The Centers for Medicare & Medicaid Services convened a formal Tribal Consultative Meeting with Clear Health Pass Holdings, Authorized Tribal Agent for the Tribal Biotechnology & Health Consortium, to review the federal coverage and reimbursement framework for Rampart™ DL Matrix (Q4347), the only FDA-cleared tribally owned skin substitute in the Medicare system.

CAPT Susan Karol, MD of the CMS Division of Tribal Affairs hosted the meeting, bringing together senior representatives from across the agency’s coverage, drug pricing, and tribal affairs leadership: Lane Terwilliger, Maria Durham of the CMS Drug Pricing team, Prabath Malluwa-Wadu of the Coverage and Analysis Group, Alice Weiss, Cory Duke, Gift Tee, Laura Kennedy, Rachel Ryan, and Rhonda Martinez. Clear Health Pass represented Blue Lake Rancheria and the broader Consortium then in active onboarding.

The Consortium’s pre-meeting brief, transmitted to CAPT Karol that morning, was titled Appreciation in Restoring Procedural Parity and Tribal Inclusion — a statement of the spirit in which the Consortium approached the engagement.

“CAPT Karol and her colleagues conducted that meeting the way it’s supposed to be conducted. They listened. They took the technical issues seriously, and they took the sovereign framing seriously. We left with a clearer path forward and a stronger working relationship. When federal agencies approach tribal engagement that way, both sides come out ahead — and so does the policy.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings

What this means for tribal health and tribal nations

The eight tribal nations now onboarding into the Consortium were watching how CMS would handle a senior-level meeting on a tribally owned product. A meeting conducted with genuine attention — not a courtesy session — tells those nations something concrete: sustained federal engagement is possible, and it produces results. That’s the practical signal the May 22 meeting sent.

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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