PURPOSE: This rule delineates the process for submitting a Letter of Intent to begin the Certificate of Need (CON) review process and outlines the projects subject to CON review.

PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here.

1. (1) Applicants shall submit by mail, fax, or email a Letter of Intent (LOI) to begin the Certificate of Need (CON) review process at least thirty (30) days prior to the submission of the CON application and will remain valid in accordance with the following time frames:

   1. (A) For full reviews, expedited equipment replacements, expedited long-term care

2. (LTC) renovation or modernization reviews, and expedited LTC facility replacement reviews, an LOI is valid for six (6) months; and

   1. (B) For expedited LTC bed expansion reviews in accordance with section 197.318.8, RSMo, an LOI is valid for twenty-four (24) months.
3. (2) Once filed, a LOI may be amended, except for project address, not later than ten
4. (10) days in advance of the CON application filing, or it may be withdrawn at any time without prejudice.
5. (3) An LTC bed expansion or replacement sought pursuant to sections 197.318.8 through 197.318.10, RSMo, requires a CON application if the capital expenditure for such bed expansion or replacement exceeds six hundred thousand dollars ($600,000), but allows for shortened information requirements and review time frames.
6. (4) When an LOI for an LTC bed expansion, except replacement(s), is filed, the Certificate of Need Program (CONP) staff shall immediately request certification for that facility’s average licensed bed occupancy and final Class 1 patient care deficiencies for the most recent six (6) consecutive calendar quarters. Such certification shall be obtained by the applicant from the Division of Regulation and Licensure (DRL), Department of Health and Senior Services, through an LTC Facility Expansion Certification (Form MO 580- 2351, incorporated by reference) to verify compliance with occupancy and deficiency requirements pursuant to section 197.318.8, RSMo. Occupancy data shall be taken from the DRL’s most recently published Six-Quarter Occupancy of Intermediate Care and Skilled Nursing Facility (or Residential Care and Assisted Living Facility) Licensed Beds reports.
7. (5) For LTC bed expansions or replacements, the sellers and purchasers shall be defined as the owner(s) and operator(s) of the respective facilities, which includes building, land, and license. On the Purchase Agreement (Form MO 580-2352, incorporated by reference), both the owner(s) and operator(s) of the purchasing and selling facilities should sign.

8. (6) The CONP staff, as an agent of the Missouri Health Facilities Review Committee (committee), will review LOIs according to the following provisions:

   1. (A) Major medical equipment is reviewed as an expenditure on the basis of cost, regardless of owners or operators, or location (mobile or stationary);
   2. (B) The CONP staff shall test the LOI for applicability in accordance with statutory provisions for expenditure minimums, exemptions, and exceptions;
   3. (C) If the test verifies that a statutory exception or exemption is met on a proposed project, or the proposed cost is below all applicable expenditure minimums, the committee chair may issue a Non-Applicability CON letter indicating the application review process is complete; otherwise, the CONP staff shall add the proposal to a list of Non- Applicability proposals to be considered at the next regularly scheduled committee meeting;
   4. (D) If an exception or exemption is not verified, and if the proposal is above any applicable expenditure minimum, then a CON application will be required for the proposed project;

   5. (E) A Non-Applicability CON letter will be valid subject to the following conditions:

      1. 1. Any change in the project scope,

including change in type of service, cost, operator, ownership, or site, could void the effectiveness of the letter and require a new review; and

1. 2. Final project costs with third-party

verification must be provided on a Periodic Progress Report (Form MO 580-1871, incorporated by reference); and

1. (F) A CON application must be made if—

   1. 1. The project involves the development

of a new hospital costing one (1) million dollars or more, except for a facility licensed under Chapter 197, RSMo, meeting the requirements described in 42 CFR, section 412.23(e);

1. 2. The project involves the acquisition

or replacement of major medical equipment in any setting not licensed under Chapter 198, RSMo, costing one (1) million dollars or more;

1. 3. The project involves the acquisition

or replacement of major medical equipment for a health care facility licensed under Chapter 198, RSMo, costing four hundred thousand dollars ($400,000) or more;

1. 4. The project involves the 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;

1. 5. The project involves a capital expen-

diture for renovation or modernization, but not additional beds, by or on behalf of an existing health care facility licensed under Chapter 198, RSMo, costing six hundred thousand dollars ($600,000) or more;

1. 6. The project involves additional LTC

(licensed or certified residential care facility, assisted living facility, intermediate care facility, or skilled nursing facility) beds licensed under Chapter 198, RSMo, costing six hundred thousand dollars ($600,000) or more; or

1. 7. The project involves the expansion of

an existing health care facility as described in subdivisions (1) and (2) of section 197.366, 19 CSR 60-50

RSMo, that either—

1. A. Costs six hundred thousand dollars

($600,000) or more; or

1. B. Exceeds ten (10) beds or ten per-

cent (10%) of that facility’s existing licensed capacity, whichever is less.

1. (7) Nonsubstantive projects are waived from review by the authority of section 197.330.1(8), RSMo, and any projects seeking such a determination shall submit information through the LOI process; those meeting the nonsubstantive definition shall be posted for review on the CON web site at least twenty (20) days in advance of the committee meeting when they are scheduled to be confirmed by the committee.

2. (8) The following forms cited in this rule are incorporated by reference and published by the Certificate of Need Program (CONP), October 1, 2009, and may be downloaded from http://www.dhss.mo.gov/CON/Forms.html, obtained by mailing a written request with a self-addressed stamped envelope to CONP, PO Box 570, Jefferson City, MO 65102- 0570, or acquired in person at the CONP Office, 3418 Knipp Drive, Jefferson City, Missouri, (573) 751-6403. This rule does not include any later amendments or additions.

   1. (A) LTC Facility Expansion Certification (Form MO 580-2351).
   2. (B) Purchase Agreement (Form MO 580- 2352).
   3. (C) Periodic Progress Report (Form MO 580-1871).

AUTHORITY: section 197.320, RSMo 2000.* Original rule filed June 2, 1994, effective Nov. 30, 1994. Emergency amendment filed Nov. 16, 1995, effective Nov. 26, 1995, expired May 23, 1996. Amended: Filed Nov. 15, 1995, effective April 30, 1996. Emergency amendment filed Nov. 26, 1996, effective Dec. 6, 1996, expired June 3, 1997. Emergency rescission filed Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998. Emergency rule filed Aug. 29, 1997, effective Sept. 8, 1997, terminated Sept. 21, 1997. Emergency rule filed Sept. 11, 1997, effective Sept. 21, 1997, expired March 19, 1998. Rescinded and readopted: Filed Aug. 29, 1997, effective March 30, 1998. Emergency rescission and rule filed June 29, 1999, effective July 9, 1999, expired Jan. 5, 2000. Rescinded and readopted: Filed June 29, 1999, effective Jan. 30, 2000. Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Emergency amendment filed Dec. 16, 2002, effective Jan. 1, 2003, expired June 29, 2003. Rescinded and readopted: Filed Dec. SENIOR SERVICES 14, 2001, effective June 30, 2002. Amended: Filed April 12, 2004, effective Nov. 30, 2004. Emergency amendment filed Aug. 14, 2006, effective Aug. 28, 2006, expired Feb. 23, 2007. Amended: Filed Aug. 14, 2006, effective March 30, 2007. Amended: Filed Oct. 1, 2010, effective May 30, 2011. *Original authority: 197.320, RSMo 1979, amended 1993, 1995, 1999.