If your facility would like to provide dialysis services as part of the Medicare End Stage Renal Disease (ESRD) Program, you must meet all Medicare Conditions for Coverage, show that you can meet minimum use requirements, and follow the medical review standards for patient care.
If you choose to apply, please submit the following items to our office as soon as possible so we can forward them to the CMS Regional Office:
- Complete the ESRD Application/Notification and Survey and Certification Report (Form CMS‑3427) This form is available in the Downloads section, complete and mail or email it to our office.
- Request the CMS‑855A form and the provider-based questionnaire from your Medicare intermediary/carrier. Direct all questions about these forms to the intermediary/carrier.
- If you are applying as a Provider‑Based Program, your intermediary will be the same as your parent provider. If you are applying as a Free‑Standing Program, your intermediary is Wisconsin Physicians Service (WPS):
Provider Enrollment
PO Box 1787
Madison, WI 53701
Phone: 866‑734‑9444
The intermediary/carrier must approve your facility and notify the State of Missouri before we can conduct an onsite Certification Survey.
- Submit a Narrative Statement that explains the services you will provide and why they are needed.
- Complete the attached Life Safety Attestation and email it to our office.
- Review and follow all instructions on the attached information sheet. (Appendix E Document)
Please find additional guidance, including the ESRD Conditions for Coverage Final Rule and the CMS‑3437 form
These regulations outline the survey and certification process used to determine whether facilities meet Medicare requirements. State health agencies perform these surveys, similar to the process for other Medicare providers and suppliers. As of February 9, 2009, the NFPA 101 Life Safety Code applies to all ESRD facilities. New facilities must follow Chapter 20 requirements for New Ambulatory Health Care Occupancies when located next to high‑hazard areas or when patient exit routes are not at ground level. Facilities must also participate in regional ESRD networks, which help coordinate patient referrals and ensure quality of care through Medical Review Boards.
If you decide to move forward with certification after reviewing the requirements, please keep our Bureau updated on your progress. To allow us to schedule your survey, notify us at least 30 days before you plan to begin operations and again when you receive your first patients.
We will keep your application file open for 90 days after receiving your forms. If we do not hear from you within that time, your file will be closed.
If your facility plans to reuse hemodialyzers or other dialysis supplies, you must follow the voluntary AAMI guidelines (RD 62:2001, RD 52:2004, RD 47:2002/A1:2003 for reuse) as well as all requirements in 42 CFR Part 494, Subparts A–D. Before the initial Medicare survey, please send us—at least two weeks before your planned opening date—a diagram and description of your water treatment and distribution system, along with chemical analysis results (pre‑ and post‑RO) and bacteriologic and endotoxin test results. For Peritoneal Dialysis, water samples are not required, but please provide dialysate bacteriologic and endotoxin results for each dialysis machine.
Please return all completed forms to:
Missouri Department of Health
Bureau of Ambulatory Care
P.O. Box 570
Jefferson City, MO 65102-0570
Email: BAC@health.mo.gov
You will be notified of the CMS Regional Office’s decision once their review is complete.