On May 3, the Centers for Medicare & Medicaid Services (CMS) published its long-awaited draft “Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities.” The draft guidance is specific to compliance with the general Conditions of Participation for hospitals (CoPs) and does not address the specific location and separateness requirements that apply to other Medicare-participating entities such as psychiatric hospitals, ambulatory surgery centers, rural health clinics, and independent diagnostic testing facilities. The draft guidance notes that “prior sub-regulatory interpretations prohibited co-location of hospitals with other healthcare entities. This guidance changes that [prior sub-regulatory guidance] to ensure safety and accountability without being overly prescriptive.”
The draft guidance clarifies that under the CoPs, a Medicare-participating hospital cannot properly share with another entity clinical space where patients receive care. “Co-mingling of patients in a clinical area such as a nursing unit, from two co-located entities, could pose a risk to the safety of a patient as the entities would have two different infection control plans. Additionally, the shared clinical space could jeopardize the patient’s right to personal privacy and confidentiality of their [sic] medical records.” The draft guidance further describes: “In general, a hospital should not share space where patients are receiving care. This would include, but is not limited to, any space within nursing units (including hallways, nursing stations, and exam and procedure rooms located within nursing units), outpatient clinics, emergency departments, operating rooms, post-anesthesia care units, etc.”
A hospital and a co-located entity can properly share public spaces and public paths of travel used by both the hospital and the co-located entity. “Examples of public spaces and paths of travel would include public lobbies, waiting rooms and reception areas (with separate “check-in” areas and clear signage), public restrooms, staff lounges, elevators and main corridors through non-clinical areas, and main entrances to a building.” Note that while a hospital and a co-located entity may share a waiting room and reception area, the hospital and the co-located entity must have separate check-in areas and clear signage. The draft guidance further explains: “[T]he sharing of spaces used for medical records and patient registration/admission could also potentially pose a risk to patient privacy as an unauthorized person could have access to patient records without consent.” Both entities would be individually responsible for compliance with the CoPs in the public spaces and public paths of travel.
An individual cannot properly access a co-located entity by utilizing a path of travel through clinical care spaces of the co-located hospital. The draft guidance provides the following example of a public path of travel: “A public path of travel is, for example, a main hospital corridor with distinct entrances to departments (such as outpatient medical clinics, laboratory, pharmacy, radiology). It is necessary [for the co-located entities] to identify, for the public, which healthcare entity is performing the services in which department.” The draft guidance also describes what “would not be public paths of travel: A hallway, corridor, or path of travel through an inpatient nursing unit; or [a] hallway, corridor, or path of travel through a clinical hospital department (e.g., outpatient medical clinic, laboratory, pharmacy, imaging services, operating room, post anesthesia care unit, emergency department, etc.).”
The draft guidance also addresses contracted services and compliance with the CoPs. The draft guidance clarifies that “[w]hen staff are obtained under arrangement from another entity, they must be assigned to work solely for one hospital during a specific shift and cannot “float” between the two hospitals during the same shift, work at one hospital while concurrently being “on-call” at another, and may not be providing services simultaneously. . . . This would also apply to the lab, pharmacy, and nursing director.” “Medical staff may be shared, or “float,” between the co-located hospitals if they are privileged and credentialed at each hospital.”
The draft guidance is available here. Public comments must be received by CMS by July 2. CMS will finalize the hospital co-location policy following the close of the 60-day comment period.