Clinical Policy Title: Drug Screens — Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals Clinical Policy Number: 00.01.02 Effective Date: Initial Review Date: Most Recent Review Date: Next Review Date: Oct. 1, 2014 May 21, 2014 June 18, 2014 May, 2015 Policy contains: • Qualitative drug screening method for illicit drug use. • Quantitative drug screening method for illicit drug use. Related Policies: (391) 00.01.01, Drug Testing in Addiction Treatment and Monitoring. ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina clinical policies are not guarantees of payment. Coverage policy I. Qualitative screening: Select Health of South Carolina considers the use of qualitative drug screening to be clinically proven and therefore, medically necessary when the following criteria are met: A. Verification of abstinence for use of drugs through episodic monitoring as part of a behavioral health or substance abuse treatment program. OR B. Qualitative drug screen performed as part of the evaluation and treatment of a member who presents in urgent/emergency room care settings with suspected drug overdose or suspected drug misuse and ONE or MORE of the following indications: 1. Unexplained coma. FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 1 2. 3. 4. 5. 6. 7. 8. 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. Multiple drug ingestions. To provide antagonist to specific drug. Member presents with clinical signs/symptoms and/ or history of substance abuse. 9. High-risk pregnancy only when the documented member history demonstrates the procedure is medically necessary. 10. EPSDT services only when the documented member history demonstrates the procedure is medically necessary. 11. The management of a member under treatment for substance abuse when there is suspicion of continued substance abuse. 12. The management of a member with chronic pain in which there is a significant pretest probability of nonadherence to the prescribed drug regimen as documented in the member’s medical record. 13. The management of members with chronic pain in a designated pain management clinic where this select population has a significant pretest probability of drug interactions and side effects. Figure 1. Drugs or classes of drugs commonly assayed by a qualitative screen followed by confirmation with a second method include the following: 1. Alcohols/ethanol — not part of a qualitative urine drug screen; alcohol testing is not performed by immunoassay. 2. Amphetamines/methamphetamine. 3. Barbiturates. 4. Benzodiazepines. 5. Cocaine and metabolites. 6. Methadones. 7. Methaqualones. 8. Opiates. 9. Phencyclidines. 10. Phenothiazines. 11. Propoxyphene. 12. Tetrahydrocannabinoids. 13. Tricyclic antidepressants. (See Figure 2 for parameters) II. Quantitative screening/confirmation screening Select Health of South Carolina considers the use of quantitative drug screening to be clinically proven and therefore, medically necessary when the following criteria are met: FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 2 1. Drugs or drug classes for which testing is performed should reflect only those likely to be present and for which knowledge of the absolute level will impact clinical decisionmaking. OR 2. Quantified and confirmation drug screen is indicated when the result of the drug screen is different than that suggested by the patient’s medical history, clinical presentation or patient’s own statement. AND 3. Quantitative testing exceeding three procedure codes or drug classes every 30 days requires rationale documented in the medical record and must meet medical necessity. Routine testing at the upper end of these limits may result in audit and/or overpayment demands among other available regulatory action. AND 4. All orders for confirmation testing (qualitative result, CPT 80102) require a positive screening test and shall be performed only for the drug class represented by the positive screening. (See CMS Local Coverage Determinations: L30574, L28145 and L32050.) AND 5. Technically quantitative or confirmatory tests must have high specificity. Figure 2. Parameters for quantification or confirmation testing of drug screens A. Quantitation testing requires a positive qualitative screening test and shall be performed only for the drug class represented by the positive qualitative screening. Automatic confirmatory testing for any drug is not reasonable and necessary without patient specific indications. Select Health of South Carolina considers confirmatory/quantitative drug testing reasonable and necessary when the results of a qualitative screen are: 1. Cocaine confirmation to identify a chronic cocaine user. 2. THC (tetrahydrocannabinoids) confirmation to document patient’s discontinuation of THC use according to the treatment plan. 3. Negative screen inconsistent with patient’s medical history or currently prescribed pain medications. 4. Suspicion of a specific drug use, such as but not limited to Fentanyl and Meperidine, or “designer drugs.” B. National pain organizations and the Federation of State Medical Boards do not advocate routine and comprehensive drugs-of-abuse testing. Frequency of testing beyond the baseline drug screen must be based on individual patient needs substantiated by documentation in the medical record. Limitations — Select Health of South Carolina does not provide coverage for testing that is not medically necessary. This includes but is not limited to: • Quantitative drug testing is allowed for a single drug on the day of service. Quantitative drug testing for multiple drugs requires a statement of medical necessity. FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 3 • • • • • • • Same-day screening of drug metabolites in both a blood and a urine specimen by either qualitative or quantitative analyses. For medico-legal purposes (i.e., court-ordered drug screening, forensic examinations). For employment purposes (i.e., as a prerequisite for employment or as a means for continuation of employment). As a component of routine physical/medical examination. As a component of medical examination for administrative purposes. As a routine component of a behavioral health assessment. Any of the following is sufficient criteria for exclusion: o Confirmation or quantitative testing is excluded from coverage if performed for forensic or legal purposes. o Quantitative testing requires a positive screening test and shall be performed only for the drug class represented by the positive screening. o Unvalidated source of the tested specimen. All other uses of qualitative drug screening are not medically necessary. NOTE for Select Health the following codes are covered by facility only: • 80100 - Drug screen, qualitative; multiple drug classes chromatographic method, each procedure; • 80102 - Drug confirmation, each procedure; • 80104 - Drug Screen, qualitative; multiple drug classes other than chromatographic method, each procedure. • The following code is not listed on the South Carolina Medicaid Fee Schedule: o G0434 - Drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter. Alternative covered services — Physician office visits and routine lab screenings. Background The collection and analysis of body fluids, especially urine samples, for the detection of alcohol, nicotine, others drugs or their metabolites, is a common feature of many addiction treatment services. The chemical compounds that act on reward pathways in the brain can be taken into the body by various routes. Laboratory testing for drugs of abuse is a medically necessary and useful component of chemical dependency treatment. The drug screen result influences treatment and level of care decisions. Ordered tests must match treatment needs, the documented history and Diagnostic and Statistical Manual of Mental Disorders (DSM IV TR) or most current DSM diagnosis. Provider should test for a broad range of commonly abused drugs to screen a patient for substance use disorders. Decisions about screened substances must be documented and based on the following criteria: a. Patient history, physical examination, and previous laboratory findings. b. Suspected abused substance. c. Substances that may present high risk for additive or synergistic interactions with prescribed medication (e.g., benzodiazepines or alcohol). Quantitative drug testing is generally used when it is medically necessary to determine the specific quantity of drug or drug metabolite present in the sample. The test result is expressed in numerical terms. FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 4 The traditional clinical role of urine drug testing (UDT) has been to support treatment decisions made in the urgent care setting where patients are unable or, in some cases, unwilling to provide information about the use of substances that may be harmful to them. When used effectively, however, UDT is more than just a verification tool and has many useful clinical applications in patient-centered testing. No “standard” UDT is suitable for all purposes and settings — rather, a multitude of options exists, that health care professionals should adapt to their particular clinical needs. The two main types of UDT — which are often used in combination — are: 1. Immunoassay drug testing, either laboratory-based or at point-of-care (POC). 2. Laboratory-based specific drug identification†: e.g., gas chromatography/mass spectrometry‡ (GC/MS) or liquid chromatography/mass spectrometry§ (LC/MS). UDT typically detects the parent drug and/or its metabolite(s) and, therefore, demonstrates recent use of prescription medications, unprescribed drugs and illegal substances. Although other biologic specimens can be used in drug testing, urine is usually preferred for determining the presence or absence of drugs because it has a one- to three-day window of detection for most drugs and/or their metabolites and is currently the most extensively validated biologic specimen for drug testing. In settings in which drug testing is done routinely for many people, the American Society of Addiction Medicine (ASAM) encourages using the full range of biological matrices — both POC and laboratory-based tests. In settings where testing is now seldom or never done, ASAM encourages using drug tests that are easily adopted, such as urine or oral fluid testing. When testing is done in high-risk populations, such as in addiction treatment, the criminal justice system, and return-to-work settings after addiction treatment, ASAM encourages the use of random rather than scheduled drug tests. The frequency of the random tests can be varied to fit the needs of the tested population just as frequency of testing in clinical settings changes with clinical indications. For example, more frequent testing at the outset may be used until stable abstinence is achieved, followed by less frequent testing as abstinence is maintained. This approach to random testing increases the effectiveness of the testing in promoting recovery and is far less expensive. Moreover, testing is most intense for the subjects at highest risk of drug use. In scheduled tests, consideration should be given to matrices more resistant to subversion, especially hair and oral fluid. Random, directly-observed testing with the donor accompanied to the restroom directly after notification of the test is the most effective way to reduce subversion with urine tests, but balancing this with privacy concerns and other practicalities should be case- and/or context-specific. When subversion of a urine drug test is proven or suspected, it is incumbent to perform an immediate recollection under monitored conditions. In many clinical settings oral fluid would be a common secondary matrix to test. Though not offered by as many laboratories, a hair test could be used as it is more resistant to subversion and offers an extended detection window. However, a hair test will not detect very recent use, and to detect marijuana, this approach must be frequent and sustained. Drug tests are valuable tools for health care professionals to use as part of a comprehensive evaluation of patients in order to reach the correct diagnosis and develop appropriate therapeutic interventions and monitoring plans. They are tools that can improve diagnosis and treatment, just as laboratory testing is a central component of most areas of health care to improve clinical accuracy and outcomes. Increasing the use of drug testing in both medical and nonmedical settings has the potential to improve public health by discouraging unhealthy or illicit drug use, and by promoting early identification of substance use disorders. Drug testing should be a key component of assessment and treatment planning, especially when integrated with other clinical information gathering, such as a substance use history, physical and mental status FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 5 examinations, withdrawal severity scores, and standardized laboratory assessments of metabolic, neurologic, and psychiatric status. A knowledgeable clinician can use drug testing to verify self-reports, confirm diagnoses, identify denial and minimization of drug and alcohol use, enhance motivation for treatment, measure biological adaptation, assist in development of treatment planning, monitor treatment response, document treatment effectiveness and outcomes, support patient advocacy by validating abstinence from alcohol and drug use, and validate adherence in taking prescribed controlled substances. Methods Searches: Select Health of South Carolina searched PubMed and the databases of: • UK National Health Services Centre for Reviews and Dissemination. • Agency for Healthcare Research and Quality Guideline Clearinghouse and evidence-based practice centers. • The Centers for Medicare & Medicaid Services. Searches were conducted in April 2014 using the terms “qualitative,” “quantitative” and "drug testing.” Included were: • Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidencegrading hierarchies. • Guidelines based on systematic reviews. • Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes — sometimes referred to as efficiency studies — which also rank near the top of evidence hierarchies. Findings: There is no scientific evidence to support the notion that quantitative UDT provides more information than qualitative UDT with respect to determining patient adherence with specific dosing recommendations. Negative urine for a prescribed drug should not be interpreted as definitive evidence of criminal behavior, such as diversion. In addition, quantitative assessment of a drug analyte in urine does not provide reliable evidence of diversion. Another limitation of UDT is that the presence of a prescribed drug cannot distinguish whether the patient has been taking the drug as directed or using only a portion of the prescribed medication (potentially hoarding or diverting the rest). While it is tempting to think that quantitative UDT results might clarify these issues, at the present time neither blood nor urine drug concentrations have been scientifically demonstrated to answer these questions. Therefore, it is important that UDT is interpreted within the whole clinical context of the patient, including other methods of assessing adherence (e.g., pill counts, PMPs). In the absence of specific symptoms of medication aberrant behavior or misuse, qualitative drug testing is reasonable and necessary when titrated to patient risk potential. National pain organizations and the Federation of State Medical Boards recommend a practical approach to confirmatory drug testing, and don’t advocate routine and comprehensive drugs of abuse testing. Frequency of testing beyond the baseline drug screen must be based on individual patient needs substantiated by quantification, and should not be used to determine adherence with a specific dosage or formulation regimen. Summary of Clinical Evidence FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 6 Citation Starrels, J., et.al. (2011) Content, methods, recommendations Key Point: Increase in drug testing in pain management. The use of drug testing in pain management has increased exponentially over the past decade. This fact conceals three important realities: 1. Drug testing remains underutilized in pain management. A recent survey of physician members of the American Pain Society, the American Academy of Pain Medicine, and the American Society of Regional Anesthesia and Pain Medicine found that only 59% of respondents order random urine drug testing. 2. Drug testing is highly skewed by medical specialty. Medicare data shows that anesthesiologists (who comprise 74% of pain specialists) ordered nearly as many drug tests in 2009 (636,880) as family practice physicians (258,132), internal medicine physicians (241, 431), neurologists (128,713), and general practitioners (70,031) combined. A recently published study of a large primary care health system found that only 8% of patients receiving long-term opioid therapy — and only 24% of the highest risk patients — were evaluated via urine drug testing. Quest Diagnostics (2013), Centers for Disease Control and Prevention. (2012) 3. Evidence indicates that, regardless of specialty, many physicians who employ drug testing are not proficient in interpreting test results. Key Point: Prescription drug monitoring • Data from Quest Diagnostics’ prescription drug monitoring service indicates that 60% of drug test specimens from patients referred by their physicians had results inconsistent with the controlled substances prescribed. • Only 40% of patients tested positive for prescribed medications and negative for other drugs. • Twenty-five percent of patients tested negative for all drugs, including medications prescribed by their physicians, 15% were negative for the prescribed drug and positive for another unprescribed drug, and 20% were positive for both the prescribed medications and other drugs. • Marijuana, present in 26% of specimens, was the most frequently detected non-prescribed drug among patients with inconsistent test results. • Additionally, individuals in this study who tested positive for marijuana were more likely to test positive for non-prescribed pharmaceuticals (45%) than individuals who tested negative for marijuana (36%). • Following marijuana, the most common non-prescribed drug classes identified in this study included opiates (22%), benzodiazepines (16%), oxycodone (14%), cocaine (8%) and FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 7 methadone (6%). The study concluded that when drug testing is not employed, physicians lack essential information about their patients’ patterns of drug use, missing both the use of non-prescribed drugs and the misuse and diversion of prescribed drugs. • Screening vs. Confirmatory Tests There are two main categories of urine drug testing — screening and confirmatory. Screening tests are initial, qualitative drug tests conducted to identify classes of drugs present in the urine and typically are done using immunoassay. They rely on a set threshold above which a positive result is produced and therefore do not detect lower concentrations of a drug. Confirmatory tests are used for further analysis of a sample — to confirm a positive, or sometimes negative, result and typically are done using GC/MS or high performance liquid chromatography (HPLC). Confirmatory testing can identify a specific drug. If the goal is to detect a synthetic or semisynthetic opioid, this test should be used, as immunoassays do not typically detect these opioids. Below is a comparison of the general characteristics of these two types of testing: Screening (POC testing is usually only screening) Confirmatory Analysis Technique Immunoassay. GC/MS or HPLC. Sensitivity (power to detect a class of drugs) Low or none when testing for semi-synthetic or synthetic opioids. High. Specificity (power to detect an individual drug) Varies based on assay used; can result in false positives and false negatives. High. Use Qualitative analysis; detects classes of drugs (Heit and Gourley, 2004). Quantitative analysis; identifies a specific drug. Cost Inexpensive (FDA five-drug testing kit ~$1). More expensive, may not be paid for by insurance. FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 8 Turnaround On-site, rapid. Slow. Other Intended for use in drug-free population; may not be useful in pain medicine context. Legally defensible results. (Compton, 2007; Heit and Gourlay, 2004; Reisfeld, et al, 2007.) Glossary Baseline testing — Used to identify the presence of illicit substances prior to prescribing controlled medications. To confirm the presence or absence of prescribed drug/drug class. CLIA-waived drug screening test — Consists of cards, dipsticks, cassettes and cups based on qualitative competitive immunoassay methodology with one or more analytes in the test. Confirmation testing — Generally used to evaluate initial qualitative screening results to minimize the potential of a clinician relying on a false negative or positive result. Confirmation testing is often recommended when initial screening involves a CLIA-waived or moderate immunoassay screening, but is not medically necessary in all patient cases. A confirmation test order must be medically necessary and reasonable and patient self-report may, in some cases, reduce the need for confirmation of screen results. Confirmation tests may be expressed in qualitative (CPT 80102) or quantitative (codes within the Therapeutic or Chemistry sections of the CPT coding manual) values. The use of qualitative versus quantitative confirmation testing depends upon the individual patient’s case and medical necessity thereof. COT — Chronic opioid therapy. Point-of-care (POC) — POC devices typically use immunochromatographic methods that produce visually read results. Medicolegal — Pertaining to legal aspects of the practice of medicine, such as malpractice, patient consent for operations or patient information. Qualitative drug testing — Generally used to determine the presence or absence of drug or drug metabolite in the sample. The test result is expressed in non-numerical terms, with a negative or positive result. Quantitative drug testing — Generally used when it is medically necessary to determine the specific quantity of drug or drug metabolite present in the sample. The test result is expressed in numerical terms. Quantification —The determination of drug concentration in the matrix with a specific numerical value. For example, THC 50 ng/ml in urine is also referred to as quantitation. Scheduled testing — Testing that is done at a routine time, as distinct from random testing. Screening test — A drug test that is designed to be rather sensitive and affordable; the results have lower specificity than a confirmatory test. This term, though imprecisely used, describes an initial immunoassay FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 9 test to identify the presence of classes of prescribed and non-prescribed medications and drugs-of- abuse, rather than devoting the more rigorous and expensive technologies of confirmatory testing. Substance abuse — Abuse is synonymous with harmful use of a specific psychoactive substance. The term “substance abuse” applies to one category of psychoactive substance-related disorders in previous editions of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM) but has been supplanted by the newer term, “substance use disorder.” While recognizing that the term “abuse” is part of past diagnostic terminology, ASAM recommends that an alternative term be found for this purpose because of the pejorative connotations of the word “abuse.” Urine drug testing (UDT) — The collection and analysis of urine samples for the detection of alcohol, nicotine or other drugs or their metabolites. References Professional Society Guidelines: American Society of Addiction Medicine, Comprehensive MRO (Medical Review Officer): http://www.asam.org/education/comprehensive-mro-(medical-review-officer) Accessed April 29, 2014. John Hopkins University School of Medicine, Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care General Counsel, Johns Hopkins Medicine (4/1/03), Updated 4/09. Centers for Disease Control and Prevention. (2012). CDC grand rounds: prescription drug overdoses – a U.S. epidemic. Morbidity and Mortality Weekly Report, 61(1), 10-13. Available: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm. Accessed May 12, 2014. Center for Substance Abuse Treatment. (2012).Clinical drug testing in primary care. Technical Assistance Publication (TAP) Series, 32. DHHS Publication No. (SMA) 12-4668. Rockville, MD: Substance Abuse and Mental Health Services Administration. Available: http://www.kap.samhsa.gov/products/manuals/pdfs/TAP32.pdf. Accessed May 12, 2014. American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women. (2011). Committee Opinion No. 479: Methamphetamine abuse in women of reproductive age. Obstetrics and Gynecology, 117(3), 751-755. American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women and the American Society of Addiction Medicine. (2012). Committee Opinion No. 524: Opioid abuse, dependence, and addiction in pregnancy. Obstetrics and Gynecology, 119(5), 1070-1076. American Academy of Pediatrics. (in press/embargoed). Testing for drugs of abuse in children and adolescents. Washington, DC: American Academy of Pediatrics. Peer-Reviewed References: Collen, M. (2012). Profit-driven drug testing. Journal of Pain and Palliative Care Pharmacotherapy, 26(1), 13-17. Compton, Reisfield, et al, The Clinical Tools, Inc. (CTI) Addiction Training Group. 2007 FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 10 http://www.opioidrisk.com/node/489. Accessed May 12, 2014. Manchikanti, L., Helm, S., Fellows, B., Janata, J. W., et al. (2012). Opioid epidemic in the United States. Pain Physician, 15(3 Suppl), ES9-ES38. Reisfield, G.M., Webb, F. J., Bertholf, R. L., Sloan, P.A., & Wilson, G. R. (2007). Family physicians' proficiency in urine drug test interpretation. Journal of Opioid Management 3(6), 333-337. Reisfield, G. M., Salazar, E., & Bertholf, R. L. (2007). Rational use and interpretation of urine drug testing in chronic opioid therapy. Annals of Clinical and Laboratory Sciences, 37(4), 301-314. Starrels, J. L., Fox, A. D., Kunins, H. V., & Cunningham, C. O. (2012). They don’t know what they don’t know: Internal medicine residents’ knowledge and confidence in urine drug test interpretation for patients with chronic pain. Journal of General Internal Medicine, 27(11), 1521-1527. Substance Abuse and Mental Health Services Administration (SAMSA), Clinical drug testing in primary care, Technical Assistance Publication Series 32 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment1 Choke Cherry Road Rockville, MD 20857, HHS Publication No. (SMA) 12-4668, 2012. Volkow, N. D., & McLellan, T. A. (2011). Curtailing diversion and abuse of opioid analgesics without jeopardizing pain treatment. JAMA, 305(13), 1346-1347. http://www.toxicologyunit.com/drug_screen.htm Accessed May 6, 2014. The Management of Opioid Therapy for Pain Working Group. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. Department of Veterans Affairs, Department of Defense; 2010. Quest Diagnostics. (2013). Prescription Drug Misuse in America: A Report on Marijuana and Prescription Drugs. Quest Diagnostics Health Trends: Prescription Drug Monitoring Report 2013. Available: http://www.questdiagnostics.com/dms/Documents/healthrends/2013_health_trends_prescription_drug_misuse.pdf. Clinical Trials: Treatment Research Institute, National Institute on Drug Abuse (NIDA) Evaluation of Web-based recovery monitoring with clinical alerts. NCT01465555 http://clinicaltrials.gov/ct2/show/NCT01465555?term=substance+abuse+monitoring&rank=2 California Pacific Medical Center Research Institute, Creare, Inc. NCT01867476. http://clinicaltrials.gov/ct2/show/NCT01867476?term=substance+abuse+monitoring&rank= 8 Centers for Medicare and Medicaid Services (CMS) National Coverage Determination As of this writing , NDC not found to date. Local Coverage Determinations: http://www.cms.gov/medicare-coveragedatabase/shared/handlers/highwire.ashx?url=http://www.cms.gov/medicare-coverage- FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 11 database/details/lcddetails.aspx@@@LCDId$$$35152***ContrId$$$248&session=w1mnxnf4zoinyxexznl1 5nql&kq=1886886355. Local Coverage Article: Qualitative Drug Screening-Supplemental Instructions Article (A48395). http://www.cms.gov/medicare-coverage-database/details/articledetails.aspx?articleId=48395&ver=44&ContrId=178&ContrVer=1&bc=AgCAAAAAAAAAAA%3d%3d&. LCDL34457: Drugs of abuse testing, 1/25/2014. http://www.cms.gov/medicare-coveragedatabase/details/lcddetails.aspx?LCDId=34457&ContrId=228&ver=3&ContrVer=2&DocID=L34457&bc=gAAAAAgAAAAAAA%3d%3 d& Local Coverage Determination (LCD): Qualitative Drug Testing (L32050), effective 03/27/2014. http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?LCDId=32050&ContrId=161&ver=22&ContrVer=2&Date=&DocID=L32050&bc=iAAAAAgAAAAA AA%3d%3d&. Local Coverage Determination (LCD): Qualitative Drug Screening (L28145), effective date 10/25/2013. http://www.cms.gov/medicare-coverage-database/details/lcd details.aspx?LCDId=28145&ContrId=269&ver=76&ContrVer=1&Date=&DocID=L28145&bc=iAAAAAgAAAAAA A%3d%3d&. Commonly Submitted Codes Below are the most commonly submitted codes for the service(s) or item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code 80100 80101 80102 Description Drug screen, qualitative; multiple drug classes, chromatographic method, each procedure. Drug screen, qualitative; single drug class method (e.g., immunoassay or enzyme assay), each drug class. Drug confirmation, each procedure. 83992 Drug screen, qualitative; multiple drug classes other than chromatographic method, each procedure. Column chromatography/mass spectrometry (e.g., GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase. Phencyclidine. 82145 Amphetamines. 82205 Barbiturates. 80154 Benzodiazepines. 83840 Methadone. G0431 Drug screen, qualitative; multiple drug classes by high-complexity test method (e.g., immunoassay or enzyme assay), per patient encounter. 80104 82520 Comment Deleted; not medically necessary. Deleted; not medically necessary. FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 12 G0434 Drug screen, other than chromatographic; any number of drug classes, by CLIA-waived test or moderate complexity test, per patient encounter. ICD-9 Code Description 276.2 Acidosis. 295.00 Simple-type schizophrenia, unspecified state 295.10 Disorganized-type schizophrenia, unspecified state. 295.20 Catatonic-type schizophrenia, unspecified state. 295.30 Paranoid-type schizophrenia, unspecified state. 304.01 Opioid-type dependence, continuous use. 304.90 Unspecified drug dependence, unspecified use. 305.90 Other mixed or unspecified drug abuse, unspecified use. 345.10 Generalized convulsive epilepsy, without intractable epilepsy. 345.11 Generalized convulsive epilepsy, with intractable epilepsy. 345.3 Grand mal status epileptic. 345.90 Epilepsy, unspecified, without intractable epilepsy. 345.91 Epilepsy, unspecified, with intractable epilepsy. 426.10 Atrioventricular block, unspecified. 426.11 First degree atrioventricular block. 426.12 Mobitz (type) ii atrioventricular block. 426.13 Other second degree atrioventricular block. 426.82 Long qt syndrome. 427.0 Paroxysmal supraventricular tachycardia. 427.1 Paroxysmal ventricular tachycardia. 780.01 Coma. 780.09 Alteration of consciousness, other. 780.1 Hallucinations. 780.39 Other convulsions. 780.97 Altered mental status. 963.0 Poisoning by antiallergic and antiemetic drugs. 965.00 Poisoning by opium (alkaloids), unspecified. 965.01 Poisoning by heroin. 965.02 Poisoning by methadone. 965.09 Poisoning by other opiates and related narcotics. 965.1 Poisoning by salicylates. Comment FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 13 965.4 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 Poisoning by barbiturates. 967.1 Poisoning by chloral hydrate group. 967.2 Poisoning by paraldehyde. 967.3 Poisoning by bromine compounds. 967.4 Poisoning by methaqualone compounds. 967.5 Poisoning by glutethimide group. 967.6 Poisoning by mixed sedatives not elsewhere classified. 967.8 Poisoning by other sedatives and hypnotics. 967.9 Poisoning by unspecified sedative or hypnotic. 969.00 Poisoning by antidepressant, unspecified. 969.01 Poisoning by monoamine oxidase inhibitors. 969.02 Poisoning by selective serotonin and norepinephrine reuptake inhibitors. 969.03 Poisoning by selective serotonin reuptake inhibitors. 969.04 Poisoning by tetracyclic antidepressants. 969.05 Poisoning by tricyclic antidepressants. 969.09 Poisoning by other antidepressants. 969.1 Poisoning by phenothiazine-based tranquilizers. 969.2 Poisoning by butyrophenone-based tranquilizers. 969.3 Poisoning by other antipsychotics, neuroleptics and major tranquilizers. 969.4 Poisoning by benzodiazepine-based tranquilizers. 969.5 Poisoning by other tranquilizers. 969.6 Poisoning by psychodysleptics (hallucinogens). 969.70 Poisoning by psychostimulant, unspecified. 969.71 Poisoning by caffeine. 969.72 Poisoning by amphetamines. 969.73 Poisoning by methylphenidate. 969.79 Poisoning by other psychostimulants. 969.8 Poisoning by other specified psychotropic agents. 969.9 Poisoning by unspecified psychotropic agent. 970.81 Poisoning by cocaine. 970.89 Poisoning by other central nervous system stimulants. FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 14 972.1 Poisoning by cardiotonic glycosides and drugs of similar action. 977.9 Poisoning by unspecified drug or medicinal substance. V15.81 V58.69 Personal history of noncompliance with medical treatment presenting hazards to health. Long-term (current) use of other medications. ICD-10 Code Description Comment HCPCS Level II Description Comment N/A FC-12092014-P-002 | Clinical Guideline 00.01.02 Drug Screens - Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals 15
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