Missouri Certificate of Need (CON) Program

Missouri Certificate of Need (CON) Introduction

Like many other states, Missouri has an extensive CON process in place for healthcare services and facilities. Winning approval for a CON application is often a time consuming and difficult undertaking. Working with RPC provides clients with a team of consultants with experience working with CON projects.

When working on a CON project, RPC can prepare the entire CON application or sections of the application as the client prefers. When the client is defining the project and deciding whether to file an application, RPC can help assess the market and regulatory situation to determine the relative likelihood of success for a project. RPC not only works to create a thorough market, need and financial analysis, but also works seamlessly with the client’s staff, architects, engineers and, other outside consultants to create a solid CON application.

RPC is led by Ron Luke, JD, PhD, who has prepared CON applications and presented testimony in CON hearings since 1981 in more than 20 states. RPC’s work on CON projects includes the opening of new acute care hospitals, hospices, physical rehabilitation and psychiatric specialty hospitals, and nursing homes, the relocation and addition of beds, and the acquisition of major medical equipment. Working with RPC during the CON process gives the applicant the advantage of a skilled expert team that can provide expert advice and produce an effective CON application.

State Agencies

Missouri Health Facilities Review Committee
This 9-member body votes on the outcome of CON applications. They meet every 8 weeks to deliberate on CON applications, make policy decisions, and administer the Certificate of Need Statute… Five of the members are appointed by the governor, two by the president pro-tem of the senate, and two by the speaker of the house, each serving two terms.

Certificate of Need Program Staff
The Certificate of Need Program staff, as an agent of the Missouri Health Facilities Review Committee, reviews Letters of Intent and CON Applications, provide technical assistance to potential applicants and conducts subsequent compliance follow-up.

Missouri Certificate of Need Program
920 Wildwood Drive, P.O. Box 570
Jefferson City, MO 65102
(573) 751-6403

Services that Require CON

Missouri’s Certificate of Need Program requires certain healthcare service providers to gain state approval through the CON application process before they can offer or expand certain services. CON is intended to reduce costs, improve quality, and increase access for Missouri’s major healthcare services. CON Projects include:

• • Development of a new hospital costing $1,000,000 or more (unless exempt under chapter 197, RSMo)
  • Acquisition or replacement of major medical equipment costing $1,000,000 or more by a facility not licensed under Chapter 198, RSMo
  • Acquisition or replacement of major medical equipment for a healthcare facility licensed under Chapter 198, RSMo, costing $400,000 or more
  • Acquisition of any equipment or beds in a long-term care hospital meeting the requirements found in 42 CFR section 412.23(e) at any cost
  • A capital expenditure for renovation, modernization, or replacement (not additional beds) by or on behalf of an existing healthcare facility licensed under Chapter 198, RSMo, costing $600,000 or more
  • Additional LTC (licensed or certified residential care, assisted living, intermediate care, or skilled nursing facility) beds or LTC bed expansions or replacements licensed under Chapter 198, RSMo, costing $600,000 or more
  • Expansion of an existing healthcare facility as described in subdivisions (1) and (2) of section 197.366, RSMo, that either:

A. Costs $600,000 or more, or

B. Exceeds 10 beds or 10% of the facility’s licensed capacity, whichever is less

Certificate of Need Process Milestones

1. File Letter of Intent
   The applicant files the LOI at least 30 days before submitting a CON application. The LOI is generally valid for 6 months (LOI for an expedited long-term care bed expansion review is valid for 24 months). The LOI provides project description, applicant information, estimated project cost, type of review (full, expedited, non-applicability), and reason/rationale for non-applicability if sought. The CONP staff evaluates whether a CON application is necessary/applicable for the proposed project, the Committee Chair confirms the staff findings by signing a Non-Applicability Letter, which is later affirmed by the Committee at its regular meeting.
2. File Application
   Full applications must be filed at least 71 days but not more than 100 days prior to each Missouri Health Facilities Review Committee meeting where it is to be decided. Expedited applications should be filed by the tenth day of each month, are processed during a 41-day cycle, and are decided by mail/email/fax ballot from the Committee members.
3. Schedule Publication
   CONP staff publishes a schedule two business days after the filing deadline with the filing date of the application, a description of the proposed service, the time and place for filing comments and requests for a public hearing, and the tentative date of the meeting at which the application is scheduled for review. This is posted on the CON website, filed with the Secretary of State for notice publication, and emailed to all affected parties.
4. Public Hearing
   Any affected person may request a public hearing within 30 calendar days from the publication date of the Application Review Schedule. The applicant has a maximum of 15 minutes to present to the CONP staff, while any person has up to 5 minutes for verbal testimony and may submit any written testimony.
5. Review
   CONP staff reviews the applications in the order filed. They send completeness notifications to applicants within 15 days of filing. They then send written analyses to the Missouri Health Facilities Review Committee 20 days before it is set to meet following the 70th day after the application is filed. The analysis is sent to the applicant at least 15 days before the committee’s meeting.
6. Decision
   Members of the Missouri Health Facilities Review Committee may use the findings from the CONP staff to vote on approval or use other factors it considers important to the decision. The committee makes a decision on an application within 130 calendar days after the filing date.
7. Judicial Review
   The Certificate of Need Statute allows only the applicant to file an appeal within 30 days of the decision. The case may be heard de novo by the administrative hearing commissioner, the circuit court of Cole County, or the circuit court in the county of the proposed project.
8. Progress Reports
   The applicant must file reports every 6 months after CON approval, or issuance of a Non-Applicability CON letter, until the project is complete. All reports contain a complete accounting of all expenditures for the period. Failure to file such reports is grounds for CON forfeiture.

What criteria are used to review a CON?

The Missouri Health Facilities Review Committee uses the Community Need and Financial Feasibility Review Criteria and Standards as guidelines and may also consider the number of patients requiring treatment, the changing complexity of treatment, obstacles to access, competitive economic considerations, and the specialized nature of the services.

Community Need Criteria and Standards:
For a New Hospital

• Documented need for the proposed hospital
• Current occupancy of other hospitals in the proposed geographic service area exceeds 80%
• Impact the proposed hospital would have on utilization of other hospitals in the geographic service area
• Unmet need in the service area for each type of bed proposed (population-based formula)

For New, Additional, or Replacement Equipment

• Need formula for the service area
• Minimum annual utilization standard for the proposed service area
• Compliance with the optimal utilization standard and justification for the additional unit
• Medical effects as documented in published scientific literature
• Degree to which the objectives of the technology have been met in practice
• Side effects, contraindications or environmental exposures
• Relationships to existing preventive, diagnostic, therapeutic or management technologies
• FDA approval
• Partnership with other institutions for joint use and financing

For New, Expanded, or Replacement Long-Term Care Facilities

• Need formula for the service area
• Minimum annual utilization standard for the proposed service area
• Compliance with replacement criteria

Financial Feasibility Review Criteria & Standards:

• Documentation from a financial institution indicating that sufficient funds are available
• Healthy institutional cash flows, service-specific revenues, and expenses projected 3 years beyond project completion
• Anticipated patient charges and methods for calculation
• Responsiveness to the needs of the medically indigent

Certificate of Need Application Filing Fee

Application fees amount to $1,000 or 0.1% of the total project cost (rounded up to the nearest dollar), whichever is greater.

Additional Sources

(links good as of April 2024)

Missouri Certificate of Need Program
http://health.mo.gov/information/boards/certificateofneed/

CON Statute Sections (197.300 to 197.366)
http://health.mo.gov/information/boards/certificateofneed/pdf/law.pdf

Applications and Forms
http://health.mo.gov/information/boards/certificateofneed/forms.php

CON State Laws and Regulations
http://health.mo.gov/information/boards/certificateofneed/laws.php

Missouri Health Facilities Review Committee
http://boards.mo.gov/UserPages/Board.aspx?307