Urine Drug/Alcohol Testing

Urine Drug/Alcohol Testing -- Commercial/Medicaid

Last Review Date: February 12, 2021

Number: MG.MM.LA.42aC2v2

Medical Guideline Disclaimer

Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, ("EmblemHealth") has adopted the herein policy in providing management, administrative and other services to EmblemHealth Plan, Inc., EmblemHealth Insurance Company, EmblemHealth Services Company, LLC and Health Insurance Plan of Greater New York (HIP) related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc.

Related Medical Guidelines See NGS Local Coverage Determination (LCD): Urine Drug Testing (L36037) for Medicare members

Definitions (or Skip definitions and go directly to guideline)

Urine drug/alcohol screening/testing is used to detect alcohol, prescription medications and illegal substances for the purpose of medical treatment.

Presumptive, also known as screening testing, is testing used to indicate possible, but not definitive presence of drugs and or drug metabolites.

Definitive, also known as confirmatory or identification testing (involves mass spectrometry methods) is testing to provide specific identification of individual drugs and or drug metabolites.

Screening and testing should focus on the detection of specific drugs and not routinely include a panel of drugs of abuse. (See Limitations/Exclusions)

Where Presumptive testing methods are available, the two laboratory urine drug testing methods to detect patient use of alcohol/drugs levels include:

Presumptive testing (qualitative or semi-quantitative; immunoassay or other non-specific methods)

Positive and inconsistent Negative presumptive results are followed/confirmed using Definitive testing (qualitative or quantitative; chromatographic and mass spectrometry methods

Where Presumptive testing methods are not available, Definitive testing is the only option to drug test

Presumptive/Qualitative Drug Testing "Presumptive" urine drug testing (UDT)

Immunoassay (IA) "Qualitative IA"

Used to identify possible use or non-use of a drug or drug class in a urine sample; results expressed qualitatively as negative or positive or semiquantitatively. Includes competitive immunoassays (IA) (below row) and thin layer chromatography.

Used to identify the presence or absence of drug classes and some specific drugs; biochemical tests measure the presence above a cutoff level of a

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Definitive/Quantitative/Confirmation "Definitive" UDT

Specimen Validity Testing Point of Care Testing (POCT) Standing Orders

Blanket Orders Reflex Testing Opioids

substance (drug) with the use of an antibody. Read by photometric technology.

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-Nmethylamphetamine (MDMA; "ecstasy") and phencyclidine (PCP), they may not be optimal tests for many prescription drugs, such as opiates, barbiturates, benzodiazepines and opioids.

Used to identify specific drugs associated with metabolites; reports the results of analytes negative or present (typically in concentrations such as ng/ml or may be qualitative reported as the name of the drugs and or drug metabolites).

Definitive methods include but are not limited to gas chromatography coupled with mass spectrometry (GC-MS) and liquid chromatography (LCMS/MS) testing methods only. These high-complexity tests as used to confirm presumptive results (positive or inconsistent) or used as the only method available and should be performed in a CLIA (CMS-certified) accredited laboratory where national quality control standards for testing and laboratory personnel training have been established.

Note: The need for definitive testing must be substantiated in the medical record. See Section D4, Chronic Opioid therapy for clinical criteria.

Urine specimen testing to ensure that urine is consistent with normal human urine and has not been adulterated or substituted; may include, but is not limited to, pH, specific gravity, oxidants and creatinine.

(See Limitations/Exclusions)

Used when immediate test results are needed for the immediate management of the patient.

POCT consists of an IA test method, which primarily identifies drug classes and a few specific drugs.

Platform consists of cups, dipsticks, cassettes or strips; read by the human eye. (See Limitations/Exclusions)

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 may encourage unnecessary or excessive testing when no clinical cause exists for many of the tests.

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.

(See Limitations/Exclusions)

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)

Opioids are a class of drugs that include the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin?), hydrocodone (Vicodin?), codeine, morphine, and many others. These drugs are chemically related and interact with opioid receptors on nerve cells in the body and brain.

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Heroin Fentanyl

Naloxone Suboxone

Opioid pain relievers are generally safe when taken for a short time and as prescribed by a doctor, but because they produce euphoria in addition to pain relief, they can be misused (taken in a different way or in a larger quantity than prescribed, or taken without a doctor's prescription). Regular use--even as prescribed by a doctor--can lead to dependence and, when misused, opioid pain relievers can lead to overdose incidents and deaths.

An opioid overdose can be reversed with the drug naloxone when given right away

Heroin is an opioid drug made from morphine, a natural substance taken from the seed pod of the Asian opium poppy plant. Heroin can be a white or brown powder, or a black sticky substance known as black tar heroin. Other common names for heroin include dope, horse, junk, and smack.

Fentanyl is a powerful synthetic opioid analgesic that is similar to morphine but is 50 to 100 times more potent. It is a schedule II prescription drug and is typically used to treat patients with severe pain or to manage pain after surgery. It is also sometimes used to treat patients with chronic pain who are physically tolerant to other opioids.

In its prescription form, fentanyl is known by such names as Actiq?, Duragesic? and Sublimaze?. Street names for fentanyl or for fentanyl-laced heroin include Apache, China Girl, China White, Dance Fever, Friend, Goodfella, Jackpot, Murder 8, TNT and Tango and Cash.

Naloxone is a medication designed to rapidly reverse opioid overdose. It is an opioid antagonist--meaning that it binds to opioid receptors and can reverse and block the effects of other opioids. It can very quickly restore normal respiration to a person whose breathing has slowed or stopped as a result of overdosing with heroin or prescription opioid pain medications.

Suboxone (buprenorphine and naloxone) sublingual film is a partial-opioid agonist indicated for treatment of opioid dependence.

Note: Information regarding parent drugs and their metabolites may be found in Appendix A

Guideline A. Urine drug/alcohol testing is considered medically necessary when the following criteria are met: 1. Medical record documentation substantiates that each test will impact treatment

2. If full panel screen is requested, medical record substantiates the need for a full panel (i.e., clinical rationale is provided for each of the drugs/drug classes to be screened with specific reference to any specialty test orders)

3. Documentation describes how results will impact the treatment plan (i.e., whether initial/continuation of treatment is medically reasonable based upon findings)

4. One of the following conditions is present: a. Altered mental status b. Medical/psychiatric condition where drug/alcohol toxicity may be a contributing factor c. Perinatal maternal drug use (e.g. current pregnancy with possible exposure of the fetus to illicit drugs taken by the mother, or history of recent delivery of infant diagnosed with Neonatal Abstinence/ Neonatal Withdrawal Syndrome) d. Need to assess adherence to prescribed medications

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e. Need to assess and treat members with substance abuse disorders including alcohol

5. Drug confirmation is indicated if: a. Presumptive testing is positive i. Will only cover the drug class represented by the positive screening ii. Will not cover if the results are confirmed by member's self-disclosed admission b. Confirmation by Definitive testing requires either a positive Presumptive screening test or an inconsistent result and shall be performed only for the drug class represented by the positive screening or inconsistent result (See D4, Chronic opioid therapy for clinical criteria)

B. New patient screening -- Presumptive IA with Definitive confirmation is considered medically necessary when all of the criteria in Section A are met. New patient screening typically involves the following drugs/drug classes: Alcohol, amphetamines/methamphetamine, barbiturates, cannabinoids, cocaine, methadone, opiates, oxycodone.

Note: Request for specialty screening or direct-to-definitive analysis, for expanded benzodiazepines and opioid panels to determine the specific drugs in the member's system, may be medically necessary if supported by documentation that substantiates the clinical rationale for the expanded test. (This includes a detailed justification for testing of specific metabolite)

C. On-going monitoring -- typically sufficient with a Presumptive IA without the need for Definitive confirmation or quantitative testing unless documentation and specific rationale supports additional testing. (The need for testing [i.e., that it impacts treatment] must be established at each meeting with previous testing documented in the record)

D. Chronic opioid therapy 1. Presumptive drug and alcohol screens will only be covered if documentation includes all of the following: History; current treatment plan; medication prescribed; risk potential for abuse, misuse and diversion accompanied by prescription drug monitoring data or pharmacy profile; use of a validated risk assessment interview (or questionnaire tool) with appropriate risk stratification and monitoring protocols

2. Periodic Presumptive monitoring is used to address risk potentials of abuse and diversion of controlled medications and/or abuse of illicit drugs, alcohol or drugs not prescribed as part of the treatment plan and obtained from an undisclosed/unsanctioned source

a. Documentation of the validated risk assessment process must establish that the need for testing impacts treatment

b. In the absence of specific symptoms of medication aberrant behavior or misuse, qualitative drug testing is only considered reasonable and necessary when titrated to patient risk potential

3. Targeting and select testing of limited drugs of abuse may be medically necessary when there is documentation of suspicious behaviors such as self-escalation of dose, doctorshopping, indications/symptoms of illegal drug use, evidence of diversion or other documented change in affect or behavioral pattern

4. Definitive drug testing may be considered medically necessary when reliable validation (member self-report, prescription drug monitoring data, pharmacy profile,

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communication from prescribing clinician) is not available and 1 of the following is documented:

a. Member reports taking a prescribed opioid, but the Presumptive drug test is negative

b. Member tests Presumptive positive for cocaine and is believed to be a chronic cocaine user

c. Member tests Presumptive positive for THC, but documentation supports that the member is discontinuing THC according to the treatment plan

d. Presumptive tests are positive for stimulant, barbiturate or benzodiazepine class of drug

e. Presumptive test is negative and inconsistent with medical history and there is documentation to support the need for confirmatory testing (This does not apply to testing for cocaine, THC or amphetamines except if the member is receiving a prescription for amphetamine for attention deficit disorder [ADD]. The reason for the exception must be documented)

Note: Definitive testing may also be indicated if criteria for testing is met and there is documentation that a Presumptive test is not available (e.g., in the case of selected synthetic or semi-synthetic opioids)

Presumptive testing frequency for chronic opioid patients For targeted testing, frequency is based upon documentation of suspicious behaviors such as selfescalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion or other documented change in affect or behavioral pattern. Presumptive testing for opioid pain management should be part of the pain management strategy and may be performed as follows:

A. Prior to initiating opioid therapy

B. At least annually

C. Every 3 months to assess effectiveness of the prescribed dose and decisions regarding tapering or increasing the dose are planned

Limitations/Exclusions A. Under Commercial plans, Presumptive and Definitive drug testing not to exceed one (1) unit per date of service up to 18 units per year (12 months), submitted by the same or different provider. (Eff. 7/1/2020)

B. Under Medicaid plans, Presumptive and Definitive drug testing not to exceed one (1) unit per date of service up to 8 units per year (12 months), submitted by the same or different provider. Definitive drug tests codes G0481-G0483 are not covered. (Eff. 1/1/2021)

C. Blanket Orders (i.e., routine standing orders for all patients in a physician's practice) are not considered reasonable and necessary are therefore not covered.

D. Coverage for point of care testing (POCT) is limited to dipstick screening.

E. Definitive testing requirements pertaining to lab performing test: 1. Test must be lab-based using the plan's participating lab Quest DiagnosticsTM 2. Use of a nonparticipating lab will be pended for review

F. Reflex Definitive UDT is not reasonable and necessary when Presumptive testing is performed at point of care because the clinician may have sufficient information to manage the member. If the clinician is not satisfied, he/she must determine the clinical appropriateness of and order

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specific subsequent Definitive testing (e.g., the member 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).

G. It is not reasonable and necessary for a physician to perform Presumptive POCT and order Presumptive IA testing from a reference laboratory (i.e., EmblemHealth will only pay for one Presumptive test result per member per date of service regardless of the number of billing providers).

H. It is not reasonable and necessary for a physician to perform Presumptive IA testing and order Presumptive IA testing from a reference laboratory with or without reflex testing (i.e., EmblemHealth will only pay for one Presumptive test result per member per date of service regardless of the number of billing providers).

I. 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.

J. Presumptive 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 IA testing methods. Definitive UDT provides specific identification and/or quantification typically by GC-MS or LC-MS/MS.

K. Drug testing of two different specimen types from the same member on the same date of service for the same drugs/metabolites/analytes is not covered.

L. Drug tests ordered by, or on behalf of, third parties (e.g., courts, employers, schools, etc.) or to protect a physician from drug diversion charges, are not covered.

M. Specimen validity testing, including, but not limited to, pH, specific gravity, oxidants and/or creatinine is not covered. EmblemHealth will deny Specimen Validity Testing when performed by the same or different provider. (Eff. 7/1/2020)

N. High complexity testing is not covered in the office-based setting.

O. Testing of saliva, blood, hair and nails is not covered, as the medical necessity of such testing has not been established due to insufficient evidence of therapeutic value.

P. EmblemHealth does not reimburse for services pertaining to the evaluation of urine dilution (i.e, analysis of creatinine levels).

Q. Testing must coincide with a paid office visit.

R. Proprietary Laboratory Analysis (CPT codes 0006U, 0007U, or 0020U, 0011U) are not considered medically necessary and are not considered under the policy guidelines pertaining to definitive drug testing. (Eff. 7/1/2020)

S. Proprietary Laboratory Analysis (CPT code 0227U eff. 01/01/2021) is not considered medically necessary and is not considered under the policy guidelines pertaining to presumptive drug testing.

T. Under Commercial plans, 80320-80374 Drug test(s), individual types (Not reimbursed). (Eff. 7/1/2020)

U. Under Commercial plans, 80375-80377 Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified (Not reimbursed). (Eff. 7/1/2020)

V. Confirmation testing when there hasn't been an initial screen or confirmation testing conducted for drug classes other than the one(s) in question. For this reason, G0482-G0483 are considered

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not covered. G0481 must be appealed with documentation to support medical necessity. (Eff. 7/1/2020)

Place-of-Service (POS) Settings

POS 11 POS 22 POS 33 POS 49 POS 50 POS 51 POS 53 POS 55 POS 56 POS 57 POS 81 Excluded

Office settings On Campus-Outpatient Hospital Custodial care facility Independent Clinic FQHC Partial Psych Hospital Community Mental Health Residential Substance Abuse Treatment Psych Rehab treatment Non-residential substance abuse center Independent Laboratory All emergency and inpatient care locations

Revision History

Aug. 13, 2021 Sep. 2, 2021

Dec. 17, 2019 Feb. 8, 2019 May 16, 2018

Clarified affected insurance plans under Limitation/Exclusions section

Amendments to Limitations/Exclusions pertaining to Medicaid plans: Added non-coverage of G0481?G0483 Changed maximum annual allowance of presumptive and definitive drug testing from 16 units to 8 units

Re-titled policy to reflect applicability to Commercial and Medicaid members Added hyperlink to Medicare LCD criteria Added reimbursement rules to Limitations/Exclusions Section denoting Mar. 18, 2020 effective date

Removed guideline applicability solely to HMO Clarified test types/technical methodologies Updated Parent Drugs and Metabolite Chart in Appendix

Added POS 22 and 81

Applicable Procedure Codes A. Presumptive/Qualitative Drug/Alcohol Testing

80305 80306 80307

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

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

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,

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DART, DESI, GC-MS, GC-MS/MS, LC-MS, LC-MS/MS, LDTD, MALDI, TOF) includes sample validation when performed, per date of service

Applicable Procedure Codes B. Definitive/Quantitative Urine/Drug Testing

G0480 G0481* G0482 G0483 G0659

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

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

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 (Not Covered)

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 (Not Covered)

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

*See Limitations/Exclusions section

C. Specimen Validity Testing

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