Drugs of Abuse: Definitive (Confirmatory) Testing
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Outpatient definitive (quantitative) drug testing coverage criteria for urine and serum drug levels, who may qualify, and tests considered not medically necessary for Arizona Complete Health members under Centene policies.
No material clinical or coverage changes in this revision.
Coverage Criteria
A. Confirmatory testing after presumptive testing
Covered when ALL of the following are met
A
- A.1: A preliminary/presumptive drug test has been previously performed, unless no reliable test exists (e.g., synthetic cannabinoids)
- A.2: Findings from the preliminary/presumptive (qualitative) test are either: a) inconsistent with expected results based on medical history, clinical presentation, or the member's statement after detailed discussion; OR b) consistent with the clinical scenario but drug class–specific assays are needed to identify the precise drug(s)
- A.3: Resolving the inconsistency is essential to the ongoing care of the member/enrollee
- A.4: Requested confirmatory/definitive test(s) are for ≤ 14 drugs/drug classes≤ 14
- A.5: Tests are limited to the specific drug(s) or number of drug classes for which preliminary analysis yielded unexpected results
B. Expected-positive presumptive testing needing quantitative identification
Covered when ALL of the following are met
B
- B.1: Information regarding the specific substance and/or quantity is desired
- B.2: There are established benchmarks for clinical decision making based on the specific substance and/or quantitative levels
- B.3: No more than ≤ 14 drugs/drug classes are requested≤ 14
- B.4: Tests are limited to the specific drug(s) or number of drug classes for which the presumptive test is expected to be positive
C. Serum therapeutic drug levels
Covered when the following is met
III. Over-limit definitive testing
Not medically necessary when
Explicitly listed as not medically necessary
Covered indications (summary)
Medically necessary indications (summary from revisions and policy statements):
Extracted from policy summary and revision notes.
Prior authorization
Prior authorization protocols and limits:
Procedural/administrative requirement.
The policy explicitly lists a set of administrative and screening uses that are considered not medically necessary. These include testing required as a condition of employment or pre-employment, testing for participation in school or community athletics or extracurricular programs, court-ordered drug screening for medico-legal purposes (unless required by state regulation), screening of asymptomatic patients except where specifically allowed, testing as part of routine physicals or other administrative examinations (e.g., licensing, insurance), same-day multi-source screening across specimen types, blanket orders or routine standing orders for all patients, and specimen validity/adulteration testing. The policy also lists performing presumptive point-of-care testing followed by ordering duplicate presumptive immunoassay testing from a reference laboratory, and using immunoassay (IA) methods to "confirm" CLIA-waived presumptive results, as not medically necessary.
Presumptive testing criteria have been moved to a separate policy (CP.MP.208); this policy focuses on definitive (confirmatory/quantitative) testing. The document emphasizes that presumptive (immunoassay) testing is generally expected before definitive testing except when no reliable presumptive test exists (for example, synthetic cannabinoids). In addition, screening of asymptomatic patients is restricted and is considered not medically necessary unless specific covered indications in this policy apply.
The policy names several explicit not medically necessary situations: outpatient definitive testing that includes >14 drugs/drug classes is considered not medically necessary; numerous administrative and screening uses (employment, school athletics, court-ordered screening except as required by law, routine physicals, blanket orders, reflex definitive tests following POC presumptive testing, and specimen validity/adulteration testing) are also listed as not medically necessary. Coding tables identify specific CPT/HCPCS procedures that do not support coverage for these uses (see coding section), including HCPCS codes G0482 and G0483, which describe multi-class definitive panels of 15–21 and 22+ drug classes respectively, and large-panel CPT codes such as 0054U, 0082U, and 0328U.
For exact billing and coding details, refer to the policy's coding module. The policy lists numerous CPT codes that support coverage criteria (see CPT tables) and identifies HCPCS codes used for definitive drug testing. Pay particular attention to HCPCS descriptors and newer CPT entries when submitting claims. When billing, ensure the selected CPT/HCPCS code matches the number of drug classes and the method claimed (definitive LC/MS or GC/MS versus presumptive immunoassay); coding mismatches with the policy's coverage rules (for example, billing codes describing >14 drug classes) may result in denials.
Covered Indications
Confirmatory/definitive quantitative testing when presumptive testing is inconsistent or when quantitative levels will inform clinical decisions, and serum therapeutic drug levels for treatment monitoring.
See policy sections A, B, and C for detailed criteria.
Definitive testing when clinically indicated (e.g., confirmation following presumptive positive test, physician standing orders, billing for specific drugs included in a panel).
Presumptive testing criteria relocated to CP.MP.208; reflex/standing-order pathways explicitly recognized.
Frequency Limits
Coding
| 0011U | Prescription drug monitoring, evaluation of drugs present by LC-MS/MS, using oral fluid, reported as a comparison to an estimated steady-state range, per date of service including all drug compounds and metabolites. |
| 80184 | Phenobarbital. |
| 80320 | Alcohols. |
| 80321 | Alcohol biomarkers; 1 or 2. |
| 80322 | Alcohol biomarkers; 3 or more. |
| 80323 | Alkaloids, not otherwise specified. |
| 80324 | Amphetamines; 1 or 2. |
| 80325 | Amphetamines; 3 or 4. |
| 80326 | Amphetamines; 5 or more. |
| 80327 | Anabolic steroids; 1 or 2. |
| 0054U | Prescription drug monitoring, 14 or more classes of drugs and substances, definitive tandem mass spectrometry with chromatography, capillary blood, quantitative report with therapeutic and toxic ranges, including steady-state range for the prescribed dose when detected, per date of service. |
| 0082U | Drug test(s), definitive, 90 or more drugs or substances, definitive chromatography with mass spectrometry, and presumptive, any number of drug classes, by instrument chemistry analyzer (utilizing immunoassay), urine, report of presence or absence of each drug, drug metabolite or substance with description and severity of significant interactions per date of service. |
| 0328U | Drug assay, definitive, 120 or more drugs and metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS), includes specimen validity and algorithmic analysis describing drug or metabolite and presence or absence of risks for a significant patient-adverse event, per date of service. |
| G0480 | Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to, GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all source(s), includes specimen validity testing, per day, 1 to 7 drug class(es). |
| G0481 | Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to, GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day, 8 to 14 drug class(es), including metabolite(s) if performed. |
| G0659 | Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including but not limited to, GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem), excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase), performed without method or drug-specific calibration, without matrix-matched quality control material, or without use of stable isotope or other universally recognized internal standard(s) for each drug, drug metabolite or drug class per specimen; qualitative or quantitative, all sources, includes specimen validity testing, per day, any number of drug classes. |
| G0482 | Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to, GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day; 15 to 21 drug class(es), including metabolite(s) if performed. |
| G0483 | Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to, GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day; 22 or more drug class(es), including metabolite(s) if performed. |
| 80367 | Code added to coding tables (listed as supporting coverage criteria in prior revisions) |
| 80368 | Code added to coding tables |
| 80369 | Code added to coding tables |
| 80370 | Code added to coding tables; description updated in 2022 |
| 80372 | Code added to coding tables |
| 80373 | Code added to coding tables |
| 82077 | 2021 CPT added to list of codes that support coverage criteria |
| G0482 | HCPCS described as not supporting coverage criteria (definitive drug test; 15 to 21 drug classes) |
| G0483 | HCPCS described as not supporting coverage criteria (definitive drug test; 22+ drug classes) |
| 0011U | HCPCS added as medically necessary in revision notes |
| G0659 | HCPCS added as medically necessary in revision notes |
| 0143U | CPT listed as not medically necessary (later deleted/removed) |
| 0144U | CPT listed as not medically necessary (later deleted/removed) |
| 0145U | CPT listed as not medically necessary (later deleted/removed) |
| 0146U | CPT listed as not medically necessary (later deleted/removed) |
| 0147U | CPT listed as not medically necessary (later deleted/removed) |
| 0148U | CPT listed as not medically necessary (later deleted/removed) |
| 0149U | CPT listed as not medically necessary (later deleted/removed) |
| 0150U | CPT listed as not medically necessary (later deleted/removed) |
| 0054U | CPT added to list that do not support coverage criteria |
| 0328U | CPT added to list that do not support coverage criteria |
Provider Actions & Requirements
Prior Authorization Required
Prior authorization is required for definitive/outpatient drug testing except for testing performed on children under 6 years of age, which is exempt from prior authorization. Prior authorization requests will be accepted up to 10 business days after specimen collection and will be reviewed for medical necessity based on the policy criteria.
- PA requests accepted up to 10 business days post-collection
- Children < 6 years — PA exempt
Documentation for Expected-Positive Presumptive Tests
When a presumptive test is expected to be positive (for example, the member reports recent use), the medical record must document the specific substance(s) and/or quantity the provider is seeking to confirm, and the clinical benchmarks or thresholds that will guide interpretation and subsequent clinical decisions. Requests should be limited to testing for specific drug(s) or drug classes for which the presumptive test is expected to be positive and to ≤ 14 drugs/drug classes.
- Document desired specific substance(s) and/or quantity
- Document established benchmarks for clinical decision making
- Limit requests to ≤ 14 drugs/drug classes
Reflex Testing
When presumptive testing is performed at point of care, reflex definitive testing may be appropriate if there is a specific physician order recognizing the reflex testing protocol. Reflex definitive testing should only be used when it meets the medical necessity criteria (e.g., to resolve unexpected or clinically important findings) and must be documented in the medical record. Blanket reflex orders without patient-specific clinical justification are not allowed.
- Reflex testing allowed only with physician standing order and patient-specific justification
- Reflex testing must meet medical necessity criteria and be documented
- Blanket/reflex orders without individualized justification are not covered
Ordering Requirements
Ordering clinician responsibilities and rationale
The ordering clinician must be knowledgeable about the type of testing requested, document the clinical rationale and level of suspicion for drug use, and understand the likelihood of false positives/negatives; presumptive testing is generally expected prior to definitive testing.
- Document reason for test and clinical suspicion
- Be familiar with test limitations (false positives/negatives)
- Order definitive testing only when criteria are met
Reflex definitive testing and standing orders are accepted ordering pathways
Reflex definitive testing after point-of-care presumptive testing and physician standing orders are recognized pathways to medical necessity; the policy references presumptive testing criteria being handled in a separate presumptive testing policy (CP.MP.208).
Not Covered
Summary of scenarios not covered: outpatient definitive testing that includes more than 14 drug/drug classes is not covered. Testing performed for administrative purposes — such as employment or pre-employment screens, school or athletic program requirements, court-ordered or other medico-legal screening (unless state-mandated), routine physicals, licensing/insurance administrative exams, blanket orders, and routine standing orders for all patients — is not covered. Reflex definitive testing ordered solely because a point-of-care presumptive test was performed without a documented clinical indication is not covered, and use of immunoassay methods to 'confirm' CLIA‑waived presumptive test results is also listed as not medically necessary.
Coding-specific not-covered notes: HCPCS codes G0482 (definitive testing for 15–21 drug classes) and G0483 (22 or more drug classes) are identified in the policy as not supporting coverage criteria for outpatient definitive testing. The policy also lists specific CPT codes that do not support coverage (examples include large-panel CPT entries such as 0054U, 0082U, and 0328U); consult the coding tables in this policy for the full and current list.
Definitions
Background
Urine drug testing is commonly used to monitor adherence to controlled substance regimens and to detect misuse. Initial screening typically uses rapid immunoassays (point-of-care tests) because they are fast and practical, but these can produce false positives or negatives. Definitive confirmatory testing uses methods such as GC/MS or LC/MS/MS (often reported as LC-MS/MS) which provide specific identification and/or quantification of drugs and metabolites with higher analytic specificity and are appropriate when results will directly impact major clinical decisions or when presumptive tests are unreliable or inconsistent with the clinical presentation.
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