On June 6, 2024, the Tribal Biotechnology & Health Consortium — through its founding partner, Blue Lake Rancheria Economic Development Corporation — submitted formal comments to the Centers for Medicare & Medicaid Services on the Local Coverage Determination framework governing skin substitute and cellular tissue product coverage.

The submission, delivered through the official CMS comment channel and copied to the HHS Office of Tribal Affairs, provides clinical evidence, sovereign legal framing, and policy recommendations on a coverage structure that affects hundreds of thousands of Medicare beneficiaries living with chronic wounds — a population in which Native Americans are dramatically overrepresented.

This filing opens what the Consortium intends as a sustained tribal sovereign engagement with CMS on skin substitute coverage — one grounded in the Indian Health Care Improvement Act, Executive Order 13175, and the federal trust responsibility.

“We’re not waiting to be asked. Tribal nations have clinical expertise, sovereign authority, and a federal trust relationship with the United States that obligates a meaningful seat at the table when coverage policy is being written. We’re taking that seat. That’s what tribal partnership in federal healthcare policy is supposed to mean.”

— John Michael Cataldi, on behalf of Blue Lake Rancheria

What this means for tribal health and tribal nations

When a diabetic foot ulcer goes untreated because a provider can’t get a claim paid for the product that would heal it, the patient doesn’t lose a reimbursement — they lose a foot. Native Americans face diabetes at rates two to three times the national average, and the downstream wound-care burden falls hardest on tribal communities with the least access to advanced therapies. The Consortium intends to be present, in writing and on the record, every time CMS touches that coverage framework.

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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