Md. Code Regs. 10.24.01.09

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.24.01.09 - Commission Decision and Action on CON Applications

A. Proposed Decision.

(1) Preparation of Proposed Decision.

(a) In a comparative or contested review, or in a review in which an evidentiary hearing is held in accordance with Regulation .11 of this chapter, the Executive Director shall appoint a single Commissioner, who may be assisted by the staff of the Commission, to act as reviewer and prepare a proposed decision for consideration by the Commission.

(b) In all other reviews, Commission staff shall review the application and prepare a staff report and recommendation for consideration by the Commission.

(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 in a contested or comparative review 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(1) 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 CON review.

(4) A staff report and recommendation on a proposed project or a reviewer's proposed decision on a project shall state the staff's conclusion or the reviewer's finding 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 is preferred under a State Health Plan standard or criterion either as a result of consideration of a preference standard or because one or more of the projects was determined to be superior based on the reviewer's consideration of the applicable criteria; and

(c) To recommend that one or more of the projects be granted a CON.

B. Exceptions.

(1) Pursuant to State Government Article, §10-216, Annotated Code of Maryland, each applicant and interested party who has submitted comments under Regulation .08F(1) of this chapter may submit written exceptions to a staff report and recommendation or a proposed decision and make oral argument to the Commission.

(2) Schedule.

(a) A proposed decision in a contested or comparative review shall be issued at least 30 days before the Commission meeting at which the proposed decision and order will be considered.

(b) Upon issuance of a staff report or proposed decision, Commission staff shall issue a notice specifying the schedule for the submission of exceptions and any response, the date on which the Commission shall hear oral argument, and rules for conduct of the hearing.

(c) Unless otherwise agreed by each applicant and interested party, the schedule issued by Commission staff in a contested or comparative review shall specify that exceptions shall be filed on a date at least 10 days after the issuance of a proposed decision and any response to the exceptions filed on a date at least 7 days after the filing of exceptions. The Commission staff may shorten these periods by agreement of the parties, or extend any deadlines set for good cause shown.

(3) Exceptions Requirements.

(a) 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.

(b) Exceptions shall be limited to 25 pages, double-spaced, excluding attachments.

(c) Responses to exceptions shall be limited to 15 pages, double-spaced, excluding attachments.

(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 Chair of the Commission. An applicant may reserve time for rebuttal.

C. Participation By Participating Entity In Certain Reviews After Issuance of a Staff Report or Reviewer's Proposed Decision.

(1) Request by Participating Entity to Address the Commission.

(a) After the issuance of a staff report or a reviewer's proposed decision, a participating entity may request the opportunity to address the Commission before Commission action on the application by submitting a written request at least 7 days before the scheduled Commission meeting that will consider an application, specifying the points that it wants to make.

(b) The Chair 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 5 days 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 Chair 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.

D. Final Decision.

(1) The Commission's final decision on a project shall contain findings of fact and conclusions of law and:

(a) Approve the application;

(b) Approve the application with conditions; or

(c) Deny the application.

(2) 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 CON 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) With the exception of CON applications to establish a health care facility, relocate a health care facility, or establish cardiac surgery services or organ transplantation services at an existing acute general hospital, a CON application filed after October 1, 2019 shall be deemed approved if the application is uncontested and final action by the Commission does not occur within 120 days after the application is docketed.

(3) On motion by an applicant or an interested party, a review of a CON application may be stayed for a period not to exceed 6 months if the reviewer, or if a reviewer is not appointed, the Executive Director, determines that there is good cause for a stay.

(4) The Commission shall notify the applicant, interested parties, participating entities, and the local health department of the Commission's final decision.

(5) The Commission may not render a final decision until:

(a) A staff report and recommendation or a reviewer's proposed decision has been provided to each party; and

(b) Each applicant and interested party 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 judicial review under State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.

(2) In order to seek judicial review, a party must be an aggrieved party.

(3) For purposes of judicial review, the record of the proceeding shall include:

(a) The application;

(b) Requests to an applicant for additional information from Commission staff, the reviewer, the Commission, and responses to the requests;

(c) Comments received from each interested party and responses from each applicant;

(d) Reports or recommendations from staff;

(e) Motions and responsive filings;

(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, 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 the Commission decides the request for reconsideration.

Md. Code Regs. 10.24.01.09

Regulations .09 amended effective February 4, 1976 (3:3 Md. R. 151)
Regulations .09A amended as an emergency provision effective July 1, 1978 (5:17 Md. R. 1321); adopted permanently effective December 15, 1978 (5:25 Md. R. 1855)
Regulations .09E amended effective January 25, 1980 (7:2 Md. R. 115)
Regulations .09_G, and .16-1 adopted effective January 25, 1980 (7:2 Md. R. 115)
Regulation .09A amended effective March 19, 1990 (17:5 Md. R. 638)
Regulations .09 adopted effective November 6, 1995 (22:22 Md. R. 1658)
Regulation .09 amended effective April 11, 2005 (32:7 Md. R. 680); April 9, 2007 (34:7 Md. R. 699)
Regulation .09A amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379)
Regulation .09A amended effective April 10, 2006 (33:7 Md. R. 672)
Regulation .09C amended effective November 24, 2003 (30:23 Md. R. 1652)
Regulation .09D amended effective April 10, 2006 (33:7 Md. R. 672); adopted effective 50:22 Md. R. 975, eff. 12/1/2023