Certificate of Need (CON) Application Consulting
Last updated: October 2026
Certificate of Need (CON) application consulting is help preparing the application that a state reviews before a healthcare organization builds a facility, adds a service or buys regulated equipment.
Integral Healthcare Solutions (IHS), founded in February 2002 by Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC, drafts the need analysis, financial projections, facility, staffing and quality sections and the application text. Your organization's named contact or your counsel files it. IHS is a consulting firm, not a law firm, and this page is not legal advice. Whether a project needs a CON, and how the review runs, depends on the law of the state where you will operate. IHS prepares CON applications in states that run CON programs.
What is a Certificate of Need?
A Certificate of Need is a state approval that a healthcare project must receive before it starts. North Carolina's Division of Health Service Regulation says its law "prohibits health care providers from acquiring certain medical equipment or developing new health services, health service facilities, and health service facility beds without the prior approval of the Department of Health and Human Services" (N.C. DHSR, Certificate of Need, page opened October 4, 2026).
Each state writes its own law, so the rules for your project come from the state where you will operate. IHS uses North Carolina below as a worked example because its statute is public and specific.
In which states does IHS prepare CON applications?
IHS prepares CON applications in states that run CON programs. The National Conference of State Legislatures lists 35 states plus D.C. with CON programs as of April 29, 2025 (NCSL, Certificate of Need state laws, page opened October 4, 2026), and that page is the list to check, because each state decides and amends its own law.
In every state the work has the same shape. IHS reads the applicable state statute, rules and forms for your project, drafts the application sections to them, and writes up the questions for your counsel. Each state's statute or agency rules set the thresholds, filing schedule, fees and review period, and your organization or counsel files. This page does not list per-state thresholds, fees or timelines because they change by state and by year.
Which projects need a CON in North Carolina?
The same DHSR page says new hospitals, nursing home facilities, adult care homes, kidney disease treatment centers, intermediate care facilities for individuals with intellectual disabilities, rehabilitation facilities, home health agencies, hospices, diagnostic centers and ambulatory surgical facilities must first obtain a CON before development begins. The statute page shows a second version of some definitions, including diagnostic center and major medical equipment, that takes effect November 21, 2026, so confirm the current list with DHSR before you rely on it. The statute's definitions in N.C. Gen. Stat. 131E-176 decide whether a particular project counts (N.C. Gen. Stat. Chapter 131E, Article 9, page opened October 4, 2026). Your counsel answers that question for your project. IHS lays out the facts and the questions for counsel to answer.
How does the CON application process work?
The process varies by state. The six steps below are the order IHS works in, and each names what IHS drafts. Where the North Carolina statute sets the rule, the step cites it so you can see a real example. IHS drafts, and your organization's named contact or your counsel files.
Step 1: Pre-application analysis
IHS compares the project with the state's definitions and thresholds and writes up the facts for your counsel. The conclusion about whether review applies belongs to your counsel and the state agency. In North Carolina the definitions sit in 131E-176.
Step 2: Letter of intent and filing schedule
IHS finds the state's need determinations and filing schedule. In North Carolina a project must be consistent with the applicable policies and need determinations in the State Medical Facilities Plan (131E-183(a)(1)), and the Department sets submission and review schedules by rule (131E-182(a)). Where a state asks for a letter of intent or similar notice before filing, IHS drafts it for your organization to file.
Step 3: Application preparation
The application is the main body of work. In North Carolina it is made "on forms provided by the Department" (131E-182(b)), and the applicant "shall identify the population to be served by the proposed project, and shall demonstrate the need that this population has for the services proposed" (131E-183(a)(3)). IHS drafts these parts:
- Need analysis, using the population, utilization and capacity data the state's criteria call for.
- Financial projections, including pro forma statements and cash flow.
- Facility plans, equipment specifications and site rationale.
- Staffing model for licensed and credentialed staff.
- Quality assurance plan.
Step 4: Comments, competing applications and any hearing
In North Carolina, any person may file written comments within 30 days after an application begins review, and the statute lists the circumstances in which a public hearing is held, including a competitive review or a request from an affected party. Applications for similar proposals in the same service area are reviewed together (131E-182(a), 131E-185(a1)). IHS drafts written responses to comments and competing applications and drafts hearing statements. Your organization's officers and counsel present them. IHS does not appear before the agency for you.
Step 5: Agency review and decision
North Carolina sets a 90-day review period that the Department may extend by up to 60 days, and the Department decides to "approve," "approve with conditions," or "deny" (131E-185(a1), 131E-185(c), 131E-186(a)). Other states set their own periods. While the agency reviews, IHS drafts your organization's answers to any request for information, and your named contact sends them.
Step 6: Conditions, progress reports and appeal
In North Carolina the holder of a certificate must materially comply with the representations made in its application (131E-181(b)), and the Department may require periodic progress reports (131E-189(a)). A decision to issue or deny can be challenged in a contested case, and the petition must be filed within 30 days after the decision (131E-188(a)). IHS tracks conditions, drafts progress reports and drafts appeal documents for your counsel to file.
What does IHS draft, and what does your organization do?
IHS drafts the documents and your organization or counsel files and presents them. The table sets out the division of work.
| Work item | IHS drafts | Your organization or counsel |
|---|---|---|
| Does the project need a CON? | Facts and questions for counsel | Counsel decides |
| Need analysis | Full draft with data sources | Reviews and approves |
| Financial, facility, staffing and quality sections | Full drafts | Reviews and approves |
| Letter of intent and application | Text | Named contact or counsel files |
| Responses to comments and competing applications | Written drafts | Named contact or counsel files |
| Public hearing | Statements | Officers and counsel present |
| Conditions and progress reports | Tracking and report drafts | Named contact files |
| Appeal | Supporting documents | Counsel files and argues |
What about home health and hospice?
The North Carolina DHSR page lists home health agencies and hospices among the projects that need a CON. IHS also offers accreditation consulting for home health and hospice providers, and can build one calendar for the CON work and the accreditation work so that neither waits on the other. See home health and hospice accreditation consulting, ACHC home health and ACHC hospice.
What does CON application consulting cost?
The cost has three parts: the state's application fee, the consulting fee and your own staff and counsel time. The state sets its fee. North Carolina's statute sets a nonrefundable application fee of $5,000 plus 0.3 percent of the proposed capital expenditure above $1,000,000, capped at $50,000 (N.C. Gen. Stat. Chapter 131E, Article 9, 131E-182(c), page opened October 4, 2026). Verify current fees with the North Carolina Department of Health and Human Services. Other states set their own fees.
IHS sets a fixed fee for each engagement after a free discovery session, because scope, number of sites and gap severity change the work.
What this is not
IHS is not a law firm and does not give legal advice. Whether a project needs a CON, and what the statute requires of it, are questions for your counsel and the state agency.
IHS does not file anything with a state agency or appear before one for you. Your organization's named contact or your counsel files, and IHS drafts the text.
IHS does not guarantee that an application will be approved. The state agency decides.
Who leads the work?
Dr. Goddard leads IHS engagements. Every IHS engagement begins with a complimentary discovery call with Dr. Goddard. See the IHS team.
Frequently asked questions
Which states require a Certificate of Need?
Each state decides, and the state's health planning agency is the source for its current law. The National Conference of State Legislatures lists 35 states plus D.C. with CON programs as of April 29, 2025 (NCSL, Certificate of Need state laws, page opened October 4, 2026). IHS prepares CON applications in states that run CON programs. North Carolina is one example: its Division of Health Service Regulation says new hospitals, nursing homes, home health agencies, hospices and several other facility types must first obtain a CON.
Do I need a CON for my project?
That depends on your state's definitions and thresholds, and the answer is for your counsel and the state agency. IHS compares your project with the state's text and writes up the facts and questions for counsel.
How long does CON review take?
The state sets the review period. North Carolina's statute sets 90 days that the Department may extend by up to 60 days. Preparing the application takes additional time before filing, and IHS sets that schedule with you at the discovery session.
How much does a CON application cost in total?
The total is the state fee, the consulting fee and your staff and counsel time. North Carolina's statute sets a state fee formula, and verifying current fees with the Department is the safe step. IHS sets a fixed fee for each engagement after a free discovery session.
Can another organization oppose my application?
In North Carolina, any person may file written comments on an application under review, and similar proposals in the same service area are reviewed together. Other states differ. IHS drafts your responses to comments and to competing applications.
What happens if a CON application is denied?
In North Carolina, an affected person, which the statute says includes the applicant, may petition for a contested case within 30 days after the decision. Your counsel files the petition. IHS drafts the supporting documents.
Does a CON mean I can open, and can it transfer if I sell?
In North Carolina a CON is valid only for the scope, physical location and person named in the application, and it is not transferable except as 131E-189(c) allows. That subsection lets the Department withdraw a CON if control is transferred before the project is complete. Licensure and other approvals have their own requirements, so your counsel confirms the full path.
Who communicates with the regulator, IHS or my organization?
Your organization does. IHS drafts the letters, application text and responses, and your named contact or your counsel sends them under your name.
Who is this not for?
This service is not for an organization that wants a law firm's opinion or wants IHS to represent it before a state agency. IHS does neither. It is for organizations that need the application drafted and a clear division of who files.
Ready to scope your CON application?
A free discovery session covers your project, the state's process and what IHS would draft.