Organ Donation Clarification Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 3569 To amend the National Organ Transplant Act to clarify the definition of valuable consideration, to clarify that pilot programs that honor and promote organ donation do not violate that Act, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MAY 28, 2021 Mr. CARTWRIGHT (for himself, Mr. WILSON of South Carolina, Mr. COHEN, Mr. FITZPATRICK, Mr. KELLY of Pennsylvania, Mr. MCKINLEY, Mr. SAN NICOLAS, Ms. SCHAKOWSKY, Mr. SCHIFF, Ms. SPEIER, Mr. TIMMONS, and Mr. YOUNG) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the National Organ Transplant Act to clarify the definition of valuable consideration, to clarify that pilot programs that honor and promote organ donation do not violate that Act, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Organ Donation Clari- 4 fication Act of 2021’’. 5 SEC. 2. FINDINGS. 6 Congress finds the following: 7 VerDate Sep 11 2014 05:42 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3569.IH H3569 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3569 IH (1) As of March 2021, 108,000 people await an 1 organ transplant, with 91,000 of those people wait- 2 ing for a kidney, and average wait times are ap- 3 proaching five years for a kidney, with over one-and- 4 a-half times as many people being added to the wait- 5 ing lists as getting a transplant. 6 (2) Of the nearly three million Americans who 7 die annually, under 30,000, representing about one 8 percent of all deaths each year, possess major or- 9 gans healthy enough for transplanting. 10 (3) On average, 17 people a day died while 11 waiting for an organ in 2020, with the majority of 12 those people waiting for a kidney. 13 (4) In 2020, approximately 3,800 people were 14 removed from kidney waiting lists and approximately 15 1,600 from liver, heart, and lungs waiting lists be- 16 cause they became permanently too sick to receive a 17 transplant. 18 (5) Over 75 percent of dialysis patients are not 19 employed because dialysis requires multiple treat- 20 ments per week which last several hours and leave 21 patients drained, thus creating a huge financial bur- 22 den on the patients, their families, and the govern- 23 ment; moreover, lost tax revenue from these individ- 24 uals is not included in the cost estimates above. 25 VerDate Sep 11 2014 05:42 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3569.IH H3569 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3569 IH (6) A patient receiving a kidney transplant, and 1 thus no longer needing dialysis, can enjoy a much 2 higher quality of life for another 10–15 years on av- 3 erage. 4 (7) As medical advances extend people’s lives on 5 dialysis, the number of patients on dialysis will in- 6 crease significantly, as will the costs for individuals 7 and the Federal Government. 8 (8) Roughly seven percent of the Medicare 9 budget goes to the End Stage Renal Disease Pro- 10 gram, with dialysis costing Medicare over $90,000 11 per patient per year, as Federal law dictates that 12 Medicare will cover dialysis for everyone who has 13 made minimal Social Security tax payments. 14 (9) A kidney transplant pays for itself in less 15 than two years, with each transplant saving an aver- 16 age of $146,000 in medical costs over a 10-year pe- 17 riod, 75 percent of which is savings to the taxpayers. 18 (10) Experts project that if the supply of trans- 19 plant kidneys could be increased to meet the de- 20 mand, taxpayers would save more than 21 $14,000,000,000 per year in medical costs. 22 (11) The World Health Organization estimates 23 that 10 percent of all transplants take place on the 24 international black market, the last choice for des- 25 VerDate Sep 11 2014 05:42 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3569.IH H3569 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3569 IH perate patients facing an alternative of death, how- 1 ever recipients often receive infected kidneys and 2 suffer poor health outcomes and donors are often 3 victimized. 4 (12) Present policy on domestic donation has 5 never been subject to studies or pilots to determine 6 effectiveness in increasing the availability of donated 7 organs and the effectiveness of safeguards that pre- 8 vent coercion or exploitation, precludes all but altru- 9 istic donation, prohibiting any form of incentive or 10 benefit for donors. 11 (13) In 2010, Israel implemented sweeping 12 changes to its national organ donation program in- 13 cluding reducing financial burdens on donors, giving 14 future transplantation priority to registered organ 15 donors and their families, and promoting donation 16 by reimbursing the donor’s medical costs, 40 days of 17 lost wages, and five years of medical and life insur- 18 ance costs, and as a result saw organ donation ap- 19 proximately triple over a 10-year period. 20 (14) Experts are arriving at a consensus that 21 trials are necessary to find new methods of pro- 22 moting additional organ donation which will save 23 lives and reduce organ trafficking. 24 VerDate Sep 11 2014 05:42 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3569.IH H3569 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 3569 IH SEC. 3. CLARIFICATION OF CERTAIN PROVISIONS OF THE 1 NATIONAL ORGAN TRANSPLANT ACT. 2 (a) RELATION TO OTHER LAWS.—Section 301 of the 3 National Organ Transplant Act (42 U.S.C. 274e) is 4 amended by adding at the end the following: 5 ‘‘(d) RELATION TO OTHER LAWS.— 6 ‘‘(1) GOVERNMENTS ENCOURAGING ORGAN DO- 7 NATION.—This section shall not— 8 ‘‘(A) apply to actions taken by the Govern- 9 ment of the United States or any State, terri- 10 tory, tribe, or local government of the United 11 States to carry out a covered pilot program; or 12 ‘‘(B) prohibit acceptance of any noncash 13 benefits provided by the pilot program under 14 subparagraph (A). 15 ‘‘(2) NO PROHIBITION ON OTHER BENEFITS 16 PROGRAMS.—Nothing in this subsection shall be con- 17 strued to prohibit actions, other than actions de- 18 scribed in this section, taken by any State, territory, 19 tribe, or unit of local government in the United 20 States to provide benefits for human organ donation. 21 ‘‘(3) COVERED PILOT PROGRAM.—For purposes 22 of this subsection— 23 ‘‘(A) the term ‘covered pilot program’ 24 means a pilot program approved by the Sec- 25 retary of Health and Human Services, subject 26 VerDate Sep 11 2014 05:42 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3569.IH H3569 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 3569 IH to an ethical review board process, with a term 1 of not more than 5 fiscal years, for the purpose 2 of measuring the effect of removing disincen- 3 tives or providing a noncash benefit that may 4 increase the organ pool. Distributions of organs 5 from deceased donors under the pilot program 6 shall be conducted only through the Organ Pro- 7 curement and Transplantation Network at a 8 transplant center approved by the United Net- 9 work for Organ Sharing or any other entity 10 designated by the Secretary of Health and 11 Human Services; and 12 ‘‘(B) the term ‘noncash benefit’ means any 13 benefit or thing of value received by an organ 14 donor that is impossible to sell, trade, or other- 15 wise transfer to another individual.’’. 16 (b) VALUABLE CONSIDERATION.—Section 301(c)(2) 17 of the National Organ Transplant Act (42 U.S.C. 18 274e(c)(2)) is amended to read as follows: 19 ‘‘(2) The term ‘valuable consideration’ does not 20 include the following: 21 ‘‘(A) Reasonable payments associated with 22 the removal, transportation, implantation, proc- 23 essing, preservation, quality control, and stor- 24 age of a human organ. 25 VerDate Sep 11 2014 05:42 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3569.IH H3569 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 3569 IH ‘‘(B) Reimbursement for travel, lodging, 1 food during travel, and other logistical expenses 2 related to donation. 3 ‘‘(C) Provision of advanced payments or 4 reimbursement for dependent care needs for 5 pre-transplant appointments in addition to dur- 6 ing the period of donation and post-transplant 7 follow-up care related to the donation for up to 8 a 10-year period. 9 ‘‘(D) Reimbursement for lost wages related 10 to donation. 11 ‘‘(E) Medical expenses related to donation 12 and all related follow-up care including prevent- 13 ative follow-up care and medication for up to a 14 10-year period. 15 ‘‘(F) Paperwork or legal costs related to 16 donation. 17 ‘‘(G) Any term life insurance policy against 18 the risk of death or disability as a result of do- 19 nating an organ or the longer-term health ef- 20 fects of having donated an organ, that— 21 ‘‘(i) in the case of a life insurance pol- 22 icy, provides for payments in amounts less 23 than $2,000,000, adjusted annually for in- 24 flation; and 25 VerDate Sep 11 2014 05:42 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3569.IH H3569 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 3569 IH ‘‘(ii) in the case of a disability insur- 1 ance policy, provides for payments equal to 2 or less than the reasonable earnings expec- 3 tations of the donor.’’. 4 Æ VerDate Sep 11 2014 05:42 Jun 22, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H3569.IH H3569 kjohnson on DSK79L0C42PROD with BILLS