Controlled Substances and Drugs of Abuse Screenings

Published 12/20/2018

Physicians and other providers are tasked with addressing legitimate patient therapeutic needs against what may be potential abuse or drug diversion. Prescription opioids are safe and effective when used appropriately to alleviate pain, but no drug is without the potential for side effects, especially above a given dose threshold.

Presumptive and/or definitive drug testing methods are used to detect controlled substances and illicit drugs. Presumptive testing is intended to provide the clinician with rapid test results while the patient is in the office/clinic prior to prescribing a controlled substance. Because presumptive testing can result in false positives or negatives, definitive testing provides confirmatory results for positive and negative tests, respectively.

Presumptive testing is limited to the following three CPT codes:

  • CPT code 80305: Drug tests(s), presumptive, any number of drug classes; any number of devices or procedures, (e.g. immunoassay) capable of being read by direct optical observation only (e.g., dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service.
  • CPT code 80306: Drug test(s), presumptive, any number of drug classes, qualitative, any number of devices or procedures, (e.g., immunoassay) read by instrument assisted direct optical observation (e.g., dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service.
  • CPT code 80307: Drug test(s), presumptive, any number of drug classes, qualitative, any number of devices or procedures by instrument chemistry analyzers (e.g., utilizing immunoassay [e.g., EIA, ELISA, EMIT, FPIA, IA, KIMS, RIA]), chromatography (e.g., GC, HPLC), and mass spectrometry either with or without chromatography, (e.g., DART, DESI, GC-MS, GC-MS/MS, LC-MS, LC-MS/MS, LDTD, MALDI, TOF) includes sample validation when performed, per date of service.

Only one presumptive service may be billed per patient per date of service (DOS) regardless of the provider. Medicare will process the first presumptive service received per patient per DOS. Any subsequent claim for a presumptive service for the given patient on the same DOS will be denied. Definitive drug testing provides positive identification, and frequently quantitation of controlled substances/illicits and/or their metabolites. Medicare recognizes five (5) definitive drug testing codes based on the number of drug classes tested, not the cumulative number of drugs/metabolites tested:

  • HCPCS code G0480: Drug test(s) definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily sterioisomers), 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(s), including metabolite(s) if performed.
  • HCPCS code G0481: Drug test(s) definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily sterioisomers), 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(s), including metabolites(s) if performed.
  • HCPCS code G0482: Drug test(s) definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily sterioisomers), 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 classes, including metabolites(s) if performed.
  • HCPCS code G0483: Drug test(s) definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily sterioisomers), 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 classes, including metabolites(s) if performed.
  • HCPCS 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 (eg, 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.

It is important to note that when a presumptive test is negative for a patient on a prescribed medication, a definitive drug test may be performed.

Only one definitive service may be billed per patient per DOS, regardless of the provider. Medicare will process the first definitive service received per patient, per DOS. All subsequent claims for a definitive service for a given patient on the same DOS will be denied.

Remember:

  • DOS refers to the date of the sample collection, not the date the test was run
  • The service reported on the claim must match the service ordered by the physician

Resources:

Local Coverage Determination (LCDs) for Palmetto GBA: A54799


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