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10.24.01.00.htm 10.24.01.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 24 MARYLAND HEALTH CARE COMMISSION Chapter 01 Certificate of Need for Health Care Facilities Authority: Health-General Article, §19-109(a)1) and 19-120, Annotated Code of Maryland
10.24.01.01.htm 10.24.01.01. 01 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Acquisition" means:. a) Any transfer of stock or assets that results in a change of the person or persons who control a health care facility; orb) The transfer of any stock or ownership interest in excess of 25 percent.. 2) "Adversely affected" for purposes of determining interested party status in a Certificate of Need review, as defined in §B(19) of this regulation,
10.24.01.02.htm 10.24.01.02. 02 Coverage.. A. Except as provided in Regulations .03 and .04 of this chapter, a Certificate of Need is required before:1) A new health care facility is built, developed, or established;. 2) An existing health care facility is moved to another site, unless the relocation is:. a) The result of a partial or complete replacement of an existing hospital or related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland, and is to another part of
10.24.01.03.htm 10.24.01.03. 03 Non-Coverage by Certificate of Need Review Requirements.. A. Acquisition of an Existing Health Care Facility.. 1) At least 30 days before closing on a contractual arrangement to acquire a health care facility that exists pursuant to a Certificate of Need or other authority recognized by the Commission, the person acquiring the facility shall notify the Commission in writing, with a copy to the local health officer in each affected jurisdiction, of the inten
10.24.01.04.htm 10.24.01.04. 04 Exemption from Certificate of Need Review.. A. Subject to the procedural requirements of this regulation, the Commission may exempt from the requirement of Certificate of Need review and approval the following actions proposed by a health care facility or merged asset system comprised of two or more health care facilities:1) Merger or consolidation of two or more hospitals or other health care facilities, if the facilities or an organization that operates the facilities
10.24.01.05.htm 10.24.01.05. 05 Ambulatory Surgical Facilities: Determination of Coverage and Data Reporting.. A. Determination of Coverage by Certificate of Need.. 1) Determination of Coverage. A Certificate of Need is not required for any center, service, office, facility, or office of one or more health care practitioners or a group practice, as defined in Health Occupations Article, Title 1, Annotated Code of Maryland, if the entity does not have more than one operating room.2) Change in Location. A
10.24.01.06.htm 10.24.01.06. 06 Access to Information and Facilities.. To the extent permitted by law, an applicant shall provide access to general information, records, plans and specifications, meetings, sites, and facilities to the Commission upon proper notice and as is reasonable and necessary in the performance of the Commission's responsibilities. The Commission may require other providers of health care to provide similar information, to the extent permitted by law.
10.24.01.07.htm 10.24.01.07. 07 Application Required for Certificate of Need Review.. A. Application Form.. 1) A proposed new health care facility or health maintenance organization, or an existing health care facility or health maintenance organization planning a change covered by these regulations or by State law, shall submit a formal application for Certificate of Need, in the form and manner prescribed by the Executive Director. The nature and extent of information required may vary according to th
10.24.01.08.htm 10.24.01.08. 08 Procedure for Review of Applications.. A. Review Schedule.. 1) An application shall be submitted in accordance with the published review schedule established by the Commission in accordance with §D(1) of this regulation, but if no review schedule has been published for a service, an application may be submitted 60 days after the filing of the letter of intent, unless a shorter period has been approved by the Executive Director.
10.24.01.09.htm 10.24.01.09. 09 Commission Decision and Action on Applications.. 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 sh
10.24.01.10.htm 10.24.01.10. 10 Miscellaneous Rules and Procedures.. 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
10.24.01.11.htm 10.24.01.11. 11 Evidentiary Hearings.. A. General.. 1) Informal Proceedings. At the request of an applicant, and if each interested party waives the right to present evidence, argument, and conduct cross-examination, the reviewer may establish at the prehearing conference informal rules for mediation, structured negotiation, or another consensual procedure for reaching a decision. The procedure shall produce a record upon which the proposed decisio2) Reviewer as Presiding Officer..
10.24.01.12.htm 10.24.01.12. 12 Effective Duration of Certificate of Need and Applicant Responsibilities.. A. Good Standing. The Certificate of Need issued for a project by the Commission shall be maintained in good standing by the applicant up to completion, licensure, and first use of the approved project.B. The Certificate of Need shall be issued with specific performance requirements, as follows:. 1) There shall be an obligation of not less than 51 percent of the approved capital expenditure, as
10.24.01.13.htm 10.24.01.13. 13 Conditions of Certificate of Need Approval.. A. Approval with Conditions. A Certificate of Need may be issued with conditions if the Commission determines that approval with conditions is appropriate.B. Quarterly Reports.. 1) As a general condition of an approved Certificate of Need, an applicant shall submit to the Commission timely, accurate, and complete quarterly reports of progress in completing the approved project, with a copy to each local health department in
10.24.01.14.htm 10.24.01.14. 14 Special Procedures.. A. Declaratory Rulings.. 1) An affected person uncertain as to how a statute or regulation enforced by the Commission applies to a person or property may file with the Commission a petition for a declaratory ruling in accordance with the procedures in §A(2)11) of this regulation.2) The Commission may decline to issue a declaratory ruling for any of the following reasons:. a) The petition is not in accordance with this section;. b) The petition contains
10.24.01.15.htm 10.24.01.15. 15 Commission Approval Required Before Certain Actions.. A. Approval of Architectural Plans. Architectural plans and specifications for a project that requires a Certificate of Need may not be approved by the agency responsible for their review under health facility licensure requirements until the project has been issued a Certificate of Need by the Commission.B. Approval of State or Federal Grants, Loans, or Mortgage Insurance under Department-Administered P
10.24.01.16.htm 10.24.01.16. 16 Voluntary Withdrawal of an Application.. During the review period, an applicant may voluntarily withdraw an application without prejudice. Written notice of the withdrawal shall be submitted to the Commission through the Health Facilities Coordination Office. A withdrawn application may be resubmitted at a later date, as a new application, requiring a new letter of intent, new docketing, and review.
10.24.01.17.htm 10.24.01.17. 17 Project Changes After Certificate of Need Approval.. A. Notification to the Commission.. 1) If the project sponsor determines that it desires to change a project that has received Certificate of Need approval, the project sponsor shall notify the following parties in writing of the proposed changes:a) The Commission;. b) The local health department; and. c) In the case of a change in the location or address of a project involving the construction of a new health care facility,
10.24.01.18.htm 10.24.01.18. 18 Review Required Before Licensing or First Use of Project.. A. Request for First Use Review and Approval. Not less than 60 days but not more than 120 days before the first use of any portion of the facility or service, an applicant shall specify the anticipated date for first use and request in writing, through the Health Facilities Coordination Office, a final review.B. Local Health Department.. 1) The local health department may review the project and services in relat
10.24.01.19.htm 10.24.01.19. 19 Reconsideration Procedures.. A. Request for Reconsideration. For good cause shown, an aggrieved party may request that the Commission conduct a hearing to reconsider a Commission final decision to grant, to grant with conditions, or to deny a Certificate of Need application or determination of exemption issued under Regulation .04 of this chapter. This request shall be in writing and filed with the Commission within 15 days of the date upon which the Commission renders its d
10.24.01.20.htm 10.24.01.20. 20 Emergency Certificate of Need.. A. Commission May Issue an Emergency Certificate of Need. If a situation presents hazards to employees or patients of a health care facility or the closing of a facility by State licensing authorities requires changes or adjustments in other facilities to accommodate displaced patients, and the changes or adjustments would otherwise require that these facilities obtain a Certificate of Need under these regulations, the Commission may issue an eme
10.24.01.21.htm 10.24.01.21. 21 Severability.. If any provision of this chapter is declared void by a court of law, the remainder of this chapter shall be unaffected and of continued force and effect.
10.24.01.22.htm 10.24.01.22. 22 Effective Date.. A. A letter of intent or application submitted after the effective date of these regulations is subject to their provisions.B. Projects.. 1) Upon request, a project that has received Certificate of Need approval may be governed by this chapter. In making its determination on a request for conversion, the Commission may, at its discretion, invoke a full review of the project in accordance with this chapter.2) A request for a determination of coverage under
10.24.01.9999.htm 10.24.01.9999. Administrative History Effective date: July 6, 1972. Regulations .01―16 amended effective February 4, 1976 (3:3 Md. R. 151). Regulations .17 and .18 adopted effective February 4, 1976 (3:3 Md. R. 151) ―. Chapter revised effective March 24, 1978 (5:6 Md. R. 466). Regulations .01B; .02A, B; .05E; .06B, D―G, K; .07A, B, E; .08A, C; .09A; .11A, D; .15A, B; and .17A, B, D amended as an emergency provision effective July 1, 1978 (5:17 Md. R. 1321) adopted permanent
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