118 HR 4343 IH: Organ Donation Clarification Act of 2023
U.S. House of Representatives
2023-06-23
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I
118th CONGRESS
1st Session
H. R. 4343
IN THE HOUSE OF REPRESENTATIVES
June 23, 2023
Ms. Matsui (for herself and Mr. Wilson of South Carolina) 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.
1.

Short title
This Act may be cited as the “Organ Donation Clarification Act of 2023”.
2.

Findings
Congress finds the following:
(1)
As of May 2023, 113,999 people await an organ transplant, with 95,957 of those people waiting for a kidney, and average wait times are approaching five years for a kidney, with over one-and-a-half times as many people being added to the waiting lists as getting a transplant.
(2)
Of the nearly three million Americans who die annually, under 30,000, representing about one percent of all deaths each year, possess major organs healthy enough for transplanting.
(3)
On average, 17 people a day died while waiting for an organ in 2020, with the majority of those people waiting for a kidney.
(4)
In 2022, approximately 4,498 people were removed from kidney waiting lists and approximately 1,500 from liver (1,123), heart (239), and lungs (145) waiting lists because they became permanently too sick to receive a transplant.
(5)
Over 75 percent of dialysis patients are not employed because dialysis requires multiple treatments per week which last several hours and leave patients drained, thus creating a huge financial burden on the patients, their families, and the government; moreover, lost tax revenue from these individuals is not included in the cost estimates above.
(6)
A patient receiving a kidney transplant, and thus no longer needing dialysis, can enjoy a much higher quality of life for another 10–15 years on average.
(7)
As medical advances extend people’s lives on dialysis, the number of patients on dialysis will increase significantly, as will the costs for individuals and the Federal Government.
(8)
Roughly seven percent of the Medicare budget goes to the End Stage Renal Disease Program, with dialysis costing Medicare over $90,000 per patient per year, as Federal law dictates that Medicare will cover dialysis for everyone who has made minimal Social Security tax payments.
(9)
A kidney transplant pays for itself in less than two years, with each transplant saving an average of $136,000 in medical costs over a 10-year period, 75 percent of which is savings to the taxpayers.
(10)
Experts project that if the supply of transplant kidneys could be increased to meet the demand, taxpayers would save more than $16,000,000,000 per year in medical costs.
(11)
The World Health Organization estimates that 10 percent of all transplants take place on the international black market, the last choice for desperate patients facing an alternative of death, however recipients often receive infected kidneys and suffer poor health outcomes and donors are often victimized.
(12)
Present policy on domestic donation has never been subject to studies or pilots to determine effectiveness in increasing the availability of donated organs and the effectiveness of safeguards that prevent coercion or exploitation, precludes all but altruistic donation, prohibiting any form of incentive or benefit for donors.
(13)
In 2010, Israel implemented sweeping changes to its national organ donation program including reducing financial burdens on donors, giving future transplantation priority to registered organ donors and their families, and promoting donation by reimbursing the donor’s medical costs, 40 days of lost wages, and five years of medical and life insurance costs, and as a result saw organ donation approximately triple over a 10-year period.
(14)
Experts are arriving at a consensus that trials are necessary to find new methods of promoting additional organ donation which will save lives and reduce organ trafficking.
3.

Clarification of certain provisions of the National Organ Transplant Act
(a)

Valuable consideration
Section 301(c)(2) of the National Organ Transplant Act (42 U.S.C. 274e(c)(2)) is amended to read as follows:
“(2)
The term valuable consideration does not include the following:
(A)
Reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ.
(B)
Advanced payments or reimbursement for travel, lodging, food during travel, and other logistical expenses related to donation.
(C)
Advanced payments or reimbursement for dependent care expenses related to donation before, during, or after the donation, but not later than the date that is 10 years after the date of the donation.
(D)
Advanced payments or reimbursement for lost wages related to donation.
(E)
Medical expenses related to donation and all related follow-up care including preventative follow-up care and medication for up to a 10-year period.
(F)
Paperwork or legal costs related to donation.
(G)
Any term life insurance policy against the risk of death or disability as a result of donating an organ or the longer-term health effects of having donated an organ, that—
(i)
in the case of a life insurance policy, provides for payments in amounts less than $2,000,000, adjusted annually for inflation; and
(ii)
in the case of a disability insurance policy, provides for payments equal to or less than the reasonable earnings expectations of the donor.”.
(b)

Covered pilot program
Section 301 of the National Organ Transplant Act (42 U.S.C. 274e) is amended by adding at the end the following:
“(d)

Covered pilot program encouraging organ donation
(1)

Approval
The Secretary may approve covered pilot programs for purposes of applying the exception in paragraph (2).
(2)

Exception to prohibition
Subsection (a) does not prohibit—
(A)
acquisition, receipt, or transfer of any noncash benefit provided pursuant to a covered pilot program; or
(B)
other actions taken to carry out a covered pilot program.
(3)

Definitions
In this subsection:
(A)
The term covered pilot program means a pilot program that—
(i)
is conducted by the Federal Government or any State, territory, Tribe, or local government;
(ii)
is approved by the Secretary under paragraph (1);
(iii)
is subject to an ethical review board process;
(iv)
has a term of not more than 5 fiscal years;
(v)
is for the purpose of providing, or allowing the provision of, noncash benefits for organ donation and organ donors, and measuring the effects of providing such noncash benefits;
(vi)
measures the effects of providing such noncash benefits; and
(vii)
allows for the determination of the recipient of an organ donated pursuant to the covered pilot program—
(I)
in the case of organs from deceased donors, only by the Organ Procurement and Transplantation Network; and
(II)
in the case of nondirected organs from living donors, only by a transplant center that is a member of, and abides by the rules and requirements of, the Organ Procurement and Transplantation Network established pursuant to section 372 of the Public Health Service Act.
(B)
The term noncash benefit means any benefit or thing of value received by an organ donor that is impossible to sell, trade, or otherwise transfer to another individual.
(4)

Report to Congress
Not later than three years after the Secretary first approves a covered pilot program, and every three years thereafter until there is no longer a covered pilot program in operation, the Secretary shall submit a report to the Congress on—
(A)
the impact of covered pilot programs on the organ pool;
(B)
the demographics of the donors participating in covered pilot programs;
(C)
the demographics of the recipients of organs donated by participants in covered pilot programs;
(D)
the effectiveness, fairness, and equitableness of the distribution of nondirected living donor organs that are donated by participants in covered pilot programs; and
(E)
recommendations to Congress on—
(i)
improving covered pilot programs; and
(ii)
expanding the use of noncash benefits to incentivize organ donation.”.
(c)

Relationship to payments by recipient of organ
Subsection (d) of section 377 of the Public Health Service Act (42 U.S.C. 274f(d)) is amended to read as follows:
“(d)

Relationship to payments under other programs
An award may be made under subsection (a) only if the applicant involved agrees that the award will not be expended to pay the qualifying expenses of a donating individual to the extent that—
(1)
payment has been made, or can reasonably be expected to be made, with respect to such expenses—
(A)
under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(B)
by an entity that provides health services on a prepaid basis; or
(2)
the recipient of the organ has made payment, or had agreed to make payment, with respect to such expenses.” .