The Tribal Biotechnology & Health Consortium today submitted the completed post-market clinical validation of Rampart™ DL Matrix (Q4347) to the Centers for Medicare & Medicaid Services and all seven Medicare Administrative Contractors as a formal sovereign evidence submission under Local Coverage Determination L35041.

The submission — led by Principal Investigator David Burke, MD, MA, Department Chairman Emeritus of the Emory University School of Medicine — delivers the real-world evidence required under the federal coverage framework for skin substitute and cellular tissue products in the treatment of diabetic foot ulcers and venous leg ulcers. The work was conducted to the same scientific standard applied to any submission to the federal evidence record.

The Consortium delivered the submission sixty days before the close of the calendar year and the start of the next coverage cycle — a deliberate choice to ensure the evidence is in the federal record well in advance of forthcoming policy determinations.

“A tribally owned, FDA-cleared advanced wound care matrix, validated through a rigorous post-market study led by one of the most respected physician-scientists in the country, delivered to the federal government as a formal sovereign submission — that’s never happened before in American healthcare. Dr. Burke and his team did extraordinary work. The tribal authority supporting this submission is real, it’s operational, and it’s now in the permanent federal evidence record.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings

What this means for tribal health and tribal nations

A wound-care researcher drawing on the federal evidence base in five years will find a tribally directed clinical study on that record. Tribal nations aren’t just subjects in the healthcare research literature — they’re producing the science that shapes federal coverage policy. The evidence the Consortium submitted on November 1 will inform advanced wound care policy for years to come, for Native and non-Native patients alike.

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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