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

Summary Reviewer 3


The parent of a three-year-old male enrollee has requested reimbursement for the FirstStepDx Plus testing performed on 12/14/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees autism spectrum disorder.The physician reviewer found that chromosome microarray testing has been accepted as an appropriate first-line genetic testing since 2010 for the evaluation of autism (Manning and Hudgins). According to the American College of Medical Genetics and Genomics (ACMG) policy statement regarding the clinical utility of genetic and genomic testing, There is great clinical value in arriving at a precise medical diagnosis, enabling, among other things, identification of a disorders cause and prognosis, as well as frequently informing preventive and treatment modalities. Therefore, given that chromosome microarray is considered first-line testing for autism, and that management is often changed and/or affected by positive chromosome microarray results, FirstStepDx Plus performed on 12/14/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2
A 54-year-old male enrollee has requested reimbursement for DecisionDx melanoma test performed on 11/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented with a mole on his left upper back.   The physician reviewer found that melanoma is a cancer of the skin. Survival rates vary based on the depth of invasion of the primary tumor. Early stage tumors with negative sentinel lymph node biopsy carry a low risk of recurrence. Multiple analyses have demonstrated that survival/ prognosis is dependent upon tumor thickness, age at diagnosis, location of primary, presence of ulceration, mitotic rate, lymph node involvement, and growth pattern. Genomic and proteomic expression profiling has been under investigation, but the role in standard therapy has not been clearly outlined. DecisionDx test is a 15 gene panel expression assay which classifies based on a calculation from the gene expression and comparison with a training set of known outcomes. Multiple studies have been performed to validate its use and these small studies indicate that the score generated permitted clinicians to individualize the patient's surveillance plan. The National Comprehensive Cancer Network (NCCN) guidelines indicate that for melanoma, wide excision be pursued with sentinel lymph node evaluation if the tumor is greater than 0.75 mm thick. For stage IA, after resection observation is recommended whereas for stage IIB or IIC, interferon alpha should also be considered. There is a lack of current recommendations to undergo genomic or proteomic analysis to assess risk or assess benefit of adjuvant therapy. Due to the high risk of metastatic recurrence, evaluation of clinical and molecular characteristics is encouraged to guide surveillance care after local therapy as there is no definitive data on the optimal follow up after initial treatment. In this patients case, although DecisionDx provided an additional risk assessment tool, the current treatment and postoperative surveillance options available have proved to have limited impact on overall survival. Therefore, the utility of the score remains of limited utility. All told, DecisionDx melanoma test performed on 11/9/16 was not likely to be superior over the standard methods of evaluating this patient. Therefore, for the reasons stated above, the service at issue was not likely to have been 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 59-year-old female enrollee has requested reimbursement for high dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, for dates of service 2/07/19, 2/09/18, 2/12/19, 2/14/19, 2/19/18, 2/21/18, 2/26/18, 2/28/18 and 3/05/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the standard treatment of skin cancer with radiation therapy is done with standard photons or electrons. Standard treatment of these lesions with photons or electrons is associated with excellent outcomes and cosmesis. The current National Comprehensive Cancer Network guidelines do not endorse the use of electronic brachytherapy for the treatment of skin cancer. There is a lack of medical literature demonstrating that outcomes are improved with the use of brachytherapy in this setting. Furthermore, there is literature that states that longer follow-up is needed before electronic brachytherapy is considered an established alternative to other forms of treatment for skin cancer. Thus, high dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, for dates of service 2/07/18, 2/09/18, 2/12/18, 2/14/18, 2/19/18, 2/21/18, 2/26/18, 2/28/18 and 3/05/18 was not likely to have been of greater benefit than other treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 42-year-old female enrollee has requested reimbursement for gene test FoundationOne (procedure codes 81201, 81210, 81211, 81235, 81270, 81275, 81292, 81295, 81298 and 81321) on 4/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic breast cancer to the liver and bones.The physician reviewer found that the FoundationOne testing offers a comprehensive panel of molecular genetic markers on an individuals tumor with the hopes of identifying markers that 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 (predictive markers) and prognosis other than for estrogen receptors (ER) and progesterone receptors (PR), and human epidermal growth factor receptor 2 (HER). FoundationOne provides genetic testing to guide therapy, and is the subject of an ongoing phase II trial. As such, it would be considered investigational/experimental for this patient. At this time, it is not likely to be more effective than available standard therapy for evaluation of this patient. All told, gene test FoundationOne (procedure codes 81201, 81210, 81211, 81235, 81270, 81275, 81292, 81295, 81298 and 81321) performed on 4/6/16 was not likely to have been more efficacious than other methods of evaluating this patient.  Therefore, for the reasons stated above, the services at issue were not likely to have been 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 43-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/2/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer.  The physician reviewer found the tomosynthesis was approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2011. The American College of Radiology (ACR) urged the technique be removed from the investigational category in 2014 due to the advantages this new tomographic technique brings to radiologists interpreting mammograms. This technique often allows radiologists to separate dense glandular elements from underlying masses and architectural distortion resulting in a decrease in callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to this patient than had her exam been done with two-dimensional imaging alone. Accordingly, the breast tomosynthesis that was performed on 9/2/16 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 service 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: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 63-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines recommend that treatment-naive genotype 1a patients should be treated with Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA)-approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment (Jezequel, et al). For these reasons, the requested treatment with Harvoni is supported as medically necessary for the treatment of this patients hepatitis C infection. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3 
 
A 65-year-old male enrollee has requested reimbursement for polymerase chain reaction (PCR) 
testing on 8/10/21. The Health Insurer has denied this request and reported that the service at 
issue was investigational for the evaluation of the enrollees severe diarrhea. The physician 
reviewer found that while PCR stool testing is indicated for patients who have severe illness or 
high-risk comorbidities, it is not indicated for patients whose diarrhea symptoms have resolved. 
In  this  clinical  setting,  standard  diagnostic  testing  involves  performing  stool  cultures  for 
microbiologic stool testing, which can identify the most common bacterial causes of diarrhea. 
PCR testing is not likely to be more beneficial than standard diagnostic testing as any specimens 
that test positive on a PCR test would need to be submitted for confirmatory stool culture for 
susceptibility testing. Therefore, PCR testing on 8/10/21 was not likely to have been more 
beneficial for the evaluation of the patients condition than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 67-year-old male enrollee has requested reimbursement for clonoSEQ assay test performed on 9/13/20. 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 the patient had B-cell clonality, otherwise known as B-cell receptor gene rearrangement analysis, for diagnostic purposes. According to the National Comprehensive Cancer Network guidelines, the initial diagnosis of any B-cell non-Hodgkin lymphoma routinely involves, aImmunohistochemistry, flow cytometry, molecular analysis to detect B-cell receptor (PCR) and T-cell receptor (TCR) gene rearrangements, karyotype or FISH for major translocations.a In this case, the technique to detect the B-cell receptor rearrangement was next generation sequencing.  The goal is to detect a gene rearrangement establishing clonality and B-cell origin for the neoplastic cells. Additionally, subtyping mantle cell lymphoma immunoglobulin heavy chain variable gene sequencing can aid in subtyping the neoplasms. Therefore, clonoSEQ assay test performed on 9/13/20 was likely to have been more beneficial for the evaluation of the patient than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

The parent of a 14-year-old female enrollee has requested authorization and coverage for colon motility (manometric) study, minimum six hours continuous recording (including provocation tests, e.g., meal, intracolonic balloon distension, pharmacologic agents, if performed), with interpretation and report, procedure code 91117, and associated one day inpatient admission. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollee, who has a history of bowel incontinence. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. The requested services are likely to further help in her care and potentially change her management.  Her provider needs this information before deciding on whether this patient needs surgery. Therefore, the requested colon motility (manometric) study, minimum six hours continuous recording (including provocation tests, e.g., meal, intracolonic balloon distension, pharmacologic agents, if performed), with interpretation and report, procedure code 91117, and associated one day inpatient admission is likely to be of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2


A 44-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/18/16.  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 that breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities.  This has been shown to be most useful in the evaluation of dense breasts.  However, in this patients case, there were no problems to be resolved.  The patient did not have dense breasts, a mass, palpable lumps, or suspicious calcifications.  In this clinical setting, a routine mammogram would have been sufficient.  Digital breast tomosynthesis has not been shown to provide significant increased value in patients who do not have dense tissue that could obscure an abnormality. Therefore, breast tomosynthesis performed on 3/18/16 was not likely to have been of greater benefit than other modalities for 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 1


A 53-year-old female enrollee has requested reimbursement for the ColonSentry testing performed on 1/20/15. The Health Insurer has denied this request indicating that the diagnostic testing at issue is considered investigational for evaluation of the enrollees risk for colorectal cancer.  The physician reviewer found that review of the submitted documentation and relevant literature fails to support the services at issue in this clinical setting. ColonSentry is a seven-gene panel test that determines a patients risk of colon cancer. It is not a substitute for colon cancer screening such as with routine colonoscopy. With no family history of colon cancer this patient is considered an average risk patient and ColonSentry testing is not recommended by any of the major published guidelines cited above as appropriate screening for average risk patients. Based on the lack of support in the peer-reviewed literature, the ColonSentry testing performed on 1/20/15 was not likely to be more beneficial for evaluation of the patients medical condition than other modalities. 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 45-year-old male enrollee has requested reimbursement for ipilimumab and nivolumab provided on 6/11/19, 7/02/19, 7/23/19 and 8/13/19. The Health Insurer has denied this request and reported that the medications at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has a rare metastatic non-clear cell renal cell carcinoma. Among the non-clear cell histologies, renal medullary carcinoma is extremely rare, comprising approximately 2% of all primary renal tumors in young people. Medullary renal carcinoma is a rare and aggressive cell carcinoma variant that almost exclusively arises in patients who are sickle-cell trait positive. Metastatic disease is seen at presentation in 67% to 95% of patients. Chemotherapy remains the focus of treatment for this subtype. Given the lack of benefit of standard therapies and the significant benefit of ipilimumab and nivolumab in patients with non-clear cell renal cell, including some limited data in medullary, the medications at issue were likely to have been superior over any available standard therapy. Therefore, ipilimumab and nivolumab provided on 6/11/19, 7/02/19, 7/23/19 and 8/13/19 were likely to have been more beneficial than other available treatment options.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 52-year-old female enrollee has requested authorization and coverage for matrix-assisted autologous chondrocyte implantation (MACI) procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees knee pain. The physician reviewer found that the records note chronic bilateral patellofemoral knee pain with chondral defects and kissing lesions that have been well-documented at the time of arthroscopy. There is sufficient support for the requested MACI procedure in this setting. Kreuz and colleagues evaluated the long-term clinical and radiological outcome of MACI for articular cartilage defects in the knee joint, and 21 patients with full-thickness grade IV cartilage defects were included. The clinical and radiological outcomes 12 years after transplantation revealed persisting good results of the mid-term follow-up. Based on a review of the recent medical literature, the MACI procedure is a good option for full thickness chondral defects. Thus, the requested MACI procedure is likely to be more effective than other available 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: Experimental
Decision: Overturned

Summary Reviewer 1

A 63-year-old male enrollee has requested reimbursement for Guardant360 liquid biopsy test performed on 9/14/20. 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 inoperable advanced pancreatic cancer is an incurable disease, but chemotherapy can prolong survival. In all cases, the genetic mutations that are present with pancreatic cancer can provide prognostic significance and can help direct therapy. Mutational analysis is also part of the algorithms that are included within the National Comprehensive Cancer Network guidelines. According to the National Comprehensive Cancer Network guidelines, aGermline testing is recommended for any patient with confirmed pancreatic cancer, using comprehensive gene panels for hereditary cancer syndromes. Genetic counseling is recommended for patients who test positive for a pathogenic mutation or for patients with a positive family history of cancer, especially pancreatic cancer, regardless of mutation status.a  The guidelines also state, aTumor/somatic gene profiling is recommended for patients with locally advanced/metastatic disease who are candidates for anticancer therapy to identify uncommon mutations...Testing on tumor tissue was preferred; however, cell-free DNA testing can be considered if tumor tissue testing is not feasible.a In this case, the records noted that tissue-based testing was not feasible. There is sufficient support for the services at issue in this clinical setting. Therefore, Guardant360 liquid biopsy test performed on 9/14/20 was likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 54-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions. In addition, AASLD/IDSA the guidelines state that high priority for treatment owing to high risk for complications includes patients with fibrosis of Metavir F2. This patient has a Metavir of F2; hence, treatment is indicated. Therefore, Harvoni should be approved as medically necessary based on national guidelines. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.