CurrentUnitedHealthcarePolicy 2026T0588MM

Molecular Oncology Testing for Solid Tumor Cancer Diagnosis, Prognosis, and Treatment Decisions

Policy governing coverage of molecular and gene expression tests (tissue and liquid biopsy) for diagnosis, prognosis, and treatment decisions in solid tumor cancers for UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

PayerUnitedHealthcare

PolicyMolecular Oncology Testing for Solid Tumor Cancer Diagnosis, Prognosis, and Treatment Decisions

Policy CodePolicy 2026T0588MM

Change TypeNo material change

Effective DateJan 1, 2026

Next Review Date

Key ActionDocument clinical details (eg, receptor/HER2 status, Bethesda category, staging) and show how results will affect management when ordering molecular assays; prior authorization may be required per member plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MultipleProven breast GEP assays listed

≤50NSCLC panel threshold

>50NGS panels >50 genes / CGP

~120Unique CPT/HCPCS & U-codes listed

6693MINDACT trial participants

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Coverage Criteria and Evidence-Based Indications

inv-15: Prostate cancer: guideline-considered uses

Prostate cancer: guideline-considered uses

ALL of the following

Genomic testing may be considered when results are likely to influence management decisions (e.g., choice between active surveillance and definitive therapy, adjuvant treatment decisions)
Consistent with ASCO, AUA/ASTRO, AUA/SUO, and NCCN guidance that support selective, not routine, use
Tests may be considered in men with newly diagnosed, clinically localized prostate cancer who are potential candidates for active surveillance and have life expectancy ≥ 10 years
NCCN and guideline panels note potential value in low or favorable-intermediate risk disease
Tissue-based genomic assays (e.g., Decipher, Oncotype DX Prostate/GPS, Prolaris) may be considered selectively to provide additional risk stratification when the result would change management
AUA/ASTRO: selective use; ASCO: may be offered when likely to affect management
Decipher genomic classifier may be considered to inform adjuvant therapy decisions after radical prostatectomy when adverse pathologic features are present (e.g., positive margins, extracapsular extension, seminal vesicle invasion) or when PSA persistence/recurrence is being evaluated
NCCN: Decipher recommended to inform adjuvant therapy; Hayes evidence limited but supportive for post-RP decision-making
Ordering clinician should be a specialist in prostate cancer management (e.g., urology, radiation oncology, medical oncology)
Operational recommendation reflected across policy criteria
Results must be used in conjunction with standard clinical and pathologic factors (e.g., PSA, Gleason score/Grade Group, clinical stage, imaging, patient comorbidities and preferences) and not as a sole determinant of management
Guideline-consensus emphasis on integrated decision-making
Routine, reflex, or broad use of genomic assays for all patients is not recommended; use should be individualized and reserved for scenarios where added information will change treatment recommendations
AUA/ASTRO and ASCO caution against routine use
Urine- or blood-based molecular screening panels for prostate cancer (e.g., ExoDx Prostate, Select mdx, Confirm mdx) are not supported by sufficient evidence for routine clinical use to guide management; select use for biopsy decision-making or after negative biopsy may be considered per guideline nuance but evidence is limited
NCCN and Hayes assessments identify limited/low-quality evidence; policy lists these tests as unproven/not medically necessary for screening or routine use
Clinicians should consider MRI and standard clinical risk factors alongside genomic testing when evaluating suitability for active surveillance; genomic tests and MRI may provide complementary information and should be used when the result is likely to alter management
ASCO expert panel endorsement of combined use when likely to affect management

Indications Considered Medically Necessary

Tests and Uses Considered Not Medically Necessary

Tests and categories explicitly listed as unproven and not medically necessary include NGS panels >50 genes/CGP (unless otherwise specified), MRD ctDNA assays for routine surveillance, multi‑cancer early detection tests, WES/WGS/WGTA, and a number of named commercial assays identified throughout the policy. These are considered not medically necessary due to insufficient evidence of efficacy.

The codes in the applicable codes section are provided for reference. Use of unlisted procedure codes such as 81479 or multianalyte unlisted 81599 may prompt request for additional documentation or prior authorization and does not imply coverage.

BluePrint used together with MammaPrint currently lacks sufficient evidence of added clinical utility; combined use is therefore not supported based on available data.

Multiple named assays (e.g., Breast Cancer Gene Expression Ratio/Theros H/I, DCISionRT, Oncotype DX DCIS) and other proprietary signatures are cited as having insufficient evidence for routine clinical utility and may be considered not covered in the absence of stronger outcome data.

Clinical guidance advises that tumor mutation burden (TMB) should not be used alone to select patients with advanced NSCLC for immune checkpoint inhibitor therapy; TMB has limitations and should be interpreted in context with other biomarkers such as PD‑L1.

Hayes concluded that GPS testing lacks sufficient evidence to support use for guiding treatment selection in untreated, lower‑risk localized prostate cancer; routine coverage for that indication is not supported by the current evidence base.

Applicable Procedure, CPT, HCPCS, and Proprietary Codes

Note

Applicable Codes

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

Proprietary and PLA/U codes (selected examples)mixed

0011M	Oncology, prostate cancer, mRNA expression assay of 12 genes
0012M	Oncology (urothelial), mRNA, gene expression profiling, urine
0022U	Targeted genomic sequence analysis panel, NSCLC, 23 genes
0179U	Oncology (NSCLC), cell-free DNA, targeted sequence analysis of 23 genes
0306U	Oncology (MRD) initial patient-specific panel, cfDNA
0307U	Oncology (MRD) subsequent patient-specific panel, cfDNA (tumor-informed)
0340U	Oncology (pan-cancer) MRD plasma personalized assays
0453U	Oncology (colorectal), cfDNA, methylation-based quantitative PCR (SEPTIN9 etc.)
0611U	Oncology (liver), analysis of >1000 methylated regions, cfDNA

Proprietary and PLA/U codes (continued)mixed

0530U	Oncology (pan-solid tumor), ctDNA NGS 77 genes, TMB, MSI
0585U	Targeted genomic panel, cfDNA, 521 genes
0569U	NGS analysis of tumor methylation markers (>20,000 DMRs) in cfDNA
0498U	Oncology (colorectal), NGS 43 genes + methylation 45 genes, blood/tissue
0343U	Oncology (prostate), exosome-based analysis of 442 sncRNAs
0539U	Cell-free ctDNA, 152 genes, NGS, whole blood

Molecular oncology CPT/HCPCS and Proprietary U-codes (selected) mixed

81445	Genomic sequence analysis panel, 5-50 genes (DNA or combined DNA/RNA)
81449	Genomic sequence panel, 5-50 genes (RNA analysis)
81455	Genomic sequence panel, 51+ genes (DNA or combined DNA/RNA)
81456	Genomic sequence panel, 51+ genes (RNA analysis)
81462	Genomic sequence panel, cell-free nucleic acid (plasma)
81463	Genomic sequence panel, cell-free nucleic acid (plasma), DNA analysis
81464	Genomic sequence panel, cell-free nucleic acid, includes TMB/MSI etc.
81479	Unlisted molecular pathology procedure (may require PA)
81599	Unlisted multianalyte assay with algorithmic analysis (may require PA)

Molecular oncology CPT/HCPCS and Proprietary U-codes (continued)mixed

81504	Tissue of origin microarray >2000 genes
81540	Tumor of unknown origin, 92-gene expression classifier
81518	Breast, 11-gene expression test (extended endocrine therapy)
81519	Breast, 21-gene expression profiling (recurrence score)
81521	Breast, 70-gene microarray (recurrence risk)
81524	CNS tumor, DNA methylation analysis 10,000+ sites

Additional HCPCS/CPT codes (selected)CPT

G0327	Colorectal cancer screening; blood-based biomarker
81457	Genomic sequence analysis panel; DNA analysis, MSI
81458	Genomic sequence analysis panel; DNA analysis, copy number and MSI
81459	Genomic sequence analysis panel; includes TMB, MSI, rearrangements

Covered/Referenced assays (examples)mixed

Prosigna (PAM50)	Breast prognostic gene signature assay; ROR score (low risk <57)
MammaPrint	70-gene signature for breast distant recurrence risk
EndoPredict	12-gene EPclin test for ER+, HER2- breast cancer
Oncotype DX Colon	Colorectal recurrence score (listed as unproven in policy excerpt)
Signatera	Tumor-informed MRD assay (listed as unproven for MRD in solid tumors)

Prior Authorization

Provider Action Highlights

Provider actions and prior authorization guidance: Prior authorization is generally required and should be aligned to guideline-indicated populations and the Medical Policy. Clinician-selected molecular testing should be documented with clinical indication and relevant prior test results. Prior authorization is likely required for Septin 9 blood-based colorectal cancer screening and similar multi-cancer early detection assays; guideline-based denials are possible for Septin 9 and other blood-based CRC screening tests listed as unproven. When genomic testing is not available locally or results are pending, document efforts to obtain testing and rationale for alternate management. Insufficient evidence for a test (e.g., MRD assays in solid tumors, multi-cancer early detection, NGS panels >50 genes outside specified indications, tissue of origin classifiers) may trigger noncoverage or denial. Regulatory or evidence cautions (e.g., FDA cleared/approved companion diagnostics vs lab-developed tests) should be noted in authorization requests. Risk of denial exists for prognostic-only testing without established impact on management (e.g., some GEP-guided therapy decisions). Stepwise use is recommended where applicable (for example, consider limited panels ≤50 genes for NSCLC before broader CGP; use of 40-gene GEP for adjuvant radiation therapy decisions should follow established stepwise protocols). Specific notes: Signatera and other tumor-informed MRD assays are listed in the policy excerpt as unproven for routine MRD use in solid tumors and may be denied. MCD (multi-cancer detection) tests and other blood-based screening assays are considered unproven for population screening and are likely not covered. Clinical documentation of pre-test treatment status, PSA/PSA density when relevant (e.g., prostate biomarker use), and sequencing rationale (per NCCN guidance for tissue of origin and prostate early detection sequencing) should be included in prior authorization submissions.

Provider Actions, Documentation, and Authorization Considerations

Prior Authorization

Applicable CPT/HCPCS codes — prior auth may be required

The policy lists applicable CPT/HCPCS and proprietary U-codes for molecular oncology testing; these codes may be subject to prior authorization per the member's benefit plan.

Examples in code lists include 81445 (5–50 gene panels), 81455/81456 (51+ gene panels), and numerous proprietary U‑codes.

Note

Prior authorization not specified in these excerpts (evidence summaries only)

The excerpts in this document do not specify explicit prior authorization coding rules or standardized PA requirements; the content summarizes evidence and intended uses rather than operational PA criteria.

Prior Authorization

Prior authorization aligned to guideline‑indicated populations

When seeking authorization, requests should align to guideline‑indicated populations (for example, ASCO/NCCN–endorsed populations for breast GEP such as postmenopausal or >50 with ER+/HER2- early-stage, node-negative or 1–3 nodes).

Definitions and Test Terminology

Comprehensive Genomic Profiling (CGP) definition

Comprehensive Genomic Profiling (CGP)A next-generation sequencing test able to detect multiple classes of genomic alterations in a single sample (mutations, copy number changes, rearrangements, MSI, TMB, gLOH) to identify actionable alterations and trial eligibility

ScopeCGP may include whole exome/genome/transcriptome approaches but policy notes WES/WGS/RNA-NGS lack sufficient evidence for routine clinical decision-making

Intended applicationUsed to identify actionable alterations in advanced/metastatic cancers and to inform enrollment in precision oncology trials (CUP, metastatic settings)

Gene Expression Profiling (GEP) definition

Gene Expression Profiling (GEP)Laboratory tests that analyze mRNA patterns to determine gene activity and provide prognostic and sometimes predictive information (examples: 21-gene Oncotype DX, 70-gene MammaPrint, 50-gene Prosigna, 12-gene EndoPredict, BCI)

Additional Provider Guidance and Operational Notes

Denial Risk

Evidence insufficiency may trigger denial (operational note)

Operationally, evidence insufficiency identified in test assessments (e.g., Signatera, other MRD assays) may prompt claim denials where clinical utility is not demonstrated.

NICE and Hayes note insufficient prospective evidence to support routine use of Signatera and similar MRD assays.

Note

Tests without FDA companion diagnostic status governed by this policy (operational)

Tests without FDA companion diagnostic status are governed by this policy; operational processes for authorization and coverage will follow the policy’s evidence and intended‑use framework.

Policy Revision History

2026-01-01policy_effective_dateLatest

Policy effective date set to January 1, 2026 (Policy Number: 2026T0588MM).

2026-01-01revision_note

Template update: created shared policy version to support application to Oxford plan membership; updated list of applicable CPT codes (added 0611U, 0612U, 0613U, and 81524); archived previous policy version 2025T0588LL.

Policy Summary

PayerUnitedHealthcare

PolicyMolecular Oncology Testing for Solid Tumor Cancer Diagnosis, Prognosis, and Treatment Decisions

Policy CodePolicy 2026T0588MM

Change TypeNo material change

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Tests such as Select mdx, Confirm mdx, and ExoDx Prostate were evaluated by Hayes and found to have low‑quality or insufficient evidence of clinical validity and utility; routine use to guide biopsy or management decisions is not supported.

Hayes' evaluation of ThyroSeq v3 GC reported very low‑quality evidence for some performance claims and insufficient evidence of clinical utility for preoperative assessment in indeterminate thyroid nodules; payer‑specific noncoverage is not explicitly stated in the assessment but evidence limitations are noted.

Guidelines do not recommend molecular testing to guide postoperative radioiodine therapy; this application is considered unsupported.

Routine prognostic GEP testing for cutaneous melanoma is discouraged by guideline panels when results do not alter management; coverage for routine prognostic use is not supported.

Hayes determined the evidence for DecisionDx‑UM to be very low quality and insufficient to support use of the test as the sole basis for management of uveal melanoma; routine coverage for such sole‑basis use is not supported.

GEP‑based approaches to direct site‑specific therapy for cancers of unknown primary lack randomized evidence of benefit; multiple reviews and guideline panels do not support routine use for directing definitive therapy and coverage for such routine use is not supported.

Hayes concluded that PancraGEN has insufficient evidence to support its use for assessing pancreatic cyst cancer risk to guide surveillance or surgical decisions; routine coverage for PancraGEN is not supported.

mSEPT9 / Epi proColon (ColoHealth) is not endorsed as an optimal routine colorectal cancer screening test by major guideline bodies; coverage for routine CRC screening with these serum tests is not supported.

NavDx and Signatera have limited evidence for routine clinical utility. Hayes and other assessments found insufficient high‑quality data demonstrating that NavDx or Signatera improve management or outcomes; routine coverage for these uses is not supported outside investigational or trial settings.

Routine use of tumor‑informed MRD assays (e.g., Signatera) and many ctDNA surveillance assays for monitoring or routine post‑treatment surveillance is not supported by current evidence and is considered not medically necessary in standard practice outside clinical trials.

Whole exome, whole genome, whole transcriptome sequencing and most ctDNA assays currently lack sufficient prospective evidence to demonstrate clinical utility in guiding therapy decisions; routine coverage is not supported absent high‑quality outcome data.

Prior authorization aligned to guideline-indicated populations
Prior authorization: guidance-based
Clinician-selected molecular testing: document indication and prior results
Prior authorization likely for Septin 9 blood-based CRC screening
Not applicable content in this window —
Insufficient evidence may trigger noncoverage
Regulatory/evidence caution: note FDA-cleared vs LDTs
Risk of denial for unsupported prognostic testing
NCCN guidance on sequencing for tissue of origin
Guideline-based denial risk for Septin 9
MCD tests for population screening are considered unproven
Signatera (tumor-informed MRD) listed as unproven for routine MRD in solid tumors
For certain tests (e.g., breast GEP, thyroid), provide clinical documentation of pre-test treatment status
When genomic testing is not available, document attempts and rationale for alternate management
Stepwise use of 40-GEP for ART decisions; GEP-guided therapy not established

ASCO: Oncotype DX, MammaPrint, BCI, EndoPredict use described for postmenopausal or >50, ER+/HER2- early breast cancer with 0–3 nodes.
NCCN guidance cited for assay‑specific preferred uses.

Prior Authorization

Prior authorization / lab QA — participate in external quality assurance

Although no payer PA rules are specified here, laboratories performing tests should participate in an external quality assurance scheme; lack of lab QA or use outside intended purpose could affect authorization decisions.

NICE recommends laboratories take part in national external quality assurance schemes when processing tests.
Policy states tests should be used within their intended purpose.

Prior Authorization

Appropriate patient selection likely required

Authorization is likely to require demonstration that the patient selection meets clinical criteria and that testing will influence management decisions (selective use per guidelines).

Examples: life expectancy ≥10 years and NCCN risk group considerations for prostate genomic assays; Bethesda III/IV cytology for thyroid nodules.

Prior Authorization

Selective use justification per guidelines

Guidelines support selective ordering of certain assays only when results are likely to change management; prior authorization may require documentation of anticipated management impact.

ASCO/AUA/NCCN endorse selective use of Decipher, Oncotype DX Prostate (GPS), Prolaris when results will influence treatment.

Prior Authorization

Prior authorization: guidance‑based (reference NCCN/AUA when requesting testing)

When requesting authorization for prostate genomic testing, reference relevant guideline guidance (NCCN/AUA) and the clinical rationale for testing (risk group, how result will affect management).

NCCN: Decipher, GPS, Prolaris may be considered in low/favorable intermediate risk with life expectancy ≥10 years.
Document guideline citations and how results will change care in the request.

Note

Clinician‑selected molecular testing should be based on clinical question

Clinician selection of molecular tests should be driven by the specific clinical question; prior authorization requests should state the clinical question the test will address.

NCCN advises selecting molecular diagnostics based on the clinical question (e.g., reclassification, targeted therapy selection).

Prior Authorization

Prior authorization for prognostic GEP testing likely expected

Prior authorization is likely to be required when prognostic GEP testing is proposed for cutaneous melanoma or when prognostic testing is requested outside guideline‑supported contexts.

AAD and NCCN discourage routine prognostic GEP testing for cutaneous melanoma; authorization may be limited to cases where results will change management or research settings.

Prior Authorization

Histology first before molecular profiling (NCCN sequencing guidance)

NCCN indicates histologic determination should precede molecular profiling for tissue‑of‑origin workup; prior authorization requests for CUP testing should document prior histology and why molecular profiling is needed.

NCCN: molecular profiling may be considered after initial histology; testing on tumor tissue preferred with cfDNA only if tissue not feasible.

Prior Authorization

Prior authorization likely for Septin 9 blood‑based CRC screening

Because guideline bodies advise against routine use of Septin 9 for CRC screening, prior authorization and coverage may be limited; document guideline rationale when requesting blood‑based SEPT9 testing.

ACG recommends against SEPT9 for CRC screening due to low sensitivity; NCCN notes performance limitations.

Prior Authorization

Prior authorization for MCD testing may be required

Prior authorization may be required for multi‑cancer detection (MCD) tests used for screening or symptomatic evaluation because professional societies do not endorse routine use and evidence of clinical utility is lacking.

Policy notes MCD tests (e.g., Galleri) lack professional society recommendations and are under study in randomized trials.

Prior Authorization

Authorization generally limited to clinical trial / investigational context for ctDNA presymptomatic detection

Authorization for ctDNA testing intended for presymptomatic detection, postsurgical MRD, or routine monitoring is generally limited to investigational or clinical trial contexts; document trial enrollment or investigational intent when requesting coverage.

NCCN and guideline statements state presymptomatic ctDNA detection should only be offered in prospective clinical trials.

Step Therapy

Step therapy not specified — studies describe test influence on chemotherapy decisions

No step therapy algorithms are specified in these excerpts; studies describe how tests like MammaPrint/BluePrint influenced chemotherapy decisions but do not establish payer step therapy requirements.

Step Therapy

Step therapy — none specified; alternatives may be used when testing unavailable

No formal step therapy requirements are described in the policy excerpts; when genomic testing unavailable, guidelines note surrogate markers (e.g., Ki67 or IHC4) may assist decision‑making.

NCCN/ASCO: Ki67 or IHC4 score may be used when genomic testing is not available.

Step Therapy

Use only after standard risk stratification

Guidelines recommend molecular biomarkers be used only after standard clinical risk stratification (e.g., for prostate cancer: PSA, Gleason, stage, MRI); document that standard evaluation was completed before ordering the assay.

ASCO/AUA/NCCN: routine ordering is not recommended; assays should be used when results will affect management after standard risk assessment.

Step Therapy

Step therapy — none described

No step therapy requirements are described for many assays in these excerpts.

Step Therapy

Management sequencing for indeterminate nodules — consider repeat FNA, observation, surgery, or molecular testing

For indeterminate thyroid nodules (Bethesda III/IV), management sequencing includes repeat FNA, observation, diagnostic surgery, or molecular testing; molecular testing is an adjunct when results would change surgical decision‑making.

ATA/AAES: molecular testing may supplement malignancy risk assessment and should be considered in the context of clinical and sonographic features.

Step Therapy

Stepwise use of 40‑GEP for ART decisions in cSCC

For cSCC, DecisionDx‑SCC (40‑GEP) is discussed as an adjunct to AJCC/NCCN staging to stratify metastatic risk and may be used stepwise to justify adjuvant radiation therapy when multidisciplinary documentation shows the result will change management.

Consensus guidance recommends multidisciplinary decision‑making and documentation when 40‑GEP results are used to support ART.

Step Therapy

GEP‑guided therapy not established — randomized trials lacking

GEP‑guided site‑specific therapy has not been shown in randomized trials to be superior to empiric therapy; guideline panels do not recommend GEP‑directed site‑specific therapy as standard care.

Randomized trials to date have not demonstrated improved PFS or OS with GEP‑guided site‑specific therapy in CUP.

Step Therapy

Step approach to biomarker testing in advanced CRC (test key genes first)

For advanced colorectal cancer, guidelines recommend stepwise testing for actionable biomarkers (KRAS/NRAS, BRAF, HER2, MSI/MMR) which may obviate the need for broader panel testing when single‑gene results inform therapy.

NCCN: test tumor gene status for KRAS/NRAS, BRAF, HER2, and MSI/MMR; NGS preferred for multi‑gene profiling but targeted testing acceptable when clinically indicated.

Step Therapy

Pancreatic cyst molecular testing sequencing — use only when results will change management

Consider molecular testing of pancreatic cyst fluid only when results are likely to change management and diagnosis is unclear; use is conditional given limited evidence.

ACG: molecular markers may be considered when diagnosis is unclear and results would change management (conditional recommendation).

Step Therapy

Prior standard surveillance recommended before ctDNA‑based monitoring

Comparative studies indicate ctDNA surveillance did not outperform standard imaging plus CEA for CRC surveillance in available cohorts; providers should document prior standard surveillance when requesting authorization for ctDNA monitoring.

Small studies showed ctDNA sensitivity comparable or inferior to imaging plus CEA; NCCN does not yet recommend postsurgical ctDNA for routine adjuvant decisions.

Documentation Required

Documentation requirements for specific tests (breast GEP, thyroid indeterminate nodule testing)

When ordering certain assays (e.g., breast GEP, thyroid indeterminate nodule testing), include clinical details such as hormone receptor/HER2 status or Bethesda category and state that results will be used to guide management.

Breast GEP: document ER/PR and HER2 status, nodal status and intended use for adjuvant or extended endocrine therapy decisions.
Thyroid: document Bethesda III/IV cytology and that results will inform surgical decision‑making.

Billing Rule

Coding and documentation — include exact CPT/HCPCS code on claims

Claims should include the exact CPT or HCPCS code that corresponds to the genomic or algorithmic assay performed (examples: 81445, 81455, 81504, 81518, 81519); submissions using unlisted codes may prompt additional documentation requests.

Include the precise code (CPT/HCPCS/U‑code) that matches the assay reported in the policy's code lists.

Documentation Required

Medical records — documentation may be required for coverage review

Medical record documentation may be required to verify that the member meets the clinical criteria for coverage; absence of supporting documentation can lead to claim review or denial.

Medical records should support diagnosis, prior testing, staging, and rationale for how results will affect management.

Documentation Required

Specimen documentation — document specimen type and concordance data when applicable

When reporting results for assays performed on core needle biopsy versus surgical resection (e.g., MammaPrint/BluePrint), document specimen type and concordance evidence when relevant to clinical decision‑making.

FLEX study reported 90.9% agreement between CNB and SR for MammaPrint; document CNB vs SR specimen source.

Documentation Required

Document pre‑test and post‑test treatment recommendation when relevant

Clinical documentation of pre‑test management plan and any post‑test change in treatment recommendation may be relevant to demonstrate clinical utility and support coverage determinations.

Studies (e.g., DCISionRT, WSG‑PRIMe) reported changes in RT/chemotherapy recommendations after testing; record intended management before and after testing.

Documentation Required

Use of results in shared decision making — document counseling and integration with clinical factors

Use of test results should be part of shared decision‑making; oncologists should explain test implications and integrate results with clinical risk factors in the medical record.

NICE and ASCO guidance emphasize explaining risks/benefits and incorporating results alongside clinical factors.

Documentation Required

Specimen quality and clinical context documentation required

Document specimen quality and clinical context (adequate tissue, biopsy vs resection, sample QC) when submitting for coverage review; sample failures and archival tissue age can affect test validity.

Studies required quality‑controlled tissue specimens and noted failures when older archived tissue or insufficient RNA was present.

Documentation Required

Clinical context and impact on management should be documented

Document the clinical context and how the assay result will impact management (for example, how a prostate genomic score will change surveillance vs treatment choices).

NCCN indicates documentation should include clinical risk group, life expectancy, and the intended management change.

Documentation Required

Document guideline rationale when requesting molecular tests

When requesting testing that is guideline‑linked, include citation of the guideline (e.g., NCCN, AUA/SUO) and specific patient risk‑group definitions or thresholds used to justify the request.

Document relevant guideline version, risk group, PSA thresholds or other supporting details used to justify testing.

Documentation Required

Informed consent / counseling recommended

Obtain informed consent and counsel patients on benefits, limitations, and uncertainties of molecular testing, particularly for nondiagnostic or indeterminate thyroid cytology or investigational ctDNA applications.

ATA recommends counseling patients about potential benefits, limitations, and long‑term uncertainties prior to molecular testing for thyroid nodules.

Documentation Required

Documentation for uveal melanoma prognostic testing — experienced provider and biopsy discussion

For uveal melanoma prognostic testing, biopsy should be discussed and performed by experienced ocular oncology providers and documentation should include biopsy risks/benefits and intended use of prognostic results.

NCCN prefers molecular/chromosomal testing over cytology when biopsy is performed and recommends careful discussion of biopsy risks.

Documentation Required

Documentation and multidisciplinary collaboration when CGP/NGS is used

When CGP/NGS is used for treatment‑selection or trial eligibility, document histology, pathology, and relevant biomarkers (e.g., MSI, TMB, PD‑L1, gLOH) and include multidisciplinary collaboration notes.

NCCN suggests pathologist/oncologist collaboration and that documentation include histology and pertinent biomarker status to assess eligibility for targeted therapy or trials.

Documentation Required

Documentation for tumor biomarker testing in CRC — document tumor gene status

For tumor biomarker testing intended to guide targeted therapy in advanced/metastatic CRC, include documentation of tumor gene status (KRAS/NRAS, BRAF, HER2, MSI/MMR) or rationale for NGS testing.

NCCN recommends documentation of KRAS/NRAS, BRAF, HER2 and MSI/MMR status and prefers NGS methodology for multi‑gene profiling.

Documentation Required

Clinical indication documentation — include stage and indication for profiling

Provide clinical stage and indication for molecular profiling (for example, metastatic pancreatic cancer for somatic profiling or confirmed pancreatic cancer for germline testing) when ordering tumor or germline testing.

NCCN: tumor/somatic profiling recommended in metastatic or locally advanced pancreatic cancer when individual is candidate for therapy.

Documentation Required

Laboratory validation note — CLIA/CAP validation preferred

Where applicable, note that assays should preferably be validated per CLIA and CAP regulatory guidelines; reference laboratory validation when relevant to the authorization request.

NCCN notes plasma cfHPV DNA assays should be validated per CLIA/CAP guidelines.

Denial Risk

Tests without FDA companion diagnostic status governed by this policy

Tests that have not been granted FDA cleared or approved companion diagnostic status (including many NGS panels >50 genes and listed named tests) are governed by this policy and may be considered unproven/non‑medically necessary; authorization should include supporting clinical evidence.

Policy: non‑FDA cleared tests, NGS panels >50 genes or CGP are listed as unproven/not medically necessary unless otherwise specified.

Billing Rule

Unlisted code scrutiny — 81479 or 81599 may require extra documentation

Use of unlisted codes such as 81479 or 81599 may trigger additional scrutiny; submit the specific assay code when available and include supporting documentation to avoid claim review or denial.

Policy explicitly notes potential need for extra documentation when unlisted molecular pathology or multianalyte assay codes are used.

Denial Risk

Documentation affects coverage — medical records may be required

Coverage determinations depend on the member's benefit plan and applicable laws; absence of required medical record documentation can result in denial even if clinical criteria appear met.

Medical records may be requested to verify clinical criteria and demonstrate intended use of test results.

Note

Prior authorization not specified in these evidence excerpts

Evidence summaries in the document do not state explicit prior authorization requirements; they summarize clinical studies, intended uses, and guideline positions only.

Denial Risk

Evidence insufficiency may prompt denial for tests lacking sufficient evidence

Tests and indications lacking sufficient evidence (examples listed in policy such as Breast Cancer Gene Expression Ratio/Theros H/I, DCISionRT, Oncotype DX DCIS and others) may be considered unsupported and could be denied.

Policy lists multiple assays as having insufficient evidence to support clinical utility.

Denial Risk

Laboratory and intended‑use compliance — use tests as intended and ensure QA participation

Tests should be used within their intended purpose and laboratories performing testing are expected to participate in external quality assurance schemes; lack of intended‑use compliance or QA may result in non‑acceptance.

NICE: laboratories should take part in national external quality assurance when processing tests.

Denial Risk

Evidence insufficiency may trigger denial

Insufficient or very low‑quality evidence for certain assays or populations (as noted for several prostate and other tests) may lead to denial or noncoverage when medical necessity is not established.

Hayes assessments cited low/very low quality evidence for Decipher, GPS, ExoDx, Select mdx and others which may limit coverage.

Primary usesGEP assays used to estimate recurrence risk and to help guide adjuvant chemotherapy or extended endocrine therapy decisions in early-stage breast cancer

Assay examplesOncotype DX (21-gene), MammaPrint (70-gene), Prosigna/PAM50 (~50 genes), EndoPredict (12-gene), Breast Cancer Index (BCI)

Liquid Biopsy definition

Liquid BiopsyTesting performed on bodily fluid (most commonly plasma) to identify tumor-derived cells or circulating tumor DNA/RNA for detection, treatment selection, or monitoring

ApplicationsUsed to detect somatic variants, methylation patterns, tumor fraction, and to assist when tissue is unavailable or to expedite genotyping (eg, NSCLC cfDNA/ctDNA use per NCCN)

LimitationsLiquid biopsy should not replace tissue diagnosis when feasible and sensitivity may vary by stage and assay; evidence for some liquid assays as screening or routine MRD is insufficient

cfDNA / ctDNA definition

cfDNA / ctDNACirculating cell-free DNA or circulating tumor DNA analyzed from plasma/blood to detect somatic variants, methylation markers, or quantify tumor fraction for profiling or monitoring

Clinical rolecfDNA/ctDNA may be used when tissue is inadequate for NGS or to accelerate actionable result availability; tumor-informed MRD assays are a specialized ctDNA use but lack routine coverage

Assay diversityIncludes targeted cfDNA panels (eg, 33–80 genes), large cfDNA panels (e.g., 311+, 521), and methylation-based assays for detection/MCD

Multigene genomic panel (CPT 81455/81456) definition

Multigene genomic panel (CPT 81455/81456)Next-generation sequencing panels interrogating 51 or greater genes for sequence variants, copy number changes, rearrangements, or expression as reported under CPT 81455/81456

Typical useUsed for broad tumor profiling/CGP to identify actionable genomic alterations in advanced or metastatic disease

Coding distinctionPanels of 5-50 genes are reported under 81445/81449 while 51+ gene panels map to 81455/81456 reflecting the policy's gene-count thresholds

Multi-gene analysis definition

Multi-gene analysisFor this policy, generally refers to a gene panel containing five or more genes; includes assays that produce expression signatures, scores, or classifiers derived from tumor tissue

IncludesBoth DNA mutation panels and RNA expression panels when containing ≥5 genes; used for prognosis, diagnosis, or therapy selection depending on assay

ExclusionsSingle-gene tests or assays assessing fewer than five targets are not considered multi-gene in this policy context unless otherwise specified

Multianalyte assay with algorithmic analysis (81599)

Multianalyte assay with algorithmic analysis (81599)An unlisted multianalyte assay reported under CPT 81599 where algorithms combine multiple molecular analytes to report probabilities, risk scores, or classifications based on molecular data

ReportingThese assays provide algorithm-derived outputs (eg, risk category, probability of disease, recurrence score) rather than single-variant reporting

DocumentationUse of unlisted multianalyte codes may require submission of additional information for claims review per payer processes

ROR score / PAM50 definition

ROR score / PAM50Risk-of-recurrence (ROR) score from the PAM50 (Prosigna) assay estimates recurrence risk and intrinsic molecular subtype; used prognostically for local and distant recurrence risk

InterpretationPAM50 provides an ROR numeric score and risk categories (eg, low ROR <57 in ABCSG-8 subgroup) to stratify patients for prognosis

LimitationsPrognostic for recurrence risk but not predictive of radiotherapy benefit in the referenced subgroup analysis

MammaPrint / BluePrint definition

MammaPrint / BluePrintMammaPrint is a 70‑gene expression test classifying tumors as low or high risk for distant recurrence; BluePrint is an 80‑gene assay for molecular subtyping often used with MammaPrint

Clinical roleMammaPrint risk category may be used to inform adjuvant treatment decisions (eg, MINDACT trial context); evidence for combined MammaPrint+BluePrint utility remains limited

SpecimenAssay analyzes tumor tissue from fresh, frozen, or FFPE specimens

EndoPredict (EPclin) definition

EndoPredict (EPclin)A 12‑gene assay combined with clinical factors (nodal status, tumor size) producing an EPclin risk score estimating recurrence risk in ER+, HER2- early breast cancer

Score rangeEPclin yields a numeric EPclin Risk Score (reported between about 1.1 and 6.2) used to stratify ten‑year distant recurrence risk

Evidence limitationsLimited prospective validation and uncertainty in applicability to premenopausal women; further studies recommended

EPclin Risk Score definition

EPclin Risk ScoreComposite score combining 12‑gene expression with nodal status and tumor size, reported as a numeric EPclin score (approx. 1.1–6.2) to estimate recurrence risk

UseEPclin integrates molecular and clinical variables to inform 10‑year distant recurrence risk assessments in ER+, HER2‑ disease

EvidenceLimited but positive evidence for prognostic validity in N0 disease; further validation needed for broader populations

Breast Cancer Index (BCI) definition

Breast Cancer Index (BCI)A combined gene expression signature (HOXB13:IL17BR ratio and Molecular Grade Index) producing a prognostic score for early and late distant recurrence risk and may predict benefit from extended endocrine therapy in select populations

Intended useUsed to estimate risk of late recurrence (5–10 years) and to inform extended endocrine therapy decisions in some guideline‑endorsed contexts

Evidence notesPredictive evidence limited to primarily postmenopausal populations; further diverse prospective data recommended

DCISionRT Decision Score (DS) definition

DCISionRT Decision Score (DS)A score (0–10) integrating seven genes and clinicopathologic factors to stratify ten‑year DCIS recurrence risk and potential radiotherapy benefit (scores 0–3 low, >3 elevated)

Clinical roleDesigned to aid decisions about adjuvant radiotherapy after breast‑conserving surgery for DCIS; evidence includes observational registries showing impact on recommendations

Evidence limitationsLack of randomized outcome data and limited long‑term clinical outcome evidence; Hayes and other assessments note insufficient high‑quality evidence

Gene expression profiling (GEP) definition with assay examples

GEP (general) with assay examplesGene expression profiling (GEP) refers to assays that measure mRNA expression patterns to provide prognostic and sometimes predictive information (examples: Oncotype DX 21‑gene, MammaPrint 70‑gene, Prosigna/PAM50 ~50‑gene, EndoPredict 12‑gene, BCI)

Typical outputsGEP assays yield recurrence scores, risk categories, intrinsic subtypes, or algorithmic indices to support adjuvant therapy decisions

Contextual recommendationNCCN prefers Oncotype DX for prognosis and chemotherapy‑benefit prediction; other assays vary in prognostic versus predictive evidence

ctDNA / cfDNA definition (liquid biopsy context)

ctDNA / cfDNA (liquid biopsy context)Circulating tumor DNA (ctDNA) or cell‑free DNA (cfDNA) are nucleic acids in plasma/blood analyzed to detect tumor genomic alterations, methylation, or tumor fraction for diagnostic, treatment selection, or monitoring purposes

Clinical usesUsed for tumor genotyping when tissue is limited, for MRD detection (tumor‑informed assays), and for some screening/early detection research; routine clinical utility for MRD and MCD remains unproven

Assay typesIncludes targeted mutation panels, broad cfDNA panels, methylation‑based assays (eg, mSEPT9) and tumor‑informed personalized assays (eg, Signatera)

Decipher genomic classifier (GC) definition

Decipher genomic classifier (GC)A transcriptome‑based 22‑gene genomic classifier (biopsy and post‑prostatectomy versions) that predicts risk of metastasis and prostate cancer outcomes to assist risk stratification and adjuvant treatment considerations

ApplicationsUsed for prognostic stratification in intermediate‑risk disease and to inform post‑radical prostatectomy adjuvant treatment discussions (NCCN category 2B for post‑RP use)

Evidence notesMultiple studies demonstrate independent prognostic association but randomized evidence of outcome improvement is lacking; evidence quality varies

Genomic Prostate Score (GPS) definition

Genomic Prostate Score (GPS)A 17‑gene expression assay (Oncotype DX Prostate) that provides a Genomic Prostate Score to predict adverse pathology and recurrence risk in localized prostate cancer

Use casesMay assist in initial risk stratification to guide active surveillance versus definitive therapy decisions in appropriate patients

EvidenceMeta‑analyses and validation studies show GPS is prognostic for adverse pathology, biochemical recurrence and distant metastasis risk

Prolaris / CCP / CCR definition

Prolaris / CCP / CCRProlaris (cell cycle progression, CCP) is a gene expression test used to derive a clinical cell‑cycle risk (CCR) score combining molecular CCP results with clinical data to assist management decisions in prostate cancer

RoleCCR score has been associated with selection of active surveillance versus definitive treatment and prognostic outcomes in some cohorts

Evidence limitationsStudies include retrospective and observational cohorts; randomized outcome benefit not established

GPS/Oncotype DX label

GPS / Oncotype DX labelOncotype DX Prostate (GPS) is described as a 17‑gene biopsy‑based assay used for prognostic assessment and to help guide management choices in localized prostate cancer

Guideline contextNCCN includes Oncotype DX Prostate among assays that may be considered in men with low or favorable intermediate‑risk disease to guide decisions

SpecimenPerformed on biopsy tissue (FFPE) with algorithmic reporting of a numeric risk score

Decipher label

Decipher labelDecipher is a 22‑gene genomic classifier available in biopsy and post‑prostatectomy versions reporting a risk score for metastasis and PCa‑specific outcomes; NCCN recognizes Decipher for risk stratification and post‑RP use

Intended useUsed to inform adjuvant therapy discussions after radical prostatectomy and to refine risk assessment pre‑treatment in some settings

Evidence caveatEvidence supports prognostic validity but is limited regarding proven improvement in long‑term clinical outcomes when used to direct therapy

NCCN prostate cancer risk groups definition

NCCN prostate cancer risk groupsRisk groups: Very low, Low, Intermediate (favorable/unfavorable), High, Very high — defined by combinations of clinical stage, Grade Group, PSA, biopsy core involvement, and PSA density per NCCN guidance

PSA density in criteriaPSA density < 0.15 ng/mL/g is included in the Very Low‑Risk definition

Use in testing decisionsThese risk group definitions are referenced when considering use of genomic assays for management decisions

Bethesda III/IV definition for indeterminate thyroid nodules

Bethesda III/IV (indeterminate thyroid nodules)Cytology categories indicating indeterminate thyroid nodules (AUS/FLUS; FN/SFN) for which molecular testing is commonly applied to assess malignancy risk and to help avoid diagnostic surgery

Testing contextMolecular classifiers (eg, ThyroSeq v3, Afirma GSC) are evaluated for nodules with Bethesda III/IV cytology to provide rule‑in or rule‑out information

EvidenceMeta‑analyses and prospective studies (eg, ThyroSeq v3) report high sensitivity/NPV and variable specificity/PPV; limitations include retrospective designs and incomplete surgical confirmation

Anaplastic thyroid cancer (ATC) definition

Anaplastic thyroid cancer (ATC)An aggressive thyroid cancer subtype for which no single genetic alteration is pathognomonic; molecular testing may aid differential diagnosis and treatment selection but cannot replace histopathology

CGP roleComprehensive genomic profiling of confirmed ATC is considered medically necessary to identify actionable alterations for targeted therapy when applicable

Guideline noteATA indicates molecular testing may aid histopathologic diagnosis in specific situations but is not diagnostic alone

167-gene expression classifier (GEC) definition

167‑gene expression classifier (GEC)A multi‑gene mRNA expression profile referenced for risk stratification in thyroid nodules with reported performance metrics (eg, PPV, NPV) in some studies

Comparative performanceMeta‑analyses indicate variable PPV/NPV across GECs; ThyroSeq v3 reported strong sensitivity and specificity in prospective studies

Clinical caveatNot routinely indicated for certain cytology categories where performance is similar to cytology per ATA guidance

31-gene expression profile (31-GEP) definition

31‑gene expression profile (31‑GEP)A prognostic genomic classifier for cutaneous melanoma that stratifies tumors into risk classes (eg, Class 1A, 1B/2A, 2B) and has been studied to inform decisions like sentinel lymph node biopsy

Clinical findingsStudies report 31‑GEP influences SLNB decision‑making and is associated with stratified survival outcomes in registry analyses, though prospective outcome impact remains limited

LimitationsEvidence includes retrospective/registry designs and some conflicts of interest; prospective randomized outcome data are lacking

Pigmented Lesion Assay (PLA) definition

Pigmented Lesion Assay (PLA)A non‑invasive adhesive patch gene expression test detecting LINC00518, PRAME, and TERT intended to help rule out melanoma and triage lesions for biopsy

Performance concernsStudies report substantial assay failure or discordance rates for some genes (eg, TERT failure up to ~70.9% in one series) and variable concordance with histopathology

Clinical statusEvidence limited and additional robust real‑world studies needed before routine clinical use

GEP general label

GEP (general label)Gene expression profiling (GEP) tests measure tumor transcriptomic patterns to provide prognostic or predictive information and may inform management when validated in the intended population

ExamplesIncluded assays: Oncotype DX, MammaPrint, Prosigna, EndoPredict, BCI, DCISionRT, and others referenced in guidelines

Policy stanceSome GEPs are considered proven and medically necessary in specified indications (eg, early‑stage ER+/HER2‑ breast cancer) while others lack sufficient evidence

CGH definition

Comparative Genomic Hybridization (CGH)A technology to detect genomic copy number variations (CNVs) used as an adjunctive diagnostic tool (eg, to differentiate melanomas from naevi) by assessing chromosomal gains/losses

ApplicationUsed in diagnosticly equivocal melanocytic lesions as an adjunct to histopathology; demonstrated differentiation in small studies

LimitationsEvidence limited in scale; CGH considered an adjunct rather than standalone diagnostic in guidelines

CGP (comprehensive genomic profiling) definition

CGP (comprehensive genomic profiling)Broad NGS‑based tumor testing assessing multiple genomic alterations (mutations, MSI, TMB, gLOH, fusions) to identify actionable alterations and clinical trial eligibility (often reported as CGP)

Clinical roleMay identify potentially targetable alterations in cancers including CUP and advanced/metastatic tumors to inform targeted therapy or trial enrollment

Evidence limitsAlthough diagnostic/actionable findings are common, routine use of CGP for some indications (eg, population screening, WES/WGS/WGTA) lacks sufficient evidence for improved patient outcomes

mSEPT9 / Epi proColon definition

mSEPT9 / Epi proColon (ColoHealth)A plasma real‑time PCR assay detecting methylated SEPT9 DNA intended as a colorectal cancer screening option for average‑risk adults who have not completed recommended screening; sensitivity is higher in advanced stages

PerformanceMeta‑analyses report pooled sensitivity ~0.69 and specificity ~0.92; overall evidence considered low quality and test not optimal compared with standard screening

Guideline stanceACG recommends against routine use as optimal screening; USPSTF does not include serum tests for CRC screening

mSEPT9 duplicate definition entry

mSEPT9 (duplicate entry)See mSEPT9 / Epi proColon definition — plasma methylated SEPT9 assay for CRC screening; evidence limited and not preferred over established screening tools

Intended populationOffered as an option for individuals noncompliant with other CRC screening methods, per manufacturer claims, but guideline support limited

Evidence cautionSensitivity increases with cancer stage; specificity variable across studies; further validation recommended

MMR/MSI testing definition

MMR/MSI testingTumor testing for mismatch repair deficiency or microsatellite instability used to identify Lynch syndrome, to guide immunotherapy decisions in metastatic disease, and to inform stage II treatment decisions

MethodologyPerformed on tumor tissue (IHC or molecular) as part of standard workup for colorectal cancer per NCCN guidance; recommended universally for CRC tumor tissue

Clinical impactIdentifies candidates for immunotherapy and hereditary cancer evaluation; essential for therapeutic decision‑making in metastatic CRC

Tumor-informed MRD assay definition (Signatera example)

Tumor‑informed MRD assay (Signatera example)Personalized ctDNA assay that uses tumor tissue sequencing to design patient‑specific targets for blood monitoring of minimal residual disease (example: Signatera); current evidence is insufficient to support routine surveillance use

ApproachTumor‑informed assays require prior tumor sequencing to select patient‑specific variants for longitudinal ctDNA monitoring

Policy stancePolicy indicates tumor‑informed MRD assays lack demonstrated clinical utility for routine monitoring or surveillance outside of clinical trials

TTMV-HPV DNA (NavDx) definition

TTMV‑HPV DNA (NavDx)A plasma assay intended to detect tumor tissue‑modified viral HPV DNA for diagnosis, monitoring response, MRD detection, and recurrence surveillance in HPV‑related cancers; current evidence limited

Performance notesSystematic reviews report high pooled specificity for TTMV‑HPV DNA in OPSCC surveillance, but standardization and prospective outcome data remain limited

Policy positionInsufficient evidence to support routine clinical use; further prospective studies needed

Multi-Cancer Detection (MCD) test definition

Multi‑Cancer Detection (MCD) testBlood‑based assays (often cfDNA methylation or targeted sequencing plus machine learning) designed to detect signals from multiple cancer types and predict tissue of origin; high specificity but variable sensitivity and lacking evidence for population screening utility

Examples and evidenceMCED tests (eg, Galleri) show high specificity (~99.5%) and modest overall sensitivity (e.g., ~51.5%), with ongoing studies; professional societies do not yet recommend routine screening use

Policy cautionUse for general population screening not supported by current evidence and may be excluded from coverage outside trials

Tumor-informed MRD assay duplicate definition

Tumor‑informed MRD assay (duplicate)Personalized ctDNA assays using tumor sequencing to select patient‑specific variants for blood monitoring (eg, Signatera) — evidence insufficient for routine surveillance use

Intended monitoring useDesigned to detect minimal residual disease after definitive therapy and to monitor for recurrence; current policy limits routine use to clinical trials or investigational contexts

Technical requirementRequires an initial tumor tissue sequencing step to identify targets for individualized blood assays

WES/WGS/RNA-NGS (WGTA) definition

WES / WGS / RNA‑NGS (WGTA) definitionWhole exome, whole genome, or whole‑transcriptome sequencing are comprehensive molecular profiling approaches assessing coding and/or noncoding regions and transcriptomes to identify somatic variants, fusions, and expression features

Policy stancePolicy states current evidence is insufficient to support routine clinical use of WES/WGS/WGTA to inform standard treatment decisions outside research or precision oncology programs

Potential roleMay identify actionable alterations in selected refractory or high‑risk cancers within research or clinical trial settings where results may influence therapy

Billing Rule

Unlisted code scrutiny reminder (81479 / 81599)

Reminder: use of unlisted codes such as 81479 or 81599 may prompt additional documentation or administrative review when submitted; include specific assay documentation to support medical necessity.

Policy explicitly flags 81479 and 81599 as unlisted codes that may require scrutiny.

Documentation Required

Documentation affects coverage reminder

Reminder that coverage depends on member‑specific benefits and that medical record documentation may be required to determine whether clinical criteria are met; lack of documentation can affect coverage decisions.