Urine Drug Screening

Urine Drug Screening I. Policy Urine Drug Screening (UDS, also known as Urine Drug Testing, or UDT) is performed to detect the presence in the urine of prescription medications and illegal substances for the purpose of medical treatment. UHA recognizes the following definitions within this policy: Presumptive/Qualitative testing to determine the presence or absence of drugs or drug classes as a Urine Drug Test; results may be negative, positive, or numeric, and methods may be TLC or immunoassay. Definitive/Quantitative testing identifies specific medications, illicit drugs, or metabolites [note these are specific chemical entities, not classes], which are absent or present in ng/ml; and tested by GC-MS or LC- MS methods. Specimen validity testing does not test drugs (or classes) but ph, specific gravity, etc. II. Criteria/Guidelines University Health Alliance (UHA) will reimburse for Urine Drug Screening when determined to be medically necessary and when it meets the medical criteria guidelines (subject to limitations and exclusions) indicated below. A. Within the scope of this policy, all Urine Drug Screening is considered medically necessary for the conditions listed below only when treatment planning by the requesting provider is dependent upon the test results: 1. Outpatient Pain Management, defined as the medical management of chronic opioid therapy for non-cancer pain. This policy does not apply to palliative or end of life comfort care. 2. To assess and treat members with substance abuse disorders B. Outpatient Pain Management: 1. In outpatient pain management, presumptive urine drug testing may be considered medically necessary within the following limitations: a. For baseline screening before initiating treatment or at the time treatment is initiated, when the following conditions are met: A. An adequate clinical assessment of patient history and risk of substance abuse is performed; B. Clinicians have knowledge of test interpretation; C. There is a plan in place regarding how to use test findings clinically b. Subsequent monitoring of treatment at a frequency appropriate for the risk level of the individual patient. The risk-level for an individual patient should include a global assessment of risk factors and monitoring for the presence of aberrant behavior. Standardized risk assessment tools are available, such as the 5-item opioid risk tool Page 1

(ORT) and should be used only by clinicians familiar with the inherent limitations of such tools. UHA allows frequency of repeat UDS as follows: A. All members on long term opioids: Up to 1 per year B. Members showing signs of aberrant behavior or opioid dose >90 MED: Up to 4 times per year A. Aberrant behavior is defined by one or more of the following: i. multiple lost prescriptions, ii. multiple requests for early refill, iii. obtained opioids from multiple providers, iv. unauthorized dose escalation, v. Apparent intoxication during previous visits. C. Testing on date of service when clinical evaluation of the patient suggests noncompliance or use of non-prescribed medications or illegal substances. Such testing is not subject to four times a year limit, but specific, clear documentation of medical necessity is required and must be available to UHA upon request. ii. iii. Documentation must clearly show medical decision making that supports medical necessity for more frequent testing and how the results of this testing will impact clinical treatment decisions. In the absence of adequate documentation, payment for UDS will be denied and may result in a significant financial burden to the patient. The clinician should discuss the potential cost with the patient at time of testing. C. Outpatient substance abuse treatment 1. Urine Drug Testing for the outpatient management of substance abuse, including opioid abuse, may be considered medically necessary under the following conditions: a. Baseline screening before initiating treatment program or at the time treatment is initiated, 1 time per program entry, when the following conditions are met: i. An adequate clinical assessment of patient history and risk of substance abuse is performed; ii. Clinicians have knowledge of test interpretation; iii. There is a plan in place regarding how to use test findings clinically 2. After patient is established in a substance abuse treatment program, Urine Drug Screening may be medically once every 1 to 3 months, up to eight random drug tests per year, per patient. a. In addition to random drug testing, testing on date of service may be medically necessary when clinical evaluation of the patient suggests noncompliance or use of Page 2

non-prescribed medications or illegal substances (not subject to eight times a year limit, but documentation required) 3. Members being tested more often than 8 times a year require documentation in the medical record of clinical reasoning that clearly shows a need for more frequent testing and how the results of testing will impact/has impacted clinical treatment decisions. a. Documentation above must be available to UHA upon request. b. In the absence of adequate documentation, payment for UDS will be denied and may result in a significant financial burden to the patient. The clinician should discuss the potential cost with the patient at time of testing. D. Definitive (confirmatory) urine drug testing 1. Definitive testing is considered medically necessary only in those instances when the results of the initial drug screening require information that may result in a change in the evaluation and/or treatment of patients. a. In agreement with nationally accepted guidelines, it is the policy of UHA that every urine drug screen does not require definitive (confirmatory) testing. The results of presumptive drug screening are often all that is necessary to initiate the conversations with patients that are an integral part of opioid therapy for treatment of chronic pain or the treatment of substance abuse. In outpatient pain management or substance abuse treatment, definitive UDS may be considered medically necessary under the following circumstances: i. There is a positive finding (e.g. presence of a substance not prescribed) on the presumptive UDS; or ii. iii. A negative finding when a positive result is expected on presumptive UDS (e.g. absence of a prescribed medication); or There is no immunoassay test commercially available. A. When testing is required and meets criteria for medical necessity for a drug not included in the initial presumptive drug screening panel, as may be the case for certain synthetic or semi-synthetic opioids B. UHA recognizes that many drugs are not available on presumptive UDS, however this exclusion is not an indication to allow coverage for definitive testing unless there is a clinical rational for such testing documented in the patient chart iv. Definitive testing should be ordered only after the results of preliminary testing have been reviewed and, when appropriate, discussed with the patient and the results of this discussion were not sufficient to answer the clinical concerns that would make definitive testing unnecessary. Page 3

b. Definitive (confirmatory) UDS must be ordered indicating the specific drug(s) requiring further testing. (e.g., order the individual substance(s) in question) instead of a comprehensive confirmatory panel. NOTE: This UHA payment policy is a guide to coverage, the need for prior authorization and other administrative directives. It is not meant to provide instruction in the practice of medicine and it should not deter a provider from expressing his/her judgment. Even though this payment policy may indicate that a particular service or supply is considered covered, specific provider contract terms and/or member s individual benefit plans may apply, and this policy is not a guarantee of payment. UHA reserves the right to apply this payment policy to all UHA companies and subsidiaries. UHA understands that opinions about and approaches to clinical problems may vary. Question concerning medical necessity (see Hawaii Revised Statutes 432E-1.4) are welcome. A provider may request that UHA reconsider the application of the medical necessity criteria in light of any supporting documentation. I. Limitations/Exclusions The following are not covered services within this policy: 1. Routine presumptive or definitive urine drug testing (e.g., frequent testing without consideration for specific patient risk factors or without consideration for whether testing is required for clinical decision making). 2. Unbundled tests when using a multi-test kit screening (e.g. strip, dip card, or cassette) 3. Definitive (confirmatory) testing instead of presumptive drug screening, or as a routine supplement to presumptive drug screens 4. Any Urine Drug testing orders for "custom profile" or "conduct additional testing as needed" 5. Definitive (confirmatory) testing that is indiscriminately carried out without a positive or unexpected negative result on initial presumptive screening. 6. Definitive (confirmatory) testing ordered prior to clinician review of the results of initial presumptive testing and, when appropriate, discussion of results with patient. 7. Testing ordered by third parties, such as school, courts, athletic programs, or employers (as a pre-requisite for employment or as a requirement for continuation of employment); or requested by a provider for the sole purpose of meeting the requirements of a third party. 8. Testing for residential monitoring. 9. UHA will allow one unit of service for presumptive testing per patient encounter regardless of the number of drug classes tested. 10. Definitive (confirmatory) testing is limited to four (4) units per date of service regardless of the number of analytes tested. 11. Definitive (confirmatory) urine drug testing will be denied when no underlying preliminary test has been performed Page 4

12. UHA does not reimburse for UDS result interpretation or supplies; as such service is considered a routine part of a patient care visit. 13. UHA does not reimburse for Specimen Validity Testing. (ph, specific gravity, creatinine, urinalysis). II. Administrative Guidelines A. Prior Authorization is not required. B. For presumptive urine drug screening, UHA recognizes (Codes) 80300, 80301 only 1. UHA will reimburse one unit with a flat fee for each code per date of service when the above criteria are met. C. Definitive (Confirmatory) Testing: 1. For Confirmatory Testing, UHA recognizes the codes for specific metabolites from the list below. a. Coverage is limited to four codes per date of service b. Frequent use of this code will be monitored for appropriateness. D. UHA does not pay for testing for Specimen Validity Testing (i.e. ph, Creatinine, specific gravity) CPT 80300 80301 Presumptive Urine Drug Screening Codes Description Drug screen, any number of drug classes from Drug Class List A; any number of non-tlc devices or procedures, (eg, immunoassay) capable of being read by direct optical observation, including instrumented-assisted when performed (eg, dipsticks, cups, cards, cartridges), per date of service Drug screen, any number of drug classes from Drug Class List A; single drug class method, by instrumented test systems (eg, discrete multichannel chemistry analyzers utilizing immunoassay or enzyme assay), per date of service Definitive (Confirmatory) Testing Codes CPT Description 80184 Phenobarbital 80299 Quantitation of therapeutic drug, not elsewhere specified 80320 Alcohols 80321 Alcohol biomarkers; 1 or 2 80323 Alkaloids, not otherwise specified 80324 Amphetamines; 1 or 2 80327 Anabolic steroids; 1 or 2 80329 Analgesics, non-opioid; 1 or 2 80332 Antidepressants, serotonergic class; 1 or 2 80335 Antidepressants, tricyclic and other cyclicals; 1 or 2 Page 5

80338 Antidepressants, not otherwise specified 80339 Antiepileptics, not otherwise specified; 1-3 80342 Antipsychotics, not otherwise specified; 1-3 80345 Barbiturates 80346 Benzodiazepines; 1-12 80348 Buprenorphine 80349 Cannabinoids, natural 80350 Cannabinoids, synthetic; 1-3 80353 Cocaine 80354 Fentanyl 80355 Gabapentin, non-blood 80356 Heroin metabolite 80357 Ketamine and norketamine 80358 Methadone 80359 Methylenedioxyamphetamines (MDA, MDEA, MDMA) 80360 Methylphenidate 80361 Opiates, 1 or more 80362 Opioids and opiate analogs; 1 or 2 80365 Oxycodone 80366 Pregabalin 80367 Propoxyphene 80368 Sedative hypnotics (non-benzodiazepines) 80369 Skeletal muscle relaxants; 1 or 2 80371 Stimulants, synthetic 80372 Tapentadol 80373 Tramadol 80374 Stereoisomer (enantiomer) analysis, single drug class 80375 Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1-3 83789 Mass spectrometry and tandem mass spectrometry (eg, MS, MS/MS, MALDI, MS-TOF, QTOF), nondrug analyte(s) not elsewhere specified, qualitative or quantitative, each specimen 83986 ph; body fluid, not otherwise specified 83992 Phencyclidine (PCP) 84311 Spectrophotometry, analyte not elsewhere specified III. Policy History Policy Number: M.DIA.05.140715 Current Effective Date: 02/01/2016 Original Document Effective Date: 07/15/2014 Previous Revision Dates: 11/07/2014, 11/15/2014, 02/01/2016 Page 6

2015 CPT Presumptive Drug Class Screening 2015 CPT Definitive Drug Testing Includes immunoassays, enzymatic methods, chromatographic methods without mass spectrometry, mass spectrometry without adequate drug resolution by chromatography, etc. 80300-80304 80320-80377 Includes methods such as:gc with mass spectrometry (any type). Any metabolites of the tested drugs Process must be able to identify individual drugs Process that distinguishes between structural isomers CPT 80301 reports single drug classes included with Drug Class List A using direct optical observation or an instrumented system such as a multichannel chemistry analyzer/enzyme assay (e.g., EIA, KIMS, CEDIA immunoassays). Code 80301 is reported once per date of service, regardless of the number of procedures performed, number of classes analyzed, or results obtained. (Generally this would be the type of testing performed in a hospital-based laboratory.) CPT 80302 is used for presumptive, single drug classes other than those in Drug Class List A, (i.e., Drug Class List B). CPT 80302 does not use direct optical observation or thin layer chromatography (TLC). Code 80302 does require the use of immunoassays or chromatography without mass spectrometry. It s reported for each drug class or procedure performed. CPT 80303 is used for presumptive, single or multiple drug class method; thin layer chromatography (TLC) procedures (e.g., acid, neutral, alkaloid plate), per date of service. CPT 80304 reports single or multiple drug screenings not specified elsewhere. Examples include: TOF, MALDI, LDTD, etc. See the CPT codebook for additional examples. CPT 80300 reports single or multiple drug class process using dipsticks, cups, or cassettes with or without the use of an instrument to complete the interpretation. Code 80300 is reported one time, regardless of the number of direct observation done/obtained on any date. For example, 80320 class of drugs is Alcohol(s). Drugs included are acetone, ethanol, ethchlovynol, ethylene glycol, isopropyl alcohol, and methanol.codes 80324-80326 class of drugs are Amphetamines. Drugs included are amphetamine, ephedrinelisdexamphetamine, methamphetamine, phentermine, phenylpropanolamine, and pseudoephedrine.for a complete listing of the 59 codes in the Definitive Drug Classes Listing, refer to the 2015 Professional Edition CPT codebook (beginning on page 474). Based on the latest information from Medicare, providers may be required to use these CPT codes for commercial payers, and Medicare G codes to report qualitative and quantitative drug screens for Medicare beneficiaries. At the November 2014 American Medical Association (AMA) CPT 2015 Symposium, Centers for Medicare & Medicaid Services (CMS) officials presented numerous G codes created for 2015. CMS overall position is that when the timing of a CPT code creation precludes adequate time for consideration of comments and Relative Value Update Committee valuation, they will implement or default to using a G code(s). In the 2015 Medicare Physician Fee Schedule (MPFS) final rule, CMS indicated they would also create a G code if the revisions and/or deletions to CPT may affect the code s relative value units. CMS said they would also add a G code whenever AMA separated a single CPT code into two CPT codes. In the 2015 MPFS final rule, CMS said: These codes represent various drug screening codes, many of which are specific to individual drug testing. While we appreciate the recommendations for these tests, we are concerned about the potential for overpayment when billing for each individual drug test rather than a single code that pays the same regardless of the number of drugs that are being tested for. Therefore, it is our recommendation to delay pricing for these codes at this time, until further information and education is obtained. As of late December 2014, CMS had not yet released the clinical lab fee schedule for 2015. Stay tuned for additional updates as we learn more on how Medicare and other payers plan to respond to these extensive changes. Because Addendum B of the final Medicare rule contains the established urine drug screen codes (G0434 Drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter and G0431 Drug screen, qualitative; multiple drug classes by high complexity test method (eg, immunoassay, enzyme assay), per patient encounter), plus 28 new HCPCS Level II codes for drug assay and confirmation, such as G6031 Benzodiazepines, G6045 Dihydrocodeinone, and G6058 Drug confirmation, each procedure, it s likely that CMS will default to using G codes for drug screening/testing in 2015. For commercial payers, use the 2015 CPT codes unless advised otherwise. Page 7

According to Barthwell, Palmetto, a CMS claims processing contractor overseeing one of the 10 CMS jurisdictions, has adopted a new urine-testing reimbursement model for its region, which she predicts will ultimately become the nationwide standard. The model does not allow for additional reimbursement when an immunoassay test at a lab is used to confirm a test from the point of care. What drug treatment programs must be aware of is that the guidance from Palmetto does not allow the use of a presumptive test to confirm a presumptive test, Barthwell tells Behavioral Healthcare. For example, if at the point of care, a clinician processes a dipstick type of test and a lab also completes a test to confirm that result, both testing providers cannot bill for that service. It s been written into the regulation now that that would be disallowed, she says. We have indications that it s going to be adopted across the country. She believes the Palmetto model is being viewed as guidance that all the other CMS jurisdictions will follow in how they reimburse for urine drug testing. And it s the lab s jurisdiction that determines the rules the provider would need to follow. Barthwell advises that treatment centers confirm with their lab partners whether or when the new guidance will be adopted. It's already policy in the Palmetto jurisdiction. You are responsible for knowing how to be in compliance with the laws you operate under, she says. For the folks I m working with, I advise to err on side of caution and act as if this policy is adopted. At this point, the regulations can only be enforced for Medicare and Medicaid claims, however, Barthwell cautions that commercial payers tend to ride on the coattails of CMS and adopt the same policies. The trend always is that CMS sets the standard and then commercials tend to follow, which is why we pay attention to what CMS is doing, she says. Four tiers In her testimony, Barthwell also recommended that CMS adopt Palmetto s tiered structure for testing: Tier I permits testing for up to 7 drugs, and prices are determined by individual drug testing codes (CPT/G-codes); Tier II allows testing for 8 to 15 drugs at a flat rate of $180; Tier III permits testing for 16 to 34 drugs for approximately $215; Tier IV allows testing for 35 or more drugs at a capped rate of $250. Adoption of this code would allow a laboratory to report all available information when ordered. Pricing should correlate with the value of the service provided to ensure that clinicians use drug testing appropriately in the treatment of their patients and valuable healthcare dollars are efficiently allocated, she said at the hearing. The new CPT codes are divided into 3 classifications: Therapeutic Drug Assay, Drug Assay and Chemistry. The Drug Assay codes are further differentiated into two categories. The Presumptive Drug Class codes are used to identify possible use or non-use of a drug. The Definitive Drug Class describes qualitative or quantitative tests to identify possible use or non-use of a drug. The Definitive Drug Class codes describe specific drugs and their associated metabolite(s). The Presumptive Drug Class Screening codes (80300-80304) are based on a List of Drugs that is included in CPT. Definitive Drug Testing codes (80320-80377) and common analytes are noted in a separate table in CPT for easy identification. The Therapeutic Drug Assays (80150-80299) are used to monitor clinical response to a known prescribed medication. These codes are specific to the medication. Page 8