Day Review

5 - Day Review 60 - Day Review NOTE: A separate Worksheet must be completed by the QIO Physician Reviewer for each medical record reviewed. To facilitate accurate completion, the CMS Regional Office (RO) will complete Section I for each medical record sent to the QIO along with the request for review. The RO must label each medical record with the unique patient identifier as found on the draft Form CMS 2567. SECTION I Complaint Control Number: Patient Identifier Number on Draft 2567: Name of Patient: DOB: Name of Alleged Violating Hospital and/or Physician: City: State: CMS Certification Number: Date and Time of Admission to Emergency Services: _________________________________ Date and Time of Discharge from Emergency Services: Name of Receiving Hospital (if applicable): Receiving Hospital Location: City: State: CMS Certification Number: Date and Time of Admission to Receiving Hospital (if applicable): Manner of Transport: Receiving Hospital Distance from Sending Hospital (if applicable and known): SECTION II Note to Physician Reviewer: Please complete the following questions to address issues related to EMTALA. Please be sure to include your clinical rationale for your findings, and make any summary comments and comments on other aspects of the case in the summary section on the last page of this document. Please keep in mind that the purpose of your comments is to provide your clinical perspective on the care rendered, for the CMS 5-day EMTALA review or for the OIG 60-day EMTALA review. Therefore, please refrain from making ANY statements about whether or not a violation of EMTALA has occurred, as that decision is the responsibility of CMS and the OIG only. (Violations of EMTALA may also constitute negligence under state malpractice law. However, determining negligence is not part of and should not be mentioned in your EMTALA review.) MEDICAL SCREENING EXAMINATION Note to Physician Reviewer: Depending upon an individual’s presenting symptoms, an appropriate medical screening examination can range from a simple process involving only a brief history and physical examination to a complex process that also involves performing ancillary studies and procedures such as (but not limited to) lumbar puncture, clinical laboratory tests, CT scans and other diagnostic tests and procedures, some of which may require the services of an on-call specialist to order, conduct or interpret. A hospital must provide appropriate screening services within the full capabilities of its staff and facilities, including access to specialists who are on call. An Emergency Medical Condition is defined as EITHER: (1) a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in: placing the individual’s health (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy; or serious impairment to bodily functions; or serious dysfunction of any bodily organ or part; OR (2) 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 the transfer may pose a threat to the health or safety of the woman or the unborn child. (See 42 CFR 489.24(b)) 1. Did the hospital provide a medical screening examination that was, within reasonable clinical confidence, sufficient to determine whether or not an EMERGENCY MEDICAL CONDITION (as defined above) existed? More specifically: 1a. Was the medical screening examination appropriate given all of the individual’s medical complaints and signs and symptoms at the time the individual presented? YES NO Please explain your clinical rationale: 1b. Was the medical screening examination appropriate given the hospital’s capabilities - including ancillary services routinely available and consultations by on–call specialist physicians? YES NO Please explain your clinical rationale: 1c. Is there any evidence that there was an inappropriately long delay, based on the individual’s clinical presentation, between the individual’s arrival and the provision of an appropriate medical screening examination? YES NO Please explain your clinical rationale: EMERGENCY MEDICAL CONDITION 2. Did this individual have an EMERGENCY MEDICAL CONDITION as defined by Part (1) of the definition noted above? (Individual conditions meeting the definition in Part 2 above are addressed in subsequent questions.) YES NO Please explain your clinical rationale: 3. Was this individual a pregnant woman who was having contractions? YES NO Please explain your clinical rationale: (If “NO” is checked, skip questions #3a & #3b and proceed to #4) 3a. If “YES” is checked in #3 and the pregnant woman was transferred/discharged, at the time of transfer/discharge, could it be determined with reasonable medical certainty that there would be adequate time to effect a safe transfer to another hospital before delivery? YES NO N/A Please explain your clinical rationale: 3b. If “YES” is checked in #3 and the pregnant woman with contractions was transferred/discharged, at the time of transfer/discharge could it be determined, with reasonable medical certainty, that the transfer/discharge would not pose a threat to the health or safety of the pregnant woman or the unborn child? YES NO N/A Please explain your clinical rationale: STABILIZING TREATMENT Note to Physician Reviewer: Terms relating to “stabilization” are specifically defined under EMTALA. These terms DO NOT REFLECT the common usage in the medical profession, but instead focus on the medical risks associated with a particular transfer/discharge. Thus, when answering questions related to “stability” for EMTALA, please be very careful to refer to the definition provided below. In addition, the clinical outcome of an individual’s condition is not a proper basis for determining whether a person transferred was stabilized. However, the individual’s outcome may be a “red flag” indicating that a more thorough evaluation of the individual’s condition at the time of transfer was needed. Under EMTALA, to stabilize means, with respect to part 1 of the definition of an “emergency medical condition,” to provide such medical treatment of the condition necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer/discharge of the individual from the hospital, or in the case of part 2 of the definition, concerning a pregnant woman having contractions, that the pregnant woman has delivered the child and placenta. 4. If the individual had an emergency medical condition (EMC), was the EMC “stabilized” (as defined above) prior to the time of the individual’s transfer or discharge? YES NO N/A Please explain your clinical rationale: Note to Physician Reviewer: A hospital must provide appropriate stabilizing treatment services for an emergency medical condition within the full capabilities of its staff and facilities, including access to specialists who are on call. 5a. Is there any evidence that the hospital was equipped with such staff, services, or equipment necessary to “stabilize” the individual’s emergency medical condition?? YES NO N/A Please explain your clinical rationale: 5b. If the hospital had the capability to stabilize the individual and the individual’s emergency medical condition was not stabilized prior to transfer/discharge, is there any information available to indicate WHY the emergency medical condition was NOT “stabilized” prior to discharge/transfer? YES NO N/A If yes, does this rationale have a sound clinical basis? 5c. Is there any evidence that there was an inappropriately long delay, based on the individual’s clinical presentation, between the individual’s arrival and the provision of appropriate stabilizing treatment for the individual’s emergency medical condition? YES NO N/A Please explain your clinical rationale: Note to Physician Reviewer: A hospital is required to inform the individual or the individual’s legal representative of the risks and benefits of further examination and treatment. If the individual/representative then refuses to consent to further examination or treatment, the medical record must contain a description of the examination or treatment, or both, which was refused, as well as documentation of the individual/representative having been informed of these risks/benefits. 6. Does the medical record indicate the individual refused to consent to necessary stabilizing treatment? YES NO (If “NO” is checked, skip question #6a and proceed to #7) 6a. If “YES” is checked and if the medical record contains a description of the communication to the individual/legal representative of the risks and benefits and benefits of further examination or treatment, was this communication appropriate, based on the information available to the hospital at the time of the refusal? YES NO N/A Please explain: APPROPRIATE TRANSFERS 7a. If your response to question 5a was "NO” finding that the hospital was not capable of stabilizing the individual’s emergency medical condition, what were the required specialized capabilities that the hospital lacked? 7b. If the individual was transferred to another hospital, did the sending hospital provide further examination and stabilizing treatment, within its capacity (including ancillary services routinely available to it) to minimize the risks of transfer to the individual’s health and, where relevant, the health of the unborn child? YES NO N/A Please explain your clinical rationale: 8. If the individual was transferred to another hospital, to minimize the risks of transfer, were qualified personnel and transportation equipment, including medically appropriate life support measures, used to effect (i.e., accomplish) the transfer? YES NO N/A Please explain your clinical rationale: 9a. If this individual was transferred to another hospital for stabilizing treatment of an unstabilized emergency medical condition, do you find that, considering the individual’s clinical condition at the time of transfer and any other pertinent information available at that point in time, the medical benefits reasonably expected from appropriate medical treatment at the other hospital outweighed the increased risk to the individual (or woman in labor or unborn child) from being transferred? YES NO N/A Please explain your clinical rationale: Note to physician reviewer: The physician certification required for an appropriate transfer must be in writing, must contain a summary of the specific risks and benefits pertaining to this individual’s clinical situation, and must be placed in the individual’s medical record. 9b. Do you find that the summary of risks and benefits of transfer contained in the physician certification was appropriate, based on the information available to the hospital at the time of transfer about the individual’s condition? YES NO N/A* Please explain: *Check N/A not only if this case does not involve a transfer, but also if there was no physician certification in the medical record 9c. If the transfer was at the request of the individual or the individual’s legal representative, rather than based on a physician’s certification of the benefits outweighing the risks, and the medical record documents this, do you find that the likely risks of the transfer were identified for the individual/representative? YES NO Please explain your clinical rationale: 10. Does the documentation suggest that the transferring hospital sent to the receiving hospital all available and pertinent medical documentation related to the emergency medical condition? YES NO N/A Please explain: RESPONSIBILITY OF HOSPITALS WITH SPECIALIZED DIAGNOSTIC OR TREATMENT CAPABILITIES OR FACILITIES Note to Physician Reviewer: While "specialized capabilities or facilities” include such facilities as burn units, shock-trauma units, neonatal intensive care units or regional referral centers, it also includes many more clinical characteristics. Most simply, if an individual with an emergency medical condition needs services to stabilize that condition that cannot be made available in a clinically appropriate timeframe at the hospital where the individual presented, but which are available at another hospital, the hospital with these capabilities/services must accept a request for transfer, if it has the capacity to provide the needed stabilizing treatment. 11. Is there any evidence that a Medicare-participating hospital that refused a transfer request has specialized capabilities or services (not available at the sending hospital) that the individual required? YES NO N/A Please explain: (If “NO” or “N/A” is checked, skip question #11a and go to #12.) 11.a If “YES” is checked in #11, is there evidence that the hospital with specialized capabilities or services lacked the capacity to treat the individual requesting stabilizing treatment, at the time of the request? Please explain: QUALITY 12. Do you have any specific concerns about the quality of care rendered to the individual that have not already been addressed fully above? YES NO If yes, please explain your clinical rationale: SUMMARY OF FINDINGS: 13. Please summarize the key facts of the case below and any concerns or clarifications to your answers above with regard to this case. Remember, do not state an opinion regarding whether EMTALA was violated. I agree to provide medical advice to the Centers for Medicare & Medicaid Services and/or the Office of Inspector General, as necessary, to properly adjudicate any issues and to testify as an expert witness on behalf of the Office of Inspector General, if necessary. Physician Reviewer Name (printed): _________________________________________ Physician Reviewer Signature: _______________________________________________ Specialty: Date: _____________________ Case ID: Time Required to Complete This Review: hours minutes Appendix 9-13 – EMTALA Resolution of Disagreement Worksheet (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) QIO Physician Reviewer’s Review of EMTALA Case Resolution of Disagreement (ROD) Worksheet Request Date: < Insert current date> To: < Insert DQI PO name> From: <Insert CMS RO DSC and CMO name> Contact information: <Insert CMS RO DSC phone number and email> Facility: < Insert facility name> Survey Date: <Insert date of facility survey> QIO Review Date: <Insert date of QIO review> Type of QIO Review (check one): _ __ 5-day review ___ 60-day review SECTION I: (To be completed by RO DSC) Summary of RO DSC concerns and/or reason for disagreement with QIO review: <Please be as specific as possible including references to sources of material used to back-up concerns (e.g. medical record, PR Worksheet, etc). Bulleted statements are acceptable as long as they are complete.> Attachments: __ Physician Review Worksheet __ Medical Record/s __ Other (Explain) _____________________________ SECTION II: (To be completed by RO CMO) Summary of RO CMO concerns and/or reason for disagreement with QIO review: <Please be as specific as possible including references to sources of material used to back-up concerns (e.g. medical record, PR Worksheet, etc). Bulleted statements are acceptable as long as they are complete.> Summary of RO DSC and CMO concerns (check all that apply): ____ Incomplete review ____Opinion inconsistent with accepted standards of practice ____Opinion outside of professional scope ____Lack of understanding of EMTALA regulations ____Evidence of biased opinion or conflict of interest SECTION III: (To be completed by RO DQI PO) • Date received: <Insert date DQI PO received the ROD Form> Case Review with QIO DQI PO • Meeting Date: < Insert date DQI PO met with DSC and CMO representatives to discuss concerns and/or areas of disagreement and next steps> • Meeting participants: <Insert name, title and RO affiliation of participants> • Meeting summary: < Insert additional pertinent notes and/or areas of agreement from the discussion> • Next steps: <Insert the agreed upon next steps by CMS staff.> Example: “All of the meeting participants agreed to discuss the review with the QIO Medical Director and to request a re-review based on the concerns identified above. The DQI PO will make arrangements for the meeting which will include…..” CMS Staff Case Review with QIO Medical Director • Meeting Date: < Insert date CMS Staff and QIO Medical Director met to review the case.> • Meeting participants: <Insert name, title and RO affiliation of participants> • Meeting summary: < Insert additional pertinent notes and/or areas of agreement from the discussion> • Next steps: <Insert the agreed upon next steps by CMS staff and QIO Medical Director by checking one of the following.> ____ Request for re-review of initial review ____ Request for 2nd 5-day review ____ Referred to OIG for 60 day review ____ 60-day review opinion different from 5-day review ____ Other (explain): ________________________________________________ Final PO Action • Forward a copy of the ROD Worksheet to the designated RO Beneficiary Protection Lead for tracking purposes. Appendix 9-16 – 60-Day QIO Review – Opportunity for Discussion (Sample Letter to Physician/Hospital) (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) (Date) (Name and Address of Hospital Administrator/Physician) RE: (Hospital Provider Number) Dear (Name of Hospital Administrator/Physician): This letter is to inform you that the (name of QIO), the Quality Improvement Organization for the State of (name of State), has received notification from the Centers for Medicare & Medicaid Services (CMS) that your hospital has violated the requirements of 42 CFR 489.20 and 42 CFR 489.24 (commonly referred to as "EMTALA" or "dumping" violations) and that CMS is referring your case for possible sanctions as a result of this (these) violation(s). A list of the deficiencies was provided in separate correspondence sent to you on (date) by the Division of Survey & Certification, Region, in (State where Regional Office is located). In this matter, it is the responsibility of the (name of QIO) to provide the hospital and/or physician(s) a reasonable opportunity for discussion and submission of additional information related to the violations prior to (name of QIO) issuing a report of the findings to CMS. You may request a meeting, either by phone or in person, to discuss the case(s) and to submit additional information. (Name of QIO) must receive the additional information within 30 days of your receiving this notice. A meeting, should you request one, must occur within that 30-day time period. The date of receiving this notice is presumed to be 5 days after the certified mail date on the notice, unless there is a reasonable showing to the contrary. The meeting is intended to afford the hospital and/or physician(s) a full and fair opportunity to present their views regarding the cases with the following provisions: • The hospital and/or physician has (have) the right to have legal counsel present during the meeting. (Name of QIO) may also have legal counsel present and will control the scope, as well as the extent and manner, of any questioning or any other presentation by the attorney representing the hospital and/or physician. • (Name of QIO) will make arrangements for a verbatim transcript of the meeting to be recorded in the event that CMS or the Office of Inspector General (OIG) requests a transcript. If CMS or OIG requests a transcript, the hospital and/or physician may request that CMS provide a copy of the transcript. • The hospital and/or physician(s) will be afforded the opportunity to present, with the assistance of legal counsel, expert testimony in either oral or written form on the medical issues presented. (Name of QIO) may limit the number of witnesses and the length of the testimony if such testimony is unrelated to the case or provides information that has already been presented. The physician and/or hospital may disclose patient records to potential expert witnesses without violating any non-disclosure requirements set forth in Title 42, Part 480 of the Code of Federal Regulations. • (Name of QIO) is not obligated to consider any additional information provided by the hospital and/or physician after the meeting unless, before the end of the meeting, it is requested by (name of QIO). If additional information is requested, the hospital and/or physician will have five (5) calendar days from the date of the meeting to provide the requested information. A report of (name of QIO) findings in this case will be submitted directly to the Regional Office who will forward a copy to OIG. Upon request, the (referring Regional Office) will provide copies of (name of QIO) medical assessment report to (name of hospital administrator and/or affected physician(s)). Copies of the regulations in 42 CFR §§489.20 and 42 CFR 489.24 are enclosed. The name(s) of the individuals who were the subject of the violations and dates of occurrence are as follows: PATIENT LISTING & DATE OF SERVICE (Name of Hospital) Patient Date of Violation (Patient's name) (Date) If you have any questions related to this letter or wish to schedule a meeting, please contact (QIO’s contact person) at (QIO’s phone number). Sincerely, QIO Medical Director (or designated person) Enclosure