.07-1 Outpatient Services — At the Hospital Determination.

A. Definitions.

(1) In this regulation, the following terms have the meanings indicated.

(2) Terms Defined.

(a) “At the hospital” means a service provided in a building on the campus of a hospital in which hospital services are provided.

(b) “Health care provider” means an individual who is licensed, certified, or otherwise authorized by law to provide health care services under Health Occupations Article, Annotated Code of Maryland.

(c) “Telehealth services” means the delivery of health care services provided through the use of interactive audio, video, or other telecommunications or electronic technology by a health care provider at a hospital to a patient at a location other than at the hospital, or to a patient at the hospital where the provider is at a location other than the hospital, which enables the patient to interact with the health care provider at the time the health care services are provided.

B. A service at the hospital is:

(1) Presumed to be an outpatient service; and

(2) Subject to rate regulation.

C. In accordance with Health-General Article, §19-201, Annotated Code of Maryland, the Commission’s rate-setting jurisdiction extends to outpatient services provided at the hospital. Outpatient services associated with the federal 340B Program under the federal Public Health Service Act provided in a department of a regulated hospital that, on or before June 1, 2015, is under a merged asset hospital system, and which are physically located at another regulated hospital under the same merged asset hospital system, shall be subject to the rate-setting jurisdiction of the Commission. The Commission may begin setting rates for these services in anticipation of the hospital’s obtaining provider-based status for purposes of the 340B Program.

D. A hospital that desires an exception to the presumption stated under §C of this regulation must receive a determination under the provisions of this regulation.

E. Commission Approval.

(1) A hospital may not charge a Commission-approved rate for an outpatient service without prior Commission or Commission staff approval.

(2) A hospital 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 is being provided at the hospital. A request for determination shall be made in writing at least 60 days before the contemplated action.

F. Upon request for an exception under §D of this regulation, the Commission's staff shall:

(1) Review the information presented;

(2) Consult with appropriate parties;

(3) Visit the site of the service as it considers necessary; and

(4) Notify the hospital of its determination as soon as practicable.

G. In deciding whether an outpatient service is at the hospital, the Commission staff may consider, among other things, the following criteria:

(1) Location of the entrances;

(2) Location and signage of parking;

(3) Location and language of signage at entrances, within buildings, on the campus, and in parking areas effectively alerting the public that a given building or service is either at the hospital or not at the hospital;

(4) Location of registration, changing, and waiting areas;

(5) Whether billing reflects clearly that the service is rate regulated or not rate regulated;

(6) Whether any physical connection from an unregulated facility to the hospital, such as tunnels, hallways, covered walkways, elevators, or connecting bridges, will be restricted to hospital staff and physician use in order to ensure that patients and visitors do not have access to the unregulated facility from the hospital;

(7) Whether there is any duplication of an unregulated service within the hospital in order to avoid inappropriate patient steering;

(8) Whether there is any inappropriate mixing of regulated and unregulated services in the same building, which would tend to have the effect of confusing patients about the regulated or nonregulated status of a given service being provided; and

(9) Whether any Medicare Part B physician's service being provided in an unregulated building also includes components of a Medicare Part A hospital service that would be reasonably expected by a patient to fall under Commission rate-setting jurisdiction.

H. Based on consideration of the criteria stated in §G of this regulation, the Commission's staff shall make its determination on the request made under §E of this regulation.

I. A hospital that fails to obtain or violates a staff determination on the hospital 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.

J. A request for a determination under this regulation is not a contested case under the Administrative Procedure Act.

K. A hospital may not bill a separate hospital facility fee when a health care provider who provided telehealth services is authorized to bill independently for the professional services rendered.

L. The delivery of telehealth services as described in §A(2) of this regulation constitutes outpatient services provided at the hospital.