Commercial

Medical Policy

Notification

Molecular Testing for the Management of Pancreatic Cysts or Barrett's Esophagus (Independence Administrators)

Notification Issue Date:

This version of the policy will become effective on 06/17/2019.

The title of the policy has been changed
FROM: PathFinderTG® (AmeriHealth Administrators)
TO: Molecular Testing for the Management of Pancreatic Cysts or Barrett's Esophagus.

This policy communicates that molecular testing using PathFinderTG®, PancraGEN®, and BarreGEN® are considered experimental/investigational and, therefore, not covered because the safety and effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Title:

Molecular Testing for the Management of Pancreatic Cysts or Barrett's Esophagus (Independence Administrators)

Policy #:

06.02.36d

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

This policy only applies to members for whom Independence Administrators serves as the claims administrator and whose group has not enrolled in the UM vendor program. For those groups who have been given the option to enroll in the UM vendor program, this policy is no longer applicable upon their renewal effective date. Individual member benefits must be verified before/prior to providing services.

The intent of this policy is to communicate the coverage positions for Molecular Testing for the Management of Pancreatic Cysts or Barrett's Esophagus; specifically PathFinderTG®, PancraGEN®, and BarreGEN®.

For information on policies related to this topic, refer to the Cross References section in this policy.

EXPERIMENTAL/INVESTIGATIONAL

Molecular testing using PathFinderTG®, PancraGEN®, and BarreGEN® are considered experimental/investigational and, therefore, not covered because the safety and effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, PathFinderTG®, PancraGEN®, and BarreGEN® are not eligible for payment under the medical benefits of the Company’s commercial products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments. Patented diagnostic tests (e.g., PancraGEN™) are available only through Interpace Diagnostics (formerly RedPath Integrated Pathology, (although the former name may still be used in the marketplace) under the auspices of the Clinical Laboratory Improvement Amendments. Laboratories that offer laboratory-developed tests must be licensed by the Clinical Laboratory Improvement Amendments for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of this test.

Description

MUCINOUS NEOPLASM OF THE PANCREAS

True pancreatic cysts are fluid-filled, cell-lined structures, which are most commonly mucinous cysts (intraductal papillary mucinous neoplasm [IPMN] and mucinous cystic neoplasm), which are associated with future development of pancreatic cancers. Although mucinous neoplasms associated with cysts may cause symptoms (e.g., pain, pancreatitis), an important reason that such cysts are followed is the risk of malignancy, which is estimated to range from 0.01% at the time of diagnosis to 15% in resected lesions.

MANAGEMENT

Given the rare occurrence but the poor prognosis of pancreatic cancer, there is a need to balance potential early detection of malignancies while avoiding unnecessary surgical resection of cysts. Several guidelines address the management of pancreatic cysts, but high-quality evidence to support these guidelines is not generally available. Although recommendations vary, first-line evaluation usually includes an examination of cyst cytopathologic or radiographic findings and cyst fluid carcinoembryonic antigen. In 2012, an international consensus panel published statements on the management of IPMN and mucinous cystic neoplasm of the pancreas. These statements are referred to as the Fukouka Consensus Guidelines and were based on a symposium held in Japan in 2010, which updated a 2006 publication (Sendai Consensus Guidelines) by this same group. The panel recommended surgical resection for all surgically fit individuals with main duct IPMN or mucinous cystic neoplasm. For branch duct IPMN, surgically fit individuals with cytology suspicious or positive for malignancy are recommended for surgical resection, but individuals without “high-risk stigmata” or “worrisome features” may be observed with surveillance. “High-risk stigmata” are obstructive jaundice in proximal lesions (head of the pancreas); the presence of an enhancing solid component within the cyst; or 10 mm or greater dilation of the main pancreatic duct. “Worrisome features” are pancreatitis; lymphadenopathy; cyst size 3 cm or greater; thickened or enhancing cyst walls on imaging; 5 to 10 mm dilation of the main pancreatic duct; or abrupt change in pancreatic duct caliber with distal atrophy of the pancreas.

The American Gastroenterological Association (2015) published guidelines on the evaluation and management of pancreatic cysts; it recommended individuals undergo further evaluation with endoscopic ultrasound-guided fine-needle aspiration only if the cyst has 2 or more worrisome features (size ≥3 cm, a solid component, a dilated main pancreatic duct). The guidelines also recommended that individuals with these “concerning features” confirmed on fine-needle aspiration undergo surgery.

BARRETT'S ESOPHAGUS

Barrett's esophagus refers to the replacement of normal esophageal epithelial layer with metaplastic columnar cells in response to chronic acid exposure from gastroesophageal reflux disease. The metaplastic columnar epithelium is a precursor to esophageal adenocarcinoma. These tumors frequently spread before symptoms are present so detection at an early stage might be beneficial.

MANAGEMENT

Surveillance for esophageal adenocarcinoma is recommended for those diagnosed with Barrett's esophagus. However, there are few data to guide recommendations about management and surveillance, and many issues are controversial. In 2015 guidelines from the American College of Gastroenterology (ACG) and a consensus statement from an international group of experts (Benign Barrett’s and CAncer Taskforce) on the management of Barrett's esophagus were published. ACG recommendations for surveillance are stratified by the presence of dysplasia. When no dysplasia is detected, ACG has reported the estimated risk of progression to cancer for individualsranges from 0.2% to 0.5% per year and ACG has recommended endoscopic surveillance every 3 to 5 years. For low-grade dysplasia, the estimated risk of progression is about 0.7% per year, and ACG has recommended endoscopic therapy or surveillance every 12 months. For high-grade dysplasia, the estimated risk of progression is about 7% per year, and ACG has recommended endoscopic therapy. The Benign Barrett’s and CAncer Taskforce consensus group did not endorse routine surveillance for people with no dysplasia and was unable to agree on surveillance intervals for low-grade dysplasia.

SOLID PANCREATICOBILIARY LESIONS

Solid pancreaticobiliary lesions refer to lesions found on the pancreas, gallbladder, or biliary ducts. A solid lesion may be detected as an incidental finding on computed tomography scans performed for another reason, though this occurs rarely. The differential diagnosis of a solid pancreatic mass includes primary exocrine pancreatic cancer, pancreatic neuroendocrine tumor, lymphoma, metastatic cancer, chronic pancreatitis, or autoimmune pancreatitis.

MANAGEMENT

Currently, if a transabdominal ultrasound confirms the presence of a lesion, an abdominal computed tomography scan is performed to confirm the presence of the mass and determine disease extent. If the computed tomography provides enough information to recommend a resection and if the patient is able to undergo the procedure, no further testing is necessary. If the diagnosis remains unclear, additional procedures may be recommended. Symptomatic individuals undergo cytology testing. If results from cytology testing are inconclusive, fluorescent in situ hybridization molecular testing of solid pancreaticobiliary lesions is recommended. PancraGEN topographic genotyping is being investigated as either an alternative to or as an adjunct to fluorescent in situ hybridization in the diagnostic confirmation process.

TOPOGRAPHIC GENOTYPING

Topographic genotyping, also called molecular anatomic pathology, integrates microscopic analysis (anatomic pathology) with molecular tissue analysis. Under microscopic examination of tissue and other specimens, areas of interest may be identified and microdissected to increase tumor cell yield for subsequent molecular analysis. Topographic genotyping may permit pathologic diagnosis when first-line analyses are inconclusive.

Interpace Diagnostics (still may use the name RedPath Integrated Pathology for certain tests) has patented a proprietary platform called PathFinderTG; it provides mutational analyses of patient specimens. The patented technology permits analysis of tissue specimens of any size, “including minute needle biopsy specimens,” and any age, “including those stored in paraffin for over 30 years.” Interpace currently describes in detail 1 PathFinderTG test called PancraGEN on its website and describes another PathFinder test called BarreGEN as in a “soft launch” (listed and briefly described in the table below). As stated on the company website, PancraGEN integrates molecular analyses with first-line results (when they are inconclusive) and pathologist interpretation.

The manufacturer calls this technique integrated molecular pathology. Test performance information is not provided on the website.

PATHFINDERTG TESTS

Test	Description	Specimen Types
PathFinderTG Pancreas (now called PancraGEN)	Uses loss of heterozygosity markers, oncogene variants, and DNA content abnormalities to stratify individuals according to their risk of progression to cancer	Pancreatobiliary fluid/ERCP brush, pancreatic masses, or pancreatic tissue
PathFinderTG Barrett (now called BarreGEN)	Measures the presence and extent of genomic instability and integrates those results with histology	Esophageal tissue

ERCP: endoscopic retrograde cholangiopancreatography.

ANALYSES OF PEER-REVIEWED LITERATURE

Evidence review evaluated 3 representative applications of topographic genotyping-pancreatic cysts, gliomas, and Barrett's esophagus. At present, Interpace Diagnostics offers tests using its technology to evaluate individuals with pancreatic cysts, Barrett's esophagus, and solid pancreaticobiliary lesions.

PANCREATIC CYSTS

PathFinderTG (Interpace Diagnostics) gene variant profiles are intended to inform complex diagnostic dilemmas in individuals at risk of cancer. The manufacturer’s website states specifically that the PancraGEN technology is “intended to be an adjunct to first line testing” and suggests that the test is useful in assessing who will benefit most from surveillance and or surgery. The clinical purpose of PancraGEN is to allow individuals with low-risk cysts to avoid unnecessary surgery or to select individuals with malignant lesions for surgery more accurately. PancraGEN would likely be used in conjunction with clinical and radiologic characteristics, along with cyst fluid analysis; therefore, one would expect an incremental benefit to using the test. The PathFinderTG Pancreas test (now called PancraGEN) combines measures of loss of heterozygosity (LOH) markers, oncogene variants, and DNA content abnormalities to stratify patients according to their risk of progression to cancer.

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.

Farrell and colleagues assessed the incremental value of DNA markers when applied against a clinically stratified patient population, rather than using the clinical information in aggregate as part of Integrated Molecular Pathology scoring. The absence of DNA abnormalities allowed a reduction in malignancy risk in patients with worrisome clinical findings (incremental relative risk of malignancy 0.4 (0.1-1.1 95% CI) to that of patients with no worrisome features or high risk stigmata.

A retrospective assessment of the clinical utility of DNA biomarkers was performed by Arner and colleagues. Results of DNA marker testing changed management decisions (as made by each of 2 experts in a retrospective case review) in approximately 27% of cases.

The performance DNA markers in assessing the malignant potential of intraductal papillary mucinous neoplasm, both independently and as part of the Integrated Molecular Pathology malignancy risk score was evaluated by two studies. The same study population, identified through retrospective chart-review, was used for both.

The evidence for the clinical validity of PancraGEN consists of several retrospective studies. Most evaluated performance characteristics of PancraGEN for classifying pancreatic cysts according to the risk of malignancy without comparison to current diagnostic algorithms. The best evidence regarding incremental clinical validity comes from the report from the NPCR, which compared PancraGEN performance characteristics with current international consensus guidelines and found that PancraGEN has slightly lower sensitivity (83% vs 91%), similar NPV (97% vs 97%), but better specificity (91% vs 46%) and PPV (58% vs 21%) than the consensus guidelines. The registry study included a very select group of patients, only a small fraction of all enrolled patients, and used a retrospective design. Longer follow-up including more of the registry individualsis needed. The manufacturer has indicated the technology is meant as an adjunct to first-line testing, but no algorithm for combining PancraGEN with consensus guidelines for decision making has been proposed, and the data reporting outcomes in individualswhere the PancraGEN and consensus guideline diagnoses disagreed was limited. There are no prospective studies with concurrent control demonstrating that PancraGEN can affect patient-relevant outcomes (eg, survival, time to tumor recurrence, reduction in unnecessary surgeries). The evidence reviewed does not demonstrate that PathFinderTG has incremental clinical value in the diagnosis or prognosis of pancreatic cysts and associated cancer.

Limitations of the aforementioned 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.

BARRETT'S ESOPHAGUS

Evidence for the clinical validity of BarreGEN is limited, consisting of a single systematic review that did not identify relevant studies. It was unclear in two observational studies whether the specific test used was BarreGEN. There is limited evidence evaluating the clinical validity of the BarreGEN test for assessing Barrett's esophagus. The evidence reviewed does not demonstrate that BarreGEN testing for prognosis of Barrett's esophagus adds incremental value to current prognostic assessments. No studies assessing the clinical utility of BarreGEN in this population were found.

SOLID PANCREATICOBILIARY LESIONS

The evidence for the clinical validity of using PancraGEN to evaluate solid pancreaticobiliary lesions consists of several retrospective studies. One study evaluated the performance characteristics of PancraGEN for classifying solid pancreatic lesions while the other two evaluated the classification of biliary strictures. Biliary strictures may be caused by solid pancreaticobiliary lesions but may have other causes. The authors of the studies did not specify what proportion of individuals with biliary stricture had solid pancreaticobiliary lesions. Compared to cytology alone, the use of cytology plus FISH plus PancraGEN increased sensitivity significantly. The incremental value of using cytology plus FISH plus PancraGEN over cytology plus FISH is unclear. The manufacturer has indicated that the technology is meant as an adjunct to first-line testing, but no algorithm for combining PancraGEN with consensus guidelines for decision making has been proposed, nor has first-line testing been defined as cytology alone or cytology plus FISH. There are no prospective studies demonstrating that PancraGEN can affect patient-relevant outcomes (eg, survival, time to tumor recurrence, reduction in unnecessary surgeries). The evidence reviewed does not demonstrate that PathFinderTG has incremental clinical value for the diagnosis of solid pancreatic lesions and associated cancer.

Whether the tradeoff between avoiding biopsies and the potential for missed cancers is worthwhile depends, in part, on patient and physician preferences. In the context of pancreaticobiliary cancers, overall survival depends on detection of these cancers at early, more treatable stages. While there is indirect evidence that cytology plus FISH plus MP may predict more solid pancreaticobiliary lesions compared with cytology alone, the sensitivity is not sufficiently high enough to identify which individuals can forego biopsy. Missing a solid pancreaticobiliary lesion diagnosis at a rate of 30%, is not inconsequential. A delay in diagnosis would delay potential treatment (surgery and/or chemotherapy).

PRACTICE GUIDELINES AND POSITION STATEMENTS

AMERICAN GASTROENTEROLOGICAL ASSOCIATION

The American Gastroenterological Association (AGA; 2015) published guidelines on the diagnosis and management of asymptomatic neoplastic pancreatic cysts based on findings from a technical review. The technical review stated the following about molecular testing: “Case series have confirmed that malignant cysts have a greater number and quality of molecular alterations, but no study has been properly designed to identify how the test performs in predicting outcome with regard to need for surgery, surveillance, or predicting interventions leading to improved survival.” The AGA guidelines also stated: “Molecular techniques to evaluate pancreatic cysts remain an emerging area of research, and the diagnostic utility of these tests is uncertain.”

AGA (2011) published a medical position statement on the management of Barrett's esophagus. Based on findings from a technical review, AGA recommended: “against the use of molecular biomarkers to confirm the histological diagnosis of dysplasia or as a method of risk stratification for individuals with Barrett’s esophagus at this time (weak recommendation, low-quality evidence).”

AMERICAN COLLEGE OF GASTROENTEROLOGY

The American College of Gastroenterology (2015) released guidelines on the diagnosis and management of Barrett's esophagus. The guidelines stated: “Given the complexity and diversity of alterations observed to date in the progression sequence, a panel of biomarkers may be required for risk stratification. At the present time, no biomarkers or panels of biomarkers are ready for clinical practice. In order to become part of the clinical armamentarium, biomarkers will have to be validated in large prospective cohorts.”

The College (2018) published guidelines on the diagnosis and management of pancreatic cysts.The guidelines stated that the evidence for the use of molecular biomarkers for identifying high-grade dysplasia or pancreatic cancer is insufficient to recommend their routine use. However, molecular markers may help identify intraductal papillary mucinous neoplasms and mucinous cystic neoplasms in cases with an unclear diagnosis and if results are likely to change the management (conditional recommendation; very low quality evidence).

National Comprehensive Cancer Network

Current National Comprehensive Cancer Network guidelines for pancreatic adenocarcinoma (v.2.2018), central nervous system cancers (v.1.2018), and esophageal and esophagogastric junction cancers (v.2.2018), do not include recommendations for molecular anatomic pathology or integrated molecular pathology.

Network guidelines on hepatobiliary cancers (v.3.2018) state that molecular testing may be considered in the following situations:

Isolated intrahepatic mass (imaging characteristics consistent with malignancy but not consistent with hepatocellular carcinoma) that is unresectable or indicative of metastatic disease
Extrahepatic cholangiocarcinoma that is unresectable or indicative of metastatic disease.

SUMMARY

For individuals who have pancreatic cysts who do not have a definitive diagnosis after first-line evaluation and who receive standard diagnostic and management practices plus topographic genotyping (PancraGEN molecular testing), the evidence includes retrospective studies of clinical validity and clinical utility. Relevant outcomes are overall survival, disease-specific survival, test validity, change in disease status, morbid events, and quality of life. The best evidence regarding incremental clinical validity comes from the National Pancreatic Cyst Registry report that compared PancraGEN performance characteristics with current international consensus guidelines and provided preliminary but inconclusive evidence of a small incremental benefit for PancraGEN. The analyses from the registry study included only a small proportion of enrolled patients, relatively short follow-up time for observing malignant transformation, and limited data on cases where the PancraGEN results were discordant with international consensus guidelines.

For individuals who have Barrett's esophagus who receive standard prognostic techniques plus topographic genotyping (BarreGEN molecular testing), the evidence includes a systematic review. Relevant outcomes are overall survival, disease-specific survival, test validity, change in disease status, morbid events, and quality of life. The systematic review identified no studies relevant to this evidence review. Two observational studies were excluded based on BCBSA selection criteria because it was unclear whether the test used was specifically BarreGEN or whether the BarreGEN prognostic algorithm was applied for classification.

For individuals who have solid pancreaticobiliary lesions who do not have a definitive diagnosis after first-line evaluation and who receive standard diagnostic and management practices plus topographic genotyping (PancraGEN molecular testing), the evidence includes 3 observational studies of clinical validity. Relevant outcomes are overall survival, disease-specific survival, test validity, change in disease status, morbid events, and quality of life. Two of the 3 studies had populations with biliary strictures and the other had a population of individuals with solid pancreaticobiliary lesions. The studies reported higher sensitivities when PancraGEN and FISH testing was added to cytology results compared with cytology alone. However, the inclusion of individuals in the analysis who may not have solid pancreaticobiliary lesions (those with biliary strictures not caused by solid pancreaticobiliary lesions) limits the interpretation of the results. While preliminary results showed a potential incremental benefit for PancraGEN plus FISH plus cytology, further research focusing on individuals with solid pancreaticobiliary lesions is warranted. Whether the tradeoff between avoiding biopsies and the potential for missed cancers is worthwhile depends, in part, on patient and physician preferences. In the context of pancreaticobiliary cancers, overall survival depends on detection of these cancers at early, more treatable stages. While there is indirect evidence that cytology plus FISH plus MP may predict more solid pancreaticobiliary lesions compared with cytology alone, the sensitivity is not sufficiently high enough to identify which individuals can forego biopsy. Missing a solid pancreaticobiliary lesion diagnosis at a rate of 30%, is not inconsequential. A delay in diagnosis would delay potential treatment (surgery and/or chemotherapy).

References

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Trikalinos T, Terasawa T, Raman G, et al. Technology Assessment: A systematic review of loss-of-heterozygosity based topographic genotyping with PathfinderTG®. Rockville, MD: Agency for Healthcare Research and Quality;2010.

U.S. Patent #7,014,999. Finkelstein et al. March 21, 2006. Topographic genotyping. http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-adv.htm&r=16&f=G&l=50&d=PTXT&S1=(redpath+AND+specimen)&OS=redpath+AND+specimen&RS=(redpath+AND+specimen). Accessed August 30, 2018.

Vege SS, Ziring B, Jain R, et al. American Gastroenterological Association Institute guideline on the diagnosis and management of asymptomatic neoplastic pancreatic cysts. Gastroenterology. Apr 2015;148(4):819-822; quize812-813.

Winner M, Sethi A, Poneros JM, et al. The role of molecular analysis in the diagnosis and surveillance of pancreatic cystic neoplasms. JOP. Mar 20 2015;16(2):143-149.

Yantiss RK. Diagnostic challenges in the pathologic evaluation of Barrett's esophagus. Arch Pathol Lab Med. Nov 2010;134(11):1589-1600.

Coding

CPT Procedure Code Number(s)

THE FOLLOWING CODES ARE USED TO REPRESENT PATHFINDERTG®, PancraGEN®, and BarreGEN®

84999, 89240

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

This service is experimental/investigational for all diagnoses.

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 06.02.36d:

05/03/2023	This policy has been reissued in accordance with the Company's annual review process.
02/23/2022	This policy has been reissued in accordance with the Company's annual review process. The following disclaimer language…: This policy only applies to members for whom Independence Administrators serves as the claims administrator and whose group has not enrolled in the UM vendor program. For those groups who have been given the option to enroll in the UM vendor program, this policy is no longer applicable upon their renewal effective date. Individual member benefits must be verified before/prior to providing services. … is replacing this disclaimer language…: This policy only applies to members for whom Independence Administrators serves as the claims administrator. For all other Independence members, refer to the policy entitled eviCore Lab Management Program.

05/03/2023

This policy has been reissued in accordance with the Company's annual review process.

02/23/2022

This policy has been reissued in accordance with the Company's annual review process.

The following disclaimer language…:

This policy only applies to members for whom Independence Administrators serves as the claims administrator and whose group has not enrolled in the UM vendor program. For those groups who have been given the option to enroll in the UM vendor program, this policy is no longer applicable upon their renewal effective date. Individual member benefits must be verified before/prior to providing services.

… is replacing this disclaimer language…:

This policy only applies to members for whom Independence Administrators serves as the claims administrator. For all other Independence members, refer to the policy entitled eviCore Lab Management Program.

Revisions From 06.02.36c:

07/01/2022	This policy has been reissued in accordance with the Company's annual review process. The following disclaimer language…: This policy only applies to members for whom Independence Administrators serves as the claims administrator and whose group has not enrolled in the UM vendor program. For those groups who have been given the option to enroll in the UM vendor program, this policy is no longer applicable upon their renewal effective date. Individual member benefits must be verified before/prior to providing services. … is replacing this disclaimer language…: This policy only applies to members for whom Independence Administrators serves as the claims administrator. For all other Independence members, refer to the policy entitled eviCore Lab Management Program.
02/23/2022	This policy has been reissued in accordance with the Company's annual review process.
04/21/2021	This policy has been reissued in accordance with the Company's annual review process.
09/09/2020	This policy has been reissued in accordance with the Company's annual review process.
06/17/2019	This version of the policy will become effective on 06/17/2019. The title of the policy has been changed FROM: PathFinderTG® (AmeriHealth Administrators) TO: Molecular Testing for the Management of Pancreatic Cysts or Barrett's Esophagus. This policy communicates that molecular testing using PathFinderTG®, PancraGEN®, and BarreGEN® are considered experimental/investigational and, therefore, not covered because the safety and effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Revisions From 06.02.36b:

12/19/2018

This policy has been reissued in accordance with the Company's annual review process.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

6/17/2019

Version Issued Date:

6/17/2019

Version Reissued Date:

5/3/2023