Tenn. Comp. R. & Regs. 0720-10-.02 - STANDARD PROCEDURES FOR CERTIFICATE OF NEED

(1) Application Form. Each application will be filed using standard application forms provided by the Agency. The applicant must provide all information requested in the application forms.

(2) Letters of Intent.

(a) Each Letter of Intent shall be filed using standard forms provided by the Agency. The applicant must provide all information requested in the Letter of Intent form. The applicant must fully comply with all instructions contained in the Letter of Intent form provided by the Agency.

(b) Each Letter of Intent for home care organization applications shall also specify all counties in the proposed service area.

(c) Any Letter of Intent which contains insufficient information may be deemed void. The Letter of Intent may be refiled, but it is subject to the same requirements as an original Letter of Intent.

(d) The Letter of Intent shall be published for one day in a newspaper of general circulation in the county where the proposed project is to be located. The Letter of Intent shall be published in the Legal Notice section in a space which should be no smaller than four (4) column inches. Publication must be in the same form and format as the Publication of Intent form provided by the Agency.

1. Both filing and publication must occur between the first and fifteenth day of the month preceding the filing of the application, except for applications seeking simultaneous review, which must be filed and published between the sixteenth and the last day of the month. If the last day for filing the Letter of Intent is a Saturday, Sunday or State holiday, filing must occur no later than the next regular business day. If both filing and publication do not occur within the required time period, the Letter of Intent will be null and void, and the applicant will be notified in writing.

2. For the purpose of these rules, "newspaper of general circulation" means a publication with the following characteristics:

(i) Is regularly issued at least once a week;

(ii) Has at least a periodicals mailing privilege;

(iii) Includes a Legal Notice Section;

(iv) Is not fewer than four (4) pages in length;

(v) Has been published continuously during the immediately preceding one year period;

(vi) Is published for dissemination of news of general interest; and

(vii) Is circulated generally in the county in which it is published.

3. In any county where a publication fully complying with this definition does not exist, the Executive Director is authorized to determine appropriate publication to receive any required Letter of Intent. A newspaper which is engaged in the distribution of news of interest to a particular interest group or other limited group of citizens, is not a "newspaper of general circulation."

4. In the case of an application for or by a home care organization, the Letter of Intent shall be published in each county in which the agency will be licensed or in a regional newspaper which qualifies as a newspaper of general circulation in each county. In those cases where the Letter of Intent is published in more than one newspaper, the earliest date of publication shall be the date of publication for the purpose of determining the date for the timely filing of the application. Both the Letter of Intent and the application must specify the counties to be served.

(3) Simultaneous Review. Those persons desiring simultaneous review for a certificate of need for which a Letter of Intent has been filed shall file a Letter of Intent with the Agency and the original applicant, and publish the Letter of Intent simultaneously in a newspaper of general circulation, as those terms are defined in subparagraph (2)(d), above, in the same county as the original applicant between the sixteenth day and last day of the month of publication by the original applicant. The Executive Director or his/her designee will determine whether applications are to be reviewed simultaneously.

(a) The applicant seeking simultaneous review shall, at the time the Letter of Intent is filed with the Agency, also file a verified statement certifying it has complied with the procedural requirements for simultaneous review and evidence that the Notice was received by the Agency business office and the original applicant between the sixteenth day and last day of the month of publication by the original applicant.

(b) In addition to the procedural requirements, the following factors may be considered by the Executive Director in determining whether the applications are appropriate for simultaneous review:

1. Similarity of services area;

2. Similarity of location;

3. Similarity of facilities; and

4. Similarity of service to be provided.

(c) If, at the time an application is filed for simultaneous review, there is already another application filed for simultaneous review against the original application, the second application seeking simultaneous review may be simultaneously reviewed against both the original application and the other application seeking simultaneous review.

(d) The order in which applications filed for simultaneous review will be placed on the agenda will be determined by the order in which the Letters of Intent were received in the Agency office.

(e) Any application which is determined to not meet the criteria for a "simultaneous review" shall be null and void. The application may be re-filed for a subsequent review cycle, but is subject to the same requirements as an original application.

(4) Applications.

(a) Applications may be filed at any time after the filing of the Letter of Intent and before the end of normal business hours on the first day of the month after publication by the applicant. If the last day for filing an application falls on a Saturday, Sunday, or State holiday, the application, to be timely, must be filed no later than the next regular business day. Applications will not be reviewed for completeness until the examination fee has been received by the Agency, and examination fees received after the first day of the month in which the application is filed may affect whether the application can enter that month's review cycle.

(b) Failure by the applicant to file an application no later than the first day of the month after publication of the Letter of Intent in accordance with (a) above shall render the Letter of Intent, and hence the application, void.

(c) When an application is received at the Agency office, it must include an initial filing fee, as provided elsewhere in these rules. The filing fee is non-refundable. Review for completeness shall not begin prior to the receipt of the filing fee.

(d) Each application that is accompanied by the applicable filing fee will be reviewed for completeness by Agency staff.

1. If it is deemed complete, the Agency will acknowledge receipt and notify the applicant that the review period will begin as of the date specified in the notification. Deeming complete means only that all questions and requests for information have been responded to in some reasonable manner. Deeming complete shall not be construed as validating the sufficiency of the information provided for the purposes of addressing the criteria under the applicable statutes, rules, and other guidelines.

2. If the application is incomplete, responses to requests for supplemental information by the staff must be completed by the applicant and filed at the Agency office within sixty (60) days of the first written request by Agency staff. Failure of the applicant to meet this deadline will result in the application being considered withdrawn and returned to the contact person. Resubmittal of the application must be accomplished in accordance with Rule 0720-10-.02 and requires an additional filing fee.

(e) An application for certificate of need shall not be amended in a substantive way by the applicant after being filed with the Agency. If the application is amended in a substantive manner varying from the Letter of Intent or the original application filed with the Agency, the application may be deemed void. This Rule does not prohibit correction of clerical errors in the application.

(5) Examination Filing Fee.

(a) The amount of the initial fee shall be equal to $2.25 per $1,000 of the estimated capital expenditure involved, but in no case shall this fee be less than $3,000 nor more than $45,000.

(b) Any unpaid balance of litigation costs previously assessed against the applicant or any related entity of the applicant by the Tennessee Health Services and Development Agency may be offset against any filing fees paid. An application will not be deemed complete until the full filing fee, as well as such offset amounts, are paid in full.

(c) A final fee will be determined upon the Agency's receipt of the final project report. The amount of the final fee shall be the difference between the initial fee and the total fee based on actual final project costs, as such fee is calculated based on $2.25 per $1,000 of project costs, but in no case shall the total fee be less than $3,000 nor more than $45,000.

(6) Distribution of Applications. The Agency will promptly forward a copy of each application deemed complete to the Department of Health, the Department of Mental Health and Substance Abuse Services, or to the Department of Intellectual and Developmental Disabilities for comment.

(7) Withdrawal of Applications. An application may be withdrawn at any time by the applicant.

(8) Beginning of the Review Cycle. The review cycle for each application shall begin on the fifteenth day of the appropriate month after the application has been deemed complete by the staff of the Agency.

(9) Staff Reports on Applications.

At the end of the review cycle, Agency staff shall make its official written report available on the Agency's website. A copy of this report shall be forwarded to the applicant, to the Department of Health, the Department of Mental Health and Substance Abuse Services, or the Department of Intellectual and Developmental Disabilities, whichever is appropriate, and to any other person requesting one.

(10) The report shall address at a minimum each of the applicable criteria for certificates of need set forth in the statutes, rules, and the criteria and standards. The report shall clearly set forth any planning methodologies, databases, and resource materials utilized in making its findings. The report may include other information the Executive Director deems appropriate and informative. The report shall address the following:

(a) The applicant's compliance with the criteria found in Agency Rules Chapter 0720-11;

(b) A verification of the methodologies provided by the applicant to meet the criteria specified in (a), as well as identification of any additional methodologies that would further clarify compliance with the criteria;

(c) An assessment of the applicant's compliance with any applicable criteria and standards a/k/a Guidelines for Growth; and

(d) An analysis of any information received from the Division of TennCare as to the previous, current and proposed TennCare participation or non-participation of the applicant and any affiliate(s) involved with the project.

(11) An applicant may provide written supporting information to its application during the review cycle. Further, the applicant will have the right to respond in writing to the report. The Health Services and Development Agency shall receive a copy of the applicant's response to the staff report not less than five (5) days prior to the Health Services and Development Agency meeting.

(12) Holder of Certificate of Need. A certificate of need will normally be issued to the person to whom the license for the health care institution is or will be issued; if not a health care institution as defined in T.C.A. § 68-11-1602, then a certificate of need will normally be issued to the person who will provide the service.

Notes

Tenn. Comp. R. & Regs. 0720-10-.02

Original rule filed August 31, 2005; effective November 14, 2005. Emergency rule filed July 1, 2016; effective through December 28, 2016. The emergency rule expired on December 29, 2016 and reverted to its previous status. Amendments filed November 15, 2016; effective February 13, 2017. Rule was previously numbered 0720-10-.03 but was renumbered 0720-10-.02 with the deletion of the original rule 0720-10-.02 filed October 24, 2017; effective January 22, 2018. Amendments filed October 24, 2017; effective January 22, 2018. Emergency rules filed September 28, 2021; effective through March 27, 2022. Amendments filed December 27, 2021; effective 3/27/2022.

Authority: T.C.A. §§ 4-5-201, et seq., 4-5-202, 68-11-1605, 68-11-1606, 68-11-1607, 68-11-1608, and 68-11-1609; 2016 Tenn. Pub. Acts Ch. 1043; and 2021 Tenn. Pub. Acts Ch. 557.