Opening an ESRD (End Stage Renal Disease) Facility

The procedure for opening an ESRD facility includes first obtaining an approved Certificate of Need (CON) from the State Health Planning and Development Agency (SHPDA:  http://hawaii.gov/shpda).   Applicants interested in participating in the voluntary Medicare/Medicaid programs will need to obtain an approved CON (public hearing process).

The applicant would then submit a copy of SHPDA’s response (an approved CON, or letter indicating that a CON is not necessary) along with a written request to the Hawaii State Department of Health, Office of Health Care Assurance (OHCA), 601 Kamokila Boulevard, Room 395, Kapolei, Hawaii  96707 for opening an ESRD facility.

To open a Medicare certified ESRD, the provider must be approved by their Medicare fiscal intermediary.  The benefit of certification is the provider becomes eligible for Medicare/Medicaid reimbursement for serving Medicare/Medicaid beneficiaries.

Medicare enrollment forms are available on https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/index.html.  The ESRD should contact OHCA when they have received notification that they have been accepted.

OHCA will then request additional documents for review to establish preliminary compliance with personnel, policies and procedures, and water treatment requirements stated in the Conditions of Participation in http://www.gpo.gov/fdsys/pkg/CFR-1999-title42-vol1/content-detail.html.

The initial Medicare survey is unannounced and a one step process with no revisits.  If the survey results in a denial, the initial application process starts anew.  Consequently, any re-application survey should not be expected for up to six months due to other workload priorities.

Our office will perform an initial Medicare certification survey only after the facility has been accepted as a Medicare provider by the fiscal intermediary and the facility has admitted a sufficient number of clients to allow the surveyors to make a reasonable judgment as to a provider’s level of compliance.  This means the ESRD facility can furnish all services necessary to meet the applicable provider requirements and be able to demonstrate that the various operational systems are in place and working.  The provider must be prepared to admit all private pay clients or absorb the cost of care for any Medicare/Medicaid clients admitted during the time between receiving SHPDA approval and the initial Medicare survey.  If there are insufficient admissions/records to review, the application and request for a Medicare survey will be denied.  While it is impractical to prescribe a specific number of admissions necessary to qualify for a certification survey, it is reasonable to expect a provider to admit some clients.  The State Survey Agency will use judgment based on variables such as size of the facility, client population of the geographical area, etc. when determining the number of admissions/records that are needed to indicate a fully operational status.  

The initial certification survey is unannounced and a one step process with no revisits.  If the survey results in a denial, the initial application process starts anew.  Consequently, any re-application survey should not be expected for up to six months due to other workload priorities.

Although the State Survey Agency will attempt to accommodate all requests for initial certification surveys in a timely manner, the State Survey Agency must do so according to national workload priorities as follows:

  1. Recertification surveys and associated revisits of nursing homes and Intermediate Care Facilities for the Mentally Retarded
  2. Recertification surveys of home health agencies
  3. Complaint investigations
  4. Validation surveys of accredited hospitals
  5. Recertification and associated revisits of non long-term care facilities
  6. Initial certification surveys

 
The goal of the survey and certification process is to determine whether a provider/supplier has systems in place that allow for the provision of services that meet certification requirements.