**History/Background and/or General Information**

Urine drug testing (UDT) provides objective information to assist clinicians
in identifying the presences or absence of drugs or drug classes in the body
and assist in making treatment decisions.

This LCD details:

  * The appropriate indications and expected frequency of testing for safe medication management of prescribed substances in risk stratified pain management patients and/or in identifying and treating substance use disorders.
  * Designates documentation, by the clinician in the patient's medical record, of medical necessity for, and testing ordered on an individual patient basis;
  * Provides 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 LCD, the following terminology
relates to the basic forms of controlled substance and drug of abuse testing:

  1. **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.
  2. **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.
  3. **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.
  4. **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.
  5. **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.
  6. **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.
  7. **Blanket Orders** \- Test request that is not for a specific patient; rather, it is an identical order for all patient's in a clinician's practice without individualized decision making at every visit.
  8. **Reflex Testing** \- Laboratory testing that is performed reflexively after initial test results to identify further diagnostic information essential to patient care. Testing 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 and the coding/billing guidance.

**A. Presumptive Testing Methods:  **

**1.   CLIA-waived Presumptive UDT:**

CLIA-waived presumptive UDT consists of various platforms including cards,
dipsticks, cassettes and cups based on qualitative competitive immunoassay
methodology with one or more analytes in the test. A CLIA- waived presumptive
IA test detects the presence of the amount of drug/substance present in urine
above a predetermined "cut-off" value.

A positive test result is reported when the concentration of drug is above the
cut-off value; a negative test result is reported when the concentration of
drug is below the cut-off value. 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. The accuracy of the results of a CLIA-waived presumptive UDT
will depend on the testing environment, type of test, and training of the
individual conducting the test.

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

**2.   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 considered confirmatory testing.

A presumptive positive IA test detects the amount of drug/substance present in
urine above a predetermined cut-off value. If the concentration of the drug is
below the cut-off value, the result will be negative. Presumptive positive
tests are not definitive due to sensitivity, specificity, and cross-reactivity
limitations. Negative test results do not necessarily indicate the absences of
a drug or substance in the urine specimen.

**3.   Presumptive UDT by Laboratory Developed Test (LDT) IA Analysis: **

Subject to appropriate internal quality control and test validation, an
immunoassay performed on a bench top chemistry analyzer becomes a high
complexity test in the following two situations:

**a.   Test Assay Not Classified:** Per CFR 493.17(c)(4), if a laboratory test
system, assay and examination does not appear on the list of tests in the
Federal Register notices, it is considered a test of high complexity until
Public Health Service (PHS) reviews the matter and notifies the applicant of
its decision. Examples of current tests that fall into this category are
listed below:

    1. Extended opioids such as fentanyl, meperidine, tramadol and tapentadol, 
    2. Muscle relaxants such as carisoprodol and meprobamate
    3. Stimulants such as methylpenidate,
    4. Sleep aids such as zolpidem

b.  **Lowering Cutoff for Detection:** Modified FDA approved/cleared test
platforms and/or reagents are considered laboratory developed tests (LDTs).
Drug testing platforms and/or reagents that are not FDA approved/cleared are
also considered LDTs. LDTs have presumably been modified to test at a lower
cutoff in order to detect substances that would have been missed at a higher
threshold. For example, a FDA labeled cutoff may be 300 ng/mL and the LDT
cutoff for the same drug may be a 100 ng/mL.

Presumptive UDT can be carried out at any validated cut-off concentration.
Lowering of the cut-off concentration provides more stringent cut-off values
for illicit drugs. LDTs may include non-FDA cleared tests not available in
CLIA-waived or moderate complexity tests (e.g. tramadol, tapentadol,
carisoprodol, fentanyl, zolpidem, etc.) Lowering the cut-off values increases
the possibility of detecting a drug when the test has been modified from the
recipe of the manufacturer.

**4.   Limitations of Presumptive UDT**

Presumptive UDT testing is limited due to

  1. 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;
  2. Produces erroneous results due to cross-reactivity with other compounds or does not detect all drugs within a drug class;
  3. Not all prescription medications or synthetic/analog drugs are detectable; it is unclear as to whether other drugs are present
  4. Cut-off value may be too high to detect presence of drug

This information could cause a practitioner to make a wrong assumption.

An IA involves an antibody that reacts best with the stimulating drug, and
reacts to a lesser extent (cross- reactive) or not at all with other drugs in
the drug class. While presumptive tests vary in their ability to detect
illicit drugs such as tetrahydrocannabinol (THC), cocaine, 3,
4-methylenedioxy-N-methylamphetamine (MDMA; "ecstasy"), and phencyclidine
(PCP), they may not be optimal tests for many prescription drugs, namely
opiates, barbiturates, benzodiazepines and opioids.

For example, opiate reagents are formulated for morphine. Consequently, the
cross-reactivity for other opioids and opiates varies based on the
manufacturer and lot number. The semisynthetic opioids, hydromorphone and
hydrocodone, may contribute to a positive presumptive result, while the
semisynthetic opioids, oxycodone and oxymorphone, will not typically be
detected even at 300 ng/mL cut-off value. Synthetic opioids, such as fentanyl,
meperidine and methadone, will not be detected by current opiate IA testing.
Consequently, a positive opiate result by IA necessitates more specific
identification of the substance(s) that account for the positive result, and a
negative result does not rule out the presence of opiates or opioids.

Presumptive UDT reagents for benzodiazepine are formulated for oxazepam, a
metabolite of diazepam (Valium) and chlordiazepoxide (Librium), the main
benzodiazepines prescribed twenty years ago. However, many of the more than 10
benzodiazepines that are currently available do not cross-react with IA
benzodiazepine reagents. In particular, clonazepam and lorazepam give false
negative results with presumptive IA tests and may necessitate more specific
identification to account for the negative result. Similarly, a positive
screening test result may require definitive UDT to identify the specific
drug(s).

Synthetic/analog or "designer" drugs manufactured to elude law enforcement
require definitive testing for detection. Most commercially available IA
reagents fail to detect designer drugs, such as psychedelic phenethylamines
even at very high concentrations.

In summary, presumptive IA UDT is unable to identify specific drugs within
many drug classes, particularly within the amphetamine, barbiturate,
benzodiazepine, tricyclic antidepressants, and opitate/opioid drug classes.
Drugs such as fentanyl, carisoprodol, tramadol, tapentadol and synthetic
designer drugs cannot be detected by presumptive IA. Therefore, it may be
medically necessary for clinicians to utilize definitive UDT with lower cut-
off levels when the presumptive tests for these drugs are negative.

**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 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.

**1\. GC-MS**

GC-MS can only be performed on molecules that are volatile. If the test drug
is not volatile in its own right, it must be modified or derivatized to a
volatile form. To derivatize, the test drug must be extracted from the urine,
eluted from the extraction device, concentrated, and then reacted with a
chemical reagent to make a volatile product. Each drug class may require a
different derivatizing agent. For patients on multiple classes of medications,
laboratories using GC procedures must make different volatile derivatives in
order to perform comprehensive testing. Since a GC column may not be able to
separate more than one class of compounds, multiple chromatographic runs on
different column types may be required to monitor multiple drug classes. Newer
GC-MS instruments use tandem systems. GC-MS methodology allows for the testing
of multiple substances but differs in ease of run.

**2\. LC-MS/MS  **

LC-MS/MS is roughly 100 times more sensitive and selective, involves less
human steps, provides quicker turn- around time, uses less specimen volume and
can test for a larger number of substances simultaneously when compared to GC-
MS. After sample preparation, it is injected into the LC-MS/MS. The sample has
to undergo hydrolysis to break the glucuronide bond that frees the drug and
drug metabolites. Hydrolysis is followed by multiple additional steps
including protein precipitation, centrifugation and purification. Deuterium-
labeled isotopic internal standards are added prior to sample preparation to
quantify the drugs and drug metabolites.

The sample is injected when the mobile phase is flowing through the
chromatographic column. Each drug and drug metabolite interacts with the
mobile phase and stationary phase differently and moves at different speeds
depending on their chemical properties. In other words, each analyte elutes at
different times. Specific drugs are identified by their retention time and
mass spectrum of each peak, and quantified against isotropic internal
standards for each drug and metabolite. Each drug peak has a minimum of two
mass transitions, which the technician has to compare to drug standards
(calibrators) in order to ensure identification.

**CLIA-Certified Laboratories**

CLIA specifies quality standards for proficiency testing, facility
administration, general laboratory systems, pre- analytic, analytic and post-
analytic systems, onsite supervision requirements, personnel qualifications
and responsibilities, quality control, and quality assessment.

High complexity laboratories must ensure that testing is carried out by onsite
qualified, trained personnel using validated reliable methods compliant with
regulatory procedures (42 CFR Part 493). Both GC-MS and LC-MS/MS require a
quality program to monitor the quality and audit the competency of the staff.
LC-MS/MS instrument maintenance must be performed daily as well as instrument
performance prior to patient specimens. Final review and approval of GC-MS and
LC-MS/MS results must be performed by qualified clinical laboratory scientist
as defined in 42 CFR Part 493.1489 (Testing Personnel Qualifications). A GC-MS
or LC-MS/MS laboratory must have a qualified laboratory director as provided
in 42 CFR 493.1443 (Laboratory Director Qualifications).

Assay validation must be consistent with FDA guidelines. Laboratories that use
"application notes" from vendors to establish drug validation do not comply
with federal standards, and put providers at risk for reporting inaccurate
test results. Only FDA 510(k) cleared test methods can be distributed by
vendors.

**Purpose of UDT:**

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

Definitive UDT is reasonable and necessary for the following circumstances:

  * Identify a specific substance or metabolite that is inadequately detected by a presumptive UDT screen;
  * 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 an unexpected 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.

**Drug Test Panels**

**1\. Presumptive UDT Panels**

Presumptive UDT testing may be ordered as a panel because the Medicare billing
codes are defined on a "per patient encounter" basis regardless of the number
of analytes tested. Presumptive UDT orders should be individualized based on
clinical history and risk assessment, and must be documented in the medical
record.

**2.  Definitive UDT Panels **

At the current time, physician-directed definitive profile testing is
reasonable and necessary when ordered for a particular patient based upon
historical use and community trends. However, the same physician-defined
profile is not reasonable and necessary for every patient in a physician's
practice. Definitive UDT orders should be individualized based on clinical
history and risk assessment, and must be documented in the medical record.

**Specimen Type**

Urine or oral fluid is the preferred biologic specimen for testing because of
the ease of collection, storage, and cost- effectiveness. UDT cannot detect
the dosage of drug ingested/used, the time of use, or the means of delivery
(intravenous vs. oral vs. inhaled). Detection time of a substance in urine is
typically 1-3 days depending on the drug, rate of metabolism, and rate of
excretion. Lipid-soluble drugs, such as marijuana, may remain in body fat and
be detected upwards of a week or more.

**Covered Indications for UDT**

**Group A - Symptomatic patients, multiple drug ingestion and/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 test results, 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 screen should be performed as part of the evaluation and
management of a patient who presents in an urgent care setting with any of the
following:

  * Coma
  * Altered mental status in the absence of a clinically defined toxic syndrome or toxidrome
  * Severe or unexplained cardiovascular instability (cardiotoxicity)
  * Unexplained metabolic or respiratory acidosis in the absence of a clinically defined toxic syndrome or toxidrome
  * Seizures with an undetermined history
  * To provide antagonist to specific drug

The presumptive findings, definitive drug tests ordered and reasons for the
testing must be documented in the patient's medical record.

**Group B - Treatment for substance abused or dependence:**

A patient in active treatment for substance use disorder (SUD) or monitoring
across different phases of recovery may undergo medical management for a
variety of medical conditions. A physician who is writing prescriptions for
medications to treat either the SUD or other conditions may need to know if
the patient is taking substances which can interact with prescribed
medications or taking prescribed medications as expected. The risk of drug-
drug interactions is inherent to the patient, and may be compounded by
prescribed medications.

UDT is medically necessary and useful component of chemical dependency
treatment. The drug screen result influences treatment and level of care
decisions. Ordered tests and testing methods (presumptive and/or definitive)
must match the stage of treatment or recovery, the documented history and
Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis.

For patients with no known indicators of risk for SUDs, the clinician may
screen for a broad range of commonly abused drugs using presumptive UDT. For
patients with known indicators of risk for SUDs, the clinician may screen for
a broad range of commonly abused drugs using definitive UDT.

For patients with a diagnosed SUD, the clinician should perform random UDT, at
random intervals in order to properly monitor the patient. Testing profiles
must be determined by the clinician based on the following medical necessity
guidance criteria:

  * Patient history, physical examination, and previous laboratory findings;
  * Stage of treatment or recovery;
  * Suspected abused substance;
  * Substances that may present high risk for additive or synergistic interactions with prescribed medication (e.g., benzodiazepines, alcohol)

The patient's medical record must include an appropriate testing frequency
based on the stage of treatment or recovery, the rationale for the drug/drug
classes ordered and the results are documented in the medical record and used
to direct care.

**1\. Frequency of Presumptive UDT for SUD:**

The testing frequency must meet the medical necessity and be documented in the
clinician's medical record. For patients with 0 to 90 consecutive days of
abstinence, presumptive UDT is expected at a frequency of 1 to 3 presumptive
UDT per week. More than 3 presumptive UDT in one week is not reasonable and
necessary and is not covered by Medicare

a. For patients with > 90 consecutive days of abstinence, presumptive UDT is
expected at a frequency of 1 to 3 UDT in one month. More than 3 physician-
directed UDT in one month is not reasonable and necessary and is not covered
by Medicare.

**2\. Frequency of Definitive UDT for SUD:**

Depending on the patient's specific substance use history, definitive UDT to
accurately determine the specific drugs in the patients system may be
necessary. Definitive testing may be ordered when accurate and reliable
results are necessary to integrate treatment decisions and clinical
assessment. The frequency and the rationale for definitive UDT must be
documented in the patient's medical record.

a.  For patients with 0 to 30 consecutive days of abstinence, definitive UDT
is expected at a frequency not to exceed 1 physician-directed testing profile
in one week. More than 1 physician-directed testing profile in one week is not
reasonable and necessary and is not covered by Medicare

b. For patients with 31 to 90 consecutive days of abstinence, definitive UDT
is expected at a frequency 1 - physician-directed testing profiles in one
month. More than 3 UDT in one month is not reasonable and necessary and is not
covered by Medicare

c.  For patients with >90 consecutive days of abstinence, definitive UDT is
expected at a frequency 1 - 3 physician-directed testing profiles in one
month. More than 3 UDT in three months is not reasonable and necessary and is
not covered by Medicare

**Group C - Chronic pain management drug testing for patients on chronic
opioid therapy (COT).**

A physician who is writing prescriptions for medication to treat chronic pain
may need to know if the patient is taking substances which can interact with
prescribed medications or taking prescribed medications as expected.
Additionally, the physician must monitor for adherence/compliance, efficacy,
patient safety, side effects, and drug-drug interaction.

A broad cross section of the general population will develop either cancer
pain syndrome or non-cancer pain which will require prolonged or chronic
opioid therapy for management. The risk of addiction in this population is
considered equivalent to the risk of the general population. In contrast to
the population of individuals who have a history of SUD in the cancer and the
non-cancer pain population the risk of SUD is inherent to the substance(s) to
which the patient is exposed.

**1\. COT UDT Patient Management Testing Objectives**

  1. Identifies absence of prescribed medication and potential for abuse, misuse, and diversion
  2. Identifies undisclosed substances, such as alcohol, unsanctioned prescription medication, or illicit substances
  3. Identifies substances that contribute to adverse events or drug-drug interactions
  4. Provides objectivity to the treatment plan
  5. Reinforces therapeutic compliance with the patient
  6. Provides additional documentation demonstrating compliance with patient evaluation and monitoring
  7. Provide diagnostic information to help assess individual patient response to medications (e.g. metabolism, side effects, drug-drug interaction, etc.) over time for ongoing management of prescribed medications.

**2\. Medical Necessity Guidance**

Criteria to establish medical necessity for drug testing must be based on
patient-specific elements identified during the clinical assessment, and
documented by the clinician in the patient's medical record and minimally
include the following elements:

  * Patient history, physical examination and previous laboratory findings
  * Current treatment plan
  * Prescribed medication(s)
  * Risk assessment plan

National pain organizations, physician societies, and the Federation of State
Medical Boards recommend a practical approach to definitive UDT for COT.
Frequency of testing beyond the baseline presumptive UDT screen must be based
on individual patient needs substantiated by documentation in the patient's
medical record. Recommendations for the ordering of presumptive and definitive
UDT for patients on COT are as follows:

**a.  COT Baseline Testing**

Initial presumptive and/or definitive COT patient testing may include
amphetamine/methamphetamine, barbiturates, benzodiazepines, cocaine,
methadone, oxycodone, tricyclic antidepressants, tetrahydrocannabinoid,
opioids, opiates, heroin and synthetic/analog or "designer" drugs.

**b. COT Monitoring Testing**

Ongoing testing may be medically reasonable and necessary based on the patient
history, clinical assessment, including medication side effects or inefficacy,
suspicious behaviors, self-escalation of dose, doctor-shopping,
indications/symptoms of illegal drug use, evidence of diversion, or other
clinician documented change in affect or behavioral pattern. The frequency of
testing must be based on a complete clinical assessment of the individual's
risk potential for abuse and diversion using a validated risk assessment
interview or questionnaire and should include the patient's response to
prescribed medications and the side effects of medications.

The clinician should perform random UDT at random intervals, in order to
properly monitor a patient. UDT testing does not have to be associated with an
office visit.

Patients with specific symptoms of medication aberrant behavior or misuse may
be tested in accordance with this document's guidance for monitoring patient
adherence and compliance during active treatment (<90 days) for substance use
or dependence.

**3\. UDT Frequency Based on Validated Risk Assessment and Stratification*:**

Testing must be based on clinician's documented medical necessity and reviewed
by the clinician in the management of prescribing/renewing a controlled
substance for every risk group outlined below:

**Risk Group**

|

Low Risk

|  
---|---|---  
  
**Baseline**

|

Prior to initiation of COT

|  
  
**Risk Level**

|

Random testing 1-2 times every 12 months for prescribed medications, non-
prescribed medications that may pose a safety risk if taken with prescribed
medications, and illicit substances based on patient history, clinical
presentation, and/or community usage.  
  


**Risk Group**

|

Moderate Risk

|  
---|---|---  
  
**Baseline**

|

Prior to initiation of COT

|  
  
**Risk Level**

|

Random testing 1-2 times every 6 months for prescription medications, non-
prescribed medication that may pose a safety risk if taken with prescribed
medications, and illicit substances, based on patient history, clinical
presentation, and/or community usage.  
  


**Risk Group**

|

High Risk

|  
---|---|---  
  
**Baseline**

|

Prior to initiation of COT

|  
  
**Risk Level**

|

Random testing performed 1-3 times every 3 months for prescribed medications,
non-prescribed medications that may pose a safety risk if mixed with
prescribed and illicit substances based on patient history, clinical
presentation and/or community usage.  
  
 *Note: Any additional definitive UDT beyond recommendations above must be justified by the clinician in the medical record in situations in which changes in prescribed medications may be needed, such as

  * Patient response to prescribed medication suddenly changes
  * Patient side effects profile changes
  * To assess for possible drug-drug interactions
  * Sudden change in patient's medical condition
  * Patient admits to use of illicit or non-prescribed controlled substance

**Other Covered Services**

1.  Reflex Testing by Reference Laboratories - since reference laboratories do not have access to patient-specific data, reflex testing under the following circumstances is reasonable and necessary:

  1. To verify a presumptive positive UDT using definitive UDT (GC-MS or LC-MS/MS) before reporting the presumptive finding to the ordering clinician and without an additional order from the clinician; or
  2. To confirm the absence of prescribed medications when a negative result is obtained by presumptive UDT in the laboratory for a prescribed medication listed by the ordering clinician.

2.  Direct to definitive UDT without a presumptive UDT is reasonable and necessary, when individualized for a particular patient, in the following circumstances:

  1. To identify a specific substance or its metabolite that is in a large class of drugs, or that is inadequately detected or not detected by presumptive UDT, such as fentanyl, meperidine, synthetic cannabinoids, and other synthetic/analog drugs;
  2. For use in a differential assessment of medication efficacy, side effects, or drug-drug interactions;
  3. To identify non-prescribed medication or illicit substance use for ongoing safe prescribing of controlled substances, where clinician has documented concerns related to safety risks attendant to failure to identify specific substances suspected based upon clinical review and judgment; or
  4. To 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).

3\. Definitive testing to confirm a negative presumptive UDT result, upon the
order of the clinician, is reasonable and necessary in the following
circumstances:

  1. The result is inconsistent with a patient's self-report, presentation, medical history, or current prescribed medication plan (should be present in the sample);
  2. Following a review of clinical findings, the clinician suspects use of a substance that is inadequately detected or not detected by a presumptive UDT; or
  3. To rule out an error as the cause of a negative presumptive UDT result.

4.  Definitive testing to confirm a presumptive UDT positive result, upon the order of the clinician, is reasonable and necessary when the result is inconsistent with the expected result, a patient's self-report, presentation, medical history, or current prescribed medication plan.

**Limitations**

**Non-Covered**

  1. Blanket Orders
  2. Reflex definitive UDT is not reasonable and necessary when presumptive testing is performed at point of care because the physician may have sufficient information to manage the patient. If the clinician is not satisfied, he/she must determine the clinical appropriateness of and order specific subsequent definitive testing (e.g., the patient admits to using a particular drug, or the IA cut-off is set at such a point that is sufficiently low that the physician is satisfied with the presumptive test result).
  3. Routine standing orders for all patients in a physician's practice are not reasonable and necessary.
  4. It is not reasonable and necessary for a reference laboratory to perform and bill IA presumptive UDT prior to definitive testing without a specific physician's order for the presumptive testing.
  5. It is not reasonable and necessary for a physician to perform presumptive POCT and order presumptive IA testing from a reference laboratory. Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.
  6. It is not reasonable and necessary for a physician to perform presumptive IA testing and order presumptive IA testing from a reference laboratory. Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.
  7. It is not reasonable and necessary for a reference laboratory to perform and bill IA presumptive UDT prior to a definitive testing without a specific physician's order for the presumptive testing.
  8. IA testing, regardless of whether it is qualitative or semi-quantitative (numerical) may not be used to "confirm" or definitively identify a presumptive test result obtained by cups, dipsticks, cards, cassettes or other CLIA- waived methods. Semi-quantitative IA testing provides a presumptive test (numerical) result. Definitive UDT provides specific identification and/or quantification by GC-MS or LC-MS/MS.
  9. Drug testing of two different specimen types from the same patient on the same date of service for the same drugs/metabolites/analytes.
  10. UDT for medico-legal and/or employment purposes or to protect a physician from drug diversion charges.
  11. Specimen validity testing including, but not limited to, pH, specific gravity, oxidants, creatinine.

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.