Clinical UM Guideline
|Subject:||Drug Testing or Screening in the Context of Substance Use Disorder and Chronic Pain|
|Guideline #:||CG-LAB-09||Current Effective Date:||04/05/2016|
|Status:||Revised||Last Review Date:||02/04/2016|
This document addresses the drug testing involving urine, blood, saliva, sweat, or hair samples in the outpatient setting for adherence monitoring of controlled substance use as part of the management of chronic pain and for individuals undergoing treatment for opioid addiction and substance use disorder.
Note: This document does not address the use of urine drug testing in the following circumstances:
Note: Drug testing or screening for employment issues may be addressed in the member certificate. Please refer to the member's benefits for further information.
Presumptive urine drug testing (UDT) to verify compliance with treatment, identify undisclosed drug use or abuse, or evaluate aberrant* behavior is considered medically necessary up to 24 times per year, beginning at the start of treatment, as part of a routine monitoring program for individuals who are:
*Aberrant behavior includes, but is not limited to, lost prescriptions, repeated requests for early refills, prescriptions from multiple providers, unauthorized dose escalation, and apparent intoxication.
Presumptive urine drug testing is also considered medically necessary for the following:
Definitive urine drug testing is considered medically necessary when all of the following criteria are met:
The use of blood samples as an alternative to urine for drug testing is considered medically necessary when the use of urine is not feasible (for example, when an individual has advanced kidney failure).
Not Medically Necessary:
The use of presumptive urine drug testing is considered not medically necessary when the criteria above are not met.
The use of definitive urine drug testing is considered not medically necessary when the criteria above are not met.
The use of presumptive or definitive testing panels is considered not medically necessary unless all components of the panel have been determined to be medically necessary based on the criteria above. However, individual components of a panel may be considered medically necessary when criteria above are met.
The use of blood samples for drug testing is considered not medically necessary in all other circumstances, including when the criteria above have not been met.
The use of saliva, sweat, or hair samples for drug testing is considered not medically necessary in all circumstances.
The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|Presumptive Drug Class Screening codes:|
|80300||Drug screen, any number of drug classes from Drug Class List A; any number of non-TLC devices or procedures (eg, immunoassay) capable of being read by direct optical observation, including instrumented-assisted when performed (eg, dipsticks, cups, cards, cartridges), per date of service|
|80301||Drug screen, any number of drug classes from Drug Class List A; single drug class method, by instrumented test systems (eg, discrete multichannel chemistry analyzers utilizing immunoassay or enzyme assay), per date of service|
|80302||Drug screen, presumptive, single drug class from Drug Class List B, by immunoassay (eg, ELISA) or non-TLC chromatography without mass spectrometry (eg, GC, HPLC), each procedure|
|80303||Drug screen, any number of drug classes, presumptive, single or multiple drug class method; thin layer chromatography procedure(s) (TLC) (eg, acid, neutral, alkaloid plate), per date of service|
|80304||Drug screen, any number of drug classes, presumptive, single or multiple drug class method; not otherwise specified presumptive procedure (eg, TOF, MALDI, LDTD, DESI, DART), each procedure|
|Definitive Drug Testing codes:|
|80321||Alcohol biomarkers; 1 or 2|
|80322||Alcohol biomarkers; 3 or more|
|80323||Alkaloids, not otherwise specified|
|80324||Amphetamines; 1 or 2|
|80325||Amphetamines; 3 or 4|
|80326||Amphetamines; 5 or more|
|80327||Anabolic steroids; 1 or 2|
|80328||Anabolic steroids; 3 or more|
|80332||Antidepressants, serotonergic class; 1 or 2|
|80333||Antidepressants, serotonergic class; 3-5|
|80334||Antidepressants, serotonergic class; 6 or more|
|80335||Antidepressants, tricyclic and other cyclicals; 1 or 2|
|80336||Antidepressants, tricyclic and other cyclicals; 3-5|
|80337||Antidepressants, tricyclic and other cyclicals; 6 or more|
|80338||Antidepressants, not otherwise specified|
|80339||Antiepileptics, not otherwise specified; 1-3|
|80340||Antiepileptics, not otherwise specified; 4-6|
|80341||Antiepileptics, not otherwise specified; 7 or more|
|80342||Antipsychotics, not otherwise specified; 1-3|
|80343||Antipsychotics, not otherwise specified; 4-6|
|80344||Antipsychotics, not otherwise specified; 7 or more|
|80347||Benzodiazepines; 13 or more|
|80350||Cannabinoids, synthetic; 1-3|
|80351||Cannabinoids, synthetic; 4-6|
|80352||Cannabinoids, synthetic; 7 or more|
|80357||Ketamine and norketamine|
|80361||Opiates, 1 or more|
|80362||Opioids and opiate analogs; 1 or 2|
|80363||Opioids and opiate analogs; 3 or 4|
|80364||Opioids and opiate analogs; 5 or more|
|80368||Sedative hypnotics (non-benzodiazepines)|
|80369||Skeletal muscle relaxants; 1 or 2|
|80370||Skeletal muscle relaxants; 3 or more|
|80374||Stereoisomer (enantiomer) analysis, single drug class|
|80375||Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1-3|
|80376||Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 4-6|
|80377||Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 7 or more|
|G0477||Drug test(s), presumptive, any number of drug classes; any number of devices or procedures, (eg, immunoassay) capable of being read by direct optical observation only (eg, dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service|
|G0478||Drug test(s), presumptive, any number of drug classes; any number of devices or procedures, (eg, immunoassay) read by instrument-assisted direct optical observation (eg, dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service|
|G0479||Drug test(s), presumptive, any number of drug classes; any number of devices or procedures by instrumented chemistry analyzers (eg, immunoassay, enzyme assay, TOF, MALDI, LDTD, DESI, DART, GHPC, GC mass spectrometry), includes sample validation when performed, per date of service|
|G0480||Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays [eg, IA, EIA, ELISA, EMIT, FPIA] and enzymatic methods [eg, alcohol dehydrogenase]); qualitative or quantitative, all sources, includes specimen validity testing, per day, 1-7 drug class(es), including metabolite(s) if performed|
|G0481||Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays [eg, IA, EIA, ELISA, EMIT, FPIA] and enzymatic methods [eg, alcohol dehydrogenase]); qualitative or quantitative, all sources, includes specimen validity testing, per day, 8-14 drug class(es), including metabolite(s) if performed|
|G0482||Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays [eg, IA, EIA, ELISA, EMIT, FPIA] and enzymatic methods [eg, alcohol dehydrogenase]); qualitative or quantitative, all sources, includes specimen validity testing, per day, 15-21 drug class(es), including metabolite(s) if performed|
|G0483||Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays [eg, IA, EIA, ELISA, EMIT, FPIA] and enzymatic methods [eg, alcohol dehydrogenase]); qualitative or quantitative, all sources, includes specimen validity testing, per day, 22 or more drug class(es), including metabolite(s) if performed|
|P2031||Hair analysis (excluding arsenic)|
Urine Drug Testing (UDT)
The use of UDT in individuals with a substance use disorder or undergoing opioid treatment for chronic pain conditions is common and serves several purposes. According to the American College of Physicians (ACP, 2008), the reasons for UDT include:
The American Pain Society (APS) and American Academy of Pain Medicine (AAPM) joint guidelines panel released their opioid treatment guidelines titled Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Non-cancer Pain in 2009 (Chou, 2009). In this document they addressed the monitoring of controlled substances use via UDT as part of a chronic opioid treatment (COT) program. The guideline section on monitoring (Section 5) states:
5.1 Clinicians should reassess patients on COT periodically and as warranted by changing circumstances. Monitoring should include documentation of pain intensity and level of functioning, assessments of progress toward achieving therapeutic goals, presence of adverse events, and adherence to prescribed therapies (strong recommendation, low-quality evidence).
5.2 In patients on COT who are at high risk or who have engaged in aberrant drug-related behaviors, clinicians should periodically obtain urine drug screens or other information to confirm adherence to the COT plan of care (strong recommendation, low-quality evidence).
5.3 In patients on COT not at high risk and not known to have engaged in aberrant drug-related behaviors, clinicians should consider periodically obtaining urine drug screens or other information to confirm adherence to the COT plan of care (weak recommendation, low-quality evidence). Clinicians should periodically reassess all patients on COT. Regular monitoring of patients once COT is initiated is critical because therapeutic risks and benefits do not remain static.
The American Society of Addiction Medicine (ASAM) published a document titled, Drug Testing: A White Paper of the American Society of Addiction Medicine (ASAM) (2013). This document details the critical issues that surround the topic of drug testing, including the various technologies available, testing of various body fluids and substances, when and why to test specific individuals, interpretation of test results, and the principles of testing in various settings. They address many of the complicated issues surrounding quantitative testing, about which they state, "Definitive (also: "confirmatory" or "identification" testing) testing, which involves chromatography and mass spectrometry, incurs additional expense and thus should be done for specific indications." As well as:
In general, positive IA [immunoassay] results need only be subjected to definitive testing when the results conflict with patients' account of their drug use or when drug specificity is needed in class-specific assays (i.e. amphetamines, benzodiazepines, opiates). In a pain practice it is sometimes, but not always, important to identify the specific drug, not just the class of the drug.
Overall, they do not provide a supporting rationale for across the board definitive testing in any setting.
The exact frequency and pattern of urine drug screening is individualized based on the risk for abuse. The Washington State Agency Medical Directors' Group (AMGD) published an Interagency Guideline on opioid dosing for chronic non-cancer pain. This guideline and related expert commentary support low-risk individuals having UDT up to once per year, moderate risk up to 2 per year, high risk individuals up to 3-4 tests per year, and individuals exhibiting aberrant behaviors should be tested at the time of the office visit. The American Pain Society guidelines (Chou, 2009) state that for individuals at low-risk for adverse outcomes, quarterly or semi-annual monitoring is sufficient. For very high-risk individuals, weekly monitoring may be reasonable. However, they state that there is insufficient evidence to support this recommendation. This observation is reiterated in a recent review article by McMillin and colleagues (2013), where they comment that there is a lack of detailed guidelines addressing the appropriate use of DUT to support chronic pain management. The ASAM white paper does not recommend an upper limit for testing. However, in the context of abuse, they do recommend no less than testing once weekly at first then down to once monthly when abstinence is established.
The risk for abuse may be measured using standard tools, such as the Screener and Opioid Assessment for Patients with Pain (SOAPP®; PainEdu.org, 2013) and the Opioid Risk Tool (Webster, 2005). These types of tools may help clinicians assess the suitability of long-term opioid therapy for chronic pain patients, and may help differentiate those patients who require more or less clinician monitoring while on long-term opioid therapy. The SOAPP tool is available for free and can be accessed at https://www.painedu.org/soapp.asp. There are 4 different versions available (5, 14, 24 questions and the Revised SOAPP [SOAPP-R]) allowing for varying levels of evaluation. All versions of the SOAPP tool may be self-administered at or prior to an office visit, or completed as part of an interview with a nurse, physician or psychologist. The ORT was developed by Webster et al. and has become widely used. Like the SOAPP, it may be self-administered or used as part of a clinical evaluation. A version of the ORT is available below. Other tools similar to the SOAPP and ORT are available elsewhere.
OPIOID RISK TOOL (ORT) (Webster, 2005)
|Circle the score that applies:|
|Mark each item that applies||Item Score if Female||Item Score if Male|
Family History of Substance Abuse:
Illegal prescription drugs
|Personal History of Substance Abuse:||Alcohol|
Illegal prescription drugs
|Age (Mark box if 16-45):||1||1|
|History of preadolescent Sexual Abuse:||3||0|
|Psychological disease:||Attention deficit disorder|
Obsessive compulsive disorder
| ||Mark "2" if any, some, or all four Psychological diseases are present|
Risk categories: Low = 0-3; Moderate = 4-7; High ≥8
Another issue within the topic of UDT is the use of presumptive vs. definitive testing. Presumptive testing is intended to identify the use or non-use of a drug or class of drugs. Definitive tests are more specific, and allow for the detection of specific drugs or metabolites of interest. In most cases presumptive testing is used because it is quick, fairly accurate, and easily accessible in a wide variety of settings. Definitive testing may be needed when presumptive results alone are not sufficient to guide clinical care. However, in most situations, the identification or quantification of a specific drug of interest may not result in a different treatment plan. Definitive testing, particularly when performed repeatedly, must be clinically meaningful and documentation must support the specific necessity of each definitive assay performed as well as how that test result will affect clinical management.
Drug Testing of Blood, Saliva, Sweat, or Hair Samples
At this time the use of samples other than urine, including blood, hair, saliva, and sweat, is not recommended by most authoritative organizations that provide guidance on drug testing, including the American Society of Addiction Medicine (ASAM, 2013, 2015), the ACP (Kirschner, 2014), the American Pain Society (APS) and the American Academy of Pain Medicine (AAPM, Chou, 2010) and the Washington State Agency Medical Directors' Group (AMGD, 2010).
The ASAM (2013) does mention the use of blood, hair, saliva (oral fluid), and sweat, but they do not make specific recommendations on how, when, and why they should be used. They do provide comments on the benefits and drawback of these substrates, however. In relation to blood samples, they state that urine is preferred as a sample substrate because blood collection is invasive, poses significant difficulties in collecting, and the samples require extensive lab preparation. Furthermore, they noted that there is significantly shorter duration of active drug and metabolites in blood vs. urine. For hair samples, the ASAM noted significant benefits including difficulty in falsify sampling and it also allows a longer period of detection. However, they noted that hair samples do not allow for the determination or when drugs were taken, and recent exposures cannot be detected. Regarding sweat patch testing, they state that such techniques are fairly tamper resistant, but vulnerable to unintentional or accidental damage. For saliva they comment that while this method shares similar attractive attributes with urine, such as noninvasive collection and easy laboratory analysis, they state that there is a much shorter duration of active drug and metabolites and lower detection rates vs. UDT. Their 2015 guideline titled "National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use" does not mention the use of blood, hair, saliva, or sweat samples for testing and recommend only urine drug testing at the standard methodology.
The U.S. Department of Health and Human Services (DHHS) Substance Abuse and Mental Health Services Administration (SAMHSA) has published two documents that address drug testing for individuals in primary care and substance abuse disorder treatment programs (SAMHSA, 2012, 2014). In these document they discus the benefits and drawbacks of drug testing using alternative sample sources. However, in their primary care document (2012) they clarify that urine is the most widely used and studied source. This was reiterated in their 2014 Treatment Improvement Protocol for opioid addiction programs.
However, in some circumstances the use of UDT is not possible. In the SAMHSA 2014 protocol they state, "Urine testing is not feasible for patients with renal failure (e.g., those on dialysis) or other bladder control impairments." In such circumstances the use of blood drug testing may be reasonable.
In summary, the use of blood, hair, saliva, and sweat is not widely recommended and they each have significant drawbacks to their use when compared to UDT.
Many commercial laboratories market multi-test panels for the presence of various prescription and illicit drugs and their metabolites. While the use of some individual tests included in these test panels may be reasonable under specific circumstances, the use of all the tests within a panel is rarely justified unless there is clinical evidence that an individual has used or been exposed to multiple substances, and knowledge of such exposure provides information that leads to meaningful impact on treatment.
Definitive testing: A type of testing that is more specific than presumptive testing, and allows for the detection of specific drugs or metabolites.
Drug diversion: Prescription drugs provided to an individual other than the one to whom the drugs were prescribed.
Planned testing: Testing being conducted at a time previously scheduled and known to the individual being tested.
Presumptive testing: A type of testing that is intended to identify the use or non-use of a drug or general class of drugs.
Random testing: Testing being conducted at a time not previously scheduled and not known to the individual being tested.
Testing panel: A type of laboratory procedure where multiple tests are automatically run on a single sample to detect the presence of a variety of substances or class of substances.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Revised||02/05/2015||Medical Policy & Technology Assessment Committee (MPTAC) review.|
|Revised||01/29/2016||Behavioral Health Subcommittee review. Revised title to change "Substance Abuse" to "Substance Use Disorder". Added the use of blood, saliva, sweat, or hair to position statement. Revised Background, Coding and Reference sections.|
|01/01/2016||Updated Coding section with 01/01/2016 HCPCS changes, removed codes G0431, G0434, G6031, G6040, G6041, G6042, G6043, G6044, G6045, G6046, G6048, G6051, G6052, G6053, G6056, G6057, G6058 deleted 12/31/2015; also removed ICD-9 codes.|
|Revised||01/30/2015||Behavioral Health Subcommittee review. Revised clinical indications section to address "presumptive" and "definitive" testing. Clarified the limit of 24 tests per calendar year to be a rolling 24 year. Updated Discussion, Definitions, and Reference sections.|
|01/01/2015||Updated Coding section with 01/01/2015 CPT and HCPCS changes; removed deleted codes and codes 80184, 82491, 82492, 82541, 82542, 82543, 82544 (no longer applicable).|
|Revised||02/07/2014||Behavioral Health Subcommittee review. Added not medically necessary statement addressing the use of testing panels. Updated Discussion, Definitions, and Reference sections.|
|MPTAC review. Initial document development.|