Applicability of EMTALA to Provider-Based Entities
(§§413.65(g)(1), 482.12(f), 489.24(b), and 489.24(i))

Set forth is the text of the commentary to the final EMTALA regulations as published in the September 9, 2003 Federal Register dealing with the applicability of EMTALA to provider-based entities. The final regulations can be viewed here and are effective November 10, 2003.

On April 7, 2000, we published a final rule specifying the criteria that must be met for a determination regarding provider-based status (65 FR 18504). The regulations in that final rule were subsequently revised to incorporate changes mandated by section 404 of Public Law 106-554 (66 FR 59856, November 30, 2001). However, those revisions did not substantively affect hospitals' EMTALA obligations with respect to off-campus departments.

A. Applicability of EMTALA to Off-Campus Hospital Departments (§§489.24(b) and (i) and §413.65(g)(1))

1. Background

In the April 7, 2000 final rule (65 FR 18504), we clarified the applicability of EMTALA to hospital departments not located on the main provider campus. At that time, we revised §489.24 to include a new paragraph (i) to specify the antidumping obligations of hospitals with respect to individuals who come to off-campus hospital departments for the examination or treatment of a potential emergency medical condition. As explained in the preamble to the April 7, 2000 final rule, we made this change because we believed it was consistent with the intent of section 1867 of the Act to protect individuals who present on hospital property (including off-campus hospital property) for emergency medical treatment. Since publication of the April 7, 2000 final rule, it has become clear that many hospitals and physicians continue to have significant concerns with our policy on the applicability of EMTALA to these off-campus locations.

2. Provisions of the Proposed Rule

After further consideration, in the May 9, 2002 proposed rule (67 FR 31476), we proposed to clarify the scope of EMTALA's applicability in this scenario to those off-campus departments that are treated by Medicare under §413.65(b) to be departments of the hospital, and that are equipped and staffed areas that are used a significant portion of the time for the initial evaluation and treatment of outpatients for emergency medical conditions. That is, we proposed to narrow the applicability of EMTALA to only those off-campus departments that are "dedicated emergency departments" as defined in proposed revised §489.24(b).

As proposed, this definition would include such departments, whether or not the words "emergency room" or "emergency department" were used by the hospital to identify the departments. The definition would also be interpreted to encompass those off-campus hospital departments that would be perceived by an individual as appropriate places to go for emergency care. Therefore, we proposed to revise the definition of "Hospital with an emergency department" at §489.24(b) to account for these off-campus dedicated emergency departments and also to amend the definition of "Comes to the emergency department" at §489.24(b) to include this same language. We believe these proposed changes would enhance the quality of emergency care by facilitating the prompt delivery of emergency care in those cases, thus permitting individuals to be referred to nearby facilities with the capacity to offer appropriate emergency care.

In general, we expect that off-campus departments that meet the proposed definitions stated above would in practice be functioning as "off-campus emergency departments." Therefore, we believe it is reasonable to expect the hospital to assume, with respect to these offcampus departments, all EMTALA obligations that the hospital must assume with respect to the main hospital campus emergency department. For instance, the screening and stabilization or transfer requirements described in section V.K.1. of the preamble of the May 9, 2002 proposed rule ("Background") would extend to the off-campus emergency departments, as well as to any such departments on the main hospital campus.

In conjunction with this proposed change in the extent of EMTALA applicability with respect to off-campus facilities, we also proposed to delete all of existing §489.24(i), which, as noted above, was established in the April 7, 2000 final rule. We proposed to delete this paragraph in its entirety because its primary purpose is to describe a hospital's EMTALA obligations with respect to patients presenting to off-campus departments that do not routinely provide emergency care. Under the proposals outlined above, however, a hospital would have no EMTALA obligation with respect to individuals presenting to such departments. Therefore, it would no longer be necessary to impose the requirements in existing §489.24(i). Even though off-campus provider-based departments that do not routinely offer services for emergency medical conditions would not be subject to EMTALA, some individuals may occasionally come to them to seek emergency care. Under such circumstances, we believe it would be appropriate for the department to call an emergency medical service (EMS) if it is incapable of treating the patient, and to furnish whatever assistance it can to the individual while awaiting the arrival of EMS personnel. Consistent with the hospital's obligation to the community and similar to the Medicare hospital CoP under §482.12(f)(2) that apply to hospitals that do not provide emergency services, we would expect the hospital to have appropriate protocols in place for dealing with individuals who come to off-campus nonemergency facilities to seek emergency care.

To clarify a hospital's responsibility in this regard, in the May 9, 2002 proposed rule, we proposed to revise §482.12(f) by adding a new paragraph (3) to state that if emergency services are provided at the hospital but are not provided at one or more off-campus departments of the hospital, the governing body of the hospital must assure that the medical staff of the hospital has written policies and procedures in effect with respect to the off-campus department(s) for appraisal of emergencies and referral when appropriate. (We note that, in a separate document (62 FR 66758, December 16, 1997), we proposed to relocate the existing §482.12(f) requirement to a new section of Part 482. The change to §482.12(f) in this final rule will be taken into account in finalizing the December 16, 1997 proposal.) However, the hospital would not incur an EMTALA obligation with respect to the individual.

In summary, we proposed in existing §489.24(b) to revise the definitions of "comes to the emergency department" and "hospital with an emergency department", and to include these off-campus departments in our new definition of "dedicated emergency department." We solicited comments on whether this new term is needed or if the term "emergency department" could be defined more broadly to encompass other departments that provide urgent or emergent care services. We proposed to delete all of existing §489.24(i) and to make conforming revisions to §413.65(g)(1).

3. Summary of Public Comments and Departmental Responses

Comment: Numerous commenters expressed strong support for the proposal to limit the applicability of EMTALA, in cases of off-campus departments, to only those departments that qualify as dedicated emergency departments. Some commenters stated that EMTALA should not apply to an off-campus department that does not hold itself out as an emergency department. Other commenters believed this would be appropriate because a prudent layperson would not regard the department as an appropriate place at which to seek emergency care. These commenters stated that an individual with a broken arm might regard the hospital's orthopedic department as an appropriate source of care, but that this should not mean that the orthopedic department should be treated as a dedicated emergency department.

Other commenters stated that EMTALA should not apply to any off-campus department unless CMS provides a narrower definition of "dedicated emergency department" and clarifies whether or under what circumstances EMTALA will apply to urgent care facilities. However, the commenters did not provide any indication of why the definition is believed to be too broad or how they would recommend changing it.

Several commenters stated that EMTALA should not apply to an off-campus urgent care center unless the center is functioning and holding itself out to the public as an emergency department.

Response: We agree that EMTALA should apply to offcampus departments only if they qualify as dedicated emergency departments, and have addressed the commenters' suggestion as part of the revision of the definition of a dedicated emergency department. In addition, we are adopting in this final rule the proposed standard under §482.12(f)(3) that hospitals have appropriate protocols in place for dealing with individuals who come to off-campus nonemergency facilities to seek emergency care.

Regarding the suggestion that a hospital's orthopedic department might be determined to be a dedicated emergency department because an individual person would look to it for emergency orthopedic care, as we have noted above, the definition of “dedicated emergency department” in section VIII. of this preamble does not include “prudent layperson” standard. Rather, with this final rule, “dedicated emergency department” means any department or facility of the hospital, regardless of whether it is located on or off the main hospital campus, that (1) is licensed by the State in which it is located under applicable State law as an emergency room or emergency department; (2) is held out to the public (by name, posted signs, advertising, or other means) as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment; or (3) during the calendar year immediately preceding the calendar year in which a determination under §489.24 is being made, based on a representative sample of patient visits that occurred during that calendar year, provides at least one-third of all of its outpatient visits for the examination or treatment of emergency medical conditions. If the orthopedic department does not met any of these three criteria for dedicated emergency department status, it is not a dedicated emergency department for EMTALA purposes, regardless of what the individual may believe as to the status of the department.

4. Provisions of the Final Rule

We are adopting, as final with modifications as discussed in earlier sections of this preamble, the proposed revisions of the definition of "come to the emergency department," "hospital with an emergency department," and "dedicated emergency department" at §489.24(b), which encompass off-campus hospital departments that would be perceived by individuals as appropriate places to go for emergency care. We also are adopting as final the related proposed deletion of the provisions under §489.24(i) and the conforming change to §413.65(g)(1). In addition, we are adopting, as final, the proposed new §482.12(f)(3) which provides that the governing body of a hospital must assure that the medical staff has written policies and procedures in effect with respect to off-campus departments for appraisal of emergencies and referrals, when appropriate.

B. On-Campus Provider-Based Applicability

1. Background

At existing §413.65(g)(1), we state, in part, that if any individual comes to any hospital-based entity (including an RHC) located on the main hospital campus, and a request is made on the individual's behalf for examination or treatment of a medical condition, the entity must comply with the antidumping rules at §489.24. Since provider-based entities, as defined in §413.65(b), are not under the certification and provider number of the main provider hospital, this language, read literally, would appear to impose EMTALA obligations on providers other than hospitals, a result that would not be consistent with section 1867, which restricts EMTALA applicability to hospitals.

2. Provisions of the Proposed Rule

To avoid confusion on this point and to prevent any inadvertent extension of EMTALA requirements outside the hospital setting, in the May 9, 2002 proposed rule (67 FR 31477), we proposed to clarify that EMTALA applies in this scenario to only those departments on the hospital's main campus that are provider-based; EMTALA would not apply to provider-based entities (such as RHCs) that are on the hospital campus.

In addition, we proposed in §489.24(b) to revise the definition of "Comes to the emergency department" to include an individual who presents on hospital property, in which "hospital property" is, in part, defined as "the entire main hospital campus as defined at §413.65(b) of this chapter, including the parking lot, sidewalk, and driveway, but excluding other areas or structures that may be located within 250 yards of the hospital's main building but are not part of the hospital, such as physician offices, RHCs, SNFs, or other entities that participate separately in Medicare, or restaurants, shops, or other nonmedical facilities." We specifically sought comments on this proposed revised definition. Generally, the proposed language would clarify that EMTALA does not apply to provider-based entities, whether or not they are located on a hospital campus. This language is also consistent with our policy as stated in questions and answers published on the CMS website: www.cms.gov (CMS EMTALA guidance, 7/20/01, Q/A #1) that clarifies that EMTALA does not apply to other areas or structures located on the hospital campus that are not part of the hospital, such as fast food restaurants or independent medical practices.

We stated that if this proposed change limiting EMTALA applicability to only those on-campus departments of the hospital became final, we believe that if an individual comes to an on-campus provider-based entity or other area or structure on the campus not applicable under the new policy and presents for emergency care, it would be appropriate for the entity to call the emergency medical service if it is incapable of treating the patient, and to furnish whatever assistance it can to the individual while awaiting the arrival of emergency medical service personnel. However, the hospital on whose campus the entity is located would not incur an EMTALA obligation with respect to the individual.

In the May 9, 2002 proposed rule, we solicited comments from providers and other interested parties on the proper or best way to organize hospital resources to react to situations on campus where an individual requires immediate medical attention.

We proposed in §489.24(b) to revise the definition of "Comes to emergency department" (specifically, under proposed new paragraph (1)) and make conforming changes at §413.65(g)(1).

In the August 1, 2002 final rule issued following the May 9, 2002 proposed rule (67 FR 50090), we only adopted as final the deletion of the second sentence of the existing §413.65(g)(1) that address the nonapplicability of EMTALA to provider-based entities. We did not adopt other proposed clarifications concerning application of EMTALA to provider-based departments, on or off the campus, or any other proposals concerning EMTALA.

3. Summary of Public Comments and Departmental Responses

Comment: Several commenters expressed general approval of the proposed clarifications of the definition of “hospital property” for purposes of the EMTALA regulations and stated that the proposals will lead to more precise interpretation of the regulations.

Response: We agree, and are adopting the proposed clarifications as part of this final rule.

Comment: One commenter expressed strong opposition to the proposed clarification under which on-campus provider-based entities would not be subject to EMTALA. The commenter noted that individuals seeking emergency treatment may be severely confused or agitated, so that they would be unable to determine whether a particular area or facility is a dedicated emergency department, and that in some cases such individuals may also be physically unable to proceed to the dedicated emergency department. The commenter also stated that provider-based departments frequently are located close to the main hospital campus, typically receive higher reimbursement from Medicare by virtue of their provider-based status, and may be indistinguishable, especially to an individual in a crisis situation, from areas at which emergency care is provided. The commenter suggested that, in view of this, it is not unreasonable to expect the provider-based entity to assume responsibility for ensuring that individuals who present with emergency care needs receive screening and stabilization. Therefore, the commenter recommended that we require that provider-based entities either ensure that transfer to a dedicated emergency department occurs safely, or provide screening and stabilization at the entity if it is able safely to do so.

Response: We understand and share the commenter's concern for individuals seeking emergency services who come to provider-based entities for assistance, but note that the legislative provision under which EMTALA responsibilities apply (section 1867 of the Act) is specific to hospitals, and does not extend to nonhospital entities (such as rural health clinics or physician offices), even where those entities may be located adjacent to hospital facilities and owned or operated by hospitals, or both. Therefore, we are not making a revision in this final rule based on this comment.

4. Provisions of the Final Rule

We are adopting, as final with minor editorial changes as explained earlier in this preamble, the proposed revision of "come to the emergency department" and "hospital property" in which hospital property is, in part, defined as "the entire main hospital campus as defined at §413.65(b) of this chapter, including the parking lot, sidewalk, and driveway, but excluding other areas or structures of the hospital's main building that are not part of the hospital, such as physician offices, RHCs, SNFs, or other entities that participate separately in Medicare, or restaurants, shops, or other nonmedical facilities." This will clarify that on-campus provider based entities would not be subject to EMTALA.

We are also adopting as final without modification the proposed clarifying change to §413.65(g)(l).