End-Stage Renal Disease (ESRD)

For information regarding the enrollment process for ESRD Treatment Facilities, please visit the CMS enrollment information website.

 Documents Required for Certification: CMS 3427 (ESRD Application/Notification and Survey/Certification Report)

The Health Standards Section (HSS) of the Bureau of Health Care Financing is contracted by the Centers for Medicare/Medicaid Services (CMS) to perform initial and periodic surveys and to certify whether providers of services meet the ESRD Medicare Conditions for Coverage. Compliance with the ESRD Conditions for Coverage is a requirement to participate in Medicare. Such Medicare approval, when required, is a prerequisite to qualifying to participate in the State Medicaid program as well.

Due to substantial federal resource limitations, HSS must currently adhere to a priority schedule when responding to requests from new hospital providers seeking to participate in Medicare. CMS now requires HSS to place a higher priority on recertification of existing Medicare-certified facilities & complaint investigations than for initial certification surveys of facilities newly seeking Medicare participation.  Please note that initial certification surveys are to be conducted in accordance with the guidelines listed in the Memorandum to Prospective Providers Seeking Initial Medicare Surveys.

New providers must be in operation and providing services to patients when surveyed for certification.  This means that at the time of the survey, the institution must have opened its doors to admissions, be furnishing all services necessary to meet the applicable provider definition and demonstrate the operational capability of all facets of its operation.  In addition to these guidelines, the state agency must receive notice from the Fiscal Intermediary that the CMS 855 form has been approved.  Please contact your fiscal intermediary for any additional requirements.

This agency is responsible for determining compliance with Medicare/Medicaid regulations and certifying its findings to the CMS Regional Office, which will make the decision as to whether you qualify for participation in the Medicare/Medicaid program.  A provider participating in the Medicare/Medicaid program under this approval will continue to be eligible to participate until a determination on non-compliance is made.

Current regulations require that the effective date of the provider agreement can be no earlier than the completion date of the certification survey, assuming all requirements are met.  In the event that a deficiency is cited at the initial certification survey, the effective date will be no earlier than the date that the facility provides an acceptable Plan of Correction.

You are cautioned about accepting Medicare/Medicaid beneficiaries prior to confirmation by the Department of Health and Human Services Regional Office, in Dallas, Texas, of the effective date of the Health Insurance Benefits Agreement.  You should notify the beneficiary or his representative, in writing, of the beneficiary’s financial responsibility in the program.

1. Provider Checklist (Please ensure all documents on the checklist have been completed before submission.)
2. A Licensing Application Form approved by the Health Standards Section must be completed.
3. Applicable licensing fees ($600 plus $5 per station). Payment Procedure This fee is not refundable in the event the facility fails to meet the licensing requirements and HSS determines that a license could not be issued.
4. A Letter of Intent must accompany each licensing application describing the DBA name of the facility to be licensed, the geographical address of the ESRD requesting to be licensed, the anticipated date of completion of the ESRD or the anticipated date by which the facility would be ready for licensing, and the types of surgical specialties to be provided in the ESRD.
5. Please complete and submit the CMS-855A to your Fiscal Intermediary as soon as possible.
6. Ownership Structure Example
7. Architectural plan approval letter from Plan Review 
8. HSS-ESRD-09 Attestation Form
9. Office of State Fire Marshal certificate for occupancy.
10. Office of Public Health certificate for occupancy.
11. ESRD Application and Survey and Certification Report (Form CMS 3427)
12. Life Safety Code Attestation for Exempt ESRD Facilities Form (HSS-LSC-ESRD)
13. Attestation for Compliance with Plan Review Directives Form (HSS-PR-ESRD)

An on-site announced licensing survey will only be scheduled and conducted by HSS after submission of all required documents.  

A renewal letter will be mailed to the provider from the Health Standards Section approximately 75 days in advance of the license expiration date.

Items that shall be submitted to the Health Standards Section for a license renewal:

• Licensing Application
• Licensing fee: There has been a change in the Payment Procedure. Please follow the link for instructions.
• Copy of the current Fire Marshall Inspection
• Copy of the current Health Inspection Report

Once all requirements have been met, a new license will be mailed to the provider on the 20th or 21st of the month before the current license expires.

(Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20)

(f) Standard: Involuntary discharge and transfer policies and procedures. The governing body must ensure that all staff follow the facility’s patient discharge and transfer policies and procedures. The medical director ensures that no patient is discharged or transferred from the facility unless –

1. The patient or payer no longer reimburses the facility for the ordered services;
2. The facility ceases to operate;
3. The transfer is necessary for the patient’s welfare because the facility can no longer meet the patient’s documented medical needs

(Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20)

1. The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team—
   1. Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record;
   2. Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge;
   3. Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility;
   4. Contacts another facility, attempts to place the patient there, and documents that effort; and
   5. Notifies the State survey agency of the involuntary transfer or discharge.
2. In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure.