Drug Testing in Pain Management and Substance Abuse Treatment

may be considered medically necessary as defined by the criteria listed in this policy.

Definition:

• Analyte: The component of a biological sample that is identified and measured. In drug testing, both parent drugs and the products of drug metabolism are targeted. Their presence indicates exposure to a substance or family of substances.
• Blanket Orders: Test request that is not for a specific patient; rather, it is an identical order for all patients in a clinician’s practice without individualized decision making at every visit.
• Chromatography: This is a collective term for a set of lab techniques used for separation of mixtures into their component substances. The mixture is dissolved in a fluid called the mobile phase and carried over another material called the stationary phase. The various constituents of the mixture travel at different speeds causing them to separate on the stationary phase. For urine drug testing Gas Chromatography or Liquid Chromatography are commonly used.
• Definitive/Quantitative/Confirmatory: Used when medically necessary to identify specific medications, illicit substances, and metabolites; Reports the results of drugs absent or present in concentration of ng/ml; limited to Gas Chromatography-Mass Spectrometry and Liquid Chromatography-Mass Spec/Mass Spec testing methods.

HeatthFirst Health Plans

• Immunoassay (IA): Ordered by clinicians to primarily identify the presence or absence of drug classes and some specific drugs; Biochemical test that measures the presence above a cut off level of a substance with the use of an antibody; Read by photometric technology.
• Matrix (plural matrices): The biological material used for analysis in a drug test. Examples include blood, urine, oral fluid (spit/saliva), hair, nails, sweat, and breath.
• Point of Care Testing (POCT): Used when medically necessary by clinicians for immediate test results for the immediate management of the patient; Available when the patient and physician are in the same location; immunoassay test method that primarily identifies drug classes and a few specific drugs; Platform consists of cups, dipsticks, cassettes, or strips; Read by human eye.
• Presumptive/Qualitative Drug Testing: Used when medically necessary to determine the presence or absence of drugs or drug classes in a urine sample; Results expressed as negative or positive or a numerical value; Includes competitive immunoassays and thin layer chromatography.
• Reflex Testing: Lab testing that is performed reflexively after initial test results to identify further diagnostic information essential to patient care. Testing performed as a step necessary to complete a physician’s order is not considered reflex testing.
• Standing Orders: Test request for a specific patient representing repetitive testing to monitor a condition or disease for a limited number of sequential visits; Individualized orders for certain patients for pre-determined tests based on historical use, risk, and community trend patient profiles; Clinicians can alter the standing order.
• Window of Detection: The range of time that a substance can be detected in a sample. It refers both to the time to detection (time to be absorbed and distributed to sample material) and time to clearance (time to be metabolized/eliminated/excreted). Each matrix and analyte have a different window of detection, ranging from minutes to months.

Clinical Criteria: (Indications/Limitations)

I. Substance Abuse Management

1. A. Urine drug testing for Substance Abuse Management may be considered medically necessary when ALL of the following conditions are met:
   1. Member is enrolled in an official substance abuse management program
   2. Detailed medical record documenting patient history, physical exam, previous lab tests which demonstrate rationale for drug classes being tested
2. B. Frequency of Presumptive (Qualitative) Urine Drug Testing Presumptive Urine drug testing may be considered medically necessary in the diagnosis, treatment, and management of patients with suspected or diagnosed Substance Abuse Disorder, who are enrolled in an official substance abuse program, with the following frequency limits:
   1. Limited to 15 tests within a 12-month period. There is insufficient clinical evidence to support the use of daily or multiple testing in clinical practice per day.
   2. Baseline screening prior to initiating treatment, 1 time per program entry. Panel selected for screening must be such that it guides treatment decisions.
   3. Stabilization phase – weekly for a maximum of 4 weeks.
   4. Maintenance phase – once every 1-3 months.
3. C. Definitive or Quantitative Testing is considered medically necessary if one of the following criteria are met:
   1. No qualitative test exists for particular drug; OR
   2. To confirm a positive or negative presumptive test if it is inconsistent with the expected result, a patient’s self-report, presentation, medical history, or current prescribed medication; OR
   3. Direct to definitive testing without presumptive testing may be considered medically necessary when a definitive concentration of a drug is needed guide treatment plan or when clinician has documented concerns related to safety risks attendant with failure to identify specific substances.
4. D. Quantitative urine testing is limited to 12 tests within a 12-month period. There is insufficient clinical evidence to support the use of daily or multiple testing per day in clinical practice.

Pain Management

Presumptive or Definitive Urine Drug Testing may be considered medically necessary in the management of patients on chronic opioid therapy, with the following frequency limits:

1. A. Baseline screening prior to initiating treatment, may include amphetamines, methamphetamines, benzodiazepines, barbiturates, cocaine, methadone, oxycodone, tricyclic antidepressants, tetrahydrocannabinol, opioids, opiates, heroin, synthetic analog/designer drugs.
2. B. Monitoring testing must be based on patient history, clinical assessment, including medication side effects or inefficacy, suspicious behavior, self-escalation of dose, or other clinician documented change in affect or behavioral pattern. Testing should be random at a frequency determined by a validated risk assessment questionnaire and should include the patient's response to medication as well as side effects.

• Low Random testing 1-2 times every 12 months 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.
• High Maximum of 2-4 times every 12 months Random testing 1-3 times every 3 months 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. Maximum of 4-12 times every 12 months

III. Documentation requirements

1. Detailed patient history including physical exam and laboratory records
2. Appropriate frequency based on stage of treatment
3. Rationale for drugs or drug classes ordered
4. Results documented and used to direct

Limitations - IV.Non – Covered Services

ALL of the following:

1. Blanket orders
2. 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).
3. Routine standing orders for all patients in a physician’s practice are not reasonable and necessary
4. It is not reasonable and necessary for a reference laboratory to perform and bill IA presumptive UDT prior to definitive testing without a specific physician’s order for the presumptive testing.
5. 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 (80305- 80307) per patient per date of service regardless of the number of billing providers.
6. It is not reasonable and necessary for a physician to perform presumptive IA testing and order presumptive IA testing from a reference laboratory with or without reflex testing. Medicare will only pay for one presumptive test result (80305-80307) per patient per date of service regardless of the number of billing providers.
7. It is not reasonable and necessary for a reference laboratory to perform and bill IA presumptive UDT prior to definitive testing without a specific physician’s order for the presumptive testing.
8. 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 by GC-MS or LC- MS/MS.
9. Drug testing of two different specimen types from the same patient on the same date of service for the same drugs/metabolites/analytes.
10. Drug testing for medico-legal and/or employment purposes or to protect a physician from drug diversion charges
11. Specimen validity testing including but not limited to, pH, specific gravity, oxidants, creatinine.
12. Only one definitive test (G0480-G0483) per patient per date of service will be covered irrespective of billing providers.