§ 9440 - Procedures
§ 9440. Procedures
(a) Notwithstanding chapter 25 of Title 3, a certificate of need application shall be in accordance with the procedures of this section.
(b)(1) The application shall be in such form and contain such information as the commissioner establishes. In addition, the commissioner may require of an applicant any or all of the following information that the commissioner deems necessary:
(A) institutional utilization data, including an explanation of the unique character of services and a description of case mix;
(B) a population based description of the institution's service area;
(C) the applicant's financial statements;
(D) third party reimbursement data;
(E) copies of feasibility studies, surveys, designs, plans, working drawings, or specifications developed in relation to the proposed project;
(F) annual reports and four-year long range plans;
(G) leases, contracts, or agreements of any kind that might affect quality of care or the nature of services provided;
(H) the status of all certificates issued to the applicant under this subchapter during the three years preceding the date of the application. As a condition to deeming an application complete under this section, the commissioner may require that an applicant meet with the commissioner to discuss the resolution of the applicant's compliance with those prior certificates; and
(I) additional information as needed by the commissioner.
(2) In addition to the information required for submission, an applicant may submit, and the commissioner shall consider, any other information relevant to the application or the review criteria.
(c) The application process shall be as follows:
(1) Applications shall be accepted only at such times as the commissioner shall establish by rule.
(2)(A) Prior to filing an application for a certificate of need, an applicant shall file an adequate letter of intent with the commissioner no less than 30 days or, in the case of review cycle applications under section 9439 of this title, no less than 45 days prior to the date on which the application is to be filed. The letter of intent shall form the basis for determining the applicability of this subchapter to the proposed expenditure or action. A letter of intent shall become invalid if an application is not filed within six months of the date that the letter of intent is received or, in the case of review cycle applications under section 9439 of this title, within such time limits as the commissioner shall establish by rule. Except for requests for expedited review under subdivision (5) of this subsection, public notice of such letters of intent shall be provided in newspapers having general circulation in the region of the state affected by the letter of intent. The notice shall identify the applicant, the proposed new health care project, and the date by which a competing application or petition to intervene must be filed. In addition, a copy of the public notice shall be sent to the clerk of the municipality in which the health care facility is located. Upon receipt, the clerk shall post the notice in or near the clerk's office and in at least two other public places in the municipality.
(B) Applicants who agree that their proposals are subject to jurisdiction pursuant to section 9434 of this title shall not be required to file a letter of intent pursuant to subdivision (A) of this subdivision (2) and may file an application without further process. Public notice of the application shall be provided upon filing as provided for in subdivision (A) of this subdivision (2) for letters of intent.
(3) The commissioner shall review each letter of intent and, if the letter contains the information required for letters of intent as established by the commissioner by rule, within 30 days, determine whether the project described in the letter will require a certificate of need. If the commissioner determines that a certificate of need is required for a proposed expenditure or action, an application for a certificate of need shall be filed before development of the project begins.
(4) Within 90 days of receipt of an application, the commissioner shall notify the applicant that the application contains all necessary information required and is complete, or that the application review period is complete notwithstanding the absence of necessary information. The commissioner may extend the 90-day application review period for an additional 60 days, or for a period of time in excess of 150 days with the consent of the applicant. The time during which the applicant is responding to the commissioner's notice that additional information is required shall not be included within the maximum review period permitted under this subsection. The public oversight commission may recommend, or the commissioner may determine that the certificate of need application shall be denied if the applicant has failed to provide all necessary information required to review the application.
(5) An applicant seeking expedited review of a certificate of need application may simultaneously file a letter of intent and an application with the commissioner. Upon making a determination that the proposed project may be uncontested and does not substantially alter services, as defined by rule, or upon making a determination that the application relates to a health care facility affected by bankruptcy proceedings, the commissioner shall issue public notice of the application and the request for expedited review and identify a date by which a competing application or petition for interested party status must be filed. If a competing application is not filed and no person opposing the application is granted interested party status, the commissioner may formally declare the application uncontested and may issue a certificate of need without further process, or with such abbreviated process as the commissioner deems appropriate. If a competing application is filed or a person opposing the application is granted interested party status, the applicant shall follow the certificate of need standards and procedures in this section, except that in the case of a health care facility affected by bankruptcy proceedings, the commissioner after notice and an opportunity to be heard may issue a certificate of need with such abbreviated process as the commissioner deems appropriate, notwithstanding the contested nature of the application.
(6) If an applicant fails to respond to an information request under subdivision (4) of this subsection within six months or, in the case of review cycle applications under section 9439 of this title, within such time limits as the commissioner shall establish by rule, the application will be deemed inactive unless the applicant, within six months, requests in writing that the application be reactivated and the commissioner grants the request. If an applicant fails to respond to an information request within 12 months or, in the case of review cycle applications under section 9439 of this title, within such time limits as the commissioner shall establish by rule, the application will become invalid unless the applicant requests, and the commissioner grants, an extension.
(7) For purposes of this section, "interested party" status shall be granted to persons or organizations representing the interests of persons who demonstrate that they will be substantially and directly affected by the new health care project under review. Persons able to render material assistance to the commissioner by providing nonduplicative evidence relevant to the determination may be admitted in an amicus curiae capacity but shall not be considered parties. A petition seeking party or amicus curiae status must be filed within 20 days following public notice of the letter of intent, or within 20 days following public notice that the application is complete. The commissioner shall grant or deny a petition to intervene under this subdivision within 15 days after the petition is filed. The commissioner shall grant or deny the petition within an additional 30 days upon finding that good cause exists for the extension. Once interested party status is granted, the commissioner shall provide the information necessary to enable the party to participate in the review process. Such information includes information about procedures, copies of all written correspondence, and copies of all entries in the application record.
(8) Once an application has been deemed to be complete, public notice of the application will be provided in newspapers having general circulation in the region of the state affected by the application. The notice shall identify the applicant, the proposed new health care project, and the date by which a competing application under section 9439 of this title or a petition to intervene must be filed.
(9) The health care ombudsman's office established under subchapter 1A of chapter 107 of Title 8 or, in the case of nursing homes, the long-term care ombudsman's office established under section 7502 of Title 33, is authorized but not required to participate in any administrative or judicial review of an application under this subchapter and shall be considered an interested party in such proceedings upon filing a notice of intervention with the commissioner.
(d) The review process shall be as follows:
(1) The public oversight commission shall review:
(A) The application materials provided by the applicant.
(B) The assessment of the applicant's materials provided by the department.
(C) Any information, evidence, or arguments raised by interested parties or amicus curiae, and any other public input.
(2) The public oversight commission shall hold a public hearing during the course of a review.
(3) The public oversight commission shall make a written findings and a recommendation to the commissioner in favor of or against each application. A record shall be maintained of all information reviewed in connection with each application.
(4) A review shall be completed and the commissioner shall make a final decision within 120 days after the date of notification under subdivision (c)(4) of this section. Whenever it is not practicable to complete a review within 120 days, the commissioner may extend the review period up to an additional 30 days. Any review period may be extended with the written consent of the applicant and all other applicants in the case of a review cycle process.
(5) After reviewing each application and after considering the recommendations of the public oversight commission, the commissioner shall make a decision either to issue or to deny the application for a certificate of need. The decision shall be in the form of an approval in whole or in part, or an approval subject to such conditions as the commissioner may impose in furtherance of the purposes of this subchapter, or a denial. In granting a partial approval or a conditional approval the commissioner shall not mandate a new health care project not proposed by the applicant or mandate the deletion of any existing service. Any partial approval or conditional approval must be directly within the scope of the project proposed by the applicant and the criteria used in reviewing the application.
(6)(A) If the commissioner proposes to render a final decision denying an application in whole or in part, or approving a contested application, the commissioner shall serve the parties with notice of a proposed decision containing proposed findings of fact and conclusions of law, and shall provide the parties an opportunity to file exceptions and present briefs and oral argument to the commissioner. The commissioner may also permit the parties to present additional evidence.
(B) If the commissioner's proposed decision is contrary to the recommendation of the public oversight commission:
(i) the notice of proposed decision shall contain findings of fact and conclusions of law demonstrating that the commissioner fully considered all the findings and conclusions of the public oversight commission and explaining why his or her proposed decision is contrary to the recommendation of the public oversight commission and necessary to further the policies and purposes of this subchapter; and
(ii) the commissioner shall permit the parties to present additional evidence.
(7) Notice of the final decision shall be sent to the applicant, competing applicants, and interested parties. The final decision shall include written findings and conclusions stating the basis of the decision.
(8) The commissioner shall establish rules governing the compilation of the record used by the public oversight commission and the commissioner in connection with decisions made on applications filed and certificates issued under this subchapter.
(e) The commissioner shall adopt rules governing procedures for the expeditious processing of applications for replacement, repair, rebuilding, or reequipping of any part of a health care facility or health maintenance organization destroyed or damaged as the result of fire, storm, flood, act of God, or civil disturbance, or any other circumstances beyond the control of the applicant where the commissioner finds that the circumstances require action in less time than normally required for review. If the nature of the emergency requires it, an application under this subsection may be reviewed by the commissioner only, without notice and opportunity for public hearing or intervention by any party.
(f) Any applicant, competing applicant, or interested party aggrieved by a final decision of the commissioner under this section may appeal the decision to the supreme court. If the commissioner's decision is contrary to the recommendation of the public oversight commission, the standard of review on appeal shall require that the commissioner's decision be supported by a preponderance of the evidence in the record.
(g) If the commissioner has reason to believe that the applicant has violated a provision of this subchapter, a rule adopted pursuant to this subchapter, or the terms or conditions of a prior certificate of need, the commissioner may take into consideration such violation in determining whether to approve, deny, or approve the application subject to conditions. The applicant shall be provided an opportunity to contest whether such violation occurred, unless such an opportunity has already been provided. The commissioner may impose as a condition of approval of the application that a violation be corrected or remediated before the certificate may take effect. (Added 1979, No. 65, § 1; amended 1985, No. 234 (Adj. Sess.), § 7; 1987, No. 96, § 14; 1991, No. 160 (Adj. Sess.), §§ 29-32, 38, eff. May 11, 1992; 1993, No. 50, §§ 2, 3; 1995, No. 180 (Adj. Sess.), § 29; 1997, No. 159 (Adj. Sess.), § 11, eff. April 29, 1998; 2003, No. 53, §§ 15, 26; 2005, No. 71, § 77e; 2007, No. 27, § 8; 2007, No. 139 (Adj. Sess.), §§ 3-5, 5d; No. 139 (Adj. Sess.), § 5a, eff. May 9, 2008; No. 139 (Adj. Sess.), § 5e, eff. July 1, 2009; 2009, No. 49, § 11.)