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

Summary Reviewer 3

A 59-year-old female enrollee has requested authorization and coverage for heart surgery to correct the heart valve using a catheter (transcatheter valve repair). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. In patients with symptomatic severe aortic regurgitation, surgical aortic valve replacement is the treatment of choice. Transcatheter aortic valve replacement is currently approved and indicated for individuals with severe aortic stenosis who are considered high risk for surgical valve replacement. There is no current U.S. Food and Drug Administration (FDA) approved prosthetic valve procedure using a transcatheter approach for patients with pure aortic regurgitation. The JenaValve is in the active recruitment phase for patients with severe aortic regurgitation and heart failure of New York Heart Association (NYHA) class II or higher, using transcatheter aortic valve replacement with a pericardial valve. This patient meets criteria in terms of prohibitive surgical risk and symptoms. There is a lack of treatment alternatives in this patients case. Thus, the requested heart surgery to correct the heart valve using a catheter (transcatheter valve repair) is likely to be more beneficial than other treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 54-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 2/5/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC)) system that defines cutaneous melanoma stages 0-IV. While the majority of clinical stage I patients will be disease-free at five years, some stage I patients will develop advanced disease. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin examinations and clinical examination. In contrast, patients diagnosed with stage III melanoma receive complete lymph node dissection, active surveillance measures and often, referral to medical oncology for adjuvant medical therapy and clinical trial participation. DecisionDx melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as Class 1 consistent with a low risk of metastasis or Class 2 suggestive of a high risk of metastasis. One peer-reviewed publication indicated that there was a statistically significant association of a Class 1 signature by DecisionDx melanoma assay for primary dermal melanoma (PDM), whereas cutaneous metastatic melanoma (CMM) were more frequently class 2 (Sidiropoulos, et al). The authors concluded that the melanoma prognostic assay may be a useful tool for distinguishing PDM from CMM. According to the results of analysis of this patients melanoma performed with DecisionDx melanoma assay, the tumor was classified as Class 1 with a low risk of near-term (within five years) metastatic disease. Therefore, DecisionDx melanoma signature may be an independent predictor of metastasis risk. However, there is a lack of peer-reviewed published studies confirming this hypothesis. All told, the DecisionDx melanoma assay performed on 2/5/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

The patient is a now deceased female who was transported by air ambulance from Lenox Hill Hospital in New York to Providence Tarzana Medical Center in Tarzana, California on 2/24/20. The patientas representative has requested reimbursement for air ambulance transport provided on 2/24/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that in order for air medical transport to be medically necessary, specific criteria must be met. These criteria include the following: the patientas condition must be such that any form of transportation other than ambulance would be medically contraindicated; the patientas condition is such that time needed to transport by ground poses a threat to the patientas survival; the patient is transported to the nearest hospital with appropriate facilities for treatment; and there is a medical condition that is life-threatening. When transporting from one facility to another, the above criteria must be met, and the first hospital should not have the required services and facilities to treat the patient. In this case, the medical records document that the patient was transported from New York to her home state of California in order to receive continuity of care from her oncologist. This does not meet criteria for medical necessity, as the transferring facility was capable of providing the necessary care. The patient chose to be transferred to receive care from the providers she preferred. Therefore, medical necessity criteria for air ambulance transport are not met. Thus, air ambulance transport provided on 2/24/20 was not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 38-year-old male enrollee has requested reimbursement for genetic testing performed on 5/31/18. 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 while a fine needle aspiration biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of fine needle aspiration biopsy results are considered to be indeterminate. Until recently, the only way to establish whether the nodule was thyroid cancer was via surgical excision, even though the majority of the cases turn out to be benign. The relatively new development of molecular techniques and the identification of genetic alterations associated with different follicular cell-derived cancers in the thyroid have led to the introduction of several commercially available tests. Among these tests is ThyGenX, which analyzes a panel of DNA mutations and RNA translocation fusion markers to assess the risk of malignancy with good negative and positive predictive value, thereby obviating the need for unnecessary surgeries. Therefore, genetic testing performed on 5/31/18 was likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 28-year-old male enrollee has requested reimbursement for 30140 (submucous resection inferior turbinate) and 30465 (repair of nasal vestibular stenosis) performed on 8/31/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that a diagnosis of obstructive sleep apnea requires a preliminary polysomnogram (sleep study) and a trial and failure of medical management of the sleep disorder with continuous positive airway pressure therapy. The submitted records did not document that the patient had a prior sleep study evaluation. Bilateral submucous resection (CPT code 30140) is a technique to improve the airway and has been beneficial in patients with severe obstruction noted on physical examination as well as in patients with allergic symptomatology. However, there is only modest clinical documentation that shows that this technique improves sleep apnea. Uvulopalatopharyngoplasty (CPT code 42145) may be appropriate for patients with symptoms of obstructive sleep apnea on polysomnogram who have failed adequate control with continuous positive airway pressure therapy. In this case, there was no polysomnogram available for clinical review. Therefore, 30140 (submucous resection inferior turbinate), 30465 (repair of nasal vestibular stenosis) and 42145 performed on 8/31/17 were not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 35-year-old male with a history of ulcerative colitis. Anser ADA testing on 6/10/19 showed a Humira level of 6.7 ug/mL and lack of anti-Humira antibodies. The physician reviewer found that this patient was taking Humira, an anti-tumor necrosis factor (TNF) medication, for the treatment of ulcerative colitis. In this case, Humira levels and anti-Humira antibody levels were checked after the patient had uncontrolled symptoms of ulcerative colitis. According to the American Gastroenterological Association (AGA) Guideline on Therapeutic Drug Monitoring in Inflammatory Bowel Disease, In adults with active inflammatory bowel disease treated with anti-tumor necrosis factor agents, the AGA suggests reactive therapeutic drug monitoring to guide treatment changes. The current medical literature supports drug level monitoring based on studies showing that anti-TNF drug levels predict response to therapy. In this case, the patient was stabilized on Humira, and then had a loss of response, which requested prednisone therapy. Testing for Humira drug level and for anti-Humira antibodies is supported by guidelines in that situation. Therefore, Anser ADA diagnostic testing performed on 6/10/19 was medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 53-year-old female enrollee has requested authorization and coverage for autologous cultured chondrocytes implant knee. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that autologous chondrocyte implantation is a proven method for salvage of large articular cartilage defects of the patellofemoral joint in the long-term. Focal chondral defects of the knee can significantly impair knee function, cause chronic pain, and affect the quality of life. The autologous chondrocyte implantation technique has evolved over the past 20 years.  The newest technique is the third-generation technique called matrix-induced autologous chondrocyte implantation, which has been recommended in this patients case. Physical examination, imaging studies, and arthroscopic findings have been utilized in this case to identify the articular defects. Conservative measures have been exhausted, and surgical treatment is indicated for the patellofemoral joint. Patients treated with matrix-induced autologous chondrocyte implantation have demonstrated significant clinical improvement and good quality repair tissue five years after surgery. This procedure has been shown to be a safe and effective treatment for symptomatic, traumatic chondral knee defects, particularly involving the patellofemoral joint, as in this case. Therefore, autologous cultured chondrocyte implantation in the knee is likely to be more beneficial than other treatment options.
Appeal type: Experimental
Decision: 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: Overturned

Summary Reviewer 


A 39-year-old male enrollee has requested reimbursement for chiropractic treatment provided from 4/20/15 through 7/24/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.  The physician reviewer found the review I am board certified in chiropractic orthopedics and I am actively practicing. I am 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. In addition, I hold a current certification by a recognized American medical specialty board in the area or areas appropriate to the treatment under review. I have no history of disciplinary action or sanctions against my license.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


The parent of a 15-year-old male enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 5/13/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that the patient is a 15-year-old male with Crohns disease.  The patient presented with bloody diarrhea and the presence of perianal fistulous disease.  Colonoscopy revealed discontinuous ulcers in the rectum and sigmoid.  After initially starting Flagyl, the patient ultimately was placed on Remicade.  He experienced healing of the fistulas with resolution of hematochezia.  The patients parent has requested reimbursement for Prometheus Anser IFX testing performed on 5/13/16.  Per the Health Insurer, the services at issue were investigational for the evaluation of this patient. The current medical evidence has not established the superior efficacy of the services at issue in this clinical setting.  The patient appeared to be responding, and there is no mention of an infusion-related adverse event.  Antibodies in low titer can be transient and not of biologic significance.  The provider increased the dose based on the testing.  There is a lack of prospective, controlled data showing that this leads to improved outcomes.  In summary, while targeted dosing of biologics may be an attractive concept, there is a lack of data demonstrating that this approach actually benefits patients.  Thus, Prometheus Anser IFX testing performed on 5/13/16 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: Overturned

Summary Reviewer 2
A 54-year-old male enrollee has requested authorization and coverage for Gilotrif (afatinib dimaleate tablet 40 mg).  The Health Insurer indicates that the requested medication is investigational for the treatment of the enrollees medical condition. Therefore, the Health Insurer has denied coverage for the requested medication.
At issue is whether the requested medication is likely to be more beneficial for treatment of the enrollees condition than any available standard therapy. The physician reviewer found that the therapy of advanced non-small cell lung cancer has been revolutionized by the finding of EGFR mutations in adenocarcinomas. Even if stage IV disease is present, therapy targeted to EGFR with erlotinib results in prolonged survival when compared with standard chemotherapy regimens. The mutational landscape of non-small cell lung cancer has significantly expanded in recent years to encompass gain of function in multiple oncogenes with major prognostic and therapeutic consequences. This patient has a rare EGFR gene rearrangement. The approach to a rare EGFR gene rearrangement is comparable to the presence of an EGFR mutation. Within the National Comprehensive Cancer Network guidelines, EGFR mutations discovered during first-line systemic therapy or those discovered prior to first-line systemic therapy should be treated with afatinib. This is a category 1 recommendation. Therefore, Gilotrif (afatinib dimaleate tablet 40 mg) is likely to be more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 56-year-old female enrollee has requested reimbursement for Oncotype DX colon cancer assay completed on 8/19/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found that there is some evidence to consider adjuvant treatment for those stage II patients with T4 disease, obstructing lesions, and other biomarkers.  The Oncotype DX colon cancer assay uses a reverse transcriptase-polymerase chain reaction assay for 12 genes in an algorithm that can be used to predict recurrence. The medical evidence for the test is sufficient to allow its use to estimate the risk of recurrence for stage II patients when incorporated with other tests, such as standard pathology and microsatellite instability testing. This patient has been diagnosed with stage II cancer. Thus, Oncotype DX colon cancer assay performed on 8/19/15 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: Upheld

Summary Reviewer 3

A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. The National Comprehensive Cancer Network guidelines indicate that genetic testing such as the DecisionDx-Melanoma testing should not be used outside of a clinical trial setting. The use of this type of testing is not considered to be standard of care in the treatment of this patients melanoma. This testing is not expected to impact the treatment or outcome of this patients melanoma. Thus, DecisionDx-Melanoma testing performed on 2/20/18 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

The patient is a 62-year-old female with a history of invasive urothelial carcinoma, high grade T4NxMx (y2aN2) status post right inguinal node biopsy on 6/29/17. Pathology was consistent with metastatic urothelial cancer, high grade with plasmacytoid features. Treatment included neoadjuvant chemotherapy with four cycles of cisplatin and gemcitabine and cystectomy. FoundationOne gene testing was performed on 8/15/16. The patient has requested reimbursement for the FoundationOne gene test provided on 8/15/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. This patient underwent molecular profiling with FoundationOne testing on 8/15/16 shortly after initial diagnosis and prior to receiving first-line therapy. As noted in the current peer-reviewed medical literature, molecular profiling is not considered the standard of care for the treatment of urothelial cancer. Moreover, in this case, the FoundationOne testing was performed when several first- and second-line therapies were available. Molecular testing to guide therapy is the ongoing subject of several active clinical trials. All told, the FoundationOne gene test provided on 8/15/16 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: Overturned

Summary Reviewer 1

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 this right handed patient has chronic refractory neuropathic pain of her right neck and right shoulder. She has failed use of a SCS as treatment for her pain as well as other standard treatment modalities. According to the American Academy of Neurology (AAN) guidelines, SCS is used to treat neuropathic pain, and is considered to be a surgery of last resort when all other treatment options have failed. She has been offered a peripheral nerve stimulator trial. Peripheral nerve stimulation has been shown to be safe and effective (Petersen and Slavin). Since she has failed use of the SCS, the peripheral nerve stimulator is the only available modality to treat her current pain (Al-Jehani and Jacques). Thus, the requested peripheral nerve stimulator (implant of neuroelectrodes (G4555)) is likely to be more beneficial for this patient than any available standard treatment. 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.