Cms 116 Application Forms

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Commonly Asked Questions about Cms 116 Application Forms

How do I change ownership of CMS CLIA?

Can I transfer my CLIA certificate to the new owners? Yes. The new owners can request a transfer by completing a CMS-116 Application Form and a CLIA Ownership Information form found under CERTIFICATION FEES on webpage.

Who is responsible for CLIA?

Three federal agencies are responsible for administering the CLIA program: the Centers for Medicare Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC).

Where does CLIA go on CMS 1500?

On each claim, the CLIA number of the laboratory that is actually performing the testing must be reported in item 23 on the CMS-1500 form. Referral laboratory claims are permitted only for independently billing clinical laboratories, specialty code 69.

What tests are considered CLIA waived?

What is waived testing? By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some urine tests, etc.

Is CLIA and CMS the same?

The Centers for Medicare Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).

What is the CMS 116 form and its purpose?

The CLIA application (Form CMS-116) collects information about your laboratorys operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. This information will also provide an overview of your facilitys laboratory operation.

How do I change my CLIA information?

Basic changes such as address, phone, fax, contact person, email, laboratory name (without ownership change), certificate corrections, and laboratory closure, require these forms: LAB 193 (PDF) - Notification of Laboratory Change. CMS 116 (PDF) - to update CLIA certificate.

What are CMS forms?

CMS Forms. The Centers for Medicare Medicaid Services (CMS) is a Federal agency within the U.S. Department of Health and Human Services. Many CMS program related forms are available in Portable Document Format (pdf).