Persius/hicric huggingface dataset:
Appeal type: Experimental
Decision: Insurer Denial 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.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

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 Guardant360 testing offers a comprehensive panel of molecular genetic markers on an individual patients tumor in an attempt to identify markers than can help guide therapy decision making. Per the National Comprehensive Cancer Network (NCCN) guidelines, it has not been determined if molecular markers are useful in treatment determination other than EGFR, ALK, ROS-1, PDL1, MET, RET, ERBB2, and BRAF. There is currently a phase II clinical trial underway that is evaluating the efficacy of broad genetic molecular testing to guide individual therapy (Masters, et al). In this case, the metastases were noted to be difficult to biopsy, which supports the additional genetic testing with Guardant360 for EGFR, ALK, ROS-1, PDL1, MET, RET, ERBB2, and BRAF. For these reasons, the EGFR, ALK, ROS-1, PDL1, MET, RET, ERBB2, and BRAF portions of the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17 were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy, while the remainder of the testing performed on 12/8/17 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, a portion of 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 partially overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

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 Based on current guidelines, lung adenocarcinoma should be evaluated for certain molecular abnormalities and mutations that have clinical implications. When this patient developed metastases, the FoundationOne assay was performed which did not reveal any significant mutations. In this case, the FoundationOne assay had already been performed, and this did not indicate any molecular or mutational results that could guide the provider. There is a lack of support additional testing with Guardant360 would have provided additional clinical benefit in this situation. Thus, the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17 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: Insurer Denial Upheld

Summary Reviewer 1


A 42-year-old male enrollee has requested reimbursement for decompression procedure performed on 10/5/15. The Health Insurer has denied this request indicating that the procedure at issue is considered investigational for treatment of the enrollees occipital neuralgia.  The physician reviewer found that the decompression procedure (neurolysis) performed on 10/5/15 was likely to be more beneficial for treatment of the patients occipital neuralgia than any available standard therapy. There is some medical literature supporting the use of neurolysis for the treatment of occipital neuralgia. Although there is a lack of data demonstrating superior results with the neurolysis, several studies have shown good results for treatment of the occipital neuralgia. In this case, the patient presented with intractable occipital neuralgia and treatment with neurolysis was 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 procedure 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: Insurer Denial Upheld

Summary Reviewer 2

A 42-year-old male enrollee has requested reimbursement for decompression procedure performed on 10/5/15. The Health Insurer has denied this request indicating that the procedure at issue is considered investigational for treatment of the enrollees occipital neuralgia.  The physician reviewer found that the procedure (neurolysis) at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. There is a lack of large, scientific, randomized, controlled studies showing the long-term effectiveness of neurolysis in this clinical setting. There are some promising studies supporting neurolysis of the greater occipital nerve (Ducic, et al; Acar, et al). However, these studies are primarily retrospective, small, uncontrolled studies with only short-term follow up. Given the lack of sufficient support in the peer-reviewed literature, the decompression procedure performed on 10/5/15 has not been established as 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 procedure at issue was 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: Insurer Denial Upheld

Summary Reviewer 3


A 42-year-old male enrollee has requested reimbursement for decompression procedure performed on 10/5/15. The Health Insurer has denied this request indicating that the procedure at issue is considered investigational for treatment of the enrollees occipital neuralgia.  The physician reviewer found that occipital neuralgia is a condition characterized by frequent and severe headaches characterized by paroxysmal stabbing pain in the distribution of the greater or lesser occipital nerves. The pain is located in the occipital area and may spread toward the vertex; it is usually unilateral but may be bilateral. The treatment plan for occipital neuralgia depends upon many factors, such as the severity of the dysfunction and pain, the type and location of the pain, as well as patients age, ongoing medical conditions, and ability to tolerate other medical therapies. Standard therapy may include medications to relieve pain and muscle spasms, localized injections, physical therapy, or massage. Surgical release of the greater occipital nerve has been demonstrated to be clinically effective in eliminating or reducing chronic migraine symptoms. However, migraine symptoms in some patients continue after this procedure. It was theorized that a different relationship between the greater occipital nerve and occipital artery may exist in these patients that may be contributing to these outcomes. Vascular pulsation may cause irritation of the nerve and is a possible explanation for migraine headaches that have the occipital region as a trigger point. Future imaging studies and clinical investigation is necessary to further examine the link between anatomy and clinical presentation. At this time, occipital release surgery warrants further investigation. As such, the decompression procedure performed on 10/5/15 was 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 procedure at issue was 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: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

The patient is a 63-year-old male who was evaluated with DecisionDx-Melanoma testing on 5/13/19. Pathology from 4/10/19 from a left forearm biopsy showed melanoma, Clarks level II, 0.36 mm thickness. The physician reviewer found that this patient had an early stage melanoma. Per the National Comprehensive Cancer Network guidelines, while there is interest in newer prognostic molecular techniques such as gene expression profiling to help differentiate benign from malignant neoplasms, or to help distinguish melanomas at low-risk versus high-risk for metastasis, routine genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, tumor biomarker or gene expression classifier test performed on 5/13/19 was not medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1


A 42-year-old female has requested reimbursement for Anser IFX Assay testing performed on 10/26/15. 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.  In this clinical setting, measuring infliximab drug levels and antibodies to infliximab was appropriate. Although the reaction the patient had appeared to have been relatively mild, there is concern that with future infusions the severity of the reactions may escalate.  The testing performed was indicated in order to accurately measure antibody levels.  Thus, Anser IFX Assay testing was likely to have been more effective than 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: Insurer Denial Upheld

Summary Reviewer 2


A 42-year-old female has requested reimbursement for Anser IFX Assay testing performed on 10/26/15. 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 a lack of support for the services at issue in this clinical setting.  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 use of the Anser IFX Assay 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 aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established.  In sum, Anser IFX Assay testing was not likely to have been superior over 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: Insurer Denial Upheld

Summary Reviewer 3


A 42-year-old female has requested reimbursement for Anser IFX Assay testing performed on 10/26/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the Anser IFX Assay testing was ordered to determine the cause for possible reaction to and loss of response to Remicade.  The use of Anser IFX Assay testing to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials.  The presence of antibodies alone does not necessarily result in reaction to or loss of response to infliximab, nor have threshold drug levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response.  Based on the clinical literature, the services at issue were not likely to have been superior over 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: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

The patient is a 59-year-old female who self-palpated a right breast mass in January 2020.  The patient has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that guidelines do not endorse the routine use of proton therapy in the treatment of breast cancer. There is a lack of data to suggest that proton therapy would be beneficial in this case or that it would be associated with less side effects than standard treatment with photons. The standard treatment in this case would be with chemotherapy followed by surgery followed by radiation with photons. Furthermore, consensus group guidelines do not support the use of proton therapy in this setting. In the vast majority of cases, intensity modulated radiation or 3D conformal techniques with photons is able to achieve an acceptable cardiac and lung dose. Also, there is a lack of level I evidence to support the use of proton beam therapy for the treatment of breast cancer. Therefore, proton beam therapy is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1


A 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found the concept of therapeutic drug monitoring of biologics in this clinical setting is not evidence-based.  There is no target drug level threshold which has been established.  Often, patients with a low or undetectable trough drug level are in clinical remission. Additionally, although antibodies are associated with lower drug levels and drug failure, in many patients, antibodies are transient and not of clinical significance.  In sum, Anser ADA testing performed on 4/25/16 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: Insurer Denial Upheld

Summary Reviewer 2


A 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.The physician reviewer found there is a lack of support for the services at issue in this clinical setting.  Some evidence exists that low serum levels of adalimumab and/or the presence of antibodies to adalimumab 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 adalimumab or the presence of adalimumab 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 use of the Anser ADA testing leads to improved patient outcomes or quality of life as compared to the standard method of treatment.  The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results.  Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement.  It has not yet been established whether the use of threshold levels aids in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established.  Therefore, Anser ADA testing performed on 4/25/16 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: Insurer Denial Upheld

Summary Reviewer 3

A 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found there is insufficient medical evidence to support the effectiveness of Anser ADA compared with conventional courses of action in the management of ulcerative colitis. Patients being treated with adalimumab may experience loss of response, but the appropriate method for determination of the cause for loss of response is not clear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature. These small studies demonstrated, at best, correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect.  Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking.  Therefore, the clinical literature has not established the superior efficacy of Anser ADA testing performed on 4/25/16.  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: Insurer Denial Overturned

Summary Reviewer 

A 63-year-old female enrollee has requested reimbursement for gene testing (breast cancer index test) performed on 7/16/18. 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 BCI is a combination of two profiles, the HOXB13-to-IL17BR expression ratio (H:I ratio) and the Molecular Grade Index (MGI). Compared with clinical prognostic factors, such as age, tumor size, tumor grade, and lymph node status, the H:I ratio was significantly and independently correlated with outcome. Subsequent studies have validated the BCI as an accurate predictor of endocrine responsiveness among patients with estrogen receptor positive breast cancer, with one case-control study suggesting it may identify those who would benefit from extended endocrine therapy. The American Society of Clinical Oncology (ASCO) supports use of the BCI. The National Comprehensive Cancer Network guidelines noted, For patients with T1 and T2 hormone receptor-positive, HER2-negative, and lymph node-negative tumors, a BCI in the low-risk range, regardless of T size, places the tumor into the same prognostic category as T1aT1b, N0, M0. Results of a secondary analysis of the aTTom trial demonstrated that in patients with hormone-receptor positive, node-positive breast cancer, patients with a high BCI (HOXB13/IL17BR) (H/I) derived significant benefit from extending tamoxifen therapy to 10 years versus five years. In contrast, BCI (H/I) low patients derived no benefit from extended adjuvant therapy. This patient fits in the latter category, and the results may allow her to come off of endocrine therapy, for which she experiencing side effects. The medical evidence supports the services at issue in this clinical setting. Therefore, gene testing (BCI test) performed on 7/16/18 was medically necessary for the evaluation of this patient.