HHS proposed rule adds new performance measures for organ procurement
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HHS has released a proposed rule that sets new performance measures for organ procurement organizations in the United States.
The changes are part of the efforts by the Trump administration and the HHS to meet the goals of the Advancing American Kidney Health. That initiative, announced last July, calls for doubling the number of kidneys available for transplant by 2030.
In a press release, HHS said the aim of the new measures is to change the way organ procurement organizations (OPOs) are held accountable for their performance.
“Our broken system of procuring organs and supporting kidney donors costs thousands of American lives each year,” HHS Secretary Alex Azar II, said. “Many organ procurement organizations do wonderful work, but some aren’t performing nearly as well as they could. We’re going to stop looking the other way while lives are lost and hold OPOs accountable.”
CMS Administrator Seema Verma said the new performance standards are needed to reduce the waitlist for organ transplants, which is currently at 113,000, most of which are for kidneys.
“We are modernizing the organ transplant system so our sickest patients can receive the care they need,” Verma said. “An imperfect organ is better than no organ at all. For someone on a waitlist, that may mean the difference between life and death.”
CMS is responsible for conducting surveys of OPOs and certifying them for participation in Medicare based on whether they meet Medicare’s Conditions for Coverage. The performance of OPOs is currently assessed through self-reported data based on measures that were last overhauled in 2006.
“CMS estimates that if all OPOs were to meet both the donation and transplantation rate measures, the number of annual transplants would increase from about 32,000 to 37,000 by 2026, for a total of almost 15,000 additional transplants in that time,” the agency said in the release.
The agency is proposing the following two quality measures in the rule:
- Donation rate measure: This measure would define donors as individuals who provided at least one organ that was transplanted, not just procured. The measure defines the potential organ pool as 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. Organs from those with metastatic cancer, for example, 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, CMS said, which may result in many donated organs going unused. 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. The measure defines the OPO transplantation rate as the number of organs transplanted as a percentage of the donor potential, which would be defined as total inpatient deaths in the donation service area (DSA) among patients 75 years of age or younger with any cause of death that would not preclude a potential donor from donating an organ.
CMS is also proposing that all OPOs meet the donation and transplantation rates of the current top 25% of OPOs, which would be made public. Twelve-month reviews would also be conducted at the end of each re-certification cycle (every 4 years).
The agency said most of the proposed changes would not take effect until 2022, although outcome measures for each DSA would be made public during the next 4-year OPO recertification cycles once the rule is finalized. Comments on the proposed rule are due 60 days after publication in the Federal Register.
In a statement, Kelly Ranum, president of the Association for Organ Procurement Organizations, said, “an independent, verifiable metric for evaluating OPO performance can be an important tool, helping to identify potential opportunities for growth, in OPOs’ quest for continual improvement. We look forward to working with CMS on implementation of the rule and ensuring the metric is used to drive the changes everyone in the donation and transplantation community wants to see.”
Ranum noted that 2018 was the eighth consecutive record-setting year in the United States for procuring deceased donors. That included 10,721 deceased organ donors providing 32,857 organs for transplant, “and 2019 is on pace to be another record year,” she said. “OPOs are committed to working in partnership with all stakeholders to identify and implement system-wide enhancements that will make organ donation and transplantation work even better for those whose lives depend it.”
References:
www.kidney.org/news/newsroom/factsheets/Organ-Donation-and-Transplantation-Stats