Pine Ridge, South Dakota, October 28, 2026 — Of more than 330 skin substitutes on a federal list, only one was identified as Tribal. Seventeen days later, a federal rule reshaped its market without a single Government-to-Government consultation. Today the Tribes behind Rampart™ DL Matrix answered with a clear principle: federal policy that reaches into Indian Country must strengthen Tribal sovereignty, not erode it. The Tribal Biotechnology & Health Consortium reaffirmed that Tribal economic interests must remain central to federal decision-making. Its member Nations will defend their sovereign right to direct their own economic and healthcare futures.

The Consortium was founded by ECHAGA Corporation of the Oglala Sioux Tribe and the Blue Lake Rancheria Economic Development Corporation. For a community as distressed as Pine Ridge, Tribal enterprise in the national marketplace is not a side venture. It is the most direct path for a people to lift themselves.

Recognition Carries an Obligation

The Tribes asked to be heard before the rules changed. Beginning in June 2024, they requested Government-to-Government consultation on Medicare skin substitute policy, and over the next 18 months they renewed that request formally at least six times.

• June 2024: The Tribes first request consultation on Medicare skin substitute policy.
• 2025: Formal consultation requests continue. None results in Government-to-Government consultation.
• December 15, 2025: CMS identifies the owner of Rampart™ DL Matrix (HCPCS Q4347) as “Tribal,” the only product among more than 330 listed skin substitutes identified by sovereign status.
• January 1, 2026: Seventeen days later, a CMS rule takes effect that directly affects this Tribally owned enterprise, adopted without consultation.

Executive Order 13175, in force across administrations of both parties since 2000, and CMS’s own Tribal Consultation Policy require consultation before an agency acts on policy with Tribal implications. When CMS recognized Tribal ownership, it also took on the obligation to consult. That obligation was not met.

The consequences are not abstract. Resources this enterprise was built to return to Tribal healthcare, youth recovery and economic development were put at risk by a rule the Tribes were never consulted on. This is not a commercial dispute. It is a question of whether federal agencies will honor their obligations to Tribal Nations.

The Consortium has formally requested Government-to-Government consultation. It is pursuing every available administrative avenue to restore the Tribes’ rights, and it reserves all rights and remedies.

What Comes Next

Clear Health Pass Holdings, LLC (CHP), the Consortium’s Authorized Tribal Agent, is moving on three fronts:

• CHP is preparing to implement a strategy to challenge the sufficiency of CMS’s consultation with Tribal Nations in developing the CY 2026 Physician Fee Schedule, which changed reimbursement rates for skin substitutes.
• CHP is also preparing to execute a strategy to engage with Administration policy officials following the release of the CY 2027 Physician Fee Schedule, which it anticipates will occur in the coming weeks.
• CHP will engage with the Administration on other initiatives affecting Tribal economic development, including peptides and sales to federal agencies under the Buy Indian Act.

The Trust Gap Is Measured in Lives

Congress has declared it national policy to ensure “the highest possible health status for Indians.” The funding has never matched that promise. In FY 2026, the Indian Health Service was funded at $8.05 billion against a $73 billion need identified by the IHS National Tribal Budget Formulation Workgroup, about 11 cents on the dollar.

The Indian Health Service’s own figures show the gap at the patient level. In fiscal 2023, IHS spent $4,078 per patient, while national health spending was $13,493 per person.

On the Pine Ridge Reservation, the shortfall is measured in years of life. Oglala Lakota County, which lies entirely within the reservation, had the lowest life expectancy of any U.S. county in peer-reviewed research spanning 1980 to 2014, and recent County Health Rankings data put it near 60 years. Testimony before the U.S. House Committee on Natural Resources in July 2024 put the statewide gap at 20 years: the average age of death in South Dakota is 78, and for Native American enrolled members it is 58.

The toll falls hardest on the young. American Indian and Alaska Native teenagers die by suicide at nearly three times the rate of all Americans their age, and Native people have had the highest drug overdose death rate of any group in the nation.

The official unemployment rate, which counts only people actively looking for work, captures little of the reality. Fewer than four in ten adults in Oglala Lakota County are in the labor force at all, compared with nearly two in three nationally. More than half of residents live below the federal poverty line.

Fire protection, clinics and emergency services remain far below what any American community would accept. Pine Ridge is not an outlier. Across much of Indian Country the same gaps persist, and the federal trust responsibility goes unmet.

These numbers describe a community with everything to gain. Given the right tools, a distressed community can lift itself, and Tribal enterprise is that tool.

Off-Reservation Enterprise Is a Lifeline

Tribal economic development no longer stops at the reservation line. The Consortium’s enterprise competes in the national healthcare market, and a significant portion of the revenue it earns there returns home. That revenue funds the social services federal appropriations leave behind, including youth behavioral health and recovery, which makes enterprise beyond the reservation a lifeline for Tribal communities.

On the Pine Ridge Reservation, one of those priorities is ECHAGA’s planned 48-bed adolescent behavioral health and residential treatment facility, which would give the Tribe’s young people recovery and mental health care at home. Enterprise revenue that returns to the Tribe is meant to help make projects like it possible.

That work depends on stable governance, clear jurisdiction and respect for Tribal authority. Recent federal actions and court decisions affecting regulatory authority over Tribal lands show why those foundations must be protected. Physicians, partners, investors and federal agencies alike should treat Tribal sovereignty as an asset to strengthen, not a complication to manage.

Physicians at the Center

The physicians who treat patients with Rampart™ DL Matrix are the heart of this enterprise. More physicians are using Rampart today than before the January 1 rule took effect. They choose it for their patients and hold themselves to the Consortium’s standards: every order requires documented medical necessity, and patients’ needs come first.

The stakes are high. American Indians and Alaska Natives have the highest rate of diabetes of any group in the United States, Native American patients carry some of the highest risk of amputation, and most diabetes-related amputations begin with a wound that does not heal. The Consortium’s continuing real-world case study is building the clinical evidence for Rampart, and the shared goal is simple: fewer amputations, and more limbs and lives saved.

A handful of bad actors in the skin substitute market drew federal scrutiny onto the entire category. The Consortium was built the other way. Doing it right costs more in documentation, follow-up and compliance, and the Consortium accepts that cost.

Physicians who choose Rampart are also choosing to support Tribal economic development. That choice places this enterprise in a different category from the commercial market, because it carries the federal government’s trust obligations with it. Together, the Tribes and these physicians are filling gaps the federal government has left open, and the Consortium will keep its physician network informed as the Tribes pursue their rights through every proper channel.

A History of Endurance

The Oglala Lakota secured their homelands by treaty with the United States at Fort Laramie in 1868. The broken promises that followed, including the taking of the Black Hills and the massacre at Wounded Knee in 1890, did not break the Nation.

Blue Lake Rancheria was established in 1908 as a home for Native people displaced by the Gold Rush. It was terminated under the California Rancheria Termination Act in 1958 and, after 25 years of advocacy, regained federal recognition in 1983 through Tillie Hardwick v. United States. The Tribe has since rebuilt its governance and economy and led nationally recognized climate resilience efforts.

Federal law has since moved decisively toward self-determination:

• The Indian Reorganization Act of 1934, whose Sections 16 and 17 provide the governmental and corporate structures ECHAGA and BLREDCO operate under.
• The Indian Self-Determination and Education Assistance Act of 1975.
• The Indian Health Care Improvement Act of 1976.
• Becerra v. San Carlos Apache Tribe (2024), in which the U.S. Supreme Court held that when Tribes run their own healthcare programs, federal support obligations extend to services funded by Medicare and Medicaid revenue.

Federal law clearly favors Tribal self-determination. Agency practice must follow it.

What Sets the Consortium Apart

• Tribally owned. The Tribal rights and leadership belong to sovereign Tribal entities.
• Sovereign authority, clearly delegated. Clear Health Pass Holdings, LLC serves as Authorized Tribal Agent for the Consortium under written delegations from ECHAGA Corporation and the Blue Lake Rancheria Economic Development Corporation. In that capacity, CHP conducts federal engagement, regulatory submissions and requests for Government-to-Government consultation on the Tribes’ behalf and serves as exclusive worldwide license holder and IP administrator for Rampart™ DL Matrix. No waiver of Tribal sovereign immunity is intended or granted.
• Built for accountability. There are no bulk sales. No order is processed without documented medical necessity, and patient follow-up is required.
• Independent. The Consortium acts only in its sovereign capacity. It is not a member of any industry coalition or a party to any manufacturer litigation.
• Aligned on program integrity. The Consortium shares the Administration’s commitment to eliminating fraud, waste and abuse in Medicare. A narrowly defined, Tribally owned enterprise built on documentation and accountability is part of that solution.

Standing, Organized and Here to Stay

Indian Country is deeply patriotic. American Indians and Alaska Natives serve in the U.S. Armed Forces at a higher rate than any other group, and Tribal citizens also serve in Tribal government and public service. A people who have answered every call to defend this country are owed the same faithfulness in return. That is the heart of the federal trust responsibility, and it is going unmet.

The Consortium will be a steady, organized and permanent presence in federal health policy, a standing voice for the Nations it serves. Eight additional federally recognized Tribes are now in active onboarding.

“Our people have kept every promise our ancestors made. We ask only that the federal government keep its own. Consultation is not a courtesy. It is a federal obligation, and it is our right.”

— Diane Sharp, Ed.D., President and Board Chairperson, ECHAGA Corporation

“The Tribes did what federal policy has asked of them for fifty years: they built their own economy to meet their own needs. When CMS recognized that enterprise as Tribal, it recognized the obligation to consult. We intend to see that obligation honored through every proper channel, for as long as it takes.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings, LLC, Authorized Tribal Agent for the Tribal Biotechnology & Health Consortium

About the Tribal Biotechnology & Health Consortium

The Tribal Biotechnology & Health Consortium is an alliance of federally recognized Tribal Nations advancing Tribally owned healthcare manufacturing and economic development. Its foundational members are ECHAGA Corporation, a Section 16 governmental corporation of the Oglala Sioux Tribe, and Blue Lake Rancheria Economic Development Corporation, a Section 17 federally chartered corporation. Clear Health Pass Holdings, LLC serves as Authorized Tribal Agent under written delegations from ECHAGA and BLREDCO, and as the Consortium’s exclusive worldwide licensee and IP administrator.

Sovereign Authority Notice: This statement is issued in the exercise of Tribal sovereign authority. Nothing herein waives the sovereign immunity of any Tribe or Tribal entity.

Forward-looking statements: This release contains forward-looking statements about regulatory matters whose outcomes are uncertain. It is not an offer to sell or a solicitation of an offer to buy any security.

Media contact, Tribal Biotechnology & Health Consortium and Clear Health Pass Holdings, LLC: Tomasz Borowik · TribalBiotech@ClearHealthPass.com · +1 (424) 444-7184 ext. 4