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

Summary Reviewer 3

A 63-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 pain. The physician reviewer found that in the article by Polly and colleagues, a randomized controlled trial of minimally invasive sacroiliac joint fusion using triangular titanium implants was compared to nonsurgical treatment at 12 months. A total of 148 patients with sacroiliac joint dysfunction were randomly assigned to minimally invasive sacroiliac joint fusion with triangular titanium implants or nonsurgical treatment.  The conclusion was that this level one study showed that minimally invasive sacroiliac joint fusion using triangular titanium implants was more effective than nonsurgical management at one year in relieving pain, improving function, and improving quality of life in patients with sacroiliac joint dysfunction caused by degenerative sacroiliitis or sacroiliac joint disruptions.  Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment.  In the article by Whang and colleague, sacroiliac joint fusion using triangular titanium implants was compared to nonsurgical management at six months with a prospective randomized controlled trial.  The authors noted that minimally invasive sacroiliac joint fusion using triangular titanium implants was more effective than nonsurgical management in relieving pain, improving function, and improving quality of life in patients with sacroiliac joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions. Thus, the requested sacroiliac joint fusion is likely to be of greater benefit than other treatment options.  Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 59-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 9/06/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrolleei12s medical condition. The physician reviewer found that this patient had an early stage melanoma with low risk features. Per the National Comprehensive Cancer Network guidelines, while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. 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. Therefore, DecisionDx-Melanoma assay performed on 9/06/18 was not medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2


A 43-year-old female enrollee has requested reimbursement for molecular pathology testing provided on 4/14/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees breast cancer.The physician reviewer found the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Per National Comprehensive Cancer Network (NCCN) guidelines for genetic/familial high risk assessment, patients with a personal and family history of a single inherited cancer are best served for testing for that syndrome. In this case, breast cancer is documented in the patient and her family member. There is no clinical indication for MyRisk hereditary cancer testing in the clinical setting of a single inherited cancer. All told, the molecular pathology testing provided on 4/14/16 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 3

A 32-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 9/24/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. This is also the consensus opinion of the National Comprehensive Cancer Network. Therefore, DecisionDx-Melanoma testing performed on 9/24/19 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 54-year-old female enrollee has requested reimbursement for Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation the enrollees ulcerative colitis. The physician reviewer found that management of ulcerative colitis using Anser IFX has not been standardized, and standardized recommendations for management based on test results have not been formed (Kornbluth, et al). The use of Anser IFX to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in high-quality controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to Remicade (infliximab), nor have threshold drug 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). A study concluded that prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies (Adedokun, et al). Another 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). Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing (Vande Casteele, et al). Based on the clinical literature, Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15 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: Overturned

Summary Reviewer 1

A 60-year-old female enrollee has requested reimbursement for laboratory services provided on 8/15/19. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that FoundationOne assay explores possible mutations in 324 genes, as well as certain other abnormalities, in an individualas cancer cells. At this time, there is a lack of convincing evidence that therapy that is determined by the assay is superior to that which an oncologist would recommend from the literature and experience. Finding a mutation does not guarantee that a treatment directed at that will be effective. It has been estimated that the percentage of patients who would benefit from using the assay to select therapy is quite small. The National Comprehensive Cancer Network guidelines for treatment of ovarian cancer does not recommend using such an assay in the selection of therapy. Therefore, laboratory services provided on 8/15/19 were not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 44-year-old female enrollee has requested reimbursement for BRCA testing performed on 3/17/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk of cancer.  The physician reviewer found that most patients for whom genetic testing is ordered have an affected first-degree relative. BRCA1 mutation can increase risk for breast, ovarian, cervical, uterine, pancreatic, gastric, and prostate cancers (Brose, et al; Thompson, et al). BRCA2 mutations can increase risk for breast, ovarian, gall bladder, bile duct, prostate, pancreatic, and gastric cancers (Liede, et al; Tai, et al). In the event the BRCA tests were negative, there is still a possibility of hereditary predisposition from another gene defect. In this case, the patients family history is not suggestive of a heritable risk. The patient should proceed to standard mammography and physical exam. In sum, there is a lack of clinical documentation supporting the BRCA testing provided on 3/17/16 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 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 40-year-old male has requested authorization and coverage for Tremfya. 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 Psoriasis is a chronic inflammatory skin disease that typically presents with sharply demarcated, inflammatory, erythematous plaques with characteristic silver-white scaling due to epidermal hyperproliferation and parakeratosis secondary to the inflammation. Psoriasis has a high negative impact on the quality of life, especially in patients moderately or severely affected by the disease. Patel and colleagues noted traditional systemic therapies for psoriasis, including methotrexate and cyclosporine, have a well-documented array of toxicities, particularly end-organ toxicities. Over the past several years, the use of anti-tumor necrosis factor (TNF) biologic therapies for the treatment of moderate to severe psoriasis has been a major clinical and research focus. Despite several difficulties with documenting risks, some systemic treatments for psoriasis have been linked with an increased risk of selected cancers. In addition, patients treated with anti-TNF drugs may develop adverse events, such as infections, acute infusion and injection reactions, autoimmunity and cardiovascular effects. Tremfya (guselkumab) has been recently approved by U.S. Food and Drug Administration (FDA) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya represents a promising therapy, providing an alternative mechanism of action with high efficacy and safety profiles, sustained total skin clearance, and rapid onset of effect in psoriasis patients who previously failed on Otezla. There is sufficient support for the requested medication in this clinical setting. Therefore, Tremfya is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 57-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 8/17/17. 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 this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The services at issue were not likely to have altered patient management. Therefore, DecisionDx-Melanoma test performed on 8/17/17 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 21-year-old female enrollee has requested reimbursement for the outpatient papanicolaou smear testing performed on 7/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees abnormal and showed atypical squamous cell of undetermined significance (ASC-US) and high risk human papilloma virus (HPV) test.   The physician reviewer found that by 2001, revised Bethesda system terminology for reporting cervical cytology results and the availability of findings from a recent randomized trial of strategies for managing minor cervical cytologic abnormalities had created the need for a standard approach to managing women with abnormal cervical cytology and cervical cancer precursors. In response, the American Society of Colposcopy and Cervical Pathology (ASCCP) initiated a process that developed comprehensive, evidence-based consensus guidelines to aid providers in managing patients with abnormal cervical cytology, cervical intraepithelial neoplasia and adenocarcinoma in situ. The ASCCP guidelines are supported by the American College of Obstetricians and Gynecologists (ACOG), which substantially changed both the interval of screening based upon age as well as the actual management of abnormal Pap smears in clinical practice. For a patient with an ASC-US Pap and a positive HPV cotest, the management per the guideline algorithm is repeat cytology at 12 months without HPV cotesting. Thus, the repeat Pap smear performed on 7/17/15 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 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 1

A 59-year-old enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/20/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. Prognostic 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. Commerically available GEPs 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 cliniopathologic factors or multivariate 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. 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 4/20/20 was not likely to have been more beneficial than other available methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Overturned

A 40-year-old female enrollee has requested an artificial insemination consultation for the treatment of her fertility potential. Findings:  The physician reviewer found that the patient had an elevated FSH level, suggesting diminished ovarian reserve, although the timing of the test is not entirely clear. At her age, with diminished ovarian reserve and a history of infertility in the past, a fertility consultation was clinically indicated and therefore medically necessary.
Appeal type: Medical Necessity
Decision: Upheld

An enrollee has requested authorization and coverage for tobramycin 20 mg/budesonide 0.6 mg.The submitted documentation does not support that the requested medication is medically necessary. The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) clinical practice guideline on adult sinusitis lists intranasal saline and corticosteroids, but not intranasal antibiotics such as tobramycin, for symptomatic relief of chronic rhinosinusitis. A 2016 Cochrane systematic review did not identify any eligible randomized controlled trials comparing intranasal (topical) antibiotics with other therapies for the medical management of chronic rhinosinusitis. In this case, the patient has been diagnosed with chronic rhinosinusitis and has no documented evidence of nasal polyposis before or after endoscopic sinus surgery. There are no reported patient comorbidities, such as asthma or cystic fibrosis, that might warrant deviation from the AAO-HNSF clinical practice guideline, which does not include intranasal antibiotics such as tobramycin for symptomatic relief of chronic rhinosinusitis. Under these circumstances, tobramycin 20 mg/budesonide 0.6 mg is not medically necessary for treatment of the patients condition.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in otolaryngology-head and neck surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for dual diagnosis residential treatment center services.The submitted documentation supports that dual diagnosis residential treatment center services were, and are, medically necessary. Applying the American Society of Addiction Medicine (ASAM) dimension analysis for placement with substance use disorders, the patient has met Level 3.5 criteria for Clinically Managed High-Intensity Residential Services. For dimension 1, intoxication/withdrawal potential, the patient displayed post withdrawal symptoms of aches, tingling, yawning, fatigue, appetite changes, and irritability that could be safely managed in a Level 3.5 setting. For dimension 2, biomedical conditions and complications, the patients medications include naltrexone, Wellbutrin, Prozac, and Topamax, and the patient needs monitoring for medication compliance, effect and side effects, and for his suicidal/homicidal ideation. For dimension 3, emotional, behavioral, or cognitive conditions and complications, the patient demonstrated dysfunctional thinking, ambivalence about change, high risk behavior, irrational fears, anxiety, and he expresses bleak hopelessness about life with a history of suicide attempts. The patient also minimizes the risks of his use. For dimension 4, readiness to change, the patient is in the contemplation stage and is not committed to planning yet. For dimension 5, relapse, continued use, or continued problem potential, the patient is not honest with his parents and avoids responsibility for his health and recovery. For dimension 6, recovery environment, the patients social network is characterized by significant social isolation or withdrawal, as his network involves few persons outside of his parents, due to his behavior of pushing others away. As noted in this ASAM analysis, the patient has multidimensional needs and requires a safe and stable living environments in order to develop his recovery skills. This qualifies the patient for Level 3.5 treatment, which would correspond with the dual diagnosis residential treatment center services that have been provided to the patient. Accordingly, the dual diagnosis residential treatment center services provided to the patient were, and are, medically necessary to treat the patients medical condition.Final Result: The reviewer determined that the services in issue and requested services were, and are, medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in psychiatry and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.