DRAFT Local Coverage Determination for Qualitative Drug Testing (DL32450)
Contractor Information
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Contractor Name Wisconsin Physicians Service Insurance Corporation |
Contractor Number 00951, 00952, 00953, 00954, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402, 52280 |
Contractor Type Carrier - MAC - FI |
LCD Information
DL32450 LCD Title Qualitative Drug Testing Contractor's Determination Number PATH-035 AMA CPT/ADA CDT Copyright Statement CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply. |
Primary Geographic Jurisdiction
Oversight Region Original Determination Effective Date Original Determination Ending Date Revision Effective Date Revision Ending Date |
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
Code of Federal Regulations (CFR) Title 42, Part 410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see section 411.15 (k)(1) of this chapter).
Medicare regulations at 42 CFR 410.32(a) state in part, that "diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem." Thus, except where other uses have been authorized by statute, Medicare does not cover diagnostic testing used for routine screening or surveillance.
CMS Internet-Only Manual (IOM) Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 130.6, Treatment of drug abuse
CMS Transmittal 653, Change Request 6852, Clinical Laboratory Fee Schedule (CLFS)- Special Instructions for Specific Test Codes (CPT CODE 80100, CPT Code 80101, CPT Code 80101QW, G0430, G0430QW and G0431QW)
CMS Transmittal 1905, Change Request 6800, February New Waived Tests
Common methods of drug analysis include chromatography, immunoassay, chemical ("spot") tests, and spectrometry.
Analysis is comparative, matching the properties or behavior of a substance with that of a valid reference compound (a laboratory must possess a valid reference agent for every substance that it identifies). Drugs or classes of drugs are commonly assayed by qualitative testing. A qualitative test may be followed by confirmation with a second method, only if there is a positive inconsistent finding from the qualitative test in the setting of a symptomatic patient, as described below.
Examples of drugs or classes of drugs that are commonly assayed by qualitative tests, followed by confirmation with a second method, are: alcohols, amphetamines, barbiturates/sedatives, benzodiazepines, cocaine and metabolites, methadone, antihistamines, stimulants, opioid analgesics, salicylates, cardiovascular drugs, antipsychotics, cyclic antidepressants, and others. Focused drug screens, most commonly for illicit drug use, may be more useful clinically.
Covered Indications:
"Although technology has provided the ability to measure many toxins, most toxicological diagnoses and therapeutic decisions are made based on historical or clinical considerations:
1. Laboratory turnaround time can often be longer than the critical intervention time course of an overdose;
2. The cost and support of maintaining the instruments, staff training, and specialized labor involved in some analyses are prohibitive;
3. For many toxins there are no established cutoff levels of toxicity, making interpretation of the results difficult."
"Although comprehensive screening is unlikely to affect emergency management, the results may assist the admitting physicians in evaluating the patient if the diagnosis remains unclear." Qualitative screening panels should be used when the results will alter patient management or disposition. (Richardson et al, 2007).
A qualitative drug test may be indicated for a symptomatic patient when the history is unreliable, when there has been a suspected multiple-drug ingestion, to determine the cause of a patient in delirium or coma, or for the identification of specific drugs that may indicate when antagonists may be used. The clinical utility of drug tests in the emergency setting may be limited because patient management decisions are unaffected, since most therapy for drug poisonings is symptom directed and supportive.
Medicare will consider performance of a qualitative drug test reasonable and necessary when a patient presents with suspected drug overdose and one or more of the following conditions:
- Unexplained coma;
- Unexplained altered mental status in the absence of a clinically defined toxic syndrome or toxidrome;
- Severe or unexplained cardiovascular instability (cardiotoxicity);
- Unexplained metabolic or respiratory acidosis in the absence of a clinically defined toxic syndrome or toxidrome;
- Seizures with an undetermined history.
A qualitative drug test may be reasonable and necessary for patients with known substance abuse or dependence, only when the clinical presentation has changed unexpectedly and one of the above indications is met.
A qualitative drug test may be reasonable and necessary for patients with symptoms of schizophrenia suspected to be secondary to drug or substance intoxication. These diagnoses will be covered in the inpatient facility setting only.
A qualitative drug test may be reasonable and necessary for chronic pain patients in whom other illicit drug use is suspected, when there has been an acute change in physical or mental status that meets the indications above.
Drugs or drug classes for which testing is performed should reflect only those likely to be present, based on the patient's medical history or current clinical presentation. Drugs for which specimens are being tested must be indicated by the referring provider in a written order.
Confirmation of drug testing (80102) is indicated when the result of the drug test is different than that suggested by the patient's medical history, clinical presentation or patient's own statement AND there is a positive inconsistent finding from the previously performed qualitative test. This test may also be used, when the coverage criteria of the policy are met AND there is no qualitative test available, locally and/or commercially, as may be the case for certain synthetic or semi-synthetic opioids. Frequent use of this code will be monitored for appropriateness.
Limitations of Coverage:
It is considered not reasonable or necessary to test for the same drug with both a blood and a urine specimen simultaneously.
Similarly, testing or confirmation of any drug using CPT codes 80150 through 80299 or 82000-84999 is governed by the coverage statements outlined in this policy.
Drug screening for medico-legal purposes (e.g., court-ordered drug screening) or for employment purposes (e.g., as a pre-requisite for employment or as a requirement for continuation of employment) is not covered. Drug screening for compliance purposes, diversion, or in asymptomatic patients is not covered under the Program. This determination applies also to CPT codes 80102, 80150 through 80299 and 82000-84999.
Coding Information
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
| 012x | Hospital Inpatient (Medicare Part B only) |
| 013x | Hospital Outpatient |
| 014x | Hospital - Laboratory Services Provided to Non-patients |
| 021x | Skilled Nursing - Inpatient (Including Medicare Part A) |
| 022x | Skilled Nursing - Inpatient (Medicare Part B only) |
| 023x | Skilled Nursing - Outpatient |
| 071x | Clinic - Rural Health |
| 072x | Clinic - Hospital Based or Independent Renal Dialysis Center |
| 073x | Clinic - Freestanding |
| 077x | Clinic - Federally Qualified Health Center (FQHC) |
| 085x | Critical Access Hospital |
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
| 0300 | Laboratory - General Classification |
| 0301 | Laboratory - Chemistry |
| 0309 | Laboratory - Other Laboratory |
| 0971 | Professional Fees - Laboratory |
| 80102 | DRUG CONFIRMATION, EACH PROCEDURE |
| G0431 | DRUG SCREEN, QUALITATIVE; MULTIPLE DRUG CLASSES BY HIGH COMPLEXITY TEST METHOD (E.G., IMMUNOASSAY, ENZYME ASSAY), PER PATIENT ENCOUNTER |
| G0434 | DRUG SCREEN, OTHER THAN CHROMATOGRAPHIC; ANY NUMBER OF DRUG CLASSES, BY CLIA WAIVED TEST OR MODERATE COMPLEXITY TEST, PER PATIENT ENCOUNTER |
The following CPT codes are Non-Covered by Medicare
| 80100 | DRUG SCREEN, QUALITATIVE; MULTIPLE DRUG CLASSES CHROMATOGRAPHIC METHOD, EACH PROCEDURE |
| 80101 | DRUG SCREEN, QUALITATIVE; SINGLE DRUG CLASS METHOD (EG, IMMUNOASSAY, ENZYME ASSAY), EACH DRUG CLASS |
ICD-9 Codes that Support Medical Necessity
80102, G0431, G0434
| 276.2 | ACIDOSIS |
| 295.00 - 295.30 | SIMPLE TYPE SCHIZOPHRENIA UNSPECIFIED STATE - PARANOID TYPE SCHIZOPHRENIA UNSPECIFIED STATE |
| 345.10 - 345.11 | GENERALIZED CONVULSIVE EPILEPSY WITHOUT INTRACTABLE EPILEPSY - GENERALIZED CONVULSIVE EPILEPSY WITH INTRACTABLE EPILEPSY |
| 345.3 | GRAND MAL STATUS EPILEPTIC |
| 345.90 - 345.91 | EPILEPSY UNSPECIFIED WITHOUT INTRACTABLE EPILEPSY - EPILEPSY UNSPECIFIED WITH INTRACTABLE EPILEPSY |
| 426.10 - 426.13 | ATRIOVENTRICULAR BLOCK UNSPECIFIED - OTHER SECOND DEGREE ATRIOVENTRICULAR BLOCK |
| 426.82 | LONG QT SYNDROME |
| 427.0 - 427.1 | PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA - PAROXYSMAL VENTRICULAR TACHYCARDIA |
| 780.01 | COMA |
| 780.09 | ALTERATION OF CONSCIOUSNESS OTHER |
| 780.1 | HALLUCINATIONS |
| 780.39 | OTHER CONVULSIONS |
| 963.0 | POISONING BY ANTIALLERGIC AND ANTIEMETIC DRUGS |
| 965.00 - 965.09 | POISONING BY OPIUM (ALKALOIDS) UNSPECIFIED - POISONING BY OTHER OPIATES AND RELATED NARCOTICS |
| 965.1 | POISONING BY SALICYLATES |
| 965.4 | POISONING BY AROMATIC ANALGESICS NOT ELSEWHERE CLASSIFIED |
| 965.5 | POISONING BY PYRAZOLE DERIVATIVES |
| 965.61 | POISONING BY PROPIONIC ACID DERIVATIVES |
| 966.1 | POISONING BY HYDANTOIN DERIVATIVES |
| 967.0 - 967.9 | POISONING BY BARBITURATES - POISONING BY UNSPECIFIED SEDATIVE OR HYPNOTIC |
| 969.00 - 969.9 | POISONING BY ANTIDEPRESSANT, UNSPECIFIED - POISONING BY UNSPECIFIED PSYCHOTROPIC AGENT |
| 972.1 | POISONING BY CARDIOTONIC GLYCOSIDES AND DRUGS OF SIMILAR ACTION |
| 977.9 | POISONING BY UNSPECIFIED DRUG OR MEDICINAL SUBSTANCE |
Diagnoses that Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
General Information
contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the identity of the physician or non-physician practitioner responsible for and providing the care of the patient.
3. The submitted medical record should support the use of the selected ICD-9-CM code(s). The
submitted CPT/HCPCS code should describe the service performed.
4. Medical record documentation (e.g., history and physical, progress notes) maintained by the
ordering physician/treating physician must indicate the medical necessity for performing a
qualitative drug test. All tests must be ordered in writing by the treating provider and all
drugs/drug classes to be tested must be indicated in the order.
5. When a confirmatory test or a quantitative test is performed, the record must show that an
inconsistent positive finding was noted on the qualitative testing or that there was no available,
commercially or otherwise, qualitative test to evaluate the presence of a semi-synthetic or
synthetic opioid in a patient who met the coverage criteria of this policy.
6. If the provider of the service is other than the ordering/referring physician, that provider must
maintain hard copy documentation of the lab results, along with copies of the ordering/referring
physician's order for the qualitative drug test. The physician must include the clinical
indication/medical necessity in the order for the for the qualitative drug test.
Appendices
Utilization Guidelines
Sources of Information and Basis for Decision
Patient/Family Education to Reverse the Epidemic of Nonmedical Prescription Drug Use and Addiction.
CDC Congressional Testimony. March 12, 2008. United States Senate Subcommittee on Crime & Drugs.
Committee on the Judiciary and the Caucus on International Narcotics Control. 2009; Vol.58:42.
Chou R, Fanciullo GJ. Opioid Treatment Guidelines; Clinical Guidelines for the Use of Chronic Opioid
Therapy in Chronic Noncancer Pain. The Journal of Pain. Feb 2009 10(2): 113-130
Department of Health and Human Services. Morbidity and Mortality Weekly Report. Overdose deaths
involving prescription opioids among enrollees- Washington, 2004-2007. Available at
http://www/cdc/gov/mmwr.
Federation of State Medical Boards of the United States. Model policy for the use of controlled substances for the treatment of pain. Available at http://www.fsmb.org/grpol_policydocs.html.
Gourlay DL, Caplan YH. Urine Drug testing in Clinical Practice (2006 edition) Educational activity
sponsored by California Academy of Family Physicians.http://www.toxicologyunit.com/drug_screen.htm retrieved from internet Septemper 2, 2009.
Jackman RP, Purvis JM. Chronic Nonmalignant Pain in Primary Care. American Family Physician. Nov
2008; 78(10): 1155-1162.
Melanson Stacy EF, Baskin LB. Interpretation and Utility of Drug of Abuse Immunoassays Lessons from
Laboratory Drug Testing Surveys. Arch Pathol Lab Med. May 2010; 134: 736-739.
Nafziger AN, Bertino JS. Utility and application of urine drug testing in chronic pain management with
opioids. Clin J Pain 2009; 25(1)73-79.
Nicholson B, Passik S. Management of chronic non-cancer pain in the primary care setting. Southern
Medical Journal 2007; 100(10)1028-1034.
Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clinic
Proceedings. July 2009;84(7):593-601.
Schneider J, Miller A. Urine drug tests in a private chronic pain practice (2008) Practical Pain
Management. January/February 2008. Retrieved from http://www.tuft.edu/data/41/528854.pdf on Sept.
1, 2009.
Standridge JB, Adams SM. Urine Drug Screening: A Valuable Office Procedure. American Family
Physician. March 1, 2010; 81(5):635-640.
Trescot AM, Standiford H. Opioids in the Management of Chronic Non-Cancer Pain: an update on
American Society of the Interventional Pain Physicians' (ASIPP) guidelines. Pain Physician 2008; 11:S5-
S61 issn 1533-3159.
Other Contractor(s)' Policies
Advisory Committee Meeting Notes
Wisconsin 01/27/2012
Illinois 01/25/2012
Michigan 02/01/2012
Minnesota 02/02/2012
J5: Iowa, Kansas, Missouri, Nebraska 02/02/2012
Open LCD meeting Date: 01/12/2012
*- An asterisk indicates a revision to that section of the policy.
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.
Start Date of Comment Period
Revision History Number
Reason for Change
LCD Attachments
Page Last Updated: Thursday, 05-Jan-2012 07:43:03 CST
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