Officials say the investigation has been ongoing for at least several months. But in a sign that the investigation is escalating, the notice said investigators from the Department of Veterans Affairs Inspector General were “dispatched to the offices and homes of 10 top executives of organ procurement organizations” in early February “as part of the investigation.” It is said that it was done. Steve Miller, chief executive of the Association of Organ Procurement Organizations, appealed to members:
Serious flaws in the nation's organ transplant system have come under increased government scrutiny in recent years, but the federal prosecutor-led investigation (with the possibility of criminal charges) is the most serious investigation yet into the current state of this difficult situation. may pose a serious threat. Multi-billion dollar organ transplant industry.
The Association of Organ Procurement Organizations is “aware that the Inspector General and Veterans Affairs Department has contacted some OPOs,” Jenny Daigle, a spokeswoman for the trade group, said in an email. He added that he has not yet been able to contact the association.
Organ procurement organizations contacted by The Washington Post about the Veterans Administration's actions and the federal investigation did not respond to emails or phone calls. Spokespeople for the Justice Department and the Office of Veterans Affairs Inspector General declined to comment.
The nation's 56 organ procurement organizations collect organs, mostly kidneys, from donors who have died in hospitals and arrange for their transport to surgeons at 250 U.S. medical centers who perform transplants. Each procurement group holds exclusive government-guaranteed rights over extensive areas of the U.S. territories in which it operates.
Some people haven't had enough organs harvested for years. According to government records, this is to meet demand. But the Centers for Medicare and Medicaid Services, the part of HHS that licenses nonprofit organizations to operate, has never revoked nonprofit accreditation. In response to criticism, CMS issued new benchmarks that could weed out poor-performing companies starting in 2026.
The transplant center pays a portion of the organization's costs, and the Medicare system reimburses the organization for additional costs and expenses associated with obtaining and transporting the kidney. These organizations collect reimbursement money from other organ transplant centers. Transplant centers are reimbursed by both public and private payers depending on the patient.
One focus of the investigation appears to be whether any of the nonprofits violated the federal False Claims Act by intentionally charging the federal government impermissible costs, according to investigators. . All spoke on condition of anonymity because they were not authorized to comment on an ongoing government investigation.
Another focus of the investigation is whether there were kickbacks between organizations in this tightly organized but loosely regulated corner of U.S. health care, one of the people said.
In addition, Investigators are investigating whether there are six organ procurement organizations. One of the people said the company fraudulently billed the Veterans Administration and Medicare. Familiar with investigations.
“Organ procurement executives have acted with total impunity for decades,” said Greg Segal, co-founder of the activist group Organize, which calls for widespread reform of the transplant industry. “They should not be above the law.”
Despite decades of improvement and an increase in the number of transplants, more than 103,000 people in the United States are still on the organ waiting list, the vast majority seeking a kidney. Some people die every day.
The federal investigation comes after some lawmakers, activists and transplant industry officials say the program is mismanaged and that some officials are using it to enrich themselves and their organizations. It is the latest attempt to address a long-standing claim.
In 2022, a Senate Finance Committee investigation found that organ testing errors led to 70 deaths between 2008 and 2015. The commission's investigation also accused federal contractors operating the transplant system of lax oversight of the careless handling of donated organs and organs. Lost during shipping. It was revealed that the entire organ transport system relied on outdated technology that had never been audited by the government. Regarding security weaknesses or other deficiencies.
Last March, the head of the Health Resources and Services Administration, part of HHS, pledged to overhaul the transplant system, eliminating a 38-year-old monopoly system. Hosted by United Network for Organ Sharing. Richmond-based nonprofit UNOS is the only organization operating the transplant system under contracts repeatedly awarded by the government.
In July, Congress passed legislation authorizing the changes.
Most False Claims Act investigations stem from complaints by whistleblowers who are not part of the government. That would allow the Justice Department to devote significant resources to determining whether a complaint has merit. The law allows prosecutors to file criminal charges or civil lawsuits depending on the outcome of the investigation.
VA, the largest healthcare company The transplant system in the United States has not featured prominently in previous criticisms of the system, and a 2021 report in the American Journal of Transplantation may provide one clue as to why. The paper found that between 2010 and 2019, 5,281 donors met donation criteria, but procurement agencies retrieved organs from only 33 deceased donors at VA hospitals. (Some authors of peer-reviewed studies have criticized the current organ transplant system.)
Some procurement groups collect skin, bones, ligaments, heart valves, and other body parts from the same donor who donates organs or from other donors who do not. They are allowed to sell these tissues into high-profit markets as materials used in surgeries and other medical treatments. Unlike organ trade, information about tissue trade is not publicly available.
Investigators want to know whether some procurement organizations may be using veteran donor tissue as a revenue source, leaving desperately needed organs behind, according to investigators. It is said that Removing organs requires more expertise and expense than harvesting tissue, and in some cases can result in large sums of money for organ procurement organizations.
The investigation represents a new level of serious investigation, but federal authorities have previously taken action against organ procurement organizations. In 2012, two employees of the Alabama group were convicted of health care fraud and other charges of receiving kickbacks from funeral homes.
Last year, the Senate Finance Committee investigated potential conflicts of interest between the groups. It sent letters to executives at eight of those companies requesting information on “instances of possible abuse of position for financial gain.”
The letter alleges that organ procurement organizations and their executives “have complex financial relationships with tissue processors, researchers, testing laboratories, and logistics providers that may create conflicts of interest.”
They also said the committee had “received credible allegations” by senior members. The UNOS Patient Protection and Policy Planning Committee said: “The UNOS may have undisclosed commercial interests and may be using their leadership position at UNOS to enrich themselves at the expense of patient care.'' There is.”
“These inconsistent financial and business relationships allegedly pose significant risks to people in need of life-saving organ transplants,” the letter said.
Many of the questions in the letter concern “any personal financial interests or business relationships.” Management and members of its board of directors have relationships with organizations that do business Work with organ procurement organizations or other similar organizations.
The Association of Organ Procurement Organizations and Midwest Transplant Network in Westwood, Varsity Wisconsin in Milwaukee and the Gift of Life Donor Program in Philadelphia sent an emailed statement to the Post saying they would cooperate with the Senate Finance Committee. He said that
Nicole L'Esperance, a spokeswoman for the commission, said she was still waiting for an answer and could not give an answer yet. Comments on the findings.
Lawmakers and investigators are not the only ones who have doubts about the business practices of organ collection organizations.
In a December lawsuit, a procurement group sued a neighborhood group. An attempt to lure a large nonprofit medical network in Reno by offering $6 million to start a new organ transplant program.
Lawyers for Donor Network West say the organization has been a federally designated entity in northern Nevada, including Reno, for about 40 years. They said the Nevada Donor Network, an organization for the rest of Nevada, It provided funding to the medical network to become its procurement organization.
They also argued that the money comes from federal pandemic stimulus funds meant to help the nation recover from the coronavirus crisis.
about 3 weeks After filing the lawsuit, Donor Network West released a statement saying that unless CMS grants hospitals a waiver, the health network will retain Donor Network West as its procurement group. The lawsuit continues.
The Nevada Donor Network said it does not comment on pending litigation, “but we look forward to hearing the facts of this case.”
