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"IĢ����ý�ve had the dubious pleasure of reading thousands of pages of rules and regulations published by the Center for Medicare and Medicaid Services in the Federal Register over the years. IĢ����ý�ve never noticed, even in the footnotes, that the authors of these documents exercised any latent capacity for irony. Consequently, while reading the  rule, I couldnĢ����ý�t quite tell if the ruleĢ����ý�s acronym (Ģ����ý�IOTAĢ����ý�) was intentional or not.

Ģ����ý�Iota,Ģ����ý� denoting the ninth (and smallest) letter in the Greek alphabet, is synonymous with Ģ����ý�a very small amount.Ģ����ý� The IOTA rule lives up to its moniker: By CMSĢ����ý�s own estimates, successful implementation of the rule would increase the total number of (living and deceased donor) transplants by a total of 2,625 kidneys transplanted. By CMSĢ����ý�s own lights, an IOTA of intervention will yield an iota of progress: A mere 1.6% increase in kidney transplant volume over 6 years!

To be fair, for anyone committed to policies which expand access to kidney transplantation, there is a lot to like in the proposed rule: Mandatory enrollment for Transplant Centers selected for the model. Financial incentives and penalties for selected kidney transplant centers will be allotted as payments (or penalties) depending on a CenterĢ����ý�s combined performance on observed-to-expected transplant volumes, rates of organ offer acceptance, and some patient-focused quality measures. Appropriately, the model weights increasing total transplant volumes much more than other measures, since the primary goal of the model is to increase the total number of transplants. CMS has proposed a clever, simple, and easy to understand graft survival metric, which avoids the complex vicissitudes of Ģ����ý�risk-adjustment,Ģ����ý� keeping the focus on prioritizing and rewarding increased kidney transplant volumes. Increasing transplants for economically vulnerable populations are incentivized in a thoughtful, balanced, Ģ����ý�upside onlyĢ����ý� fashion.

Long-sought system-level efforts to improve transparent communication with waitlisted patients are included. The model benchmarks the CenterĢ����ý�s organ offer acceptance rate and requires Centers to notify patients within 30 days about organ offers declined on their behalf by the Center, and/or notify patients biannually about Ģ����ý�filtersĢ����ý� the Center uses to screen out certain organ offers altogether. Fans of Ģ����ý�patient reported outcomesĢ����ý� will appreciate the inclusion of metrics tracking, Ģ����ý�shared decision-making,Ģ����ý� and self-reported comprehension of care transition plans. ThereĢ����ý�s no evidence that these particular (or any) metrics will durably change Center behavior rather than be (another) exercise in box-checking, but it is a reasonable first effort. There are plenty of details to quibble over, but in general, CMS got a lot right.

But, as formulated, IOTA likely wonĢ����ý�t improve overall access to kidney transplants. Both the financial incentives and financial penalties proposed are a scintilla of whatĢ����ý�s needed to pay for the resources needed to fundamentally shift Center behaviors. The proposed rule projects an aggregate total of $26M in bonus payments and only $1M in penalties to 90 enrolled Centers over 6 years. On a per Center basis, that would not fully pay for even one more transplant coordinator. This is all made worse by IOTAĢ����ý�s accounting: The scoring system includes all patients regardless of payer type (great!), but the payments/penalties are only applied to transplanted patients with Medicare Fee for Service (FFS) insurance (primary or secondary). Patients with Medicare Advantage (MA) coverage donĢ����ý�t count as a Ģ����ý�MedicareĢ����ý� transplant for attributing bonuses and penalties, because to do so would require a Ģ����ý�waiverĢ����ý� for the MA rules () which CMS has currently chosen not to pursue. As MA now makes up a large and growing fraction of coverage for Medicare-eligible patients with kidney disease, and as that trend continues, the pool of transplanted patients on which both IOTA bonuses and penalties are based will shrink proportionately.  

Enrolled Centers which failed to meet the requirements of the model could be Ģ����ý�terminated,Ģ����ý� and potentially liable for penalties applied in that performance year, but thatĢ����ý�s it. Centers not interested in expending the efforts and resources needed to succeed in IOTA could just seek termination, treat a one-time fine as the price of ongoing operations, and move on. This isnĢ����ý�t a recipe for change as much as a path to entropy.

If the purpose of the IOTA model is to change entrenched institutional behaviors made more complex by durable, socially influenced health inequities, the revolution will cost more money. This can be accomplished by keeping the proposed IOTA scoring system and quality metrics, while increasing the financial bonuses for successful Centers, increasing the financial penalties (with opportunities for remediation) for less successful Centers, and imposing meaningful multi-year downside performance penalties for enrolled Centers who are terminated from the model for deliberate non-compliance. Kidney transplant programs already operate on thin financial margins everywhere, so financial penalties should not come without built-in opportunities for remediation and appeal. Achieving needed change will be hard, but avoiding needed change should be made much harder.

Increasing organ acceptance rates and overall transplant volume combined with efforts to address access inequities will not be easily or rapidly achieved. It will require meaningful and durable investments in long-term and system-level change, requiring dedicated people and resources to address upstream inefficiencies and the many opportunities for patients to get lost in the referral, evaluation, and waitlisting process, a predictable increase in early post-transplant complications (such as delayed graft function) from using higher risk organs, more downstream resources for continuous care coordination and (considerably less lucrative, but no less essential) long-term post-transplant care to ensure the Ģ����ý�gift of lifeĢ����ý� keeps giving as long as possible.

Here's a recommended approach to fix the IOTA proposal: (a) Increase the financial bonuses from $26M to $260M over six years; (b) Seek a waiver from SSA Section 1851(i)(2) so that transplanted MA beneficiaries are included in the IOTA bonuses and penalties; (c) Narrowing the band of enrolled Centers who receive neither a bonus nor penalty based on IOTA performance; (d) Increase the financial penalties from $1M to $100M over six years with opportunities for remediation and appeal; and (e) Impose meaningful financial penalties on enrolled Centers who are terminated from the model for gross non-compliance with the model requirements. Pay-forĢ����ý�s can be found in increasing transplant volume targets, thereby saving otherwise needed expenditures for maintenance dialysis.

If you care about improving access to kidney transplantation for all patients, submit a public comment to CMS about the new rule. For your reference, Ģ����ýĢ����ý�s public comment has been posted here. Durable change requires adequate funding.  Patients, the public, and taxpayers deserve not one iota less."

Publication date: June 2024