🚨 Special Interests Co-Opted CMS Rulemaking Defying Science 🚨

Below are two new emails obtained through a FOIA request to CMS from SID&T that lay out the development of the scheme. Then ead the first four emails we released.

From: Uehlecke, Nick (HHS/IOS) <Nicholas.Uehlecke@hhs.gov>
Sent: Monday, October 5, 2020 3:20 PM
To: Lynch, Calder (CMS/QA) <Calder.Lynch@cms.hhs.gov>
CC: Parker, Jim (HHS/IOS) <Jim.Parker@hhs.gov>; Yelinski, Dominique (HHS/IOS) <Dominique.Spadavecchia@hhs.gov>
Subject: Are you familiar with this change he is flagging?

Thanks Calder. Looking at the paper there seems to be a change made that would immediately decertify 22 OPOs now instead of 10. Not passing judgement on the policy change as of now, while I do have some questions I will raise in the DS meeting, this change looks like it is pretty impactful. The concern I am raising here is what this does to the impact analysis and what that does to timeline? I have talked with EOP and hope to have concurrent and expedited review of this rule so that we can publish based on the timeline of late October per your confirmation last week. Just want to make sure this change does not effect that.

Thank you

Re: IFC4 a€" I understand that there might be one more addition coming to us? We have asked DS for expedited scheduling for a briefing on the new items so that we can help move this along. Let me know if you hear anything different.

Let’s get this done.

From: Lynch, Calder (CMS/OA) <Calder.Lynch@cms.hhs.gov>
Sent: Monday, October 5, 2020 12:44 PM
To: Uehlecke, Nick (HHS/IOS) <Nicholas.Uehlecke@hhs.gov>
CC: Parker, Jim (HHS/IOS) <Jim.Parker@hhs.gov>; Yelinski, Dominique (HHS/IOS) <Dominique.Spadavecchia@hhs.gov>
Subject: RE: OPOs

are asking for the rule to complete the EO. Thank

FOIA reveals a HHS senior official shortly before adoption warned the flawed metric would close 22 not 10 OPOs. This “pretty impactful” and devastating disruption was not supported by sound data nor vetted prior to the Rule’s release.

From: Wickliffe, Jim (CMS/OSORA) <Jim.Wickliffe@cms.hhs.gov>
Sent: Thursday, April 18, 2019 6:34 AM
To: Postma, Terri L. (CMS/CM) <Terri.Postma@cms.hhs.gov>; Barringer, Elise (CMS/CM) <elise.barrinqer@cms.hhs.gov>; Swygert, Tiffany T. (CMS/CM) <Tiffany.Swyqert@cms.hhs.gov>; Corning, Diane H. (CMS/CCSQ) <Diane.Corning@cms.hhs.gov>; French, Beth A. (CMS/CM) <Beth.French@cms.hhs.gov>; Ahern, Robert J. (CMS/CM) <Robert.Ahern@cms.hhs.gov>; Henry, Renee G (CMS/CCSQ) <Renee.Henry@cms.hhs.gov>; Renals, Kayla B. (CMS/CCSQ)<Kayla.Renals@cms.hhs.gov>; Parker, Lisa M. (CMS/CCSQ) <Lisa.Parker@cms.hhs.gov>; Rice, David (CMS/CM) <David.Ricel@cms.hhs.gov>; Barco, Evell J. (CMS/OSORA) <Evell.Barco@cms.hhs.gov>; Owens, Bryan C. (CMS/OSORA) <Bryan.Owens@cms.hhs.gov>; Wilson, Lynette N. (CMS/OSORA) <Lynette.Wilson@cms.hhs.gov>; Garcia, Vanessa (CMS/OSORA) <Vanessa.Garcia@cms.hhs.gov>; Collins, Mary E. (CMS/CCSQ) <Mary.Collins@cms.hhs.gov>; Blackstock, Sheila C. (CMS/CCSQ) <Sheila.Blackstockl@cms.hhs.gov>; Jones, Martique S. (CMS/OSORA) <Martique.Jones@cms.hhs.gov>; Harris, SheIi E. (CMS/OSORA) <Sheli.Harris@cms.hhs.gov>; Lafferty, Tiffany R. (CMS/OSORA) <Tiffany.Lafferty@cms.hhs.gov>; Hubbard, Lisa A. (CMS/OSORA) <Lisa.Hubbard@cms.hhs.gov>; Cantwell, Kathleen M. (CMS/OSORA) <Kathleen.Cantwell@cms.hhs.gov>; Miller, Ruth A. (CMS/OSORA) <Ruth.Miller@cms.hhs.gov>; Swann, Renee L. (CMS/OSORA) <Renee.Swann@cms.hhs.gov>
Subject: RE: CMS-1717-P--OPPS Segment 1 (0MB PASSBACK)

Attached is OMB's passback on segment 1 and below is a question related to OPPS OPO (which I believe is still being discussed, so it is not clear how germane these comments might be).

Subject: RE: Quick Q on OPPS OPO

Hi Aaron and Rebecca,

Please find attached passback on Seg 1 of OPPS - please note that we did not review the OPO section per HHS request and will await a revised copy and a briefing when HHS is ready. In addition please find two broader comments stemming from the briefing:

We commend CCSQ for its interest in reforming the OPO process. We concur on the importance of this issue and agree we are overdue for change. We request that the agency strengthen its approach overall to increase the likelihood that changes lead to efficiency gains and increased organ transplantation. One specific that comes to mind is that the RFI should be turned into a proposal as we have a clear sense of logical steps to take in this space based on the proposal brought forward by ORGANIZE and the Arnold Foundation.

Would request CCSQ come back with a list of the changes they would like to make in the OPO space and an assessment for how each change will impact the system (i.e., number of additional organ procured). It would be helpful for HHS to aim for a robust shift in line with Secretary Azar's remarks. When ready, would appreciate a briefing from CCSQ on their approach. If possible to have Senior Advisor Boehler speak in that briefing to how the proposal meets the Secretary's call to transform kidney care that would be helpful.

Thank you for the background provided on skin substitutes. Recommend CMS indicate in OPPS that they will develop a quality or outcome linked basis to justify having different categories. In the interim, recommend the CMS propose paying an average amount to both

categories. This is prompted by a concern that the high and low categories may set up a bad incentive structure that distorts development and puts upward pressure on cost.

Please let me know if there are any questions. Will anticipate receiving segment 2 soon.

Thanks

Q

Was the fix in? FOIA reveals officials replacing the traditional RFI process with simply adopting the Organize flawed metric based on poor data.

→ Previously, the reaction inside CMS was telling. John J. Thomas, Director of Standards in CMS's Center for Clinical Standards and Quality (CCSQ) wrote on April 18, 2019: “They didn't even review the OPO part, but requested we turn the RFI into a proposal to adopt the ORGANIZE metric. We're getting outflanked.”

Unnecessary disruption is looming for the world’s leading organ donation and transplant system thanks to a faulty CMS regulation that will decertify up to two-thirds of the nation’s nonprofit organ procurement organizations later this year.

Five SID&T FOIA emails released so far reveal that CMS officials knew they had been “outflanked” and that the process had been co-opted by outside special interests. Science in Donation and Transplant has published links to 23 peer-reviewed studies from leading researchers showing the fatal flaws of a tier-system measurement so fragile that a third of OPOs change tiers every year. That decertification is based on faulty two-year-old data.

Additional FOIA emails alarmingly demonstrate that CMS regulators questioned the Organize/Arnold Foundation, Bridgespan-sponsored Tier system that would decertify more than twice, 22 rather than 10, the number of OPOs. That revelation came shortly before the rule adoption and was not thoroughly vetted for its impact.

Earlier emails show CMS officials warning that an expedited process would not allow sufficient time to study the impact and unintended consequences of new, untested OPO measure.

“WE’RE GETTING OUTFLANKED”

FOIA Emails Demand Pause in CMS Rule

Co-opted by special interests an organ procurement governing rule will cause unnecessary disruption for patients and donor families if not paused immediately.

Below is the first set of emails we released from a FOIA request to CMS from SID&T that outlines the scheme's development. Read the two new emails we just released.

From: bryan@tragos.org [mailto:bryan@tragos.org1 On Behalf Of Bryan Sivak
Sent: Tuesday, August 23, 2016 5:47 AM
To: Shantanu.Agrawal@cms.hhs.gov; Ciccarone, Michael <Michael.Cicca rone@bridgespan.org>
Subject: Intro to the Bridgespan group

Shantanu,

Given your role as the "organ czar" (maybe I should come up with a different title for that...) I wanted to connect you to a team from the Bridgespan Group (Mike Ciccarone is copied here). They are a nonprofit consulting firm that is doing research on policy changes in the organ donation and transplantation space.

They are doing a project to identify policy initiatives that could increase the number of transplants and are hoping to talk with some people at CMS and HRSA to refine these ideas and get a sense of what is required for statutory and regulatory changes. I spoke with them recently and I think they could learn a lot from you.

Mike, Shantanu is a good friend and the Director of the CMS Center for Program Integrity, as well as running point on the organ work that the agency has recently agreed to work on.

Over to you guys!

Bryan

This email marks the start of the 2016 push by Arnold Ventures (then Laura and John Arnold Foundation) to capture federal OPO policy through lobbying CMS with predetermined “research” results.

From: Ciccarone, Michael
Sent: Thursday, September 22, 2016 3:48 PM
To: 'Shantanu.Agrawal@cms.hhs.gov' <Shantanu.Agrawal@cms.hhs.gov>; 'Kate.Goodrich@cms.hhs.gov' < Kate.Goodrich@cms.hhs.gov>; 'Shari.Ling@cms.hhs.gov' <Shari. Ling@cms.hhs.gov>; 'Mary.Greenel@cms.hhs.gov' <Mary.Greenel@cms.hhs.gov>; 'Jonathan. Morse@cms.hhs.gov' <Jonathan.Morse@cms.hhs.gov>; 'Tennille.Brown@cms.hhs.gov' <Tennille.Brown@cms.hhs.gov>; 'Melissa. Heesters@cms.hhs.gov' <Melissa.Heesters@cms.hhs.gov>; 'Melissa.Cooley@cms.hhs.gov' <Melissa.Cooley@cms.hhs.gov>
Cc: 'Simms, Bridget (CMS/CPI)' <Bridget.Simms@cms.hhs.gov>; Ramirez, Juan <Juan.Ramirez@bridgespan.org>; Fu, Lily <Lily.Fu@bridgespan.org>
Subject: Introduction to the Bridgespan Group - Agenda for 2PM meeting tomorrow

Dear Dr. Agrawal and team,

We're looking forward to our conversation tomorrow at 2PM-I will come in person to the Hubert Humphrey Building, and my colleague Juan Ramirez will be joining via VTC. Please find a suggested agenda below, and some context for our work (which we can expand upon tomorrow).

Context for our work: The Bridgespan Group is a nonprofit consulting firm that collaborates with mission-driven leaders to achieve positive social change. This project, funded by the Laura and John Arnold Foundation, is focused on identifying

policy initiatives that could improve the organ donation, procurement, and transplantation space. We are three months into our research and have developed some perspectives which we are now testing with the field, and believe your insights will be invaluable at this stage.

Agenda:

Introduction to our work and objectives
Discuss areas of potential improvement to the organ donation system
Discuss process to facilitate policy change and potential barriers

I look forward to speaking with you soon, and please don't hesitate to reach out with any questions or concerns in the meantime.

Demonstrates Arnold Ventures use of funded proxies (Bridgespan) to engage CMS directly, part of their multi-year “research” and lobbying campaign that ultimately shaped the 2020 Final Rule.

From: Roach, Jesse L. (CMS/CCSQ) [mailto:Jesse.Roach@cms.hhs.gov]
Sent: Tuesday, October 17, 2017 3:25 PM
To: Walsh, Robert (HRSA) <RWalsh@hrsa.gov>; Schwartz, Daniel L. (CMS/CCSQ) <Daniel.Schwartz2@CMS.hhs.gov>; Wilkerson, Peggye A. (CMS/CCSQ) <Peggye.Wilkerson@cms.hhs.gov>; Rice, Melissa C. (CMS/CCSQ) <Melissa.Rice@cms.hhs.gov>
Cc: Jennifer Erickson (B)(6) Oviatt, Lauren E. (CMS/CCSQ) <lauren.oviatt@cms.hhs.gov>
Subject: RE: Transplant metrics for OPOs

I am copying Jennifer on this email. If everyone could give me their ability for a meeting this this week or next, that would be great. I will then set up a meeting so we can get together.

Jesse

Jennifer Erickson, sponsored by Arnold Ventures, embedding herself inside CMS to advance Arnold Ventures and Organize Inc. policy goals.

From: Wickliffe, Jim (CMS/OSORA) <Jim.Wickliffe@cms.hhs.gov>
Sent: Thursday, April 18, 2019 6:34 AM
To: Postma, Terri L. (CMS/CM) <Terri.Postma@cms.hhs.gov>; Barringer, Elise (CMS/CM) <elise.barrinqer@cms.hhs.gov>; Swygert, Tiffany T. (CMS/CM) <Tiffany.Swyqert@cms.hhs.gov>; Corning, Diane H. (CMS/CCSQ) <Diane.Corninq@cms.hhs.gov>; French, Beth A. (CMS/CM) <Beth.French@cms.hhs.gov>; Ahern, Robert J. (CMS/CM) <Robert.Ahern@cms.hhs.gov>; Henry, Renee G (CMS/CCSQ) <Renee.Henry@cms.hhs.gov>; Renals, Kayla B. (CMS/CCSQ) <Kayla.Renals@cms.hhs.gov>; Parker, Lisa M. (CMS/CCSQ) <Lisa.Parker@cms.hhs.gov>; Rice, David (CMS/CM) <David.Ricel@cms.hhs.gov>; Barco, Evell J. (CMS/OSORA) <Evell.Barco@cms.hhs.gov>; Owens, Bryan C. (CMS/OSORA) <Bryan.Owens@cms.hhs.gov>; Wilson, Lynette N. (CMS/OSORA) <Lynette.Wilson@cms.hhs.gov>; Garcia, Vanessa (CMS/OSORA) <Vanessa.Garcia@cms.hhs.gov>; Collins, Mary E. (CMS/CCSQ) <Mary.Collins@cms.hhs.gov>; Blackstock, Sheila C. (CMS/CCSQ) <Sheila.Blackstockl@cms.hhs.gov>; Jones, Martique S. (CMS/OSORA) < Martique.Jones@cms.hhs.gov>; Harris, SheIi E. (CMS/OSORA) <Sheli.Harris@cms.hhs.gov>; Lafferty, Tiffany R. (CMS/OSORA) <Tiffany.Lafferty@cms.hhs.gov>; Hubbard, Lisa A. (CMS/OSORA) <Lisa.Hubbard@cms.hhs.gov>; Cantwell, Kathleen M. (CMS/OSORA) <Kathleen.Cantwell@cms.hhs.gov>; Miller, Ruth A. (CMS/OSORA) <Ruth.Miller@cms.hhs.gov>; Swann, Renee L. (CMS/OSORA) <Renee.Swann@cms.hhs.gov>
Subject: RE: CMS-1717-P--OPPS Segment 1 (0MB PASSBACK) Attached is OMB's passback on segment 1 and below is a question related to OPPS OPO (which I believe is still being discussed, so it is not clear how germane these comments might be).

Hi Aaron and Rebecca,

Please find attached passback on Seg 1 of OPPS - please note that we did not review the OPO section per HHS request and will await a revised copy and a briefing when HHS is ready. In addition please find two broader comments stemming from the briefing:

We commend CCSQ for its interest in reforming the OPO process. We concur on the importance of this issue and agree we are overdue for change. We request that the agency strengthen its approach overall to increase the likelihood that changes lead to efficiency gains and increased organ transplantation. One specific that comes to mind is that the RFI should be turned into a proposal as we have a clear sense of logical steps to take in this space based on the proposal brought forward by ORGANIZE and the Arnold Foundation.

Would request CCSQ come back with a list of the changes they would like to make in the OPO space and an assessment for how each change will impact the system (i.e., number of additional organ procured). It would be helpful for HHS to aim for a robust shift in line with Secretary Azar's remarks. When ready, would appreciate a briefing from CCSQ on their approach. If possible to have Senior Advisor Boehler speak in that briefing to how the proposal meets the Secretary's call to transform kidney care that would be helpful.

Thank you for the background provided on skin substitutes. Recommend CMS indicate in OPPS that they will develop a quality or outcome linked basis to justify having different categories. In the interim, recommend the CMS propose paying an average amount to both categories. This is prompted by a concern that the high and low categories may set up a bad incentive structure that distorts development and puts upward pressure on cost.

Please let me know if there are any questions. Will anticipate receiving segment 2 soon.

Thanks,

Q

Explicit reference to “the proposal brought forward by Organize Inc. and the Arnold Foundation.”

FOIA emails further revealed the standard RFI process was being ignored and that the Organize/Ray Lynch and David Goldberg metric was being adopted as a predetermined result.

The goal was to close, not evaluate, OPOs by ignoring the RFI process and adopting the false evaluations. Waiting list patients and donor families deserve oversight that is accurate, equitable, and grounded in the best available evidence. Those twenty-three peer-reviewed studies, a Congressionally mandated National Academies report, four active federal lawsuits, and the voices of the nation's leading transplant professionals all point in the same direction.

In September 2020, a group of OPO leaders from across the country met with CMS metrics specialists. The OPO group presented concerns with the proposed CMS OPO regulations.

After hearing the presentation, the administrator who remained shared with the remaining OPO leaders that “no one in this meeting disagrees with you. You have to realize that this proposed rule did not come from CMS.”

Pause the rule now and take corrective, data-supported action free from outside special interest interference. The science is clear, and the solutions are available. What is needed now is the will to act before decertification decisions produce consequences that cannot be undone. Patients pay the price for policies that should never have been implemented.

In September 2020, a group of OPO leaders from across the country met with CMS metrics specialists. The OPO group presented concerns with the proposed CMS OPO regulations. After hearing the presentation, the administrator who remained shared with the remaining OPO leaders that “no one in this meeting disagrees with you. You have to realize that this proposed rule did not come from CMS.”

This statement in 2020 has been confirmed with the release of internal CMS emails in which CMS official John Thomas wrote in a FOIA-obtained email that: “They didn’t even review the OPO part but requested we turn the RFI into a proposal to adopt the ORGANIZ metric. We’re getting outflanked. Although I continue to think that the RFI is the best approach initial research indicated the CDC data, at best, 2 years old, we anticipate this and had staff proactively begin drafting proposal language. Not sure what step to take next but think a high-level conversation needs to happen so, at the very least, OS and OMB understand that the measure in question may not be the elegant solution they’ve told it is”