This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
PancraGEN testing is considered experimental/investigational (E/I), and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
- Experimental/Investigational molecular and genomic (MolGen) tests refer to assays involving chromosomes, DNA, RNA, or gene products that have insufficient data to determine the net health impact, which typically means there is insufficient data to support that a test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (clinical utility), and/or performs better than an existing standard of care medical management option. Such tests are also not generally accepted as standard of care in the evaluation or management of a particular condition.
- In the case of MolGen testing, FDA clearance is not a reliable standard given the number of laboratory developed tests that currently fall outside of FDA oversight and FDA clearance often does not assess clinical utility.
- A small base of evidence comprised of a few clinical studies have evaluated the correlation between genetic testing using the PancraGen test and histology, cytology and pathology of surgical or biopsy specimens of pancreatic tissue. Two of the most relevant studies, both published by the manufacturer and evaluating the same patient population, reported results of a retrospective analysis of the National Pancreatic Cyst Registry study (n=492).
- In the study by Al-Haddad et al. (2015), patients underwent testing with PathFinderTG (now PancraGEN) and were followed to evaluate disease progression to malignancy. Diagnostic performance of PathFinder TG testing were compared with a set of international consensus guidelines, published in 2012, used for disease management in clinical practice. After a median follow up of 35 months, negative predictive values and sensitivity values for PathFinderTG and consensus guidelines were comparable, although positive predictive value and positive likelihood ratios were significantly improved for PathFinder TG. Study authors concluded that the PathFinder TG test may improve disease management by supporting a surveillance decision established by the Sendai guideline criteria.
- In the same study population from the National Pancreatic Cyst Registry described in by Al-Haddad et al. (n=491), Loren et al. (2016) compared the association between diagnoses made with PancraGEN and those made with the consensus guidelines by Sendai and Fukouka (2012), and also reported on the subsequent clinical decisions made in the real world regarding choices made for either surveillance or surgical intervention. Study results suggest that testing with PancraGEN testing is significantly associated with real-world decisions, although it is not known if physician influence or patient preferences could have also impacted these decisions. Study results suggest that PancraGEN testing might properly reclassify some patients misclassified by consensus guidelines.
- Limitations of the evidence include retrospective study designs, limited follow-up times to adequately observe malignant progression, and a very small number of cases where results of PancraGEN and consensus guidelines do not agree.
- Given that the evidence base consists primarily of retrospective study designs, it is not clear if PancraGEN would perform well in a broad, general population of patients with pancreatic cysts. Small sample sizes may lead to imprecise estimates of test accuracy.
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Experimental/Investigational (E/I) services are not covered regardless of place of service.
PancraGEN is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
