Proposed LCD - Urine Drug Testing (DL36029)

GC-MSGC-MS can only be performed on molecules that are volatile. If the test drug is not volatile in its own right, it must be modified or derivatized to a volatile form. To derivatize, the test drug must be extracted from the urine, eluted from the extraction device, concentrated, and then reacted with a chemical reagent to make a volatile product. Each drug class may require a different derivatizing agent. For patients on multiple classes of medications, laboratories using GC procedures must make different volatile derivatives in order to perform comprehensive testing. Since a GC column may not be able to separate more than one class of compounds, multiple chromatographic runs on different column types may be required to monitor multiple drug classes1. Newer GC-MS instruments often use tandem systems. GC-MS methodology allows for the testing of multiple substances but differs in ease of run.LC-MS/MSLC-MS/MS is roughly 100 times more sensitive and selective, involves fewer human steps, provides quicker turn-around time, uses less specimen volume, and can test for a larger number of substances simultaneously when compared to GC-MS1. After sample preparation, it is injected into the LC-MS/MS. The sample has to undergo hydrolysis to break the glucuronide bond that frees the drug and drug metabolites. Hydrolysis is followed by multiple additional steps including protein precipitation, centrifugation, and purification. Deuterium-labeled isotopic internal standards are added to quantify the drugs and drug metabolites.The sample is injected when the mobile phase is flowing through the chromatographic column. Each drug and drug metabolite interacts with the mobile phase and stationary phase differently and moves at different speeds depending on their chemical properties. In other words, each analyte elutes at different times. Specific drugs and metabolites are identified by their retention time and quantified against isotopic internal standards for each drug and metabolite. Each drug peak has a minimum of 2 mass transmissions to be compared to drug standards (calibrators) to ensure identification.CLIA-Certified Laboratories-Informational onlyCLIA specifies quality standards for proficiency testing, facility administration, general laboratory systems, pre-analytic, analytic, and post-analytic systems, onsite supervision requirements, personnel qualifications and responsibilities, quality control, and quality assessment3.High complexity laboratories must ensure that testing is carried out by onsite qualified, trained personnel using validated reliable methods compliant with regulatory procedures (42 CFR Part 493). Both GC-MS and LC-MS/MS require a quality program to monitor the quality and audit the competency of the staff. LC-MS/MS instrument maintenance must be performed daily as well as the validation of instrument performance prior to patient specimens. Final review and approval of GC-MS and LC-MS/MS results must be performed by a qualified clinical laboratory scientist as defined in 42 CFR Part 493.1489 (Testing Personnel Qualifications). A GC-MS or LC-MS/MS laboratory must have a qualified laboratory director, qualified physician, or qualified clinical laboratory scientist, as provided in 42 CFR 493.1443 (Laboratory Director Qualifications).Purpose of UDT:Presumptive UDT may be ordered by the clinician caring for a beneficiary when it is necessary to rapidly obtain and/or integrate results into clinical assessment and treatment decisions.Definitive UDT is considered reasonable and necessary when the clinical information supplied supports the definitive testing as in:Identify a specific substance or metabolite that is inadequately detected by a presumptive UDT screen;Definitively identify specific drugs in a large family of drugs;Identify a specific substance or metabolite that is not detected by presumptive UDT such as fentanyl, meperidine, synthetic cannabinoids, and other synthetic/analog drugs;Identify drugs when a definitive concentration of a drug is needed to guide management (e.g., discontinuation of THC use according to a treatment plan);Identify a negative, or confirm a positive, presumptive UDT result that is inconsistent with a patients self-report, presentation, medical history, or current prescribed pain medication plan;Rule out an error as the cause of a presumptive UDT result;Identify non-prescribed medication or illicit use for ongoing safe prescribing of controlled substances; andUse in a differential assessment of medication efficacy, side effects, or drug-drug interactions.Definitive UDT may be reasonable and necessary based on patient specific indications, including historical use, medication response, and clinical assessment, when accurate results are necessary to make clinical decisions1.To establish that a test is reasonable and necessary,the clinicians rationale for the definitive UDT and the tests ordered must be documented in the patients medical record.Drug Testing PanelsPresumptive UDT PanelsPresumptive UDT typically involves testing for multiple analytes based on the specific beneficiary's clinical history and risk assessment and must be documented in the medical record. May be ordered as a panel and billed a "Per Patient encounter" regardless of the number of analytes tested.B. Definitive UDT PanelsPhysician-directed definitive profile testing is reasonable and necessary when ordered for a particular patientbased upon historical use, clinical findings, and community trends. However, the same physician-defined profile is not reasonable and necessary for every patient in a physicians practice.Definitive UDT orders should be individualized based on clinical history and risk assessment and must be documented in the medical record.Specimen TypeUrine or oral fluid is the preferred biologic specimen for testing because of the ease of collection, storage, and cost-effectiveness1. UDT cannot detect the dosage of drug ingested/used, the time of use, or the means of delivery (intravenous vs. oral vs. inhaled). Detection time of a substance in urine is typically 1-3 days depending on the drug, rate of metabolism, and rate of excretion. Lipid-soluble drugs, such as marijuana, may remain in body fat and be detected upwards of a week or more.Ethanol is not discussed in this LCD:Note: Ethanol is a known drug of abuse but is routinely tested in blood, not urine. In addition, the DEA Resource Guide8states that alcohol is exempt from control by the Controlled Substances Act (CSA).Covered Indications for UDTGroup A  Symptomatic patients, Multiple drug ingestion, and/or Patients with unreliable historyA patient who presents in a variety of medical settings with signs or symptoms of substance use toxicity will be treated presumptively to stabilize the patient while awaiting presumptive, then definitive testing to determine the cause(s) of the presentation. The need for definitive UDT is based upon presumptive test findings, responses to medical interventions, and treatment plan1. A presumptive UDT should be performed as part of the evaluation and management of a patient who presents in an emergency room or urgent care setting with any 1 of the following:Coma;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;To provide antagonist to specific drug.The presumptive findings, definitive drug tests ordered, and reasons for the testing must be documented in the patients medical record.Group B - Diagnosis and treatment for substance abuse or dependenceA patient in active treatment for a SUD or monitoring across different phases of recovery may undergo medical management for a variety of medical conditions. A physician who is writing prescriptions for medications to treat either the SUD or other conditions may need to know if the patient is taking substances which can interact with prescribed medications or taking prescribed medications as expected1. The risk of drug-drug interactions is inherent to the patient and may be compounded by prescribed medications. UDT is a medically necessary and useful component of chemical dependency diagnosis and treatment. The UDT result influences treatment and level of care decisions3.Ordered tests and testing methods (presumptive and/or definitive) must match the stage of screening, treatment, or recovery; the documented history; and Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis. For patients with no known indicators of risk for SUD, the clinician may screen for a broad range of commonly abused drugs using presumptive UDT. For patients with known indicators of risk for SUD, the clinician may screen for a broad range of commonly abused drugs using definitive UDT. For patients with a diagnosed SUD, the clinician should perform random UDT at random intervals to properly monitor the patient3. Testing profiles must be determined by the clinician based on the following medical necessity guidance criteria:Patient history, physical examination, and previous laboratory findings;Stage of treatment or recovery;Suspected abused substance;Substances that may present high risk for additive or synergistic interactions with prescribed medication (e.g., benzodiazepines, alcohol).The patients medical recordmust include an appropriate number of UDTs billed over time based on the stage of screening, treatment, or recovery9and the rationale for the drugs/drug classes ordered; and the results must be documented in the medical record and used to direct care3.1. Maximum Number of Allowed Presumptive UDTs for SUDThe number of UDTs billed over time must meet medical necessity and be documented in the patients medical record9.For patients with0 to 30 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 7 days More than 3 presumptive UDTs in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with31 to 90 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 7 days More than 3 presumptive UDTs in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with> 90 consecutive days of abstinence, presumptive UDT is not to exceed 3 presumptive UDTs in a rolling 30 days. More than 3 presumptive UDTs a rolling 30 days is not reasonable and necessary and is not covered by Medicare.2. Maximum Number of Allowed Definitive UDTs for SUDDepending on the patients specific substance use history, definitive UDT to accurately determine the specific drugs in the patients system may be necessary. Definitive testing may be ordered when accurate and reliable results are necessary to integrate treatment decisions and clinical assessment. The number of UDTs billed over time and the rationale for definitive UDT must be documented in the patients medical record.For patients with0 to 30 consecutive days of abstinence, definitive UDT is not to exceed 1 definitive UDT in a rolling 7 days More than 1 definitive UDT in a rolling 7 days is not reasonable and necessary and is not covered by Medicare.For patients with31 to 90 consecutive days of abstinence,definitive UDT is not to exceed 3 definitive UDTs in a rolling 30 days. More than 3 definitive UDTs in a rolling 30 days is not reasonable and necessary and is not covered by Medicare.For patients with> 90 days of consecutive abstinence, definitive UDT is not to exceed 3 definitive UDTs in a rolling 90 days. More than 3 definitive UDTs in a rolling 90 days is not reasonable and necessary and is not covered by Medicare.Group C - Treatment for patients on chronic opioid/opiate therapy (COT).A physician who is writing prescriptions for medications to treat chronic pain can manage a patient better if the physician knows whether the patient is consuming another medication or substance, which could suggest the possibility of SUD or lead to drug-drug interactions. Additionally, UDT may help the physician monitor for medication adherence, diversion, efficacy, side effects, and patient safety in general11. A broad cross section of the general population will develop either cancer pain syndrome or non-cancer pain which will require prolonged or chronic opioid therapy for management with normal risk of addiction inherent to the substance(s) exposed12.COT UDT Testing Objectives:Identifies absence of prescribed medication and potential for abuse, misuse, and diversion;Identifies undisclosed substances, unsanctioned prescription medication, or illicit substances;Identifies substances that contribute to adverse events or drug-drug interactions;Provides objectivity to the treatment plan11;Reinforces therapeutic compliance with the patient;Provides additional documentation demonstrating compliance with patient evaluation and monitoring13;Provides diagnostic information to help assess individual patient response to medications (e.g., metabolism, side effects, drug-drug interaction, etc.) over time for ongoing management of prescribed medications.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: