The Centers for Medicare & Medicaid Services today published its CY 2026 Medicare Physician Fee Schedule Policy Update in the Federal Register, formally identifying Rampart™ DL Matrix (HCPCS Q4347) as a tribally owned product in the federal record of covered skin substitute and cellular tissue products.

This is the first formal federal identification of a tribally owned skin substitute in the Medicare program in the history of the United States. The designation places the tribal ownership of Q4347 into the permanent federal record — accessible to every Medicare Administrative Contractor, every commercial payer, every clinical institution, and every future federal rulemaking process.

The federal designation follows six days after the Tribal Consortium’s December 9 Sovereign Notice and Board Resolution. The Consortium recognizes and appreciates the work of the CMS staff who ensured the federal record now reflects what has always been true: the only FDA-cleared advanced wound care matrix in this category, with an assigned Medicare Q-code and a sovereign tribal owner, is identified as such in the official record.

“For the first time, the federal government has identified a tribally owned advanced wound care matrix in its official record. Pine Ridge, Blue Lake, and the eight nations now onboarding share in this milestone. So do the thousands of tribal entrepreneurs, clinicians, scientists, lawyers, and elders whose work over generations made any of this possible. We honor them today.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings

What this means for tribal health and tribal nations

The designation is structural, not ceremonial. A wound-care provider, a commercial payer, or a future federal rulemaker looking at Q4347 in the federal record now sees a tribal owner named. Every conversation about advanced wound care in Indian Country starts from a different place. And the next tribal nation to enter regulated healthcare manufacturing has a precedent in the Federal Register to point to. That precedent is permanent.

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

⊕ Investor Onboarding

Visit us on social media: Facebook Twitter LinkedIn Instagram