TL;DR: UnitedHealthcare modified its molecular pathology, molecular diagnostics, and genetic testing coverage policy for Medicare Advantage members, effective January 5, 2026. Here's what billing teams need to do.
UnitedHealthcare updated policy code molecular-pathology-diagnostics-genetic-testing to reflect current coverage criteria across more than 108 CPT codes. This includes codes for oncology panels, hereditary condition testing, and NGS-based assays — from CPT 81170 (ABL1) to 81519 (Oncotype DX breast) to 0315U (cutaneous squamous cell carcinoma). If your lab or practice bills genetic testing for Medicare Advantage members, this coverage policy change touches nearly every category of molecular diagnostics you run.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | UnitedHealthcare |
| Policy Title | Molecular Pathology/Molecular Diagnostics/Genetic Testing – Medicare Advantage Medical Policy |
| Policy Code | molecular-pathology-diagnostics-genetic-testing |
| Change Type | Modified |
| Effective Date | January 5, 2026 |
| Impact Level | High |
| Specialties Affected | Pathology, Oncology, Hematology/Oncology, Genetics, Urology, Pulmonology, Neurology |
| Key Action | Audit your active genetic testing claims against the updated covered indications and LCD compliance requirements before billing under this policy |
UnitedHealthcare Genetic Testing Coverage Criteria and Medical Necessity Requirements 2026
The UnitedHealthcare genetic testing coverage policy sets medical necessity criteria at the individual gene, panel, and clinical indication level. That's not unusual for molecular pathology — but the scope here is large. Coverage depends on diagnosis, clinical presentation, and in many cases, the specific testing technology used.
The policy draws a clear line between NCD coverage and LCD coverage. For NGS-based tests, CMS NCD 90.2 governs somatic and germline cancer testing. For RNA sequencing and protein analysis using NGS, Medicare Administrative Contractors (MACs) make the call. If your MAC has a local coverage determination (LCD) for a specific molecular test, that LCD controls — not just the covered indications in this policy.
That's the piece billing teams miss most often. UnitedHealthcare's Medicare Advantage coverage policy defers to active LCDs where they exist. Before you assume a test is covered based on the indications list below, check whether your jurisdiction has a relevant LCD. If it does, you must meet those LCD criteria and document accordingly.
Medical necessity for specific covered tests requires:
| # | Covered Indication |
|---|---|
| 1 | Clinical, laboratory, or pathological findings consistent with the indicated diagnosis |
| 2 | The test must guide therapeutic decision-making or prognostication — not just confirm a known diagnosis |
| 3 | Documentation supporting the indication in the patient's record before the test is ordered |
Prior authorization requirements are not uniformly specified in this policy for every code. However, given the high-dollar nature of NGS panels and proprietary assays (like Oncotype DX or BDX-XL2), check prior auth requirements at the claim level before submission. Missing prior authorization on a high-cost molecular assay is one of the most common — and most expensive — claim denial scenarios in genetic testing billing.
UnitedHealthcare Genetic Testing Exclusions and Non-Covered Indications
Laboratory developed tests (LDTs) without FDA approval or clearance carry elevated scrutiny under this policy. The policy defines an LDT as any test developed by a laboratory without FDA approval or clearance. That definition matters because many proprietary assays — including some listed here under "Provisional Coverage" — fall into this category.
Tests listed under Provisional Coverage are not fully covered indications. They're covered provisionally, which means conditions apply. Treat these differently in your billing workflow. If you're billing 0018U (thyroid microRNA profiling), 0026U (thyroid DNA/mRNA NGS), or 0080U (lung mass spectrometric analysis), verify that provisional coverage criteria are met before submitting.
The policy also flags that tests covered under NCD 90.2 follow CMS rules — UHC Medicare Advantage is bound by those same NCD criteria. If the NCD excludes a specific use case, this policy does not expand coverage for it.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| ABL1 kinase domain variants — ALL and CML, therapeutic guidance | Covered | 81170 | Must guide therapeutic decision-making |
| ASXL1 — AML, MPD (ET, myelofibrosis, PV), MDS prognostication | Covered | 81175, 81176 | Prognostic use; not for initial diagnosis alone |
| BDX-XL2 (Biodesix) — lung nodule 8–30mm, age ≥40, pre-test cancer risk ≤50% (Mayo Model) | Covered | 0080U | Identifies benign nodules for CT surveillance vs. invasive workup |
| Genomic Prostate Score (GPS) / Oncotype DX GPS — very low, low, favorable intermediate risk prostate cancer | Covered | 0047U | Formerly Oncotype DX Genomic Prostate Score |
| JAK2 exon 12 — JAK2 V617F-negative adults with findings suggesting polycythemia vera | Covered | 81279 | Initial workup only; JAK2 V617F negative required |
| MPL gene — BCR-ABL and JAK2 V617F-negative adults with thrombocytosis, ET, or primary myelofibrosis | Covered | 81338, 81339 | Dual negative (BCR-ABL and JAK2) required |
| KIT — gastrointestinal stromal tumor (GIST) | Covered | 81272 | Somatic mutation; therapeutic guidance |
| PDGFRA — GIST | Covered | 81314 | Paired with KIT testing in GIST workup |
| PIK3CA — colorectal and other cancers | Covered | 81309, 0155U | Includes liquid biopsy assay (0155U) for breast cancer |
| TERT — thyroid carcinoma, glioblastoma multiforme | Covered | 81345 | Specific tumor types only |
| Oncotype DX Breast (21-gene recurrence score) | Covered | 81519 | FFPE tumor tissue; algorithmic recurrence score |
| Oncotype DX DCIS (12-gene) | Provisional Coverage | 0045U | Ductal carcinoma in situ; provisional status |
| Thyroid microRNA profiling (10 microRNA, RT-PCR) | Provisional Coverage | 0018U | FNA specimen; provisional status |
| Thyroid DNA/mRNA NGS (112 genes) | Provisional Coverage | 0026U, 0287U | FNA specimen; two codes, verify which applies |
| Thyroid mutation analysis (10 genes, 37 RNA fusions, 4 mRNA markers) | Provisional Coverage | 0245U | Provisional; distinct from 0026U/0287U |
| Oncology thyroid mRNA (10,196 genes, FNA) | Covered | 81546 | Full gene expression analysis from FNA |
| Cutaneous squamous cell carcinoma (40-gene mRNA profiling, RT-PCR) | Provisional Coverage | 0315U | RT-PCR; provisional status |
| Melanoma (PRAME and LINC00518 expression) | Provisional Coverage | 0089U | Superficial collection; provisional status |
| Cutaneous melanoma (23-gene mRNA profiling) | Provisional Coverage | 0090U | RT-PCR; provisional status |
| Lung cancer recurrence risk (11-gene quantitative PCR) | Provisional Coverage | 0288U | FFPE tumor tissue; RiskReveal / DetermaRx |
| Fetal chromosomal aneuploidy (e.g., trisomy 21, monosomy X) — cfDNA | Covered | 81420 | Circulating cell-free fetal DNA |
| Fetal chromosomal microdeletion (e.g., DiGeorge, Cri-du-chat) | Covered | 81422 | NGS-based |
| Whole genome sequencing — unexplained constitutional/heritable disorder | Covered | 81425, 81426, 81427 | 81427 for re-evaluation of prior sequencing |
| Hearing loss genomic sequencing (non-syndromic, Usher, Pendred) | Covered | 81430, 81431 | Panel includes GJB2, MYO7A, PCDH15, OTOF, others |
| Hereditary retinal disorders (retinitis pigmentosa, Leber congenital amaurosis) | Covered | 81434 | Includes RP2, RPE65, RPGR, USH2A |
| Nuclear encoded mitochondrial genes — neurologic/myopathic phenotypes | Covered | 81440 | Includes POLG, SCO1, SCO2, SUCLA2, TK2, others |
| Severe inherited conditions panel (CF, Ashkenazi Jewish-associated, others) | Covered | 81443 | Includes CFTR, FANCC, GBA, HEXA, IKBKAP, MCOLN1, SMPD1 |
| HBA1/HBA2 — alpha thalassemia | Covered | 81258, 81259 | Common and rare deletion variants |
| HTT — Huntington disease | Covered | 81271, 81274 | Expansion detection and allele characterization |
| FXN — Friedreich ataxia | Covered | 81284, 81285, 81286, 81289 | Multiple assay types; choose correct code |
| MECP2 — Rett syndrome | Covered | 81302, 81303, 81304 | Full sequence, known familial variant, dup/del |
| PMP22 — Charcot-Marie-Tooth, hereditary neuropathy | Covered | 81324, 81325, 81326 | Full sequence, known familial, dup/del |
| SMN1 — spinal muscular atrophy | Covered | 81329, 81336, 81337 | Dosage/deletion, full gene, known familial |
| SNRPN/UBE3A — Angelman/Prader-Willi syndromes | Covered | 81331 | Methylation analysis |
| Hereditary peripheral neuropathies genomic panel | Covered | 81448 | Includes Charcot-Marie-Tooth, spastic paraplegia |
| AR — spinal/bulbar muscular atrophy, Kennedy disease | Covered | 81173, 81174, 81204 | Multiple assay types |
| ASPA — Canavan disease | Covered | 81200 | Common variants |
| IKBKAP — familial dysautonomia | Covered | 81260 | Common variants |
| MCOLN1 — Mucolipidosis type IV | Covered | 81290 | Common variants |
| MTHFR — hereditary hypercoagulability | Covered | 81291 | Specific variants |
| SMPD1 — Niemann-Pick disease type A | Covered | 81330 | Common variants |
| AFF2 (FMR2) — Fragile X intellectual disability 2 | Covered | 81171, 81172 | Expansion detection and allele characterization |
| BCKDHB — maple syrup urine disease | Covered | 81205 | Common variants |
| SMN1 — known familial variant | Covered | 81337 | Targeted familial testing |
| FISH urinary tract (UroVysion) — cytopathology | Covered | 88120, 88121 | Note: deleted CPT codes for 3–5 probe manual/automated UroVysion removed 04/23/2025 |
| JAK2 targeted sequence analysis (0027U) | Provisional Coverage | 0027U | Proprietary assay; provisional status |
UnitedHealthcare Molecular Diagnostics Billing Guidelines and Action Items 2026
| # | Action Item |
|---|---|
| 1 | Audit active charge capture against the January 5, 2026 effective date. Any claims for dates of service on or after January 5, 2026 must align with the updated criteria. Pull your genetic testing charges from the last 90 days and verify each billed code maps to a covered indication with documented medical necessity. |
| 2 | Remove deleted CPT codes from your charge master immediately. The CPT codes for 3–5 molecular probe FISH (UroVysion) — both manual and computer-assisted — were deleted on April 23, 2025. If these codes are still active in your charge master, they will generate claim denial. Use 88120 and 88121 instead for FISH urinary tract cytopathology with morphometric analysis. |
| 3 | Separate your provisional coverage codes from your covered codes in your billing workflow. Codes like 0018U, 0026U, 0027U, 0045U, 0047U, 0080U, 0089U, 0090U, 0155U, 0245U, 0287U, and 0288U carry provisional status. Flag these for additional documentation review before submission. Provisional status means extra scrutiny on claim review — not automatic denial, but not automatic payment either. |
| 4 | Check for an active LCD before billing NGS-based tests. This policy defers to MAC-level LCDs where they exist. For any NGS test — whether it's a somatic panel, a germline cancer test, or an RNA sequencing assay — look up your MAC's coverage article before assuming the covered indications in this policy are sufficient. Billing guidelines at the local level can be more restrictive than what this policy states. |
| 5 | Document the clinical indication at the gene and condition level, not just the test name. For ABL1 (81170), you need documented ALL or CML. For JAK2 exon 12 (81279), you need a documented JAK2 V617F-negative result plus clinical or pathological findings suggesting polycythemia vera. Vague documentation — "genetic testing ordered" — will not support medical necessity under this policy. Pair the CPT code to the specific clinical condition in your documentation. |
| 6 | Confirm prior authorization status for high-cost proprietary assays before the test is performed. BDX-XL2 (0080U), Genomic Prostate Score (0047U), and Oncotype DX Breast (81519) are all high-reimbursement tests with specific patient selection criteria. A missed prior authorization on one of these is a significant revenue loss. Verify authorization requirements with UnitedHealthcare before the specimen is collected. |
| 7 | If you bill thyroid molecular testing, clarify which code applies to your assay. Codes 0026U, 0245U, and 0287U all describe thyroid NGS-based tests with overlapping descriptions. These are not interchangeable. Bill the proprietary test code that matches the specific assay the lab performed. If you're unsure, your compliance officer should review before the claim goes out. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Molecular Pathology/Molecular Diagnostics/Genetic Testing Under molecular-pathology-diagnostics-genetic-testing
Covered CPT Codes (When Medical Necessity Criteria Are Met)
| Code | Description |
|---|---|
| 81170 | ABL1 (ABL proto-oncogene 1) — acquired imatinib tyrosine kinase inhibitor resistance variants |
| 81171 | AFF2 (FMR2) — Fragile X intellectual disability 2; evaluation to detect abnormal alleles |
| 81172 | AFF2 (FMR2) — Fragile X intellectual disability 2; characterization of alleles |
| 81173 | AR (androgen receptor) — spinal and bulbar muscular atrophy, Kennedy disease; full sequence |
| 81174 | AR (androgen receptor) — known familial variant |
| 81175 | ASXL1 — myelodysplastic syndrome, myeloproliferative disorder; full gene sequence |
| 81176 | ASXL1 — targeted sequence analysis |
| 81200 | ASPA (aspartoacylase) — Canavan disease; common variants |
| 81204 | AR (androgen receptor) — characterization of alleles |
| 81205 | BCKDHB — maple syrup urine disease; common variants |
| 81258 | HBA1/HBA2 — alpha thalassemia; common deletions |
| 81259 | HBA1/HBA2 — alpha thalassemia; rare variants |
| 81260 | IKBKAP — familial dysautonomia; common variants |
| 81271 | HTT (huntingtin) — Huntington disease; evaluation to detect abnormal alleles |
| 81272 | KIT — gastrointestinal stromal tumor; targeted sequence analysis |
| 81274 | HTT (huntingtin) — Huntington disease; characterization of alleles |
| 81279 | JAK2 — myeloproliferative disorder; targeted sequence analysis (exons 12–15) |
| 81284 | FXN (frataxin) — Friedreich ataxia; evaluation to detect abnormal alleles |
| 81285 | FXN (frataxin) — Friedreich ataxia; characterization of alleles |
| 81286 | FXN (frataxin) — Friedreich ataxia; full gene sequence |
| 81289 | FXN (frataxin) — Friedreich ataxia; known familial variant(s) |
| 81290 | MCOLN1 — Mucolipidosis type IV; common variants |
| 81291 | MTHFR — hereditary hypercoagulability; common variants |
| 81302 | MECP2 — Rett syndrome; full sequence analysis |
| 81303 | MECP2 — Rett syndrome; known familial variant |
| 81304 | MECP2 — Rett syndrome; duplication/deletion variants |
| 81309 | PIK3CA — colorectal and other cancers |
| 81314 | PDGFRA — gastrointestinal stromal tumor |
| 81324 | PMP22 — Charcot-Marie-Tooth, hereditary neuropathy; duplication/deletion analysis |
| 81325 | PMP22 — full sequence analysis |
| 81326 | PMP22 — known familial variant |
| 81329 | SMN1 — spinal muscular atrophy; dosage/deletion analysis |
| 81330 | SMPD1 — Niemann-Pick disease type A; common variants |
| 81331 | SNRPN/UBE3A — Angelman/Prader-Willi syndromes |
| 81336 | SMN1 — full gene sequence |
| 81337 | SMN1 — known familial variant |
| 81338 | MPL — myeloproliferative disorder; common variants |
| 81339 | MPL — myeloproliferative disorder; sequence analysis |
| 81345 | TERT — thyroid carcinoma, glioblastoma multiforme |
| 81420 | Fetal chromosomal aneuploidy (e.g., trisomy 21, monosomy X) — cfDNA genomic sequence analysis |
| 81422 | Fetal chromosomal microdeletion(s) — genomic sequence analysis |
| 81425 | Genome sequencing — unexplained constitutional or heritable disorder; sequence analysis |
| 81426 | Genome sequencing — each additional sample |
| 81427 | Genome sequencing — re-evaluation of previously sequenced data |
| 81430 | Hearing loss genomic sequencing (non-syndromic, Usher, Pendred); full panel |
| 81431 | Hearing loss — duplication/deletion analysis |
| 81434 | Hereditary retinal disorders (retinitis pigmentosa, Leber congenital amaurosis, cone-rod dystrophy) |
| 81440 | Nuclear encoded mitochondrial genes — neurologic or myopathic phenotypes; genomic sequence panel |
| 81443 | Genetic testing for severe inherited conditions (CF, Ashkenazi Jewish-associated, others) |
| 81448 | Hereditary peripheral neuropathies (Charcot-Marie-Tooth, spastic paraplegia) — genomic sequence panel |
| 81519 | Oncotype DX Breast — 21-gene mRNA expression profiling; real-time RT-PCR; FFPE tissue |
| 81546 | Oncology (thyroid) — mRNA, gene expression analysis of 10,196 genes; FNA specimen |
| 88120 | Cytopathology, in situ hybridization (FISH), urinary tract specimen with morphometric analysis |
| 88121 | Cytopathology, in situ hybridization (FISH), urinary tract specimen with morphometric analysis; computer-assisted |
Provisional Coverage CPT/Proprietary Codes (Additional Documentation Required)
| Code | Description |
|---|---|
| 0018U | Oncology (thyroid) — microRNA profiling by RT-PCR of 10 microRNA sequences; FNA specimen |
| 0026U | Oncology (thyroid) — DNA and mRNA of 112 genes; NGS; FNA specimen |
| 0027U | JAK2 — myeloproliferative disorder; targeted sequence analysis (proprietary assay) |
| 0045U | Oncology (breast DCIS) — mRNA, 12-gene expression profiling by real-time RT-PCR |
| 0047U | Oncology (prostate) — mRNA, 17-gene expression profiling by real-time RT-PCR |
| 0080U | Oncology (lung) — mass spectrometric analysis of galectin-3-binding protein and scavenger receptor cysteine-rich type 1 protein M130; with five clinical risk factors; plasma |
| 0089U | Oncology (melanoma) — gene expression profiling by RTqPCR; PRAME and LINC00518; superficial collection |
| 0090U | Oncology (cutaneous melanoma) — mRNA, 23-gene expression profiling by RT-PCR |
| 0155U | Oncology (breast cancer) — DNA, PIK3CA (liquid biopsy) |
| 0245U | Oncology (thyroid) — mutation analysis of 10 genes and 37 RNA fusions and expression of 4 mRNA markers |
| 0287U | Oncology (thyroid) — DNA and mRNA, NGS analysis of 112 genes; FNA specimen (updated assay code) |
| 0288U | Oncology (lung) — mRNA, quantitative PCR of 11 genes (BAG1, BRCA1, CDC6, CDK2AP1, ERBB3, FUT3, IL11, LCK, RND3, SH3BGR, WNT3A) and 3 reference genes; FFPE tumor tissue (RiskReveal/DetermaRx) |
| 0315U | Oncology (cutaneous squamous cell carcinoma) — mRNA, 40-gene expression profiling by RT-PCR |
Deleted Codes (Do Not Bill)
| Code | Description | Deletion Date |
|---|---|---|
| [3–5 molecular probes, manual — UroVysion] | Cytopathology FISH; urinary tract; 3–5 probes; manual | 04/23/2025 |
| [3–5 molecular probes, computer-assisted — UroVysion] | Cytopathology FISH; urinary tract; 3–5 probes; computer-assisted | 04/23/2025 |
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