URL for source document:

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38333&ver=15&bc=0
LCD Title
MolDX: Blood Product Molecular Antigen Typing

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2021 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or
dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2021 American Dental Association. All rights reserved.

Copyright © 2013 - 2021, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be
copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without
the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal
purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof,
including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also
contact us at [email protected].

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a
malformed body member.

42 CFR §410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

CMS Internet- Online Manual Pub. 100-02, Medicare Benefit Policy Manual, Ch. 15, §80.0 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This policy provides limited coverage for molecular phenotyping of blood product antigens as part of the 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 one of the following criteria is met:

• Long term, frequent transfusions 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.

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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

For patients who require a blood product transfusion, an important step taken prior to the transfusion of any blood product is 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 al6 demonstrated that
Deoxyribonucleic acid (DNA) from blood samples could be used to genotype patients who had recently been transfused. Castilho et al10 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) patients10, and in 9 of 10 alloimmunized thalassemic patients.11 A number of investigators have replicated these findings, most notably Bakanay et al12 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 Wagner5 highlighted the practical utility of molecular testing over serologic testing for chronically transfused patients.

In a prospective observational study, Klapper et al13 used the HEA BeadChip to provide extended human erythrocyte antigen (xHEA) phenotyped donor units and recipient patient samples. XHEA-typed units were assigned to pending
transfusion requests using a web-based inventory management system to simulate blood order processing at four hospital transfusion services. The fraction of requests filled (FF) in 3 of 4 sites was > 95% when matching for ABO, D and known
alloantibodies, with a FF of > 90% when additional matching for C, c, E, e, and K antigens. The most challenging requests came from the fourth site where the FF was 62 and 51% respectively, even with a limited donor pool. A small prospective
observational study by Da Costa et al 14 found that 21 of 35 sickle cell anemia (SCA) patients had discrepancies or mismatches, mainly in the Rh, Duffy, Jk and MNS blood groups, between the genotype profile and the serologically-matched
blood unit for multiple antigens. These authors report that their genotype-matching program resulted in elevated hemoglobin levels, increased time between transfusions and prevented the development of new alloantibodies.

Two papers showed the feasibility of routinely applying molecular blood banking techniques in a hospital transfusion service. Routine RBC testing has been implemented in a large tertiary care hospital in Los Angeles, CA to maximize efficient
use of blood units.15 Patients with warm or cold reacting autoantibodies, patients with SCA and patients with antibodies that could not be identified were molecularly genotyped and received molecularly matched blood from the hospital s
genotyped donor inventory. The practical implementation of molecular erythrocyte antigen typing was described for a large hospital in Cleveland, OH;16 pre-transfusion molecular typing is performed on chronically transfused patients, patients
with autoantibodies, multiple antibodies, when no antigen specific antibody is available for testing and to solve laboratory discrepancies. The authors note that the major benefit of molecular typing is its application for patients who cannot be
typed by serology due to an unsuitable sample. Valid results can be obtained even when they have been transfused within a few days of testing or have been massively transfused. Samples selected for molecular testing were based on an
algorithm.

The emergence of novel medications, particularly monoclonal antibodies, has also created challenges for serologic phenotyping methods. Two recent research studies have demonstrated that treatment with daratumumab, a CD38 monoclonal
antibody, can bind to CD38 expressed on the surface of RBCs and interferes with serologic testing, thereby preventing cross match.17 More recent evidence suggests that treatment with Hu5F9-G4, an IgG4 monoclonal antibody targeting CD47
also interferes with pretransfusion testing.18

Analysis of Evidence (Rationale for Determination)

Numerous prior Medicare coverage decisions have considered the evidence in the hierarchical framework of Fryback and Thornbury22 where Level 2 addresses diagnostic accuracy, sensitivity, and specificity of the test; Level 3 focuses on
whether the information produces change in the physician's diagnostic thinking; Level 4 concerns the effect on the patient management plan and Level 5 measures the effect of the diagnostic information on patient outcomes. To apply this same
hierarchical framework to analyze an in vitro diagnostic test, we utilized the ACCE Model Process for Evaluating Genetic Tests.23 The practical value of a diagnostic test can only be assessed by taking into account subsequent health outcomes.
When a proven, well established association or pathway is available, intermediate health outcomes may also be considered. For example, if a particular diagnostic test result can be shown to change patient management and other evidence has

2
demonstrated that those patient management changes improve health outcomes, then those separate sources of evidence may be sufficient to demonstrate positive health outcomes from the diagnostic test.

It has long been recognized that immunohematologic compatibility is critical to a successful blood product transfusion. It has also long been recognized that serologic methods of determining compatibility, while useful in many cases have
limitations for particular groups of patients. Molecular methods for blood product antigen determination are not subject to the same limitations, and Food and Drug Administration (FDA)-approved tests using molecular methods have been
developed and validated to detect particular alleles within particular blood group systems. As such, FDA-approved tests are reasonable and necessary for blood product antigen typing in patients for whom a transfusion is needed when
conventional serologic testing methods are inadequate or at a high risk of producing unreliable or misleading results.

The evidence reviewed here did not seek to identify laboratory-developed tests intended to be used for the same purpose. However, since FDA-approved tests to detect all clinically significant alleles are not available at this time as the position
statement from Association for the Advancement of Blood & Biotherapies (AABB), America s Blood Centers, and American Red Cross24 notes, laboratory developed tests (LDTs) remain important to allow for the identification of unusual
alleles unlikely to be readily available on FDA-approved platforms. LDTs may be considered reasonable and necessary if peer-reviewed evidence demonstrates that a rigorous validation has been done to show that they accurately predict/identify
the blood product antigens.

General Information

Associated Information

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this Local Coverage Determination (LCD). (See Coverage Indications, Limitations, and/or Medical Necessity") This
documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available to the MAC upon request.

Sources of Information

1. Association Bulletin #16-02, Mitigating the Anti-CD38 Interference with Serologic Testing, American Association of Blood Banks, January 15, 2016.
2. Chapuy CI, Nicholson RT, Aguad MD, et al. Resolving the daratumumab interference with blood compatibility testing. Transfusion. 2015;55(6pt2):1545-54.
3. Nance S, Keller M. Comments on: molecular matching red blood cells is superior to serological matching in sickle cell disease patients. Rev Bras Hematol Memoter. 2013;35(1):9-11.
4. Wilkinson K, Harris S, Gaur P, et al. Molecular blood typing augments serologic testing and allows for enhanced matching of red blood cells for transfusion in patients with sickle cell disease. Transfusion. 2012;52(2):381-8.

Bibliography

1. International Society of Blood Transfusion. Table of blood group systems . Accessed 4/5/2022.
2. Anstee DJ. Red cell genotyping and the future of pretransfusion testing. Blood. 2009;114(2):248-256.
3. Hillyer CD, Shaz BH, Winkler AM, Reid M. Integrating molecular technologies for red blood cell typing and compatibility testing into blood centers and transfusion services. Transfus Med Rev. 2008;22(2):117-132.
4. Chapman J, Forman K, Kelsey P, et al. Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories. Transfusion Medicine. 1996;6(3):273-283.
5. Wagner FF. Why do we use serological blood group phenotype determination in chronically transfused patients? Blood Transfusion. 2014;12(1):1-2.
6. Reid ME, Rios M, Powell CP VI, Malavade V. DNA from blood samples can be used to genotype patients who have recently received a transfusion. Transfusion. 2000;40(1):48-53.
7. Lomas-Francis C, DePalma H. DNA-based assays for patient testing: their application, interpretation, and correlation of results. Immunohematology. 2008;24(4):180-190.
8. Westhoff C. The potential of blood group genotyping for transfusion medicine practice. Immunohematology. 2008;24(4):190-195.
9. Legler TJ, Eber SW, Lakomek M, et al. Application of RHD and RHCE genotyping for correct blood group determination in chronically transfused patients. Transfusion. 1999;39(8):852-855.
10. Castilho L, Rios M, Bianco C, et al. DNA-based typing of blood groups for the management of multiply-transfused sickle cell disease patients. Transfusion. 2002;42(2):232-238.
11. Castilho L, Rios M, Pellegrino J, Jr, Saad, STO, Costa, FF. Blood group genotyping facilitates transfusion of beta-thalassemia patients. J Clin Lab Anal. 2002;16(5):216-220.
12. Bakanay SM, Ozturk A, Ileri T, et al. Blood group genotyping in multi-transfused patients. Transfus Apher Sci. 2013;48(2):257-261.
13. Klapper E, Zhang Y, Figueroa P, et al. Toward extended phenotype matching: a new operational paradigm for the transfusion service. Transfusion. 2010;50(3):536-546.
14. da Costa DC, Pellegrino J, Jr., Guelsin GA, Ribeiro KA, Gilli SC, Castilho L. Molecular matching of red blood cells is superior to serological matching in sickle cell disease patients. Rev Bras Hematol Hemoter. 2013;35(1):35-38.
15. Shafi H, Abumuhor I, Klapper E. How we incorporate molecular typing of donors and patients into our hospital transfusion service. Transfusion. 2014;54(5):1212-1219.
16. Sapatnekar S, Figueroa PI. How do we use molecular red blood cell antigen typing to supplement pretransfusion testing? Transfusion. 2014;54(6):1452-1458.
17. Oostendorp M, Lammerts van Bueren JJ, Doshi P, et al. When blood transfusion medicine becomes complicated due to interference by monoclonal antibody therapy. Transfusion. 2015;55(6 Pt 2):1555-1562.
18. Velliquette RW, Aeschlimann J, Kirkegaard J, Shakarian G, Lomas-Francis C, Westhoff CM. Monoclonal anti-CD47 interference in red cell and platelet testing. Transfusion. 2019;59(2):730-737.
19. Food and Drug Administration. Approval Letter - Immucor PreciseType . 2014. Accessed 04/05/2022.
20. Food and Drug Administration Center for Biologics Evaluation and Research. ID CORE XT Premarket Approval Order. In: Administration FaD, ed2018.

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 21. Food and Drug Administration Center for Biologics Evaluation and Research. ID CORE XT Summary of Safety And Effectiveness Data. In: Administration FaD, ed2018.
22. Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making. 1991;11(2):88-94.
23. Centers for Disease Control and Prevention. ACCE Model List of 44 Targeted Questions Aimed at a Comprehensive Review of Genetic Testing . 2010. Accessed 04/05/2022.
24. Carr-Greer MA. A Joint Statement Presented Before the Food and Drug Administration's Blood Products Advisory Committee . Accessed 04/05/2022.

Revision History Information

Revision
Revision History
History Date Number Revision History Explanation
05/26/2022 R3 Under Sources of Information changes were made to citations to reflect AMA citation guidelines. Under Bibliography revised the broken hyperlink for the first reference and changes were made to citations to reflect AMA c
throughout the LCD. Acronyms were inserted where appropriate throughout the LCD.
This revision is effective on 5/26/2022.
02/10/2022 R2 Under Sources of Information deleted references that are also listed under the Bibliography section. Under Bibliography citation number 13 was deleted as it was a duplicate. Citations were renumbered and accessed dates w
were corrected throughout the LCD.

12/06/2020 R1 Under Coverage Indications, Limitations and/or Medical Necessity verbiage in the first paragraph was revised from This policy provides limited-coverage for molecular phenotyping of blood product antigens performed
FDA-approved use for patients who are required or expected to require a blood product transfusion (Red Blood cell, Platelets or White Blood cells) meeting at least one of the following criteria: to now read This policy pro
part of the pre-transfusion evaluation for patients who may require or are expected to require a blood product transfusion(s) (Red Blood Cells, Platelets or Leukocytes) when at least one of the following criteria is met: . Verbi
considered germline tests and thus must comply with relevant Contractor policies regarding germline testing. to now read Blood product molecular antigen typing tests are considered germline tests and thus must comply w

Under Bibliography corrected the links in references #1 and #20.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the field
Associated Documents

Attachments
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Related Local Coverage Documents

Articles
A57376 - Billing and Coding: MolDX: Blood Product Molecular Antigen Typing
A58506 - Response to Comments: MolDX: Blood Product Molecular Antigen Typing
LCDs
DL38333 - (MCD Archive Site)

Related National Coverage Documents

N/A

Public Versions

Updated On Effective Dates Status

05/18/2022 05/26/2022 - N/A Currently in Effect

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=57376&ver=10

Article Title

4
Billing and Coding: MolDX: Blood Product Molecular Antigen Typing

Article Type
Billing and Coding

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2021 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or
dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2021 American Dental Association. All rights reserved.

Copyright © 2013 - 2021, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be
copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without
the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal
purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof,
including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also
contact us at [email protected].

Title XVIII of the Social Security Act, §1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

Article Text

The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Blood Product Molecular Antigen Typing.

Blood product antigen typing is a germline test and the use of panels 0001U and 0084U will be limited to once in a beneficiary lifetime.

The individual codes 0180U-0201U, 0221U, 0222U and codes 81105-81112 are also germline tests. These will be noncovered as multiple antigens must be utilized as part of a comprehensive antigen evaluation and will be considered only as part
of a panel.

To report a Blood Product Molecular Antigen Typing service, please submit the following claim information:

• Select PLA code

• Enter unit of service (UOS)
• Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
• Loop 2400 or SV101-7 for the 5010A1 837P
• Item 19 for paper claim
• Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
• Line SV202-7 for 837I electronic claim
• Block 80 for the UB04 claim form
• Select the appropriate ICD-10-CM code

CMS National Coverage Policyo:p 5

Expand All | Collapse All

(3 Codes)

Group 1 Paragraph

The use of 81403 does not automatically imply coverage

Group 1 Codes

Code Description
81403 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 4 (EG, ANALYSIS OF SINGLE EXON BY DNA SEQUENCE ANALYSIS, ANALYSIS OF >10 AMPLICONS USING MULTIPLEX PCR IN 2 OR MORE INDEPENDEN
VARIANTS OF 2-5 EXONS)
0001U RED BLOOD CELL ANTIGEN TYPING, DNA, HUMAN ERYTHROCYTE ANTIGEN GENE ANALYSIS OF 35 ANTIGENS FROM 11 BLOOD GROUPS, UTILIZING WHOLE BLOOD, COMMON RBC ALLELES REPOR
0084U RED BLOOD CELL ANTIGEN TYPING, DNA, GENOTYPING OF 10 BLOOD GROUPS WITH PHENOTYPE PREDICTION OF 37 RED BLOOD CELL ANTIGENS

(32 Codes)

Group 2 Paragraph

These codes are non-covered

Group 2 Codes

Code Description
81105 HUMAN PLATELET ANTIGEN 1 GENOTYPING (HPA-1), ITGB3 (INTEGRIN, BETA 3 [PLATELET GLYCOPROTEIN IIIA], ANTIGEN CD61 [GPIIIA]) (EG, NEONATAL ALLOIMMUNE THROMBOCYTOPENIA [NAIT], POST-TRA
(L33P)
81106 HUMAN PLATELET ANTIGEN 2 GENOTYPING (HPA-2), GP1BA (GLYCOPROTEIN IB [PLATELET], ALPHA POLYPEPTIDE [GPIBA]) (EG, NEONATAL ALLOIMMUNE THROMBOCYTOPENIA [NAIT], POST-TRANSFUSION P
81107 HUMAN PLATELET ANTIGEN 3 GENOTYPING (HPA-3), ITGA2B (INTEGRIN, ALPHA 2B [PLATELET GLYCOPROTEIN IIB OF IIB/IIIA COMPLEX], ANTIGEN CD41 [GPIIB]) (EG, NEONATAL ALLOIMMUNE THROMBOCYTO
COMMON VARIANT, HPA-3A/B (I843S)
81108 HUMAN PLATELET ANTIGEN 4 GENOTYPING (HPA-4), ITGB3 (INTEGRIN, BETA 3 [PLATELET GLYCOPROTEIN IIIA], ANTIGEN CD61 [GPIIIA]) (EG, NEONATAL ALLOIMMUNE THROMBOCYTOPENIA [NAIT], POST-TRA
(R143Q)
81109 HUMAN PLATELET ANTIGEN 5 GENOTYPING (HPA-5), ITGA2 (INTEGRIN, ALPHA 2 [CD49B, ALPHA 2 SUBUNIT OF VLA-2 RECEPTOR] [GPIA]) (EG, NEONATAL ALLOIMMUNE THROMBOCYTOPENIA [NAIT], POST-TRA
HPA-5A/B [K505E])
81110 HUMAN PLATELET ANTIGEN 6 GENOTYPING (HPA-6W), ITGB3 (INTEGRIN, BETA 3 [PLATELET GLYCOPROTEIN IIIA, ANTIGEN CD61] [GPIIIA]) (EG, NEONATAL ALLOIMMUNE THROMBOCYTOPENIA [NAIT], POST-T
HPA-6A/B (R489Q)
81111 HUMAN PLATELET ANTIGEN 9 GENOTYPING (HPA-9W), ITGA2B (INTEGRIN, ALPHA 2B [PLATELET GLYCOPROTEIN IIB OF IIB/IIIA COMPLEX, ANTIGEN CD41] [GPIIB]) (EG, NEONATAL ALLOIMMUNE THROMBOCY
COMMON VARIANT, HPA-9A/B (V837M)
81112 HUMAN PLATELET ANTIGEN 15 GENOTYPING (HPA-15), CD109 (CD109 MOLECULE) (EG, NEONATAL ALLOIMMUNE THROMBOCYTOPENIA [NAIT], POST-TRANSFUSION PURPURA), GENE ANALYSIS, COMMON VAR
0180URED CELL ANTIGEN (ABO BLOOD GROUP) GENOTYPING (ABO), GENE ANALYSIS SANGER/CHAIN TERMINATION/CONVENTIONAL SEQUENCING, ABO (ABO, ALPHA 1-3-NACETYLGALACTOSAMINYLTRANSFERAS
SUBTYPING, 7 EXONS
0181URED CELL ANTIGEN (COLTON BLOOD GROUP) GENOTYPING (CO), GENE ANALYSIS, AQP1 (AQUAPORIN 1 [COLTON BLOOD GROUP]) EXON 1
0182URED CELL ANTIGEN (CROMER BLOOD GROUP) GENOTYPING (CROM), GENE ANALYSIS, CD55 (CD55 MOLECULE [CROMER BLOOD GROUP]) EXONS 1-10
0183URED CELL ANTIGEN (DIEGO BLOOD GROUP) GENOTYPING (DI), GENE ANALYSIS, SLC4A1 (SOLUTE CARRIER FAMILY 4 MEMBER 1 [DIEGO BLOOD GROUP]) EXON 19
0184URED CELL ANTIGEN (DOMBROCK BLOOD GROUP) GENOTYPING (DO), GENE ANALYSIS, ART4 (ADP-RIBOSYLTRANSFERASE 4 [DOMBROCK BLOOD GROUP]) EXON 2
0185URED CELL ANTIGEN (H BLOOD GROUP) GENOTYPING (FUT1), GENE ANALYSIS, FUT1 (FUCOSYLTRANSFERASE 1 [H BLOOD GROUP]) EXON 4
0186URED CELL ANTIGEN (H BLOOD GROUP) GENOTYPING (FUT2), GENE ANALYSIS, FUT2 (FUCOSYLTRANSFERASE 2) EXON 2
0187URED CELL ANTIGEN (DUFFY BLOOD GROUP) GENOTYPING (FY), GENE ANALYSIS, ACKR1 (ATYPICAL CHEMOKINE RECEPTOR 1 [DUFFY BLOOD GROUP]) EXONS 1-2
0188URED CELL ANTIGEN (GERBICH BLOOD GROUP) GENOTYPING (GE), GENE ANALYSIS, GYPC (GLYCOPHORIN C [GERBICH BLOOD GROUP]) EXONS 1-4
0189URED CELL ANTIGEN (MNS BLOOD GROUP) GENOTYPING (GYPA), GENE ANALYSIS, GYPA (GLYCOPHORIN A [MNS BLOOD GROUP]) INTRONS 1, 5, EXON 2
0190URED CELL ANTIGEN (MNS BLOOD GROUP) GENOTYPING (GYPB), GENE ANALYSIS, GYPB (GLYCOPHORIN B [MNS BLOOD GROUP]) INTRONS 1, 5, PSEUDOEXON 3
0191URED CELL ANTIGEN (INDIAN BLOOD GROUP) GENOTYPING (IN), GENE ANALYSIS, CD44 (CD44 MOLECULE [INDIAN BLOOD GROUP]) EXONS 2, 3, 6
0192URED CELL ANTIGEN (KIDD BLOOD GROUP) GENOTYPING (JK), GENE ANALYSIS, SLC14A1 (SOLUTE CARRIER FAMILY 14 MEMBER 1 [KIDD BLOOD GROUP]) GENE PROMOTER, EXON 9

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6
0193URED CELL ANTIGEN (JR BLOOD GROUP) GENOTYPING (JR), GENE ANALYSIS, ABCG2 (ATP BINDING CASSETTE SUBFAMILY G MEMBER 2 [JUNIOR BLOOD GROUP]) EXONS 226
0194URED CELL ANTIGEN (KELL BLOOD GROUP) GENOTYPING (KEL), GENE ANALYSIS, KEL (KELL METALLO-ENDOPEPTIDASE [KELL BLOOD GROUP]) EXON 8
0195UKLF1 (KRUPPEL-LIKE FACTOR 1), TARGETED SEQUENCING (IE, EXON 13)
0196URED CELL ANTIGEN (LUTHERAN BLOOD GROUP) GENOTYPING (LU), GENE ANALYSIS, BCAM (BASAL CELL ADHESION MOLECULE [LUTHERAN BLOOD GROUP]) EXON 3
0197URED CELL ANTIGEN (LANDSTEINER-WIENER BLOOD GROUP) GENOTYPING (LW), GENE ANALYSIS, ICAM4 (INTERCELLULAR ADHESION MOLECULE 4 [LANDSTEINER-WIENER BLOOD GROUP]) EXON 1
0198URED CELL ANTIGEN (RH BLOOD GROUP) GENOTYPING (RHD AND RHCE), GENE ANALYSIS SANGER/CHAIN TERMINATION/CONVENTIONAL SEQUENCING, RHD (RH BLOOD GROUP D ANTIGEN) EXONS 1-10 AND R
0199URED CELL ANTIGEN (SCIANNA BLOOD GROUP) GENOTYPING (SC), GENE ANALYSIS, ERMAP (ERYTHROBLAST MEMBRANE ASSOCIATED PROTEIN [SCIANNA BLOOD GROUP]) EXONS 4, 12
0200URED CELL ANTIGEN (KX BLOOD GROUP) GENOTYPING (XK), GENE ANALYSIS, XK (XLINKED KX BLOOD GROUP) EXONS 1-3
0201URED CELL ANTIGEN (YT BLOOD GROUP) GENOTYPING (YT), GENE ANALYSIS, ACHE (ACETYLCHOLINESTERASE [CARTWRIGHT BLOOD GROUP]) EXON 2
0221URED CELL ANTIGEN (ABO BLOOD GROUP) GENOTYPING (ABO), GENE ANALYSIS, NEXTGENERATION SEQUENCING, ABO (ABO, ALPHA 1-3-N-ACETYLGALACTOSAMINYLTRANSFERASE AND ALPHA 1-3-GALACTO
0222URED CELL ANTIGEN (RH BLOOD GROUP) GENOTYPING (RHD AND RHCE), GENE ANALYSIS, NEXT-GENERATION SEQUENCING, RH PROXIMAL PROMOTER, EXONS 1-10, PORTIONS OF INTRONS 2-3

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(108 Codes)

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Group 1 Codes

Code Description
C85.80 Other specified types of non-Hodgkin lymphoma, unspecified site
C85.89 Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites
C85.90 Non-Hodgkin lymphoma, unspecified, unspecified site
C85.91 Non-Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck
C85.92 Non-Hodgkin lymphoma, unspecified, intrathoracic lymph nodes
C85.93 Non-Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes
C85.94 Non-Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb
C85.95 Non-Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb
C85.96 Non-Hodgkin lymphoma, unspecified, intrapelvic lymph nodes
C85.97 Non-Hodgkin lymphoma, unspecified, spleen
C85.98 Non-Hodgkin lymphoma, unspecified, lymph nodes of multiple sites
C85.99 Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites
C90.00 Multiple myeloma not having achieved remission
C90.01 Multiple myeloma in remission
C90.02 Multiple myeloma in relapse
C91.00 Acute lymphoblastic leukemia not having achieved remission
C91.01 Acute lymphoblastic leukemia, in remission
C91.02 Acute lymphoblastic leukemia, in relapse

Group 2o:p 7
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.61 Acute myeloid leukemia with 11q23-abnormality in remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A1 Acute myeloid leukemia with multilineage dysplasia, in remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality
D46.Z Other myelodysplastic syndromes
D51.0 Vitamin B12 deficiency anemia due to intrinsic factor deficiency
D53.9 Nutritional anemia, unspecified
D55.0 Anemia due to glucose-6-phosphate dehydrogenase [G6PD] deficiency
D55.1 Anemia due to other disorders of glutathione metabolism
D55.2 Anemia due to disorders of glycolytic enzymes
D55.3 Anemia due to disorders of nucleotide metabolism
D55.8 Other anemias due to enzyme disorders
D55.9 Anemia due to enzyme disorder, unspecified
D56.0 Alpha thalassemia
D56.1 Beta thalassemia
D56.2 Delta-beta thalassemia
D56.3 Thalassemia minor
D56.5 Hemoglobin E-beta thalassemia
D56.8 Other thalassemias
D56.9 Thalassemia, unspecified
D57.00 Hb-SS disease with crisis, unspecified
D57.01 Hb-SS disease with acute chest syndrome
D57.02 Hb-SS disease with splenic sequestration
D57.03 Hb-SS disease with cerebral vascular involvement
D57.09 Hb-SS disease with crisis with other specified complication
D57.1 Sickle-cell disease without crisis
D57.20 Sickle-cell/Hb-C disease without crisis
D57.211 Sickle-cell/Hb-C disease with acute chest syndrome
D57.212 Sickle-cell/Hb-C disease with splenic sequestration
D57.213 Sickle-cell/Hb-C disease with cerebral vascular involvement
D57.218 Sickle-cell/Hb-C disease with crisis with other specified complication
D57.219 Sickle-cell/Hb-C disease with crisis, unspecified
D57.3 Sickle-cell trait
D57.40 Sickle-cell thalassemia without crisis
D57.411 Sickle-cell thalassemia, unspecified, with acute chest syndrome
D57.412 Sickle-cell thalassemia, unspecified, with splenic sequestration
D57.413 Sickle-cell thalassemia, unspecified, with cerebral vascular involvement
D57.418 Sickle-cell thalassemia, unspecified, with crisis with other specified complication
D57.419 Sickle-cell thalassemia, unspecified, with crisis
D57.42 Sickle-cell thalassemia beta zero without crisis
D57.431 Sickle-cell thalassemia beta zero with acute chest syndrome
D57.432 Sickle-cell thalassemia beta zero with splenic sequestration
D57.433 Sickle-cell thalassemia beta zero with cerebral vascular involvement
D57.438 Sickle-cell thalassemia beta zero with crisis with other specified complication
D57.439 Sickle-cell thalassemia beta zero with crisis, unspecified
D57.44 Sickle-cell thalassemia beta plus without crisis
D57.451 Sickle-cell thalassemia beta plus with acute chest syndrome
D57.452 Sickle-cell thalassemia beta plus with splenic sequestration
D57.453 Sickle-cell thalassemia beta plus with cerebral vascular involvement
D57.458 Sickle-cell thalassemia beta plus with crisis with other specified complication
D57.459 Sickle-cell thalassemia beta plus with crisis, unspecified

Group 1o:p 8
D57.80 Other sickle-cell disorders without crisis
D57.811 Other sickle-cell disorders with acute chest syndrome
D57.812 Other sickle-cell disorders with splenic sequestration
D57.813 Other sickle-cell disorders with cerebral vascular involvement
D57.818 Other sickle-cell disorders with crisis with other specified complication
D57.819 Other sickle-cell disorders with crisis, unspecified
D58.0 Hereditary spherocytosis
D58.1 Hereditary elliptocytosis
D58.9 Hereditary hemolytic anemia, unspecified
D59.0 Drug-induced autoimmune hemolytic anemia
D59.10 Autoimmune hemolytic anemia, unspecified
D59.11 Warm autoimmune hemolytic anemia
D59.12 Cold autoimmune hemolytic anemia
D59.13 Mixed type autoimmune hemolytic anemia
D59.19 Other autoimmune hemolytic anemia
D59.9 Acquired hemolytic anemia, unspecified
D60.0 Chronic acquired pure red cell aplasia
D60.1 Transient acquired pure red cell aplasia
D60.8 Other acquired pure red cell aplasias
D60.9 Acquired pure red cell aplasia, unspecified
D61.01 Constitutional (pure) red blood cell aplasia
D61.09 Other constitutional aplastic anemia
D61.1 Drug-induced aplastic anemia
D61.2 Aplastic anemia due to other external agents
D61.3 Idiopathic aplastic anemia
D61.89 Other specified aplastic anemias and other bone marrow failure syndromes
D63.0 Anemia in neoplastic disease
D63.1 Anemia in chronic kidney disease
D63.8 Anemia in other chronic diseases classified elsewhere
D64.0 Hereditary sideroblastic anemia
D64.1 Secondary sideroblastic anemia due to disease
D64.2 Secondary sideroblastic anemia due to drugs and toxins
D64.3 Other sideroblastic anemias
D64.4 Congenital dyserythropoietic anemia
D64.89 Other specified anemias
Z85.72 Personal history of non-Hodgkin lymphomas

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ICD-10-CM Codes that DO NOT Support Medical Necessityo:p 9

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types
indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other
Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

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Revision History Date Revision History Number Revision H

12/06/2020 R1 Under CPT/HCPCS Codes Group 2: Codes added 0221U and 0222U. This revision is due

Related Local Coverage Documents

LCDs
DL38333 - (MCD Archive Site)
L38333 - MolDX: Blood Product Molecular Antigen Typing

Related National Coverage Documents

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Statutory Requirements URLs

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Rules and Regulations URLs

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CMS Manual Explanations URLs

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Public Versions

Updated On Effective Dates Status

Bill Type Codeso:p 10

11/10/2020 12/06/2020 - N/A Currently in Effect

URL for source document:

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=58506&ver=4

Article Title
Response to Comments: MolDX: Blood Product Molecular Antigen Typing

Article Type
Response to Comments

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2021 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or
dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2021 American Dental Association. All rights reserved.

Copyright © 2013 - 2021, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be
copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without
the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal
purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof,
including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also
contact us at [email protected].

Article Guidance

Article Text

The comment period for the MolDX: Erythrocyte Molecular Antigen Typing DL38333 Local Coverage Determination (LCD) began on 10/22/2019 and ended on 12/06/19. The notice period for L38333 begins on 10/22/2020 and will become
effective on 12/06/2020.

The title of the LCD was revised from MolDX: Erythrocyte Molecular Antigen Typing to MolDX: Blood Product Molecular Antigen Typing. The comments below were received from the provider community.

Response To Comments

Number Comment
1 The following comment was submitted to CGS, Noridian, and Palmetto GBA:

Thank you for the opportunity to review and comment on the proposed coverage policy for Erythrocyte Molecular Antigen Typing. The Association for Molecular Pathology (AMP) is an international medical and professional association repr
physicians, doctoral scientists, and medical technologists who perform or are involved with laboratory testing based on knowledge derived from molecular biology, genetics, and genomics. Membership includes professionals from the governm
and hospital-based clinical laboratories, and the in vitro diagnostics industry.

The College of American Pathologists (CAP) is the world s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs. The CAP serves patients, pathologists, and the
excellence in the practice of pathology and laboratory medicine worldwide.

Associated Documentso:p 11
 Members of AMP and the CAP appreciate the willingness of the contractors to offer limited coverage for molecular typing of red blood cell antigens using both FDA-approved tests and laboratory developed tests that meet the criteria outlined
level of evidence at this time our organizations agree with the limited coverage that is outlined in the proposed policy.

Thank you again for the opportunity to review and comment on this proposed policy.
2 Thank you for the opportunity to comment on DL38240, MolDx Erythrocyte Molecular Antigen Typing. Overall, we agree with the coverage guidance, including the description of FDA-approved/cleared tests and LDTs that meet the criteria
determination. We are pleased to see MolDX s recognition of the rise in therapies that are shown to interfere with serology-based assays. We do have a few comments and suggestions, as detailed below:

Comment 1: In the Summary of Evidence section, there are two FDA-approved tests described. However, in the last paragraph, redundant text from the previous LCD L36074 remains. From our point-of-view, this legacy statement of cove
guidance as it does not address the second FDA-approved test, nor LDTs. We recommend removing the following paragraph from the evidence summary as this would likely cause confusion with the stated coverage guidance.

Medicare will cover pretransfusion molecular testing using the HEA BeadChip assay for the following categories of patients:

• Long term, frequent transfusions anticipated to prevent the development of alloantibodies (e.g. sickle cell anemia, thalassemia or other reason);
• 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 a
receive or on daratumumab therapy, other reactivity of no apparent cause);
• Suspected antibody against an antigen for which typing sera is not available; and
• Laboratory discrepancies on serologic typing (e.g. rare Rh D antigen variants)

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 serolo
require long term, frequent transfusions.

Comment 2: In the CPT/HCPCS Codes section, the additional CPT-PLA code for the ID CORE XT test, as described in the Summary of Evidence section, is missing. If CPT codes are listed in this section, the following should be added
completeness:

CODE: 0084U

DESCRIPTION: Red blood cell antigen typing, DNA, genotyping of 10 blood groups with phenotype prediction of 37 red blood cell antigens

Comment 3: The proposed LCD recognizes that the anti-CD47 antibodies now on the rise to treat various cancers have a proven interference with serological testing for red cell antigen identification. In the Summary of Evidence section, th
recent evidence suggests that the treatment with Hu5F9-G4, and IgG4 monoclonal antibody targeting CD47 also interferes with pretransfusion testing. However, the table under the ICD10 Codes that Support Medical Necessity is missing
published application of anti-CD47, including:

• Acute myeloid leukemia (AML)

• Acute lymphoblastic leukemia (ALL)
• Non-Hodgkin s lymphoma (NHL)
• Myelodysplastic Syndrome (MDS)

Anti- CD47 Application

• AML Publication

♦ Liu J, Wang L, Zhao F, et al. Pre-clinical development of a humanized anti-CD47 antibody with anti-cancer therapeutic potential. PLoS One 2015;10:e0137345
♦ Vonderheide RH. CD47 blockade as another immune checkpoint therapy for cancer. Nat Med. 2015 Oct;21(10):1122-3. doi: 10.1038/nm.3965
♦ Sallman DA, et al. The first-in-class anti-CD47 antibody Hu5F9-G4 is active and well tolerated alone or with azacitidine in AML and MDS patients: Initial phase 1b results. Journal of Clinical Oncology 2019 37:15_su
♦ Russ A, et al. Blocking "don't eat me" signal of CD47-SIRPα in hematological malignancies, an in-depth review. Blood Rev. 2018 Nov;32(6):480-489. doi: 10.1016/j.blre.2018.04.005. Epub 2018 Apr 14
• ALL Publication

♦ Mark P. Chao, Ash A. Alizadeh, Chad Tang, et al. Therapeutic antibody targeting of CD47 eliminates human acute lymphoblastic leukemia
♦ Cancer Res. 2011 Feb 15; 71(4): 1374 1384. Published online 2010 Dec 21. Doi: 10.1158/0008-5472.CAN-10-2238
• NHL Publication

Associated Documentso:p 12
 o

♦ Liu J, Wang L, Zhao F, et al. Pre-clinical development of a humanized anti-CD47 antibody with anti-cancer therapeutic potential. PLoS One 2015;10:e0137345.
♦ Vonderheide RH. CD47 blockade as another immune checkpoint therapy for cancer. Nat Med. 2015 Oct;21(10):1122-3. doi: 10.1038/nm.3965
♦ Advani R, Flinn I, Popplewell L, et al. CD47 Blockade by Hu5F9-G4 and Rituximab in Non-Hodgkin s Lymphoma N Engl J Med 2018; 379:1711-1721
♦ Advani R, et al. CD47 Blockade by Hu5F9-G4 and Rituximab in NonHodgkin s Lymphoma. N Engl J Med 2018; 379:1711-1721
• MDS Publication

♦ Sallman DA, et al. The first-in-class anti-CD47 antibody Hu5F9-G4 is active and well tolerated alone or with azacitidine in AML and MDS patients: Initial phase 1b results. Journal of Clinical Oncology 2019 37:15_su
♦ Russ A, et al. Blocking "don't eat me" signal of CD47-SIRPα in hematological malignancies, an in-depth review. Blood Rev. 2018 Nov;32(6):480-489. doi: 10.1016/j.blre.2018.04.005. Epub 2018 Apr 14

For your convenience, below is the list of applicable ICD-10 codes we suggest should be added to the medical necessity table.

ICD-10 CODE DESCRIPTION

C92.6 Acute myeloid leukemia with 11q23abnormality

C92.A Acute myeloid leukemia with multilineage dysplasia

C92.A1 Acute myeloid leukemia with multilineage dysplasia, in remission

C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse

C92.61 Acute myeloid leukemia with multilineage dysplasia, in relapse

C92.62 Acute myeloid leukemia with 11q23abnormality in relapse

C92.60 Acute myeloid leukemia with 11q23abnormality not having achieved remission

C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission

C85.97 Non-Hodgkin lymphoma, unspecified, spleen

Z85.72 Personal history of non-Hodgkin lymphoma

C85.90 Non-Hodgkin lymphoma, unspecified, unspecified site

C85.80 Other specified types of non-Hodgkin lymphoma, unspecified site

C85.92 Non-Hodgkin lymphoma, unspecified, intrathoracic lymph nodes

C85.96 Non-Hodgkin lymphoma

C85.9 Non-Hodgkin lymphoma, unspecified

C85.99 Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites

C85.91 Non-Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck

C85.89 Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites

C85.93 Non-Hodgkin lymphoma, unspecified, intraabdominal lymph nodes

Associated Documentso:p 13
 C85.98 Non-Hodgkin lymphoma, unspecified, lymph nodes of multiple sites

C85.94 Non-Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb

C85.95 Non-Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb

C85 Other specified and unspecified types of non-Hodgkin lymphoma

C91.02 Acute lymphoblastic leukemia, in relapse

C91.01 Acute lymphoblastic leukemia, in remission

C91.00 Acute lymphoblastic leukemia not having achieved remission

D46 Myelodysplastic Syndrome

D46.9 Myelodysplastic Syndrome, unspecified

D46.C Myelodysplastic Syndrome with isolated del(5q) chromosomal abnormality

D46.Z Other Myelodysplastic Syndrome

Associated Documents

Related Local Coverage Documents

LCDs
DL38333 - (MCD Archive Site)
L38333 - MolDX: Blood Product Molecular Antigen Typing

Related National Coverage Documents

N/A

Public Versions

Updated On Effective Dates Status

10/14/2020 12/06/2020 - N/A Currently in Effect

Associated Documentso:p 14