Conditions of Participation for Hospitals

Set forth is the text of the commentary to the final EMTALA regulations as published in the September 9, 2003 Federal Register concerning EMTALA and the Conditions of Participation for Hospitals. The final regulations can be viewed here and are effective November 10, 2003.

We are reminding hospitals and others that while these final regulations make it clear that, while stabilizing an individual with an emergency medical condition (or admitting the individual to the hospital as an inpatient) relieves the hospital of its EMTALA obligations, it does not relieve the hospital of all further responsibility for the patient who is admitted. Stabilization or inpatient admission also does not indicate that the hospital is thus free to improperly discharge or transfer the individual to another facility. Inpatients who experience acute medical conditions receive protections under the Medicare hospital CoPs, which are found at 42 CFR Part 482. In addition, as noted earlier in this preamble and in the May 9, 2002 proposed rule preamble, we believe that outpatients who experience what may be an emergency medical condition after the start of an encounter with a health professional would have all protections afforded to patients of a hospital under the Medicare hospital CoPs. There are six hospital CoPs that provide these protections: emergency services, governing body, discharge planning, quality assessment and performance improvement, medical staff, and outpatient services. In the May 9, 2002 proposed rule, we proposed to make only one change in these CoPs: one relating to the governing body having written policies and procedures in effect for off-campus departments that do not offer emergency services for appraisal of emergencies and referral when appropriate (§482.12(f)(3)).

If a hospital inpatient develops an acute medical condition and the hospital is one that provides emergency services, the hospital is required to ensure that it meets the emergency needs of the patient in accordance with accepted standards of practice. Similarly, regardless of whether the hospital provides emergency services, if an inpatient develops an acute medical condition, the governing body CoP (§482.12(f)(2), which applies to all Medicare-participating hospitals) would apply. This CoP requires that the hospital governing body must ensure that the medical staff has written policies and procedures for appraisal of emergencies, initial treatment, and referral when appropriate.

The discharge planning CoP (§482.43, which applies to all Medicare-participating hospitals) requires hospitals to have a discharge planning process that applies to all patients. This CoP ensures that patient needs are identified and that transfers and referrals reflecting adequate discharge planning are made by the hospital. If an inpatient develops an acute medical condition and the hospital either does not offer emergency services or does not have the capability to provide necessary treatment, a transfer to another hospital with the capabilities to treat the emergency medical condition could be warranted. Hospitals are required to meet the discharge planning CoP in carrying out such a transfer.

The hospital CoP governing medical staff (§482.22) requires that the hospital have an organized medical staff that operates under bylaws approved by the governing body and is responsible to the governing body for the quality of medical care provided to patients by the hospital. Should the medical staff not be held accountable to the governing body for problems regarding a lack of provision of care to an inpatient who develops an emergency medical condition, this lack of accountability may be reviewed under the medical staff CoP, as well, and may result in a citation of noncompliance at the medical staff condition level for the hospital.

Finally, the quality assessment and performance improvement CoP (§482.21, which applies to all Medicare-participating hospitals) requires the governing body to ensure that there is an effective, hospital-wide quality assessment and performance improvement program to evaluate the provision of patient care. In order to comply with this CoP, the hospital must evaluate the care it provides hospital-wide. Complaints regarding a lack of provision of care to an inpatient who develops an emergency medical condition must be addressed under the hospital’s quality assurance program and may be reviewed under the quality assessment and performance improvement CoP.

A hospital’s failure to meet the CoPs requirements cited above may result in a finding of noncompliance at the condition level for the hospital and lead to termination of the hospital’s Medicare provider agreement. As we explained in the preamble to the January 24, 2003 final rule (69 FR 3435), the CoPs are the requirements that hospitals must meet to participate in the Medicare and Medicaid programs. The CoPs are intended to protect patient health and safety and to ensure that high quality care is provided to all patients. The State survey agencies (SAs), in accordance with section 1864 of the Social Security Act (the Act), survey hospitals to assess compliance with the CoPs. The SAs conduct surveys using the instructions in the State Operations Manual (SOM), (Health Care Financing Administration (HCFA) Publication No. 7). The SOM contains the regulatory language of the CoPs as well as interpretive guidelines and survey procedures and probes that elaborate on regulatory intent and give guidance on how to assess provider compliance. Under § 489.10(d), the SAs determine whether hospitals have met the CoPs and report their recommendations to us. The standards, procedures, and SA personnel involved in developing recommendations regarding EMTALA compliance are the same as those for recommendations regarding CoP compliance, since alleged violations of EMTALA are treated as allegations that a hospital has not complied with a requirement for Medicare participation.

Under the authority of section 1865 of the Act and the regulations at § 488.5, hospitals accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or the American Osteopathic Association (AOA) are deemed to meet the requirements in the CoPs, and therefore, are not routinely surveyed for CoP compliance by the SAs. However, all Medicare and Medicaid participating hospitals are required to be in compliance with our CoPs regardless of their accreditation status.

Comment: Some commenters expressed general approval of the proposed revision to §482.12(f), which is applicable to hospitals that provide emergency services but have departments off campuses that do not provide emergency services.

Response: We appreciate these commenters' support and have kept their views in mind in evaluating the other comments recommending specific changes in this final rule.

Comment: Some commenters stated that the proposed revision to §482.12(f) seems to imply that hospitals must have staff trained in appraisal of emergencies on duty on a 24-hour per day, 7-day a week basis to comply with the requirement. The commenters believed that this would be an unreasonable requirement.

Response: We agree that such a requirement for off-campus departments would be unreasonably stringent. Therefore, we plan to clarify in the interpretive guidelines or training materials used to implement this requirement that the policies and procedures in place for appraisal of emergencies and referral when appropriate must be implemented only within the hours of operation and normal staffing capability of the facility.

Comment: Some commenters opposed adding a specific CoP provision for off-campus departments of hospitals that have dedicated emergency departments but do not offer emergency services at their off-campus locations. The commenters believed this is an unnecessary burden on hospital governing bodies and medical staffs.

Response: We do not agree that adding this condition will impose an unnecessary burden on hospitals. First, the amount of burden will be minimal, because the regulation does not require that the facilities provide emergency care or add to their existing medical capabilities, but only that appropriate policies and procedures be in place. While developing and implementing these policies and procedures will require some effort from facilities that do not have them in place, the effort involved should be considerably less than that required to comply with current regulations at §489.24(i) regarding EMTALA compliance by hospitals with off-campus nonemergency departments, which are being replaced by the condition. We also do not agree that any remaining burden associated with the revised requirement is unnecessary. On the contrary, the ability of such an off-campus facility to respond promptly and appropriately to an unexpected request for emergency care can be crucial to the health and safety of the individual with the emergency condition. Because we believe that the burden of having a plan in place to deal with an occasional emergency is minimal and the potential benefit to the individual of having such a plan is considerable, we are not making changes to the proposed CoP in this final rule in response to this comment.