HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 

Medical Policy:
L-102-020
Topic:
Drug Testing in Pain Management and Substance Abuse Treatment
Section:
Laboratory
Effective Date:
October 1, 2017
Issued Date:
February 26, 2018
Last Revision Date:
February 2017
 
 

Individuals in pain management and substance abuse treatment programs may misuse prescribed opioids and/or may use non-prescribed drugs. Therefore, individuals in these settings are often assessed before treatment and monitored while they are receiving treatment. Drug screening is one (1) monitoring strategy; it is most often used as part of a multifaceted intervention that includes other components such as individual contracts.

Presumptive (i.e., qualitative, immunoassay) tests can be performed either in a laboratory or at point of service (POS). Immunoassay tests are based on the principle of competitive binding and use antibodies to detect a particular drug or drug metabolite in a sample.

Definitive (i.e., confirmatory, quantitative) are always performed in a laboratory. Gas chromatography/mass spectrometry (GC/MS) is considered to be the gold standard for confirmatory testing. This technique involves using GC to separate the analytes in a specimen and MS to identify the specific molecular structures of the drug and its metabolites.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Outpatient pain management, presumptive (i.e., qualitative, immunoassay) drug testing may be considered medically necessary when the following are met:

  • Baseline screening (induction phase) before initiating treatment or at the time treatment is initiated, when ALL of the following conditions are met:
    • An adequate clinical assessment of individual history and risk of substance abuse is performed; and
    • Clinicians have knowledge of test interpretation; and
    • There is a plan in place regarding how to use test findings clinically.
  • Subsequent monitoring of treatment at a frequency appropriate for the risk level of the individual.

Frequency of drug screening to monitor individuals on opioid therapy for chronic pain is a risk-based approach, as recommended by the Washington State Inter-Agency Guideline:

  • Low risk by opioid risk tool (ORT): Up to one (1) per year; or
  • Moderate risk by ORT: Up to two (2) per year; or
  • High risk or opioid dose greater than 120 MED/d: Up to three (3) to four (4) per year; or
  • Recent history of aberrant behavior, each visit.

*Aberrant behavior is defined by ONE (1) or more of the following:

  • Multiple lost prescriptions; or
  • Multiple requests for early refill; or
  • Obtained opioids from multiple provider; or
  • Unauthorized dose escalation; or
  • Apparent intoxication during previous visits.

Outpatient substance abuse treatment, in-office or point-of-care presumptive (i.e., qualitative, immunoassay) drug testing may be considered medically necessary when the following are met:

  • Baseline screening (induction phase ) before initiating treatment or at the time treatment is initiated, one (1) time per program entry, when ALL the following are met:
    • Adequate clinical assessment of individual history and risk of substance abuse is performed; and
    • Clinicians have knowledge of test interpretation; and
    • There is a plan in place regarding how to use test findings, clinically.
  • Stabilization phase – targeted weekly presumptive screening for a maximum of four (4) weeks; or 
  • Maintenance phase – targeted presumptive screening once every one (1) to three (3) months. 

Stabilization phase: Some complicated individuals may need frequent drug testing longer than four (4) weeks. (i.e., individuals on an opioid abuse therapy [Suboxone] could require additional drug testing more frequently and longer than four (4) weeks; based on the individual's compliance and drug testing results).

Maintenance phase: More frequent testing may be appropriate for more complicated individuals.

The use of presumptive drug testing is considered not medically necessary when the above criteria are not met.

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Definitive (i.e., confirmatory, quantitative) drug testing, in outpatient pain management or substance abuse treatment, may be considered medically necessary when the following are met:

  • When immunoassays for the relevant drug(s) are not commercially available; or
  • In specific situations for which quantitative drug levels are required for clinical decision making (i.e. unexpected positive test inadequately explained by the individual; unexpected negative test (suspected medication diversion); need for quantitative levels to compare with established benchmarks for clinical decision making).

Outpatient pain management and outpatient substance abuse treatment definitive drug testing is considered not medically necessary when the above criteria are not met.

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Limitations

Presumptive drug testing may be considered medically necessary and will only be allowed one (1) per individual encounter regardless of the number of drug classes tested:

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Presumptive drug testing be considered medically necessary when billed in any combination are limited to six (6) tests in a benefit period regardless of the test performed.

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Presumptive drug testing may be considered medically necessary and will be limited to 12 tests in a benefit period regardless of the test performed.

Quantity level limits (QLLs) are considered not medically necessary when the frequency guidelines listed above are exceeded.

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Definitive drug testing may be considered medically necessary when billed in any combination are allowed one (1) service per date with a limit of 12 tests per benefit period.

QLLs are considered not medically necessary when the frequency guidelines listed above are exceeded.

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Drug Testing for Opioid Dependency Limitations 

Drug testing for opioid dependency may be considered medically necessary when billed in any combination are allowed one (1) service per date with a limit of 48 tests per benefit period.

QLLs are considered not medically necessary when the frequency guidelines listed above are exceeded.

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Individual drug tests are considered not medically necessary.

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The collection date of the specimen must equal the date of service for the drugs tested.

Benefit year limits do not apply to the following:

  • Emergency room visits
  • Inpatient admissions
  • Federally regulated testing

 The following tests are considered non-covered:

  • Non-forensic testing (i.e. job related testing)
  • State/legally mandated drug testing

Related Policies

Refer to medical policy I-92 Naltrexone (Vivitrol®) for Treatment of Alcohol and Opioid Dependence for additional information.

Refer to medical policy I-160 Buprenorphine Implant for Treatment of Opioid Dependence for additional information.

Refer to medical policy Y-22 Opioid Dependence Therapy for additional information.


Professional Statements and Societal Positions Guidelines

42 CFR 8.12 - Federal opioid treatment standards.
An Opioid Treatment Programs (OTPs) organizational structure and facilities shall be adequate to ensure quality patient care and to meet the requirements of all pertinent Federal, State, and local laws and regulations. At a minimum, each OTP shall formally designate a program sponsor and medical director. The program sponsor shall agree on behalf of the OTP to adhere to all requirements set forth in this part and any regulations regarding the use of opioid agonist treatment medications in the treatment of opioid use disorder which may be promulgated in the future. The medical director shall assume responsibility for administering all medical services performed by the OTP. In addition, the medical director shall be responsible for ensuring that the OTP is in compliance with all applicable Federal, State, and local laws and regulations.

Centers for Disease Control and Prevention (CDC) 2016 guideline for prescribing opioids for chronic pain:

  • When prescribing opioids for chronic pain, clinicians should use drug testing before starting opioid therapy and consider drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

The guideline is intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death. CDC is committed to evaluating the guideline to identify effects on clinician and patient outcomes, both intended and unintended, and will revisit the guideline to determine if evidence gaps have been sufficiently addressed to warrant an update of the guideline and revise the recommendations in future updates when warranted.

Substance Abuse and Mental Health Service Administration (SAMHSA).
Medication-Assisted Treatment (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a whole-patient approach to the treatment of substance use disorders. Research shows that a combination of medication and therapy can successfully treat these disorders, and for some people struggling with addiction, MAT can help sustain recovery.

Federal legislation, regulations, and guidelines govern MAT for opioid addiction. SAMHSA’s Division of Pharmacologic Therapies (DPT), part of the SAMHSA Center for Substance Abuse Treatment (CSAT), oversees accreditation standards and certification processes for OTPs. DPT also works with the Drug Enforcement Administration (DEA) and the states to regulate certain medications used in MAT. Additionally, DPT works directly with MAT professionals to improve treatment outcomes and to meet regulatory criteria.


Place of Service: Outpatient

Drug testing in pain management and substance abuse treatment is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.





    Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

    Discrimination is Against the Law
    The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.