Proposed Local Coverage Determination (LCD)

Controlled Substance Monitoring and Drugs of Abuse Testing

DL36393

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Document Information

Source LCD ID
L36393
Proposed LCD ID
DL36393
Proposed LCD Title
Controlled Substance Monitoring and Drugs of Abuse Testing
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Issue

Issue Description

This LCD has been revised to create a uniform LCD with another MAC Jurisdiction and updated to the 21st Century Cures Act format. The revision provides a listing of the distinct drug classifications for urine drug testing and the associated medically reasonable and necessary criteria.

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Controlled Substance Monitoring and Drugs of Abuse Testing. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Controlled Substance Monitoring and Drugs of Abuse Testing and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

IOM Citations:

  • CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
    • Chapter 15, Sections 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1 Clinical Laboratory Services and 80.1.1 Certification Changes
  • CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
    • Chapter 1, Part 2, Sections 130.5 Treatment of Alcoholism and Drug Abuse in a Freestanding Clinic, 130.6 Treatment of Drug Abuse (Chemical Dependency) and 130.7 Withdrawal Treatments for Narcotic Addictions
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Federal Register References:

  • CFR Title 42, Volume 2, Chapter IV, Part 410.32 (a) Ordering diagnostic tests, (d) Diagnostic laboratory tests and (e) Diagnostic laboratory tests furnished in hospitals and CAHs
  • CFR Title 42, Volume 2, Chapter IV, Part 411.15(k)(1) Particular Services excluded from coverage
  • CFR Title 42, Volume 5, Chapter IV, Part 493.17(c) Process for device/test categorization
  • CFR Title 42, Chapter I, Part 8.12(f)(6) Drug abuse testing services
  • CFR Title 49, Part 40.89 Validity testing

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

History/Background and/or General Information

Urine drug testing (UDT) provides objective information to clinicians by identifying the presence or absence of drugs of potential abuse in the body to assist in making treatment decisions.

This LCD:

  • Provides an overview of presumptive UDT and definitive UDT testing by various methodologies.
  • Provides a listing of the distinct drug classifications.
  • Outlines the covered indications and limitations for UDTs.
  • Details what supporting documentation will be required to justify a UDT for coverage purposes.

Definitions:

As used in this document, the following terminology relates to the basic forms of UDT:

  1. Presumptive/Qualitative Drug Testing (hereafter called "presumptive" UDT)

Per the Current Procedural Terminology (CPT®) Codebook1:

    • Testing performed to “identify possible use or non-use of a drug or drug class”
    • Includes immunoassays (IA), enzymatic methods, chromatographic methods without mass spectrometry, or “mass spectrometry without adequate drug resolution by chromatography”
  1. Definitive/Quantitative/Confirmation Drug Testing (hereafter called “definitive” UDT)

Per the CPT® Codebook1:

    • Testing performed, qualitative or quantitative, to identify use or non-use of specific drugs and associated metabolites
    • Testing can distinguish between individual drugs and structural isomers, although not necessarily distinguish between stereoisomers
    • Includes gas chromatography with mass spectrometry (GC/MS) and liquid chromatography with mass spectrometry (LC/MS)
    • EXCLUDES immunoassays and enzymatic methods
  1. Specimen Validity Testing
    • Per CFR Title 49, Part 40.89: “specimen validity testing is the evaluation of the specimen to determine if it is consistent with normal human urine. The purpose of validity testing is to determine whether certain adulterants or foreign substances were added to the urine, if the urine was diluted, or if the specimen was substituted.”
    • Validity testing may include, but is not limited to pH, specific gravity, oxidants, creatinine, and DNA tests2
  1. Standing Order
    • A clinician’s test order for a specific patient that involves repeated testing for a limited number of sequential visits in order to monitor a condition, a disease, and/or particular medication(s)
  1. Blanket Order
    • An identical test order used for all patients in a clinician’s practice without individualized customization per patient
  1. Reflex Testing
    • Laboratory testing that is performed automatically in reaction to certain initial test results

Note that testing performed as a necessary step in completing a physician’s order is NOT considered reflex testing

Drug Classification

Parent Drugs and Metabolites

The following list illustrates parent drugs and their metabolites but may not be totally inclusive of all drugs and metabolites.1-3 However, it defines all the various drug classes recognized as distinct per this LCD.

Note: Ethanol is a known drug of abuse but is routinely tested in blood, not urine. In addition, the DEA Resource Guide3 states that alcohol is exempt from control by the Controlled Substances Act (CSA). Ethanol is not under discussion in this LCD.

  1. Analgesics, non-opioid (e.g., acetaminophen, salicylate)
  2. Anticonvulsants/Antiepileptics (e.g., carbamazepine, lamotrigine, gabapentin, phenytoin, pregabalin, valproic acid)
  3. Antidepressants (e.g., paroxetine, fluoxetine, citalopram, amitriptyline)
  4. Antispasmodics/Anticholinergics (e.g., atropine, belladonna, hyoscyamine, scopolamine)
  5. Barbiturates (e.g., phenobarbital, amobarbital)
  6. Benzodiazepines (e.g., alprazolam, diazepam, flunitrazepam [also known as Rohypnol], midazolam)
  7. Cannabinoids (e.g., delta 9 - tetrahydrocannabinol [THC], K2/spice)
  8. Dissociative anesthetics (e.g., phencyclidine [PCP], ketamine)
  9. Hallucinogens (e.g., lysergic acid diethylamide [LSD], psilocybin, peyote, mescaline, methylenedioxymethamphetamine [MDMA], antitussives [such as dextromethorphan])
  10. Hypnotics/Sedatives (non-benzodiazepines/non-barbiturates) (e.g., gamma-hydroxybutyric acid [GHB], methaqualone, meprobamate)
  11. Muscle relaxants (e.g., carisoprodol, meprobamate, methocarbamol)
  12. Neuroleptics/Antipsychotics (e.g., clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  13. Opioids/Narcotics (e.g., morphine, heroin, fentanyl, methadone, tramadol, hydrocodone, oxycodone, propoxyphene, tapentadol)
  14. Stimulants (e.g., cocaine, amphetamines, cathinones [e.g., khat, bath salts])

Covered Indications for UDT

Presumptive UDT may be ordered by the clinician caring for a patient when the drugs/metabolites/analytes of interest can be detected by a presumptive UDT and it is necessary to rapidly obtain and integrate results into clinical assessment and treatment decisions.2,4-5

Use of presumptive UDT must be based on patient specific indications, including history and physical examination and/or behavior of the patient. The clinician’s rationale for the presumptive UDT ordered must be documented thoroughly and clearly in the patient’s medical record.

Definitive UDT is medically reasonable and necessary for the following circumstances2,4,6-9:

  • To identify a specific substance(s) and/or metabolite(s) that are inadequately or not at all detected by a presumptive UDT (e.g., fentanyl, meperidine, synthetic cannabinoids, other synthetic/analog drugs)
  • 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)
  • To identify non-prescribed medication or illicit substance use for ongoing safe prescribing of controlled substances (e.g., chronic opioid therapy) when presumptive UDT is insufficient to identify all substances of concern
  • To use in a differential diagnostic assessment of medication efficacy, side effects, and/or drug-drug interactions

Use of definitive UDT must be based on patient specific indications, including historical use, medication response, and clinical assessment. The clinician’s rationale for the definitive UDT ordered must be documented thoroughly and clearly in the patient’s medical record.

Limitations

The following are considered not medically reasonable and necessary:

  1. Blanket orders
  2. Routine standing orders not customized for a specific patient’s clinical circumstances
  3. Any reflexive testing without a documented order from the treating provider for the reflexive testing
  4. Performing multiple presumptive UDTs utilizing the same or different methodologies (e.g., an immunoassay test and a chromatographic method without mass spectrometry) on the same date of service. Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.
  5. More than one definitive test result per patient per date of service regardless of the number of billing providers; Medicare will only pay for one definitive test result per patient per date of service regardless of the number of billing providers.
  6. Drug testing of two different specimen types (e.g., blood and urine) from the same patient on the same date of service for the same drugs/metabolites/analytes
  7. Performing a presumptive UDT when the provider is testing for drugs/metabolites/analytes that are not detected by a presumptive UDT
  8. UDT for medico-legal and/or employment purposes
  9. UDT for protection of a physician from drug diversion charges
  10. Definitive UDT for ruling out a testing error as the cause of an unexpected presumptive UDT result
  11. Unbundling specimen validity testing (e.g., pH, specific gravity, oxidants, creatinine, and DNA tests) from the overall UDT claim(s)
  12. Testing for substances in which results would not affect patient management

Provider Qualifications

Services provided within the LCD coverage indications will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the provider’s professional licensure; and when all procedures are performed by appropriately trained providers in the appropriate setting.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

Summary of Evidence

A literature search was conducted using the following key words: drug testing; drug testing guidelines; controlled substances; urine drug testing; immunoassay; screening drug tests; definitive drug tests. The literature search was filtered to locate articles within 5-10 years, full-text articles, clinical trials, and systematic reviews.

This evidence review focuses on UDT testing used to guide treatment and whether the evidence behind this testing is adequate to draw conclusions about improved health outcomes for the Medicare population. In general, health outcomes of interest include patient mortality, morbidity, quality of life, and function.

Urine Drug Testing – Presumptive Testing and Definitive Testing in Pain Management Patients

Drug use can be detected through various biological samples such as urine, blood, oral fluid, exhaled breath, sweat, and hair. Different matrices have advantages and disadvantages concerning sensitivity and specificity with various time windows, time to obtain results, unique susceptibility to sample tampering, and ease of collection. Generally, urine is the most common agent for drug testing as it has a longer window of detection compared to blood, has a sufficient specimen quantity for drug screening and confirmation, and drug markers (parent drug or metabolites) are revealed in high concentrations.2

Currently, urine drug testing (UDT) is considered the standard for adherence monitoring of patients taking controlled substances for management of chronic pain. Evidence-based guidelines recommend UDT for the detection of applicable over-the-counter (OTC) medications, prescribed and nonprescribed drugs, and illicit substances in pain management patients (quality of evidence II) (strength of recommendation B).2

There are two primary types of UDTs, presumptive and confirmatory tests. Presumptive UDT, also referred to as a screening immunoassay, may be used in the laboratory or in the office/clinic setting with point of care testing (POCT), producing relatively rapid results.5 Three primary immunoassays are used: 1) Enzyme-multiplied immunoassay technique, 2) Enzyme-linked immunosorbent assay (ELISA), and 3) Fluorescence polarization immunoassay. Generally, immunoassays utilize antibodies to detect the presence of drug metabolites or classes of drug metabolites in the urine.5 Presumptive test results are a) read by direct optical observation only, b) read by instrument-assisted direct optical observation, or c) performed by instrument chemistry analyzers.6

Immunoassays usually have variable sensitivity and specificity; therefore, substances may be missed leading to inaccurate results. For example, immunoassays will detect substances with similar characteristics, resulting in cross-reactivity leading to false-positive results.5 UDTs are usually enzyme immunoassays that target amphetamines/methamphetamines, cannabis, cocaine, phencyclidine, and opioids and are based on a specific antidrug antibody reaction. Opiate immunoassays can detect naturally occurring opiate alkaloids more accurately (i.e., morphine, codeine) than frequently prescribed synthetic (e.g., fentanyl, methadone) and semisynthetic (e.g., buprenorphine, oxycodone, oxymorphone, hydromorphone) opioids. Immunoassays are somewhat semiquantitative (i.e., an estimate of levels only) because of cross-reaction across multiple drugs. Sensitive options are currently available for testing many common drug classes.

Negative results are generally used to exclude drug abuse. Positive samples are typically sent for definitive laboratory-based testing to identify the drug(s) present and to establish adherence or identify abuse or diversion.2

The provider will need to use clinical judgment, patient history, and collaborative information to determine if definitive/confirmatory testing is necessary for optimal care of the patient.5 Evidence-based guidelines recommend definitive testing for any immunoassay (laboratory-based or POCT) result that is inconsistent with the clinical expectation in a pain management patient (quality of evidence III) (strength of recommendation A).2

Definitive UDT can be utilized for initial or confirmatory testing and involves qualitative or quantitative gas chromatography (GC)–mass spectrometry (MS), liquid chromatography (LC)–MS, and LC–tandem MS (LC-MS/MS) technologies.6 Definitive testing is not as sensitive to adulterants (i.e., any substance that reduces validity of testing) and decreases the probability of inaccurate or false results. Definitive testing can accurately identify metabolites, verifying that a parent drug was truly ingested; definitive testing can also detect potentially abnormal opioid metabolism.6

Evidence-based guidelines recommend specimen validity testing (e.g., pH, temperature, creatinine, oxidants) as it is a valuable means to ensure outcomes (e.g., use of relevant OTC, prescribed, and non-prescribed drugs) are accurately interpreted in pain management patients. Specimen validity testing establishes the appropriateness of the urine specimen collected/received, which impacts the capability to properly identify applicable OTC medications, prescribed and non-prescribed drugs, and illicit substances used by pain management patients (quality of evidence I) (strength of recommendation A).2

Urine Drug Testing – Presumptive Testing and Definitive Testing for Patients in Addiction Treatment and Recovery

Jarvis et al4 provides a consensus statement from the American Society of Addiction Medicine (ASAM) that offers guidance about the effective use of drug testing for patients in addiction treatment and recovery, where drug testing is utilized to evaluate patients for a substance use disorder, monitor the efficacy of a treatment plan, and support recovery. In this regard, drug testing is recommended for the following (this is not an all-inclusive list): 1) As a therapeutic tool in conjunction with evidence-based addiction treatment, 2) To explore denial, motivation, and actual substance use behaviors, 3) At intake to assist in a patient’s initial assessment and treatment planning, 4) To assist in determining optimal placement in a level of care, 5) As an objective means of validating a patient’s substance use history, 6) To support the difference between intoxication and the presence of an underlying psychiatric and/or medical condition in a patient presenting with altered mental status, and 7) To monitor recent substance utilization in all addiction treatment settings.

Opioid Treatment Services

Stratification of risk for patients started or maintained on chronic opioid therapy is vital to avoid misuse and abuse. Prior to initiating chronic opioid therapy, the provider should perform a history and physical examination and appropriate testing, involving an evaluation of risk of substance abuse, misuse, or addiction.7

The principal objectives of drug testing in opioid treatment services (OTS) are: a) Identifying substance use that could complicate treatment response and patient management, b) Monitoring for adherence with the prescribed medication, and c) Monitoring for potential diversion.4 Clinical drug testing for OTS is utilized for the goals of diagnosis, monitoring, and evaluating progress in treatment and in the promotion of long-term recovery. Drug testing detects the patient’s use of specific drugs and establishes the absence of prescribed medications that may be an indication of diversion. The frequency of drug testing is determined by assessing the clinical appropriateness in relation to the patient’s stage of treatment and risk stratification.7-8

Providers should utilize UDT before a patient starts taking opioids for chronic pain and periodically during opioid therapy based on risk factor analysis to evaluate for prescribed opioids in addition to other controlled substances and illicit drugs that raise the risk for overdose when mixed with opioids, including nonprescribed opioids, benzodiazepines, and heroin.7,9

Presumptive UDT is recommended at initiation of opioid therapy and subsequently as adherence monitoring, using in-office POCT. Qualitative immunoassay drug testing prior to prescribing controlled substances may be utilized to detect some illicit drug use and reduce adverse outcomes in pain management patients (quality of evidence II) (strength of recommendation B).2

Definitive testing may be needed in select patients to identify specific opioids that cannot be detected on standard immunoassays or for unexpected UDT results. However, providers should not test for substances in which results would not affect patient management.7,9 Random drug testing is required a minimum of eight times per year for patients in maintenance opioid treatment programs.8,10

American Association for Clinical Chemistry (AACC) Academy Laboratory Medicine Practice Guideline Recommendations for UDTs

Jannetto et al2 provides the AACC Academy laboratory medicine practice guidelines that offer evidence-based recommendations for the utilization of laboratory and POC urine drug tests for relevant OTC drugs, prescribed and non-prescribed medication, and illicit substances in pain management patients. This document also includes expert opinion guidelines on laboratory testing for pain management which were jointly developed with the Clinical and Laboratory Standards Institute.

Per consensus-based expert opinion, random drug testing should be conducted at least one to two times per year for low-risk patients (based on history of past substance abuse/addiction, aberrant behaviors, and opioid risk screening assessment), and more frequently for higher-risk patients who are prescribed controlled substances.2 Evidence-based guidelines recommend more frequent laboratory testing for patients with a personal or family history of substance abuse, mental illness, indication of aberrant behavior, or other high-risk attributes (quality of evidence II) (strength of recommendation A).2

Overall, the evidence is weak for precise schedules for drug testing primarily due to the lack of randomized clinical trials to contrast the efficacy of testing schedules or methods particularly for patients with chronic pain. Current clinical practice guidelines recommend drug testing at baseline and randomly at least once a year for low-risk patients based on observational studies or expert consensus opinion. However, more frequent monitoring is recommended for patients with risk factors for misuse/abuse, although the ideal frequency has not been established.2

Jannetto et al2 recommends the following drug classes for testing for pain management patients based on risk:

  • Amphetamines (e.g., Methamphetamine [MDMA])
  • Barbiturates (e.g., phenobarbital)
  • Benzodiazepines (e.g., alprazolam, diazepam)
  • Cannabinoids (e.g., delta 9 - tetrahydrocannabinol [THC], 11-nor-9-carboxy-THC [THCCOOH])
  • Cocaine (e.g., benzoylecgonine)
  • Opiates/Opioids (e.g., hydrocodone, oxycodone)
  • Anticonvulsants (e.g., carbamazepine, lamotrigine, gabapentin, phenytoin, pregabalin, valproic acid)
  • Antidepressants (e.g., paroxetine, fluoxetine, citalopram, amitriptyline)
  • Synthetic cathinones (e.g., methylone)
  • Antitussive (e.g., dextromethrophan)
  • Dissociative anesthetic (e.g., ketamine)
  • Hallucinogens (e.g., lysergic acid diethylamide [LSD])
  • Muscle relaxants (e.g., carisoprodol, meprobamate, methocarbamol)
  • Narcotic pain-reliever (e.g., propoxyphene)
  • OTC analgesic (e.g., acetaminophen, salicylate)
  • Antihistamine (e.g., certirizine)
  • Antipsychotics (e.g., clozapine, haloperidol, olanzapine)
  • Synthetic cannabinoids (e.g., JWH-018)

Drugs of Abuse: A Drug Enforcement Administration Resource Guide

The Drug Enforcement Administration (DEA) and the U.S. Department of Justice3 provide ‘Drugs of Abuse - A DEA Resource Guide’ concerning the most commonly abused and misused drugs in the U.S. with significant information regarding the harms and consequences of drug utilization, overdose potential, origin, legal status, and other strategic information such as a description of the Controlled Substances Act (CSA).

The CSA regulates the following classes of drugs:

  • Narcotics (e.g., opium, opium derivatives, and their semi-synthetic substitutes). Examples: OxyContin®, Vicodin®, heroin, codeine, morphine, methadone, and fentanyl.
  • Depressants - Examples: barbiturates (butalbital [Fiorina®], phenobarbital, Pentothal®, Seconal®, and Nembutal®), benzodiazepines (Valium®, Xanax®, Halcion®, Ativan®, Klonopin®, Restoril®, and Rohypnol®), Lunesta®, Ambien®, Sonata®, meprobamate, methaqualone (Quaalude®), and Gamma-Hydroxybutyric acid (GHB).
  • Stimulants - Examples: amphetamines (Adderall® and Dexedrine®), methylphenidate (Concerta® and Ritalin®), diet aids (e.g., Didrex®, Bontril®, Preludin®, Fastin®, Adepex-P®, Lomamin®, and Meridia®), methamphetamine, cocaine, methcathinone, and other synthetic cathinones that are commonly disguised as “bath salts”.
  • Hallucinogens - Examples: MDMA (ecstasy), LSD, Ketamine, and hallucinogenic mushrooms.
  • Anabolic steroids – Examples: testosterone, trenbolone, oxymetholone, methandrostenolone, nandrolone, stanozolol, boldenone, and oxandrolone.
  • Marijuana/Cannabis (e.g., THC [delta 9 - tetrahydrocannabinol]).
  • Designer drugs (e.g., synthetic stimulants). Examples: “Bath salts”, K2 and Spice (synthetic cannabinoids), and synthetic opioids.

Each class has distinguishing properties, and drugs within each class frequently produce similar effects. However, all controlled substances, regardless of class, share some common characteristics. All controlled substances have abuse potential or are immediate precursors to substances with abuse potential. When controlled substances are utilized in a method or amount not consistent with the legitimate medical use, it is referred to as drug abuse. In addition to having abuse potential, most controlled substances can produce dependence; physical or psychological.

Analysis of Evidence (Rationale for Determination)

Urine drug testing is regarded as the standard for adherence monitoring of patients taking controlled substances for management of chronic pain. Evidence-based guidelines recommend UDT for the detection of applicable OTC medications, prescribed and nonprescribed drugs, and illicit substances in pain management patients.

Testing may be presumptive or definitive. Per evidence-based guidelines, presumptive UDT is considered medically reasonable and necessary when the drugs/metabolites/analytes of interest can be detected by a presumptive UDT and when it is necessary to rapidly obtain and integrate results into clinical assessment and treatment decisions. Use of presumptive UDT must be based on patient specific indications, including history and physical examination and/or behavior of the patient.

Use of definitive UDT must be based on patient specific indications, including historical use, medication response, and clinical assessment.

According to the evidence evaluated, definitive UDT is considered medically reasonable and necessary when utilized: 1) To identify a specific substance(s) and/or metabolite that are inadequately or not at all detected by a presumptive UDT (e.g., fentanyl, meperidine, synthetic cannabinoids, other synthetic/analog drugs), 2) 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) To identify non-prescribed medication or illicit substance use for ongoing safe prescribing of controlled substances (e.g., chronic opioid therapy) when presumptive UDT is insufficient to identify all substances of concern, and 4) To use in a differential diagnostic assessment of medication efficacy, side effects, and/or drug-drug interactions. Therefore, coverage has been extended for definitive UDT consistent with the evidence.

A list has been included in this LCD under ‘Drug Classification’ which illustrates parent drugs and their metabolites and defines all the various drug classes that are recognized as distinct classes by this LCD. This list is based upon the drug classes listed in the DEA Drugs of Abuse Resource Guide,3 the AACC evidence-based guidelines,2 and the AMA CPT® Codebook1 references. Therefore, coverage has been extended for the use of no more than 14 classes of drugs for UDT.

Current clinical practice guidelines recommend drug testing at baseline and randomly at least once a year for low-risk patients (based on history of past substance abuse/addiction, aberrant behaviors, and opioid risk screening criteria). However, more frequent monitoring is recommended for patients with risk factors for misuse/abuse, although the ideal frequency has not been established.

Consistent with Medicare guidelines and evidence evaluated, the following are considered not medically reasonable and necessary: 1) Blanket orders, 2) Routine standing orders not customized for a specific patient’s clinical circumstances, 3) Any reflexive testing without a documented order from the treating provider allowing the reflexive testing, 4) Performing multiple presumptive UDTs utilizing the same or different methodologies (e.g., a POCT immunoassay test and a chromatographic method without mass spectrometry) on the same date of service; Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers, 5) More than one definitive test result per patient per date of service regardless of the number of billing providers; Medicare will only pay for one definitive test result per patient per date of service regardless of the number of billing providers, 6) Drug testing of two different specimen types (e.g., blood and urine) from the same patient on the same date of service for the same drugs/metabolites/analytes, 7) Performing a presumptive UDT when the provider is testing for drugs/metabolites/analytes that are not detected by a presumptive UDT, 8) UDT for medico-legal and/or employment purposes, 9) UDT for protection of a physician from drug diversion charges, 10) Definitive UDT for ruling out a testing error as the cause of an unexpected presumptive UDT result, 11) Unbundling specimen validity testing (e.g., pH, specific gravity, oxidants, creatinine, and DNA tests) from the overall UDT claim(s), and 12) Testing for substances in which results would not affect patient management. Therefore, coverage will not be extended for these types of orders/testing situations.

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
The ‘History/Background and/or General Information’ section has been revised to clearly describe the services addressed in the LCD. The ‘Definitions’ section has been revised to be consistent with the evidence. A ‘Drug Classification’ section has been added to provide a listing of the distinct drug classes recognized as distinct per the LCD. The following sections of the LCD have been removed: ‘Drug Test Methods’, ‘Limitations of Presumptive UDT’, ‘CLIA-Certified Laboratories’, ‘Purpose of UDT’, ‘Drug Test Panels’, ‘Specimen Type’, ‘Other Covered Services’, ‘Utilization Guidelines’. The ‘Covered Indications for UDT’ section and the ‘Limitations’ section have been revised to be consistent with the evidence. The ‘Documentation Requirements’ section has been removed from the LCD and is now located in the associated billing and coding article (A57077). The following sections were added: ‘Summary of Evidence’ and ‘Analysis of Evidence’. Also, formatting changes have been made throughout the LCD. Coverage Indications, Limitations and/or Medical Necessity
Associated Information
Associated Information

Please refer to the related Draft Local Coverage Article: Billing and Coding: Controlled Substance Monitoring and Drugs of Abuse Testing (DA57077) for documentation requirements, utilization parameters and all coding information as applicable.

Sources of Information

N/A

Bibliography

This bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.

  1. American Medical Association, Current Procedural Terminology (CPT®) Professional 2022 Codebook. 4th ed. Chicago, IL: AMA; 2021.
  2. Jannetto PJ, Bratanow NC, Clark WA, et al. Executive Summary: American Association of Clinical Chemistry Laboratory Medicine Practice Guideline—Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients. JALM. 2018;2(4):489–526. https://doi.org/10.1373/jalm.2017.023341.
  3. Drug Enforcement Administration, U.S. Department of Justice, Drugs of Abuse: A DEA Resource Guide, 2020 Edition. https://www.dea.gov/sites/default/files/2020-04/Drugs%20of%20Abuse%202020-Web%20Version-508%20compliant-4-24-20_0.pdf?adlt=strict. Accessed August 1, 2022.
  4. Jarvis M, Williams J, Hurford M, et al. Appropriate Use of Drug Testing in Clinical Addiction Medicine. J Addict Med. 2017;11(3):163-173. doi:10.1097/ADM.0000000000000323.
  5. Moeller KE, Kissack JC, Atayee RS, Lee KC. Clinical Interpretation of Urine Drug Tests: What Clinicians Need to Know About Urine Drug Screens. Mayo Clin Proc. 2017;92(5):774-796. doi:10.1016/j.mayocp.2016.12.007.
  6. Argoff CE, Alford DP, Fudin J, et al. Rational Urine Drug Monitoring in Patients Receiving Opioids for Chronic Pain: Consensus Recommendations. Pain Medicine. 2018;19:97-117. doi:10.1093/pm/pnx285.
  7. Manchikanti L, Kaye AM, Knezevic NN, et al. Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain Physician. 2017;20(2S):S3-S92.
  8. Substance Abuse and Mental Health Services Administration. Federal Guidelines for Opioid Treatment Programs, HHS Publication No. (SMA) PEP15-FEDGUIDEOTP. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2015. https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf. Accessed August 3, 2022.
  9. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. JAMA. 2016;315(15):1624-1645. doi:10.1001/jama.2016.1464.
  10. American Society of Addiction Medicine. The ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 Focused Update. ASAM. 2020. https://www.asam.org/quality-care/clinical-guidelines/national-practice-guideline. Accessed August 3, 2022.
  11. Centers for Disease Control and Prevention (CDC). Clinical Laboratory Improvement Amendments (CLIA). 2021 Nov 4. http://wwwn.cdc.gov/clia/Resources/TestComplexities.aspx/ Accessed July 5, 2022.
Open Meetings
Meeting DateMeeting StatesMeeting Information
10/27/2022 Florida
Puerto Rico
Virgin Islands

The open meeting is a meeting for MAC JN.

Location of Meeting:

Teleconference/Webinar Only

Time of Meeting:

1PM ET

Link to JN website:

https://medicare.fcso.com/Open_Public_Meeting/0458851.asp

Contractor Advisory Committee (CAC) Meetings
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
10/13/2022
Comment Period Start Date
10/13/2022
Comment Period End Date
11/26/2022
Reason for Proposed LCD
  • Creation of Uniform LCDs With Other MAC Jurisdiction
Requestor Information
This request was MAC initiated.
Contact for Comments on Proposed LCD
Medical Affairs
2020 Technology Parkway
Suite 100
Mechanicsburg, PA 17050
ProposedLCDComments@fcso.com

Associated Documents

Attachments
N/A
Related National Coverage Documents
NCDs
130.6 - Treatment of Drug Abuse (Chemical Dependency)

Keywords

N/A

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