Pending Policies - Medicine


Drug Testing In Pain Management and Substance Use Disorder Monitoring

Number:MED207.154

Effective Date:04-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Documentation Requirements: Drugs or drug classes for which screening is performed should only reflect those likely to be present based on the patient’s medical history or current clinical presentation, and without duplication. Each drug or drug class being tested for, must be indicated by the referring clinician in a written order and so reflected in the patient’s medical record. Additionally, the clinician’s documentation must be patient specific and accurately reflect the need for each test.

Urine Drug Testing (UDT)

Qualitative (presumptive) UDT (i.e., immunoassay to evaluate, indicates the drug is present) that is utilized for outpatient pain management or substance use disorder monitoring may be considered medically necessary for:

Baseline screening/induction phase before initiating treatment or at the time treatment is initiated, when the following conditions are met:

o An adequate clinical assessment of patient history and risk of substance abuse is performed;

o Clinicians have knowledge of test interpretation;

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

Stabilization phase of treatment with targeted weekly qualitative (presumptive) screening for a maximum of 4 weeks. (This type of monitoring is done to identify those patients who are expected to be on a stable dose of opioid medication within a 4-week timeframe.)

Maintenance phase of treatment with targeted qualitative (presumptive) screening once every 1 to 3 months.

Subsequent monitoring phase of treatment at a frequency appropriate for the risk-level of the individual patient. (This type of monitoring is done to identify those patients who are non-compliant or abusing prescription drugs or illicit drugs.)

NOTE 1: In general, qualitative (presumptive) UDT should not require more than 15 tests within a 12-month period. Additional testing would require clinical justification of medical necessity.

Quantitative (definitive) UDT (i.e., gas chromatography-mass spectrometry [GC-MS] as confirmatory, indicates the amount of drug is present) that is utilized for outpatient pain management or substance use disorder monitoring, may be considered medically necessary under the following circumstances:

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

In specific situations when quantitative (definitive) drug levels are required for clinical-decision making the following qualitative (presumptive) urine drug screen results must be present and documented:

o Positive for a prescription drug that is not prescribed to the patient; or

o Negative for a prescription drug that is prescribed to the patient; or

o Positive for an illicit drug.

NOTE 2: In general, quantitative (definitive) UDT should not require more than 12 tests within a 12-month period. Additional testing would require clinical justification of medical necessity.

NOTE 3: Quantitative (definitive) testing is not appropriate for every specimen and should not be done routinely. This type of test should be performed in a setting of unexpected results and not on all specimens. The rationale for each quantitative (definitive) test must be supported by the ordering clinician’s documentation. The record must show that an inconsistent positive finding was noted on the qualitative (presumptive) testing or that there was not an available qualitative (presumptive) test to evaluate the presence of semi-synthetic or synthetic opioid in a patient.

NOTE 4: Simultaneous blood and urine drug screening or testing is not appropriate and should not be done.

NOTE 5: Risk stratification is discussed in the Description section of this medical policy.

UDT for pain management or substance use disorder monitoring, is considered not medically necessary when the above criteria are not met, including but not limited to routine qualitative (presumptive) or quantitative (definitive) UDT (see the NOTEs above and the coverage statements below for routine screenings, standing orders, and validity testing).

Routine screenings, including quantitative (definitive) panels, performed as part of a clinician’s protocol for treatment, without documented individual patient assessment, are considered not medically necessary.

Standing orders are those routine orders given to a population of patients and may result in testing that is not individualized, not used in the management of the patient’s specific medical condition and are considered not medically necessary.

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, and is considered not medically necessary as a separate evaluation.

Hair Drug Testing and Oral Fluid Drug Testing

In outpatient pain management and substance use disorder treatment, hair drug testing and oral fluid drug testing are considered experimental, investigational and/or unproven.

Description:

Patients in pain management programs and substance abuse treatment may misuse prescribed opioids and/or may use non-prescribed drugs. Thus, patients are often assessed before treatment and monitored while they are receiving treatment. Urine drug screening (UDS) 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 benefit contracts.

Background

Opioids

According to a 2012 evidence assessment by the American Society of Interventional Pain Physicians (ASIPP), approximately one-third of chronic pain patients do not use opioids as prescribed or may abuse them. (1) In 2016, the International Narcotics Control Board (INCB) reported that between 1999 and 2010, the number of deaths related to the use of prescription opioid painkillers increased 5-fold among U.S. women and increased by a factor of 3.6 among U.S. men. (2) Additionally, studies have found that a substantial proportion of chronic pain patients inaccurately report nonadherence to prescribed medications and use of illicit drugs. (3)

The U.S. Drug Enforcement Administration (DEA) classifies drugs, substances, and chemicals into 5 distinct categories or schedules depending on the drug’s acceptable medical use and the drug’s abuse or dependency potential. (41) The following schedule listing defines those substances or drugs included in each level:

Schedule I – Drugs with no currently accepted medical use and a high potential for abuse. Examples include: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.

Schedule II – Drugs with higher potential for abuse, with use potentially leading to severe psychological or physical dependence and are considered dangerous. Examples include: combination products with less than 15 mg per of hydrocodone per dosage unit (Vicodin), cocaine, methamphetamine, methadone, hydromorphone (Dilaudid) meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, and Ritalin.

Schedule III – Drugs with a moderate to low potential for physical and psychological dependence; abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Examples include: Products containing less than 90 mg of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone.

Schedule IV – Drugs with a low potential for abuse and low risk of dependence. Examples include: Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, Tramadol.

Schedule V – Drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics; used for antidiarrheal, antitussive, and analgesic purposes. Examples include: Cough preparations with less than 200 mg of codeine or per 100 mL (Robitussin AC), Lomotil, Motofen, Lyrica, Parapectolin.

Monitoring Strategies

Various strategies are available to monitor pain management and substance use disorder treatment in 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 (e.g., taking medication as prescribed) and not engage in (e.g., 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 24-item tool Screener and Opioid Assessment for Patients with Pain (SOAPP), (42) and the 5-item Opioid Risk Tool (ORT), (39) 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.

Risk stratification assists the clinician (healthcare provider) to determine the individualized treatment strategy for the individual patient. To access the addiction liability, the clinician triages or screens the patient into 1 of the 3 different categories (low-, medium-, and high-risk): (43)

Low-risk patients with chronic non-cancer pain have no history of substance abuse and lack any major psychiatric co-morbidity. There are no indications of aberrant behaviors in such patients, or any warning signs that they may abuse medications.

Medium-risk patients may have a prior history of substance abuse, or may have psychiatric co-morbidity.

High-risk patients are those with active addictive disorders. These individuals are at an increased risk for aberrant behaviors.

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 display of intoxication during office visits.

Testing Strategies

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 (e.g., blood, oral fluids, hair, sweat) can also be tested and may gain in popularity over time as techniques for collecting and analyzing these specimens become more standardized. In addition to urine testing, this review will address testing for oral fluids and hair.

The following Table 1 displays the interpretation of the unexpected results of UDTs was adapted from one developed by the Canadian National Opioid Use Guideline Group that was cited by ASIPP in their guideline on prescribing opioids for chronic non-cancer pain (1, 5):

Table 1: Interpretation of and Possible Action for Unexpected Results of UDTs (1, 5)

Unexpected Result

Possible Explanations

Possible Actions for the Provider

Test is negative for prescribe opioid.

False-negative.

Non-compliance.

Diversion.

Conduct confirmatory testing, specifying the drug of interest (e.g., oxycodone often missed by immunoassay).

Take a detailed history of the patient’s medication used for the preceding 7 days (e.g., could learn that patient ran out several days prior to test).

Ask patient if they’ve given drug to others.

Monitor compliance with pill counts.

Test is positive for non-prescribe opioid or benzodiazepines.

False-positive.

Patient acquired opioids from other sources (double-doctoring, “street”).

Repeat UDT regularly.

Ask patients if they accessed opioids from other sources.

Assess for opioid misuse or addiction.

Review or revise treatment agreement.

Urine drug screen (UDS) positive for illicit drugs (e.g., cocaine, cannabis).

False-positive.

Patient is occasional user or addicted to the illicit drug.

Cannabis is positive for patients taking certain medications (e.g., dronabinol).

Repeat UDT regularly.

Assess for abuse or addiction and refer for addiction treatment as appropriate.

Additionally, for those patients in a substance abuse treatment plan, monitoring the phases of drug use is considered:

Stabilization phase: Most patients are expected to be on a stable dose of opioid medication within 4 weeks of initiating treatment. In some complicated patients, the stabilization phase may last longer than 4 weeks.

Maintenance phase: For most patients, targeted qualitative (presumptive) screening once every 1 to 3 months is sufficient during the maintenance phase of treatment. More frequent testing may be appropriate for some complicated patients.

Urine Drug Testing (UDT)

There are 2 primary categories of UDT: immunoassay testing and specific drug identification. Each will be discussed below.

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 to 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 1 to 4 hours for laboratory-based tests. (4)

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 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 requires specification of the drug or drugs to be identified. Alternatively, “broad-spectrum screens” can be conducted. There is a several-day turnaround time for GC/MS and LC/MS testing. (5)

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 UDS 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 (qualitative) versus definitive (quantitative) 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 (VA)/Department of Defense (DOD) guideline, patients’ refusal to consent to urine testing should be considered a factor in the overall assessment of patients’ ability to adhere to treatment. (6)

Guidance on Definitive (Confirmatory) Testing

Situations for quantitative (definitive) drug testing may include, but are not limited to the following:

Unexpected positive test inadequately explained by the patient.

Unexpected negative test (suspected medication diversion).

Need for quantitative levels to compare with established benchmarks for clinical decision making.

There may not be commercially available tests for certain synthetic or semisynthetic opioids. The following information on immunoassay availability and diagnostic capacity is included in the Washington State Interagency Guideline (Washington State Agency Medical Directors’ Group [2015]) (35):

Natural opioids (e.g., codeine, morphine): “Immunoassays for ‘opiates’ are responsive for morphine and codeine but do not distinguish which is present. Confirmatory testing is required to reliably identify drug(s) present. Since codeine is metabolized to morphine and small quantities to hydrocodone, these drugs may be found in the urine. Also, morphine may metabolize to produce a small amount (<10%) of hydromorphone.”

Semisynthetic Opioids (e.g., hydrocodone, hydromorphone, oxycodone, oxymorphone): “‘Opiates’ immunoassays may also detect semisynthetic opioids depending on their cross-reactivity pattern. However, a negative result does not exclude use of semisynthetic opioids. Confirmatory testing (GC/MS [gas chromatography/mass spectrometry] or LC/MS/MS [liquid chromatography tandem mass spectrometry]) is required to verify compliance with the prescribed semisynthetic opioid(s).” Since hydrocodone is metabolized in small amounts to hydromorphone, both may be found in the urine. Likewise, oxycodone is metabolized to oxymorphone, so these may both be present in the urine of oxycodone users. However, the reverse is not true. In other words, hydromorphone and oxymorphone use does not result in positive screens for hydrocodone and oxycodone, respectively.

Synthetic Opioids (e.g., fentanyl, meperidine, methadone, propoxyphene): “Current ‘opiates’ immunoassays do not detect synthetic opioids. Thus, confirmatory testing (GC/MS or LC/MS/MS) is needed to identify these drugs. If the purpose is to document compliance with treatment, the laboratory can be instructed to remove the cutoff concentration so that the presence of lower concentrations can be identified.”

Oral Fluid Drug Testing

Oral fluid (liquid samples obtained from the oral cavity) can potentially be used to test for drug use. Oral fluid contains secretions from several different sources, including secretions from the 3 pairs of major salivary glands (parotid, sublingual, and submandibular), secretions from the minor salivary glands, oro-naso-pharyngeal secretions, and cellular debris. The mixture of fluids obtained varies depending on the collection method used (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 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 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 Drug 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 (i.e., within past 7 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).

Regulatory Status

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. To date, the U.S. Food and Drug Administration (FDA) has chosen not to require any regulatory review of this test.

A CLIA waiver is available for the use of certain point-of-care immunoassays. Tests eligible for a CLIA waiver are those considered to be simple, with low risk of error and low potential for harm. FDA is tasked with approving manufacturers’ applications for test system waivers. There are commercially available CLIA-waived urine tests for drugs such as cocaine, methadone, morphine/opiates, and oxycodone. Moreover, there are commercially available hair testing tests such as Quest Diagnostics ELISA tests for amphetamines, opiates, cocaine, marijuana metabolites, and phencyclidine. In addition, Omega Laboratories (Mogadore, OH) offers hair drug screening for cocaine and cocaine metabolites.

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

Intercept™ Oral Fluid Drug Testing System (OraSure Technologies, Bethlehem, PA),

Oral-Eze Saliva Collection System (Quest Diagnostics, Madison NJ),

Quantisal® Oral Fluid Collection Device (Alere, Waltham, MA).

In addition to the oral fluid collection devices, the FDA has cleared a number of assays for analysis of oral samples. For example, there are FDA-cleared assays for 9 drugs collected with the Intercept™ device: amphetamines, methamphetamine, cocaine/metabolite, opiates, marijuana/THC, phencyclidine, barbiturates, benzodiazepines, and methadone.

Rationale:

This policy was created in December 2014 with a search of the MedLine database and updated with a literature review through February 2018. This policy addresses urine drug testing (UDT) as a component of pain management and substance abuse treatment. For each of these programs or treatments, the literature search focused on the accuracy of testing and on the clinical utility of testing (i.e., the impact of test results on patient management and/or on health outcomes).

Medical policy evidence reviews assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition.

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Medical policy evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of this medical policy, and credible information on technical reliability is available from other sources.

This policy addresses drug testing as a component of pain management and substance use disorder treatment. For each of these settings, the literature search focused on the accuracy of testing and on the clinical usefulness of testing (i.e., the impact of test results on patient management and/or on health outcomes). When published studies were not identified, relevant national and regional clinical practice guidelines were sought. In 2016, testing oral fluids and hair was added to this medical policy. The following is a summary of the key literature to date.

Urine, Oral Fluid, and Hair Drug Testing

Clinical Context and Test Purpose

The purpose of drug testing in patients with chronic pain treated using opioids or patients with drug addiction in substance use disorder treatment is to determine drug use. This medical policy evaluates drug testing on urine, oral fluids, and hair.

The question addressed in this medical policy is: Does urine drug testing (UDT), oral fluid drug testing, or hair drug testing improve the net health outcome in individuals with chronic pain being treated with opioids or individuals with drug addiction being treated for a substance use disorder?

The following PICOTS (defined below) were used to select literature to inform this medical policy:

Patients:

The populations of interest include the following: patients with chronic pain who are being treated with opioids and patients with a drug addiction who are being treated for a substance use disorder.

Interventions

The interventions of interest are UDT, oral fluid drug testing, and hair drug testing.

Comparators

For UDT, the comparator is no testing.

For oral fluid drug testing and hair drug testing, the comparators are UDT and no testing.

Outcomes

Outcomes of interest for all tests are test accuracy and validity, health status outcomes, and resource utilization.

A negative result for a prescribed opioid could indicate a false negative, noncompliance, or diversion. The physician may conduct confirmatory testing, obtain a detailed history of medication use to determine the cause of noncompliance, and/or discuss whether the prescribed medication was given to others.

A positive result for a nonprescribed opioid or benzodiazepine could indicate a false-positive or that the patient is obtaining medication from other sources. The physician may request regularly repeated drug testing, discuss how the patient is accessing medication, address medication addiction, and/or revise the treatment agreement.

A positive result for illicit drug use could indicate a false-positive, a patient who is an occasional user, or a patient who is addicted to the illicit drug. The physician may request regularly repeated drug testing and/or assess the patient for drug abuse or addiction.

Timing

In patients with chronic pain being treated with opioids, drug testing may occur at baseline prior to treatment initiation. Subsequent tests may be conducted at a frequency appropriate for the addiction risk level of the individual patient.

In patients with drug addiction being treated for substance use disorders, drug testing may occur at baseline screening. During the stabilization phase, drug testing should be performed weekly for 4 weeks. During the monitoring phase, drug testing may be performed every 1 to 3 months.

Setting

In patients with chronic pain being treated with opioids, drug testing can be conducted in outpatient settings.

In patients with drug addiction being treated for substance use disorders, drug testing may be conducted in outpatient substance use disorder centers.

Urine Drug Testing (UDT)

There are 2 primary categories of UDT: immunotherapy and specific drug identification.

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this medical policy and alternative sources exist. This policy focuses on the clinical validity and clinical utility.

Clinical Validity of Detecting Prescribed Opioids and/or Illicit Drugs

A study evaluating the accuracy of UDT outside of the research setting was published in 2011 by Manchikanti et al. (7) The investigators compared in-office immunoassay testing with gas chromatography/mass spectrometry (GC/MS) as the criterion standard comparison. The study recruited consecutive patients from a single pain management practice. Urine samples were tested for opioids and for illicit drugs. A total of 1000 patients had both the immunoassay and confirmatory tests performed on the same urine sample. Personnel analyzing the tests were blinded to the results of the other test and to patient demographics. The diagnostic accuracy of in-office immunoassays for detecting opioids compared with the reference standard are shown in Table 2. The most common illicit drugs identified were marijuana and amphetamines. Immunoassay sensitivity and specificity for detecting marijuana were 91% and 98%, and for amphetamines 47% and 99%, respectively. There were too few data to report diagnostic accuracy of other illicit drugs reliably.

To most effectively monitor medication compliance of patients being treated for chronic pain, an algorithm has been proposed. The algorithm would first test patients using immunoassays; next, samples with positive immunoassays plus pertinent negatives (samples with negative immunoassays for a medication that was prescribed) would undergo liquid-chromatography tandem mass spectrometry (LC-MS/MS, considered the criterion standard). A study by Snyder et al. (2017) tested this algorithm on 530 urine samples of patients being treated for chronic pain. (8) Urine samples were tested for amphetamines, buprenorphine, benzodiazepines, cocaine, opiates, and oxycodone. Overall sensitivity of the immunoassay tests for these 6 drugs/drug classes was 78.5%. When positive immunoassay samples and pertinent negative samples were further tested by LC/MS, the overall sensitivity was increased to 84.6%. Table 2 provides sensitivity results for immunoassays conducted on subsamples from patients prescribed specific drugs.

Table 2: Diagnostic Accuracy of Immunoassay Compared with Gas- or Liquid-Chromatography/ Mass Spectrometry

Group

n

Sensitivity (95% CI)

Specificity (95% CI)

Manchikanti et al. (2011) (7)

Patients prescribed opioidsa

748

92.5% (90%-94%)

89.6% (82-95%)

Patients prescribed oxycodone

134

80.0% (71%-87%)

84.2% (60%-96%)

Patients prescribed methadone

46

97.8% (88%-99%)

100% (2%-100%)

Snyder et al. (2017) (8)

Patients prescribed opioidsa

284

79.4

NR

Patients prescribed oxycodone or

oxymorphone

207

92.5

NR

Patients prescribed methadone

82

65.4

NR

Table Key:

a: includes morphine, hydrocodone, codeine, or hydromorphone;

n: number;

CI: confidence interval;

NR: not reported.

A 2016 retrospective analysis by Johnson-Davis et al. evaluated the diagnostic accuracy of an in-house urine drug screen (UDS) panel at a national reference laboratory. (9) Samples were from routine clinical testing in consecutive patients. The panel tested for 9 drug classes using immunoassay testing. Specimens that screened positive underwent confirmatory testing with GC/MS or LC-MS/MS. A shared confirmatory panel was used for samples testing positive to opiates or oxycodone. A total of 8825 samples were tested. Of them, 2642 (30%) tested positive for opiates and 1215 (14%) tested positive for oxycodone. Confirmatory testing identified 898 (34%) false-positive tests for opiates and 23 (2%) false-positives tests for oxycodone. Authors did not include information on what drugs, if any, were prescribed to patients.

A retrospective analysis by Bertholf et al. (2016) evaluated the diagnostic accuracy of UDS in an outpatient setting by sending unexpected positive specimens to a reference laboratory for confirmatory testing. (10) A total of 786 urine specimens with positive screening results were submitted for confirmation. Of the 387 amphetamine-positive specimens, 36 were confirmed by the reference laboratory as having amphetamine and/or methamphetamine, for a positive predictive value (PPV) of 9.3%. Of the 114 opiate-positive specimens, 99 were confirmed for a PPV of 86.8%. The PPV for methadone was 44.1% (45/102 positive specimens). The PPV for oxycodone and/or oxymorphone was 67.6% (38/74 positive specimens) and for both cannabinoid and cocaine was 100% (19/19 positive cannabinoid specimens and 27/27 positive cocaine specimens).

Section Summary: Clinical Validity of Detecting Prescribed Opioids and/or Illicit Drugs

Few studies have evaluated the accuracy of UDT outside of the research setting, either for pain management or substance use disorder treatment patients. Two studies conducted in pain management clinical settings reported that diagnostic accuracy varied by drug type. Among patients prescribed opiates, sensitivity of the UDT ranged from 79% to 93%, and among patients prescribed oxycodone, sensitivity ranged from 80% to 93%. A retrospective analysis of a urine drug panel found false-positive rates of 34% for opiates and 2% for oxycodone. A retrospective analysis focusing on unexpected positive samples reported a wide range of PPVs for UDS, from 100% for cocaine and cannabis to 87% for opioids.

Clinical Utility of Chronic Pain Patients Treated with Opioids

The preferred study design is a randomized controlled trial (RCT) comparing treatment decisions and/or health outcomes in patients managed with and without the use of UDT. When multifaceted interventions are used, it may be difficult to isolate the impact of drug testing from that of other components of the intervention. In that case, the preferred study design would include an arm with the full intervention and another arm with the same intervention but without UDT. In the absence of RCTs, the next most preferred study design is a nonrandomized controlled trial that adjusts findings for potential confounding factors.

Managing Patients with UDT versus Without UDT

Systematic Reviews

A systematic review of the available literature on UDT in the chronic pain management setting, alone or as part of a treatment agreement, was published in 2010 by Starrels et al. (11) Studies were eligible for inclusion in the review if they enrolled patients with chronic non-cancer pain who were treated in an outpatient setting and measured opioid misuse outcomes after intervention implementation. Eleven studies met eligibility criteria; none was an RCT. Quality of the studies was assessed as poor to fair. Eight studies included UDT, with 7 of the 8 interventions also involving treatment agreements. The protocol and frequency of UDT varied in these studies. In 3 studies, UDTs were performed at baseline and annually, with additional testing performed according to the judgment of the treating clinician. One study performed testing at baseline and on a monthly basis. In the remaining four studies, the frequency was not specified explicitly, but was described as “regular” or “random.” Five studies described the type of testing used; 4 of them included confirmatory GC/MS testing.

Reviewers reported that 4 of the studies included a control or comparison group. (12-15) However, 2 of those studies used historical comparison groups and one was a prospective single-arm study. Due to the heterogeneity of interventions, Starrels et al. did not pool findings of the 4 studies, with individual studies reporting opioid misuse reductions from 7% to 23% after intervention compared with preintervention rates or historical controls. In the 7 uncontrolled studies in the systematic review, the proportion of patients with opioid misuse after treatment agreements, drug testing, or both ranged from 3% to 43%.

Only a single study included in the systematic review used a concurrent comparison group. Goldberg et al. (2005) retrospectively reviewed data from a university-affiliated Veterans Affairs (VA) medical center database on 91 patients with a documented pain management contract. (12) By signing the contract, the patient agreed to 8 provisions, 1 of which was “lab tests may be used to check opioid use.” Among the other 7 provisions was an agreement not to use illegal drugs and not to share or sell any medication, and an agreement that the patient would receive opioid medication only from a single primary care or pain clinic physician. The comparison group consisted of 224 patients who received opioid prescriptions without pain management contracts during the same time period, matched by age, sex, and race. Consumption of opioids was higher in the intervention group (average of 91 opioid units quarterly) than in the comparison group (average of 81 opioid units quarterly), though this difference was not statistically significant. An opioid unit was defined as 1 systematic administration of morphine sulfate 10 mg. Patients in the intervention group visited their primary care providers significantly more than the control group. Visits to the emergency department did not differ statistically between the groups.

In 2014, Dupouy et al. published a systematic review of the literature on the impact of UDT on patient management. (16) All study designs and clinical settings were eligible for inclusion. For a study to be included, the UDS had to be conducted using the enzyme immunoassay technique. For controlled studies, the comparison arm was patient management in the absence of urine testing. In addition, some type of medical management outcome had to be reported (e.g., reassessment of treatment, referral for specialist visits, hospitalization). Eight studies met reviewers’ inclusion criteria. Five were rated as poor quality and 3 as fair quality. The studies consisted of 1 RCT, 2 quasi-randomized studies, 1 observational cohort study, and 4 cross-sectional studies. The RCT was a study of routine drug screening in a psychiatric emergency center, a setting not addressed in this policy. Other studies were either drug screening in an emergency department or parents requesting screening of their children. Only 2 studies evaluated relevant populations for this policy: 1 was an uncontrolled evaluation of UDT of opioid-addicted patients, and the other was a quasi-randomized study conducted in U.S. pain centers. The latter study, by Manchikanti et al. (2006), (14) was included in the 2010 systematic review, (11) previously described. Authors of the 2014 systematic review (Dupouy et al. [16]) did not pool study findings.

Observational Studies

In 2016, Krishnamurthy et al. conducted a retrospective cohort study in a university-based pain clinic comparing no-show with dropout rates in chronic pain patients who did and did not receive UDT. (17) Before each clinic visit, patients received a letter stating that their provider might monitor adherence to treatment, including UDT. Investigators used propensity score matching to adjust for potential selection bias and confounding. The sample included 723 patients with a total of 4448 clinic visits (all patients had at least 2 visits). Results showed that UDT at the first visit was significantly associated with a higher rate of no-shows at the second visit (odds ratio, 2.73; 95% confidence interval [CI], 1.66 to 4.47; p<0.001). The no-show rate was 10.2% in patients without UDT and 23.8% in patients with UDT. Moreover, the no-show rate was higher in patients testing positive for illicit drugs (34.6%) than in those testing negative for illicit drugs (21.7%). In addition, the rate of dropout from treatment increased significantly with each additional UDT (95% CI of the hazard ratio, 1.54 to 2.61).

To address the increase in suicide and overdose events occurring with the increase in prescription opioid use, the VA and the Department of Defense (DoD) formulated clinical practice guidelines for the safe use of opioid treatment for chronic pain. In the guideline, baseline and random UDS were recommended (see the Supplemental Information section). Brennan et al. (2016) evaluated the effect of implementing these guidelines on suicide- and overdose-related events. (18) Facility-level data and patient-level data were used in the analysis. From 141 VA healthcare facilities, the facility percentage of opioid-prescribed patients who obtained one or more UDS was calculated. The following data on 484,241 patients from the VA National Patient Care Data files was collected: age, sex, race (white or non-white), marital status, medical comorbidities, mental health comorbidities, UDS, and suicide or drug-related events. The statistical model estimated the effect of UDS practices from 2010 to 2013 on opioid-prescribed patients’ suicide/overdose risk in 2013. Patients’ average age was 60 years, and 7% were women, 19% non-white, and 50% unmarried. Twenty-nine percent had medical comorbidities, and 55% had mental health comorbidities. From 2010 to 2013, the percent of opioid-prescribed patients who received UDS increased from 29% to 42% in VA health care facilities. Patient-level analyses showed that younger, non-white, and unmarried patients had significantly higher risk of suicide or overdose events. Facility-level analyses showed that conducting more UDS in a facility was significantly related to a reduction in suicide and overdose events. Model estimates suggested that for every 1% increase in UDS, there was a 1% reduction in patient-level risk of suicide or overdose event.

Stammet et al. (2016) evaluated treatment changes occurring after a pharmacist-run UDT e-consult service was implemented in a southeast VA health care system. (19) During the 2-year pilot study period, 143 e-consults interpreting 190 UDT results were assessed. Based on VA prescription records, the UDS results were classified as: expected (18%), unexpected (28%), and not necessarily inappropriate (54%). In more than 50% of the unexpected results group, the e-consult service recommended immediate action to be taken and, in 35% of those situations, providers documented action within a 30-day period. Other recommendations by the pharmacist included: orders for immediate UDT or more frequent UDT, changes in drug prescriptions, and referrals to pain management services or substance use disorder treatment programs. Follow-up to the recommendations was not available.

Managing Patients with Routine UDT versus Selective UDT

No studies were identified.

Managing Patients with Routine Confirmation of Positive Qualitative (Presumptive) Tests versus Selective Confirmation of Positive Qualitative (Presumptive) Tests

No studies were identified.

Section Summary: Clinical Utility of Chronic Pain Patients Treated with Opioids

A single RCT in the systematic reviews was identified, though the setting was a psychiatric emergency facility and not relevant to this policy. There are several nonrandomized studies with comparison groups and several observational studies. However, both the interventions and the outcomes differed among studies. The interventions often involved patient contract agreements in which UDTs were a component, and 1 intervention was an e-consult service that included UDT recommendations. UDTs were usually conducted randomly and at the discretion of the health care provider. Outcomes across the studies included: primary care visits, emergency room visits, suicide and overdose risk, and opioid misuse. Due to the heterogeneity across interventions and outcomes, pooling of results studies was not possible.

Clinical Utility of Substance Use Disorder Treatment

Managing Patients with UDT versus Without UDT

One RCT was identified that suggested UDT increases treatment compliance when receiving take-home methadone compared with no UDT. In 2001, Chutuape et al. conducted a study of patients in a methadone treatment program who had submitted fewer than 80% positive opiate and/or cocaine-positive urine samples during a 5-week baseline period in which patients were tested every Monday, Wednesday, and Friday. (20) These patients then participated in a methadone take-home program and were randomized into 1 of 3 groups: 1) continued permission to take-home methadone was contingent on 1 negative urine sample, randomly selected each week (n=16); 2) continued permission to take-home methadone was contingent on 1 negative urine sample, randomly selected each month (n=18); or 3) permission to take-home methadone was not based on results of urine testing, but on results of a random drawing in which half of the control group were given the take-home methadone (control group) (n=19). Ten subjects withdrew from the trial, six from the weekly-tested group, 3 from the monthly-tested group, and one from the never-tested group. After participating in the intervention, the rate of sustained (≥8 weeks) opiate and cocaine abstinence was significantly higher in the groups receiving UDT. The percentages of patients with sustained (≥8 weeks) opiate and cocaine abstinence were 56.6%, 38.9%, and 10.5% in the weekly, monthly, and control groups, respectively (p<0.002).

In 2016, McDonell published an RCT evaluating a drug treatment intervention in primary care that included an analysis of whether UDT can detect underreporting of drug use. (21) The trial included 829 patients with self-reported nonprescribed drug use or illegal drug use in the past 90 days. UDT was performed at baseline and at 3, 6, 9, and 12 months. Investigators found that 331 (40%) participants denied drug use but had a positive drug screen during at least 1 of the 5 assessments. Patients who denied opioid use but whose UDT was positive were more likely to be older, female, and have a higher Addiction Severity Index drug composite score. This trial was not designed to compare treatment success rates in patients managed with and without UDT.

Managing Patients with Routine UDT versus Selective UDT

No studies were identified.

Managing Patients with Routine Confirmation of Positive Qualitative (Presumptive) Tests versus Selective Confirmation of Positive Qualitative (Presumptive) Tests

No studies were identified.

Section Summary: Clinical Utility of Substance Use Disorder Treatment

One small RCT on UDT of patients in substance use disorder treatment focused on the specific situation of testing to determine eligibility for take-home methadone. The percentage of patients with ≥8 weeks of opiate or cocaine abstinence was significantly larger in the groups receiving UDT compared with the group not receiving UDT, though there was a large dropout rate in the groups receiving UDTs. Another RCT found UDT identified drug use in a substantial number of patients who denied illicit usage; the impact on treatment success was not addressed in this trial. A currently ongoing RCT sponsored by the French Ministry of Health is evaluating the effectiveness of performing on-site UDS on patients receiving drug addiction treatment in a general practitioner’s office. (22) Patients were randomized to a control group (usual care) or to an intervention group in which the practitioners receive UDS supplies and a training session on the use and interpretation of UDS. The primary outcome is retention of opioid management treatment at 6 months. Secondary outcomes are patient adherence to buprenorphine, psychoactive substance use, patient acceptance of UDS, and practitioner acceptance of UDS. Data collection is expected to continue through July 2018.

Oral Fluid Drug Testing

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this evidence review and alternative sources exist.

Clinically Valid

In 2011 Heltsley et al. collected oral fluid samples from 231 pain clinics across 20 states, analyzed the samples for 40 drugs or metabolites, and ran confirmatory tests with LC-MS/MS. (23) A total of 6441 samples were collected and 5401 tested positive for at least 1 drug category: 38% for 1 drug, 33% for 2 drugs, and 29% for 3 or more drugs. The highest drug prevalence rates detected through immunoassay testing were: opiates (52%), oxycodone (41%), and benzodiazepines (16%). Confirmatory analyses showed the true positive rates for the oral fluid tests of these 3 highest detected drugs to be 76%, 88%, and 99%, respectively.

Several studies have compared oral fluid testing with UDT using paired samples collected concurrently. For example, in 2011, Vindenes et al. in Norway published a study comparing drug detection in oral fluid with urine samples in the drug treatment setting. (24) A total of 164 pairs of urine and oral fluid samples, obtained at the same time, were collected from 45 opioid-dependent patients participating in a drug treatment program. Oral fluid samples were collected using the Intercept device and analyzed using an LC-MS/MS method developed in Norway. Urine samples were screened using immunoassays and confirmed using LC-MS/MS. All patients were treated with buprenorphine or methadone, so it was expected that one of these drugs would be detected in each sample. Other than these 2 drugs, drugs most commonly detected were 7-aminoflunitrazepam (metabolite of flunitrazepam), amphetamine, and tetrahydrocannabinol (THC). The sensitivity and specificity of the oral fluid samples compared with urine results were calculated. Key findings are shown in Table 3.

A 2012 study by Heltsley et al. included 133 patients undergoing pain management treatment who consented to provide oral fluid and urine samples. (25) Oral samples were collected with the Quantisal device and specimens were analyzed by LC-MS/MS. Urine specimens were screened by immunoassay procedures, and non-negative samples were confirmed by MS. Samples were tested for 34 drugs or drug metabolites, although in some instances different analyses were performed on urine and oral fluid specimens. A total of 1544 paired tests were performed; of these, 329 (21.3%) were positive, and 984 (63.7%) were negative in both matrices, for an overall agreement of 85%. Eighty-three (5.4%) findings were positive in oral fluid only, and 148 (9.6%) were positive in urine only. Authors conducted several analyses of the sensitivity and specificity of oral fluid samples using urinalysis as the reference standard (see Table 3).

Table 3: Sensitivity and Specificity of Oral Fluid Samples Using Urinalysis as the Reference Standard

Drug

Sensitivity

Specificity

Vindenes et al. (2011) (24)

Methadone

100%

100%

Buprenorphine

75%

Not applicable (analytic problems)

7-aminoflunitrazepam

76%

97%

Amphetamine

100%

95%

Tetrahydrocannabinol

82%

98%

6-Monoacetylmorphine (heroin)

95%

80%

Heltsley et al. (2012) (25)

All drugs

69.0 (64.6 to 73.1)

92.2 (90.4 to 93.7)

Four drug categoriesa

76.1 (60.9 to 86.9)

95.9 (92.0 to 98.0)

Six drug categoriesb

82.3 (75.0 to 87.9)

92.2 (88.7 to 94.7)

Table Key:

CI: confidence interval;

a: Categories include amphetamines, cannabis, cocaine, and opiates;

b: Includes the above categories plus hydrocodone and oxycodone.

In 2014, Conermann et al. compared findings of oral fluid and urinalysis in 153 paired samples from patients attending a pain management clinic. (26) This study focused on confirmation that a treatment drug was being taken and did not report the sensitivity and specificity of oral fluid samples compared with urine samples. Oral fluid samples were collected with the Quantisal device. All specimens were screened with immunoassays, and presumptive positive findings were confirmed using LC/MS. A total of 136 (89%) of the 153 paired samples tested positive for 1 or more treatment drugs (i.e., opioids, benzodiazepines) in one or both matrices. After excluding 4 paired samples due to missing data, 101 (76.5%) of 132 positive specimen pairs had exact drug class matches. In another 21 paired samples, there was at least 1 (15.9%) drug class match. Thus, there was an overall agreement between samples of 92.4%. Two analyses were positive in oral fluid only, and eight were positive in urine only.

Kunkel et al. (2015) conducted a retrospective analysis of 4560 unobserved urine collection samples and 2368 observed oral fluid collection samples of patients undergoing opioid addiction treatment. (27) The samples were tested for 13 different illicit and prescription drugs. Oral fluid testing detected higher rates of most of the drugs compared with urine testing. For example, oral fluid tests detected 6.5% morphine, 5.2% oxycodone, 3.8% codeine, and 3% cocaine use, while urine tests detected 2.3% morphine, 0.6% oxycodone, 0.7% codeine, and 1.4% cocaine use. Interpretation of these results is limited because the urine and oral fluid samples were not paired.

Clinically Utility

No studies were identified that compared patient management decisions or health outcomes in patients managed using oral fluid drug testing versus UDT or no drug testing.

Section Summary: Oral Fluid Testing

The limited number of studies on the 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.

Hair Drug Testing

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this evidence review and alternative sources exist.

Clinically Valid

No studies were identified that compared the accuracy of hair and urine testing using paired samples collected concurrently in the pain management setting or drug use disorder treatment setting. One study using paired samples of urine and hair from patients in a psychiatric facility was identified (Musshoff et al., 2006). (28) Patients underwent drug testing as part of the intake process for psychiatric treatment. Urine and hair samples (both head hair and pubic hair) from known drug users were analyzed. Fifty-one patients were included; all provided urine samples, 47 provided head hair samples (1-3 segments), and 36 provided pubic hair samples. Drug analysis was done using GC-MS methods. The hair test was considered positive if any segment had a positive finding. Urine samples were analyzed using standard immunoassays; positive findings were not confirmed. Prevalence rates of drugs identified in hair and urine samples, as well as self-report of drug use, are shown in Table 4.

Table 4: Prevalence Rates of Drug Use

Opiates

Cocaine

Methadone

Cannabinoids

Amphetamines

Musshoff et al. (2006) (28) (n=47)

Self-Report

42 (89%)

18 (38%)

15 (32%)

26 (55%)

1 (2%)

Urine Test

33 (70%)

13 (28%)

14 (30%)

21 (45%)

0 (0%)

Hair Test

38 (81%)

26 (55%)

23 (49%)

15 (32%)

1 (2%)

Table Key:

n: number.

Note that values are n (%).

Hair tests revealed a higher prevalence of drug use than UDT for most drugs, with the exception of cannabinoids. The prevalence of amphetamines was too low to make meaningful comparisons. Cannabinoids are known to be excreted slowly in urine and to have a low incorporation rate into hair. It is important to note that the hair analysis was used to detect drug use anytime during the past several months and the urine analysis to detect drug use in the past several days.

Clinically Utility

No studies were identified that compared patient management decisions or health outcomes in patients managed using testing of hair versus UDT or no drug testing.

Section Summary: Hair Drug Testing

Hair drug testing cannot detect recent drug use (i.e., in the past few days). One study looked at this longer time frame in patients starting psychiatric treatment. It found a higher prevalence of drug use with hair testing versus UDT for most drugs; however, the implications of study findings for patients in pain management or substance use disorder treatment is unclear. No studies were identified on the diagnostic accuracy of hair testing versus UDT in patients with chronic pain or substance use disorder. In addition, no studies were identified on the clinical utility of hair testing in pain management or substance use disorder treatment.

Ongoing and Unpublished Clinical Trials

A currently unpublished trial that might influence this policy is listed in Table 5.

Table 5. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02345655

Impact of On-site Evaluation of Substances Consumption on Opiate Maintenance in the Context of Family Practice

400

Jan 2018

Table Key:

NCT: national clinical trial.

Practice Guidelines and Position Statements

Pain Management

In 2014, Nuckols et al. published a systematic review of guidelines that addressed management of opioid use for chronic pain. (29) Reviewers included guidelines from national organizations and specialty societies, as well as guidelines from state agencies and specific health systems. Moreover, reviewers identified 9 guidelines with recommendations on UDT. Recommendations varied widely; 2 recommended mandatory testing for all patients, another recommended testing only patients at increased risk of medication use disorder, and 2 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 1 guideline, at least yearly in another, and randomly in 2.

Centers for Disease Control and Prevention (CDC)

In 2016, the CDC published guidelines on opioids for chronic pain. (30) 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.”

American Society of Interventional Pain Physicians (ASIPP)

In 2017, the ASIPP issued guidelines for responsible, safe, and effective opioid prescribing for chronic non-cancer pain. (31) The guidelines included the following recommendations on UDT (see Table 6).

Table 6. Recommendations on Urine Drug Testing for Chronic Non-Cancer Pain

Recommendation

LOE

SOE

“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.”

I

Strong

“Screening for opioid abuse is recommended, as it will potentially identify opioid abusers and reduce opioid abuse.”

II-III

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.”

III

Moderate

Table Key:

LOE: level of evidence;

SOE: strength of evidence;

UDT: urine drug testing.

American Pain Society (APS) and American Academy of Pain Medicine (AAPM)

In 2009, the APS and AAPM jointly published clinical guidelines on the use of opioid therapy in chronic non-cancer pain. (32) The guidelines did not address UDT or other forms of monitoring adherence.

American College of Occupational and Environmental Medicine (ACOEM)

The latest guidelines from the ACOEM on the use of opioids for the treatment of acute, subacute, chronic, and postoperative pain, were published in 2014. (33) The following recommendations on UDT were made for subacute (1-3 months) and chronic pain (>3 months) (see Table 7).

Table 7. Recommendations on Opioid Use to Treat Acute, Subacute, Chronic, and Postoperative Pain

Recommendation

SOR

CIR

“Baseline and random urine drug screening, qualitative and quantitative, for patients prescribed opioids for the treatment of subacute or chronic pain to evaluate presence or absence of the drug, its metabolites and other substance(s) use. In certain situations, other screenings (e.g., hair particularly for information regarding remote use or blood) (for acute toxicity) may be appropriate.”

C

High

Table Key:

CIR: confidence in recommendation;

SOR: strength of recommendation.

Note the recommendations rating schema as: A: strongly recommended; B: moderately recommended; C: recommended.

UDS was not recommended for acute pain (up to 4 weeks) or for postoperative pain (up to 4 weeks).

As a companion to the guidelines, ACOEM developed a combined Opioid Consent Form and Opioid Treatment Agreement. (34) The form provides explanations of the potential benefits and harms to be expected from opioid treatment, and asks the patient to agree to numerous terms of opioid use, which include submitting to unscheduled urine, blood, saliva, or hair drug testing at the prescriber’s request and seeing an addiction specialist if requested.

Screening was recommended for all patients at baseline, and then randomly at least twice and up to 4 times a year, and at termination. Screening should also be performed if the provider suspects abuse of prescribed medication.

Canadian National Opioid Use Guideline Group

The National Opioid Use Guideline Group issued guidelines in Canada in 2010 on the safe and effective use of opioids for chronic non-cancer pain that included the following recommendation on UDS (5): “When using urine drug screening (UDS) to establish a baseline measure of risk or to monitor compliance, be aware of benefits and limitations, appropriate test ordering and interpretation, and have a plan to use results. (Grade C).”

The guidelines also stated that there was no “compelling evidence” to guide physicians on identifying patients who should have UDS, or on how often they should be tested. The document stated that the following factors should be considered when deciding whether to order a UDS:

Patient’s risk for opioid misuse and addiction,

Aberrant drug-related behaviors,

Testing availability (Note: this may be a Canadian-specific issue).

Department of Veterans Affairs (VA) and Department of Defense (DoD)

In 2010, the VA and DoD issued clinical practice guidelines for managing opioid therapy for treatment of chronic pain. (6) The recommendations on assessing adherence to prescribed opioids includes obtaining a urine drug test (with patient consent) before initiating opioid therapy, and then randomly at 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 (SOAPP).

The guidelines included the following specific recommendations on UDT:

“RECOMMENDATIONS:

1. 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.

2. With patient consent, obtain a UDT in all patients prior to initiation of OT.

3. 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.

4. 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.

5. 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.)

6. 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. (35) 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: 3-4 times per year.

Aberrant behavior: each visit.

No pain management guidelines were identified that had recommendations on oral fluid drug testing or hair drug testing.

Substance Use Disorder Treatment

American Society of Addiction Medicine (ASAM)

The ASAM has published several documents on drug testing: a public policy statement (2010), (36) a white paper (2013), which provided background on the science and current practices of drug testing, (37) and guidelines (2017) on the effective use of drug testing. (38)

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.” (36) 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.” (37) The paper acknowledged that more specific guidance on drug testing was needed, which led to the development of the 2017 guidelines, described below.

The 2017 ASAM guidance on appropriate drug testing in clinical addiction medicine advises health care providers that before choosing the type of drug test, they should first identify the questions they are seeking to answer and be aware of benefits and limitations of the various drug tests. Table 8 summarizes characteristics of urine, oral fluid, and hair drug tests that may inform the decision of what type of drug test to use.

Table 8. Summary of Drug Testing Characteristics

Characteristics

Urine

Oral Fluid

Hair

General detection period

Hours to days

Minutes to hours

Weeks to months

Point-of-care testing

Yes

Yes

No

Primarily detects

Drug metabolite

Parent drug compound

Parent drug compound

Best use in treatment setting

Intermediate-term detection in ongoing treatment

Short-term detection in ongoing treatment

Long-term monitoring, 3-month history

Ease of collection

Requires restroom

Easily collected

Easily collected

Resistance to tampering

Low

High, with some uncertainty

High when chemically untreated

Retesting same sample

Possible

Difficult

Easy

Note: adapted from Jarvis et al. (2017). (38)

Summary of Evidence

For individuals who have chronic pain treated with opioids who receive urine drug testing (UDT), the evidence includes nonrandomized comparative studies and systematic reviews. Relevant outcomes are test accuracy and validity, health status measures, and resource utilization. The evidence on the diagnostic accuracy of urine immunoassay tests, as confirmed by gas- or liquid-chromatography/mass spectrometry, shows sensitivities ranging from about 80% to 93% for both opiates and oxycodone. No randomized controlled trials (RCTs) evaluating clinical utility were identified. Several nonrandomized comparative studies have been conducted, though interventions and outcomes have varied across the studies. Most interventions included patient contracts along with UDT, and therefore, the effect of UDT alone could not be determined. Most studies did not provide details on the frequency of UDTs and whether the testing was random or scheduled. As a result, these studies 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 who are in substance use disorder treatment who receive UDT, the evidence includes 2 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 use disorder treatment. One small RCT focused specifically on UDT to determine eligibility for take-home methadone. The second RCT found that UDT identified drug use in a substantial number of patients 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.

For individuals who have chronic pain treated with opioids or with a drug addiction in substance use disorder 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 the diagnostic accuracy of oral fluid testing compared with UDT have varied 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 with a drug addiction in substance use disorder treatment who receive hair drug testing, the evidence includes a diagnostic accuracy study in the psychiatric treatment setting. Relevant outcomes are test accuracy and validity, health status measures, and resource utilization. Hair drug testing cannot detect recent drug use (i.e., in the past few days), and thus has limited applicability to pain management or substance use disorder treatment settings, except, perhaps, for initial intake. There are no studies comparing the diagnostic accuracy of hair testing with UDT in either setting. 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 use disorder treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

Drug class testing may be done on any type of specimen, such as urine, blood, oral fluid, meconium, hair. The purpose of the testing can be qualitative, semi-quantitative, or quantitative. More than one test and/or more than one specimen may be tested. Not all procedure codes listed on this medical policy specify in the procedure code the type of specimen. This medical policy addresses only urine drug testing.

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

80156, 80188, 80299, 80305, 80306, 80307, 80320, 80321, 80322, 80323, 80324, 80325, 80326, 80327, 80328, 80329, 80330, 80331, 80332, 80333, 80334, 80335, 80336, 80337, 80338, 80339, 80340, 80341, 80342, 80343, 80344, 80345, 80346, 80347, 80348, 80349, 80350, 80351, 80352, 80353, 80354, 80355, 80356, 80357, 80358, 80359, 80360, 80361, 80362, 80363, 80364, 80365, 80366, 80367, 80368, 80369, 80370, 80371, 80372, 80373, 80374, 80375, 80376, 80377, 82542, 82570, 83992, 84311, 84999, 0006U, 0007U, 0011U, 0051U, 0054U, 0082U, [Deleted 1/2017: 80300, 80301, 80302, 80303, 80304]

HCPCS Codes

G0480, G0481, G0482, G0483, G0659, [Deleted 1/2017: G0477, G0478, G0479]

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. 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. Jul 2012; 15(3 Suppl):S1-65. PMID 22786448

2. International Narcotics Control Board (INCB). Report of the International Narcotics Control Board (2016). Available at: <https://www.incb.org> (accessed February 27, 2018).

3. Fishbain DA, Cutler RB, Rosomoff HL, et al. Validity of self-reported drug use in chronic pain patients. Clin J Pain. Sep 1999; 15(3):184-91. PMID 10524471

4. Manchikanti L, Atluri S, Trescot AM, et al. Monitoring opioid adherence in chronic pain patients: tools, techniques, and utility. Pain Physician. Mar 2008; 11(2 Suppl):S155-80. PMID 18443638

5. National Opioid Use Guideline Group (NOUGG): Canada. Canadian guideline for safe and effective use of opioids for chronic non-cancer pain (2017). CMAJ. May 08 2017; 189(18): E659-66. Available at: <http://nationalpaincentre.mcmaster.ca> (accessed February 27, 2018).

6. 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 (2017). Available at: <http://www.guideline.gov> (accessed February 27, 2018).

7. Manchikanti L, Malla Y, Wargo BW, et al. Comparative evaluation of the accuracy of immunoassay with liquid chromatography tandem mass spectrometry (LC/MS/MS) of urine drug testing (UDT) opioids and illicit drugs in chronic pain patients. Pain Physician. Mar-Apr 2011; 14(2):175-87. PMID 21412372

8. Snyder ML, Fantz CR, Melanson S. Immunoassay-based drug tests are inadequately sensitive for medication compliance monitoring in patients treated for chronic pain. Pain Physician. Feb 2017; 20(2S):SE1-9. PMID 28226337

9. Johnson-Davis KL, Sadler AJ, Genzen JR. A retrospective analysis of urine drugs of abuse immunoassay true positive rates at a national reference laboratory. J Anal Toxicol. Mar 2016; 40(2):97-107. PMID 26668238

10. Bertholf RL, Sharma R, Reisfield GM. Predictive value of positive drug screening results in an urban outpatient population. J Anal Toxicol. Nov 2016; 40(9):726-31. PMID 27550994

11. 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. Jun 2010; 152(11):712-20. PMID 20513829

12. Goldberg KC, Simel DL, Oddone EZ. Effect of an opioid management system on opioid prescribing and unscheduled visits in a large primary care clinic. J Clinical Outcomes Management. Dec 2005; 12:621-28. PMID not issued by the National Institutes of Health

13. Manchikanti L, Manchukonda R, Damron KS, et al. Does adherence monitoring reduce controlled substance abuse in chronic pain patients? Pain Physician. Jan 2006; 9(1):57-60. PMID 16700282

14. Manchikanti L, Manchukonda R, Pampati V, et al. Does random urine drug testing reduce illicit drug use in chronic pain patients receiving opioids? Pain Physician. Apr 20.06; 9(2):123-9. PMID 17883742

15. 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. Oct-Nov 2007; 8(7):573-84. PMID 17883742

16. Dupouy J, Memier V, Catala H, et al. Does urine drug abuse screening help for managing patients? A systematic review. Drug Alcohol Depend. Mar 2014; 136:11-20. PMID 24417964

17. Krishnamurthy P, Ranganathan G, Williams C, et al. Impact of urine drug screening on no shows and dropouts among chronic pain patients: a propensity-matched cohort study. Pain Physician. Feb 2016; 19(2):89-100. PMID 26815253

18. Brennan PL, Del Re AC, Henderson PT, et al. Healthcare system-wide implementation of opioid-safety guideline recommendations: the case of urine drug screening and opioid-patient suicide- and overdose-related events in the Veterans Health Administration. Transl Behav Med. Dec 2016; 6(4):605-12. PMID 27384953

19. Stammet MM, Spradley SS. Evaluation of treatment changes following electronic consultation to a pharmacist-run urine drug testing service in a Veterans Healthcare System. J Opioid Manag. Nov/Dec 2016; 12(6):389-95. PMID 28059431

20. Chutuape MA, Silverman K, Stitzer ML. Effects of urine testing frequency on outcome in a methadone take-home contingency program. Drug Alcohol Depend. Mar 2001; 62(1):69-76. PMID11173169

21. McDonell MG, Graves MC, West, II, et al. Utility of point-of-care urine drug tests in the treatment of primary care patients with drug use disorders. J Addict Med. May-Jun 2016; 10(3):196-201. PMID 27159345

22. Esub-Mg Study Group. Study protocol of the ESUB-MG cluster randomized trial: a pragmatic trial assessing the implementation of urine drug screening in general practice for buprenorphine maintained patients. BMC Fam Pract. Mar 01 2016; 17:24. PMID 26931763

23. Heltsley R, DePriest A, Black DL, et al. Oral fluid drug testing of chronic pain patients. I. Positive prevalence rates of licit and illicit drugs. J Anal Toxicol. Oct 2011; 35(8):529-40. PMID 22004671

24. Vindenes V, Yttredal B, Oiestad EL, et al. Oral fluid is a viable alternative for monitoring drug abuse: detection of drugs in oral fluid by liquid chromatography-tandem mass spectrometry and comparison to the results from urine samples from patients treated with Methadone or Buprenorphine. J Anal Toxicol. Jan 2011; 35(1):32-9. PMID 21219701

25. Heltsley R, Depriest A, Black DL, et al. Oral fluid drug testing of chronic pain patients. II. Comparison of paired oral fluid and urine specimens. J Anal Toxicol. Mar 2012; 36(2):75-80. PMID 22337775

26. Conermann T, Gosalia AR, Kabazie AJ, et al. Utility of oral fluid in compliance monitoring of opioid medications. Pain Physician. Jan-Feb 2014; 17(1):63-70. PMID 24452646

27. Kunkel F, Fey E, Borg D, et al. Assessment of the use of oral fluid as a matrix for drug monitoring in patients undergoing treatment for opioid addiction. J Opioid Manag. Sep-Oct 2015; 11(5):435-42. PMID 26535971

28. Musshoff F, Driever F, Lachenmeier K, et al. Results of hair analyses for drugs of abuse and comparison with self-reports and urine tests. Forensic Sci Int. Jan 27 2006; 156(2-3):118-23. PMID 16410161

29. Nuckols TK, Anderson L, Popescu I, et al. Opioid Prescribing: A Systematic Review and Critical Appraisal of Guidelines for Chronic Pain. Ann Intern Med. Jan 2013; 160(1):38-47. PMID 24217469

30. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain--United States, 2016. JAMA. Apr 19 2016; 315(15):1624-45. PMID 26977696

31. 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. Jul 2012; 15(3 Suppl):S67-116. PMID 22786449

32. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain Feb 2009; 10(2):113-30. PMID 19187889

33. Hegmann KT, Weiss MS, Bowden K, et al. ACOEM practice guidelines: opioids for treatment of acute, subacute, chronic, and postoperative pain. J Occup Environ Med. Dec 2014; 56(12):e143-59. PMID 25415660

34. American College of Occupational and Environmental Medicine (ACOEM). ACOEM opioid treatment guidelines (2017). Available at: <http://www.acoem.org> (accessed February 27, 2018).

35. Washington State Agency Medical Directors' Group. Interagency guideline on opioid dosing for chronic non-cancer pain: an educational aid to improve care and safety with opioid treatment (2010 Update). Available at: <http://www.guideline.gov> (accessed February 27, 2018).

36. 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 (July 1, 2002; rev. October 1, 2010). Available at: <http://www.asam.org> (accessed February 27, 2018).

37. American Society of Addiction Medicine (ASAM). Drug Testing: A white paper of the American Society of Addiction Medicine (ASAM) (October 26, 2013). Available at: <https://www.asam.org> (accessed February 27, 2018).

38. Jarvis M, Williams J, Hurford M, et al. Appropriate use of drug testing in clinical addiction medicine. J Addict Med. May/Jun 2017; 11(3):163-73. PMID 28557958

39. Opioid Risk Tool (ORT) (2018 Update). Available at: <http://www.opioidrisk.com> (accessed February 27, 2018).

40. Centers for Disease Control. CDC and prevention guideline for prescribing opioids for chronic pain – United States (March 18, 2016). CDC Recommend Report. 2018; 65(1):1–49. Available at: <http://www.cdc.gov> (accessed February 27, 2018).

41. Drug Enforcement Agency. Drug Schedules (February 2018). Available at: <http://www.dea.gov> (accessed February 27, 2018).

42. Akbik H, Butler SF, Budman SH, et al. Validation and clinical application of the screener and opioid assessment for patients with pain (SOAPP). J Pain Symptom Manage. Sep 2006; 32(3): 297-93. PMID 16939853

43. Manubay JM, Muchow C, Sullivan MA. Prescription drug abuse: epidemiology, regulatory issues, chronic pain management with narcotic analgesics. Primary Care. Mar 2011; 38(1):71-90. PMID 21566422

44. Drug Testing in Pain Management and Substance Use Disorder Treatment. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2017 December) Pathology/Laboratory 2.04.98.

Policy History:

Date Reason
4/15/2018 Document updated with literature review. Coverage unchanged; however, “substance abuse treatment” was replaced with “substance use disorder treatment” throughout entire policy. “Urine” and “Abuse” removed from title and exchanged “Including” for “In” in the title; title changed to: Drug Testing In Pain Management and Substance Use Disorder Monitoring. References added: 2, 8-10, 17-19, 21-23, 27, 30, 33; and reference list updated.
4/15/2017 Reviewed. No changes.
12/15/2016 Document update with literature review. The following coverage statement was added: In outpatient pain management and substance abuse treatment, hair drug testing and oral fluid drug testing are considered experimental, investigational and/or unproven. The following was added to the routine screening coverage statement that is considered not medically necessary: “without documented individual patient assessment.” The following NOTEs were added: NOTE 1: In general, qualitative urine drug testing should not require more than 15 tests within a 12-month period. Additional testing would require clinical justification of medical necessity; NOTE 2: In general, quantitative urine drug testing should not require more than 12 tests within a 12-month period. Additional testing would require clinical justification of medical necessity; NOTE 4: Simultaneous blood and urine drug screening or testing is not appropriate and should not be done routinely; and, NOTE 5: Risk stratification is discussed in the Description section of this medical policy.
11/1/2015 Document updated with literature review. Coverage unchanged.
12/15/2014 New medical document. Urine drug testing, qualitative or quantitative, is considered medically necessary when specific criteria are met, for outpatient pain management or for outpatient substance abuse monitoring. Urine drug testing, qualitative or quantitative, is considered not medically necessary when specific criteria are not met, for outpatient pain management or for outpatient substance abuse monitoring.

Archived Document(s):

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