A certificate of need (CON) is a state approval required before certain health care facilities make major capital expenditures or start covered projects, and it sits alongside the state facility license a new program needs before it opens. This page is for organizations starting a new facility or service in a state that licenses it and, in many states, requires a CON. Integral Healthcare Solutions (IHS) maps the licenses a new program needs and drafts the policies and application narratives you file.
Last reviewed: October 2026.
What is a certificate of need?
A CON is a state-level approval for capital projects. The National Conference of State Legislatures (NCSL), a legislative research organization rather than a regulator, summarizes it this way: “Certificate of need (CON) laws are state regulatory mechanisms for approving major capital expenditures and projects for certain health care facilities.” It adds: “Currently, 35 states and Washington, D.C., operate CON programs, with wide variation by state” (NCSL, Certificate of Need State Laws, updated April 29, 2025).
The governing text is each state's own CON law and its facility licensing rules, and both vary by state and facility type. North Carolina is the worked example on this page:
- The requirement. “No person shall offer or develop a new institutional health service without first obtaining a certificate of need from the Department” (N.C. Gen. Stat. 131E-178(a)).
- The agency. “The Healthcare Planning and Certificate of Need (HPCON) Section (the ‘Section’) in the department's Division of Health Service Regulation is responsible for its implementation” (NC DHHS, HPCON).
- The application. “An application for a certificate of need shall be made on forms provided by the Department. The application forms, which may vary according to the type of proposal, shall require such information as the Department, by its rules deems necessary to conduct the review” (N.C. Gen. Stat. 131E-182(b)).
Facility licensing is a separate set of rules. This page does not quote any state's facility licensing rules; IHS works from the current rules for your state and facility type.
Who needs it and what triggers it
The buyer is an organization opening a new facility, adding a service, or making a large capital investment in a state that regulates it. The triggers, as the sources state them:
- Offering or developing a “new institutional health service” in North Carolina (G.S. 131E-178(a)).
- Planning “major capital expenditures and projects for certain health care facilities” in one of the states NCSL lists as operating a CON program (NCSL).
- Opening any facility or program that the state licenses, whether or not a CON applies.
How IHS helps
IHS starts by mapping every license and approval the start-up needs, in order, then runs a rule-by-rule gap assessment for each one. The full sequence:
- A sequence map of every license and approval the program needs.
- A rule-by-rule gap assessment against each governing text.
- Questionnaires to your program and clinical leads.
- Drafted policy manuals. IHS drafts the program, policies and clinical content for your clinicians to review and approve.
- Drafted CON or license application narratives built on your own need and financial data.
- A mock licensing review of the drafted manuals and records against the state rules.
- Drafted correspondence for your organization to send to the agency.
What you supply
- Site, ownership and financial data.
- A need study.
- Counsel.
- Clinical leads who review and approve clinical content.
The limit
A contested CON proceeding is legal work for your counsel; IHS drafts narrative and exhibits, not advocacy. Physical-plant review needs your architect. IHS does not file with or contact the state agency. Your organization's named contact files; IHS drafts the text.
What to have ready
North Carolina's statute is the reference for this list; check each item against your own state's law.
- A written description of each planned service, checked against whether it is a “new institutional health service” (G.S. 131E-178(a)).
- Confirmation of whether your state operates a CON program; NCSL counts 35 states and Washington, D.C. as of April 29, 2025 (NCSL).
- The agency section that administers the program; in North Carolina, the HPCON Section of the Division of Health Service Regulation (NC DHHS).
- The current application form for your type of proposal, since forms “may vary according to the type of proposal” (G.S. 131E-182(b)).
- The need and financial data the form calls for: “such information as the Department, by its rules deems necessary to conduct the review” (G.S. 131E-182(b)).
- The proposed capital expenditure, which sets the North Carolina application fee (G.S. 131E-182(c)).
- Funds for a fee that “is not refundable, regardless of whether a certificate of need is issued” (G.S. 131E-182(c)).
- A project calendar that allows for a 90-day review, which G.S. 131E-185(a1) says begins “on the day established by rule” for the particular service in the service area, plus a possible extension of up to 60 days under 131E-185(c). G.S. 131E-182(a) has the Department set submission and review schedules by rule, so elapsed time includes waiting for the review start date (G.S. 131E-185; G.S. 131E-182).
- A plan for written comments: “Any person may file written comments and exhibits concerning a proposal under review with the Department, not later than 30 days after the date on which the application begins review” (G.S. 131E-185).
If you are still working out which of these apply in your state, the introductory call is where IHS scopes the license map.
How it compares
The main difference between states is whether a CON program exists at all. Per NCSL, 35 states and Washington, D.C. operate CON programs, so the remaining states do not (NCSL).
| Situation | Approvals to map | Source |
|---|---|---|
| State operates a CON program | CON for covered projects, plus the facility license | NCSL; for North Carolina, G.S. 131E-178 |
| State without a CON program | Facility license | NCSL |
NCSL's count is dated April 29, 2025, and NCSL is a secondary source. Confirm your own state's current law before relying on it.
What it costs
The cost has two state-set parts, the CON application fee where a CON applies and any licensing fee, plus your consulting and counsel costs. North Carolina's statute sets its CON fee: “The application fee is five thousand dollars ($5,000) plus an amount equal to three-tenths of one percent (.3%) of the amount of the capital expenditure proposed in the application that exceeds one million dollars ($1,000,000). In no event may the fee exceed fifty thousand dollars ($50,000).” And: “The fee is not refundable, regardless of whether a certificate of need is issued” (N.C. Gen. Stat. 131E-182(c)).
Applying that formula, a proposed capital expenditure of $5,000,000 gives $5,000 plus 0.3% of $4,000,000, or $17,000. Verify current fees with the NC DHHS Division of Health Service Regulation.
We have not reviewed other states' CON fees or any state's facility licensing fees; those depend on the state and the scope.
IHS scopes each engagement after a free introductory call.
What this is not
- IHS is a consulting firm, not a law firm, and this page is not legal advice.
- It is not a guarantee of any state agency's decision on a license or certificate of need.
- IHS does not file with, contact, or represent a client before a state agency. Your organization files; IHS drafts the text.
Frequently asked questions
What licenses and approvals does a new healthcare program need before it opens?
It depends on the state and the facility type: at least the state facility license, and in states with a CON program, a certificate of need for covered projects. IHS builds a sequence map of every license and approval the program needs, then runs a rule-by-rule gap assessment for each.
What is a certificate of need, and does my state require one?
NCSL describes CON laws as “state regulatory mechanisms for approving major capital expenditures and projects for certain health care facilities” (source). It reports that 35 states and Washington, D.C. operate CON programs, with wide variation by state. Whether your project is covered depends on your state's law.
How many states still have certificate of need laws?
NCSL reports that 35 states and Washington, D.C. operate CON programs, in a page updated April 29, 2025 (source). NCSL is a legislative research organization and a secondary source. Check your own state's current statute before relying on the count.
Does a certificate of need come before or after the facility license?
The North Carolina statute text reviewed for this page does not state the order of the CON and the facility license, and North Carolina's facility licensing rules were not part of the sources reviewed. What the statute does say is that a covered service may not be offered or developed “without first obtaining a certificate of need” (G.S. 131E-178(a)). Other states' sequencing depends on their own law.
How long does a certificate of need review take?
In North Carolina, the statute sets “a time limit of 90 days for review of the applications,” which G.S. 131E-185(a1) says begins “on the day established by rule” for the particular service in the service area, and the Department may extend the review by up to 60 days with notice to all applicants under 131E-185(c). G.S. 131E-182(a) has the Department set submission and review schedules by rule, so elapsed time includes waiting for the review start date. G.S. 131E-185(a1)(2) also provides for a public hearing for competitive reviews, for proposals of $5,000,000 or more, or on request (G.S. 131E-185). Other states set their own timelines.
How much does a certificate of need application cost?
In North Carolina the fee is $5,000 plus 0.3% of the proposed capital expenditure above $1,000,000, capped at $50,000, and it is not refundable (G.S. 131E-182(c)). Verify current fees with the NC DHHS Division of Health Service Regulation. Other states set their own fees.
Can competitors comment on or challenge our CON application?
In North Carolina, “Any person may file written comments and exhibits concerning a proposal under review with the Department, not later than 30 days after the date on which the application begins review” (G.S. 131E-185). A contested proceeding is legal work for your counsel; IHS drafts narrative and exhibits.
What goes into a CON application narrative?
North Carolina's application forms “may vary according to the type of proposal” and require the information the Department's rules deem necessary to conduct the review (G.S. 131E-182(b)). IHS drafts the narrative on your own need and financial data, and your organization files it.
What policies and procedures do we need ready for the state licensing survey?
That depends on your state's licensing rules for your facility type. IHS runs a rule-by-rule gap assessment, drafts the policy manuals with clinical content your clinicians approve, and runs a mock licensing review before the state survey.
Do we need a lawyer for a certificate of need application?
IHS is a consulting firm, not a law firm. A contested CON proceeding is legal work for counsel, and IHS's role there is drafting narrative and exhibits, not advocacy. Counsel is also one of the things the client supplies on an IHS licensing engagement.