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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Pathology
Policy Number:068
Effective Date: 06/09/2020
Original Policy Date:02/01/2012
Last Review Date:06/09/2020
Date Published to Web: 05/06/2019
Subject:
Drug Testing in Pain Management and Substance Use Disorder Treatment Settings

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

__________________________________________________________________________________________________________________________

Patients in pain management programs and substance use disorder treatment may misuse prescribed opioids and/or may use nonprescribed drugs. Thus, these patients are often assessed before treatment and monitored while receiving treatment. Drug testing can be part of this monitoring strategy; it is most often used as part of a multifaceted intervention that includes other components, such as patient contracts.

PopulationsInterventionsComparatorsOutcomes
Individuals:
    • With chronic pain treated with opioids
Interventions of interest are:
    • Drug testing
Comparators of interest are:
    • No drug testing
Relevant outcomes include:
    • Health status measures
    • Resource utilization
Individuals:
    • With a drug addiction who are in substance use disorder treatment
Interventions of interest are:
    • Drug testing
Comparators of interest are:
    • No drug testing
Relevant outcomes include:
    • Health status measures
    • Resource utilization

BACKGROUND

Pain Management

According to a 2012 evidence assessment by the American Society of Interventional Pain Physicians, approximately one-third of chronic pain patients do not use opioids as prescribed or may abuse them.1, In 2016, the International Narcotics Control Board reported that between 1999 and 2010, the number of deaths related to the use of prescription opioid painkillers increased 5-fold among U. S. women and increased by a factor of 3.6 among U. S. men.2, Additionally, studies have found that a substantial proportion of chronic pain patients inaccurately report nonadherence to prescribed medications and the use of illicit drugs.3,

A discussion of the controversies related to opioid therapy for the treatment of chronic non-cancer pain is beyond the scope of this review. For a review of evidence-based guidelines from national and international medical societies that examine the place of opioid-based interventions within the management of selected chronic noncancer pain indications, see the BCBSA Special Report 'Opioids for Management of Chronic Noncancer Pain'.

Substance use disorder

Substance use, abuse, and addiction involving numerous prescription and illicit drugs is also a serious social and medical problem. Addiction is a primary, chronic disease of brain reward, motivation, memory, and related circuitry and is manifested by theindividual pathologic pursuit of reward and/or relief by substance use and other behaviors.

Monitoring Strategies

Various strategies are available to monitor pain management and substance use disorder treatment patients, and multicomponent interventions are often used. Many settings require patients to sign a contract before they are given a prescription for opioids. The contracts generally involve obtaining patients' agreement on behaviors they will engage in during the treatment period (eg, taking medication as prescribed) and not engage in (eg, selling prescribed medication and/or obtaining additional prescriptions from other physicians).

Confirming whether patients follow these behavioral guidelines can be a challenge. Risk-assessment screening instruments, such as the Screener and Opioid Assessment for Patients with Pain, and the Opioid Risk Tool, can aid in the assessment of patients' risk for inappropriate drug use. In addition, the presence of "aberrant behaviors" can be used as a marker for patients who are at high-risk for deviating from treatment protocols. Aberrant behaviors include multiple lost prescriptions, obtaining prescriptions from other practitioners, and displaying evidence of acute intoxication during office visits.

Testing Matrices

Another strategy for monitoring patients is testing of biologic specimens for the presence or absence of drugs. Currently, urine is the most commonly used biologic substance. Advantages of urine drug testing (UDT) are that it is readily available and standardized techniques for detecting drugs in urine exist. Other biologic specimens (eg, blood, oral fluids, hair, sweat) can also be tested. All matrices have advantages and disadvantages with respect to sensitivity and specificity over different time windows, time to obtain results, different susceptibility to sample tampering and ease of collection.

Urine Drug Testing

There are two primary categories of UDT: immunotherapy and specific drug identification.

Presumptive (Immunoassay) Testing

Immunoassay testing (also called presumptive testing or qualitative testing or screening) can be performed in a laboratory or at point-of-service. Immunoassay tests are based on the principle of competitive binding and use antibodies to detect a particular drug or drug metabolite in a urine sample. With competitive binding, a fixed amount of a labeled drug is added to the urine sample, and the drug or metabolite in the sample competes with the labeled drug for binding sites on the antibody. The amount of labeled antigen that binds with the antibody is inversely proportional to the amount of the drug or metabolite in the sample.

Immunoassay tests vary in the type of compounds they can detect. Some detect specific drugs and may fail to recognize similarly structured drugs within the same class. Other immunoassays identify only classes of drugs and thus results cannot be used to determine which drug a patient is taking. For example, a positive result of an opiate immunoassay can be due to morphine or hydromorphone. The degree of crossreactivity (ie, an antibody's reactivity with a compound other than the target of the test) varies widely among immunoassays.

Immunoassay findings are generally reported qualitatively as either positive (drug level above a prespecified threshold) or negative (drug level below a prespecified threshold). Raising or lowering the threshold thus changes the proportion of positive tests. A negative test is interpreted as a level below the threshold and does not necessarily mean that the drug or metabolite is absent.

Immunoassays generally have a rapid turnaround time, to within minutes for on-site tests, and one to four hours for laboratory-based tests.4,

Confirmatory (Specific Drug Identification)

Confirmatory tests are always performed in a laboratory. Gas chromatography/mass spectrometry (GC/MS) and liquid chromatography/mass spectrometry (LC/MS) are considered to be the criterion standard for confirmatory testing. These techniques involve using GC or LC to separate the analytes in a specimen and for MS to identify the specific molecular structures of the drug and its metabolites. The tests are able to quantify the amount of drug or metabolite present in the urine sample. Definitive quantitative tests can be used to confirm the presence of a specific drug identified by a screening test and can identify drugs that cannot be isolated by currently available immunoassays. Results are reported as the specific levels of substances detected in the urine. GC/MS and LC/MS generally requirethe specification of the drug or drugs to be identified. Alternatively, "broad-spectrum screens" can be conducted. There is a several-day turnaround time for GC/MS and LC/MS testing.5,

An issue with both types of UDT is the possibility of sample tampering to mask the presence of illegal drugs. A variety of products and techniques are available to patients and can be as simple as drinking a large amount of water to dilute the sample. There are also commercial dilution and cleaning products, additives, and urine substitutes. Some of these techniques can be detected by visual inspection of the sample (eg, color) or by on-site testing of sample characteristics including urine temperature, creatinine concentration, and specific gravity.

The correct interpretation of UDT results is very important. Knowledge of drug metabolites is essential for accurate interpretation. Accurate interpretation of test results also requires knowledge of the drug manufacturing process. For example, due to manufacturing impurities, a small amount of hydrocodone may be present in urine samples from patients prescribed oxycodone. Thus, it would be acceptable to detect a small amount of hydrocodone if high amounts of oxycodone were also present.

There are various approaches to incorporating UDT into pain management and substance use disorder treatment settings. Most commonly, patients undergo urine drug screening before beginning treatment to verify current drug use. Some clinicians believe that UDT should be routinely used to establish baseline information about substance use, but the optimal frequency and interval of testing remains uncertain. A universal approach to screening may uncover more inappropriate use and may reduce patients' sense that testing is being performed due to a lack of trust. However, routine universal screening may place an unnecessary burden on the health care system and on the doctor-patient relationship. An alternative approach is selective testing of patients who are judged to be at increased risk for drug misuse.

Existing protocols vary for the use of presumptive vs definitive tests. Some involve conducting routine confirmation of positive presumptive tests with definitive quantitative testing. Others use selective confirmation of positive presumptive tests, such as when an unexpected immunoassay result is not adequately explained by the patient. There is also a mixed approach, with routine confirmation of presumptive tests only for drugs with poor-performing immunoassays.

Full informed consent is a requirement before UDT. Patients should be informed of the specific drug testing protocol before treatment and should provide written agreement with the plan for monitoring. As stated in a joint U.S. Veterans Affairs/Department of Defense guideline, patients' refusal to consent to urine testing should be considered a factor in the overall assessment of patients' ability to adhere to treatment.6,

Oral Fluid Drug Testing

Oral fluid (liquid samples obtained from the oral cavity) can potentially be used to test for drug use. Oral fluid contains secretions from several different sources, including secretions from the three pairs of major salivary glands (parotid, sublingual, and submandibular), secretions from the minor salivary glands, oro-nasopharyngeal secretions, and cellular debris. The mixture of fluids obtained varies depending on the collection method used (eg, spitting, suctioning, draining, or collection on some type of absorbent material). Drug concentrations can be affected by the collection method and by the use of saliva stimulation methods. Several collection devices are commercially available in the U.S., and they generally involve collection on an absorbent material, such as foam pads; pads are then placed in a container with a stabilizing buffer solution. Drug concentrations may also depend on how the oral fluid is recovered from the collection device (eg, by centrifugation or by applying pressure). Drug concentrations may not reflect blood levels because of residual amounts of a drug (specifically those ingested or smoked) remaining in the oral cavity after recent use.

Analysis techniques must be able to detect drugs present in low concentration and in a small volume of fluid (often <1 mL). Immunoassay techniques are available to detect drugs in oral fluid; they require a small sample volume (»25 μL). Immunoassays tend to be relatively sensitive techniques, but they have low specificity. Confirmation analysis is generally performed using MS-based methods. In recent years, advancements have been made in MS analysis techniques, including the development of multianalyte LC/MS methods.

A practical advantage of oral fluid collection compared with urine collection is that samples can be obtained under the direct supervision and without loss of privacy. It has been used in situations where urine sampling is impractical, such as testing drivers during traffic stops. Oral fluid sampling also has the potential to be useful in pain management or substance use disorder treatment settings, particularly when substitution or tampering with urine drug samples is suspected.

Hair Testing

Hair is composed of protein that traps chemicals in the blood at the time the hair develops in the follicle. Hair on the human head grows at approximately 0.5 inches per month. Thus, a 1.5-inch hair sample could be used to detect drug use during the previous 90 days. Potential advantages of hair as a drug testing source include noninvasive collection; ease of collection, storage, and shipping; availability of samples for testing and retesting; and difficulty in tampering. Potential disadvantages include: recent drug use (ie, within the past seven days) cannot be detected; difficulty in detecting very light drug use (eg, a single episode); and drug levels can be affected by environmental exposure. In addition, variation in hair texture as well as cosmetic hair treatments can affect drug incorporation into hair and the accuracy of drug tests on hair samples. As with other types of samples, hair can be initially tested using immunoassay techniques, with confirmation by MS-based methods. Hair testing has been used in a variety of situations where detection of drug use during the previous several months is desired (eg, pre-employment screening, post-drug-treatment verification of relapse).

Regulatory Status

The Food and Drug Administration (FDA) regulates drugs of abuse tests that are sold to consumers or health care professionals in the U. S.. The FDA reviews many of these tests before they are sold for use. In its review, the FDA evaluates the design and performance of tests and sample collection systems to help ensure that they produce accurate results. The FDA does not review drugs of abuse tests intended for employment and insurance testing provided they include a statement in their labeling that the device is intended solely for use in employment and insurance testing. The FDA review does not include test systems intended for federal drug testing programs (eg, programs run by the Substance Abuse and Mental Health Services Administration, the Department of Transportation, and the U.S. military.)

The FDA has cleared assays for urine testing of drugs of abuse as well as oral fluid specimen collection devices and assays for analysis of oral fluid for drugs of abuse through the 510(k) regulatory pathways.Several collection devices are commercially available in the U. S., and they generally involve collection on an absorbent material, such as foam pads; pads are then placed in a container with a stabilizing buffer solution. Immunoassays of urine specimens have previously been cleared by the FDA and are used as the predicates for the oral fluid immunoassays.

Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments. Testing with GC/MS and some immunoassays are performed in laboratory settings. Laboratories that offer laboratory-developed tests must be licensed by the Clinical Laboratory Improvement Amendments for high-complexity testing.

Related Policies

  • Biofeedback (Policy #060 in the Treatment Section)
  • Intravenous Anesthetics for the Management of Chronic Pain and Depression (Policy #035 in the Drugs Section)

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

[INFORMATIONAL NOTE: Pursuant to the New Jersey State Mandate on substance use disorder (P.L.2017, c.28, effective May 16, 2017), health benefit plans are required to provide unlimited benefits for medically necessary inpatient (IP) and outpatient (OP) treatment of substance use disorder at in-network facilities. It also prohibits any prior authorization or prospective utilization management for the first 180 days per plan year of medically necessary IP and OP treatment of substance use disorder, including outpatient prescription drugs. In addition, it places restrictions on prescription of opioids, such as a 5-day supply limit on initial prescriptions for treatment of acute pain.

For additional information and specific provisions, please refer to the mandate.

For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.]

1. Urine drug testing must be ordered by a licensed practitioner such as a physician or an advanced practitioner (Physician Assistant or Nurse Practitioner) directly involved in care management of the member.

2. In the outpatient pain management setting, presumptive (i.e., immunoassay) urine drug testing (UDT) is considered medically necessary for:
    - Baseline screening before initiating treatment or at the time treatment is initiated, when the following conditions are met:
      o An adequate clinical assessment of patient history and risk of substance abuse is performed;
      o Clinicians have knowledge of test interpretation;
      o There is a plan in place regarding how to use test findings clinically

    Requirements for UDT:
      o baseline screening and subsequent monitoring of treatment should be performed using presumptive method of testing in an office or point-of-care (POC) setting utilizing a CLIA-waived test, or in a CLIA certified laboratory;
      o one (1) baseline presumptive UDT is appropriate;
      o presumptive UDT exceeding these frequency guidelines (e.g., for patients with recent aberrant behavior) will be reviewed on individual case basis (requires documentation of medical necessity from the ordering physician or qualified health care provider);
      o a presumptive UDT without definitive UDT is typically sufficient for ongoing clinical monitoring.

3. In the outpatient substance use disorder treatment setting, in-office or point-of-care presumptive (i.e., immunoassay) urine drug testing (UDT) is considered medically necessary under the following conditions:
    - Baseline screening before initiating treatment or at the time treatment is initiated (ie, induction phase) when the following conditions are met:
      o An adequate clinical assessment of patient history and risk of substance abuse is performed;
      o Clinicians have knowledge of test interpretation;
      o There is a plan in place regarding how to use test findings clinically

    Requirements for UDT:
      o baseline screening and subsequent monitoring of treatment should be performed using presumptive method of testing in an office or point-of-care (POC) setting utilizing a CLIA-waived test, or in a CLIA certified laboratory;
      o one (1) time baseline presumptive UDT is appropriate per program entry;
      o presumptive UDT exceeding these frequency guidelines (e.g., for complicated cases) will be reviewed on individual case basis (requires documentation of medical necessity from the ordering physician or qualified health care provider);
      o a presumptive UDT without definitive UDT is typically sufficient for ongoing clinical monitoring.
4. Definitive (i.e., confirmatory) urine drug testing (UDT), in the pain management or substance use disorder treatment setting, is considered medically necessary under the following circumstances:
     When presumptive (i.e., immunoassay) UDT for the relevant drug(s) are not commercially available.
     In specific situations for definitive UDT is required for clinical decision making (see Policy Guidelines section)

    Requirements for definitive UDT:
      o definitive UDT should be performed in a CLIA certified laboratory;
      o after the 24th test in any one calendar year, there needs to be specific clinical notes from the ordering physician/APN/PA directly involved in the members care, supporting the need for continued testing;
      o Horizon BCBCNJ shall allow one (1) unit of presumptive testing AND one (1) unit of definitive testing, on the same date of service if supporting documentation is provided. The one (1) unit of definitive testing should correlate to the results of the presumptive testing;
      o definitive UDT requires a positive presumptive UDT and should be performed only for the drug class represented by the positive presumptive UDT;
      o definitive UDT for negative presumptive UDT requires documentation of medical necessity from the ordering physician or qualified health care provider;
      o definitive UDT should be performed, processed and interpreted in a timely manner, and there should be clear documentation in the medical records how the test result impacts management of the patient;
      o a presumptive UDT without definitive UDT is typically sufficient for ongoing clinical monitoring.

5. In the outpatient pain management setting and outpatient substance use disorder treatment setting, urine drug testing is not considered medically necessary when the above criteria are not met including but not limited to routine presumptive or definitive urine drug testing (eg testing at every visit, without consideration for specific patient risk factors or without consideration for whether definitive testing is required for clinical decision-making).

6. In the outpatient pain management setting and outpatient substance use disorder treatment setting, hair drug testing and oral fluid drug testing are considered investigational.


Policy Guidelines: (Information to guide medical necessity determination based on the criteria contained within the policy statements above.)

This policy does not apply to testing required by third parties such as but not limited to: testing for a medico-legal purpose such as child custody; testing for pre-employment or random testing for employment; or testing for athletics.

Validity testing includes pH, specific gravity, nitrates, chromates, and creatinine which are performed on the same specimen that is being drug tested. Validity testing is an internal process to affirm that the reported results are accurate and valid.

Pain Management

The risk level for an individual patient should include both a global assessment of risk factors and monitoring for the presence of aberrant behavior. Standardized risk-assessment tools are available, such as the 5-item Opioid Risk Tool (ORT). Another screening instrument is the Screener and Opioid Assessment for Patients in Pain, a 24-item tool.

Aberrant behavior is defined by one or more of the following:

    • multiple lost prescriptions,
    • multiple requests for early refill,
    • obtained opioids from multiple providers,
    • unauthorized dose escalation, and
    • apparent intoxication during previous visits.
Opinions vary on the optimal frequency of urine drug screening to monitor patients on opioid therapy for chronic pain. Screening frequency using a risk-based approach, as recommended by the Washington State interagency guideline (Washington State Agency Medical Directors' Group, 2015) is as follows:
    • Low risk by ORT: Once a year\
    • Moderate risk by ORT: Twice a year
    • High risk or opioid dose >120 mg MED/d: 3 to 4 times a year
    • Recent history of aberrant behavior: Each visit
Note that the ORT is a copyrighted instrument The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain does not include specific screening frequencies but states that an individual patient's risk for opioid misuse and addiction should be considered when deciding when to order a urine drug screen

Substance use disorder

The 2017 consensus statement from the American Society of Addiction Medicine provides guidance on appropriate use of drug testing in substance use disorder.

Medical records should support the need for testing for the specific substance(s) of interest by documentation regarding the diagnosis, history and physical examination and/or behavior of the patient. Medical records should also justify the test that is being used and describe how results of testing will guide medical decision-making.

Presumptive Testing

Selecting an appropriate test

A medical and psychosocial assessment should guide the process of choosing a drug test that is individualized based on the patient’s needs, appropriate for the substance(s) targeted and the particular window of time of suspected use.

If a panel that includes testing for several substances is being ordered, justification for the use of a panel instead of individual testing is needed.

Selecting an appropriate matrix

Urine, blood, exhaled breath, oral fluid, sweat, and hair are matrices used in drug testing. Urine is the preferred matrix but all matrices have advantages and disadvantages with respect to sensitivity and specificity over different time windows, time to obtain results, different susceptibility to sample tampering and ease of collection.

Matrices other than urine may also be appropriate when urine cannot be collected (eg, patients on dialysis or with shy bladder) or when a sample collection technique is too invasive. Justification of matrix other than urine should be included in the medical record.

Selecting an appropriate frequency of testing

There may be certain threshold for the number of tests that are approved without review with subsequent tests requiring medical review. Patients who have unusually high numbers of tests ordered need medical review to confirm that the tests meet medical necessity.

Appropriate frequency of testing depends on many factors:

    • Tests’ detection capabilities and windows of detection
    • Patient factors such as severity and chronicity of addiction
    • Substance(s) used
    • Phase of treatment
        • During the stabilization phase, drug testing may be scheduled more frequently
        • During the maintenance phase, drug testing may be scheduled less frequently
Presumptive test availability

There may not be commercially available tests for certain synthetic or semisynthetic opioids. Table PG1 describes limitations on availability of presumptive tests.

Table PG1, Limitations in Availability of Presumptive Immunoassays
Drug TypePotential limitations in availability of or sensitivity of presumptive immunoassays for certain drugs in urine
Benzodiazepines·Clonazepam and lorazepam are detected with varying sensitivity by different assays.

·Therapeutic doses of benzodiazepines are generally not detected

Semisynthetic Opioids·Oxycodone and oxymorphone (a metabolite of oxycodone) are detected in a few but not most standard opiate immunoassays depending on the antibodies used by the manufacturer.

·Hydrocodone and hydromorphone (a metabolite of hydrocodone) are also detected in most standard opiate immunoassays.

Synthetic opiates·Meperidine, methadone, buprenorphine, and fentanyl will not be detected in a standard opiate immunoassay and require their own definitive test for detection.
Natural opioids·Morphine and codeine (which is metabolized to morphine) are detected by standard immunoassays for opiates but presumptive testing does not distinguish specific drug present.

·Heroin is unable to be specifically detected by presumptive tests due to rapid metabolism to 6-MAM and subsequently to morphine.

Sources: Based on information included in ASAM 2017 guideline and Washington State interagency guideline (Washington State Agency Medical Directors’ Group, 2015)

Guidance on Definitive (Confirmatory) Testing

Specific situations for definitive drug testing may include, but are not limited to the following:

    • Need to detect a specific substance not adequately identified by presumptive methods (see Presumptive Test Availability, above)
    • Unexpected positive test inadequately explained by the patient (e.g., a positive result on a presumptive test is inconsistent with the history and physical exam)
    • Unexpected negative test (suspected medication diversion)
    • Need for quantitative levels to compare with established benchmarks for clinical decision making such as treatment transition or changes in medication therapies.
Table PG2, on interpreting unexpected results of urine drug tests, is adapted from a table developed by the Canadian National Opioid Use Guideline Group that was cited by the American Society of Interventional Pain Physicians in its guideline on prescribing opioids for chronic non-cancer pain.

Table PG2. Interpreting Unexpected Urine Drug Tests Results
Unexpected ResultPossible ExplanationsPossible Actions for the Physician
Test is negative for prescribed opioid•False-negative

•Noncompliance

•Diversion

•Conduct confirmatory testing, specifying the drug of interest (eg, oxycodone often missed by immunoassay)

•Take a detailed history of patient's medication use for the preceding 7 days (eg, could learn that patient ran out several days before test)

•Ask patients if they've given the drug to others

•Monitor compliance with pill counts

Test is positive for nonprescribed opioid or benzodiazepines•False-positive

•Patient acquired opioids from other sources (double-doctoring, "street")

•Repeat urine drug testing regularly

Ask patients if they accessed opioids from other sources

•Assess for opioid misuse/addiction

•Review/revise treatment agreement

UDS positive for illicit drugs (eg, cocaine, cannabis)•False-positive

•Patient is occasional user or addicted to the illicit drug

•Cannabis is positive for patients taking certain medications (eg, dronabinol)

•Repeat urine drug test regularly

•Assess for abuse/addiction and refer for addiction treatment as appropriate

UDS: urine drug screen.


Medicare Coverage:
Drug Testing in Pain Management and Substance Abuse Treatment Settings is covered when Local Coverage Determination (LCD): Controlled Substance Monitoring and Drugs of Abuse Testing (L35006) and Local Coverage Article: Billing and Coding: Controlled Substance Monitoring and Drugs of Abuse Testing (A56645) criteria are met. For additional information and eligibility, refer to Local Coverage Determination (LCD): Controlled Substance Monitoring and Drugs of Abuse Testing (L35006) and Local Coverage Article: Billing and Coding: Controlled Substance Monitoring and Drugs of Abuse Testing (A56645). Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35396&ver=118&name=331*1&UpdatePeriod=754&bc=AAAAEAAAAAAAAA%3d%3d&

Also see National Coverage Determination (NCD) for Hair Analysis (190.6). Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?MCDId=11&ExpandComments=n&McdName=Monitoring+of+Erythropoietin+Stimulating+Agents+for+Beneficiaries+with+End+Stage+Renal+Disease&mcdtypename=CMS+Solicitation+of+Public+Comments&MCDIndexType=4&NCDId=189&ncdver=1&bc=AgAEAAAAAQAAAA%3D%3D&.

Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for service codes for Drug Testing in Pain Management and Substance Abuse Treatment Settings when there is no applicable local or national CMS coverage determination or CMS guidance.

Per Palmetto GBA (MAC Jurisdiction J – J), Local Coverage Determination (LCD): Lab: Controlled Substance Monitoring and Drugs of Abuse Testing (L35724) and Local Coverage Article: Billing and Coding: Lab: Controlled Substance Monitoring and Drugs of Abuse Testing (A54799), proprietary lab codes 0143u-0150u are covered when LCD L35724 and Article A54799 criteria are met.

Only one presumptive test result per patient per date of service is covered regardless of the number of billing providers.

The following are noncovered:

Reflex definitive UDT is not reasonable and necessary and therefore noncovered when presumptive testing is performed at point of care because the clinician 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).

Blanket Orders for individuals

Routine standing orders for all patients in a physician’s practice are not reasonable and necessary and therefore noncovered.

It is not reasonable and necessary and therefore noncovered for a physician to perform presumptive POCT and order presumptive IA testing from a reference laboratory.

It is not reasonable and necessary and therefore noncovered for a physician to perform presumptive IA testing and order presumptive IA testing from a reference laboratory with or without reflex testing.

It is not reasonable and necessary and therefore noncovered 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.

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

Drug testing of two different specimen types from the same patient on the same date of service for the same drugs/metabolites/analytes is noncovered.

UDT for medico-legal and/or employment purposes or to protect a physician from drug diversion charges is noncovered.

Specimen validity testing including, but not limited to, pH, specific gravity, oxidants, creatinine is noncovered.

Palmetto GBA (MAC Jurisdiction J – J), Local Coverage Determination (LCD): Lab: Controlled Substance Monitoring and Drugs of Abuse Testing (L35724) and Local Coverage Article: Billing and Coding: Lab: Controlled Substance Monitoring and Drugs of Abuse Testing (A54799). Available to be accessed at: LCD by State Index search: https://www.cms.gov/medicare-coverage-database/indexes/lcd-state-index.aspx?bc=AgAAAAAAAAAA&

Medicaid:

FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

PROPRIETARY LABS (Labs that are the sole source for the diagnostic lab test)

For labs which are proprietary (that is, the sole source for the diagnostic lab test involved), Medicare Advantage Products will follow the Medicare Local Coverage Determination of the State where the proprietary lab is located.
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Drug Testing in Pain Management and Substance Use Disorder Treatment Settings
Drug Testing in Pain Management and Substance Abuse Treatment Settings
Urine Drug Testing in Pain Management and Substance Abuse Treatment Settings
Drug Screening/Testing in the Context of Substance Abuse Treatment
Substance Abuse Treatment, Drug Testing
Substance Use Disorder Treatment, Drug Testing
Pain Management Treatment, Drug Testing
Point-of-Care Drug Testing
Laboratory-Based Drug Testing
Screening/Testing, Drug
Urine Drug Testing
Hair Drug Testing
Oral Fluid Drug Testing

References:
1. Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment. Pain Physician. Jul 2012;15(3 Suppl): S1-65. PMID 22786448

2. International Narcotics Control Board (INCB). Report of the International Narcotics Control Board for 2016. 2016; https://www.incb.org/documents/Publications/AnnualReports/AR2016/English/AR2016_E_ebook.pdf. Accessed October 16, 2019.

3. Fishbain DA, Cutler RB, Rosomoff HL, et al. Validity of self-reported drug use in chronic pain patients. Clin J Pain. Sep 1999;15(3):184-191. PMID 10524471

4. Manchikanti L, Atluri S, Trescot AM, et al. Monitoring opioid adherence in chronic pain patients: tools, techniques, and utility. Pain Physician. Mar 2008;11(2 Suppl):S155-180. PMID 18443638

5. National Opioid Use Guideline Group (NOUGG). Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain. Part B: Recommendations for practice. Version 5.6. 2010; http://nationalpaincentre.mcmaster.ca/documents/opioid_guideline_part_b_v5_6.pdf. Accessed October 16, 2019.

6. Veteran's Affairs (VA) and Department of Defense (DoD) Management of Opioid Therapy for Chronic Pain Working Group. Clinical practice guideline: management of opioid therapy for chronic pain. 2010; http://www.va.gov/painmanagement/docs/cpg_opioidtherapy_fulltext.pdf. Accessed October 16, 2019.

7. Jarvis M, Williams J, Hurford M, et al. Appropriate use of drug testing in clinical addiction medicine. J Addict Med. May/Jun 2017;11(3):163-173. PMID 28557958

8. Nuckols TK, Anderson L, Popescu I, et al. Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. Jan 7 2014;160(1):38-47. PMID 24217469

9. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain--United States, 2016. JAMA. Apr 19 2016;315(15):1624-1645. PMID 26977696

10. 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. Feb 2017;20(2S): S3-S92. PMID 28226332

11. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. Feb 2009;10(2):113-130. PMID 19187889

12. Hegmann KT, Weiss MS, Bowden K, et al. ACOEM practice guidelines: opioids for treatment of acute, subacute, chronic, and postoperative pain. J Occup Environ Med. Dec 2014;56(12):e143-159. PMID 25415660

13. American College of Occupational and Environmental Medicine (ACOEM). Opioid Treatment Contract. 2017; https://acoem.org/Guidance-and-Position-Statements/Guidelines/Opioid-Treatment-Contract. Accessed October 16, 2019.

14. Washington State Agency Medical Directors' Group. Interagency guideline on prescribing opioid dosing for pain. 2015; 3rd:http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf. Accessed October 16, 2019

15. American Society of Addiction Medicine (ASAM). Public Policy Statement On Drug Testing as a Component of Addiction Treatment and Monitoring Programs and in other Clinical Settings. 2010; http://www.asam.org/docs/publicy-policy-statements/1drug-testing---clinical-10-10.pdf?sfvrsn=0. Accessed October 16, 2019.

16. American Society of Addiction Medicine (ASAM). Drug Testing: A White Paper of the American Society of Addiction Medicine (ASAM). 2013; https://www.asam.org/docs/default-source/public-policy-statements/drug-testing-a-white-paper-by-asam.pdf. Accessed October 16, 2019.

17. American Society of Addiction Medicine (ASAM). Consensus Statement: Appropriate Use of Drug Testing in Clinical Addiction Medicine. 2017; https://www.asam.org/docs/default-source/quality-science/appropriate_use_of_drug_testing_in_clinical-1-(7).pdf?sfvrsn=2. Accessed Jul 23, 2019.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

    80184
    80188
    80305
    80306
    80307
    80320
    80321
    80322
    80323
    80324
    80325
    80326
    80327
    80328
    80329
    80330
    80331
    80332
    80333
    80334
    80335
    80336
    80337
    80338
    80339
    80340
    80341
    80342
    80343
    80344
    80345
    80346
    80347
    80348
    80349
    80350
    80351
    80352
    80353
    80354
    80355
    80356
    80357
    80358
    80359
    80360
    80361
    80362
    80363
    80364
    80365
    80366
    80367
    80368
    80369
    80370
    80371
    80372
    80373
    80374
    80375
    80376
    80377
    82397
    82542
    83516
    83520
    83789
    83992
    84311
    0006U
    0007U
    0011U
    0079U
    0093U
    0117U
HCPCS
G0480
G0481
G0482
G0483
G0659

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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