CPT Code 80305: Drug Testing, Presumptive, Non-Instrumented

What is non-instrumented presumptive drug testing?

CPT code 80305 describes presumptive drug testing performed using a CLIA-waived method such as a dipstick, cup, or cassette, with direct optical observation (e.g., visual read without instrumentation). This qualitative test detects the presence or absence of one or more drug classes, such as opioids, THC, benzodiazepines, amphetamines, or methadone.

The test is typically performed on urine samples and is used to identify drugs of abuse. It is commonly ordered in settings involving pain management, substance use disorder monitoring, and pre-employment drug screenings. The response is immediate and provides initial results that may later be confirmed by definitive drug testing (e.g., CPT codes 80320–80377).

Medical necessity, proper documentation, and appropriate ICD-10 diagnosis codes must support the service for reimbursement. CPT code 80305 should not be billed on the same date of service as a definitive test unless both are clearly separate and medically indicated.

Documentation requirements

• To support CPT code 80305, documentation must justify the medical necessity of the presumptive drug test and comply with billing and CLIA standards. Key elements include:
• Reason for testing, such as treatment monitoring, history of drug dependence, or detection of drugs of abuse like amphetamines, opioids, or heroin
• Test method used, such as urine dipstick, cassette, or cup, and confirmation it was read by direct optical observation
• Date and time of specimen collection and date of service
• Results, including provider interpretation or clinical response
• Confirmation of CLIA-waived status and that the test complies with CMS and American Medical Association guidelines

Billing guidelines

CPT code 80305 is reported once per patient encounter, regardless of the number of drug classes tested. It is a CLIA-waived presumptive drug test and requires the provider to hold a valid CLIA waiver certificate. The test must be read by direct optical observation, such as with a dipstick, cup, or cassette.

Do not report 80305 with CPT codes 80306 or 80307 for the same sample, as these represent different methods of presumptive drug testing and are considered mutually exclusive by most payers. Additionally, reimbursement may be subject to frequency limits, ICD-10 diagnosis code justification, and payer-specific guidelines related to medical necessity and drug abuse testing.

To avoid claim denials, ensure documentation supports the service, and verify HCPCS codes, billing rules, and coverage policies when conducting urine drug or abuse testing on the same date of service as other lab procedures.

Other  relevant CPT codes

• 80306 – Drug test, presumptive, instrument-based (e.g., immunoassay analyzer)
• 80307 – Drug test, presumptive, chemisty analyzer
• 80320–80377 – Drug test(s), definitive (identification and quantification of specific drugs or drug classes)