A Waived Office Test Still Needs the Right Laboratory Setup

Simple testing still has requirements

A midwifery practice may view a urine or pregnancy test as a small part of an appointment. The test may be simple, but the office still needs to determine whether its testing falls under Clinical Laboratory Improvement Amendments requirements.

CMS's March 2026 CLIA guidance explains that laboratory requirements reach office testing and are not limited to laboratories submitting Medicare claims. A certificate of waiver permits testing categorized as waived; waived does not mean exempt from the program. [1]

Review the exact test system

Before adding a test, identify the manufacturer and exact system, verify its classification, and confirm that the practice holds the appropriate certificate. Do not assume all versions of a test have the same classification because they measure the same thing.

CMS states that laboratories performing only waived testing must enroll, pay applicable certificate fees, and follow the manufacturer's instructions. State requirements also need review. [1]

Assign responsibility for the operational details: staff training, supplies, expiration checks, result documentation, and follow-up. These are practice procedures worth checking before the first patient is tested, not after a claim rejects. A clinician's midwifery credential does not itself establish the business's laboratory certification.

Separate permission to test from payment

Once the testing setup is correct, review the billing requirements independently. Confirm the appropriate code, whether a modifier or laboratory identifier is required for that test and payer, and whether the service is separately payable. The existence of a CLIA certificate does not guarantee reimbursement.

Describe midwifery credentials accurately throughout the process. Certified nurse-midwives, certified midwives, and other state-recognized midwifery credentials are not interchangeable descriptions of licensure or payer eligibility. Check the rules that apply to the individual and the location.

Patients should receive results with a clear explanation of who reviews them and what happens next. A small office test still needs a complete clinical and administrative process.

Sources

[1] CMS CLIA Program and Medicare Laboratory Services March 2026

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