Genetic Testing — Coverage Criteria for Genetic & Molecular Testing
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Policy governing medical necessity, coverage, and prior authorization requirements for genetic and molecular testing for eocco members, including prenatal, diagnostic, tumor marker assays, and pharmacogenetic tests.
No material clinical or coverage changes in this revision.
Coverage Criteria
Pregnancy-related testing
Covered when ANY of the following are met for pregnant persons or those planning pregnancy:
Pre-test genetic counseling must be provided by a qualified and appropriately trained practitioner.
Pre/Post Symptomatic Testing (General)
Covered when ALL of the following are met (if specific guidelines unavailable):
Refer to Moda Health MHMNC or Milliman Care Guidelines for disorder‑specific criteria when available.
Tumor Marker Genetic Assays
Specific tumor marker assays considered medically necessary for listed indications:
Coverage subject to referenced clinical guidelines.
Refer to modality‑specific guidance (MCG or Moda Health criteria) for indication details.
Tests Considered Experimental/Investigational
The following assays/panels are considered experimental/investigational (not covered) due to insufficient evidence:
This is not an all‑inclusive list; panels referenced in Moda Health guidance as investigational are excluded.
This is not an all‑inclusive list.
Direct-to-Consumer Testing
Requests for direct‑to‑consumer testing will be denied.
Not Medically Necessary — Selected Conditions
The following condition-specific germline genetic testing is considered not medically necessary:
Tests for these indications are considered not medically necessary per policy.
Panel-based testing: coverage criteria
Covered when ALL of the following are met for named panels:
Providers must document panel gene content and include required genes; see policy for full gene lists.
Coverage contingent on panel meeting both gene‑content and indication requirements; refer to policy Appendix and gene lists.
Direct-to-consumer genetic testing (for example, 23andMe and Color) is not covered. Tests must be ordered by an appropriate provider, performed by a CLIA-approved laboratory, and meet the medical necessity criteria for the specific indication to be considered for coverage.
A substantial list of specific CPT codes is explicitly identified as not covered in the policy. Examples include single-gene, multigene, exome/genome, mitochondrial genome, HLA typing, and various multianalyte/algorithmic assay codes; see the 'CPT codes NOT covered' section for the full enumerated list.
The policy designates numerous CPT codes as not covered. Representative codes listed as not covered include 81175, 81176, 81225, 81226, 81227, 81230, 81231, 81232, 81291, 81313, 81350, 81355, 81377, 81383, 81415, 81416, 81417, 81425, 81426, 81427, 81440, 81455, 81460, 81465, 81470, 81471, 81490, 81493, 81500, 81503, 81525, 81529, 81551 (see 'CPT codes NOT covered' for context and complete listings).
Germline genetic testing for certain listed conditions is considered not medically necessary. Conditions specifically named include familial Alzheimer disease, amyotrophic lateral sclerosis (ALS), age-related macular edema, narcolepsy, scoliosis, depression, mood disorders, bipolar disorder, anxiety disorders, attention deficit hyperactivity disorder (ADHD), and anorexia nervosa.
Several pharmacogenetic testing panels are considered experimental/investigational and therefore not covered due to insufficient evidence of clinical utility. Examples enumerated in the policy include Genecept, GeneSight, PGXL Broad Spectrum Panel, Millenium PGT, AmpliChip, STAR SureGene, Genomind Neuropsych Pharmacogenetic report, among others.
The policy lists numerous examples of pharmacogenomic and single-gene common-variant tests that are treated as investigational or not covered. Examples called out in the text and code listings include common-variant analyses for cytochrome P450 genes such as CYP2C19 (81225), CYP2D6 (81226), CYP2C9 (81227), CYP3A4 (81230), CYP3A5 (81231), as well as DPYD (81232), UGT1A1 (81350), VKORC1 (81355), and MTHFR (81291).
Covered Indications
Pregnancy-related testing — personal/family history, high-risk ancestry, parental testing after recurrent pregnancy loss, CF and SMA screening standard care
Covered when ANY of the following are met for pregnant persons or those planning pregnancy:
Pre‑test genetic counseling required by a qualified and appropriately trained practitioner.
Diagnostic pre/post symptomatic testing
Refer to Moda Health MHMNC or Milliman Care Guidelines for disorder‑specific criteria; pre‑test genetic counseling required.
Specific tumor marker genomic assays
Specific tumor marker genomic assays considered medically necessary for listed cancer-related indications:
See MCG A‑0532 for indication details and clinical application.
Refer to Moda Health MHMNC or specific MCG guidelines for use criteria and documentation requirements.
Various hereditary and disease-specific indications
Various hereditary and disease-specific indications with panel gene‑content requirements:
Duplication/deletion analysis panels must include analyses for TGFBR1, TGFBR2, MYH11, and COL3A1.
Used for carrier screening in individuals of Ashkenazi Jewish ancestry.
Order corresponding panel code and document gene content.
Refer to listed gene set for panel composition.
Duplication/deletion analysis panels must include copy number analyses for STRC and DFNB1 (GJB2/GJB6) deletions.
Duplication/deletion analysis panels must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK11.
Refer to policy for full gene content.
Use appropriate CPT code (eg, 81435/81436) and document gene content.
See CPT 81442 context.
See policy CPT mappings.
Order must match clinical indication (eg, hypertrophic or dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy).
Genetic testing corresponding to ICD-10 ranges in Appendix 1
Refer to Appendix 1 for the full list of covered diagnosis code ranges.
Eligibility Requirements
Coverage for pre- or post-symptomatic genetic testing requires clinical justification: the patient must have signs/symptoms or be at risk because of family history or ancestry, and the test must meet the policy’s medical necessity criteria. For pregnancy-related testing (or those planning pregnancy), coverage is provided when any of the following apply: personal or family history of a genetic disorder; ancestry that meets test-specific high‑risk criteria; parental testing after unexplained stillbirth, two or more first‑trimester miscarriages, or a previous child with a genetic abnormality; and standard prenatal carrier screening for CFTR (CF) and SMA. Pre-test genetic counseling by a qualified practitioner is required for pregnancy-related testing.
Additional eligibility requirements and disorder-specific entry criteria are detailed in the policy appendices and referenced guidance; where applicable, follow the named disorder criteria in Moda Health MHMNC or Milliman Care Guidelines for testing eligibility.
When disorder-specific criteria are available, providers should follow Moda Health MHMNC or Milliman Care Guidelines. If no specific guideline exists, general eligibility requires that testing be medically necessary: standard evaluation is inconclusive, the requested test is proven in evidence-based literature to be diagnostic for the suspected condition, and the results are expected to directly impact patient management. Prior authorization documentation should include provider chart notes, family history, and documentation of pre-test genetic counseling when available.
Provider Actions & Documentation
Submit chart notes, family history, and pre-test genetic counseling with prior auth
Prior authorization requests should include provider chart notes, a documented family history, and documentation of pre-test genetic counseling from a qualified and appropriately trained provider when available.
- Provider chart notes
- Family history
- Documentation of pre-test genetic counseling from a qualified and appropriately trained provider
Verify code-to-panel and criteria alignment before billing
Ensure the CPT code(s) billed match the panel and its gene content and that any listed code-specific criteria in the policy are met and documented before submission; coverage is contingent on meeting the code-to-panel/gene-content alignment and stated criteria.
- Verify billed CPT corresponds to the panel's gene list and minimum gene count
- Document how the panel meets the indication-specific criteria required by the policy
Comply with applicable NCDs/LCDs for prior authorization
Where CMS Local Coverage Determinations (LCDs) or National Coverage Determinations (NCDs) apply, comply with those determinations; additional indications may be covered at the plan's discretion.
- Check the CMS Medicare Coverage Database for applicable NCDs/LCDs
- Follow LCD/NCD documentation requirements when they apply
Provide and document pre-test genetic counseling
Pre-test genetic counseling must be provided by a qualified and appropriately trained practitioner for pregnancy-related and pre/post-symptomatic testing; include counseling documentation with requests when available.
- Qualified and appropriately trained practitioner must provide counseling
- Include counseling documentation in prior authorization submission if available
Confirm and document required panel gene content
Panel-based tests must include the required minimum genes and specific named genes for the indicated syndrome; verify and document panel composition against the policy's gene lists and thresholds when ordering.
- Confirm panel includes minimum gene count (policy gives examples such as >=9, >=14, >=60 depending on panel)
- Document which required genes are included for the indicated syndrome
Step therapy not specified
No step therapy requirements are specified in this policy excerpt; no step-therapy actions are required by the provider based on the provided text.
- Providers need not follow a step-therapy sequence per this excerpt
Include chart notes, family history, and counseling documentation with PA
When requesting prior authorization, submit provider chart notes, family history, and documentation of pre-test genetic counseling from a qualified practitioner to support medical necessity.
- Provider chart notes
- Family history
- Pre-test genetic counseling documentation
Document panel includes required genes and minimum gene count
Coverage for many named multi-gene panels is conditional on inclusion of specified genes and minimum gene counts (for example, hereditary breast cancer panels must include sequencing of at least 14 genes including ATM, BRCA1, BRCA2, BRIP1, CDH1, MLH1, MSH2, MSH6, NBN, PALB2, PTEN, RAD51C, STK11, and TP53).
- Document that the panel includes the listed required genes
- Confirm panel meets the policy's minimum gene count for the indicated syndrome
Follow CMS NCD/LCD documentation requirements
Follow applicable CMS NCDs/LCDs and include supporting documentation consistent with those determinations when applicable to the requested test or indication.
- Reference the applicable LCD/NCD and include required supporting documentation
- Be aware that additional indications may be covered at the plan's discretion
Panel requests may be denied if panel evidence is insufficient
Requests for group or panel testing may be denied as investigational when evidence-based literature does not support clinical validity or utility of the panel as a whole.
- Avoid ordering panels whose combined evidence has not been supported in the literature
- Be prepared to justify clinical validity/utility of multi-gene panels in the request
DTC genetic tests are not covered — order through provider/CLIA lab
Direct-to-consumer (DTC) genetic tests (eg, 23andMe, Color) are not covered and will be denied if submitted; tests must be ordered by an appropriate provider and performed by a CLIA-approved laboratory to be considered.
- Do not submit DTC test results or claims for coverage
- Order tests through an appropriate provider and a CLIA-approved lab
Billing with listed NOT‑covered CPT codes may trigger denial
Certain CPT codes are explicitly listed as not covered in the policy; billing or submitting claims with those CPT codes may result in denial.
Claims with CPT codes from the 'NOT covered' list risk denial
The presence of CPT codes designated as NOT covered in a claim may trigger claim denial; verify code applicability to the indication and policy before billing.
- Review the policy's 'CPT codes NOT covered' section before submitting claims
- If in doubt, confirm medical necessity and policy applicability prior to billing
Noncompliance with NCD/LCD requirements may cause denial
Noncompliance with applicable NCDs/LCDs where they apply may result in denial of the request or claim; verify and adhere to those determinations when relevant.
- Confirm whether an NCD/LCD applies to the requested service
- Include documentation required by the applicable NCD/LCD
Provide pre-test genetic counseling by a qualified practitioner
Pre-test genetic counseling must be provided by a qualified and appropriately trained practitioner for pregnancy-related testing and for pre/post-symptomatic testing per the policy; ensure counseling is performed and documented.
- Qualified and appropriately trained practitioner required to provide counseling
- Document counseling in the medical record
Order tests through an appropriate provider and CLIA lab
Tests must be ordered by an appropriate provider and performed by a CLIA‑approved laboratory to be considered for coverage.
- Order tests through an appropriate licensed provider
- Use a CLIA‑approved laboratory for testing
Coding — CPT/HCPCS/ICD-10
| 81105 | Human Platelet Antigen 1 genotyping (HPA-1) (ITGB3) gene analysis, common variant, HPA-1a/b |
| 81106 | Human Platelet Antigen 2 genotyping (HPA-2) (GP1BA) gene analysis, common variant, HPA-2a/b |
| 81107 | Human Platelet Antigen 3 genotyping (HPA-3) (ITGA2B) gene analysis, common variant, HPA-3a/b |
| 81108 | Human Platelet Antigen 4 genotyping (HPA-4) (ITGB3) gene analysis, common variant, HPA-4a/b |
| 81109 | Human Platelet Antigen 5 genotyping (HPA-5) (ITGA2) gene analysis, common variant |
| 81110 | Human Platelet Antigen 6 genotyping (HPA-6w) (ITGB3) gene analysis, common variant, HPA-6a/b |
| 81111 | Human Platelet Antigen 9 genotyping (HPA-9w) (ITGA2B) gene analysis, common variant |
| 81112 | Human Platelet Antigen 15 genotyping (HPA-15) (CD109) gene analysis, common variant, HPA-15a/b |
| 81161 | DMD (dystrophin) deletion and duplication analysis |
| 81162 | BRCA1 and BRCA2 full sequence and duplication/deletion analysis |
| 81352 | TP53 gene analysis; full gene sequence |
| 81353 | TP53 gene analysis; targeted sequence analysis |
| 81357 | Known familial variant analysis (example context provided) |
| 81360 | U2AF1 gene analysis, common variants |
| 81362 | HBB gene analysis; common variants (eg, HbS, HbC, HbE) |
| 81401 | Molecular pathology procedure, Level 2 |
| 81408 | Molecular pathology procedure, Level 9 |
| 81414 | Catecholaminergic polymorphic ventricular tachycardia panel (genomic sequence analysis) |
| 81415 | Duplication/deletion gene analysis panel (listed in both covered and not-covered contexts) |
| 81416 | Exome sequence analysis, comparator exome (parents, siblings) |
| 81175 | ASXL1 gene analysis; full gene sequence |
| 81176 | ASXL1 gene analysis; targeted sequence analysis |
| 81225 | CYP2C19 Gene Analysis, Common Variants |
| 81226 | CYP2D6 Gene Analysis, Common Variants |
| 81227 | CYP2C9 Gene Analysis, Common Variants |
| 81230 | CYP3A4 gene analysis, common variant(s) |
| 81231 | CYP3A5 gene analysis, common variants |
| 81232 | DPYD gene analysis, common variant(s) |
| 81291 | MTHFR gene analysis, common variants |
| 81313 | PCA3/KLK3 ratio (prostate cancer) |
| CPT codes NOT covered | Section header indicating there is a list of CPT codes that are not covered (specific codes not included in this excerpt) |
| D56.0-D56.9 | Thalassemia |
| D57.00-D57.819 | Sickle cell disorders |
| D58.0-D58.9 | Other hereditary hemolytic anemias |
| D66 | Hereditary factor VIII deficiency |
| D67 | Hereditary factor IX deficiency |
| D68.0-D68.9 | Other coagulation defects |
| D70.0-D71 | Neutropenia |
| E75.00-E75.6 | Disorders of sphingolipid metabolism and other lipid storage disorders |
| F70-F79 | Intellectual Disabilities |
| G10-G14 | Systemic atrophies primarily affecting the CNS |
Not Covered
Direct-to-consumer genetic testing (for example, 23andMe and Color) is expressly identified as not covered by the policy and will be denied if submitted. Tests must be ordered by an appropriate provider and performed by a CLIA-approved laboratory to be considered for coverage.
Specific assays and pharmacogenetic panels listed in the policy as experimental or investigational are not covered. The policy provides illustrative lists (not exhaustive) that include tests such as Genecept, GeneSight, PGXL Broad Spectrum, Millenium PGT, AmpliChip, STAR SureGene, Genomind Neuropsych report, plus many named multigene and specialty panels referenced as investigational.
A long enumerated list of CPT codes and tests is explicitly designated as not covered. The not-covered list includes many pharmacogenomic tests, certain exome and genome sequencing codes (81415–81417, 81425–81427), mitochondrial genome sequencing codes (81460, 81465), large tumor panels (81455), HLA typing (81377, 81383), and multiple multianalyte algorithmic assay codes (81490, 81493, 81500, 81503, 81525, 81529, 81551), among others.
The policy’s 'CPT codes NOT covered' section explicitly identifies numerous CPT codes as not covered. Presence of these codes on a claim may trigger denial; consult the not-covered code list in the policy for specific billing guidance.
Certain named tests are referenced in the policy’s revision history and are identified as investigational; for example, the Genomind Neuropsych Pharmacogenetic report was added to the investigational list in the 06/2024 annual review. These named items are treated as investigational and not covered as reflected in the document history.
Definitions and Background
Genetic testing examines DNA, chromosomes, or proteins to identify inherited changes that may increase disease risk or affect offspring. The policy notes that results can be complex, and appropriate interpretation with genetic counseling is important. Genetic testing is applied across contexts including prenatal risk assessment, diagnosis of suspected genetic disease, tumor marker assays to inform cancer management, and pharmacogenetic considerations.
Revision History
Added Annual Review table with review date, revisions, and effective date (effective 2013-03-01).
Added requirement that genetic test must be proven for the diagnosis or considered experimental/investigational; clarified panels must be medically necessary to be covered (effective 2014-09-25).
Reaffirmed that tests must be medically necessary for the diagnosis; noted annual review with no clinical changes (effective 2014-08-30).
Added section on pharmacogenetics (14 tests) and a section on investigational genetic tests (effective 2016-02-15).
Updated template and revised statements; added new 2016 codes (effective 2017-02-02).
Added new genetic testing codes (effective 2017-10-25).
Added Mammaprint to criteria to align with CMS (effective 2018-07-01).
Added definition of GBM and CM (effective 2018-11-19).
Annual review with no changes recorded (effective 2019-07-01).
Updated covered and non-covered code lists; code 81551 marked investigational and added to non-covered list (effective 2019-11-01).
Code updates including EndoPredict and addition of CF and SMA testing as part of standard prenatal care; clarified no coverage for fetal sex determination.
Policy effective date set to 2026-07-01 with last review on 2025-06-24.
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