Prominent medical groups fear a federal push to increase organ transplants could face a significant slowdown under a proposed rule by the Biden administration that would reduce Medicare payment for certain costs related to the organ acquisition process.

One payment revision in the proposed rule would save an estimated $4.1 billion over 10 years and help cut wasteful and duplicative program spending—sometimes for organs not used by Medicare beneficiaries. It would reimburse only for “organs transplanted into Medicare beneficiaries so that Medicare more accurately records and pays its share of organ acquisition costs,’’ the proposal said.

This change and others sought by the Centers for Medicare & Medicaid Services would “provide clarity and allow providers and stakeholders to more easily locate and understand organ acquisition payment policy, resulting in more accurate payment based on reasonable cost principles,” the proposal states.

Transplant hospitals, doctors, and organ procurement organizations (OPOs) say the proposals would hurt the acquisition of organs from deceased donors—and access to those organs—while increasing the number of patients who die while awaiting a transplant. 

That’s partly because the proposal specifies that an organ wouldn’t be eligible for reimbursement as a “Medicare usable organ or a total usable organ” if it’s found “upon initial inspection or after removal” to not be “viable” or “medically suitable for transplant” and “is determined to be unusable and discarded.”

That provision could make transplant centers and OPOs “risk averse” when acquiring organs, said Jerry McCauley, vice president of the board of directors at the United Network for Organ Sharing. If procured organs are “not clearly transplantable, then you may want to skip them for financial reasons. And that would reduce the number of transplants we’re doing,” McCauley said in an interview. 

That could slow the growth of procuring organs from marginal and less-than-perfect donors, like older people and those with hepatitis C, said McCauley, a nephrologist in Philadelphia. Previously these kinds of donors would have been rejected for transplants, but medical advances have allowed less-than-perfect organs to be transplanted in certain patients.

Effort to Increase Donations, Transplants

Those medical advances helped fuel a Trump administration push to increase organ donations and transplants by harvesting more suboptimal organs. But the new proposed rule could make that effort more difficult, according to groups like UNOS, the American Medical Association, the American Society of Transplant Surgeons, and the American Association of Kidney Patients.

In a joint public comment letter, these groups, hospitals and other organizations expressed their frustration.

“We are puzzled that these proposals have been put forward at a time when CMS has clearly acknowledged that transplantation is generally the best and most cost-effective treatment option for those with end-stage renal disease and is undertaking numerous initiatives focused on increasing the availability of kidney transplantation,” the letter said.

What’s equally troubling, the groups say: The proposed rules don’t consider the potential increased costs that Medicare would incur, like additional dialysis treatments, if access to transplants are reduced under the measure.

“For these reasons, we strongly urge CMS not to move forward with the proposed transplant-related proposals in the IPPS Proposed Rule prior to completion of a comprehensive study of the potential impact,” the letter states. If finalized, the payment rule would take effect in October 2021.

The proposed payment rules comes amid heightened scrutiny of the nation’s 57 nonprofit OPOs. The groups, which connect organ donors with recipients, have faced criticism for questionable spending practices, poor performance, and not making enough organs available for transplant. The Senate Finance Committee and the House Committee on Oversight Reform are conducting separate investigations into their operations.

Medicare has always paid all organ acquisition-related costs incurred by OPOs “because we assumed that all kidneys procured were for Medicare beneficiaries,” the proposed rule said. “However, we now realize that this assumption is incorrect and that technology has allowed a significant number of kidneys to be shipped overseas. Since the Medicare program has been paying the cost of procuring kidneys shipped overseas or transplanted into non-Medicare beneficiaries, we believe that some action needs to be taken.”

‘Aggressive Oversight’ Sought

Greg Segal, CEO of Organize, a nonprofit patient advocacy organization, said he supports the proposal’s enhanced financial oversight of the organ procurement process.

“The current OPO financial reimbursement structure is in direct tension with the goals of maximizing organ recovery and maintaining Medicare program integrity,” Segal said in a statement. “Given the equity implications of OPO reform as well as research showing that COVID-19 increases the need for organ transplants, it’s critical that the Administration and Congress provide aggressive oversight.”

But the proposed changes would come at a price. Currently “organs that are procured at a Transplant Center hospital and transplanted at another Transplant Center are ‘counted’ as Medicare organs for the purpose of determining Medicare’s portion of organ acquisition costs,” the industry groups said in their letter.

This feature provides a “strong incentive for Transplant Center hospitals to establish effective programs for the identification of potential deceased organ donors,” the letter added. “The incentive has worked: Transplant Centers constitute only 4% of Medicare certified hospitals but retrieve 36% of deceased donor organs.”

The “precipitous elimination” of that feature under the proposed rule “has the potential to significantly reduce the deceased donor organs available for transplantation, reduce access to transplantation, and increase the number of patients who die while waiting for a transplant,” the letter said.