New CMS Guidelines for Dialysis: Safety, Rights, and Reporting

The new CMS guidelines for dialysis facilities keep the framework of the Conditions for Coverage that any Medicare-certified center must follow, and add scheduled changes to the End-Stage Renal Disease Quality Incentive Program through 2027. Facilities have to run a data-driven quality program, follow CDC infection protocols, protect patient rights, and report clinical performance data to CMS. Missing the mark on quality and reporting can cut a facility’s Medicare payments by up to 2 percent.1CMS. ESRD Quality Incentive Program

What the Quality Program Has to Cover

Every certified dialysis facility must operate a Quality Assessment and Performance Improvement (QAPI) program. It has to be data-driven, and the facility has to track its own performance over time so that gains hold instead of fading.2Legal Information Institute. 42 C.F.R. § 494.110

The QAPI program has to review, at minimum:2Legal Information Institute. 42 C.F.R. § 494.110

  • Dialysis adequacy
  • Anemia management
  • Vascular access
  • Patient satisfaction and grievances

Patients or their representatives take part in building the care plan.3Legal Information Institute. 42 C.F.R. § 494.90 When the facility finds something that puts a patient’s health or safety at immediate risk, it has to correct it right away.2Legal Information Institute. 42 C.F.R. § 494.110

Infection Control and Safety

Facilities have to follow CDC protocols for tracking infections and preventing spread inside the unit. Staff must use proper technique when drawing or giving intravenous medications from vials or ampules, and the facility needs written procedures for cleaning and disinfecting equipment and surfaces. The building has to stay sanitary, and infectious waste has to be disposed of under state and local law.4Legal Information Institute. 42 C.F.R. § 494.30

Patient Rights, Grievances, and Financial Disclosures

When treatment starts, the facility has to inform patients of their rights and responsibilities. A patient can file a grievance inside the facility or with an outside body such as the state survey agency, and can’t be dropped from care or otherwise retaliated against for doing so. Complaints can be filed by the patient personally, anonymously, or through a representative, and the facility has to provide contact information for external bodies like the ESRD Network for anyone who wants to escalate.5Legal Information Institute. 42 C.F.R. § 494.70

If the facility or its parent company helps pay a patient’s private insurance premiums, it has to give that patient clear financial information every year, including how much it is contributing and how different coverage options (Medicare or private plans) affect the patient’s out-of-pocket costs and access to specific providers or drugs.5Legal Information Institute. 42 C.F.R. § 494.70

Data Reporting and the Quality Incentive Program

The ESRD Quality Incentive Program ties a facility’s Medicare payment to how well it performs.6CMS. CY 2025 ESRD PPS Final Rule (CMS-1805-F) Facilities submit clinical and performance data to CMS electronically.7Legal Information Institute. 42 C.F.R. § 494.180 Several changes are phasing in:

A facility that falls short on the combined quality and reporting requirements can see its Medicare payments reduced by up to 2 percent.1CMS. ESRD Quality Incentive Program