The Centers for Medicare & Medicaid Services has finalized changes to the rules for organ procurement organizations, which coordinate the recovery and placement of organs from deceased donors. The rule is scheduled to be published in the Federal Register on November 3. It changes competition, appeals and quality requirements while keeping the existing donor and transplant performance measures and three-tier structure, CMS says.
Service areas and oversight
CMS says 54 organ procurement organizations currently serve 55 donation service areas. The final rule clarifies when a service area opens for competition and allows an organization to serve more than one area. It also revises designation and appeal procedures. These are changes to the organizations' Medicare and Medicaid conditions for coverage, not a direct change to a patient's place on a transplant waiting list.
The rule specifies how an organization taking over a new service area is assessed when a full 12 months of performance data are not yet available. Its revised hospital-agreement text requires an organization to have written agreements with 95 percent of Medicare and Medicaid participating hospitals and critical access hospitals in each of its service areas that have both a ventilator and an operating room and have no CMS waiver to work with another organization. The agreements must describe both parties' responsibilities for donation after cardiac death when the organization has such a protocol, address specified hospital requirements, and define “timely referral” and “imminent death.”
Quality failures named
The rule's quality-assessment provisions identify examples of adverse events. They include avoidable loss of a medically suitable potential donor after consent; delivery to a transplant program of an organ not meant for the intended recipient or whose blood type does not match that recipient; and an organ lost, delayed until too late for transplantation, or arriving in a condition incompatible with transplantation. These are categories organizations must address under the requirements, not a count of events that occurred.
CMS says the rule does not change its focus on donor and transplant volume in the outcome measures or the tier structure used for recertification and decertification. Its public-inspection DATES line leaves the effective date as 60 days after publication, still in a bracket. Publication is scheduled, so this record does not state a fixed effective date or claim a measured increase in available organs.