Is 81025 a CLIA waived test?

Yes, CPT code 81025 for a urine pregnancy test is a CLIA-waived test.

Key Details

• Test Type: Qualitative urine pregnancy test read by visual color comparison (dipstick or strip).
• Modifier Rule: It is one of a select group of codes exempt from requiring the -QW modifier for Medicare and many other payers to recognize it as waived.
• Facility Requirement: The performing facility must still hold a valid CMS CLIA Certificate of Waiver.
• Manufacturer Guidelines: Staff must follow the test kit's instructions exactly to maintain its waived status.

You can determine if a specific test is CLIA-waived by searching the FDA CLIA Database or checking the product's labeling and manufacturer's instructions.

How to Check Status

• Search the FDA Database: Look up the test system, manufacturer, or brand name in the official database of CLIA Database Categories to see its assigned complexity level.
• Review Product Packaging: Check the product insert, box, or specifications provided by the manufacturer. Waived tests often state their CLIA status directly on the labeling or indicate that they are cleared for over-the-counter or point-of-care professional use under a Certificate of Waiver.
• Ask the Distributor or Manufacturer: Contact the supplier or check the company's official product page to request documentation of its CLIA waiver status before purchasing.

Key Characteristics of Waived Tests

• Low Complexity: The methodology is simple and automated, meaning there is little risk of an incorrect result if instructions are followed.
• Home/OTC Clearance: Tests cleared by the FDA for home use or over-the-counter purchase are automatically categorized as waived.
• Specific to the Test System: Waiver status applies to the specific test kit or system, not to a general category of tests or a blanket approval for a facility.

Clinical Laboratory Improvement Amendments (CLIA)-waived tests include hundreds of specific commercial test systems spanning dozens of CPT codes, most of which require the QW modifier on insurance claims.

Because the FDA continually approves new waived tests and updates the official catalog quarterly, there is no single static list of CPT codes; instead, you must verify specific products against the CMS Official CLIA Waived Tests List.

CPT Codes Exempt from the QW Modifier

A small, specific group of classic waived tests does not require the -QW modifier to be recognized by Medicare and Medicaid on claims:

• 81002: Urinalysis, non-automated, without microscopy
• 81025: Urine pregnancy test
• 82270: Fecal occult blood, 1-3 simultaneous determinations
• 82272: Fecal occult blood, other source
• 82962: Glucose, blood by glucose monitoring device cleared by the FDA for home use
• 83026: Hemoglobin, copper sulfate, non-automated
• 84830: Ovulation tests by visual color comparison
• 85013: Blood count; spun microhematocrit
• 85651: Sedimentation rate, erythrocyte; non-automated

Common CPT Codes That Require the QW Modifier

Most other diagnostic or infectious disease tests performed under a Certificate of Waiver must be appended with the QW modifier (e.g., 87804QW). Examples include:

• 80047QW / 80048QW / 80053QW: Basic and comprehensive metabolic panels (for approved portable analyzers)
• 83036QW: Hemoglobin A1c (glycated hemoglobin)
• 87494QW: Infectious agent detection by nucleic acid (e.g., Chlamydia/Gonorrhea multiplex)
• 87804QW: Influenza antigen detection
• 87811QW: SARS-CoV-2 (COVID-19) antigen detection by direct optical observation
• 87812QW: SARS-CoV-2 and influenza A/B multiplex
• 87880QW: Strep A antigen detection (e.g., OSOM Ultra Strep A)

CPT code 81025 reports a qualitative urine pregnancy test performed via visual color comparison (such as a dipstick or test cassette).

Core Billing Guidelines

• Code Definition: Represents a point-of-care, non-automated test detecting human chorionic gonadotropin (hCG) with immediate visual results.
• CLIA Requirements: The testing site must hold a valid CLIA Certificate of Waiver. Code 81025 is on the CMS list of waived tests that do not require the -QW modifier for most payers.
• Split-Billing Prohibited: Code 81025 cannot be split-billed and must not be reported with professional or technical component modifiers like -26 or -TC.
• Global OB Period: Routine pregnancy testing is generally bundled into the global obstetric package once pregnancy is confirmed. However, it may be separately billable for initial confirmation, pre-procedure evaluations, or checking status before prescribing potentially harmful medications. Check specific payer rules.
• Documentation Requirements: Medical records must state the specific clinical indication (e.g., missed period, pelvic pain, pre-procedure screening), the visual method used, and the explicit positive or negative result interpretation.
• Reimbursement Structure: Many insurance payers and Medicare reimburse 81025 under the Clinical Laboratory Fee Schedule rather than the Physician Fee Schedule.

You can find the official, searchable list of CLIA-waived tests using the FDA CLIA Database.

Where to Search

• FDA Public Databases: Search by test system name, analyte, or complexity to see if a specific product holds waived status.
• CDC Waived Tests Guidance: Offers regulatory details and links to the official FDA test lists.

Common Examples

• Blood glucose meters
• Urine dipstick urinalysis
• Over-the-counter pregnancy tests
• Rapid strep and influenza tests