Procedure code and Description
G0434 Drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter
G0431 Drug screen, qualitative; multiple drug classes by high complexity test method (for example, immunoassay, enzyme assay), per patient encounter
Update from Medicare
Current coding for testing for drugs of abuse relies on a structure of “screening” (known as “presumptive” testing) followed by “confirmation” to confirm the results of the screening tests and quantitative or “definitive” testing that identifies the specific drug and quantity in the patient.
In the 2015 CLFS final determinations file, we decided to not pay for new Procedure codes for drugs of abuse testing. We stated our concern about the potential for overpayment when billing for each individual drug test rather than a single code that pays the same amount regardless of the number of drugs that are being tested. Therefore, we delayed pricing for these codes to allow additional time to study the issue. However, we agreed with commenters that this policy would leave insufficient codes available to bill for drugs of abuse testing. For that reason, we maintained the 2014 status quo for 2015 by creating alphanumeric G codes to replace the 2014 Procedure codes that were deleted for 2015. For 2015, providers are using these G codes in the same manner in which they used the corresponding CPT codes for 2014.
In addition, for some of the drugs of abuse testing codes, the AMA Procedure did not delete the 2014 code numbers, but revised the instructions or code descriptors in the 2015 Procedure Manual.
Following these instructions would have left providers without billing options. Thus, we also instructed the public to use these G codes exactly as they used them for 2014, regardless of the 2015 instruction or code descriptor changes.
In July 2015, we proposed to delete all current drug testing G codes, continue to not recognize the new AMA CPT codes, and create a single G code for presumptive testing and a single G code for definitive testing. We received written public comments to respond to our proposal as well as comment and discussion at the Annual Laboratory Public Meeting.
Section 216 of the Protecting Access to Medicare Act (PAMA) of 2014 replaces the current pricing methodology for the CLFS with one based on the weighted median of private payor rates for each laboratory test code collected directly from laboratories on a periodic basis, beginning July 1, 2017. Public commenters suggested using the CPT drugs of abuse testing codes and developing claims processing logic that groups codes into tiered payments based on volume or discount payment based in the presence of multiple test codes. We do not believe that such a methodology would be permitted under the PAMA.
After further consideration of this issue, several meetings with the public, and in consultation with the advisory panel on clinical diagnostic laboratory tests (established under the PAMA), the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of National Drug Control Policy, we are proposing to modify our proposal for coding and payment of drugs of abuse testing as follows:
1. Delete the following G-codes:
a. G0431, G0434
b. HCPCS codes G6030 through G6058
2. Continue to not recognize the AMA CPT codes 80300 – 80377
3. For presumptive testing, create three G codes:
Code: GXXX1 (Drug tests(s), presumptive, any number of drug classes; any number of devices or procedures, (eg immunoassay) capable of being read by direct optical observation only (eg, dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service)
Drug Screen Testing
Current Procedural Terminology (CPT®”) lists coding for presumptive drug class screening in addition to individual definitive drug testing codes. Therefore, effective with dates of service on or after May 1, 2015, based on HCPCS instructions to refer to CPT for alternate codes, HCPCS codes G0431 (drug screen, qualitative) and G0434 (drug screen, other than chromatographic) will not be eligible for reimbursement. The Drug Screen Testing policy will be updated to reflect these changes and codes G0431 and G0434 will also be added to section 1 of the Bundled Services policy. (Please refer to CPT codes 80047-89398 for alternate coding). [Please refer to reimbursement policies: Drug Screen Testing and Bundled Services and Supplies].
This article describes how clinical diagnostic laboratories should bill for certain types of tests that are covered under Medicare and paid based on the Clinical Laboratory Fee Schedule (CLFS). Specifically, the article addresses the billing of two CLFS Healthcare Common Procedure Coding System (HCPCS) test codes – G0431 (drug screen, qualitative; multiple drug classes by high complexity test method (e.g., immunoassay, enzyme assay), per patient encounter) and G0434 (drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter) – beginning January 1, 2011. HCPCS code G0434 is new for calendar year (CY) 2011. Please be certain that your billing staffs are aware of these changes.
Each year, the Centers for Medicare and Medicaid Services (CMS) hosts an annual public meeting to discuss test codes that have been established by the Common Procedural Terminology (CPT) committee and may be covered by Medicare and paid based on the CLFS in the upcoming calendar year.
During the 2009 annual public meeting, CMS introduced two new CY 2010 HCPCS codes for reporting qualitative drug screen testing – G0430 (drug screen, qualitative; multiple drug classes other than chromatographic method, each procedure), which was reported once per procedure and G0431, which is reported once per drug class. Please note that G0430 was deleted beginning January 1, 2011. After the introduction of these codes, CMS determined that it needed to further refine these drug screen testing codes and revise the descriptors to avoid unnecessary or excessive utilization of code G0431 for relatively simple point-of-care tests that screen for multiple substances. During the 2010 annual public meeting, CMS introduced code G0434 to report qualitative point-of-care drug screen testing and to limit billing for such testing to one time per patient encounter. CMS also revised the descriptor for code G0431 to emphasize that the code describes all screening for multiple drug classes per patient encounter.
CMS recognizes that there could be rare instances where a patient requires multiple, medically necessary screening tests for drugs of abuse to be performed in a single day. For instance, a patient seen in an outpatient pain clinic who requires a drug screening test as a part of his/her care is later admitted to an emergency department after an automobile accident and requires another medically necessary drug screening test. The use of ‘per patient encounter’ will allow payment to be made for this rare circumstance.
Effective January 1, 2011, CMS will utilize two test codes to report drug screen testing:
G0434 (drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter) will be used to report very simple testing methods, such as dipsticks, cups, cassettes and cards, that are interpreted visually, with the assistance of a scanner or are read utilizing a moderately complex reader device outside the instrumented laboratory setting (e.g., non-instrumented devices). This code is also used to report any other type of drug screen testing using tests that are classified as Clinical Laboratory Improvement Amendments (CLIA) moderate complexity tests, keeping the following points in mind:
o G0434 includes qualitative drug screen tests that are waived under CLIA as well as dipsticks, cups, cards, cassettes, etc. that are not CLIA waived
o Laboratories with a CLIA certificate of waiver may perform only those tests cleared by the Food and Drug Administration (FDA) as waived tests. Laboratories with a CLIA certificate of waiver shall bill using the QW modifier.
o Laboratories with a CLIA certificate of compliance or accreditation may perform non-waived tests. Laboratories with a CLIA certificate of compliance or accreditation do not append the QW modifier to claim lines.
o Only one unit of service for code G0434 can be billed per patient encounter regardless of the number of drug classes tested and irrespective of the use or presence of the QW modifier on claim lines
* G0431 (drug screen, qualitative; multiple drug classes by high complexity test method (e.g., immunoassay, enzyme assay), per patient encounter) will be used to report more complex testing methods, such as multi-channel chemistry analyzers, where a more complex instrumented device is required to perform some or all of the screening tests for the patient. Note that the descriptor has been revised for CY 2011. This code may only be reported if the drug screen tests is classified as CLIA high complexity tests with the following restrictions:
o G0431 may only be reported when tests are performed using instrumented systems (e.g., durable systems capable of withstanding repeated use)
o CLIA waived tests and comparable non-waived tests may not be reported under test code G0431; they must be reported under test code G0434
CLIA moderate complexity tests should be reported under test code G0434 with one unit of service (UOS)
o G0431 may only be reported once per patient encounter
o Laboratories billing G0431 must not append the QW modifier to claim lines
CMS has also made changes to the following related tests:
* G0430 was deleted as of January 1, 2011
* Code 80100 has not been priced under Medicare effective January 1, 2011
* Code 80104 has not been priced under Medicare effective January 1, 2011
Also, please remember that code 80101 has not been priced under Medicare since July 1, 2010.
1. Refer to the Correct Coding Initiative (CCI) for correct coding guidelines and specific applicable code combinations prior to billing Medicare. Provisions of this LCD do not take precedence over CCI edits.
2. Diagnosis (es) must be present on any claim submitted and coded to the highest level of specificity for that date of service.
3. Qualitative/presumptive drug testing codes (G0431 & G0434) should only be billed once per patient encounter as indicated by the code description and should only be billed at one unit.
4. All coverage criteria must be met before Medicare can reimburse this service.
5. When billing for this service in a non-covered situation (e.g., does not meet indications of the related LCD), use the appropriate modifier (see below). To bill the patient for services that are not covered (investigational/experimental or not reasonable and medically necessary) will generally require an Advance Beneficiary Notice (ABN) be obtained before the service is rendered.
GA: Waiver of liability statement issued as required by payer policy, individual case (Use for patients who do not meet the covered indications and limitations of this LCD and who did sign an ABN.)
GZ: Waiver of liability statement is not on file. (Use for patients who do not meet the covered indications and limitations of this LCD and who did not sign an ABN.)
GY: Item or service is statutorily excluded or does not meet the definition of any Medicare benefit.
Specific coding guidelines for this policy:
For dates of service on, or after 04/01/2011, append modifier QW to G0434 to indicate a CLIA waived test.
For dates of service on or after 04/01/2011, code G0431QW will be denied for claims submitted by facilities with a valid, current CLIA certificate of waiver. Code G0431 describes a high complexity test, and should not be reported with a QW modifier; the QW modifier indicates a Clinical Laboratory Improvement Amendments (CLIA) waived test Hospital outpatient claims:
1. The hospital should report the full diagnosis code for the diagnosis shown to be chiefly responsible for the outpatient services in FL 67. If no definitive diagnosis is made during the outpatient evaluation, the patient’s symptom is reported. If the patient arrives without a referring diagnosis, symptom or complaint, the provider should report an ICD-10-CM code for Persons Without Reported Diagnosis Encountered During Examination and Investigation of Individuals and Populations.
2. The hospital enters the full diagnosis codes in FLs 67A–67Q for up to eight other diagnoses that coexisted in addition to the diagnosis reported in FL 67.
3. For dates of service on or after January 1, 2011, append modifier QW to CPT code G0434 to indicate a CLIA waived test.
4. For services requiring a referring/ordering physician, the name and National Provider Identifier (NPI) of the referring/ordering physician must be reported on the claim.
5. A claim submitted without a valid diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act. The diagnosis code(s) must best describe the patient’s condition for which the service was performed.
6. For diagnostic tests, report the result of the test if known; otherwise, the symptoms prompting the performance of the test should be reported.