Clinical Pathology Laboratories, Inc. (CPL) recently underwent a post-payment Medical Review relating to Medicare beneficiaries who had a claim including procedure code G0480 - Drug test definitive. The review resulted in several denied claims due to insufficient documentation of medical necessity. CPL wishes to share some takeaways from the review relating to documentation and medical necessity requirements for definitive urine drug tests (UDTs).

Key takeaways:  

  • The clinician’s rationale of the medical necessity for the definitive UDT, including the drugs or drug classes to be tested, must be documented in the patient’s medical record.
  • All documentation must be maintained in the patient’s medical record and made available to the Medicare contractor upon request.

What are the documentation requirements for definitive UDTs?  

  • The medical record documentation and test order must indicate the medical necessity for performing a definitive UDT.
  • All tests must be ordered in writing by the treating provider and all drugs/drug classes to be tested must be indicated in the order.
  • The record must show that an inconsistent positive finding was noted on the presumptive testing or that there was no available, commercially or otherwise, presumptive test.
  • For symptomatic patients, multiple drug ingestion, or patients with unreliable history: the presumptive findings, definitive drug tests ordered, and reasons for testing must be documented in the patient’s medical record.
  • For the diagnosis and treatment for substance abuse or dependence: the patient’s medical record must include an appropriate testing frequency based on the stage of screening, treatment, or recovery; the rationale for the drugs/drug classes ordered; and the results.
  • For the treatment for patients on chronic opioid therapy: the documentation should minimally include patient history, physical examination, and previous laboratory findings; current treatment plan; prescribed medication(s); and risk assessment plan. The frequency of testing beyond the baseline presumptive UDT must be substantiated by documentation in the patient’s medical record, including 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.

When are definitive UDTs reasonable and necessary?  

  • To identify a specific substance/metabolite inadequately detected by a presumptive UDT;
  • To definitively identify specific drugs in a large family of drugs;
  • To identify a specific substance/metabolite that is not detected by presumptive UDTs;
  • To identify drugs when a definitive concentration of a drug is needed to guide management;
  • To identify a negative or confirm a positive presumptive UDT result that is inconsistent with a patient’s self-report, presentation, medical history, or current prescribed pain medication plan;
  • To rule out an error as the cause of a presumptive UDT result;
  • To identify non-prescribed medication or illicit use for ongoing safe prescribing of controlled substances; and
  • To use in differential assessment of medication efficacy, side effects, or drug-drug interactions.

Recommendations:  

  • Ensure the documentation in the patient’s medical record supports services billed to the Medicare program.
  • Remain current with Medicare requirements and educational information referenced in the various publications available to Medicare providers at the Novitas Solutions, Inc. website at www.novitas-solutions.com.
  • Attend Provider Outreach and Education seminars to remain current on Medicare updates.
  • For additional general education or information pertaining to Medicare, contact the Provider Outreach and Education Department at [email protected].