Coverage Policy Manual
Policy #: 2009013
Category: Laboratory
Initiated: July 2009
Last Review: October 2018
  Testing for Drugs of Abuse or Drugs at Risk of Abuse Including Controlled Substances

Description:
Testing of various body fluids (usually urine or blood) or other samples (e.g., hair, sweat, saliva, or nails) is routinely performed to seek evidence for the use of an illicit or prescribed substance by a person.  
 
Typically, a urine specimen is obtained under controlled circumstances and the specimen is analyzed by immunoassay for the presence of specific drugs or drug-classes.  Because of the possibility of false positives using the immunoassay screening techniques, positive results may need confirmation with more specific and expensive methods, such as gas chromatography, mass spectroscopy, or high-performance liquid chromatography.
 
For physicians prescribing medications that have the potential for abuse, misuse or diversion, periodic urine drug testing may assist the physician in monitoring pain therapy compliance, detect other nonprescribed pain medications and test for other drugs of abuse or drugs at risk of abuse including controlled substances.  
 
This policy does not apply to the regular measurement of serum levels of drugs (with established therapeutic ranges) in order to ensure that there are sufficient levels in the blood to be therapeutically effective, while avoiding potentially toxic excess.  Examples of drugs with established therapeutic ranges include, but are not limited to: carbamazepine, digoxin, gentamicin, haloperidol, lithium, procainamide, phenobarbital, phenytoin, theophylline, tobramycin, valproic acid and vancomycin. In addition, this policy does not apply to testing for blood alcohol levels or mandatory work or legal drug testing.
 
Coding
 
In January 2017, CPT introduced 3 new permanent Presumptive Drug Class Screening (PDCS) codes (80305-80307). These codes are intended to replace the temporary “G” codes (G0477- G0479) established by CMS which have been terminated in January 2017. Additionally, the PDCS CPT codes that were established in 2015 (80300-80304) have been deleted this year.
 
For presumptive testing: Only one of the three presumptive codes may be billed per day. Note: See Policy/Coverage Section for coverage determination of each code.
 
80305 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.
 
80306 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.
 
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.
 
For definitive testing: Both CPT and HCPCS include code sets for billing definitive testing. Note: See Policy/Coverage Section for coverage determination of each code.
 
CPT
In 2015, CPT introduced new Definitive Drug Testing codes (80320-80377; 83992). Each category of a drug class, including metabolite(s) if performed (except stereoisomers), is reported once per date of service. Definitive drug procedures that are not specified in 80320-80377; 83992 should be reported using the unlisted definitive procedure codes 80375-80377; 83992, unless the specific analyte is listed in the Therapeutic Drug Assays (80150-80203) or Chemistry (82009-84830).
 
HCPCS
In January 2016, CMS introduced four codes to be used to bill definitive testing. The appropriate code should be chosen from one of the four codes based on the number of drug classes tested. Each drug class can only be used once per day when determining which code to bill. Note: See Policy/Coverage Section for coverage determination of each code.
 
 
Code: 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
 
Code: 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), (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; 15-21 drug class(es), including metabolite(s) if performed
 
Code: 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), (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; 22 or more drug class(es), including metabolite(s) if performed
 
Effective January 1, 2017 CMS introduced HCPCS code G0659 to capture drug tests performed by physician office laboratories 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,   
 
Code: 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
 
Coding and Processing Guidelines:
Services performed for urine testing for drugs of abuse should be submitted according to the following guidelines:
 
Screening (Presumptive) Testing
    • Three CPT codes are available for Drug Screening (Presumptive Testing). These codes include 80305, 80306, 80307. Please note that per Coverage Policy #2009013, Services billed using CPT 80307 do not meet member benefit certificate primary coverage criteria and are not covered.
    • Only one presumptive code (80305 or 80306) may be billed per day.
    • There is a limit of a maximum of one unit of procedure code 80305 or 80306 per date of service.
    • There is a limit of 24 screening services per year (combined total of 80305 and 80306).
    • Drug screening tests performed on saliva, hair, swear, or nails are not covered.
Confirmatory (Definitive) Testing
    • Confirmatory (Definitive) Testing should be billed using the HCPCS codes G0480-G0482 and G0659 as appropriate
    • Please note that per Coverage Policy #2009013 Services billed using HCPCS G0483 do not meet member benefit certificate primary coverage criteria and are not covered.
    • Only one of the five definitive codes (G0480, G0481, G0482, G0483, G0659) may be billed per day.
    • There is a limit of a maximum of one unit of procedure code G0480-G0483 and/or G0659 per date of service.
    • There is a limit of 24 confirmatory services per year (combined total of G0480-G0482 and/or G0659)
    • Confirmatory (definitive) drug testing performed on saliva, hair, sweat, or nails is not covered.
 
For definitive testing, the selection of the correct definitive G code to bill is based on two factors:
 
1. The use or absence of specific (1) calibration controls, (2) quality controls, and (3) internal standards. (CMS, 2017)
 
2. The number of drug classes documented as tested.
 
          • The available drug classes are specified by CMS.
          • The AMA CPT Manual may be consulted for examples of individual drugs within each drug class.
 
Report a code from range G0480 – G0483 if the drug testing method utilized “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 “method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift)” (CMS, 2017)
 
G0659 must be reported if the definitive drug testing method was 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.
 
Specimen validity testing is not eligible to be separately billed under any procedure codes (e.g. 81000, 81001, 81002, 81003, 81005, 81099, 82570, 83986, or any other code). This is because for all codes in range 80305 – 80307 & G0480 – G0483, G0659, the code description indicates that this testing is included if it was performed.
 
CPT codes 80321-80377; 83992 are not accepted for processing claims. These services should be reported with G0480-G0483, G0659.

Policy/
Coverage:
EFFECTIVE BEGINNING JANUARY 1, 2019:
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Screening (Presumptive) testing meets member benefit certificate primary coverage criteria when performed using immunoassay (e.g., dipsticks, cups, cards or cartridges) devices or procedures either capable of being read by direct optical observation only or read by instrument assisted direct optical observation as described in CPT codes 80305 and 80306.
 
Confirmatory (Definitive testing)  (G0480-G0482 or G0659) for specific drugs of abuse or drugs at risk of abuse including controlled substances meets member benefit certificate primary coverage criteria only when a precedent qualitative drug screen (80305-80306) has been positive for the specific drug or drug class. For cases in which a specific drug test is performed in the absence of a positive drug screen, medical records should be submitted to justify the exception (e.g., in the event of an unexpected negative test where medication diversion may be expected).
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Testing for drugs of abuse or drugs at risk of abuse using hair, sweat, saliva, or nail specimens does not meet member benefit certificate primary coverage criteria.
 
For members with contracts without primary coverage criteria, testing for drugs of abuse using hair, sweat, saliva, or nail specimens is considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Confirmatory (Definitive testing)  (G0480-G0483; G0659) for specific tests for drugs of abuse or drugs at risk of abuse including controlled substance, in the absence of a positive drug screen do not meet member benefit primary coverage criteria for effectiveness as such additional testing is not cost-effective.
 
For members with contracts without Primary Coverage Criteria, Confirmatory (Definitive testing)  (G0480-G0483; G0659) specific tests for drugs of abuse or drugs of risk of abuse including controlled substance, in the absence of a positive drug screen, are considered not medically necessary and are not covered. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
The use of quantitative testing [i.e., definitive (80321-80377; 83992 or G0480-G0483; G0659) or complex presumptive (80307)] as a drug screen does not meet member benefit certificate primary coverage criteria because such testing is not cost-effective.
 
For members with contracts without Primary Coverage Criteria, the use of quantitative testing [i.e., definitive 80321-80377; 83992 or G0480-G0483; G0659) or complex presumptive (80307)] as a drug screen is considered not medically necessary and is not covered. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Confirmatory (Definitive testing) of more than 21 drug classes as described in HCPCS code G0483 do not meet member benefit certificate primary coverage criteria.
 
For members with contracts without Primary Coverage Criteria, Confirmatory (Definitive testing) of more than 21 drug classes as described in HCPCS code G0483 is considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
The use of genetic testing for specimen validity, authentication or for any other reason, including but not limited to the use of the ToxLok (CPT 0020U) or the ToxProtect (CPT 0007U) test does not meet member benefit certificate primary coverage criteria.
 
For members with contracts without primary coverage criteria, the use of genetic testing for specimen validity, authentication or for any other reason, including but not limited to the use of the ToxLok (CPT 0020U) or the ToxProtect (CPT 0007U) test is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
The use of prescription drug monitoring panel tests, including but not limited to the Aegis InterACT Rx (CPT 0006U) and the Cordant Core test (CPT 0011U)  does not meet member benefit certificate primary coverage criteria.
 
For members with contracts without primary coverage criteria, the use of prescription drug monitoring panel tests , including but not limited to the Aegis InterACT Rx (CPT 0006U) and the Cordant Core test (CPT 0011U)  is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective January 2017 - December 2018
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Quantitative or Definitive testing (80320-80377 or G0480-G0483; G0659) for specific drugs of abuse or drugs at risk of abuse including controlled substances meets member benefit certificate primary coverage criteria only when a precedent qualitative drug screen (80305-80306) has been positive for the specific drug or drug class. For cases in which a specific drug test is performed in the absence of a positive drug screen, medical records should be submitted to justify the exception (e.g., in the event of an unexpected negative test where medication diversion may be expected).
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Quantitative or Definitive testing (80320-80377 or  G0480-G0483; G0659) for specific tests for drugs of abuse or drugs at risk of abuse including controlled substance, in the absence of a positive drug screen do not meet member benefit primary coverage criteria for effectiveness as such additional testing is not cost-effective.
 
For members with contracts without Primary Coverage Criteria, Quantitative or Definitive testing (80320-80377 or G0480-G0483; G0659) specific tests for drugs of abuse or drugs of risk of abuse including controlled substance, in the absence of a positive drug screen, are considered not medically necessary and are not covered. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
The use of quantitative testing [i.e., definitive (80320-80377 or G0480-G0483; G0659) or complex presumptive (80307)] as a drug screen does not meet member benefit certificate primary coverage criteria because such testing is not cost-effective.
 
For members with contracts without Primary Coverage Criteria, the use of quantitative testing [i.e., definitive (80320-80377 or G0480-G0483; G0659) or complex presumptive (80307)] as a drug screen is considered not medically necessary and is not covered. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Effective January 2016 – December 2016
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Quantitative or Definitive testing (80320-80377 or G0480-G0483) for specific drugs of abuse or drugs at risk of abuse including controlled substances meets member benefit certificate primary coverage criteria only when a precedent qualitative drug screen (80300-80301 or G0477-G0478) has been positive for the specific drug. For cases in which a specific drug test is performed in the absence of a positive drug screen, medical records should be submitted to justify the exception (e.g., in the event of an unexpected negative test where medication diversion may be expected).
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Quantitative or Definitive testing (80320-80377 or  G0480-G0483) for specific tests for drugs of abuse or drugs at risk of abuse including controlled substance, in the absence of a positive drug screen do not meet member benefit primary coverage criteria for effectiveness as such additional testing is not cost-effective.
 
For members with contracts without Primary Coverage Criteria, Quantitative or Definitive testing (80320-80377 or G0480-G0483) specific tests for drugs of abuse or drugs of risk of abuse including controlled substance, in the absence of a positive drug screen, are considered not medically necessary and are not covered. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
The use of quantitative testing as a drug screen (80302-80304 or G0479) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and such testing is not cost-effective.
 
For members with contracts without Primary Coverage Criteria, the use of quantitative testing as a drug screen (80302-80304 or G0479) is considered not medically necessary and is not covered. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Effective February 2015 – December 2015
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Quantitative or Definitive testing (80320-80377 or G6030-G6058) for specific drugs of abuse or drugs at risk of abuse including controlled substances meets member benefit certificate primary coverage criteria only when a precedent qualitative drug screen (80300-80301 or G0431, G0434)  has been positive for the specific drug. For cases in which a specific drug test is performed in the absence of a positive drug screen, medical records should be submitted to justify the exception (e.g., in the event of an unexpected negative test where medication diversion may be expected).
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Quantitative or Definitive testing (80320-80377 or G6030-G6058) for specific tests for drugs of abuse or drugs at risk of abuse including controlled substance, in the absence of a positive drug screen do not meet member benefit primary coverage criteria for effectiveness as such additional testing is not cost-effective.
 
For members with contracts without Primary Coverage Criteria, Quantitative or Definitive testing (80320-80377 or G6030-G6058) specific tests for drugs of abuse or drugs of risk of abuse including controlled substance, in the absence of a positive drug screen, are considered not medically necessary and are not covered. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
The use of quantitative testing as a drug screen (80302-80304) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and such testing is not cost-effective.
 
For members with contracts without Primary Coverage Criteria, the use of quantitative testing as a drug screen (80302-80304) is considered not medically necessary and is not covered. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Effective June 2011- January 2015
Testing for specific drugs of abuse or drugs at risk of abuse including controlled substances meets member benefit primary coverage criteria only when a precedent drug screen has been positive for the specific drug.  For cases in which a specific drug test is performed in the absence of a positive drug screen, medical records should be submitted to justify the exception.
  
Specific tests for drugs of abuse or drugs of risk of abuse including controlled substance, in the absence of a positive drug screen do not meet member benefit primary coverage criteria for effectiveness as such additional testing is not cost-effective.
  
For contracts without Primary Coverage Criteria, specific tests for drugs of abuse or drugs of risk  of abuse including controlled substance, in the absence of a positive drug screen, are considered investigational and are not covered. Investigational services are an exclusion in the member benefit certificate.
 
Effective May 2011
Testing for specific drugs of abuse or drugs at risk of abuse including controlled substances meets member benefit primary coverage criteria only when a precedent drug screen has been positive for the specific drug.  For cases in which a specific drug test is performed in the absence of a positive drug screen, medical records should be submitted to justify the exception.
 
Specific tests for drugs of abuse or drugs of risk of abuse including controlled substance, in the absence of a positive drug screen do not meet member benefit primary coverage criteria for effectiveness as such additional testing is not cost-effective.
 
For contracts without Primary Coverage Criteria, specific tests for drugs of abuse or drugs of risk of abuse including controlled substance, in the absence of a positive drug screen, are considered investigational and are not covered. Investigational services are an exclusion in the member benefit certificate.
 
This policy does not apply to assays of therapeutic drugs for the purpose of managing the drug therapy or testing for blood alcohol levels.
 
A chain of custody for the specimen must be documented.
 
Effective Prior to May 2011
Testing for specific drugs of abuse meets member benefit primary coverage criteria only when a precedent drug screen has been positive for the specific drug.  For cases in which a specific drug test is performed in the absence of a positive drug screen, medical records should be submitted to justify the exception.
 
Specific tests for drugs of abuse, in the absence of a positive drug screen do not meet member benefit primary coverage criteria for effectiveness as such additional testing is not cost-effective.
 
For contracts without Primary Coverage Criteria, specific tests for drugs of abuse, in the absence of a positive drug screen, are considered investigational and are not covered. Investigational services are an exclusion in the member benefit certificate.
 
This policy does not apply to assays of therapeutic drugs for the purpose of managing the drug therapy or testing for blood alcohol levels.
 
A chain of custody for the specimen must be documented.

Rationale:
This policy was initiated in June 2009 to address payment for multiple specific drug tests in patients who had either not had a drug screen or who had a negative drug screen.  While false positives are a problem with drug screens, false negatives are not an issue.  A positive result on a drug screen should not be considered definitive without a confirmatory test (a negative test on a drug screen does not require a confirmatory test except in rare instances when the use of "blocking" drugs is suspected) (Jaffee, 2008).
  
The appropriate test to detect the presence of drugs of abuse or drugs of potential abuse, misuse or diversion is a drug screen, usually using a urine specimen collected, stored, and transferred under controlled conditions. Laboratories shall have their own procedures to ensure the security and validity of each specimen. Testing for specific drugs in the absence of a positive screening test does not meet member benefit certificate primary coverage criteria for effectiveness as such additional testing is not cost-effective.
 
Center for Disease Control and Prevention
The Center for Disease Control and Prevention published a guideline for prescribing opioids for chronic pain (CDC, 2018).  In this guideline, the CDC has indicated that urine drug testing should be considered by clinicians for use prior to starting therapy and then annually and/or randomly going forward.  Urine drug testing can aid the clinician in assessing prescribed medication use and possible opioid-related harm.  The prescriber should take steps to evaluate the patient for risk factors associated with opioid-related harm.  Based on a patient’s risk factors, the provider should then determine the need for and frequency of testing.
 
Center for Disease Control and Prevention
The Center for Disease Control and Prevention published a guideline for prescribing opioids for chronic pain (CDC, 2018).  In this guideline, the CDC has indicated that urine drug testing should be considered by clinicians for use prior to starting therapy and then annually and/or randomly going forward.  Urine drug testing can aid the clinician in assessing prescribed medication use and possible opioid-related harm.  The prescriber should take steps to evaluate the patient for risk factors associated with opioid-related harm.  Based on a patient’s risk factors, the provider should then determine the need for and frequency of testing.
 
The recommendation does not specify a specific modality to use for the urine drug testing. However, it does indicate that in most instances initial drug testing can be performed with an immunoassay panel. Confirmatory testing should be based on the need to detect a specific drug that cannot be detected on the immunoassay panel or in the event of an unexpected drug showing up on the urine drug test results.
 
Genetic Testing for Specimen Validity and Prescription Drug Monitoring Panels
Emerging technology is being used to validate urine samples and to monitor adherence to dosing regimens. Genetic tests have been developed that use DNA markers to aid in validation of the identity of laboratory specimens, including but not limited to the ToxLok™ (InSource Diagnostics) and the ToxProtect™ (Genotox Laboratories) tests.
 
Additionally, tests have been developed to aid in the management of prescription drug regimens. The Cordant Core test is designed to help evaluate whether a patient’s drug concentration is within the expected range for the patient’s particular prescribed dosing regimen. The test uses the patient’s weight, dose frequency and oral fluid pH along with a patent-pending algorithm to evaluate whether the sample is within the expected steady state range through oral fluid testing. The Aegis InterACT Rx (formerly identified as the Aegis Drug-Drug Interaction test) test is designed to test for drug-drug interaction to reduce the risk of adverse drug. The test detects over 1200 substances known to cause drug-drug interactions.
 
There is currently a lack of peer-review published scientific literature regarding the clinical utility of genetic testing for specimen validity and prescription drug monitoring panels.

CPT/HCPCS:
0006UDetection of interacting medications, substances, supplements and foods, 120 or more analytes, definitive chromatography with mass spectrometry, urine, description and severity of each interaction identified, per date of service
0007UDrug 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
0011UPrescription 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
0020UDrug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, with specimen verification including DNA authentication in comparison to buccal DNA, per date of service
0082UDrug 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
80299Quantitation of therapeutic drug, not elsewhere specified
80305Drug 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
80306Drug 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
80307Drug 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
80321Alcohol biomarkers; 1 or 2
80322Alcohol biomarkers; 3 or more
80323Alkaloids, not otherwise specified
80324Amphetamines; 1 or 2
80325Amphetamines; 3 or 4
80326Amphetamines; 5 or more
80327Anabolic steroids; 1 or 2
80328Anabolic steroids; 3 or more
80332Antidepressants, serotonergic class; 1 or 2
80333Antidepressants, serotonergic class; 3-5
80334Antidepressants, serotonergic class; 6 or more
80335Antidepressants, tricyclic and other cyclicals; 1 or 2
80336Antidepressants, tricyclic and other cyclicals; 3-5
80337Antidepressants, tricyclic and other cyclicals; 6 or more
80338Antidepressants, not otherwise specified
80339Antiepileptics, not otherwise specified; 1-3
80340Antiepileptics, not otherwise specified; 4-6
80341Antiepileptics, not otherwise specified; 7 or more
80342Antipsychotics, not otherwise specified; 1-3
80343Antipsychotics, not otherwise specified; 4-6
80344Antipsychotics, not otherwise specified; 7 or more
80345Barbiturates
80346Benzodiazepines; 1-12
80347Benzodiazepines; 13 or more
80348Buprenorphine
80349Cannabinoids, natural
80350Cannabinoids, synthetic; 1-3
80351Cannabinoids, synthetic; 4-6
80352Cannabinoids, synthetic; 7 or more
80353Cocaine
80354Fentanyl
80355Gabapentin, non-blood
80356Heroin metabolite
80357Ketamine and norketamine
80358Methadone
80359Methylenedioxyamphetamines (MDA, MDEA, MDMA)
80360Methylphenidate
80361Opiates, 1 or more
80362Opioids and opiate analogs; 1 or 2
80363Opioids and opiate analogs; 3 or 4
80364Opioids and opiate analogs; 5 or more
80365Oxycodone
80366Pregabalin
80367Propoxyphene
80368Sedative hypnotics (non-benzodiazepines)
80369Skeletal muscle relaxants; 1 or 2
80370Skeletal muscle relaxants; 3 or more
80371Stimulants, synthetic
80372Tapentadol
80373Tramadol
80374Stereoisomer (enantiomer) analysis, single drug class
80375Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1-3
80376Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 4-6
80377Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 7 or more
83992Phencyclidine (PCP)
G0480Drug 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
G0481Drug 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
G0482Drug 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; 15-21 drug class(es), including metabolite(s) if performed
G0483Drug 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; 22 or more drug class(es), including metabolite(s) if performed
G0659Drug 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

References: CMS.(2017) “Calendar Year (CY) 2017 Clinical Laboratory Fee Schedule (CLFS) Final Determinations.” Accessed January 9, 2017. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2017-CLFS-Codes-Final-Determinations.pdf

Dowell D., Haegerich TM, and Chou R.(2016) Guideline for Prescribing Opioids for Chronic Pain-United States, 2016. Recommendations and Reports. Recommendations and Reports. March 18, 2016. 65(1):1-49.

Federal Register. Substance Abuse and Mental Health Services Administration.(2004) Mandatory guidelines for federal workplace drug testing programs. Federal Register. 2004 69:19644-19673.

Jaffee WB, Trucco E, Teter C, et al.(2008) Focus on alcohol & drug abuse: ensuring valididty in urine drug testing. Psychiatr Serv. 2008 Feb;59(2):140-142.

Moeller KE, Lee KC, Kissack JC.(2008) Urine drug screening: practical guide for clinicians. Mayo Clinic Proc. 2008; 83:66-76.

Vincent EC, Zebelman A, Goodwin C, Stephens MM.(2006) What common substances can cause false positives on urine screens for drugs of abuse? J Fam Pract 2006; 10:893-897.


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