Kidney News in Brief: December 18, 2025

Here is a look at recent developments and headlines in nephrology.

 Changes Coming to ESRD PPS in 2026

Changes are coming January 1, 2026, under the Centers for Medicare & Medicaid Services (CMS) final rule updating the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS). The ESRD PPS base rate will increase to $281.71 per treatment. Under the 2026 rule, Medicare expects to pay $6 billion to roughly 7,600 facilities for providing renal dialysis services. The rule also establishes a new nonlabor cost adjustment for ESRD facilities in Hawaii, Alaska, and US Pacific Territories.

The update aligns acute kidney injury dialysis payments with the ESRD PPS rate and revises outlier policies. It also modifies the ESRD Quality Incentive Program; starting with Payment Year 2027, three health equity and social driver measures will be removed. In Payment Year 2028, 23 questions will be removed from the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems survey.

Under the final rule, the ESRD Treatment Choices Model will also terminate early, on December 31, 2025. The CMS Innovation Center program, which incentivized home dialysis and transplant waitlisting, did not meet projected improvements in patient outcomes or cost savings, prompting the model’s termination.

CMS Launches ACCESS Model to Expand Technology-Supported Care for Chronic Conditions

The CMS has introduced the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, a 10-year voluntary program starting July 1, 2026, designed to expand access to technology-supported care for chronic conditions common among Medicare beneficiaries, including hypertension, diabetes, chronic kidney disease, musculoskeletal pain, and depression.

ACCESS will test outcome-aligned payments that reward care organizations for achieving measurable improvements in patient health rather than specific service volume. Participating organizations may offer integrated, clinician-guided care using in-person, virtual, or digital technologies, including FDA-authorized devices and software, to support condition management and lifestyle modification. Primary care providers and referring clinicians can receive co-management payments while maintaining oversight and coordination.

The model organizes care into four clinical tracks—early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal, and behavioral health—with outcome targets informed by clinical guidelines, including biomarkers and validated patient-reported outcomes. The CMS will monitor performance and publish risk-adjusted results to inform patients and providers. Participating organizations must be enrolled in Medicare Part B, designate a medical director to oversee quality of care and compliance, and meet regulatory requirements, including Health Insurance Portability and Accountability Act and FDA compliance. Applications will be accepted on a rolling basis. 

FDA Grants Breakthrough Device Designation to Implantable Kidney Replacement System

Nephrodite Inc. announced that the FDA has granted Breakthrough Device Designation to Holly, an investigational implantable, continuous kidney replacement system. The Breakthrough status is intended to expedite regulatory review and FDA interaction for technologies addressing life-threatening conditions.

Holly is designed as a continuously functioning implantable system intended to replace kidney function in patients with ESRD. The platform combines hemofiltration technology with biocompatible materials and is engineered to continuously filter waste, balance fluids, and manage electrolytes. The system incorporates intelligent sensors, machine learning algorithms, and remote monitoring to enable physician oversight and is designed to interface with a portable home unit used nightly for dialysis support.

The designation was supported by data from a multiday large animal study demonstrating sustained kidney function replacement with reported safety and performance outcomes. Nephrodite reported that it is preparing for Good Laboratory Practice studies and subsequent regulatory submissions to support first-in-human clinical trials. Holly remains an investigational device and is not approved for commercial use.

CMS Issues National Coverage Determination for Renal Denervation

The CMS has finalized its National Coverage Determination for renal denervation (RDN), extending Medicare coverage to patients with uncontrolled hypertension despite lifestyle changes and medications.

The decision applies to Recor Medical’s Paradise Ultrasound Renal Denervation (uRDN) system and Medtronic’s Symplicity Spyral RDN system, both of which received FDA approval in November 2023. Paradise uRDN delivers two to three doses of 360-degree ultrasound energy to renal sympathetic nerves, while Symplicity Spyral uses radiofrequency energy via a catheter to the same target.

Clinical trials have demonstrated sustained BP reductions with favorable safety profiles. Recor’s RADIANCE program enrolled more than 500 patients in three sham-controlled trials, while Medtronic’s SPYRAL HTN global program studied more than 5,000 patients, including those with high cardiovascular risk.

With coverage in place, the CMS now enables broader access to RDN for Medicare beneficiaries, offering an adjunctive treatment for patients struggling to achieve BP control with conventional therapy.

FDA Approves MediBeacon Next-Generation TGFR System for Point-of-Care Kidney Function Assessment

The FDA has approved the next-generation MediBeacon Transdermal Glomerular Filtration Rate (TGFR) System, including the new reusable TGFR Sensor, for point-of-care assessment of kidney function. The system measures the clearance of relmapirazin, a nonradioactive, noniodinated fluorescent glomerular filtration rate (GFR) agent, using a sensor placed on the skin.

The reusable sensor is designed for comfort, ease of application, and lower cost compared with the previously FDA-approved single-use sensor. The TGFR System is intended to provide efficacy across different age, sex, weight, race, and ethnic groups.

The system was highlighted in a peer-reviewed study published in the Journal of the American Society of Nephrology, demonstrating its use in patients with diverse kidney function and skin pigmentation. MediBeacon noted that more than 700 publications and conference abstracts have been published on preclinical use of transdermal GFR methodology.

MediBeacon plans to offer early access at select academic medical centers in the US and China. Chief executive officer Steven Hanley said the approval positions the company to scale its technology for inpatient and outpatient care and offer a comprehensive, sustainable, and cost-efficient way to assess kidney function.