Big trade associations representing interests involved in heart, lung and kidney transplants pitched a series of changes to proposed CMS rules to overhaul how the nation's organ donation system works, though the almost 840 public comments were generally supportive of the Trump administration's push to eliminate regional monopolies in organ donation.
The comment period closed on Friday on the proposal issued last year that's intended to raise the standards for organ procurement among the nearly five dozen organ procurement organizations that participate in Medicare, and improve outcomes as well.
The key proposal: All OPOs would have to match the performance of the top 25% in terms of outcomes. CMS estimates this could lead to anywhere from seven to as many as 33 of the OPOs eventually facing decertification. Most of the proposal rules would not go into effect until 2022.
CMS is aiming to improve the way organs are procured and distributed throughout the United States, particularly as some 20 Americans die every day awaiting an organ transplant that never occurs. Its proposed new rules would impose stringent standards to participate in organ procurement, with the goal of a 15% increase in transplanted organs by 2026.
Many of the comments from the provider community came from individual hospitals and healthcare systems, and a few lobbies representing medical specialists. The American Hospital Association, American Society of Nephrology and the Association of Organ Procurement Organizations did not appear to submit comments, though there can be a lag time in publication to the Federal Register.
The AHA, ANS and AOPO did not immediately respond to requests seeking comment.
Spectrum Health, a 15-hospital system in Michigan, was among the largest hospital systems to submit comments. It asked for some minor tweaks to the CMS proposed rules, including OPOs receiving some credit for matching so-called "marginal" organs (that are unsuitable for transplant) to medical researchers. It also raised some concerns about the proposed 25% rule. Specifically, it was seeking clarification as to how a transplant center such as Spectrum could realign itself with another OPO if its current OPO was receiving substandard performance grades.
Sanford Medical Center in North Dakota also submitted comments expressing concern about implementing the 25% cutoff rule.
"The results of such a massive decertification, or anything even remotely resembling it, would significantly disrupt the system. This would likely lead to a substantial decrease in donation," Nadim Koleilat, Sanford's transplant program director, wrote.
The comments submitted by the Society for Thoracic Surgeons included a request that CMS adjust the death rates for transplant recipients for a variety of factors.
"The organ transplantation rate metric should be adjusted for age, demographics and socioeconomic status using well established statistical methods," the comments read. "Donation rate is heavily influenced by these factors. Differences, in these factors, from one OPO to the next will influence donation rates."