Medicare Program; Clarifying Policies Related to the Responsibilities of Medicare-Participating Hospitals in Treating Individuals With Emergency Medical Conditions

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 413, 482, and 489

[CMS-1063-F]

RIN 0938-AM34

Medicare Program; Clarifying Policies Related to the Responsibilities of Medicare-Participating Hospitals in Treating Individuals With Emergency Medical Conditions

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Final rule.

SUMMARY:

This final rule clarifies policies relating to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions who present to a hospital under the provisions of the Emergency Medical Treatment and Labor Act (EMTALA).

The final rule responds to public comments received on a May 9, 2002 proposed rule (67 FR 31404) that both reiterated the agency's interpretations under EMTALA and proposed clarifying changes relating to the implementation of the EMTALA provisions. These reiterations and clarifying changes related to, among other areas, seeking prior authorization from insurers for services, emergency patients presenting at off-campus outpatient clinics that do not routinely provide emergency services, the applicability of the EMTALA provisions to hospital inpatients and outpatients, the circumstances under which physicians must serve on hospital medical staff “on-call” lists, and the responsibilities of hospital-owned ambulances.

These reiterations and clarifying changes are needed to ensure uniform and consistent application of policy and to avoid any misunderstanding of EMTALA requirements by individuals, physicians, or hospital employees.

DATES:

The provisions of this final rule are effective on November 10, 2003.

FOR FURTHER INFORMATION CONTACT:

Thomas Gustafson, (410) 786-4487.

SUPPLEMENTARY INFORMATION:

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Table of Contents

I. Background

II. Special Advisory Bulletin on EMTALA Obligations

III. Summary of the Provisions of the May 9, 2002 Proposed Rule Relating to EMTALA and Hospital Responsibility for Communication with Medicare+Choice Organizations Concerning Post-Stabilization Care Services

A. Summary of the Proposed Provisions Relating to EMTALA

B. Summmary of the Proposed Provisions Relating to Communication with Medicare+Choice Organizations Concerning Post-Stabilization Care Services

IV. General Comments on the Proposed Rule

V. Prior Authorization

A. Provisions of the Proposed Rule

B. Summary of Public Comments and Departmental Responses

1. General Comments

2. Concurrent Authorization and Furnishing of Stabilizing Services

3. Authorization Requests by Nonphysician Practitioners

4. Medical Staff Communications

5. Out-of-Network Coverage

C. Provisions of the Final Rule on Prior Authorizations

VI. Clarification of “Come to the Emergency Department”

A. Background

B. Provisions of the Proposed Rule

C. Summary of Public Comments and Departmental Responses

1. General Support

2. Objective Test of “Significant Portion of the Time”

3. Nature of Care

4. State Law Criterion

5. Held Out to the Public Standard

6. Labor and Delivery Departments and Psychiatric Units

7. Use of Arizona State Bill Language Defining Freestanding Urgent Care Center

8. Urgent Care Centers

9. Evaluation and Treatment Issue

10. Prudent Layperson Observer Standard

11. Specially Equipped and Staffed Area

12. Unscheduled Appointments Criterion

13. Related Definition of “Hospital with an Emergency Department”

14. Other Related Suggested Revisions

D. Provisions of the Final Rule Regarding Clarification of “Comes to the Emergency Department”

VII. Applicability of EMTALA: Individuals Come to the Dedicated Emergency Department for Nonemergency Services

A. Background

B. Provisions of the Proposed Rule

C. Summary of Public Comments and Departmental Responses

D. Provisions of the Final Rule

VIII. Applicability of EMTALA: Individuals Present at an Area of the Hospital's Main Campus Other than the Dedicated Emergency Department

A. Background

B. Provisions of the Proposed Rule

C. Summary of Public Comments and Departmental Responses

1. Presentation Outside the Dedicated Emergency Department

2. Prudent Layperson Standard

3. Determination of “What May Be an Emergency Medical Condition”

4. Other Issues

D. Provisions of the Final Rule

IX. Scope of EMTALA Applicability to Hospital Inpatients

A. Background and Provisions of the Proposed Rule

B. Summary of Public Comments and Departmental Responses

1. Applicability of EMTALA to Inpatients

1. Definition of Stability

2. Logs on EMTALA Patients

4. Other Issues

C. Provisions of the Final Rule

X. Applicability of EMTALA to Provider-Based Entities

A. Applicability of EMTALA to Off-Campus Hospital Departments

1. Background

2. Provisions of the Proposed Rule

3. Summary of Public Comments and Departmental Responses

4. Provisions of the Final Rule

B. On-Campus Provider-Based Applicability

1. Background

2. Provision of the Proposed Rule

3. Summary of Public Comments and Departmental Responses

4. Provisions of the Final Rule

XI. EMTALA and On-Call Requirements

A. Background

B. Provisions of the Proposed Rule

C. Summary of Public Comments and Departmental Responses

1. General Comments

2. Minimal Interpretation of On-Call Responsibilities

3. Recommended Definition of “Best Meets the Needs of the Hospitals' Patients”

4. Physicians' Responsibility for On-Call Coverage

5. Hospital Responsibility for On-Call Coverage

6. Simultaneous Call and Performance of Other Physician Services While On Call

7. Limiting On-Call Responsibility by Subspecialty

8. Other On-Call Issues

D. Provisions of the Final Rule

XII. EMTALA Applicability to Hospital-Owned Ambulances

A. Background

B. Provisions of the Proposed Rule

C. Summary of Public Comments and Departmental Responses

D. Provisions of the Final Rule

XIII. Conditions of Participation for Hospitals

XIV. Other Issues

A. Editorial/Clarifying Changes

B. Out-of-Scope Public Comments

XV. Information Collection Requirements

XVI. Regulatory Impact Analysis

A. Introduction

1. Executive Order 12866

2. Regulatory Flexibility Act

3. Effects on Rural Hospitals

4. Unfunded Mandates

5. Federalism

B. Anticipated Impact

C. Office of Management and Budget Review

List of Subjects

Regulation Text

I. Background

Sections 1866(a)(1)(I), 1866(a)(1)(N), and 1867 of the Social Security Act (the Act) impose specific obligations on Medicare-participating hospitals and critical access hospitals (CAHs) that offer emergency services. (Throughout this final rule, when we reference the obligation of a “hospital” under these sections of the Act and in our regulations, we mean to include CAHs as well.) These obligations concern individuals who come to a hospital emergency department and request examination or treatment for medical conditions, and apply to all of these individuals, regardless of whether or not they are beneficiaries of any program under the Act. Section 1867 of the Act sets forth requirements for medical screening examinations for medical conditions, as well as necessary stabilizing treatment or appropriate transfer. In addition, section 1867(h) of the Act specifically prohibits a delay in providing required screening or stabilization services in order to inquire about the individual's payment method or insurance status. Section 1867(d) of the Act provides for the imposition of civil monetary penalties on hospitals and physicians responsible for the following: (a) Negligently failing to appropriately screen an individual seeking medical care; (b) negligently failing to provide stabilizing treatment to an individual with an emergency medical condition; or (c) negligently transferring an individual in an inappropriate manner. (Section 1867(e)(4) of the Act defines “transfer” to include both transfers to other health care facilities and cases in which the individual is released from the care of the hospital without being moved to another health care facility.)

These provisions, taken together, are frequently referred to as the Emergency Medical Treatment and Labor Act (EMTALA), also known as the patient antidumping statute. EMTALA was passed in 1986 as part of the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA). Congress enacted these antidumping provisions in the Social Security Act because of its concern with an “increasing number of reports” that hospital emergency rooms were refusing to accept or treat individuals with emergency conditions if the individuals did not have insurance:

“* * * the Committee is most concerned that medically unstable patients are not being treated appropriately. There have been reports of situations where treatment was simply not provided. In numerous other situations, patients in an unstable condition have been transferred improperly, sometimes without the consent of the receiving hospital.

“There is some belief that this situation has worsened since the prospective payment system for hospitals became effective. The Committee wants to provide a strong assurance that pressures for greater hospital efficiency are not to be construed as license to ignore traditional community responsibilities and loosen historic standards.

“[Under the statute] [a]ll participating hospitals with emergency departments would be required to provide an appropriate medical screening examination for any individual who requests it (or has a request made on his [or her] behalf) to determine whether an emergency medical condition exists or if the patient is in active labor.” (H.R. Rept. No. 99-241, Part I, 99th Cong., 1st Sess. (1985), p.27.)

In addition, section 1867(d)(2) of the Act provides for a private right of enforcement for any individual who is harmed as a “direct result” of a violation of the Act. In enacting this section of the law, Congress did not intend for the statute to be used as a Federal malpractice statute. Indeed, many courts are in agreement that EMTALA is not a Federal malpractice statute (for example,

Bryan

v.

Rectors and Visitors of University of Virginia,

95 F.3d 349, 351 (4th Cir. 1996);

Lopez-Soto

v.

Hawayek,

175 F.3d 170, 177 (1st Cir. 1999); and

Baker

v.

Adventist Health, Inc.,

260 F.3d 987, 994 (3rd Cir. 2001).

The regulations implementing section 1867 of the Act are found in 42 CFR 489.24, Special responsibilities of Medicare hospitals in emergency cases. Existing § 489.24 provides for the following:

• Requires that when an individual presents to a hospital's emergency department and a request is made on the individual's behalf for examination or treatment of a medical condition, the hospital must provide for an appropriate medical screening examination to determine whether or not an emergency medical condition exists. (Paragraph (a))

• Defines certain terms, including “comes to the emergency department,” “emergency medical condition,” “stabilized,” and “to stabilize.” (Paragraph (b))

• Addresses procedures a hospital must follow when it determines, with respect to a patient, that an emergency medical condition exists. If the hospital determines that an emergency medical condition exists, the hospital must provide for further medical examination and treatment as required to stabilize the individual. If the hospital does not have the capabilities to stabilize the individual, an appropriate transfer to another facility is permitted. (Paragraph (c)) A transfer is appropriate when the medical benefits of the transfer outweigh the medical risks of the transfer and other requirements, specified in the regulations, are met. (Paragraph (d)) In addition, the hospital may transfer an unstable patient who makes an informed written request. A hospital may not delay an appropriate medical screening examination, or further examination or treatment, to inquire about the patient's payment method or insurance status. (Paragraph (c))

In addition, § 489.24 addresses: (a) Restriction of a transfer until the individual is stabilized; (b) the responsibilities of the receiving hospital; (c) termination of the provider agreement for failure to comply with EMTALA requirements; and (d) matters concerning consultation with Quality Improvement Organizations (QIOs). (Paragraphs (d) through (h), respectively)

Some EMTALA-related requirements are implemented under regulations at §§ 489.20(l), (m), (q), and (r)(1), (r)(2), and (r)(3). Those regulations deal with

a hospital's obligations to report the receipt of patients whom it has reason to believe may have been transferred inappropriately; to post signs in the emergency department describing an individual's rights to emergency treatment under section 1867 of the Act; and to maintain patient records, physician on-call lists, and emergency room logs. We are including this brief description for informational purposes but, because we are not changing the regulations in § 489.20, they will not be discussed further in this document.

In promulgating these cited regulatory sections and in enforcing the provisions of EMTALA, we are aware of the necessary balance between the hospital's and a physician's legal duty to provide examination and treatment (both under the statute and under the common law) and the practical realities of the manner in which hospitals and medical staffs are organized and operated on a day-to-day basis, as well as proper mobilization of resources within hospitals in order to comply with these legal duties. Reports of overcrowding are common in many parts of the country. Within the requirements of EMTALA, individuals should be treated at the appropriate site of care.

Hospitals and physicians have now had over 15 years of experience in organizing themselves to comply with the provisions of EMTALA. Therefore, in a proposed rule published in the

Federal Register

on May 9, 2002 as part of the annual proposed rules for the acute care hospital inpatient prospective payment system (67 FR 31469), we solicited comments from hospitals, physicians, patients, and beneficiary groups on certain proposed changes to the EMTALA policies as discussed in sections III. through XIV. of this preamble.

II. Special Advisory Bulletin on EMTALA Obligations

On November 10, 1999, CMS (then HCFA) and the Office of the Inspector General (OIG) published jointly in the

Federal Register

a Special Advisory Bulletin addressing the requirements of the EMTALA statute and the obligations of hospitals to medically screen all individuals seeking emergency services and to provide stabilizing medical treatment as necessary to all individuals, including enrollees of managed care plans, whose conditions warrant it (64 FR 61353). The Special Advisory Bulletin addressed issues of dual staffing of hospital emergency rooms by managed care and nonmanaged care physicians, prior authorization requirements of some managed care plans, use of advance beneficiary notices (ABNs) or other financial responsibility forms, handling of individuals' inquiries about financial liability for emergency services, and voluntary withdrawal of a treatment request. Although it did not amend the Code of Federal Regulations, the Special Advisory Bulletin informs individuals of HHS policy regarding application of the EMTALA statute and offers advice on the best practices to follow to avoid violation of the requirements imposed under that statute.

As discussed further in section V. of this preamble, in the May 9, 2002 proposed rule, we proposed to codify certain policies on prior authorization that are currently stated only in the Special Advisory Bulletin. We believe these changes in the regulations are needed to ensure uniform and consistent application of policy and to avoid any misunderstanding of EMTALA requirements by patients, physicians, or hospital employees.

III. Summary of the Provisions of the May 9, 2002 Proposed Rule Relating to EMTALA and Hospital Responsibility for Communication With Medicare+Choice Organizations Concerning Post-Stabilization Care Services

A. Summary of the Proposed Provisions Relating to EMTALA

Recently, a number of questions have been raised about the applicability of § 489.24 to specific situations. These questions arise in the context of managed care plans' requirements for prior authorization, case experiences involving elective procedures, and situations where individuals have been admitted as inpatients without being stabilized, or patients who had been stabilized later experience a deterioration in their medical condition. Some hospitals are uncertain about whether various conditions of participation (CoPs) found in 42 CFR part 482 apply to these situations or whether the EMTALA requirements included in the provider agreement regulations at § 489.24 apply, or both. Some representatives of the provider community have asked us to reexamine CMS policy on the applicability of EMTALA to physicians who are “on call” and to hospitals that own ambulances when those ambulances operate under communitywide emergency medical services (EMS) protocols.

To help promote consistent application of the regulations concerning the special responsibilities of Medicare-participating hospitals in emergency cases, in the May 9, 2002 proposed rule (67 FR 31469), we proposed changes to § 489.24 to clarify its application in these situations and at the same time address concerns about EMTALA raised by the Secretary's Advisory Committee on Regulatory Reform. These changes are discussed more fully below and include the following:

• We proposed to change the requirements relating to individuals who present with what may be emergency medical conditions at off-campus outpatient clinics and facilities that do not routinely provide emergency medical services. We believe these changes will enhance the quality and promptness of emergency care by permitting individuals to be referred to appropriately equipped emergency facilities close to such clinics, rather than being transported to the main campus emergency department, which may be located at a greater distance from the clinic.

• We proposed to clarify the extent to which EMTALA applies to inpatients and outpatients. We believe these clarifications will enhance understanding for hospitals as to what their obligations are under EMTALA, so that they more clearly understand to whom they are obligated under this provision of the statute, and whose care will be governed by the Medicare hospital CoPs.

• We proposed to clarify the circumstances in which physicians, particularly specialty physicians, must serve on hospital medical staff “on-call” lists. We expect these clarifications will help improve access to physician services for all hospital patients by permitting hospitals local flexibility to determine how best to maximize their available physician resources. We are currently aware of reports of physicians, particularly specialty physicians, severing their relationships with hospitals, especially when those physicians belong to more than one hospital medical staff. Physician attrition from these medical staffs could result in hospitals having no specialty physician service coverage for their patients. We proposed clarification of the on-call list requirements to permit hospitals to continue to attract physicians to serve on their medical staffs and thereby continue to provide services to emergency room patients.

• We proposed to clarify the responsibilities of hospital-owned ambulances so that these ambulances can be more fully integrated with citywide and local community EMS procedures for responding to medical emergencies and thus use these

resources more efficiently for the benefit of these communities.

In the May 9, 2002 proposed rule, we specifically solicited comments on all of these proposed changes. In response to the proposed rule, we received approximately 600 pieces of correspondence, most of which contained multiple comments. A large number of these comments were received on the last day of the comment period for the proposed rule (July 8, 2002). Because of the number and nature of the public comments we received on our proposed clarifications and our limited timeframe for developing the final acute care hospital inpatient prospective payment system regulations for publication by the statutory deadline of August 1, we decided, with one exception (application of the EMTALA provisions to provider-based entities), to address the public comments and finalize the proposed clarifications relating to implementation of EMTALA in a separate document. This final rule is that separate document.

In the next several sections of the preamble of this final rule, we summarize the public comments received on the proposed EMTALA clarifications and present our responses to those comments, including any further revisions that we are making in this final rule to the proposed regulation changes as a result of these comments.

B. Summmary of the Proposed Provisions Relating to Communication with Medicare+Choice Organizations Concerning Post-Stabilization Care Services

In the May 9, 2002 proposed rule (67 FR 31471), we proposed to specify that a hospital must promptly contact the Medicare+Choice organization after a Medicare+Choice enrollee who is treated for an emergency medical condition is stabilized (proposed § 489.24(d)(6)). We received a number of public comments on this proposed provision. However, we are not addressing public comments received on this provision in this final rule but plan to address them in future policy guidance.

IV. General Comments on the Proposed Rule

Comment:

Some commenters expressed overall support for our proposed clarifying changes to establish more flexible standards on EMTALA, but did not offer specific recommendations for modifying them. However, one commenter, the administrator of a small rural hospital in the Midwest, expressed concern that our proposals appear to represent a shift from national requirements to community-based standards, under which the level of emergency care available in a community would be determined by the medical staffs of individual hospitals. This commenter stated that, in many cases, it is possible to continue to maintain emergency department services in the local community only because of the pressure exerted on physicians by EMTALA to continue to see patients in the emergency department. Therefore, the commenter recommended that any changes in EMTALA regulatory requirements be directed to making those requirements more stringent and specific and stated that relaxing EMTALA requirements as proposed will only undermine the efforts of small rural hospitals to maintain viable emergency services for their patients.

Response:

We appreciate the commenters' support, and have kept their views in mind in considering the comments of those respondents who recommended revisions. In regard to the commenter's recommendations that we make the EMTALA requirements more stringent (rather than relaxing them) for the benefit of small rural hospitals, we note that we received many comments expressing concern that the current requirements may be too burdensome, and therefore, the commenters recommended more flexible EMTALA rules. We considered all of the comments received when finalizing our policy.

V. Prior Authorization (§ 489.24(d)(4))

A. Provisions of the Proposed Rule

Some managed care plans may seek to pay hospitals for services only if the hospitals obtain approval from the plan for the services before providing the services. Requirements for this approval are frequently referred to as “prior authorization” requirements. However, EMTALA (specifically, section 1867(h) of the Act and our existing regulations at § 489.24(c)(3)) explicitly prohibit hospitals from delaying screening or stabilization services in order to inquire about the individual's method of payment or insurance status. Thus, prior authorization requirements are a matter of concern because a hospital's actions in seeking prior authorization from an insurer could result in a delay in the provision of services required by EMTALA. Our existing policy prohibits a participating hospital from seeking authorization from the individual's insurance company for screening services or services required to stabilize an emergency medical condition until after the hospital has provided the appropriate medical screening examination required by EMTALA to the individual and has initiated any further medical examination and treatment that may be required to stabilize the patient's emergency medical condition.

In the May 9, 2002 proposed rule, we solicited public comments as to whether the regulations should be revised to state that the hospital may seek other information (apart from information about payment) from the insurer about the individual, and may seek authorization for all services concurrently with providing any stabilizing treatment, as long as doing so does not delay required screening and stabilization services (67 FR 31471).

In addition, we proposed to clarify that an emergency physician is not precluded from contacting the patient's physician at any time to seek advice or information regarding the patient's medical history and needs that may be relevant to the medical screening and treatment of the patient, as long as this consultation does not inappropriately delay required screening services or stabilizing treatment.

As explained earlier, this policy was stated in a Special Advisory Bulletin published jointly by CMS (then HCFA) and the OIG. We proposed to clarify the existing language at § 489.24(c)(3) (which was proposed to be redesignated as paragraph (d)(4)) in the proposed rule to include this policy in the regulations.

B. Summary of Public Comments and Departmental Responses

1. General Comments

Comment:

Several commenters expressed general approval of our proposals without recommending more specific changes.

Response:

We appreciate the commenters' support of the proposals and have taken their views into account in considering the comments of those respondents who recommended revisions.

2. Concurrent Authorization and Furnishing of Stabilizing Services

Comment:

Two commenters recommended that we delete any reference to seeking authorization for post-stabilization services concurrently with the provision of stabilizing treatment. The commenters believed clinical staff cannot easily distinguish between screening services and stabilizing treatment, and thus may be uncertain as to when stabilizing treatment has begun in order to seek authorization for the services. Another

commenter believed that allowing such concurrent authorization serves no useful purpose and leaves the hospital open to charges that the steps taken to obtain concurrent authorization actually delay stabilization services. This commenter also recommended that the regulations not allow the concurrent authorization of stabilizing treatment and the furnishing of actual stabilizing treatment.

Response:

We recognize that the distinction between screening services and stabilizing treatment may be difficult to define outside the context of a specific case. However, we believe clinicians will be able, when dealing with a particular patient or case, to identify clearly when the assessment of an individual has concluded and they have begun stabilizing the patient with an emergency medical condition. We expect that these clinical judgments will be the basis for determining when contact will be appropriate, and that surveyors will use their own clinical training and experience in evaluating clinicians' actions.

Regarding the comment that authorization serves no useful purpose, we note that the regulation merely permits, but does not require, hospitals to seek concurrent authorization with the furnishing of stabilizing treatment. We do not believe it is appropriate to prohibit the practice in all cases and, therefore, are not making any revision to the proposed language, which we are adopting in this final rule, based on this comment.

We would like to clarify again that hospitals that choose to seek concurrent authorization while administering stabilizing treatment must not delay such treatment in order to obtain authorization. Even if the approving insurer or physician denies authorization for the stabilizing treatment, the hospital is

obligated

under EMTALA to provide the necessary stabilizing treatment (if the hospital has such capabilities).

Comment:

Some commenters stated that restrictions on contact with a patient's insurer are not appropriate because a hospital's administrative staff might not be fully aware of the status of an individual's treatment (that is, whether a screening has occurred and stabilizing treatment has been initiated) and that a hospital might, therefore, violate this requirement inadvertently by requesting authorization prematurely, even though no delay in the screening or stabilization actually occurs.

Response:

We recognize the possibility pointed out by the commenter, but believe that hospitals will be able to develop procedures to alert administrative staff as to when contact may be initiated.

3. Authorization Requests by Nonphysician Practitioners

Comment:

Five commenters recommended that we state more specifically that CMS' policies on prior authorization apply to authorization for both hospital and physician (and nonphysician practitioner) services. In addition, the commenters recommended that the regulations be revised to clarify whether EMTALA policies also apply to emergency medical or stabilizing services furnished by nonphysician practitioners.

A number of commenters recommended that the regulations be revised to state that nurse practitioners and all other medical or hospital personnel involved in the individual's treatment, and not just emergency physicians, are permitted to contact the patient's physician for information and advice relevant to the patient's medical history and needs, as long as screening services or stabilizing treatment are not inappropriately delayed.

Another commenter recommended a change in the wording of proposed § 489.24(d)(4)(iii) regarding contacts between emergency physicians and individuals' personal physicians. The commenter believed that the regulations should also allow such contacts with the individual's physician to be initiated by a qualified medical person other than a physician, such as a physician assistant or nurse practitioner.

Response:

We agree with the commenters that the prior authorization policies apply equally to hospital services, physician services, and nonphysician practitioner services, and are revising § 489.24(d)(4)(ii) to clarify this point. We also agree that qualified medical personnel other than physicians, such as nonphysician practitioners (physician assistants and nurse practitioners), should be permitted to initiate such contacts, and are revising § 489.24(d)(4)(iii) in this final rule accordingly.

Comment:

A number of commenters recommended that the final rule be revised to state that concurrent contact with an individual's insurer (that is, contact undertaken by administrative staff not involved in patient screening or treatment that occurs while clinical staff continue to screen the individual) is not a violation of EMTALA as long as it does not delay screening or stabilization.

Response:

We recognize that section 1867(h) of the Act states only that a hospital may not delay an EMTALA screening or stabilization in order to inquire about the individual's method of payment or insurance status, and does not specifically address the issue of when it is appropriate for contact with the individual's insurer to be made. Hospitals have in the past expressed a need for further guidance on the agency's policy in this area and the Special Advisory Bulletin cited earlier was developed to provide guidance on this and other issues. We do not wish to be overly prescriptive on this issue, but do believe that hospitals should have a clear statement of the agency's policy and that the policy should strike a reasonable balance between the need to avoid creating circumstances in which screening or stabilization will be likely to be delayed and the equally important need to protect the individual from avoidable liability for the costs of emergency health care services. We believe the policy in the Special Advisory Bulletin and reiterated in proposed rule strikes that balance. Therefore, we are not adopting the commenters' suggestion.

Further, we note that many insurers now provide a “window” of at least 24 hours following emergency department treatment during which authorization can be obtained. In addition, many States have enacted revisions to their insurance statutes over the past several years that explicitly contemplate the existence of the Federal EMTALA statute. As a practical matter, we believe this feature of private insurance contracts, as well as State laws governing health insurance contracts, will allow screening and stabilization to go forward without compromising the individual's rights to have care covered under his or her health plan.

4. Medical Staff Communications

Comment:

Two commenters objected to the proposed language under which contact by an emergency physician with the individual's physician is not prohibited as long as the consultation does not inappropriately delay EMTALA-mandated screening or stabilization. One commenter stated that it is never appropriate for regulations to restrict physicians' communications with one another. The other commenter stated that section 1867(h) of the Act governs only contacts for the purpose of insurance information and does not relate in any way to contact with the individual's physician. The commenter believed the proposed language at § 489.24(d)(4)(iii) should be deleted because, in the commenter's view, it implies that some contacts with individuals' physicians might be

prohibited by EMTALA, and that making such contacts therefore could expose the hospital or the emergency physician to sanctions.

Response:

We agree that physician communication regarding patient medical status and information is essential. We expect the regulations will dispel any possible concerns about the appropriateness of this communication. Therefore, we do not believe it is necessary to make any change in the regulations in this final rule based on this comment.

Comment:

Two commenters stated that the proposed language regarding contact with the patient's physician not being prohibited as long as the consultation does not inappropriately delay EMTALA-mandated screening or stabilization is unclear, and recommended that it be revised to state that such contact is not inappropriate as long as it does not otherwise delay the start of the medical screening examination.

Response:

We do not believe the language as proposed is less clear than the commenters' recommended alternative. The commenters' alternative could suggest instead that delays in stabilizing treatment would be acceptable. Therefore, we are not adopting the recommendation of the commenters.

Comment:

One commenter suggested that CMS clarify the proposed regulatory language by citing lists of appropriate referral physicians or participating providers as examples of the types of information that may appropriately be obtained as long as prior authorization is not sought.

Response:

We agree that it would not be inappropriate to discuss the types of information the commenter cited with the patient's attending physician. However, we do not believe these types of information are representative samples of the types of information that such contacts should elicit. Therefore, we are not making any change in the final rule based on this comment.

5. Out-of Network Coverage

Comment:

Some commenters stated that they understood the need to avoid delaying EMTALA screening or stabilization to obtain prior authorization, but suggested that, if such authorization is not obtained, patients might be left with substantial financial responsibility. The commenters noted that individuals may request information about the costs of services while awaiting a screening examination. They stated that, while it is important to avoid even the appearance of coercion of an individual to leave the emergency department, it is also important to recognize the patient's right to be informed of potential financial liability for services (including increased liability for out-of-network services) before, rather than after, the services are furnished. These commenters recommended that the regulations be revised to state that a hospital may request financial or coverage information as long as doing so does not delay screening or stabilization. The commenters also recommended that we state that there may be discussion of the limits of an individual's health insurance coverage if the individual asks about the charges for the emergency department visit.

Response:

As noted in the Special Advisory Bulletin cited earlier (64 FR 61355), current Interpretive Guidelines indicate that hospitals may continue to follow reasonable registration processes for individuals presenting with an emergency medical condition. Reasonable registration processes may include asking whether an individual is insured and, if so, what that insurance is, as long as that inquiry does not delay screening or treatment. Reasonable registration processes should not unduly discourage individuals from remaining for further evaluation. As requested by the commenter, in this final rule, we are revising proposed § 489.24(d)(4) by adding a new paragraph (iv) to clarify this policy. To avoid any misunderstanding of the requirement, we have revised the language of the interpretative guidelines to state that reasonable registration processes must not unduly discourage individuals from remaining for further evaluation.

Regarding a hospital's response to an individual's inquiry about financial liability for emergency services, the Special Advisory Bulletin states that any such inquiry should be answered by a staff member who is well-trained and knowledgeable and that the staff member should explain to the individual that, regardless of the individual's ability to pay, the hospital stands ready and willing to provide any necessary screening or stabilization services or both. Staff should encourage the individual to defer further discussion of financial responsibility issues, if possible, until after any necessary screening has been performed. We do not believe that this explanation needs to be included in the regulations.

Comment:

One commenter suggested that, in the interest of avoiding any appearance that an individual's screening or stabilization may have been influenced by the individual's perceived ability or inability to pay, financial information collected by registration or billing staff should not be included in the patient chart that goes back to the clinical staff who are caring for the individual.

Response:

We agree that such a procedure could help avoid the perception of improper financially based influences on screening or treatment decisions. We do not believe it is necessary to revise the final rule to require that such information be excluded from the patient's chart.

C. Provisions of the Final Rule on Prior Authorizations

In summary, we are adopting the proposed changes relating to prior authorization for necessary stabilizing treatment for emergency medical conditions under § 489.24(d)(4) as final, with the following modification:

We are revising paragraph (d)(4)(ii) to indicate that prior authorization policies apply to services furnished by a hospital, a physician, or a nonphysician practitioner.

We are revising paragraph (d)(4)(iii) to specify that an emergency physician as well as any nonphysician practitioner involved in the emergency treatment is not precluded from contacting the individual's physician at any time to seek advice regarding the individual's medical history as long as the consultation does not delay screening and stabilizing services.

We are adding a new paragraph (d)(4)(iv) to specify that hospitals may follow reasonable registration processes for individuals for whom examination or treatment is required under EMTALA, as long as the procedures do not result in a delay in screening or treatment.

VI. Clarification of “Comes to the Emergency Department” (§ 489.24(a) and (b))

A. Background

Section 1867(a) of the Act and our existing regulations at § 489.24(a) provide, in part, that if any individual comes to the emergency department of a hospital and a request is made on that individual's behalf for examination or treatment of a medical condition, the hospital must provide an appropriate medical screening examination within the capability of the hospital's emergency department. Section 1867(b) of the Act and our existing regulations at § 489.24(c) provide, in part, that if the hospital determines that such an individual has an emergency medical condition, the hospital is further obligated to provide either necessary

stabilizing treatment or an appropriate transfer. Occasionally, questions have arisen as to whether these EMTALA requirements apply to situations in which an individual comes to a hospital, but does not present to the hospital's emergency department.

B. Provisions of the Proposed Rule

In the May 9, 2002 proposed rule (67 FR 31472), we proposed to consolidate the EMTALA requirements for screening (currently in § 489.24(a)) and for stabilization or appropriate transfer (currently in § 489.24(c)) into a single revised paragraph (a). This consolidation was not intended to change the substance of the requirements, but only to set forth more concisely, in a single opening paragraph, the essential requirements of EMTALA. In proposed paragraph (b), we proposed to clarify the criteria for determining under what conditions a hospital is obligated by EMTALA to screen and, if necessary, stabilize or transfer an individual who comes to a hospital, presenting either at its dedicated emergency department, as we proposed to define, or elsewhere on hospital property, and requests examination or treatment, or has such a request made on his or her behalf.

In developing the proposed criteria, we recognized that sometimes individuals come to hospitals seeking examination or treatment for medical conditions that could be emergency medical conditions, but present for examination or treatment at areas of the hospital other than the emergency department. In recognition of this possibility, and for other reasons explained in the preamble to the proposed rule (including the need to assure that an individual is not denied services simply because he or she failed to actually enter the hospital's designated emergency department), we proposed to clarify under proposed § 489.24(b) that an individual can “come to the emergency department,” creating an EMTALA obligation on the part of the hospital, in one of two ways: The individual can present at a hospital's dedicated emergency department (as we proposed to define that term) and request examination or treatment for a medical condition; or the individual can present elsewhere on hospital property in an attempt to gain access to the hospital for emergency care (that is, at a location that is on hospital property but is not part of a dedicated emergency department), and request examination or treatment for what they believe to be an emergency medical condition.

Because of the need to clarify the applicability of EMTALA to a particular individual depending on where he or she presents on hospital property in order to obtain emergency care, we proposed to define “dedicated emergency department.” We proposed that “dedicated emergency department” would mean a specially equipped and staffed area of the hospital that is used a significant portion of the time for the initial evaluation and treatment of outpatients for emergency medical conditions, as defined in § 489.24(b), and is either located: (1) on the main hospital campus; or (2) off the main hospital campus and is treated by Medicare under § 413.65(b) as a department of the hospital.

The EMTALA statute was intended to apply to individuals presenting to a hospital for emergency care services. Accordingly, we believe it is irrelevant whether the dedicated emergency department is located on or off the hospital main campus, as long as the individual is presenting to “a hospital” for those services. Therefore, we proposed in our definition of “dedicated emergency department” that such a department may be located on the main hospital campus, or it may be a department of the hospital located off the main campus. (We note that the proposed definition would encompass not only what is generally thought of as a hospital's “emergency room” but would also include other departments of hospitals, such as labor and delivery departments and psychiatric units of hospitals, if these departments provide emergency psychiatric or labor and delivery services, or both, or other departments that are held out to the public as an appropriate place to come for medical services on an urgent, nonappointment basis.)

In the May 9, 2002 proposed rule, we solicited public comments on whether this proposed definition should more explicitly define what is a “dedicated emergency department” (67 FR 31472). Specifically, we sought comments on whether a “significant portion of time” should be defined more objectively; for example, in terms of some minimum number or minimum percent of patients (20, 30, 40 percent or more of all patients seen) presenting for emergency care at a particular area of the hospital in order for it to qualify as a dedicated emergency department. As an alternative, we proposed considering a qualifying criterion that is based on determining whether the facility is used “regularly” for the evaluation or treatment of emergency medical conditions, and how we could define “regularly.” We further sought comments from hospitals, physicians, and others on how hospitals currently organize themselves to react to situations in which individuals come to a hospital requesting a screening examination or medical treatment, or both.

C. Summary of Public Comments and Departmental Responses

1. General Support

Comment:

Many commenters supported our proposed revised definition of “dedicated emergency department.” The commenters believed the proposed revised definition is clear and did not need to be further revised.

Response:

We appreciate the support of the commenters and have taken their views into account in considering the comments of those respondents who recommended revisions.

2. Objective Test of “Significant Portion of the Time”

Comment:

Some commenters believed that an objective test (such as a percentage of emergency patients seen or treated for emergency medical conditions) to determine dedicated emergency department status would reduce confusion in the provider industry. Several other commenters stated that while a finite, objective test, such as a standard of 20, 30, 40 percent or more of all patients seen, would be desirable because of the certainty and consistency it would provide in determining a “significant portion of the time” for purposes of “dedicated emergency department” determination, the commenters believed the percentages cited by us are too low.

One commenter asked us to clarify what is meant by patients who “seek emergency care” in our discussion of whether “significant portion of the time” should be defined more objectively. For instance, the commenter stated the view that while many patients present for immediate care of nonemergency problems (and these patients must be screened for an emergency under EMTALA regulations), they should not be counted in determining whether a department is considered a dedicated emergency department.

Response:

After consideration of these comments and the following related comments in this section VII.C. of this preamble, we believe that providing an objective criterion as part of the definition of “dedicated emergency department” for purposes of EMTALA will provide predictability and consistency to the health care industry, as the commenters suggest. Therefore, as

one part of the definition of “dedicated emergency department,” as described in more detail below, we are specifying in this final rule that a department or facility that does not otherwise qualify as a “dedicated emergency department” based on State licensure or the way it is held out to the public will nevertheless be considered to be a dedicated emergency department if, during the calendar year immediately preceding the calendar year in which a determination is being made, based on a representative sample of patient visits that occurred during that calendar year, the department or facility provided at least one-third of all its outpatient visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment. We adopted this definition because we believe it adds the element of objectivity requested by many commenters and thus enables hospitals to know in advance whether they will be subject to EMTALA. We included a reference to a “representative sample” of visits for two reasons. First, we believe any determination under this definition must be based on information that accurately represents the type and mix of services delivered by the department or facility over a period of time, not merely during certain parts of the year. However, we also recognize that the large number of visits provided by some departments or facilities will make it a practical necessity to sampling techniques to obtain information on the type of care furnished instead of attempting to review all records of all visits by all patients during a year. Therefore, we intend to issue instructions, through interpretative guidelines, to our surveyors on how to determine such a representative sample. In addition, we may develop a series of questions and answers for posting on our website that will provide further clarification and guidance to providers.

In response to the comment regarding visits for the care of nonemergency problems, we agree that such visits should not normally be counted as being for the treatment of emergency medical conditions. However, as discussed in section VIII. of this preamble, individuals who suffer an unexpected emergency medical condition after they arrive at the hospital for an outpatient visit but before they begin an outpatient encounter and individuals whose appearance or behavior would cause a prudent layperson observer to believe they need examination or treatment for an emergency medical condition would be counted toward the “one-third” standard.

Comment:

One commenter recommended that we use the term “regularly” instead of “a significant portion of the time” in the definition of dedicated emergency department. The commenter opposed the use of additional qualifying criteria (percentages) to determine whether a facility is used “regularly” for the evaluation and treatment of emergency medical conditions and believed that hospitals should have maximum flexibility to determine which part of their facility is appropriate for the delivery of emergency care.

Response:

As explained in the response to the previous comment, we believe that an objective criterion relating to the percentage of visits for the treatment of emergency medical conditions, such as the one we are including in this final rule for purposes of EMTALA, provides needed predictability for those who are determining dedicated emergency department status. In addition, we believe this objective criterion in the definition of dedicated emergency department, along with the other two criteria in the definition in this final rule, provides the most flexibility for determining dedicated emergency department status, as the commenter suggested.

Comment:

One commenter suggested that we not include an objective standard of “significant portion of the time” for the determination of a hospital's “dedicated emergency department.” The commenter believed that an objective standard for “significant” may have the unintended effect of creating a benchmark that some providers might use to avoid their EMTALA obligations. For example, the commenter stated, if the standard for “significant portion of the time” is set at 30 percent, a hospital's labor and delivery department may determine that its staff spend only 15 percent of their time evaluating and treating outpatients who meet the regulatory definition of emergency medical condition. The commenter stated that if the majority of the staff's time is spent caring for inpatients in active labor, such a hospital may then decide that its labor and delivery department no longer has to provide an emergency medical screening examination to all women who present with contractions, since the department does not meet the objective criteria of being used a significant portion of the time for the initial evaluation and treatment for emergency medical conditions.

Another commenter did not support the percentage-based definition of dedicated emergency department proposed because the commenter believed “it potentially could result in a patient having or not having EMTALA protections based on a fraction of a percentage point and dependent on the accounting method chosen to determine volume.” Also, the commenter believed that volumes fluctuate by days, weeks, and months, among other things. The commenter stated that fluctuating volume could potentially cause an area or department to move in and out of EMTALA coverage as the volume fluctuates.

Response:

We agree with the commenters that using objective criteria in the determination of a hospital's dedicated emergency department may lead to some cases in which the standard is exceeded or not met by a narrow margin. However, this result is an unavoidable consequence of any objective standard. By assessing a facility's performance over a calendar year, we believe that the effects of seasonal or other variations in utilization will be mitigated.

In response to the comment concerning labor and delivery departments, we would like to clarify that CMS believes that EMTALA requires that a hospital's dedicated emergency department would not only encompass what is generally thought of as a hospital's “emergency room,” but would also include other departments of hospitals, such as labor and delivery departments and psychiatric units of hospitals, that provide emergency or labor and delivery services, or both, to individuals who may present as unscheduled ambulatory patients but are routinely admitted to be evaluated and treated. Because labor is a condition defined by statute as one in which EMTALA protections are afforded, any area of the hospital that offers such medical services to treat individuals in labor to at least one-third of the ambulatory individuals who present to the area for care, even if the hospital's practice is to admit such individuals as inpatients rather than treating them on an outpatient basis,

would

be considered a dedicated emergency department under our revised definition in this final rule. In such cases, whether the department of the hospital chooses to directly admit the emergency patient upon presentment is irrelevant to the determination of whether the department is a dedicated emergency department.

3. Nature of Care

Comment:

Some commenters believed that the amount of time a facility is used for emergency screening and treatment is not relevant, and that it is the “nature of the care provided” that distinguishes it as a dedicated emergency department.

Response:

We appreciate the comment concerning the “nature of the care provided” as determinative of meeting the definition of “dedicated emergency department” rather than the amount of time a facility is used for emergency screening and treatment. However, if we used the suggested language of “nature of the care provided” as the standard for determining “dedicated emergency department” status, we believe that treatment for one emergency case by one hospital clinic would meet the suggested standard. We believe that the suggested standard is too general in its reach and would encompass too many departments of hospitals. Therefore, we are not adopting the commenters' proposed language.

4. State Law Criterion

Comment:

Several commenters suggested that “dedicated emergency department” status should be determined by State law in the State in which the hospital is located. Another commenter suggested that we define “dedicated emergency department” as any facility licensed by the State in which it is situated as an emergency department. The commenter stated that this would avoid the confusion as to whether urgent care or walk-in clinics do or do not devote a “significant portion of time” to the provision of emergency services.

Response:

As explained under section VII.D. of this preamble, based on consideration of all of the comments received, in this final rule we are revising the proposed definition of “dedicated emergency department” to state that a facility licensed by the State as an emergency department will be recognized as such under Federal EMTALA rules. However, because of the variations in State licensure laws, we do not agree that

only

facilities that are licensed as emergency departments by the State should be considered dedicated emergency departments for purposes of EMTALA, and have therefore included other criteria for dedicated emergency department status, as specified in this final rule.

5. Held Out to the Public Standard

Comment:

Many commenters agreed with statements in the preamble of the proposed rule to the effect that a “held out to the public standard” is appropriate for determining “dedicated emergency department” status. One commenter specifically suggested that a “dedicated emergency department” should be defined as “the department of a hospital that is held out to the public as the appropriate place to go for the examination and treatment of emergency medical conditions as defined in this section.”

Similarly, another commenter stated that a “24/7” rule with routine emergency care may be more appropriate to designating a “dedicated emergency department” rather than our proposal of tracking patients and developing some minimum percentage of emergency patients. The commenter stated that if the area is not open and staffed on a continuous basis, and it is not held out to the public as such, then it should

not

be considered a dedicated emergency department.

Response:

As explained in section VI.D. of this preamble, we are revising the proposed definition of “dedicated emergency department” in several areas. In the revised definition of dedicated emergency department that we are adopting in this final rule, we state that a department or facility that 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 will be considered to be a dedicated emergency department. Consistent with what we have stated above, we believe that most provider-based urgent care centers that are held out to the public as such will meet the revised definition of dedicated emergency department for purposes of EMTALA.

6. Labor and Delivery Departments and Psychiatric Units

Comment:

Several commenters addressed our clarification in the preamble of the proposed rule at 67 FR 31472 that other types of hospital departments, such as labor and delivery and psychiatric units, could qualify as a dedicated emergency department for purposes of EMTALA under our proposed definition.

One commenter stated that if a hospital has a department held out to the public as the place to go for a labor or psychiatric emergency medical condition, that department should fall under the definition of “dedicated emergency department” for purposes of EMTALA.

Two commenters stated that it was unclear which of the EMTALA requirements (such as the EMTALA log) would apply to the labor and delivery unit and the psychiatric unit that meet the definition of “dedicated emergency department.” In addition, these commenters asked whether EMTALA would apply to all patients who present to these locations or only to obstetrical and psychiatric patients who present under orders of their physicians at the locations.

Response:

As explained further below, under the revised definition in this final rule, departments of the hospital will be considered to be “dedicated emergency departments” if they are held out to the public as places that provide care for emergency medical conditions on an urgent, nonappointment basis. These departments will be subject to EMTALA requirements applicable to dedicated emergency departments, including requirements related to maintenance of an emergency department log and on-call requirements. Individuals who present at these locations and request examination or treatment for a medical condition or have such a request made on their behalf must be screened under EMTALA and, if an emergency medical condition is determined to exist, provided necessary stabilizing treatment, because these locations are dedicated emergency departments.

We note that the dedicated emergency department to which an individual presents does not necessarily have to be the one to do EMTALA screening and stabilization. For example, if a man with cold symptoms or another medical condition were to seek treatment in the obstetrics and gynecology department rather than the general emergency department, this presentation would create an EMTALA obligation for the hospital, but the hospital would not be prohibited from transporting the individual to its general emergency department for screening and stabilization if that action were medically indicated.

7. Use of Arizona State Bill Language Defining Freestanding Urgent Care Center

Comment:

One commenter cited language of a State bill (Arizona SB1098 (1999)) that, if enacted, would amend the Arizona State statutes to create standards in Arizona for “freestanding urgent care centers.” The commenter suggested that we adopt the legislative language for a “freestanding urgent care center” as the Medicare definition of “dedicated emergency department.” Specifically, the commenter suggested that the definition state:

An “emergency department” means a medical facility that, regardless of its

posted or advertised name, meets the following requirements:

(a) Is a department of a hospital and is intended to routinely provide unscheduled medical services; or

(b) Meets any one of the following requirements:

(1) Is open 24 hours a day to provide unscheduled medical care, excluding, at its option, weekends or certain holidays;

(2) By its posted or advertised name, give the impression to the public that it provides medical care for urgent, immediate or emergency conditions; or

(3) Routinely provides ongoing unscheduled medical services for more than 8 consecutive hours for an individual patient.

Response:

We have considered this suggested Arizona bill language defining urgent care centers for the State and believe it has merits for further revision of the CMS definition of “dedicated emergency department,” with some modification.

Under subparagraph (2) of the revised definition in this final rule, we are adopting as one of three options that a “dedicated emergency department” may be any department or facility of a hospital, regardless of whether it is located on or off the main hospital campus, that is held out to the public as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment. We have not limited the definition to a hospital “department” because we do not believe it would be appropriate to exclude facilities that otherwise function as dedicated emergency departments from that definition solely because they may not fully meet the requirements for departments of providers in 42 CFR 413.65.

Second, under subparagraph (3) of the revised definition in this final rule, we are adopting the criterion that during the calendar year immediately preceding the calendar year in which a determination is being made, based on a representative sample of patient visits that occurred during that calendar year, the department or facility provided at least one-third of all of its outpatient visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment. We are not using the Arizona bill 24-hour or 8-hour requirements because we believe an objective measure based on outpatient visits for the treatment of emergency medical conditions will be easier to understand and implement and better reflects the operating patterns of some emergency departments, including those at small or rural hospitals, or both, that may not offer treatment for emergency medical conditions continuously on a 24-hour, 7 days a week basis. (The hospital CoPs governing emergency services of hospitals (§ 482.55) and CAHs (§ 485.618) do not require that emergency departments be operated continuously. Under some circumstances, such as local shortages of emergency care personnel or limited demand for emergency services, hospitals and CAHs may choose to open and staff their emergency departments on less than a 24-hour, 7 days a week basis.)

8. Urgent Care Centers

Comment:

Many commenters were concerned that hospital “urgent care centers” or “acute care centers” would be included, inappropriately, as “dedicated emergency departments” for purposes of EMTALA. The commenters stated that urgent care centers “are capable of responding to an urgent need, but not an emergency medical condition.”

Several commenters suggested that only those urgent care centers that are functioning and holding themselves out to the public as an emergency department should be considered a dedicated emergency department for purposes of EMTALA.

Response:

We believe it would be very difficult for any individual in need of emergency care to distinguish between a hospital department that provides care for an “urgent need” and one that provides care for an “emergency medical condition” need. Indeed, to CMS, both terms seem to demonstrate a similar, if not exact, functionality. Therefore, we are not adopting the commenters' suggestion to except urgent care centers from dedicated emergency department status. As we have discussed above, if the department or facility is held out to the public as a place that provides care for emergency medical conditions, it would meet the definition of dedicated emergency department. An urgent care center of this kind would fall under this criterion for dedicated emergency department status.

Although not specifically stated in a comment, an underlying issue is that urgent care centers, participating in Medicare through a hospital, and which operate as satellite facilities off the main hospital campus, would meet the current definition of a dedicated emergency department, but would generally not have the capacity on site to treat patients who had been screened and determined to have serious emergency conditions. In this situation, some might argue that it would be inappropriate for such a facility to refer a patient in an unstable condition to the main hospital campus (which could be 30 miles or more away and involve a lengthy ambulance ride) rather than to a nearby hospital that would be able to treat a patient.

Both under past and current rules, a transfer from an urgent care center to a nonaffiliated hospital is allowed under EMTALA where the facility at which the individual presented cannot stabilize the individual and the benefits of transfer exceed the risks of transfer and certain other regulatory requirements are met. Thus, our rules permit a satellite facility covered under the definition of dedicated emergency department, in this example, to screen and determine whether the case is too complex to be treated on site, that a lengthy ambulance ride to an affiliated hospital would present an unacceptable risk to the individual, and then conclude that the benefit of transfer exceeds the risk of transfer. In this case, the satellite facility could then transfer the individual to an appropriate nearby medical facility.

9. Evaluation and Treatment Issue

Comment:

One commenter was concerned about the “evaluation

and

treatment” aspect of our proposed “dedicated emergency department” definition, and suggested that the reference to evaluation would make the definition overly inclusive, since an ambulatory clinic might have no patients

treated

as emergencies, but many

evaluated

(and ruled out) for emergencies. The commenter believed that part of

any

prudent ambulatory practice is to consider first the possibility of an emergency with

all

patients who are seen. The commenter suggested dropping the “evaluation and” portion of the definition to rely exclusively on an area's treatment of actual emergencies as the criterion.

Response:

We agree that reference to evaluation may make the definition of “dedicated emergency department” overly inclusive, in that it would count any individuals coming to emergency rooms who are evaluated but not treated for such conditions to rule out emergency medical conditions. Therefore, we are limiting the objective criterion in the third part of the “dedicated emergency department” definition in this final rule to a department or facility that provides at least one-third of all its outpatient visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment.

10. Prudent Layperson Observer Standard

Comment:

Two commenters expressed opposing opinions regarding our language at 67 FR 31477 of the preamble portion of the proposed rule that stated that the definition of “dedicated emergency department” would also be interpreted to encompass those off-campus hospital departments that would be perceived by a prudent layperson as appropriate places to go for emergency care. One commenter believed that while the prudent layperson standard makes sense as it relates to the assessment of an individual's

medical condition,

it is less appropriate with respect to an individual's assessment of an appropriate

site of service.

The commenter stated that such assessments would likely vary, depending on factors such as perceived seriousness of the individual's condition, and urged CMS to adopt an objective test to avoid the uncertainty inherent in a “prudent layperson standard” for determinations of dedicated emergency department status.

Another commenter supported our proposed adoption of the “prudent layperson standard” in determining whether a facility is a dedicated emergency department and stated that the prudent layperson standard is preferable to the “significant portion of the time” or “regularly” definitions or standards.

Response:

We believe that our revised definition of “dedicated emergency department” specified under section VII.D. of this final rule establishes an objective standard of determination. For instance, we believe it is an objective standard of dedicated emergency department status whether or not an emergency department is licensed by the State. We also believe that it is an objective standard if a hospital department holds itself out to the public as providing emergency care.

We understand the comment concerning an individual's assessment of an appropriate site of service. However, in view of the revised “dedicated emergency department” definition we are adopting in this final rule, we believe the prudent layperson standard is unnecessary for assessment of an area of the hospital as a dedicated emergency department. We believe our revised criteria for such status will permit the status of departments or facilities to be objectively determined.

11. Specially Equipped and Staffed Area

Comment:

Several commenters addressed the “specially equipped and staffed area of the hospital” part of the proposed definition of “dedicated emergency department.” One commenter, a hospital, stated that it has a main campus and several off-site locations, all of which are considered departments of the hospital and that none of these off-site departments are dedicated to the provision of emergency care. They also indicated that none of the staff at these off-campus departments are qualified to provide such care. One commenter believed our definition of “dedicated emergency department” should incorporate a provision that staff be specially trained in providing emergency medical care.

Another commenter requested that we clarify the terms “specialized staff” and “specialized equipment” in the proposed “dedicated emergency department” definition. The commenter suggested that “true” emergency departments have coding equipment and coding staff who know how to assign appropriate billing codes.

Several commenters believed that we should clarify that CMS will apply EMTALA only if a site is functioning as a dedicated emergency department. Another commenter stated that the obligations of EMTALA should apply to those hospital departments or other off-site locations that provide “traditional” emergency department services.

Response:

As we explained earlier, based on our review of comments on the proposed definition of “dedicated emergency department,” we are adopting an alternative definition of that term that does not include a reference to special equipment or staffing. Therefore, we have not attempted to further define “specialized staff” or “specialized equipment” in this final rule.

We agree with the latter comments, but the range of comments received on the definition of a dedicated emergency department included in our proposed rule illustrates that there are varying differences in opinion as to what “functioning as a dedicated emergency department” and “traditional emergency department services” mean. Therefore, we do not believe these phrases alone are sufficient to define a dedicated emergency department. EMTALA applies not only to dedicated emergency departments but also to presentments for emergency care anywhere on hospital property.

Comment:

One commenter brought to our attention a contradiction in the preamble to the proposed rule when we discuss the definition of “dedicated emergency department” at 67 FR 31472. On the one hand, the commenter recognized that we proposed to define “dedicated emergency department” as an area that is “specially staffed and equipped” for emergency care and that “is used a significant portion of the time” for evaluation of patients for emergency medical conditions. However, the commenter pointed out that, in the same paragraph, CMS proposed that EMTALA applicability also be extended to hospital departments “that are held out to the public as an appropriate place to come for medical services on an urgent, nonappointment basis.” Because the “held out to the public” test was not included in the proposed regulation text, the commenter requested clarification on this point.

One commenter believed that only an area of the hospital with an “Emergency” sign or a “well-accepted synonym in its title” should be impacted by the EMTALA regulations.

Response:

As noted earlier, and as explained more fully in section VII.D. of this preamble, we are adopting a revised definition of “dedicated emergency department” that does not reference special equipment or staffing, but does recognize departments or facilities that are held out to the public as places that provide care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment. We believe this revised definition will resolve any uncertainty about the “held out to the public” test.

We agree that use of the term “emergency” or a well-recognized synonym in a facility's signage would help to identify how the facility is held out to the public and will keep this comment in mind as we develop interpretative guidelines for EMTALA surveys. However, we are not including the suggested language in the final rule because we are concerned that it could be overly prescriptive.

12. Unscheduled Appointments Criterion

Comment:

Several commenters addressed the issue of defining dedicated emergency department as one that accepts unscheduled appointments. One commenter suggested that the definition of “dedicated emergency department” should focus on why the patient is present at the hospital's emergency department. The commenter suggested that the definition should include any location that the hospital holds out as open to evaluate patients seeking unscheduled evaluation or treatment for a medical condition.

Similarly, another commenter recommended that we revise the definition of dedicated emergency department to state that it is a specially

equipped and staffed area of the hospital that is primarily dedicated to “unscheduled” evaluation and treatment of outpatients for emergency medical conditions.

One commenter suggested that our proposed definition of dedicated emergency department be revised to specify that departments of the hospital that accept walk-in or unscheduled patients for assessment are deemed to be dedicated emergency departments for the purposes of EMTALA. The commenter stated that this definition would exempt routine clinics or hospital-based physician offices that function on an appointment-only basis, administrative areas, inpatient units, and laboratory areas that provide testing but do not provide assessment or diagnosis services for patients.

Another commenter asked us to include places that are “held out to the public as an appropriate place to come for medical services on an urgent, nonappointment basis' under the definition of dedicated emergency department. This suggestion would include the labor and delivery department of a hospital, but would exclude outpatient clinics that permit “walk-in patients”, according to the commenter.

The commenter suggested that “dedicated emergency department” be defined as any area of the hospital that provides more than 10 percent of its nonscheduled patients treatment for outright emergencies.

Response:

We agree that the practice of accepting patients without requiring appointments is an important indicator of emergency department status. After consideration of all of the comments on this issue, we are adopting in this final rule a criterion in the definition of “dedicated emergency department” that permits a department or facility to be considered a dedicated emergency department if it is held out to the public as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment.

13. Related Definition of “Hospital With an Emergency Department”

Comment:

One commenter requested that we amend the proposed regulatory text at § 489.24(a), consistent with our proposed definition of “dedicated emergency department,” to state that EMTALA requirements apply to a hospital that has

a dedicated

emergency department. Other commenters suggested that our proposed definition of “hospital with an emergency department” at § 489.24(b) should either be deleted or revised so that it is defined as a “hospital with a dedicated emergency department,” to make it consistent with our definition of “dedicated emergency department.”

Response:

We considered the suggestion that we amend the “Application” paragraph of § 489.24(a) to limit EMTALA applicability to hospitals with dedicated emergency departments. However, “hospital with an emergency department” is a term of art from section 1867 of the Act that we have separately included in the definitions under § 489.24(b) to mean generally “a hospital that offers services for emergency medical conditions.” Thus, we believe it would be preferable to keep the statutory language “hospital with an emergency department” in the Application section in the regulation text. To clarify our policy in this area, we are revising the definition of “Hospital with an emergency department” under § 489.24(b) to state that it means a hospital with a dedicated emergency department as defined in § 489.24(b).

14. Other Related Suggested Revisions

Comment:

One commenter recommended that the last sentence in proposed paragraph (1) of the definition of “Comes to the emergency department” in § 489.24(b) be revised to read:

“In the absence of such a request by or on behalf of the individual, a request on behalf of the individual will be considered to exist if a prudent layperson observer would believe, based on the individual's appearance or behavior, that the individual needs examination or treatment for an

emergency

medical condition.” [New language is underlined.]

(As proposed, this definition would require only that the prudent layperson observer believe that the individual needs examination or treatment for a

medical

condition.)

Response:

Section 1867 of the Act requires a hospital to provide examination and necessary stabilizing treatment to any individual who “comes to the hospital” for emergency care. We are interpreting this statutory requirement to mean that individuals who present to areas of the hospital other than departments that are labeled “Emergency” must receive care from the hospital. We believe we have clarified this requirement in prior rulemakings and in the proposed rule. However, we are including this clarification in this final rule, as well, as part of the revised final definition of dedicated emergency department.

Comment:

One commenter stated that if the proposed rules are adopted as final, on-call physicians and hospitals will refuse to accept transfers if the transfers will be received through the hospital dedicated emergency department. The commenter believed that if we apply EMTALA to patients admitted via the dedicated emergency department, it will create “perverse incentives” for hospitals and physicians to avoid admitting patients through the dedicated emergency department. The commenter stated: “On-call physicians will be reluctant to agree to accept patients for admission through the ED because then their stabilizing care of the patient in the hospital will subject them to civil monetary penalties and civil liability under EMTALA.”

Response:

It is a statutory requirement under section 1867(g) of the Act that receiving hospitals with special capabilities

must

accept the transfer of an individual with an unstable emergency medical condition. The receiving hospitals must accept the patients whether or not they are received through that hospital's dedicated emergency department—the EMTALA obligation for the receiving hospital transfers with the individual until the condition has been stabilized. Therefore, we do not believe on-call physicians and hospitals would refuse to accept transfers if the transfers are being received through the hospital dedicated emergency department, as the commenter believed. In particular, we hold this view because the EMTALA obligation is incurred at the time of arrival of the individual in accordance with an appropriate transfer, regardless of which door the individual enters or whether he or she is admitted immediately to the receiving hospital.

D. Provisions of the Final Rule Regarding Clarification of “Come to the Emergency Department”

For the reasons discussed throughout section VII. of this preamble, and after full consideration of the public comments received—

We are adopting as final the proposed organizational changes to § 489.24(a) on the application of EMTALA to include both the screening and stabilization or transfer requirements. (We note that later in this preamble under section X., we make an additional change to paragraph (a) to clarify that if the hospital admits the individual as an inpatient for further treatment after screening, the hospital's obligation under EMTALA ends.)

We are adopting paragraphs (1) and (2) under the proposed definition of “come to the emergency department” as final without changes.

We are revising the proposed definition of “dedicated emergency department” at § 489.24(b), to read as follows:

“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 meets at least one of the following requirements:

(1) It is licensed by the State in which it is located under applicable State law as an emergency room or emergency department;

(2) It 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, it provided at least one-third of all its outpatient visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment.

We believe this revised definition of “dedicated emergency department” sufficiently addresses many of the suggested proposals submitted by the commenters on determining what is an emergency department for purposes of EMTALA.

We are revising the proposed definition of “hospital with an emergency department” to make it consistent with our revised definition of “dedicated emergency department.”

VII. Applicability of EMTALA: Individuals Come to the Dedicated Emergency Department for Nonemergency Services (§ 489.24(c))

A. Background

We sometimes receive questions whether EMTALA's requirements apply to situations in which an individual comes to a hospital's dedicated emergency department, but no request is made on the individual's behalf for emergency medical evaluation or treatment. In view of the specific language of section 1867 of the Act and the discussion in section VII. of this preamble, which addresses the definition of a hospital's dedicated emergency department, we believe that a hospital must be seen as having an EMTALA obligation with respect to any individual who comes to the dedicated emergency department, if a request is made on the individual's behalf for examination or treatment for a medical condition, whether or not the treatment requested is explicitly for an emergency condition. A request on behalf of the individual would be considered to exist if a prudent layperson observer would believe, based on the individual's appearance or behavior, that the individual needs examination or treatment for a medical condition.

This does not mean, of course, that all EMTALA screenings must be equally extensive. The statute plainly states that the objective of the appropriate medical screening examination is to determine whether or not an emergency medical condition exists. Therefore, hospitals are not obligated to provide screening services beyond those needed to determine that there is no emergency medical condition.

In general, a medical screening examination is the process required to reach, with reasonable clinical confidence, a determination about whether a medical emergency does or does not exist. We expect that in most cases in which a request is made for medical care that clearly is unlikely to involve an emergency medical condition, an individual's statement that he or she is not seeking emergency care, together with brief questioning by qualified medical personnel, would be sufficient to establish that there is no emergency condition and that the hospital's EMTALA obligation would thereby be satisfied.

B. Provisions of the Proposed Rule

To clarify our policy in this area, in the May 9, 2002 proposed rule (67 FR 31473), we proposed to redesignate paragraphs (c) through (h) of § 489.24 as paragraphs (d) through (i) (we proposed to remove existing paragraph (i)) and to add a new paragraph (c) to state that if an individual comes to a hospital's dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an “emergency medical condition” as defined in the regulations. (In the May 9, 2002, proposed rule, we included an Example 1 as illustrative of application of this policy (67 FR 31473).)

C. Summary of Public Comments and Departmental Responses

Comment:

Many commenters addressed our proposed clarification of presentments of individuals to dedicated emergency departments for nonemergency services at 67 FR 31473. One commenter stated that only those individuals requesting a “medical examination” be required to receive a medical screening examination by a physician or other qualified medical personnel. Another commenter recommended that EMTALA not apply to requests for nonemergency care inside the dedicated emergency department. One commenter believed that EMTALA should not apply to individuals coming to the dedicated emergency department to obtain previously scheduled or followup care.

Response:

At 67 FR 31473,

et seq.

, of the preamble to the May 9, 2002 proposed rule, and also above, we explicitly clarified the issue concerning when an individual comes to a hospital's dedicated emergency department but no request is made on the individual's behalf for emergency medical evaluation or treatment. To address this scenario, we stated that hospitals are not obligated to provide screening services beyond those needed to determine whether an emergency medical condition exists. In addition, we proposed regulatory language to address the issue (proposed § 489.24(c)) to specify that if an individual comes to a hospital's dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. Therefore, while EMTALA

does

apply to any individual who presents to a hospital's dedicated emergency department with a medical condition, it does so only to the extent that the individual must be screened for emergency medical conditions and supplied necessary stabilizing treatment.

Section 1867(a) of the Act clearly states that a hospital with an emergency department is required to provide an appropriate medical screening examination to every individual who presents at the hospital's emergency department with a medical condition. However, this screening is only necessary to the extent it takes the hospital to determine whether the individual has an emergency medical condition. Once the individual is screened and it is determined the individual has only presented to the dedicated emergency department for a

nonemergency purpose, such as followup care, the hospital's EMTALA obligation ends for that individual at the completion of the medical screening examination.

Comment:

One commenter noted that, in many cases, individuals come to the dedicated emergency department of the hospital at which their regular physician practices and ask to be seen for nonemergency medical conditions that could appropriately be treated in the physician's office. The commenter asked whether, in these circumstances, a registered nurse or other qualified medical person on duty at the dedicated emergency department could perform a screening to rule out the presence of an emergency medical condition and, if it is determined that the patient does not have an emergency medical condition, refer the patient to the physician's office for treatment.

Another commenter stated that we should provide more guidance to allow busy emergency departments to refer patients without an “emergency medical condition” to primary care or specialty care clinics, or both.

Response:

As stated in proposed § 489.24(c), if an individual comes to a dedicated emergency department and a request is made for examination or treatment of a medical condition, but the nature of the request makes it clear that the condition is not of an emergency nature, the hospital is required to perform only such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. Under the circumstances described by these commenters, the regulations would not require that such screening be done by a physician. On the contrary, we believe the individual could be screened by the appropriate nonphysician emergency department staff and, if no emergency medical condition is found to exist, referred to his or her physician's office for further treatment. Because we believe that proposed paragraph (c) clearly would permit such a referral, we do not believe a further regulations change is needed in this final rule to clarify this point. We note that while EMTALA does not require that all screenings be performed by an M.D. or D.O., any nonphysician (such as an emergency room registered nurse) who performs such screening should be an individual whom the hospital has designated as a “qualified medical person” for purposes of appropriate transfer certification under § 489.24(d)(1)(ii)(C) (redesignated in this final rule as § 489.24(e)(1)(ii)(C)).

Comment:

Many commenters believed that the final rule should make clear that EMTALA does not apply to nonemergency services delivered in a dedicated emergency department and does not apply to a site other than a dedicated emergency department unless emergency services are requested.

Similarly, several commenters requested that we clarify that a hospital has no obligation under EMTALA to an individual who presents at a dedicated emergency department but does not request examination or treatment for a medical condition. Specifically, one commenter believed that we should clarify that hospitals are not required under EMTALA to provide medical screening examinations to individuals who request a medical service that is not examination or treatment for a medical condition, such as preventive care services, pharmaceutical services, or medical clearances for law enforcement purposes (such as blood alcohol tests required by police).

Response:

We agree that a hospital has no obligation under EMTALA to an individual who comes to a dedicated emergency department if there is no request made by or on behalf of the individual for examination or treatment for a medical condition, and the individual's appearance or behavior would not cause a prudent layperson observer to believe that examination or treatment for a medical condition is needed and that the individual would request that examination or treatment if he or she were able to do so. We do not agree that a hospital has no obligation under EMTALA to an individual who presents at a dedicated emergency department for “nonemergency purposes” because such a purpose can be a medical one and the statute requires that a hospital perform a medical screening examination to any individual who presents to the emergency department with a medical condition. We agree with another commenter that if an individual presents to a dedicated emergency department and requests services that are not examination or treatment for a medical condition, such as preventive care services, the hospital is not obligated to provide a medical screening examination under EMTALA to this individual.

We note that pharmaceutical services in a dedicated emergency department may be for medical conditions and are, therefore, subject to EMTALA. We also wish to emphasize that the applicable principle is that presentments to a dedicated emergency department that meet other applicable criteria for EMTALA applicability will be considered to be subject to EMTALA if there is a request by or on behalf of the individual for examination or treatment for a medical condition, or the appearance or behavior of the individual would cause a prudent layperson observer to believe that the individual needed such examination or treatment and that the individual would request that examination or treatment if he or she were able to do so. Under this general principle, we will evaluate specific presentments, including requests by law enforcement authorities for medical clearance of persons who are about to be incarcerated or for blood alcohol or other tests to be used as evidence in criminal proceedings, on a case-by-case basis.

For example, an individual being maintained on psychotropic medication may come to an emergency department and complain of experiencing suicidal or homicidal urges because he or she has exhausted his or her supply of medication. If examination of the individual verifies the existence of an emergency medical condition and a supply of the patient's normal medication is required to stabilize that condition, then EMTALA would require that the hospital provide that medication. Of course, this does not mean that hospitals are required by EMTALA to provide medication to patients who do not have an emergency medical condition, simply because the patient is unable to pay or does not wish to purchase the medication from a retail pharmacy. We will address these types of issues in our interpretative guidelines.

Comment:

One commenter noted that the issue of nonemergency patient care that takes place in the dedicated emergency department and overcrowding is a significant concern. The commenter stated that education aimed at the public by CMS to help them understand appropriate alternatives could contribute to reducing abuse.

Response:

We agree that it is worthwhile to encourage patients to seek more appropriate sources of nonemergency care, and will take this into account as we develop EMTALA-related patient information and education material.

Comment:

One commenter described a situation where hospitals use their emergency departments as an access point for registration purposes for the entire hospital after the normal registration area is closed. The commenter asked whether every individual would be covered under EMTALA and would require a medical screening even though not everyone is

coming to the emergency department seeking emergency medical treatment.

Similarly, another commenter stated that some hospitals, particularly rural ones, have found that it is most cost-effective for the hospital if it was configured to have one hospital entrance for patients who present for emergency care and for patients who do not present for emergency care. The commenter requested clarification on whether an EMTALA screening would be required for both types of patients who walk through that one entrance.

One commenter described a situation where a hospital operates ambulatory care centers and other facilities (such as primary care clinics) in tandem with the hospital's dedicated emergency department. The commenter believed the nondedicated emergency department of the hospital should be explicitly excepted from the definition of “dedicated emergency department” to address this “tandem” scenario.

Response:

Regarding the first two comments, we agree that EMTALA does not apply to individuals who may pass through a hospital's emergency department but do not request examination or treatment for a medical condition, have such a request made on their behalf, or indicate through their appearance or behavior that examination or treatment for a medical condition would, in the judgment of a prudent layperson, be needed. We have not revised the final rule on this point, but intend to take it into account in developing interpretative guidelines and training materials for EMTALA surveyors. The third comment does not raise an issue of EMTALA policy, but merely shows that it will be necessary in some cases to determine exactly which physical locations constitute a hospital's dedicated emergency department. Such decisions will be made a case-by-case basis by CMS, based on information provided by the State survey agency.

Comment:

One commenter suggested that we define whether there has been a request for examination or treatment under EMTALA by the resources that it would take to fulfill the request. The commenter gave an example of a request for unscheduled medical services that would require the service of a “qualified medical provider.” The commenter stated that a request to take out stitches does not require a doctor or consultation with a doctor unless there is an additional complaint expressed.

Response:

While this is an interesting suggestion, we believe that it is one that would be difficult to implement as an objective standard, because estimates of resources needed will necessarily be subjective. Therefore, we are not revising the final rule based on this comment.

Comment:

One commenter believed that the standard stated at proposed § 489.24(c), “the nature of the request makes it clear the medical condition is not of an emergency nature”, is too subjective. The commenter believed it would almost certainly invite State surveyors to second guess the determination of the qualified medical person.

Response:

The purpose of conducting an EMTALA investigation is to ascertain whether or not the hospital has violated the requirements of § 489.24 or the related requirements of § 489.20. The survey is conducted in accordance with applicable CMS survey procedures and policies. The surveyor's recommendation of a violation determination is based on facts uncovered by the onsite investigation. The CMS regional office will make the final compliance determination with information obtained after the onsite investigation by the State survey agency.

Comment:

Several commenters believed that triage of the individual presenting to the dedicated emergency department should be adequate for purposes of fulfilling EMTALA screening obligations. Specifically, one commenter did not believe that EMTALA should apply to individuals who present to the dedicated emergency department with no “significant distress or risk” as determined by triage of vital signs, and “who are comfortable and active” in a waiting area whereby they are well provided for while they are waiting for care or treatment.

Another commenter asked us to clarify whether vital signs must be obtained in every medical screening examination upon presentment to a hospital's dedicated emergency department.

Response:

Section 1867(a) of the Act requires that individuals coming to the emergency department be provided a medical screening examination. The statute states:

“In the case of a hospital that has a hospital emergency department, if any individual (whether or not eligible for benefits under this title) comes to the emergency department and a request is made on the individual's behalf for examination or treatment for a medical condition, the hospital must provide for an appropriate medical screening examination within the capability of the hospital's emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition (within the meaning of subsection (e)(1)) exists.”

Triaging is not equivalent to a medical screening examination. Triaging merely determines the “order” in which patients will be seen, not the presence or absence of an emergency medical condition. If the medical screening examination is appropriate and does not reveal an emergency medical condition, the hospital has no further obligation under § 489.24.

The decision to take vital signs may be required by the qualified medical professional or the hospital's emergency department's policies and procedures, or both. Vital signs are indicators of a patient's level of wellness and are valuable parameters to assist health professionals in making medical decisions concerning a patient's health needs. The patient's medical condition and the discretion of the practitioner will determine the need for monitoring of vital signs.

We do not believe the taking of a patient's vital signs is required for every presentment to a hospital's dedicated emergency department. As we have stated above, we expect that, in most cases in which a request is made for medical care that clearly is unlikely to involve an emergency medical condition, an individual's statement that he or she is not seeking emergency care, together with brief questioning by qualified medical personnel, would be sufficient to establish that there is no emergency medical condition and the hospital's EMTALA obligation would thereby be satisfied.

Comment:

One commenter requested that we modify proposed § 489.24(c) to provide that EMTALA imposes no minimum requirements for conducting medical screening examinations for cases falling within this paragraph. The commenter stated that the extent of the necessary examination is within the sole discretion of the qualified medical personnel performing the examination.

Response:

As required by statute, we believe that a hospital

must

be seen as having an EMTALA obligation with respect to any individual who comes to the dedicated emergency department for examination or treatment for a medical condition. While we will refrain from dictating what type of medical screening examination is required for each individual who presents to the dedicated emergency department, we believe that such screenings should be provided to each individual commensurate with the condition that is presented. As we have stated previously, this does not mean that all EMTALA screenings must be equally extensive. Hospitals are not obligated to

provide screening services beyond those needed to determine that there is no emergency medical condition.

We agree with the commenter that the extent of the necessary examination is generally within the judgment and discretion of the qualified medical personnel performing the examination. However, we note that the extent and quality of the screening by the qualified medical personnel are subject to review (by QIOs and State surveyors, for example), in the case of a complaint filed in accordance with section 1867 of the Act.

Comment:

One commenter expressed concern about enforcement of the standard stated in proposed § 489.24(c). The commenter was concerned with the scenario in which it is later determined that an individual who had presented to the dedicated emergency department for such medical treatment as suture removal (as used in the example at 67 FR 31473) was, in fact, suffering from an emergency medical condition, and this emergency medical condition was not detected during this less extensive examination.

Response:

As we stated in the proposed rule, hospitals are not obligated to provide screening services in the dedicated emergency department beyond those needed to determine that there is no emergency medical condition. We assume that qualified medical personnel or physicians will be performing the medical screening examination (however modified for the condition presented) to determine whether the individual is suffering an emergency medical condition. If it is later found that the individual

had

been suffering an emergency medical condition upon presentment to the dedicated emergency department but only asks for examination or treatment for the suture removal, or some lesser medical condition, and a complaint is filed for an alleged dumping in accordance with section 1867 of the Act, as stated above, the extent and quality of the screening by the qualified medical personnel would be subject to review by State surveyors to permit a determination to be made as to whether there was an EMTALA violation. We note that if, upon investigation of the alleged dumping, it is found that an adequate medical screening had been performed, the hospital would not be found liable under EMTALA.

Comment:

One commenter asked why CMS needed to add a new § 489.24(c) to reinforce the requirement that all visits to the emergency department triggers EMTALA obligations, whether the individual is requesting emergency services or coming for nonemergency services. The commenter indicated that “any individual” who comes to the emergency department requesting care is already covered by EMTALA.

Another commenter stated that the real issue is when a hospital is required to perform a medical screening examination and when it is

not

required to perform one. The commenter indicated that staff of hospital emergency departments should be able to ask patients why they have come to the emergency department.

Response:

In proposed § 489.24(c), and accompanying language in the preamble at 67 FR 31473, we attempted to provide some guidance to hospitals and physicians as to whether EMTALA's requirements apply to situations in which an individual comes to a hospital's dedicated emergency department, but no request is made for emergency medical evaluation or treatment. While we have repeatedly stated that we are refraining from dictating to hospitals standards for medical screening examinations, we hoped to address some concerns in the provider community that all EMTALA screenings must be equally extensive to each individual who presents to the dedicated emergency department. Rather, once an individual states that he or she is not at a hospital's dedicated emergency seeking emergency care as the commenter suggested, some brief questioning by qualified medical personnel of why the individual is there would be adequate to fulfill the requirements of the medical screening examination for purposes of EMTALA.

Comment:

One commenter asked for clarification on whether EMTALA applies to individuals who seek outpatient services from the hospital on an unscheduled basis; for example, when an individual's physician directs the individual to go to the hospital to obtain laboratory and x-rays so that the physician may determine whether the individual has pneumonia or another condition.

Response:

As explained elsewhere in this preamble, whether EMTALA applies to a specific individual will depend on whether the individual presents to the hospital's dedicated emergency department or to another area of the hospital, and on what type of request for examination or treatment is made. For example, an individual being sent to a hospital for specific diagnostic tests ordered by a physician outside the hospital would normally be directed by that physician to go to the hospital's laboratory and radiology department, not to the dedicated emergency department. In either setting, a simple request for a diagnostic test or image generally would not be considered a request for examination or treatment for what may be an emergency medical condition, so the hospital would have no EMTALA obligation to that individual. However, if the individual were to tell the hospital staff at the laboratory or radiology department that he or she needed emergency care, EMTALA would apply. EMTALA also would apply if, in the absence of a verbal request, the individual's appearance or behavior were such that a prudent layperson observer would believe the individual needed examination or treatment for an emergency medical condition and that the individual would request that examination or treatment if he or she were able to do so. Of course, in any actual complaint investigation, the State survey agency and, where appropriate, the QIO would review all actual relevant facts and circumstances to ensure that the regulations are applied appropriately in that case.

Comment:

One commenter was concerned with the example at 67 FR 31473 of the proposed rule of a woman presenting to a hospital's emergency department with a request for suture removal. The commenter asked for information on the location of the outpatient clinic to which the qualified medical nurse refers the woman for the suture removal after the nurse screens the woman for any emergency medical conditions and also the timing of the clinic's evaluation. The commenter also stated that it would be helpful to clarify that “same-day on-campus referral” to another medical facility outside the dedicated emergency department is not mandatory for EMTALA purposes.

Response:

By the commenter's request for information about the location of the outpatient clinic to which the patient is referred, we assume the commenter is interested in whether the outpatient clinic in the example is a department of the hospital (that is, provider-based). We do not see this as a particularly relevant fact, nor do we see the issue of timing of that outpatient clinic's evaluation to the issue of the applicability of EMTALA to that patient on the part of the hospital.

However, we do believe that it would not be an

EMTALA

obligation for the qualified medical nurse in the example to make the referral to the outpatient clinic upon finding that the woman does not have an emergency medical condition. Nevertheless, it would appear to us that good standards of practice would dictate that any qualified medical personnel screening the patient would refer the patient elsewhere for treatment of her obvious medical

condition, rather than simply sending her out of the emergency department upon finding that she did not have an emergency medical condition.

D. Provisions of the Final Rule

We are adopting, as final, the proposed provisions under § 489.24(c).

VIII. Applicability of EMTALA: Individual Presents at an Area of the Hospital's Main Campus Other Than the Dedicated Emergency Department (§ 489.24(b))

A. Background

Routinely, individuals come to hospitals as outpatients for many nonemergency medical purposes. If such an individual initially presents at an on-campus area of the hospital other than a dedicated emergency department, we would expect that the individual typically would not be seeking emergency care. Under most of these circumstances, EMTALA would therefore not apply (this concept is further discussed in section IX.B. of this preamble). However, questions have arisen as to whether a hospital would incur an EMTALA obligation with respect to an individual presenting at that area (that is, an on-campus area of the hospital other than a dedicated emergency department) who requests examination or treatment for what is believed to be an emergency medical condition, or had such a request made on his or her behalf.

B. Provisions of the Proposed Rule

In the May 9, 2002 proposed rule (67 FR 31473 and 31506), we proposed to specify in the regulations (§ 489.24(b), definition of “come to the emergency department”) that, for an individual who presents on hospital property other than the dedicated emergency department and requests examination or treatment for what may be an emergency medical condition, a request would be considered to exist if the individual requests examination or treatment for what the individual believes to be an emergency medical condition. We further explained that if there is no actual request, for example, if the individual is unaccompanied and is physically incapable of making a request, the request from the individual would be considered to exist if a prudent layperson observer would believe, based upon the individual's appearance or behavior, that the individual needs treatment for an emergency medical condition. We stated that the proposed policy was appropriate because section 1867 protections should not be denied to those individuals whose need for emergency services arises upon arrival on hospital property at the hospital's main campus, but before they have presented to the dedicated emergency department.

Under the proposed policies, a request for examination or treatment by an individual presenting for what is believed to be an emergency medical condition at an on-campus area of the hospital other than the dedicated emergency department would not have to be expressed verbally in all cases. In some cases, the request may be inferred from what a prudent layperson observer would conclude from an individual's appearance or behavior. While there may be a request (either through the individual or a prudent layperson), thereby triggering an EMTALA obligation on the part of the hospital, this policy does not mean that the hospital must maintain emergency medical screening or treatment capabilities in each department or at each door of the hospital, nor anywhere else on hospital property, other than the dedicated emergency department.

Our proposal, and the considerations on which it is based, are further discussed in the preamble to the May 9, 2000 proposed rule (67 FR 31473). We also specifically solicited comments from hospitals and physicians on examples of ways in which hospitals presently react to situations in which individuals request emergency care in areas of the hospital other than the hospital's emergency department.

In the May 9, 2002 proposed rule, we also proposed that EMTALA would not apply to an individual who experiences what may be an emergency medical condition if the individual is an outpatient (as that term is defined in 42 CFR 410.2). We explained that we would consider such an individual to be an outpatient if he or she has begun an encounter (as that term is defined in 42 CFR 410.2) with a health professional at the outpatient department. Because such individuals are patients of the hospital already, we believe it is inappropriate that they be considered to have “come to the hospital” for purposes of EMTALA. However, we note that such an outpatient under our proposal who experiences what may be an emergency medical condition after the start of an encounter with a health professional would have all protections afforded to patients of a hospital under the Medicare hospital CoPs (as discussed in section XIV. of the preamble). Hospitals that fail to provide treatment to these patients could face termination of their Medicare provider agreements for a violation of the CoPs. In addition, as patients of a health care provider, these individuals are accorded protections under State statutes or common law (for example, State malpractice law and patient abandonment torts) as well as under general rules of ethics governing the medical profession. Our proposal, and the considerations on which it is based, are further discussed in the preamble to the May 9, 2002 proposed rule (67 FR 31473 through 31474).

In the proposed rule, we also proposed to retitle the definition of “property” at § 489.24(b) to “hospital property” and relocate it as a separate definition. In addition, we proposed to clarify which areas and facilities are not considered hospital property.

C. Summary of Public Comments and Departmental Responses

1. Presentation Outside the Dedicated Emergency Department

Comment:

Regarding our proposed clarifications on the applicability of EMTALA for presentments on hospital property outside the dedicated emergency department, one commenter believed that, while the clarifications were necessary, “it is perhaps a sad indictment of our healthcare system that we actually have to mandate medical providers that someone unconscious must receive immediate medical care. * * * Anyone doing this sort of denial of care deserves more than an EMTALA citation.” Many other commenters expressed concern about the absence from the proposed regulatory text of qualifying language that is set forth in the preamble of the proposed rule. Specifically, one commenter cited the proposed preamble language at 67 FR 31473 that states:

“* * * EMTALA is triggered in on-campus areas of the hospital other than a dedicated emergency department where, in an attempt to gain access to the hospital for emergency care, an individual comes to a hospital and requests an examination or treatment for a medical condition that may be an emergency.” (Emphasis added.) The commenter further cited the preamble at 67 FR 31474:

“We are proposing that EMTALA would not apply to * * * an individual who * * * experiences what may be an emergency medical condition

if the individual is an outpatient

(as that term is defined at 42 CFR § 410.2)

who has come to the hospital outpatient department for the purpose of keeping a previously scheduled appointment.

We would consider such an individual to be an outpatient if he or she has

begun an encounter

(as that term is

defined at § 410.2) with a health professional at the outpatient department.” (Emphasis added.)

The commenter then compared this language in the preamble to the proposed regulatory text at § 489.24(b) that would hold a hospital accountable under EMTALA when an individual has presented on hospital property other than a dedicated emergency department, “and requests examination or treatment for what may be an emergency medical condition, or has such a request made on his or her behalf. * * *” The commenter was concerned that neither of the preamble's purported tests for EMTALA's applicability outside of the dedicated emergency department that are quoted above is referenced in the proposed regulatory text: neither the test of whether the individual came to the hospital in an attempt to gain access to the hospital for emergency care, nor the objective test of whether the patient has begun an encounter with a health professional at the outpatient department. This commenter believed that the regulatory text should be revised to clearly state that EMTALA is not applicable to outpatients who have initiated an encounter with a health professional in a hospital outpatient department other than a dedicated emergency department.

Another commenter suggested that we substitute the term “member of the public” for “outpatients” in the definition of dedicated emergency department (“a dedicated emergency department would mean a specially equipped and staffed area of the hospital that is used a significant portion of the time for the initial evaluation and treatment of

outpatients

for emergency medical conditions”). The commenter believed that the clear implication of the definition is that an outpatient may be covered under EMTALA, a conclusion that is inconsistent with other provisions in the proposed rule.

Other commenters requested that we clarify that EMTALA would not apply when individuals arrive on the orders of their physicians, such as when a pregnant woman or a psychiatric patient arrives upon a physician's order either for testing or because he or she is in need of immediate medical care. In addition, some commenters believed that CMS should clearly state that only the Medicare hospital CoPs and not EMTALA would apply to individuals with scheduled outpatient appointments or procedures.

Another commenter disagreed with the CMS statement in the preamble to the proposed rule that EMTALA does not apply to “established patients” who need emergency care while on hospital property. The commenter stated that it may be impossible to distinguish such a patient from anyone else experiencing a similar emergency also on hospital property, and was concerned that the concept of excluding an established patient from EMTALA will raise many definitional and logistical issues.

One commenter believed that we intended for EMTALA not to apply in situations where the individual has arrived for an appointment, even if they had not yet been assisted. The commenter urged clarification on this issue.

One commenter stated that there may be occasions where individuals present to the hospital for outpatient services where

no

orders are necessary to provide services to the individual, such as annual mammograms or health fairs. The commenter requested that EMTALA should not apply to individuals in these circumstances.

Response:

As we describe above, in the preamble to the May 9, 2002 proposed rule, we proposed that EMTALA would

not

apply to an individual who experiences what may be an emergency medical condition if the individual is an outpatient (as that term is defined at 42 CFR 410.2) who has come to a hospital outpatient department for the purpose of keeping a previously scheduled appointment. In response to the comments requesting further clarification of the text of the regulations, and in consideration of the role of the Medicare hospital CoPs in protecting the health and safety of hospital outpatients, we are revising the final rule to state that EMTALA does not apply to any individual who,

before

the individual presents to the hospital for examination or treatment for an emergency medical condition, has begun to receive outpatient services as part of an encounter, as defined in 42 CFR 410.2, other than an encounter that the hospital is obligated by EMTALA to provide. We believe this revised language sufficiently encompasses any individuals who come to a hospital to receive nonemergency services and have begun to receive those services. Such individuals would be included under this policy, regardless of whether or not they began the nonemergency encounter in order to keep a previously scheduled appointment or under orders of a physician or other medical practitioner. We also assume that specific mention of outpatient registration is unnecessary in the revised language because we believe all individuals who have begun an encounter under § 410.2 are registered outpatients in the hospital's records. This change is reflected in the revision of the proposed definition of “patient” under § 489.24(b) in this final rule. As we stated in the preamble to the proposed rule, we believe it is inappropriate to consider such individuals, who are hospital outpatients who have protections under the CoPs, to have “come to the hospital” for purposes of EMTALA as well, even if they subsequently experience an emergency medical condition.

We note that individuals who are already patients of a hospital and who experience emergency medical conditions are protected by existing Medicare hospital CoPs. We discuss these CoPs in greater detail in section XIII. of this final rule. Hospitals that fail to provide treatment to these patients could face termination of their Medicare provider agreements for a violation of the CoPs. In the January 24, 2003

Federal Register

(68 FR 3435 through 3436), we describe the process by which we enforce compliance with these CoPs. For example, we explained that if our surveyors discover noncompliance with the hospital CoPs, “the hospital will be scheduled for termination from the Medicare and Medicaid programs.” Thus, for violations of the CoPs, as well as for violations of EMTALA (compliance with which is a Medicare participation requirement) hospitals face the extreme sanction of termination from the Medicare program. In addition, as patients of a health care provider, these individuals are accorded protections under State statutes or common law as well as under general rules of ethics governing the medical professions.

In response to the comment concerning the individual who comes to the hospital for purposes of an annual mammogram or health fair, with or without an order or referral by a physician, that individual is not presenting to the hospital with a particular emergency medical condition. Therefore, EMTALA would not apply. We believe this is consistent with our policy stated elsewhere in this preamble.

Of course, where EMTALA applies to a particular individual who has presented to the hospital for examination or treatment for an emergency medical condition, EMTALA's application does not end just because the individual has begun an outpatient encounter;

only

screening and, where necessary, stabilization, admission for inpatient services, or appropriate transfer end the hospital's EMTALA obligation to the individual (see section VIII. of this preamble for further discussion of the issue of when an EMTALA obligation ends). The fact

that protections under the CoPs may later be afforded to an outpatient who is already protected by EMTALA does not end the individual's EMTALA protection.

In response to the commenter's concern that we incorporate the language regarding coming to the hospital in order “to gain access to the hospital for emergency care” into the regulation text, while in most emergency cases individuals will come to a hospital in order to gain access to emergency care at the hospital, not all emergency patients start out that way. Some individuals may come to the on-campus hospital property for reasons other than to seek medical services for themselves (examples would include a hospital employee, or a visitor of the hospital). Such individuals would not be protected by the hospital CoPs if they happen to experience what may be an emergency medical condition while on hospital property, since they are not hospital patients. Therefore, we are clarifying here that we consider such individuals to have “come to the emergency department.” Under section 1867(a) of the Act, such individuals are protected by EMTALA and hospitals must provide them with screening and necessary stabilizing treatment.

To address the comment concerning the substitution of the term “outpatients” in the proposed definition of “dedicated emergency department”, we mention the comment in this section of the preamble of this final rule because, as the commenter pointed out, it would appear to be inconsistent with our policy in our proposed regulations text at § 489.24 that EMTALA would not apply to any

patient,

as defined in proposed § 489.24(b), who would include “outpatients” as defined at § 410.2, and yet we would use the term “outpatients” in our application of EMTALA for individuals that present at dedicated emergency departments. In addition, we also proposed in the preamble to the proposed rule that EMTALA would not apply to outpatients with emergency medical conditions that arise during an encounter. We are clarifying in this final rule that EMTALA

will

apply to any individual who presents to the hospital for examination or treatment for an emergency medical condition, but EMTALA

will not

apply to individuals who have begun to receive outpatient services as part of an encounter, as defined in § 410.2, other than an encounter that the hospital is obligated by EMTALA to provide.

In this final rule, in response to comments, we are revising our definition of “dedicated emergency department” at § 489.24(b) to specify that such a department is a unit in the hospital that meets at least one of three criteria, one of which is that it is any department or facility of the hospital that provides for the examination or treatment of emergency medical conditions for at least one-third of all of its outpatient visits, based on a representative sample of patient visits for the calendar year immediately preceding the calendar year in which a determination is being made. This revised language avoids using the term “individuals” or “member of the public” and would sufficiently encompass any person, including hospital staff who may become ill, who comes to a hospital's emergency department for medical care.

In addition, we are revising the proposed definition of “patient” under § 489.24(b) to indicate that EMTALA does not apply to an individual who has begun to receive outpatient services as part of an encounter, as defined in § 410.2, other than an encounter that the hospital is obligated by EMTALA to provide.

Comment:

One commenter asked us to clarify whether EMTALA is triggered for an individual who comes to the hospital as an outpatient for a scheduled appointment and who, after treatment has commenced, experiences an emergency medical condition, and is then moved to the dedicated emergency department for treatment. Similarly, the commenter asked whether an individual transported by the hospital to the dedicated emergency department from an off-campus department that is not a dedicated emergency department is an EMTALA patient upon arrival. The commenter asked whether individuals in these two settings should be handled differently.

Response:

As we have described above, in this final rule, we are providing that individuals who have begun to receive outpatient services during an encounter are not protected under EMTALA if they are later found to have an emergency medical condition (even if they are then transported to the hospital's dedicated emergency department). These individuals are considered patients of the hospital and are protected by the Medicare hospital CoPs and relevant State law. In addition, as we describe below, individuals who present to a provider-based, off-campus department that is not a dedicated emergency department with emergency conditions are not protected by EMTALA, but rather by the hospital CoPs as well as relevant State law.

Comment:

A number of commenters expressed concern about EMTALA applicability to individuals who present at a hospital for emergency care outside the dedicated emergency department. One commenter stated that establishing a “different set of expectations” for departments that are not dedicated emergency departments when an individual presents for care is likely to cause confusion and is asking potentially nonclinical persons to make clinical judgments they have no training to make. Another commenter stated that medical personnel cannot be at all hospital locations to conduct screening and stabilization services, and believed that we should revise how medical staff are required to respond to medical emergencies in nonemergency department locations.

Response:

As we have expressed above, whether an individual presents for care at a hospital's dedicated emergency department, or elsewhere on hospital property, if EMTALA is triggered, the hospital has the same obligations to that individual. It is up to the hospital to determine how best to provide the screening and necessary stabilizing treatment to the individual who presented. In either case, the hospital is responsible for treating the individual within the capabilities of the hospital as a whole, not necessarily in terms of the particular department at which the individual presented. Whether the hospital sets up procedures to immediately transport the individual to the hospital's dedicated emergency department, or whether the hospital sets up procedures to send a “trauma crew” or “crash team” of physicians and nurses out to the individual on site, we do not believe it is appropriate for us to dictate to hospitals how best to treat individuals who present for emergency care in hospital departments other than dedicated emergency department locations.

In addition, we do not believe treatment of an emergency patient would involve having nonclinical hospital staff making determinations about an individual's medical condition; rather, we envision that, as stated above, hospitals would set up procedures to provide for emergency care to individuals who present in hospital departments other than dedicated emergency department locations on the hospital campus.

2. Prudent Layperson Standard

Comment:

A number of commenters expressed concern about our proposed “prudent layperson” standard. We stated in the proposed rule that, for both presentments inside the dedicated

emergency department and also elsewhere on hospital property, a request for examination or treatment would be considered to exist if a

prudent layperson observer

would believe, based on the individual's appearance or behavior, that the individual needs examination or treatment for an emergency medical condition (or examination or treatment for a medical condition for presentments inside the dedicated emergency department).

Many other commenters supported our proposed prudent layperson standard; they believed that the standard would ensure that the obvious emergency situation would be addressed, even if the individual were unable to verbalize the request.

Several other commenters requested that we substitute the term “obvious implied request” or “implied request,” instead of relying on the perceptions of a prudent layperson for individuals who are unable to articulate their needs.

Many commenters believed that hospitals must be on notice of an individual's presentment in order for EMTALA to be triggered to that individual. One commenter stated: “Because an EMTALA obligation is triggered by a patient-generated request, hospital personnel must be made aware of the individual's presence and observe the appearance or behavior or both of that person in order to respond appropriately. Additionally, all hospitals need policies that describe steps to be taken to assure that a person in clear need, for example, a visitor who collapses in the cafeteria, receives medical attention.”

Several commenters requested that the final rule make clear that EMTALA does not apply to an individual presenting on on-campus hospital property other than a dedicated emergency department unless emergency services are requested.

Response:

First, we agree with the commenters that hospital personnel must be aware of the individual's presence and observe the appearance or behavior, or both, of that person in order for EMTALA to be triggered. Obviously, the hospital must be on notice of the individual's existence and condition for any violation of the statute to take place. This also applies to presentments for off-campus dedicated emergency departments; only if the hospital's staff are aware of an individual's presence in the department for examination or treatment for a medical condition is EMTALA triggered.

We also agree with the commenters that EMTALA does not apply elsewhere on on-campus hospital property other than a dedicated emergency department unless

emergency

services are requested. As we clarified in section V.J.8 of the preamble of the May 9, 2002 proposed rule (67 FR 31473 through 31474), and also as we discuss in section IX. of the preamble, a request for treatment would be considered to exist if the individual requests examination or treatment for what the individual believes to be an emergency medical condition. Where there is no actual request because, for example, the individual is unaccompanied and physically incapable of making the request, the request from the individual will be considered to exist if a prudent layperson observer would believe, based upon the individual's appearance or behavior, that the individual needs examination or treatment for an emergency medical condition.

However, to address the commenters who requested an “obvious implied request standard” instead of the “prudent layperson standard”, we believe the prudent layperson standard is necessary for both presentments inside the dedicated emergency department and elsewhere on hospital property. We are concerned about the circumstance where hospital staff observe the appearance or behavior of an individual who clearly has an emergency medical condition, but do nothing to provide treatment for that individual.

In addition, the term “prudent layperson” is consistent with the Medicare and Medicaid programs, in general. We believe it is appropriate and realistic to utilize this objective standard in the EMTALA context as well, because it reflects a standard for judging whether the hospital should have acted—it does not shift control of events to any particular individual layperson.

Comment:

One commenter who supported the prudent layperson standard suggested that the proposed regulatory language at paragraphs (1) and (2) under the definition of “comes to the emergency department” under § 489.24(b) is too broad and could encompass situations for which CMS did not intend EMTALA to apply. The commenter recommended that CMS modify the language in those paragraphs to state: “a request on behalf of the individual will be considered to exist if

the individual is unable to make the request and

a prudent layperson observer would believe. * * *” The commenter stated that an individual need not rely on the prudent layperson observer if he or she is able to request examination or treatment for himself or herself.

Another commenter requested that CMS limit application of the prudent layperson language to circumstances where the need for emergency services is clear and the individual cannot make the request and there is no one to make the request on behalf of the individual.

Response:

We agree with the commenters that the prudent layperson standard is to be relied upon only in circumstances where the individual is unable to make the request for examination or treatment of himself or herself. However, we do not agree that a change in the regulatory language is needed. We believe that our proposed regulatory language in that section, which states: “

In the absence of such a request by or on behalf of the individual,

a request on behalf of the individual will be considered to exist if a prudent layperson observer * * *” (emphasis added), encompasses any situation in which an individual has come to the hospital and a prudent layperson observer would believe the individual may have an emergency medical condition and that the individual would request examination or treatment if he or she were able to do so, whether or not the individual is unaccompanied.

Comment:

One commenter stated that hospital staff do not want to be in the position of interpreting the “prudent layperson” terminology. Another commenter was concerned that some members of a hospital's staff may not be “prudent laypeople” who are in the position of determining whether someone needs emergency care. For example, a hospital may employ a disabled worker to provide basic yard services. A third commenter stated that many hospitals use volunteers to staff courtesy desks to assist patient families and provide directions in and around the hospital. The commenter was concerned that requesting volunteer hospital staff to provide emergency care for individuals presenting at the hospital outside of the dedicated emergency department is “excessive.” The commenter stated that if volunteers are assigned this responsibility, they may no longer provide volunteer services and the hospital would need to add paid staff, which would increase the cost of care. The commenter added that these volunteers or other staff would need training to comply with this new definition and responsibility.

Response:

Our rationale for the prudent layperson standard is to determine whether an EMTALA obligation has been triggered toward a particular individual. It is a legal standard that would be used to determine whether EMTALA was

triggered—it is not meant for hospital staff, including volunteers, to be “interpreting” the prudent layperson standard. Rather, we foresee that in cases in which hospital staff or other individuals at the hospital have witnessed the behavior of the individual upon his or her presentation to the hospital, the prudent layperson standard will be applied to the facts (the appearance and behavior of the presenting individual) to determine if EMTALA had been triggered.

Comment:

One commenter stated that EMTALA should apply only in situations where the prudent layperson believes the individual needs emergency examination or treatment, and not simply examination or treatment at some later date or time.

Response:

We proposed the prudent layperson standard to apply to presentments both inside and outside the dedicated emergency department. Therefore, for presentments inside the dedicated emergency department, the proposed standard is that the prudent layperson observer would believe, based on the individual's appearance or behavior, that the individual needs examination or treatment for a

medical condition.

For presentments on hospital property outside the dedicated emergency department, the prudent layperson would believe the individual needs examination or treatment for an

emergency medical condition.

However, we do agree with the commenter that the standard is that the prudent layperson would believe that the individual needs the examination or treatment at the time of the presentment (when the hospital is on notice of the individual's existence on hospital property), and not at a later date or time.

Comment:

One commenter describes a scenario where an individual with a bad cough and wheezing visits a family member in the dedicated emergency department. The commenter believed that, even though the individual may need examination or treatment, the hospital should have no duty to offer or provide care unless that individual actually asks for care. The commenter indicated that in such a case it should not matter whether a prudent layperson observer would believe that the individual

needs

care.

Response:

We agree with the commenter that the prudent layperson standard should not be applied so broadly as to mandate EMTALA screenings for individuals who are fully capable of making a verbal request for examination or for a medical condition, but elect not to do so. Inherent in such a standard is not only the notion that the individual's appearance or behavior would lead a prudent layperson observer to believe that the individual needs examination or treatment for a medical condition, but a belief by the prudent layperson that there has been no verbal request only because the individual's medical condition, or some other factor beyond the individual's control, such as a language barrier, makes a verbal request impossible. We are not revising the final rule based on this commenter's concern because we believe it is not feasible to attempt to codify all of the various conditions and circumstances under which a verbal request would not be possible. However, we will keep this concern in mind as we develop interpretative guidelines or other instructional material for State surveyors.

3. Determination of “What May Be an Emergency Medical Condition”

Comment:

Several commenters did not agree with the language used in the regulatory standard for EMTALA applicability outside the dedicated emergency department that the presenting individual requests examination or treatment for

what may be

an emergency medical condition. One commenter stated that the universe of conditions that may be emergency medical conditions is extraordinarily broad and recommended that this standard be clarified to avoid unnecessary and excessive EMTALA obligations to individuals presenting outside of dedicated emergency departments. The commenter recommended that EMTALA is triggered outside of the dedicated emergency department only when the individual “requests examination or treatment for what more likely than not is an emergency medical condition.”

Response:

When we proposed the “what may be an emergency medical condition” language in the definition of “come to the emergency department” at § 489.24(b), we did so to clarify that an emergency medical condition would not actually have to

exist

upon examination of such an individual presenting outside the dedicated emergency department. Instead, the individual presenting (or the prudent layperson observer) must believe he or she needs emergency care. We do not believe it is necessary to adopt the commenter's suggested clarifying language. We believe we have provided sufficient explanation about “what may be an emergency medical condition” both in our response above and in the preamble to the proposed rule (67 FR 31473).

Comment:

One commenter requested that CMS clarify that the proposed standard language “such a request would be considered to exist if the individual requests examination or treatment

for what the individual believes

to be an emergency condition” (67 FR 31473) (emphasis added), is an objective standard. The commenter was concerned about our enforcement of this standard; specifically, the concern was that the determination as to whether an EMTALA obligation has been triggered would hinge on a subjective belief that an emergency medical condition exists.

Response:

EMTALA is triggered when there has been a

request

for medical care inside the dedicated emergency department or for emergency care on hospital property outside the dedicated emergency department. The request can only be made by or on behalf of the individual or the request from the individual would be considered to exist if a prudent layperson would believe the individual needs emergency care. We believe this standard for when EMTALA is triggered is based on objective criteria; that is, the act of the individual or someone acting on his or her behalf requesting medical care for what the individual believes or what the person accompanying the individual believes to be an emergency medical condition. It is also objective when the prudent layperson standard is considered in determining whether, based on the appearance, signs, and symptoms of the individual presenting to the hospital, a prudent layperson would believe that the individual has a medical condition (in the dedicated emergency department) or an emergency medical condition (in a nondedicated emergency department).

4. Other Issues

Comment:

One commenter requested that we clarify that, although it may be appropriate for staff of the dedicated emergency department to leave the department in order to provide emergency medical treatment to an individual who has presented on hospital property outside the dedicated emergency department, it is not required that an emergency department “physician” leave to respond and provide treatment to an individual.

Response:

Under these circumstances, EMTALA requires that the hospital must provide treatment to the individual within its capabilities; if the hospital lacks, for instance, sufficient specific staff, the hospital should must provide alternative means of treating such an individual, within its capabilities, or provide an appropriate transfer. Or if the hospital decides to send other medical staff rather than physician staff to an emergency patient who has presented on hospital property

outside the dedicated emergency department, that action is within the hospital's discretion. CMS would look to see what type of capabilities the hospital has in responding to such emergency cases and whether the hospital responded appropriately.

Comment:

One commenter believed that having different EMTALA policies based on which door of the hospital the individual enters is fundamentally flawed and exacerbates the confusion about when the EMTALA duty has been met. The commenter requested that we simplify the issue by delineating that EMTALA applies in any case of any individual who comes to the dedicated emergency department and for whom a request for emergency care is made, until that individual is stabilized or admitted.

Another commenter found it confusing to have a separate definition of dedicated emergency department. The commenter stated that it is already well-established and accepted that any individual who arrives anywhere on hospital property, whether it is the emergency department or a sidewalk within 250 yards of the main building and requests care for a emergency medical condition triggers EMTALA obligations for the hospital. Therefore, the commenter added, it is immaterial whether or not an individual presents to a “dedicated emergency department,” since arrival anywhere on a hospital campus automatically triggers EMTALA.

Response:

As we explain in the discussion above regarding clarification of the definition of “dedicated emergency department,” and also in the proposed rule, there has been much confusion on the applicability of EMTALA to individuals who present for emergency care, but do not make it to a hospital's emergency department. We have stated previously that an individual may not be denied emergency services simply because a person failed to actually enter a hospital's emergency department. That is, under certain conditions, an individual does not need to present at a hospital's emergency department in order to be protected by EMTALA.

Thus, in clarifying our policy, it is necessary to address

where

and under what conditions the individual is presenting in order to determine whether EMTALA is triggered. EMTALA is not triggered by a request for physical therapy (that is, for a

medical condition

) at the hospital's on-campus physical therapy department. However, EMTALA would be triggered by that same request inside a hospital's dedicated emergency department, since the statute clearly states that requests for examination or treatment of “medical conditions” at emergency departments trigger EMTALA. By the same token, request for treatment of a gunshot wound at the on-campus radiology department would also trigger EMTALA, since a gunshot wound is clearly an “emergency medical condition.”

We believe that, in making our clarification of “dedicated emergency department,” we are assisting in clarifying a hospital's responsibilities under EMTALA to screen and provide necessary stabilizing treatment to an individual who comes to a hospital, presenting either at its dedicated emergency department or elsewhere on hospital property; that is, we are clarifying at what point EMTALA is

triggered

. The “which door” concept is integral to this analysis. An individual can “come to the emergency department” under the statute creating an EMTALA obligation on the part of the hospital, in one of two ways: The individual can present at a hospital's dedicated emergency department and request examination or treatment for a

medical condition

; or the individual can present elsewhere on hospital property (that is, at a location that is on hospital property but is not part of a dedicated emergency department), and request examination or treatment for an

emergency medical condition

.

D. Provisions of the Final Rule

In summary, in consideration of the comments discussed under this section, in this final rule, we are—

• Adopting as final the proposed definition of hospital property under § 489.24(b) with one clarifying editorial change concerning the language in the proposed definition about excluding other areas or structures that are located within 250 yards of the hospital's main building.” We are removing the proposed phrase “located within 250 yards of the hospital's main building” because the phrase is duplicative of the language in the definition of “us” at § 413.65(b). “Campus” includes the 250 yards concept in its definition; therefore, by referencing § 413.65(b) in the definition of “hospital property” under EMTALA, we are already including the concept of 250 yards.

• Adopting as final the proposed definition of patient under § 489.24(b), with a modification to reflect the nonapplicability of EMTALA to an individual who has begun to receive outpatient services at an encounter at the hospital other than an encounter that the hospital is obligated by EMTALA to provide.

IX. Scope of EMTALA Applicability to Hospital Inpatients (§ 489.24(d)(2))

A. Background and Provisions of the Proposed Rule

While most issues regarding EMTALA arise in connection with ambulatory patients, questions have occasionally been raised about whether EMTALA applies to inpatients. In late 1998, the United States Supreme Court considered a case (

Roberts

v.

Galen of Virginia

, 525 U.S. 249 (1999)) that involved, in part, the question of whether EMTALA applies to inpatients in a hospital. In the context of that case, the United States Solicitor General advised the Supreme Court that the Department of Health and Human Services (DHHS) would develop a regulation clarifying its position on that issue. After reviewing the issue in the light of the EMTALA statute, in the May 9, 2002 proposed rule (67 FR 31475), we proposed that EMTALA would apply to admitted emergency patients until they have been stabilized.

As we noted in the proposed rule, once a hospital has incurred an EMTALA obligation with respect to an individual, that obligation continues while the individual remains at the hospital, so that any transfer to another medical facility or discharge of the individual must be in compliance with the rules restricting transfer until the individual is stabilized under existing § 489.24(d). In these cases, we stated that the hospital continues to be obligated under section 1867 of the Act, irrespective of the inpatient admission, and that an individual's emergency medical condition will be considered to have been stabilized only when the criteria in § 489.24(b) are met. That is, the individual's condition must be such that no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during a transfer of the individual from the facility or, if the patient is a pregnant woman who is having contractions, that the woman

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