59C-1.010. Certificate of Need Application Review Procedures

(1) The Agency shall review all applications in the context of the review criteria specified in Section 408.035, F.S. and Chapters 59C-1 and 59C-2, F.A.C., and all information relevant to the criteria contained therein.

(2) General Provisions.

(a) Applications subject to comparative or expedited review shall be submitted to the Agency on AHCA Form 3150-0001, August 2020 “Application For A Certificate of Need” or 3150-0003, August 2020 “Transfer of A Certificate of Need” as referenced in paragraph 59C-1.008(1)(f), F.A.C.

(b) Applications for projects involving an existing health care facility shall be filed by the current license holder as listed on the current Agency license in effect at the time of the applicant omission deadline specified in subparagraphs (3)(a)3. or (4)(d)3. of this rule, or the application shall be withdrawn from consideration. Applications submitted by corporations required to have filed incorporation papers or foreign corporation papers in order to do business in Florida must be able to do business in Florida prior to notifying the Agency of its intentions in a comparative review cycle or by the time it files an expedited application, if the project is subject to expedited review.

(c) An application shall not be deemed complete by the Agency unless all information required by statute and rule has been submitted by the applicant.

(3) Comparative Review. Applications subject to comparative review shall be reviewed according to the following timetable:

(a) Completeness Review.

1. Within 15 calendar days after the application submission deadline promulgated under paragraph 59C-1.008(1)(g), F.A.C., the Agency shall determine whether the application is complete.

2. If the application is deemed incomplete by the Agency, the Agency shall request in writing from the applicant specific information necessary for the application to be deemed complete.

3. If an applicant does not provide the specific additional information required by statute and rule in writing to the Agency within 21 calendar days of the receipt of the Agency’s request, the application shall be deemed withdrawn from consideration. The applicant’s response must be received by the Agency no later than 5:00 p.m. (local time) on or before the omissions due date promulgated under paragraph 59C-1.008(1)(g), F.A.C.

(b) The Agency shall deem the application complete or withdrawn within 7 calendar days of the receipt of the requested information. Subsequent to an application being deemed complete or withdrawn by the Agency, no further application information or amendment will be accepted by the Agency.

(c) The Agency shall conduct public hearings in accordance with the provisions in Section 408.039(3)(b), F.S. The presiding officer at the hearing will be assigned by the Agency, or the Local Health Council. Unless otherwise ordered by the presiding officer, the applicant and those in support of the proposal will speak followed by those opposing the proposal, and the applicant may then present rebuttal information. The Agency will preserve the proceedings at the hearing.

(d) The Agency shall issue a State Agency Action Report within 60 calendar days from the date the application is deemed complete unless the review period is extended pursuant to subsection (6) of this rule.

(4) Expedited Review. Applications subject to expedited review shall be reviewed according to the following timetable:

(a) Applications shall not be accepted for an expedited review unless they are submitted at least 90 days prior to the implementation of the project. Transfer applications shall be accepted consistent with the provisions of paragraph 59C-1.0085(1)(g), F.A.C.

(b) All such applications shall be exempt from the batching requirements set forth in paragraph 59C-1.008(1)(g), F.A.C.

(c) No letter of intent or letter of intent publication, as prescribed by subsection 59C-1.008(1), F.A.C., shall be required.

(d) Completeness Review.

1. Within 15 calendar days of receipt of an application by the Agency, the Agency shall determine whether the application is complete.

2. If the application is deemed incomplete by the Agency, the Agency shall request in writing from the applicant specific information necessary for the application to be deemed complete.

3. If an applicant does not provide the specific additional information required by statute and rule in writing to the Agency within 21 calendar days of the receipt of the Agency’s request, the application shall be deemed withdrawn from consideration.

(e) The Agency shall deem the application complete or withdrawn within seven calendar days of the receipt of the requested information. Subsequent to an application being deemed complete by the Agency, no further application information or amendment will be accepted by the Agency, unless a statutorily required item was omitted and the Agency failed to clearly request the specific item in its omissions request. In the later case, the application may be supplemented only with the omitted item.

(f) A public hearing shall be held only if the Agency determines there are issues of significant public interest related to the proposed project.

(g) The Agency shall issue a State Agency Action Report within 45 calendar days from the date the application is deemed complete unless the review period is extended pursuant to subsection (6) of this rule.

(5) Issuance of State Agency Action Report.

(a) The Agency shall issue a State Agency Action Report describing the Agency’s findings for each application deemed complete. All applications that were comparatively reviewed shall be described in a single State Agency Action Report. The report shall state the Agency’s intent to grant or deny certificates of need for projects in their entirety or for identifiable portions thereof, and state the conditions required of the Certificate of Need holder, if any. The Agency Secretary or their designee shall sign State Agency Action Reports. The Agency shall publish its notice of intent, as set forth in the State Agency Action Report, in the F.A.R. within 14 calendar days after the State Agency Action Report is issued. A notice of intent and State Agency Action Report shall be mailed to each applicant. The Agency decision embodied in the State Agency Action Report to grant additional beds, services, or programs will be reflected in the Agency’s inventories.

(b) If there is no challenge to all or any part of the Agency decision embodied in the State Agency Action Report within 21 days after the publication of the notice of intent, consistent with Rule 59C-1.012, F.A.C., the State Agency Action Report shall become the final order of the Agency. The Certificate of Need shall be signed by the Secretary of the Agency or their designee and shall become effective on the date when the final order is filed in the Office of the Agency Clerk.

(c) If a request for an Administrative Hearing is filed timely, and a final order is subsequently entered which grants a Certificate of Need in whole or in part, a Certificate of Need shall be signed by the Secretary of the Agency or their designee. The Certificate of Need shall become effective on the date when the final order is filed in the Office of the Agency Clerk. The Agency shall provide a copy of the final order to the local health councils.

(d) The Agency shall issue a Certificate of Need according to the timeframes specified in subsections (3) or (4) of this rule, specifying the scope of the project, any conditions placed on the Certificate of Need, and an approved dollar amount for the project in its entirety or for identifiable portions of the total project; or the Agency shall deny a Certificate of Need for the project in its entirety. The Agency may impose conditions on a Certificate of Need predicated upon statements of intent expressed by an applicant in the Certificate of Need application, which the Agency relied upon in its decision to issue the Certificate of Need, and which relate to the criteria set forth in Section 408.035, F.S. and Chapters 59C-1 and 59C-2, F.A.C.

(6) Review period extension. The Agency shall issue a State Agency Action Report pursuant to the timeframes specified in Section 408.039(4), F.S., and this rule unless an extension is granted by written mutual agreement of all applicants which are subject to comparative review in the applicable batching cycle, or an applicant subject to expedited review, and the Agency.

(7) For purposes of the administration of the Health Facility and Services Development Act, any oral or written communication, regarding the merits of a specific application, between the applicant, any person acting on behalf of the applicant, or any person opposing the application and any person in the Agency who exercises any responsibility respecting the application, subsequent to an application being deemed complete pursuant to paragraph (3)(b) or (4)(e) of this rule, and prior to the time of the Agency’s determination pursuant to paragraph (3)(d) or (4)(g) or this rule, is prohibited.

(8) This rule is in effect for five years from its effective date.

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.033(1), 408.036(2), 408.039(3), (4), (5) FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6-5-79, 4-25-80, 2-1-81, 3-31-82, 12-23-82, Formerly 10-5.10, Amended 11-24-86, 11-17-87, 3-23-88, 8-28-88, 1-31-91, 7-1-92, 7-14-92, Formerly 10-5.010, Amended 10-8-97, 12-12-00, 4-2-01, 6-23-05, 4-21-10, 8-8-21.