CMS SOM App. H, Tag V751

§ 494.180 – The ESRD facility is under the control of an identifiable governing body, or

designated person(s) with full legal authority and responsibility for the governance and

operation of the facility. The governing body adopts and enforces rules and regulations

relative to its own governance and to the health care and safety of patients, to the

protection of the patients’ personal and property rights, and to the general operation of the

facility.

Interpretive Guidance § 494.180:

“Identifiable” means that the individual or individuals who are responsible for the conduct and

oversight of the operations of the facility are identified in writing. This may be demonstrated in

governing body bylaws or minutes, or in ownership documents.

Terminology related to ownership:

• “Hospital-based” ESRD facility is a separately certified ESRD facility that is an

outpatient department of a hospital and meets the ESRD CfCs at 42 CFR part 494. A

hospital-based facility is owned and administered by a hospital or CAH and is physically

located on a hospital campus. See also 42 CFR §413.174(c) and SOM section 2272. An

ESRD facility physically located inside a hospital but owned by another entity, such as a

dialysis corporation, would not be considered “hospital-based.”

• “Satellite facility” renal dialysis facility is a hospital-owned and hospital-administered

ESRD facility but is not located on the hospital campus. A satellite facility is surveyed

separately and has its own CMS certification number (CCN).

• “Corporate entity” means owned by a group, individual or company; generally these

facilities are part of a multi-facility group numbering from several to hundreds of

facilities.

• “Physician-owned” means owned by a physician through a sole proprietorship, limited

liability company, or corporation; may be one or multiple facilities.

The governing body bylaws should clearly define the ownership of the facility. In some cases, the

owner has a contract with another entity for management of the facility. If so, this relationship

should be clear in the governing body records of the facility.

Facilities that are part of a dialysis organization with multiple widespread facilities must have a

local governing body designated to guide the day-to-day operation of the facility. The governing

body may consist of one person or a group of persons. It should be clear in the governing body

records who constitutes the governing body and who has the legal authority and responsibility

for the governance and operation of the specific facility.