As National Kidney Month comes to a close, Avalere’s kidney care experts have identified five major themes in the policy and market landscape to monitor in the coming year.

CKD: Chronic Kidney Disease; ESRD: End-Stage Renal Disease; PPS: Prospective Payment System

ESRD PPS Bundle Changes

Since the implementation of the present system in 2011, the End-Stage Renal Disease Prospective Payment System has not incorporated oral-only products in its bundled payment. However, CMS has planned for oral-only products (i.e., phosphate binders) to be included in the bundle beginning in 2025.  Federal lawmakers with concerns about limited access and rising dialysis treatment costs are seeking to postpone this action until 2033 or until new therapies become available, whichever comes earlier.

Beyond the potential incorporation of these products, stakeholders also continue to navigate complexities surrounding the transitional drug add-on payment adjustment (TDAPA) and newly-finalized post-TDAPA bundle incorporation. The limited duration of these payment adjustments has introduced concerns over reimbursement opportunities and may limit broad utilization of new products that treat patients in the dialysis setting.

Medicare Advantage (MA) Enrollment

Since 2021 amendments to the 21^st Century Cures Act, patients with ESRD have been able to enroll directly in MA. ESRD Over this period, Medicare enrollment has increased dramatically: as of December 2022, the share of ESRD beneficiaries enrolled in MA plans was 47%. This shift in source of coverage has presented some challenges for stakeholders surrounding payment adequacy; we expect continued advocacy for reforms to determine reimbursement for MA payments.

Innovation in Stakeholder Capabilities

Across kidney care settings, payers and providers are increasingly entering into value-based care arrangements with organizations called specialty kidney care companies. These firms comprise a $15 billion dollar market and offer advanced analytic and care management capabilities. In value-based care arrangements, payers can incentivize high-touch care to drive improvements in outcomes and subsequently reduce the total cost to the plan. We expect to see continued partnerships in the coming year that provide a vehicle to drive innovation in kidney care.

Expanded Treatment Indications

While initially approved for treatment of diabetes and heart failure, sodium-glucose cotransporter-2 inhibitors (SGLT2is) have gained attention based on recently expanded labels to slow the advancements of CKD. This class of drugs is one of many that are increasingly being leveraged to treat patients before CKD progresses to later stages where dialysis may be required.

As is the case across several therapeutic areas, stakeholders are also closely monitoring the potential impacts from glucose-like peptide-1s (GLP-1s) being tested to treat patients with CKD. There is currently speculation about the impact these medications may have on the dialysis market overall, as obesity and diabetes are common drivers of kidney failure and increase patient risk of requiring dialysis treatment.

Transplant System Reforms

Although evidence exists for the clinical and economic benefits of kidney transplantation compared to dialysis as long-term management, longstanding barriers limit improvements in transplantation rates. In 2019, the federal government launched the Advancing American Kidney Health initiative, a top priority of which was to double the number of kidneys available for transplant by 2030. Efforts such as the Organ Procurement and Transplantation Network Modernization Initiative, launched by the Health Resources and Services Administration in March 2023, seek to improve organ donation and transplantation, with specific attention paid toward increasing transparency and availability of data to assist various stakeholder groups, build capacity for modernization, and collaborate with the US Data Service and healthcare industry stakeholders.

Looking Ahead

While the 2024 elections present uncertainty on the future of healthcare initiatives broadly, stakeholders can expect many policy-focused kidney efforts to continue, given historical bipartisan support. Beyond rulemaking and legislative priorities, it is likely that investments in data analytics, research, and treatment will continue to focus on earlier identification and slowed progression of disease.

Avalere is monitoring these developments and will continue to leverage its expertise across policy, market access, data analytics, and quality disciplines to assess how kidney care policy and markets evolve in the coming months. To learn more about the evolving kidney care space and how Avalere can help your business drive access and continuity of care in this dynamic time, connect with us.