LCD L35006: Controlled Substance Monitoring and Drugs of Abuse Testing

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

For purposes of clarification the term physician or clinician refers to a Physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements).

Urine drug testing (UDT) provides objective information to assist clinicians in identifying the presence or absence of drugs or drug classes in the body and making treatment decisions. A presumptive drug screen is used to detect the presence of a drug in the body. A blood or urine sample may be used. However, urine is the best specimen for presumptive screening, as blood is relatively insensitive for many common drugs, including psychotropic agents, opioids, and stimulants.

Common methods of drug analysis include chromatography, immunoassay, chemical ("spot") tests, and spectrometry. Analysis is comparative, matching the properties or behavior of a substance with that of a valid reference compound (a laboratory must possess a valid reference agent for every substance that it identifies). Drugs or classes of drugs are commonly assayed by presumptive testing. A presumptive test may be followed by definitive testing, when there is a positive inconsistent finding from the presumptive test in the setting of a symptomatic patient, as described below. Typically, the "spot" chemical tests (referred to above) are urine dipsticks or multiple drug cup devices.

Examples of drugs or classes of drugs that are commonly assayed by presumptive tests, followed by definitive testing, are: alcohols, amphetamines, barbituates/sedatives, benzodiazepines, cocaine and metabolites, methadone, antihistamines, stimulants, opioid analgesics, salicylates, cardiovascular drugs, antipsychotics, cyclic antidepressants, and others. Focused drug screens, most commonly for illicit drug use, may be more useful clinically.

There should be a direct correlation between those positive findings generated from presumptive testing and those requested definitive tests to specifically confirm such findings.

This policy provides:

• The appropriate indications and expected frequency of testing for safe medication management of prescribed substances in risk stratified pain management patients or in identifying and treating substance use disorders.

• Documentation requirements, by the clinician in the patient’s medical record, to support the medical necessity for drug testing on an individual patient basis.

• An overview of presumptive urine drug testing (UDT) and definitive UDT testing by various methodologies.

Definitions:

By way of definition and as used in this document, the following terminology relates to the basic forms of UDT:

• Presumptive (Qualitative) Drug Testing (hereafter called "presumptive" UDT)

• Used when medically necessary to determine the presence or absence of drugs or drug classes in a urine sample;

• Results expressed as negative or positive or as a numerical result;

• Includes competitive immunoassays (IA) and thin layer chromatography.

• Definitive (Quantitative) Confirmation (hereafter called “definitive” UDT)

• Used when medically necessary to identify specific medications, illicit substances and metabolites; Reports the results of drugs absent or present in concentrations of ng/ml;

• Limited to GC-MS and LC-MS/MS testing methods only.

• Specimen Validity Testing

• Urine specimen testing to ensure that it is consistent with normal human urine and has not been adulterated or substituted;

• May include pH, specific gravity, oxidants and creatinine.

• Point of Care Testing (POCT)

• Used when medically necessary by clinicians for immediate test results for the immediate management of the patient;

• Available when the patient and physician are in the same location;

• IA test method that primarily identifies drug classes and a few specific drugs;

• Platform consists of cups, dipsticks, cassettes, or strips; read by the human eye.

• Immunoassay (IA)

• Ordered by clinicians primarily to identify the presence or absence of drug classes and some specific drugs;

• Biochemical tests that measure the presence above a cutoff level of a substance (drug) with the use of an antibody;

• Read by photometric technology.

• Standing Orders

• Test request for a specific patient representing repetitive testing to monitor a condition or disease for a limited number of sequential visits;

• Individualized orders for certain patients for pre-determined tests based on historical use, risk and community trend patient profiles;

• Clinician can alter the standing order.

Note: A “profile” differs from a “panel” in that a profile responds to the clinical risks of a particular patient, whereas a panel encourages unnecessary or excessive testing when no clinical cause exists.

• Blanket Orders

• Test request that is not for a specific patient; rather, it is an identical order for all patients in a clinician’s practice without individualized decision making at every visit.

• Reflex Testing

• Laboratory testing that is performed reflexively after initial test results to identify further diagnostic information essential to patient care.

• Testing Indications, performed as a step necessary to complete a physician’s order is not considered reflex testing.

Drug Test Methods

The Clinical Laboratory Improvement Amendments (CLIA) regulates laboratory testing and requires clinical labs to be certified by their State as well as the CMS before they can accept human samples for diagnostic testing. Multiple types of CLIA certificates may be obtained based on the complexity of testing a lab conducts. CLIA levels of complexity (CLIA-waived, moderate complexity and high complexity) are addressed only as they relate to the HCPCS code description.

A. Presumptive Testing Methods:

• CLIA-waived Presumptive UDT:

• CLIA-waived presumptive UDT consist of various platforms including cards, dipsticks, cassettes and cups based on qualitative competitive immunoassay methodology with one or more analytes in the test.

• Positive test results are presumptive or not definitive due to sensitivity and cross-reactivity limitations.

• Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen.

• Presumptive UDT may be ordered when it is necessary to rapidly obtain and integrate results into clinical assessment and treatment decisions.

• This type of test should only be used when results are needed immediately.

• Presumptive UDT by FDA Approved/Cleared IA Analysis

• Chemistry analyzers with IA UDT technology are used in an office or clinical laboratory setting. When FDA approved/cleared platforms and reagents are used, testing is classified as moderately complex.

• This test may be used when less immediate test results are required.

• At no time is IA technology by chemistry analyzer analysis considered confirmatory (definitive) testing.

• Presumptive positive tests are not definitive due to sensitivity, specificity, and cross-reactivity limitations.

• Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen.

• Presumptive UDT by Laboratory Developed Test (LDT) IA Analysis:

• Similar to #2 above except only performed in a clinical laboratory setting.

Limitations of Presumptive UDT:

Presumptive UDT testing is limited for the following reasons:

• Primarily screens for drug classes rather than specific drugs, and therefore, the practitioner may not be able to determine if a different drug within the same class is causing the positive result;

• Produces erroneous results due to cross-reactivity with other compounds or does not detect all drugs within a drug class;

• Given that not all prescription medications or synthetic/analog drugs are detectable or have assays available, it is unclear as to whether other drugs are present when some tests are reported as positive;

• Cut-off may be too high to detect presence of a drug. This information could cause a practitioner to make a wrong assumption or clinical decision.

B. Definitive UDT:

Gas Chromatography coupled with Mass Spectrometry (GC-MS) and High Performance Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS) are complex technologies that use the separation capabilities of gaseous or liquid chromatography with the analytical capabilities of mass spectrometry.

Both methodologies require the competency of on-site highly trained experts in this technology and interpretation of results. While these tests require different sample preparation and analytical runs, they are quantitative tests that identify all specific drugs, metabolites, and most illicit substances and report the results as absent or present in concentrations of ng/mL.

Quantification should not be used to determine adherence with a specific dosage or time of dose of a pain medication or illicit drug for clinical purposes. Rather, the use of quantitative drug data may be important for many reasons such as in a differential patient assessment.

For example, when several opioids are present in the urine of a patient prescribed a single opioid, quantification may help the clinician decide whether the presence of the other opioids is consistent with metabolism of the prescribed opioid, opioid contamination during manufacturing, or if more than one drug within a class is being used.

Quantification may also provide information in the setting of illicit drug use. Serial creatinine-corrected quantitative values may assist in the differential assessment of ongoing drug use or cessation of drug use with continued drug excretion.

Definitive UDT is reasonable and necessary in order to:

• Identify a specific substance or metabolite that is inadequately detected by a presumptive UDT;

• Definitively identify specific drugs in a large family of drugs;

• Identify a specific substance or metabolite that is not detected by presumptive UDT such as fentanyl, meperidine, synthetic cannabinoids and other synthetic/analog drugs;

• Identify drugs when a definitive concentration of a drug is needed to guide management (e.g., discontinuation of THC use according to a treatment plan);

• Identify a negative, or confirm a positive, presumptive UDT result that is inconsistent with a patient’s self-report, presentation, medical history, or current prescribed pain medication plan;

• Rule out an error as the cause of a presumptive UDT result;

• Identify non-prescribed medication or illicit use for ongoing safe prescribing of controlled substances; and

• Use in a differential assessment of medication efficacy, side effects, or drug-drug interactions.

Definitive UDT may be reasonable and necessary based on patient specific indications, including historical use, medication response, and clinical assessment, when accurate results are necessary to make clinical decisions. The clinician’s rationale for the definitive UDT and the tests ordered must be documented in the patient’s medical record.

Covered Indications for UDT

Group A – Symptomatic patients, multiple drug ingestion or patients with unreliable history.

A patient who presents in a variety of medical settings with signs or symptoms of substance use toxicity will be treated presumptively to stabilize the patient while awaiting rapid, then definitive testing to determine the cause(s) of the presentation.

The need for definitive UDT is based upon rapid test findings, responses to medical interventions, and treatment plan.

A presumptive UDT should be performed as part of the evaluation and management of a patient who presents in an urgent care setting with any one of the following:

• Coma

• Altered mental status in the absence of a clinically defined toxic syndrome or toxidrome

• Severe or unexplained cardiovascular instability (cardiotoxicity)

N/A