The Tribal Biotechnology & Health Consortium today filed its formal comment on the proposed CY 2026 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System rule (CMS-1834-P), addressing the proposed treatment of skin substitute and cellular tissue products in the outpatient setting.

The comment is submitted on behalf of ECHAGA Corporation, the Section 17 economic development entity of the Pine Ridge Oglala Sioux Tribe, and Blue Lake Rancheria Economic Development Corporation, the Section 16/17 federal corporation of the Blue Lake Rancheria, as the two foundational tribal partners of the Consortium. Eight additional federally recognized tribal nations are in active onboarding.

The filing addresses three substantive areas: the sovereign legal framework governing federal rulemaking when tribally owned regulated products are affected; the clinical and economic implications of the proposed payment methodology for advanced wound care access in Indian Country; and the procedural obligations that arise under Executive Order 13175 and the federal trust responsibility.

“The OPPS docket is where the rules are written for the hospital outpatient setting — which is where most advanced wound care is delivered to Medicare beneficiaries. If the tribal sovereign perspective is absent from the OPPS record, it doesn’t matter what we put on the PFS record. We’re filing both. The federal government is going to receive a complete tribal sovereign submission on every docket that affects this product, every year, on time, in writing.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings

What this means for tribal health and tribal nations

Most advanced wound care is delivered in the hospital outpatient department. That’s where tribal members are treated when they travel off the reservation for specialized care, where chronic wound clinics operate, and where the federal payment rules either enable or constrain access. By filing on the OPPS docket with the same rigor as the PFS docket, the Consortium ensures the tribal sovereign voice reaches every setting where federal payment policy is written.

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