On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet and final rule that updates the conditions that Organ Procurement Organizations (OPOs) must meet in order to have their services covered by Medicare and Medicaid. Fifty-eight OPOs operate in the U.S. as not-for-profit organizations responsible for recovering organs from deceased donors for transplant into waiting recipients.[1],[2] This rule finalizes proposals that implement Section 7 of Executive Order 13879 on Advancing American Kidney Health by “revising OPO rules and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance” as well as other policies:
- Updates definitions for organ, donor, and donor potential;
- Standardizes measurement for donation rate and transplantation rate;
- Increases timeliness of monitoring by reviewing OPO performance every 12 months;
- Sets performance benchmarks at the lowest rates of the top 25 percent of OPOs;
- Expects OPOs not meeting benchmarks to implement improvement efforts; and
- Ranks OPOs in performance tiers at the end of each 4-year recertification cycle with only the highest 25% being automatically recertified for another four years.
The proposed rule is scheduled to be published on December 2, 2020 and the effective date of this final rule is January 31, 2021. The new outcome measures will be implemented during the next OPO survey cycle, which begins August 1, 2022. OPOs will be held accountable for the new measures for recertification purposes in 2026.
CMS believes that the new measures and expectations included in this final rule will improve OPO performance through more timely and transparent monitoring, an increased focus on performance improvement, and the use of tier-ranking to increase accountability. The aim of the final rule is to reduce variation and improve performance across all OPOs so that they achieve outcomes that are consistent with current high-performers (top 25 percent).
CMS Will Standardize OPO Performance Measurement
Under current rules, OPOs must meet minimum thresholds for two of three outcome measures: the donation rate of eligible donors, the observed (or actual) donation rate, and the donor yield (meaning the number of procured organs donated per donor). However, these measures are calculated using self-reporting data and some stakeholders advised CMS that they discouraged OPOs from seeking as many organs as possible for transplantation. To address these issues, CMS finalized provisions that standardize measurement across OPOs.
Definitions
CMS changes various definitions to support the revised OPO performance measures:
- Donor is defined as a deceased individual from whom at least one vascularized organ (heart, kidney, liver, lung, pancreas, or intestine) is transplanted;[3],[4]
- Donor potential is defined as the number of inpatient deaths within the donor service area (DSA) among patients 75 years of age and younger with a primary cause of death that is consistent with organ donation;[5]
- Death that is consistent with organ donation means all deaths from state death certificates with the primary cause of death listed as the ICD-10-CM codes I20-I25 (ischemic heart disease); I60-I69 (cerebrovascular disease); and V-1-Y89 (external causes of death including blunt trauma, gunshot wounds, drug overdose, suicide, drowning, and asphyxiation); and
- Organ is defined as a human kidney, liver, heart, lung, pancreas, or intestine (or multivisceral organs when transplanted at the same time as an intestine).[6]
Measures
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. The revised measure will encourage OPOs to pursue all potential donors, even those who are only able to donate one organ and CMS estimates that if every OPO were to meet or exceed this measure, an additional 5,600 more organs per year would be transplanted.
- Donation Rate = (Donors) / (Donor Potential);
CMS is also 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, an additional 33,000 to 41,000 annual transplants would be performed by 2026.
- Organ Transplantation Rate = (Number of Transplanted Organs) [7] / (Donor Potential);
CMS will Align Recertifications with OPO Performance
To make the most of these standardized measures, CMS will use them to highlight the best and worst OPOs in terms of performance and require them to be transparent and compete on their ability to successfully facilitate transplants. To do this, CMS will increase monitoring and hold OPOs accountable to performance benchmarks. Those OPOs whose performance falls in the bottom 50 percent will be decertified and not able to compete for any donor service area.
Benchmarks
OPO performance benchmarks for the two measures are set at the lowest rates of the top 25 percent of OPOs from the previous 12-month period (approximately the 75th percentile) and these rankings and performance data will be available to the public. OPOs that do not meet these benchmarks are expected to initiate improvement activities as part of their quality assurance and performance improvement (QAPI) programs.
Review Period
CMS will review OPO performance every 12 months during the 4-year recertification cycle
and the Agency believes that this increase in monitoring will foster continuous improvement and corrective actions necessary to increase the number of organs available for transplant.
Performance Tiers
CMS will also tier OPOs at the end of each 4-year recertification cycle based on their performance on outcome measures and their re-certification survey.
| TIER | RANKING | RESULT |
| Tier 1 | Top quartile | Automatically recertified for another 4 years |
| Tier 2 | Second quartile | Will have to compete to retain their DSA(s) |
| Tier 3 | Bottom 50% | Will be decertified and not able to compete for any DSA |
Conclusion
The Administration’s efforts to improve kidney care and transplantation, as displayed in its Advancing American Kidney Health initiative, are significant and more far-reaching than any time since the ESRD and transplant benefits were introduced in the 1970s and 1980s. Along with these OPO changes, CMS is also implementing various kidney disease innovation models, increasing incentives for new dialysis technologies, and allowing ESRD beneficiaries to receive benefits through Medicare Advantage plans. These efforts are especially helpful as the effects of COVID-19 are increasingly felt across the kidney and transplant communities.[8]
[1] The National Organ Transplant Act of 1984 (NOTA) is the authorizing legislation whose aim is to enable and support the equitable distribution of donated organs. This legislation established a national computer registry, called the Organ Procurement and Transplantation Network (OPTN) that matches donor organs with possible recipients. The OPTN is managed by the United Network for Organ Sharing (UNOS), and all 58 OPOs use the UNOS proprietary computer system.
[2] As of November 2020, there were 108,725 persons on waiting lists for a life-saving organ transplant.
[3] Individuals would also be considered a donor if only the pancreas is procured for research or islet cell transplantation as required by Section 371(c) of the Public Health Service Act.
[4] This change requires that an organ be transplanted in order for a person to be considered a donor. The previous definition considered a person a donor if an organ was recovered for the purpose of transplantation.
[5] Quantified using data from the Multiple Cause of Death (MCOD) file maintained by the National Center for Health Statistics.
[6] The pancreas counts as an organ even if it is used for research or islet cell transplantation.
[7] Also includes organs transplanted into patients on the OPTN waiting list as part of research.
[8] Dialysis and kidney transplant mortality during the spring of 2020 increased by 37% and 61%, respectively. (USRDS ADR 220)