CMS finalizes rule to improve performance of organ procurement organizations

On Nov. 20, CMS issued a final rule regarding how the performance of organ procurement organizations is measured in the United States.

According to a CMS press release, “the rule enacts sweeping reform of the Medicare Conditions for Coverage (CfCs) for Organ Procurement Organizations,” with the primary aims being to change how OPOs are held accountable and to motivate “underperforming” organizations to perform as do those in the top 25%.

“Today’s final rule is an opportunity to improve the quality of life for millions of Americans,” CMS AdministratorSeema Verma,said in the release. “Organ transplants offer hope for a fuller life untethered from dialysis machines and waiting lists. We’re helping to increase the supply of donated organs available for transplant by making sure OPOs are performing at optimal levels.”

Many of the measures are consistent with those released in the proposed rule, which Healio Nephrology reported on in December 2019 (more details can be foundhere). The proposed changes, now in the final rule, include 12-month reviews of the organizations and publicly available rankings. In addition, changes have been made regarding how the donation rate is measured (aimed at encouraging OPOs to pursue even donors who can only donate one organ) and how the transplantation rate is measured (from the number of transplanted organs in an OPO donor service area to a percentage of inpatient deaths among patients 75 years old or younger who experience mortality from organ donation).

CMS estimates these changes could increase the number of organs available for transplant by 5,600 per year and that the annual number of transplants performed could increase from approximately 33,000 to 41,000 by 2026.

A related fact sheet highlighted additional changes to the following key areas, not included in the proposed rule: performance tiers and increased competition.

More specifically, OPOs will now be placed in one of three tiers at the end of each re-certification cycle.

“The highest performing OPOs that are ranked in the top 25[%] will be assigned to tier 1 and automatically recertified for another [4] years,” CMS wrote. “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 [donation service areas] 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.”

In addition to ensuring the highest performing OPOs are awarded with OPO DSAs at the end of each re-certification cycle, DSAs for tier 2 and tier 3 will be opened for competition, with only OPOs in tier 1 and tier 2 able to compete.

“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,” according to CMS. “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.”

In a statement, HHS SecretaryAlex Azarcommented on the rule.

“There are few more transformative interventions for someone’s health than an organ transplant, but thousands of Americans are deprived of this lifesaving opportunity every year by a broken system,” he said. “By making overdue reforms to hold organ procurement organizations accountable, we’re giving thousands of Americans waiting for organ transplants a chance at better, longer, and healthier lives.”

The new measures will be implemented on Aug. 1, 2022, and full enforcement will begin in 2026. To read the final rule in full, please visit:https://www.cms.gov/files/document/112020-opo-final-rule-cms-3380-f.pdf.