While the healthcare delivery and financing landscape is evolving broadly, the treatment, coverage, and payment for end-stage renal disease (ESRD) and chronic kidney disease treatments and services face particular changes and uncertainty in the coming years. Given the number of potential policy changes and expected market events within this therapeutic area, dialysis and kidney care is facing a level of potential disruption perhaps not seen since the introduction of the bundled payment approach to the ESRD Prospective Payment System (PPS) in 2011.

The following issues are top of mind for patients, providers, manufacturers, and payers–both the federal government and (increasingly) Medicare Advantage plan sponsors.

Launch of the Advancing American Kidney Health Executive Order

On July 10, 2019, President Trump signed an executive order to launch Advancing American Kidney Health, an initiative that aims to improve kidney disease care by reducing the number of patients who develop kidney failure and receive care in dialysis centers and increasing the availability of kidneys for transplant. The order set 3 goals with measurable targets to reach by 2030, including:

1. Reduction in the number of Americans developing ESRD by 25%
2. Increase the number of ESRD patients receiving home dialysis or receiving a kidney transplant to 80%
3. Double the number of kidneys available for transplant

The executive order’s policy goals align with statements from President Trump and Health & Human Services (HHS) Secretary Alex Azar to deliver “bold change” to improve prevention, treatment, and transplants for America’s kidney patients.

New Payment Models Incentivizing Home-Based Care

As part of the administration’s push for increased patient choice and encouraging higher quality care for ESRD treatments, CMS proposed the ESRD Treatment Choices (ETC) model—mandatory for selected facilities and clinicians, representing 50% of ESRD beneficiaries—that would adjust payment based on providers’ performance and improvement in home dialysis and kidney transplant rates for their patients. The administration has highlighted the disparity in home dialysis rates in the United States (about 12% in 2016) and this rule—along with 4 additional voluntary kidney care models—represents a significant and targeted effort by CMS to increase the utilization of home dialysis and kidney transplants for Medicare beneficiaries with ESRD.

Providers selected to participate in the mandatory ETC model must understand both the financial up-side opportunities and down-side risks associated with this model and be prepared to adjust treatment patterns accordingly. Dialysis facilities and physicians treating ESRD patients will have to successfully operationalize increased home dialysis and incorporate greater shared decision making with beneficiaries.

Upcoming Access to Medicare Advantage for ESRD Beneficiaries

The 21st Century Cures Act, signed into law in December 2016, allows all Medicare beneficiaries diagnosed with ESRD to enroll in Medicare Advantage (MA) starting in 2021. Today, patients with ESRD are permitted to enroll in MA in only limited circumstances. Last year, approximately 121,000 ESRD beneficiaries were enrolled in MA, while over 537,000 beneficiaries were entitled to Medicare in 2017 because of an ESRD diagnosis.

ESRD beneficiaries may be more likely to enroll in MA in order to receive out of pocket protections, like a maximum out of pocket limit, and supplemental benefits. ESRD beneficiaries enrolled in traditional Medicare are less likely to have access to supplemental coverage because of limitations on Medigap enrollment created at the state level. In 2015, 24% of ESRD beneficiaries had no supplemental coverage compared to only 12% of aged beneficiaries.

MA payment for ESRD differs in significant ways compared to MA payment for the general Medicare population and tends to fluctuate year to year. These differences could take on increased importance starting in 2021 if a growing number of ESRD patients enroll in MA.

Evolving Payment Considerations for New Technologies

While ESRD dialysis services and drugs are paid through a patient- and facility-adjusted bundled payment, CMS has sought to create payment adjustments to (1) account for the additional costs of innovative therapies and (2) incentivize further innovation in this space. While CMS has utilized the Transitional Drug Add-on Payment Adjustment for calcimimetic therapies since January 2018, the payment terms and eligibility criteria for this payment adjustment has evolved and will likely be refined in the coming annual rulemaking cycles. Further, CMS has finalized a new payment adjustment for innovative equipment and supplies—the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies—to drive further innovation in the kidney care space.

Understanding the reimbursement dynamics for these payment adjustments and potential changes to the ESRD PPS bundle payment itself (e.g., bundle rebasing) will be critical for providers and manufacturers.

Conclusion

Avalere is partnering with organizations across the healthcare spectrum to assess the implications these factors may introduce to the broader dialysis and kidney care space. Avalere has deep expertise across a wide range of issues central to the evolving kidney care market, including reimbursement considerations for dialysis treatment, federal- and state-level policy developments impacting providers and patients, and the development and implementation of innovative delivery and payment models. This expertise is all backed by a rich data capability through our Health Economics and Advanced Analytics team.

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