The American Society of Nephrology (ASN) provided comments of support and recommendations for improvement in February 2020 on the proposed rule for Organ Procurement Organizations (OPOs) Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations proposed by the Centers for Medicare & Medicaid Services (CMS). The proposed rule intends to require transparent, verifiable, and uniform metrics by which CMS can evaluate OPO performance.
ASN supported the proposal, writing “[W]ith 115,000 Americans waiting for an organ, ASN supports the proposed rule to establish both transparent, uniform metrics to help assess the performance of each of the 58 OPOs and clear procedures for evaluating those organizations including processes for improvement and re-certification. ASN believes that reforming the current system of OPO performance oversight is necessary to enable the Advancing American Kidney Health goal of doubling the number of kidneys available for transplant by 2030 as well as to approach the proposed target transplant rate described in the ESRD Treatment Choices proposed model and the four tracks of the voluntary model.”
In July 2019, President Donald J. Trump issued the Executive Order 13879 titled Advancing American Kidney Health (1), aspects of which are addressed in the proposed rule. The Executive Order specifically calls on the Secretary of Health and Human Services to “propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising Organ Procurement Organization (OPO) rules and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance.”
In highlights summarizing the major points in its comment letter, ASN stated its support for the following:
■ Using the inclusionary Cause, Age, and Location Consistent (CALC) metric described in the Proposed Rule, as opposed to the proposed denominator that uses exclusionary diagnosis,
■ Avoiding penalties for “zero organ donors,”
■ Opposing risk adjustment based on race and ethnicity,
■ Creating a system that transparently evaluates OPO performance with clear pathways to addressing improvement and consequences for not improving,
■ Reporting outcome measures of organ transplant rates by type of organ, and
■ Taking future steps in other proposed rules to address waitlist criteria, less than ideal organs and patients, and payment issues for less than ideal patients.
CMS proposed to replace the existing outcome measures for OPO recertification with two new outcome measures that would be used to assess an OPO’s performance: “donation rate” and “organ transplantation rate,” effective beginning in 2022. The “donation rate” would be measured as the number of actual deceased donors as a percentage of 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 be an absolute contraindication to organ donation. The “organ transplantation rate” would be measured as the number of organs procured within the DSA and transplanted as a percentage of total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not be an absolute contraindication to organ donation (2).