Drug Testing in Pain Management and Substance Use Disorder Treatment

Number: 0965

Policy

Aetna considers presumptive urine drug testing medically necessary for the following indications for persons in chronic pain programs or substance use disorder program:

• Persons who are initiating treatment in a pain management or substance use disorder program; or
• Persons whose clinical evaluation suggests use of illegal substances or non-prescribed medications with abuse potential; or
• Suspected drug overdose in persons with unexplained coma or altered mental status, severe or unexplained cardiovascular stability, unexplained metabolic or respiratory acidosis, or seizures of undetermined etiology; or
• Monitoring of persons on chronic opioid therapy who are receiving treatment for chronic pain with prescription opioid or other potentially abused medications; or 
• Persons on chronic opioid therapy or other potentially abused medications who have a history of substance abuse, exhibit aberrant behavior (e.g., multiple lost prescriptions, multiple requests for early refill, obtained opioids from multiple providers, unauthorized dose escalation, and apparent intoxication), or who are otherwise at high risk for medication abuse (see appendix for validated standardized risk assessment tools); or
• Persons in a pain management or substance abuse program when medical records document testing as part of an active treatment plan.

To be considered medically necessary, drug testing should be individualized to test for substances only specific to the individual member's plan of treatment. Clinical documentation must specify how the test results will be used to guide clinical decision making. The medically necessary frequency of drug testing for any indication should be individualized to the treatment plan.

Aetna considers definitive or confirmatory urine drug testing medically necessary for persons who meet medical necessity criteria for presumtive urine drug testing, and have any of the following medically necessary indications for definitive testing:

• A presumptive test for the specific drug is not commercially available; or
• A presumptive test was negative for prescribed medications with abuse potential and the provider was expecting the test to be positive for the prescribed medication, and the member disputes the drug testing results; or
• A presumptive test was positive for a prescription drug with abuse potential that was not prescribed to the member and the member disputes the drug testing results; or
• A presumptive test was inconclusive or inconsistent; or
• A presumptive test was positive for an illegal drug and the member disputes the presumptive drug testing results.

Aetna considers the following drug tests not medically necessary

• Standing or blanket orders of drug tests (i.e., routine orders that are not individualized to the member's history and clinical presentation); or
• Simultaneous performance of presumptive and definitive tests for the same drugs or metabolites at the same time (Definitive testing should be guided by the results of presumptive testing); or 
• Same-day testing of the same drug or metabolites from two different specimen types (e.g., both a blood and a urine specimen); or
• Broad panels of drug tests (see Appendix) (to be considered medically necessary, the specific drugs being tested should be supported by the person's clinical presentation (e.g., drug abuse history, symptoms, physical findings). An exception may be in an emergency setting for persons in a coma or with altered mental status where a reliable history is not available); or
• Immunoassay (IA) testing to definitively identify or "confirm" a presumptive drug test result (e.g., performance by a clinician of a qualitative point-of-care test and ordering a presumptive test from a reference laboratory for the same drug). Definitive urine drug testing provides specific identification and/or quantification typically by gas chromatography-mass spectrometry (GC-MS) or liquid chromatography - tandem mass spectrometry (LC-MS/MS); or
• Reflex definitive testing of point-of-care presumptive urine drug tests (see Appendix); or
• Performance of definitive tests of excessive frequency not justified by medical necessity (for example, routine weekly ordering of definitive testing to confirm buprenorphine/norbuprenorphine levels without change in member status).

Aetna considers testing ordered by or on the behalf of third parties (e.g., courts, school, employment, sports and recreation, community extracurricular activities, residential monitoring, marriage licensure, insurance eligibility) not medically necessary treatment of disease.

Aetna considers serum drug testing medically necessary in emergency room settings or when urine testing is not feasible (e.g., persons in renal failure).

For drug testing by oral fluid analysis, see CPB 0608 - Salivary Tests.

For drug testing by hair analysis, see CPB 0300 - Hair Analysis.

Note: Specimen verification is considered part of a laboratory's quality assurance process and is not separately reimbursed.

Note: This CPB does not address therapeutic drug monitoring, drug testing in the emergency room, or monitoring of persons prescribed drugs with abuse potential that are prescribed outside of a pain management program or substance use disorder program (e.g., amphetamines for attention-deficit hyperactivity disorder, benzodiazepines for anxiety disorders, certain controlled drugs indicated for seizure disorders).

Background

Urine Drug Testing is an important tool in the care of patients with substance use disorder, chronic pain and other medical conditions. The challenge for clinicians who order these tests is making sure that the test they order for each individual patient is the right test, done in the right order and right frequency in a manner consistent with clinical practice guidelines.

A presumptive urine drug test uses an immunoassay to qualitatively identify the presence or absence of one or more drugs or drug classes (ASAM, 2017).

Definitive urine drug testing is a quantitative test that identifies a specific drug or metabolite by a specific test such as gas chromatography mass spectrometry (GC-MS) or liquid chromatography tandem mass spectrometry (LC-MS/MS). Definitive urine drug testing is typically used to confirm a presumptive urine drug test (ASAM, 2017).

A white paper by the American Society of Addiction Medicine (ASAM, 2017) stated that, in general, a presumptive immunoassay test result 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). The ASAM also stated that random testing schedules are preferred to fixed testing schedules. 

The ASAM appropriate use criteria for drug testing in clinical addiction medicine (Jarvis, et al., 2017) state that presumptive testing provides immediate, albeit less accurate, results and should be a routine part of patient assessment. The ASAM stated that urine testing is the best specimen type for presumptive testing, as well as for testing at the point of care. The ASAM states that definitive testing should be used where highly accurate results are needed, when necessary to quantify substance levels, and where necessary to detect specific substances not identified by presumptive methods. The ASAM stated that definitive testing should be used when the results will inform decisions that have major implications for the patient, such as changes in medications, transitions in treatment, and where test results have legal implications. They also stated that definitive testing should be done when the patient disputes the results of a presumptive test.

The ASAM appropriate use criteria for drug testing in addiction (Jarvis, et al., 2017) stated that the frequency of testing should be dictated by patient acuity and level of care. Clinicians should consider the tests' detection capabilities, including the window of detection, in determining the appropriate frequency of testing. Drug testing should be scheduled more frequently at the beginning of treatment, and less frequently as recovery progresses. They state that drug testing should occur on a random schedule, and recommend testing at least weekly during the intial phase of substance abuse treatment. They recommend at least monthly random drug testing once a patient is stable, with consideration of less frequent testing for patients in stable recovery. The appropriate use criteria noted that, although increasing the frequency of drug testing increases the likelihood of detection, there is insufficient evidence that increasing the frequency of drug testing affects the substance abuse itself.

An ASAM public policy statement on the ethical use of drug testing in addiction medicine (ASAM, 2019) states that drug tests should be selected based on an individualized clinical assessment of the patient. The scope of the analyte panel and the frequency of testing should be justified by the patient’s clinical status and the ordering clinician’s need for information. They state that clinicians should document the rationale for the drug tests they order and the decisions they make based on the test results. They state that panels that test for multiple drugs may be useful 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. They noted that it is not appropriate to use drug testing panels for every patient at every testing time regardless of the patient’s individual clinical history and needs. The public policy statement said that it is inappropriate to repeatedly order definitive testing for all analytes in every drug test, without regard to the results from previous tests or the patient’s overall response to addiction treatment interventions.

American Pain Society (APS) and American Academy of Pain and Medicine (AAPM) joint clinical practice guidelines on the use of opioid therapy in chronic noncancer pain (Chou, et al., 2009) state that most urine drug screening tests utilize immunoassays, but cross-reactivity between various drugs and chemicals can cause false positive results. The guidelines state that urine tests based on gas chromatography-mass spectrometry are considered the most specific for identifying individual drugs and metabolites and are often used to confirm positive immunoassay results.

The Centers for Disease Control and Prevention (CDC) guidelines on opioids for chronic pain (Dowell, et al., 2016) recommends: “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."

The Washington State Agency Medical Directors' Group published an Interagency Guideline on opioid dosing for chronic non-cancer pain (AMDG, 2010). This guideline recommends that low risk individuals have urine drug testing 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. 

Appendix

Documentation Requirements

Drugs or drug classes for which screening is performed should only reflect those likely to be present based on the member's medical history or current clinical presentation. Each drug or drug class being tested for must be ordered by the clinician and documented in the member's medical record. Additionally, the clinician’s documentation must be specific to the member and accurately reflect the need for each test.

If definitive testing for an individual drug or drugs (qualitative or quantitative) is required based on the member's specific history and treatment plan and the indications above, a targeted and limited number of tests defined by codes in the CPT range 80320 - 80377 is generally medically necessary; the rationale for each test ordered should be included in the medical record.

If definitive testing for substances of abuse are medically necessary based on the member's specific history and treatment plan and the indications above, HCPCS G0480 (1 - 7 drug classes) or G0481 (8 - 14 drug classes) should be used. When choosing between G0480 and G0481, the clinician should consider which drug classes are pertinent to the care of each member based on the medical indications listed above; the target drug classes should be documented on the order for the test and in the medical record.

Definitive tests G0482 (15 – 21 drug classes) and G0483 (22 or more drug classes) are rarely medically necessary for routine testing in the outpatient setting. In the rare instances where these tests may be medically necessary, the medical record must include a specific rationale, based on the history and other relevant details (including a detailed list of all drug classes in question), for such expansive definitive testing.

Examples of Validated Risk Assessment Tools

The following are links to standard validated tools for assessing the risk for abuse:

• Screener and Opioid Assessment for Patients with Pain (SOAPP) 
• Opioid Risk Tool.

Note on Medical Necessity of Reflex Testing

Reflex definitive testing is not considered medically necessary when presumptive testing is performed at point of care because the clinician should have sufficient information to determine if confirmation of a presumptive test is needed, such as when the member admits to using a particular drug, or the immunoassay cut-off is sufficiently low that the clinician is satisfied with the presumptive test . If the clinician is not satisfied, he can then order specific subsequent definitive testing. 

Because reference laboratories do not have access to patient-specific data, it is considered medically necessary for a reference lab to reflex to a definitive test before reporting a positive presumptive result to the clinician. It is also considered medically necessary for a reference lab to reflex to a definitive test to confirm the absence of prescribed medications when a negative presumptive result is obtained for a prescribed medication listed by the ordering physician.

Table: CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+" :
CPT codes covered if selection criteria are met:
0007U	Drug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, includes specimen verification including DNA authentication in comparison to buccal DNA, per date of service
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
0054U	Prescription drug monitoring, 14 or more classes of drugs and substances, definitive tandem mass spectrometry with chromatography, capillary blood, quantitative report with therapeutic and toxic ranges, including steady-state range for the prescribed dose when detected, per date of service
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
80375	Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1-3
80376	4-6
80377	7 or more
CPT codes not covered for indications listed in the CPB:
0051U	Prescription drug monitoring, evaluation of drugs present by LC-MS/MS, urine, 31 drug panel, reported as quantitative results, detected or not detected, per date of service
0078U	Pain management (opioid-use disorder) genotyping panel, 16 common variants (ie, ABCB1, COMT, DAT1, DBH, DOR, DRD1, DRD2, DRD4, GABA, GAL, HTR2A, HTTLPR, MTHFR, MUOR, OPRK1, OPRM1), buccal swab or other germline tissue sample, algorithm reported as positive or negative risk of opioid-use disorder
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
0093U	Prescription drug monitoring, evaluation of 65 common drugs by LC-MS/MS, urine, each drug reported detected or not detected
0143U - 0150U	Drug assay, definitive, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS) using multiple reaction monitoring (MRM), with drug or metabolite description, comments including sample validation, per date of service
HCPCS codes covered if selection criteria are met:
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	qualitative or quantitative, all sources, includes specimen validity testing, per day, 8-14 drug class(es), including metabolite(s) if performed
G0482	qualitative or quantitative, all sources, includes specimen validity testing, per day; 15-21 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 (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase), performed in a single machine run without drug or class specific calibrations; qualitative or quantitative, all sources, includes specimen validity testing, per day
G2074	Medication assisted treatment, weekly bundle not including the drug, including substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)
HCPCS codes not covered for indications listed in the CPB:
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
ICD-10 codes covered if selection criteria are met:
F10.10 - F19.99	Substance use disorder, and drug abuse
G89.21 - G89.29	Chronic pain
T50.901A - T50.901S	Poisoning by unspecified drugs, medicaments and biological substances, accidental (unintentional)
T50.911A - T50.912S	Poisoning by, adverse effect of and underdosing of multiple unspecified drugs, medicaments and biological substances [suspected drug overdose]
Z79.891	Long term (current) use of opiate analgesic. Long term (current) use of methadone for pain management
Z86.59	Personal history of other mental and behavioral disorders [history of substance abuse]

The above policy is based on the following references: