The Tribal Biotechnology & Health Consortium today filed a 910-page substantive comment with the Centers for Medicare & Medicaid Services on the proposed CY 2026 Medicare Physician Fee Schedule. The filing, docketed at Regulations.gov as Comment ID CMS-2025-0304-0009, is among the largest tribal sovereign submissions of its kind on a federal rulemaking record.

The comment addresses the proposed treatment of skin substitute and cellular tissue products under Part B reimbursement methodology, with specific attention to the sovereign obligations the federal government carries when its rulemaking affects tribally owned regulated products. The submission invokes Executive Order 13175, the Indian Health Care Improvement Act, and the federal trust responsibility, and it provides clinical, economic, and policy analysis grounded in tribal sovereign authority.

The Consortium filed through the public Regulations.gov channel to ensure the tribal sovereign perspective enters the permanent administrative record for the rulemaking.

“You don’t get to claim the federal trust responsibility was honored if the tribal sovereign perspective isn’t in the record. We put nine hundred and ten pages on the record because the tribal interests at stake — clinical, economic, sovereign — deserve nine hundred and ten pages of treatment. We did the work. The federal government now has it.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings

What this means for tribal health and tribal nations

Nine hundred and ten pages is what it takes to represent a population that faces diabetes at twice the national rate in a rulemaking where the default framing has historically left them out. The filing is a statement of capacity: tribal nations can engage federal rulemaking at the same level of rigor as any major regulated sector of the American economy. Other tribal nations building their own engagement strategies can read it, cite it, and build on it.

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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