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    Schold JD, et al. Failure to advance access to kidney transplantation over two decades in the United States. JASN 2021; 32:913926. doi: 10.1681/ASN.2020060888

Improving Kidney Payment Model, Increasing Transparency in Transplant Waitlisting, and Creating Medicare Coverage on Innovative Devices

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The American Society of Nephrology (ASN) is actively engaging with the federal government on multiple fronts on a host of issues, from COVID-19 to addressing equity in kidney healthcare. Three current fronts of activity focus on the kidney care payment models, transplant access, and support for payment pathways for innovative devices.

Payment models

Even before the recent delay in the voluntary Kidney Care Choices (KCC) Model, ASN had engaged the Center for Medicare and Medicaid Innovation (CMMI) to advocate for changes in the model based on ASN members' concerns. With ASN's request for CMMI to use the delay until January 1, 2021, to address multiple issues to improve the model, the first item raised was getting Medicare to address the issue of those nephrologists and practices that were planning to participate in KCC and would have been in an Alternative Payment Model (APM) in 2021 and not reporting in the Merit-based Incentive Payment System (MIPS). Medicare has indicated that nephrologists affected in this way will be allowed to file “hardship exemptions” due to COVID-19 and will be excused from reporting in MIPS if they wish—meaning they will receive no adjustment up or down for 2021.

Second, ASN asked CMMI to address modifications to the following areas of concern:

  1. Withholding 30% of payments to avoid clawbacks from participants whose payment exceeded their performance will severely affect cash flow for all practices, particularly small ones, and in many cases preclude participation.

  2. Removing the facility fee will negatively impact the ability of some groups to participate in the model, thereby limiting the scope of kidney patient participation, which is key to the model's success.

  3. Compensating with a transplant bonus may help make up for these two cash flow issues in the longer term. However, because it is paid over 3 years, it cannot overcome the immediate cash flow challenges these two issues create in the short term as well as the challenges of payment of the bonus in the last 2 years of the model.

  4. Overcoming challenges of administering the patient activation measure (PAM) and providing a sufficient opportunity to improve PAM scores. Administering the PAM will be challenging for nephrologists with patients in multiple facilities.

  5. Increasing the payment levels of the chronic kidney disease (CKD) Quarterly Capitated Payment (QCP).

ASN believes the payment pathways of the KCC Model are vitally important steps to improving kidney care, but that the above issues must be addressed for the program to have a chance at success. ASN will update readers as the year progresses.

Transplant access

Transplant issues for 2021 are shaping up as challenging, as always, but also are providing opportunities for change. On March 30, the Biden administration allowed the long-awaited Organ Procurement Organization (OPO) Metric final rule to take effect. ASN supported this step to provide more transparency and objectivity in the OPO performance-rating system with real consequences for underperforming OPOs. ASN also supports more transparency in the area of transplant centers. First, however, it is engaging the Health Resources and Services Administration (HRSA) to address transplant waitlist challenges and the need for increased access to waitlist data for nephrologists and healthcare professionals. These advocacy efforts are designed to both increase access to transplantation and provide the transparency needed to address inequities in the transplant process.

Recently published research in JASN demonstrated that waitlist practices have not improved waitlist times over the last two decades (1). “Our study highlights the failure to improve waitlisting for ESRD [end-stage renal disease] patients that greatly impacts our most vulnerable patients over the past two decades,” said Sumit Mohan, MD, MPH, FASN, one of the study's authors.

Payment pathways for innovative devices

The lack of innovation in kidney care remains an important issue. By addressing the payment for innovation in all of healthcare, ASN is urging the Centers for Medicare & Medicaid Services (CMS) to implement the Interim Final Rule (IFR) “Medicare Program: Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary.'” MCIT will provide a Medicare coverage pathway for US Food and Drug Administration (FDA)-designated breakthrough medical devices. The MCIT program will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices, and coverage would last for 4 years. The goal is that this new coverage pathway will offer beneficiaries nationwide predictable access to new, breakthrough devices to help improve their health outcomes.

ASN has long advocated for streamlined approaches to Medicare coverage of innovative medical devices and diagnostics that improve health outcomes for beneficiaries who suffer from kidney diseases—especially kidney failure. Although ASN's comments have most recently dealt with the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) in the ESRD bundle, ASN urged CMS to implement the MCIT program on May 15, 2021, as scheduled.



Schold JD, et al. Failure to advance access to kidney transplantation over two decades in the United States. JASN 2021; 32:913926. doi: 10.1681/ASN.2020060888