CMS Regional Office Responsibilities

9125 – CMS Regional Office Responsibilities (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) When the CMS Regional Office Division of Survey and Certification (DSC) receives a complaint, information, or an allegation about inappropriate or lack of emergency medical screening, stabilizing treatment, appropriate transfer, or failure to accept an appropriate transfer, DSC is responsible for authorizing the State Survey Agency to conduct an investigation and develop a report of this investigation for the Regional Office DSC’s consideration. If the Regional Office DSC finds that the case involves a possible violation of §1867 and this determination rests wholly or in part on the clinical aspects of the case, then the DSC must consult with the QIO before determining whether the hospital has violated EMTALA, unless delay in obtaining a QIO review would jeopardize the health or safety of individuals. Clinical aspects of the case may include questions such as whether the individual had an emergency medical condition, whether there was an appropriate medical screening examination, whether a hospital had the capability to provide stabilizing treatment, whether an individual’s emergency medical condition was stabilized, whether a transfer was appropriate, whether a recipient hospital had the required capability and capacity to provide stabilizing treatment and any other questions as necessary. See §9130 for the process followed when CMS has questions or concerns about a QIO review. The Regional Office DSC must send the following information/documents to the QIO: • All relevant information for clinical review (e.g., medical record, draft State Agency Report [Form CMS 2567], and other items as listed on the EMTALA Physician Review Checklist in Appendix 9-11); • EMTALA Physician Review Document Checklist (Appendix 9-11); • EMTALA Physician Review Worksheet (Appendix 9-12);and • EMTALA Case Resolution of Disagreement Worksheet (Appendix 9-13)when applicable. NOTE: The Regional Office DSC uses this worksheet to document information and actions when issues are identified with the QIO process/decisions. (See §9130.) If the Regional Office DSC determines that there is a violation and the case meets the criteria for referral that OIG established, DSC will forward all supporting documentation to the QIO for a 60-day review, when applicable to the facts of the case, at the same time it makes the referral to OIG. The supporting documentation provided to the QIO should include the State Agency report, a copy of the medical record(s), copies of letters to the hospital(s) from CMS regarding any enforcement actions, and a copy of the five (5)-day advisory medical review. The Regional Office should not delay forwarding the case to the QIO if all documentation is not available. As a part of the 60-day review, the QIO is required to provide the physician/hospital an opportunity to discuss the case and an opportunity to submit additional information. (See 42 CFR §489.24(h)(2) and §9135.2.1.) The QIO 60-day review required to support OIG enforcement is considered a separate review and has no substantive bearing on the original Regional Office DSC determination related to CMS enforcement. If there is a discrepancy between the five (5)-day and 60-day review findings, that discrepancy may affect whether OIG pursues the case for CMPs or physician exclusion, but it may not change the Regional Office’s original determination of noncompliance. The Regional Office DSC will have already followed its procedures and taken enforcement action as appropriate to protect other individuals who seek emergency care at the hospital. The Regional Office DSC may, but is not obligated to, release the five (5) day QIO review results to the affected physician and/or hospital, and to the individual or his/her representative. The sixty (60) day review remains confidential until such time as the OIG investigation is complete. The QIO physician reviewer’s identity is confidential unless he/she consents to release his/her identity in accordance with the disclosure regulations. (See 42 CFR §§480.132 and 480.133.) The QIO physician peer reviewer identity is kept confidential from all requestors, including DSC, unless the reviewer agrees to the release of his/her identity. See 42 CFR §§480.139(a) and 489.24(i). Furthermore, the physician peer reviewer name is redacted from all documentation provided to CMS and other parties, unless the physician agrees to release his/her name. NOTE: QIO review is not required in cases where a delay in effecting a sanction would jeopardize the health and safety of individuals or in situations where medical review is inappropriate (e.g., cases where the individual was denied a medical screening examination). NOTE: The hospital and/or practitioner may only contact the CMS Regional Office DSC if they have questions about the EMTALA review, and they may NOT contact the QIO during the five (5)-day review period.