Human Leukocyte Antigen (HLA) Testing Mandate Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 06|01|2025 POLICY LAST REVIWED: 01|07|2026 OVERVIEW This policy documents the state-mandated coverage guidelines for human leukocyte antigen (HLA) testing as required by Rhode Island General Law § 27-20-36 (see full text below). This service is covered for all Blue Cross & Blue Shield of Rhode Island (BCBSRI) members. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION
Not applicable POLICY STATEMENT Medicare Advantage Plans and Commercial Products The following are the guidelines under the human leukocyte antigen testing mandate: • Members must participate in the National Marrow Donor Program • Members are limited to one testing per lifetime • Claims must be submitted using modifier 32 for Mandated Services National Marrow Donor Program A signed informed consent form must be completed at the time of testing. This form will authorize results of the test to be used for participation in the national marrow donor program. Additional information on the program and forms may be found on the National Marrow Donor Program website:
National Marrow Donor Program Website All other uses of HLA testing are covered when medically necessary. Although Rhode Island-mandated benefits generally do not apply to Medicare Advantage Plans, this service is covered for all BCBSRI members. COVERAGE Benefits may vary between groups/contracts. Please refer to the appropriate Evidence of Coverage for applicable not medically necessary/not covered benefits/coverage. Self-funded groups may or may not choose to follow state mandates. BACKGROUND Rhode Island General Law (RIGL) §27-20-36 requires coverage of human leukocyte antigen testing as follows: § 27-20-36 Human leukocyte antigen testing – Every individual or group hospital or medical services plan contract delivered or renewed in this state shall include coverage of the cost for human leukocyte antigen testing, also referred to as histocompatibility locus antigen testing, for A, B, and DR antigens for utilization in bone marrow transplantation. The testing must be performed in a facility that is accredited by the American Association of Blood Banks or its successors, and is licensed under the Clinical Laboratory Improvement Act, 42 U.S.C. § 263a. At the time of the testing, the person being tested must Medical Coverage Policy | Human Leukocyte Antigen (HLA) Testing Mandate

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor Program. The group hospital or medical services plan contract may limit each subscriber to one of these tests per lifetime.

CODING Medicare Advantage Plans and Commercial Products To report Bone marrow screening, append modifier 32 (Mandated Service): Please Note: All other uses of HLA testing should be submitted without modifier 32.

81370 HLA Class I and II typing, low resolution (eg, antigen equivalents); HLA-A, -B, -C, -DRB1/3/4/5, and -DQB1 81371 HLA Class I and II typing, low resolution (eg, antigen equivalents); HLA-A, -B, and -DRB1 (eg, verification typing) 81372 HLA Class I typing, low resolution (eg, antigen equivalents); complete (ie, HLA-A, -B, and -C) 81373 HLA Class I typing, low resolution (eg, antigen equivalents); one locus (eg, HLA-A, -B, or -C), each 81374 HLA Class I typing, low resolution (eg, antigen equivalents); one antigen equivalent (eg, B*27), each 81375 LA Class II typing, low resolution (eg, antigen equivalents); HLA-DRB1/3/4/5 and -DQB1 81376 HLA Class II typing, low resolution (eg, antigen equivalents); one locus (eg, HLA-DRB1, - DRB3/4/5, -DQB1, -DQA1, -DPB1, or -DPA1), each 81377 HLA Class II typing, low resolution (eg, antigen equivalents); one antigen equivalent, each

81378 HLA Class I and II typing, high resolution (ie, alleles or allele groups), HLA-A, -B, -C, and -DRB1 81379 HLA Class I typing, high resolution (ie, alleles or allele groups); complete (ie, HLA-A, -B, and -C) 81380 HLA Class I typing, high resolution (ie, alleles or allele groups); one locus (eg, HLA-A, -B, or -C), each 81381 HLA Class I typing, high resolution (ie, alleles or allele groups); one allele or allele group (eg, B57:01P), each 81382 HLA Class II typing, high resolution (ie, alleles or allele groups); one locus (eg, HLA-DRB1, - DRB3/4/5, -DQB1, -DQA1, -DPB1, or -DPA1), each 81383 HLA Class II typing, high resolution (ie, alleles or allele groups); one allele or allele group (eg, HLA- DQB106:02P), each 86812 HLA typing; A, B, or C (eg, A10, B7, B27), single antigen 86813 HLA typing; A, B, or C, multiple antigens
86816 HLA typing; DR/DQ, single antigen 86817 HLA typing; DR/DQ, multiple antigens
86821 HLA typing; lymphocyte culture, mixed (MLC) 86825 Human leukocyte antigen (HLA) crossmatch, non-cytotoxic (eg, using flow cytometry); first serum sample or dilution 86826 Human leukocyte antigen (HLA) crossmatch, non-cytotoxic (eg, using flow cytometry); each additional serum sample or sample dilution (List separately in addition to primary procedure) 86829 Antibody to human leukocyte antigens (HLA), solid phase assays (eg, microspheres or beads, ELISA, Flow cytometry); qualitative assessment of the presence or absence of antibody(ies) to HLA Class I or Class II HLA antigens 86830 Antibody to human leukocyte antigens (HLA), solid phase assays (eg, microspheres or beads, ELISA, Flow cytometry); antibody identification by qualitative panel using complete HLA phenotypes, HLA Class I 86831 Antibody to human leukocyte antigens (HLA), solid phase assays (eg, microspheres or beads, ELISA, Flow cytometry); antibody identification by qualitative panel using complete HLA phenotypes, HLA Class II 86832 Antibody to human leukocyte antigens (HLA), solid phase assays (eg, microspheres or beads, ELISA, Flow cytometry); high definition qualitative panel for identification of antibody specificities (eg, individual antigen per bead methodology), HLA Class I 86833 Antibody to human leukocyte antigens (HLA), solid phase assays (eg, microspheres or beads, ELISA, Flow cytometry); high definition qualitative panel for identification of antibody specificities (eg, individual antigen per bead methodology), HLA Class II

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

86834 Antibody to human leukocyte antigens (HLA), solid phase assays (eg, microspheres or beads, ELISA, Flow cytometry); semi-quantitative panel (eg, titer), HLA Class I 86835 Antibody to human leukocyte antigens (HLA), solid phase assays (eg, microspheres or beads, ELISA, Flow cytometry); semi-quantitative panel (eg, titer), HLA Class II

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REFERENCES

1. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD), Histocompatibility Testing (190.1)
2. Centers for Medicare and Medicaid Services (CMS) Local Coverage Determination (LCD), Molecular Pathology Procedures (L35000)
3. Centers for Medicare and Medicaid Services (CMS) Local Coverage Determination (LCD) Article, Billing and Coding: Molecular Pathology Procedures (A56199)
4. Centers for Medicare and Medicaid Services (CMS) Local Coverage Determination (LCD), Pharmacogenomic Testing (L39995)
5. Centers for Medicare and Medicaid Services (CMS) Local Coverage Determination (LCD) Article, Billing and Coding: Pharmacogenomic Testing (A59915)
6. Medicare National Coverage Determinations Manual, Chapter 1, Part 3 (Sections 170 – 190.34) Coverage Determinations: https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/downloads/ncd103c1_Part3.pdf
7. Rhode Island General Law § 27-20-36 Human leukocyte antigen testing.

8. http://webserver.rilin.state.ri.us/Statutes/title27/27-20/27-20-36.HTM i

   This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS