Organ Donation
Finalized Rule to Remove Disincentives to Living Organ Donation
On September 22, 2020, the Department of Health and Human Services (“DHHS”) finalized a new rule to expand the scope of qualified reimbursable expenses incurred by living organ donors to include lost wages, child-care expenses, and elder-care expenses. The new rule goes into effect on October 22, 2020, and is a win for living organ donation. This final rule aligns with the initial proposed rule, and you can read our post on the proposed rule here for additional background. The final rule is associated with Section 8 of Executive Order 13879 titled “Advancing American Kidney Health,” issued on July 10, 2019. The Executive Order directed DHHS to propose a regulation allowing living organ donors to be reimbursed for related lost wages, child-care expenses, and elder-care expenses through the Reimbursement of Travel and Subsistence Expenses Incurred toward Living Organ Donation program (the “Program”) authorized under section 377 of the Public Health Service Act. Every 10 minutes, another person is added to the national organ transplant waiting list, and approximately 20 people die every day while waiting for a transplant. This final rule should expand the pool of willing organ donors and also improve donation outcomes by: (i) providing for the receipt of more high quality organs; (ii) reducing the waiting period for an organ; and (iii) resulting in better clinical outcomes than continuing dialysis or receiving a deceased donor kidney transplant. A new regulatory section will be added at 42 C.F.R. § 121.14 to list the categories of “incidental non-medical expenses” to include lost wages, child-care expenses, and elder-care expenses. The other criteria of the Program remain applicable and will still need to be met for reimbursement to be provided to living organ donors and other individuals evaluated for living organ donation. Of note, concurrently with the publication of this final rule DHHS published a final notice that changes the Program’s eligibility guidelines to increase the household income eligibility threshold to 350 percent of the DHHS Poverty Guidelines (from the current threshold of 300 percent) for living organ donors and organ recipients. If you have any questions on this new rule, one of the authors or your regular Dorsey attorney would be happy to assist you.
October 1, 2020
by Randall Hanson and Neal N. Peterson
Organ Donation
New Proposal to Remove Disincentives to Living Organ Donation
On December 20, 2019, the Department of Health and Human Services (“DHHS”) issued a notice of proposed rulemaking (the “Proposal”) that removes financial barriers to organ donation by expanding the scope of reimbursable expenses paid through the Health Resources and Services Administration’s Reimbursement of Travel and Subsistence Expenses Incurred toward Living Organ Donation program (the “Program”). Specifically, the Proposal would allow living organ donors to be reimbursed for donation-related lost wages, child-care expenses, and elder-care expenses through the Program. With the Proposal, DHHS is hoping to increase the number of living organ transplants and improve the overall quality and outcome of organ donations. Generally, federal law prohibits any person from knowingly acquiring, receiving, or otherwise transferring any human organ for valuable consideration for use in human transplantation. 42 U.S.C. § 274e. However, valuable consideration does not include “the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.” Id. (emphasis added). Therefore, organ donors can be reimbursed for their donation-related expenses under certain circumstances. Primarily to aid low-income organ donors in such reimbursement, 42 U.S.C. § 274f describes the Program, which funds the National Living Donor Assistance Center (the “NLDAC”), to reimburse an eligible organ donor’s qualified expenses. Nevertheless, the Program’s current guidelines specifically limit NLDAC qualifying expenses to only those incurred by the donor and/or his/her accompanying person(s) as part of: (1) donor evaluation and/or (2) hospitalization for the living donor surgical procedure, and/or (3) medical or surgical follow-up, clinic visits, or hospitalization within two calendar years following the living donation procedure. As such, the Program (through the NLDAC), does not currently reimburse organ donation-related expenses such as lost wages, child-care, or elder-care. Rather, reimbursement for such expenses can only be received from sources such as state compensation programs, insurance policies, or the recipient of the organ. This reduces the reimbursement options available, which may be especially significant to the low-income organ donors utilizing the Program. To address this, the Proposal sets out to amend the Organ Procurement and Transplantation Network Final Rule by adding Section 121.14(a), stating: The following incidental nonmedical expenses incurred by donating individuals toward making living donations of their organs may be reimbursed: (1) Lost wages; (2) Child-care expenses; and (3) Elder-care expenses. The Proposal fulfills the President’s mandate under Executive Order 13879: Advancing American Kidney Health that DHHS propose a regulation to allow living organ donors to be reimbursed for donation-related lost wages, child-care expenses, and elder-care expenses through the Program. Therefore, some form of the Proposal is likely to become final, and DHHS is accepting comments on the Proposal until February 18, 2020. If you would like to submit comments or have any questions, one of the authors or your regular Dorsey attorney would be happy to assist you.
January 6, 2020
by Randall Hanson and Neal N. Peterson