§16-2D-7 Procedures for certificate of need reviews.
§16-2D-7. Procedures for certificate of need reviews.
(a) Prior to submission of an application for a certificate of need, the state agency shall require the submission of long-range plans by health care facilities with respect to the development of proposals subject to review under this article. The plans shall be in such form and contain such information as the state agency requires.
(b) An application for a certificate of need shall be submitted to the state agency prior to the offering or development of all new institutional services within this state. Persons proposing new institutional health services shall submit letters of intent not less than fifteen days prior to submitting an application. The letters of intent shall be of such detail as specified by the state agency.
(c) The state agency may adopt rules pursuant to section eight of this article for:
(1) Provision for applications to be submitted in accordance with a timetable established by the state agency;
(2) Provision for such reviews to be undertaken in a timely fashion; and
(3) Except for proposed new institutional health services which meet the requirements for consideration under subsection (f), section nine of this article with regard to the elimination or prevention of certain imminent safety hazards or to comply with certain licensure or accreditation standards, provision for all completed applications pertaining to similar types of services, facilities or equipment to be considered in relation to each other at least three times a year.
(d) An application for a certificate of need shall specify the time the applicant will require to make such service or equipment available or to obligate such expenditure and a timetable for making such service or equipment available or obligating such expenditure.
(e) The application shall be in such form and contain such information as the state agency establishes by rule, but requests for information shall be limited to only that information which is necessary for the state agency to perform the review.
(f) Within fifteen days of receipt of application, the state agency shall determine if the application is complete. The state agency may request additional information from the applicant.
(g) The state agency shall provide timely written notice to the applicant and to all affected persons of the beginning of the review and to any person who has asked the state agency to place the person's name on a mailing list maintained by the state agency. Notification shall include the proposed schedule for review, the period within which a public hearing during the course of the review may be requested by affected persons, which period may not be less than thirty days from the date of the written notification of the beginning of the review required by this section, and the manner in which notification will be provided of the time and place of any public hearing so requested. For the purposes of this subsection, the date of notification is the date on which the notice is sent or the date on which the notice appears in a newspaper of general circulation, whichever is later.
(h) Written notification to members of the public and third-party payers may be provided through newspapers of general circulation in the applicable health service area and public information channels; notification to all other affected persons shall be by mail which may be as part of a newsletter.
(i) If, after a review has begun, the state agency requires the person subject to the review to submit additional information respecting the subject of the review, such person shall be provided at least fifteen days to submit the information and the state agency shall, at the request of such person, extend the review period by fifteen days. This extension applies to all other applications which have been considered in relation to the application for which additional information is required.
(j) The state agency shall adopt schedules for reviews which provide that no review may, to the extent practicable, take longer than ninety days from the date that notification, as described under subsection (g) of this section, is sent to the applicant to the date of the final decision of the state agency and in the case of expedited applications, may, by rules adopted pursuant to section eight of this article, provide for a shortened review period.
(k) The state agency shall adopt criteria for determining when it would not be practicable to complete a review within ninety days.
(l) The state agency shall provide a public hearing in the course of agency review if requested by any affected person and the state agency may on its own initiate such a public hearing:
(1) The state agency shall, prior to such hearing, provide notice of such hearing and shall conduct such hearing in accordance with administrative hearing requirements in article five, chapter twenty-nine-a of this code and its procedure adopted pursuant to this section.
(2) In a hearing any person has the right to be represented by counsel and to present oral or written arguments and evidence relevant to the matter which is the subject of the hearing. Any person affected by the matter which is the subject of the hearing may conduct reasonable questioning of persons who make factual allegations relevant to such matter.
(3) The state agency shall maintain a verbatim record of the hearing.
(4) After the commencement of a hearing on the applicant's application and before a decision is made with respect to it, there may be no ex parte contacts between: (A) The applicant for the certificate of need, any person acting on behalf of the applicant or holder of a certificate of need or any person opposed to the issuance of a certificate for the applicant; and (B) any person in the state agency who exercises any responsibility respecting the application.
(5) The state agency may not impose fees for such a public hearing.
(m) If a public hearing is not conducted during the review of a new institutional health service, the state agency may, by rules adopted pursuant to section eight of this article, provide for a file closing date during the review period after which date no other factual information or evidence may be considered in the determination of the application for the certificate of need. A detailed itemization of documents in the state agency file on a proposed new institutional health service shall, on request, be made available by the state agency at any time before the file closing date.
(n) The extent of additional information received by the state agency from the applicant for a certificate of need after a review has begun on the applicant's proposed new institutional health service, with respect to the impact on such new institutional health service and additional information which is received by the state agency from the applicant, may be cause for the state agency to determine the application to be a new proposal, subject to a new review cycle.
(o) The state agency shall in timely fashion notify, upon request, providers of health services and other persons subject to review under this article of the status of the state agency review of new institutional health services subject to review, findings made in the course of such review and other appropriate information respecting such review.
(p) The state agency shall prepare and publish, at least annually, reports of reviews completed and being conducted with general statements about the status of each review still in progress and the findings and rationale for each completed review since the publication of the last report.
(q) The state agency shall provide for access by the general public to all applications reviewed by the state agency and to all other pertinent written materials essential to agency review.
(r) (1) Any person may request in writing a public hearing for purposes of reconsideration of a state agency decision. No fees may be imposed by the state agency for the hearing. For purposes of this section, a request for a public hearing for purposes of reconsideration shall be considered to have shown good cause if, in a detailed statement, it:
(A) Presents significant, relevant information not previously considered by the state agency and demonstrates that with reasonable diligence the information could not have been presented before the state agency made its decision;
(B) Demonstrates that there have been significant changes in factors or circumstances relied upon by the state agency in reaching its decision;
(C) Demonstrates that the state agency has materially failed to follow its adopted procedures in reaching its decision; or
(D) Provides such other bases for a public hearing as the state agency determines constitutes good cause.
(2) To be effective, a request for such a hearing shall be received within thirty days after the date of the state agency decision and the hearing shall commence within thirty days of receipt of the request.
(3) Notification of such public hearing shall be sent, prior to the date of the hearing, to the person requesting the hearing, the person proposing the new institutional health service and to others upon request.
(4) The state agency shall hold public reconsideration hearings in accordance with the provisions for administrative hearings contained in:
(A) Its adopted procedures;
(B) Ex parte contact provisions of subdivision (4), subsection (l) of this section; and
(C) The administrative procedures for contested cases contained in article five, chapter twenty-nine-a of this code.
(5) The state agency shall make written findings which state the basis for its decision within forty-five days after the conclusion of such hearing.
(6) A decision of the state agency following a reconsideration hearing shall be considered a decision of the state agency for purposes of sections nine and ten of this article and for purposes of the notification of the status of review, findings and annual report provisions of subsections (o) and (p) of this section.
(s) The state agency may adopt rules pursuant to section eight of this article for reviews and such rules may vary according to the purpose for which a particular review is being conducted or the type of health services being reviewed.
(t) Notwithstanding other provisions of this article, the state agency shall adopt rules for determining when there is an application which warrants expedited review.