1. Illinois College of Emergency Physicians On Our Watch Preparing for Overcrowding and Bioterrorism in the Emergency Department “ EMTALA: An Everyday Violation” January 10, 2003 Presented By: Michael R. Callahan Katten Muchin Zavis Rosenman 525 West Monroe Street Chicago, IL 60661 312.902.5634

2. 2 50086631 Introduction Hospitals participating in the Medicare program must comply with the obligations set forth in the Emergency Medical Treatment and Active Labor Act (EMTALA). Congress passed EMTALA as part of the Consolidated Omnibus Budget Reconciliation Act of 1986. Briefly, EMTALA requires the hospital participating in the Medicare program to provide a medical screening examination to all persons who present at the hospital, regardless of the person’s ability to pay for treatment or services. If the patient has an emergency medical condition, the hospital must either treat the patient or stabilize the patient and transfer the patient to another facility.

3. 3 50086631 EMTALA: The Legal Obligation The Statute and Regulations 42 U.S.C. § 1395dd 42 C.F.R. § 489.24 See also State Operations Manual Provider Certification –Investigation Procedures –Interpretative Guidelines

4. 4 50086631 EMTALA: The Legal Obligation The Statute and Regulations Step 1: Medical Screening Examination –In the case of a hospital that has a hospital emergency department, if any individual (whether or not eligible for benefits under [the Medicare program]) 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 exists.

5. 5 50086631 EMTALA: The Legal Obligation The Statute and Regulations Step 2: Emergency Medical Condition –If the medical screening examination reveals that an emergency medical condition does exist, the hospital must either: treat the patient in order to stabilize the medical condition; or stabilize the patient in order to transfer the patient to another medical facility

6. 6 50086631 EMTALA: The Legal Obligation Key Components/Definitions “Comes to the Emergency Department” –means that the individual is on hospital property hospital property is defined to include: ambulances owned and operated by the hospital (even if the ambulance is not on hospital property); nonhospital owned ambulances on hospital property; In July of 1998, the Health Care Financing Administration (“HCFA”) revised its interpretive guidelines for EMTALA (“Revised Guidelines”). Among other revisions, HCFA “clarified” that EMTALA obligations apply to all hospital-owned facilities, including off-campus and non-contiguous facilities, which are operated under the hospital’s Medicare provider number.

7. 7 50086631 EMTALA: The Legal Obligation Key Components/Definitions On May 9, 2002, HHS proposed major changes to EMTALA, including a clarification to the definition of “comes to the emergency department” –Proposed rule now refers to the hospital’s “dedicated emergency department” which is a specially equipped and staffed area of hospital used a significant portion of the time for emergency medical conditions and is located: on main hospital campus; or off main campus but treated by Medicare as a department of hospital –Patient or individual on behalf of patient requests examination or treatment or a “prudent layperson observer” would believe an examination or treatment is needed

8. 8 50086631 EMTALA: The Legal Obligation Key Components/Definitions –Presents on hospital property, other than dedicated emergency department, and requests services or there is a reasonable belief of need –Hospital property means entire hospital campus, parking lot, sidewalk and driveway but excludes areas and structures within 250 yards of main building not part of hospital such as physician offices, rural health center, skilled nursing facilities, restaurants, shops or other non- medical facilities –Would also include other departments on the hospital that provide emergency services, such as labor, delivery and psych, or departments that hold themselves out as providing such services on an urgent and unscheduled basis

9. 9 50086631 EMTALA: The Legal Obligation Key Components/Definitions –If patient presents but request and condition make it clear that there is no emergency, scope of screening is only that which is necessary to determine whether patient does or does not have an emergency medical condition –EMTALA triggered if patient presents to hospital at a site other than the dedicated emergency room or other similar department but requests or needs emergency services –Outpatients who come for treatment but later manifest an emergency medical condition are not considered to have “come to the hospital’ for EMTALA purposes but need be treated consistent with Medicare Conditions of Participation

10. 10 50086631 EMTALA: The Legal Obligation Key Components/Definitions –EMTALA would apply to inpatients only if never considered stabilized. If stabilized, it does not but other requirements such as Medicare Conditions of Participation may apply. Proposed rule states that EMTALA does not apply would apply either to an inpatient who was not admitted in an emergent condition or one who was but was later stabilized –No EMTALA requirements if a patient presents to an off campus but provider based entity or department which does not routinely provide emergency care. Should provide whatever assistance it can and contact EMS personnel. Hospital needs to develop appropriate policies to define its procedures for this situation –EMTALA would not apply to hospital based entities, such as a rural health clinic, as opposed to a department that is on the hospital campus

11. 11 50086631 EMTALA: The Legal Obligation Key Components/Definitions Stabilization –With respect to an emergency medical condition, stabilized means: no material deterioration of the condition is likely, within reasonable medical probability, to result from the transfer. –In the Revised Guidelines, HCFA clarified that a patient will be deemed stabilized if the treating physician attending to the patient has determined, within reasonable clinical confidence, that the emergency medical condition has been resolved.

12. 12 50086631 EMTALA: The Legal Obligation Key Components/Definitions Stabilization (Continued) for patients whose emergency medical condition has not been resolved, a determination of whether the patient is stable may occur in one of two circumstances: –“stable for transfer” occurs when the attending physician determines, within reasonable clinical confidence, that the patient is expected to leave the hospital and be received at the second hospital with no material deterioration in his/her medical condition and the treating physician believes the receiving facility has the capability to manage the patient’s medical condition. –“stable for discharge” occurs when, within reasonable clinical confidence, it is determined that the patient has reached the point where his/her care could be reasonably performed as an outpatient or later as an inpatient, provided the patient is given a plan for appropriate follow-up care with discharge instructions.

13. 13 50086631 EMTALA: The Legal Obligation Key Components/Definitions Medical Screening Examination –A medical screening examination is the process required to determine, with reasonable clinical confidence, whether an emergency medical condition exists. –Triage is not equivalent to a medical screening examination. –Depending on the patient’s symptoms, a medical screening examination can be a simple process (brief history and physical examination) or a complex procedure involving various ancillary services. –A medical screening examination need not be performed by a physician. –A medical screening examination is not an isolated event. The record must reflect continued monitoring of the patient’s condition until he/she is stabilized or appropriately transferred. There should be evidence of the evaluation prior to discharge.

14. 14 50086631 EMTALA: The Legal Obligation Key Components/Definitions Emergency Medical Condition –For purposes of EMTALA, an emergency medical condition means a medical condition manifesting itself by acute systems of sufficient severity such that absence of immediate medical condition could reasonably be expected to result in: placing the health of the individual in serious jeopardy; serious impairment; serious dysfunction; or in regard to a pregnant woman, there is inadequate time to effectuate a safe transfer before delivery or the transfer may threaten the health or safety of the woman or unborn child.

15. 15 50086631 EMTALA: The Legal Obligation Additional Considerations Signage –Under EMTALA, a hospital is required to post signage, in a conspicuous place and in language clearly understandable by the population served by the hospital, specifying the rights of individuals with emergency conditions and women in labor. –Signage must indicate whether the facility participates in the Medicaid program.

16. 16 50086631 EMTALA: The Legal Obligation Additional Considerations On-Call List –Hospitals must have an on-call list of physicians available to stabilize individuals with emergency medical conditions. –If a hospital offers a service to the public, the service should be available through on-call coverage to the emergency department. –Proposed rule would provide that physician, including specialists and subspecialists do not have to be on call at all times. Hospital needs to develop policies to respond to situations where specialty coverage is not available on the on-call physician cannot respond for reasons beyond their control.

17. 17 50086631 EMTALA: The Legal Obligation Additional Considerations June 13, 2002 DHHS Program Memorandum regarding EMTALA on-call requirements makes the following points: –In addition to proposed rule discussed above, guidance states that where hospital lacks capacity to treat a patient, transfer consistent with EMTALA requirements is appropriate –Where there is limited physician availability and hospital resources, CMS “allows hospitals flexibility to comply with EMTALA obligations by maintaining a level of on-call coverage that is within their capability.” There is no set requirement on how often physicians are required to be on-call. Key is to document –Allowing the hospital and medical staff the flexibility to exempt certain physicians based, for example on age or years of service, is acceptable as long as it “does not affect patient care adversely.”

18. 18 50086631 EMTALA: The Legal Obligation Additional Considerations –Although there are no set ratios relating to the number of physicians required to provide 24/7 coverage in any specialty, CMS will look to various factors such as numbers of physicians, demands on these physicians and for emergency services and alternative coverage or transfer arrangements when determining whether EMTALA coverage obligations have been met made by the hospital –In response to a question as to whether hospitals in the same community can share on-call coverage so that there is 100% coverage in one or more specialties, CMS essentially stated that this option was available but emphasized the need to adopt appropriate policies, procedures and bylaws defining these responsibilities and options, particularly if circumstances do not permit either hospital to provide needed coverages on its own –Call schedules must list physician by their individual names. Naming a specific physician group is not permitted

19. 19 50086631 EMTALA: The Legal Obligation Additional Considerations –CMS, while recognizing that hospital may have particular problems with availability of on-call physicians, raised concerns over a policy which would permit an on-call physician to schedule an elective procedure at the same time –Physicians can be on call simultaneously at more than one hospital consistent with standards discussed above

20. 20 50086631 EMTALA: The Legal Obligation Additional Considerations Central Log –Hospitals must maintain a central log to track care provided to individuals who come to the hospital seeking care for an emergency medical condition. –Multiple logs are permitted (i.e., logs from different departments).

21. 21 50086631 EMTALA: The Legal Obligation Additional Considerations Managed Care Enrollees –See Notice of Proposed Special Advisory Bulletin, 63 Fed. Reg. 67486 (Dec. 7, 1998). –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.

22. 22 50086631 EMTALA: The Legal Obligation Additional Considerations Continued Obligation? –Do transfer/discharge obligations survive for so long as patient has an EMC? See Roberts v. Galen of Virginia, Inc., 119 S. Ct. 685 (1999). But see comments on proposed rule. –Once an emergency medical condition has been determined not to exist or the emergency medical condition is stabilized, prior authorization for further services may be sought. –Regardless of whether a hospital will be paid by the managed care payor, it is obligated to provide the services required by EMTALA.

23. 23 50086631 EMTALA: The Legal Obligation Additional Considerations Continued Obligation? (Continued) –Notwithstanding the foregoing, a hospital may continue to follow a reasonable registration process for emergency room patients, including requesting insurance information, so long as those procedures do not delay the provision of necessary treatment and so long as those procedures are applied equally to all patients. –In St. Anthony Hospital v. DHHS, a hospital was found liable under EMTALA for refusing to accept a patent transfer because it had “specialized capabilities or facilities” not otherwise available at the transferring hospital.

24. 24 50086631 EMTALA: The Legal Obligation Enforcement HCFA –Surveys and investigations through state survey agencies. Common violations of EMTALA include: failure to screen; inappropriate transfer of an unstable patient; lack of notices; failure to maintain a central log; failure to adhere to hospital policies and procedures (e.g., who is qualified to perform MSE, on-call obligations. –Statement of Deficiencies Plan of Correction –Notice of Termination Fast Track (23 days) Non immediate jeopardy cases (90 days)

25. 25 50086631 EMTALA: The Legal Obligation Enforcement OIG –Investigation by PRO –Recommendation to OIG –Civil money penalties Up to $50,000 (or not more than $25,000 in case of a hospital with less than 100 beds). Note: No showing of improper motive is required. See Roberts v. Galen of Virginia, Inc., 119 S. Ct. 685 (1999). May also be asserted against physicians –Civil actions may also be brought by individuals and medical facilities against offending hospital (but not physician or physician group).

26. 26 50086631 Governmental or Accrediting Body Pronouncements Affecting Issues of Overcrowding, Bioterrorism or Other Similar Disasters CMS –November 29, 2001 Guidance on EMTALA and hospital capacity Recipient hospital generally required to accept transfer of a patient in need of available specialized capabilities and where it has capacity to receive and transferring hospital does not have the capability or capacity. See St. Anthony Hospital. “The capacity to render care is not reflected simply by the number of persons occupying a specialized unit, the number of staff on duty, or the amount of equipment on the hospital’s premises. Capacity includes whatever a hospital customarily does to accommodate patients in excess of its occupancy limits (§489.24(b)). If a hospital has customarily accommodated patients in excess of its occupancy limits by whatever means (e.g., moving patients to other units, calling in additional staff, borrowing equipment from other facilities) it has, in fact, demonstrated their ability to provide services to patients in excess of its occupancy limits.”

27. 27 50086631 Governmental or Accrediting Body Pronouncements Affecting Issues of Overcrowding, Bioterrorism or Other Similar Disasters November 8, 2001 Question and Answer to Bioterrorism and EMTALA –EMTALA applies and therefore stabilizing treatment must be provided within the hospital’s capability and capacity and/or within the provisions of a community response plan developed by a state or local government. For example, if a patient presented at a hospital which was not designated to treat victims of bioterrorism as part of a state or local community plan, transfer to a designated facility after first determining that the patient fits this description without performing a screening would not be treated as an EMTALA violation

28. 28 50086631 Governmental or Accrediting Body Pronouncements Affecting Issues of Overcrowding, Bioterrorism or Other Similar Disasters JCAHO –EC.1.4 The organization has an emergency management plan. If the organization determined that it will grant emergency privileges during a disaster, then the requirements of MS.5.14.1 should be followed. –MS.5.14.1 Emergency privileges may be granted when the emergency management plan has been activated and the organization is unable to handle immediate patient needs.

29. 29 50086631 Governmental or Accrediting Body Pronouncements Affecting Issues of Overcrowding, Bioterrorism or Other Similar Disasters –EC.2.8 Personnel have been oriented to and educated about the environment and possess the knowledge and skills to perform their responsibilities in the environment –Hospital staff participating in the emergency management plan among other things, must be able to describe or demonstrate a multitude of tasks and responsibilities involving drills, emergency equipment management, utility systems and communications systems –EC.2.9 The hospital conducts emergency drills regularly –EC.2.9.1 Drills are conducted regularly to test emergency management

30. 30 50086631 Governmental or Accrediting Body Pronouncements Affecting Issues of Overcrowding, Bioterrorism or Other Similar Disasters –The response phase of the emergency management plan is tested twice a year, either in response to an actual emergency or in planned drills. Drills are conducted at least four months apart and no more than eight months apart. –Testing includes: For organizations that offer emergency services or are designated as disaster receiving stations, at least one drill yearly that includes an influx of volunteer or simulated patients. Participation in at least one community-wide practice drill yearly (where applicable) relevant to the priority emergencies identified by the organization’s hazard vulnerability analysis, that assesses communication, coordination, and the effectiveness of the organization’s and community’s command structures.

31. 31 50086631 Governmental or Accrediting Body Pronouncements Affecting Issues of Overcrowding, Bioterrorism or Other Similar Disasters Notes:1.Tests of a and b may be separate, simultaneous, or combined. 2.Drills that involve packages of information that simulate patients, their families, and visitors are acceptable. 3.Tabletop exercises, though useful in planning or training, are not acceptable substitutes for test a. 4.Staff in each freestanding building classified as a business occupancy, as defined by the Life Safety Code®, that do not offer emergency services nor are designated as disaster receiving stations need only participate in one emergency preparedness drill annually. Staff in areas of the building that the organization occupies must participate in such drills. 5.In test b, “community-wide” may range from a contiguous geographic area served by the same health care providers, to a large borough, town, city, or region.