Medical Policy: 02.04.49 

Original Effective Date: November 2014 

Reviewed: October 2018 

Revised: October 2018 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

The collection and analysis of body fluids, especially urine samples, is commonly performed in support of addiction treatment services. The detection of drugs such as alcohol, opiates, benzodiazepines, or their metabolites, and other illegal substances, can provide evidence of ongoing substance abuse and assist in directing treatment. Urine drug testing (UDT) to detect the parent drug and/or its metabolite(s) to demonstrate use of prescription medications and illegal substances of concern for medical treatment purposes are considered beneficial.

 

The simplicity of use and access to rapid results has increased demand for and use of immunoassays. Frequency of testing should be at the lowest level to detect presence of drugs bearing in mind the pharmaco-dynamics for which the drug is being screened.

 

Drug testing can provide evidence of current or recent exposure to intoxicants which could affect the patient’s current status, and can serve as an objective means of verifying the patient’s substance use history as reported by the patient.  ASAM (American Society of Addiction Medicine) recommends the use of drug testing where medically appropriate in clinical diagnostic settings.

 

Frequency of testing, composition of panels and number of analytes tested should align with clinical history, current symptoms and other corroborating evidence of continuing use.   The specimens should be submitted promptly to a reference lab and be returned in a timely way that will assist in improving the outcome of care. Consensus panel directs that collection should occur not more frequently than every 3 days. It is important that the scheduled frequency of urine collection match the usual detection window for the primary drug. Most substances of abuse can be detected for approximately 2 to 4 days. However, the higher the dose taken and the more frequently the substance has been used over an extended time, the more likely that it will be detected longer. Although substances are excreted at various rates, they accumulate in the body with continued use. Once clients are stabilized in treatment, they require less intensive monitoring of abstinence. At this point, most programs reduce the frequency of scheduled tests and randomize the collection times. Drug testing can be an effective therapeutic tool to assist in contingency contracting or other behavioral therapies. It can also serve as a deterrent to substance use and increase the likelihood of successful abstinence, especially if specimens are collected at random intervals. There is a flexible standard of care for the frequency of testing. During intensive outpatient therapy, monthly testing is standard in most programs. Documentation should support the need for continued testing.

 

Specific drug identification (ie, confirmatory testing, definitive testing): Confirmatory tests are always performed in a laboratory. Gas chromatography/mass spectrometry (GC/MS) is considered to be the criterion standard for confirmatory testing. This technique involves using GC to separate the analytes in a specimen and MS to identify the specific molecular structures of the drug and its metabolites. The tests are able to quantify the amount of drug or metabolite present in the urine sample. Quantitative tests can be used to confirm the presence of a specific drug identified by a screening test and can identify drugs that cannot be isolated by currently available immunoassays. Results are reported as the specific levels of substances detected in the urine. GC/MS generally requires specification of the drug or drugs to be identified. Alternatively, “broad spectrum screens” can be conducted. There is a several day turnaround time for GC/MS testing.

 

Oral Fluid Drug Testing

Oral fluid (liquid samples obtained from the oral cavity) can potentially be used to test for drug use. Oral fluid contains secretions from several different sources, including secretions from the 3 pairs of major salivary glands (parotid, sublingual, and submandibular), secretions from the minor salivary glands, oro-naso-pharyngeal secretions, and cellular debris. The mixture of fluids obtained varies depending on the collection method used (eg, spitting, suctioning, draining, or collection on some type of absorbent material). Drug concentrations can be affected by the collection method and by the use of saliva stimulation methods. Several collection devices are commercially available in the United States, and they generally involve collection on an absorbent material, such as foam pads; pads are then placed in a container with a stabilizing buffer solution. Drug concentrations may also depend on how the oral fluid is recovered from the collection device (eg, by centrifugation or by applying pressure). Drug concentrations may not reflect blood levels because of residual amounts of drug (specifically those ingested or smoked) remaining in the oral cavity after recent use.

 

Several oral fluid drug test collection devices have been cleared for marketing by FDA through the 510(k) process. They include:

  • Intercept™ Oral Fluid Drug Testing System (OraSure Technologies, Bethlehem, PA)
  • Oral-Eze Saliva Collection System (Quest Diagnostics, Madison NJ)
  • Quantisal® Oral Fluid Collection Device (Alere, Waltham, MA)

 

Guidelines and Position Statements

Opinions vary on the optimal frequency of urine drug screening to monitor patients on opioid therapy for chronic pain. Frequency of screening using a risk-based approach, as recommended by the Washington State Inter-Agency Guideline is as follows:

  • Low risk by Opioid Risk Tool (ORT): Up to 1 per year
  • Moderate risk by ORT: Up to 2 per year
  • High risk or opioid dose >120 MED/d: Up to 3 to 4 per year

 

The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain

This guideline does not include specific screening frequencies but states that an individual patient’s risk for opioid misuse and addiction should be considered when deciding when to order a urine drug screen.

 

American Society of Addiction Medicine

The American Society of Addiction Medicine (ASAM) has published several documents on drug testing: a public policy statement (2010),  a white paper (2013), which provided background on the science and current practices of drug testing,37 and guidelines (2017) on the effective use of drug testing.

 

ASAM’s public policy statement asserts that: “Urine drug testing is a key diagnostic and therapeutic tool that is useful for patient care and in monitoring of the ongoing status of a person who has been treated for addiction. As such, it is a part of medical care, and should not face undue restrictions.” ASAM recommended drug testing where medically appropriate in clinical diagnostic settings and clinical treatment settings. The term “drug testing” in this document was a broad term that included urine or other body fluids or tissues.

 

The ASAM White Paper concluded that “The most important challenge in drug testing today is not the identification of every drug that we are technologically capable of detecting, but to do medically necessary and accurate testing for those drugs that are most likely to impact clinical outcomes.” The paper acknowledged that more specific guidance on drug testing was needed, which led to the development of the 2017guidelines, described below.

 

The 2017 ASAM guidance on appropriate drug testing in clinical addiction medicine advises health care providers that before choosing the type of drug test, they should first identify the questions they are seeking to answer and be aware of benefits and limitations of the various drug tests.

 

Prior Approval:

Not applicable

 

Policy:

Drug testing should be individualized to test for substances only specific to the individual plan of treatment. Clinical documentation must specify how the test results will be used to guide clinical decision making.

 

The member should be in an active phase of treatment, chronic pain program, or actively followed by a physician in maintenance.

 

In substance abuse settings drug testing may be considered medically necessary for:

  • Baseline screening before initiating treatment or at the time treatment is initiated, 1 time per program entry
  • Stabilization phase - targeted weekly screening for a maximum of 4 weeks
  • Maintenance phase – targeted screening once every 1 to 3 months

 

Drug testing for patients receiving pain medication are considered medically necessary under the following conditions:

  • At the beginning of treatment 
  • Twice a year for patients who are low or moderate risk
  • Four times a year for patients who are high risk 
  • At the time of the office visit for patients demonstrating aberrant behavior defined by one or more of the following: 
    • Lost prescriptions; 
    • Requests for early refills; 
    • Obtained opioids from multiple providers; 
    • Unauthorized dose escalation; 
    • Apparent intoxication.

 

Frequency

The frequency of drug testing in any scenario should be individualized to the treatment plan. Frequency shall not exceed every 7 days at any time during the treatment process for both presumptive and definitive testing.

 

The testing of presumptive and definitive testing at the same time would be considered not medically necessary. The results of presumptive testing should be guiding occurrence of definitive testing.

 

Drug testing should not routinely include a panel of all drugs of abuse. The need to quantify presumptive testing results in a large number of different drugs to specifically guide management is clinically unlikely.

 

Drug testing is considered not medically necessary in all other situations, including but not limited to:

  • Routine testing or testing completed due to standing orders, due to non-individualized treatment
  • Testing for non-medical purposes
  • Testing for employment reasons
  • Testing for sports participation or recreational purposes
  • When the patient is not in an active phase of treatment, chronic pain program or actively followed by a physician in maintenance.

 

Drug testing via oral fluid is considered investigational.

 

DNA analysis to determine testing validity is considered investigational.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 80305  Drug test(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
  • 80306  Drug test(s), presumptive, any number of drug classes, any number of devices or procedures (eg, immunoassay); read by instrument assisted direct optical observation (eg, dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service
  • 80307  Drug test(s), presumptive, any number of drug classes, any number of devices or procedures, by instrument chemistry analyzers (eg, utilizing immunoassay [eg, EIA, ELISA, EMIT, FPIA, IA, KIMS, RIA]), chromatography (eg, GC, HPLC), and mass spectrometry either with or without chromatography, (eg, DART, DESI, GC-MS, GC-MS/MS, LC-MS, LC-MS/MS, LDTD, MALDI, TOF) includes sample validation when performed, 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 sources, includes specimen validity testing, per day; 1-7 drug class(es), including metabolite(s) if performed
  • 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; 8-14 drug class(es), including metabolite(s) if performed
  • 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; 15-21 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
  • 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
  • 0006U Prescription drug monitoring, 120 or more drugs and substances, definitive tandem mass spectrometry with chromatography, urine, qualitative report of presence (including quantitative levels, when detected) or absence of each drug or substance with description and severity of potential interactions, with identified substances, per date of service
  • 0007U Drug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, includes specimen verification including DNA authentication in comparison to buccal DNA, per date of service
  • 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
  • 0051U Prescription drug monitoring, evaluation of drugs present by LC-MS/MS, urine, 31 drug panel, reported as quantitative results, detected or not detected, per date of service
  • 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
  • 0079U Comparative DNA analysis using multiple selected single-nucleotide polymorphisms (SNPs), urine and buccal DNA, for specimen identity verification

 

Selected References:

  • Substance Abuse and Mental Health Services Administration (US); 2006 Urine Collection and Testing Procedures and Alternative Methods for Monitoring Drug Use. (Treatment Improvement Protocol (TIP) Series, No. 47.)
  • Substance Abuse and Mental Health Services Administration (US); 2009 Screening and Assessing Adolescents for Substance Use Disorders. (Treatment Improvement Protocol (TIP) Series, No. 31.)
  • Substance Abuse and Mental Health Services Administration (US); 1999 Treatment of Adolescents with Substance Use Disorders.  (Treatment Improvement Protocol (TIP) Series, No. 32.)
  • ASAM Policy Statement Drug Testing As A Component Of Addiction Treatment and Monitoring Programs and in Other Clinical Settings July 1, 2002; rev. October 1, 2010.
  • The American Psychiatric Publishing Textbook of Substance Abuse Treatment, 4th Edition. Edited by Marc Galanter, Herbert Kleber. 2009.
  • Principles of Addiction Medicine, 4th Edition. Edited by Richard Ries, David Fiellin, Schannon Miller, Richard Saitz. 2009.
  • American Psychiatric Association guidelines for treatment of substance use disorders, American Journal of Psychiatry. 2007 Apr;164(4 Suppl):5-123.
  • Manchikanti L, Manchukonda R, Pampati V et al. Does random urine drug testing reduce illicit drug use in chronic pain patients receiving opioids? Pain Physician 2006; 9(2):123-9
  • Manchikanti L, Atluri S, Trescot AM et al. Monitoring opioid adherence in chronic pain patients: tools, techniques, and utility. Pain Physician 2008; 11(2 Suppl):S155-80.
  • Manchikanti L, Abdi S, Atluri S et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment. Pain Physician 2012; 15(3 Suppl):S1-65.
  • American Society of Addiction Medicine (ASAM). Public Policy Statement On Drug Testing as a Component of Addiction Treatment and Monitoring Programs and in other Clinical Settings.
  • Washington State Agency Medical Directors' Group. Interagency guideline on opioid dosing for chronic non-cancer pain: an educational aid to improve care and safety with opioid treatment.
  • Hamill-Ruth RJ, Larriviere K, McMasters MG. Addition of objective data to identify risk for medication misuse and abuse: the inconsistency score. Pain Medicine 2013 Dec;14(12):1900-1907.
  • Opioid Risk Tool (ORT).
  • Dupouy J, Memier V, Catala H, et al. Does urine drug abuse screening help for managing patients? A systematic review. Drug Alcohol Depend. Mar 1 2014;136:11-20. PMID 24417964
  • American Academy of Child and Adolescent Psychiatry (AACAP) Practice parameter for the assessment and treatment of children and adolescents with substance use disorders. Published June 2015
  • PubMed Health. Drug names and classes Published August 2015.
  • UpToDate, Inc. Screening for unhealthy use of alcohol and other drugs in primary care. Updated July 2016.
  • UpToDate, Inc. Substance use disorder: principles for recognition and assessment in general medical care. Updated July 2016.
  • UpToDate, Inc. Testing for drugs of abuse (DOA). Updated July 2016.
  • Manchikanti L, Kaye AM, Knezevic NN, et al. Responsible, safe, and effective prescription of opioids for chronic non-cancer pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain Physician. Feb 2017;20(2S):S3-S92. PMID 28226332
  • Jarvis M, Williams J, Hurford M, et al. Appropriate use of drug testing in clinical addiction medicine. J Addict Med. May/Jun 2017;11(3):163-173. PMID 28557958
  • Bertholf RL, Sharma R, Reisfield GM. Predictive value of positive drug screening results in an urban outpatient population. J Anal Toxicol. Nov 2016;40(9):726-731. PMID 27550994
  • 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. Feb 2017;20(2S):SE1-SE9. PMID 28226337 

 

Policy History:

  • October 2018 - Annual review, Policy revised
  • July 2018 - Interim Review, Policy revised
  • October 2017 - Annual review, Policy renewed
  • October 2016 - Annual review, Policy revised
  • October 2015 - Annual review, Policy renewed
  • November 2014 - New policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.