NC Division of Health Service Regulation

Please be aware that there may be variations in the process since individual projects may have special circumstances. The flow chart is intended to be a general guide to aid the applicant in completing the overall project.

Contacts: For questions regarding any part of this process, please contact the appropriate sections of the N.C. Division of Health Service Regulation:

Certificate of Need Section	(919) 855-3873
Construction Section	(919) 855-3893
Licensure; Acute and Home Care Branch	(919) 733-1610
Medical Facilities Planning Section	(919) 855-3865

Procedure Summary:
In order to establish a hospice inpatient facility in North Carolina, an applicant first consults the State Medical Facilities Plan (SMFP) to determine if there is a projected need. If the SMFP indicates need for additional hospice inpatient beds, the applicant must apply for a certificate of need. The need for hospice residential care facilities is not set forth in the SMFP, but a certificate of need is required and the applicant must document the need. Applicants successfully obtaining a certificate of need for either type of facility must then apply for and obtain a license. Hospice inpatient facilities and hospice residential care facilities, must also get approval for the construction. Steps for hospice inpatient facilities to obtain certification for Medicare and Medicaid are taken after the facility is licensed and in operation.

Please note:

For Hospice Inpatient Facilities, follow procedures 1, 2, 3, 4 and 5.
For Hospice Residential Care Facilities, follow steps 2, 3, and 4.

Step	Process followed
1.0	Consult the State Medical Facilities Plan: Medical Facilities Planning Section
1.1	Applicants can learn the number of hospice inpatient beds needed in the annual State Medical Facilities Plan (SMFP), which is published for each calendar year and which specifies where in the state they are needed. The SMFP does not set forth the number of hospice residential care beds that are needed, rather the applicant must document need in the proposed service area.
1.2	Applicants can also find the certificate of need review schedule and deadlines for submittal of applications for both hospice inpatient and hospice residential care beds in the SMFP. No one may develop new hospice inpatient beds or hospice residential care beds without first obtaining a certificate of need.
2.0	Obtain a Certificate of Need: Certificate of Need Section
2.1	The applicant submits a certificate of need application for the proposed hospice inpatient or hospice residential care beds according to the review schedule outlined in the SMFP. Both the prospective owner/lessor and the lessee of the facility must submit a joint application.
2.2	The CON Section advertises a written public comment period and local public hearing. Within 30 days of the beginning of the review period, written comments may be filed by any person, including the applicant, regarding the proposals under review.
2.3	A public hearing is conducted by the CON Section within 30 to 50 days from the beginning of the review period, at which time the applicant is given the opportunity to respond to written comments submitted to the CON Section and inquiries made at the hearing.
2.4	A decision to approve or disapprove an application is made by the CON Section within 150 days of the beginning of the review period.
2.5	A certificate of need is issued 35 days after the date of approval if a petition for a contested case hearing is not filed.
2.6	After a certificate of need is issued, the applicant contacts the Construction Section and the Acute and Home Care Branch about their requirements for the development of a hospice inpatient facility or a hospice residential care facility.
3.0	Obtain Construction Approval: Construction Section
3.1	For a hospice inpatient facility or a hospice residential care facility, the owner or his representative submits facility plans to the Construction Section for review. The Construction Section writes the owner with requirements or review comments and instructions.
3.2	The Construction Section acts as the control point for distribution of plans and specifications to the Department of Insurance. Plans are generally reviewed in three stages: schematic, design development, and final working drawings.
3.3	Owners and designers must work closely with local building officials and fire prevention officials as well as the Construction Section to ensure the design is code- and licensure-compliant.
3.4	At least two weeks before construction is complete, the applicant sends a letter to the Construction Section requesting a final construction inspection with project information and local approvals. The facility must be ready with all systems operational and all construction completed by the final construction inspection date. The Construction Section does not do punchlist inspections; they are the responsibility of the designer, contractor, and owner.
3.5	The Construction Section schedules the final inspection with the owner.
3.6	The Construction Section inspects the facility and reviews required final documentation. If the facility is a hospice inpatient facility that will be certified for Medicare/Medicaid and the conditions of Procedure 5.4 (below) have been met, Life Safety Code Surveyors from the Construction Section also participate. This is a joint inspection effort to ensure that the building meets construction standards for licensure and for Medicare/Medicaid certification.
3.7	If all items are acceptable, the Construction Section sends an approved transmittal form (Form 4086) to the Acute and Home Care Branch.
4.0	Obtain a license: Acute and Home Care Branch
4.1	The applicant requests a license application from the Branch. The applicant submits a completed application to the Branch.
4.2	The Branch reviews the application for completeness.
4.3	An initial licensure survey is scheduled.
4.4	If the facility is in substantial compliance with the hospice licensure rules at the time of the survey, a survey report is generated and a license is issued.
4.5	If the facility is not in substantial compliance with the hospice licensure rules, the applicant will be informed at the time of the survey what additional information is needed to be in substantial compliance.
4.6	If there is a question of safety or adequacy of care, then the Branch attempts to assist the facility to reach compliance through consultations. If those efforts fail, licensure is denied.
5.0	Obtain certification: Acute and Home Care Branch
5.1	A facility that has a certificate of need for hospice inpatient services and wishes to be certified for Medicare/Medicaid must contact the Branch for an application packet. Hospice residential care facilities cannot be certified for Medicare/Medicaid.
5.2	The facility completes all required information and returns it to the Branch.
5.3	As soon as the facility is ready for operation, it contacts the Branch to request an on-site survey.
5.4	If the certification packet has been approved by the Branch and by the facility’s fiscal intermediary, the Branch schedules the on-site survey, generally within three weeks of the request.
5.5	The Branch conducts the general survey. If the facility has deficiencies during the initial survey, the effective date of certification will be one of the following: the last date of either the certification general survey or the life safety code survey, or the last date of a acceptable plan of correction from either of these surveys.
5.6	The Branch forwards all information to the Atlanta Health Care Financing Administration (HCFA) Regional Office for approval.
5.7	The Regional Office assigns the provider number and notifies the facility’s fiscal intermediary.

Step

Process followed

1.0

Consult the State Medical Facilities Plan: Medical Facilities Planning Section

1.1

Applicants can learn the number of hospice inpatient beds needed in the annual State Medical Facilities Plan (SMFP), which is published for each calendar year and which specifies where in the state they are needed. The SMFP does not set forth the number of hospice residential care beds that are needed, rather the applicant must document need in the proposed service area.

1.2

Applicants can also find the certificate of need review schedule and deadlines for submittal of applications for both hospice inpatient and hospice residential care beds in the SMFP. No one may develop new hospice inpatient beds or hospice residential care beds without first obtaining a certificate of need.

2.0

Obtain a Certificate of Need: Certificate of Need Section

2.1

The applicant submits a certificate of need application for the proposed hospice inpatient or hospice residential care beds according to the review schedule outlined in the SMFP. Both the prospective owner/lessor and the lessee of the facility must submit a joint application.

2.2

The CON Section advertises a written public comment period and local public hearing. Within 30 days of the beginning of the review period, written comments may be filed by any person, including the applicant, regarding the proposals under review.

2.3

A public hearing is conducted by the CON Section within 30 to 50 days from the beginning of the review period, at which time the applicant is given the opportunity to respond to written comments submitted to the CON Section and inquiries made at the hearing.

2.4

A decision to approve or disapprove an application is made by the CON Section within 150 days of the beginning of the review period.

2.5

A certificate of need is issued 35 days after the date of approval if a petition for a contested case hearing is not filed.

2.6

After a certificate of need is issued, the applicant contacts the Construction Section and the Acute and Home Care Branch about their requirements for the development of a hospice inpatient facility or a hospice residential care facility.

3.0

Obtain Construction Approval: Construction Section

3.1

For a hospice inpatient facility or a hospice residential care facility, the owner or his representative submits facility plans to the Construction Section for review. The Construction Section writes the owner with requirements or review comments and instructions.

3.2

The Construction Section acts as the control point for distribution of plans and specifications to the Department of Insurance. Plans are generally reviewed in three stages: schematic, design development, and final working drawings.

3.3

Owners and designers must work closely with local building officials and fire prevention officials as well as the Construction Section to ensure the design is code- and licensure-compliant.

3.4

At least two weeks before construction is complete, the applicant sends a letter to the Construction Section requesting a final construction inspection with project information and local approvals. The facility must be ready with all systems operational and all construction completed by the final construction inspection date. The Construction Section does not do punchlist inspections; they are the responsibility of the designer, contractor, and owner.

3.5

The Construction Section schedules the final inspection with the owner.

3.6

The Construction Section inspects the facility and reviews required final documentation. If the facility is a hospice inpatient facility that will be certified for Medicare/Medicaid and the conditions of Procedure 5.4 (below) have been met, Life Safety Code Surveyors from the Construction Section also participate. This is a joint inspection effort to ensure that the building meets construction standards for licensure and for Medicare/Medicaid certification.

3.7

If all items are acceptable, the Construction Section sends an approved transmittal form (Form 4086) to the Acute and Home Care Branch.

4.0

Obtain a license: Acute and Home Care Branch

4.1

The applicant requests a license application from the Branch. The applicant submits a completed application to the Branch.

4.2

The Branch reviews the application for completeness.

4.3

An initial licensure survey is scheduled.

4.4

If the facility is in substantial compliance with the hospice licensure rules at the time of the survey, a survey report is generated and a license is issued.

4.5

If the facility is not in substantial compliance with the hospice licensure rules, the applicant will be informed at the time of the survey what additional information is needed to be in substantial compliance.

4.6

If there is a question of safety or adequacy of care, then the Branch attempts to assist the facility to reach compliance through consultations. If those efforts fail, licensure is denied.

5.0

Obtain certification: Acute and Home Care Branch

5.1

A facility that has a certificate of need for hospice inpatient services and wishes to be certified for Medicare/Medicaid must contact the Branch for an application packet. Hospice residential care facilities cannot be certified for Medicare/Medicaid.

5.2

The facility completes all required information and returns it to the Branch.

5.3

As soon as the facility is ready for operation, it contacts the Branch to request an on-site survey.

5.4

If the certification packet has been approved by the Branch and by the facility’s fiscal intermediary, the Branch schedules the on-site survey, generally within three weeks of the request.

5.5

The Branch conducts the general survey. If the facility has deficiencies during the initial survey, the effective date of certification will be one of the following: the last date of either the certification general survey or the life safety code survey, or the last date of a acceptable plan of correction from either of these surveys.

5.6

The Branch forwards all information to the Atlanta Health Care Financing Administration (HCFA) Regional Office for approval.

5.7

The Regional Office assigns the provider number and notifies the facility’s fiscal intermediary.

Procedure for Establishing a Hospice Inpatient or a Hospice Residential Care Facility