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

Summary Reviewer 1


An 18-year-old female enrollee has requested reimbursement for the gene testing performed on 9/1/16. 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 testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Although, more research is needed to fully develop its potential, there is growing support for genetic testing for psychoactive drugs. In this case, the patient has not tolerated most standard mood stabilizers. The test results show that she will likely have problems tolerating antipsychotic medications, which are commonly used as mood stabilizers. She will also have difficulty tolerating any SSRIs, which are the primary treatment for both anxiety and depression. Therefore, this patients circumstances support genetic testing in this specific clinical setting. Therefore, the gene testing performed on 9/1/16 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: Experimental
Decision: Upheld

Summary Reviewer 2
A 47-year-old male enrollee has requested reimbursement for automated evacuation of meibomian glands performed on 2/2/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees meibomian gland dysfunction. The physician reviewer found that the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Meibomian gland dysfunction is one of the underlying components of blepharitis (Bron, et al). There are many treatments to temporarily reduce the annoyance of blepharitis, but there is no lasting cure. LipiFlow is an automated process that warms the eye lids to reduce the viscosity of the glandular secretions, and then mechanically massages the lids to express these secretions (Friedland, et al). Although treatment with LipiFlow may provide some relief, the effect is temporary, frequently wearing off in days or weeks. In addition, the service at issue is not the standard of care and not likely to be more beneficial for treatment of the patients medical condition than any other modalities. 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 2


A 37-year-old female enrollee has requested authorization and coverage for bronchoscopic thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is investigational for treatment of the enrollees persistent asthma. The physician reviewer found that currently, the three trials of bronchoscopic thermoplasty have demonstrated improved symptom control after the procedure was completed. The AIR trial examined 112 subjects with moderated to severe asthma and demonstrated improved control over the course of the one year follow-up (Cox, et al). The RISA study examined the safety of thermoplasty and found short-term worsening in symptoms, but evidence of improved long-term control of asthma (Pavord, et al). The authors found that the thermoplasty group had fewer exacerbations and improved quality of life when compared to the sham group. The AIR2 trial had 30% of the enrolled patients in the thermoplasty group on other controlling agents and fewer patients on oral corticosteroids (Castro, et al). Several years ago, two follow-up studies were performed establishing a long term improvement in asthma control over five years after the bronchoscopic thermoplasty was performed. While this patient has severe asthma, likely allergic, her elevated IgE is not being addressed. Thus, prior to initiating bronchoscopic thermoplasty, the patient may respond to treatment with omalizumab. Accordingly, the requested bronchoscopic thermoplasty 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 procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
A 38-year-old female enrollee has requested reimbursement for Guardant360 CDx panel performed on 
4/01/21. 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 
understanding the molecular drivers of cancer progression and metastases is an area of ongoing 
and active research, predominantly driven by the goal of identifying specific genomic aberrations 
that may ultimately result in individualized cancer treatment. In addition to likely providing 
prognostic information, the value of next generation sequencing (NGS) to predict candidates for 
specific mutation-driven treatment holds promise. Patients with inflammatory and metastatic 
breast cancers benefit from NGS to identify markers that may indicate benefit from targeted 
treatment or clinical trials. For hormone receptor-positive/HER2-negative breast cancer, testing 
for PIK3CA mutations with tumor or liquid biopsy to identify candidates for alpelisib plus 
fulvestrant should be performed. Therefore, Guardant360 CDx panel performed on 4/01/21 was 
likely to have been more beneficial for evaluation of the patients medical condition than any 
available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 56-year-old male enrollee has requested reimbursement for FoundationOne testing performed on 3/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees recurrent myxofibrosarcoma.  The physician reviewer found that this patients tumor was submitted to FoundationOne for molecular testing to identify mutations that allow enrollment in appropriate clinical trials or the use of an approved therapy that matches the identified mutation. The accessibility of this technology is directly affecting clinical practice because oncologists frequently encounter situations where cancers progress on standard therapies. At that juncture, usually the medical literature is consulted to use something that has been tested in clinical protocols or the patient is enrolled into an active protocol. This process is considered standard of care. Recently, it has become important to identify mutations that may be amenable to targeted therapy. A study of 86 patients was published in the Journal of Clinical Oncology where the progression free survival on regimen selected by molecular profiling was compared to PFS on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage (Von Hoff, et al). FoundationOne has developed a panel of 400 oncogenes and tumor suppressors to be tested by next generation sequencing in hematologic malignancies and sarcomas. There are many parallels in the molecular genetics between soft tissue sarcomas and hematologic malignancies. For example, dermatofibrous protuberans are characterized by recurrent translocation involving PDGFB, which may be targeted by imatinib.  Invariably, this patient may be offered something off label or a phase I/II clinical trial but the results from molecular profiling offer a rational selection of the next regimen. In sum, FoundationOne testing performed on 3/14/17 was likely to have been more efficacious than the available options for the evaluation of this patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to have been 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: Overturned

Summary Reviewer 


A 56-year-old male enrollee has requested authorization and coverage for Xiaflex. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the request for Xiaflex is medically necessary for treatment of the patients medical condition. Xiaflex has been shown to have modest efficacy in clinical trials and is U.S. food and Drug Administration (FDA) approved for use in patients with Peyronies disease with at least 30 degrees of curvature and a palpable plaque. Xiaflex is the only FDA approved drug for Peyronies disease. This patient has failed conservative therapy and is an appropriate candidate for treatment with Xiaflex. Given the above, the medical necessity for Xiaflex has been established for treatment of the patients Peyronies disease. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 68-year-old male enrollee has requested reimbursement for proton beam radiation therapy. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found that Proton beam radiation therapy was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In this clinical setting, other treatment approaches such as intensity-modulated radiation therapy (IMRT) are also highly effective and well tolerated. To date, there is a lack of compelling data to suggest that proton therapy is clinically superior or more beneficial than IMRT. The National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer state that there is no clear evidence supporting a benefit or decrement to proton therapy over IMRT for either treatment efficacy or long-term toxicity. Conventionally fractionated prostate proton therapy can be considered a reasonable alternative to x-ray based regimens. In addition, a systemic review by Lodge and colleagues concluded that patients treated with proton therapy fare comparably to patients treated with photon radiation (i.e. IMRT). Another study, compared prostate IMRT with proton therapy; they concluded that there was no difference in toxicity in a comprehensive cohort of Medicare beneficiaries with prostate cancer at 12 months post-treatment (Yu et al). Therefore, the proton beam therapy was not likely to be more beneficial treatment than standard medical therapy in this clinical setting. 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 2


The parent of a 17-year-old male enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 6/30/14. 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 Prometheus Anser IFX test is a quantitative measurement of serum infliximab and anti-infliximab antibodies.  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, while there have been testimonials, there are few well-controlled clinical trials to confirm that the testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment.  It has not yet been established whether the use of threshold levels aids 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 6/30/14 was not likely to have been more efficacious than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were 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 52-year-old female enrollee has requested authorization and coverage for sclerotherapy. 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 the requested services are not likely to be more effective for this patient than other available options. There is insufficient evidence in the record to support this indication. Both ultrasound reports are insufficient and below reporting standards for the disease. In addition, both direct and ultrasound guided primary venous sclerotherapy lack support in the literature. The review by Tisi and colleagues suggests that the current place of sclerotherapy in modern clinical practice is limited to the treatment of accessory recurrent varicose veins following surgery and thread veins. In sum, sclerotherapy 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: Overturned

Summary Reviewer 2 
 
An  83-year-old  male  enrollee  has  requested  reimbursement  for  Guardant360  CDx  testing 
performed on 3/31/21. 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 the medical evidence supports the services at issue in this clinical setting. Non-
small cell lung cancer, particularly adenocarcinoma, should be tested for multiple mutations, 
including EGFR, ALK, ROS, and BRAF. Usually, this is done from a tissue biopsy, but it is accepted 
that liquid assay of cancer DNA in blood (Guardant assay) can substitute for tissue biopsy, if tissue 
biopsy is considered not feasible or not safe. According to the records in this case, this was the 
situation in this patients case. Therefore, Guardant360 CDx testing performed on 3/31/21 was 
likely to have been more beneficial for evaluation of the patients medical condition than any 
available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2
A 36-year-old female enrollee has requested authorization and coverage for peripheral nerve stimulator (implant of neuroelectrodes (G4555)). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees paraclavicular and neck pain.  The physician reviewer found that although peripheral nerve stimulation is a novel treatment, several prospective studies have demonstrated its efficacy in this clinical setting. In the medical literature, Deogaonkar and Slavin found that peripheral nerve stimulation works well in both established indications, such as post-traumatic and postsurgical neuropathy. Given the lack of other treatment modalities available to this patient, she is likely to benefit from a trial of peripheral nerve stimulation to proceed for the treatment of her neuropathic pain. Consistent with these findings, the requested peripheral nerve stimulator (implant of neuroelectrodes (G4555)) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined 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: Upheld

Summary Reviewer 1

A 55-year-old male enrollee has requested reimbursement for the prostate cancer antigen 3 (PCA3) gene testing performed on 1/30/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the testing at issue was not likely to be more effective for this patient than other available treatment options. The American Urological Association (AUA) National Comprehensive Cancer Network (NCCN) guidelines do not recommend use of PCA3 testing for screening or diagnosing prostate cancer. In addition, there is a lack of clinical studies demonstrating that PCA3 testing is sufficiently accurate to diagnose or exclude the presence of prostate cancer. For the reasons provided, the testing performed on 1/30/15 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: Experimental
Decision: Upheld

Summary Reviewer 2 
 
A 64-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing 
performed on 8/14/19. 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 the use of gene expression profiling (GEP) testing to differentiate 
melanomas at low versus high risk for metastasis should not replace pathologic staging 
procedures. Moreover, since there is a low probability of metastasis in stage I melanoma and a 
higher proportion of false-positive result, GEP testing should not guide clinical decision making 
in this group. Commercially available GEPs, such as DecisionDx-Melanoma testing, are 
marketed as being able to classify cutaneous melanoma into separate categories used on risk of 
metastasis. However, it remains unclear where these GEP platforms provide clinically 
actionable prognostic information when used in addition to or in comparison with known 
clinicopathologic factors or multivariate nomograms that incorporate patient sex, age, tumor 
location and thickness, ulceration, mitotic rate, lymphovascular invasion, and sentinel lymph 
node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-
up schedules has not been established. Various (mostly retrospective) studies of prognostic GEP 
testing suggest its role as an independent predictor of worse outcome, although not superior to 
Breslow thickness or sentinel lymph node status. It remains unclear whether this GEP profile is 
reliably predictive of outcome across the risk spectrum of melanoma. Prospective validation 
studies are required to more accurately define the clinical utility of molecular testing prior to 
widespread implementation of GEP for prognostication of cutaneous melanoma, and in  particular to determine its role in guiding surveillance imaging, sentinel lymph node biopsy and 
adjuvant treatment decisions. Therefore, DecisionDx-Melanoma testing performed on 8/14/19 
was not likely to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 68-year-old female enrollee has requested DecisionDX melanoma assay test performed on 6/19/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this patients case.  DecisionDx is a study of 15 to 31 genes in the melanoma cells.  It has been used to classify the patients melanoma as having high or low risk of metastasis.  There is much controversy as to its value in cutaneous melanoma when compared to the more usual prognostic factors.  However, it does appear to be particularly useful in the analysis of prognosis for uveal melanomas, and this has been validated in several studies.  This testing has become a standard in many ocular cancer centers.  Its clinical value lies in the fact that it implies no real need for surveillance for metastasis in those with a low risk of metastasis, whereas those with a higher risk should undergo more intense surveillance and perhaps be considered for adjuvant therapy.  All told, DecisionDX melanoma assay test was likely to have been more effective than other modalities for 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: Overturned

Summary Reviewer 1

A 62-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found the review of the submitted documentation and relevant literature fails to support the services at issue in this clinical setting. There is a lack of evidence in the peer-reviewed literature that supports the use of breast tomosynthesis compared to currently available techniques. Although digital breast tomosynthesis is a promising technology, there is a lack of peer-reviewed literature supporting its use in this clinical setting. As such, the services at issue were not likely to be more beneficial than standard modalities. 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.