Efforts to Support Living Donors and OPO Metric Improvements on the Way

By David White, Zach Kribs, and Rachel Meyer

The White House announced Tuesday that the administration is taking action on two policy priorities for ASN: improving the data used to evaluate Organ Procurement Organizations (OPOs) and removing financial barriers to living donation.

The Unified Spring Agenda, released May 22, provides insight into which issues the administration will address through a proposed rule process in the coming months. ASN urged Secretary Azar and other senior administration officials to address these issues during a February meeting and applauds its bold leadership on both fronts.

The Spring Agenda indicated the administration will address transplantation on at least two rulemaking fronts : 

1) removing financial barriers to living organ donation by expanding allowable costs that can be reimbursed; and
2) changing standards used to evaluate Organ Procurement Operations (OPOs) and ensure proper data on available organs and transplants is collected.

“This is an incredibly important moment in nephrology and one that could provide real, meaningful change for our patients, who have been waiting a very long time for that change,” said Scott D. Bieber, DO, and chair of the ASN Quality Committee, that develops policy recommendations, regulatory proposals, and care models.

Living Organ Donor Lost Wages Reimbursement

The notice of the first proposed rule would amend the Organ Procurement and Transplantation Network (OPTN) final rule to “further remove financial barriers to living organ donation by expanding allowable costs that can be reimbursed.”  ASN supported a letter led by Representative Jaime Herrera Beutler (WA-3) in March which requested that the Health Resources and Services Administration (HRSA) change their policy to allow the National Living Donor Assistance Center (NLDAC) to reimburse lost wages and other non-travel expenses of living donors as currently permitted under the National Organ Transplant Act of 1984 (NOTA).

More recently, the House Appropriations Committee included $10 million in funding for the NLDAC (a $6.5 million increase over prior levels), with report language encouraging NLDAC to utilize the funds to reimburse lost wages and other non-travel expenses. Together, this newly proposed rule and increased funding would allow HRSA to reimburse living organ donors for lost wages and other non-travel expenses as soon as both the rule and funding are finalized.

While the full text of the rule has not been released, please visit the following link for real-time updates: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201904&RIN=0906-AB23
 

Objective and Verifiable Metrics for Organ Procurement Organizations

The notice of the second proposed rule would propose changes to the “standards used to evaluate OPOs and ensure proper data on available organs and transplants is collected.” Ensuring that the metrics used to evaluate OPOs are objective and verifiable has been a priority of this current administration.

In anticipation of upcoming movement on this issue, ASN President Mark E. Rosenberg, MD, FASN, wrote to CMS Administrator Seema Verma this week to recommend an alternative quality metric for OPOs in support of the objective of increased transplantation.  Dr. Rosenberg wrote, “that objective is accomplished by using existing data to enable us to identify best practices and opportunities for improvement in organ procurement efforts—critical to enabling more patients to receive a kidney transplant.”  

While the full text of the rule has not been released (including the specific metrics proposed), please visit the following link for real-time updates: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201904&RIN=0938-AU02
 

HHS-Wide Kidney Strategy Forthcoming

The inclusion of these topics in the Spring Agenda may be a sneak preview of the Department of Health and Human Services (HHS)’ comprehensive kidney care strategy, which is anticipated to be unveiled later this summer. The NPRM gives us a glimpse into some of the levers the department will utilize to accomplish one of its core goals for the new strategy, increased transplantation.                              

American Society of Nephrology (ASN) has had extensive, positive dialogue with Centers for Medicare and Medicaid Innovation (CMMI), HHS, and the White House about what the society believes are key components to a comprehensive kidney strategy and is eagerly anticipating the unveiling of the strategy later in 2019.

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David White, Zach Kribs, and Rachel Meyer
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The White House announced Tuesday that the administration is taking action on two policy priorities for ASN: improving the data used to evaluate Organ Procurement Organizations (OPOs) and removing financial barriers to living donation.

The Unified Spring Agenda, released May 22, provides insight into which issues the administration will address through a proposed rule process in the coming months. ASN urged Secretary Azar and other senior administration officials to address these issues during a February meeting and applauds its bold leadership on both fronts.

The Spring Agenda indicated the administration will address transplantation on at least two rulemaking fronts : 

1) removing financial barriers to living organ donation by expanding allowable costs that can be reimbursed; and
2) changing standards used to evaluate Organ Procurement Operations (OPOs) and ensure proper data on available organs and transplants is collected.

“This is an incredibly important moment in nephrology and one that could provide real, meaningful change for our patients, who have been waiting a very long time for that change,” said Scott D. Bieber, DO, and chair of the ASN Quality Committee, that develops policy recommendations, regulatory proposals, and care models.

Living Organ Donor Lost Wages Reimbursement

The notice of the first proposed rule would amend the Organ Procurement and Transplantation Network (OPTN) final rule to “further remove financial barriers to living organ donation by expanding allowable costs that can be reimbursed.”  ASN supported a letter led by Representative Jaime Herrera Beutler (WA-3) in March which requested that the Health Resources and Services Administration (HRSA) change their policy to allow the National Living Donor Assistance Center (NLDAC) to reimburse lost wages and other non-travel expenses of living donors as currently permitted under the National Organ Transplant Act of 1984 (NOTA).

More recently, the House Appropriations Committee included $10 million in funding for the NLDAC (a $6.5 million increase over prior levels), with report language encouraging NLDAC to utilize the funds to reimburse lost wages and other non-travel expenses. Together, this newly proposed rule and increased funding would allow HRSA to reimburse living organ donors for lost wages and other non-travel expenses as soon as both the rule and funding are finalized.

While the full text of the rule has not been released, please visit the following link for real-time updates: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201904&RIN=0906-AB23
 

Objective and Verifiable Metrics for Organ Procurement Organizations

The notice of the second proposed rule would propose changes to the “standards used to evaluate OPOs and ensure proper data on available organs and transplants is collected.” Ensuring that the metrics used to evaluate OPOs are objective and verifiable has been a priority of this current administration.

In anticipation of upcoming movement on this issue, ASN President Mark E. Rosenberg, MD, FASN, wrote to CMS Administrator Seema Verma this week to recommend an alternative quality metric for OPOs in support of the objective of increased transplantation.  Dr. Rosenberg wrote, “that objective is accomplished by using existing data to enable us to identify best practices and opportunities for improvement in organ procurement efforts—critical to enabling more patients to receive a kidney transplant.”  

While the full text of the rule has not been released (including the specific metrics proposed), please visit the following link for real-time updates: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201904&RIN=0938-AU02
 

HHS-Wide Kidney Strategy Forthcoming

The inclusion of these topics in the Spring Agenda may be a sneak preview of the Department of Health and Human Services (HHS)’ comprehensive kidney care strategy, which is anticipated to be unveiled later this summer. The NPRM gives us a glimpse into some of the levers the department will utilize to accomplish one of its core goals for the new strategy, increased transplantation.                              

American Society of Nephrology (ASN) has had extensive, positive dialogue with Centers for Medicare and Medicaid Innovation (CMMI), HHS, and the White House about what the society believes are key components to a comprehensive kidney strategy and is eagerly anticipating the unveiling of the strategy later in 2019.

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Date:
Friday, May 24, 2019