SUMMARY: USET SPF provides comment to the Centers for Medicare and Medicaid Services (CMS) on the agency’s request for input and recommendations regarding the elimination of specific stringent Scope of Practice Medicare regulations, including supervision and licensure requirements. According to CMS, the agency is seeking feedback on part of President Trump’s Executive Order (EO) #13890, “Protecting and Improving Medicare for Our Nation’s Seniors.” The EO directs HHS to propose regulations that would eliminate a number of burdensome regulatory requirements of the Medicare program. As CMS considers the elimination of burdensome regulatory requirements, it must, in consultation with Tribal Nations, work to identify those that act as barriers to the exercise of Tribal sovereignty and the execution of the federal trust responsibility and obligations. This includes the requirement for physician supervision of mid-level practitioners.
Despite the critical role that 3rd party billing has in the Indian Healthcare System, Tribal health programs must meet stringent requirements under 42 CFR part 405, subpart X, and 42 CFR part 491 in order to bill Medicare under current regulations as a Federally Qualified Health Center (FQHC). These regulations mandate that services rendered by Tribal health programs as an FQHC must be provided under the supervision of a physician.
In order to meet these statutory requirements, some of our member Tribal Nations have turned to contracting the services of locum tenens, or temporary physicians. While locum tenens serve a valuable purpose in covering gaps in patient care during short-term and usual circumstances, Tribal Nations have been faced with contracting locum tenens as a long-term and expensive solution due to lack of available options. This requirement has placed an unfunded mandate on Tribal Nations by requiring Tribal health programs to use limited resources to essentially pay to bill Medicare; a violation of the trust obligation.
While USET SPF appreciates CMS’s efforts to reduce regulatory burdens within Medicare, the agency must ensure these efforts include Tribal Nations and the Indian Health System as full partners. This includes removing barriers to accessing the resources and health care to which we are entitled. As always, USET SPF stands ready to assist CMS in endeavors that would improve the agency’s delivery of its trust responsibility and obligations.
SUMMARY: USET SPF recognizes that sharing data among the scientific community is imperative for scientific discovery and advancement. However, as NIH advances its policy regarding data management and sharing, the agency must recognize the historical relationship between scientific study and Tribal Nations, where researchers committed ethical violations against our communities and our people. We underscore that NIH must seek to prevent these violations from ever occurring again by ensuring all NIH policies are reflective of the federal government’s obligation to honor, protect and uphold Tribal sovereignty by requiring explicit consent from Tribal Nations.
Native people and Tribal communities continue to face negative impacts from previously unauthorized and unpermitted use of genomic data without Tribal Nation informed consent (Arizona Board of Regents v. Havasupai Tribe). Despite Tribal efforts to require informed consent regarding the use of Tribal data, NIH has continued to advance certain initiatives, including a Tribal Consultation Policy, without engaging in meaningful consultation with Tribal Nations. In August 2018, USET SPF provided comments to NIH regarding the agency’s inadequate Tribal consultation on three initiatives, including proposed provisions for the Draft NIH Data Management and Sharing Policy. In our comments, we note NIH’s ineffective and insufficient consultation practices with Tribal Nations which are in violation of the U.S. Department of Health and Human Services (HHS) Tribal Consultation Policy. While we recognize some improvement with the addition of clear deadlines and a request for broader guidance on research with our population, we remain focused on the results of these efforts. As stated in past communications, we expect NIH to engage in consultation with Tribal Nations in a transparent and meaningful manner to resolve outstanding concerns from Indian Country to ensure sovereignty is upheld and past abuses never happen again. This includes taking active steps to implement the recommendations and guidance of Tribal Nations.
Within the Draft NIH Policy for Data Management, the ‘Effective Date’ seems to include only research to be conducted in the future. Because of the historical research abuses outlined above, USET SPF believes that ALL projects, current and future, be required to submit a Data Management Plan. There is an opportunity to ensure that data currently being collected and utilized is protected. Under the ‘Compliance and Enforcement’ section, USET SPF insists that an oversight mechanism, specific to Tribal Nation data, designed consultation with Tribal Nations, be included. This mechanism would detail Tribal Nation data protection best practices, procedures, ensure researcher compliance, and recommend consequences for violations.
In addition, No Tribal Nation data should be included in any level of access without explicit Tribal Nation consent. The consent mechanism varies from Tribal Nation to Tribal Nation and may take the form of Tribal Nation Council resolutions, signed memorandums of understanding with a designated Tribal Nation leader, etc. In addition to documented Tribal Nation consent, the plan must address additional considerations between the researcher and the Tribal Nation. USET SPF believes that such a required element for all NIH-funded research proposals will integrate Tribal Nation protection and sovereignty concerns into common research practice.