Catastrophic Health Emergency Fund

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Indian Health Service</SUBAGY> <CFR>42 CFR Part 136</CFR> <DEPDOC>[RIN 0917-AA10]</DEPDOC> <SUBJECT>Catastrophic Health Emergency Fund</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Indian Health Service, Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Indian Health Service (IHS or Service) administers the Catastrophic Health Emergency Fund (CHEF) pursuant to section 202 of the Indian Health Care Improvement Act (IHCIA). The purpose of the CHEF is to meet the extraordinary medical costs associated with the treatment of victims of disasters or catastrophic illnesses who are within the responsibility of the Service. This document finalizes the regulations governing the administration of the CHEF, with clarifying edits, and responds to comments received on the proposed rule. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This final rule is effective on October 29, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> For technical questions concerning this rule contact: Carl Mitchell, Director, Division of Regulatory and Policy Coordination (DRPC), Office of Management Services (OMS), Indian Health Service, 301-443- 6384, <E T="03">carl.mitchell@ihs.gov;</E> or CAPT John Rael, Director, Office of Resource Access and Partnerships (ORAP), Indian Health Service, 301-443-0969, <E T="03">john.rael@ihs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> The CHEF was established by section 202 of the IHCIA, Public Law 94-437 (25 U.S.C. 1621a). The Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act of 2010, Public Law 111-152 (collectively, the Affordable Care Act or “the ACA”), reauthorized the IHCIA and amended the CHEF, directing the Secretary to promulgate regulations governing the administration of the CHEF. In the <E T="04">Federal Register</E> of July 18, 2023 (88 FR 45867), the IHS published a proposed rule entitled “Catastrophic Health Emergency Fund” with a 60-day comment period. <EXTRACT> <FP SOURCE="FP-2">I. Background</FP> <FP SOURCE="FP-2">II. Provisions of the Regulation</FP> <FP SOURCE="FP1-2">A. Definitions</FP> <FP SOURCE="FP1-2">B. Threshold Cost</FP> <FP SOURCE="FP1-2">C. Compliance With PRC Regulations</FP> <FP SOURCE="FP1-2">D. Alternate Resources</FP> <FP SOURCE="FP1-2">E. Reimbursement Procedure</FP> <FP SOURCE="FP1-2">F. Recovery of the CHEF Reimbursement Funds</FP> <FP SOURCE="FP-2">III. Collection of Information Requirements</FP> <FP SOURCE="FP-2">IV. Summary of Comments</FP> <FP SOURCE="FP-2">V. Regulatory Impact Analysis</FP> <FP SOURCE="FP1-2">A. Executive Order 12866</FP> <FP SOURCE="FP1-2">B. Regulatory Flexibility Act (RFA)</FP> <FP SOURCE="FP1-2">C. Unfunded Mandates Reform Act (UMRA)</FP> <FP SOURCE="FP1-2">D. Federalism</FP> <FP SOURCE="FP1-2">E. Executive Order 13175</FP> <FP SOURCE="FP1-2">F. Congressional Review Act</FP> </EXTRACT> <HD SOURCE="HD1">I. Background</HD> The purpose of the CHEF is to meet the extraordinary medical costs associated with the treatment of victims of disasters or catastrophic illnesses who are within the responsibility of the Service. The IHS administers the CHEF to reimburse certain IHS and Tribal purchased/referred care (PRC) costs that exceed the cost threshold. Although the CHEF was first established in 1988, a similar fund was authorized by Public Law 99-591, a Joint Resolution continuing appropriations for fiscal year (FY) 1987. The IHS developed operating guidelines for the management of the CHEF in August of 1987, which were approved by the Office of Management and Budget (OMB). Those guidelines were developed with input from Tribal Organizations and IHS personnel who work with the daily processing and management of Contract Health Services (CHS), now known as the Purchased/Referred Care (PRC) Program. Congress passed the Indian Health Care Improvement Reauthorization and Extension Act of 2009, S. 1790, 111th Cong. (2010) (IHCIREA), as section 10221(a) of the Patient Protection and Affordable Care Act, Public Law 111-148. Through IHCIREA, Congress permanently reauthorized and amended the IHCIA, Public Law 94-437. Section 202 of the IHCIA (25 U.S.C. 1621a) establishes the CHEF and directs the IHS to promulgate regulations for its administration. The operating guidelines and twenty-eight (28) years of experience (FYs 1987-2015) contributed to the design of the proposed rule published on January 26, 2016 (81 FR 4239). Following additional Tribal Consultation and additional years of experience, the IHS issued a new notice of proposed rulemaking (NPRM). The new NPRM, published on July 18, 2023 (88 FR 45867), superseded and replaced the proposed rule published on January 26, 2016 (81 FR 4239); as such, the 2016 NPRM was rescinded. <HD SOURCE="HD1">II. Provisions of This Final Regulation</HD> This final regulation (1) establishes definitions governing the CHEF, including definitions of disasters and catastrophic illnesses; (2) establishes that a Service Unit shall not be eligible for reimbursement for the cost of treatment from the CHEF until its cost of treating any victim of such catastrophic illness or disaster has reached a certain threshold cost; (3) establishes a procedure for reimbursement of the portion of the costs for authorized services that exceed such threshold costs; (4) establishes a procedure for payment from the CHEF for cases in which the exigencies of the medical circumstances warrant treatment prior to the authorization of such treatment; and, (5) establishes a procedure that will ensure no payment will be made from the CHEF to a Service Unit to the extent the provider of services is eligible to receive payment for the treatment from any other Federal, State, local, or private source of reimbursement for which the patient is eligible. No part of the CHEF, or its administration, shall be subject to contract or grant under any law, including the Indian Self-Determination and Education Assistance Act (ISDEAA), Public Law 93-638 (25 U.S.C. 5301 <E T="03">et seq.</E> ) and may not be allocated, apportioned, or delegated to a Service Unit, Area Office, or any other IHS organizational unit. Accordingly, the IHS Division of Contract Care within ORAP, the IHS, shall remain responsible for administration of the CHEF. This final regulation incorporates provisions on severability. Congress has specifically directed the promulgation of these rules for the administration of the CHEF, which is administered by the Secretary, United States (U.S.) Department of Health and Human Services (HHS) (“the Secretary”) acting through IHS Headquarters. The sole purpose of the CHEF is meeting extraordinary medical costs associated with treatment of victims of disasters or catastrophic illnesses who are within the responsibility of the Service. In the event that any portion of the final regulation is declared invalid, the Secretary, acting through the IHS, will continue to be responsible for the administration of the CHEF. The IHS anticipates that the remainder of the regulation could function sensibly and continue to govern the administration of the CHEF. For these reasons, if any portion of the final regulation is declared invalid, the IHS intends that the remaining provisions be severable. The final regulation also incorporates clarifying edits to §§ 136.501, 136.503, and 136.506. Under § 136.501, the IHS added a missing comma in the definition of alternate resources. The IHS had unintentionally omitted the comma from the proposed rule and correction was important to ensure consistency with § 136.61(c). The IHS removed an unnecessary comma in the definition of catastrophic illness in § 136.501 for clarity. The IHS also corrected a typographical error in the preamble regarding the definition of PRC, which did not change the definition of PRC under § 136.501. In § 136.503(a), the IHS clarified that the initial threshold is being established for fiscal year 2024. Under § 136.506, the IHS added two clarifications regarding alternate resources, based upon public comments received in response to the proposed rule. The first clarification regarding alternate resources, located at § 136.506(b), explains that patients are not required to expend personal resources for health services to meet alternate resource eligibility, nor are they required to sell valuables or property to become eligible for alternate resources. The second clarification, located at § 136.506(c), explains that when a PRC program pays primary to ( <E T="03">i.e.,</E> before) a Tribal self-insurance plan, this will not impact whether a PRC program's expenditures are eligible for reimbursement from the CHEF, as long as the Service Unit clearly demonstrates that the PRC program was responsible and did in fact assume that responsibility by making the payments at issue in the CHEF request. Further details are included in response to the comments under section IV, below. <HD SOURCE="HD2">A. Definitions</HD> The IHS establishes the following definitions for governing the CHEF, including definitions of disasters and catastrophic illnesses: 1. Alternate Resources—health care resources other than those of the IHS. Such resources include health care providers and institutions, and health care programs for the payment of health services including, but not limited to programs under title XVIII or XIX of the Social Security Act ( <E T="03">i.e.,</E> Medicare, Medicaid), State or local health care programs, and private insurance. 2. Catastrophic Health Emergency Fund (CHEF)—the fund established by Congress to reimburse extraordinary medical expenses incurred for catastrophic illnesses and disasters paid by a PRC program of the IHS, whether such pr ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 64k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━