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CMS-proposed rule revises measures of OPO performance — Part Three

Published Jan. 21, 2020
Written by Alexis Denny, Director of Government Affairs

PART THREE OF FOUR


The effort to address the kidney health crisis in the U.S. started in July when President Trump issued the Advancing American Kidney Health Executive Order (EO). PKD Foundation staff and patient advocates including CEO Andy Betts and myself were there to see this order signed by the President — you can read about our experience in my blog post.

 

Earlier this month, you read an update and primer on the newest rules put forth by the Trump Administration. This week, we will focus on one of those rules.

Revise the Organ Procurement Organization (OPO) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current measures with new transparent, reliable, and objective measures.

This rule, from the Centers for Medicare and Medicaid Services (CMS), part of the Department of Health and Human Services (HHS), is set to take effect in 2022, after an open comment and finalization period. Like the rule we discussed last week, this rule is also designed to address the part of the July Executive Order that identifies an issue with the number of organs available for transplant.

If you read the rule as it is written, it may seem confusing (you aren’t alone!). The critical take-away is that the government will finally be exerting more oversight over the organizations that handle organ donations.

There are 58 nonprofit OPOs in the country, and until now they have functionally been self-regulated and self-reported regarding status and outcomes. Without standardization, the statistics reported do not necessarily tell the full story, so the Administration recognized a critical need to tighten this up. The new rule will put quality metrics in place including (but not limited to):

  • The number of donations that take place each year at each OPO. While this seems an obvious outcome to measure, there are ways to report the number to make it seem like more or less donations occur than truly do. The new rule lays out exactly how to determine those donation rates and will encourage OPOs to seek out all potential donations, even when an individual may only have the ability to donate one organ.
  • More frequent reviews of OPO performance. The new rule will review OPO performance annually; the current review rate is every four years. Additionally, if the performance on key metrics falls below a certain threshold, CMS will require the OPO to put an improvement plan in place.
  • Make donation and transplantation rates of OPOs publicly available, increasing transparency for the public.

CMS estimates that if all OPOs meet the new metrics, the number of transplants will increase by thousands per year.


Stay tuned for the rest of January. Each week we will have a new blog unpacking the details of each new rule, as well as an update on other ongoing policy and advocacy efforts to address issues important to PKD and the larger CKD community.

Next week, the final blog in this series will lay out the current state of advocacy in the PKD and CKD world, and give an update on our latest activities. You won’t want to miss it!

If you have questions, don’t hesitate to reach out via the comments section below or email us at pkdadvocacy@pkdcure.org.

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