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.
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.
This medical policy outlines Highmark Health Options services for Drug Testing.
Highmark Health Options (HHO) – Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services Delaware Medicaid: Diamond State Health Plan (DSHP), Delaware Healthy Children Program (DHCP), and Diamond State Health Plan Plus (DSHP) LTSS members.
Presumptive tests – Tests are usually performed at the point of service (POS). Immunoassay tests are based on the principle of competitive binding and use antibodies to detect a particular drug or drug metabolite in a sample.
Definitive tests – Always performed in a laboratory and assess multiple drugs at one time. Individual tests are specific to one drug only. Definitive testing is a panel that includes individual drug tests and the associated levels of the specific drugs. Definitive drug testing is more cost effective than individual testing. Gas chromatography/mass spectrometry (GC/MS) is considered to be the gold standard for confirmatory testing.
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:
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:
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:
EXCEPTIONS
Benefit year limits do not apply to the following:
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:
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.
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.
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/