The Centers for Medicare & Medicaid Services has issued Rampart™ DL Matrix (HCPCS Q4347), the only FDA-cleared tribally owned skin substitute in the Medicare system, on the Q4 2025 Average Sales Price file for Medicare Part B. The Q4 2025 ASP rate took effect for Medicare Part B billing on October 1, 2025.

The issuance is the operational outcome of 482 days of sustained work — sixteen months of sovereign engagement that began with the Tribal Consortium’s formal consultation request to HHS Tribal Affairs and the LCD Comment Package submitted to CMS and the Medicare Administrative Contractors on June 6, 2024.

Between those two points sits the full record of the Consortium’s federal partnership: the June 2024 working session with CMS and Novitas Solutions; the May 2025 Tribal Consultative Meeting hosted by CAPT Susan Karol of the CMS Division of Tribal Affairs; the June 2025 ASP and HCPCS code corrections completed with Maria Durham, Prabath Malluwa-Wadu, and the CMS Coverage and Analysis Group; the MUE expansion request; the 910-page comment on the CY 2026 Physician Fee Schedule; and the parallel filings on the OPPS, IPPS, and ASC dockets.

With Rampart™ issued on the Q4 2025 ASP file, providers across all seven Medicare Administrative Contractor jurisdictions can now bill Medicare Part B for the only FDA-cleared, tribally owned advanced wound care matrix in the United States.

“Four hundred and eighty-two days. From the first consultation request to the Q4 ASP issuance — and every one of those days, the Consortium and our colleagues at CMS were doing the work. CAPT Karol, Maria Durham, Prabath Malluwa-Wadu, the Division of Tribal Affairs, the Coverage and Analysis Group, the Drug Pricing team — they held up their end, and we held up ours. A tribally owned, FDA-cleared advanced wound care matrix is now billable across Medicare Part B because tribal nations and the federal government built this together.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings

What this means for tribal health and tribal nations

The clinical impact is immediate: every wound-care provider treating a Medicare beneficiary with a diabetic foot ulcer, a venous leg ulcer, or a surgical wound can now bill Medicare Part B for Rampart™ at the Q4 2025 ASP rate. Revenue from those claims flows directly into the sovereign treasuries of ECHAGA Corporation and Blue Lake Rancheria Economic Development Corporation. The precedent is documented in plain terms: tribal nations can build, code, validate, and list a federally regulated product on the Medicare Part B billing schedule. The pathway is on the record. It took 482 days. It works.

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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