I believe you are correct Sir " Yes, first CLI

I believe you are correct Sir

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" Yes, first CLIA commercialization then FDA commercialization. "

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In the later case, in order to invoice (generate revenue) against the insurance companies, including Medicare & Medicaid, you 1st need to have an authorized/validated CPT code under federal regulatory guidelines.

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"The CPT code set (copyright protected by the AMA) describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes."

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"Despite the copyrighted nature of the CPT code sets, the use of the code is mandated by almost all health insurance payment and information systems, including the Centers for Medicare and Medicaid Services (CMS) and HIPAA, and the data for the code sets appears in the Federal Register. As a result, it is necessary for most users of the CPT code (principally providers of services) to pay license fees for access to the code".

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