Clinical UM Guideline
|Subject:||Drug Testing or Screening in the Context of Substance Abuse and Chronic Pain|
|Guideline #:||CG-LAB-09||Current Effective Date:||01/01/2015|
|Status:||Revised||Last Review Date:||02/13/2014|
This document addresses the use of urine drug testing (UDT) in the outpatient setting for compliance monitoring of controlled substance use as part of the management of chronic pain and for individuals undergoing treatment for opioid addiction and substance abuse.
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.
Qualitative urine drug testing to verify compliance with treatment, identify undisclosed drug use or abuse, or evaluate aberrant* behavior is considered medically necessary up to 24 times per calendar year, 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.
Qualitative urine drug testing is also considered medically necessary for the following:
Quantitative urine drug testing is considered medically necessary when all of the following criteria are met:
Not Medically Necessary:
The use of qualitative urine drug testing is considered not medically necessary when the criteria above are not met.
The use of quantitative urine drug testing is considered not medically necessary when the criteria above are not met.
The use of qualitative or quantitative 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 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|
|G0431||Drug screen, qualitative; multiple drug classes by high complexity test method (eg, immunoassay, enzyme assay), per patient encounter|
|G0434||Drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter|
|G6040||Alcohol (ethanol); any specimen except breath|
|G6041||Alkaloids, urine, quantitative|
|G6042||Amphetamine or methamphetamine|
|G6043||Barbiturates, not elsewhere specified|
|G6044||Cocaine or metabolite|
|G6056||Opiate(s), drug and metabolites, each procedure|
|G6058||Drug confirmation, each procedure|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2015]|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2015]|
The use of urine drug testing (UDT) in individuals with a substance abuse issue 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 and American Academy of Pain Medicine 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 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 quantitative 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 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 four 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 for opioid use is the use of qualitative vs. quantitative testing. Qualitative testing usually utilizes immunoassay methodology and provides result information that is drug class, but does not identify the presence of specific drugs or metabolites. This method is very useful because it is quick, fairly accurate, and easily accessible. Quantitative testing is used to identify specific drugs or metabolites through a variety of methodologies, including mass spectrometry or chromatography. Quantitative tests are used to identify the specific drug or metabolite present and provide information regarding the concentration of that substance as well. Quantitative testing may be needed when qualitative results alone are not sufficient to guide clinical care. However, in most situations, the identification of the exact opioid being abused or quantity of another drug of abuse may not result in a different treatment plan. Quantitative testing, particular when performed repeatedly must be clinically meaningful and documentation must support the specific necessity of each quantitative assay performed as well as how that test result will affect clinical management.
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.
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.
Qualitative urine drug testing: A testing methodology which can identify the presence or absence of a substance belonging to a general class of drugs.
Quantitative urine drug testing: A testing methodology which can identify the presence or absence of a specific substance as well as its concentration.
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.
|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||02/13/2014||Medical Policy & Technology Assessment Committee (MPTAC) review.|
|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.|