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July 8, 2002

Thomas A. Scully, Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Room 443-G
Washington, DC 20201

Attention: CMS-1203-P Medicare Program: Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2003 Rates

Dear Administrator Scully:

On behalf of the 62,000 Fellows of the American College of Surgeons, we are pleased to submit the following comments in response to the provisions relating to the Emergency Medical Treatment and Active Labor Act (EMTALA) in the proposed rule for "Responsibilities of Medicare Participating Hospitals in Emergency Cases" published in the May 9, 2002 Federal Register.

Over the last several years, many surgeons have become more reluctant to take call at hospitals due to the expansion of EMTALA requirements. The College hears frequently from its Fellows that the current situation is unsustainable and that while physicians and surgeons will continue to put patients first, access to care will continue to deteriorate unless EMTALA is reformed. We therefore applaud CMS for recognizing many of the problems that physicians are encountering in trying to comply with EMTALA and for taking steps to modify the regulations so that they more accurately reflect the original intent of the law.

The College is particularly pleased that CMS has issued two program memorandums to its Associate Regional Administrators since the release of this proposed rule that elaborate on EMTALA requirements. These guidance documents provide clarification on some of the critical issues that have long concerned surgeons and other physicians in regards to EMTALA. We greatly appreciate CMS' responsiveness to these concerns and the priority the agency has placed on reform of EMTALA. In addition to the revisions and clarification that CMS has proposed, the College believes there are several key areas of the proposed rule that need further review.

The College's comments on the proposed rule can be summarized as follows:

• Although CMS has clarified that physicians are not required to be on call 24 hours a day, seven days a week, the College urges CMS to state explicitly that hospitals are prohibited from requiring physicians to be on continuous call.
• The College wholeheartedly supports CMS' change of policy that will allow on-call physicians to provide coverage simultaneously at several hospitals.
• The College asks that CMS clarify that on-call physicians should not be required to respond to emergent cases or perform procedures for which they do not hold hospital privileges.
• CMS should clarify that physicians are allowed to perform elective services at their own discretion while on call.
• The College asks that CMS establish a clear policy that states once patients are admitted to the hospital on an inpatient basis, EMTALA no longer applies.
• The College supports the revision of CMS policy on the applicability of EMTALA to off-campus hospital departments and clarification that it does not apply to on-campus provider-based entities.
• CMS should clarify that the movement of a patient with an emergency medical condition from the main hospital building to another on-campus entity does not constitute a "transfer" if done in order to provide that patient with an EMTALA-mandated service.

On-Call Requirements

Our strongest concern in regards to the proposed revisions of EMTALA remains the on-call provisions and their impact on the ability of surgeons to practice "real-world" medicine in a manner that is feasible and that best meets the needs of patients.

In many parts of the country, especially in rural areas and those with small hospitals providing care over a great distance, there is an insufficient population base to support a large number of specialists in a number of fields, including neurosurgery, cardiovascular services, pediatric surgery, obstetrics/gynecology and orthopedics. A single specialist—who covers multiple hospitals, possibly across a wide area—might be required as a condition for joining a hospital's staff to be on-call 24-hours a day, seven days a week. Surgeons cannot be selective about the day or the circumstance, such as limiting their on-call responsibilities to just weekdays or weekends. In fact, the surgeon is expected to leave other activities, such as office practice or potentially even a surgical procedure, in order to answer the call from the emergency department.

These requirements are clearly impossible to meet. The issues of continuous call, simultaneous call, limiting on-call coverage to physician's scope of practice and elective surgery while on call have become ones that surgeons and other physicians struggle within an effort to maintain their regular practice and meet EMTALA requirements. The College asks that CMS consider ways in which it can direct hospitals to work with physicians to develop reasonable bylaws relating to on-call coverage that accomplish the goals of EMTALA. The fear of EMTALA violation should not be the overriding factor in making decisions on how and where to treat patients. This decision should be based on medical judgements made by appropriate health professionals. The system under which this can occur is best devised by the hospitals and physicians, in consultation with each other and not unilaterally by hospitals, under the advice of lawyers who are legitimately consumed with immunizing their hospitals from EMTALA violation and penalties.

Continuous Call

The College appreciates CMS clarifying the on-call requirements of EMTALA by proposing to add a new paragraph to EMTALA to specify that "physicians, including specialists and subspecialists, are not required to be on call at all times." While CMS clarifies in the Federal Register notice and the subsequent June 13th memorandum that EMTALA does not require physicians to be on-call 24 hours a day, seven days a week, the rule does not prohibit hospitals from requiring that of physicians in their hospital bylaws or other rules. We remain concerned that hospitals may still demand unreasonable on-call hours from their hospital staff on the basis that doing so "best meets the needs of the hospital's patients."

The College realizes that CMS has a responsibility to ensure that an infrastructure is in place that provides emergency coverage to all who need it, to the maximum extent possible. The College also shares this commitment and would like to see a system that provides this safety net, without creating schedules and demands that are so unreasonable that they drive surgeons out of emergency care altogether – a result that would be especially disastrous in small and rural communities.

The College urges CMS to adopt a policy that prohibits hospitals from requiring individual surgeons to be on-call at all times. Many physicians are currently unclear as to what is required by EMTALA, or what is required as a part of hospital bylaws or rules. Establishing a policy that states hospitals cannot require physicians to be on continuous call will provide clear guidelines for physicians when working with hospitals to develop reasonable on-call schedules that best meet the needs of patients.

Simultaneous Call

The College is pleased that CMS issued a program memorandum on June 13, 2002 that provides guidance to regional offices, survey agency personnel, physicians and hospitals on simultaneous on-call as it relates to EMTALA. We wholeheartedly endorse CMS' change of policy that will allow on-call physicians to provide coverage simultaneously at several hospitals.

Many surgeons, especially specialists who are in short supply in a particular area, have privileges at several hospitals. This, of course, serves the interests of patients living in these communities. It is absolutely critical that they be allowed to take call simultaneously at different hospitals in order to ensure that patients at more than one hospital have access to physicians' services. The College interprets this program memorandum to clarify that a surgeon who responds to an emergency call at one hospital and who can therefore not immediately respond to a call at another hospital, would not be in violation of EMTALA. Because CMS allows simultaneous call, the surgeon's ability to respond to the second emergency call is "beyond the physician's control." The College agrees that explicitly permitting simultaneous on-call will maximize patient access to emergency care.

Elective Surgery When On-Call

CMS' policy on performing elective surgery while on call is unclear. CMS has made conflicting statements in guidelines as to whether a physician would be in violation of EMTALA if he or she were performing elective surgery and could not respond to an emergency call. Many surgeons perform elective procedures when they are on call to the emergency department. Based on anecdotal evidence, it is rare that a physician cannot respond to an emergency call because he or she is performing an elective procedure; however, these circumstances could occur.

It is unreasonable to expect physicians, particularly those surgeons who are on call for days or weeks at a time, to forgo their practice while on-call. Such requirements would place a significant financial burden on surgeons who have to abandon their regular medical activities for extensive periods of time and could compromise the health and safety of patients who are undergoing elective procedures. If not allowed to perform elective procedures while on call, many surgeons would be forced to either attempt to not take call, or quit practice altogether.

The College urges CMS to provide strong, clear language that clarifies surgeons can perform elective surgery while on call. Physicians who are on call and cannot respond to a situation at the emergency department should not be in violation of EMTALA because they are unavailable due to "circumstances beyond the physician's control."

Scope of Practice

Many physicians limit their scope of practice to well-defined subspecialty areas, even though they are often credentialed by their hospital to perform all surgery for the broader specialty for which they are board-certified. An unintended consequence of the current requirements of EMTALA is that they inhibit appropriate transfer of patients for specialized care. The threat of EMTALA violation may prevent hospitals from transferring patients to facilities where an appropriate subspecialist is available. As an example: a thoracic surgeon who performs general thoracic procedures is on call at a hospital where a pediatric patient presents with an emergent cardiac condition. The surgeon on-call does not have experience in pediatric cardiac care and does not hold hospital privileges in that area. Rather than being treated by the thoracic surgeon who is not qualified to handle the case, the patient should be transferred to the nearest facility—assuming that facility is located within a reasonable distance—that has a pediatric cardiac surgeon. The thoracic surgeon on-call should not be met with threats of potential EMTALA violations if he or she does not respond when called because the emergency is beyond the scope of his or her practice.

The College appreciates the clarification provided by the June 13, 2002, CMS memorandum which states that if a hospital does not have on-call coverage for a particular specialty, that hospital lacks capacity to treat patients needing that specialty service and it is therefore appropriate to transfer the patient because the medical benefits of transfer outweigh the risks. We seek additional clarification that on-call physicians should not be expected to provide care or perform procedures for which they do not hold hospital privileges. The College asks that CMS set forth standards that permit the medical staff working with the hospital to establish policies and procedures to ensure that patients receive an appropriately high level of care if it is available and relatively close in proximity to the receiving hospital.

Scope of EMTALA Applicability to Hospital Inpatients

The College commends CMS for stating in the proposed rule that EMTALA does not apply to inpatients, except under limited circumstances. As the proposed rule indicates, if a patient is admitted to the hospital on an inpatient basis and later develops an emergency condition, EMTALA would not apply. Clearly, if an inpatient develops an emergency condition, the hospital is obligated by the Medicare conditions of participation to provide the necessary care. We agree that CMS has made the appropriate determination in this regard, based on the original intent of EMTALA.

While we greatly appreciate CMS' clarification in regards to inpatients, the proposed rule raises serious concerns for the College about the difficulties that will result from hospitals and physicians trying to distinguish between "stable for inpatient admission" and "inpatient admission for an emergency medical condition that has not yet been stabilized." We believe this proposed rule unnecessarily complicates the medical decision making for hospitals and physicians and does so without providing any additional protection to inpatients beyond what is already available under existing regulations that apply to hospitals. We understand that CMS is concerned with hospitals evading their EMTALA obligations by admitting patients to the hospital; however, we believe that the Medicare conditions of participation, as stated above, provide sufficient assurance that hospitals will provide the necessary care to inpatients, regardless of whether they start out in the emergency room or as an inpatient. The College asks that CMS establish a clear policy that states once patients are admitted to the hospital on an inpatient basis, EMTALA would no longer apply.

Applicability of EMTALA to Provider-Based Entites

Since the enactment of EMTALA, much confusion has arisen over the applicability of EMTALA to various locations on and off the hospital campus and, more specifically, what constitutes an "emergency department." While some questions may remain, CMS' proposed rule provides clearer guidelines as to when EMTALA obligations are triggered, based on where the patient presents with the emergency condition and where emergency services are provided.

The College particularly appreciates CMS revising its policy on the applicability of EMTALA to off-campus hospital departments. CMS has appropriately proposed to narrow the scope of EMTALA applicability in regards to off-campus departments to only those that are treated by Medicare to be departments of the hospital and that are considered to be "dedicated emergency departments", according to the new definition provided by CMS in this proposal. We agree that off-campus hospital departments that do not hold themselves out to be dedicated emergency departments, such as hospital-owned physician practices, should not be subject to EMTALA.

The College also supports CMS' clarification that EMTALA applies to only those provider-based departments that are located on the main campus and that EMTALA would not apply to provider based entities, such as rural health clinics, that are on the hospital campus.

To address a remaining concern, the College seeks clarification from CMS that the movement of a patient with an emergency medical condition from the main hospital building to another on-campus entity does not constitute a "transfer" if done in order to provide that patient with an EMTALA-mandated service. Emergency surgical patients often require radiological services, for example, that are not provided in the main hospital building, but are necessary for the screening and treatment of the emergency condition. These services must often be provided prior to stabilization of the patient, requiring moving the patient to a different location on the hospital campus. We urge CMS to state that this is not a "transfer," as defined by EMTALA, and that and if the patient's medical condition were to deteriorate during the move, this would not be a violation of EMTALA.

Conclusion

While a well-intentioned attempt to provide anti-dumping protection in the emergency room setting, the consequences of today's EMTALA requirements are impractical, unrealistic, expensive, and compromises the safety net that it was intended to create.

For this reason, the College greatly appreciates CMS' responsiveness to many of the issues that our organization, and other physician groups, have raised regarding EMTALA. In particular, we are pleased with the revisions and clarifications made to the on-call requirements and ask that CMS seriously consider the recommendations proposed by the College for further revision.

Finally, the College urges CMS to propose and advocate for a legislative solution to the issue of uncompensated care. Significant reductions in payments for surgical services under Medicare's resource-based physician payment system and the managed care industry's reluctance to pay for many EMTALA mandated services have further exacerbated the problems detailed in these comments. The government should reimburse hospitals and physicians for services rendered under EMTALA mandates through Medicare, Medicaid or some form of uncompensated care pool.

The College hopes that CMS finds these comments useful in developing a final rule on EMTALA. We look forward to continuing to work with you to modify EMTALA and in doing so, provide greater access to emergency health care services. If you have any questions, please do not hesitate to contact Cynthia Brown, Director of the Division of Advocacy and Health Policy in our Washington, DC office at 202-337-2701.

Sincerely,

Thomas R. Russell, MD
Executive Director

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