Currentharvard pilgrim health carePolicy N/A

Molecular Diagnostic Testing Prior Authorization

Defines prior authorization requirements and program management for a broad set of molecular diagnostic tests for Harvard Pilgrim members, including which tests require authorization, who must request it, and how denials/changes are handled.

Policy Summary

Payerharvard pilgrim health care

PolicyMolecular Diagnostic Testing Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionOrdering clinicians must start the Carelon prior authorization process on or before the sample collection date and obtain approval before testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11/01/24most recent update noted

Carelonmanaged by

24/7authorization access

TXN# requiredtransaction requirement

~200+listed codes

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.

This prior authorization policy applies to Harvard Pilgrim members for the molecular diagnostic services listed in the program and managed through Carelon Medical Benefits Management. It does not apply to members with the Choice or Choice Plus products offered through Passport Connect unless otherwise specified. The program covers a broad range of services including reproductive carrier screening, prenatal diagnosis, preimplantation genetic testing, single-gene and multifactorial testing, whole exome/genome sequencing, hereditary cancer and cardiac testing, tumor molecular testing, and pharmacogenetic testing.

The Referral/Notification/Authorization section of this document lists CPT and PLA/unique codes and includes descriptions for each test to support prior authorization processing. Entries serve to identify which molecular diagnostic services are subject to Carelon authorization procedures and provide test descriptions, sample types, and gene/panel size information that should be supplied with authorization requests.

Certain proprietary/PLA codes are explicitly restricted from being reported with specified CPT exome/genome procedure codes. For example, 0212U is not to be reported with 81425; 0213U is not to be reported with 81426; 0214U is not to be reported with 81415; and 0215U is not to be reported with 81416. These reporting prohibitions are noted alongside the PLA code descriptions in the Referral/Notification/Authorization listings.

The policy publication history documents multiple updates over time. The 08/12/20 update included numerous language additions to reflect that portions of the prior medical policy were retired and added clarifying language related to denials for failure to notify. Subsequent coding and administrative updates are recorded in the publication history.

Coding — Managed Codes and Groups

Billable CPT Codes managed by CarelonCPT

81120
81121	81121.
81161	81161.
81162	81162.
81163	81163.
81164	81164.
81165	81165.
81166	81166.
81167	81167.
81168

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Listed Molecular/Genetic/Cancer Panels and ProceduresCPT | HCPCS | mixed

81266	Comparative analysis using Short Tandem Repeat (STR) markers; each additional specimen
81272	KIT gene (e.g., GIST) analysis
81301	Microsatellite instability analysis, includes comparison of neoplastic and normal tissue, if performed
81329	SMN1 gene analysis; dosage/deletion analysis, includes SMN2 analysis, if performed
81400	Molecular pathology procedure, Level 1
81401	Molecular pathology procedure, Level 2
81402	Molecular pathology procedure, Level 3
81403	Molecular pathology procedure, Level 4
81404	Molecular pathology procedure, Level 5
81405	Molecular pathology procedure, Level 6

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PLA/Unique codes (excerpt)mixed

0049U	0049U
0050U	0050U
0055U	0055U
0060U	0060U
0069U	0069U
0070U	0070U
0071U	0071U
0073U	0073U
0074U	0074U
0075U	0075U

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PLA/Unique codes (detailed excerpt)mixed

0101U	Hereditary breast cancer-related disorders genomic sequence analysis panel (17 genes).
0102U	Hereditary ovarian cancer genomic sequence analysis panel (24 genes; EPCAM deletion/duplication only).
0111U	Oncology (colon cancer) targeted KRAS and NRAS gene analysis utilizing FFPE tissue.
0120U	Oncology (B-cell lymphoma classification) mRNA gene expression profiling of 58 genes, FFPE tissue.
0130U	Hereditary colon cancer disorders targeted mRNA sequence analysis panel (multiple genes) (List separately) (Use with 81435, 0101U).
0131U	Hereditary breast cancer-related targeted mRNA sequence analysis panel (13 genes) (List separately) (Use with 81162, 81432, 0102U).
0132U	Hereditary ovarian cancer-related targeted mRNA sequence analysis panel (17 genes) (List separately) (Use with 81162, 81432, 0103U).
0138U	BRCA1/BRCA2 mRNA sequence analysis (List separately).
0153U	Oncology (breast) mRNA gene expression profiling by NGS of 101 genes, FFPE tissue, triple negative breast cancer subtype and immune info.
0162U	Hereditary colon cancer (Lynch syndrome) targeted mRNA sequence analysis panel (MLH1, MSH2, MSH6, PMS2).

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PLA / Proprietary Lab Analyte Codes describedCPT

0397U	Oncology (non-small cell lung cancer), cell-free DNA from plasma, targeted sequence analysis of at least 109 genes
0400U	Description = .
0401U	Description = 0401U.
0403U	Oncology (prostate), mRNA, gene expression profiling of 18 genes, first-catch post-digital rectal examination urine
0405U	Oncology (pancreatic), 59 methylation haplotype block markers, next-generation sequencing, plasma
0409U	Oncology (solid tumor), DNA (80 genes) and RNA (36 genes), by next-generation sequencing from plasma
0410U	Oncology (pancreatic), DNA, whole genome sequencing with 5-hydroxymethylcytosine enrichment, whole blood or plasma
0411U	Psychiatry (eg, depression, anxiety, ADHD), genomic analysis panel, variant analysis of 15 genes, including deletion/duplication analysis of CYP2D6
0413U	Oncology (hematolymphoid neoplasm), optical genome mapping for copy number alterations, aneuploidy, and balanced/complex structural rearrangements
0414U	Oncology (lung), augmentative algorithmic analysis of digitized whole slide imaging for 8 genes and KRAS G12C and PD-L1 if performed

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Panel gene count thresholds

Targeted oncology panels (5-50 genes)CPT 81449/81450/81451 describe targeted genomic sequence analysis panels for solid organ and hematolymphoid neoplasms that interrogate 5–50 genes.

Large oncology panels (51+ genes)CPT 81456 describes targeted genomic sequence analysis panels for solid organ or hematolymphoid neoplasms with 51 or greater genes.

Named panel minimums — hereditary colon cancerCPT 81435 (hereditary colon cancer genomic sequence panel) must include sequencing of at least 10 specified genes.

Named panel minimums — neuroendocrine tumorsCPT 81437 (hereditary neuroendocrine tumor genomic sequence panel) must include sequencing of at least 6 specified genes.

Named panel minimums — Noonan/LEOPARDCPT 81442 (Noonan/LEOPARD syndrome panel) must include sequencing of at least 12 specified genes.

Examples of panel gene counts

Small named panels (example counts)Examples in the policy list panels of 17 genes (e.g., certain hereditary breast cancer panels) and 24 genes (e.g., hereditary ovarian cancer panels).

Large comprehensive panels (examples)Examples include panels of 257 genes (comprehensive genomic profiling), 311+ genes (cell-free DNA pan-cancer panels), and 437 genes (broad DNA/RNA oncology panels).

Mitochondrial/nuclear gene setsExamples include a 335-gene nuclear-encoded mitochondrial analysis (CPT 0417U).

Intermediate panelsExamples include 80 DNA + 36 RNA gene plasma panels and 109-gene cfDNA panels referenced for specific oncology applications.

Provider Actions — Authorization & Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required before sample collection and testing. The ordering clinician must initiate the Carelon prior authorization on or before the sample collection date and receive approval prior to sending the member for testing. Failure to notify Carelon in advance for services that require prior authorization will result in payment denial; the member may not be balance-billed and is responsible only for applicable copayments/coinsurance.

Ordering clinician must start Carelon prior authorization on or before sample collection.
Servicing lab must verify an approved Carelon transaction number before performing testing.
Denial for lack of prior authorization; member cannot be balance-billed.

Prior Authorization

Authorization Required for Listed Genomic, PLA, and PLA-like Tests

Many molecular and genomic tests listed in the Referral/Notification/Authorization section require prior authorization through Carelon. This includes listed CPT and PLA/unique codes for molecular/genetic panels, targeted sequence analyses, exome/genome testing (and comparator samples), and numerous PLA/PLA-like codes — omission of appropriate authorization may affect coverage.

Prior authorization required for targeted genomic sequence panels (e.g., CPT 81449–81456 and related entries).
Prior authorization required for exome/genome testing (e.g., CPT 81416, 81426) — list comparator exome/genome samples separately when submitting.
Prior authorization required for PLA and PLA-like codes (e.g., 0049U–0094U, 0101U–0130U, 0397U–0419U, etc.).
Many PLA/unique code entries include a brief description/clinical indication; provide the test description and clinical indication with the authorization request.

Documentation Required

Information Required for Authorization

Carelon will request specific information when processing an authorization request. Have the following available at the time of the call or online submission to avoid delays and to ensure the authorization is linked to the correct test(s) and lab.

Ordering physician name, office phone, mailing address, fax number, TIN and NPI.
Office contact name and direct line/extension.
Patient name, date of birth, and Harvard Pilgrim ID number.
Planned test(s) (include code and description) and reason for testing/clinical indication (e.g., further evaluation, rule out, baseline, evaluation of therapy).
Sample collection date and date testing is expected to begin.
A valid, specific ICD-10 diagnosis code representing the condition being tested.
Name, address, TIN and NPI of the laboratory where the test(s) will be performed.
Diagnosis and clinical information pertinent to the test ordered.

Note

Authorization Change Notification

If any change to an approved authorization is needed (change to test(s), servicing lab, or date of service), Carelon must be notified by telephone prior to the service commencing and before the authorization expiration. Changes after the authorization has expired will not be allowed; some changes may require a new authorization and medical necessity review.

Notify Carelon by phone for changes to tests, testing lab, or date(s) of service prior to service start and prior to authorization expiration.
Requests to change servicing provider and/or date(s) of service after the authorization start date must be made by contacting the Provider Service Center.
Any change to the test(s) may require a new authorization and medical necessity review.

Billing Rule

Authorization Coding & Test Description Requirements

Authorization coding and test descriptions matter — include the specific code(s), comparator/sample details, and test description/clinical indication when requesting authorization. For exome/genome testing, list comparator exome/genome samples separately (e.g., parents or siblings) in addition to the primary procedure code.

Provide code-specific descriptions and clinical indication for PLA/unique codes as part of the authorization request.
List comparator exome/genome samples separately (e.g., 81416, 81426 comparator entries).
Omission of appropriate authorization or incomplete coding/test description may affect coverage and result in denial.

Denial Risk

Failure to Notify May Trigger Denial

Failure to notify Carelon or to obtain/verify authorization may trigger denial of payment. Servicing laboratories should require evidence of an approved Carelon transaction number before performing testing; tests performed without authorization or after denial will not be reimbursed and the member cannot be billed.

Servicing lab must confirm ordering provider completed prior authorization by verifying approved Carelon transaction number.
If a servicing lab conducts a test without prior authorization or after denial, Harvard Pilgrim will not reimburse and the member cannot be billed.
Clarifying language regarding failure to notify denials was added (08/12/20 update).

Covered Indications and Test-Linked Uses

Broad categories of covered testing

Covered when related to the clinical indications and test types listed below:

Reproductive carrier screening and prenatal diagnosis (including cfDNA and diagnostic testing).

Preimplantation genetic testing, including embryo biopsy (CPT 89290, 89291).

Single-gene and multifactorial testing for suspected inherited conditions (germline testing).

Whole exome and whole genome sequencing (proband and comparator exomes/genomes when indicated).

Hereditary cancer susceptibility and hereditary cardiac disease testing (multi-gene panels and single-gene analyses).

Molecular testing of solid and hematologic tumors and malignancies, including tumor profiling, targeted panels, and liquid biopsy (cfDNA).

Pharmacogenetic testing and thrombotic disorder testing (gene-drug interaction panels, drug metabolism panels, and thrombosis gene panels).

Examples of indications tied to specific tests

Examples of specific test–indication pairs included in the authorization listing:

Microsatellite instability testing for Lynch syndrome (CPT 81301).

Hereditary peripheral neuropathy panels (e.g., Charcot–Marie–Tooth panels) requiring sequencing of at least 5 peripheral neuropathy-related genes (example gene list: BSCL2, GJB1, MFN2, MPZ, REEP1, SPAST, SPG11, SPTLC1) (see 81449/81445-style targeted panels).

Whole mitochondrial genome sequencing for suspected mitochondrial disorders (CPT 81460).

Hereditary cancer syndromes

Hereditary cancer testing is covered for clinically indicated syndromes and multi-gene panels:

Hereditary breast and ovarian cancer panels (multi-gene BRCA1/BRCA2-containing panels; example PLA/CPT entries: 0101U, 0102U, 0103U).

Hereditary endometrial cancer and pan-cancer panels (targeted mRNA or genomic sequence analysis listed as adjunct codes 0134U/0135U when used with the primary procedure).

Hereditary colorectal cancer/Lynch syndrome panels (germline MMR genes MLH1, MSH2, MSH6, PMS2, EPCAM) and related targeted mRNA panels (e.g., 0162U, 0238U).

Hereditary prostate cancer panels and pan-cancer multi-gene testing where clinically indicated (use of targeted mRNA adjunct codes 0133U, 0134U as specified).

Oncology tumor profiling

Tumor profiling and oncology molecular testing covered when ordered for diagnostic, prognostic, or therapy-association reporting:

Solid tumor and pan-tumor comprehensive genomic profiling (DNA and RNA NGS) with interpretive reports for SNVs, indels, CNAs, fusions, TMB, and MSI (examples: 0211U, 0391U, 81459).

Non–small cell lung cancer (NSCLC) targeted panels and plasma cfDNA assays (examples: CPT 81457; PLA examples 0179U, 0397U, 0397U-related cfDNA panels).

Tumor profiling for prostate, thyroid, and pancreatic cancers when clinically indicated (examples: prostate expression and urine exosome assays 0343U; thyroid RNA panels 0287U; pancreatic methylation panels 0405U, 0410U).

Hematology genetic disorder panels

Hematology genetic disorder panels are covered for evaluation of inherited or congenital hematologic conditions:

Congenital coagulation disorder panels (e.g., genomic sequence analysis of ~20 genes; see 0270U).

Inherited thrombocytopenia and platelet disorder panels (examples: 0276U, 0274U, 0277U describing 23–43 gene panels).

Genetic thrombosis and related hypercoagulable disorder panels (example: 0278U and related targeted genomic analyses).

Congenital neutropenia panels and other hematology-specific sequencing panels (example: 0271U for congenital neutropenia, 23 genes).

Pharmacogenomic/drug metabolism testing

Pharmacogenomic and drug metabolism testing is covered when used to guide medication selection or dosing:

Drug metabolism and pharmacogenomic panels reporting gene–drug interactions and phenotypes (examples: CPT 81462; PLA examples 0347U [16-gene], 0348U [25-gene], 0349U/0350U [27-gene] panels).

Panels must include relevant analyses such as CYP2D6 deletion/duplication when specified by the test description (documentation should indicate whether CYP2D6 CNV analysis is performed).

Reproductive medicine testing

Reproductive medicine testing covered when clinically indicated for embryo selection or endometrial assessment:

Endometrial receptivity testing by RNA gene expression profiling for window-of-implantation assessment (example: 0253U, 238-gene expression profile on endometrial tissue).

Preimplantation genetic assessment of embryos for aneuploidy and mitochondrial DNA scoring per embryo (example: 0254U, 24-chromosome analysis with mtDNA score).

Miscellaneous oncology, neurology/psychiatry, and rare disease testing

Additional oncology, neurology, psychiatry, and rare disease tests included in the authorization listing:

Examples

Lung cancer related molecular assays and plasma cfDNA panels (examples: 0397U, 0409U, 0397U-related entries).
Prostate cancer urine/exosome expression assays and prostate genomic tests (examples: 0343U, 0403U).
Pancreatic tumor assays including methylation and whole-genome–based blood tests (examples: 0405U, 0410U).
Psychiatry pharmacogenomic panels for depression, anxiety, ADHD (examples: 0345U, 0411U; 15-gene panels including CYP2D6).
Mitochondrial and constitutional disorder testing including whole mitochondrial genome with heteroplasmy detection and large nuclear-encoded mitochondrial gene sets (example: 0417U, 335 nuclear genes).

Definitions and Terminology

Molecular pathology procedure levels (81400–81408)

Range of procedure levelsMolecular pathology procedure codes 81400–81408 correspond to procedure complexity levels used to classify molecular tests (Level 1 through Level 9).

Level 5 example81404: Level 5 — e.g., analysis of 2–5 exons by DNA sequence analysis, mutation scanning, or duplication/deletion variants of 6–10 exons, or characterization of a dynamic mutation disorder/triplet repeat by Southern blot analysis.

Level 6 example81405: Level 6 — e.g., analysis of 6–10 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of 11–25 exons, or regionally targeted cytogenomic array analysis.

Level 9 example81408: Level 9 — e.g., analysis of >50 exons in a single gene by DNA sequence analysis.

Comparator exome/genome

Comparator exome/genome—definitionWhen submitting exome (81416) or genome (81426) testing, each comparator exome/genome (e.g., parents, siblings) must be listed separately in addition to the code for the primary procedure.

Billing instructionComparator exome/genome codes are reported for each additional family member tested (listed separately).

Typical use caseUsed when trio or family-based exome/genome sequencing is performed for rare constitutional/heritable disorder evaluation.

PLA / Unique CPT-like codes (examples)

PLA/Unique code purposePLA/unique CPT Category I/III-like codes (e.g., 0212U, 0213U, 0214U, 0215U) correspond to proprietary laboratory analyses or newly established service codes describing whole exome/genome and related analyses.

Whole genome/exome examples0212U: Rare diseases whole genome and mitochondrial DNA sequence analysis (proband) — note: do not report 0213U with 81426; 0214U should not be reported with 81415; 0215U not with 81416.

Neurology examples0216U/0217U: Neurology (inherited ataxias) genomic DNA sequence analyses described as PLA/unique entries with 12 or 51 genes respectively.

cfDNA (cell-free DNA) testing

cfDNA definitioncfDNA (cell-free DNA) testing refers to analysis of plasma-derived cell-free DNA for tumor profiling or methylation-based cancer detection (e.g., CPT/PLA entries for plasma cfDNA panels such as targeted sequence analysis of at least 109 genes or methylation haplotype NGS assays).

cfDNA examples0397U: NSCLC cfDNA targeted sequence analysis of at least 109 genes (plasma); 0405U: pancreatic cancer methylation haplotype block NGS in plasma reported as cancer signal detected/not detected.

Sample typecfDNA tests are performed on plasma as specified in the PLA/CPT descriptions.

PLA / PLA-like codes referenced in policy

PLA/PLA-like code examplesPolicy lists numerous proprietary laboratory analysis (PLA) and PLA-like codes used to identify specific tests (e.g., 0397U, 0405U, 0417U).

Oncology PLA examples0397U: NSCLC plasma cfDNA targeted sequence analysis of ≥109 genes; 0409U: Oncology solid tumor DNA (80 genes) + RNA (36 genes) from plasma.

Mitochondrial PLA example0417U: Whole mitochondrial genome sequence with heteroplasmy detection plus nuclear-encoded mitochondrial gene analysis of 335 genes for rare diseases.

Other PLA usesPLA codes also describe mRNA expression profiling, methylation assays, optical genome mapping, and psychiatric pharmacogenomic panels as listed in the policy descriptions.

OpenPayer

Molecular Diagnostic Testing Prior Authorization

Coverage Criteria

Coding — Managed Codes and Groups

Provider Actions — Authorization & Operational Requirements

Covered Indications and Test-Linked Uses

Not Covered / Denial Conditions

Background and Management

Definitions and Terminology