CurrentSelectHealthPolicy 603

PancraGEN Molecular Diagnostic Test for Evaluation of Pancreatic Cysts

SelectHealth coverage policy for use of the PancraGEN (Interpace Diagnostics) molecular diagnostic test in the evaluation of pancreatic cysts for Commercial, Medicare, and Medicaid/CHIP members.

Policy Summary

PayerSelectHealth

PolicyPancraGEN Molecular Diagnostic Test for Evaluation of Pancreatic Cysts

Policy CodePolicy 603

Change TypeModified exclusion (material)

Effective DateNov 29, 2016

Next Review Date

Key ActionDo not bill for PancraGEN for routine evaluation of pancreatic cysts for Commercial and CHIP members because the test is not covered.

SourceLink

POLICY UPDATE CHANGES

For Commercial Plan Policy, modified exclusion to state Select Health does NOT cover the PancraGEN molecular diagnostic test for routine evaluation of pancreatic cysts as it is considered experimental/investigational.

15genetic markers measured by PancraGEN

10chromosomal regions assessed

~1,500samples reported in literature since 2006

75-100%reported specificity range in studies

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Not covered for Commercial and CHIP

Commercial Plan Coverage Stance

Commercial exclusion: Select Health does NOT cover the PancraGEN molecular diagnostic test for routine evaluation of pancreatic cysts as it is considered experimental/investigational.

Policy explicitly states noncoverage for Commercial and CHIP plans.

Medicare/Medicaid applicability

Medicare and Medicaid rules

Alternate determinations: Medicare coverage is determined by the Centers for Medicare and Medicaid Services (CMS); if CMS has not adopted a coverage determination and InterQual criteria are not available, the Select Health Commercial policy applies.

Implies Commercial policy (noncoverage) will apply when no higher-level determination exists.

State Medicaid determination: Utah State Medicaid determines coverage for Select Health Community Care (Medicaid); if Utah State Medicaid has no published coverage position and InterQual criteria are not available, the Select Health Commercial criteria will apply.

Implies Commercial policy (noncoverage) will apply when no state-level determination exists.

Select Health does NOT cover the PancraGEN (Interpace Diagnostics) molecular diagnostic test for routine evaluation of pancreatic cysts. The policy specifies that PancraGEN is considered experimental/investigational for this indication and is excluded from coverage for Commercial Plan and CHIP members.

The peer-reviewed literature does not demonstrate sufficient clinical utility of PancraGEN to support coverage. Multiple systematic reviews and primary studies (approximately 1,500 samples reported since 2006) show some measure of clinical validity, including high specificity in some studies, but overall the evidence fails to show that test use alters management to improve clinical outcomes (morbidity, mortality, or progression-free survival).

Individual studies and reviews note that while molecular testing may increase diagnostic sensitivity and specificity when combined with clinical features, the body of evidence is limited, study quality is low, and there is a lack of prospective data showing improved patient outcomes or demonstrated impact on management decisions sufficient to justify routine use.

PancraGEN integrates cytology, cyst fluid chemistry, imaging parameters, and DNA analysis (measuring 15 genetic markers across 10 chromosomal regions including KRAS and GNAS), but although these data may stratify malignancy risk, current evidence is inadequate to establish that topographic genotyping results in improved clinical outcomes or meaningful clinical utility.

Covered Indications

No covered indications are listed. The policy states the PancraGEN molecular diagnostic test is not covered for routine evaluation of pancreatic cysts.

Policy explicitly lists the test as experimental/investigational and not covered for Commercial and CHIP plans.

Coding

CPT codes (listed as unlisted molecular/chemistry procedures)CPT

81479	Unlisted molecular pathology procedure
84999	Unlisted chemistry procedure

HCPCS codesHCPCS

No codes listed

CEA concentration category — intermediate 45-800 ng/mL

CEA concentration categoryIntermediate: 45–800 ng/mL

Clinical implicationDNA molecular analysis most often alters management when CEA is intermediate (45–800 ng/mL)

Source studyArner et al (2018) retrospective review referenced in policy

Provider Actions and Documentation

Note

Recommended diagnostic sequence

Recommended initial diagnostic evaluation for pancreatic cysts includes high-quality cross-sectional imaging and targeted sampling when indicated. Obtain MRI with MRCP as the first step to characterize cyst morphology and assess high-risk features (for example, cyst > 3 cm, a solid component, or main pancreatic duct dilation). If further characterization is needed, perform endoscopic ultrasound with fine-needle aspiration (EUS-FNA) to provide detailed imaging and enable cyst fluid sampling for cytology and biochemical analysis (CEA, amylase). Intraductal EUS may increase diagnostic accuracy but is not part of routine evaluation.

First-line imaging: MRI with MRCP
If indicated: EUS-FNA with cyst fluid analysis (cytology, CEA, amylase)
Intraductal EUS: not routine

Documentation Required

Supporting clinical documentation

Providers should supply prior relevant clinical documentation when requesting advanced molecular testing for pancreatic cysts. Include prior imaging reports (MRI/MRCP, CT), EUS findings, and results of cyst fluid testing such as cytology, CEA, and amylase. Documentation of cyst features (size, solid component, ductal dilation) and the clinical rationale for additional testing should be provided to support medical necessity.

Eligibility Requirements

No top-level eligibility criteria are specified for PancraGEN in this policy. The document contains zero defined eligibility nodes and does not list any covered indications that would render PancraGEN medically necessary for routine evaluation of pancreatic cysts.

Not Covered

PancraGEN is considered not covered as it is classified experimental/investigational for routine evaluation of pancreatic cysts. Select Health states that PancraGEN is not supported because the literature is insufficient to demonstrate that topographic genotyping improves clinical outcomes or clinical utility.

For Commercial Plan and CHIP members, requests for PancraGEN for routine pancreatic cyst evaluation will be denied in accordance with this noncoverage determination.

Background

Pancreatic cystic lesions are commonly detected incidentally on abdominal imaging and increase in prevalence with age. Initial evaluation requires cross-sectional imaging, typically MRI with MRCP, to characterize cyst type and identify features associated with higher malignancy risk (for example, cyst size > 3 cm, a solid component, or main pancreatic duct dilation).

Endoscopic ultrasound with fine-needle aspiration (EUS-FNA) provides high-quality imaging and allows sampling of cyst fluid for cytology and chemistry (including CEA and amylase). When these standard tests are indeterminate, integrated molecular tests such as PancraGEN have been studied to further stratify malignancy risk, but the policy does not authorize routine coverage.

Some studies suggest molecular analysis may be most helpful when cyst fluid CEA is in an intermediate range (45–800 ng/mL) or when CEA is unavailable, but additional research is needed to confirm clinical benefit and impact on management decisions.

Definitions

PancraGEN — test description and markers measured (cytology, chemistry, DNA analysis)

Test name and vendorPancraGEN (Interpace Diagnostics LLC; formerly Pathfinder TG)

Sample types analyzedCyst fluid cytology and cyst fluid chemistry (CEA, amylase)

DNA analysis componentsMeasures quantity, quality, DNA damage including loss of heterozygosity (LOH) and oncogene point mutations

Genetic markers measured15 genetic markers across 10 chromosomal regions including KRAS and GNAS

High risk stigmata (HRS) and Worrisome features (WFs) — clinical/imaging features used to stratify cyst risk

High-risk stigmata (HRS) — examplesJaundice; main pancreatic duct > 1 cm; solid pancreatic mass