CPT® Code 81230

Official Description

CYP3A4 (cytochrome P450 family 3 subfamily A member 4) (eg, drug metabolism), gene analysis, common variant(s) (eg, *2, *22)

Common Language Description

The CPT® Code 81230 pertains to the gene analysis of CYP3A4, which is a member of the cytochrome P450 family 3 subfamily A. This gene plays a crucial role in drug metabolism, as it encodes enzymes that are responsible for the biotransformation of various medications. The analysis specifically targets common variants of the CYP3A4 gene, such as *2 and *22, which can significantly influence how individuals metabolize certain drugs. The CYP3A4 gene is located on the long (q) arm of chromosome 7 at position 22.1. Understanding the genetic variations in this gene is essential for predicting an individual's response to medications, particularly those that are commonly prescribed, including acetaminophen, opioids, statins, oral contraceptives, and chemotherapeutic agents. The presence of specific variants may indicate a reduced ability to metabolize these drugs, which can lead to an increased risk of adverse drug reactions or toxicity. Conversely, the absence of these variants typically suggests that a patient will metabolize drugs at a normal rate, allowing for standard dosing protocols. The gene analysis is performed using a sample obtained from peripheral blood or buccal mucosa, which is collected through a separate reportable procedure. The testing method employed is multiplex polymerase chain reaction (PCR) combined with primer extensions, ensuring accurate identification of the common variants in the CYP3A4 gene. This genetic information is vital for healthcare providers to tailor medication plans and monitor patients effectively, especially those with a personal or family history of adverse drug reactions.

1. Indications

The CYP3A4 gene analysis (CPT® Code 81230) is indicated for individuals who may have a personal or family history of adverse drug reactions. This test is particularly relevant for patients who are prescribed medications that are metabolized by the CYP3A4 enzyme, as understanding their genetic makeup can help predict their response to these drugs. The analysis may be beneficial in cases where there is a need to assess the risk of drug toxicity or to optimize medication dosing based on the patient's metabolic capacity.

Adverse Drug Reactions Identification of individuals with a personal or family history of adverse drug reactions to medications metabolized by CYP3A4.
Medication Management Optimization of medication dosing for drugs metabolized by CYP3A4, particularly in patients at risk for toxicity.

2. Procedure

The procedure for conducting the CYP3A4 gene analysis involves several key steps to ensure accurate results. First, a sample is collected from the patient, which can be either a peripheral blood sample or a buccal mucosa sample. This collection is performed as a separate reportable procedure to ensure that the sample is suitable for genetic testing. Once the sample is obtained, it is processed using multiplex polymerase chain reaction (PCR) techniques. This method allows for the simultaneous amplification of multiple DNA sequences, specifically targeting the common variants of the CYP3A4 gene, such as *2 and *22. Following amplification, primer extensions are performed to facilitate the identification of these variants. The results of this analysis provide critical information regarding the patient's ability to metabolize drugs that are substrates of the CYP3A4 enzyme, guiding healthcare providers in making informed decisions about medication management.

Sample Collection A peripheral blood sample or buccal mucosa sample is obtained from the patient through a separate reportable procedure.
Multiplex PCR The sample is tested using multiplex polymerase chain reaction (PCR) to amplify the DNA sequences of interest.
Primer Extensions Following amplification, primer extensions are conducted to identify the common variants of the CYP3A4 gene.

3. Post-Procedure

After the CYP3A4 gene analysis is completed, the results are interpreted to determine the presence or absence of the common variants *2 and *22. If one or more variant alleles are detected, it may indicate decreased enzyme activity, necessitating closer monitoring of the patient for potential drug toxicity. In contrast, the absence of these variants typically suggests that the patient can metabolize drugs normally, allowing for standard dosing to be employed. Healthcare providers should discuss the results with the patient, providing guidance on any necessary adjustments to medication regimens based on the findings. Additionally, it is important to document the results and any subsequent changes in treatment plans in the patient's medical record for future reference.

Short Descr	CYP3A4 GENE COMMON VARIANTS
Medium Descr	CYP3A4 GENE ANALYSIS COMMON VARIANTS
Long Descr	CYP3A4 (cytochrome P450 family 3 subfamily A member 4) (eg, drug metabolism), gene analysis, common variant(s) (eg, 2, 22)
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)	none
MUE	1

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.
XU	Unusual non-overlapping service, the use of a service that is distinct because it does not overlap usual components of the main service
XS	Separate structure, a service that is distinct because it was performed on a separate organ/structure
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.
91	Repeat clinical diagnostic laboratory test: in the course of treatment of the patient, it may be necessary to repeat the same laboratory test on the same day to obtain subsequent (multiple) test results. under these circumstances, the laboratory test performed can be identified by its usual procedure number and the addition of modifier 91. note: this modifier may not be used when tests are rerun to confirm initial results; due to testing problems with specimens or equipment; or for any other reason when a normal, one-time, reportable result is all that is required. this modifier may not be used when other code(s) describe a series of test results (eg, glucose tolerance tests, evocative/suppression testing). this modifier may only be used for laboratory test(s) performed more than once on the same day on the same patient.
GA	Waiver of liability statement issued as required by payer policy, individual case
GV	Attending physician not employed or paid under arrangement by the patient's hospice provider
GW	Service not related to the hospice patient's terminal condition