Procedures for Coordinating 60 day QIO Review

5480.1 - Procedures for Coordinating 60 day QIO Review (Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26) The CMS location requests the QIO to provide a medical opinion on EMTALA violation cases within 60 calendar days. The cases referred for 60-day QIO review are outlined in §5480B. The CMS location uses the “Model Letter Requesting QIO Review of a Confirmed Violation of 42 CFR 489.24 for Purposes of Assessing Civil Monetary Penalties or Excluding Physicians,” (Exhibit 212). The QIO provides the physician and the hospital reasonable notice of its review a reasonable opportunity for discussion, and an opportunity for the physician and hospital to submit additional information before issuing its report. (Instructions on notice of review and opportunity for discussion, and additional information that follow the regulatory requirements in 42 CFR 489.24(h) are found in §§9100-9150 of the QIO Manual.) The CMS location is responsible for providing the QIO with all information relevant to the case that is within its possession and control. The CMS location sends the “Physician Review Outline for Emergency Care Obligations of Medicare Hospitals,” (Exhibit 138) to capture this information. This outline is helpful for organizing the review of the medical record. The specialty of the reviewing physician should be matched to the specialty of the physician who attended the patient and/or the individual’s medical condition. If the patient was not seen by a physician, the QIO uses the diagnosis of the patient or the usual physician assignment practice of the hospital to determine the specialty of the physician reviewer. Within 60 calendar days of receiving the case, the QIO must submit to the CMS location a report on its findings. The report provides an expert medical opinion regarding whether the individual involved had an emergency medical condition, whether the individual’s emergency medical condition was stabilized, whether the individual was transferred appropriately, and whether there are any medical utilization or quality of care issues involved in the case. Upon request, the CMS location provides copies of the QIO report to the affected physician and/or hospital after all investigative activity has been completed. When there was no screening examination or when a delay would jeopardize the health or safety of individuals, QIO Review is not required before the OIG may impose CMPs or exclude a physician from the Medicare program. In addition, if the QIO determines, after a preliminary review, that there was an appropriate medical screening examination and the individual did not have an emergency medical condition, the QIO returns the case to the CMS location with its documented opinion. The CMS location will close the case and no referral to OIG is necessary. When the CMS location determines that a hospital was non-compliant with the requirements of 42 CFR 489.24, one of its notice requirements is to notify the OIG that the violation was confirmed and that termination action was initiated. (See Exhibit 208.) The CMS location completes the notification after receipt of the QIO 60-day review report. If the QIO report does not support an EMTALA violation, the CMS location closes the case without referring it to the OIG. The CMS location forwards the following documents to the OIG: • Form CMS-1541B; • Form CMS-2567; • Medical record; • Summary of interviews; • Explanation of sample selection; • Copies of pertinent hospital policies and procedures related to the identified deficiencies; • Complaint investigation narrative; • Certification of benefits versus risks of the transfer (if this is a transfer case); • Copy of the 5 working-day advisory QIO Review, and • Copy of the 60 calendar-day advisory QIO Review. The CMS location sends the above information and any other pertinent documentation in its possession to the OIG at the following address: Office of Inspector General Office of Counsel to the Inspector General Department of Health and Human Services Room 5527, Cohen Building 330 Independence Avenue SW Washington, D.C. 20201