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Date Printed: October 20, 2017: 12:00 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

05-86000-32

Original Effective Date: 11/15/13

Reviewed: 02/23/17

Revised: 03/15/17

Next Review: No Longer Scheduled for Routine Review (NLR)

Subject: Drug Testing in Pain Management and Substance Abuse Treatment

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Patients in pain management programs and substance abuse treatment may misuse prescribed opioids and/or may use nonprescribed drugs. Patients in these settings are often assessed before treatment and monitored while they are receiving treatment. Urine drug screening is one monitoring strategy and is often part of a multifaceted intervention.

Currently, urine is the most commonly used biological substance. Advantages of urine sampling are that it is readily available, and standardized techniques for detecting drugs in urine exist. Other biological specimens (e.g., blood, oral fluids, hair and sweat) can also be tested and may gain in popularity over time as techniques for collecting and analyzing these specimens become more standardized.

There are 2 primary categories of urine drug testing:

POSITION STATEMENT:

In the outpatient pain management setting, presumptive (i.e., immunoassay) urine drug testing meets the definition of medical necessity for:

• Baseline screening before initiating treatment or at the time treatment is initiated, when the following conditions are met:

o A clinical assessment of member history and risk of substance abuse is performed;

o Clinicians have knowledge of test interpretation and;

o 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 member.

In the outpatient substance abuse treatment setting, point-of-care, or in-office presumptive (i.e., immunoassay) urine drug testing meets the definition of medical necessity under the following conditions:

• Baseline screening before initiating treatment or at the time treatment is initiated (i.e., induction phase), one (1) time per program entry, when the following conditions are met:

o A clinical assessment of member history and risk of substance abuse is performed;

o Clinicians have knowledge of test interpretation and;

o There is a plan in place regarding how to use test findings clinically.

• Stabilization phase - targeted weekly qualitative screening for a maximum of 4 weeks

• Maintenance phase – targeted qualitative screening once every 1 to 3 months.

Note: Presumptive urine drug testing is limited to fifteen (15) tests within a 12-month period. There is insufficient clinical evidence to support the use of daily or multiple testing per day in clinical practice. Refer to section entitled Reimbursement Information.

Definitive (i.e., confirmatory) urine drug testing, in outpatient pain management or substance abuse treatment, meets the definition of medical necessity under the following circumstances:

• When immunoassays for the relevant drug(s) are not commercially available or

• In specific situations for which definitive drug levels are required for clinical decision making (i.e. unexpected positive test inadequately explained by the member; unexpected negative test (suspected medication diversion); need for definitive levels to compare with established benchmarks for clinical decision making).

Note: Definitive urine drug testing is limited to twelve (12) tests within a 12-month period. There is insufficient clinical evidence to support the use of daily or multiple testing per day in clinical practice. Refer to section entitled Reimbursement Information.

In the outpatient pain management setting and outpatient substance abuse treatment urine drug testing does not meet the definition of medical necessity when the above criteria are not met including but not limited to:

• Routine presumptive or definitive urine drug testing (e.g., testing at every visit, without consideration for specific member risk factors or without consideration for whether definitive testing is required for clinical decision making)

Definitive testing instead of drug screening or as a routine supplement to drug screens

• Routine urinalysis for confirmation of specimen integrity

• Simultaneous blood and urine specimen screening

• Testing ordered by third parties (such as courts, schools, or employers) or ordered for the sole purpose of meeting the requirements of a third party

• Testing for residential monitoring.

BILLING/CODING INFORMATION:

CPT Coding

80305

Drug test(s), presumptive, any number of drug classes, any number of devices or procedures (eg, immunoassay); capable of being read by direct optical observation only (eg, dipsticks, cups, cards, cartridges) includes sample validation when performed, per date of service

80306

Drug test(s), presumptive, any number of drug classes, any number of devices or procedures (eg, immunoassay); read by instrument assisted direct optical observation (eg, dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service

80307

Drug test(s), presumptive, any number of drug classes, any number of devices or procedures, by instrument chemistry analyzers (eg, utilizing immunoassay [eg, EIA, ELISA, EMIT, FPIA, IA, KIMS, RIA]), chromatography (eg, GC, HPLC), and mass spectrometry either with or without chromatography, (eg, DART, DESI, GC-MS, GC-MS/MS, LC-MS, LC-MS/MS, LDTD, MALDI, TOF) includes sample validation when performed, per date of service

80320

Alcohols

80321

Alcohol biomarkers; 1 to 2

80322

Alcohol biomarkers; 3 or more

80324

Amphetamines, 1 to 2

80325

Amphetamines, 3 to 4

80326

Amphetamines, 5 or more

80345

Barbiturates

80346

Benzodiazepines; 1‐12

80347

Benzodiazepines; 13 or more

80348

Buprenorphine

80349

Cannabinoids, natural

80350

Cannabinoids, synthetic 1 to 3

80351

Cannabinoids, synthetic 4 to 6

80352

Cannabinoids, synthetic 7 or more

80353

Cocaine

80354

Fentanyl

80356

Heroin metabolite

80357

Ketamine and norketamine

80358

Methadone

80359

Methylenedioxyamphetamines (MDA, MDEA, MDMA)

80360

Methylphenidate

80361

Opiates, one or more

80362

Opioids and opiate analogs; 1 to 2

80363

Opioids and opiate analogs; 3 to 4

80364

Opioids and opiate analogs; 5 or more

80365

Oxycodone

80367

Propoxyphene

80371

Stimulants, synthetic

80375

Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1 to 3

80376

Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 4 to 6

80377

Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 7 or more

83992

Phencyclidine (PCP)

HCPCS Coding

G0480

Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day, 1-7 drug class(es), including metabolite(s) if performed.

G0481

Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day, 8-14 drug class(es), including metabolite(s) if performed.

G0482

Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift) ; qualitative or quantitative, all sources, includes specimen validity testing, per day, 15-21 drug class(es), including metabolite(s) if performed.)

G0483

Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day, 22 or more drug class(es), including metabolite(s) if performed.

G0659

Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem), excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase), performed without method or drug-specific calibration, without matrix-matched quality control material, or without use of stable isotope or other universally recognized internal standard(s) for each drug, drug metabolite or drug class per specimen; qualitative or quantitative, all sources, includes specimen validity testing, per day, any number of drug classes

REIMBURSEMENT INFORMATION:

Codes 80305, 80306, 80307, G0480, G0481, G0482, G0483, and G0659 when billed in any combination, are limited to fifteen (15) tests within a 12-month period regardless of the number of tests performed.

The following units of service will only be allowed per member date of service, regardless of the number of drug classes tested:

• One (1) unit of service for codes 80305, 80306, 80307, , G0480, G0481, G0482, G0483, G0659.

Codes 80320, 80321, 80322, 80324, 80325, 80326, 80345, 80346, 80347, 80348, 80349, 80350, 80351, 80352, 80353, 80354, 80356, 80357, 80358, 80359, 80360, 80361, 80362, 80363, 80364, 80365, 80367, 80371, 80375, 80376, 80377, and 83992, when billed in any combination, are limited to twelve (12) tests within a 12-month period regardless of the number of tests performed.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Controlled Substance Monitoring and Drugs of Abuse Testing (L36393) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. American Society of Addiction Medicine. Public Policy Statement on Drug Testing as a Component of Addiction Treatment and Monitoring Programs and in Other Clinical Settings. Revised October 2010. Accessed at asam.org 02/12/15.
  2. Blue Cross Blue Shield Association Medical Reference Policy Manual 2.04.98 Urine Drug Testing in Pain Management and Substance Abuse Treatment Settings, 12/16.
  3. Brandhorst G, et al. Liquid Chromatography–Tandem Mass Spectrometry or Automated Immunoassays: What Are the Future Trends in Therapeutic Drug Monitoring? Clinical Chemistry 58:5 821–825 (2012).
  4. Centers for Medicare & Medicaid Services (CMS), MLN Matters, Number:SE1105 Medicare Drug Screen Testing, August 2009.
  5. Christo PJ, et al. Urine drug testing in chronic pain. Pain Physician. 2011 Mar-Apr;14(2): 123-143.
  6. Conermann T, Gosalia AR, Kabazie AJ, et al. Utility of oral fluid in compliance monitoring of opioid medications. Pain Physician. Jan-Feb 2014;17(1):63-70.
  7. 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.
  8. Drug Testing: A White Paper of the American Society of Addiction Medicine (ASAM), 10/26/13. Accessed at asam.org 02/12/15.
  9. First Coast Service Options, Inc. (FCSO), Local Coverage Determination: Controlled Substance Monitoring and Drugs of Abuse Testing (L36393), 01/01/17.
  10. First Coast Service Options, Inc. (FCSO), Local Coverage Determination: Qualitative Drug Screening (L3358130574), retired 11/30/15. Gourlay DL, Heit HA, Caplan YH. Urine Drug Testing in Clinical Practice. The Art and Science of Patient Care. Edition 4. Sponsored by the California Academy of Family Physicians. 2010.
  11. Heltsley R, Depriest A, Black DL, et al. Oral fluid drug testing of chronic pain patients. II. Comparison of paired oral fluid and urine specimens. J Anal Toxicol. Mar 2012;36(2):75-80.
  12. 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.
  13. 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 2 Guidance. Pain Physician. Jul 2012;15(3 Suppl):S67-116.
  14. U.S. Preventive Services Task Force (USPSTF), Screening for Illicit Drug Use. Release Date: January 2008. Accessed at uspreventiveservicestaskforce.org.
  15. Vindenes V, Yttredal B, Oiestad EL, et al. Oral fluid is a viable alternative for monitoring drug abuse: detection of drugs in oral fluid by liquid chromatography-tandem mass spectrometry and comparison to the results from urine samples from patients treated with Methadone or Buprenorphine. J Anal Toxicol. Jan 2011;35(1):32-39.
  16. Washington State Agency Medical Directors' Group. Interagency guideline on opioid dosing for chronic non-cancer pain: an educational aid to improve care and safety with opioid treatment, accessed at guideline.gov 02/12/15.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/23/17.

GUIDELINE UPDATE INFORMATION:

11/15/13

New Medical Coverage Guideline.

08/15/14

Review; position statements, title, description, reimbursement section & references updated; formatting changes.

01/01/15

Annual HCPCS/CPT update. Added codes 80300-80377, G6030-G6058; removed codes 80100-80102 and 80104.

04/15/15

Review; position statements maintained, guideline title, reimbursement section and references updated.

09/15/15

Revision; position statement, coding, & reimbursement sections updated.

01/01/16

Annual HCPCS/CPT update; codes G0477-G0483 added; codes G0431, G0434, G6030-G6058 deleted; reimbursement section updated.

03/15/16

Annual review; update position statement section, title, and references; formatting changes.

01/01/17

Annual CPT/HCPCS update.Added 80305-80307, G0659; revised G0480-G0483; deleted 80300-80304, G0477-G0479; reimbursement section updated; formatting changes.

03/15/17

Revision; qualitative and quantitative replaced with presumptive and definitive in position statements; coding, description, and references updated.

Date Printed: October 20, 2017: 12:00 PM