Testing for Drugs of Abuse
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Governs urine and other specimen drug-of-abuse testing coverage rules for WellCare of Kentucky members, including limits on presumptive and definitive tests, prior authorization protocols, and circumstances considered not medically necessary; applies to providers submitting tests for WellCare of Kentucky enrollees.
Revised policy to state that HCPCS codes G0482 & G0483 are not medically necessary, and to reflect a 10 day post-collection authorization period.
Added HCPCS codes 0011U and G0659 as medically necessary.
Changed name of policy from Outpatient Testing for Drugs of Abuse to Drugs of Abuse: Definitive Testing and removed presumptive testing criteria to separate policy CP.MP.208.
Added protocols that testing for children < 6 years of age is exempt from prior authorization and PA requests will be accepted up to 10 business days after specimen collection and reviewed for medical necessity.
Corrected medical necessity statement in section I. to state that 'one' of the following must be met, instead of 'both'.
Coverage Criteria and Medical Necessity
Outpatient confirmatory/definitive testing beyond 16/year
Medically necessary when ANY of the following groups A, B, or C are met for outpatient confirmatory/definitive testing beyond 16 in a calendar year:
Coverage criteria and limits
Covered when ALL of the following (policy-level summary and limits):
KY-specific protocol; PA window and exemption per policy revisions.
Meets policy definition of definitive testing.
KY-specific annual limits stated in policy.
Explicit NMN indications added in revisions.
Urine drug testing is excluded when performed as a condition of employment or pre-employment, or as a requirement for continuation of employment, and when performed for participation in school, community athletic, or extracurricular activities. Drug testing done for medico-legal purposes such as court-ordered screening is excluded unless specifically required by state regulations. Routine asymptomatic screening, testing as part of routine physical or administrative examinations (for example, enrollment in school, military, marriage licensure, or insurance eligibility), and same-day duplicate metabolite screening across specimen types are also excluded.
Blanket orders and routine physician standing orders that apply to all patients are excluded; physician-defined, time-limited standing orders for specific patient profiles may be reasonable if documented in the medical record. Also excluded are billing individual definitive CPT codes when a comprehensive definitive drug testing panel is ordered, performing point-of-care (POC) presumptive testing and then ordering the same presumptive immunoassay (IA) testing from a reference laboratory, and performing presumptive IA testing and ordering additional presumptive IA testing from a reference laboratory with or without reflex testing.
The policy excludes automatic or reflex confirmatory testing where a presumptive point-of-care test has already been performed; reflex definitive drug tests following POC presumptive testing are specifically listed as excluded. Blanket orders and physician standing orders for all patients are not acceptable mechanisms to trigger reflex or routine confirmatory testing.
Additionally, presumptive immunoassay testing performed in a laboratory when a POC presumptive test was already done, and use of IA testing to 'confirm' results from CLIA-waived POC devices (cups, dipsticks, cards, cassettes) are considered improper bases for reflex definitive testing and are excluded from coverage.
Urine drug testing is considered not medically necessary when provided for the exclusionary reasons listed in the policy, including employment/pre-employment screening, school or athletic participation requirements, court-ordered medico-legal screening (unless required by state regulation), asymptomatic screening, routine physicals or administrative examinations, same-day duplicate metabolite screening across specimen types, blanket orders, reflex definitive testing after POC presumptive testing, routine standing orders, billing individual definitive CPTs when a comprehensive panel is ordered, performing POC and then ordering lab-based presumptive IA testing, and specimen validity/adulteration testing.
The policy also denotes IA testing—whether qualitative or semiquantitative—used to 'confirm' presumptive POC results as not medically necessary, and considers specimen validity/adulteration testing part of laboratory quality control rather than a separately covered medical necessity indication.
Previously enumerated indications considered not medically necessary are restated here and refer the reader to the exclusions above. These include blanket orders, reflex definitive testing when presumptive POC testing has been performed, routine standing orders for all patients, billing for individual drugs already included in a billed panel, and using IA testing to confirm CLIA-waived presumptive POC test results.
The policy clarifies that presumptive IA screening prior to definitive testing without a specific physician order is not medically necessary, and that presumptive laboratory IA testing ordered after POC presumptive testing is likewise not medically necessary. Providers should refer to the exclusion list for the full set of previously identified not medically necessary indications.
When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state-specific coverage rules that supersede the policy.
For Medicare members, applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare Coverage Articles should be reviewed prior to applying the criteria in this clinical policy to ensure consistency with Medicare coverage requirements.
Coding — CPT/HCPCS and ICD-10 References
| 0328U | 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; 1 or 2. |
| 80324 | Amphetamines; 1 or 2. |
| 80325 | Amphetamine; 3 or 4. |
| 80326 | Amphetamines; 5 or more. |
| 80327 | Anabolic steroids; 1 or 2. |
| G0480 | Definitive drug test(s), 1-7 drug class(es), includes specimen validity testing, qualitative or quantitative |
| G0481 | Definitive drug test(s), 1-7 drug class(es), includes specimen validity testing (alternate phrasing present in document) |
| G0482 | Definitive drug test(s), 8-14 drug class(es), includes specimen validity testing |
| G0483 | Definitive drug test(s), 15-21 drug class(es) or 22+ (document lists 15-21 and 22+ under G0482/G0483 descriptions) |
| 80367 | CPT/Code added to coding tables (supporting coverage criteria) |
| 80368 | CPT/Code added to coding tables |
| 80369 | CPT/Code added to coding tables |
| 80370 | CPT/Code description updated |
| 80372 | CPT/Code added to coding tables |
| 80373 | CPT/Code added to coding tables |
| 80372 | Listed multiple times in revision history |
| 80373 | Listed multiple times in revision history |
| 0143U | Previously listed as not medically necessary; removed (deleted CPT codes) |
| 0144U | Previously listed as not medically necessary; removed |
| 0145U | Previously listed as not medically necessary; removed |
| 0146U | Previously listed as not medically necessary; removed |
| 0147U | Previously listed as not medically necessary; removed |
| 0148U | Previously listed as not medically necessary; removed |
| 0149U | Previously listed as not medically necessary; removed |
| 0150U | Previously listed as not medically necessary; removed |
| F10.10 | Alcohol abuse (range of related F10 codes listed) |
| F11.10 | Opioid-related use/abuse codes listed |
| F12.10 | Cannabis use codes listed |
| F13.10 | Sedative, hypnotic or anxiolytic abuse/dependence codes |
| F14.10 | Cocaine-related use/abuse codes |
| F15.10 | Other stimulant use/abuse codes |
| F16.10 | Hallucinogen abuse/dependence codes |
| F18.10 | Inhalant abuse/dependence codes |
| F19.10 | Other psychoactive substance use/abuse codes |
| F55.0 | Abuse of antacids (example among F55 series) |
Provider Actions, Prior Authorization, and Documentation
Prior authorization limits and operational notes
Up to 35 presumptive (qualitative) tests/panels and up to 16 definitive (quantitative) tests/panels are allowed per calendar year without prior authorization; prior authorization is required for outpatient confirmatory/definitive testing beyond 16 per calendar year unless the request meets the medical necessity criteria in sections A, B, or C. Requests for prior authorization will be accepted up to 10 business days after specimen collection and reviewed for medical necessity.
- PA required for outpatient confirmatory/definitive testing beyond 16 per calendar year unless criteria A, B, or C are met.
- Up to 35 presumptive and up to 16 definitive tests allowed per calendar year without authorization.
- PA requests will be accepted up to 10 business days after specimen collection for review.
KY-specific prior authorization limits and exceptions
Kentucky-specific protocol: testing for children under 6 years of age is exempt from prior authorization; the KY policy allows up to 35 presumptive and up to 16 definitive tests without authorization and accepts PA requests up to 10 business days after specimen collection for review.
- Children < 6 years: testing exempt from prior authorization.
- KY limits: ≤35 presumptive and ≤16 definitive tests without prior authorization.
- PA window: requests accepted up to 10 business days post-collection.
KY prior authorization protocol (submission window & pediatric exemption)
KY-specific prior authorization protocol requires that testing for children <6 years is exempt from prior authorization and that prior authorization requests may be submitted up to 10 business days after specimen collection for medical necessity review based on the policy criteria.
- Exemption: testing for children < 6 years does not require PA.
- Submission window: PA requests accepted up to 10 business days after specimen collection and reviewed against criteria A, B, or C.
Review Medicare NCDs/LCDs before applying policy
For Medicare members, review all applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare Coverage Articles before applying the criteria in this clinical policy to ensure consistency with Medicare coverage.
- Refer to CMS (http://www.cms.gov) for applicable NCDs, LCDs, and Coverage Articles prior to applying this policy for Medicare members.
Medical record documentation requirements for confirmatory testing
The medical record must document a history or suspicion of illicit or prescription drug use, noncompliance, or a high probability of non-adherence and must include the rationale for confirmatory testing (e.g., prior presumptive test results, inconsistencies with expected results, need to identify precise drug(s), and why resolving inconsistencies is essential to ongoing care). Requests for serum therapeutic drug levels should document relation to medical treatment of a disease or condition.
- Documented history or suspicion of drug use/noncompliance or high probability of non-adherence is required in the medical record.
- Include prior presumptive test results and rationale (inconsistency with expected results or need to identify specific drug(s)).
- For serum therapeutic levels, document relation to medical treatment (example: phenobarbital for seizures).
Contractual binding of providers and members to plan terms
Providers, members/enrollees, and their representatives are bound by the terms and conditions of their contracts and agree to be bound where no contract exists by providing services or submitting claims; documentation and coverage are governed by those contractual terms.
- Contract terms and conditions govern coverage, documentation, and administration of benefits.
- When state Medicaid provisions conflict with this policy, state Medicaid provisions take precedence.
Denial risk: administrative, employment, school, and court-ordered testing
Urine drug testing may be denied as not medically necessary when performed for employment/pre-employment, participation in school or athletic programs, or for medico-legal/court-ordered screening (unless required by state regulations); these and other listed administrative or blanket uses are considered not medically necessary.
- Not medically necessary when performed as a condition of employment or pre-employment.
- Not medically necessary for school, community athletic, or extracurricular participation.
- Not medically necessary for court-ordered screening unless required by state regulations.
Not medically necessary: blanket orders and reflex confirmatory testing
The policy adds that blanket orders and reflex definitive testing following point-of-care presumptive testing are considered not medically necessary; testing must be individualized and meet medical necessity rather than performed automatically or by blanket/standing orders.
- Blanket orders and physician standing orders for all patients are not medically necessary.
- Reflex definitive tests when presumptive point-of-care testing was performed are not medically necessary.
- Presumptive IA testing in a lab after POC presumptive testing, and using IA to confirm POC tests, are not medically necessary.
Denial risk: coverage decisions subject to plan documents
Coverage decisions and administration of benefits are subject to all terms, conditions, exclusions, and limitations of the coverage documents (evidence of coverage, certificate of coverage, policy, contract), which may affect authorization and denial determinations.
- Decisions are governed by the member's coverage documents and applicable state/federal requirements.
- This policy is a guide to medical necessity and does not guarantee payment.
Documentation operational details for presumptive and definitive testing
Ensure documentation supports that a presumptive test was performed when required by criteria (unless no reliable test exists) and that confirmatory testing is limited to specific drug(s) or drug classes indicated by preliminary analysis or clinical need.
- If criteria A applies, document that a preliminary/presumptive test was previously performed unless no reliable test exists.
- Confirmatory testing must be limited to the specific drug(s) or number of drug classes identified by preliminary analysis or expected positive results.
Operational note: reflex and blanket orders not applicable
Testing must be individualized and meet medical necessity criteria; automatic reflex testing, blanket orders, or routine standing orders that bypass clinical evaluation are not acceptable operational practices.
- Testing driven by individualized clinical need per criteria A, B, or C only.
- Blanket or reflex testing approaches are specifically excluded as not medically necessary.
Background and Rationale
Urine drug testing is used to monitor adherence to controlled substance regimens and to detect misuse. Initial screening commonly uses immunoassay (IA) methods—often performed at point of care—to detect classes such as amphetamines, cocaine, cannabinoids, opioids, and phencyclidine, with other targets added per regional trends. Immunoassay screens are rapid but subject to false positives and false negatives and may underperform relative to laboratory methods.
When precise identification or quantification is clinically necessary—for example, to resolve inconsistencies between a patient's history and presumptive test results or to inform treatment decisions—definitive (confirmatory) testing is used. Definitive testing employs analytical methods such as gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/mass spectrometry (LC/MS or LC-MS/MS) that can identify individual drugs and distinguish structural isomers, and typically uses stable isotope/internal standards, method-specific calibration, and matrix-matched quality control. Definitive testing may be qualitative or quantitative and can include specimen validity testing.
Definitions
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