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).
Cause, Age, and Location Consistent (CALC) donation measure
CMS proposed two methodologies for calculating the denominator in these measures: 1) the Cause, Age, and Location Consistent (CALC) donation measure that uses ICD-10 codes to identify deaths that are consistent with donation (that is, inclusion criteria) and 2) an alternative where CMS would exclude ICD-10 codes that are absolute contraindications to organ donation (that is, exclusion criteria).
ASN supported using the inclusionary CALC metric described in the Proposed Rule, as opposed to the proposed denominator that uses exclusionary diagnosis. Although CMS has shown that the net result in terms of among-OPO comparisons is similar, “the CALC metric has superior face validity, because it restricts the denominator to inpatient deaths from causes that are consistent with donation, rather than the exclusionary measure, which includes causes of death that never lead to donation,” ASN commented.
As lead researcher on the CALC metric David Goldberg, MD, and his colleagues accurately summarize, “compared to the current metric that relies on eligible deaths, the benefits of our proposed donation metric are that it:
■ Does not rely on self-reported data,
■ Utilizes a uniform process of estimating the donation potential within each donor service area,
■ Includes potential DCD donors that are excluded from the eligible death definition, and
■ Provides a reliable year-to-year measure of OPO performance to track changes in performance.” (3)
The researchers also write, “[T]hese conclusions should provide CMS, and the transplant community, with comfort that the proposed CMS metric using CDC inpatient death data as a tool to compare OPO is not compromised by its lack of inclusion of ventilation or other comorbidity data.” (4)
Donation rate numerator (or definition of donor)
ASN encouraged CMS to avoid penalizing OPOs under the scenarios when extensive efforts are made to procure organs for transplant, but ultimately no organs are placed for transplant (so called “zero organ donors”). ASN outlined the following scenario as an example that could occur, and credit for the attempt would be denied if only donors from whom organs are transplanted are considered donors:
A deceased (brain-dead or donation after cardiac death) donor is identified that matches a locally available potential recipient.
There is preliminary determination of medical suitability, and preliminary offer acceptance by a transplant center.
The donor is taken to the operating room, but during organ procurement the transplant surgeon unexpectedly finds an unacceptable situation (such as unsuspected intra-abdominal cancer).
The surgeon appropriately cancels use of the organs for transplant.
ASN maintained that the effort and expense to reach this stage is unlikely to lead to “gaming” to obtain credit for donation noting “more aggressive pursuit of higher risk and older donors will likely lead to more identification of medical contraindications at later stages. Aggressive pursuit of organ donors will always be accompanied by some medically appropriate non-utilization.”
Risk adjustment
ASN supported CMS’ decision to not risk adjust based on race, quoting Janice F. Whaley, MPH, CTBS, CPTC, Chief Executive Officer of Donor Network West from the organization’s comment letter to CMS in September 2019 on its proposed rule on “Organ Procurement Organizations Conditions for Coverage: Proposed Revision of the Definition of Expected Donation Rate.”
“As [P}ast-President of the Association for Multicultural Affairs in Transplant (AMAT) and deeply steeped in minority and ethnic concerns during my nearly 30-year career in donation and transplantation, I would like to offer a word about donation and communities of color. Increased focus has been given recently to minority authorization rates and a perceived burden of producing good results in these measures based on the racial and ethnic composition of the OPO service area. This increased attention has been a positive development because it allows for a full-throated discussion about race, ethnicity, and the nexus of organ donation. The view of race and ethnicity needs to evolve in our community much the same as it has for our nation across various assets and services. Minorities donate. Further, in some parts of the country, minorities donate at the same rate as do Caucasians. Thus, it can be done, and when the DSA functions as a true community, it is done.”
Success threshold and expected donation rate/decertification
ASN supported redefining the definition of success and basing that success on how OPOs perform on the outcome measures of donation rate and organ transplantation rate compared with a top percent of donation and transplantation rates for all OPOs.
Currently, CMS conducts recertification inspections of OPOs for compliance with requirements and performance standards every four years as a condition of Medicare and Medicaid participation.
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 . . . .
ASN recommended that CMS “should stagger the end of the four-year deadline so that not all 58 OPOs are on the same deadline—for example, 1/3, 1/3, 1/3 as the elections for the United States Senate are structured— to ensure that as some OPOs are potentially decertified, other higher-functioning OPOs are in existence to maintain the supply of procured organs as well as bid for the contracts of any OPOs that have failed to improve their performance during their four-year window.”
While mindful of the need to ensure access to organs and transplantation, ASN reminded CMS that “[O]verall, however, stakeholders’ fear of change should be weighed against the very real fear, lived and expressed by the patients ASN members serve, that their lives will end before they can access a transplant because OPOs are underperforming. These patients might not receive a transplant because the system has not asked every OPO to meet an objective, verifiable standard of performance with an evidence-based standard of practice.”
Organ transplantation rates by type of organ
ASN supported reporting outcome measures of organ transplant rates by type of organ. The criteria for qualifying for a transplant not only differ based on transplant center, but also on the type of organ. In reporting these data, ASN suggested that CMS consider how to distinguish the rate of organs transplanted versus those that were expected to be transplanted by organ type as well. This ratio would likely differ based on type of procurement, such as thoracic and abdominal organ procurement; donor management factors prior to procurement as these can affect usability and transplant success; and other factors.
Other regulatory steps to improve access to transplantation are expected this year. Follow Kidney News for more details.
