Wednesday 14 December 2011

What Are Category B Clinical Trials?


The costs of the clinical trials bared by the medicare services were historically bearded by the sponsors of the clinical trial. The centers of the medicare and Medicaid Services provide guidance on billing the medical trials. Medicare is liable to pay the amounts to the medical devices that are predetermined which are termed as category B trials.

Category B trials are those trials that are considered investigation whose safety and effectiveness have been resolved. Predetermination of the Clinical trial should not be confused with the pre authorization. Predetermination of the medical trials includes completing the application, CMS form and submitting it to MAC along with other specific documentation concerning the device and the expected coding scenario. This will be followed by obtaining approval from the MAC, with an Investigation Device Exception (IDE) number. Once the IDE is obtained the clinical trials will be billed according to guidelines of CMS.

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