Persius/hicric huggingface dataset:
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

The patient is a 67-year-old male who was diagnosed with melanoma. The patient has requested reimbursement for DecisionDx-Melanoma testing performed on 1/01/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that this patient has an early stage melanoma. Gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. 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, DecisionDx-Melanoma testing performed on 1/01/20 was not medically necessary for the evaluation of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

A 23-year-old transgender female enrollee has requested reimbursement for facial feminization surgery provided on 11/01/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found that the current medical evidence supports the medical necessity of the services at issue. The services at issue were likely to have improved the patients psychological and social functioning. Per World Professional Association for Transgender Health (WPATH), medically necessary gender affirming/confirming surgical procedures include complete hysterectomy, bilateral mastectomy, chest reconstruction or augmentation as appropriate to each patient, genital reconstruction, facial hair removal and certain facial plastic reconstruction. This patient has a documented history of gender dysphoria and has been on hormone therapy. Based on the documented history of gender dysphoria, facial feminization surgery was medically necessary for the treatment of this patient. Thus, facial feminization surgery provided on 11/01/18 was medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1
A 42-year-old female enrollee has requested reimbursement for the Ova 1 test performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees risk for ovarian cancer.  The physician reviewer found that Ovarian cancer usually presents at advanced stages since considerable tumor growth can occur without symptoms. At this juncture, ideal screening tests have not been determined and studies are in progress. The CA 125 serum test is sensitive but can also be elevated in other nonmalignant conditions. This patients provider noted that this was possible in the patients case and warranted further information with the Ova 1 assay before recommending surgery or another diagnostic procedure. The Ova 1 test is a multivariate proteomic test that analyzes five proteins that are differentially expressed in ovarian cancer. The expression levels are fed into a proprietary algorithm that generates an ovarian malignancy risk index score. The test was approved by the U.S. Food and Drug Administration (FDA) for use in women who are considering surgery for complex adnexal masses based on findings in clinical studies (Kozak, et al). The sensitivity for ovarian cancer detection was 80.8% for pre-menopausal women and 91.3% for post-menopausal women. The negative predictive value for pre-menopausal women was 93.1%. These findings constitute good evidence supporting the Ova 1 testing for use in this patients clinical situation and suggest that it was likely to be more beneficial for evaluation of the patients medical condition than any available standard testing. Based upon the information set forth above, I have determined 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 Overturned

Summary Reviewer 2
A 42-year-old female enrollee has requested reimbursement for the Ova 1 test performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees risk for ovarian cancer.  The physician reviewer found that while malignant masses in the adnexa require surgical removal, other masses may not. Specific features of history, family history, CT, and ultrasound findings assist in making this determination. However, this information may be lacking and further testing is needed. The most well-known marker for ovarian cancer in CA 125, but up to 50% of patients with stage I ovarian cancer have a normal value and a number of other malignant and benign conditions can cause an elevated level as well (Bast, et al). The Ova 1 test incorporates five biomarkers including CA 125 for a more thorough tumor assessment. In one study from Ueland and colleagues, the authors reported that adding the Ova 1 to a physician assessment correctly identified 70% of cancers missed by gynecologists. Although there was a lack of specificity since 261 benign tumors were also referred gynecologic oncology, the authors concluded that the use of the Ova 1 with standard clinical parameters improved detection of malignancy. Accordingly, the use of the Ova 1 was likely to have been more beneficial in this patients evaluation and treatment than any available standard modality. Based upon the information set forth above, I have determined 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 Overturned

Summary Reviewer 3

A 42-year-old female enrollee has requested reimbursement for the Ova 1 test performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees risk for ovarian cancer.  The physician reviewer found that the Ova 1 assay consists of measurement of the levels of five tumor markers and their analysis using a predefined algorithm. The Ova 1 has been shown to be predictive of the risk of malignancy in the evaluation of un-biopsied ovarian masses. The National Comprehensive Cancer Network (NCCN) guidelines include a brief discussion of the Ova 1 assay, and conclude that all patients should undergo surgery by an experienced gynecological oncologist in this clinical setting. This is also consistent with the recommendations from the American College of Obstetricians and Gynecologists (ACOG). As such, the use of Ova 1 would not be recommended as a standard of care for the patients condition and its use was not likely to have yielded additional data beyond that expected with standard available testing. Based upon the information set forth above, I have determined 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 


The parent of an eight-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis (ABA) therapy at the frequency of 30 hours per week of H2019, 12 hours per month of H0031 and 12 hours per month of H0032 provided from 7/16/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder.  The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the services at issue. ABA has been shown in the medical literature to be effective for children with autism spectrum disorders. The review by Reichow and colleagues shows that early intensive behavioral intervention is effective to increase IQ, improve communication and adaptive skills. In this case, there is a lack of evidence submitted for review that demonstrates the patient has made enough progress to support a reduction in services. The patient presents with maladaptive behaviors with tantrums and frequent aggression. As such, 30 hours per week of H2019, 12 hours per month of H0031 and 12 hours per month of H0032 provided from 7/16/15 forward was and is medically necessary for this patient.Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1


The parent of a 17-year-old male enrollee has requested reimbursement for intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015. 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 the patient presents for cognitive dysfunction and fatigue of long-standing duration.  The records do not include a positive IgG antibody titer.  The patient has had multiple courses of antibiotics, without lasting and significant improvement.  The diagnosis of late stage Lyme disease has not been established.  The treatment of late stage Lyme disease is a four-week course of intravenous antibiotic. Prolonged courses or repeat courses have not been shown to be efficacious.  All told, intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015 was not likely to have been of greater benefit than other 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: Insurer Denial Upheld

Summary Reviewer 2


The parent of a 17-year-old male enrollee has requested reimbursement for intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015. 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 there is a lack of support for the services at issue in this patients case.  Per the medical evidence, strictly clinical diagnosis of Lymes disease is not the standard of care in late disease. Early in the course of the disease, serology may be negative.  However, late in the course, serologic testing is indicated.  In general, it is difficult to clinically diagnose a disease with such a wide range and common spectrum of symptoms.  In addition, the standard approach for Lyme disease is oral doxycycline for limited disease and ceftriaxone for central nervous system infection.  The records do not include a cerebrospinal fluid analysis.  In sum, the superior efficacy of the services at issue has not been established.  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: Insurer Denial Upheld

Summary Reviewer 3


The parent of a 17-year-old male enrollee has requested reimbursement for intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015. 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 this patient has a history of a fatiguing illness.  The etiology is not clear although one pediatrician did make a diagnosis of chronic fatigue syndrome.  The patient was subsequently given a clinical diagnosis of Lyme disease.  He was prescribed oral and parenteral antibiotics in the absence of any evidence of an infection.  The period of therapy was also extended past the recommended duration.  It is well-established that a maximum of 28 days is needed to treat late Lyme disease.  Thus, intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015 was not likely to have been of greater benefit than other 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: Insurer Denial Upheld

Summary Reviewer 1


A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Actemra provided from 7/14/15 through 12/15/15 and ongoing. The Health Insurer has denied this request indicating that the medication at issue was and is investigational for the treatment of the enrollees medical condition.  The physician reviewer found that Tocilizumab inhibits the effects of the cytokine, IL-6, which has been associated with rejection of kidney transplants. It has shown efficacy in rheumatoid arthritis and is currently approved for that indication by the U.S. Food and Drug Administration (FDA). An uncontrolled phase I/II trial in highly sensitized patients awaiting kidney transplantation has shown the drug to be safe (Vo, et al); and other kidney transplant studies are planned (NCT02108600). However, at this time there is a lack of peer-reviewed literature demonstrating the efficacy of Actemra for treatment in patients with AMR as a basis for off-label use. Thus, the use of tocilizumab in kidney transplantation is considered controversial and is not the standard of care. As such, Actemra was not and 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 medication at issue was not and is 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 2

A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Actemra provided from 7/14/15 through 12/15/15 and ongoing. The Health Insurer has denied this request indicating that the medication at issue was and is investigational for the treatment of the enrollees medical condition.  The physician reviewer found that at this time there is an unmet need in the treatment of AMR for renal transplant recipients. In this case, the patient has received IVIG, Rituximab and pulse steroids for the treatment of his chronic active AMR which are acceptable treatments. However, the patient did not have plasmapheresis in an attempt to remove the DSAs, the latter probably associated with the AMR. Plasmapheresis is a standard treatment which is performed in most patients with AMR either alone or in conjunction with the therapies that this patient received. Also, there are several reports in the peer-reviewed literature of other potential therapies such as bortezomib and eculizumab in the treatment of patients with AMR. This patient has not been tried on these therapies. Moreover, there is a lack of studies on the use of tocilizumab in the treatment of AMR, except as an investigational drug. This is not a standard therapy for AMR and has not been recommended by the American Society of Transplantation or received U.S. Food and Drug Administration (FDA) approval for this indication. More randomized controlled trials are required comparing tocilizumab to the currently available anti-AMR therapies. In addition, the patients renal function has been stable and the usage of tocilizumab has not made it better thus far. For the reasons provided, the medication at issue was not and 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 medication at issue was not and is 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 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Actemra provided from 7/14/15 through 12/15/15 and ongoing. The Health Insurer has denied this request indicating that the medication at issue was and is investigational for the treatment of the enrollees medical condition.  The physician reviewer found that Actemra was not and is not likely to be more beneficial for treatment of the patients medical condition than other modalities. There is a lack of support in the peer-reviewed literature for Actemra in this clinical setting. At this time there is a lack of literature supporting tocilizumab for the treatment of patients post-transplant. In addition, the records do not indicate that the patient has tried treatment with bortezomib, which does have reports in the peer-reviewed literature. Given the above, the medication at issue was not and 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 medication at issue was not and is 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 


A 52-year-old male enrollee has requested authorization and coverage for Otezla. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for treatment of the enrollees plaque psoriasis. The physician reviewer found that this patient has a history of chronic plaque psoriasis. Per the records, he has tried and failed treatment with topical steroids. However, there is no medical documentation of a contraindication, intolerance or adverse effect to using the preferred agents, including methotrexate, acitretin, Enbrel, Humira, Stelara or Remicade. In this patients case, the provider noted that disease-modifying antirheumatic drugs are contraindicated due to high blood pressure. However, disease-modifying antirheumatic drugs are contraindicated in the instances of liver disease and certain liver infections (such as hepatitis B or C), not high blood pressure. The patients provider noted that biologic agents have been avoided due to coronary artery disease. However, biologic agents are contraindicated in the setting of congestive heart failure, not coronary artery disease. The conditions reported for this patient do not represent contraindications to the use of the preferred formulary agents. As there are other effective, preferred agents offered for the treatment of the patients chronic plaque psoriasis, the requested medication Otezla is not medically necessary for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

A 31-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the lumbar spine, cervical spine, and pelvis. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees back and neck pain. The physician reviewer found that the records provided for review do not support the medical necessity of the requested MRI studies. The physical examination on 5/16/18 does not detail which muscles are weak or hypotonic. In addition, the neurological examination was limited and the note of prior physical therapy does not include details as to duration, evaluation or outcome. Moreover, there are no laboratory values in the chart to support an indication for an inflammatory process such as sacroiliitis. All told, there is a lack of documentation supporting the medical necessity for MRI of the lumbar spine, cervical spine, and pelvis for evaluation of this patients medical condition. Based on the foregoing discussion, the requested services are not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

The patient is a 55-year-old female who has requested authorization and coverage for pembrolizumab.  The Health Insurer has denied this request and reported that the requested medication is 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 the phase III study by Schmid and colleagues demonstrated that the addition of pembrolizumab  to neoadjuvant chemotherapy consisting of weekly paclitaxel and carboplatin followed by doxorubicin or epirubicin and cyclophosphamide raised the overall pathologic complete response rate from 51 to 65 percent. While patients with programmed cell death ligand 1-expressing (PD-L1-positive) cancers had higher pathologic complete response rates whether they received pembrolizumab or not, the addition of pembrolizumab increased pathologic complete response rates in both PD-L1-positive and PD-L1-negative cancers. Use of this medication is supported by this phase III trial as well as off-label use by major drug compendia. There is sufficient support for the requested medication in this clinical setting. Therefore, pembrolizumab is medically necessary for the treatment of this patient.