Md. Code Regs. 10.24.01.02

Current through Register Vol. 51, No. 10, May 17, 2024

Section 10.24.01.02 - Coverage

A. Except as provided in Regulations .03-.05 of this chapter or as otherwise provided by law, a CON 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 the site or immediately adjacent to the site of the existing hospital or related institution;

(b) Of an existing health care facility owned or controlled by a merged asset system, subject to the provisions of Regulations .03E or .04A(2) of this chapter, whichever is applicable; or

(c) By a hospital converting to a limited service hospital, subject to the provisions of Regulation .04A(4) of this chapter, and is to a site within the immediate area, as determined by the Commission, as described in §B of this regulation;

(3) The bed capacity of a health care facility is changed;

(4) The type or scope of any health care service offered by a health care facility is changed, and the change:

(a) Establishes a new medical service;

(b) Establishes a new cardiac surgery, organ transplant surgery, burn treatment, or neonatal intensive care program;

(c) Establishes a new home health agency, general hospice care program, or ambulatory surgical facility;

(d) Builds or expands surgical capacity in a hospital, freestanding medical facility subject to rate regulation by the Health Services Cost Review Commission, or ambulatory surgical facility;

(e) Results in:

(i) The establishment of a new parent home health agency; or

(ii) The expansion of an existing home health agency into a jurisdiction in which it was not previously authorized by the Commission to operate;

(f) Eliminates an existing medical service; or

(g) Closes an existing health care facility or converts it to a non-health-related use; or

(5) A hospital makes a capital expenditure, as defined in Health-General Article, §19-120(k), Annotated Code of Maryland, and in this chapter, that exceeds the hospital capital threshold, including a capital expenditure:

(a) For the relocation of an existing health care facility owned or controlled by a merged asset system, except as provided in Regulation .03E of this chapter; and

(b) By a relocated health care facility to permit the facility to offer a new health care service for which CON is otherwise required.

B. Definition of Immediate Area for Limited Service Hospital Conversion.

(1) For the purpose of §A(2)(c) of this regulation, "immediate area" means a location on the site of the existing hospital, or on an adjacent site.

(2) A hospital may provide evidence as to why the Commission should approve a site for a limited service hospital beyond the immediate area of the converting hospital.

(3) The Commission may not approve a site for a limited service hospital unless the site is within:

(a) A 5-mile radius of the site of the hospital proposing the conversion; and

(b) Its primary service area.

C. A person may not divide a project into component parts except as permitted by this chapter. Commission staff shall issue a determination regarding whether two or more apparently individual projects actually represent component parts of a single project, considering, among other things, the timing of the projects, the functional areas of a facility to be affected, the number of construction contracts entered into, and whether expenditures under one contract depend upon the completion of a prior contract.

D. Proposed Change After Acquisition. If a person acquires an existing health care facility or service without a CON, in accordance with Regulation .03 of this chapter, and proposes to change the health care services it provides or its bed capacity, the proposed change requires review and approval in accordance with §A of this regulation.

E. A health maintenance organization, or health care facility that either controls, directly or indirectly, or is controlled by an HMO or a group of HMOs, shall obtain a CON before it builds, develops, operates, or participates in building, developing, or operating:

(1) A hospital; or

(2) Any other health care project for which a CON is required under §A of this regulation, unless at least 90 percent of the patients who will receive health care services from the project will be individuals enrolled in that health maintenance organization.

F. If a person is uncertain whether a project requires a Certificate of Need, the person shall request a determination of coverage in accordance with Regulation .14A of this chapter.

Md. Code Regs. 10.24.01.02

Regulations .02 amended effective February 4, 1976 (3:3 Md. R. 151)
Regulations .02A, B 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 .02A amended effective January 25, 1980 (7:2 Md. R. 115)
Regulations .02A amended as an emergency provision effective February 28, 1986 (13:6 Md. R. 669) (Emergency provisions are temporary and not printed in COMAR)
Regulations .02A_C effective November 17, 1986 (13:23 Md. R. 2480); March 19, 1990 (17:5 Md. R. 638)
Regulation .02D amended effective March 19, 1990 (17:5 Md. R. 638)
Regulations .02 adopted effective November 6, 1995 (22:22 Md. R. 1658)
Regulations .02 repealed and new Regulation .02 adopted effective August 21, 2000 (27:16 Md. R. 1523)
Regulation .02 amended effective April 11, 2005 (32:7 Md. R. 680)
Regulation .02A amended effective February 5, 2001 (28:2 Md. R. 100); adopted effective 50:22 Md. R. 975, eff. 12/1/2023