Md. Code Regs. 10.24.01.04

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

Section 10.24.01.04 - Exemption from Certificate of Need Review

A. The Commission may exempt from the requirement of CON review and approval the following actions:

(1) Merger or consolidation of two or more hospitals or other health care facilities, if the facilities or an organization that operates the facilities give the Commission 45 days written notice of their intent to merge or consolidate;

(2) Relocation of an existing health care facility owned or controlled by a merged asset system, if:

(a) The relocation is to a site outside:

(i) The primary service area of the hospital to be relocated but within the primary service area of the merged asset system; or

(ii) The service area of the non-hospital health care facility to be relocated but within the primary service area of the merged asset system; and

(b) The relocation of the existing health care facility does not:

(i) Change the type or scope of health care services offered; and

(ii) In the case of a hospital, require a capital expenditure for its construction that exceeds the hospital capital threshold, adjusted for inflation, except as provided by Regulation .03J of this chapter;

(3) A change in the bed capacity of an existing health care facility pursuant to the consolidation or merger of two or more health care facilities, or conversion of a health care facility or part of a health care facility to a non-health-related use, except as provided in Regulation .03F of this chapter;

(4) A change in the type or scope of the health care services offered by a health care facility, if, at least 45 days before increasing or decreasing the volume of one or more health care services, the Commission finds that the proposed change is pursuant to the:

(a) Consolidation or merger of two or more health care facilities;

(b) Conversion of all or part of a health care facility to a non-health-related use; or

(c) Conversion of a hospital to a limited service hospital;

(5) A capital expenditure that exceeds the review threshold for capital expenditure made as part of a consolidation or merger of two or more health care facilities, or conversion of a health care facility or part of a health care facility to a non-health-related use; or

(6) The establishment of a freestanding medical facility through the conversion of an acute general hospital, as provided in §F of this regulation and in COMAR 10.24.19.04C.

B. Unless otherwise provided in this chapter for a specific type of health care facility, complete notice of intent to seek exemption from CON review shall be filed with the Commission at least 45 days before the intended action, and shall include:

(1) The name and location of each affected health care facility;

(2) A general description of the proposed project including, in the case of mergers and consolidations, any proposed:

(a) Conversion, expansion, relocation, or reduction of one or more health care services;

(b) Renovation of existing facilities;

(c) New construction;

(d) Relocation or reconfiguration of existing medical services; or

(e) Change in bed capacity at each affected facility;

(3) The scheduled date of the project's completion;

(4) Identification of each outstanding public obligation;

(5) Information demonstrating that the project:

(a) Is not inconsistent with the State Health Plan;

(b) Will result in the delivery of more efficient and effective delivery of health care services; and

(c) Is in the public interest; and

(6) Any other information, analyses, or other requirements established in State Health Plan regulation for requests seeking exemption from CON review.

C. Notice by the Commission to the Public, Elected Officials, and Other State Agencies.

(1) Within 5 days after it receives a complete Notice of Intent from a health care facility seeking exemption from CON review, the Commission shall publish notice of its receipt:

(a) In at least one newspaper of general circulation in the affected area;

(b) In the next available issue of the Maryland Register; and

(c) On the Commission's website.

(2) The Commission shall mail the same notice to elected public officials in whose district or jurisdiction the exemption from CON review is proposed.

(3) The Commission shall solicit comment from the affected public, in evaluating whether the action or project proposed for exemption from CON review is in the public interest.

D. Public Informational Hearing.

(1) An acute general hospital shall hold a public informational hearing in the jurisdiction where it is located within 30 days after it has filed with the Commission notice of its intent to:

(a) Close;

(b) Partially close, if the hospital is located in a jurisdiction with fewer than three acute general hospitals; or

(c) Convert to a limited service hospital or freestanding medical facility.

(2) Before holding the public informational hearing, the hospital shall consult with the Commission, to ensure that:

(a) Within 5 days of notifying the Commission of its intent to close, partially close, or convert, the hospital has provided public notice of the proposed closure or conversion and of the time and location of the required public informational hearing and how the public can electronically obtain additional information, including publication in at least one newspaper of general circulation in the affected area; and

(b) The public hearing will address the information required by §D(3) of this regulation.

(3) Requirements for a Public Informational Hearing.

(a) The acute general hospital proposing to close, partially close, or convert to a limited service hospital or freestanding medical facility shall hold a public informational hearing at the hospital or if that is not feasible at a public meeting area near the hospital.

(b) The hospital shall post a notice of the public informational hearing in public areas of its facility and on the landing page of its website.

(c) The hospital shall identify to the public the names of the senior management and Board of Directors attending the hearing;

(d) The hospital shall present at least the following information at the public informational hearing:

(i) The reasons for the closure, partial closure, or conversion;

(ii) The plan for transitioning acute care services previously provided by the hospital to residents of the hospital service area;

(iii) The plan for addressing the health care needs of the residents of the hospital service area;

(iv) The plan for retraining and placing displaced employees;

(v) The plan for the hospital's physical plant and site; and

(vi) The proposed timeline for the closure, partial closure, or conversion to a freestanding medical facility.

(e) The public informational hearing shall be recorded.

(f) Within 10 business days after the public informational hearing, the hospital shall make available on its website a recording of the public informational hearing and provide a written summary of the hearing, which shall also be provided to:

(i) The Governor;

(ii) The Secretary;

(iii) The governing body of the jurisdiction in which the hospital is located;

(iv) The local health department and the local board of health or similar body for the jurisdiction in which the hospital is located;

(v) The Commission; and

(vi) Subject to State Government Article, §2-1257, Annotated Code of Maryland, the Senate Finance Committee, the House Health and Government Operations Committee, and the members of the General Assembly who represent the district in which the hospital is located.

E. Commission Action.

(1) Unless otherwise provided in this chapter for a specific type of health care facility, the Commission shall issue an exemption from CON review to the health care facility or the merged asset system seeking this determination within 45 days after it receives the notice of intent required by §B of this regulation, if:

(a) The facility or system has provided the information required by the notice of intent, and has held a public informational hearing if required by §D of this regulation; and

(b) The Commission, in its sole discretion, finds that the action proposed:

(i) Is not inconsistent with the State Health Plan or an institution-specific plan developed by the Commission under Health-General Article, §19-119, Annotated Code of Maryland;

(ii) Will result in more efficient and effective delivery of health care services; and

(iii) Is in the public interest.

(2) For any project that the Commission may exempt from CON review under §A of this regulation, for which a final Commission decision has not been issued within 45 days after it receives a complete notice of intent as required by §B of this regulation, Commission staff shall provide a status report at the next Commission meeting and any subsequent Commission meeting stating the reasons for the delay and the expected time frame for issuing its final decision.

(3) CON review is not required and the exemption request shall be deemed approved for any project which the Commission may exempt from CON review under §A of this regulation if final action by the Commission does not occur within 90 days after the facility or system has provided complete notice of intent as required by §B of this regulation and has held a public hearing if required by §D of this regulation.

(4) Upon request, Commission staff shall provide written confirmation that an exemption request has been deemed approved in accordance with §E(3) of this regulation.

F. Freestanding Medical Facility.

(1) In accordance with COMAR 10.24.19.04C and this regulation, the Commission may exempt from CON review the establishment of a freestanding medical facility as a result of a conversion from a licensed acute general hospital.

(2) At least 60 days before the conversion, written notice of intent to convert the licensed general hospital to a freestanding medical facility shall be filed with the Commission in accordance with COMAR 10.24.19.04C.

(3) Provided that all the requirements of this regulation and COMAR 10.24.19.04C are met, the Commission shall grant the exemption if it finds, in its sole discretion, that the conversion:

(a) Is consistent with the State Health Plan;

(b) Will result in the delivery of more efficient and effective health care services;

(c) Will maintain adequate and appropriate delivery of emergency care within the statewide emergency medical services system as determined by the State Emergency Medical Services Board; and

(d) Is in the public interest.

(4) The Commission may approve, approve with conditions, or deny the requested exemption.

(5) Failure to maintain compliance with conditions on an exemption or with the time frame for completion of the conversion may result in withdrawal of the exemption issued by the Commission in accordance with Regulation .12 of this chapter. An exemption holder may request approval of a reasonable modification to the conversion timeline in accordance with Regulation .12A(4) of this chapter.

Md. Code Regs. 10.24.01.04

Regulations .04 amended effective February 4, 1976 (3:3 Md. R. 151)
Regulations .04 adopted effective November 6, 1995 (22:22 Md. R. 1658)
Regulations .04 repealed and new Regulation .04 adopted effective August 21, 2000 (27:16 Md. R. 1523)
Regulation .04 amended effective April 11, 2005 (32:7 Md. R. 680); adopted effective 50:22 Md. R. 975, eff. 12/1/2023