Wyden, Grassley, Cardin, Young Investigate Organ Donation System for Potential Self-Dealing and Financial Conflicts of Interest

Letter

Dear Mr. Massa:

As part of our ongoing investigation into the U.S. organ donation system, we write with concerns
about potential serious and compromising conflicts of interest among organ procurement
organizations (OPOs) and their leadership's financial and business relationships.

Investigative reporting has uncovered that some OPO executives may have financial interests in
for-profit companies conducting business with OPTN members. OPOs and their executives have engaged in a complex web of financial relationships with tissue processors, researchers,
testing laboratories, and logistics providers, which have the potential for creating conflicts of
interest. Some OPOs have also engaged in criminal activity. For example, in 2012, federal
investigators uncovered an illegal kickback scheme between an OPO and a local funeral home,
resulting in OPO executives being sentenced to federal prison. The Committee has also heard
testimony and received credible allegations that senior members of the current OPTN
contractor, the United Network for Organ Sharing's (UNOS) patient protection and policymaking committees may harbor undisclosed for-profit interests and may be leveraging their
UNOS leadership positions to self-enrich at the expense of patient care.

Currently, the Organ Procurement and Transplantation Network (OPTN), the government
contractor charged with oversight of the transplant system, does not collect OPO's financial
information such as financial relationships, board member compensation or affiliated
businesses. Additionally, even when formal complaints regarding concerning financial
relationships are raised to the OPTN, the current OPTN contractor, the United Network for
Organ Sharing (UNOS), has ignored them. As evidenced in the Senate Committee on Finance's
2022 bipartisan report, initial complaints brought to UNOS about the 2012 FBI case discussed
above were not acted on. These financial relationships require additional scrutiny.

These alleged conflicting financial and business relationships pose serious risks to those in need
of a lifesaving organ transplant. As noted in our October 2020 letter to Health and Human
Services (HHS), 'OPOs have greater financial incentives to focus more on tissue recovery
compared to their incentives to recover lifesaving organs.' Additionally, investigative reporting
has highlighted that, '80% of [OPOs] were harvesting tissues and sending them in exchange for
fees to tissue processors and distributors, many of which are for-profit companies…Today the
selling of human tissue is a multibillion-dollar global business.' As the only organizations
federally certified to procure organs for transplant, these financial incentives are concerning as they potentially incentivize OPOs to prioritize profit over procuring organs for lifesaving
transplant.

We are also troubled by the lack of transparency in the current system, which allows OPO
executives to potentially maintain personal financial interests in entities doing business with
OPOs or other members of the OPTN, especially those financial interests which may affect
patient care. We are also concerned about financial relationships and conflicts of interest from
OPOs with outside entities, as well as volume-based incentives that may distort OPO priorities
regarding the delivery of organ procurement.

The Senate Committee on Finance has broad subject matter jurisdiction over our nation's tax and
health laws and policies.12 Your organizations maintain non-profit tax status and receive federal
Medicare and Medicaid taxpayer dollars, which avails you of the Senate Committee on Finance's
oversight and jurisdiction. To evaluate and better understand your OPO's financial and business
relationships, please provide the following information no later than September 19, 2023:

1) Describe all personal financial interests or business relationships you and/or other board
members or executives of your OPO or any related entities (e.g., related foundations or
institutes) had from 2015 to the present, or continue to maintain, with any for-profit or
non-profit organization that conducts business with your or another OPO or other OPTN
member.13
2) For each interest and relationship described in question 1, provide all records.14
3) For each interest and relationship described in question 1, describe the process by which
all conflicts were publicly disclosed. Provide all records.
For each interest and relationship described in question 1, provide all communications in
which you have promoted these organizations to other OPOs or OPTN members and a
description of the basis for which you promoted the organizations.
5) From 2015 to the date of this letter, provide copies of all agreements between you and the
OPO, including any incentive-based bonuses related to volume, revenue, and other
metrics.
6) From 2010 to the date of this letter, provide the standard acquisition costs (SAC) your
OPO charged for each organ type.
7) From 2015 to the date of this letter, provide the bylaws and policies submitted to CMS as
part of any CMS surveys of your OPO (both recertification and complaint investigations).
8) From 2015 to the date of this letter, for each of your board(s), provide the bylaws and
policies that address potential conflicts of interest (financial and personal), length of
terms, and criteria for selecting and removing members.
9) From 2015 to the date of this letter, provide all memoranda of understanding (MOU)
your organization had with tissue banks, including those that address any conflicts
between organ recovery and tissue recovery and those that were submitted to CMS as
part of any CMS survey of your OPO (both recertification and complaint investigations).
10) Between 2013 and 2021, LifeCenter Organ Donor Network transferred $16,328,855 to
LifeCenter Memorial Foundation, including $6,000,000 in 2021.15 Please provide the
following information:
a) From 2013 to the present, all records related to your OPO's relationship with
LifeCenter Memorial Foundation, including any financial relationships between
board members or executives at your OPO and your foundation;
b) From 2013 to the present, an explanation for each transfer from your OPO to your
foundation and each OPO foundation expenditure.

Thank you in advance for your response.

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