*** This policy was implemented in the absence of National Coverage Determinations (NCD) or Local Coverage Determinations (LCD) coverage criteria. This policy applies to all Blue Medicare HMO, Blue Medicare PPO, Healthy Blue + MedicareSM (HMO-POS D-SNP), Blue Medicare Rx members, and members of any third-party Medicare plans supported by Blue Cross NC through administrative or operational services. ***

Description of Procedure

Proprietary Laboratory Analyses (PLA) Codes are codes assigned to unique laboratory tests that are created and performed by a specific laboratory or manufacturer. Unlike standard laboratory tests that may be offered by many laboratories, PLA tests are proprietary and use specialized methods, technologies, or algorithms that are typically available only from the laboratory that developed the test.

PLA tests may incorporate advanced molecular, genetic, proteomic, biomarker, or algorithmic technologies and are intended to provide diagnostic, prognostic, predictive, or therapeutic management information. Each PLA code represents a specific laboratory assay and should be evaluated individually for medical necessity and coverage based on the clinical indication, supporting evidence, and applicable Medicare coverage requirements.

PLA codes are a part of the overall code sets developed and released by the American Medical Association – Current Procedural Terminology (AMA-CPT) Editorial Panel. These are alpha-numeric codes consisting of four numbers ending in a capital U.

PLA code set includes the following: Advanced Diagnostic Laboratory Tests (ADLTs), Clinical Diagnostic Laboratory Tests (CDLTs), Multianalyte Assays with Algorithmic Analyses (MAAA), Genomic Sequencing Procedures.

Policy Statement

Coverage will be provided for a PLA test when it is determined to be medically necessary when the medical criteria and guidelines are met. For Medicare purposes, a test must demonstrate that it provides clinically actionable information not otherwise obtainable through established testing methods.

Benefit Application

Please refer to the member’s individual Evidence of Coverage (EOC) for benefit determination. Coverage will be approved according to the EOC limitations if the criteria are met.

Coverage decisions will be made in accordance with:

• The Centers for Medicare & Medicaid Services (CMS) national coverage decisions;
• General coverage guidelines included in original Medicare manuals unless superseded by operational policy letters or regulations; and
• Written coverage decisions of local Medicare carriers and intermediaries with jurisdiction for claims in the geographic area in which services are covered.
• In accordance with Title XVIII of the Social Security Act, Section 1862(a)(1)(A), Medicare covers only items and services that are reasonable and necessary for the diagnosis or treatment of a specific illness or injury. Consequently, Proprietary Laboratory Analysis (PLA) tests utilized solely for pre-symptomatic screening, disease risk prediction, or population health assessment—rather than the diagnosis or active management of an existing medical condition—are considered screening services and do not constitute a covered Medicare benefit.

Benefit payments are subject to contractual obligations of the Plan. If there is a conflict between the general policy guidelines contained in the Medical Coverage Policy Manual and the terms of the members’ particular Evidence of Coverage (E.O.C.), the E.O.C. always governs the determination of benefits.

Indications for Coverage

1. Clinical findings, symptoms, abnormal diagnostic results, or a documented personal history associated with the condition being evaluated, and the results of the test are expected to assist in diagnosis, prognosis, treatment selection, or other clinical management decisions; AND
2. The test demonstrates unique clinical utility such that the information generated is not available through conventional laboratory testing and is expected to provide additional clinically actionable information that will directly influence patient management; AND
3. The test must be supported by evidence demonstrating analytical validity, clinical validity, and clinical utility for the specific indication under review. Published evidence should show that the test provides clinically actionable information beyond that available through standard diagnostic testing and that the results are expected to directly influence patient management; AND
4. The test is ordered by the physician or qualified practitioner responsible for the member's care and management of the condition being evaluated. The results of the test must be reasonably expected to influence diagnosis, prognosis, treatment planning, or other medically necessary patient management decisions; AND
5. The test must be performed in a CLIA-certified laboratory.

The medical record must substantiate the medical necessity of the requested test and demonstrate compliance with all applicable coverage criteria. Tests performed solely for screening, risk prediction, surveillance in the absence of signs, symptoms, or a relevant clinical indication, or general health assessment are not covered, as they do not meet the Medicare requirement that services be reasonable and necessary for the diagnosis or treatment of illness or injury.

When Coverage Will Not be Approved

1. The test must be performed in a CLIA-certified laboratory. 
2. Tests performed solely for screening in asymptomatic individuals are not covered unless specifically identified as a covered preventive or screening service under Medicare. Such services are considered not medically reasonable and necessary for the diagnosis or treatment of illness or injury.
3. Tests that confirm a diagnosis or known information
4. Tests to determine risk for developing a disease or condition.
5. Tests performed to measure the quality of a process
6. Coverage is not provided for testing when the results are not expected to directly impact clinical decision-making or result in a meaningful change in the member's management, treatment, or monitoring plan.
7. The test is not covered when it is considered experimental, investigational, or unproven. This includes tests for which the available peer-reviewed scientific evidence is insufficient to establish analytical validity, clinical validity, and clinical utility for the intended use, or does not demonstrate that the test results improve clinical decision-making, patient management, or health outcomes.

Billing/ Coding/Physician Documentation Information

This policy is applicable to the following codes: 0007U, 0035U, 0038U, 0058U, 0059U, 0061U, 0062U, 0063U, 0067U, 0077U, 0082U, 0086U, 0093U, 0106U, 0108U, 0110U, 0116U, 0121U, 0122U, 0123U, 0163U, 0164U, 0165U, 0176U, 0178U, 0210U, 0219U, 0220U,0243U, 0251U, 0255U, 0256U, 0257U, 0261U, 0275U, 0279U, 0280U, 0281U, 0283U, 0284U, 0311U, 0316U, 0317U, 0328U, 0337U, 0342U, 0358U, 0359U, 0390U, 0393U, 0394U, 0399U, 0404U, 0406U, 0408U, 0414U, 0418U, 0427U

Inclusion of a code in this section does not guarantee that it will be reimbursed.

The Plan may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Special Notes

Please also review Medicare Part C Medical Policy Investigational (Experimental) Services.

References

1. Medicare Benefit Policy Manual, Ch. 15 – Covered Medical and Other Health Services, §80.1 - Clinical Laboratory Services, Rev. 13774; Issued: 05/08/2026. 
2. Centers for Medicare & Medicaid Services, HHS: §410.32
3. U.S. Centers of Disease Control and Prevention (CDC). Prescription Drug Monitoring Programs (PDMPs). Prescription Drug Monitoring Programs (PDMPs) | Overdose Prevention | CDC: https://www.cdc.gov/overdose-prevention/hcp/clinical-guidance/prescription-drug-monitoring-programs.html Accessed 8/6/2026.
4. Kang JS, Lee MH. Overview of therapeutic drug monitoring. Korean J Intern Med. 2009 Mar;24(1):1-10. doi: 10.3904/kjim.2009.24.1.1. PMID: 19270474; PMCID: PMC2687654
5. CMS. Medicare NCCI Policy Manual. Chapter 10 - Pathology/Laboratory Services CPT Codes 80000-89999, E. Drug Testing. https://www.cms.gov/medicare/coding-billing/national-correct-coding-initiative-ncci-edits/medicare-ncci-policy-manual. Accessed 8/6/2026.
6. Nordley, B. Making Sense of Proprietary Laboratory Analyses (PLA) Codes. January 30, 2020. Medlearn Publishing.
7. Humana Medical Coverage Policy: Molecular Diagnostic Assays and Breath Testing for Transplant Rejection
8. BCBS Massachusetts Medical Technology Assessment Guidelines Policy: Policy Number 350
9. BCBS Massachusetts Medical Technology Assessment Investigational (Non-Covered) Services List. Policy Number 400. 
10. BCBS Rhode Island Medical Coverage Policy: Laboratory Tests Post Transplant and for Heart Failure. Effective Date 8/1/2025.
11. Shah M, Shrestha K, Tseng C, Goyal A, Liewluck T, Gupta L. Statin‐associated muscle symptoms: A comprehensive exploration of epidemiology, pathophysiology, diagnosis, and clinical management strategies. International Journal of Rheumatic Diseases. 2024;27(9)
12. Premera Blue Cross Medical Policy 7-01.596 Adjunctive Techniques for Screening, Surveillance, and Risk Classification of Barrett Esophagus and Esophageal Dysplasia. Effective Date 2/1/2026.
13. BCBSNC Commercial Policy: Prescription Medication and Illicit Drug Testing in the Outpatient Setting AHS - T2015 | Providers | Blue Cross NC: https://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/laboratory/updates/prescription-medication-and-illicit-drug-testing-in-the-outpatient-setting. Effective Date 1/1/2026.

Policy Implementation/Update Information:

New Policy created August 2026 in the absence of NCD and LCD for Palmetto. (JM).

Approval Dates:

Physician Advisory Group Committee: August 2026