Code of Maryland Regulations (Last Updated: April 6, 2021) |
Title 10. Maryland Department of Health |
Part 4. |
Subtitle 24. MARYLAND HEALTH CARE COMMISSION |
Chapter 10.24.01. Certificate of Need for Health Care Facilities |
Sec. 10.24.01.09. Commission Decision and Action on Applications
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A. Proposed Decision.
(1) Preparation of Proposed Decision.
(a) In a noncomparative review in which no interested party has submitted written comments opposing an application, or in a review in which no evidentiary hearing is held in accordance with Regulation .10D of this chapter, the staff shall review the application and prepare a staff report and recommendation.
(b) In all other reviews, the Executive Director shall appoint a single Commissioner, who may be assisted by the staff of the Commission, to act as reviewer.
(2) Project Status Conference.
(a) The reviewer or staff, as appropriate, may request that a project status conference be held before the issuance of a proposed decision or staff report, to apprise each applicant, interested party, and participating entity of those aspects of a proposed project that appear to be inconsistent with applicable standards and review criteria.
(b) Following the project status conference, the reviewer or staff will send each applicant, interested party, and participating entity a summary of the project status conference that includes dates, as needed, for additional filings.
(c) The applicant shall send to each interested party and participating entity a copy of proposed project changes made pursuant to the project status conference.
(d) Each interested party and participating entity in the review of an application shall have 7 days to file comments on the proposed changes made pursuant to the project status conference.
(3) Opportunity to Present Oral Argument. Each applicant and interested party may request the opportunity to present oral argument to the reviewer before the reviewer prepares a proposed decision on the application for consideration by the full Commission, as follows:
(a) The request shall be made within the time period for an applicant's response to comments under Regulation .08F(2) of this chapter;
(b) The decision to grant oral argument is at the sole discretion of the reviewer;
(c) The reviewer may set reasonable time limits for oral argument; and
(d) The reviewer may, if there is a genuine dispute as to the credibility of a material witness on a matter of fact, require the witness to answer questions on that matter under oath during the oral argument portion of a Certificate of Need review.
(4) The proposed decision shall state the reviewer's determination as to whether:
(a) Each relevant State Health Plan standard or review criterion set forth in Regulation .08G of this chapter:
(i) Is met by the applicant,
(ii) Is not applicable to the project, or
(iii) Is applicable to the project and is not met by the applicant;
(b) In a comparative review, one or more of the projects should be preferred under a State Health Plan standard or criteria either as a result of meeting a preference standard or because an applicant complied with one or more criteria in a superior way relative to another applicant; and
(c) To recommend that a project or projects be granted a Certificate of Need.
B. Exceptions.
(1) Each applicant and interested party who has submitted written comments under Regulation .08F(1) of this chapter may submit written exceptions to a proposed decision and order by submitting written argument and supporting documentation from the record.
(2) Schedule.
(a) Upon issuance of a proposed decision, Commission staff shall issue a notice specifying the schedule for the submission of exceptions and any response, and the date on which the Commission shall hear oral argument on the exceptions.
(b) Unless otherwise agreed by each applicant and interested party, the schedule issued by Commission staff shall specify that exceptions shall be filed at least 15 days before the Commission meeting at which the proposed decision and order will be considered, and any response to the exceptions filed at least 10 days before the Commission meeting, except that a party filing exceptions has at least 7 days to file exceptions, and a party filing a response to exceptions has at least 5 days to file a response. The Commission staff may shorten these periods by agreement of the parties, or extend any deadlines set for good cause shown.
(3) Written exceptions shall specifically identify each finding and conclusion to which exception is taken, citing those portions of the record on which each exception is based.
(4) Oral arguments before the full Commission concerning the proposed decision are limited to 10 minutes per applicant and 10 minutes per interested party, unless extended by the Chairman of the Commission.
C. Participation By Participating Entity In Certain Reviews After Issuance of a Staff Report or Reviewer's Proposed Decision.
(1) Participating Entity Request to Address the Commission.
(a) In a project upon which it timely filed comments on an applicant's conformance with State Health Plan standards and review criteria, and after the issuance of a staff report or a reviewer's proposed decision, and at least 3 days before the scheduled Commission meeting that will consider an application, a participating entity may notify the Commission that it desires to address the Commission before Commission action on the application, specifying the points that it wants to make.
(b) The Chairman of the Commission, after consultation with the executive director, may permit a participating entity, or combination of participating entities, to make an oral presentation to the Commission on matters it addressed in written comments on the application.
(c) At least 1 day before the scheduled Commission meeting that will consider an application, the executive director shall advise each applicant, interested party, and participating entity in a review whether the Chairman will permit a participating entity or combination of participating entities, to make an oral presentation to the Commission, and shall specify the format of the presentation.
(2) An applicant may address the Commission in any review in which a participating entity is granted permission to address the Commission before action on an application.
(3) This section does not:
(a) Confer interested party status or aggrieved party status upon a participating entity; or
(b) Grant a participating entity the right to judicial appeal under State Government Article, Title 10, Annotated Code of Maryland.
D. Final Decision.
(1) The Commission shall issue a final decision based on the record of the proceeding. The final decision shall take one of the following two forms:
(a) A statement of exceptions that have been accepted, if any, and a statement that the proposed decision is adopted into the final decision except as otherwise noted; or
(b) A new final decision in the format for proposed decisions, as specified in §A(3) of this regulation.
(2) The Commission's decision shall do one of the following:
(a) Approve the application;
(b) Approve the application with conditions; or
(c) Deny the application.
(3) The decision of the Commission shall be by a majority of the quorum present and voting.
E. Action on the Application.
(1) The Commission shall act on an application for a Certificate of Need not later than 150 days after the application has been docketed. If no evidentiary hearing is held, the Commission shall act on an application within 90 days after the docketing of the application. Staff shall report to the Commission the status of all projects where a staff report is not issued for Commission action within 90 days.
(2) The Commission shall notify the applicant and the local health department, of one of the following determinations:
(a) The project is granted a Certificate of Need;
(b) The project is granted a Certificate of Need with specific conditions; or
(c) The project is not granted a Certificate of Need.
(3) The decision of the Commission shall include findings of fact and conclusions of law.
(4) The decision of the Commission shall be by a majority of the quorum present and voting.
(5) The decision shall be in writing and shall state the reasons and grounds for the Commission's decision.
(6) The Commission may not render a final decision until:
(a) A proposed decision, including findings of fact and conclusions of law, has been served upon each party; and
(b) Each party adversely affected by the proposed decision has been given an opportunity to file exceptions and present oral argument before the Commission.
F. Judicial Review.
(1) The Commission's final decision is subject to the judicial review under State Government Article, Title 10, Annotated Code of Maryland.
(2) In order to take a judicial appeal, an interested party must be an aggrieved party.
(3) For purposes of judicial review, the record of the proceeding shall include:
(a) The application;
(b) Requests for additional information from the reviewer, the Commission, or Commission staff, and responses to them;
(c) Comments received from each interested party, and supporting documentation, affidavits, and responses from each applicant;
(d) Reports or recommendations from staff;
(e) Motions and pleadings;
(f) The prehearing conference report, if any;
(g) Prefiled testimony, if any;
(h) A recording or transcript of any hearing;
(i) The reviewer's proposed decision, and all exceptions and responses to exceptions; and
(j) The Commission's final decision.
(4) A decision of the Commission is a final decision for purposes of judicial review.
(5) A request for reconsideration in accordance with Regulation .19 of this chapter will stay the final decision of the Commission for purposes of judicial review until a decision is made on the reconsideration.