HCFA’s New Guidelines for Enforcement of EMTALA
HCFA’s New Guidelines for Enforcement of EMTALA
By Robert A. Bitterman, MD, JD, FACEP, Director of Risk Management & Managed Care, Department of Emergency Medicine, Carolinas Medical Center, Charlotte, NC.
Introduction
In April 1996, the American Hospital Association (AHA) expressed concern to the Health Care Financing Administration (HCFA) regarding HCFA’s enforcement of EMTALA, the federal law governing hospital-based delivery of emergency medical care. The AHA sought to decrease the inconsistent and unpredictable enforcement of the statute across the different regions of the country, to reframe the investigative process away from a presumption of noncompliance, and to adapt interpretation of the law to today’s markets and methods of delivering emergency services.1 In response, HCFA convened an "EMTALA Work Group" to make recommendations for clarification of the EMTALA statute, the implementing regulations, and HCFA’s interpretive guidelines and enforcement procedures.2
The work group consisted of representatives from HCFA, the AHA, the federal Office of Inspector General (OIG), the American College of Emergency Physicians (ACEP), the American Medical Association (AMA), the American Association of Health Plans (AAHP), the American Association of Retired Persons (AARP), the State Hospital Associations of New York and Connecticut, and several state health departments.
HCFA requested the work group produce consensus recommendations for clarifications or changes regarding EMTALA, with emphasis on changes that could be quickly implemented without legislative action or formal regulatory or rulemaking processes. HCFA would not consider consensus recommendations unless the hospitals, physicians, managed care plans, consumer groups, state survey agencies, and the federal government representatives unanimously agreed with each recommendation.
The work group addressed three general issues: 1) definitions and interpretations of the key terms in the law, 2) the enforcement process and procedures, and 3) the interplay between managed care and EMTALA. Many of the recommended changes should effectively reduce the ambiguity of the statute and its inconsistent application, and allow hospitals and physicians more flexibility in delivering the services required under EMTALA. The new provisions should also improve due process for providers undergoing HCFA’s enforcement actions.
Not all of the "new" interpretive guidelines are actually new. Some are codifications of HCFA’s existing interpretations or enforcement provisions. Some are merely clarifications written at the request of the work group, primarily to help providers deal with managed care entities. Nor did all the changes originate from the work group. A number of changes, particularly those expanding the reach of EMTALA, came from HCFA alone, and were often contrary to the recommendations of the work group.
Recognize that these new interpretive guidelines (IG) do not have the same legal effect as laws or regulations, but are intended to provide direction to state survey agencies and regional HCFA offices in the interpretation and enforcement of the law. None of the guidelines have yet been tested in the crucible of the court judicial system. They became effective July 14, 1998, and HCFA intends to issue future periodic clarification letters when deemed necessary.3
Appropriate Medical Screening Examination
Despite 10 years of enforcement experience and court rulings, hospitals, physicians, and managed care plans continually fail to understand the impact of EMTALA on the role of triage, the scope of the medical screening examination (MSE), and the delivery of services to managed care enrollees. By a large margin, the most common HCFA citation for failure to comply with EMTALA is failure to provide an appropriate MSE to all patients, especially managed care patients, seeking emergency care.
What is HCFA’s Definition of an Appropriate MSE?
"A MSE is the process required to reach with reasonable clinical confidence, the point at which it can be determined whether a medical emergency does or does not exist. If a hospital applies in a non-discriminatory manner, . . . a screening process that is reasonably calculated to determine whether an emergency medical condition exists, it has met its obligations under EMTALA."
The process language is reinforced by HCFA’s admission that the adequacy of the screening process is not relevant to determining if the hospital provided an appropriate screening exam under EMTALA: "The clinical outcome of a patient’s condition should not be the basis for determining whether an appropriate screening exam was provided."
The federal courts uniformly hold that the critical element of complying with EMTALA’s screening requirement is not the adequacy of the screening exam, but whether the screening exam that was performed deviated from the hospital’s customary procedures for evaluation of patients with similar conditions. (For example, Baber v. Hospital Corp., 977 F.2d 872 [4th Cir. 1992].) Physicians and hospitals that follow their standard procedures do not violate EMTALA, regardless of whether their screening exam was negligent under state malpractice laws.
It remains to be seen whether the state survey agents, the HCFA regional offices, and the OIG will follow the lead of the courts and HCFA’s new guidelines in judging a hospital’s screening examinations. Citations and referrals to the OIG continue to occur, in direct contradistinction to the process interpretation. Furthermore, on December 11, 1998, in open forum at a conference in Washington, DC, the OIG stated that it disagreed with the federal courts’ interpretation, and it would continue to seek criminal monetary penalties from physicians and hospitals when its peer-review physicians deem the screening inadequate under the malpractice standard.
The downside to the process language is its corollary: the absence of harm to the patient does not prove that a violation of the law did not occur in the hospital’s screening exam. For purposes of government enforcement, in contrast to civil lawsuits under the Act, no harm need come to the patient for a physician or hospital to be held in violation of EMTALA.4 Furthermore, HCFA’s instructions to the investigating agencies include the caveat that "outcome may be a red flag’ indicating that a more thorough investigation is needed."3
What is the Scope of an Appropriate MSE?
A MSE may range "from a simple process involving only a brief history and physical examination to a complex process that also involves performing ancillary studies and procedures such as (but not limited to) lumbar punctures, clinical laboratory tests, CT scans, diagnostic tests and procedures, or involvement of on-call specialists. A MSE is not an isolated event. It is an ongoing process."
This guideline also tracks the scope of an "appropriate" MSE expected by the federal courts. The purpose of the screening exam is to decide whether an individual is suffering from an emergency medical condition (EMC). The scope of the exam constitutes "whatever it takes" to make that decision, within the resources available to the ED. This includes the services of on-call physicians if their expertise is required to decide if the patient has an EMC.
HCFA’s interpretation of the scope of the MSE, coupled with the process language, should help hospitals and emergency physicians obtain proper reimbursement from managed care plans. Since the scope of the MSE can be limited or extensive, the level of evaluation and management billing code for the screening should be commensurate. Managed care should not be allowed to pigeonhole all ED services as "screening exams" and pay only one, set, low fee. The Balance Budget Act of 1997 already requires Medicaid and Medicare managed care plans to pay for whatever services are required to determine if the patient has an EMC, under the prudent layperson definition of an emergency.
Does Triage Constitute an Appropriate MSE?
"Triage is not equivalent to a medical screening exam, hospitals must provide an MSE beyond initial triage. Triage merely determines the order in which patients will be seen, not the presence or absence of an emergency medical condition."
This does not represent a change in HCFA’s position regarding the MSE, and the language tracks the interpretation uniformly held by the federal courts of appeal. Neither HCFA nor the courts ever accepted triage as adequate to determine if an EMC exists. Many hospitals have been cited by HCFA for violating EMTALA by "triaging out" state managed care Medicaid patients denied authorization by the MA gatekeeper. This common practice violated the law in three ways: 1) delaying access to the screening exam on account of the patient’s insurance (by waiting to examine the patient until authorization was obtained from the MA carrier); 2) discriminatory screening of Medicaid patients because non-Medicaid patients were screened by a physician; and 3) the triage exam alone was not adequate or, in the court’s words, "reasonably calculated" to determine whether an EMC was present.
The purpose of triage is to determine the order in which patients will be screened by a physician, or other "qualified medical personnel," specifically designated by the hospital’s governing body to perform screening exams. HCFA does not require physicians to perform the screening on behalf of the hospital, but it does expect that the full capabilities of the hospital’s emergency department will be used if they are necessary to determine if the patient has an EMC.
Where Can Hospitals Conduct the MSE?
HCFA’s new interpretive guidelines effect a major change in where hospitals can provide the MSE and any further required stabilizing treatment.
"Emergency services need not be provided in a location specifically identified as an emergency department. Hospitals may use areas to deliver emergency services which are also used for other inpatient or outpatient services."
"As long as the patient is directed to a hospital-owned facility which is contiguous (i.e., any area within the hospital or a hospital-owned facility on land that touches land where the hospital’s ED sits) or is part of the hospital "campus" and is owned by the hospital, and is operating under the hospital’s MC provider number, the hospital is complying with [EMTALA]."
The conditions precedent for movement away from the ED are uniformity and non-discrimination. This means that a patient presenting to the ED could be sent to whatever contiguous or on-campus facility that the hospital deemed appropriate to conduct or complete the medical screening exam, as long as:
1. The hospital owns the on-campus facility;
2. The hospital operates the on-campus facility under its Medicare provider number;
3. All persons with the same medical condition (same acuity level as determined by triage) are moved to that location, regardless of ability to pay or insurance status;
4. There exists a bona fide medical reason to move the patient; and
5. Qualified medical personnel accompany the patient.
Typically, for patients presenting to the ED, such movement would occur only after a triage assessment determined it was proper and safe to move the patient away from the ED to conduct the MSE. For example, pregnant women at more than 20 weeks gestation, with only pregnancy-related complaints, could be directly triaged to Labor and Delivery for the MSE. Patients with minor complaints could be directed to on-campus urgent cares or pediatric clinics for the MSE. HCFA will not consider such movement on the hospital’s campus as a transfer under EMTALA.
Physicians’ offices may also be defined as such a facility, provided that they are located on-campus, owned by the hospital, operated under the hospital’s MC number, all patients with the same condition are triaged to the physician’s office, the movement is medically indicated, and qualified medical personnel accompany the patient to the office—a very unlikely combination of circumstances.
However, hospitals may not move patients away from the main campus to off-campus facilities to complete the MSE or conduct stabilizing treatment, assuming it has the capability to provide the MSE and necessary stabilizing treatment on-campus. Movement off-campus is considered a transfer, and must meet all the legal requirements for transfers defined under EMTALA.
When Does an Individual Come to the Emergency Department’ and Trigger the Hospital’s Duty to Provide an MSE?
A hospital must provide an MSE to any individual who "comes to the emergency department" and requests examination or treatment for a medical condition.5 HCFA’s regulations previously defined "comes to the emergency department" as anywhere on hospital property.6 In the new guidelines, HCFA uses that definition to proclaim that the MSE duty attaches even when patients present to hospital property located off-campus, such as an urgent care center or satellite clinic many miles away from the hospital itself.
"If a patient comes to a hospital-owned facility which is non-contiguous or off-campus and operates under the hospital’s Medicare provider number, EMTALA applies to that facility. The facility must, therefore, screen and stabilize the patient to the best of its ability or execute an appropriate transfer according to EMTALA guidelines if necessary."
The work group argued against this expansion of EMTALA’s MSE provision, believing HCFA exceeded its statutory authority. The plain language of the statute states: "In the case of a hospital that has an emergency department, if any individual comes to the emergency department . . . "5 The courts have generally narrowly construed the law, ascribing to the words used only their natural and obvious meaning. HCFA’s expansion also appears to reach far beyond the intent of Congress when it passed EMTALA. HCFA’s interpretation is certain to be challenged in court if HCFA begins enforcing this requirement.
Interestingly, one work group’s subgroup recommended EMTALA be extended to off-campus facilities that "held themselves out" as providing emergency services, such as free-standing emergency centers, but HCFA refused to adopt the qualification.
HCFA’s interpretation raises a host of issues for off-campus hospital facilities. To what extent must the facility provide screening or stabilizing treatment? Must the facility maintain an on-call list? Must it post EMTALA signs, which may give patients a false impression that the facility is actually equipped to handle emergencies? Does HCFA expect the facility to move patients back to its main hospital ED to properly screen or stabilize them, or send them to the closest appropriate hospital? Can it call 911 to transfer emergencies or must it arrange for transfers via its own resources? (HCFA Region IV, in Atlanta, recently opined that hospitals should not call 911-EMS to move patients already on its campus into its ED, regardless of where patients "go to ground" on the hospital’s campus. The Chicago Region required now famous Ravenswood Hospital to implement a hospital personnel manned "mini-emergency team" to respond to emergencies occurring both on-campus and within a reasonable distance off-campus.)
Obviously, this interpretation means that hospital-owned, off-campus facilities must provide a medical screening exam to all patients presenting on its premises, regardless of their ability to pay or their insurance status. Neither can it delay access to the MSE to inquire about the patient’s insurance or managed care status. Also, all transfers to other area hospital EDs must comply with all the elements of EMTALA, exposing the facility to additional, federal liability.
Currently, HCFA imposes EMTALA requirements on hospital-owned, off-campus facilities only if operated under the same Medicare number as the hospital. Some health care systems always operated outpatient facilities under a different Medicare number than the main hospital, and some appear to have legally reorganized specifically to avoid attachment of EMTALA so as to continue financial discrimination at their outpatient facilities.
HCFA may even further expand its definition of "comes to the ED" through its outpatient prospective payment regulations by eliminating the "operated under the same MC number" requirement. The proposed rule, issued September 8, 1998, would then define "hospital property" to include: "the entire main hospital campus, including parking lot, sidewalk, and driveway, as well as any facility or organization that is located off the main hospital campus but has been determined under Section 416.35 of this chapter to be a department of the hospital [provider] . . ."
HCFA then defines a "department of a provider" to mean: "a facility or organization or clinic either created by, or acquired by, a main provider for the purpose of furnishing health care services under the name, ownership, and financial and administrative control of the main provider . . ." (The proposed rule may be viewed in the Federal Register at http://www.nara.gov/fedreg/.)
Stabilization
The work group and HCFA expanded the definitions of "to stabilize," and bifurcated stabilization into "stable for transfer" and "stable for discharge." The guidelines state: "A patient will be deemed stabilized if the treating physician has determined, within reasonable clinical confidence, that the emergency medical condition has been resolved."
For patients whose EMC has not been resolved, the patient will be considered "medically" stable if the treating physician determines the patient is "stable for transfer" or "stable for discharge."
A patient is "stable for transfer" if the patient is: "transferred from one facility to a second facility and the treating physician has determined, within reasonable clinical confidence, that the patient is expected to leave the hospital and be received at the second facility, with no material deterioration in his/her condition; and the treating physician reasonably believes the receiving facility has the capability to manage the patient’s medical condition and any reasonably foreseeable complication of that condition."
A patient is "stable for discharge" when: "within reasonable clinical confidence, it is determined that the patient has reached a point where his/her continued care, including diagnostic work-up and/or treatment, could be reasonably performed as an outpatient or later scheduled as an inpatient, provided the patient is given a plan for appropriate follow-up care with the discharge instructions."
This expanded definition (which in my opinion is superceded by the explicit definition of "stabilized" in the statute) could be fertile ground for increased lawsuits. It could make the hospital and emergency physician liable if the on-call physician refused to see a patient because of economic reasons, who was referred to him under the "stable to discharge" definition, particularly if the discharging emergency physician or the hospital had prior knowledge of the on-call physician’s proclivity to refuse patients referred from the ED.
A psychiatric patient is considered "stable for transfer" when he/she is protected from injuring himself/herself or others. This definition will substantially benefit facilities that transfer medically stable psychiatric patients to state-sponsored psychiatric institutions based on economic considerations. (See ED Legal Letter 1998;10:94-104, on the Screening, Stabilization, and Transfer of Psychiatric Patients.)
The psychiatric patient is considered "stable for discharge" when he/she is no longer considered to be a threat to himself/herself or to others.
The new guidelines on stabilization further state that: "determination that patients are stable for transfer’ or stable for discharge’ does not require the final resolution of the EMC."
HCFA now recognizes that patients with legally defined emergency medical conditions can be safely transferred, either to another facility or even home, under standard medical practices and in compliance with EMTALA. This will give providers larger grounds to argue that the transfer or discharge was appropriate, either during HCFA investigations or in civil lawsuits brought under EMTALA.
Managed Care
Several of the new guidelines should help hospitals deal with managed care entities. The law always prohibited hospitals from delaying a patient’s MSE or stabilizing treatment by inquiring about an individual’s ability to pay for care. This should have killed managed care preauthorization procedures, but failed to do so. Now HCFA specifically states: "It is not appropriate for a hospital to request or a health plan to require prior authorization before the patient has received a MSE to determine the presence or absence of an EMC, or until an existing EMC has been stabilized."
Managed care authorization is for payment only, not treatment. Hospitals cannot delay or refuse screening of managed care enrollees until authorization for payment is obtained or authorization is denied. Also, if a hospital or emergency physician believes a patient has an EMC, or is not stable for discharge or for transfer to a managed care facility, the new guidelines side with the examining physician. "The determination of whether an EMC exists is made by the examining physician(s) actually caring for the patient at the treating facility, not the managed care plan" and "If there is disagreement between the treating physician and an off-site physician (e.g., a physician at the receiving facility or the patient’s primary care physician if not physically present at the first facility) about whether the patient is stable for transfer, the medical judgment of the treating physician usually takes precedence over that of the off-site physician."
Managed care physicians would have to physically appear in the ED to personally examine the patient and assume responsibility for the patient’s care if they wanted to countermand the judgment of the initial examining physician. Such language from HCFA should help providers obtain proper reimbursement for services to managed care patients. (See sidebox on page 119.)
Unfortunately, HCFA continues to believe that discussion with the patient regarding payment issues before the MSE could constitute economic coercion and violate EMTALA. "Hospitals may not attempt to coerce individuals into making judgments against their best interest by informing them that they will have to pay for their care if they remain . . ."7
The work group could not convince HCFA to adopt any proposal on what may be communicated to a managed care enrollee about the limits of their coverage and their potential financial responsibility. The AHA plans to convene a separate work group of associations to develop a proposal and resume discussions with HCFA on this issue.
HCFA will allow hospitals to continue following reasonable registration processes, however, including requesting information about insurance, "as long as these procedures do not delay screening or treatment."
Miscellaneous Enforcement Provisions
The new interpretive guidelines also revised the State Operations Manual, the investigational and enforcement tool HCFA provides the state survey agencies and the HCFA regional offices for use in enforcing EMTALA. The manual contains a number of important changes in the enforcement provisions:
1. Data Sharing. The work group recommended that HCFA share all information about a complaint and the findings of its investigation, and that it allow providers an opportunity to respond to the allegations before HCFA determined that a violation had occurred. HCFA demurred, but in keeping with the spirit of the recommendation, the revision indicates that the HCFA regional office "may," but is not required, to confer and share data with the hospital regarding the alleged violation.
2. Eliminated Automatic 23-Day Fast Track Termination Procedures. Previously, HCFA policy considered all alleged violations to be "an immediate and serious threat to patient health and safety," and automatically initiated 23-day termination from Medicare proceedings against the hospital. It was irrelevant to HCFA whether or not the alleged violation really did represent a health threat or was a mere paperwork violation, or that it occurred nine months previously and had already been corrected by the hospital. It is chaotic and very difficult for hospitals to adequately investigate, formulate, and implement a plan of correction under 23-day proceedings. In reality, the hospital has only 19-21 calendar days, since at that time HCFA will post conclusionary public notices in the community newspapers if the hospital has not produced a satisfactory compliance plan—a public relations nightmare for the hospital.
Also, many of the regional offices ignored HCFA policy and initiated 90-day rather than 23-day terminations, based on their discretion and in compliance with standard procedures for other violations of the Medicare Act.
The new manual allows the regional office discretion to implement either a 23-day or a 90-day termination. It also requires an actual, current, and true immediate and serious threat to patient health and safety before initiating the 23-day proceeding, described as: "a situation that prevents individuals from getting MSEs and/or a lack of treatment reflecting both the capacity and capability of the hospital’s full resources, as guaranteed under [EMTALA]."
Similarly, HCFA clearly indicates that violations not immediate and serious require use of the 90-day track. The manual lists example illustrations of serious and non-serious violations to help guide the regional office in choosing which track to implement.
This change in the termination proceedings should substantially benefit providers. Previously, hospitals needed to investigate a claimed violation, deal with the state agency and HCFA offices, put together a plan of correction and compliance, and educate its entire administrative, nursing, ancillary, and medical staff within approximately 19-21 calendar days. The process will now proceed at a more controlled pace.
3. Peer Review Not Required. The work group strongly urged HCFA to require physician peer review of the medical issues of the alleged violation before a regional office could initiate termination proceedings against a hospital. HCFA refused. However, the state surveyors may recommend a medical review to the regional office, and HCFA urges the regional office to obtain physician review when the medical care is an issue in the case. Also, HCFA states the review physicians should be board certified (if the physician being investigated is board certified) and should be actively practicing in the same medical specialty as the treating physician whose care is in question. These changes should be of particular benefit to emergency physicians.
4. Recourse to Central HCFA. Because of the substantial inconsistent enforcement of EMTALA by the various state survey agencies and HCFA regional offices, the work group wanted the central HCFA office in Baltimore to function as an appellate arbitrator. If a hospital believed the investigators were incorrectly enforcing EMTALA, it could request that HCFA intervene in the proceedings. HCFA declined, citing its long-standing policy vesting each regional office with independent decision-making powers. Hospitals may, however, contact HCFA to clarify policy questions anytime, including during or following an investigation.
5. Effect a Plan of Correction. HCFA explicitly states that a hospital’s submission of a plan of correction to come into compliance with EMTALA, as determined by HCFA, does not mean that the hospital "admits" violating the law. Nonetheless, HCFA will still add the facility to its log of violators of EMTALA, and note that the hospital submitted an acceptable plan of correction and that HCFA discontinued the termination process.
Conclusions
HCFA’s new interpretive guidelines for its regional office and state agency investigators represent a substantial clarification of provider obligations under EMTALA. HCFA is to be commended for its effort at collaborative policymaking, and for recognizing that some policies needed to be changed, better explained, or applied more evenhandedly.
Some changes, though, may create more rather than less confusion, particularly the expansion of the law to cover services provided at off-campus urgent cares and satellite clinics. Other interpretations may settle out with time, or end up being decided through litigation. EMTALA still remains a difficult, complex government imposition, especially in the era of managed care.
No matter how much one tinkers with the implementing regulations and interpretive guidelines, the underlying reason EMTALA was initially passed and why it requires continuous vigorous enforcement still exists—the substantial amount of uncompensated care provided by our nation’s hospitals and physicians.
EMTALA represents an anomalous right to emergency health care, a giant unfunded government mandate. If fact, EMTALA may represent our country’s largest health care program, larger than either Medicaid or Medicare, and, for the most part, it’s entirely unfunded. Until our nation addresses the issue of uncompensated care, EMTALA violations and ever expanding regulations can be expected.
Editor’s note: The American College of Emergency Physicians (ACEP) intends to create an EMTALA Task Force to work with ACEP state chapters, the AHA, HCFA, and the OIG to educate physicians, hospitals, and managed care entities on the requirements of EMTALA, including the new interpretive guidelines. Interested ACEP members, or any party wishing to offer comments, can reply to the author at [email protected].
References
1. Letter from Office of the General Counsel of the AHA to HCFA. May 9, 1997.
2. Stieber JM, Spar LJ. EMTALA in the 90s—Enforcement Challenges. Health Matrix 1998;8:57-82.
3. State Operations Manual (SOM) Provider Certification, HCFA Pub. 7, Transmittal No. 2, June 1, 1998. (Available at HCFA’s web site, www.hcfa.gov/pubforms/progman.htm.)
4. 42 USC 1395dd(d)
5. 42 USC 1395dd(a)
6. 42 CFR 489.24
7. 59 Fed. Reg. 32,101
Recommended Reading
Baker CH, Goldsmith TM. From triage to transfer: HCFA’s update on EMTALA. Health Law Digest 1998;26:3-14.
Bonner S. New EMTALA guidelines hot off the press: Here’s what your ED needs to know. ED Management 1998;10:97.
Bitterman RA. Screening, stabilization, and transfer of psychiatric patients. ED Legal Letter 1998;10:94-104.
Dame LA. EMTALA: The anomalous right to health care. Health Matrix 1998;8:3-28.
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