Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A57110 (Billing and Coding: MolDX: Blood Product Molecular Antigen Typing) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A57110: Billing and Coding: MolDX: Blood Product Molecular Antigen Typing (Billing and Coding, effective 2024-10-01)
- Covered ICD-10-CM codes
- 116
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 35
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| C85.80 | — |
| C85.89 | — |
| C85.90 | — |
| C85.91 | — |
| C85.92 | — |
| C85.93 | — |
| C85.94 | — |
| C85.95 | — |
| C85.96 | — |
| C85.97 | — |
| C85.98 | — |
| C85.99 | — |
| C90.00 | — |
| C90.01 | — |
| C90.02 | — |
| C91.00 | — |
| C91.01 | — |
| C91.02 | — |
| C92.60 | — |
| C92.61 | — |
| C92.62 | — |
| C92.A0 | — |
| C92.A1 | — |
| C92.A2 | — |
Procedure codes: 0001U, 0084U, 0180U, 0181U, 0182U, 0183U, 0184U, 0185U, 0186U, 0187U, 0188U, 0189U, 0190U, 0191U, 0192U, 0193U, 0194U, 0195U, 0196U, 0197U, 0198U, 0199U, 0200U, 0201U, 0221U, 0222U, 81105, 81106, 81107, 81108, 81109, 81110, 81111, 81112, 81403.
Coverage indications, limitations and medical necessity
This policy provides limited coverage for molecular phenotyping of blood product antigens as part of a pre-transfusion evaluation for patients who may require or are expected to require a blood product transfusion(s) (Red Blood cells [RBCs], Platelets or Leukocytes) when at least 1 of the following criteria is met:
• Long term, frequent transfusions are anticipated to prevent the development of alloantibodies (e.g., sickle cell anemia, thalassemia, chronic transfusion dependent hematologic disorders or other reasons); OR
• Autoantibodies or other serologic reactivity that impedes the exclusion of clinically significant alloantibodies (e.g., autoimmune hemolytic anemia, warm autoantibodies, patient recently transfused with a positive DAT, high-titer low avidity antibodies, patients about to receive or on daratumumab therapy, other reactivity of no apparent cause); OR
• Suspected antibody against an antigen for which typing sera is not available; OR
• Laboratory discrepancies on serologic typing (e.g., rare Rh D antigen variants)
Laboratory developed tests (LDTs) that perform molecular phenotyping of blood product antigens may be considered covered for the same indications if the test demonstrates validity and clinical utility equivalent to or better than covered tests as demonstrated in a technical assessment.
Medicare does not expect molecular testing to be performed on patients undergoing surgical procedures such as bypass or other cardiac procedures, hip or knee replacements or revisions, or patients with alloantibodies identifiable by serologic testing that are not expected to require long term, frequent transfusions.
The medical necessity for molecular blood product phenotyping must be documented in the patient’s medical record.
Blood product molecular antigen typing tests are considered germline tests and thus must comply with relevant Medicare or Contractor policies regarding germline testing.
As molecular genotyping includes a review of many genes that code for cellular antigens that must be evaluated for proper patient care, single gene tests are not reasonable and necessary.
If there is a rare instance that a single blood product antigen is reasonable and necessary, its utility must be appropriately documented in the patient’s medical record for validation by medical review.
Summary of evidence (opening)
For patients who require a blood product transfusion, an important step taken prior to the transfusion of any blood product compatibility testing between the recipient’s serum and the blood product being transfused. In addition to the ABO and Rh system there are 34 other recognized blood group antigen systems by the International Society of Blood Transfusion. 1 Identifying the blood product antigens to which the transfusion recipient will have an immune reaction is a critical component of this compatibility testing, though for most patients identification of ABO and Rh compatibility is sufficient. 2 However, for patients who have alloantibodies or patients who have a predisposition to develop alloimmunization (e.g., patients with sickle cell disease and others who are chronically transfused), compatibility testing of additional systems may be needed. 2,3 Hemagglutination has traditionally been the most common serologic method of determining a blood product phenotype. In this technique, the patient’s RBCs are tested with antisera specific for the antigens of interest. 2,4 However, this method has limitations. It requires direct agglutination typing sera for the antigen, and hemagglutination testing results are not meaningful if a patient has a positive direct antiglobulin test (DAT). 3,4 In addition, serologic phenotyping is likely to be erroneous in the transfused patient who may have persistent donor blood products in circulation, such as patients getting chronic frequent transfusions, and it has been suggested that chronically transfused patients or patients who have had a massive transfusion should not receive phenotyping using serological methods, or that if serological methods are used, they should be confirmed with molecular techniques. 3,5
Because molecular genotyping is not subject to the limitations of conventional serologic testing, the transfusion community has recognized molecular typing as a potential tool to aid in the determination of immune compatibility between donated blood products and the transfusion recipient in a number of circumstances where conventional methods may not be adequate, such as in patients who have a positive direct antigen test, in patients who have been recently transfused or those who are chronically transfused, 6 in patients where a distinction between autoantibodies and alloantibodies is needed, or in situations where the presence of a weakly reactive anti-body is suspected. 2,3,7,8
Prior to broad clinical availability of molecular genotyping in the United States, a number of studies demonstrated both the feasibility of this technique and the incremental information it could provide over serologic typing in limited clinical contexts.
As early as 1999, a study from Germany in patients receiving chronic transfusions demonstrated disparate molecular Rh phenotyping in 7 of 27 patients compared to serologic typing. 9 Soon afterwards, Reid et al 6 demonstrated that Deoxyribonucleic acid (DNA) from blood samples could be used to genotype patients who had recently been transfused. Castilho et al 10 confirmed the unreliability of serologic testing when they showed that 6 of 40 molecular genotypes differed from serologic phenotypes in multiply transfused sickle cell anemia (SCA) patients 10 , and in 9 of 10 alloimmunized thalassemic patients. 11 A number of investigators have replicated these findings, most notably Bakanay et al 12 when they demonstrated genotypic and phenotypic discrepancies in 19 or 37 multi-transfused patients in multiple alleles. The discrepancies aided in the selection of antigen-matched blood products and improved RBC survival, ultimately improving patient care. A recent case report by Wagner 5 highlighted the practical utility of molecular testing over serologic testing for chronically transfused patients.
The contractor cites 24 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2020-10-25
- Current revision effective
- 2026-09-24
- Last reviewed by the contractor
- 2026-09-03
- MCD version
- 17
Other related documents: A58431 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Wisconsin Physicians Service Insurance Corporation hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L38441 cover?
This policy provides limited coverage for molecular phenotyping of blood product antigens as part of a pre-transfusion evaluation for patients who may require or are expected to require a blood product transfusion(s) (Red Blood cells [RBCs], Platelets or Leukocytes) when at least 1 of the following criteria is met: The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L38441 apply to?
Wisconsin Physicians Service Insurance Corporation applies it to Medicare claims in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L38441?
The companion billing and coding article A57110 lists 116 ICD-10-CM codes in 1 group that support medical necessity; the first 24 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L38441?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.