Licensing and Regulatory Affairs
This page is designed to assist providers through the federal certification process, as well as provide additional resources to maintain compliance.
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
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):
Addition of Station(s)
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).
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.
After the Move
Involuntary Discharge of ESRD Patient
For a change in administrator, please email BCHS_FedDivision@michigan.gov the following:
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