End-Stage Renal Disease (ESRD) Centers

State Operation Manual (SOM) Chapter 2

SOM Appendix H

SOM Appendix Z

To voluntarily become a Medicare certified provider, you will need to complete the following steps and submit the paperwork electronically to LARA-BSCSupport@michigan.gov, unless otherwise noted in the instructions.

• Complete Provider Enrollment Application (CMS-855A) and submit to Medicare Administrative Contractor (MAC). The MAC will provide you a recommendation letter once the initial review is complete.

• 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.
  • 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 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 or email: LARA-BCHS-HFES@michigan.gov for physical plant construction, plan review and occupancy survey.
  • Once occupancy approval is received from HFES, treatment in the requested modalities may begin.
  • Home program evaluations 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.
  • Submit the “ESRD Application and Survey and Certification Report” (CMS-3427), a Life Safety Code (LSC) attestation form, a description of the program, including treatment services offered, the date services were started for each modality, and the hours of operation. Send completed documents to LARA-BSCSupport@michigan.gov.

• The MAC will notify LARA once the CMS-855A is approved.  An unannounced initial survey will then be scheduled by LARA, Bureau of Survey and Certification.  CMS requires the initial survey to be conducted no later than 90 days after the MAC approval. If you elect to become accredited/Deemed, please notify Department of Licensing and Regulatory Affairs (LARA), Bureau of Survey and Certification (BSC) at LARA-BSCSupport@michigan.gov. and your accrediting organization.

• Once all of the above documents have been received, your application will be deemed complete and the Bureau of Survey and Certification will review and forward the packet to the MAC for final determination and issuance of the Medicare provider number.
• If an AO completed the initial survey, please ensure the Department of Licensing and Regulatory Affairs (LARA), Bureau of Survey and Certification (BSC) receives a copy of the survey report and final approval letter from your deeming authority.  Please send documents to LARA-BSCSupport@michigan.gov .
• Please note, this process can take up to 30-60 days from the day of receipt by the MAC.

Addition of Stations

• Contact the LARA Health Facilities Engineering Section (HFES) at 517-241-3408 or email: LARA-BCHS-HFES@michigan.gov for physical plant construction, plan review and occupancy survey, if needed.
• Submit the “ESRD Application and Survey and Certification Report” (CMS-3427), a description of the program, the number of stations and the hours of operation. Send completed documents to LARA-BSCSupport@michigan.gov.
• Once all of the above documents have been received, the Bureau of Survey and Certification will review and determine if an onsite survey will be conducted. Once your application is deemed complete, it will be forwarded to the MAC for final determination.

 

Addition Services

•  Submit the “ESRD Application and Survey and Certification Report” (CMS-3427),  a description of the program, the number of stations and the hours of operation. Send completed documents to LARA-BSCSupport@michigan.gov.
•  Once all of the above documents have been received, the Bureau of Survey and Certification will review and determine if an onsite survey will be conducted.  Once your application is deemed complete, it will be forwarded to the MAC for final determination.

 

Addition of Services in a Nursing Home

• Submit the “ESRD Application and Survey and Certification Report” (CMS-3427), a description of the program, the number of stations and the hours of operation. Send completed documents to LARA-BSCSupport@michigan.gov.

 

Relocations

• Contact the LARA Health Facilities Engineering Section (HFES) at 517-241-3408 or email: LARA-BCHS-HFES@michigan.gov for physical plant construction, plan review and occupancy survey, if needed. 
• Submit the “ESRD Application and Survey and Certification Report” (CMS-3427), a Life Safety Code (LSC) attestation form, include date of move, hours of operation, and an explanation of how patients will continue to receive uninterrupted dialysis services during the relocation. Send completed documents to LARA-BSCSupport@michigan.gov.
• Once all of the above documents have been received, Bureau of Survey and Certification will review and determine if an onsite survey will be conducted. Once your application is deemed complete, it will be forwarded to the MAC for final determination.
• If additional or replacement dialysis machines will be used in the new location, documentation must be submitted to confirm that baseline dialysate readings, bacteria and endotoxin levels have been completed on those machines.
• If facility has an approved In-center hemodialysis (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.
• Once all of the above documents have been received the Bureau of Survey and Certification will review and forward the packet to the MAC for final determination and issuance of final approval letter.
• If you do not receive a final approval notice from the MAC within 90 days of submission, please reach out to LARA-BSCSupport@michigan.gov for assistance.

Bureau Phone: 517-284-0193

Bureau Fax Number: 517-763-0214

Help for general questions: LARA-BSCHelp@michigan.gov

Certification Support email (document submission): LARA-BSCSupport@michigan.gov