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CIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain CIA certification.
A. Yes, the testing you perform qualifies as waived laboratory testing, and you need a CIA Certificate of Waiver. This testing requires a CIA certificate regardless of how many tests you perform and even if you do not charge the patient or bill Medicare or other insurances.
Generally yes, as those tests likely qualify as waived laboratory testing, you need a CIA Certificate of Waiver and you must follow the manufacturer's instructions.
According to the CIA regulations, any laboratory that conducts even a single test on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or the impairment of, or assessment of, the health of human beings” is required to obtain a ...
Obtaining CIA Waiver. Apply for a CIA Certificate using Form CMS-116, available through the Centers for Medicare and Medicaid Services. ... Review your qualifications for a waiver. ... Apply for a certificate of waiver. ... Develop a quality assurance plan.
As defined by CIA, waived tests are simple tests with a low risk for an incorrect result. They include: Certain tests listed in the CIA regulations. ... Tests that the manufacturer applies to the FDA for waived status by providing scientific data that verifies that the CIA waiver criteria have been met.
Obtaining CIA Waiver. Apply for a CIA Certificate using Form CMS-116, available through the Centers for Medicare and Medicaid Services. ... Review your qualifications for a waiver. ... Apply for a certificate of waiver. ... Develop a quality assurance plan.
Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CIA criteria. Although CIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof.
The fee for a Certificate of waiver is $150. For additional information or assistance in filling out the CIA waiver application, please call CMS Toll-Free: 877-267-2323; Local: 410-786-3000; TTY Toll-Free: 866-226-1819; TTY Local: 410-786-0727. Or visit the CIA Website.
Depending on your state health department, it can take between 4-12 weeks to receive your CIA certificate. The CIA certificate of waiver is necessary for state and federal compliance, and provides the benefit of facilitating provider reimburse- meet for the use of CLIA-waived tests.
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