EMTALA TOPS_Amend 2_05112011.docx

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop S3-02-01 Baltimore, Maryland 21244-1850

Office of Clinical Standards and Quality

TOPS MEMORANDUM

QIP TOPS

CONTROL NBR: 2011-04

DATE: May 12, 2011

SUBJECT: Revisions to QIO Manual Chapter 9, Sanction and Abuse Issues; Emergency Medical Treatment and Labor Act (EMTALA), Sections 9100 – 9150; Physician Review Responsibilities - Amendment #2 as of May 12, 2011

The purpose of this memorandum is to standardize Quality Improvement Organizations (QIO) processes for Emergency Medical Treatment and Labor Act (EMTALA) reviews effective August 1, 2011. The EMTALA review process is outlined in Sections 9100 -9150 of the QIO Manual Chapter 9.

The content of this memo supplements and supersedes the information in the October 3, 2003, version of the QIO Manual Chapter 9, any previously issued QUEST Q&A guidance, and any previously issued TOPS and SDPS memos related to Chapter 9 EMTALA processes. A revised version of the Chapter 9 QIO Manual is currently going through the clearance process.

Intake Processes Effective August 1, 2011, the National Coordinating Center for Beneficiary and Family Centered Care (NCCBFCC) will be responsible for intake processes for Chapter 9 EMTALA reviews.

Revised Section 9130: Responsibilities of RO DSC - 5-Day QIO Review

1. Effective following the EMTALA training, the RO will submit to the QIO all relevant information in its possession for the QIO to complete an EMTALA review. The information/documents sent to the QIO must include the following:

1. All relevant information for clinical review (e.g., medical record).

1. EMTALA Physician Review Document Checklist (Exhibit 9-11).

1. EMTALA Physician Review Worksheet (Exhibit 9-12).

1. Statement of Deficiencies (Form 2567) that is marked “Draft” so the QIO knows this document is not yet finalized or not permissible for release to the public.

1. The hospital/and or practitioner may only contact CMS RO DSC if they have questions about the EMTALA review, and they may not contact the QIO during the 5-day review period.

1. The identity of the QIO physician reviewer (PR) is kept confidential from all requestors, including CMS, unless the reviewer agrees to the release of the reviewer’s identity. See 42 CFR 480.139(a) and 489.254 (i). Furthermore, the PR name is to be redacted from all documentation provided to CMS and other parties, unless the PR agrees to release.

Revised Section 9140: QIO Review Responsibilities - 5 Day QIO Review

1. The QIO will conduct a 5- day review when requested by the DSC.

1. The PR will provide his or her clinical assessment of the case based solely on the documentation provided by CMS RO DSC.

1. The PR will not state whether an EMTALA violation occurred.

1. The PR will complete necessary paper work including the EMTALA Physician Review Document Checklist (Exhibit 9-11) and the EMTALA Physician Review Worksheet (Exhibit 9-12).

1. It is not permissible for the QIO to meet with the hospital and/or practitioner(s)to discuss the EMTALA review case.

1. If the PR needs additional information, the QIO is to communicate directly with the CMS RO DSC that assigned the case.

1. The QIO must forward the original EMTALA Physician Review Worksheet (Exhibit 9- 12) provided by DSC to the PR for completion. The QIO cannot use a CMS-designated information system printout as an original form to be completed by the PR. In addition, the PR must include a legibly written and complete rationale for each question on the EMTALA Physician Review Worksheet. The PR must be well versed on key regulatory definitions such as “emergency medical condition” and “stabilized” as well as the criteria for appropriate EMTALA medical screening examinations and transfers.

1. The QIO should type the PR responses from the EMTALA Physician Review Worksheet verbatim into the CMS-designated information system. The QIO must not change the PR response unless the PR gives approval and this approval is noted on the original EMTALA Physician Review Worksheet. A copy of the original EMTALA Physician Review Worksheet (with the PR’s name redacted) and a printout of the completed CMS-designated information system EMTALA Worksheet should be forwarded to the CMS RO DSC. See the EMTALA Physician Review Document Checklist (Exhibit 9-11) for a complete listing of documents the QIO must submit to the DSC upon completion of the review.

1. The PR should not state on the EMTALA PR Worksheet, or other documentation, the following:

1. An opinion as to whether an EMTALA violation occurred,

1. Other observations about the case that are not specifically asked to be addressed (e.g., personal comments regarding the case).

The criteria for an acceptable EMTALA PR review are as follows:

1. The review must meet all timeliness, administrative, and clinical requirements.

1. The review must be consistent with:

0. Accepted standards of medical practice,

0. EMTALA statutory definitions,

0. Evidence-based clinical standards, and

0. Sound clinical judgment.

1. If the CMS RO DSC identifies an administrative* concern, a simple request to correct the issues will be made by DSC. This may involve a direct discussion with the QIO and DSC RO.

1. If the CMS RO DSC identifies a clinical *concern, then the DSC representative, CMS Medical Officer, and COTR will discuss the case. As a result of this discussion, one or more of the following may occur:

1. The COTR will ask for a re-review by the same PR; or

1. The COTR will ask for a second re-review by a completely new PR.

Note: The concern is administrative when the review is incomplete, unclear, internally inconsistent, and/or suggests an apparent lack of understanding of the EMTALA standards that govern the review. The concern is clinical when the opinion rendered appears biased, does not follow accepted standards of medical practice or addresses issues outside the expert competency of the PR.

Revised Section 9150: QIO Review Responsibilities - 60 Day QIO Review As appropriate, the changes noted above for the 5-day review process will apply to the 60-day review process. The most significant changes to the 60-day review process include the following:

1. It is preferred that the same PR complete the 5-day and 60-day EMTALA reviews.

1. If the hospital and/or practitioner(s) elect to discuss the case with the QIO or PR during a formal meeting, the QIO and PR will not provide a clinical opinion about the case during this exchange.

1. If the hospital and/or practitioner request a copy of the QIO PR 5-day review, this request must only be addressed to and fulfilled by the CMS RO DSC.

1. The QIO is required to keep a recording of the hospital and/or practitioner meeting. However, it is not necessary to hire a professional stenographer to record the meeting. An audio recording is acceptable unless a written transcript is requested by CMS RO DSC or the Office of Inspector General (OIG).

If you have questions regarding this memorandum, please contact Linda D. Smith by e-mail at Linda.Smith@cms.hhs.gov or by telephone at 410-786-5650.

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