CMS Finalizes Changes to Organ Procurement Organization Conditions for Coverage

King & Spalding

On November 20, 2020, CMS issued a final rule (the Final Rule) strengthening the Organ Procurement Organization (OPO) Conditions for Coverage. The new Conditions of Coverage will subject OPOs to greater scrutiny with the intent of improving OPO performance, thereby increasing the number of organs available for transplant.

OPOs are non-profit organizations that are responsible for the procurement of organs for transplantation. There are approximately 58 OPOs operating in the United States with each assigned to their own donation service area. CMS is responsible for conducting surveys of OPOs and re-certifying them every four years based on whether they meet Conditions of Coverage, which include outcome and process measures. Under current rules, OPOs must meet minimum thresholds for at least two of three outcome measures: (1) the donation rate of eligible donors, (2) the observed – or actual – donation rate, and (3) donor yield (meaning the number of procured organs donated per donor). See 42 C.F.R. § 486.318. The existing outcome measures are calculated using data self-reported from OPOs.

Overall, CMS’s changes are intended to increase OPO performance and transparency, and foster competition among OPOs. The key provisions in the Final Rule include:

  • Donation Rate Measure – CMS is changing the OPO donation rate measure to encourage OPOs to pursue all potential donors, even those who are only able to donate one organ.
  • Transplantation Rate Measure - OPOs will no longer receive credit for simply procuring an organ – it must be actually transplanted to count. This change is intended to incentivize OPOs to procure and match all viable organs with recipients.
  • Increased Transparency - CMS is making outcome measure performance public to increase transparency.
  • 12-Month Review Periods – CMS is increasing the number of reviews conducted. CMS will begin reviewing OPO performance every 12 months throughout the four-year recertification cycle.
  • 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. 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.
  • 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.
  • Increased Competition – Under the Final Rule, underperforming OPOs will be required to compete for their organizational contracts – which are necessary for them to function as OPOs – and the lowest performing OPOs will be unable to renew their contracts.
  • Objective Data – CMS is no longer accepting self-reported data from OPOs and will instead calculate outcome measures using death certificate data.

The new outcome 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 certification purposes in 2026.

CMS’s fact sheet is available here. The Final Rule is available here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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