E&C Launches Bipartisan Oversight Inquiry into Organ Transplant Contractor and Implementation of Bipartisan Reforms

Letter

Dear Administrator Johnson,

Pursuant to Rules X and XI of the U.S. House of Representatives, the Committee writes to request detailed information related to the development and oversight of contracts related to the Organ Procurement and Transplantation Network (OPTN). We note the announcement by the Biden administration of the Health Resources and Services Administration’s (HRSA) Modernization Initiative, which aims to strengthen accountability and transparency in the OPTN. The unanimous passage of H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act, by the House and Senate last year underscores our commitment to enhancing this vital network. According to HRSA statistics, approximately 17 Americans die every day waiting for an organ transplant, and a disproportionate number of them are patients of color and rural Americans. It is therefore crucial to reform the OPTN, and the Committee welcomes HRSA’s announcement and initial steps of implementation.

As you know, the Securing the U.S. Organ Procurement and Transplantation Network Act supports the objectives of HRSA’s Modernization Initiative by giving the agency the authority to update its OPTN contract process by increasing competition, including making multiple awards for program management and removing the previous $7 million cap on direct appropriations. These reforms also support the independence of the OPTN Board of Directors. Since its inception,
the OPTN contract has only been awarded to a single contractor – United Network for Organ Sharing (UNOS). Investigative reporting, Office of Inspector General (OIG) audits, congressional investigations, and whistleblower accounts have exposed evidence of inefficiency and vulnerability throughout the system that pose risks to patients. The Committee is committed to supporting and monitoring the implementation of the new law intended to give HRSA increased
ability to address these concerns, particularly as HRSA has recently issued solicitations for new OPTN contracts.

Errors and inefficiencies in OPTN management can have deadly consequences. A HRSAfunded study found that, while Americans die each day waiting for organ transplants, as few as one in five potential donor organs have been recovered. The Committee wants to ensure HRSA's ability to manage the successful implementation of the OPTN Modernization Initiative to improve accountability and effectiveness of the system that does not currently meet the needs of patients.

A 2021 report, by the United States Digital Service (USDS) titled “Lives are at Stake” raises serious concerns about UNOS’s management of its IT system and about HRSA’s capacity to access the system and assess its security. Specifically, the report found that a “lack of technology expertise in the government program office that administers the OPTN contract is creating missteps in overseeing parts of the OPTN contract. Troublingly, the USDS further observed that “there also appeared to be a lack of interest in knowing more about the details and problems with UNOS’ IT systems because that would put [HRSA] in a position of knowing the problems but
lacking the ability to fix them.”

An August 2022 report from the Department of Health and Human Services (HHS) OIG found multiple, basic cybersecurity failures by UNOS. The OIG report noted that UNOS’s policies and procedures for access controls, risk assessment, and system monitoring “were either in draft or did not exist.”Given the highly sensitive nature of the personal patient data UNOS keeps, it is vital that there are strong and enforceable security measures required under any OPTN contracts.

The Committee supports HRSA’s proposed reforms to improve the competitiveness of the contracting process to help ensure patients are served by the best contractors for each function. Previous OPTN contract solicitations have put potential contractors other than UNOS at a disadvantage to compete for the contract. Reports have also suggested that UNOS has taken aggressive action to discredit bids from other industry stakeholders for the OPTN contract.

As HRSA proceeds through the solicitation and review process for new OPTN contracts, the Committee wants to know how the agency plans to structure, award, and exercise ongoing oversight of the contracts, and about its past experience contracting with UNOS.

Accordingly, to assist the Committee in our oversight, please respond to the following questions by April 3, 2024:

Ensuring Fair and Competitive Practices in Upcoming OPTN Contract:

1. HRSA has issued OPTN contract solicitations for the selection of a new independent OPTN
Board of Directors and review of current OPTN operations. How does HRSA expect these
solicitations and future planned solicitations will ensure a competitive process that includes
multiple eligible awardees?

2. What is HRSA doing to prohibit anticompetitive practices by UNOS or other prospective
contractors during the contracting process?

3. If a contractor other than UNOS is awarded a separate IT contract, how will HRSA ensure
successful collaboration between UNOS and a different IT contractor, especially in the
areas of data transfer, synchronization, and the integration of new Application
Programming Interface (API) functionalities? Provide any relevant continuity plans.

4. Does the U.S. government own and retain access to the data currently stored in the OPTN
or its contractor’s system? Is HRSA’s access to that data ongoing, or provided by request
only? How will HRSA ensure its ongoing ability to access OPTN data in the event a new
contractor is selected?

Data Transparency and Patient Safety

5. Provide an explanation of and relevant documentation relating to HRSA’s response
protocols for reports of patient safety violations, and how HRSA, the Centers for Medicare
& Medicaid Services, and UNOS share these reports and investigate allegations.

6. In light of previous technology failures by UNOS, does HRSA plan on updating contractor
reporting requirements to HRSA? If so, provide information on those plans.

7. Does HRSA plan to update its public dashboards containing data on individual OPO
compliance and performance assessments regarding number of donors and transplants and
equity of access to transplant? If so, provide information on when and how HRSA will
make these updates.

Security and Operability:

8. What is HRSA’s role with respect to monitoring the effectiveness of UNOS’s cybersecurity
efforts under its current OPTN contract with UNOS?

9. Has HRSA conducted any reviews, audits, or assessments of UNOS’s systems and
technology since 2018? If so, please provide dates, results, and action plans associated with
each review, audit, or assessment, as well as copies for all Authority to Operate (ATO)
forms.

10. Please explain how HRSA plans to assess the IT systems of prospective contractors during
the upcoming contracting period and whether routine monitoring of IT system operability
and cybersecurity will be incorporated into the contract terms, along with public reporting
of system lapses. Please also explain how HRSA plans to enforce such cybersecurity
requirements.

Oversight and Conflicts of Interest:

11. In February 2024, HRSA released a draft “contract solicitation to break up the OPTN
monopoly and create an independent OPTN Board of Directors” that included
“[e]stablishing a transitional nominating committee and seeking public input to develop a
slate of candidates for a Board of Directors special election.”10 Given how critical it is to
avoid conflicts of interest, and to establish a truly independent board, what steps will HRSA
take to ensure that any current or recently-nominated board members of any entity bidding
for any OPTN contract are not eligible to serve on this new OPTN board?

12. Once a new OPTN Board of Directors is selected, who is authorized to make future
decisions on appointments and removals to the OPTN Board? How is HRSA preparing to
ensure that the composition of the OPTN Board meets the criteria that it includes
representatives from organ procurement organizations, transplant centers, voluntary health
associations, and the general public, as required in the Securing the U.S Organ Procurement
and Transplantation Network Act?

13. Provide a list of all complaints of racial discrimination in waitlist management received by
HRSA since 2018 and documentation of the allegations, all internal communications
regarding such allegations, and the results of any investigations.
14. Please provide any analysis by HRSA evaluating the extent to which UNOS’s registration
fees and any other fees collected from transplant centers are appropriate and in compliance
with OPTN contract terms.
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15. UNOS financial statements12 state that while “certain financial assets are restricted for use
by the OPTN Contract,” UNOS “has determined that the use of the restricted cash and
investment amounts will be for mission-related activities within one year” and become
unrestricted and available for general UNOS use after one year. Does this practice violate
the OPTN contract and bylaws? If so, what enforcement authority does HRSA have to
remedy this violation, including, but not limited to, clawing back inappropriately spent
funds?
16. Provide a copy of the letter from HRSA to UNOS in or around March 2022 stating that
derogatory language used by UNOS officials in publicly released emails used
“inappropriate and unacceptable” language to refer to patients.13
If you have any questions, please contact the Majority Committee staff at (202) 225-3641
and the Minority Committee staff at (202) 225-2927. Thank you for your attention to this request.

Sincerely,

Source