Understand this confusing law or prep for lawsuits, penalties
December 1, 1999
Understand this confusing law or prep for lawsuits, penalties
By David L. Freedman, MD, JD, FAAEM, Emergency Medicine Physician, Chelsea Community Hospital, Chelsea, MI; Attorney, Miller, Canfield, Paddock & Stone PLC, Ann Arbor, MI.
This is the first of what we intend to be annual updates of the Emergency Medical Treatment and Active Labor Act (EMTALA) legal and regulatory developments. In these updates, we will primarily focus on EMTALA developments that have occurred during the previous year. These developments may include new regulations, court decisions, or directives from the Health Care Financing Administration (HCFA) or the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG). In the past 18 months, two significant documents have been published by the HCFA: the State Operations Manual Transmittal No. 2 (June 1, 1998) and the OIG/HCFA Special Advisory Bulletin on the Patient Anti-Dumping Statute which addressed managed care issues (Nov. 10, 1999). In this inaugural issue, some material from before Jan. 1, 1999, is included (e.g., the State Operations Manual Transmittal No. 2). In the future, it is expected that only material from the previous year will be included.
As is discussed in detail in this issue, HHS and its various agencies, in particular the OIG, continue to take a very broad view of the EMTALA statute. In fact, the agencies’ view appears to be ever-broadening. This is reflected in the OIG’s expansive interpretation of the statutory provision "comes to the emergency department" and its interpretation that EMTALA applies to hospital inpatients. These interpretations may well reach beyond the clear meaning of the statute and the original legislative intent.
In comments at this year’s American Health Lawyers Association annual meeting, Jessica Bowman, associate counsel to the Office of the Counsel to the Inspector General, made it clear that the government is devoting increased resources to the pursuit of alleged EMTALA violations: "The OIG has been turning up the heat on the physicians who have violated the EMTALA statute." From 1986 to 1996, OIG reached 66 settlements or judgments in its enforcement of EMTALA and levied $1.45 million in fines.1 In the next two years, 1997 and 1998, recoveries surpassed the total amount recovered in the previous 10 years. During those two years, OIG obtained 67 settlements or judgments worth a total of $2.31 million. Settlements totaled $252,500 in FY 1995; by FY 1998 the total had increased to $1,822,500.
During the first half of FY 1999, the OIG reported it was receiving referrals of potential EMTALA violations "at a steady pace."2 In that six-month period, the OIG report indicates that there were 140 cases of alleged EMTALA violations being investigated, and that the OIG had settled 34 cases imposing nearly $1 million in civil monetary penalties.
Some believe that HCFA has been overly expansive in its interpretation and aggressive in its enforcement of EMTALA. This opinion seems to be shared by at least one federal court of appeals, at least as to HCFA’s aggressiveness in its prosecution of Dr. Theodore Cherukuri, a case familiar to most, if not all, emergency physicians. In its decision reversing the HHS Administrative Law Judge and HHS’s Appeals Board, the Sixth Circuit Court of Appeals was clear in expressing its displeasure with the result and, more importantly, the process (or lack thereof). This decision is discussed in detail below.
In this issue we discuss the first U.S. Supreme Court decision involving EMTALA, disappointing as it was. We will also discuss the two significant documents mentioned above issued by HCFA in the past 18 months: the Special Advisory Bulletin Addressing Managed Care Issues and State Operations Manual Transmittal No. 2.
A complete review of EMTALA is far beyond the scope of this article. Rather, we will selectively address those issues that generated the most interest this year, whether through HCFA interpretations or court opinions. It should be noted that, as EMTALA case law has accumulated, splits among the federal appeals courts have developed (i.e., various federal appeals courts have decided a given issue differently). At times, different courts have taken nearly opposite positions on an issue, e.g., the application of EMTALA’s requirements in areas of the hospital other than the emergency department. Roberts v Galen of Virginia, Inc., involved a split in the circuits regarding whether a plaintiff must prove an improper motive on the part of the hospital to recover in a suit alleging a violation of EMTALA’s stabilization requirement (§ 1395dd[b]).3 With time, splits among the circuits will likely increase, making it increasingly important to know what the law is in your particular federal circuit.
Roberts v Galen of Virginia, Inc.
The Supreme Court handed down its decision in Roberts v Galen4 on Jan. 13, 1999. This was the first EMTALA case that the Supreme Court had agreed to hear. Anyone who expected significant guidance from the Court in the interpretation of the statute or HCFA’s implementing regulations, interpretations, or enforcement policies was sorely disappointed. In fact, the case had real significance only to those of us in the Sixth Circuit, where the Appeals Court’s opinion was reversed. In Roberts, the Court considered only a very narrow issue: Was the Sixth Circuit Court of Appeals correct in holding that, in order to recover in a suit alleging a violation of § 1395dd(b) (the stabilization requirement), a plaintiff must prove that the hospital acted with an improper motive in failing to stabilize the patient? The Court did not address whether EMTALA even applied to inpatients (the patient, Wanda Johnson, had been in the hospital nearly two months before she was transferred in an allegedly unstable condition). The Sixth Circuit’s holding, it should be noted, had been contrary to every other federal appeals court that had considered the issue. That alone did not mean that the Court could not have upheld the decision; it did, however, make it unlikely, especially considering the fact that the plain language of the statute contained no motive requirement.
In Roberts, the patient, Wanda Johnson, was a pedestrian hit by a truck in May 1992. She was taken to the defendant hospital, The Humana Hospital University of Louisville in Louisville, KY. She had been severely injured, suffering serious injuries to her brain, spine, right leg, and pelvis. During her approximately six weeks in the hospital, Ms. Johnson’s health remained in a "volatile state." The hospital arranged for her transfer on July 24, 1992, to the Crestview Health Care Facility, an extended care facility, which was across the river in Indiana. On arrival at the extended care facility, Johnson’s condition deteriorated significantly. Johnson was then taken to the Midwest Medical Center, also in Indiana, where she was hospitalized for many months, during which time she incurred substantial medical expenses.
Ms. Johnson applied for financial assistance under Indiana’s Medicaid program but her application was denied because she failed to satisfy Indiana’s residency requirements. Thus, Ms. Johnson was left with substantial medical bills, which she would not have been personally responsible for had she remained in the hospital in Kentucky. Jane Roberts, Ms. Johnson’s guardian then filed suit under § 1395dd(d) of EMTALA, alleging a violation of § 1395dd(b) failure to stabilize.
The Federal District Court had granted summary judgment for the hospital on the grounds that the plaintiff had failed to show that "either the medical opinion that Johnson was stable or the decision to authorize her transfer was caused by an improper motive."5 The Sixth Circuit affirmed. For the Sixth Circuit, this holding was an extension of its previous decision in Cleland v Bronson Health Care Group, Inc.,6 in which the Court had held that the "appropriate medical screening" duty under § 1395dd(a) likewise required proof of an improper motive. As a result of these two cases, in the Sixth Circuit, EMTALA plaintiffs had to prove improper motive in order to prevail on either an improper medical screening (§ 1395dd[a]) or failure to properly stabilize (§ 1395dd[b]) claim.
As mentioned above, all other circuits that had considered the issue had held that there was no such requirement that an improper motive be proven in order for a plaintiff to prevail in an EMTALA failure-to-stabilize case. In deciding the case, the Supreme Court simply looked to the plain language of the statute and found that "the text of § 1395dd(b) does not require an appropriate’ stabilization, nor can it reasonably be read to require an improper motive."7 While it might easily be argued that, from a policy standpoint, the requirement of an improper motive might be appropriate, the Supreme Court never considered the merits of such a requirement because the language of the statute was clear if the Congress had wanted an improper motive requirement, it would have included it in the statute.
The Court did not decide whether an improper motive was required for a plaintiff to prevail on a § 1395dd(a) claim, the medical screening examination section. The Court did, however, note in a footnote that the Sixth Circuit’s holding that there was such a requirement was "in conflict with the law of other circuits."8 Given the fact that, just as subsection (b) of EMTALA has no improper motive requirement, subsection (a) also lacks such language, there seems little doubt how the Supreme Court would decide the issue if it should hear such a case.
There has been considerable debate as to whether a hospital’s obligation under EMTALA should end once a patient has been appropriately screened and stabilized after initial entry into the emergency department. In Roberts, the Court refused to hear the hospital’s argument that EMTALA did not apply to an inpatient such as Ms. Johnson because the argument had not been "sufficiently developed below for us to assess [the argument]."9 From the facts given, it was not clear that Ms. Johnson’s condition had ever been stabilized, although the condition which precipitated her deterioration at the extended care facility (urinary tract infection) was different from the condition she had on presentation to the hospital (multiple trauma). In any case, the issue was not resolved by the Court. During oral argument, James A. Feldman, Assistant to the Solicitor General, who argued on behalf of the Department of Justice in a friend-of-the-court capacity, announced that the Secretary of the Department of Health and Human Services intends to initiate a rulemaking on EMTALA, "in part because of this case," and also to clarify other questions under the statute, such as for how long a hospital’s duty under EMTALA extends.10 We are still awaiting this official clarification from the department.
State Operations Manual Transmittal No. 2
On June 1, 1998, HCFA published State Operations Manual Transmittal No. 2 Responsibilities of Hospitals in Emergency Cases (the "Transmittal"). This document contains updates on instructions and policy interpretations based upon recommendations from state survey agencies, HCFA regional offices, and the OIG. As such, it is not "law." That being said, it does contain the recommendations of the agencies for the conduct of an EMTALA complaint investigation and, therefore, the lowest risk option for hospitals is to comply with them.
The Transmittal reiterates HCFA’s position, originally stated in the EMTALA Interim Final Rule,11 that, although the medical screening examination need not necessarily be conducted by a physician, it must be conducted by persons formally delegated that authority by the hospital:
"A hospital must formally determine who is qualified to perform the initial medical screening examinations, i.e., qualified medical person. The delegation must be set forth in a document that is approved by the governing body of the hospital It is not acceptable for the hospital to allow the medical director of the emergency department to make what may be informal delegations that could frequently change."12
On-call responsibilities of the medical staff, in particular coverage of the emergency department, are on-going problems in many hospitals. The problem is complicated by the fact that EMTALA imposes certain on-call responsibilities on the hospital, but does not require any particular physician or group of physicians to be on-call. Two HCFA interpretations are made clear in the Transmittal in relation to emergency department on-call coverage. First, "If a hospital offers a service to the public, the service should be available through on-call coverage of the emergency department."13 Second, the Transmittal recognizes that there will be situations where a hospital will not be able to arrange full coverage at all times "Physicians, including specialists and subspecialists (e.g., neurologists) are not required to be on call at all times."14 In such cases, the "hospital must have policies and procedures to be followed when a particular specialty is not available or the on-call physician cannot respond because of situations beyond his or her control."15 For example, a hospital with only one orthopedist will be unlikely to have continuous orthopedic coverage of the emergency department. Even if the physician never takes a vacation, he or she will not be reasonably available while in the middle of a lengthy surgical procedure.
The most significant and controversial interpretation in the Transmittal relates to the interpretation of the statutory language "comes to the emergency department." The term is not specifically defined in the statute. Some might argue that its meaning is clear. HCFA is not among that group. By regulation, HCFA has indicated that it interprets this language quite broadly "comes to the emergency department" means "comes to the premises of the hospital," including being in a hospital-owned ambulance."16 This is now expanded to include the "parking lot, sidewalk, and driveway" of the hospital.17 Finally, HCFA takes another expansive step and determines that "comes to the premises of the hospital" (i.e., EMTALA medical screening and stabilization are required) includes patients who present to any "hospital-owned facility which is non-contiguous or off-campus and operates under the hospital’s Medicare provider number."18 This could include urgent care facilities, outpatient facilities and physician offices, so long as they are hospital-owned and were operated under the hospital’s Medicare provider number.
If the hospital-owned facility is "contiguous" to or part of the hospital "campus," patients may be transported to another hospital-owned facility for their medical screening examination, so long as: 1) all persons with the same medical condition are moved to this location regardless of their ability to pay for the treatment; 2) there is a bona fide medical reason to move the patient; and 3) qualified medical personnel accompany the patient.19 Note the requirement that "qualified medical personnel accompany the patient." It is not sufficient to simply direct the patient to another area of the hospital or, in the case of a potential medical emergency, to use an unqualified patient transporter to move the patient.
If a patient presents to a hospital-owned facility (operated under the hospital’s Medicare provider number) which is non-contiguous or off-campus, the individual must be medically screened and stabilized at that facility prior to transport. The medical screening and stabilization requirement is, of course, qualified by the caveat that the facility need only provide stabilization "to the best of its ability," i.e., within its capabilities.
The Transmittal reiterates that triage does not constitute an "appropriate medical screening examination" under EMTALA:
"Triage is not equivalent to a medical screening examination. Triage merely determines the order’ in which patients will be seen, not the presence or absence of an emergency medical condition."20
This interpretation comes as no surprise and actually makes both legal and medical sense. The Transmittal also states that the medical screening examination should be an ongoing process, not an isolated event:
"A medical screening examination is not an isolated event. It is an ongoing process. The record must reflect continued monitoring according to the patient’s needs and must continue until he/she is stabilized or appropriately transferred. There should be evidence of this evaluation prior to discharge or transfer."21
What constitutes an adequate medical screening examination is not specified in the statute or the regulations. HCFA gives some indication of what it thinks constitutes an adequate medical screening examination in the Transmittal:
"Medical records should contain documentation of medically indicated screens, tests, mental status evaluations, impressions, and diagnoses (supported by a history and physical examination, laboratory, and other test results).
For pregnant women, the medical records should show evidence that the screening examination included ongoing evaluation of fetal heart tones, regularity and duration of uterine contractions, fetal position and station, cervical dilation, and status of the membranes, i.e., ruptured, leaking, intact.
For individuals with psychiatric symptoms, the medical records should indicate an assessment of suicide or homicide attempt or risk, disorientation, or assaultive behavior that indicates danger to self or others." 22
The Transmittal addresses the issue of patients with emergency medical conditions leaving against medical advice prior to the completion of stabilizing treatment. In such cases, if the hospital performs an appropriate medical screening examination which has revealed an emergency medical condition and then instructs the individual to wait for treatment, but the patient leaves prior to receiving such treatment, the hospital will not have violated EMTALA so long as: 1) the patient did not leave the department based on a "suggestion" by the hospital (e.g., "This treatment will be very expensive;" "We don’t accept your insurance;" "The waiting time at St. Elsewhere is much shorter;" etc.); and/or 2) the hospital was not operating beyond its capacity and failed to attempt to transfer the individual to another facility.23
The Patient Anti-Dumping Statute
A Special Advisory Bulletin (the "Bulletin") was issued Nov. 9, 1999, by the Department of Health and Human Services’ Office of Inspector General and HCFA discussing the application of the provisions of EMTALA to individuals insured by managed care plans.24 The Bulletin had previously been published in the Federal Register as a proposed bulletin on Dec. 7, 1998, at which time the agencies solicited comments from interested parties.25 In response to issues raised by more than 150 commenters, primarily addressing the issues of dual staffing, prior authorization, the use of financial responsibility forms and advanced beneficiary notifications, and the handling of patient inquiries regarding the obligation to pay for emergency services, the Bulletin was revised and published in final form on Nov. 10, 1999. The draft Bulletin had addressed four issues related to the interpretation of EMTALA in the context of managed care plans:
"1) The obligations of hospitals to provide appropriate medical screening examinations to all patients seeking emergency services and stabilizing treatment when necessary;
"2) Some of the special concerns in the provision of emergency services to enrollees of managed care plans;
"3) The rules governing Medicare and Medicaid managed care plans with respect to prior authorization requirements and payment for emergency services; and
"4) What types of practices would serve to promote hospital compliance with the patient anti-dumping statute when managed care enrollees seek emergency services."26
Dual Staffing. A majority of the comments received addressed the draft Bulletin’s handling of the dual staffing issue. In the draft Bulletin, the agencies acknowledged that certain managed care organizations (MCOs) and hospitals have entered into what was termed "dual staffing," an arrangement whereby "the hospital permits the MCO to station its own physicians in the hospital’s emergency department, separate from the hospital’s own emergency physician staff, for the purpose of screening and treating MCO patients who request emergency services."27 The agencies acknowledged that under such an arrangement, the screening and treatment of patients would be carried out by "two separate groups of physicians" who might be "using different policies and protocols, performing different procedures, using different referral practices and drug formularies, relying on different on-call physicians, and having different credentials."28 Despite all these potential differences that would seem likely to potentially lead to disparate treatment of the two groups of patients (managed care patients vs other patients), the agencies felt that it was "theoretically" possible to "construct two equally good emergency service tracks,’ each adequately staffed and each with equally good access to all of the medical capabilities of the hospital, such that both MCO and non-MCO patients received equal access to screening and stabilizing medical treatment."29
Those opposed to allowing dual staffing opined that allowing such an arrangement would lead to "disparate standards in the ED by fostering separate but unequal treatment.’"30 Certainly, it is difficult to imagine the attractiveness for MCOs to utilize a dual staffing arrangement, at least as to EMTALA screening and stabilization treatment, if the two tracks must be precisely equal (other than different, although equal, personnel), as the agencies apparently require. Issues of potential disparate standards raised by commenters related to: "physician credentialing, drug formularies, equal access, and use of ancillary services, consistency in specialty referrals, waiting times and quality assurance."31
In response to the criticisms of dual staffing made by the commenters, the agencies acknowledged that "dual staffing raises serious issues;" however, dual staffing "would not necessarily constitute a per se violation of the anti-dumping statute."32 The following potential violations are pointed out in the Bulletin:
"Where the emergency department directs a hospital-owned and operated ambulance differently in field care or facility destination depending on which members of a dual staff (that is, either managed care organization or non-managed care organization physicians or practitioners) are either on the radio to emergency medical services or are expected to see the patient.
If the emergency department alert status affecting acceptance of EMS cases differs depending on which "side" (managed care organization or non-managed care organization) is expected to see the patient.
If either the managed care organization or non-managed care organization track is understaffed or simply overcrowded, and a patient in a particular track is subjected to a delay in screening and stabilizing treatment, even though a physician in the alternative track was available to see the individual. Where there is no emergency department policy or procedure, or custom or practice, which requires cross-over coverage between the dual staffs as required for patient care. (Delays in screening or stabilization of patients on one track but not the other are delays in screening or stabilization based on the insurance status of the individual and thus represent potential violations of EMTALA.)
If the hospital’s emergency department quality oversight plan differs between the two "sides" (managed care organization and non-managed care organization) of the dually staffed emergency department.
Where the protocols for transfer of unstable patients differ other than administratively, for example, 1) if the substance of stability determination criteria between the two staffs are different, or 2) when patients are unstable and are transferred routinely to different facilities that are not equivalent to each other in level of care or distance, and their destinations depend on their insurance status."33
With all these potential violations, it seems unlikely that dual staffing could ever actually work in practice.
The Bulletin points out that, while the agencies would not find the use of dual staffing a per se violation of EMTALA, states are free to prohibit such arrangements under state law.34 When enacted, the EMTALA statute provided that it did not preempt (i.e., foreclose) state or local law requirements, unless they were in direct conflict with EMTALA.35 While Congress has the power to preempt an entire field, thereby preventing any state or local legislation in the field, such power was not exercised by Congress in this case. Therefore, states are free to enact legislation which is stricter than the requirements of EMTALA (as interpreted by the federal agencies), so long as there is no direct conflict with EMTALA.
Prior Authorization. Some commenters urged the agencies to expand the reach of the no prior authorization prior to screening or stabilization requirement proposed in the draft Bulletin to all health plans, not just to hospitals and Medicare and Medicaid managed care plans. The draft Bulletin had provided that: "It is not appropriate for a hospital to request or a health plan to require prior authorization before the patient has received a medical screening examination to determine the presence or absence of an emergency medical condition or before the patient’s emergency medical condition is stabilized."36 The agencies declined to expand the reach of this requirement to non-Medicare and non-Medicaid managed care plans on the basis that there was no statutory authority to do so.37
Medicare and Medicaid managed care plans are prohibited by statute from requiring prior authorization for emergency services, including those that are needed to evaluate or stabilize an emergency medical condition, under statutory amendments enacted as part of the Balanced Budget Act of 1997 (Pub.L. 105-33).
In response to the comments, this section of the Bulletin was revised and now provides that: "It is not appropriate for a hospital to seek, or direct a patient to seek, authorization to provide screening or stabilizing services to an individual from the individual’s health plan or insurance company until after the hospital has provided 1) an appropriate medical screening examination to determine the presence or absence of an emergency medical condition, and 2) any further medical examination and treatment necessary to commence stabilization of an emergency medical condition."38
The Bulletin addresses when a hospital may seek, or direct a patient to seek, authorization for payment. According to the Bulletin: "The hospital may seek authorization for payment for all services after providing a medical screening examination and once necessary stabilizing treatment is underway."39 This statement is in conflict with the direction previously provided on the issue in the HCFA State Operations Manual on Provider Certification.40 The State Operations Manual differed in that it provided that authorization for payment could not be requested "until an emergency medical condition [if present] has been stabilized."41 HCFA intends to revise the State Operations Manual to conform to the language in the Bulletin, i.e., authorization for payment may be sought once necessary stabilizing treatment is underway, but prior to complete stabilization of the patient.
Financial Responsibility and Advanced Beneficiary Notification Forms. The agencies’ prohibition on the completion of financial responsibility forms or advanced beneficiary notification forms (required to be provided to beneficiaries if the hospital is to be permitted to bill the beneficiary later for a non-covered service) prior to performing an appropriate medical screening examination, as originally proposed, was relaxed. In the draft Bulletin, hospitals were prohibited from asking a patient to complete either of these forms "[p]rior to performing an appropriate medical screening examination."42
The agencies clarified that it would be a violation if a hospital "delayed a medical screening examination or necessary stabilizing treatment in order to prepare an [Advanced Beneficiary Form] and obtain a beneficiary signature."43 As to financial responsibility forms, the requirement has been modified to provide that "[t]he best practice would be for a hospital not to give financial responsibility forms or notices to an individual, or otherwise attempt to obtain the individual’s agreement to pay for services before the individual’s stabilizing treatment is under way."44 This is, however, not characterized as a requirement, rather as a "best practice."
In response to comments regarding the effect compliance with this "best practice" would have on routine registration procedures, which often utilize consent forms at the time of registration that include an agreement that the patient will pay for services not covered by insurance, the Bulletin states that: "It normally is permissible to ask for general registration information prior to performing an appropriate medical screening examination. The hospital may not, however, condition such a screening and further treatment upon the individual’s completion of a financial responsibility form or provision of a co-payment for any services."45 Putting these two together, it appears that it is a best practice not to provide such forms prior to initiating stabilizing treatment, but it is not a violation unless the hospital conditions screening and treatment on completion of the forms or receipt of a co-payment. The final Bulletin was, therefore, clarified to conform with the State Operations Manual, which provides that a hospital "may continue to follow reasonable registration processes for individuals presenting with an emergency medical condition."46 The key is: 1) not to delay screening or treatment and 2) not to "unduly discourage individuals from remaining for further evaluation."47
Inquiries Concerning Financial Liability for Emergency Services by the Individual. The draft Bulletin provided that a patient’s inquiries regarding his or her obligation to pay should be answered by "a staff member who has been well trained to provide information regarding potential financial liability."48 In addition, it was proposed that hospital staff should encourage patients to stay if the hospital believes that the patient has an emergency medical condition and "to defer further discussion of financial responsibility issues until after the medical screening has been performed."49 Commenters alternatively argued that: 1) deferral of financial discussion when a patient has inquired might discourage the patient from staying for examination and treatment, and 2) hospital staff should be permitted to respond to patient inquiries with specific financial information so long as the hospital continued to offer and encourage the patient to stay for examination.
The agencies declined to substantially revise this section of the Bulletin, although their response to the commenters’ arguments was generally positive in that they stated that the "[a]lternatives suggested by the commenters [respond to patient inquires while encouraging the patient to stay for a medical screening examination and allowing conversations about financial liability issues so long as such discussion does not delay screening and treatment] would be acceptable if such alternatives did not conflict with a minimum effort to defer discussions about financial liability issues until after the provision of screening and the commencement of stabilizing treatment."50 The bottom line, therefore, is:
1) Questions regarding financial liability should be answered only by qualified personnel;
2) Inform the patient of the hospital’s obligation to screen and stabilize, regardless of the patient’s ability to pay; and
3) Make at least a "minimum effort" (whatever that is) to defer discussions about financial liability issues until after the provision of screening and the commencement of stabilizing treatment.
Voluntary Withdrawal. The draft Bulletin provided that hospitals were obligated to do three things if an individual chose to withdraw his or her request for examination or treatment:
1) Offer the individual further medical examination and treatment within the staff and facilities available at the hospital as may be required to identify and stabilize an emergency medical condition;
2) Inform the individual of the risks and benefits of such examination and treatment, and of the risks and benefits of withdrawal prior to receiving such examination and treatment; and
3) Take all reasonable steps to secure the individual’s written informed consent to refuse such examination and treatment.51
In response to comments received, the requirement was modified to make allowance for those times when a hospital is not aware of the individual’s departure until after he or she has left the hospital: "If an individual chooses to withdraw his or her request for examination or treatment at the presenting hospital, and if the hospital is aware that the individual intends to leave prior to the screening examination, a hospital should take the following steps"52 The agencies added an admonition, however, about patients leaving before examination because of excessive waits: "Since every patient who presents seeking emergency services is entitled to a screening examination, a hospital could violate the patient anti-dumping statute if it routinely keeps patients waiting so long that they leave without being seen, particularly if the hospital does not attempt to determine and document why individual patients are leaving, and reiterate to them that the hospital is prepared to provide a medical screening if they stay."53
Transfer/Discharge of Inpatients
HCFA has interpreted EMTALA such that its stabilization and transfer provisions apply to inpatients. Courts have been divided on this issue. The Roberts case, discussed on page 110, involved the transfer of an allegedly unstable inpatient, and the Supreme Court did not specifically address the issue. The case was remanded without comment as to the propriety of an inpatient bringing an EMTALA failure-to-stabilize case. It is important, though, to note that the Supreme Court addresses only specific issues when it decides a case and this issue was not an issue before the Court. As a result, the fact that the Court remanded the case without comment on this issue does not mean the Court endorses the Sixth Circuit’s opinion that EMTALA stabilization requirements apply to inpatients.
In Baxter v Holy Cross Hospital of Silver Spring,54 the Fourth Circuit affirmed a lower court decision dismissing the EMTLA claims of an inpatient alleging a failure to stabilize. In Baxter, the patient claimed that after 30 days of hospitalization he was still unstable due to cardiac and renal problems and should not have been transferred to an extended care facility. The court held that after a hospital stabilizes a patient, EMTALA drops from the picture and any subsequent disputes concerning adequacy of treatment should be governed by state medical malpractice law. On March 22, 1999, the U.S. Supreme Court declined to review the Fourth Circuit’s decision in this case.55
There is a split in the circuits as to whether EMTALA’s stabilization requirement applies to inpatients in the Sixth Circuit, an inpatient may make an EMTALA failure to stabilize claim (Roberts);56 in the Fourth Circuit, such a claim fails (Baxter). This would, perhaps, be an appropriate issue for the Supreme Court should it decide to hear another EMTALA case. Clarification as to HCFA’s position on the issue should be forthcoming prior to any decision by the Supreme Court. As discussed above, during oral argument of Roberts, James A. Feldman, Assistant to the Solicitor General, who argued on behalf of the Department of Justice in a friend-of-the-court capacity, announced that the Secretary of the Department of Health and Human Services intends to initiate a rulemaking on EMTALA, "in part because of this case [Roberts]," and also to clarify other questions under the statute, such as for how long a hospital’s duty under EMTALA extends.57 There is reason to believe that a draft of this new proposed rule is being circulated and discussed at HCFA and the OIG, but it has not yet been made public. It appears that there may be debate in the agencies as to the extent EMTALA should be applicable to patients admitted to the hospital. This will undoubtedly be addressed in any new proposed rule. On June, 28, 1999, in a speech before the American Health Lawyers Association, Jessica Bowman, associate counsel to the Office of the Counsel to the Inspector General said: "Our office takes a broad view of the EMTALA statuteThe OIG was particularly excited about the Roberts caseThe OIG does believe the EMTALA statute applies to inpatients."
Cherukuri v Shalala
On May 3, 1999 (nearly 8 years after the alleged violation and 2 years after an Administrative Law Judge’s [ALJ] imposition of a $100,000 fine), the Sixth Circuit Court of Appeals decided Cherukuri v Shalala.58 In its decision, the Court reversed the Department of Health and Human Services Administrative Law Judge’s imposition of the fine on Dr. Cherukuri, a surgeon who was on-call for the emergency department at Williamson Hospital the day the alleged EMTALA violation occurred. This had been the largest fine ever imposed under EMTALA until it was reversed by the Appeals Court.
At about 3:30 a.m. on Sunday morning, Sept. 15, 1991, five injured auto accident victims were brought to the Williamson Hospital emergency room. There was, at that time, one physician and one nurse (nurse Hatfield) on duty in the emergency room. Dr. Cherukuri, the general surgeon on call, was immediately called. He responded promptly and came to the emergency room immediately. A second nurse (the house supervisor) was summoned to the emergency room where Dr. Cherukuri and the two nurses cared for the five trauma patients for the next six hours. According to the two nurses, the small emergency department was "almost overwhelmed" by the situation.59 Of the five patients, two were critically injured and another was seriously injured.
Dr. Cherukuri found one of the patients (Crum) to be "nonresponsive with massive cranial injuries, very low blood pressure and fixed dilated pupils."60 He apparently performed a peritoneal tap which was grossly positive. He began resuscitation with crystalloid and blood and determined that he would have to operate on Crum’s abdomen before transferring him to St. Mary’s Hospital in Huntington, WV, a teaching hospital with a trauma center to which such patients were routinely transferred from Williamson.
Dr. Cherukuri found a second patient (Mills) to be "responsive but unconscious with a serious head injury and low blood pressure."61 He also had a grossly positive peritoneal tap. A plan for Mills, similar to that begun for Crum, was initiated and the doctor turned his attention to the other three patients. At this time, Dr. Cherukuri attempted to find a second general surgeon to come to the hospital to assist him in the treatment of the multiple patients, but was unsuccessful.
After approximately four hours of treatment, Crum and Mills were transferred to St. Mary’s in Huntington. Time had been lost attempting to arrange helicopter transfer of the two patients. Eventually, the helicopter pilots had advised that they were unable to come to Williamson because of weather conditions.
The transfer had also been delayed because of Dr. Cherukuri’s difficulties in finding an anesthesiologist to provide anesthesia to the two patients at Williamson. It was undisputed that by 4 a.m., Dr. Cherukuri had decided to take Crum and Mills to the operating room for exploratory laparotomies, so as to stabilize their conditions. Over the next three hours, Dr. Cherukuri was unable to convince the anesthesiologist on call, Dr. Thambi, to provide anesthesia for the surgery. Dr. Thambi advised strongly against the surgery because it was his opinion that administering anesthesia to these patients to operate on their abdomens was too risky because they would be unable to monitor intracranial pressure. He testified that he advised Dr. Cherukuri to transfer the patients immediately to St. Mary’s Hospital in Huntington and that he would only have provided anesthesia "under protest" if ordered to do so.
Dr. Cherukuri and Pat White, the house supervisor, attempted over the next two hours to convince Dr. Thambi to come to the hospital and also tried unsuccessfully to find another anesthesiologist. When Dr. Thambi finally came to the hospital, approximately two and a half hours after the initial call, he testified that "he told the parents of the patients that they must be transferred to Huntington for surgery because it could not be performed at Williamson."62
At about 4 a.m., after Dr. Thambi had refused to provide anesthesia, Dr. Cherukuri called Dr. Arya, the on-call surgeon at St. Mary’s in Huntington, who advised him to find an anesthesiologist and to take the patients to the operating room for exploratory laparotomies. Dr. Arya testified that "he was irate when he learned later that morning that the patients were on their way by ambulance.63 Dr. Arya testified that he was angry and suspected patient dumping and, therefore, reported the incident as an improper transfer. Thus began nearly eight years of difficulty for Dr. Cherukuri. On the basis of the complaints of Dr. Arya, the administrator at St. Mary’s, and others, the government initiated an investigation and, ultimately, a prosecution of Dr. Cherukuri for violation of EMTALA.
Despite the fact that the administrator at St. Mary’s and Dr. Arya both changed their minds completely once they knew all the facts and circumstances that Dr. Cherukuri faced, the government was not deterred in its prosecution of Dr. Cherukuri. While the government claimed that Dr. Cherukuri had lied about receiving permission from Dr. Arya to transfer the patients, Dr. Arya’s testimony did not support this conclusion. In answer to a question by government counsel, "after having this conversation [about 4 a.m. with Dr. Cherukuri] what was your expectation of what should occur before transfer," Dr. Arya gave this answer:
"Difficult for me to say what was going on in the other side. I thought that he would probably find a way to take care of the patient [by operating]. At the same time it is conceivable he was so desperate to do something, he sent the patient over. That is quite conceivable to me."64
According to the Sixth Circuit, "[w]hile recognizing that Dr. Thambi had made his position very clear that he did not intend to provide anesthesiology because it might kill the brain-injured patients, the ALJ concluded that EMTALA required the surgeon to force Dr. Thambi to perform by expressly ordering him to administer anesthesia."65 The ALJ concluded that "the law necessarily required’ Dr. Cherukuri to stop the bleeding for the patient to be considered stabilized’ under the statute and that this required Dr. Cherukuri to force Dr. Thambi against his will [to] administer anesthesia."66
By the time the patients were transferred, all witnesses, as well as the ALJ, agreed that they were normotensive and not in shock. However, two witnesses, an emergency room physician and a general surgeon, testified for the government as experts that, in a case such as this, "stabilization’ for transfer to another hospital could not occur, as a matter of definition, unless abdominal surgery was performed to stop the internal bleeding."67 The ALJ accepted their inflexible definition of "stabilize" which, according to them, apparently meant that patients could never be transferred while internal bleeding remained.68 At the time of arrival at St. Mary’s, all witnesses agreed that neither of the patients’ conditions had deteriorated.
The ALJ adopted the two government experts’ definition of "stabilize," rejecting the opinions of eight expert witnesses, including Dr. Cherukuri, that "stabilize’ must be given a more flexible meaning and that the on-the-spot risk analysis of Dr. Cherukuri leading to transfer was appropriate under the circumstances."69 The witnesses testifying for Dr. Cherukuri included Dr. Arya (the receiving surgeon at Huntington who operated on Crum and Mills when they arrived), Dr. Thambi (the Williamson anesthesiologist), Dr. Sakhai (a neurosurgeon in Huntington), Dr. Aaron ("a board certified quality assurance’ and peer review physician"), Dr. Paul Fowler (specializing in "legal medicine"), and nurses Hatfield and White.
The Sixth Circuit was clear, and rather caustic, in its criticism of the ALJ and Appeals Board’s conduct:
"Therefore, we conclude that the ALJ did not apply the proper meaning of stabilization’ and hence the proper standard for transfer and seriously erred in concluding that anesthesiology was available. It is unfortunate that the errors we have uncovered were not caught earlier in the administrative process. When the administrative Review Board’ established to administer EMTALA cases chooses without explanation to make an ALJ decision in an important case binding without review, the burden on the Court of Appeals to comb the record is substantially increased. We respectfully suggest that the Board should review cases like this one closely and should not simply pass them on to a federal appellate court without providing a reasoned disposition of the objections raised by the parties. Our own close review of the record clearly shows that the decision is not supported by substantial evidence on the record as a whole, does not justify the legal conclusion made by the ALJ that Dr. Cherukuri "knew or should have known that the benefits [of transfer] did not outweigh the risks" (§ 1395dd(d)(1)(B)), and accordingly must be set aside."70
Clearly, the Sixth Circuit felt that the government’s prosecution had been overzealous and its application of EMTALA requirements overly rigid.
Conclusion
In the coming months we can expect some communication from HCFA clarifying the extent that EMTALA obligations extend to inpatients. Whether this will come as a proposed rule subject to comment, or as something more final (e.g., a clarification of the existing regulations) is not clear. In the meantime, hospitals generally ignore EMTALA as to inpatients, plaintiffs bring lawsuits alleging improper transfer of inpatients, the OIG’s position is that EMTALA applies to inpatients, and courts vary in their interpretation. That is, the situation is confused. The fact that this issue was not addressed in either the Special Advisory Bulletin or the State Operations Manual Transmittal may indicate that debate on this subject inside HCFA and the OIG is ongoing.
Some EMTALA issues remain unsettled by the courts, or at least there is a split among the federal circuits, e.g., application of EMTALA to inpatients and EMTALA obligations at hospital-owned, off-campus facilities. There has been some direction from HCFA in the form of the Special Advisory Bulletin and State Operations Manual Transmittal. While these documents do not carry the force of law, the conservative approach is to follow their direction. They do represent HCFA’s and/or OIG’s interpretation of the law and indicate how those agencies intend to enforce it.
Perhaps next year’s EMTALA Update will contain the answers to some of these current controversies, or at least further direction from HCFA or the courts. However, if a significant development occurs, it will be promptly announced in ED Legal Letter.
Endnotes
1. BNA’s Health Law Reporter Vol. 8, No. 28, 1081 (July 1, 1999). (Other figures in this paragraph are also from this article.)
2. Department of Health and Human Services Semiannual Report (Oct 1, 1998 March 31, 1999).
3. 525 U.S. 249, 119 S.Ct. 685 (1999).
4. Id.
5. 111 F.3d 405 (6th Cir. 1997).
6. 917 F.2d 266 (6th Cir. 1990).
7. 119 S.Ct. at 687.
8. Id.
9. Id.
10. 4 Health Law Reports 1915 (Dec. 3, 1998).
11. 59 FR 32086, 32092.
12. Transmittal, Investigative Procedures, § 1 (emphasis added).
13. Id. , Interpretive Guidelines, § A404.
14. Id.
15. Id.
16. 42 CFR § 489.24(b).
17. Transmittal, Interpretive Guidelines, § A406.
18. Id. (emphasis added).
19. Id.
20. Id.
21. State Operations Manual ("SOM") § V, Appendix V. tag A406.
22. SOM, Appendix V, Task 3, Record Review.
23. Id.
24. 64 FR 61353.
25. 63 FR 67486.
26. OIG/HCFA Special Advisory Bulletin on the Patient Anti-Dumping Statute, 64 FR 61353, 61354 (Nov. 10, 1999).
27. Solicitation of Comments on the OIG/HCFA Special Advisory Bulletin on the Patient Anti-Dumping Statute, 63 FR 67486 (Dec. 7, 1998).
28. 63 FR 67486, 67487.
29. Id.
30. 64 FR 61353, 61354.
31. Id.
32. Id.
33. Id. at 61357.
34. Id.
35. 42 USC § 1395dd(f).
36. 63 FR 67486, 67488.
37. Id.
38. 64 FR 61353, 61358.
39. Id. (emphasis added).
40. Transmittal No. 2, May 1988, Interpretive Guidelines Responsibilities of Medicare Participating Hospitals in Emergency Cases, Data Tag No. A406, p. V-20).
41. Id. (emphasis added).
42. 63 FR 67486, 67488.
43. 64 FR 61353, 61355.
44. Id.
45. Id.
46. Id.
47. 64 FR 61353, 61355.
48. 63 FR 67486, 67488.
49. Id.
50. 64 FR 61353, 61355.
51. 63 FR 67486, 67488.
52. 64 FR 61353, 61359 (emphasis added).
53. Id. at 61356.
54. 155 F.3d 557 (4th Cir. 1997), U.S., No. 98-1169, cert. denied.
55. Id.
56. See also, Thornton v Southwest Detroit Hospital, 894 F.2d 1131 (6th Cir. 1990).
57. 4 Health Law Reporter, 1915 (Dec. 3, 1998).
58. 175 F.3d 446 (6th Cir. 1999).
59. Id. at 451.
60. Id.
61. Id.
62. Id. at 452.
63. Id. at 454.
64. Id.
65. Id. at 452.
66. Id.
67. Id.
68. I would certainly have argued that the definition of statutory terms is a question of law for the court (here an ALJ), not an appropriate area of opinion for an expert, and their opinions on this matter should never have been admitted into evidence.
69. 175 F.3d at 453.
70. Id. at 455.
Physician CME Questions
5. In order to prevail on an EMTALA claim, a court:
a. will require the plaintiff to prove an improper motive in a failure to stabilize case.
b. may require the plaintiff to prove an improper motive in a failure to properly screen case, depending on the circuit.
c. both of the above.
d. neither of the above.
6. A medical screening examination:
a. must be performed by a physician.
b. may be performed by anyone delegated such a responsibility by the emergency physician.
c. should be an ongoing process.
d. none of the above.
7. A patient’s inquiries regarding financial liability for emergency services should:
a. be answered only be qualified personnel.
b. if answered, include a statement of the hospital’s obligation to screen and stabilize, regardless of the patient’s ability to pay.
c. be deferred through the use of at least "minimum effort."
d. all of the above.
8. Medical screening examinations:
a. are inadequate if all medical conditions are not discovered.
b. should be uniform for all patients having the same or similar condition.
c. both of the above.
d. neither of the above.
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