ModifiedUnitedHealthcarePolicy MMP185.45

Clinical Diagnostic Laboratory Services

Defines Medicare Advantage coverage principles, coding guidance, and compliance requirements for clinical diagnostic laboratory tests for UnitedHealthcare Medicare Advantage members; applies to providers ordering, performing, or billing clinical laboratory services under Medicare Advantage.

Policy Summary

PayerUnitedHealthcare

PolicyClinical Diagnostic Laboratory Services

Policy CodePolicy MMP185.45

Change TypeCode list updates (additions, removal, and code deletion notation)

Effective DateMay 1, 2026

Next Review Date

Key ActionOrder and document laboratory tests only when medically necessary and ensure tests are ordered and used promptly by the treating physician or qualified practitioner and that CLIA requirements are met.

SourceLink

POLICY UPDATE CHANGES

Applicable CPT/HCPCS codes not covered when submitted with screening diagnosis were added (includes new U-codes and other codes).

Removed code 0354U from the list of applicable codes.

Notation added that HCPCS code 0361U was deleted Dec. 31, 2025.

References to multiple recent CMS transmittals and MLN Matters articles were added or updated.

Related Billing Codes

CPT-0611U-HELIOHCCSTRAT-CFDNA-METHYLATION-LIVER-CANCER-ASSAY

CPT 0611U: Plasma cfDNA Methylation Assay for Liver Cancer Risk Assessment

CPT-0601U-SYNOVASURE-COMPREHENSIVE-PJI-PANEL

CPT 0601U: Synovasure Comprehensive PJI Test Panel

CPT-0600U-MOLECULAR-WOUND-INFECTION-PCR-TEST

CPT 0600U: Molecular Wound Infection PCR Test

CPT-0602U-DIABETES-RISK-TEST-GENETIC-AND-METABOLIC-ANALYSIS

CPT 0602U: Diabetes Risk Test — Genetic and Metabolic Analysis

CPT-81524-CNS-TUMOR-DNA-METHYLATION-PROFILING-MGMT

CPT 81524: CNS Tumor DNA Methylation Profiling

CPT-86794-ZIKA-IGM-IMMUNOASSAY-SERUM

CPT 86794: Zika Virus IgM Immunoassay, Serum

CPT-0609U-CLARITYDX-PROSTATE-PSA-ALGORITHM-SCORE

CPT 0609U: ClarityDX Prostate PSA Algorithm-Based Risk Score

CPT-0607U-ENDOMETRIAL-MICROBIOME-METAGENOMIC-ANALYSIS-EMMA

CPT 0607U: Endometrial Microbiome Metagenomic Analysis (EMMA)

CPT-0610U-LIFESCALE-GRAM-NEGATIVE-ANTIBIOTIC-SUSCEPTIBILITY

CPT 0610U: LifeScale Gram Negative Antibiotic Susceptibility Test

CPT-0608U-ALICE-ENDOMETRIAL-PCR-CHRONIC-ENDOMETRITIS

CPT 0608U: ALICE Endometrial PCR Test for Chronic Endometritis

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Coverage Criteria

General Medical Necessity Criteria

Covered when ALL of the following general conditions are met:

General coverage requirements: 1) Test is reasonable and necessary for diagnosis or treatment of illness or injury; 2) Test is ordered and used promptly by the treating physician or qualified nonphysician practitioner; 3) Test and performing laboratory comply with applicable NCDs/LCDs and CLIA requirements (42 CFR part 493); 4) Test is supported by an appropriate ICD-10-CM diagnosis or narrative when required by a national coverage policy.

Applies to UnitedHealthcare Medicare Advantage members per policy.

Clinical diagnostic laboratory tests are subject to UnitedHealthcare Medicare Advantage coverage rules that require services be reasonable and necessary for diagnosis or treatment of illness or injury and ordered by a treating physician or qualified non-physician practitioner. Tests performed solely for administrative purposes (for example, exams required by insurance companies, employers, government agencies, or other third parties) are not covered. Claims may also be denied when a laboratory lacks appropriate CLIA certification, when required ICD-10-CM codes or narrative diagnoses specified by a national coverage policy are missing, or when testing exceeds frequency expectations identified in a national coverage policy.

The policy update dated 05/01/2026 revised the list of CPT/HCPCS procedure codes that are designated Not Covered When Submitted With Screening Diagnosis. Several new codes were added to that list and one code was removed; providers should refer to the policy's coding section for the current list when submitting claims with a screening diagnosis to avoid denial.

Medicare policy and this UnitedHealthcare policy state that tests performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are generally not covered unless expressly authorized by statute or a national coverage determination. Submitting tests as screening without clinical indication can result in denial as not reasonable and necessary.

Covered Indications and Preventive Services

Selected Preventive Screening Tests

Selected preventive screening tests are covered when authorized by the cited NCDs or the Medicare Preventive Services Chart; refer to those sources for specific coding and coverage criteria.

Covered preventive screening tests when authorized by NCD/Medicare chart: Cardiovascular disease screening tests (see Medicare Preventive Services Chart, NCD references); Cervical cancer screening with HPV tests (see NCD 210.2.1); Diabetes screening (see Medicare Preventive Services Chart); Prostate cancer screening (NCD 210.1); Pap test screening (NCD 210.2); Colorectal cancer screening tests (NCD 210.3); Screening for Hepatitis B virus infection (NCD 210.6); HIV screening (NCD 210.7); STI screening and High-Intensity Behavioral Counseling to prevent STIs (NCD 210.10); Screening for Hepatitis C virus in adults (NCD 210.13).

Coverage, coding, and frequency follow the specific NCD text and the Medicare Preventive Services Chart.

Coding and Code Lists

CPT/HCPCS Codes (examples referenced in coding clarifications)CPT

86790	CPT code listed in coding clarifications
86794	CPT code listed in coding clarifications
87662	CPT code listed in coding clarifications
87798	CPT code listed in coding clarifications
87801	CPT code listed in coding clarifications
87480	CPT code listed in coding clarifications
87510	CPT code listed in coding clarifications
87660	CPT code listed in coding clarifications
87661	CPT code listed in coding clarifications

Applicable CPT/HCPCS Codes Not Covered When Submitted With Screening DiagnosismixedNot Covered

0600U	code added to 'Not Covered When Submitted With Screening Diagnosis' list
0601U	code added to 'Not Covered When Submitted With Screening Diagnosis' list
0602U	code added to 'Not Covered When Submitted With Screening Diagnosis' list
0604U	code added to 'Not Covered When Submitted With Screening Diagnosis' list
0605U	code added to 'Not Covered When Submitted With Screening Diagnosis' list
0606U	code added to 'Not Covered When Submitted With Screening Diagnosis' list
0607U	code added to 'Not Covered When Submitted With Screening Diagnosis' list
0608U	code added to 'Not Covered When Submitted With Screening Diagnosis' list
0609U	code added to 'Not Covered When Submitted With Screening Diagnosis' list
0610U	code added to 'Not Covered When Submitted With Screening Diagnosis' list

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Referenced Laboratory NCDs / Prevention NCDs / Other Lab NCDsmixed

NCD 190.19	Collagen Crosslinks, any Method
NCD 190.20	Blood Glucose Testing
NCD 190.21	Glycated Hemoglobin/Glycated Protein
NCD 190.22	Thyroid Testing
NCD 190.23	Lipid Testing
NCD 190.24	Digoxin Therapeutic Drug Assay
NCD 190.25	Alpha-fetoprotein
NCD 190.32	Gamma Glutamyl Transferase
NCD 190.33	Hepatitis Panel/Acute Hepatitis Panel
NCD 190.34	Fecal Occult Blood Test

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Provider Actions, Documentation, and Billing Guidance

Prior Authorization

Follow Delegate Prior Authorization Rules

Prior authorization requirements may be delegated. When a delegated entity manages utilization review or prior authorization for a member, providers must follow the delegate’s prior authorization rules and processes for authorization submission and verification.

Follow delegate-managed utilization management/prior authorization when applicable.

Denial Risk

Screening Diagnosis Code Conflicts May Cause Denial

Claims for laboratory tests submitted with a screening diagnosis code (e.g., codes indicating routine screening without signs/symptoms) may be marked not covered where the CPT/HCPCS code is identified by the policy or national guidance as non-covered for screening indications. Submit an appropriate, supported diagnosis that documents medical necessity when testing is for diagnostic purposes. Failure to submit an ICD-10-CM code or narrative diagnosis listed as covered in a national coverage policy may result in denial.

Ordering and Authorization Requirements

Billing Rule

Ordering must be by treating physician or qualified nonphysician practitioner

Laboratory services must be ordered and used promptly by the treating physician or a qualified nonphysician practitioner acting within the scope of their license, as required by Medicare regulations.

Orders must comply with 42 CFR 410.32(a).
Treating physician or qualified nonphysician practitioner must be acting within scope of license.

Prior Authorization

Follow member-specific benefit plan and delegate prior authorization processes

Follow member-specific benefit plan documents for authorization and coverage requirements; when a delegate manages utilization management/prior authorization for a UnitedHealthcare Medicare Advantage plan, follow the delegate's processes.

Frequency Limits

Frequency expectations for tests specified by NCD/LCD

ScopeVarious tests as specified by NCDs/LCDs may be subject to frequency expectations identified in national coverage policies.

Common implicationClaims may be denied if testing exceeds frequency expectations identified by a national coverage policy.

Related requirementFrequency rules referenced here apply in addition to other policy limits (e.g., medical necessity, ordering/provider requirements).

Action for providersVerify the applicable NCD/LCD for the specific test to confirm any frequency expectations before ordering or billing.

DocumentationSupport claims with documentation showing timing and clinical necessity when frequency limits from NCDs/LCDs are relevant.

Services Not Covered

Not covered: laboratory tests conducted for administrative purposes (insurance, employment, government or other third-party requirements), tests that are not reasonable and necessary for diagnosis or treatment, and tests performed without clinical signs, symptoms, complaints, or personal history of disease or injury unless statutorily authorized. Additional denial triggers include missing required ICD-10-CM codes or narrative diagnoses when a national coverage policy requires them, tests that exceed national coverage frequency expectations, tests not ordered by an authorized treating provider, and testing performed by a laboratory without the required CLIA certification.

As of the policy revision on 05/01/2026, the policy's list of CPT/HCPCS codes that are Not Covered When Submitted With Screening Diagnosis was updated: multiple codes were added and 0354U was removed; the policy also notes that 0361U was deleted as of Dec. 31, 2025. Providers should use the updated code table when preparing claims to ensure screening diagnosis submissions use supported procedure codes.

Definitions

Definition — Screening

DefinitionScreening — Testing for disease or disease precursors in asymptomatic individuals to enable early detection and treatment; performed when no specific sign, symptom, or exposure is present.

Typical contextUsed for population- or age-based preventive services authorized by statute or specific NCDs (e.g., certain cancer screenings).

Contrast with diagnosticScreening is performed in absence of signs/symptoms; diagnostic testing is used when signs/symptoms are present and explain the reason for the test.

Coverage noteSome screening tests are covered only if authorized by a specific NCD or Medicare Preventive Services provisions.

Definition — Diagnostic testing

DefinitionDiagnostic testing — Testing to rule out or confirm a suspected diagnosis because of a sign and/or symptom; the sign or symptom should explain the reason for the test.

Background

Clinical laboratory services include examination and analysis of human-derived specimens using biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, and pathological methods to diagnose, prevent, or treat disease and to assess medical condition. Medicare distinguishes screening (testing asymptomatic individuals to detect disease or precursors) from diagnostic testing (testing driven by signs or symptoms), and some preventive screening tests are covered only when authorized by specific CMS national coverage determinations or the Medicare Preventive Services Chart.