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Standards and Procedures

Corporate Responsibility & Compliance

All laboratory testing sites are regularly monitored to safeguard against unintentional violations of federal compliance guidelines. Monitoring activities are also aimed at raising awareness of federal guidelines and assisting in developing mechanisms for successfully meeting them.

Physicians UNA

Drug Screen Compliance

Staying Reasonable with your Drug Screens and Testing. It has become increasingly common for practitioners of all specialties to routinely test for the presence of both legal and illegal substances before prescribing certain medications such as opiates for pain control and to monitor patients who are on chronic opiate therapy for long term pain management. CMS effectively killed this "cash cow" by code revisions and single unit billings and are now taking additional steps to combat abuses on testing that lacks actual necessity to manage the patient's treatment.

This discussion paper is a supplement to our March 2014 release and prompted by additional CMS carrier general audit policies on the frequency of testing and challenges to its "necessity". We must focus on their increased scrutiny and enforcement that coverage is dependent on proper documentation of your clinical decision-making and written test orders that are tailored to the individual patient's medical needs. Carriers frequently invoke 42 CFR Section 410.32 to deny testing based on an absence of a written order and/or lack of documentation that the testing and the results are reasonable and necessary for proper case management. For the most part, our members test prior to or during chronic pain management cases using opioid therapy of some type and therefore should be aware of the conditions specific to Treatment for patients on chronic opioid therapy (COT).

A Provider 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, efficacy, side effects, and patient safety in general.

Standards and Procedures

COT UDT Testing Objectives:

  • Identifies absence of prescribed medication and potential for abuse, misuse, and diversion
  • Identifies undisclosed substances, such as alcohol, unsanctioned prescription medication, or illicit substances
  • Identifies substances that contribute to adverse events or drug-drug interactions
  • Provides objectivity to the treatment plan
  • Reinforces therapeutic compliance with the patient
  • Provides additional documentation demonstrating compliance with patient evaluation and monitoring
  • Provide 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.

In Keeping with these identified objectives, we suggest, at a minimum, you include in your documentation statements of necessity such as the ones provided below:

New Patient - Established Patient with initial New Order I am ordering baseline UDT prior to prescription of narcotics for pain to identify any undisclosed medications or substances that could potentially lead to adverse interactions or compromise efficacy of care. We will specifically screen for AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MTD, OPI, OXY, TCA, THC using a CLIA waived UDT. Confirmatory, qualitative testing will be performed based on results.

Periodic Radom Testing: We are performing a random precautionary monitoring UDT today to assess the patient for presence of prescribed medications, non-prescribed medication and illicit substances that may pose a safety risk if taken with prescribed medications. We will specifically screen for AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MTD, OPI, OXY, TCA, THC using a CLIA waived UDT Confirmatory, qualitative testing will be performed based on results.

These statements are examples of justification statements for initial and periodic monitoring tests. They will vary by circumstance and should be modified by the test being used and, if applicable the substance analytes.

Standards and Procedures

Medical Necessity Guidance:

Criteria to establish medical necessity for drug testing must be based on patient-specific elements identified during the clinical assessment, and documented by the clinician in the patient's medical record and minimally include the following elements:

  • Patient 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 Boardsrecommend a practical approach to definitive UDT for COT. Frequency of testing beyond the baseline presumptive UDT must be based on individual patient needs substantiated by documentation in the patient's medical record.

National pain organizations, physician societies, and the Federation of State Medical Boards recommend a practical approach to definitive UDT for COT. Frequency of testing beyond the baseline presumptive UDT must be based on individual patient needs substantiated by documentation in the patient's medical record.

Recommendations for the ordering of presumptive and definitive UDT for patients on COT areas follows:

Standards and Procedures

COT Baseline Testing:

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.
Standards and Procedures

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, selfescalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern. The frequency of testing must be based on a complete clinical assessment of the individual's risk potential for abuse and diversion using a validated risk assessment interview or questionnaire and should include the patient's response to prescribed medications and the side effects of medications. The clinician should perform random UDT at random intervals, in order to properly monitor a patient. 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 document's guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.
Standards and Procedures

Other Covered Services

  • Reflex 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 UDT (GC-MS or LCMS/ MS) before reporting the presumptive finding to the ordering clinician and without an additional order from the clinician; or
    • To 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.
  • Direct to definitive UDT without a presumptive UDT is reasonable and necessary, when individualized for a particular patient, in the following circumstances:
    • To identify a specific substance or its metabolite that is in a large class of drugs, or that is inadequately detected or not detected by presumptive UDT, such as fentanyl, meperidine, synthetic cannabinoids, and other synthetic/analog drugs;
    • For use in a differential assessment of medication efficacy, side effects, or drugdrug interactions;
    • To identify non-prescribed medication or illicit substance use for ongoing safe prescribing of controlled substances, where clinician has documented concerns related to safety risks attendant to failure to identify specific substances suspected based upon clinical review and judgment; or
    • To 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).
  • 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 patient's 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; or
    • To rule out an error as the cause of a negative presumptive UDT result.
  • 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 patient's self-report, presentation, medical history, or current prescribed medication plan.

UDT Frequency Based on Validated Risk Assessment and Stratification*
Testing must be based on clinician's documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.

Risk Group Baseline Frequency of Testing
Low Risk Prior to Initiation of COT 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.
Moderate Risk Moderate Risk Random testing 1-2 times every 6 months 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 Risk Prior to Initiation of COT Random testing performed 1-3 times every 3 months 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.
Standards and Procedures

COT UDT Testing Objectives:

Monthly testing is NOT considered reasonable or necessary by Medicare and many other carriers and billing a monthly screen before you write the new prescription will probably trigger an audit or at least an additional documentation request.

Any additional definitive UDT beyond recommendations above must be justified by the clinician in the medical record in 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
  • Sudden change in patient's medical condition
  • Patient admits to use of illicit or non-prescribed controlled substance.
  • Routine standing orders for all patients in a physician's practice are not reasonable and necessary.
Standards and Procedures

ICD-10-CM Diagnoses coding

Most testing for any form of drug monitoring will fall to one of these new codes.
Z51.81 Encounter for therapeutic drug level monitoring
Z79.891 Long term (current) use of opiate analgesic
Z79.899 Other long term (current) drug therapy

Substance ABUSE is coded in the F10-F19 section of the ICD-10.

F10. - Mental and behavioral disorders; due to use of alcohol
F11. - due to use of opioids
F12. - due to use of cannabinoids
F13. - due to use of sedative hypnotics
F14. - due to use of cocaine
F15. - due to use of other stimulants, including caffeine
F16. - due to use of hallucinogens
F17. - due to use of tobacco
F18. - due to use of volatile solvents
F19. - due to multiple drug use and use of other psychoactive substances
Standards and Procedures

Examples of coding

F11.20
Opioid dependence, uncomplicated
F11.220
Opioid dependence with intoxication, uncomplicated
F11.221
Opioid dependence with intoxication delirium
F11.222
Opioid dependence with intoxication with perceptual disturbance
F11.229
Opioid dependence with intoxication, unspecified
F11.23
Opioid dependence with withdrawal
F11.24
Opioid dependence with opioid-induced mood disorder
F11.250
Opioid dependence with opioid-induced psychotic disorder with delusions
F11.251
Opioid dependence with opioid-induced psychotic disorder with hallucinations
F11.259
Opioid dependence with opioid-induced psychotic disorder, unspecified
F11.281
Opioid dependence with opioid-induced sexual dysfunction
F11.282
Opioid dependence with opioid-induced sleep disorder
F11.282
Opioid dependence with other opioid-induced disorder
F11.29
Opioid dependence with unspecified opioid-induced disorder
F19.20
Other psychoactive substance dependence, uncomplicated

We suggest you look to carrier policies under; Drugs of Abuse Testing, Qualitative Drug Testing; Controlled Substance Monitoring and Drugs of Abuse Testing Or Urine Drug Screening. Carrier publications and policies are often under different titles.

We offer the follow "General Guidelines" in regards to Medicare coverage.

Non-Covered

  • Routine nonspecific or wholesale orders for drug screening (qualitative), confirmation, and quantitative drugs of abuse testing.
  • Test for the same drug(s) using a blood and a urine specimen at the same time on the same date of service.
  • Drug screening for medico-legal purposes (e.g., court-ordered drug screening) and for employment purposes (e.g., as a pre-requisite for employment or as a requirement for continuation of employment)
  • Un-validated specimen sources.
  • Specimen Validity testing

Documentation

A signed and dated physician order for clinical drug screening and/or testing is a key element the medical record and the clinical decision-making based thereon. Documentation is important to the billing and claims for reimbursement of clinical laboratory services. Copies of the test results alone without a proper clinician order for the test are not sufficient documentation to support a claim for the testing services.

The physician order must specifically match the number, level, and complexity of the testing panel components performed. Orders for "custom profiles", "standing orders" or "orders to conduct additional testing as needed" are typically not sufficiently detailed and thus cannot be used to verify the medical necessity for the specific tests the ordering clinician intended to be performed.

From a post drug testing payment review prospective, an order from a non-qualified person (i.e. lab technician, front office personnel, sales rep), or one lacking the documentation required to verify that the billed tests were specifically ordered and medical necessary and reasonable may result in overpayment.

All documentation must be maintained in the patient's medical record and available to the contractor upon request. The following additional documentation requirements apply:

  • Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the identity of the physician or non-physician practitioner responsible for and providing the care of the patient
  • The submitted medical record should support the use of the selected ICD-9-CM/ICD-10- CM code(s). The submitted CPT/HCPCS code should accurately describe the service performed.
  • Medical record documentation (e.g., history and physical, progress notes) maintained by the ordering physician/treating physician must indicate the medical necessity for performing a qualitative drug test.
  • The treatment agreement (sometimes called a "contract") notifying the patient of his or her responsibility to provide urine/serum samples upon request is not sufficient by itself to support medical necessity.
  • The treating provider performing in-office/onsite POCT should use a CLIA-waived device or CLIA-approved test (FDA cleared/approved) containing specimen validity components to measure pH, specific gravity and temperature. Results of the drug test must be read according to the manufacturer's instructions. Specimen validity is not a covered service and should be used as a quality control measure to ensure a valid specimen. If the treating provider has a concern about the validity of the specimen, the provider should document these concerns and take steps to obtain a valid specimen for testing. Inability to obtain a valid specimen should be factored into the ongoing management of the patient.
  • Patient drug testing should be conducted and reviewed prior to the initial issuance or dispensing of a controlled substance prescription.
  • Clinicians should exercise caution when relying on customized test panels and standing orders and ensure that medical necessity exists for the testing of all drugs/drug classes within the panel. Failure to back up customized test panels with medical necessity information for each individual patient and for each of the drug test panels ordered will be considered "routine test orders" and are excluded from coverage, resulting in the denial of the claim, audit, and/or overpayment request, among other program means for enforcing this policy.
  • If the provider of the service is other than the ordering/referring physician, that provider must maintain hard copy documentation of the lab results, along with copies of the ordering/referring physician's order for the qualitative drug test. The physician must include the clinical indication/medical necessity in the order for the for the qualitative drug test.
  • Multiple ICD-9/ICD-10 codes should be assigned according to the individual patient case and used to justify the ordered testing. If the provider of the service is other than the ordering or referring physician, that provider must maintain hard copy documentation of the lab results, along with copies of the ordering/referring physician's order for the drug test. The ordering or referring physician must include the clinical indication/medical necessity in the order for the drug test. By being aware of the increased scrutiny and being proactive with your documentation, we hope your incidents of denials will be ZERO.