Reopening of Cases – Regulatory Guidance

9240 – Reopening of Cases – Regulatory Guidance (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) Cases that the QIO previously reviewed may be reopened at any time under the following circumstances: • A QIO or its subcontractor may review and issue denial of payment any time there is a finding that the claim for service involves fraud or a similar abusive practice that does not support a finding of fraud. An initial denial determination or change as a result of a DRG validation may be reopened and revised anytime there is a finding that it was obtained through fraud or a similar abusive practice that does not support a finding of fraud. (42 CFR §476.96(c)). • Whenever there is a finding that a reconsidered determination review or a re- review determination of a DRG change was obtained through fraud or a similar abusive practice, and that does not support a formal finding of fraud, then the QIO should reopen and revise the reconsidered determination or the DRG change, or notify the appropriate ALJ or Appeals Council so that they may reopen a decision of theirs (42 CFR §478.48(c)). Appendices Appendix 9-1 – Office of Council to the Inspector General Mailing Address (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) Exclusions/Civil Monetary Penalties Contact: Office of Council to the Inspector General Chief, Administrative and Civil Remedies Branch 330 Independence Avenue, SW Cohen Building Room 5527 Washington, DC 20201 Fraud Questions: Assistant Special Agent in Charge Investigations Branch (800)-447-8477 Appendix 9-2 – Initial Sanction Notice of Substantial Violation in a Substantial Number of Cases (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) QIO LETTERHEAD (Name and Address of Practitioner or Provider) (Dear Dr. :) Or (Dear Mr./Mrs./Ms. :) The purpose of this notice is to inform you that (name of QIO), the Quality Improvement Organization (QIO) for the State of (name of State), has concluded that there is a reasonable basis for determining that (you have) (your hospital has) violated (your) (its) obligation(s) under §1156(a) of the Social Security Act (the Act) to assure that the services provided to program beneficiaries are: [SELECT OBLIGATION(S) VIOLATED]. Choose (1), (2), and/or (3) from below: (1) Provided economically and only when, and to the extent, they are medically necessary; (2) Of a quality that meets professionally recognized standards of health care; and/or (3) Supported by the appropriate evidence of medical necessity and quality of the services in a form and fashion and at such time as may be required. (Name of QIO) has concluded that there is a reasonable basis for determining that (you have) (your hospital has) failed to comply substantially with your statutory obligations in a substantial number of cases. • If the QIO determines finally that such a violation has occurred and recommends a sanction to the Secretary of the Department of Health & Human Services (HHS), and if a final determination is made by the Secretary through the Office of Inspector General (OIG) to impose a sanction, (YOU) (YOUR HOSPITAL) MAY BE EXCLUDED FROM PARTICIPATING IN PROGRAMS UNDER TITLES V, XVIII, XIX, AND XX of the Social Security Act (including THE MEDICARE PROGRAM AND ANY STATE HEALTH CARE PROGRAM AS DEFINED IN §1128(h) OF THE ACT) EITHER PERMANENTLY OR FOR A SPECIFIED PERIOD OF TIME OF AT LEAST 1 YEAR OR, ALTERNATIVELY, REQUIRED TO PAY THE UNITED STATES GOVERNMENT A MONETARY PENALTY AS A CONDITION FOR (YOUR) (YOUR HOSPITAL'S) CONTINUED PARTICIPATION IN THE MEDICARE AND STATE HEALTH CARE PROGRAMS. Therefore, you are strongly encouraged to contact the (name of QIO) to provide additional information and/or meet with (name of QIO). • An in-depth discussion of the cases involved is included below in the case summary section. • You will be given an opportunity to provide additional information and/or request a meeting with (name of QIO). Although no sanction recommendation will be made to OIG after this meeting, it is nevertheless an important first step in the sanction process. The “Additional Information” section explains how to submit the additional information and/or request a meeting. • Enclosure 1 provides a brief overview of the sanction process. OBLIGATIONS Section 1156 of the Act (42 U.S.C. 1320c-5) imposes certain obligations upon health care practitioners and other persons who furnish or order services under Medicare or State health care programs. These obligations are to assure that the services are: (l) Provided economically and only when, and to the extent, they are medically necessary; (2) Of a quality that meets professionally recognized standards of health care; and (3) Supported by the appropriate evidence of medical necessity and quality of the services in a form and fashion and at such time as may be required. See also 42 CFR Part 1004. QIO RESPONSIBILITIES The Secretary of HHS has a contract with the (name of QIO) to review Medicare services. Section 1156(b) of the Act provides that if (name of QIO) determines that a practitioner or other person has failed to comply substantially with any of these obligations in a substantial number of cases or has grossly and flagrantly violated such obligation in one or more instances, (name of QIO) must report such determinations to the HHS OIG, along with a recommendation for an appropriate sanction. If OIG agrees with the QIO’s recommendation and finds that the practitioner or other person is unable or unwilling substantially to comply with his/her statutory obligations, OIG may impose a sanction. These sanctions may include exclusion from eligibility to provide services to patients of the Medicare program and State health care programs, such as Medicaid, on a payable basis either permanently or for a specified period of time. Alternatively, payment of a monetary penalty in the amount of the actual or estimated cost of medically improper or unnecessary services may be required as a condition for continued eligibility to receive payment under the programs. VIOLATION OF OBLIGATION – CASE SUMMARY The (name of QIO) has reviewed medical records pertaining to (your medical practice) (the health care services and items furnished in your hospital). As a result of this review, the (name of QIO) is concerned that (your medical practice) (your hospital's health care services and items furnished to program beneficiaries), as documented in these medical records, does not appear to comply substantially with the obligations imposed on (you) (your hospital) under the Act in the following respects: (Include an in-depth discussion of each situation, circumstance, or activity that resulted in a violation as well as the obligation involved.) EXAMPLES: Providing Services Not Medically Necessary and/or Not Provided in the Most Economical Setting 1. Chart No. Admission Date • Hospitalization was totally unnecessary for this active, 72-year-old male who was not acutely ill and did not receive intensive medical services. All he required was a protective environment and assistance with activities of daily living. His dementia, which resulted in his not taking medications properly, was caused by Alzheimer's disease. 2. Chart No. Admission Date • Although this patient had lowered hemoglobin, it was not so low that the 65- year-old female required transfusing. The diagnostic studies needed to ascertain the cause of her anemia could have been performed safely and effectively on an outpatient basis. Providing Services That Do Not Meet Professionally Recognized Standards of Care 1. Chart No. Admission Date • Several glaring omissions exist in the initial evaluation and management of this non-surgical patient. For example, recent hematemesis is mentioned in the history, but no nasal gastric tube was passed and no rectal exam was performed. • In addition, no additional Hemoglobin or Hematocrits were obtained. A marked deficiency of management occurred on the second day of hospitalization when the patient spiked a temperature to 104°F, accompanied by shaking chills, and was given aspirin. The temperature remained elevated in the range of 102.6– 103°F for the next 2 days. No evaluation or treatment of the elevated temperature was undertaken until the fifth day of the stay. 2. Chart No. Admission Date • This insulin-dependent diabetic was admitted for a cholecystectomy. Her preoperative blood sugar was 103, but this was drawn 1 week prior to admission. Her post-operative course was eventful in that she had an elevated temperature of 103–104° on the third and fourth postoperative days, for which the physician ordered the administration of IV antibiotics. A fasting blood sugar drawn on the third post-operative day was 300. No other laboratory studies were performed. On the fifth post-operative day, the day before her discharge, she complained of lower abdominal pain and was noted on that date, as well as the day of discharge, to be lethargic. • Her fasting blood sugar on the day of discharge was 380. Because there were no studies to determine the source of her fever, the evaluation of her febrile state was not adequate. In addition, the evaluation of her diabetic condition was not adequate to determine the possible presence of impending diabetic ketoacidosis. -ETC.- A summary of the information (name of QIO) considered in arriving at the above findings is enclosed. CORRECTIVE ACTION PLAN (if applicable) [Describe the method and timeframe for correcting the identified violation(s)]. ADDITIONAL INFORMATION If you do not believe that the care rendered in the above cases is in violation of (your) (your hospital's) obligations under §1156, you may, within 30 days of the date of receiving this notice, submit additional information to and/or request a meeting with (name of QIO). The date of receipt is presumed to be 5 days after the date on this letter. The additional information and/or request for a meeting should be submitted to: (Contact Person) (Name of QIO) (Address) IF YOU REQUEST A MEETING The purpose of the meeting is to allow (you) (your hospital) to present (your) (the hospital's) views regarding the care rendered to program beneficiaries in the above cited cases, to discuss those views with the (name of QIO), and to assist (name of QIO) in making its final determination as to whether such care failed to comply with the statutory obligations of §1156 of the Act and its recommendation about the appropriate sanction. • The meeting will be held within 30 calendar days of your request. The (name of QIO) will contact you regarding date, time, and place for the meeting. The meeting date may be extended, but only if you can demonstrate good cause. • You may have an attorney represent (you) (your hospital) at the meeting. The attorney may make opening and closing statements, assist you in presenting expert testimony, and ask clarifying questions. • You may bring professional (expert) witnesses to testify on (your) (your hospital's) behalf. The purpose of the witnesses is to discuss relevant medical views pertaining to the above-cited cases. You should bring to the meeting all relevant documentation (including office records) regarding the cases in question to fully support your views. Sincerely yours, (QIO Medical Director) Enclosures: (1) Overview of the Sanction Process; and (2) Summary of Information Used in Determining Findings. Enclosure 1: Overview of Sanction Process for Substantial Violations INITIAL SANCTION NOTICE* Thirty days to submit additional information and/or request a meeting and consideration of corrective action (if appropriate) QIO DECISION Not a substantial violation Second sanction notice Thirty days to submit additional information and/or request a meeting and consideration of corrective action (if appropriate) QIO DECISION Not a substantial violation Final sanction notice recommendation to OIG Thirty days to submit additional information OIG DECISION Do not sanction Sanction Right to appeal to an administrative law judge (including a pre-exclusion hearing, if applicable) * The enclosed letter is an initial sanction notice. Appendix 9-3 – Second Sanction Notice of Substantial Violation in a Substantial Number of Cases (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) QIO LETTERHEAD (Name and Address of Practitioner or Provider) (Dear Dr. :) or (Dear Mr./Mrs./Ms. :) [The purpose of this notice is to inform you that (name of QIO), the Quality Improvement Organization (QIO) for the State of (name of State), has reviewed the additional information you submitted in response to our letter of _________. It has been determined that this material does not modify the original determination of (name of QIO) that there was a reasonable basis for determining that (your medical practice does) (the health care services and items furnished in your hospital do) not comply with the obligations imposed on you under §1156(a) of the Social Security Act (the Act) and that, in fact, specific violations of (your) obligations do exist.] AND/OR [The purpose of this letter is to advise you that, based on its most recent review, the (name of QIO) has concluded that there is a reasonable basis for determining that (you have) (your hospital has) failed to substantially comply with the corrective action plan you submitted to the (name of QIO) on (date) and which was approved on (date). The (name of QIO) has determined that previously identified problems persist.] (Name of QIO) has concluded that there is a reasonable basis for determining that (you have) (your hospital has) violated your obligation to assure that the services provided to program beneficiaries are: [SELECT OBLIGATION(S) VIOLATED]. Choose (1), (2), and/or (3) from below: (1) Provided economically and only when, and to the extent, they are medically necessary; (2) Of a quality that meets professionally recognized standards of health care; and/or (3) Supported by the appropriate evidence of medical necessity and quality of the services in a form and fashion and at such time as may be required. If the QIO determines finally that such a violation has occurred and recommends a sanction to the Secretary of the Department of Health & Human Services (HHS), and if a final determination is made by the Secretary through the Office of Inspector General (OIG) to impose a sanction, (YOU) (YOUR HOSPITAL) MAY BE EXCLUDED FROM PARTICIPATING IN PROGRAMS UNDER TITLES V, XVIII, XIX, AND XX OF THE SOCIAL SECURITY ACT (INCLUDING THE MEDICARE PROGRAM AND ANY STATE HEALTH CARE PROGRAM AS DEFINED IN §1128(h) OF THE ACT) EITHER PERMANENTLY OR FOR A SPECIFIED PERIOD OF TIME OF AT LEAST 1 YEAR OR, ALTERNATIVELY, REQUIRED TO PAY THE UNITED STATES GOVERNMENT A MONETARY PENALTY AS A CONDITION OF (YOUR) (YOUR HOSPITAL'S) CONTINUED PARTICIPATION IN THE MEDICARE AND STATE HEALTH CARE PROGRAMS. Because of the serious nature of a QIO’s final determination to recommend a sanction to OIG, you are strongly encouraged to contact (name of QIO) to provide additional information to assist you in responding to the initial determination of a violation and/or to set up a meeting with the (name of QIO). THE MEETING WITH THE QIO WILL BE YOUR ONLY OPPORTUNITY TO DISCUSS YOUR SITUATION WITH THE QIO BEFORE IT MAKES A FINAL DECISION WHETHER TO RECOMMEND TO OIG THAT (YOU) (YOUR HOSPITAL) BE SANCTIONED. • An in-depth discussion of the cases involved is included below in the case summary section. A detailed synopsis of cases is also enclosed. • The “Additional Information” section explains how to submit the additional information and/or request a meeting. • Enclosure 1 provides a brief overview of the sanction process. VIOLATION OF OBLIGATION – CASE SUMMARY The (name of QIO) has reviewed medical records pertaining to (your medical practice) or (the health care services and items furnished in your hospital) (if applicable: and the additional information you submitted to [name of QIO]). a result of this review, the (name of QIO) has a reasonable basis for determining that (you have) (your hospital has) failed to comply substantially with the obligations imposed on you under the Act in the following respects: 1. Chart No. Admission Date • Conclusion: 2. Chart No. Admission Date • Conclusion: -ETC.- A copy of the material (name of QIO) used in arriving at this initial determination is enclosed. Also enclosed is a detailed case synopsis identifying each case (name of QIO) reviewed, the issues (name of QIO) raised, your response to the issues raised, and (name of QIO)’s final determination. (See Appendix 9-4 for Synopsis of Cases.) It has also been determined that the violations of (your obligations) (your hospital's obligations) under §1156 of the Act are serious enough to warrant recommending to the HHS OIG that sanctions be imposed upon (you) (your hospital) pursuant to Federal statute and regulations. The sanction to be recommended is [exclusion from participation in the Medicare and State health care programs for a period of _____years] OR [a monetary penalty in the amount of _____ to be paid to the Government of the United States as a prerequisite for (your) (your hospital’s) continued participation in the Medicare and State health care programs]. If OIG agrees with the QIO's recommendation and finds that (you are) (your hospital is) unable or unwilling substantially to comply with your statutory obligations, OIG may impose a sanction. [NOTE: If a corrective action plan was offered, include information here]. ADDITIONAL INFORMATION By this letter you are hereby formally notified that you may submit to the (name of QIO), within 30 days of the date of receiving this letter, additional information which you feel might modify our position and/or a written request to meet with us to review and discuss case specifics. The date of receipt is presumed to be five (5) days after the date on this letter. The additional information and/or request for a meeting should be submitted to: (Contact Person) (Name of QIO) (Address) IF YOU REQUEST A MEETING The purpose of the meeting is to allow (you) (your hospital) to present (your) (your hospital's) views regarding the care rendered to program beneficiaries in the above-cited cases, to discuss these views with the (name of QIO), and to respond to the initial determination of a violation before (name of QIO) makes a final decision whether to recommend a sanction to OIG. • The meeting will be held within 30 calendar days of your request. The (name of QIO) will contact you regarding date, time, and place for the meeting. The meeting date may be extended, but only if you can demonstrate good cause. • You may have an attorney represent (you) (your hospital) at the meeting. The attorney may make opening and closing statements, assist (you) (your hospital) in presenting expert testimony, and ask clarifying questions. • (You) (Your hospital) may bring professional (expert) witnesses to testify on (your) (your hospital’s) behalf. The purpose of the witnesses is to discuss relevant medical views pertaining to the above-cited cases. • The (name of QIO) will make a verbatim record of the meeting and provide this record to you as soon as is practicable, but no later than the time a sanction recommendation (if any) is forwarded to OIG. • You should bring all relevant documentation (including office records) regarding the cases cited above to the meeting to fully support your views. • You may request that the physician at the QIO who determined that there is a reasonable basis for concluding that (you have) (your hospital has) violated one or more obligations under the Act appear at the meeting to discuss the basis for his/her determination, although the QIO does not have to grant that request. • You may object to any member of the QIO being permitted to participate in the decision of (your) (your hospital's) case if you believe that he/she has a personal bias against or is in direct economic competition with (you) (your hospital). • If, prior to the end of the meeting with (name of QIO), you believe that additional documentation exists which relates to the cases or issues discussed at the meeting, you may request an additional period of time (not to exceed 5 days) to submit the relevant information to (name of QIO). If the (name of QIO) concurs, it may grant an additional period of time (not to exceed 5 days) for the submission of this information. Sincerely yours, (QIO Medical Director) Enclosures: (1) Overview of Sanction Process; (2) Summary of Information Used in Determining Findings; (3) Case Synopsis; and (4) Current QIO Instruction. Enclosure 1: Overview of Sanction Process for Substantial Violations INITIAL SANCTION NOTICE Thirty (30) days to submit additional information and/or request a meeting and consideration of a corrective action (if applicable) QIO DECISION Not a substantial second sanction notice* violation Thirty (30) days to submit additional information and/or request a meeting and consideration of corrective action (if appropriate) *The enclosed letter is a second sanction notice. QIO DECISION Not a substantial violation Violation recommendation to OIG Final sanction notice Thirty days to submit additional information to OIG and consideration of OIG DECISION Do not sanction Sanction Right to an administrative law judge (including a pre- exclusion hearing, if applicable) Appendix 9-4 – Synopsis of Cases for Use with 30-Day Letter (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) (Substantial Number of Cases Only) Case #: ______________ Physician: ______________ Admitted: ____________ Discharged: _____________ Principal Diagnosis: (Diverticulosis) Secondary Diagnosis: (Hemorrhoids and Arteriosclerotic heart disease) Procedures Performed: (Sigmoidoscopy Barium Enema Colonoscopy) Example: An 80-year-old patient admitted in stable condition with history of constipation, pain in lower left abdominal quadrant, and occasional rectal bleeding. The admitting/working diagnosis was possible sigmoid tumor. No outpatient evaluation was performed prior to admission. The hospital course was unremarkable and pain due to constipation was attributable to poor dietary habits. Issues Raised and Discussed with Practitioner: 1. Why wasn't there some outpatient workup to determine cause of rectal bleeding and extent of bleeding? 2. A colonoscopy was performed in the presence of a normal barium enema. The validity of performing this study is in question, particularly since a sigmoidoscopy was performed a few days before the colonoscopy and revealed the presence of large internal hemorrhoids. 3. There was no evidence of instructions about importance of diet, exercise, and adequate fluid intake on prevention of constipation. Oral Arguments or Written Information Provided by Practitioner: 1. A rectal examination performed in the office prior to admission was positive for occult blood. Complete blood count not performed because frank bleeding just started; therefore, Hgb and Crit would not yet be deviant. 2. The patient complained of weakness; therefore, the preparation for a barium enema would have made him weaker. Since he was not bleeding at the time of the sigmoidoscopy, the decision was made to perform a more extensive examination. I believed that the colonoscopy was more reliable than a barium enema. 3. This 80 year old patient has not followed my instructions in the past. QIO Evaluation of Arguments or Written Information Presented: 1. A rectal examination is not an adequate workup for a patient who was not acutely ill (i.e., complained of occasional bleeding). The CBC performed upon admission and on the day following admission indicated an Hgb of 12 and a Crit of 36, certainly well within normal range. 2. The admission history and physical examination states that the patient was "in no acute distress." No measures were taken (either prophylactically or therapeutically) to indicate that the patient was in any acute distress. The prep for the colonoscopy is not any less stringent than the prep for the barium enema. 3. The ongoing treatment of his condition is so dependent upon such items as dietary habits, it is most important that this information be emphasized and reinforced multiple times with an aged individual. CONCLUSION OF QIO: The physician violated his statutory obligations as follows: 1. Substantially violated his obligation to order or furnish only care that is medically necessary by: a. Unnecessarily admitting patient to the hospital in that the diagnostic studies performed could have been performed on an outpatient basis. b. Inappropriately performing a colonoscopy in the presence of normal barium enema results. 2. Substantially violated his/her obligation to provide such evidence of medical necessity and quality of health care services provided as a QIO may reasonably require by failing to adequately document the reasons for admission and performance of procedures. 3. Substantially violated his/her obligation to furnish care which meets professionally recognized standards of quality by failing to provide adequate instructions to prevent readmission of this patient in the future. Case #: ______________ Physician: ______________ Admitted: ____________ Discharged: _____________ Principal Diagnosis: (Peripheral vascular disease) Secondary Diagnosis: (Hypokalemia, History of Cancer of Uterus) Procedures Performed: (Venogram, Arteriogram) Example: A 73-year-old patient admitted to hospital because of leg cramps. Admitting/working diagnosis was thrombophlebitis. Issues Raised and Discussed with Practitioner: 1. Admission history and physical examination failed to support the diagnosis of thrombophlebitis; however, the patient received parenteral Heparin therapy for four days without sufficient documentation to support its use. 2. Progress notes for four days were illegible, and the progress notes written on two days do not permit assessment of need for hospital level of care. 3. Physical examination documents the presence of an abdominal fistula. There is no further reference made to this significant abnormality. 4. Why was there no review of old records in this patient who could not give an adequate history of past illnesses? 5. No documentation of pelvic examination in this patient with previous total abdominal hysterectomy with radiation for uterine cancer. Oral Arguments or Written Information Provided by Practitioner: 1. There was marked edema of the leg, and the patient responded to touch as if the leg was painful; therefore, I believed that this patient had a thrombophlebitis. (Since this patient was confused and uncooperative, I was unable to elicit correct responses to questions asked about symptomatology.) I did not see the necessity of performing a venogram before beginning intravenous Heparin therapy since this is the treatment of choice for acute thrombophlebitis. 2. All physicians have illegible handwriting. All that is important is that I can read what I wrote. If the patient got better, why should the QIO nitpick about the quality of my handwriting? 3. I saw no need to investigate the abdominal fistula since it was evident to me that she had it for a number of years, it was not draining, and she did not exhibit any signs of an infection in this area. 4. She was admitted in the evening, and the medical records department was closed. 5. There was no need to subject this patient to a pelvic examination even if she had cancer in the past. QIO Evaluation of Arguments or Written Information Presented: 1. The edema and redness of the legs were bilateral, not just contralateral. There also was not contralateral redness. Given the fact that the signs and symptoms do not lend themselves to an appropriate conclusion that the patient had an acute thrombophlebitis, treatment with intravenous Heparin was not medically indicated without additional diagnostic findings to confirm the diagnosis. 2. The fact that some physicians have poor handwriting is no excuse to have practically no progress notes for the stay. It is imperative that all people rendering care (as well as internal and external review entities) be able to read the progress notes so that they can understand what the physician perceives is happening to the patient (for example, if a particular treatment modality is improving the patient's condition). 3. There was an inadequate description of the abdominal fistula in the chart. Given the information submitted, we agree that non-treatment of the fistula is not an issue. 4. The medical records could have been obtained the next morning. It is essential to have the past records to adequately care for the patient. 5. We continue to believe that a pelvic examination should have been performed. 6. Also, given the history of radiation for uterine cancer, the edema of the legs could have been related to metastatic disease, and there was no workup for this. CONCLUSION OF QIO: The physician violated his statutory obligations as follows: 1. Substantially violated his obligation to order or furnish care that meets professionally recognized standards of quality by: a. Failing to understand the appropriate diagnosing of thrombophlebitis. b. Failing to document a pelvic examination in a patient with previous total hysterectomy with radiation for uterine cancer. 2. Substantially violated his obligation to provide such evidence of medical necessity and quality of health care services provided as a QIO may reasonably require by: a. Failing to write a progress note on two days and failure to write legible progress notes on four days. b. Failing to obtain the previous medical records and include vital information from those records in the medical records for the stay. Case #: ______________ Physician: ______________ Admitted: ____________ Discharged: _____________ Principal Diagnosis: Chronic Obstructive Pulmonary Disease Secondary Diagnosis: Myocardial Ischemia Arteriosclerotic Heart Disease Diabetes Mellitus, Adult Onset Urinary Tract Infection A 78-year-old patient with past history of myocardial ischemia admitted with acute crushing chest pain radiating down his left arm. Patient also complained of shortness of breath. Issues Raised and Discussed with Practitioner: 1. Inappropriate admission to a hospital without active coronary care unit. 2. Inadequate evaluation of this patient's complaints of chest pain and shortness of breath. Although a LDH and CPK were performed as part of the SMA-21, no cardiac enzymes were drawn, and no additional cardiac evaluation was performed, other than an EKG. 3. The initial ABGs were abnormal, yet no follow-up ABGs or other studies were performed. In addition, there were no changes to the treatment plan based upon the abnormal ABGs. 4. Why wasn't a medical consultation ordered? Oral Arguments or Written Information Provided by Practitioner: 1. The patient's family phoned and stated that the patient had acute chest pain. Since I happened to be at XYZ Hospital, where I only occasionally practice, I told them I would meet them there. 2. Since the initial enzymes were normal, I saw no need to have them repeated. This hospital was unable to perform many of the sophisticated tests one would perform in other hospitals. 3. Given he had a history of underlying lung disease and I had seen him with ABGs that abnormal before, I did not believe that I needed to intervene. I also believed that the abnormal ABGs were as a result of his hyperventilating due to his apprehension. 4. I had cared for this gentleman for a number of years, and I felt that if I called in a consultant, it would frighten him. I have more than adequately cared for people with the same problems in my 52 years of medical practice. QIO Evaluation of Arguments or Written Information Presented: 1. The XXX Hospital, which is less than half a block away from the XYZ Hospital, has a Coronary care unit. Since the physician has privileges at that hospital also, he should have instructed the patient's family to take him there, as the admission history and physical examination indicates that the patient complained of crushing chest pain, unlike any he had ever experienced. 2. The initial enzymes many times will not indicate the presence of an acute infarct. Since the admission history states that the patient arrived at the hospital within 30 minutes of the onset of the pain, the blood work was performed early in relation to the onset of symptoms. 3. The ABGs, at a minimum, should have been repeated to ascertain if there was something that needed to be addressed, either prophylactically or therapeutically. The fact that the ABGs had been that abnormal in the past is not relevant. The acute exacerbation of a chronic lung disease can cause havoc with the treatment of a patient. 4. A surgeon, faced with an acute medical crisis, particularly in one of his non-surgical patients, should obtain a medical consultation. The patient's fears could have been assuaged by reassuring him that he was being cared for by a "team" of health care professionals. CONCLUSION OF QIO: The physician violated his statutory obligations as follows: 1. Substantially violated his obligation to furnish care that meets professionally recognized standards of quality by: a. Failing to investigate adequately the chest pain, which was the presenting complaint. b. Failing to repeat blood gases on a patient admitted with abnormal blood gases. c. Failing to adequately treat a patient with abnormal blood gases. d. Failure to transfer patient to medical service in the absence of a surgical problem. Case #: ______________ Physician: ______________ Admitted: ____________ Discharged: _____________ Principal Diagnosis: (Noninfectious gastroenteritis) Secondary Diagnosis: (Arteriosclerotic Heart Disease) (Diabetes Mellitus, Adult Onset) Example: A 75-year-old female with history of nausea, vomiting, and diarrhea of three days duration. Although patient complained of weakness, admission electrolytes were normal, and no additional diagnostic studies were obtained other than a chest X-ray, EKG, and SMA-21. She received intravenous fluids; however, the rate of administration was ordered as KVO. Issues Raised and Discussed with Practitioner: 1. Inappropriate admission to a hospital for a clinically stable patient. 2. If patient was not stable, why were additional diagnostic studies not performed or fluid replacement not more aggressive? Oral Arguments or Written Information Provided by Practitioner: 1. The patient's family phoned and reported that she had nausea, vomiting, and diarrhea of three days duration. Knowing that the aged dehydrate quickly, I feared that this was the case and, thus, admitted her. I had no way of knowing that her electrolytes would be normal. 2. Once it was determined that her electrolytes were normal, I saw no need to do anything other than to treat her symptoms (i.e., medication for diarrhea). I saw no need to administer intravenous fluids and set her up for a round of congestive heart failure. QIO Evaluation of Arguments or Written Information Presented: 1. An evaluation of her condition could have been performed on an outpatient basis (e.g., a physical examination for signs of dehydration, electrolytes, etc.). 2. The QIO is not alleging that the physician should have put the patient in a fluid overload. Rather, the QIO is pointing out that the physician, upon admission, must not have believed that the patient was not stable in that intravenous fluid replacement was limited to a KVO order. CONCLUSION OF QIO: The physician violated his statutory obligations as follows: 1. Substantially violated his obligation to order or furnish only care that is medically necessary by unnecessarily admitting patient to the hospital. Appendix 9-5 – Initial Sanction Notice of Gross and Flagrant Violation (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) QIO LETTERHEAD (Name and Address of Practitioner or Provider) (Dear Dr. :) or (Dear Mr./Mrs./Ms. :) The purpose of this notice is to inform you that (name of QIO), the Quality Improvement Organization (QIO) for the State of (name of State), has concluded that there is a reasonable basis for determining that (you have) (your hospital has) violated (your) (its) obligation under §1156 of the Social Security Act (the Act) to assure that the services provided to program beneficiaries are: (SELECT OBLIGATION(S) VIOLATED). Choose (1), (2), and/or (3) from below: (1) Provided economically and only when, and to the extent, they are medically necessary; (2) Of a quality that meets professionally recognized standards of health care; and/or (3) Supported by the appropriate evidence of medical necessity and quality of the services in a form and fashion and at such time as may be required. (Name of QIO) has concluded that there is a reasonable basis for determining that (you have) (your hospital has) grossly and flagrantly violated (your) (its) statutory obligations. • If the QIO determines finally that such a violation has occurred and recommends a sanction to the Secretary of the Department of Health & Human Services (HHS), and if a final determination is made by the Secretary through the Office of Inspector General (OIG) to impose a sanction, (YOU) (YOUR HOSPITAL) MAY BE EXCLUDED FROM PARTICIPATING IN PROGRAMS UNDER TITLES V, XVIII, XIX, AND XX OF THE SOCIAL SECURITY ACT (INCLUDING THE MEDICARE PROGRAM AND ANY STATE HEALTH CARE PROGRAM AS DEFINED IN §1128(h) OF THE ACT) EITHER PERMANENTLY OR FOR A SPECIFIED PERIOD OF TIME OF AT LEAST 1 YEAR OR, ALTERNATIVELY, REQUIRED TO PAY THE UNITED STATES GOVERNMENT A MONETARY PENALTY AS A CONDITION FOR (YOUR) (YOUR HOSPITAL'S) CONTINUED PARTICIPATION IN THE MEDICARE AND STATE HEALTH CARE PROGRAMS. Because of the serious nature of a final determination by the QIO to recommend a sanction to OIG, you are strongly encouraged to contact (name of QIO) to provide additional information to assist you in responding to the initial determination of a violation and/or to set up a meeting with the (name of QIO). THE MEETING WITH THE QIO WILL BE YOUR ONLY OPPORTUNITY TO DISCUSS (YOUR) (YOUR HOSPITAL'S) SITUATION WITH THE QIO BEFORE IT MAKES A FINAL DECISION WHETHER TO RECOMMEND TO OIG THAT (YOU) (YOUR HOSPITAL) BE SANCTIONED. IF, AS A RESULT OF THE MEETING, A CORRECTIVE ACTION PLAN (CAP) IS IMPLEMENTED, NO FINAL DECISION WILL BE MADE UNTIL THE END OF THE CAP PERIOD. • An in-depth discussion of the cases involved is included below in the case summary section. A detailed synopsis of cases is also enclosed. • The “Additional Information” section explains how to submit additional information to and/or request a meeting with the QIO. • Enclosure 1 provides a brief overview of the sanction process. OBLIGATIONS Section 1156 of the Act (42 U.S.C. 1320c-5) imposes certain obligations upon health care practitioners and other persons who furnish or order services under Medicare or State health care programs. These obligations are to assure that the services are: (1) Provided economically and only when, and to the extent, they are medically necessary; (2) Of a quality that meets professionally recognized standards of health care; and (3) Supported by the appropriate evidence of medical necessity and quality of the services in a form and fashion and at such time as may be required. See also 42 CFR Part 1004. QIO RESPONSIBILITIES The Secretary of HHS has a contract with the (name of QIO) to review Medicare services. Section 1156(b) of the Act provides that if (name of QIO) determines that a practitioner or other person either has failed to comply substantially with any of these obligations in a substantial number of cases, or has grossly and flagrantly violated any such obligation in one or more instances, (name of QIO) must report such determination(s) to the HHS OIG, along with a recommendation for appropriate sanction actions. If OIG agrees with the QIO’s recommendation and finds that the practitioner or other person is unable or unwilling substantially to comply with his/her statutory obligations, OIG may impose a sanction. These sanctions may include exclusion from eligibility to provide services to patients of the Medicare and State health care programs on a payable basis either permanently or for a specified period of time. Alternatively, payment of a monetary penalty in the amount of the actual or estimated cost of medically improper or unnecessary services may be required as a condition for continued eligibility to receive payment under the programs. VIOLATION OF OBLIGATION – CASE SUMMARY The (name of QIO) has reviewed medical records pertaining (to your medical practice), or (to the health care services and items furnished in your hospital). As a result of this review, the (name of QIO) has a reasonable basis for determining that (you have) (your hospital has) grossly and flagrantly violated (your) (its) obligations under §1156 of the Act in the following respects: 1. Chart No. Admission Date • Conclusion: 2. Chart No. Admission Date • Conclusion: -ETC.- A copy of the material (name of QIO) used in arriving at this initial determination is enclosed. Also enclosed is a detailed case synopsis identifying each case (name of QIO) reviewed, the issues (name of QIO) raised, your response to the issues raised, and (name of QIO)’s final determination. (See Appendix 9-6 for Sample Synopsis of a Case.) It has also been initially determined that the violations of (your) (your hospital's) obligations under §1156 of the Act are serious enough to warrant recommending to HHS that sanctions be imposed upon you pursuant to Federal statute and regulations. The sanction to be recommended is (exclusion from participation in the Medicare and State health care programs [for a period of _____ years]) or (that [you] [your hospital] pay to the Government of the United States a monetary penalty in the amount of as a condition for your continued participation in the Medicare and State health care programs). CORRECTIVE ACTION PLAN (if applicable) [Describe the method and timeframe for correcting the identified violation(s)]. ADDITIONAL INFORMATION By this letter you are hereby formally notified that you may submit to the (name of QIO), within 30 days of the date of receiving this letter, additional information that you feel might modify our position and/or a written request to meet with us to review and discuss case specifics. The date of receipt is presumed to be five (5) days after the date on this letter. The additional information and/or request for a meeting should be submitted to: (Contact Person) (Name of QIO) (Address) IF YOU REQUEST A MEETING The purpose of the meeting is to allow (you) (your hospital) to present (your) (your hospital's) views regarding the care rendered to program beneficiaries in the above-cited cases, to discuss these views with the (name of QIO), and to respond to the initial determination of a violation before (name of QIO) makes a final decision whether to recommend a sanction to OIG. • The meeting will be held within 30 calendar days of your request. The (name of QIO) will contact you regarding date, time, and place for the meeting. The meeting date may be extended, but only if you can demonstrate good cause. • You may have an attorney represent (you) (your hospital) at the meeting. The attorney may make opening and closing statements, assist (you) (your hospital) in presenting expert testimony, and ask clarifying questions. • (You) (Your hospital) may bring professional (expert) witnesses to testify on (your hospital's) behalf. The purpose of the witnesses is to discuss relevant medical views pertaining to the above-cited cases. • The (name of QIO) will make a verbatim record of the meeting and provide this record to you as soon as is practicable, but no later than the time a sanction recommendation (if any) is forwarded to OIG. • You should bring all relevant documentation (including office records) regarding the cases cited above to the meeting to fully support your views. • You may request that the physician at the QIO who determined that there is a reasonable basis for concluding that (you have) (your hospital has) violated one or more obligations under the Act appear at the meeting to discuss the basis for the determination, although the QIO does not have to grant that request. • You may object to any member of the QIO being permitted to participate in the decision of (your) (your hospital's) case if you believe that he/she has a personal bias against or is in direct economic competition with (you) (your hospital). • If, prior to the end of the meeting with (name of QIO), you believe that additional documentation exists that relates to the cases or issues discussed at the meeting, you may request an additional period of time (not to exceed 5 days) to submit the relevant information to (name of QIO). If the (name of QIO) concurs, it may grant an additional period of time (not to exceed 5 days) for the submission of this information. Sincerely yours, (QIO Medical Director) Enclosures: (1) Overview of Sanction Process; (2) Summary of Information Used in Determining Findings; (3) Case Synopsis; and (4) Current QIO Instructions. Enclosure 1: Overview of Sanction Process for Gross and Flagrant Violations INITIAL SANCTION NOTICE* Thirty (30) days to submit additional information and/or request a meeting and consideration of corrective action (if appropriate) QIO DECISION Not a gross violation Final sanction recommendation and flagrant notice Not a substantial violation Final sanction notice to OIG Thirty days to submit additional information and/or request a meeting Thirty days to submit additional information to OIG and consideration of corrective action (if appropriate) OIG DECISION OIG DECISION Do not sanction Sanction Right to an administrative law judge (including a pre- exclusion hearing, if applicable) *The enclosed letter is an initial sanction notice. Appendix 9-6 - Synopsis of Cases for Use with 30-Day Letter (Gross and Flagrant Violations Only) (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) Case #: ______________ Physician: ______________ Admitted: ____________ Discharged: _____________ Example: Principal Diagnosis: (Diabetes with Hyperosmolar Coma) Diagnoses: (Pneumonia, Arteriosclerotic Heart Disease, Status Post Cerebral Thrombosis) Procedures Performed: N/A REVIEW SUMMARY This 72-year-old patient was admitted in a comatose state from a nursing home with the diagnosis of diabetes mellitus with hyperosmolar coma. The patient’s initial blood sugar was 926, with no ketoacidosis. A portable chest X-ray was obtained shortly after admission; however, the radiologist stated on the report that a second X-ray should be obtained to rule out the presence of pneumonia. The patient's temperature was 102 degrees upon admission, but on the following day it spiked to 104 degrees. No serum osmolality levels were obtained (or calculated), the chest X-ray was not repeated timely, and no blood or sputum cultures were ordered. The patient was given 5% dextrose in water and large amount of insulin; however, the patient expired on the second day of the stay. SPECIFIC FINDINGS The physician violated his statutory obligation as follows: • GROSSLY AND FLAGRANTLY failed to furnish proper medical care that meets professionally recognized standards of care. • Failed to order the appropriate diagnostic tests for a diabetic hyperglycemic patient with no ketoacidosis. • Failed to use isotonic salt solution to rehydrate the patient. • Failed to repeat a questionable chest X-ray for a diabetic patient in hyperosmolar coma. • Failed to order diagnostic studies to ascertain the cause of the fever. Appendix 9-7 – Final QIO Sanction Notice (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) (Name and Address of Practitioner or Provider) (Dear Dr. :) or (Dear Mr./Mrs./Ms. :) As you are aware, on (date), (name of QIO), the Quality Improvement Organization (QIO) for the State of (Name of State), informed (you) (your hospital) of an initial identification of a possible (substantial) (gross and flagrant) violation of obligations in the care of (a) program patient(s). Subsequently, (name of QIO) informed (you) (your hospital) by letter, dated (date), of its conclusion that there was a reasonable basis for determining that (you) (your hospital) had, in fact, (substantially) (grossly and flagrantly) violated the obligations under §1156 of the Social Security Act (the Act). Section 1156 of the Act (42 U.S.C. 1320c-5) imposes certain obligations upon health care practitioners and other persons who furnish or order services under Medicare or State health care programs. These obligations are to assure that the services are: (1) Provided economically and only when, and to the extent, they are medically necessary; (2) Of a quality that meets professionally recognized standards of health care; and (3) Supported by the appropriate evidence of medical necessity and quality of the services in a form and fashion as may be required. On the basis of additional information provided in response to the above letters and the results of corrective action measures, if applicable, (name of QIO) has determined that (you have) (your hospital has) failed to comply with the obligation(s) (CHOOSE (1), (2), and/or (3) from paragraph above) imposed on you by §1156 of the Act. Therefore, the (name of QIO) has submitted a recommendation to the Secretary of the Department of Health & Human Services, Office of Inspector General (OIG), that (you) (your hospital) be: 1. Excluded from participating (as a provider) in the Medicare program and any State health care program as defined in §1128(h) of the Act for a period of _____ years; OR 2. Required to pay to the United States Government a monetary penalty in the amount of _____ as a condition for [your] [your hospitals] continued participation in the Medicare and State health care programs.) The (name of QIO) has determined that (you have) (your hospital has) (substantially) (grossly and flagrantly) violated the obligations under §1156 of the Act in the following respects: 1. Chart No. Admission Date • Conclusion: 2. Chart No. Admission Date • Conclusion: -ETC.- A copy of the material (name of QIO) used in arriving at this determination is enclosed. Also enclosed is a detailed case synopsis identifying each case (name of QIO) reviewed, the issues (name of QIO) raised and to which you responded, and a clear statement of the factual bases for the (name of QIO)’s determination in each case that (you) (your hospital) violated (your) (its) obligations under the Program. This information is the same material that is being sent to OIG. (You) (Your hospital) may submit, within 30 days from the date of receiving this letter, any additional material that affects the recommendation (to exclude (you) (your hospital) from Medicare and State health care programs) (to impose a monetary penalty). The date of receipt is presumed to be 5 days after the date on this letter. Such material should be sent to: Office of Inspector General Administrative and Civil Remedies Branch – Social Security Act §1156 Coordinator 330 Independence Avenue, SW Mail Stop: Room 5527 Cohen Building Washington, DC 20201 If OIG agrees with our recommendation and determines that (you are) (your hospital is) either unwilling or unable to comply with your obligations under §1156, it may impose a sanction. OIG may accept, reject, or modify our sanction recommendation. OIG is required by law to determine, within 120 days after receiving an exclusion recommendation from the QIO, whether a sanction action is warranted. Therefore, where an exclusion has been recommended, the time period for submitting additional material to OIG will not be extended, and any material received by OIG after the 30-day period will not be considered. Sincerely yours, (QIO Medical Director) Enclosures Appendix 9-8 – Combined Initial Sanction Notice of Substantial Violation in a Substantial Number of Cases and in a Gross and Flagrant Violation(s) (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) QIO LETTERHEAD (Name and Address of Practitioner or Provider) (Dear Dr. :) or (Dear Mr./Mrs./Ms. :) The purpose of this notice is to inform you that (name of QIO), the Quality Improvement Organization (QIO) for the State of (name of State), has concluded that there is a reasonable basis for determining that (you have) (your hospital has) violated (your) (its) obligation(s) under §1156 of the Social Security Act (the Act) to assure that the services provided to program beneficiaries are: (SELECT OBLIGATION(S) VIOLATED). Choose (1), (2), and/or (3) from below: (1) Provided economically and only when, and to the extent, they are medically necessary; (2) Of a quality that meets professionally recognized standards of health care; and/or (3) Supported by the appropriate evidence of medical necessity and quality of the services in a form and fashion and at such time as may be required. (Name of QIO) has concluded that there is a reasonable basis for determining that (you have) (your hospital has) failed to comply substantially with your statutory obligations in a substantial number of cases and grossly and flagrantly violated your statutory obligations. • If the QIO determines finally that such violations have occurred and recommends a sanction to the Secretary of the Department of Health & Human Services (HHS), and if a final determination is made by the Secretary through the Office of Inspector General (OIG) to impose a sanction, (YOU) (YOUR HOSPITAL) MAY BE EXCLUDED FROMPARTICIPATING IN PROGRAMS UNDER TITLES V, XVIII, XIX, AND XX OF THE SOCIAL SECURITY ACT (INCLUDING THE MEDICARE PROGRAM AND ANY STATE HEALTH CARE PROGRAM AS DEFINED IN §1128(h) OF THE ACT) EITHER PERMANENTLY OR FOR A SPECIFIED PERIOD OF TIME OF AT LEAST 1 YEAR OR, ALTERNATIVELY, REQUIRED TO PAY THE UNITED STATES GOVERNMENT A MONETARY PENALTY AS A CONDITION FOR (YOUR) (YOUR HOSPITAL'S) CONTINUED PARTICIPATION IN THE MEDICARE AND STATE HEALTH CARE PROGRAMS. Therefore, you are strongly encouraged to contact the (name of QIO) to provide additional information and/or meet with (name of QIO). • An in-depth discussion of the cases involved is included below in the case summary sections for both types of violations. You will be given an opportunity to provide additional information and/or request a meeting with (name of QIO) to discuss both types of violations. The “Additional Information” section explains how to submit additional information and/or request a meeting that covers/includes these violations. Although no sanction recommendation based on the substantial viola tions in a substantial number of cases will be made to OIG after this initial meeting, it is nevertheless an important first step in the sanction process. With respect to substantial violations in a substantial number of cases, you are entitled (after this initial meeting) to another opportunity to provide additional information and/or request a meeting with (name of QIO). With respect to gross and flagrant violations, you are not entitled to this additional opportunity before a sanction recommendation can be made to OIG. • THE INITIAL MEETING WITH THE QIO MAY BE (YOUR) (YOUR HOSPITAL'S) ONLY OPPORTUNITY (WITH RESPECT TO GROSS AND FLAGRANT VIOLATIONS) TO DISCUSS (YOUR) (YOUR HOSPITAL'S) SITUATION WITH THE QIO BEFORE IT MAKES A FINAL DECISION WHETHER TO RECOMMEND TO OIG THAT (YOU) (YOUR HOSPITAL) BE SANCTIONED BASED ON A GROSS AND FLAGRANT VIOLATION(S). Therefore, because of the serious nature of a QIO’s final determination to recommend a sanction to OIG based on the gross and flagrant violation(s), you are strongly encouraged to contact (name of QIO) to provide additional information to assist you in responding to the initial determination of a violation and/or to set up a meeting with the (name of QIO). IF, AS A RESULT OF THE INITIAL MEETING WITH (name of QIO) PROVIDED AS A RESULT OF THE NOTIFICATION YOU HAVE JUST RECEIVED, A CORRECTIVE ACTION PLAN (CAP) IS IMPLEMENTED, NO FINAL DECISION WILL BE MADE UNTIL THE END OF THE CAP PERIOD. DEPENDING ON WHETHER THE VIOLATION(S) INVOLVES A GROSS AND FLAGRANT OR SUBSTANTIAL VIOLATION, YOU MAY BE ENTITLED TO AN ADDITIONAL OPPORTUNITY TO MEET WITH (name of QIO). YOU ALSO ARE NOTIFIED THAT ANY VIOLATIONS THAT HAVE BEEN INITIALLY FOUND TO BE GROSS AND FLAGRANT ARE ALSO CONSIDERED TO BE SUBSTANTIAL VIOLATIONS. THEREFORE, THESE CASES ARE ALSO LISTED UNDER SUBSTANTIAL VIOLATIONS IN A SUBSTANTIAL NUMBER OF CASES. • Enclosure 1 provides a brief overview of the sanction process for concurrent identification of gross and flagrant and substantial violations in a substantial number of cases. OBLIGATIONS Section 1156 of the Act (42 U.S.C. 1320c-5) impose certain obligations upon health care practitioners and other persons who furnish or order services under Medicare or State health care programs. These obligations are to assure that the services are: (1) Provided economically and only when, and to the extent, they are medically necessary; (2) Of a quality that meets professionally recognized standards of health care; and (3) Supported by the appropriate evidence of medical necessity and quality of the services in a form and fashion and at such time as may be required. See also 42 CFR Part 1004. QIO RESPONSIBILITIES The Secretary of HHS has a contract with the (name of QIO) to review Medicare services. Section 1156(b) of the Act provides that if (name of QIO) determines that a practitioner or other person either has failed to comply substantially with any of these obligations in a substantial number of cases, or has grossly and flagrantly violated any such obligation in one or more instances, (name of QIO) must report such determination(s) to the HHS OIG, along with a recommendation for appropriate sanction actions. If OIG agrees with the QIO’s recommendation and finds that the practitioner or other person is unable or unwilling substantially to comply with his/her statutory obligations, OIG may impose a sanction. These sanctions may include exclusion from eligibility to provide services to patients of the Medicare and State health care programs on a payable basis either permanently or for a specified period of time. Alternatively, payment of a monetary penalty in the amount of the actual or estimated cost of medically improper or unnecessary services may be required as a condition for continued eligibility to receive payment under the programs. • The section below entitled "GROSS AND FLAGRANT VIOLATION(S)" identifies the case(s) in which the (name of QIO) has initially determined that (you have) (your hospital has) grossly and flagrantly violated (your) (its) statutory obligations. The section below entitled "SUBSTANTIAL VIOLATIONS" identifies the cases in which the (name of QIO) has initially determined that (you have) (your hospital has) substantially violated (your) (its) statutory obligations. An in-depth discussion of each case is included in the enclosed case synopsis. GROSS AND FLAGRANT VIOLATION(S) OF OBLIGATION – CASE SUMMARY The (name of QIO) has reviewed medical records pertaining (to your medical practice) (to the health care services and items furnished in your hospital). As a result of this review, the (name of QIO) has a reasonable basis for determining that (you have) (your hospital has) grossly and flagrantly violated (your) (its) obligations under §1156 of the Act in the following respects: 1. Chart No. Admission Date • Conclusion: 2. Chart No. Admission Date • Conclusion: -ETC.- A copy of the material (name of QIO) used in arriving at this initial determination is enclosed. Also enclosed is a detailed case synopsis identifying each case (name of QIO) reviewed, the issues (name of QIO) raised, your response to the issues raised, and (name of QIO) final determination. (See Appendix 9-6 for Sample Synopsis of a Case.) You are also notified that any violations that have been initially found to be gross and flagrant are also considered to be substantial violations. CORRECTIVE ACTION PLAN FOR GROSS AND FLAGRANT VIOLATION(S) (if applicable) Describe the method and timeframe for correcting the identified violation(s). SUBSTANTIAL VIOLATION OF OBLIGATION IN A SUBSTANTIAL NUMBER OF CASES – CASE SUMMARY The (name of QIO) has reviewed medical records pertaining to (your medical practice) (the health care services and items furnished in your hospital). As a result of this review, the (name of QIO) is concerned that (your medical practice) (your hospital's health care services and items furnished to program beneficiaries) as documented in these medical records does not appear to comply substantially with the obligations imposed on you under the Act in the following respects: (Include an in-depth discussion of each situation, circumstance, or activity that resulted in a violation as well as the obligation involved.) EXAMPLE: Providing Services Not Medically Necessary and/or Not Provided in the Most Economical Setting: 1. Chart No. Admission Date • Conclusion: 2. Chart No. Admission Date • Conclusion: Providing Services That Do Not Meet Professionally Recognized Standards of Care: 1. Chart No. Admission Date • Conclusion: 2. Chart No. Admission Date • Conclusion: A summary of the information considered by (name of QIO) in arriving at the above findings is enclosed. CORRECTIVE ACTION PLAN FOR SUBSTANTIAL VIOLATIONS (If applicable) Describe the method and timeframe for correcting the identified violation(s). ADDITIONAL INFORMATION By this letter you are hereby formally notified that you may submit to the (name of QIO), within 30 days of the date of receiving this letter, additional information for both gross and flagrant violation(s) and substantial violations that you feel might modify our position and/or a written request to meet with us to review and discuss case specifics. You may request, if you wish, to meet and discuss both types of violations at a combined meeting or you may opt for separate meetings to discuss each type. The date of receipt is presumed to be 5 days after the date on this letter. The additional information and/or request for a meeting should be submitted to: (Contact Person) (Name of QIO) (Address) IF YOU REQUEST A MEETING The purpose of the meeting with (name of QIO) is to allow you to present (your) (your hospital's) views regarding the care rendered to program beneficiaries in the above-cited cases, to discuss these views with the (name of QIO), and to respond to the initial determination of a violation before (name of QIO) makes a final decision whether to recommend a sanction to OIG. As stated above, you are entitled to an additional opportunity to meet with the (name of QIO) with regard to substantial violations in a substantial number of cases before (name of QIO) makes a final decision to recommend sanction to OIG for this type of violation. • The meeting will be held within 30 calendar days of your request. The (name of QIO) will contact you regarding date, time, and place for the meeting. The meeting date may be extended, but only if you can demonstrate good cause. • You may have an attorney represent (you) (your hospital) at the meeting. The attorney may make opening and closing statements, assist you in presenting expert testimony, and ask clarifying questions. • You may bring professional (expert) witnesses to testify on (your) (your hospital's) behalf. The purpose of the witnesses is to discuss relevant medical views pertaining to this case. The (name of QIO) will make a verbatim record of the meeting and provide this record to you, as soon as is practicable, but no later than the time a sanction recommendation for a gross and flagrant violation (if any) is forwarded to OIG. • You should bring all relevant documentation (including office records) regarding the cases cited above to the meeting to fully support your views. • You may request that the physician at the QIO who determined that there is a reasonable basis for concluding that you have violated one or more obligations under §1156 of the Social Security Act appear at the meeting to discuss the basis for the determination, although the QIO does not have to grant that request. • You may object to any member of the QIO being permitted to participate in the decision of (your) (your hospital's) case if you believe that he/she has a personal bias against or is in direct economic competition with (you) (your hospital). • If, prior to the end of the meeting with (name of QIO), you believe that additional documentation exists (with respect to the gross and flagrant violations) that relates to the cases or issues discussed at the meeting, you may request an additional period of time (not to exceed 5 days) to submit the relevant information to (name of QIO). If the (name of QIO) concurs, it may grant an additional period of time (not to exceed 5 days) for the submission of this information). Sincerely yours, (QIO Medical Director) Enclosures: (1) Overview of Sanction Process; (2) Summary of Information Used in Determining Findings; (3) Case Synopsis; and (4) Current QIO Instructions. Enclosure 1: Overview of Sanction Process for a Combined Initial Sanction Notification for Gross and Flagrant Violations and Substantial Violations INITIAL SANCTION NOTICE* Thirty days to submit additional information and/or request a meeting and consideration of corrective action (if appropriate) NOTE: You may opt to discuss the different types of violations at separate initial meetings. QIO DECISION Not a gross violation Final sanction recommendation and flagrant notice Not a substantial violation Second sanction notice to OIG Thirty days to submit additional information and/or request a meeting Thirty days to submit additional information to OIG and consideration of corrective action (if appropriate) OIG DECISION QIO DECISION Do not sanction Sanction Not substantial violation Final sanction notice recommendation to QIG Right to an administrative law judge (including a pre- exclusion hearing, if applicable) Thirty days to submit additional information to OIG *The enclosed letter is a combined initial sanction notice. Appendix 9-11 – EMTALA Physician Review Document Checklist (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) Instructions: • The CMS Regional Office Division of Survey and Certification will indicate whether each of the documents listed below is included in the EMTALA review package. All of the documents listed should be included in the package, if available. • The QIO Physician Reviewer will mark “Yes” for each document reviewed and “No” for each document included in the EMTALA review package but not reviewed. The Physician Reviewer should review all documents included in the package. Document Name Included in Package? Yes/No/Not Applicable (N/A) Reviewed by BFCC-QI Physician Reviewer Yes/No/Not Applicable (N/A) Hospital Medical Record(s): Initial Facility Hospital 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) Transcripts of notes of relevant interviews (staff, patient, family, other witnesses, etc.) Hospital census as provided by the facility, including capacity of relevant units (such as ICU, inpatient psychiatric unit, OB unit) Staffing schedules (by unit) Document Name Included in Package? Yes/No/Not Applicable (N/A) Reviewed by BFCC-QI Physician Reviewer Yes/No/Not Applicable (N/A) Description of hospital services/capabilities Physician on-call schedule at the 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 Other Other Other Appendix 9-12 – EMTALA Physician Review Worksheet (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)