Urine Drug Screen Risk Assessment Requirements

Published 10/15/2024

The Centers for Medicare & Medicaid Services (CMS) established the Comprehensive Error Rate Testing (CERT) program to monitor and report the accuracy of Medicare fee-for-service (FFS) payments, by measuring the error rate of submitted claims to Medicare Administrative Contractors (MACs).

Laboratory services are one of the top service types with high improper payment rates due to insufficient documentation. We are seeing documentation of the risk level but the risk assessment to support the risk level is not included. 

Urine drug testing (UDT) provides timely, objective, and actionable information to clinicians by identifying the presence or absence of drugs of potential abuse in the body to assist the clinician in making treatment decisions. 

Palmetto GBA policy L35724 details:

  • The appropriate indications and allowed number of UDTs billed over time for safe medication management of prescribed substances in risk stratified pain management patients and/or in identifying and treating substance use disorders (SUDs)
  • Designates documentation, by the clinician caring for the beneficiary in the beneficiary’s medical record, of medical necessity for, and testing ordered on an individual patient basis
  • Provides an overview of presumptive UDT and definitive UDT testing by various methodologies

Testing must be based on clinician’s documented medical necessity and reviewed by the clinician in the management of prescribing or renewing a controlled substance for every risk group as outlined below.

Table 1.
Risk Group Baseline Frequency of Testing
Low Risk Prior to Initiation of COT Presumptive and definitive UDT not to exceed two 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 Risk Prior to Initiation of COT Presumptive and definitive UDT not to exceed two 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 Risk Prior to Initiation of COT Presumptive and definitive UDT not to exceed three 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.

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 patient’s medical condition or behavior
  • Patient admits to use of illicit or non-prescribed controlled substance

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