Organ Procurement Organization (OPO) Conditions for Coverage Proposed Rule: Revisions to Outcome Measures for OPOs
CMS-3380-P
On December 17, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update the Organ Procurement Organization (OPO) Conditions for Coverage that OPOs must meet to receive Medicare and Medicaid payment. The proposal is a directive of President Trump’s Executive Order on Advancing American Kidney Health and would apply to procurement of all organs from deceased donors. As a key goal, the President’s Executive Order and this proposed rule seek to help the more than 113,000 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 proposed 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 wait lists; reduce discarded but viable organs; and increase safe, timely transplants that save lives.
Comments on the proposed rule are due 60 days after publication in the Federal Register.
BACKGROUND
OPOs are non-profit organizations responsible for the evaluation and procurement of organs for transplantation. They are the entities legally permitted by law 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 donor hospitals. There are currently 58 OPOs, each assigned to their own donation service area (DSA).
Several government agencies, including the Health Resources and Services Administration (HRSA), regulate different aspects of the U.S. organ transplant system. Under federal law, CMS is charged with conducting reviews (“surveys”) of OPOs and certifying them every four years based on whether they meet the Conditions for Coverage, including outcome and process measures. Facilities must correct any problems cited in 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. CMS then assigns 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 or access to organ procurement services, especially donated organs. The next OPO survey cycle will begin in 2022, when the proposed changes to the OPO measures would take effect, although the proposed rule seeks comments on whether to implement the changes sooner.
OPOs are critical to the transplant system that millions of lives depend on, which is why CMS is proposing changes 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
A key change to the existing outcome measures, this rule would define donors as individuals who provided at least one organ that was actually transplanted, not just procured. The proposed measure would improve on the current measure by using objective, transparent, and reliable data, rather than OPO self-reported data, to establish the donor potential in the OPO’s service area. If adopted, the revised measure would also encourage OPOs to pursue all potential donors, even those who are only able to donate one organ. Specifically, CMS proposes changing the OPO donation rate measure to the number of organ donors in the OPO’s service area as a percentage of inpatient deaths among patients 75 years old or younger from any cause of death that would not prevent donation (e.g., organs from those with metastatic cancer cannot be transplanted).
Transplantation Rate Measure
The current outcome measure allows OPOs to count organs procured for research as part of their organ count for performance, which may result in many donated organs going unused because there is no penalty for discarding a “less than perfect” organ. Under the proposed measure, an OPO would not receive credit for procuring an organ if it is not transplanted, thus incentivizing OPOs to ensure all viable organs are transplanted. Specifically, CMS proposes changing the OPO transplantation rate measure to the number of transplanted organs from an OPO’s service area as a percentage of inpatient deaths among patients 75 years old or younger from any cause of death that would not prevent donation.
Monitoring and Enforcement
By law, CMS conducts recertification inspections of OPOs for compliance with requirements and performance standards every four years as a condition of Medicare and Medicaid participation and payment. In addition to those periodic recertification inspections, the rule proposes a review of OPO performance every 12 months to provide more frequent feedback to all OPOs. If an OPO’s outcome measures — its donation and transplantation rates — fall below the top 25 percent of OPOs’, CMS would require that OPO to revise its quality assurance and performance improvement (QAPI) program in order to improve. CMS believes more frequent reviews of OPOs and monitoring of their improvement efforts would promote best practices that would increase the number of organs available for transplant.
Performance Benchmark
Under the proposed rule, all OPOs would have to meet at least the donation and transplantation rates of the top 25 percent of OPOs, a ranking that would be publicly available. OPOs with rates that are statistically significantly below the top 25 percent would be required to take action to improve their rates through a quality assurance and performance improvement (QAPI) program, which CMS would assess at least every 12 months. These changes would hold OPOs to greater 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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