Sec. 10.24.01.05. 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 determination of coverage letter for an office with ambulatory surgery capacity is issued only for the exact address specified. A change in address before the office is built, developed, or established requires a new determination of coverage.

(3) Change in Ownership. A determination of coverage letter for ambulatory surgery capacity is issued only for the person specified. A new determination of coverage will be required if the principal owner or a majority of other owners changes.

(4) Expiration Date of Coverage Determination Letter. A determination of coverage letter for new freestanding ambulatory surgical capacity is effective for 2 years from the date of the letter. If that capacity is not built, developed, or established within 2 years, that letter of determination is void.

(5) Notice.

(a) Before seeking to establish a new operating room or rooms, or making any change in the information provided for initial determination of coverage by Certificate of Need, a person shall provide notice to the Commission at least 45 days in advance.

(b) The notice shall include the intended start-up date of the proposed ambulatory surgical services at the specified location.

(c) The notice shall provide the following information:

(i) The name and address of the entity seeking to provide ambulatory surgical services, and the location where these services will be provided;

(ii) A statement that the operating room or rooms will meet the requirements relating to quality of care and patient safety necessary to obtain Medicare certification or State licensure, whichever is appropriate, for life and fire safety, control of infection, quality assessment and improvement, patient transfer, credentialing, and medical record keeping, with documentation of having received licensure or certification, as appropriate, to be submitted in the next annual data survey conducted by the Commission;

(iii) The number of operating rooms at the location, and a drawing or plans showing the location and dimensions of each proposed operating room and other rooms in the office;

(iv) The names of each person and organization with an ownership interest in the entity, and its officers, directors, partners, and owners;

(v) The names of any other ambulatory surgical facilities in which individuals listed in response to §A(5)(c)(iv) of this regulation have an interest or other economic relationship, as an officer, director, partner, member, or owner;

(vi) A listing of each other ambulatory surgical facility at the same address;

(vii) Contractual relationships to provide ambulatory surgical services between the entity and other health care facilities or health care providers who are not employees of the entity, or exercise only medical practice privileges at the location; and

(viii) The names and specialties of each health care practitioner who will perform surgical services at the facility and the general types of surgery to be performed there.

(6) For purposes of this regulation, all centers, services, offices, facilities, or offices of one or more health care practitioners or a group practice primarily providing ambulatory surgical services 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, or this regulation.

(7) The office of one or more health care providers or a group practice performing ambulatory surgical services with two operating rooms may be exempt from Certificate of Need requirements if the Commission, in its sole discretion, determines that:

(a) A second operating room is necessary to promote the efficiency, safety, and quality of the surgical services offered; and

(b) The office meets the criteria for exemption from Certificate of Need review as an ambulatory surgical facility set forth in the State Health Plan under COMAR 10.24.11.

(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 after June 1, 1995, without obtaining a Certificate of Need.

(9) A Certificate of Need 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 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 Certificate of Need requirements, existing providers in offices or facilities primarily providing ambulatory surgical services shall provide annually 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.

(3) The information to be provided includes the following:

(a) The information listed in §A(5) of this regulation, only if there have been any changes in this information during the reporting period;

(b) Cost, charge, and reimbursement data, including the amount of care reimbursed by Medicaid and Medicare, and the amount of uncompensated care provided by the entity;

(c) Utilization data, including types of procedures;

(d) Operating policies, including hours of operation;

(e) Patient-specific or patient-aggregate data, including demographic data, reimbursement source and levels, and patient disposition data; and

(f) Staffing requirements and patterns.