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The Health Resources and Services Administration (HRSA) seeks to use the authority described in 42 CFR 121.4(b)(2) to make policies of the Organ Procurement and Transplantation Network (OPTN) enforceable by formally approving them through the federal rulemaking process. Currently, compliance with OPTN policies is voluntary unless the Secretary has formally approved the policies. HRSA is also proposing rulemaking action to: (1) update regulatory language to align it with provisions of the Securing the U.S. Organ Procurement and Transplantation Act, Public Law 118-14 (Sept. 22, 2023) and (2) remove a paragraph of part 121 that references a prior effective date of the regulations.

Statement of Need:

HRSA is pursuing rulemaking to address widespread non-compliance with OPTN policies, resulting in harm to patients and families. HRSA-led investigations, external investigative reporting, and Congressional hearings have revealed problems with the organ procurement and transplant system stemming from the failure of Organ Procurement Centers and transplant centers to adhere to OPTN policy. HRSA is also pursuing rulemaking to align existing regulations with the 2023 Securing the U.S. Organ Procurement and Transplantation Act.

Summary of the Legal Basis:

The implementing regulations of the National Organ Transplant Act (NOTA) (the OPTN final rule, 42 C.F.R. part 121), describe a process by which certain policies of the OPTN may be made enforceable by HHS by promulgating those policies through federal rulemaking (42 CFR 121.4(b)(2)). Additionally, Section 1138 of the Social Security Act (42 U.S.C. 1320b-8) (section 1138) requires Medicare and Medicaid participating hospitals that perform transplants to be members of the OPTN and to abide by its rules and requirements. ^[1] Since violations of section 1138 could result in the withholding of a transplant hospital’s reimbursement under Medicare or Medicaid, or termination from these programs, HHS has stated that for an OPTN policy to be considered a rule or requirement of the OPTN, and therefore mandatory or binding on OPOs and hospitals participating in Medicare or Medicaid, the Secretary must have given formal approval to the rule or requirement. Therefore, the term rules and requirements of the OPTN means those rules and requirements formally approved by the Secretary through the rulemaking process.^[2] Once certain OPTN policies are enforceable by the Secretary, CMS and HRSA, as per the authority delegated by the Secretary, may take enforcement actions based on violations of these OPTN policies.

HRSA also seeks to make technical edits to 42 C.F.R. 121.3(c)(1), to align the OPTN final rule with provisions of the Securing the U.S. Organ Procurement and Transplantation Act (Securing Act), Public Law 118-14 (Sept. 22, 2023) and to delete 42 C.F.R. 121.3(d), which refers to a date in the past (June 30, 2000) by which requirements of 42 C.F.R. 121.3 needed to be met.

[1] See 54 Fed. Reg. 51802 (December 18, 1989) (Federal Register notice setting forth Secretary’s interpretation of section 1138 provisions.)

[2] See 63 Fed. Reg. 16297 (April 2, 1998).

Alternatives:

TBD

Anticipated Costs and Benefits:

We anticipate benefits related to reduced health and safety risks for patients, and improvements in the equitable allocation of organs, patient safety, and transparency. We anticipate costs associated with greater adherence to documentation requirements, provider responsibilities, screening criteria, and increased reporting on patient safety events.

Risks:

TBD