The Centers for Medicare & Medicaid Services Coverage and Analysis Group today confirmed receipt of the Tribal Biotechnology & Health Consortium’s post-market clinical validation submission for Rampart™ DL Matrix (Q4347) and confirmed it had forwarded the evidence to the Medicare Administrative Contractors for review.

The confirmation, issued through the proper CMS channel by the senior coverage policy team, marks the entry of the Consortium’s clinical evidence into the federal evaluation pipeline. The submission — led by Principal Investigator David Burke, MD, MA and delivered November 1 — is now in the hands of the Medicare Administrative Contractors that author Local Coverage Determinations for skin substitute and cellular tissue products across the United States.

“Receipt confirmed in writing, forwarding confirmed in writing, all through the proper channel. That’s how formal sovereign engagement is supposed to work. We’re grateful to the Coverage and Analysis Group for handling this submission the way it deserved to be handled, and we look forward to engaging on the substance of the evidence in the months ahead.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings

What this means for tribal health and tribal nations

A written agency acknowledgment of a tribal sovereign evidence submission is the procedural foundation for every subsequent engagement on that evidence. It establishes that the Consortium’s clinical work is in the federal record and that the agency has actual notice of it. For tribal enterprises considering entry into federally regulated markets, the November 17 acknowledgment is a precedent: CMS receives tribal sovereign evidence on the same terms it receives any other evidence in the federal record.

About Clear Health Pass™  

Clear Health Pass™ is a bioinformatics, bio-surveillance. Clear Health Pass™ is a minority/veteran-operated organization in partnership as tribal is a portfolio partner of The Native American Venture Fund (NAVF). Clear Health Pass Holdings, LLC, DBA Clear Health Pass™ is an appointed “Tribal Agent” for The Tribal Consortium, a federal, Section 17 Tribal Corporation, whose tribal sovereignty’s authority is derived from The Indian Reorganization Act Of 1934 (IRA), 25 U.S.C. § 477. If you would like to know more information and investment opportunities with Clear Health Pass™ you can request information via this link

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