Q: Why are you looking into the nation’s organ procurement and transplant system?
A: Advances in medical science, specifically organ transplants, save lives and give loved ones a new lease on life. Incredible gifts of life are made possible when family members and even total strangers donate to a patient in need. Postmortem donations give the gift of life from deceased donors who match an individual on the national wait list through the Organ Procurement and Transplantation Network (OPTN). Administered by the U.S. Department of Health and Human Services (HHS), the OPTN operates the national database of all patients waiting for a transplant. The OPTN contracts with the Unified Network for Organ Sharing (UNOS), which is charged with overseeing the 58 organ procurement organizations (OPOs) located throughout the United States. Americans on the wait list are in a life and death situation. It is imperative the system functions fairly and effectively. There’s a scarcity of available organs compared to the number of people added to the wait list every single day. This shortfall contributes to a dire situation in which 113,000 Americans on the wait list risk losing their lives without receiving a transplant in time. According to the head of the Centers for Medicare & Medicaid Services (CMS), at least 20 Americans die each day because a potentially life-saving organ transplant is out of reach. Based on investigative reports and whistleblower accounts, I’m concerned about inefficiencies and mismanagement of the procurement process, as well as the performance standards used by the 58 OPOs. As chairman of the Senate Finance Committee, which has legislative and oversight jurisdiction of many public health programs, I’m calling for increased oversight to correct flaws in this vital network in the nation’s health care system. For more than a dozen years, the need for more accountability and transparency in the organ procurement and transplantation system has been on my radar as a taxpayer watchdog and healthcare policymaker. In 2005, I raised concerns about alleged violations of transplant protocols and requested an investigation into practices prohibited by federal law, including purchase or sale, for profit, of human organs that affects interstate commerce. I’ve also flagged misuse of taxpayer dollars based upon audits and investigations conducted by the HHS Office of Inspector General. The integrity of the U.S. organ procurement and transplant system is paramount for life-saving care. The federal government must uphold accountability standards, to require transparency, uphold public confidence, prevent avoidable deaths and protect taxpayer dollars.
Q: How will the proposed rules by the Trump administration help improve the system?
A: President Trump issued an executive order in July to help increase the organ supply and improve the allocation of organs available through deceased donations. HHS proposed a rule in December that would update the conditions that organ procurement organizations (OPOs) must meet to receive Medicare and Medicaid payments under federal health care programs. Better incentives, better oversight, and better accountability standards can be achieved with more transparent, reliable, and standardized metrics to help gauge if the nation’s system of donor networks is performing as effectively and efficiently as possible. The Health Resources and Services Administration (HRSA) also issued a proposed rule to remove the financial barriers to living organ donations. If finalized, it would expand the range of expenses eligible for reimbursement to include lost wages and childcare and eldercare expenses for those donors who lack other forms of financial support. The rule could be a game changer for the hundreds of thousands of Americans on dialysis. Outcomes for kidney transplant recipients show that living donations provide a better quality organ in a shorter period of time than those who continue on dialysis or eventually receive a kidney transplant from a deceased donor. The rule encourages a higher living donor transplant rate which would improve the quality of life and increase the life expectancy of Americans currently on dialysis. CMS estimates if all OPOs were to meet the new proposed metrics, the number of transplants would increase by nearly 15,000 additional transplants by 2026. Increasing patient access to healthy, quality organ donations and safe, high-quality transplants would save more lives and improve the quality of life for Americans for generations to come. I’m glad the Trump administration is moving forward with these reforms. However, even more can be done. In December, I called upon the HHS IG to conduct a comprehensive examination of the system. In a joint letter with Senator Todd Young of Indiana, I spelled out substantive flaws in oversight and misspending that need to be flushed out and fixed. I’ll continue working to fix what’s broken in our system of procurement and distribution so that as many Americans as possible may benefit from the gift of life made possible by organ donations.
Public comments to the two proposed rules may be submitted electronically to http://www.regulations.gov. All comments are public.