U.S. launches probe into organ collection organizations

Today’s edition: Many congressional Republicans who have come out in support of fertility treatments co-sponsor a bill protecting life “at conception.” Details on California Gov. Gavin Newsom’s (D) latest foray into red-state abortion politics. But first …

U.S. launches probe into organ collection organizations

Federal authorities have launched a wide-ranging investigation of the nonprofit organizations that collect organs for transplant in the United States, according to six people familiar with the inquiry. 

The probe is seeking to determine whether organ procurement organizations (OPOs) in at least five states have been overbilling the government for their costs, among other concerns. Notably, U.S. attorneys and investigators from the Department of Health and Human Services, alongside the inspector general's office of the Department of Veterans Affairs, are spearheading the effort.

The investigation has been underway for at least several months, but recent developments indicate the probe is intensifying. In a significant move, investigators from the VA inspector general were “dispatched” to the offices and homes of 10 chief executives of organ procurement organizations at the beginning of February “as part of an inquiry,” according to a notice that Steve Miller, chief executive of the Association of Organ Procurement Organizations, sent to his membership.

Serious deficiencies in the nationwide organ transplant system have been the subject of increasing government scrutiny in recent years. But an investigation led by federal prosecutors — which carries the possibility of criminal charges — could be the gravest threat yet to the status quo in the troubled, multibillion-dollar organ transplant industry.

The Association of Organ Procurement Organizations “is aware the Department of Veterans Affairs Office of the Inspector General has made inquiries of some OPOs,” Jenny Daigle, a spokeswoman for the trade association, said in an email. She added that the association hasn’t been contacted by the agency.

A closer look 

The nation’s 56 OPOs play a pivotal role in collecting organs, mainly kidneys, from deceased donors in hospitals and facilitating their transportation to the 250 U.S. medical centers that perform transplants. Each organization holds a government-backed monopoly over a designated area of the country.

Some groups have failed for years to collect enough organs to meet demand, yet none have been decertified by the Centers for Medicare and Medicaid Services — though this may soon change. New benchmarks set by the agency will allow it to weed out poor performers starting in 2026. 

Financially, transplant centers cover certain costs of OPOs, and Medicare reimburses them for additional expenses they say they have incurred for activities like organ acquisition and transportation. Transplant centers are then reimbursed by both public and private payers, depending on the patient.

A primary thrust of the investigation appears to be whether any of the nonprofits have violated the federal False Claims Act by knowingly billing the federal government for unallowable costs. Additionally, investigators are delving into allegations of kickbacks within the closely knit and lightly regulated realm of U.S. medical procurement.

The probe is also examining whether six organ procurement organizations have engaged in fraudulent billing practices targeting both VA and Medicare.

“Organ procurement executives have acted with complete impunity for decades,” said Greg Segal, co-founder of Organize, an activist group that seeks widespread reform of the transplant industry. “They should not be above the law.”

You can read Lenny, Mark and Lisa’s full report here. 

Reproductive wars

Republicans who say they support IVF backed a bill protecting life ‘at conception’

Many of the congressional Republicans who have come out in support of in vitro fertilization since the Alabama Supreme Court ruled that frozen embryos are children and people can be held liable for destroying them have co-sponsored an abortion ban that echoes arguments made in the controversial decision, The Post’s Mariana Alfaro reports. 

The details: The congressional proposal, dubbed the Life at Conception Act, would define a “human being” as “each member of the species homo sapiens at all stages of life,” including fertilization or cloning. It would also extend equal protection under the 14th Amendment to the unborn. Notably, the bill has no carve-out for processes such as IVF, meaning access to the procedure would not be protected. 

The legislation is co-sponsored by 125 Republicans in the House, including Speaker Mike Johnson (R-La.), who, in the wake of the Alabama ruling, told The Post that he supports efforts to allow IVF treatments because he believes “the life of every single child has inestimable dignity and value.”

On our radar: Several lawmakers are now scrambling to introduce bills that would protect fertility treatments. Yet, Sen. Tammy Duckworth (D-Ill.), who utilized IVF to conceive her children, said yesterday that “not a single Republican” has spoken to her about a bill she introduced that would safeguard access to IVF and other assisted reproductive technology services nationwide. 

• “Let’s make it clear: Republicans will say whatever they need to say to try to cover themselves on this,” Duckworth said on ABC News’s “This Week.” “Let’s see if they vote for it when we bring it to the floor.” 

In other news related to the Alabama Supreme Court ruling …

• Alabama Attorney General Steve Marshall (R) has “no intention” of prosecuting IVF providers or families who use their services, according to his chief counsel, Katherine Robertson.
• At least one major embryo shipping company has paused all activity in Alabama until there is more clarity around the decision, Sarah Kliff reports for the New York Times. 

State scan

Newsom escalates abortion rights push in red states

California Gov. Gavin Newsom (D) is kicking off an advertising campaign pushing back against Republican-led efforts to restrict out-of-state travel for abortions and other reproductive health care. 

The six-figure ad campaign and an online petition effort are set to launch today, beginning with a TV commercial targeting two bills under consideration in Tennessee. There, lawmakers are debating whether to make it a felony for an adult to help a minor get an abortion without parental consent, Newsom said yesterday on NBC News’s “Meet the Press.”

• The effort is being paid for by Campaign for Democracy, a political action committee that Newsom launched last spring. 
• The group plans to run similar ads in other states where travel bans are being considered, such as in Alabama, Mississippi and Oklahoma. 

Key context: This isn’t the first time Newsom has waded into red-state politics. The Democratic governor, who is widely viewed as a potential future White House contender, previously aired TV ads and billboards promoting California as an abortion sanctuary in states where the procedure is restricted. 

California Gov. Gavin Newsom (D): 

Meanwhile, across the country …

In the District: The Justice Department said the D.C. government may be violating federal disability law by sending police rather than trained mental health responders to 911 calls for psychiatric emergencies, The Post’s Rachel Weiner reports. 

In Oregon: State officials will no longer require prescription drug companies to compile annual reports on price increases, a key provision of a transparency law enacted in 2018 that the pharmaceutical industry argued was unconstitutional, Ed Silverman reports for Stat. 

Daybook

📅 Welcome back! The House and Senate are both in session this week.

What we’re watching: Congress has until Friday night to figure out how to extend federal finances to avert a partial government shutdown. Lawmakers will start the week under serious time constraints, after negotiations between House and Senate leaders slowed over the weekend because of disagreements about Republican policy demands. 

Remember, funding for 20 percent of the federal government, including the Food and Drug Administration, will lapse on March 2 without action. A deadline for the remaining 80 percent looms just a week later. 

On tap today: Health and Human Services Secretary Xavier Becerra will travel to Jackson, Miss., to tout the Biden administration’s progress toward expanding access to health care in rural areas as part of the president’s Investing in America tour, according to an announcement shared with The Health 202. 

On Wednesday: The Senate Budget Committee will hold a hearing on the economic impacts of restricting reproductive freedom; a Senate Armed Services subcommittee will hear testimony on traumatic brain injuries and blast exposure care. 

Meanwhile, at the agencies, independent advisers to the Centers for Disease Control and Prevention are expected to vote on whether vulnerable groups should again be offered the chance to get a coronavirus booster shot this spring, among other vaccine recommendations. 

On Thursday: A House Energy and Commerce subcommittee will consider legislative proposals to support patients with rare diseases. 

And at The Post, our colleagues will speak with FDA Commissioner Robert M. Califf and other experts in health care about the ongoing challenges around rare diseases. 

Health reads

Alabama embryo ruling may have devastating effect on cancer patients (By Sabrina Malhi | The Washington Post)

As Medicaid shrinks, clinics for the poor are trying to survive ( By Noah Weiland | The New York Times)

One of the last abortion doctors in Indiana (By Peter Slevin | The New Yorker)

Sugar rush

Thanks for reading! See you tomorrow.