Md. Code Regs. 10.24.01.05

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

Section 10.24.01.05 - Ambulatory Surgery Centers: Determination of Coverage and Data Reporting

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.

B. Data Reporting and Annual Survey of Ambulatory Surgical Centers, Facilities, and Providers.

(1) To provide information for the Commission's planning purposes and to determine changes in circumstances and operation that may affect coverage by CON requirements, each existing ambulatory surgery center, facility, office, and provider that primarily provides ambulatory surgical services shall annually provide to the Commission the information required by COMAR 10.24.04.

(2) A person providing ambulatory surgical services who is required to obtain a license under Health-General Article, §19-3B-02(a), Annotated Code of Maryland, shall annually provide the required information on a form provided by the Commission.

Md. Code Regs. 10.24.01.05

Regulations .05E 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 .05 amended effective February 4, 1976 (3:3 Md. R. 151)
Regulations .05 adopted effective November 6, 1995 (22:22 Md. R. 1658)
Regulations .05 repealed and new Regulation .05 adopted effective April 6, 1998 (25:7 Md. R. 527)
Regulation .05 amended effective April 11, 2005 (32:7 Md. R. 680); adopted effective 50:22 Md. R. 975, eff. 12/1/2023