CurrentCapital BluecrossPolicy MP 2.266

Molecular testing for the management of pancreatic cysts and solid pancreaticobiliary lesions

This policy governs coverage of PathFinderTG (PancraGEN) topographic genotyping used to evaluate pancreatic cyst fluid and solid pancreaticobiliary lesions for members of Capital BlueCross products to which the policy applies.

Policy Summary

PayerCapital Bluecross

PolicyMolecular testing for the management of pancreatic cysts and solid pancreaticobiliary lesions

Policy CodePolicy MP 2.266

Change TypeNo material changes

Effective Date10/1/2025

Next Review Date

Key ActionDo not request prior authorization for PathFinderTG/PancraGEN because the test is considered investigational and is not covered.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

InvestigationalCoverage stance

10/1/2025Effective

MP 2.266Policy #

81479, 84999, 89240, 0313UInvestigational codes

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inv-01: Investigation/Not covered

Covered when ALL of the following are met

Investigational determination: Molecular testing using the PathFinderTG system is considered investigational for all indications including evaluation of pancreatic cyst fluid and solid pancreaticobiliary lesions.

Insufficient evidence to conclude improvement in net health outcome based on available observational studies and registry data.

Molecular testing using the PathFinderTG (PancraGEN) system is considered investigational for all indications, including evaluation of pancreatic cyst fluid and solid pancreaticobiliary lesions. The policy determination is based on available evidence that is insufficient to demonstrate an improvement in net health outcome with the use of this test.

Available evidence consists primarily of retrospective observational studies and registry data that provide preliminary but inconclusive information about incremental benefit. Limitations include small analytic cohorts within larger registries, short follow-up for malignant transformation, inclusion of mixed patient populations in some studies, and insufficient data on discordant results. Because these data do not reliably demonstrate improved clinical outcomes, the evidence is insufficient to support coverage.

inv-20: None — test listed investigational for pancreatic cysts and solid pancreaticobiliary lesions

No covered indications identified; test is investigational for the listed specimen types

None — investigational: PathFinderTG (PancraGEN) topographic genotyping for evaluation of pancreatic cyst fluid, pancreatobiliary fluid/ERCP brush, pancreatic masses, or pancreatic tissue is investigational and not covered.

Although the technology is described as an adjunct when first-line analyses are inconclusive, evidence is insufficient to demonstrate net health benefit.

Procedure and billing codes

Procedure codes specifically identified in the policy as investigational and therefore not covered include 81479, 84999, 89240, and 0313U. Tests billed using these codes may be denied per the policy because the underlying molecular testing (PathFinderTG/PancraGEN) is considered investigational.

Investigational; therefore, not coveredCPT | HCPCS | mixedNot Covered

81479	Unlisted molecular pathology procedure
84999	Unlisted chemistry procedure
89240	Cytology, cell block preparation
0313U	Proprietary molecular test (as listed)

Investigational; therefore, not coveredCPTNot Covered

81479	Unlisted molecular pathology procedure
84999	Unlisted chemistry procedure
89240	Cytology, cell block
0313U	Proprietary molecular test (new code added in administrative history)

Provider responsibilities, prior authorization, and billing guidance

Prior Authorization

Prior Authorization — investigational tests

Prior authorization is required for investigational molecular tests described in this policy. Tests considered investigational (not covered) must have prior authorization requested when submitted for benefit determination; absence of prior authorization may result in claim denial.

Affected codes: 0313U, 81479, 84999, 89240, 84999 (other unspecified procedure codes listed as investigational)
Prior authorization required for program/product lines where this policy applies; check member-specific benefits

Note

Plan-dependent coverage and investigational code handling

Coverage of the tests described in this policy is plan-dependent. Presence of a CPT/HCPCS code in this document does not imply coverage. Verify member benefits and plan-specific medical policy applicability prior to ordering or billing.

FEP PPO: Refer to FEP Medical Policy Manual at https://www.fepblue.org/benefit-plans/medical-policies-and-utilization-managementguidelines/medical-policies
Confirm program applicability (some Capital BlueCross programs/products may be exempt)

Denial Risk

Investigational codes not covered

Investigational codes listed in this policy are considered not covered. Submitting investigational procedure codes may result in denial and potential member financial liability if ordered without documented medical necessity and prior authorization where required.

Investigational / not covered codes include: 0313U, 81479, 84999, 89240 (and other unspecified investigational procedure codes shown)
Do not assume separate reimbursement for investigational services; bundling or noncoverage may apply

Documentation Required

Program applicability and lab regulatory expectations (CLIA/high-complexity)

Laboratory-developed tests (LDTs) and other molecular assays must meet CLIA requirements for high-complexity testing. Providers should ensure testing laboratories are CLIA-certified for high-complexity testing and that any patented tests (e.g., PancraGEN) are obtained through authorized vendors.

Labs must be CLIA high-complexity certified to offer LDTs referenced in this policy
Patented tests (e.g., PancraGEN) are available only through Interpace Diagnostics; FDA has not required regulatory review to date

Documentation Required

Verify member benefits and coding

Verify member benefits, program applicability, and correct coding before ordering tests. If coverage is uncertain, obtain prior authorization and document clinical rationale, prior testing (imaging, cytology, FISH/CEA as applicable), and why an investigational test is being considered.

Document prior diagnostic sequence (imaging ± cytology; FISH recommended when cytology inconclusive) when submitting for authorization
Include clinical notes showing how testing will impact management to support any coverage requests

Services and codes not covered

PathFinderTG (PancraGEN) molecular testing for pancreatic cysts and solid pancreaticobiliary lesions is considered investigational and not covered. The policy concludes that current evidence is insufficient to demonstrate that use of this test improves relevant clinical outcomes and therefore does not support routine clinical use for these indications.

Molecular tests billed with the listed investigational procedure codes are considered not covered. Specifically, claims submitted with 81479, 84999, 89240, or 0313U to report PathFinderTG/PancraGEN testing are investigational and may be denied according to plan rules.

Background and rationale

Topographic genotyping (also termed molecular anatomic pathology) integrates microscopic/anatomic pathology microdissection with molecular analyses to increase tumor cell yield from selected areas and characterize molecular abnormalities (for example, loss of heterozygosity, oncogene variants, and DNA content changes). PathFinderTG (marketed as PancraGEN) applies this approach to pancreatic cyst fluid and cytology specimens to attempt risk stratification of cysts and aid diagnosis of solid pancreaticobiliary lesions. Although the technology is intended as an adjunct to standard diagnostics when first-line evaluation is inconclusive, available clinical evidence has not established that its use improves patient outcomes.

Key definitions

Topographic genotyping / PathFinderTG (PancraGEN) definition

TermTopographic genotyping (PathFinderTG / PancraGEN)

DefinitionA proprietary platform (PathFinderTG, now marketed as PancraGEN) that integrates microscopic anatomic pathology with molecular tissue analysis; areas of interest are microdissected to increase tumor cell yield for subsequent molecular analysis.

Analytes / outputsLoss of heterozygosity markers, oncogene variants, and DNA content abnormalities used to stratify risk of progression to cancer.

Specimen typesPancreatobiliary fluid/ERCP brush, pancreatic masses, or pancreatic tissue (including minute needle biopsy specimens and archived paraffin blocks).

Proprietary / regulatory notePatented technology provided by RedPath Integrated Pathology (now Interpace Diagnostics) as a laboratory service.

Molecular analysis / mutational profiling definition

TermMolecular analysis / mutational profiling

DefinitionAnalysis of DNA and other molecular markers from pancreatic cyst fluid or cytology specimens to help determine cyst type and malignant potential.

Example targetsKRAS and GNAS mutations, microsatellite loss of heterozygosity (LOH), and other oncogene variants as reported in referenced studies.

Clinical useUsed to aid differentiation of benign and malignant pancreatic lesions and to stratify risk when first-line diagnostic tests are inconclusive.

Evidence sourcesPublished studies and case series (e.g., PANDA study, EUS-guided DNA analysis, microsatellite LOH research) referenced in the policy.

OpenPayer