Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 24 - MARYLAND HEALTH CARE COMMISSION › Chapter 10.24.01 - Procedural Regulations for Health Care Facilities and Services › Section 10.24.01.05 - Ambulatory Surgery Centers: Determination of Coverage and Data Reporting

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Determination of Coverage.
(1) A CON is not
				  required for an ambulatory surgery center.
(2) A person shall obtain a determination of
				  coverage from the Commission before:
(a)
				  Establishing a new ambulatory surgery center;
(b) Adding a new operating room or any other
				  rooms in which procedures are performed to an existing ambulatory surgery
				  center; or
(c) Making any change in
				  the information provided for initial determination of coverage.
(3) Change in Location. A
				  determination of coverage for an ambulatory surgery center is issued only for
				  the exact address specified in the determination. A change in address or in the
				  layout of the center before it is built, developed, or established requires a
				  new determination of coverage.
(4)
				  Change in Ownership. A determination of coverage regarding an ambulatory
				  surgery center is issued only for the person specified in the determination. If
				  the principal owner or a majority of other owners of an existing ambulatory
				  surgery center is expected to change, a request for a new determination of
				  coverage shall be filed and include:
(a) A
				  complete list of the existing owners and the post-transaction owners;
				  and
(b) An attestation by the
				  ambulatory surgery center that, subsequent to the issuance of the original
				  determination of coverage, no changes have been made and that, as a result of
				  the planned change in ownership, no changes will be made:
(i) To the physical plant or layout of the
				  ambulatory surgery center; or
(ii)
				  In the surgical specialties provided.
(5) Expiration of Determination of Coverage.
				  A determination of coverage for a new ambulatory surgery center or for new
				  capacity at an existing ASC-P or ASC-1 may be issued and is effective for 2
				  years from the date of the determination. If that capacity is not built or
				  established within 2 years, the determination of coverage is void.
(6) Notice. Before seeking to establish a new
				  operating room or any other rooms in which procedures are performed, or to make
				  any change in the information provided for initial determination of coverage, a
				  person shall provide notice to the Commission at least 45 days in advance that
				  includes all information required by COMAR 10.24.11.04A.
(7) For purposes of this regulation, all
				  ambulatory surgery centers that are located in the same building and that share
				  any common ownership or control shall be considered one entity, and their
				  operating rooms shall be considered together for purposes of determining
				  coverage under Regulation .02 of this chapter.
(8) Except as provided in this regulation or
				  permitted in the Certificate of Need or exemption criteria in the State Health
				  Plan under COMAR 10.24.11, an ambulatory surgical facility or other entity
				  primarily providing ambulatory surgical services may not relocate beyond an
				  adjacent site or expand its number of operating rooms without obtaining a
				  Certificate of Need.
(9) A CON is
				  not required for ambulatory surgical services provided as part of an office of
				  one or more individuals licensed to practice dentistry under Health-Occupations
				  Article, Title 4, Annotated Code of Maryland, for the purpose of practicing
				  dentistry, if the ambulatory surgical facility is not used in a medical
				  practice other than dentistry.