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 require patients to be new to the home modality.
  • A minimum of six 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 that the 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 date of receipt by the MAC.

Expansions and Change in Modalities

• Review CMS State Operations Manual (SOM) Chapter 2 (2278-2280) for regulatory requirements.
• It is recommended that you submit plans to BCHS Health Facilities Engineering Section (HFES) for review. Visit the website www.michigan.gov/hfes for instructions on how to submit the plans. 
• Email the following to LARA-BSCSupport@michigan.gov:
  • A completed CMS-3427 form.
  • A floor plan highlighting the area for new stations.
    • Ensure that each station has adequate space to provide for patient privacy, infection control, and safety.   
    • Explanation of building renovations and what mitigations will be taken to protect current patients during construction.
• Once the paperwork is reviewed, BSC will forward our recommendation and applicable paperwork to the Medicare Administrative Contractor (MAC).  The final determination notification will be sent by the MAC.
  • Please note: this process can take 30-60 days from the date of receipt by the MAC.
• BSC may perform an on-site review as needed.

Addition of a Modality

• Review CMS SOM Chapter 2 (2278-2280) for regulatory requirements.
• Submit the following to LARA-BSCSupport@michigan.gov:
  • A completed CMS-3427 form.
    • The facility must indicate at least one patient is on census for each modality requested.
  • A written confirmation of patient’s education and treatment start dates provided by this facility. CMS will not accept the transfer of an already trained home dialysis patient.
• Once the paperwork is reviewed, BSC will forward our recommendation and applicable paperwork to the MAC. The final determination notification will be sent by the MAC. This process can take 30-60 days from the date of receipt by the MAC.
• BSC may perform an on-site review as needed.

Adding a Dialysis Den to a Nursing Home

• Review CMS SOM Chapter 2 (2271a) for implementing the regulatory requirements.
• It is required that you submit plans to BCHS Health Facilities Engineering Section (HFES) and Bureau of Fire Services (BFS) for review and approval. Visit the website www.michigan.gov/hfes for instructions on how to submit the plans. 
• Submit the following to the LARA-BSCSupport@michigan.gov:
  
  • A completed CMS-3427 form.
  • Provide a copy of the written agreement between the ESRD and the nursing home per QSO Memo 18-24-ESRD.
    • The written agreement must be signed by authorized representatives of the Medicare certified dialysis facility and the nursing home prior to the provision of dialysis care at the nursing home and must:
      • Delineate the lines of authority of each party.
      • Delineate the responsibilities of each party.
      • Describe how coordination between the parties will occur.
      • Describe the accountability for the dialysis services provided.
  • Be consistent with the written policies and procedures of the ESRD facility and the nursing home.
  • Specify the method by which the parties will ensure adherence to the terms of the agreement, communicate as issues arise, and take remedial action when appropriate.
  • Be reviewed at least annually and updated as needed.
• BSC will review the submitted documentation. If any questions arise, BSC will contact you for clarification.
• No formal approval will be provided.

Eliminating a Modality

To discontinue providing an approved dialysis modality or dialyzer reprocessing/reuse, it is important to review SOM Chapter 2 (2280) for implementing the regulatory requirements.

• Submit the following to LARA-BSCSupport@michigan.gov:
  • A completed CMS-3427 form reflecting the modalities/services that it plans to provide after the elimination.
  • Written explanation of the changes to include the following:
    • The date the facility plans to eliminate the modality or service.
    • Plans for the transition of patients who rely upon the discontinued service.  
      • Assess each patient who will be affected.
      • Inform patients of their option for continuing treatment.
      • Include patients in the decision-making process.
      • Confirmation that transportation arrangements have been secured for all affected patients.
• Arrange for the transfer of patients to other facilities.
• Report to the Renal Network (info@midwestkidneynetwork.org) with a cc to LARA-BSCSupport@michigan.gov
  • Any patient who feels they were transferred without their consent (involuntary transfer)
  • The date the facility plans to eliminate the modality or service.
• BSC will review the submitted documentation. If any questions arise, BSC will contact you for clarification.
• BSC may perform an on-site review as needed.

Relocations

• A notification of relocation must be completed within 90 days of the move. Review CMS State Operations Manual (SOM) Chapter 2 (2280) and implement the regulatory requirements.
  • It is recommended that a facility submits its plans to BCHS Health Facilities Engineering Section (HFES) for review. Visit the website www.michigan.gov/hfes for instructions on how to submit the plans.
  • Email the following information to LARA-BSCSupport@michigan.gov email box:
    • The floor plan at the new location.
    • The estimated date for opening at the new location.
    • A CMS-3427 form for the new location.
    • A summary of the move to the new location; including how care will be provided to the patients during the transition.
    • The Life Safety Code Attestation form.
    • A contact person (include their name, phone number and email) in case any questions arise.
  • Notify the Renal Network of relocation plans at: info@midwestkidneynetwork.org.
  • No later than one week prior to opening email the following to LARA-BSCSupport@michigan.gov:
    • A confirmation the opening date.
    • The water testing results:
      • The bacterial cultures and endotoxin levels of the water treatment system and the new dialysis machines.
      • The AAMI results of the full chemical analysis.
  • Once the paperwork is reviewed, BSC will forward our recommendation and the applicable paperwork to the Medicare Administrative Contractor (MAC). The final determination notification will be sent by the MAC. Please note, this process can take 30-60 days from the date of receipt by the MAC.
  • Please be advised that the BSC may perform on-site reviews as needed.

• Please Note: Per the State Operations Manual Chapter 2, in the event that an ESRD facility relocates without notifying the BSC or does not submit the above referenced documentation and information to the BSC before relocating patients, the BSC will conduct an immediate jeopardy complaint investigation to ensure that water testing has been done appropriately, there is adequate space for the stations, and all Life Safety Code requirements have been met.

Temporary Closures

A temporary closure may occur as a planned event to allow for repair or remodeling, or as an unplanned event due to damage from a natural or man-made disaster. CMS does not recognize a zero census as a temporary closure. 

• Within one day of the closure, submit the following to LARA-BSCSupport@michigan.gov with a cc to the Renal Network (info@midwestkidneynetwork.org):
  • The reason for the closure.
  • The estimated length of the closure.
    • The projected timeframe for closure must be consistent with the repairs or renovations required.
  • Description of repairs and modifications.
• Monitoring:
  • Email LARA-BSCSupport@michigan.gov when there are changes in the timeline or scope of repair.
    Please note that continued extensions to the timeline may be viewed as a cessation of business which may lead to termination.
• No later than one week prior to reopening email the following to LARA-BSCSupport@michigan.gov:
  • A confirmation of the opening date
  • The water testing results:
    • Bacterial cultures and endotoxin levels of the water treatment system and new dialysis machines.
    • Full chemical analysis results (Association for the Advancement of Medical Instrumentation-AAMI results).
• BSC will review the documentation submitted and respond if it is approved to resume operations.
• BSC may perform an on-site review as needed.

Bureau Phone: 517-284-0193

Bureau Fax Number: 517-763-0214

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

Certification support email for document submission: LARA-BSCSupport@michigan.gov