0906-AB23 201910 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0906 Health Resources and Services Administration HRSA 0900 Department of Health and Human Services HHS Removing Financial Disincentives to Living Organ Donation

This proposed rule would amend the Organ Procurement and Transplantation Network (OPTN) final rule to further remove financial barriers to living organ donation by expanding allowable costs that can be reimbursed.  The changes would apply to specified incidental nonmedical expenses incurred toward living organ donation.   

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No Fully or Partially Exempt 42 CFR 121.14 sec. 301 of the National Organ Transplant Act of 1984 (42 U.S.C. 274f) Yes

As of January 2019, more than 113,000 men, women, and children were on the national organ transplant waiting list.  Living organ donation is an important option for thousands of men, women, and children on the national transplant waiting list.  Transplants using organs from living donors accounted for 19 percent (6,849) of the total (36,528) transplants performed in 2018.  Transplants involving organs from deceased donors, who can provide multiple organs, comprised the other 81 percent (29,680) of the 2018 total. 

This regulatory change is needed to remove financial barriers for individuals interested in being a living donor, but who may not be able to financially cover the nonmedical expenses associated with living donation.  The regulation will remove financial disincentives by expanding coverage to include reimbursement for lost wages and childcare and eldercare expenses.  The agency believes that this regulatory change, designed to increase living organ donation by removing financial disincentives for living organ donations, such as those proposed in this rule, can benefit the transplantation community overall.

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Congress provided specific authority under section 377 of the Public Health Service (PHS) Act, as amended, 42 U.S.C. 274f, [1] to the Secretary of Health and Human Services (the Secretary) for reimbursement of travel and subsistence expenses, which encompasses cost for travel to medical and clinical appointments, lodging, and meals, incurred by eligible individuals making living donations of their organs, and other individuals accompanying the living organ donors.  Additionally, Congress authorized the Secretary to reimburse additional incidental non-medical expenses incurred by living organ donors under 42 U.S.C. 274f(a)(2), if the Secretary determines by regulation that reimbursing such expenses is appropriate. 

[1] https://www.govinfo.gov/content/pkg/PLAW-108publ216/pdf/PLAW-108publ216.pdf .

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HHS discussed alternatives, including covering these expenses directly through Medicare. It was determined that expanding the expenses eligible for reimbursement under the Program would be the most effective means to remove disincentives to living organ donation consistent with the requirements of the Executive Order.

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A reimbursement of lost wages and child and elder care expenses could increase number of living organ donor transplants annually by an estimated 10 to 15 percent.  More patients receiving transplants will save Medicare and Medicaid expenses. However, an estimate of costs of full implementation is not available at this time. There are no anticipated costs to this regulation on its own. The proposed rule, if finalized, will only change how HRSA spends the limited funds appropriated.

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HRSA considered potential risks associated with this regulation and none have been identified other than the uncertainty around meeting the increased funding needs of an expanded reimbursement program.  The transplant community supports increased financial assistance for living organ donors.

]]> NPRM 11/00/2019 Undetermined No None No No No No Cheryl Dammons Associate Administrator, Healthcare Systems Bureau 0906 Health Resources and Services Administration HRSA 301 443-3300 cdammons@hrsa.gov 5600 Fishers Lane, Room 8W-21, Rockville MD 20857