CPT® Code 81378

Official Description

HLA Class I and II typing, high resolution (ie, alleles or allele groups), HLA-A, -B, -C, and -DRB1

Common Language Description

The HLA Class I and II typing, high resolution (CPT® Code 81378) is a specialized laboratory procedure that focuses on identifying specific human leukocyte antigen (HLA) alleles or allele groups. The HLA system is a critical component of the major histocompatibility complex (MHC), which plays a vital role in the immune system by facilitating self-recognition. This means that the MHC helps the body distinguish its own cells and tissues from foreign substances, including pathogens and non-self cells. The HLA molecules are located on the short arm of chromosome 6 and are essential for the normal functioning of the immune response. HLA molecules are categorized into two classes: Class I and Class II. Class I includes the most significant loci, namely HLA-A, HLA-B, and HLA-C, while Class II encompasses five loci, with HLA-DR, HLA-DQ, and HLA-DP being the most clinically relevant. Each locus can have multiple variants known as alleles, which are designated by the locus name followed by an asterisk (*) and a series of digits that provide specific information about the allele. For example, HLA-B*08:01 indicates a specific allele within the HLA-B locus. The high-resolution typing of HLA Class I and II is crucial for various medical applications, including organ transplantation, where matching donor and recipient HLA types can significantly reduce the risk of transplant rejection. Additionally, HLA typing is important in understanding susceptibility to certain diseases, including autoimmune disorders and some cancers. The procedure typically involves molecular techniques for DNA extraction, which require cell lysis and protein digestion. Polymerase chain reaction (PCR) is commonly employed to amplify specific DNA sequences, and one method used for high-resolution typing is PCR sequence-specific priming (SSP). This technique utilizes a panel of primer pairs to amplify groups of alleles, allowing for precise identification of HLA types. The CPT® Code 81378 is specifically used when high-resolution testing is conducted for the three Class I loci (HLA-A, HLA-B, and HLA-C) and the Class II locus (HLA-DRB1).

1. Indications

Organ Transplantation HLA typing is essential for matching organ donors with recipients to minimize the risk of transplant rejection.

Autoimmune Diseases Understanding HLA types can help identify individuals at risk for certain autoimmune conditions.

Cancer Susceptibility HLA typing may provide insights into an individual's susceptibility to specific cancers.

Bone Marrow Transplantation Accurate HLA typing is critical for the success of bone marrow transplants, ensuring compatibility between donor and recipient.

2. Procedure

Step 1: Sample Collection The procedure begins with the collection of a blood sample or other nucleated cell source from the patient. This sample serves as the basis for DNA extraction, which is necessary for HLA typing.

Step 2: DNA Extraction Following sample collection, the next step involves the extraction of DNA from the nucleated cells. This process requires cell lysis to break down the cell membrane and protein digestion to remove proteins that may interfere with DNA analysis.

Step 3: Polymerase Chain Reaction (PCR) Once the DNA is extracted, polymerase chain reaction (PCR) is employed to amplify specific regions of the DNA that correspond to the HLA loci of interest. This amplification is crucial for obtaining sufficient DNA for analysis.

Step 4: High-Resolution Typing The high-resolution typing is performed using PCR sequence-specific priming (SSP), which utilizes a panel of primer pairs designed to amplify specific groups of HLA alleles. This step allows for the identification of specific alleles or allele groups at the HLA-A, HLA-B, HLA-C, and HLA-DRB1 loci.

Step 5: Analysis and Reporting After amplification, the results are analyzed to determine the specific HLA types present in the sample. The findings are then compiled into a report that details the identified alleles, which can be used for clinical decision-making.

3. Post-Procedure

Post-procedure care typically involves monitoring the patient for any immediate reactions to the blood draw, although there are no specific post-procedure requirements related to the HLA typing itself. The results of the HLA typing are usually available within a few days, and healthcare providers will use this information to guide treatment decisions, particularly in the context of organ transplantation or assessing disease susceptibility. It is important for healthcare professionals to communicate the results to the patient and discuss any implications for treatment or further testing that may be necessary.

Short Descr	HLA I & II TYPING HR
Medium Descr	HLA I&II HIGH RESOLUTION HLA-A -B -C AND -DRB1
Long Descr	HLA Class I and II typing, high resolution (ie, alleles or allele groups), HLA-A, -B, -C, and -DRB1
Status Code	Statutory Exclusion (from MPFS, may be paid under other methodologies)
Global Days	XXX - Global Concept Does Not Apply
PC/TC Indicator (26, TC)	9 - Not Applicable
Multiple Procedures (51)	9 - Concept does not apply.
Bilateral Surgery (50)	9 - Concept does not apply.
Physician Supervisions	09 - Concept does not apply.
Assistant Surgeon (80, 82)	9 - Concept does not apply.
Co-Surgeons (62)	9 - Concept does not apply.
Team Surgery (66)	9 - Concept does not apply.
Diagnostic Imaging Family	99 - Concept Does Not Apply
CLIA Waived (QW)	No
APC Status Indicator	Service Paid under Fee Schedule or Payment System other than OPPS
Type of Service (TOS)	5 - Diagnostic Laboratory
Berenson-Eggers TOS (BETOS)	T1H - Lab tests - other (non-Medicare fee schedule)
MUE	1
CCS Clinical Classification	234 - Pathology

90	Reference (outside) laboratory: when laboratory procedures are performed by a party other than the treating or reporting physician or other qualified health care professional, the procedure may be identified by adding modifier 90 to the usual procedure number.
26	Professional component: certain procedures are a combination of a physician or other qualified health care professional component and a technical component. when the physician or other qualified health care professional component is reported separately, the service may be identified by adding modifier 26 to the usual procedure number.
59	Distinct procedural service: under certain circumstances, it may be necessary to indicate that a procedure or service was distinct or independent from other non-e/m services performed on the same day. modifier 59 is used to identify procedures/services, other than e/m services, that are not normally reported together, but are appropriate under the circumstances. documentation must support a different session, different procedure or surgery, different site or organ system, separate incision/excision, separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual. however, when another already established modifier is appropriate it should be used rather than modifier 59. only if no more descriptive modifier is available, and the use of modifier 59 best explains the circumstances, should modifier 59 be used. note: modifier 59 should not be appended to an e/m service. to report a separate and distinct e/m service with a non-e/m service performed on the same date, see modifier 25.