ModifiedUnitedHealthcarePolicy MMP185.45

Clinical Diagnostic Laboratory Services

Medicare Advantage coverage and clinical policy governing clinical laboratory testing (diagnostic and preventive) for UnitedHealthcare Medicare Advantage members; describes coverage principles, applicable CMS NCDs/LCDs, and ordering and CLIA requirements that affect providers and laboratories.

Policy Summary

PayerUnitedHealthcare

PolicyClinical Diagnostic Laboratory Services

Policy CodePolicy MMP185.45

Change TypeCodes added/removedreference updates

Effective DateMay 1, 2026

Next Review Date

Key ActionOrder laboratory tests only when reasonable and necessary, ensure tests are ordered and used promptly by the treating provider, and confirm the performing laboratory has appropriate CLIA certification.

SourceLink

POLICY UPDATE CHANGES

Applicable Codes CPT/HCPCS Codes Not Covered When Submitted With Screening Diagnosis — Added multiple HCPCS/CPT codes including 0600U–0613U, 81354, 81524, 84999, 87182, and 87183.

Removed code 0354U from applicable codes list.

Noted that 0361U was deleted Dec. 31, 2025.

Added multiple CMS Transmittal and MLN reference links including transmittals and MLN articles through 2026 (e.g., Transmittal 13619, 13639, 13514 and MLN articles MM14153-MM14372).

NCD & LCD referencedNCD/LCD referenced

CLIA requirementCLIA requirement

List presentNon-covered diagnoses

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Preventive tests listed

MultipleCodes added to NCWS

Coverage Criteria

General Coverage Criteria

Covered when ALL of the following are met:

General medical necessity: Test is reasonable and necessary for the diagnosis or treatment of illness or injury

Per Section 1862(a)(1)(A)

Ordering provider: Ordered and used promptly by the physician who is treating the member or by a qualified nonphysician practitioner

42 CFR 410.32(a)

Laboratory certification: Performed by a laboratory meeting CLIA requirements (42 CFR part 493)

Failure to have appropriate CLIA certificate may result in denial

Coverage alignment: Consistent with applicable CMS national coverage determinations (NCDs), local coverage determinations (LCDs), or local coverage articles (LCAs) where present

See referenced NCD/LCD lists for test‑specific criteria and coding

Tests performed for administrative purposes are not considered reasonable and necessary and are excluded from coverage. Examples include examinations required by insurance companies, employers, government agencies, or other third parties when the test is performed solely to satisfy an administrative requirement rather than to diagnose or treat illness or injury. Claims for such tests will be denied as not reasonable and necessary.

Other common administrative- or process-driven testing that is not covered includes tests ordered without an appropriate clinical indication or without an ICD-10-CM or narrative diagnosis listed as covered in a national coverage policy, tests performed by laboratories that lack the required CLIA certification, and tests not ordered by a treating physician or qualified nonphysician practitioner acting within their scope of license.

Effective 05/01/2026, the policy operationally updated the list of CPT/HCPCS codes designated as "Not Covered When Submitted With Screening Diagnosis." The May 1, 2026 summary of changes documents multiple additions and removals to that applicable-codes list and should be consulted when submitting claims with a screening diagnosis.

Claims for tests performed in the absence of signs, symptoms, complaints, or personal history of disease or injury (i.e., screening when not otherwise authorized) will be denied as not reasonable and necessary unless coverage is explicitly authorized by statute or a Medicare NCD. Exceptions apply only where a specific statute or national coverage determination expressly permits screening in asymptomatic individuals.

Additionally, a test for which a national coverage policy exists may be denied if submitted without an ICD-10-CM or narrative diagnosis listed as covered in that policy, or if the test exceeds any frequency expectations identified by the national coverage policy.

Covered Indications (Medicare NCD/LCD Examples)

Preventive and diagnostic testing as specified by Medicare NCDs

Preventive and diagnostic testing is covered when it is specified by an applicable Medicare National Coverage Determination (NCD); examples include:

Examples of preventive/diagnostic NCDs: Cardiovascular disease screening tests per the Medicare Preventive Services Chart

Refer to the referenced NCDs and Preventive Services Chart for specific coding and criteria

Examples of preventive/diagnostic NCDs: Cervical cancer screening with HPV testing (NCD 210.2.1)

See NCD 210.2.1 for clinical coverage criteria

Examples of preventive/diagnostic NCDs: Diabetes screening per the Medicare Preventive Services Chart and relevant NCDs

See referenced prevention NCDs for test‑specific requirements

Coding and Code Changes

Coding clarifications / referenced CPT codesCPT

86790	CPT code listed (Zika testing example exclusion noted)
86794	CPT code listed (Zika testing example exclusion noted)
87662	CPT code listed (Zika testing example exclusion noted)
87798	CPT code listed (Zika testing example exclusion noted)
87801	CPT code listed (Zika and other testing exclusions noted)
87480	CPT code listed (exclusion exceptions for Z11.3)
87510	CPT code listed (exclusion exceptions for Z11.3)
87660	CPT code listed (exclusion exceptions for Z11.3)
87661	CPT code listed (exclusion exceptions for Z11.3)

Non-Covered Diagnosis CodesICD-10Not Covered

ICD-10

Non-Covered Diagnosis Codes List (contains ICD-10 codes never covered when given as the primary reason for the test)

Applicable CPT/HCPCS codes added/removed in updatemixed

0600U	listed in 'Added' codes
0601U	listed in 'Added' codes
0602U	listed in 'Added' codes
0604U	listed in 'Added' codes
0605U	listed in 'Added' codes
0606U	listed in 'Added' codes
0607U	listed in 'Added' codes
0608U	listed in 'Added' codes
0609U	listed in 'Added' codes
0610U	listed in 'Added' codes

1–10 of 20

1/2

Referenced Medicare 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

1–10 of 22

1/3

inv-09: Frequency expectations

Frequency enforcementPer national coverage policy when specified — claims that exceed a national coverage policy’s stated frequency expectation may be denied as not reasonable and necessary.

Action for providersVerify applicable NCD/LCD frequency rules before ordering repeat tests; document medical necessity when exceeding usual intervals.

Claims requirementClaims for tests subject to an NCD frequency expectation must include appropriate ICD-10-CM diagnosis or narrative listed as covered in the policy.

Denial triggerA claim exceeding an NCD-specified frequency without supporting documentation or covered diagnosis can be denied.

inv-10: None specified

Provider Actions and Billing Guidance

Billing Rule

Coding and Claim Requirements

Coding and claim requirements. The codes listed in this policy are for reference and do not guarantee payment. Claims must include an appropriate ICD-10-CM diagnosis or narrative diagnosis that aligns with any national coverage policy; inclusion of a code in this policy is not a determination of coverage. Claims are adjudicated against the member-specific benefit plan and applicable laws and regulations.

Listing of codes is informational only; review member plan for coverage
Presence of a code here does not guarantee payment
Claims must meet national coverage and local plan rules

Prior Authorization

Prior Authorization / Delegate Requirements

Ordering Requirements

Documentation Required

Order Tests Promptly and Include Required Diagnosis Information

Tests must be ordered and used promptly by the treating physician or a qualified nonphysician practitioner acting within the scope of their license; claims missing appropriate ordering or diagnosis information may be denied.

Ordering provider must be the treating physician or qualified nonphysician practitioner as described in 42 CFR 410.32(a).
Ensure order is timely and that required diagnosis information accompanies the claim.

Note

Policy Is Informational — Follow Member Benefit and Prior Authorization Processes

This policy is informational. Providers must follow member-specific benefit plan documents and any applicable prior authorization or delegate processes when ordering or billing for laboratory services.

Benefit coverage is determined by the member-specific benefit plan document and applicable laws; in a conflict, the plan document supersedes this policy.

Not Covered

Not covered examples include tests performed for administrative purposes or tests that are not reasonable and necessary for diagnosis or treatment. Claims for tests submitted with a primary diagnosis code listed in the policy’s Non-Covered Diagnosis Codes List are never covered when that code is provided as the primary reason for testing; providers should contact UnitedHealthcare for an Integrated Denial Notice (IDN) process when such services are rendered.

Other denial triggers include claims submitted without an appropriate covered ICD-10-CM code or narrative diagnosis, tests performed by laboratories without appropriate CLIA certification, tests not ordered by an authorized treating provider, and tests that exceed national coverage frequency expectations.

Certain CPT/HCPCS codes added to the May 1, 2026 update may be not covered when submitted with a screening diagnosis. The policy’s Summary of Changes lists the specific codes added and removed; providers should reference that list when submitting claims with screening diagnosis codes.

Codes referenced in the update include additions such as 0600U–0613U, 81354, 81524, 84999, 87182, and 87183, with 0354U removed and notation that 0361U was deleted effective Dec. 31, 2025.

Definitions

inv-20: Screening vs Diagnostic Testing definitions

Screening testingTesting performed when no specific sign, symptom, or diagnosis is present to detect disease or disease precursors; covered only when statutorily authorized or by specific NCDs.

Diagnostic testingTesting performed 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.

Coverage distinctionMedicare distinguishes screening from diagnostic uses; coverage depends on statutory authorization or applicable NCDs/LCDs.

inv-21: CLIA definition and regulatory reference (42 CFR part 493)

CLIA definitionClinical Laboratory Improvement Amendments of 1988 (CLIA) — laboratories must meet CLIA requirements as set forth at 42 CFR part 493.

Consequence of noncompliance

Frequency Limits

inv-25: Frequency limits vary by test per NCD/LCD

Varies by testFrequency limits differ by test and are specified in applicable Medicare NCDs/LCDs; consult the individual NCD/LCD for test-specific limits.

ExamplesMany preventive and diagnostic tests (e.g., blood glucose, glycated hemoglobin, lipid, cancer screening tests) have NCD-defined coverage rules that may include frequency guidance.

Claims impactClaims exceeding an NCD/LCD frequency expectation may be denied as not reasonable and necessary.

Provider actionCheck the referenced NCD/LCD (listed in the policy) before ordering repeat testing and document medical necessity when applicable.

inv-26: Placeholder for frequency limits not specified in this document segment

No specific limits in this segment

Background

Clinical laboratory services encompass a broad range of examinations of human-derived materials — biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, and pathological — used to diagnose, prevent, treat, or assess medical conditions. These services include both diagnostic testing performed to evaluate signs or symptoms and screening testing performed in asymptomatic individuals.

Medicare distinguishes screening from diagnostic testing: screening is performed when there are no specific signs or symptoms and is only covered when statutorily authorized or covered by a specific national coverage determination (NCD). Laboratories must meet CLIA (42 CFR part 493) requirements and tests must be ordered and used promptly by the treating physician or qualified nonphysician practitioner to qualify for coverage.

Policy Summary

PayerUnitedHealthcare

PolicyClinical Diagnostic Laboratory Services

Policy CodePolicy MMP185.45

Change TypeCodes added/removedreference updates

Effective DateMay 1, 2026

Next Review Date

SourceLink

On This Page

Examples of preventive/diagnostic NCDs: Prostate cancer screening tests (NCD 210.1)

Refer to NCD 210.1 for coverage criteria

Examples of preventive/diagnostic NCDs: Pap test screening (NCD 210.2) and colorectal cancer screening tests (NCD 210.3)

See NCD 210.2 and NCD 210.3 for details

Examples of preventive/diagnostic NCDs: Screening for HBV (NCD 210.6), HIV (NCD 210.7), and HCV in adults (NCD 210.13)

Refer to each NCD for specific indications and coding

Various screening and diagnostic indications defined by referenced Medicare NCDs

Coverage for specific screening and diagnostic indications follows the requirements of the referenced Medicare NCDs; examples include the following categories and NCD references:

Screening/diagnostic category: Pathology and test‑specific NCDs such as histocompatibility testing, diagnostic Pap smears, cytogenetic studies (see NCD 190.1, NCD 190.2, NCD 190.3)

See linked NCD pages for full clinical criteria

Screening/diagnostic category: Basic laboratory and diagnostic tests including blood counts, PT/PTT, serum iron studies (see NCDs in Clinical Diagnostic Laboratory Services and NCD 190.15–190.18)

Refer to listed laboratory NCDs for test‑specific coverage

Screening/diagnostic category: Specific biochemical and serologic tests (e.g., collagen crosslinks, blood glucose, glycated hemoglobin, thyroid testing, lipid testing; see NCD 190.19–190.23)

Consult each NCD for indications and frequency limitations

Screening/diagnostic category: Tumor markers and related tests (e.g., alpha‑fetoprotein, gamma glutamyl transferase; see NCD 190.25, 190.32)

Coverage and coding per referenced NCDs

Screening/diagnostic category: Hepatitis panels and fecal occult blood testing (see NCD 190.33 and 190.34)

Refer to the NCDs for detailed coverage rules

Screening/diagnostic category: Other technology‑specific NCDs including pharmacogenomic testing for warfarin response and next generation sequencing (NCD 90.1, NCD 90.2)

See NCDs 90.1 and 90.2 for applicability

No frequency specified in segmentThis document segment lists no separate test-specific frequency limits beyond referring to applicable NCDs/LCDs and the CMS manuals.

Follow NCD/LCDsWhen frequency limits are not specified here, follow the referenced NCDs/LCDs and member plan rules.

Provider actionRetain documentation supporting medical necessity and ordering when frequency is clinically justified.

Prior authorization and delegate requirements. Follow the member-specific plan and any delegated entity rules for prior authorization. If services require prior authorization under the member's benefit plan or delegated arrangement, obtain authorization prior to performing the service to avoid denial.

Confirm whether the member's plan or delegated provider agreement requires prior authorization
Obtain and document authorization prior to service when required

Denial Risk

Frequency Enforcement & Triggers for Denial

Frequency enforcement and denial triggers. If a national coverage policy includes an expected testing frequency, claims exceeding that frequency may be denied as not reasonable and necessary. Tests submitted without required prior authorization, submitted with a screening diagnosis when not allowed, lacking medical necessity, not ordered by an appropriate treating practitioner, or performed by a laboratory without the required CLIA certification are all grounds for denial.

Claims exceeding frequency expectations may be denied
Denial triggers: lack of medical necessity, no required prior authorization, screening-only diagnoses when not permitted, improper ordering clinician, non-CLIA-certified laboratory

Denial Risk

Not Covered When Submitted with Screening Diagnosis

Not covered when submitted with screening diagnosis. Certain CPT/HCPCS codes are designated as not covered when billed with a screening diagnosis code. Refer to the policy's non-covered diagnosis code list and the CPT/HCPCS code list for affected codes; some diagnosis-code exclusions and exceptions are noted (see coding clarifications).

Operational rule: specific CPT/HCPCS codes may be not covered if submitted with a screening diagnosis — consult the policy code list
See coding clarifications for exceptions (e.g., Z36.89 and specific Z-codes excluded for certain tests)
Added/removed codes and status updates reflected in the policy history (05/01/2026)

Documentation Required

Ordering and Laboratory Certification

Ordering and laboratory certification. Clinical laboratory services must be ordered and used promptly by the treating physician or qualified nonphysician practitioner. Laboratories must have the appropriate CLIA certificate (42 CFR part 493); failure to meet CLIA requirements will result in claim denial.

Tests must be ordered and used promptly by the treating practitioner (42 CFR 410.32(a))
Laboratory must hold appropriate CLIA certificate per 42 CFR part 493

Documentation Required

Maintain Supporting Documentation

Provider responsibilities — maintain supporting documentation. Providers and delegated entities are expected to retain and make available documentation to support coverage and medical necessity decisions upon request. This includes records of orders, clinical indications, prior authorizations, and CLIA certification documentation.

Retain clinical records showing signs, symptoms, and medical necessity
Keep copies of prior authorizations and ordering practitioner credentials
Maintain CLIA certificate documentation for the performing laboratory

Note

Provider Action Highlights

Provider actions — additional notes. Use this policy as a guide only; the member-specific benefit plan document governs coverage. When in doubt about coverage or coding, contact UnitedHealthcare customer service or refer to the Administrative Guide. Providers must exercise independent clinical judgment and ensure compliance with applicable laws and delegated arrangements.

This policy does not replace clinical judgment
Contact UnitedHealthcare or consult the Administrative Guide for member-specific coverage questions

Failure of the performing laboratory to have the appropriate CLIA certificate will result in denial of claims.

Ordering requirement linkLaboratory services must meet CLIA requirements and be ordered and used promptly by the treating physician or qualified nonphysician practitioner (42 CFR 410.32(a)).

inv-22: CMS Chapter 15; § 80.1-80.1.3 reference for Clinical Laboratory Services

CMS referenceCMS Benefit Policy Manual, Chapter 15; § 80.1-80.1.3 — Clinical Laboratory Services.

Related sectionsSee Chapter 15 sections on preventive and screening services (e.g., § 280 series for colorectal cancer screening and Pap smears).

Use for coverage interpretationRefer to Chapter 15 when determining Medicare coverage policy for clinical laboratory services in the absence of specific NCD/LCD language.

This document segment does not specify additional frequency limits beyond referring to NCD/LCD expectations.

Follow policy referencesWhen frequency limits are not provided here, follow the applicable NCDs/LCDs and member benefit rules.

DocumentationMaintain documentation to justify frequency when clinically indicated or when exceeding typical intervals.