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Testing for Drugs of Abuse or Drugs at Risk of Abuse Including Controlled Substances | |
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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) 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.
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
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,
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
Confirmatory (Definitive) Testing
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.
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). 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.
G0659 must be reported if the definitive drug testing method was performed:
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.
Note: Medically necessary confirmatory (definitive) testing services should be reported with G0480-G0482, G0659. CPT codes 80321-80328; 80332-80353, 80355-80377; 83992 are not accepted for processing claims.
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Policy/ Coverage: |
Effective March 2023
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 or for the management of an individual on medication assisted treatment for opioid use disorder).
*Note: Medically necessary confirmatory (definitive) testing services should be reported with G0480-G0482, G0659. CPT codes 80321-80328 80332-80353, 80355-80377; 83992 are not accepted for processing claims. There is a limit of one unit per date of service for procedure codes 80305 and 80306 and a limit of 24 screening services per year (combined total of 80305 and 80306). There is a limit of one unit per date of service for procedure codes G0480-G0482 and/or G0659 and a limit of 24 confirmatory services per year (combined total of G0480-G0482 and/or G0659)
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 does 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, 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.
The use of quantitative testing [i.e., definitive (80321-80328; 80332-80353, 80355-80377; 83992 or G0480-G0483; G0659) 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 (80321-80328; 80332-80353, 80355-80377; 83992 or G0480-G0483; G0659) 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.
CPT codes 80321-80328, 80332-80353, 80355-80377; 83992 are not accepted for processing claims. Medically necessary confirmatory (definitive) testing services should be reported with G0480-G0482, G0659.
The use of a complex presumptive test (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 a complex presumptive test (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, 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, and 0150U does 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, 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, and 0150U 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.
Screening (presumptive testing) performed using services described in CPT or HCPCS codes other than 80305 or 80306 as addressed above (e.g. 0227U) does not meet primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, screening (presumptive testing) performed using services described in CPT or HCPCS codes other than 80305 or 80306 as addressed above (e.g. 0227U) is considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Effective November 2022 through February 2023
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 or for the management of an individual on medication assisted treatment for opioid use disorder).
*Note: Medically necessary confirmatory (definitive) testing services should be reported with G0480-G0482, G0659. CPT codes 80321-80328 80332-80377; 83992 are not accepted for processing claims. There is a limit of one unit per date of service for procedure codes 80305 and 80306 and a limit of 24 screening services per year (combined total of 80305 and 80306). There is a limit of one unit per date of service for procedure codes G0480-G0482 and/or G0659 and a limit of 24 confirmatory services per year (combined total of G0480-G0482 and/or G0659)
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 (80321-80328; 80332-80377; 83992 or G0480-G0483; G0659) 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 (80321-80328; 80332-80377; 83992 or G0480-G0483; G0659) 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.
CPT codes 80321-80377; 83992 are not accepted for processing claims. Medically necessary confirmatory (definitive) testing services should be reported with G0480-G0482, G0659.
The use of a complex presumptive test (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 a complex presumptive test (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, 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, and 0150U 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, 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, and 0150U 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.
Screening (presumptive testing) performed using services described in CPT or HCPCS codes other than 80305 or 80306 as addressed above (e.g. 0227U) does not meet primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, screening (presumptive testing) performed using services described in CPT or HCPCS codes other than 80305 or 80306 as addressed above (e.g. 0227U) is considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Effective January 2021 through October 2022
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 (80321-80328; 80332-80377; 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 (80321-80328; 80332-80377; 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, 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, and 0150U 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, 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, and 0150U 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 2019 through December 2020
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.
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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.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The 2017 consensus statement from the American Society of Addiction Medicine provides guidance on appropriate use of drug testing in substance use disorder.
Medical records should support the need for testing for the specific substance(s) of interest by documentation regarding the diagnosis, history and physical examination and/or behavior of the patient. Medical records should also justify the test that is being used and describe how results of testing will guide medical decision-making.
The ASAM has published several documents on drug testing: a public policy statement, a white paper, which provided background on the science and current practices of drug testing, and guidelines on the effective use of drug testing (ASAM, 2010; ASAM, 2013; Jarvis, 2017; ASAM, 2017).
The ASAM's public policy statement asserts that: "Urine drug testing is a key diagnostic and therapeutic tool that is useful for patient care and in monitoring of the ongoing status of a person who has been treated for addiction. As such, it is a part of medical care, and should not face undue restrictions (ASAM, 2010)". The ASAM recommended drug testing where medically appropriate in clinical diagnostic settings and clinical treatment settings. The term "drug testing" in this document was a broad term that included urine or other body fluids or tissues.
The ASAM White Paper concluded that "The most important challenge in drug testing today is not the identification of every drug that we are technologically capable of detecting, but to do medically necessary and accurate testing for those drugs that are most likely to impact clinical outcomes (ASAM, 2013)." The paper acknowledged that more specific guidance on drug testing was needed, which led to the development of the 2017guidelines, described below.
The ASAM guidance on appropriate drug testing in clinical addiction medicine advises health care providers that before choosing the type of drug test, they should first identify the questions they are seeking to answer and be aware of the benefits and limitations of the various drug tests (ASAM, 2017). The characteristics of urine, oral fluid, and hair drug tests may help determine what type of drug test to use.
The general detection period for urine testing is hours to days. It is point-of-care testing that detects drug metabolite. It is best used for intermediate-term detection in ongoing treatment. A restroom is required for collection. There is low resistance to tampering, and it is possible to retest the same sample.
The general detection period for oral fluid testing is minutes to hours. It is point-of-care testing that detects parent drug compound. It is best used for short-term detection in ongoing treatment. It is easily collected. There is high resistance to tampering with some uncertainty, and it is difficult to retest the same sample.
The general detection period for hair testing is weeks to months. It is not point-of-care testing. It detects parent drug compound. It is best used for long-term monitoring, 3-month history. It is easily collected. There is high resistance to tampering when clinically untreated, and it is easy to retest the same sample.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2018, the American Academy of Pain Medicine (AAPM) published consensus recommendations on urine drug monitoring in patients receiving opioid for chronic pain (Argoff, 2018). The AAPM recommended definitive testing at baseline for patients prescribed opioids for chronic pain unless presumptive testing is required by institutional or payer policy. The AAPM also recommended that the choice of substances to be analyzed should be based on considerations that are specific to each patient and related to illicit drug availability. Baseline risk assessment for aberrant medication-taking behavior, misuse, and opioid use disorder should be conducted using patient history, validated risk assessment tools, prescription drug monitoring program data, previous urine drug monitoring results, and evaluation of behaviors indicative of risk. The recommended frequency of urine drug monitoring was based on risk assessment: At least annually for patients at low risk, 2 or more times per year for those at moderate risk, and 3 or more times per year for those at high risk.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Guidelines with evidence reviews of published peer-reviewed scientific literature suggest that the evidence of benefit on health outcomes for drug testing for both patients in chronic pain using opioids and patients with substance use disorder is limited and usually confounded with drug testing as part of a multifaceted intervention of risk mitigation or contingency management. There is also no clear evidence in the literature regarding the most effective frequency of testing (Jarvis, 2017; VA and DoD, 2017).
In 2017, the Department of Veterans Affairs and Department of Defense updated clinical practice guidelines for managing opioid therapy for the treatment of chronic pain (VA and DoD, 2017). The recommendations on risk mitigation to prescribed opioids include obtaining a UDT (with patient consent) before initiating opioid therapy, and then randomly at a follow-up to confirm appropriate use. Other strategies recommended include clinical assessment such as random pill counts and use of prescription drug monitoring programs.
The guidelines included the following specific recommendations on UDT as part of risk mitigation:
"We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include:
The guideline states that gaining consent is required prior to a UDT; if a patient declines consent, "a provider can factor that declination into their thinking about whether it is safe to continue with opioid therapy for that patient, which is ultimately required if long-term opioid therapy is to be instituted/continued."
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
According to a 2012 evidence assessment by the American Society of Interventional Pain Physicians, approximately one-third of chronic pain patients do not use opioids as prescribed or may abuse them (Manchikanti, 2012). In 2016, the International Narcotics Control Board (INCB) reported that between 1999 and 2010, the number of deaths related to the use of prescription opioid painkillers increased 5-fold among U.S. women and increased by a factor of 3.6 among U.S. men (INCB, 2016).,As far as age groups, the INCB reported the rates of drug overdose deaths increased over the period from 1999 to 2017 for all age groups, however in 2017, rates were significantly higher for those 25 to 64 years of age (31.4 per 100,000) than for those age 65 and over (6.9 per 100,000) (INCB, 2020). Additionally, studies have found that a substantial proportion of chronic pain patients inaccurately report nonadherence to prescribed medications and the use of illicit drugs (Fishbain, 1999).
In 2015, the Washington State Agency Medical Directors' Group updated its interagency guidelines on opioid dosing for chronic non-cancer pain (Washington State AMDG, 2015). The guidelines included recommendations on UDT. Recommendations on testing frequency differed depending on the patient risk of opioid addiction and opioid dosage, as listed below:
In 2020, Washington State Agency Medical Directors' Group released a guideline on long-term opioid therapy prescribing. Use of UDT was mentioned as an element of assessment of patients on long-term opioid therapy (Washington State AMDG, 2020). No pain management guidelines were identified that had recommendations on oral fluid or hair testing.
The ASAM also published a focused update in 2020 focusing on the treatment of opioid use disorder. The guideline states that "urine drug testing is a reasonably practical and reliable method to test for adherence to medication and illicit drug use. However, other reliable biological tests for the presence of drugs may be used. The frequency of drug testing should be determined by a number of factors, including the stability of the patient, the type of treatment, and the treatment setting. Drug testing is required a minimum of eight times per year for patients in OTP [opioid treatment programs]" (ASAM, 2020).
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2016, the Centers for Disease Control and Prevention published guidelines on opioids for chronic pain (Dowell, 2016). These guidelines were updated and expanded to include management of pain of a shorter duration, and to clarify that they are not applicable to sickle cell disease- or cancer-related pain or patients receiving palliative or end-of-life care, in 2022 (Dowell, 2022). The updated guidelines recommend the following regarding drug testing: "When prescribing opioids for subacute or chronic pain, clinicians should consider the benefits and risks of toxicology testing to assess for prescribed medications as well as other prescribed and nonprescribed controlled substances." The authors note that such testing should not be used punitively, including as a basis for dismissing patients from care, and that clinicians should consider the benefits and risks of toxicology testing prior to initiation and at least annually during opioid therapy. The guideline authors further note that restricting definitive confirmatory testing to situations and substances for which results are expected to affect management (e.g., results will influence decisions with major clinical or non-clinical implications, there is a need to detect specific agents or agents that cannot be identified in standard immunoassays, or to confirm unexpected screening test results) can reduce costs.
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American Society of Addiction Medicine (ASAM).(2010) Public Policy Statement On Drug Testing as a Component of Addiction Treatment and Monitoring Programs and in other Clinical Settings. 2010; http://www.asam.org/docs/publicy-policy-statements/1drug-testing---clinical-10-10.pdf?sfvrsn=0. Accessed October 16, 2019. American Society of Addiction Medicine (ASAM).(2013) Drug Testing: A White Paper of the American Society of Addiction Medicine (ASAM). 2013; https://www.asam.org/docs/default-source/public-policy-statements/drug-testing-a-white-paper-by-asam.pdf. Accessed October 16, 2019. American Society of Addiction Medicine (ASAM).(2017) Consensus Statement: Appropriate Use of Drug Testing in Clinical Addiction Medicine. 2017; https://www.asam.org/docs/default-source/quality-science/appropriate_use_of_drug_testing_in_clinical-1-(7).pdf?sfvrsn=2. Accessed Jul 23, 2019. American Society of Addiction Medicine (ASAM).(2020) National Practice Guideline For the Treatment of Opioid Use Disorder. 2020; https://sitefinitystorage.blob.core.windows.net/sitefinity-production-blobs/docs/default-source/guidelines/npg-jam-supplement.pdf?sfvrsn=a00a52c2_2. Accessed September 28, 2022. Argoff CE, Alford DP, Fudin J, et al.(2018) Rational Urine Drug Monitoring in Patients Receiving Opioids for Chronic Pain: Consensus Recommendations. Pain Med. Jan 01 2018; 19(1): 97-117. PMID 29206984 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. Fishbain DA, Cutler RB, Rosomoff HL, et al.(1999) Validity of self-reported drug use in chronic pain patients. Clin J Pain. Sep 1999; 15(3): 184-91. PMID 10524471 International Narcotics Control Board (INCB).(2016) Report of the International Narcotics Control Board for 2016. 2016; https://www.incb.org/documents/Publications/AnnualReports/AR2016/English/AR2016_E_ebook.pdf. Accessed September 24, 2022. International Narcotics Control Board (INCB).(2020) Report of the International Narcotics Control Board for 2020. 2020; https://www.incb.org/documents/Publications/AnnualReports/AR2020/Annual_Report/E_INCB_2020_1_eng.pdf. Accessed September 28, 2022. 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. Jarvis M, Williams J, Hurford M, et al.(2017) Appropriate use of drug testing in clinical addiction medicine. J Addict Med. May/Jun 2017;11(3):163-173. PMID 28557958 Manchikanti L, Abdi S, Atluri S, et al.(2012) American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment. Pain Physician. Jul 2012; 15(3 Suppl): S1-65. PMID 22786448 Moeller KE, Lee KC, Kissack JC.(2008) Urine drug screening: practical guide for clinicians. Mayo Clinic Proc. 2008; 83:66-76. Veteran's Affairs (VA) and Department of Defense (DoD) Opioid Therapy for Chronic Pain Work Group.(2017) Clinical practice guideline: opioid therapy for chronic pain. 2017; https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOTCPG022717.pdf. Accessed September 30, 2021 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. Washington State Agency Medical Directors' Group (AMDG).(2015) Interagency guideline on prescribing opioid dosing for pain. 2015; 3rd: http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf. Accessed September 22, 2022. Washington State Agency Medical Directors' Group (AMDG).(2020) Interagency guideline on opioid prescribing: long-term opioid therapy report and recommendations. 2020; https://www.qualityhealth.org/bree/wp-content/uploads/sites/8/2020/05/Bree-Long-Term-Opioid-Use-Recommendations-FINAL-20-05.pdf. Accessed September 28, 2022. |
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