The Centers for Medicare & Medicaid Services has issued formal Government-to-Government receipt confirmation for the Tribal Biotechnology & Health Consortium’s post-market clinical validation evidence submission on Rampart™ DL Matrix (Q4347), submitted under Local Coverage Determination L35041.

The G2G receipt confirmation, transmitted through the official sovereign engagement channel, formalizes the entry of the Consortium’s clinical evidence into the Government-to-Government record on coverage matters. Combined with the December 15 Federal Register designation of Q4347 as a tribally owned product, the federal record now reflects two foundational facts in writing: the tribal ownership of the product and the formal federal receipt of the tribal clinical evidence supporting it.

Rampart™ DL Matrix remains the only FDA-cleared, tribally owned skin substitute in the Medicare system, designated as such by the federal government, supported by post-market clinical validation conducted under the leadership of Principal Investigator David Burke, MD, MA, and recognized through formal Government-to-Government channels. The Consortium’s coverage status with respect to CMS continues, and the Consortium remains in active sovereign engagement with the agency.

“We close this chapter where it should be closed — in writing, on the record, through the proper channels. The tribal nations of the Consortium are recognized. The science is in the federal record. The working relationship with CMS is intact. There’s more ahead — the next rulemaking cycle, the eight nations onboarding, the broader vision of tribal entry into regulated healthcare manufacturing — but we close this chapter on solid ground.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings

What this means for tribal health and tribal nations

A formal G2G receipt confirmation closes one chapter and opens the next. The Consortium has now established, on the federal record, a complete arc: tribal sovereign engagement at the outset, federal recognition in the middle, and Government-to-Government acknowledgment at the close. The eight tribal nations now onboarding build from a foundation of documented federal recognition that didn’t exist eighteen months ago. It’s permanent now.

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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