N.C. 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
Licensure & Certification/Acute & Home Care Section	(919) 855-4620
Medical Facilities Planning Section	(919) 855-3865

Procedure Summary:
In order to operate a Medicare-certified home health agency in North Carolina, an applicant first consults the State Medical Facilities Plan (SMFP) to determine if there is a projected need for one. If the SMFP does not indicate need for an additional agency, no certificate of need can be issued for development of a certified home health agency. If the SMFP indicates need for an additional agency, the applicant must apply for a certificate of need. Applicants successfully obtaining a certificate of need must then apply for and obtain a license. Steps to obtain certification for Medicare and Medicaid are taken after the agency is licensed and in operation.

Step	Process followed
1.0	Consult the State Medical Facilities Plan: Medical Facilities Planning Section
1.1	Applicants can learn the number of certified home health agencies 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.
1.2	Applicants can also find the certificate of need review schedule and deadline for submittal of applications for these agencies, if there is a projected need, in SMFP. No one may develop a new certified home health agency without first obtaining a certificate of need. A certificate of need cannot be issued if the SMFP does not show a need for the agency in the county where it is proposed.
2.0	Obtain a Certificate of Need: Certificate of Need Section
2.1	The applicant submits a certificate of need application for the proposed certified home health agency according to the review schedule outlined in the SMFP.
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 Acute and Home Care Branch about its respective requirements for the development of a certified home health agency.
3.0	Obtain a license: Acute and Home Care Branch
3.1	The applicant requests a license application from the Branch. Since certified home health agencies may provide one or more “home care” services, a multi-purpose licensure application is used and a multi-program license may be issued. The applicant submits a completed application to the Acute and Home Care Branch.
3.2	The Branch reviews the application for completeness.
3.3	If the proposed home health agency is accredited by any of the bodies specified in the Home Care Licensure Act (N.C. G.S. 131E – 138), it is deemed to be in compliance with the home care licensure rules and a license is issued designating the services that the agency is authorized to provide.
3.4	If the proposed home health agency does not qualify for deemed status, an initial licensure survey is scheduled.
3.5	If the proposed home health agency is in substantial compliance with the home care licensure rules at the time of the survey, a survey report is generated and a license is issued.
3.6	If the proposed home health agency is not in substantial compliance with the home care licensure rules, the applicant will be informed at the time of the survey what additional information is needed to be in substantial compliance.
3.7	If there is a question of safety or adequacy of care, then the Branch attempts to assist the proposed home health agency to reach compliance through consultations. If those efforts fail, licensure is denied.
4.0	Obtain certification: Acute and Home Care Section
4.1	Licensed home care agencies that have a certificate of need for certified home health services must contact the Branch for an application packet to request Medicare/Medicaid certification.
4.2	The agency completes all required information and returns it to the Branch.
4.3	As soon as the agency is ready for operation, it contacts the Branch to request an on-site survey.
4.4	If the application packet has been approved by the Branch and by the agency’s fiscal intermediary, the Branch schedules the on-site survey, generally within three weeks of the request.
4.5	The Branch conducts the survey. If an agency has deficiencies during the initial survey, the effective date of certification will be the latest date a plan of correction is signed by the agency.
4.6	The Branch forwards all information to the Atlanta Health Care Financing Administration (HCFA) Regional Office for approval.
4.7	The Regional Office assigns the provider number and notifies the agency’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 certified home health agencies 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.

1.2

Applicants can also find the certificate of need review schedule and deadline for submittal of applications for these agencies, if there is a projected need, in SMFP. No one may develop a new certified home health agency without first obtaining a certificate of need. A certificate of need cannot be issued if the SMFP does not show a need for the agency in the county where it is proposed.

2.0

Obtain a Certificate of Need: Certificate of Need Section

2.1

The applicant submits a certificate of need application for the proposed certified home health agency according to the review schedule outlined in the SMFP.

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 Acute and Home Care Branch about its respective requirements for the development of a certified home health agency.

3.0

Obtain a license: Acute and Home Care Branch

3.1

The applicant requests a license application from the Branch. Since certified home health agencies may provide one or more “home care” services, a multi-purpose licensure application is used and a multi-program license may be issued. The applicant submits a completed application to the Acute and Home Care Branch.

3.2

The Branch reviews the application for completeness.

3.3

If the proposed home health agency is accredited by any of the bodies specified in the Home Care Licensure Act (N.C. G.S. 131E – 138), it is deemed to be in compliance with the home care licensure rules and a license is issued designating the services that the agency is authorized to provide.

3.4

If the proposed home health agency does not qualify for deemed status, an initial licensure survey is scheduled.

3.5

If the proposed home health agency is in substantial compliance with the home care licensure rules at the time of the survey, a survey report is generated and a license is issued.

3.6

If the proposed home health agency is not in substantial compliance with the home care licensure rules, the applicant will be informed at the time of the survey what additional information is needed to be in substantial compliance.

3.7

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

4.0

Obtain certification: Acute and Home Care Section

4.1

Licensed home care agencies that have a certificate of need for certified home health services must contact the Branch for an application packet to request Medicare/Medicaid certification.

4.2

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

4.3

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

4.4

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

4.5

The Branch conducts the survey. If an agency has deficiencies during the initial survey, the effective date of certification will be the latest date a plan of correction is signed by the agency.

4.6

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

4.7

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

Procedure for Establishing a Certified Home Health Agency