Proposed LCD - Urine Drug Testing (DL36029)

Medical Necessity Guidance:Criteria to establish medical necessity for UDT must be based on patient-specific elements identified during the clinical assessment, and documented by the clinician in the patients medical record and minimally include the following elements:14Patient history, physical examination, and previous laboratory findings;Current treatment plan;Prescribed medication(s);Risk assessment plan.National pain organizations, physician societies, and the Federation of State Medical Boards15recommend a practical management approach to definitive UDT for COT. The number of UDTs billed over time beyond the baseline presumptive UDT must be based on individual patient needs substantiated by documentation in the patients medical record. Recommendations for the ordering of presumptive and definitive UDT for patients on COT are as follows:COT Baseline Testing:Depending on the patients specific circumstances, initial presumptive and/or definitive COT patient testing may include amphetamine/ methamphetamine, barbiturates, benzodiazepines, cocaine, methadone, oxycodone, tricyclic antidepressants, tetrahydrocannabinol, opioids, opiates, heroin, and synthetic/analog or designer drugs.COT Monitoring Testing:Ongoing testing may be medically reasonable and necessary based on the patient history, clinical assessment, including medication side effects or inefficacy, suspicious behaviors, self-escalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern16. As part of the clinical evaluation of the patient, the provider should inquire about prescription compliance and potential issues of abuse or diversion such as lost prescriptions, early refill requests, or requests for escalating dose of medication16. The number of UDTs billed over time must be based on the individuals risk potential1. Appropriate number of UDTs billed over time based on risk is listed in the table below14.The clinician should perform random UDT at random intervals to properly monitor a patient17.UDT testing does not have to be associated with an office visit.Patients with specific symptoms of medication aberrant behavior or misuse may be tested in accordance with this documents guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.UDT Frequency Based on Risk Assessment and Stratification*:Testing must be based on clinicians documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.Risk GroupBaselineFrequency of TestingLow RiskPrior to Initiation of COTPresumptive and definitive UDTnot to exceed 2 times each in a rolling 365 days for prescribed medications, non- prescribed medications that may pose a safety risk if taken with prescribed medications, and illicit substances based on patient history, clinical presentation, and/or community usage.Moderate RiskPrior to Initiation of COTPresumptive and definitive UDTnot to exceed 2 times each in a rolling 180 days for prescription medications, non- prescribed medication that may pose a safety risk if taken with prescribed medications, and illicit substances, based on patient history, clinical presentation, and/or community usage.High RiskPrior to Initiation of COTPresumptive and definitive UDTnot to exceed 3 times each in a rolling 90 days for prescribed medications, non-prescribed medications that may pose a safety risk if mixed with prescribed and illicit substances based on patient history, clinical presentation and/or community usage.*Note: Any additional definitive UDT beyond recommendations above must be justified by the clinician in the medical situations in which changes in prescribed medications may be needed, such as:Patient response to prescribed medication suddenly changes;Patient side effect profile changes;To assess for possible drug-drug interactions;Change in patients medical condition or behavior;Patient admits to use of illicit or non-prescribed controlled substance.Opioid Risk Tool:The patients risk category must be clearly defined in the medical record and is essential in determining number of UDTs billed over time and medical necessity.This TOOL is to be used as a suggestion for defining Risk and this document is just an example and other tools accepted by the Opioid Use treating community may be used. Example, accepted by SAMHSA (Substance Abuse and Mental Health Services Administration)The Opioid Risk Tool (ORT)18is a brief, self-report screening tool designed for use with adult patients in primary care settings to assess risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain15,16. Patients categorized as high-risk are at increased likelihood of future abusive drug-related behavior14. The ORT can be administered and scored in less than 1 minute and has been validated in both male and female patients, but not in non-pain populations. This tool should be administered to patients upon an initial visit prior to beginning opioid therapy for pain management. A score of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid abuse, and a score of 8 or higher indicates a high risk for opioid abuse15, 18.Mark each box that appliesFemaleMaleFamily history of substance abuseAlcoholIllegal drugsRx drugsPersonal history of substance abuseAlcoholIllegal drugsRx drugsAge between 16-45 yearsHistory of preadolescent sexual abusePsychological diseaseADD, OCD, bipolar, schizophreniaDepressionScoring totalsOther Covered ServicesReflex Testing by Reference Laboratories  since reference laboratories do not have access to patient-specific data, reflex testing under the following circumstances is reasonable and necessary:To verify a presumptive positive UDT using definitive methods that include but are not limited to GC-MS or LC-MS/MS before reporting the presumptive finding to the ordering clinician and without an additional order from the clinician; orTo confirm the absence of prescribed medications when a negative result is obtained by presumptive UDT in the laboratory for a prescribed medication listed by the ordering clinician.When medical record documentation that is individualized for a particular patient satisfies medical necessity requirements found elsewhere in this LCD (e.g., risk assessment, frequency), direct to definitive UDT without a presumptive UDT may be reasonable and necessary.Definitive testing to confirm a negative presumptive UDT result, upon the order of the clinician, is reasonable and necessary in the following circumstances:The result is inconsistent with a patients self-report, presentation, medical history, or current prescribed medication plan (should be present in the sample);Following a review of clinical findings, the clinician suspects use of a substance that is inadequately detected or not detected by a presumptive UDT; orWhen there is an unexpected negative presumptive UDT result, and it is clinically imperative to know if it is truly positive or negative; the medical record should state such.Definitive testing to confirm a presumptive UDT positive result, upon the order of the clinician, is reasonable and necessary when the result is inconsistent with the expected result, a patients self-report, presentation, medical history, or current prescribed medication plan.Non-Covered Services-therefore not reasonable and necessary servicesBlanket Orders-same orders for all patients in a health care providers practice.Reflex definitive UDT is not reasonable and necessary when presumptive testing is performed at point of care because the clinician may have sufficient information to manage the patient. If the clinician is not satisfied, he/she must determine the clinical appropriateness of and order specific subsequent definitive testing (e.g., the patient admits to using a particular drug, or the IA cut-off is set at such a point that is sufficiently low that the physician is satisfied with the presumptive test result).Routine standing orders for all patients in a physicians practice are not reasonable and necessary.It is not reasonable and necessary for a physician to perform presumptive POCT and order presumptive IA testing from a reference laboratory. In other words, Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.It is not reasonable and necessary for a physician to perform presumptive IA testing and order presumptive IA testing from a reference laboratory. Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.It is not reasonable and necessary for a reference laboratory to perform and bill IA presumptive UDT prior to definitive testing without a specific physicians order for the presumptive testing.IA testing, regardless of whether it is qualitative or semi-quantitative (numerical), may not be used to confirm or definitively identify a presumptive test result obtained by cups, dipsticks, cards, cassettes, or other IA testing methods. Definitive UDT provides specific identification and/or quantification typically by GC-MS or LC-MS/MS. Semi-Quantitative is defined as a numerical estimation of the approximate concentrations.Drug testing of 2 different specimen types from the same patient on the same date of service for the same drugs/metabolites/analytes.UDT for medico-legal and/or employment purposes or to protect a physician from drug diversion charges.Specimen validity testing including, but not limited to, pH, specific gravity, oxidants, creatinine.General InformationAssociated InformationN/ASources of InformationOther Contractor(s)' PoliciesBibliographyDuPont RL, Shea CL, Barthwell AG, et al. DRUG TESTING: A White Paper of the American Society of Addiction Medicine (ASAM). American Society of Addiction Medicine. White Paper. 2013.Gourlay DL, Heit HA, Caplan YH. Urine drug testing in clinical practice. The art and science of patient care. 2015(6):1-30SAMHSA, Clinical DRUG TESTING in Primary Care, Rockville, MD: SAMHSA; 2012. Technical Assistance Publication (TAP) 32, HHS publication (SMA) 12-4668.Agency Medical Directors Group. Interagency guideline on opioid dosing for chronic non-cancer pain: An educational aid to improve care and safety with opioid therapy 2010 Update.Melanson Stacy EF, Baskin LB. Interpretation and utility of drug of abuse immunoassays: lessons from laboratory drug testing surveys. Arch Pathol Lab Med. 2010;134:736-739.Standridge JB, Adams SM. Urine drug screening: a valuable office procedure. American Family Physician. 2010;81(5):635-640.American Medical Association, CPT 2021 Professional Edition, 26 November 2020, ISBN: 1640160493.Drug Enforcement Administration, U.S. Department of Justice, Drugs of Abuse: A DEA Resource Guide, 2020 Edition.Jannetto PJ, Bratanow NC, Clark WA, et al. Executive Summary: American Association of Clinical Chemistry Laboratory Medicine Practice GuidelineUsing Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients. The Journal of Applied Laboratory Medicine. 2018;2(4):489526.https://doi.org/10.1373/jalm.2017.023341AMA Report 2 of the Council on Science and Public Health (I-08): Improving Medical Practice and Patient/Family Education to Reverse the Epidemic of Nonmedical Prescription Drug Use and Addiction.American Academy of Pain Medicine, Guideline Statement, Use of Opioids for the Treatment of Chronic Pain, March 2013.Passik SD, Kirsh KL, Casper D. Addiction-related assessment tools and pain management: instruments for screening, treatment planning and monitoring compliance. Pain Med. 2008;9:S145-S166.Jones T, McCoy D, Moore TM, Browder, JH, Daffron S. Urine drug testing as an evaluation of risk management strategies. Practical Pain Management. 2010;10(5):26-30.Chou R, Fanciullo GJ. Opioid Treatment Guidelines; Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J Pain. 2009; 10(2): 113-130.Federation of State Medical Boards (FSMB), Model Policy for the Use of Opioid Analgesics for the Treatment of Chronic Pain, July 2013.Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clinic Proceedings. 2009;84(7):593-601.Centers for Disease Control and Prevention. Unintentional Drug Poisoning in the United States. July 2010.Webster LR, Webster R. Predicting aberrant behaviors in Opioid-treated patients: preliminary validation of the Opioid risk tool. Pain Med. 2005;6(6):432.Additional literature reviewed but not citedMichna, E. et al. Urine toxicology screening among chronic pain patients of opioid therapy: frequency and predictability of abnormal findings. Clin J Pain. 2007;23(2):173-179.