EMTALA for QIOs. CDR Frances R. Jensen, MD, USPHS Medical Officer/EMTALA Lead CMS Central Office

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1 EMTALA for QIOs CDR Frances R. Jensen, MD, USPHS Medical Officer/EMTALA Lead CMS Central Office

2 Disclaimer The information provided in this presentation is only intended to be general summary information for the QIOs and their subcontractors. It is not intended to take the place of statute, regulation or other official CMS policy.

3 Objectives Review some basic EMTALA terminology and requirements Acquaint you with some key players/resources available to you Understand the purpose and importance of the QIO 5-day and 60-day medical reviews Describe the components for a high-quality review Introduce the process of handling a substandard review

4 Goals Appreciate the unique nature of EMTALA language and intent Realize the importance and uses of medical reviews Learn the components of and expectations for high-quality reviews Understand the new procedure for handling substandard reviews Know who/what to turn to for questions and concerns

5 Contact Information CDR Frances R. Jensen, MD, USPHS EMTALA Lead/Medical Officer, CMS Central Office (410) Derek Robinson, MD, MBA, FACEP Chief Medical Officer, CMS RO V (312) Derek.Robinson2@cms.hhs.gov Sandra Sands, JD Senior Counsel, OIG (202) Sandra.Sands@oig.hhs.gov

6 Some relevant acronyms EMTALA = Emergency Medical Treatment and Labor Act MSE = Medical Screening Examination EMC = Emergency Medical Condition SSA = Social Security Act PR = Physician Reviewer CMS = Centers for Medicare & Medicaid Services OIG = Office of the Inspector General SOM = State Operations Manual CAH = Critical Access Hospital QMP = Qualified Medical Person DED = Dedicated Emergency Department

7 Some Initial Thoughts Key points Case-based Complaint-driven QIO role very important CMS uses 5-day findings to enforce the law OIG uses 60-day findings to enforce the law Stakes are high Hospitals can be terminated from Medicare Hospitals and physicians can be fined Physicians can be excluded from Medicare

8 Laws, Regulations & Guidelines Terminology and definitions are as defined by: Law: SSA Section 1867 (42 USC 1395 (dd)), enacted 1986 Regulations: 42 CFR & Interpretive Guidelines: Appendix V of SOM Note: Definitions of some terms may be somewhat different from common medical parlance (e.g., stable v. stabilized). All official CMS policy is contained in above public documents and this is cited on the slides where applicable.

9 An EMTALA Obligation is Triggered when 1. A hospital (including CAH) has a DED and 2. An individual comes to the ED seeking screening/treatment of: A medical condition (presents to the DED) An emergency medical condition (presents elsewhere on hospital property)

10 What does EMTALA require of a hospital or CAH with a DED? To provide an appropriate MSE to determine if an EMC exists If an EMC exists, then the hospital must Stabilize the EMC within their capability and capacity; this may necessitate admission or Transfer the individual to a hospital with specialized capabilities

11 What does EMTALA require of a hospital or CAH with a DED? To provide an appropriate MSE to determine if an EMC exists If an EMC exists, then the hospital must Stabilize the EMC within their capability and capacity; this may necessitate admission or Transfer the individual to a hospital with specialized capabilities

12 An MSE is appropriate when It is based on and appropriate to presenting signs and symptoms, reasonably calculated to determine whether an EMC exists Timeliness may be a factor (think chest pain) It must be provided within the capability of the ED, including: Consultation with on-call physicians Ancillary services routinely available to ED It must be provided by a QMP It occurs without delay to inquire about payment It occurs without disparity of exam between different sources of payment or nonpayment, race, national origin, etc.

13 A few notes on the MSE Triage is NOT an MSE Triage merely determines the order, or priority, of the MSE by a QMP MSE is a process that can be simple and short or involve multiple steps and reassessment over time (including lab, radiology, CT, EKG, procedures, e.g., lumbar puncture, and even consultation and exam by other on-call specialty physicians)

14 What does EMTALA require of a hospital or CAH with a DED? To provide an appropriate MSE to determine if an EMC exists If an EMC exists, then the hospital must Stabilize the EMC within their capability and capacity; this may necessitate admission or Transfer the individual to a hospital with specialized capabilities

15 Define: EMC A medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in: placing the health of the individual (or, for a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, serious impairment to bodily functions, or serious dysfunction of any bodily organ or part; or

16 Define: EMC (cont.) With respect to a pregnant woman who is having contractions: that there is inadequate time to effect a safe transfer to another hospital before delivery, or that transfer may pose a threat to the health or safety of the woman or the unborn child. [42 USC 1395 (dd)] (e)(1)

17 Psychiatric Emergency = EMC In the case of psychiatric emergencies, if an individual expressing suicidal or homicidal thoughts or gestures, if determined dangerous to self or others, would be considered to have an EMC. SOM Interpretive Guidelines (d)(1)(i)

18 What does EMTALA require of a hospital or CAH with a DED? To provide an appropriate MSE to determine if an EMC exists If an EMC exists, then the hospital must Stabilize the EMC within their capability and capacity; this may necessitate admission or Transfer the individual to a hospital with specialized capabilities

19 Define: Stabilized The SSA defines stabilized to mean: with respect to an EMC that no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer of the individual from a facility, or, with respect to an EMC of a pregnant woman who is having contractions that the woman has delivered (including the placenta). [42 USC 1395 (dd)] (e)(3)

20 Stabilization (cont) An individual will be deemed stabilized if the treating physician or QMP attending to the individual in the emergency department has determined, within reasonable clinical confidence, that the EMC is no longer a threat to the health and safety of the individual. Upon stabilization of the EMC, the hospital no longer has an EMTALA obligation.

21 Define: Transfer Transfer the movement (including the discharge) of an individual outside a hospital s facilities at the direction of any person employed by (or affiliated or associated, directly or indirectly, with) the hospital, but does not include the movement of an individual who (A) has been declared dead, or (B) leaves the facility without the permission of any such person. [42 USC 1395 (dd)] (e)(4)

22 What does EMTALA require of a hospital or CAH with a DED? To provide an appropriate MSE to determine if an EMC exists If an EMC exists, then the hospital must Stabilize the EMC within their capability and capacity; this may necessitate admission or Transfer the individual to a hospital with specialized capabilities

23 Hospital-Hospital Transfer Hospitals may not transfer someone with an unstabilized EMC unless: The individual requests the transfer in writing after being informed of the hospital s EMTALA obligations and of the risk of transfer or A physician (or other QMP) certifies that the expected benefits of transfer outweigh the risks Generally this is the case if the hospital does not have the capability or capacity to provide the treatment necessary to stabilize the EMC. In either case, the transfer must be appropriate as defined by the law.

24 What is an appropriate transfer? Transferring hospital treats within capability and capacity that minimizes risk to health; (They do what they can ) The receiving facility has capability and capacity and agrees to accept and treat individual; (Cannot be a lateral transfer) Transferring hospital sends all related records and the name of on-call physician who refused or failed to appear, when applicable; and The transfer is effected through qualified personnel and transportation equipment 42 CFR (e)(2)

25 A few more notes on Recipient Hospital Responsibilities The transfer may not be delayed while the recipient hospital inquires into payment issues. They may not refuse to accept if they have the capability and capacity to treat the EMC, even without an DED.

26 Comes to DED MSE EMC No EMC Treat and Stabilize? Discharge if yes Admit if no C&C? Transfer to HSC EMTALA over

27 Economic Coercion Hospitals may not attempt to coerce individuals into making judgments against their interests by informing them that they will have to pay for their care if they remain but that their care will be free or at a lower cost if they transfer to another hospital. SOM Appendix V Interpretive Guidelines (d)(3)

28 EMTALA & Inpatient Admission No further EMTALA obligation when a hospital admits an individual with an unstabilized EMC in good faith for treatment. Admission means inpatient admission, does not include individuals in observation status who are still considered as outpatients (as opposed to admission to hospital as inpatient).

29 QIO involvement in EMTALA Violation? N Y N Y Enforcement RO decides if enforcement action warranted.

30 What is required of an EMTALA PR? The Physician Review (PR) must answer the following questions in accordance with the terms defined by the Law: Was the MSE appropriate? Was there an EMC? If so, was EMC stabilized prior to transfer/discharge? If not, was transfer appropriate? Did the recipient hospital refuse an appropriate transfer?

31 Other requirements for the EMTALA PR Provide detailed clinical rationale when answering the questions. We need to know why you came to your conclusion. Cite relevant facts from the history, physical, lab/radiology data, interventions, interviews, medical literature, etc. Review all documents provided by CMS. Do not offer an opinion about whether EMTALA was violated!

32 Document Name EMTALA Physician Review Document Checklist Hospital medical record(s): initial facility Hospital(s) medical record(s): facility to which patient was transferred Ambulance report Form CMS-2567, Statement of Deficiencies and Plan of Correction ( marked as Draft for 5-day review, final for 60-day review) Complaint investigation narrative Transcripts of/notes of relevant interviews (staff, patient, family, other witnesses, etc.) Hospital census as provided by facility, including capacity of relevant units (such as ICU, inpatient psychiatric unit, OB unit) Staffing schedules (by unit) Description of hospital services /capability Physician on-call schedule at time of case, including description of specialty/privileges Patient written transfer request (if not in medical record) Relevant hospital policies/procedures/protocols Police report and/or court order(s) for involuntary commitment Included in Package? Yes/No/Not Applicable Reviewed by QIO Physician Reviewer? Yes/No/Not Applicable

33 Criteria for Acceptable PR review Must meet all timeliness, administrative and clinical requirements; Must be consistent with: Accepted standards of practice EMTALA statutory definitions Evidence-based clinical standards Sound clinical judgment

34 Quality Concerns #1 Administrative Incomplete Unclear Internally inconsistent Apparent lack of understanding of EMTALA regulations

35 Quality Concerns #2 Clinical Does not follow accepted standards of practice, Is biased, and/or Is outside of professional scope.

36 What if the review is unacceptable? If an administrative concern, a simple request to correct is made by DSC If a clinical concern, then DSC representative, CMS Medical Officer and COTR will attempt to resolve the disagreement with an internal process documented on ROD form Then one or more of the following may occur: COTR will ask for a re-review by same PR COTR will ask for a new 2 nd review by a different PR The PR will receive a copy of ROD for guidance

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