End Stage Renal Disease (ESRD)/Dialysis Centers

State licensing is not required for dialysis CMS certified providers.

Important Note: The Centers of Medicare and Medicaid Services (CMS) has suspended some survey activities in order to prepare for the protentional threat of the 2019 Novel Coronavirus (COVID-19). CMS issued Quality, Safety & Oversight (QSO) Memos with details and guidance for infection control and prevention: QSO-20-13-Hospitals, QSO-20-14-NH, QSO-20-15 Hospital/CAH/EMTALA, QSO-20-16-Hospice, QSO-20-17-All, QSO-20-18-HHA, QSO-20-19-ESRD, QSO-20-20-All, QSO-20-22-ASC,CORF,OPT,RHC/FQHCs, QSO-20-24-ASC, QSO-20-28-NH

Dialysis (ESRD) providers may apply for certification to participate in the Medicare/Medicaid programs.  The Centers for Medicare and Medicaid Services (CMS) contracts with LARA to evaluate compliance with the federal regulations by conducting certification surveys and complaint investigations.

FEDERAL CERTIFICATION PROCESS

Initial Application for Federal Certification

An applicant wanting to participate in Medicare/Medicaid must submit a CMS-855A form to the Medicare Administrative Contractor (MAC).  For Michigan, the MAC is Wisconsin Physician Services (WPS).

The facility must be operational prior to submission of a CMS-855A.  Operational means completion of all construction and service being delivered to patients in each modality requested in the CMS-855A.

The MAC will notify LARA once the CMS-855A is approved.  An unannounced initial survey will then be scheduled by LARA.  CMS requires the initial survey to be conducted no later than 90 days after the MAC approval.

If the applicant is not operational, the initial survey will be terminated and a recommendation to deny certification will be made to CMS.  Upon notification of certification denial by CMS, the facility will need to submit a new enrollment application if wanting to continue to seek Medicare certification.  To continue, the facility will need to submit a new CMS 855A.

The following steps are recommended to ensure survey readiness within 90 days after MAC CMS-855A approval (steps are to be followed in the order written):

• Contact the LARA Health Facilities Engineering Section (HFES) at 517-241-3408 for physical plant construction and plan review.
• Upon completion of physical plant construction, again contact HFES to schedule an occupancy survey.
• Once occupancy approval is received from HFES, begin treatment in the requested modalities.
  • Home program evaluation requires patients to be new to the home modality.
  • A minimum of six (6) weeks of patient treatment is required to allow for program evaluation during the Initial survey.
• Once operational, complete the Provider Enrollment Application (CMS-855A) and submit to the MAC.
• Submit to LARA the ESRD Application and Survey and Certification Report (CMS-3427) ESRD Initial Application. 
• Forward to LARA a description of the program, including treatment services offered, the date services were started for each modality, and the hours of operation.

Addition of Station(s)

• Contact the Health Facilities Engineering Section (HFES) at 517-241-3408 for physical plant construction/plan review requirements. Upon notification of project completion, HFES will schedule an occupancy survey, if need is determined.
• Complete and submit to BCHS:
  • ESRD Application and Survey and Certification Report (CMS-3427)
  • Description of the program and treatment, number of stations to be added

• The SA will review submitted materials and determine if an onsite survey will be conducted.

*Please note: Expansion of Services and Addition of Station surveys will be completed as Tier 3, and Initial Certification surveys are now Tier 1 level, as per CMS requirements for FY 2020 (10/1/19-9/30/20).

Relocation

When an ESRD relocates to a new address, the State Agency (SA) has the option to conduct a desk review to approve these requests if documentation submitted by the ESRD facility confirms that its operations remain essentially the same (serving the same patients with the same staff).  The ESRD facility must submit the following information to the SA prior to the move, and an on-site survey may be performed if determined necessary by the SA.

• Contact the Health Facilities Engineering Section (HFES) at 517-241-3408 for physical plant/plan review requirements.

• Complete and submit to BCHS:
  • ESRD Application and Survey and Certification Report (CMS-3427)
    • Include new location request information and date of move.
    • Explain how patients will continue to receive dialysis treatments uninterrupted during the relocation. 
• Submit Life Safety Code Attestation form for the new facility.
• If additional or replacement dialysis machines will be used in the new location, documentation must be submitted to confirm that baseline dialysate, bacteria and endotoxin have been completed on those machines.
• If facility has an approved In-center HD program, provide test document to the SA confirming acceptable results of product water quality testing, including chemical analysis and reports of acceptable results from testing for bacteria and endotoxins at the new location.

After the Move

• The dialysis facility must notify the Medicare contractor (MAC) via a revised CMS-855A within 90 days following the move. 

Involuntary Discharge of ESRD Patient

• Please review the Involuntary Discharge guidance/checklist developed by Renal Network 11.
• Complete Involuntary Discharge of ESRD Patient report form and submit to BCHS to report the involuntary discharge.

For a change in administrator, please email BCHS_FedDivision@michigan.gov the following:

• Facility name, address, and provider #
• New administrator full name
• Effective start date of administrator

Michigan Department of Licensing and Regulatory Affairs
Bureau of Community & Health Systems
Federal Survey & Certification Division
611 W. Ottawa Street
PO Box 30664
Lansing, MI 48909
Phone: 517-284-8953
FAX: 517-241-3354
Email: BCHS-CMSCertification@michigan.gov

• Dialysis︱CMS
• CMS Forms – Federal
• HHS Forms (Civil Rights) – Federal
• State Operations Manual – Federal

• Wisconsin Physician Services (WPS) – MAC/FI