Pathology/Lab Coding Alert

Recall presumptive, definitive difference and hierarchy.

At first glance, you might think CPT^® 2018 left the drug test codes alone - finally. But you would be wrong.

Look back: Billing for drug testing has been a hotbed of misunderstanding and fraud that has led to constant coding changes for years, both in the CPT^® codes and in HCPCS Level II codes. For instance, CPT® 2017 replaced presumptive drug test G-codes with new Category I codes, but many Medicare contractors were slow to adopt the changes, leading to much confusion.

Now: Although CPT^® 2018 leaves the Category I drug test codes unchanged, you'll find some different drug test codes in the new Proprietary Laboratory Analyses (PLA) section at the end of the Pathology and Laboratory chapter.

Read on to see how all these parts fit together, so that you can master drug test coding for your lab. Remember that physicians order drug tests for a host of reasons, such as substance abuse screening, monitoring treatment regimens for pain management or addiction, or evaluating prescribed therapeutic drug levels.

Glossary tip: A "drug class" is a collection of drugs that have similar chemical structure, or have the same mode of action, and/or serve the same clinical purpose.

Follow Presumptive Test Rules

Often called drug "screening," labs perform "presumptive" drug testing to determine the presence or absence of drugs or drug class(es). "That means the test results are typically qualitative, expressed as a positive or negative finding. But presumptive tests are just that: a presumed positive or negative for a particular drug or class of drugs, which typically requires further testing," says William Dettwyler, MT AMT, president of Codus Medicus, a laboratory coding consulting firm in Salem, Ore.

CPT^® provides the following three codes to describe presumptive testing, based on the lab method used:

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

If you recall needing to distinguish between Class A and Class B drugs for presumptive test coding, you should know that the distinction is not relevant with the advent of codes 80305-80307 in 2017.

Although presumptive testing no longer links to specific drugs, clinicians often order presumptive tests for certain types of drugs:

"Some examples of drugs or a Drug Class that are commonly assayed by presumptive tests, followed by definitive testing are: alcohols, amphetamines, barbiturates/sedatives, benzodiazepines, cocaine and metabolites, methadone, antihistamines, stimulants, opioid analgesics, salicylates, cardiovascular drugs, antipsychotics, and cyclic antidepressants," according to CPT^® Assistant, March 2017; Volume 27: Issue 3

Extra: You might encounter code H0003 (Alcohol and/or drug screening; laboratory analysis of specimens for presence of alcohol and/or drugs), which many state Medicaid agencies must use to identify mental health services related to alcohol and drug treatment services.

Stay on Track for Definitive Tests

When the ordering physician finds it necessary to identify specific medications or drugs and their metabolites, and possibly to quantify the level of these drugs in the specimen, the clinical lab will perform "definitive" drug testing.

Clinicians often order a presumptive test first, then "positive drugs are usually confirmed with a method of testing that will allow that presumptive identification to be confirmed with a 'definitive' drug testing method. Certain of these definitive testing methods are able to distinguish between the presumptive drug's structural isomers, while certain methodologies can distinguish the sterioisomers of drugs," Dettwyler explains.

In other words, definitive drug tests may be used for confirmation testing, but not always. The physician may order a definitive drug test as the initial assay.

CPT^® provides 59 codes in the range 80320-80377 to describe definitive drug tests by class, such as 80320 (Alcohols). But CMS won't accept these codes, so you'll need to choose one of the following codes for definitive drug testing for Medicare beneficiaries:

• G0480 (Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day; 1-7 drug class(es), including metabolite(s) if performed)
• G0481 (... 8-14 drug class(es), including metabolite(s) if performed)
• G0482 (... 15-21 drug class(es), including metabolite(s) if performed)
• G0483 (... 22 or more drug class(es), including metabolite(s) if performed)
• G0659 (Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem), excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydro­genase), performed without method or drug-specific calibration, without matrix-matched quality control material, or without use of stable isotope or other universally recognized internal standard(s) for each drug, drug metabolite or drug class per specimen; qualitative or quantitative, all sources, includes specimen validity testing, per day, any number of drug classes).

Go Rogue with PLA Codes

Here's the catch for all the preceding drug-test coding advice - if your lab performs a PLA test, you must use the appropriate PLA code instead of a Category I code.

Definition: Each PLA code describes a "proprietary" clinical lab test. That means only a single lab performs the test (sole source), or multiple labs may have a license to perform a test by a specific manufacturer, such as a test approved by the Food and Drug Administration (FDA). The PLA code is specific to the sole-source lab or the commercial test and manufacturer.

Here are the PLA drug-test codes new to CPT^® 2018:

• 0006U (Prescription drug monitoring, 120 or more drugs and substances, definitive tandem mass spectrometry with chromatography, urine, qualitative report of presence (including quantitative levels, when detected) or absence of each drug or substance with description and severity of potential interactions, with identified substances, per date of service) Aegis® Drug-Drug Interaction Test from Aegis Sciences Corporation
•  0007U (Drug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, includes specimen verification including DNA authentication in comparison to buccal DNA, per date of service) ToxProtect™ Test from Genotox Laboratories, LTD
• 0011U (Prescription drug monitoring, evaluation of drugs present by LC-MS/MS, using oral fluid, reported as a comparison to an estimated steady-state range, per date of service including all drug compounds and metabolites) Cordant CORE™ test from Cordant Health Solutions
• 0020U (Drug 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) ToxLok™, InSource Diagnostics, Agena Bioscience, Inc.

The tests may provide a unique solution for drug testing. For instance, 0007U allows labs to authenticate the urine specimen to the specific patient by comparing it to the patient's buccal-swab DNA, according to Matthew McCarty, MD, representing Genotox Laboratories at the 2017 CMS Annual Laboratory Public Meeting for Clinical Diagnostic Laboratory Tests.

You'll notice that the code definitions for 0007U and 0020U are identical, although the specific proprietary test name and manufacturer is different. CPT^® has created the symbol "" to identify that more than one PLA code shares the same descriptor.