Clinical UM Guideline
Subject: Drug Testing or Screening in the Context of Substance Use Disorder and Chronic Pain
Guideline #: CG-LAB-09 Publish Date: 10/01/2024
Status: Revised Last Review Date: 08/08/2024
Description

This document addresses the use of drug testing (using urine, blood, saliva, sweat or hair) in the outpatient setting for adherence monitoring in the following situations:

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.

Note: Sample validation is a method that is sometimes needed to assure source integrity. Quality assurance to assure sample integrity is part of expected clinical laboratory test management.

Note: For more information about pain biomarker urine testing, please see:

Clinical Indications

Medically Necessary:

Presumptive urine drug testing (UDT) to verify compliance with treatment, identify undisclosed drug use or abuse, or evaluate aberrant* behavior is considered medically necessary, beginning at the start of treatment, as part of a monitoring program tailored to the unique needs of individuals who are:

  1. Receiving treatment for chronic pain with prescription opioid or other potentially abused medications; or
  2. Undergoing treatment for, or monitoring for relapse of, opioid addiction or substance use disorder.

Presumptive urine drug testing is also considered medically necessary for the following:

  1. To assess an individual when clinical evaluation suggests use of non-prescribed medications or illegal substances; or
  2. On initial entrance into a pain management program or substance use disorder recovery program.

Definitive urine drug testing to verify compliance with treatment, identify undisclosed drug use or abuse, or evaluate aberrant* behavior is considered medically necessary, beginning at the start of treatment, as part of a monitoring program tailored to the unique needs of individuals whose requests meet criteria both A and B below:

  1. Testing indications- either 1 or 2 below must be present:
    1. Receiving treatment for chronic pain with prescription opioid or other potentially abused medications; or
    2. Undergoing treatment for, or monitoring for relapse of, opioid addiction or substance use disorder;
      and
  2. Testing scenarios- either 1 or 2 below have been met:
    1. Definitive testing following prior presumptive testing:
      1. The presumptive urine drug testing was done for a medically necessary reason; and
      2. The presumptive test was positive for an illegal drug (for example, but not limited to methamphetamine or cocaine), positive for a prescription drug with abuse potential which was not prescribed, or negative for prescribed medications; and
        1. The specific definitive test(s) ordered are supported by documented rationale for each test ordered; and
        2. Clinical documentation reflects how the results of the test(s) will be used to guide clinical care;
          or
    2. Definitive testing without prior presumptive testing:
      1. Presumptive urine drug tests are not available for the drug in question (examples may include, opioids and their metabolites such as fentanyl, meperidine, tramadol, and tapentadol, muscle relaxants and their metabolites such as carisoprodol, synthetic cannabinoids and their metabolites, as well as cathinones [“Bath Salts”] and their metabolites); and
      2. The specific definitive test(s) ordered are supported by documented rationale for each test ordered; and
      3. Clinical documentation reflects how the results of the test(s) will be used to guide clinical care.

*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.

Note: When testing exceeds 24 per year, review of medical records may be requested.

Note: Each definitive test request must be based on the tested individual’s diagnosis, substance use patterns, results of presumptive testing and other clinical factors documented in the medical record. Community patterns of illicit drug use must not be imputed to an individual without a documented rationale. UDT monitoring of prescribed drugs is not a clinically appropriate way to estimate the therapeutic effectiveness of prescribed drugs. Definitive testing for more than 7 classes of drugs (including metabolites) would be unusual for most individuals. For a list of drug classes, see the Appendix below.

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 use of any of the following for definitive drug testing of urine or blood samples is considered not medically necessary in all circumstances:

  1. Reflex testing; or
  2. Standing orders; or
  3. Blanket orders.
Coding

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.

When services may be Medically Necessary when criteria are met:

CPT

 

 

Presumptive Drug Class Screening codes:

80305

Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; capable of being read by direct optical observation only (eg, utilizing immunoassay [eg, dipsticks, cups, cards, or cartridges]) includes sample validation when performed, per date of service

80306

Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; read by instrument assisted direct optical observation (eg, utilizing immunoassay [eg, dipsticks, cups, cards, or cartridges]), includes sample validation when performed, per date of service

80307

Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; by instrument chemistry analyzers (eg, utilizing immunoassay [eg, EIA, ELISA, EMIT, FPIA, IA, KIMS, RIA]), chromatography (eg, GC, HPLC), and mass spectrometry either with or without chromatography, (eg, DART, DESI, GC-MS, GC-MS/MS, LC-MS, LC-MS/MS, LDTD, MALDI, TOF) includes sample validation when performed, per date of service

 

 

 

Definitive Drug Testing codes:

80320

Alcohols

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

80329

Analgesics, non-opioid, 1 or 2

80330

Analgesics, non-opioid, 3-5

80331

Analgesics, non-opioid, 6 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

80345

Barbiturates

80346

Benzodiazepines; 1-12

80347

Benzodiazepines; 13 or more

80348

Buprenorphine

80349

Cannabinoids, natural

80350

Cannabinoids, synthetic; 1-3

80351

Cannabinoids, synthetic; 4-6

80352

Cannabinoids, synthetic; 7 or more

80353

Cocaine

80354

Fentanyl

80355

Gabapentin, non-blood

80356

Heroin metabolite

80357

Ketamine and norketamine

80358

Methadone

80359

Methylenedioxyamphetamines

80360

Methylphenidate

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

80365

Oxycodone

80366

Pregabalin

80368

Sedative hypnotics (non-benzodiazepines)

80369

Skeletal muscle relaxants; 1 or 2

80370

Skeletal muscle relaxants; 3 or more

80371

Stimulants, synthetic

80372

Tapentadol

80373

Tramadol

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

83992

Phencyclidine (PCP)

0328U

Drug assay, definitive, 120 or more drugs and metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS), includes specimen validity and algorithmic analysis describing drug or metabolite and presence or absence of risks for a significant patient adverse event, per date of service
CareView360; NewStar Medical Laboratories

 

 

HCPCS

 

G0480

Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays [e.g., IA, EIA, ELISA, EMIT, FPIA] and enzymatic methods [e.g., alcohol dehydrogenase]), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day, 1-7 drug class(es), including metabolite(s) if performed

G0481

Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays [e.g., IA, EIA, ELISA, EMIT, FPIA] and enzymatic methods [e.g., alcohol dehydrogenase]), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day, 8-14 drug class(es), including metabolite(s) if performed

G0482

Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays [e.g., IA, EIA, ELISA, EMIT, FPIA] and enzymatic methods [e.g., alcohol dehydrogenase]), stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day, 15-21 drug class(es), including metabolite(s) if performed

G0483

Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays [e.g., IA, EIA, ELISA, EMIT, FPIA] and enzymatic methods [e.g., alcohol dehydrogenase]), stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day, 22 or more drug class(es), including metabolite(s) if performed

G0659

Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem), excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase), performed without method or drug-specific calibration, without matrix-matched quality control material, or without use of stable isotope or other universally recognized internal standard(s) for each drug, drug metabolite or drug class per specimen; qualitative or quantitative, all sources, includes specimen validity testing, per day, any number of drug classes

 

 

ICD-10 Diagnosis

 

 

All diagnoses

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

When services are also Not Medically Necessary:
For the following procedure codes, or when the code describes a procedure designated in the Clinical Indications section as not medically necessary.

CPT

 

0011U

Prescription drug monitoring, evaluation of drugs present by LC-MS/MS, using oral fluid, reported as a comparison to an estimated steady-state range, per date of service including all drug compounds and metabolites
Cordant CORE; Cordant Health Solutions

0082U

Drug test(s), definitive, 90 or more drugs or substances, definitive chromatography with mass spectrometry, and presumptive, any number of drug classes, by instrument chemistry analyzer (utilizing immunoassay), urine, report of presence or absence of each drug, drug metabolite or substance with description and severity of significant interactions per date of service
NextGen Precision Testing, Precision Diagnostics, Precision Diagnostics LBN Precision Toxicology, LLC

0093U

Prescription drug monitoring, evaluation of 65 common drugs by LC-MS/MS, urine, each drug reported detected or not detected
ComplyRX, Claro Labs

0116U

Prescription drug monitoring, enzyme immunoassay of 35 or more drugs confirmed with LC-MS/MS, oral fluid, algorithm results reported as a patient-compliance measurement with risk of drug to drug interactions for prescribed medications
Snapshot Oral Fluid Compliance, Ethos Laboratories

0227U

Drug assay, presumptive, 30 or more drugs or metabolites, urine, liquid chromatography with tandem mass spectrometry (LC-MS/MS) using multiple reaction monitoring (MRM), with drug or metabolite description, includes sample validation
Comprehensive Screen, Aspenti Health

0517U

Therapeutic drug monitoring, 80 or more psychoactive drugs or substances, LC-MS/MS, plasma, qualitative and quantitative therapeutic minimally and maximally effective dose of prescribed and non-prescribed medications
PrecisView® CNS, Phenomics Health Inc, Phenomics Health Inc

0518U

Therapeutic drug monitoring, 90 or more pain and mental health drugs or substances, LC-MS/MS, plasma, qualitative and quantitative therapeutic minimally effective range of prescribed and non-prescribed medications
SyncView® Pain, Phenomics Health Inc, Phenomics Health Inc

0519U

Therapeutic drug monitoring, medications specific to pain, depression, and anxiety, LC-MS/MS, plasma, 110 or more drugs or substances, qualitative and quantitative therapeutic minimally effective range of prescribed, non-prescribed, and illicit medications in circulation
SyncView® PainPlus, Phenomics Health Inc, Phenomics Health Inc

 

 

HCPCS

 

P2031

Hair analysis (excluding arsenic)

 

 

ICD-10 Diagnosis

 

 

All diagnoses

Discussion/General Information

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, the AAPM 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.

In 2017, the American Society of Addition Medicine (ASAM) published a document titled Appropriate Use of Drug Testing in Clinical Addiction Medicine (Jarvis, 2017). The ASAM provided an array of recommendations related to UDT and other drug testing procedures. The document included the following recommendations regarding presumptive and definitive testing:

The ASAM document also addressed testing frequency:

Finally, ASAM recommended the following related to UDT:

*Point of care tests.

In 2019 ASAM published a document titled Public Policy Statement on the Ethical Use of Drug Testing in the Practice of Addiction Medicine. This document contained important statements regarding the ethical use of drug testing, including:

  1. Drug testing should be used only when clinically necessary. Tests should be selected based on an individualized clinical assessment of the patient and performed after informed consent whenever possible.
    1. Clinicians should document the rationale for the drug tests they order and document the clinical decisions they make based on those tests. The use of drug screening panels that test for multiple classes of drugs or multiple compounds within a drug class is a pragmatic approach that can be helpful especially in primary care practices. Drug testing panels may be pragmatic for new patients in addiction treatment programs, but follow-up testing should be individualized to the patient's history, needs, initial test results, and drugs commonly used in the patient’s geographic location and peer group. (This may not be possible where an external entity such as a governmental agency requires routine testing drug panels to be performed periodically on a set time frame.)
    2. The use of drug testing panels which apply to every patient at every testing time regardless of the patient’s individual clinical history and needs may not be appropriate because this can result in over- or underutilization of diagnostic services.
  2. Presumptive testing should be a routine part of initial and ongoing patient assessment. Definitive testing may be used to detect specific substances not identified by presumptive methods and to refine the accuracy of the test results. Definitive testing may be used when the results are needed to inform clinical decisions where the results will alter the care plan.
    1. Clinical decisions may be made based on drug test results or on patient self-report of use. Patient self-report of negative use is often unreliable and positive self-report is complicated by purchasing of illicit drugs that are not consistent or reliable in their components.
    2. It is inappropriate to order definitive testing for all analytes in every drug test conducted on a patient and to do so repeatedly, without regard to the results from previous tests or the patient’s overall response to addiction treatment interventions. Ethical use of drug testing requires that the scope of the analyte panel and the frequency of testing be justified by the patient’s clinical status and the ordering clinician’s need for information.

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 pain. This guideline and related expert commentary support low-risk individuals having 1 UDTs up to once per year, moderate-risk up to 2 UDTs per year, high-risk individuals up to 3-4 UDTs per year. 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, the AMGD states that there is insufficient evidence to support this recommendation. This observation is reiterated in a 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, the McMillin review recommends testing no less than once weekly at first then once monthly once abstinence is established. Such limits apply to both presumptive and definitive testing. There is insufficient clinical reasoning to support the use of definitive testing at a frequency greater than for presumptive testing.

The American College of Obstetricians and Gynecologists (ACOG) recommends a screening interview for substance use be completed on the first prenatal visit as part of comprehensive obstetric care (2017). ACOG recommends following up with UDT to detect or confirm suspected substance use when the individual consents.

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 Revised Opioid Risk Tool (ORT-R or ORT-OUD; Cheatle, 2019). These tools aid clinicians in assessing the suitability of long-term opioid therapy for individuals with chronic pain, and help differentiate those who may 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.mcstap.com/docs/SOAPP-5.pdf. Four different versions are available to allow for varying levels of evaluation. All versions of the SOAPP tool may be self-administered at or prior to an office visit or can be completed as part of an interview with a nurse, physician or psychologist. The ORT was developed by Webster (2005) and was modified by Cheatle in 2019 (ORT-R/ORT-OUD). Like the SOAPP, it may be self-administered or used as part of a clinical evaluation. The ORT-R/ORT-OUD can be accessed for free at https://nida.nih.gov/nidamed-medical-health-professionals/screening-tools-resources/opioid-risk-tool-oud-ort-oud.

Presumptive versus 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

The 2017 ASAM recommendations (Jarvis, 2017) address the use of alternate sample matrices in the following statements:

These recommendations support the use of oral fluid testing for presumptive detection; however, the evidence cited in the guideline discussion consists of low-quality references including reviews and a study that evaluates the volume of oral fluid needed for an appropriate sample. The recommendations reference a Committee Opinion from the American College of Obstetricians and Gynecologists (ACOG) on ethical issues in relation to alcohol abuse and other substance use disorders. ACOG recommends routine screening with validated questionnaires or conversations and does not recommend routine laboratory testing of biologic samples for substance use disorders (ACOG, 2015). ASAM does suggest that oral fluid testing might be useful in some cases, but further research on which specific drugs and metabolites oral fluid testing might best detect is recommended (Jarvis, 2017).

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 documents, the benefits and drawbacks of drug testing using alternative sample sources is evaluated. However, in their primary care document (2012) SAMHSA clarifies that urine is the most widely used and studied source. This was reiterated in their 2014 Treatment Improvement Protocol (TIP) for opioid addiction programs.

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 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, 2015). The American Society of Transplantation recommends urine drug testing in individuals when needed to identify abuse and diversion and to guide treatment (Jowsey-Gregoire, 2022). The use of UDT is not possible in some circumstances. Individuals with renal failure who are on dialysis or those with bladder control impairments may be unable to provide a sample. In these limited circumstances, UDT may need to be replaced by blood tests.

There is growing support for the use of saliva testing, especially in cases where a urine sample is unobtainable, when such results may be unreliable, or when there is a history of urine sample tampering. However, as noted above, there is little evidentiary support for this approach.

In summary, the use of blood, hair, saliva, and sweat is not widely recommended and these matrices each have significant drawbacks to their use when compared to UDT.

Testing Panels

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.

Reflex testing, Standing orders, and Blanket orders

The use of reflex testing, standing orders, and blanket orders for definitive testing of urine or blood samples is contrary to good clinical practice, which is based on clinical decision-making as to the necessity of specific laboratory tests. In the case of these types of tests, they are done in the absence of the requisite clinical decision-making process and are based solely on automated processes devoid of clinical judgment. They do not meet the requirement for there to be documentation of a specific rationale for each ordered test and documentation of how the test will be used to modify treatment for the tested individual.

Definitions

Blanket order: A test request that is not for a specific individual, but it is an identical order for all individuals in a clinician’s practice. Such orders do not take the clinical situation of each individual into consideration at the time of request, or during each visit.

Definitive testing: A type of testing that is more specific than presumptive testing, and allows for the detection of specific drugs or metabolites.

Drug class: Drugs, medications or illicit substances (including metabolites of each member of the class) that share similar essential aspects of their chemical structure and at least one similar mechanism of action (i.e., bind to the same biological target). For example, opioids interact with one or more opioid receptor. Drugs associated with substance use disorders, including alcohol and inhalants, are thought to directly activate the brain reward system as a common mode of action.

Drug diversion: Prescription drugs provided to an individual other than the one to whom the drugs were prescribed.

Drug testing panel: A type of test that involves tests for more than one type of drug and may test for a pre-defined set of drug classes or metabolites of specific drugs or drug classes.

Member-specific profile: This term refers to the specific characteristics of an individual being treated for chronic pain or an individual undergoing treatment for opioid addiction and substance use disorder, which may be used to help guide treatment. These characteristics may include current and past alcohol and drug use patterns and clinical findings such as slurred speech, hallucinations or pin-point pupils that tend to be specific to a drug or drug class. Use of member-specific profiles assist in guiding the selection of the specific tests for drugs and their metabolites.

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.

Reflex Testing: A laboratory test that is performed "reflexively" after an initial or presumptive test result suggests the need for further diagnostic information. This type of testing is not based on a specific clinical situation and provider's order, but is built into the testing process. Testing performed as a step necessary to complete the request of physician responsible for a members care and provided by an order is not considered reflex testing.

Standing order: A test request for a specific individual representing: 1) repetitive testing to monitor a condition or disease, or 2) individualized orders for repetitive automatic testing for certain individuals for pre-determined tests based on historical use, risk, and community trend patient profiles. Definitive drug testing standing orders are not consistent with ordering laboratory testing based upon clinical findings, nor are they sensitive to the individual’s history of drug use and community patterns of drug use.

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.

References

Peer Reviewed Publications:

  1. Cheatle MD, Compton PA, Dhingra L, et al. Development of the revised opioid risk tool to predict opioid use disorder in patients with chronic nonmalignant pain. J Pain. 2019; 20(7):842-851.
  2. Christo PJ, Manchikanti L. Ruan X, et al. Urine drug testing in chronic pain. Pain Physician. 2011; 14(2):123-143.
  3. Owen GT, Burton AW, Schade CM, Passik S. Urine drug testing: current recommendations and best practices. Pain Physician. 2012; 15(3 Suppl):ES119-ES133.
  4. Melanson SE. The utility of immunoassays for urine drug testing. Clin Lab Med. 2012; 32(3):429-447.
  5. Melanson SE, Ptolemy AS, Wasan AD. Optimizing urine drug testing for monitoring medication compliance in pain management. Pain Med. 2013; 14(12):1813-1820.
  6. Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med. 2005; 6(6):432-442.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American College of Obstetricians and Gynecologists (ACOG). Committee opinion.
  2. American Society of Addiction Medicine (ASAM).
  3. Chou R, Fanciullo GJ, Fine PG, et al.; American Pain Society–American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009. 10(2):113-130.
  4. Centers of Medicare and Medicaid, Complying with documentation requirements for laboratory services. August 2018. Available at: https://www.cms.gov/files/document/mln909221-complying-documentation-requirements-lab-services.pdf. Accessed on July 23, 2024.
  5. Jarvis M, Williams J, Hurford M, et al. Appropriate Use of Drug Testing in Clinical Addiction Medicine. J Addict Med. 2017; 11(3):163-173.
  6. Jowsey-Gregoire S, Jannetto PJ, Jesse MT, et al. Substance use screening in transplant populations: Recommendations from a consensus workgroup. Transplant Rev (Orlando). 2022; 36(2):100694.
  7. Manchikanti L, Kaye AM, Knezevic NN, et al. Responsible, safe, and effective prescription of opioids for chronic non-cancer pain: American Society of Interventional Pain Physicians (ASIPP) guidelines. Pain Physician. 2017; 20(2S):S3-S92.
  8. McMillin GA, Slawson MH, Marin SJ, Johnson-Davis KL. Demystifying analytical approaches for urine drug testing to evaluate medication adherence in chronic pain management. J Pain Palliat Care Pharmacother. 2013; 27(4):322-339.
  9. New Hampshire Medical Society. New Hampshire Opioid Prescribing Risk. Opioid risk screening tools and articles. 2024. Available at: Opioid Risk Screening - New Hampshire Medical Society (nhms.org). Accessed on July 23, 2024.
  10. PainEDU.org. Screener and Opioid Assessment for Patients with Pain- Revised (SOAPP® -R) . Available at: https://d1li5256ypm7oi.cloudfront.net/colospine/2016/08/SOAPP-R-Screener-and-Opioid-Assessment-for-Patients-with-Pain-Revised-160816-57b258fc9a277.pdf . Accessed on August 8, 2024.
  11. U.S. Department of Health and Human Services. Substance Abuse and Mental Health Services Administration (SAMHSA).
  12. 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 therapy. 2015 Update. Available at: https://agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf. Accessed on August 8, 2024.
Index

Buprenorphine
Naloxone
Suboxone®

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.

History

Status

Date

Action

Revised

08/08/2024

Medical Policy & Technology Assessment Committee (MPTAC) review. Revised MN criteria addressing annual testing limit. Revised References section. Updated Coding section with 10/01/2024 CPT changes, added 0517U, 0518U, 0519U.

Reviewed

11/09/2023

MPTAC review. Updated Discussion/General Information and References section.

 

06/28/2023

Updated Coding section with 07/01/2023 CPT changes; removed 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, 0150U, codes deleted as of 07/01/2023.

Reviewed

11/10/2022

MPTAC review. Updated Description, Discussion and References section.

 

06/29/2022

Updated Coding section with 07/01/2022 CPT changes; added 0328U.

Reviewed

11/11/2021

MPTAC review. Updated Discussion and References section.

 

01/07/2021

Corrected date error in History section.

Reviewed

11/05/2020

MPTAC review. Updated Reference sections. Reformatted Coding section and updated with 01/01/2021 CPT changes, added PLA code 0227U.

Revised

05/14/2020

MPTAC review. Revised note in Clinical Indications section in relation to drug classes. Added Appendix section with drug class table. Updated Rationale and References sections. Updated Coding section; added codes 80329, 80330, 80331.

 

04/01/2020

Updated Coding section with 04/01/2020 CPT changes; removed 0006U deleted 03/31/2020.

Reviewed

11/07/2019

MPTAC review. Updated Rationale and References sections. Updated Coding section with 01/01/2020 CPT changes; added codes 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, 0150U.

 

10/01/2019

Updated Coding section with 10/01/2019 CPT changes; added 0116U, revised descriptor for 0082U.

 

06/27/2019

Updated Coding section with 07/01/2019 CPT changes; added 0093U.

Revised

01/24/2019

MPTAC review. Clarified MN statement for presumptive testing. Expanded MN statement regarding definitive testing. Added note regarding number of drug classes tested for during definitive testing. Updated Rationale and References sections.

 

12/27/2018

Updated Coding section with 01/01/2019 CPT changes; added 0082U.

 

06/28/2018

Updated Coding section with 07/01/2018 CPT changes; revised descriptor for code 0006U.

Reviewed

03/22/2018

MPTAC review.

Reviewed

02/23/2018

Behavioral Health Subcommittee review. Updated References section.

 

12/27/2017

The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Coding section with 01/01/2018 CPT descriptor changes for codes 80305-80307.

Revised

08/03/2017

MPTAC review.

Revised

07/21/2017

Behavioral Health Subcommittee review. Updated formatting in Clinical Indications section. Added new NMN statement regarding reflex testing, standing orders, and blanket orders. Updated Description, Discussion, and References sections. Updated Coding section with 08/01/2017 CPT changes; added 0006U and 0011U.

 

01/01/2017

Updated Coding section with 01/01/2017 CPT and HCPCS changes; removed codes 80300, 80301, 80302, 80303, 80304, G0477, G0478, G0479 deleted 12/31/2016.

Reviewed

08/04/2016

MPTAC review.

Reviewed

07/29/2016

Behavioral Health Subcommittee review. Updated Discussion and References sections.

Revised

02/04/2016

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 References 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

02/05/2015

MPTAC review.

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 References 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

02/13/2014

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 References sections.

New

11/14/2013

MPTAC review. Initial document development.

Appendix

The following table lists drugs and their metabolites in drug classes based on Generic Product Index level 2 classifications (GPI2), the FDA’s National Drug Classifications (NDC), PubChem classifications, and the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), but does not include every drug and metabolite. Metabolites not listed in the table should be categorized with their parent drug.

Drug Class

Drugs and Metabolites

 

Reference

 

Alcohols

Ethyl Glucuronide

PubChem

Ethyl Sulfate

PubChem

ETOH

PubChem

Methanol

PubChem

Analgesics, NonNarcotic

Acetaminophen

GPI2, PubChem

Diclofenac

DSM-5, NDC

Ibuprofen

DSM-5, NDC

Ketoprofen

DSM-5, NDC

Naproxen

DSM-5, NDC

Androgens, Anabolic

Anabolic Steroids

PubChem

Clostebol

PubChem

Danazol

GPI2, PubChem

Methyltestosterone

GPI2, PubChem, NDC

Anticonvulsants

Carbamazepine

GPI2, PubChem, NDC

Cannabidiol

GPI2, PubChem

Gabapentin

GPI2, PubChem

Lamotrigine

GPI2, PubChem, NDC

Phenytoin

GPI2, PubChem, NDC

Pregabalin

GPI2, PubChem

Primidone

GPI2, PubChem

Topiramate

GPI2, PubChem, NDC

Valproic Acid

GPI2, PubChem

Zonisamide

GPI2, PubChem

Antidepressants

Amitriptyline

GPI2, PubChem, NDC

Amoxapine

GPI2, PubChem

Bupropion

GPI2, PubChem, NDC

Citalopram

GPI2, PubChem

Desipramine

GPI2, PubChem, NDC

Desvenlafaxine

GPI2, PubChem, NDC

Doxepin

GPI2, PubChem, NDC

Duloxetine

GPI2, PubChem, NDC

Fluvoxamine

GPI2, PubChem

Fluoxetine

GPI2, PubChem

Escitalopram

GPI2, PubChem, NDC

Imipramine

GPI2, PubChem, NDC

Mirtazapine

GPI2, PubChem

Nefazodone

GPI2, PubChem

Nortriptyline

GPI2, PubChem, NDC

Paroxetine

GPI2, PubChem, NDC

Phenelzine

GPI2, PubChem

Selegiline

PubChem, NDC

Sertraline

GPI2, PubChem, NDC

Tranylcypromine

GPI2, PubChem, NDC

Trazodone

GPI2, PubChem, NDC

Venlafaxine

GPI2, PubChem, NDC

Vilazodone

GPI2, PubChem

Vortioxetine

GPI2, PubChem

Antipsychotics/Antimanic Agents

Aripiprazole

GPI2, PubChem, NDC

Cariprazine

GPI2, PubChem

Chlorpromazine

GPI2, PubChem, NDC

Clozapine

GPI2, PubChem, NDC

Haloperidol

GPI2, PubChem, NDC

Lurasidone

GPI2, PubChem

Olanzapine

GPI2, PubChem, NDC

Paliperidone

GPI2, PubChem, NDC

Perphenazine

GPI2, PubChem, NDC

Risperidone

GPI2, PubChem, NDC

Thioridazine

GPI2, PubChem, NDC

Ziprasidone

GPI2, PubChem, NDC

Barbiturates and Barbituate-Like Drugs

Amobarbital

GPI2, PubChem, DSM-5

Butabarbital

GPI2, PubChem, DSM-5

Butalbital

DSM-5, PubChem, NDC

Glutethimide

DSM-5, PubChem

Meprobamate

DSM-5, PubChem

Pentobarbital

GPI2, PubChem, DSM-5

Phenobarbital

GPI2, PubChem, DSM-5

Secobarbital

GPI2, PubChem, DSM-5

Benzodiazepine and Benzodiazepine-Like Drugs

Alprazolam

GPI2, PubChem, DSM-5, NDC

Chlordiazepoxide

GPI2, PubChem, DSM-5, NDC

Clonazepam

GPI2, PubChem, DSM-5, NDC

Clorazepate

GPI2, PubChem, DSM-5

Diazepam

GPI2, PubChem, DSM-5, NDC

Eszopiclone

GPI2, PubChem, DSM-5

Flumazenil

GPI2, PubChem, DSM-5, NDC

Lorazepam

DSM-5, PubChem, NDC

Oxazepam

GPI2, PubChem, DSM-5

Temazepam

GPI2, PubChem, DSM-5, NDC

Zaleplon

GPI2, PubChem, DSM-5

Zolpidem

DSM-5, PubChem

Cannabinoids

Dronabinol

PubChem

K2/Spice

PubChem

Marijuana

DSM-5

Marinol

PubChem

THC

PubChem

Cathinones

Bath salts

DSM-5, PubChem

Kratom

DSM-5, PubChem

Hallucinogen-Related Disorders, Other Hallucinogen Use Disorder

Atropine

PubChem

Dimethyltryptamine (DMT)

DSM-5, PubChem

DOM

DSM-5, PubChem

Jimson weed

DSM-5, PubChem

LSD (Ergolines)

DSM-5, PubChem

Mescaline (Phenylalkylamines)

DSM-5, PubChem

MDA

DSM-5, PubChem

MDEA

DSM-5, PubChem

MDMA

DSM-5, PubChem

Morning Glory Seeds

DSM-5, PubChem

Phenethylamine

PubChem

Psilocybin (Indoleamines)

DSM-5, PubChem

Salvia Divinorum

DSM-5, PubChem

Salvinorin

PubChem

Scopolamine

PubChem

Hallucinogen-Related Disorders, Phencyclidine Use Disorder

Phencyclidine

DSM-5, PubChem

Ketamine (Including Esketamine)

DSM-5, PubChem

Cyclohexamine (1-Phenylcyclohexylamine)

DSM-5, PubChem

Dizocilpine

DSM-5, PubChem

Norketamine

PubChem

Musculoskeletal Therapy Agents

Baclofen

GPI2, PubChem

Carisoprodol

GPI2, PubChem, NDC

Cyclobenzaprine

GPI2, PubChem, NDC

Metaxalone

GPI2, PubChem

Methocarbamol

GPI2, PubChem, NDC

Orphenadrine

GPI2, PubChem, NDC

Tizanidine

GPI2, PubChem

Opioids

6-Acetylmorphine (6-MAM)

PubChem

Acetylcodeine

PubChem

Acetylfentanyl

PubChem

Actiq

GPI2, PubChem

Alfentanil

GPI2, PubChem, NDC

Belbuca

GPI2, PubChem

Bunavail

GPI2, PubChem

Buprenorphine (for example, Subutex and others)

GPI2, PubChem, NDC

Butorphanol

GPI2, PubChem, NDC

Butrans

GPI2, PubChem

Codeine

GPI2, PubChem, NDC

Desomorphine

PubChem

Dextromethorphan

PubChem

Dextrophan

PubChem

Diacetylmorphine (commonly known as heroin)

PubChem

Diamorphine (commonly known as heroin)

PubChem

Dihydrocodeine

GPI2, PubChem, NDC

EDDP

PubChem

Fentanyl

GPI2, PubChem

Heroin

PubChem

Hydrocodone

GPI2, PubChem, NDC

Hydromorphone

GPI2, PubChem, NDC

Kratom

PubChem

Levorphanol

GPI2, PubChem

Meperidine

GPI2, PubChem, NDC

Methadone

GPI2, PubChem, NDC

Mitragynine

PubChem

Morphine

GPI2, PubChem, NDC

Naloxone

GPI2, PubChem, NDC

Naltrexone

GPI2, PubChem, NDC

Norfentanyl

PubChem

Noroxycodone

PubChem

Norpropoxyphene

PubChem

O-Desmethyltramadol

PubChem

Oxycodone

GPI2, PubChem, NDC

Oxymorphone

GPI2, PubChem, NDC

Pentazocine

GPI2, PubChem, NDC

Probuphine

GPI2, PubChem, NDC

Propoxyphene

GPI2, PubChem

Sublocade

GPI2, PubChem

Suboxone

GPI2, PubChem

Subutex

PubChem

Sufentanil

PubChem

Tapentadol

GPI2, PubChem

Tramadol

GPI2, PubChem, NDC

Ultram

GPI2, PubChem, NDC

Zubsolv

GPI2, PubChem, NDC

Other Drugs or Metabolites

Drugs or Metabolites Not Otherwise Specified

N/A

Other (or Unknown) Substance Use Disorder

Cortisol

DSM-5

Nitrous Oxide (“Laughing Gas”)

DSM-5

Amyl-, Butyl, Isobutyl-Nitrites

DSM-5

Betel Nut

DSM-5

Kava

DSM-5

Stimulants, Amphetamine-Type Substance

Amphetamine

DSM-5, PubChem, NDC

D/L Isomer Analysis

DSM-5, PubChem

Dextroamphetamine

DSM-5, PubChem, NDC

Lisdexamfetamine

DSM-5, PubChem

Methamphetamine

DSM-5, PubChem, NDC

Methylphenidate

DSM-5, PubChem, NDC

Phentermine

DSM-5, PubChem, NDC

Phenylpropanolamine

DSM-5, PubChem

Pseudoephedrine

PubChem

Ritalinic Acid

PubChem

Stimulants, Cocaine

Benzoylecgonine

DSM-5, PubChem

Cocaine

DSM-5, PubChem

Ecgonine Methyl Ester

DSM-5, PubChem

Tobacco Use Disorder

Cotinine

DSM-5, PubChem

Nicotine

DSM-5, PubChem

 


Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card.

Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner.

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