Urine Drug Testing

POLICY NUMBER

A.2.04.98

DESCRIPTION

Patients in pain management programs and substance use disorder treatment may misuse prescribed opioids and/or may use nonprescribed drugs. Thus, these patients 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 patient contracts.

Pain Management

According to an 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 5-fold among United States women and increased by a factor of 3.6 among United States men. As far as age groups, the INCB reported the rates of drug overdose deaths increased over the period from 1999 to 2017 for all age groups, however in 2017, rates were significantly higher for those 25 to 64 years of age (31.4 per 100,000) than for those age 65 and over (6.9 per 100,000). In the United States, drug overdose deaths have increased fivefold over the past 2 decades, and in 2021 alone there were over 106,000 deaths due to drug overdose. 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.

Monitoring Strategies

Various strategies are available to monitor pain management and substance use disorder 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 during the treatment period (eg, taking medication as prescribed) and not engage in (eg, selling prescribed medication and/or obtaining additional prescriptions from other physicians).

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, and the Opioid Risk Tool, 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.

Testing Matrices

Another strategy for monitoring patients is testing of biologic specimens for the presence or absence of drugs. Currently, urine is the most commonly used biologic substance. Advantages of urine drug testing (UDT) are that it is readily available and standardized techniques for detecting drugs in urine exist. Other biologic specimens (eg, blood, oral fluids, hair, 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

There are two primary categories of UDT: presumptive testing (immunoassay) and confirmatory testing (specific drug identification).

Presumptive (Immunoassay) TestingImmunoassay 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 crossreactivity (ie, 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 onsite tests, and 1 to 4 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 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 (eg, 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 use of presumptive versus 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 (eg, spitting, suctioning, draining, or collection on some type of absorbent material). Drug concentrations can be affected by the collection method and by the use of saliva stimulation methods. Several collection devices are commercially available in the United States, and they generally involve collection on an absorbent material, such as foam pads. Pads are then placed in a container with a stabilizing buffer solution. Drug concentrations may also depend on how the oral fluid is recovered from the collection device (eg, by centrifugation or by applying pressure). Drug concentrations may not reflect blood levels because of residual amounts of 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 liquid chromatography-mass spectrometry (LC-MS) methods.

A practical advantage of oral fluid collection compared with urine collection is that samples can be obtained under 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 the pain management or substance use disorder treatment settings, particularly when substitution or tampering with urine drug samples is suspected.

Hair Testing

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 inch 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 (ie, within past 7 days) cannot be detected; difficulty in detecting very light drug use (eg, 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 (eg, pre-employment screening, post-drug-treatment verification of relapse).

The U.S. Food and Drug Administration (FDA) regulates drugs of abuse tests that are sold to consumers or health care professionals in the U.S. 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 (eg, 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 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. 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 (LDTs) must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments (CLIA). Testing with gas chromatography/mass spectrometry and some immunoassays are performed in laboratory settings. Laboratories that offer LDTs must be licensed by the CLIA for high-complexity testing.

Related policies -

• Opioid and Opioid Combination Medications

POLICY

Chronic Pain Management TreatmentIn chronic non-cancer pain management treatment, presumptive (ie, immunoassay) urine drug testing may be considered medically necessary for:

• One (1) baseline screening before initiating opioid treatment or at the time treatment is initiated, when the following conditions are met:

  • An adequate clinical assessment of individual history and risk of substance use disorder is performed;

  • Clinicians have knowledge of test interpretation;

  • There is a plan in place regarding how to use test findings clinically.

• Subsequent monitoring of opioid treatment up to 3 times per year (in a 12-month period)

Urine drug testing in chronic non-cancer pain management treatment is considered not medically necessary when the above criteria are not met.

Routine presumptive urine drug testing in chronic non-cancer pain management treatment (eg, testing at every visit or without consideration for specific patient risk factors) is considered not medically necessary.

Hair drug testing and oral fluid drug testing are considered investigational in chronic non-cancer pain management treatment.   

Substance Use Disorder Treatment

In substance use disorder treatment, in-office or point-of-care presumptive (ie, immunoassay) urine drug testing may be considered medically necessary under the following conditions:

• One (1) baseline screening before initiating treatment or at the time treatment is initiated (ie, induction phase), when the following conditions are met:

  • An adequate clinical assessment of individual history and risk of substance use disorder is performed;

  • Clinicians have knowledge of test interpretation;

  • There is a plan in place regarding how to use test findings clinically.

• Stabilization phase – one (1) targeted weekly presumptive screening for a maximum of 4 weeks

• Maintenance phase – one (1) targeted presumptive screening every 1 to 3 months

Urine drug testing in substance use disorder treatment is considered not medically necessary when the above criteria are not met.

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

Hair drug testing and oral fluid drug testing are considered investigational in substance use disorder treatment.

Confirmatory Urine Drug Testing

Definitive (ie, confirmatory) urine drug testing, in outpatient chronic non-cancer pain management or substance use disorder treatment, may be considered medically necessary under the following circumstances:

• When immunoassays for the relevant drug(s) are not commercially available

• In specific situations for which definitive drug levels are required for clinical decision making (see Policy Guidelines section)

Routine definitive urine drug testing in chronic non-cancer pain management or substance use disorder treatment (eg, testing at every visit or without consideration for whether definitive testing is required for clinical decision making) is considered not medically necessary.

Non-emergent urine drug testing for any other treatment, including but not limited to ADHD treatment with amphetamines, is considered not medically necessary.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

Validity testing includes pH, specific gravity, nitrates, chromates, and creatinine, which are performed on the same specimen that is being drug tested. Validity testing is an internal process to affirm that the reported results are accurate and valid.

Pain Management

The risk level for an individual should include both a global assessment of risk factors and monitoring for the presence of aberrant behavior. Standardized risk-assessment tools are available, such as the 5-item Opioid Risk Tool (ORT). Another screening instrument is the Screener and Opioid Assessment for Patients in Pain, a 24-item tool.

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, and

• apparent intoxication during previous visits.

Opinions vary on the optimal frequency of urine drug screening to monitor individuals on opioid therapy for chronic pain. Screening frequency using a risk-based approach, as recommended by the Washington State interagency guideline (Washington State Agency Medical Directors' Group, 2015) is as follows:

• Low risk by ORT: Once a year

• Moderate risk by ORT: Twice a year

• High risk or opioid dose >120 morphine milligram equivalents/day: 3 to 4 times a year

• Recent history of aberrant behavior: Each visit

Note that 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's risk for opioid misuse and addiction should be considered when deciding when to order a urine drug screen.

Substance Use Disorder

The 2017 consensus statement from the American Society of Addiction Medicine provides guidance on appropriate use of drug testing in substance use disorder.

Medical records should support the need for testing for the specific substance(s) of interest by documentation regarding the diagnosis, history and physical examination, and/or behavior of the individual. Medical records should also justify the test that is being used and describe how results of testing will guide medical decision-making.

Presumptive Testing

Selecting an Appropriate Test

A medical and psychosocial assessment should guide the process of choosing a drug test that is individualized based on the individual's needs, appropriate for the substance(s) targeted, and the particular window of time of suspected use.

If a panel that includes testing for several substances is being ordered, justification for the use of a panel instead of individual testing is needed.

Selecting an Appropriate Matrix

Urine, blood, exhaled breath, oral fluid, sweat, and hair are matrices used in drug testing. Urine is the preferred matrix, but 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.

Matrices other than urine may also be appropriate when urine cannot be collected (eg, individuals on dialysis or with shy bladder) or when a sample collection technique is too invasive. Justification of matrix other than urine should be included in the medical record.

Presumptive Test Availability

There may not be commercially available tests for certain synthetic or semisynthetic opioids. The table below describes limitations on availability of presumptive tests.

Limitations in Availability of Presumptive Immunoassays

Guidance on Definitive (Confirmatory) Testing

Specific situations for definitive drug testing may include, but are not limited to the following:

• Need to detect a specific substance not adequately identified by presumptive methods (see Presumptive Test Availability, above)

• Unexpected positive test inadequately explained by the individual (e.g. a positive result on a presumptive test is inconsistent with the history and physical exam)

• Unexpected negative test (suspected medication diversion)

• Need for quantitative levels to compare with established benchmarks for clinical decision making such as treatment transition or changes in medication therapies.

The table below, on interpreting unexpected results of urine drug tests, is adapted from a table developed by the Canadian National Opioid Use Guideline Group that was cited by the American Society of Interventional Pain Physicians in its guideline on prescribing opioids for chronic non-cancer pain.

Interpreting Unexpected Urine Drug Tests Results

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.  

POLICY HISTORY

02/27/2017: Effective 03/01/2017, the "Urine Drug Testing in Chronic Pain Management and Substance Use Disorders Treatment" Medical Policy replaces the "Urine Drug Testing in Chronic Pain" Medical Policy. Approved by Medical Policy Advisory Committee. Policy number A.2.04.98.

08/01/2017: Code Reference section updated to add CPT code 0006U to the medically necessary codes table. Added CPT codes 0007U and 0011U as investigational. Effective 08/01/2017.

09/29/2017: Code Reference section updated to remove the following ICD-10 diagnosis codes: F10.10, F11.10, F12.10, F13.0, F14.10, F15.10, F16.10, F18.10, and F19.10. Added new CPT code 0020U, effective 10/01/2017.

12/22/2017: Code Reference section updated to revise descriptions for CPT codes 80305, 80306, and 80307 effective 01/01/2018.

01/18/2018: Policy description updated regarding 2016 data and to add liquid-chromatography/mass spectrometry testing as a confirmatory test. Policy statements unchanged.

02/08/2018: Policy description and policy statements updated to change "substance abuse" to "substance use disorder."

06/29/2018: Code Reference section updated to remove CPT code 0006U.

10/01/2018: Code Reference section updated to add new CPT code 0078U.

12/19/2018: Code Reference section updated to add new CPT code 0082U, effective 01/01/2019.

09/16/2019: Code Reference section updated to add new CPT codes 0116U and 0117U, effective 10/01/2019.

10/25/2019: Policy title changed from "Urine Drug Testing in Chronic Pain Management and Substance Use Disorders Treatment" to "Urine Drug Testing." Added policy statement that non-emergent urine drug testing for any other treatment, including but not limited to ADHD treatment with amphetamines, is considered not medically necessary.

12/20/2019: Code Reference section updated to add new CPT codes 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, and 0150U effective 01/01/2020. Removed deleted CPT code 0020U.

12/17/2020: Code Reference section updated to add new CPT code 0227U, effective 01/01/2021.

08/11/2021: Policy description updated regarding substance use disorder, testing matrices, urine drug testing, and FDA regulation. Policy statements unchanged. Policy Guidelines updated regarding pain management, substance use disorder, presumptive testing and availability, and confirmatory testing. "Nervous/Mental Conditions" changed to "Mental Health Disorders" and "Medically Necessary" changed to "medical necessity."

12/22/2021: Code Reference section updated to add CPT code 0051U as investigational.

01/31/2022: Policy reviewed; no changes.

09/30/2022: Code Reference section updated to add new ICD-10 diagnosis codes F10.90, F10.91, F11.91, F12.91, F13.91, F14.91, F15.91, F16.91, F18.91, and F19.91, effective 10/01/2022.

01/20/2023: Policy description updated regarding drug overdose deaths. Policy statements and Policy Guidelines updated with minor wording changes.

02/21/2023: Policy reviewed. Clarification added to state "per year" is equivalent to a 12-month period.

07/01/2023: Code Reference section updated to make note of deleted CPT codes.

01/04/2024: Policy description updated regarding drug overdose deaths. Policy statements unchanged. Policy Guidelines updated to change "patient" to "individual."

04/10/2024: Policy reviewed; no changes.

10/01/2024: Code Reference section updated to remove deleted CPT codes 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, and 0150U.

01/30/2025: Policy description updated regarding drug overdose deaths in the U.S. Policy statements unchanged.

03/27/2025: Policy reviewed; no changes.

01/01/2026: Code Reference section updated to add new CPT code 0603U.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.04.98

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.