MEDICAL POLICY For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS DRUG TESTING Policy Number: CMP - 029 Effective Date: June 18, 2016 Table of Contents BACKGROUND POLICY REFERENCES POLICY HISTORY/REVISION HISTORY Page 1 4 6 6 INSTRUCTIONS FOR USE This Medical Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Summary Plan Description (SPD)) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this Medical Policy. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Medical Policy. Other Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational purposes. It does not constitute medical advice. UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. BACKGROUND Drug abuse is a growing problem in the United States. In 2008, there were 36,450 deaths from overdose in the United States, with prescription drugs causing 74%1. Death from opioid pain relievers increased four-fold over the period from 1999-2008, and these overdoses accounted for more deaths from overdose than heroin and cocaine combined. Just under a million Americans use heroin, and 3.6 million regularly use cocaine.2 Qualitative drug testing in most cases refers to urine tests. Urine testing can include validity testing measures including creatinine, urine specific gravity, pH, and detection of additives. A sensitive test, the immunoassay, is usually the first assay for the initial evaluation, and it detects the presence of certain selected classes of drugs. Then, if the test is positive and there is a need for specific identification of a drug, gas chromatography/mass Proprietary Information of UnitedHealthcare. Copyright 2016 United HealthCare Services, Inc. Page 1 CMP-029_Drug Testing_20160524_v2.1 spectroscopy (GC/MS) can confirm results, reduce false positives and false negatives, and give a specific identification. This assay is the standard in forensic testing. The use of presumptive qualitative versus definitive quantitative confirmation3 depends on whether or not there is a medical necessity to obtain the exact concentration of the drug or its metabolite in the specimen. Proper documentation by the ordering provider (physician) will include the medical necessity in the order. For qualitative drug tests, proper documentation is needed when the testing exceeds 12 per calendar year. For example, patients suffering from substance abuse disorder (SUD) can have excessive qualitative tests done not exceeding 3 times within a seven day period. Quantitative testing is usually done: To support a patient’s ongoing use or discontinuation of a specific drug. To confirm the screening result identifying the analyte causing a positive reaction or to ensure that the patient is truly negative for a drug. Quantitative tests also require proper documentation4. This documentation is needed for example when testing exceeds 12 definitive tests per calendar year (~1-3 times every 3 months)3. Limitations to initial testing with immunoassays include cross-reactivity and failure to detect structural diversity within a class. According to recommendations made for the use of laboratory testing for poisoned patients presenting to the emergency department, cross-reacting substances should be listed when a positive result is reported.4 Examples of some cross-reactive substances include poppy seeds (causes false positive for morphine) and Zoloft (causes false positives for benzodiazepines). Clonazepam and lorazepam can produce false-negative results. Due to drug metabolism, immunoassay cannot distinguish between morphine, codeine, and heroin. Semi-synthetic and synthetic opioids such as oxycodone and fentanyl may not be detected by standard immunoassays, but specific enzyme immunoassays are available for these drugs. Qualitative drug tests do not screen for drug use in the strict sense of the word because the initial assay used does not detect all drugs. The actual tests performed and the drugs that are screened differ depending on the setting, as does the need for confirmatory testing. Screening cutoff concentrations vary depending on the context. Qualitative drug testing serves different purposes in a variety of settings. The testing can be used to screen for drug use in the emergency department and the workplace. In settings where drug use is the norm, such as pain clinics and psychiatric units, the tests can be used to establish compliance and detect prescription abuse. Medico legal drug testing follows forensic protocols, where chain of custody is an issue. In the emergency department, drug testing is often done to guide clinical care for unstable patients who, due to conditions such as drowsiness or seizure, may not provide a history. In this setting, the clinician is often attempting to ascertain if drug toxicity can explain the patient’s symptoms, and if so, to identify the drug(s). Fast turnaround times are essential to the utility of the assay. Drugs tested in the emergency department include drugs of high abuse potential such as cocaine, amphetamines, methamphetamines, barbiturates, benzodiazepines, heroin, and methadone. According to recommendations written for emergency department laboratory tests, drug testing panels should not be based on toxidromes (a collection of signs and symptoms characteristic of use of a particular drug class) because this practice introduces a potential for misdiagnosis.4 Proprietary Information of UnitedHealthcare. Copyright 2016 United HealthCare Services, Inc. Page 2 CMP-029_Drug Testing_20160524_v2.1 These recommendations state that “stat” qualitative urine toxicology assays supporting an emergency department should detect cocaine, opiates, barbiturates, amphetamines, propoxyphene, phencyclidine, and tricyclic antidepressants. Test results for selected drug classes are reported as positive or negative. Drug testing in the emergency department has fallen under criticism due to concerns of cost and low impact on treatment. Testing for acetaminophen toxicity, which is a separate serum quantitative test, is largely immune to this scrutiny because there is a specific antidote (N-acetylcysteine) that can prevent fulminant hepatic failure when used early in the course of the overdose. The National Academy of Clinical Biochemistry has stated that if recommendations were made to deter use of qualitative urine drug screening, it is unlikely that emergency departments would change their use of the tests.4 While qualitative drug tests continue to be used frequently in the emergency department, cost and turnaround time for confirmatory testing with GC/MS may preclude its overall utility in this setting. Controlled prescription drugs are commonly prescribed in outpatient pain clinics, and this setting is often the site of prescription fraud and abuse. Chronic non-cancer pain patients are at the highest risk to abuse controlled substances compared to all other patient populations who undergo urine drug testing.5 Medicaid populations are at a higher risk for death from opioid pain relievers than their non-Medicaid counterparts. Comorbid substance use disorders are common in patients treated for chronic pain.6 Clinicians who treat patients with chronic pain need to know if the patient is taking the drugs as prescribed or if the patient has been stockpiling drugs for later diversion to the criminal market, a practice that is estimated to cost insurance companies $72.5 billion annually in healthcare costs. Although there is no evidence-based literature for the practice,7 in the chronic pain clinic, urinary drug testing is the test of choice for adherence monitoring. Urine drug tests can provide caregivers with results that are important to monitor and safeguard their prescribing practices. The results of the tests for any one patient can lead to several possible conclusions7: 1. The patient is taking the drugs as prescribed because testing is positive for the prescribed drugs and negative for other drugs. 2. The patient is diverting prescription drugs to the illicit marketplace because the patient tests negative for the prescribed opioid. 3. The patient abuses controlled substances because there are positive results for the prescribed drug and for other non-prescribed opioids or benzodiazepines. 4. The patient has a comorbid substance use disorder because the test detected street narcotics. 5. The patient is likely abusing the system due to results that indicate specimen tampering. A new local carrier determination that was issued in 2009 has curtailed monitoring of chronic pain patients in the outpatient setting. Subsequently, in some regions, qualitative drug tests are only covered if the patient’s behavior suggests illicit drug use. Yet studies have shown that clinicians cannot predict drug abuse based on patient behavior.2, 5 One multicenter study of patients receiving long-term opioid therapy found that 72% of patients with urine drug tests indicative of potential addiction or drug diversion did not display behaviors that would suggest deviance.5 Behaviors that are suggestive of inappropriate drug use include lost or stolen prescriptions, consumption of drugs in excess of prescribed amount, reporting multiple drug allergies, making office visits without appointments, and calling the clinic frequently.2 Proprietary Information of UnitedHealthcare. Copyright 2016 United HealthCare Services, Inc. Page 3 CMP-029_Drug Testing_20160524_v2.1 In the workplace qualitative drug tests are often used as part of a pre-employment screen and as a means to ensure peak employee performance. Other circumstances for testing include suspicion of drug use and accident investigation. The Department of Health and Human Services guidelines authorize testing of federal employees for amphetamines, cannabinoids, cocaine, opiates, and phencyclidine.8 To avoid false positives, cutoff values in the workplace are generally set higher than clinical cutoffs used in emergency departments.4 Positive results usually indicate drug use within the past one to three days, with marijuana the exception. It can be detected weeks after heavy use. Tests for specimen adulteration are important in this setting. Point of care testing, while offering convenience, has not been universally accepted for drug testing. The National Academy of Clinical Biochemistry (NACB) guidelines for point of care testing state there is no evidence base for the use of point of care testing in pain clinics. Due to lack of evidence from outcome studies, the NACB guidelines state that point of care testing in the emergency department has controversial value9. These tests generally have a higher unit cost than qualitative drug tests performed by a central laboratory. POLICY For the following CPT code(s) in Table 1 and 2, the patient should have a diagnosis (ICD-10-CM) code(s) listed in the attached files below. Table 1. HCPCS Group 1 (presumptive) Codes (Alphanumeric, CPT AMA) Code G0477 Description Drug tests(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. G0478 Drug tests(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. Drug tests(s), presumptive, any number of drug classes; any number of devices or procedures by instrumented chemistry analyzers (eg, immunoassay, enzyme assay, TOF, MALDI, LDTD, DESI, DART, GHPC, GC mass spectrometry), includes sample validation when performed, per date of service. G0479 Proprietary Information of UnitedHealthcare. Copyright 2016 United HealthCare Services, Inc. Page 4 CMP-029_Drug Testing_20160524_v2.1 Table 2. CPT and HCPCS Group 2 (definitive) Codes (Alphanumeric, CPT AMA) Code 80159 Drug assay clozapine 80171 Drug screen quantitative gabapentin 80173 Drug screen quantitative halopridol 80183 Drug screen quantitative oxcarbazepine 80184 Drug screen quantitative phenobarbital 83992 Assay of phencyclidine G0480 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 and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); qualitative or quantitative, all sources, includes specimen validity testing, per day, 1-7 drug class(es), including metabolite(s) if performed 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 and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); qualitative or quantitative, all sources, includes specimen validity testing, per day, 8-14 drug class(es), including metabolite(s) if performed. G0481 Description G0482 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 and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); 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 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)); qualitative or quantitative, all sources, includes specimen validity testing, per day, 22 or more drug class(es), including metabolite(s) if performed Group1 ICD-10 Diagnosis Codes (Proven) CMP-029 Drug Testing ICD10 Grp1 Group2 ICD-10 Diagnosis Codes (Proven) CMP-029 Drug Testing ICD10 Grp2 Proprietary Information of UnitedHealthcare. Copyright 2016 United HealthCare Services, Inc. Page 5 CMP-029_Drug Testing_20160524_v2.1 REFERENCES 1. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers— United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487-1492. 2. Katz NP,Sherburne S,Beach M, et al. Behavioral monitoring and urine toxicology testing in patients receiving long-term opioid therapy. Anesth. Analg. 2003;97(4):1097-1102. 3. Novitas Solutions. Local Coverage Determination (LCD) L35006 Controlled Substance Monitoring and Drugs of Abuse Testing. Effective 12/31//15. 4. Wu AHB,McKay C,Broussard LA, et al. National academy of clinical biochemistry laboratory medicine practice guidelines: recommendations for the use of laboratory tests to support poisoned patients who present to the emergency department. Clin. Chem. 2003;49(3):357-379. 5. Gilbert JW,Wheeler GR,Mick GE, et al. Urine drug testing in the treatment of chronic noncancer pain in a Kentucky private neuroscience practice: the potential effect of Medicare benefit changes in Kentucky. Pain physician. 2010;13(2):187-194. 6. Morasco BJ,Gritzner S,Lewis L, et al. Systematic review of prevalence, correlates, and treatment outcomes for chronic non-cancer pain in patients with comorbid substance use disorder. Pain. 2011;152(3):488-497. 7. Christo PJ,Manchikanti L,Ruan X, et al. Urine drug testing in chronic pain. Pain physician. 2011;14(2):123143. 8. Department of Health and Human Services Substance Abuse and Mental Health Services Administration. Mandatory guidelines for federal workplace drug testing programsnotice November 25 Fed Regist. 2008;73(228 ):71857-71907. 9. Nichols JH, Christenson RH, Clarke W, et al. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Evidence Based Practice for Point of Care Testing. AACC Press; 2006. POLICY HISTORY/REVISION HISTORY Date 06/18/2016 Action/Description Revised policy CPT/HCPCS codes and ICD10 codes to reflect Novitas’ LCD Policy #35006 “Controlled Substance Monitoring and Drugs of Abuse Testing”. 12/03/2015 Annual Policy Review Completed – no changes. 10/01/2015 Removed ICD9 table. Embedded ICD9/ ICD10 PDF files. Proprietary Information of UnitedHealthcare. Copyright 2016 United HealthCare Services, Inc. Page 6 CMP-029_Drug Testing_20160524_v2.1
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