mp-566 - mp-566 - Medical Policies
Policy Number: MP-566
Latest Review Date: November 2020
Policy Grade: B
In pain management programs for patients with chronic non-cancer pain, qualitative (i.e., screening) urine drug testing may be considered medically necessary up to 4 (four) times per year for:
- Baseline screening before initiating treatment or at the time treatment is initiated using a controlled substance when ALL of the following conditions are met:
- An adequate clinical assessment of patient history and risk of substance abuse is performed;
- Clinicians have knowledge of test interpretation;
- There is a plan in place regarding how to use test findings clinically
- Subsequent monitoring of treatment using a controlled substance
In substance abuse treatment programs, qualitative (i.e., screening) urine drug testing may be considered medically necessary under the following conditions:
- Baseline screening before initiating treatment or at the time treatment is initiated, 1 (one) time per program entry, when ALL of the following conditions are met:
- An adequate clinical assessment of patient history and risk of substance abuse is performed;
- Clinicians have knowledge of test interpretation;
- There is a plan in place regarding how to use test findings clinically
- Stabilization phase – targeted weekly qualitative screening for a maximum of 4 weeks
- Maintenance phase – targeted qualitative screening once every 1 to 3 months
Quantitative (i.e., confirmatory) urine drug testing, in pain management or substance abuse treatment, may be considered medically necessary for coverage for up to three (3) confirmatory tests per qualitative urine drug screen when specifically requested by the treating physician and the test results are necessary for treatment planning under the following conditions:
- The result of the qualitative drug screen is positive
- The result of the qualitative drug screen is negative and the negative finding is unexpected or inconsistent with the patient’s current medication program
Urine drug testing in pain management or substance abuse treatment is considered not medically necessary for coverage and is non-covered when the above criteria are not met, including but not limited to:
- routine qualitative urine drug testing (e.g., testing at every visit, without consideration for specific patient risk factors, current clinical presentation, current medication program or how the test findings will impact treatment options)
- quantitative (i.e., confirmatory) urine drug testing without qualitative (i.e., screening) urine drug testing
- the use of comprehensive confirmatory panels (not to be confused with a comprehensive screening panel)
In pain management and substance abuse treatment, hair drug testing and oral fluid drug testing is considered not medically necessary and investigational.
Testing for the same drug with blood and urine simultaneously is considered not medically necessary for coverage.
Drugs or drug classes which are being tested should reflect only those that are likely to be present based on the medical history, current clinical presentation and current medication program.
Limits on testing are specific for the patient, not based on the provider.
A comprehensive screening panel should only be considered for initial testing when appropriate or when the patient’s behavior suggests the use of drugs not commonly identified on a basic screening panel. Medical documentation must support the justification for conducting a comprehensive screening panel. Subsequent testing should only be conducted for those substances identified on the patient’s initial profile.
Testing performed for quality control or to determine sample integrity is not a billable service.
Testing on other biologic specimens, e.g., blood, oral fluids, hair or sweat, to circumvent the criteria or intent of this policy is not covered.
The risk-level for an individual patient should include a global assessment of risk factors, and monitoring for the presence of aberrant behavior. Standardized risk assessment tools are available, such as the five-item opioid risk tool (ORT). Another screening instrument is the SOAPP-R, a 24-item tool.
Aberrant behavior is defined by one or more of the following:
- multiple lost prescriptions,
- multiple requests for early refill,
- obtained controlled substances from multiple providers,
- unauthorized dose escalation,
- apparent intoxication during previous visits.
Opinions vary on the optimal frequency of urine drug screening to monitor patients on controlled substance 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 (one) per year
- Moderate risk by ORT: Up to 2 (two) per year
- High risk or opioid dose >120 MED/d: Up to 3 (three) to 4 (four) per year
- Recent history of aberrant behavior: Each visit
*NOTE: The ORT is a copyrighted instrument.
The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain does not include specific screening frequencies but states that an individual patient’s risk for controlled substance misuse and addiction should be considered when deciding when to order a urine drug screen.
Stabilization phase: Most patients are expected to be on a stable dose of opioid medication within 4 (four) weeks of initiating treatment. In some complicated patients, the stabilization phase may last longer than 4 (four) weeks.
Maintenance phase: For most patients, targeted qualitative screening once every 1 (one) to 3 (three) months is sufficient during the maintenance phase of treatment. More frequent testing may be appropriate for some complicated patients.
- All documentation must be maintained in the member's medical records and available upon request.
- Every page of the record must be legible and include appropriate member identification information (e.g., complete name, dates of service). The record must include the identity of the physician or non-physician practitioner responsible for and providing the care of the member.
- The submitted medical record should clearly describe the service(s) performed.
- Medical record documentation (e.g., history and physical, progress notes) maintained by the ordering physician/treating physician must indicate the medical necessity for performing a qualitative drug test. All tests must be ordered in writing by the treating provider and all drugs/drug classes to be tested must be indicated in the order. In addition, the names of drugs prescribed, dosages and frequency and dates prescribed should also be clearly documented. Documentation must exist for how the results will drive the treatment options (e.g., an anticipated treatment plan based on confirmation of inconsistencies in the initial urine drug testing, to include implementation and follow-up procedures).
- When a confirmatory (laboratory-based specific identification) test is performed, the record must show that an inconsistent positive finding was noted on the qualitative testing or that there was no available, commercially or otherwise, qualitative test to evaluate the presence of a semi-synthetic or synthetic controlled substance in a member who met the medical necessity criteria in this policy.
- If the provider of the service is other than the ordering/referring physician, that provider must maintain hard copy documentation of the lab results, along with copies of the ordering/referring physician's order for the qualitative drug test. The physician must include the clinical indication/medical necessity in the order for the qualitative drug test.
- Drugs or drug classes for which testing are performed should reflect only those likely to be present, based on the patient's medical history, current clinical presentation and current medication program. Drugs for which specimens are being tested must be indicated by the ordering health care provider in a written order.
- It is not considered reasonable or necessary to test for the same drug with both a blood and urine specimen simultaneously.
DESCRIPTION OF PROCEDURE OR SERVICE:
Patients in pain management programs and substance abuse treatment may misuse prescribed controlled substances and/or may use non-prescribed drugs. Thus, patients in these settings are often assessed before treatment and monitored while they are receiving treatment. Urine drug testing (UDT) is one monitoring strategy; it is most often used as part of a multifaceted intervention that includes other components such as patient contracts.
According to a 2012 evidence assessment by the American Society of Interventional Pain Physicians, approximately one-third of chronic pain patients do not use opioids as prescribed or may abuse them. In 2016, the International Narcotics Control Board reported that between 1999 and 2010, the number of deaths related to the use of prescription opioid painkillers increased five-fold among United States women and increased by a factor of 3.6 among United States men. Additionally, studies have found that a substantial proportion of chronic pain patients inaccurately report nonadherence to prescribed medications and the use of illicit drugs.
Substance Use Disorder
Substance use, abuse, and addiction involving numerous prescription and illicit drugs is also a serious social and medical problem. Addiction is a primary, chronic disease of brain reward, motivation, memory, and related circuitry and is manifested by the individual pathologic pursuit of reward and/or relief by substance use and other behaviors.
Various strategies are available to monitor pain management and substance abuse treatment patients, and multicomponent interventions are often used. Many settings require patients to sign a contract before they are given a prescription for opioids. The contracts generally involve obtaining patients’ agreement on behaviors they will engage in (e.g., taking medication as prescribed) and will not engage in (e.g., selling prescribed medication and/or obtaining additional prescriptions from other physicians) during the treatment period.
Confirming whether patients follow these behavioral guidelines can be a challenge. Risk-assessment screening instruments, such as the Screener and Opioid Assessment for Patients with Pain-Revisited (SOAPP-R), and the Opioid Risk Tool (ORT), can aid in the assessment of patients’ risk for inappropriate drug use. In addition, the presence of “aberrant behaviors” can be used as a marker for patients who are at high risk for deviating from treatment protocols. Aberrant behaviors include multiple lost prescriptions, obtaining prescriptions from other practitioners, and displaying evidence of acute intoxication during office visits.
Another strategy for monitoring patients is testing of biological specimens for the presence or absence of drugs. Currently, urine is the most commonly used biological substance. Advantages of urine sampling are that it is readily available, and standardized techniques for detecting drugs in urine exist. Other biological specimens e.g., blood, oral fluids, hair and sweat, can also be tested. All matrices have advantages and disadvantages with respect to sensitivity and specificity over different time windows, time to obtain results, different susceptibility to sample tampering and ease of collection.
Urine Drug Testing
Urine drug testing (UDT) is performed to detect the use of prescription medications as well as to detect the misuse or abuse of illicit or non-prescribed licit drugs. Laboratory-based specific drug identification (sometimes referred to as “confirmatory” testing) is additional testing completed to identify the specific agent causing a positive result. This policy addresses the use of UDT in the outpatient setting for compliance monitoring of controlled substance use as part of pain management and substance abuse treatment. UDT should not routinely include a panel of all drugs of potential abuse.
There are two primary categories of UDT: presumptive testing (immunoassay) and confirmatory testing (specific drug identification).
Presumptive (Immunoassay) Testing
Immunoassay testing (also called presumptive testing or qualitative testing or screening) can be performed in a laboratory or at point-of-service. Immunoassay tests are based on the principle of competitive binding and use antibodies to detect a particular drug or drug metabolite in a urine sample. With competitive binding, a fixed amount of a labeled drug is added to the urine sample, and the drug or metabolite in the sample competes with the labeled drug for binding sites on the antibody. The amount of labeled antigen that binds with the antibody is inversely proportional to the amount of the drug or metabolite in the sample.
Immunoassay tests vary in the type of compounds they can detect. Some detect specific drugs and may fail to recognize similarly structured drugs within the same class. Other immunoassays identify only classes of drugs and thus results cannot be used to determine which drug a patient is taking. For example, a positive result of an opiate immunoassay can be due to morphine or hydromorphone. The degree of cross reactivity (i.e. an antibody's reactivity with a compound other than the target of the test) varies widely among immunoassays.
Immunoassay findings are generally reported qualitatively as either positive (drug level above a prespecified threshold) or negative (drug level below a prespecified threshold). Raising or lowering the threshold thus changes the proportion of positive tests. A negative test is interpreted as a level below the threshold and does not necessarily mean that the drug or metabolite is absent.
Immunoassays generally have a rapid turnaround time, to within minutes for on-site tests, and one to four hours for laboratory-based tests.
Confirmatory (Specific Drug Identification)
Confirmatory tests are always performed in a laboratory. Gas chromatography/mass spectrometry (GC/MS) and liquid chromatography/mass spectrometry (LC/MS) are considered to be the criterion standard for confirmatory testing. These techniques involve using GC or LC to separate the analytes in a specimen and for 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. Definitive 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 and LC/MS generally require the 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 and LC/MS testing.
An issue with both types of UDT is the possibility of sample tampering to mask the presence of illegal drugs. A variety of products and techniques are available to patients and can be as simple as drinking a large amount of water to dilute the sample. There are also commercial dilution and cleaning products, additives, and urine substitutes. Some of these techniques can be detected by visual inspection of the sample (e.g., color) or by on-site testing of sample characteristics including urine temperature, creatinine concentration, and specific gravity.
The correct interpretation of UDT results is very important. Knowledge of drug metabolites is essential for accurate interpretation. Accurate interpretation of test results also requires knowledge of the drug manufacturing process. For example, due to manufacturing impurities, a small amount of hydrocodone may be present in urine samples from patients prescribed oxycodone. Thus, it would be acceptable to detect a small amount of hydrocodone if high amounts of oxycodone were also present.
There are various approaches to incorporating UDT into pain management and substance use disorder treatment settings. Most commonly, patients undergo urine drug screening before beginning treatment to verify current drug use. Some clinicians believe that UDT should be routinely used to establish baseline information about substance use, but the optimal frequency and interval of testing remains uncertain. A universal approach to screening may uncover more inappropriate use and may reduce patients' sense that testing is being performed due to a lack of trust. However, routine universal screening may place an unnecessary burden on the health care system and on the doctor-patient relationship. An alternative approach is selective testing of patients who are judged to be at increased risk for drug misuse.
Existing protocols vary for the use of presumptive vs definitive tests. Some involve conducting routine confirmation of positive presumptive tests with definitive quantitative testing. Others use selective confirmation of positive presumptive tests, such as when an unexpected immunoassay result is not adequately explained by the patient. There is also a mixed approach, with routine confirmation of presumptive tests only for drugs with poor-performing immunoassays.
Full informed consent is a requirement before UDT. Patients should be informed of the specific drug testing protocol before treatment and should provide written agreement with the plan for monitoring. As stated in a joint U.S. Veterans Affairs/Department of Defense guideline, patients' refusal to consent to urine testing should be considered a factor in the overall assessment of patients' ability to adhere to treatment.
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 three pairs of major salivary glands (parotid, sublingual, and submandibular), secretions from the minor salivary glands, oro-nasopharyngeal secretions, and cellular debris. The mixture of fluids obtained varies depending on the collection method used (e.g., 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 U.S., 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 (e.g., by centrifugation or by applying pressure). Drug concentrations may not reflect blood levels because of residual amounts of a drug (specifically those ingested or smoked) remaining in the oral cavity after recent use.
Analysis techniques must be able to detect drugs present in low concentration and in a small volume of fluid (often <1 mL). Immunoassay techniques are available to detect drugs in oral fluid; they require a small sample volume (»25 μL). Immunoassays tend to be relatively sensitive techniques, but they have low specificity. Confirmation analysis is generally performed using MS-based methods. In recent years, advancements have been made in MS analysis techniques, including the development of multianalyte LC/MS methods.
A practical advantage of oral fluid collection compared with urine collection is that samples can be obtained under the direct supervision and without loss of privacy. It has been used in situations where urine sampling is impractical, such as testing drivers during traffic stops. Oral fluid sampling also has the potential to be useful in pain management or substance use disorder treatment settings, particularly when substitution or tampering with urine drug samples is suspected.
Hair is composed of protein that traps chemicals in the blood at the time the hair develops in the follicle. Hair on the human head grows at approximately 0.5 inches per month. Thus, a 1.5-inch hair sample could be used to detect drug use during the previous 90 days. Potential advantages of hair as a drug testing source include noninvasive collection; ease of collection, storage, and shipping; availability of samples for testing and retesting; and difficulty in tampering. Potential disadvantages include: recent drug use (i.e., within the past seven days) cannot be detected; difficulty in detecting very light drug use (e.g., a single episode); and drug levels can be affected by environmental exposure. In addition, variation in hair texture as well as cosmetic hair treatments can affect drug incorporation into hair and the accuracy of drug tests on hair samples. As with other types of samples, hair can be initially tested using immunoassay techniques, with confirmation by MS-based methods. Hair testing has been used in a variety of situations where detection of drug use during the previous several months is desired (e.g., pre-employment screening, post-drug-treatment verification of relapse).
Aberrant Behavior: Behaviors that are outside the boundaries of the agreed-upon treatment plan and may constitute aberrant substance use behavior including, but is not limited to, lost prescriptions, repeated requests for early refills, prescriptions from multiple providers, unauthorized dose escalation, and apparent intoxication.
Compliance (laboratory-based specific drug identification) Testing: Assessment of a patient’s adherence to a treatment plan, typically looking for the presence of prescribed medications.
Enzyme-Linked Immune Assay (EIA): A laboratory technology using drug-class specific antibodies to screen for presence of drugs: this technology is used for screening.
Gas Chromatography/Mass Spectrometry (GC/MS): A laboratory technology used to identify the presence of specific drugs or their metabolites when EIA test screening is positive for unexpected illicit or non-prescribed licit drugs and/or negative for expected drugs.
High-Performance Liquid chromatography (HPLC): A laboratory technology used to identify the presence of specific drugs or their metabolites when EIA test screening is positive for unexpected illicit or non-prescribed licit drugs and/or negative for expected drugs.
Liquid Chromatography/Mass Spectrometry (LC/MS): Liquid chromatography is used to separate the different components in a specimen, and mass spectrometry is used to specifically identify the components of the specimen.
NOTE: This policy does not address the use of UDT in the following circumstances:
- Emergency department testing, including for the detection of potential overdose or poisoning;
- Federally regulated testing;
- Non-forensic testing for commercial drivers licensing or any other job-related testing;
- State/legally mandated drug testing.
This policy is based on evidence reviews. Most recent evidence review completed October 12, 2020.
Summary of Evidence
For individuals who have chronic pain 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 RCTs evaluating clinical utility were identified. Several nonrandomized comparative studies have provided inconclusive evidence on whether UDT in the pain management setting improves patient outcomes. 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 who 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 on the specific situation of testing to determine eligibility for take-home methadone. The second RCT found that UDT identified drug use in a substantial number of patients who denied using; the impact on treatment success was not addressed. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have chronic pain treated with opioids or with a drug addiction in substance abuse treatment who 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 urine testing had variable findings. No studies were identified on 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 with a drug addiction in substance abuse treatment who receive hair drug testing, the evidence includes one diagnostic accuracy study in the setting of psychiatric treatment. 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 urine testing in either of these settings. 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 timeframe 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.
Clinical Input Received From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.
In response to requests, input was received through five physician specialty societies and eight academic medical centers while this policy was under review. There was near consensus among reviewers that, in the outpatient pain management, qualitative UDT may be considered medically necessary for patients who meet the stated criteria and that the frequency of repeat drug testing should be dependent on the risk level of the individual. There was also near consensus among reviewers that, in substance abuse treatment, baseline qualitative drug testing may be considered medically necessary for patients who meet the stated criteria and that targeted weekly qualitative screening for a maximum of four weeks may be considered medically necessary during the stabilization phase. There was mixed input on the frequency of qualitative drug testing that may be considered medically necessary during the maintenance phase of substance abuse treatment. In addition, clinical input was mixed on confirmatory quantitative drug testing and particularly on the issue of whether quantitative drug testing should only be performed on a drug-specific basis.
Practice Guidelines and Position Statements
Nuckols et al (2014) published a systematic review of guidelines that addressed the management of opioid use for chronic pain. Reviewers included guidelines from national organizations and specialty societies, as well as guidelines from state agencies and specific health systems. Moreover, reviewers identified nine guidelines with recommendations on urine drug testing (UDT). Recommendations varied widely; two recommended mandatory testing for all patients, another recommended testing only patients at increased risk of a medication use disorder, and two stated that testing patients at low risk of abuse is not cost-effective. If UDT is used, the recommended frequency of follow-up testing was at least quarterly in one guideline, at least yearly in another, and randomly in two.
American Academy of Pain Medicine
In 2018, the American Academy of Pain Medicine published consensus recommendations on urine drug monitoring in patients receiving opioid for chronic pain. The Society recommended definitive testing at baseline for patients prescribed opioids for chronic pain unless presumptive testing is required by institutional or payer policy. The Society also recommended that the choice of substances to be analyzed should be based on considerations that are specific to each patient and related to illicit drug availability. Baseline risk assessment for aberrant medication-taking behavior, misuse, and opioid use disorder should be conducted using patient history, validated risk assessment tools, prescription drug monitoring program data, previous urine drug monitoring results, and evaluation of behaviors indicative of risk. The recommended frequency of urine drug monitoring was based on risk assessment: At least annually for patients at low risk, two or more times per year for those at moderate risk, and three or more times per year for those at high risk.
American Society of Interventional Pain Physicians
In 2017, the American Society of Interventional Pain Physicians issued guidelines for responsible, safe, and effective opioid prescribing for chronic non-cancer pain. The guidelines included the following recommendations on UDT for Chronic Non-Cancer Pain:
“Comprehensive assessment and documentation is recommended before initiating opioid therapy, with documentation of comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history.” Level of Evidence: I; Strength of Evidence: Strong
“Screening for opioid abuse is recommended, as it will potentially identify opioid abusers and reduce opioid abuse.” Level of Evidence: II-III; Strength of Evidence: Moderate
“Presumptive UDT is implemented at initiation of opioid therapy, along with subsequent use as adherence monitoring, using in-office point of service testing, followed by confirmation with chromatography/mass spectrometry for accuracy in select cases, to identify patients who are not compliant or abusing prescription drugs or illicit drugs. UDT may decrease prescription drugs abuse of illicit drug use when patients are in chronic pain management therapy.” Level of Evidence: III; Strength of Evidence: Moderate
Centers for Disease Control and Prevention
In 2016, Centers for Disease Control and Prevention (CDC) guidelines on opioids for chronic pain was published. The guidelines included the following recommendation on UDT: “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.”
Department of Veterans Affairs and Department of Defense
In 2010, these federal agencies issued clinical practice guidelines for managing opioid therapy for the treatment of chronic pain. The recommendations on assessing adherence to prescribed opioids includes, with patient consent, obtaining a urine drug test before initiating opioid therapy and randomly at a follow-up to confirm appropriate use. Other strategies recommended include clinical assessment and screening aids such as random pill counts, adherence checklists and standardized instruments such as the Screener and Opioid Assessment for Patients with Pain.
The guideline included the following specific recommendations regarding urine drug testing:
- Inform patients that drug testing is a routine procedure for all patients starting or on opioid therapy, and is an important tool for monitoring the safety of their treatment.
- With patient consent, obtain a UDT in all patients prior to initiation of OT.
- With patient consent monitor all patients on OT with periodic random UDTs to confirm adherence to the treatment plan. Increase the frequency of UDTs based on risk level for aberrant drug-related behaviors and following each dose increase.
- Take into consideration a patient’s refusal to take a UDT as part of the ongoing assessment of the patient’s ability to adhere to the treatment plan and the level of risk for adverse outcomes.
- When interpreting UDT results take into account other clinical information (e.g., past SUD, other risk factors, aberrant drug-related behaviors, and other conditions indicating risk.)
- Understanding of lab methods for drug testing and reporting are necessary to interpret UDT results (i.e., screen versus confirmatory test, substances tested, cut-off levels for tests). Maintain a close working relationship with the clinical laboratory to answer any questions about the UDT or for confirming the results.”
Washington State Agency Medical Directors' Group
In 2015, the Washington State Agency Medical Directors’ Group updated its interagency guidelines on opioid dosing for chronic non-cancer pain. The guidelines included recommendations on UDT. Recommendations on testing frequency differed depending on the patient risk of opioid addiction and opioid dosage, as listed below:
- Low risk: Once per year
- Moderate risk: Twice per year
- High risk or opioid dose over 120 mg MED/d: 3 (three)-4 (four) times per year
- Aberrant behavior: Each visit.
No pain management guidelines were identified that had recommendations on oral fluid or hair testing.
Substance Use Disorder Treatment
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, and guidelines (2017) on the effective use of drug testing.
The 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.” The 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 the benefits and limitations of the various drug tests. The following table summarizes the characteristics of urine, oral fluid, and hair drug tests that may inform the decision of what type of drug test to use:
Table. Summary of Drug Testing Characteristics
General detection period
Hours to days
Minutes to hours
Weeks to months
Parent drug compound
Parent drug compound
Best use in treatment setting
detection in ongoing
Short-term detection in
Ease of collection
Resistance to tampering
High, with some
High when chemically
Retesting same sample
Adapted from Jarvis et al (2017).
U.S. Preventive Services Task Force Recommendations
Urine drug testing, UDT, chronic pain, substance abuse
APPROVED BY GOVERNING BODIES:
The Food and Drug Administration (FDA) regulates drugs of abuse tests that are sold to consumers or health care professionals in the United States. The FDA reviews many of these tests before they are sold for use. In its review, the FDA evaluates the design and performance of tests and sample collection systems to help ensure that they produce accurate results. The FDA does not review drugs of abuse tests intended for employment and insurance testing provided they include a statement in their labeling that the device is intended solely for use in employment and insurance testing. The FDA review does not include test systems intended for federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration, the Department of Transportation, and the U.S. military.)
The FDA has cleared assays for urine testing of drugs of abuse as well as oral fluid specimen collection devices and assays for analysis of oral fluid for drugs of abuse through the 510(k) regulatory pathways. 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. Immunoassays of urine specimens have previously been cleared by the FDA and are used as the predicates for the oral fluid immunoassays.
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments (CLIA). Testing with GC/MS and some immunoassays are performed in laboratory settings. Laboratories that offer laboratory-developed tests must be licensed by CLIA for high-complexity testing.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply.
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Effective for dates of service on or after January 1, 2017: The Plan has adopted the revised coding position articulated by CMS. Use of CPT codes 80320-80377 are not reimbursed separately and the appropriate corresponding G code (G0480-G0483, G0659) should be billed for quantitative/confirmatory (definitive) testing.
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, cartridges]) includes sample validation when performed, per date of service.
Drug test(s), presumptive, any number of drug classes, any number of devices or procedures read by instrument assisted direct optical observation (e.g., utilizing immunoassay [e.g. dipsticks, cups, cards, cartridges]), includes sample validation when performed, per date of service.
Drug test(s), presumptive, any number of drug classes, any number of devices or procedures, by instrument chemistry analyzers (e.g., utilizing immunoassay [e.g., EIA, ELISA, EMIT, FPIA, IA, KIMS, RIA]), chromatography (e.g., GC, HPLC), and mass spectrometry either with or without chromatography, (e.g., DART, DESI, GC-MS, GC-MS/MS, LC-MS, LC-MS/MS, LDTD, MALDI, TOF) includes sample validation when performed, per date of service.
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 (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), 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 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.
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 (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), 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 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.
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 (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), 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 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.
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 (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), 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 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.
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
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Medical Policy Group, February 2015(1): New policy
Medical Policy Administration Committee, February 2015
Available for comment January 28 through March 15, 2015
Medical Policy Group, February 2015 (1): Added coverage criteria for qualitative confirmatory urine drug testing along with corresponding HCPCS code G6058 during draft period; policy remains available for comment through March 15, 2015
Medical Policy Group, March 2015 (1): Added coverage criteria for quantitative confirmatory testing along with corresponding applicable HCPCS codes G6030-G6058
Medical Policy Group, December 2015 (1): 2016 Annual Coding Update. Added HCPCS codes G0477-G0483 to current coding section. Moved HCPCS codes G0431, G0434 and G6030-G6058 from current coding section to previous coding section.
Medical Policy Group, February 2016 (1): Added coverage criteria for substance abuse treatment patients, added investigational statement around hair and oral fluid drug testing, changed title to read Drug Testing; updated Key Points, Key Words, Governing Bodies and References.
Medical Policy Administration Committee, February 2016
Available for comment February 19 through April 3, 2016
Medical Policy Group, December 2016 (1): 2016 Updates to Key Points & References; no change in intent of policy statement; 2017 Annual Coding Update, added CPT codes 80305, 80306 and 80307 and HCPCS code G0659 to current coding section. Moved HCPCS codes G0477, G0478 and G0479 from current coding section to previous coding section.
Medical Policy Group, December 2017. Annual Coding Update 2018. Updated verbiage for revised codes 80305 and 80306.
Medical Policy Group, October 2019 (9): Updates to Description, Key Points, References. Removed policy section effective for dates of service March 27, 2015 through April 3, 2016. Removed “effective for dates of service on or after April 4, 2016” verbiage from policy section. Removed previous coding section. No changes to intent of policy statement.
Medical Policy Group, November 2019 (9): Updates to Description, Key Points, References. No changes to policy statement.
Medical Policy Group, November 2020 (9): 2020 Updates to Description, Key Points, References. No changes to policy statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.