Definition. In this regulation, “freestanding medical facility” means a freestanding medical facility licensed under Health-General Article, Title 19, Subtitle 3A, Annotated Code of Maryland. The following outpatient services provided at a freestanding medical facility are considered hospital services under Health-General Article, §19-201, Annotated Code of Maryland: Emergency Services; Observation Services; and Associated Ancillary Services, such as laboratory, radiology, imaging, EKG, and Medical/Surgical Supplies and Drugs. In accordance with Health-General Article, §19-201, Annotated Code of Maryland, the Commission’s rate-setting jurisdiction extends to those outpatient services provided at a freestanding medical facility, as designated by the Commission. A freestanding medical facility or a proposed freestanding medical facility that desires to provide a service not designated in §B of this regulation (an undesignated service) must receive a determination under the provisions of this regulation. Commission Approval. A freestanding medical facility may not charge a Commission-approved rate for an undesignated service without prior Commission staff approval. A freestanding medical facility may not open a new outpatient service, relocate an existing outpatient service, or convert an existing outpatient service from regulated or unregulated status without a prior determination from the Commission’s staff as to whether the service constitutes a hospital service subject to Commission rate regulation. A request for determination shall be made in writing at least 60 days before the contemplated action. Upon request for a determination, the Commission’s staff shall: Review the information presented; Consult with appropriate parties; Visit the site of the service as it considers necessary; and Notify the freestanding medical facility of its determination as soon as practicable. In deciding whether the service constitutes a hospital service subject to Commission rate regulation, Commission staff shall consider, among other things, the following criteria: Cost of the service; In consultation with Maryland Health Care Commission (MHCC) staff, access to and need for the service in the community; Feasibility of providing the outpatient service in the community on an unregulated basis; and Impact of the service on the All-Payer Model including, but not limited to, the Total Cost of Care limitations as prescribed in the All-Payer Model Agreement with the Center for Medicare and Medicaid Innovation. Based on the consideration of the criteria stated in §G of this regulation, the Commission staff shall make its determination on the request made under §E of this regulation within a reasonable period of time, taking into account, among other things, whether either a Certificate of Need application to establish a freestanding medical facility or a request for exemption from Certificate of Need to convert a licensed general hospital to a freestanding medical facility is pending before the MHCC and, if so, the time frame for staff to comment to MHCC on the financial feasibility of the proposed project. A freestanding medical facility that fails to obtain, or violates, a staff determination on the regulated status of a given service may be subject to fines for inaccurate reporting under COMAR 10.37.01.03R and paybacks for inappropriate charges made during the time a staff determination on an outpatient service was not obtained or adhered to.