Medicare Advantage

Medical Policy

Title:

Presumptive and Definitive Drug Testing in Substance Abuse and Pain Management Treatments

Policy #:

MA06.025s

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

COVERAGE LIMITS

In accordance with the Center for Medicare & Medicaid Services (CMS) guidelines, the Company will not cover the following CPT code ranges and codes, which represent definitive drug testing for substance abuse and pain management treatments, because of the potential for inappropriate payment when billing for each individual drug test rather than a single code that pays the same amount regardless of the number of drugs that are being tested:

80320-80331, 80345-80354, 80356-80365, 80367-80373, 80375-80377, 83992.

The Company will cover the following appropriate procedure codes for drug screening/testing:

CPT drug screening codes for presumptive drug testing for substance abuse and pain management treatments: 80305, 80306, 80307.
HCPCS codes for definitive drug testing for substance abuse and pain management treatments: G0480, G0481, G0482, G0483, G0659.

Drug testing, for any drug class, by any test method, and/or testing combinations, is considered medically necessary and, therefore, covered, on a maximum of 24 dates of service in a calendar year when the criteria defined in this policy are met.

PRESUMPTIVE DRUG TESTING (CPT CODES: 80305, 80306, 80307)
For individuals receiving treatment for pain management, presumptive drug testing is considered medically necessary and, therefore, covered, when either of the following criteria are met:

Testing is performed as baseline screening before initiating treatment, or at the time treatment is initiated, when clinical assessment of an individual’s history and risk of substance abuse is performed, and a plan is in place to use the test findings clinically.
Testing is performed for subsequent monitoring of treatment at a frequency appropriate for the risk level of the individual as described in the policy guidelines.

For individuals receiving treatment for substance abuse, presumptive drug testing is considered medically necessary and, therefore, covered, when either of the following criteria are met:

Testing is performed as baseline screening before initiating treatment, or at the time treatment is initiated, when clinical assessment of an individual’s history and risk of substance abuse is performed, and a plan is in place to use the test findings clinically.
Testing is performed during the stabilization phase or maintenance phase of treatment and at a frequency identified in the policy guidelines.

Presumptive drug testing is considered medically necessary, and, therefore, covered, in individuals suspected of drug overdose who exhibit one or more of the following symptoms:

Unexplained coma
Unexplained altered mental status in the absence of a clinically defined toxic syndrome or toxidrome
Severe or unexplained cardiovascular instability
Unexplained metabolic or respiratory acidosis in the absence of a clinically defined toxic syndrome or toxidrome
Seizures with an undetermined history

DEFINITIVE DRUG TESTING (HCPCS CODES: G0480, G0481, G0482, G0483, G0659)
Confirmatory definitive drug testing is considered medically necessary and, therefore, covered, only when it is ordered by a treating provider when any of the following criteria are met:

The presumptive test results are positive AND the definitive testing is only for substances identified as present or positive on the presumptive test AND the definitive test is ordered within 24 hours of a presumptive test OR the presumptive test result is negative and the finding is inconsistent with the individual’s medical history/behavior AND the definitive test is ordered within 24 hours of the presumptive test.
The above criteria for presumptive testing are met, and there is no presumptive test available, as may be the case for certain synthetic or semisynthetic opioids.
Immunoassays for the relevant drug(s) are not commercially available.
In specific situations for which definitive drug levels are required for clinical decision making.

All procedure codes, other than HCPCS codes G0480, G0481, G0482, G0483, G0659, for definitive drug testing are not accepted by the Company.

Specimen validity/adulteration testing is not eligible for separate reimbursement, as this is considered part of the laboratory quality control practices.

When definitive drug testing is performed on the same date of service as presumptive drug testing by instrumented chemistry analyzers for the same individual, there will be separate reimbursement for definitive drug testing of one to seven drug classes. Definitive drug testing for eight or more drug classes will require a subsequent order from the treating provider and will not be separately reimbursed when performed on the same date of service as presumptive testing.

NOT MEDICALLY NECESSARY

In the pain management and substance abuse settings, drug testing is considered not medically necessary, and, therefore, not covered, when the above criteria are not met, including, but not limited to, routine presumptive or definitive drug testing (e.g., testing at every visit, without consideration for specific member risk factors, or without consideration for whether definitive testing is required for clinical decision making). Testing of the same drug with both a blood and a urine specimen simultaneously is considered not medically necessary and, therefore, not covered. More than 24 dates of service for presumptive and/or definitive drug tests in a calendar year will be considered not medically necessary and, therefore, not covered.

EXPERIMENTAL INVESTIGATIONAL

In the outpatient pain management and substance abuse treatment setting, hair drug testing and oral fluid drug testing are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

Panel Drug Tests/Testing, including proprietary tests, are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

BENEFIT EXCLUSION

Subject to the terms and conditions of the applicable Evidence of Coverage, drug testing for medicolegal purposes (e.g., court-ordered drug screening) or for employment purposes (e.g., as a prerequisite for employment or as a requirement for continuation of employment) is not covered by the Company because it is an item or service not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to, records from the physician's office, hospital, nursing home, home health agencies, therapies, other health care professionals, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, drug testing is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Subject to the terms and conditions of the applicable Evidence of Coverage, drug testing for medicolegal purposes (e.g., court-ordered drug screening) or for employment purposes (e.g., as a prerequisite for employment or as a requirement for continuation of employment) is not covered by the Company because it is an item or service not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

Health Maintenance Organization (HMO) and Health Maintenance Organization Point-of-Service (HMO-POS) products require that the member obtain medically necessary laboratory services at the Primary Care Physician's (PCP's) designated capitated laboratory site.* In most cases, laboratory services that are rendered at a noncapitated site for members enrolled in HMO or HMO-POS products are not eligible for reimbursement consideration by the Company.

*Members who are enrolled in New Jersey products may choose to receive routine laboratory services authorized by their PCP from a participating outpatient laboratory provider other than their PCP’s capitated laboratory provider. This requires the member to have a referral issued by their PCP.

PAIN MANAGEMENT

Opinions vary on the optimal frequency of drug testing to monitor individuals; however, the risk level for an individual patient should include a global assessment of risk factors, as well as monitoring for the presence of aberrant behavior. Several standardized risk assessment tools are available, such as the 5-item Opioid Risk Tool (ORT) or the SOAPP-R, a 24-item screening tool (available at: https://nida.nih.gov/sites/default/files/opioidrisktool.pdf).

Aberrant behavior is defined by one or more of the following:

Multiple lost prescriptions
Multiple requests for early refill
Obtained opioids from multiple providers
Unauthorized dose escalation
Apparent intoxication during previous visits

SUBSTANCE ABUSE

Stabilization phase: While in some complicated cases, the stabilization phase may last longer; this phase is typically 4 weeks for most individuals receiving treatment for substance abuse. During this phase, weekly testing is generally appropriate.

Maintenance phase: The frequency of drug testing following completion of the stabilization phase generally decreases. During this maintenance phase, while some complicated cases may require more frequent testing, for most individuals receiving treatment for substance abuse, targeted qualitative testing once every 1 to 3 months is sufficient.

REGULATORY STATUS

Clinical laboratories may develop and validate tests in-house and market them as laboratory service; laboratory-developed tests (LDTs) must meet the general regulatory standards of the Clinical Laboratory Improvement Act (CLIA).

Gas chromatography/mass spectrometry (GC/MS) tests and some immunoassays are performed in laboratory settings. Laboratories that offer LDTs must be licensed by CLIA for high-complexity testing.

Description

SUBSTANCE ABUSE

Drug tests identify specific drugs, drug classes, and drug metabolites in the body fluids or tissue; they are a commonly utilized tool in the treatment of individuals with drug addiction. Drug tests are often used to identify drug use, misuse, diversion, or a suspected substance use disorder or relapse. According to the 2010 policy statement by the American Society of Addiction Medicine (ASAM), urine drug testing is a useful diagnostic and therapeutic tool in the care and management of individuals treated for addiction.

PAIN MANAGEMENT

According to the American Society of Interventional Pain Physicians (ASIPP), approximately one third of individuals receiving treatment for chronic pain do not use opioids as prescribed. Because of its noninvasive collection and the ability to test for a wide range of drugs on test panels, urine testing is the most commonly used method for monitoring individuals who are most likely to deviate from treatment protocol.

A 2013 systematic review of guidelines that address management of opioid use for chronic pain identified nine guidelines with recommendations on urine drug testing. The recommendations varied widely; two guidelines recommend mandatory testing for all patients, one recommends testing only individuals at increased risk of medication abuse, and two state that testing patients at low risk of abuse is not cost-effective. If urine drug testing is used, the recommended frequency of follow-up testing was at least quarterly in one guideline, at least yearly in one guideline, and randomly in two guidelines.

ASIPP recommends implementation of urine drug testing both for monitoring and for decreasing prescription drug abuse or illicit drug use in individuals receiving chronic pain management. Management of individuals in pain management and substance abuse treatment settings typically comprises a multifaceted approach. Prior to drug testing, an individual's full informed consent and written agreement on monitoring is generally required. According to the Joint Guidelines by the US Department of Veterans Affairs (VA) and Department of Defense (DOD), an individual's refusal to consent to regular urine testing should be considered a factor in the overall assessment of the patient’s ability to adhere to treatment. An individual is most likely to relapse during the Stabilization Phase, which typically lasts for the first 4 weeks after initiating treatment, rather than during the Maintenance Phase. The Joint Clinical Practice Guidelines for Management of Opioid Therapy for Chronic Pain by the VA/DOD recommend periodic random urine drug tests to confirm adherence to the treatment plan with increased frequency based on the individual's risk level. The 2010 Canadian Guidelines for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain also recommend the use of urine drug screening to establish a baseline measure of risk and monitoring for compliance.

EXAMPLES OF DRUG CLASSES IN PAIN MANAGEMENT AND SUBSTANCE ABUSE FOR WHICH DRUG TESTING MAY BE USED

OPIOIDS
Opioids are a class of pain medications generally used for moderate to severe chronic pain and are commonly delivered intravenously, orally, or topically. Common opioids used to treat chronic pain include codeine, oxycodone, fentanyl, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, and pentazocine.

NONOPIOID ANALGESICS
Nonopioid analgesics are pain medications typically prescribed for mild to moderate pain and may be taken in combination with opioid medication. Nonopioid analgesics may be short acting or long acting, and include medications such as ibuprofen and other nonsteroidal anti-inflammatory drugs.

SKELETAL MUSCLE RELAXANTS
Skeletal muscle relaxants are centrally acting agents that may be used for either treatment of spasticity or treatment of musculoskeletal conditions. Typically, the mechanism of action may differ between classes of skeletal muscle relaxants. Common skeletal muscle relaxants are baclofen, carisoprodol, chlorzoxazone, cyclobenzaprine, dantrolene, metaxalone, methocarbamol, orphenadrine, and tizanidine.

AMPHETAMINES
Amphetamines are stimulant medications often prescribed to treat attention deficit hyperactivity disorder and can be taken in tablet or capsular forms with varying dosage. Other types of amphetamines, such as speed or crystal methamphetamine, are produced illegally.

CANNABINOIDS
Cannabinoids are natural compounds and can be classified as phytocannabinoids, which are derived from plant leaves, flowers, stems from the cannabis sativa plant, and are ingested; purified cannabinoids, which are naturally occurring from purified from plant sources (e.g., tetrahydrocannabinol [THC] or cannabidiol [CBD]); or synthetic cannabinoids, which are analogues of natural cannabinoids that are chemically synthesized. Synthetic cannabinoids are classified as a Class I substance and are illegal to possess, sell, and use.

CATEGORIES AND METHODS OF DRUG TESTING

Although drugs can be identified in any specimen (e.g., urine, blood, oral fluid, hair, nails, sweat, and breath), the most common specimen for testing is urine.

There are two primary categories of drug testing: Presumptive and Definitive. Presumptive drug tests detect the presence or absence of drug or drug classes; they do not typically indicate a specific level of drug but rather give a positive or negative result. Definitive drug tests are typically considered the gold standard of confirmatory testing. Unlike presumptive tests, these tests are able to quantify the amount of drug or metabolite present in the sample. In most cases, an individual’s current drug use is verified by an initial drug screen prior to receiving pain management or substance abuse treatment. Relapse during the early stages of treatment (e.g., Stabilization Phase) is more common than during the Maintenance Phase; therefore, individuals in the Stabilization Phase may require more frequent drug testing. Although most guidelines and clinicians believe routine monitoring of individuals receiving treatment should be incorporated into the treatment plan, a general consensus on optimal frequency and interval of testing has not yet been established.

Other methods of drug testing are being investigated, including oral fluid testing and hair testing.

In oral fluid testing, the liquid samples are obtained from the oral cavity. The matrix of the sample obtained varies depending on the collection method used (e.g., spitting, suctioning, draining, or collection on some type of absorbent material). Concentration of drug in the matrix may also vary depending on the method used to recover oral fluid form the collection device (e.g., centrifugation or by applying pressure). Whereas oral fluid testing may have some practical advantage to urine testing, in that samples can be obtained under direct supervision and without the loss of privacy, oral fluid testing may not reflect blood levels, as there may be a residual amount of drug (specifically those ingested or smoked) remaining in the oral cavity after recent use.

Three studies have compared oral fluid testing and urine testing using paired samples collected concurrently to evaluate the diagnostic accuracy of oral fluid testing to urine testing in pain management individuals or substance abuse individuals. The studies report sensitivities in the range of 75% to 100%, with variability in the sensitivity by type of drug and specificities greater than 90% across different drugs. No studies were identified on the clinical utility of oral fluid testing in pain management or substance abuse treatment.

Hair is made up of proteins that trap chemical in the blood at the time the hair was made in the hair follicle. As human hair is expected to grow 1.5 inches of hair per month, a 1.5-inch sample can be used to reveal drug use during the previous 90-day period. While this method of testing is noninvasive and easy to collect, variations in the hair texture as well as cosmetic hair treatments can affect drug incorporation in hair and the accuracy of drug tests on hair samples. Additionally, hair testing cannot detect recent drug use (i.e., within the past 7 days); it is difficult to detect single episodes or light drug use; and a positive result could be caused by environmental exposure. There are no studies comparing the diagnostic accuracy of hair testing to urine testing in a substance abuse or pain management setting; however, a relatively small study of hair testing in individuals beginning psychiatric treatment was compared to urine testing. The hair analysis revealed a higher prevalence of drug use than urine for most drugs as the hair analysis detected drug use anytime during the past several months, while urine analysis detected drug use in the past several days. Therefore, hair testing cannot detect recent drug use and thus has limited applicability to pain management or substance abuse treatment setting.

Overall, the current published evidence does not permit a conclusion on the impact of hair or oral fluid drug testing on clinical outcomes. Based on the available evidence and clinical practice guidelines, urine drug testing may be useful under certain circumstances when criteria are met.

SPECIMEN VALIDITY/ADULTERATION TESTING

Urine specimen testing to ensure that it is consistent with normal human urine and has not been adulterated or substituted may include, but is not limited to, pH, specific gravity, oxidants, and creatinine.

Urine for clinical drug testing is the specimen of choice because of its high drug concentrations and well-established testing procedures. Nevertheless, urine is one of the easiest specimens to adulterate. Urine samples can be diluted, swapped for another individual’s, or tampered with using commercially available or homemade products that change the chemical profile of the urine. If the clinician suspects that a sample has been adulterated, substituted, swapped, or otherwise altered in attempt to defeat evaluation and monitoring, the clinician may choose to evaluate specimen validity using built-in validity tests such as temperature, creatinine, and pH readings, or to witness collection (if no alternative matrix sampling is available such as blood or saliva). Most basic urine immunoassays have specimen validity checks built in to the screening process and allow for a basic determination of potential urine sample tampering (e.g., dilution, substituted specimen). Pain management laboratories may have specimen validity testing protocols. However, these too are deemed quality-control measures.

PANEL DRUG TESTS/TESTING (INCLUDING PROPRIETARY TESTS)

Panel Drug Tests/Testing, including proprietary tests, lack published peer-reviewed data regarding analytic validity; therefore, technical accuracy and precision for them cannot be established. Clinical validity data are typically missing to evaluate any specific and proprietary features (e.g., algorithm and/or index etc.) of these tests. Additionally, high-quality clinical studies are still warranted to gain data regarding clinical utility of these tests.

SUMMARY

Individuals in pain management programs and substance abuse treatment may misuse prescribed opioids and/or may use nonprescribed drugs. Thus, these individuals are often assessed before treatment and monitored while receiving treatment. Urine drug testing (UDT) can be part of this monitoring strategy; it is most often used as part of a multifaceted intervention that includes other components such as individual contracts.

For individuals who have chronic pain treated with opioids who receive UDT, the evidence includes nonrandomized comparative studies and a systematic review. Relevant outcomes are test accuracy and validity, health status measures, and resource utilization. There is insufficient evidence on diagnostic accuracy. No randomized controlled trials (RCTs) evaluating clinical utility were identified. Several nonrandomized comparative studies have provided inconclusive evidence on whether UDT in the pain management setting improves outcomes for individuals. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have a drug addiction and are in substance abuse treatment and receive UDT, the evidence includes two RCTs. Relevant outcomes are test accuracy and validity, health status measures, and resource utilization. No studies were identified that evaluated the accuracy of UDT compared with a valid reference standard in individuals undergoing substance abuse treatment. One RCT focused specifically on testing to determine eligibility for take-home methadone. The second RCT found that UDT identified drug use in a substantial number of individuals who denied illicit usage; the impact on treatment success was not addressed. The evidence is insufficient to determine the effects of the technology on health outcomes.

Clinical inputs appear to indicate that UDT is standard of care and support the medical necessity of UDT under certain circumstances with defined protocols and algorithms. In 2010, the American Society of Addiction Medicine (ASAM) issued an updated policy statement (from 2005) on drug testing in the substance abuse treatment programs (an update since then could not be located). As stated therein, it is ASAM policy that: “Urine drug testing [UDT] 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.” Thus, UDT may be considered medically necessary in selected situations with established planning, and finite parameters for routine testing contributing to clinical care.

For individuals who have chronic pain treated with opioids or have a drug addiction and are in substance abuse treatment and receive oral fluid drug testing, the evidence includes diagnostic accuracy studies using UDT as the reference standard. Relevant outcomes are test accuracy and validity, health status measures, and resource utilization. The limited number of studies on diagnostic accuracy of oral fluid testing compared with UDT had variable findings. No studies were identified assessing the impact of oral fluid testing on health outcomes compared with UDT or no drug testing. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have chronic pain treated with opioids or have a drug addiction and are in substance abuse treatment and receive hair drug testing, the evidence includes one diagnostic accuracy study in the psychiatric treatment setting. Relevant outcomes are test accuracy and validity, health status measures, and resource utilization. Hair testing cannot detect recent drug use (i.e., in the past few days) and thus has limited applicability to pain management or substance abuse treatment settings, except, perhaps, for initial intake. There are no studies comparing the diagnostic accuracy of hair testing compared to UDT in either setting. However, one relatively small study tested the hair and urine of known drug users recruited from a psychiatric clinic. The study looked for drug use over the past several months rather than the shorter time frame generally needed in pain management or drug treatment settings. No studies were identified on the clinical utility of hair testing in pain management or substance abuse treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

In April 2017, ASAM’s expert panel and Quality Improvement Council (with endorsement by the American College of Medical Toxicology) published a consensus statement on Appropriate Use of Drug Testing in Clinical Addiction Medicine. “… ASAM is acutely aware that this document will be released in a context where a lack of clarity about the appropriate use of drug testing has led not only to inconsistent clinical practice, but also unethical and/or fraudulent activities. The inappropriate use of drug testing can have extraordinary costs to third-party payers, taxpayers, and at times the patients who are receiving care. Though nonmonetary, this has also cost the addiction treatment field because of loss of credibility. Examples of inappropriate and often-costly drug-testing practices are (1) the routine use of large, arbitrary test panels, (2) unnecessarily frequent drug testing without consideration for the drug’s window of detection, and (3) the confirmation and quantification of all presumptive positive and negative test results [3,4]. It is ASAM’s position that these and other inappropriate drug-testing practices are harmful not only because they waste valuable resources but because they do not fit the standards of appropriate clinical care. Providers have an obligation to ensure the highest possible quality of treatment for all patients, which includes the appropriate use of clinical drug testing. One of the purposes of this document is to clarify appropriate clinical use of drug testing and, in so doing, shine a light on drug-testing practices that are clearly outside of these boundaries. The delineation of appropriate treatment practices will confer multiple benefits; most importantly, it will improve patient care. At the same time, it will reduce waste and fraud.”

In addition to other evidentiary limitations for routine clinical uses, there is insufficient reliable evidence that panel drug tests/testing, including proprietary tests, result in net health improvements.

References

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. Available at: https://www.asam.org/advocacy/public-policy-statements/details/public-policy-statements/2021/08/09/drug-testing-as-a-component-of-addiction-treatment-and-monitoring-programs-and-in-other-clinical-settings. Accessed August 1, 2023.

Chou R, Fanciullo GJ, Fine PG, et al. Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic noncancer Pain. J Pain. 2009;10(s):113-130. Appendix 8 (Pain Assessment and Documentation Tool).

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.

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.

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 2--guidance. Pain Physician. 2012;15(3 Suppl):S67-116.

National Opioid Use Guideline Group (NOUGG): Canada. Canadian Guideline for Opioids for Chronic Non-Cancer Pain. 2017. Available at: https://npc.healthsci.mcmaster.ca/guidelines/. Accessed August 1, 2023.

Novitas, Inc. Local Coverage Determination (LCD). L35006 Controlled Substance Monitoring and Drugs of Abuse Testing [Novitas website]. 10/17/2019. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=35006&DocID=L35006. Accessed August 1, 2023.

Nuckols TK, Anderson L, Popescu I et al. Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. 2014;160(1):38-47.

Opioid Risk Tool (ORT). Available at: https://nida.nih.gov/sites/default/files/opioidrisktool.pdf. Accessed August 1, 2023.

Starrels JL, Becker WC, Alford DP et al. Systematic review: treatment agreements and urine drug testing to reduce opioid misuse in patients with chronic pain. Ann Intern Med. 2010; 152(11):712-20.

Veteran's Affairs (VA) and Department of Defense (DoD) Management of Opioid Therapy for Chronic Pain Working Group. VA/DoD clinical practice guideline for management of opioid therapy for chronic pain. Available at: www.guideline.gov. Accessed August 1, 2023.

Wiedemer NL, Harden PS, Arndt IO et al. The opioid renewal clinic: a primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse. Pain Med. 2007; 8(7):573-84.

Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

PRESUMPTIVE DRUG CLASS TESTING

80305, 80306, 80307

WHEN PERFORMED IN CONJUNCTION WITH PRESUMPTIVE AND DEFINITIVE DRUG TESTING, THE FOLLOWING PROCEDURE CODES REPRESENT SPECIMEN VALIDITY/ADULTERATION TESTING AND ARE NOT SEPARATELY REIMBURSED (THESE CODES ARE NOT REIMBURSED WHEN BILLED IN CONJUNCTION WITH PROCEDURE CODES THAT THE COMPANY DOES NOT ACCEPT)

82542, 82570, 83986, 84311, 84315

EXPERIMENTAL/INVESTIGATIONAL

0007U, 0011U, 0051U, 0054U, 0082U, 0093U, 0110U, 0116U, 0117U, 0227U, 0517U, 0518U, 0519U, 0520U, 0603U

THE COMPANY DOES NOT ACCEPT THESE PROCEDURE CODES FOR DEFINITIVE DRUG-CLASS TESTING

80320, 80321, 80322, 80323, 80324, 80325, 80326, 80327, 80328, 80329, 80330, 80331, 80345, 80346, 80347, 80348, 80349, 80350, 80351, 80352, 80353, 80354, 80356, 80357, 80358, 80359, 80360, 80361, 80362, 80363, 80364, 80365, 80367, 80368, 80369, 80370, 80371, 80372, 80373, 80375, 80376, 80377, 83992

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

N/A

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

DEFINITIVE DRUG CLASS TESTING

G0480 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 and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); 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 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 (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); 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 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 (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); 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 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 (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); 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 (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, 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

EXPERIMENTAL/INVESTIGATIONAL

P2031 Hair analysis (excluding arsenic)

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA06.025s:

06/05/2026

This version of the policy will become effective on 06/05/2026.

Policy is being updated with the following:

Clarification regarding reimbursement of presumptive and definitive testing on the same date of service is being added.
Policy statement for panel drug tests/testing, including proprietary tests, is being added.

Revisions From MA06.025r:

06/25/2025	This policy has been reissued in accordance with the Company's annual review process.
10/01/2024	This version of the policy went through a code update process effective 10/01/2024: The following procedure codes were added to the policy: 0517U 0518U 0519U 0520U

Revisions From MA06.025q:

06/26/2024	This policy has been reviewed and reissued to Communicate the Company's continued position on Presumptive and Definitive Drug Testing in Substance Abuse and Pain Management Treatments.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
08/23/2023	This policy has been reviewed and reissued to Communicate the Company's continued position on Presumptive and Definitive Drug Testing in Substance Abuse and Pain Management Treatments.
07/01/2023	This policy has been identified for the CPT code update, effective 07/01/2023. The following CPT Codes have been termed (i.e., no longer valid) and have been removed from this policy: 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, 0150U

Revisions From MA06.025p:

01/01/2023

This version of the policy communicating the Company's continuing position on Presumptive and Definitive Drug Testing in Substance Abuse and Pain Management Treatments will be reissued effective 01/01/2023.

Revisions From MA06.025o:

10/01/2021

This version of the policy is a result of code updates effective 10/01/2021.

Narrative for the following procedure code was revised: 0051U.

Revisions From MA06.025n:

06/02/2021	This policy has been reissued in accordance with the Company's annual review process.
01/01/2021	This version of the policy went through a code update process effective 01/01/2021, and procedure code 0227U was added to the policy.

Revisions From MA06.025m:

04/01/2020

This version of the policy went through a code update process effective 04/01/2020:

· Procedure code 0006U was deleted from this policy.

Revisions From MA06.025l:

03/25/2020	This policy has been reissued in accordance with the Company's annual review process.
01/01/2020	This version of the policy will become effective on 01/01/2020 due to coding updates. The following codes are being added to the policy: 0143U 0144U 0145U 0146U 0147U 0148U 0149U 0150U

Revisions From MA06.02k:

10/01/2019

This version of the policy went through a code update process effective 10/01/2019, and 0110U, 0116U, and 0117U were added to this policy on that date.

Revisions From MA06.02j:

07/01/2019

This version of the policy went through a code update process effective 07/01/2019, and 0093U was added to this policy on that date.

Revisions From MA06.02i:

06/17/2019

This version of the policy will become effective on 06/17/2019.

The CPT code range under the COVERAGE LIMITS section in policy criteria was further clarified.

Revisions From MA06.02h:

01/01/2019

Effective 01/01/2019, the following procedure code has been added to this policy due to coding updates:

0082U

Revisions From MA06.02g:

11/21/2018	This policy has been reissued in accordance with the Company's annual review process.
10/01/2018	This version of the policy is effective as of 10/01/2018. The following CPT code has been deleted from this policy as a result of procedure code updates: 0020U

Revisions From MA06.02f:

07/01/2018

This version of the policy is effective as of 07/01/2018.

The following CPT codes have been added to this policy as an experimental/investigational service: 0051U, 0054U

Narrative for the following CPT code has been revised, and the position for this code remains experimental/investigational: 0006U

Revisions From MA06.025e:

01/01/2018

This version of the policy will become effective on 01/01/2018.

In accordance with the Center for Medicare and Medicaid Services (CMS) guidelines, the Company will not cover CPT codes 80320 – 80377 & 83992 for definitive drug testing for substance abuse and pain management treatments.

The Company will cover the following appropriate procedure codes for drug screening / testing when medical necessity criteria in this policy are met:

CPT drug screening codes for presumptive drug testing for substance abuse and pain management treatments : 80305, 80306, 80307.
HCPCS codes for definitive drug testing for substance abuse and pain management treatments: G0480, G0481, G0482, G0483 and G0659.

Drug testing, for any drug class, by any test method, and/or testing combinations, is considered medically necessary and, therefore, covered, on a maximum of 24 dates of service in a calendar year when the criteria defined in this policy are met. More than 24 dates of service for presumptive and/or definitive drug tests in a calendar year, will be considered not medically necessary and, therefore, not covered.

Effective 01/01/2018, the narratives for the following procedure codes have been revised in this policy due to a coding update:

80305, 80306, 80307

Revisions From MA06.02d:

10/01/2017

This version of the policy is effective as of 10/01/2017.

The following CPT code has been added to this policy as an experimental/investigational service:

0020U

Revisions From MA06.025c:

08/01/2017

This version of the policy will become effective on 08/01/2017.

The title of this policy topic has been changed to include “in Substance Abuse and Pain Management Treatments.”

Updates to Presumptive and Definitive Drug Testing in Substance Abuse and Pain Management Treatments:

Specimen validity/adulteration testing not eligible for separate reimbursement, as this is considered part of the laboratory quality control practices.

The following procedure codes, which represent specimen validity/adulteration testing, have been added to the policy. These procedure codes are not separately reimbursed:

82542
82570
83986
84311
84315

Hair and oral drug testing: experimental/investigational

For pain management and substance abuse treatment, hair drug testing and oral fluid drug testing are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

Additional codes added to this policy

The following codes have been added to this policy and are included, as other codes in the policy are, in the coverage limit of 120 units per year:

80323
80327
80328
80329
80330
80331
80368
80369
80370
80372
80373

The following three procedure codes, which will become effective on 08/01/2017, were added to this version of the policy bulletin as experimental/investigational services:

0006U, 0007U, 0011U

Revisions From MA06.025b:

01/01//2017

This version of the policy will become effective on 01/01/2017.

The following HCPCS codes have been revised in this policy:

G0480, G0481, G0482, G0483

The following CPT have been deleted from this policy:

80300, 80301, 80302, 80303, 80304, G0477, G0478, G0479

The following CPT/HCPCS codes have been added to this policy:

80305, 80306, 80307, G0659, P2031

Revisions From MA06.025a:

01/01//2016

The following codes were added
G0477, G0478, G0479, G0480, G0481, G0482, G0483.

The Following codes have been deleted:
G6031, G6039, G6040, G6042, G6043, G6044, G6045, G6046, G6051, G6052, G6053, G6056, G6058

Revisions From MA06.025:

01/01/2015

The following new policy has been developed to communicate the Company's coverage criteria for drug testing for drug abuse and pain management. This policy will become effective 1/1/2015.

Version Effective Date:

6/5/2026

Version Issued Date: