On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates the Organ Procurement Organization (OPO) Conditions for Coverage (CfCs) that OPOs must meet to receive Medicare and Medicaid payment. This final rule is an outcome of President Trump’s Executive Order on Advancing American Kidney Health and applies to the procurement of all organs from deceased donors. As a key goal, the President’s Executive Order and this final rule seek to help the almost 109,000 people in the United States currently on the wait list for a lifesaving organ transplant, which far exceeds the number of transplantable organs available. On average, 20 people die every day because not enough organs are available for transplant.
As changing community practices impact donation and transplant rates across the country, CMS also updates the OPO and transplant center regulations periodically to avoid unnecessary burden on healthcare providers while ensuring safe, high-quality care that puts patients first. Specifically, this final rule would revise the outcome measures for assessing OPO performance to ensure they are transparent, reliable, and enforceable; support higher donation rates; help shorten transplant waiting lists; reduce discarded but viable organs; and increase safe, timely transplants that save lives.
BACKGROUND
OPOs are non-profit organizations responsible for the procurement of organs for transplantation. They are the entities legally permitted to recover organs from deceased donors and also provide support to donor families, clinical management of organ donors, and professional and public education about organ donation. Other specific tasks include identifying potential organ donors, requesting consent from the families of donors, procuring organs and working with other agencies to identify potential transplant recipients, and ensuring that organs are transferred to transplant hospitals. There are currently 58 OPOs, each assigned to their own donation service area (DSA).
Several government agencies, including the Centers for Medicare and Medicaid Services (CMS), regulate different aspects of the U.S. organ transplant system. Under federal law, CMS is charged with conducting surveys of OPOs and re-certifying them every four years based on whether they meet the CfCs, which include outcome and process measures. Facilities must correct any problems or deficiencies cited in these surveys in order to continue receiving payment for services from Medicare and Medicaid. If an OPO is decertified, the OPO’s DSA is opened to competition from other OPOs that are qualified to compete. If no OPO competes for the open DSA, CMS will assign one or more other OPOs to serve all or part of the decertified OPO’s DSA. Existing regulations ensure a DSA is never without an OPO for organ procurement services, especially donated organs.
The new measures will be implemented during the next OPO survey cycle, which is scheduled to begin in 2022. OPOs will be held accountable for the new measures for recertification purposes in 2026.
OPOs are critical to the transplant system and tens of thousands of lives depend on them, which is why CMS is finalizing changes to OPO CfCs to improve the quality of OPO services and hold underperformers accountable. These changes aim to drive the performance of all OPOs closer to those in the top 25 percent.
KEY PROVISIONS
Donation Rate Measure
CMS is changing the OPO donation rate measure to the number of organ donors in the OPO’s DSA as a percentage of inpatient deaths among patients 75 years old or younger with a primary cause of death that is consistent with organ donation. A key change from the previous outcome measures is that a donor is now defined as a deceased individual from whom at least one vascularized organ (heart, liver, lung, kidney, pancreas, or intestine) is transplanted, not just procured for transplant, or an individual from whom a pancreas is procured and is used for research or islet cell transplantation. The revised measure will encourage OPOs to pursue all potential donors, even those who are only able to donate one organ. CMS estimates that if every OPO were to meet or exceed this measure, we could have approximately 5,600 more organs per year to transplant.
Transplantation Rate Measure
CMS is changing the OPO transplantation rate measure to the number of transplanted organs from an OPO’s DSA as a percentage of inpatient deaths among patients 75 years old or younger with a primary cause of death that is consistent with organ donation. CMS estimates that if every OPO were to meet or exceed this proposed measure, we could increase the number of annual transplants from approximately 33,000 to 41,000 by 2026.
Performance Benchmark
The performance rates that OPOs will be encouraged to meet for the donation and transplantation rates will be established by the lowest rates of the top 25 percent of OPOs from the previous 12-month period, a ranking that will be publicly available. OPOs with performance rates that are below the top 25 percent will be required to take action to improve their rates through a quality assurance and performance improvement (QAPI) program.
12-month review periods
CMS will review OPO performance every 12 months throughout the four-year recertification cycle to ensure fewer viable organs are wasted and more timely transplants occur. Reviewing OPOs at least every 12 months would allow CMS to more quickly identify OPOs that need improvement so action could be taken to implement needed changes. CMS believes more frequent reviews of OPOs and monitoring of their improvement efforts will promote best practices that will increase the number of organs available for transplant. If an OPO ultimately does not improve enough to meet the outcome measures before the end of the recertification cycle, the OPO may be de-certified and lose its DSA.
Performance Tiers
At the end of each re-certification cycle, each OPO will be assigned a tier ranking based on its performance for both the donation rate and transplantation rate measures and its performance on the re-certification survey. The highest performing OPOs that are ranked in the top 25 percent will be assigned to Tier 1 and automatically recertified for another four years. Tier 2 OPOs are the next highest performing OPOs, where performance on both measures exceed the median but do not reach Tier 1. Tier 2 OPOs will not automatically be recertified and will have to compete to retain their DSAs. Tier 3 OPOs are the lowest performing OPOs that have one or both measures below the median. Tier 3 OPOs will be decertified and will not be able to compete for any other open DSA.
Increased Competition
CMS will ensure that OPO DSAs are awarded to the highest performing OPOs. At the end of each 4-year re-certification cycle, DSAs for Tier 2 and Tier 3 OPOs will be opened for competition. Only Tier 1 and Tier 2 OPOs will be able to compete for DSAs. Tier 2 OPOs will need to successfully compete for their DSA or another open DSA in order to be re-certified for another 4 years. All the DSAs for Tier 3 OPOs will be replaced by a better performing OPO and DSAs for Tier 2 OPOs could be replaced by a higher performing OPO.
Transparent OPO Performance
The new outcome measures improve on the prior measures by using objective, transparent, and reliable data, rather than OPO self-reported data, to establish the donor potential in the OPO’s DSA. CMS will publish OPO performance on the outcome measures annually. CMS believes this transparency will drive OPOs to maintain better performance for the patients and communities they serve.
Implementation Timeline
For the current re-certification cycle ending on July 31, 2022, OPO performance will be evaluated according to the current outcome measures. CMS will implement the new measures on August 1, 2022, beginning full application and enforcement of the new measures in 2026. These changes will hold OPOs to greater standards of oversight, transparency, and accountability while driving higher OPO performance across the board to increase patients’ access to needed organ transplants no matter where they live.
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