Medical Policy

D-1015-003

Policy Id

HHO-DE-MP-1015

Topic

Drug Testing

Section

Management of Chronic Conditions

Effective Date

Jun 16, 2025

Issued Date

May 16, 2025

Last Revision Date

05/2025

Annual Review

05/2026

Prepared By

J Fletcher

DISCLAIMER

Highmark medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.

POLICY STATEMENT

This policy provides information regarding the coverage of, as determined by applicable federal and/or state legislation. 

This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.

The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations. 

Policy Position

Prior Authorization

Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool https://www.highmarkhealthoptions.com/providers/prior-auth-lookup

Procedures

Routine presumptive urine drug testing in substance use disorder treatment (i.e., testing at every visit or without consideration for specific individual risk factors) is considered not medically necessary.

Urine drug testing must be ordered by a licensed practitioner such as a physician or an advanced practitioner (Physician Assistant or Nurse Practitioner) directly involved in care management of the member. Only testing ordered by these providers will be eligible for reimbursement.

Presumptive Tests

Presumptive drug testing may be considered medically necessary and will only be allowed one (1) per date of service, regardless of the number of drug classes tested. Quantity level limits (QLLs) are considered not medically necessary when the frequency guideline above is exceeded.

Presumptive drug testing, when billed in any combination, may be considered medically necessary and will be limited to 24 tests in a benefit period regardless of test performed. QLLs are considered not medically necessary when the frequency guidelines above are exceeded.

Specimen validation testing is inherent to presumptive and confirmatory testing and is considered medically necessary.

Definitive Tests

Definitive testing should be on an individualized basis in accordance with the member’s specific needs. Urine drug testing should be based on an individualized assessment in accordance with the member’s specific needs.

Definitive drug testing may be considered medically necessary under ANY ONE of the following conditions:

  • When performed as a reflex by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory after a positive presumptive test when ANY ONE of the following are met:
    • To verify a presumptive positive urine drug test before reporting the presumptive finding to the ordering clinician and without an additional order from the clinician; or
    • In specific situations for which definitive testing is required for clinical decision making and would significantly change a treatment plan (e.g., to distinguish drug supplementation from products of minor metabolic pathways; to help identify individuals diverting medications); or
    • To identify non-prescribed medication or illicit substance use so as to allow safe prescribing of controlled substances in a member without documented or known substance use disorder, where the clinician has documented concerns related to safety risks that may arise due to failure to identify non-prescribed medications or illicit substances.
  • When presumptive drug tests are not available for the drug(s) for which there is a suspicion of abuse or misuse, and ALL of the following criteria are met:
    • The clinical presentation of the individual being tested supports the need for the specific drug testing being requested; and
    • Results of testing will impact treatment; and
    • Testing is performed in a CLIA certified laboratory.

Definitive and presumptive drug testing is considered not medically necessary when the above criteria are not met.

Definitive drug testing specifically is considered not medically necessary if utilized to identify an adulterant or contaminant that is not an addictive substance unless that substance has a known medically established antidote that reverses its clinical effect.

Definitive drug testing, when billed in combination, may be considered medically necessary and will be allowed one (1) service per date with a limit of 24 tests per benefit period. QLLs are considered not medically necessary when the frequency guidelines listed above are exceeded.

 

PROCEDURE NONCOVERED

The following tests are considered noncovered:

  • Nonforensic testing (i.e., job related testing)
  • Generic standing orders or reflex testing that are applied in all cases to all members

Individual drug tests are not considered medically necessary.

80320

80321

80322

80323

80324

80325

80326

80327

80328

80332

80333

80334

80335

80336

80337

80338

80345

80346

80347

80348

80349

80350

80351

80352

80353

80354

80355

80356

80357

80358

80359

80360

80361

80362

80363

80364

80365

80366

80367

80368

80369

80370

80371

80372

80373

80374

80375 

80376 80377

The following drug tests are considered experimental/investigational, and therefore, noncovered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature:

  • Hair drug testing; and
  • Oral fluid drug testing; and
  • Meconium drug testing

EXCEPTIONS

Benefit year limits do not apply to the following:

  • Emergency room visits
  • Inpatient admissions
  • Federally regulated testing

REIMBURSEMENT

Participating facilities will be reimbursed per their Highmark Health Options contract.

Highmark Health Options shall consider for reimbursement one (1) unit for CPT codes 80305-80307 and one (1) unit of HCPCS code G0480 or G0659 per member, per date of service, subject to the limitations noted above. HCPCS codes G0481, G0482 and G0483 are not eligible for reimbursement. Highmark Health Options shall not reimburse for more than one (1) unit of presumptive testing, or more than one (1) unit of definitive testing performed on the same date of service, assuming the medical necessity criteria outlined in the above paragraphs are met.

CPT codes 80320–80377 shall be denied, advising the provider to bill with the appropriate HCPCS code, as provided above.

Additional units will be considered for reimbursement upon receipt of the following documentation:

  • •           Signed requisition form from the ordering provider. The requisition form must include:
  • o          A complete list of the drug class(es) being tested
  • o          Both the identity of the member and the provider
  • o          The provider credentials including the NPI number and a legible signature
  • o          The date and time the sample was collected and/or received at the laboratory
  • o          Primary diagnosis and/or appropriate ICD-10 code (2)
  • •           Pertinent medical records (History and Physical with assessment and plan)

Post-Payment Audit Statement

The medical record should include documentation that reflects the medical necessity criteria and is subject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement.

Place of Service

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Drug testing is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

          CPT Code          Description                                 

80305

Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; capable of being read by direct optical observation only (e.g., utilizing immunoassay [e.g., dipsticks, cups, cards, or cartridges]) includes sample validation when performed, per date of service

80306

Item provided without cost to provider, supplier or practitioner, or credit received for replacement device; examples include, but not limited to, covered under warranty, replaced due to defect, free samples.

80307

Partial credit received for replaced device.

82542

Column chromatography/mass spectrometry, if performed (e.g., GC/MS, or HPLC/MS), non-drug analyte not elsewhere specified; qualitative or quantitative, each specimen.

82570

Creatinine; other source.

83986

Ph, body fluid, not otherwise specified.

84311

Spectrophotometry, analyte not elsewhere specified.

84315

Specific gravity (except urine).

83992

Assay of Phencyclidine.

G0480

Drug test(s), definitive, utilizing one (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; 1-7 drug class(es), including metabolite(s) if performed

G0481

Drug test(s), definitive, utilizing one (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; 8-14 drug class(es), including metabolite(s) if performed

G0482

Drug test(s), definitive, utilizing one (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; 15-21 drug class(es), including metabolite(s) if performed

G0483

Drug test(s), definitive, utilizing one (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

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

Summary of Literature

 

The Clinical Laboratory Improvement Amendment of 1988 (CLIA) was established to ensure the accuracy and reliability of laboratory testing. All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the CLIA. Labs performing such tests must have a CLIA certificate, with the exception of certain CLIA waived tests which include test systems cleared by the FDA for home use and those tests approved for waiver under certain CLIA criteria. Highmark Health Options follows guidance from the FDA and CMS regarding which tests may be performed in labs without CLIA certification. Claims for CLIA-waived tests should be submitted with the QW modifier when appropriate.

42 CFR 8.12 - Federal opioid treatment standards 2017

An Opioid Treatment Programs (OTPs) organizational structure and facilities shall be adequate to ensure quality patient care and to meet the requirements of all pertinent Federal, State, and local laws and regulations. At a minimum, each OTP shall formally designate a program sponsor and medical director. The program sponsor shall agree on behalf of the OTP to adhere to all requirements set forth in this part and any regulations regarding the use of opioid agonist treatment medications in the treatment of opioid use disorder which may be promulgated in the future. The medical director shall assume responsibility for administering all medical services performed by the OTP. In addition, the medical director shall be responsible for ensuring that the OTP is in compliance with all applicable Federal, State, and local laws and regulations.

Centers for Disease Control and Prevention (CDC) 2016

When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

The guideline is intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death.

Substance Abuse and Mental Health Service Administration (SAMHSA) 2015

Medication-Assisted Treatment (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a whole-patient approach to the treatment of substance use disorders. Research shows that a combination of medication and therapy can successfully treat these disorders, and for some people struggling with addiction, MAT can help sustain recovery.

Federal legislation, regulations, and guidelines govern MAT for opioid addiction. SAMHSA’s Division of Pharmacologic Therapies (DPT), part of the SAMHSA Center for Substance Abuse Treatment (CSAT), oversees accreditation standards and certification processes for OTPs. DPT also works with the Drug Enforcement Administration (DEA) and the states to regulate certain medications used in MAT. Additionally, DPT works directly with MAT professionals to improve treatment outcomes and to meet regulatory criteria.

American Society of Addiction Medicine (ASAM) 2017

Appropriate Use of Drug Testing in Clinical Addiction Medicine was published by ASAM in 2017.

  • “As a general principle, drug testing should be scheduled more frequently at the beginning of treatment. The Expert Panel recommends that a patient in early recovery be tested at least weekly. As the patient becomes more stable in recovery, the frequency of drug testing should be decreased, but performed at least on a monthly basis. Individual consideration may be given for less frequent testing if a patient is in stable recovery. If the patient returns to substance use after a period of abstinence, the provider should resume the early recovery testing schedule, possibly in conjunction with an adapted or intensified treatment plan.”

References

42 CFR 8.12 - Federal opioid treatment standards. 2017.

Snyder ML, Fantz CR, Melanson S. Immunoassay-based drug tests are inadequately sensitive for medication compliance monitoring in patients treated for chronic pain. Pain Physician. 2017;20(2S):SE1-SE9.

Jarvis M, Williams J, Hurford M, et al. Appropriate use of drug testing in clinical addiction medicine. J Addict Med. 2017;11(3):163-173.

American Society of Addiction Medicine (ASAM). Consensus statement: Appropriate use of drug testing in clinical addiction medicine. 2017.

Hayes, Inc. Hayes Medical Technology Directory Report. Pharmacogenetic and Pharmacogenomic Testing to Improve Outcomes Related to Opioid Use Disorder. Lansdale, PA: Hayes, Inc; 01/27/2022.

Socias ME, Ahamad K, Le Foll B, et al. The OPTIMA study, buprenorphine/naloxone and methadone models of care for the treatment of prescription opioid use disorder: Study design and rationale. Contemp Clin Trials. 2018; 69:21-27.

InterQual ® Level of Care Criteria 2021. Acute Care Adult. McKesson Health Solutions, LLC.

Jarvis, Margaret MD, DFASAM; Williams, Jessica MPH; Hurford, Matthew MD; Lindsay, Dawn PhD; Lincoln, Piper MS; Giles, Leila BS; Luongo, Peter PhD; Safarian, Taleen BA. Appropriate Use of Drug Testing in Clinical Addiction Medicine. Journal of Addiction Medicine 11(3):p 163-173, May/June 2017. | DOI: 10.1097/ADM.0000000000000323

Centers for Medicare & Medicaid Services. (2023).MS PFS Relative Value Files. Retrieved from https://www.cms.gov/medicare/payment/fee-schedules/physician/pfs-relative-value-files

Centers for Medicare & Medicaid Services. (2020). Complying with Laboratory Services Documentation Requirements. Retrieved from https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/providercompliancelabservices-fact-sheet-icn909221.pdf

Centers for Medicare & Medicaid Services. (2019). Controlled Substance Monitoring and Drugs of Abuse Testing. Retrieved from https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=35006&ver=119&Date=&DocID=L35006&bc=iAAAABABAAAA&

Centers for Medicare & Medicaid Services. (2018). Proper Coding for Specimen Validity Testing Billed in Combination with Drug Testing. Retrieved from https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/se18001.pdf

American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services. Retrieved from https://www.ama-assn.org/