and may include transvaginal ultrasonography and measurement of levels of the serum tumor marker CA125. HE4 tumor markers are not recommended to help make the decision as to whether an adnexal mass represents a benign or malignant process. The results should not be used in the decision-making process of which patients should have additional surgical evaluation of an adnexal mass. Tumor marker panels have not been evaluated prospectively in large population-based studies and have not been proven to improve early detection and survival rates.  In sum, HE4 testing performed on 11/20/15 was not likely to have been superior over 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: Upheld

Summary Reviewer 2

A 51-year-old female has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. 

 The physician reviewer found that the patient is a 51-year-old female who was diagnosed with a cutaneous melanoma in June 2016. At that time, she was found to have a superficial spreading melanoma, 0.8 mm in thickness, with no ulceration. DecisionDx-Melanoma testing was performed on 4/13/18. The patient has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. The prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami and colleagues reported on 217 cases, with good correlation between DecisionDx-Melanoma classification and prognosis, in patients who had undergone sentinel node biopsy. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it not clear that the DecisionDx-Melanoma classification can be used to make clinical decisions. In sum, genetic testing performed on 4/13/18 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: Overturned

Summary Reviewer 3
A 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye. The physician reviewer found that the service at issue was likely to be more effective than other methods of evaluating this patient. This patient has a rare disease, ocular melanoma.  However, knowledge of the propensity for metastasis directly affects surveillance of patients by computed tomography scan. Along these lines, there are clinical studies that support the use of gene expression classifier DecisionDX uveal melanoma. This assay defines two classes of ocular melanoma. Class 1 is associated with a low risk of metastasis and class 2 has a 50% risk at two years and 72% risk at five years. Currently, there is no other standard prognostic indicator that could serve as an alternative. Thus, the current medical evidence favors the use of this test in the post-operative surveillance of patients with ocular melanoma. As such, the DecisionDX uveal melanoma multigene assay performed on 4/10/15 was likely to be superior over other available 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: Upheld

Summary Reviewer 2


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 the Anser ADA test assesses serum adalimumab (ADA) and anti-ADA antibodies. Some evidence exists that low serum levels of infliximab or adalimumab and/or the presence of antibodies to infliximab or adalimumab may play a role in primary or secondary response failures. However, 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.  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. While there have been testimonials, 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. Moreover, it has not been established how patient management would change based on test results.  In sum, the Prometheus Anser ADA diagnostic test performed on 12/30/15 was not likely to have been more effective than other treatment modalities for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for the evaluation of this patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 39-year-old male enrollee has requested authorization and coverage for autologous cultured chondrocyte and autologous chondrocyte implantation of the knee. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that in this patients case, the records document a history of severe localized right knee pain. Upon failure of various conservative treatments, he underwent arthroscopic surgery of the right knee in January 2018 and was found to have multiple chondral defects of the medial and lateral femoral condyles and trochlear groove. The patient continues to experience localized severe pain and swelling in the knee. The provider has recommended autologous cultured chondrocyte implantation of the knee. Multiple chondral defects of the patellofemoral joint of the knee, as in this case, are common and can result in chronic pain and impair quality of life. The autologous chondrocyte implantation technique has evolved over the past 20 years and is associated with good to excellent mid-term and long-term results. The newest third-generation technique is matrix-induced autologous chondrocyte implantation. Physical examination and imaging is important to characterize the location and source of pain and identify associated injuries. In this case, arthroscopic evaluation has accurately localized the cartilage defects. Conservative measures have been exhausted. Therefore, surgical treatment is necessary to improve the quality of life. In sum, the requested autologous cultured chondrocyte and autologous chondrocyte implantation of the knee are likely to be more beneficial than other treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 19-year-old female enrollee has requested reimbursement for the Anser IFX test provided on 2/16/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that in this case, Anser IFX was ordered to determine infliximab level and whether antibodies to Remicade were present. Loss of response to infliximab can occur for many reasons, although there was not a clear loss of response to infliximab in this case (Mahadevan, et al). In addition, the presence of antibodies alone has not been proven to result in loss of response to infliximab or infusion reactions, nor have threshold levels been established (Steenholdt, et al). Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response (Vande Casteele, et al; Nanda, et al). One study, with some patients undergoing dose intensification following initial non-response, showed no difference in serum levels of infliximab between patients who responded to dose intensification versus those who did not (Pariente, et al). In summary, the current medical literature lacks high-quality controlled studies to define drug level or antibody level thresholds requiring action, compare clinical strategies based on those thresholds, and then definitively establish that use of Anser IFX improves outcome when used in those treatment pathways. Given these findings, the Anser IFX test provided on 2/16/16 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: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 29-year-old female enrollee has requested reimbursement for emergency services provided on 5/24/17. The Health Insurer has denied this request indicating the services at issue did not meet the prudent layperson criteria for treatment of an emergency medical condition. The physician reviewer found at issue in this case is whether a prudent layperson in the patients circumstances would believe he or she was experiencing an emergency medical condition on 5/24/17. California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. In the medical literature, Martin and colleagues noted that, allergic contact dermatitis (ACD) is an inflammatory skin disease that affects about 20% of the adult general population. The authors reported that first-line treatment includes topical emollients and anti-inflammatory agents and avoidance of the culprit allergen. In this case, the medical records do not indicate that the patient developed any urgent or emergent symptoms, such as interference with breathing or rapid swelling of the face or lips. A prudent layperson would not have sought immediate medical attention for the patients cutaneous eruption. Thus, the services provided on 5/24/17 were not required for the treatment of an emergency medical condition. Based on the foregoing discussion, the services at issue were not required on an emergent basis. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 7/29/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that there is a lack of peer-reviewed literature that supports the use of three-dimensional breast tomosynthesis compared to currently available techniques, especially in a patient without an increased risk of breast cancer. Although breast tomosynthesis may be a promising technique, its clinical efficacy is yet to be substantiated in the peer-reviewed medical literature. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 7/29/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

The patient is a 36-year-old female who presented on 7/11/16. The records noted hormone imbalance. She was started on low dose birth control pills. The patient ultimately developed headaches on the birth control pills, which limited further use. On 11/07/16, the records noted major depressive disorder and generalized anxiety disorder.  She was started on Viibryd. On 11/18/16, the records noted painful periods. On 12/30/16, endometrial ablation was performed. The Health Insurer has denied reimbursement for the services at issue. Per the Health Insurer, endometrial ablation was investigational for the treatment of this patient.  The submitted documentation fails to demonstrate the superior efficacy of the services at issue. The submitted records do not include a complete blood count to attempt to document the anemia of heavy cycles. There is no documentation of sampling of the endometrium, such as endometrial biopsy or dilation and curettage (D&C). In this patients case, addressing her issues of mood disorders (which can have a strong effect on perception of pain) and offering a trial of medical management was reasonable. Although progesterone only may have worsened her mood disorders, but this would not be the case with Mirena. If the patient had a relatively normal complete blood count, she could have benefitted from the use of nonsteroidal anti-inflammatory drugs with or without progesterone. If the patient had contraindications to these management options, then an endometrial ablation may have been an appropriate next step. However, an endometrial biopsy should have been done before the ablative procedure was contemplated. Therefore, endometrial ablation was not likely to have been more effective than other available treatment options. 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: Upheld

Summary Reviewer 1


A 62-year-old female has requested reimbursement gene testing performed on 11/01/15. 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 molecular profiling is an assay to detect genomic or molecular abnormalities or gene overexpressions in an individuals cancer cells, with the hope that this information will guide therapy.  However, there is a lack of convincing evidence that such assays add to our decision-making ability.  There are a variety of non-randomized studies exploring the value of molecular profiling that have as yet not yielded evidence of significant benefit to such assays.  Therefore, the superior efficacy of gene testing performed on 11/01/15 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: Upheld

Summary Reviewer

The patient is a 44-year-old female with a history of dense breasts on mammography and calculated lifetime risk of breast cancer at 20.8%. She had magnetic resonance imaging (MRI) of the breasts on 9/22/17 which revealed a single lymph node requiring second look, ultrasound but no evidence of malignancy. For the MRI, computer aided detection (CAD) was also performed. The patient has requested reimbursement for the computer aided detection provided on 9/22/17. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary. The MRI of the breasts performed on 9/22/17 was indicated in light of the limitations inherent in routine mammography especially in patients with dense breasts and the calculated lifetime risk of breast cancer exceeding 20%. However, there is a lack of data demonstrating improve health outcomes with use of CAD with breast MRI. Overall, the studies suggest the use of CAD can improve the speed and throughput of the imaging, but does not support its utility in terms of superior detection of breast cancer. Thus, the CAD provided on 9/22/17 was not medically necessary for evaluation of this patients medical condition.  Based on the foregoing discussion, the diagnostic procedure at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary  
The patient is a four-year-old female with a history of lamellar ichthyosis. The records provided 
for review indicate that the patient was previously treated with tazarotene cream with great efficacy 
and improvement in her skin condition. The provider has recommended treatment with tazarotene 
cream. The Health Insurer has denied the requested treatment as not medically necessary for the 
treatment  of  the  patients  medical  condition.  This  denial  is  the  subject  of  this  appeal  and 
determination. The physician reviewer found that currently, there is a lack of U.S. Food and Drug 
Administration (FDA) approved treatments for patients with lamellar ichthyosis. According to the 
Pediatric Dermatology Research Alliance (PeDRA) guidelines, topical retinoids are preferred over 
systemic retinoids for the treatment of pediatric patients with lamellar ichthyosis, as topical 
retinoids have been demonstrated to have a higher level of tolerability and a greater reduction of 
side effects (Hanson, et al.; Zaenglein, et al.). In this case, the patient has a history of lamellar 
ichthyosis which has been successfully treated with tazarotene cream. The records provided for 
review indicate that the discontinuation of topical tazarotene resulted in worsening of the patients 
scales and symptoms. Furthermore, the medical literature suggests that topical retinoids are the 
preferred treatment option over systemic retinoids for pediatric patients with lamellar ichthyosis. 
For these reasons, the requested tazarotene cream 0.1% is medically necessary for the treatment of 
this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 58-year-old female enrollee has requested reimbursement for the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage lung adenocarcinoma. The physician reviewer found that molecular diagnostic studies in non-small cell lung cancer (NSCLC) are considered the current standard of care. Numerous gene alterations have been identified that impact therapy selection. The National Comprehensive Cancer Network (NCCN) guidelines advise broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with NSCLC. Testing of lung cancer specimens for these alterations is important for identification of potentially efficacious targeted therapies, as well as avoidance of therapies unlikely to provide clinical benefit. Thus, molecular profiling with the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17 was likely to be more beneficial 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.