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. 10.24.01.10. Miscellaneous Rules and Procedures
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A. Filing of Documents with the Commission.
(1) In computing a period of time prescribed by these regulations, by order of the Commission, or by an applicable statute, the day of the action or default initiating the designated period of time is not included. The last day of the period so computed is to be included unless it is a day on which the office of the Commission is closed, in which event the period extends until the next day on which the office of the Commission is open.
(2) At the discretion of the reviewer, the Executive Director, or the Executive Director's designee, and upon a showing of substantial reasons by the submitting party, a period of time to submit a document or perform any act permitted or prescribed by these regulations may be extended for a reasonable period of time.
(3) In all matters before the full Commission, filings may not be made directly to individual commissioners except at the direction of the reviewer, the Executive Director, or the Executive Director's designee.
B. Motion Practice.
(1) A motion shall be made in writing, except when made at a hearing or prehearing conference in accordance with Regulation .11 of this chapter, and shall state concisely the question which the Commission is called upon to determine, or the action the movant desires the Commission to take. It shall state all reasons, authorities, and citations in the body of the motion or in a supporting memorandum.
(2) A motion made in response to a determination by the Commission or its staff shall be filed within 20 days of the determination to which the motion responds.
(3) The following actions shall be taken by motion:
(a) A demand for an action which the movant desires the Commission, the reviewer, or the staff of the Commission to take;
(b) A request for reconsideration, under Regulation .19 of this chapter;
(c) An objection to the introduction of a statement or other evidence by a party during an evidentiary hearing held under Regulation .11 of this chapter;
(d) A challenge to a reviewer or other member of the Commission;
(e) An action that might be initiated properly or undertaken by a party to a review, and that is not otherwise provided for in these regulations; and
(f) Any other question that is justiciable.
(4) A motion need not be verified unless it is based on facts not apparent from the record or documents filed in the proceeding.
(5) A party to the hearing may file one written answer to a motion, in the same format required of motions.
(6) The reviewer, or, in a matter in which no reviewer has been appointed, a commissioner appointed as motions officer by the Executive Director, may hear oral argument on the motion at the request of a party.
C. Summary Decision.
(1) At any time after an application is docketed, staff may file a motion for summary decision to deny a docketed application if the proposed project is inconsistent with one or more standards of the State Health Plan that make the project unapprovable.
(2) The motion shall identify the grounds for the motion and the staff's position and argument. The motion need not address every State Health Plan standard. The affected applicant has the opportunity to respond to the motion in writing.
(3) If staff is reviewing the application, as specified in Regulation .09A(1)(b) of this chapter, a quorum of the full Commission shall decide the motion.
(4) If a commissioner is acting as reviewer, that commissioner shall decide the motion, subject to review by the full Commission. An affected applicant has 10 days to respond to the motion in writing and, at the applicant's request, to present oral argument to the reviewer before the reviewer rules on the motion.
D. Evidentiary Hearing.
(1) At the request of an interested party in a Certificate of Need review, an evidentiary hearing may be held on any Certificate of Need application for the construction of an acute general or special hospital.
(2) An evidentiary hearing may not be held on an application for an ambulatory surgical facility or new or expanded ambulatory surgical capacity in a setting owned or controlled by a hospital.
(3) If an applicant requests a hearing to show cause why a Certificate of Need should not be withdrawn, the Commission shall hold an evidentiary hearing before it withdraws a Certificate of Need, under Regulation .12 of this chapter.
(4) The Commission may hold an evidentiary hearing in a Certificate of Need review for a proposed new facility or service if, in the judgment of the reviewer, an evidentiary hearing is appropriate due to the magnitude of impact the proposed project would have on the existing health care system, by meeting the requirements of this subsection and of §D(5) of this regulation. The project, if approved, would result in one of the following:
(a) A significant increase in public costs, or in costs and charges paid by a substantial number of patients and third-party payors;
(b) A significant decrease in the availability and overall quality of health care services in the affected area in a manner not consistent with policies or need projections set forth in the State Health Plan, such as by causing a loss of reasonable access to an essential medical service by a substantial number of patients;
(c) An additional demand on limited resources available to support health care facilities or medical services in a proposed service area that has existing budgetary and competitive constraints, such as a high penetration of managed care, or a high level of existing excess capacity; or
(d) Any impact that the reviewer concludes may be sufficiently serious to merit an evidentiary hearing.
(5) An evidentiary hearing will assist the reviewer in resolving questions of material fact or witness credibility.
(6) Request for Evidentiary Hearing.
(a) Each applicant and interested party may request that the reviewer conduct an evidentiary hearing on a proposed project by the 45th day after docketing, or within 30 days of a modification of an application in a review.
(b) The reviewer may hear oral arguments from any party on the question of whether to conduct an evidentiary hearing.
(c) An interested party may appeal an adverse ruling on this question by motion to the full Commission at its next regular meeting.
(7) The evidentiary hearing shall be conducted in accordance with Regulation .11 of this chapter.
E. Ex Parte Contacts. After the docketing of an application and until the Commission renders its decision under this regulation, the ex parte provisions of the Administrative Procedure Act, State Government Article, Title 10, Annotated Code of Maryland, apply.
F. Local Health Department Review and Comment.
(1) The Commission shall seek information and comment from each local health department in the health planning region in which a proposed project may be located, and consider any response from the local health department in making a final decision on an application.
(2) The Commission shall consider a positive recommendation of the local health department to be one measure of community support for a proposed project. If a local health department makes a recommendation on a specific project, and the Commission's decision differs from that proposed by the local health department, the Commission shall make a written, detailed explanation as to the basis for the difference to the local health department.
G. Required Approvals. Unless the Commission finds that the facility or service for which the proposed expenditure is to be made is not needed or is not consistent with the State Health Plan, the Commission shall approve an application for a Certificate of Need to the extent that the capital expenditure is made to eliminate or prevent an imminent safety hazard, as defined by federal, State, or local fire, building, or life safety codes or regulations, to comply with State licensing standards, or to comply with the accreditation standards for reimbursement under Title XVII of the Social Security Act or under the State Medical Assistance Program approved under Title XIX of the Social Security Act.
H. Notice of Certificate of Need Approval.
(1) Notice that a facility or project has been granted a Certificate of Need shall be made in writing by the Commission to those agencies responsible under the licensure program and other agencies that may have interests or responsibilities related to the project.
(2) The notice shall be given at the same time that notice is given to each applicant, interested party, and the local health department.
(3) The notice of Certificate of Need approval shall contain the following information:
(a) The nature and scope of the approved health service or facility, described in suitable detail;
(b) The actual capital costs associated with the approved project, to include construction, equipment acquisition (whether by purchase or lease), architects' and consultants' fees, and all other costs, other than financing costs, to be incurred by the applicant in order to complete the project;
(c) The total principal amount of funds to be borrowed, if any, and a description of the terms of the financing mechanism through which this borrowing will be accomplished; and
(d) Each condition associated with the project approval.
I. Changes to an Approved Project. If an applicant proposes to make changes to an approved project, the applicant shall notify the Commission of the proposed change in accordance with the procedure established in Regulation .17 of this chapter.
J. Participation of Staff. The reviewer may seek the assistance of any member of the Commission staff in preparing a proposed decision.