Howard Pitluk, MD, MPH, FACS VP/CMO, Health Services Advisory Group, Inc. Mark Michelman, MD, MBA Clinical Director, FMQ

1. Your Medicare QIO* Answers Your QuestionsPhysicians & the SCIP VTE Measures: Protecting Patients, Perfecting Performance, Limiting Liability, and Cutting Costs (What’s Not to Like?) Howard Pitluk, MD, MPH, FACS VP/CMO, Health Services Advisory Group, Inc. Mark Michelman, MD, MBA Clinical Director, FMQAI, Inc. *QIO = Quality Improvement Organization. This Presentation is brought to you by the QIOs of California, Arizona, and Florida

2. To Submit Questions 1. To submit a Question, click on the little blue “text balloon” on the floating toolbar. 2. A text-box window will open. Type in your question, indicate that you want to send it to the Host, and click on Send. 2

3. Today’s Panelists Howard Pitluk, MD, MPH, FACS Vice President and Chief Medical Officer, Health Services Advisory Group, Inc. Mark Michelman, MD, MBA Clinical Director, FMQAI, Inc. 3

4. Sponsoring Organizations • Health Services Advisory Group, Inc. • Medicare Quality Improvement Organization for Arizona since 1979. • Health Services Advisory Group of California, Inc. • Medicare Quality Improvement Organization for California since 2008 • FMQAI, Inc. • Medicare Quality Improvement Organization for Florida since 1993. 4

5. Q1: What is SCIP? www.medqic.org/scip 5

6. Surgical Care Improvement ProjectNational Goal • To reduce preventable surgical morbidity and mortality by 25% by 2010. 6

7. SIP/SCIP National Expert Panel/Steering Committee • American College of Surgeons • American Hospital Association • Agency for Healthcare Research and Quality • American Association of Critical Care Nurses • American College of Chest Physicians • American College of Obstetricians & Gynecologists • American Geriatrics Society • American Academy of Orthopedic Surgeons • American Society of Anesthesiologists • American Society of Health System Pharmacists • Association of Professionals in Infection Control and Epidemiology • Association of PeriOperative Registered Nurses • Centers for Disease Control and Prevention • Centers for Medicare & Medicaid Services • Department of Veteran’s Affairs • Institute for Healthcare Improvement • The Joint Commission • Society for Critical Care Medicine • Society of Colon and Rectal Surgeons • Surgical Infection Society • Society for Healthcare Epidemiology of America • Society of Thoracic Surgeons • The Medical Letter • Sanford Guide 7

8. Surgical Care Improvement Project (SCIP) Preventable Complication Measures Surgical infection prevention Cardiovascular complication prevention Venous thromboembolism prevention 8

9. Surgical Care Improvement Project 9 *NQF endorsed

10. Q2: What are the SCIP/VTE Measures? 10

11. The SCIP VTE-1 Measure Description: Surgery patients with recommended venous thromboembolism (VTE) prophylaxis ordered anytime from hospital arrival to 24 hours after Anesthesia End Time. [The information on this and the following slides is adapted from the Specifications Manual for National Hospital Inpatient Quality Measures, version 3.0b. You can always find the most up-to-date information about quality measures in the Specifications Manual, which can be found by going to www.qualitynet.org, clicking on the “Hospitals-Inpatient” tab, then clicking on the Specifications Manual option.] 11

12. The SCIP VTE-1 Measure: Rationale • There are over 30 million surgeries performed in the United States each year. • Despite the evidence that VTE is one of the most common postoperative complications and prophylaxis is the most effective strategy to reduce morbidity and mortality, it is often underused. • The frequency of venous thromboembolism (VTE), that includes deep vein thrombosis and pulmonary embolism, is related to the type and duration of surgery, patient risk factors, duration and extent of postoperative immobilization, and use or nonuse of prophylaxis. 12

13. The SCIP VTE-1 Measure: Rationale • According to Heit et al, 2000, surgery was associated with over a twenty-fold increase in the odds of being diagnosed with VTE. • Studies have shown that appropriately used thromboprophylaxis has a positive risk/benefit ratio and is cost effective. • Prophylaxis recommendations for this measure are based on selected surgical procedures from the 2004 American College of Chest Physicians guidelines (updated in 2008). 13

14. The SCIP VTE-2 Measure Description: Surgery patients who received appropriate venous thromboembolism (VTE) prophylaxis within 24 hours prior to Anesthesia Start Time to 24 hours after Anesthesia End Time 14

15. The SCIP VTE-2 Measure Rationale • Timing of prophylaxis is based on the type of procedure, prophylaxis selection, and clinical judgment regarding the impact of patient risk factors. • The optimal start of pharmacologic prophylaxis in surgical patients varies and must be balanced with the efficacy-versus-bleeding potential. • Due to the inherent variability related to the initiation of prophylaxis for surgical procedures, 24 hours prior to surgery to 24 hours post surgery was recommended by consensus of the SCIP Technical Expert Panel in order to establish a timeframe that would encompass most procedures. 15

16. Q3: Can you help us understand why VTE is such a high-priority topic? 16

17. VTE: Significant Health Impact • VTE refers to DVT and its most serious complication, PE • VTE is a significant cause of mortality, morbidity, and resource expenditure • DVT occurs in ~2 million Americans annually • PE occurs in ~600,000 Americans annually • 3-month mortality rate with PE is as high as 17% • Fatal PE may be the very first symptom of VTE • PE is the third most common cause of hospital-related deaths in the United States Heit JA, Cohen AT, Anderson FA on behalf of the VTE Impact Assessment Group. [Abstract] American Society of Hematology Annual Meeting, 2005. 17

18. Annual Fatality Rates in the U.S. 18

19. Q4: What is driving public reporting of these quality measures, and who supports them? 19

20. Who’s Driving the Quality Reporting Initiative? Professional forces Consumer forces Government (CMS, NCQA) Public reporting (IOM, media) National quality organizations (JC, NQF) Consumer demand Business (PFP, Leapfrog) 20 CMS=Centers for Medicare and Medicaid Services; JC=Joint Commission; NCQA=National Committee for Quality Assurance; NQF=National Quality Forum.

21. Q5: What are the barriers to following the recommended VTE prophylaxis? (Why are some physicians unwilling to follow the recommended evidence-based VTE prophylaxis guidelines?) 21

22. VTE Prophylaxis: Perceived Barriers • “I ambulate my patients quickly.” • “My patients don’t get DVT/PE.” • “No literature to support VTE prophylaxis.” • “ASA is just fine for all my patients. It was good enough 30 years ago and is still good enough now.” • “Elastic stockings are all you need.” • “My patient had a bleeding ulcer 10 years ago; it’s too risky to give anticoagulants.” 22

23. Responses to Perceived Barriers • Having bathroom privileges is inadequate for VTE prophylaxis. • Any surgical patient can get a DVT/PE. • The literature is extensive and quite clear in supporting VTE prophylaxis. • ASA has no value in VTE prophylaxis. • Elastic stockings (not to be confused with Sequential Compression Devices, or SCDs), by themselves, are inadequate VTE prophylaxis. • Remote GI bleeding is not a contraindication for VTE chemoprophylaxis. • Patients over age 40, having general anesthesia for more than 30 minutes, and a LOS greater than 2 days, need some type of prophylaxis. 23

24. Q6: What Can Hospitals Do to Improve on the VTE Quality Measures? 24

25. What Can Hospitals Do to Implement VTE Quality Measures? Shift the hospital practice paradigm from inconsistent risk assessment and periodic prophylaxis to evidence-based standardized protocols Develop a formal, active strategy that addresses the prevention of VTE utilizing: Written, institution-wide thromboprophylaxis policy Strategies known to increase thromboprophylaxis adherence: Computer decision support systems Preprinted orders Periodic audit and feedback 25

26. What Can Hospitals Do to Implement VTE Quality Measures? • Provide education on VTE as it pertains to morbidity, cost, and care measures • Create and educate a dedicated in-hospital team, and provide them with necessary tools to implement VTE quality measures • Hospitalist/Surgeon as chairperson(s) • Pharmacists and nurses as key team members • Foster an integrated patient management approach 26

27. What Can Hospitals Do to Implement VTE Quality Measures? • Utilize all available quality improvement resources and tools (QIO, MedQIC, TJC, IHI, AHRQ, etc.) • Stay aware of the current measures and updates • Support activities in raising awareness and implementation of pending TJC measures • Partner with organizations in efforts to improve quality • Implement VTE protocols and standing orders 27

28. VTE Prophylaxis Protocols Exist • Protocols and guidelines for VTE prophylaxis and effective treatment in hospital settings are available from a number of organizations: • A good source of Orderset/Protocol examples from around the country is the Society of Hospital Medicine VTE Resource Room: http://www.hospitalmedicine.org/ResourceRoomRedesign/RR_VTE/html_VTE/12ClinicalTools/02_Ordersets.cfm • Additional resources are listed in the supplemental document, which will be provided at the end of this Webinar. 28

29. Q7: What are the accepted methods for surgical VTE prophylaxis? 29

30. VTE Prophylaxis Options for Surgery General Surgery (Appendix A, Table 5.19) Any of the following: • Low-dose unfractionated heparin (LDUH). • Low molecular weight heparin (LMWH). • Factor Xa Inhibitor (fondaparinux) • LDUH or LMWH or Factor Xa Inhibitor (fondaparinux) combined with IPC or GCS. General Surgery with a reason for not administering pharmacological prophylaxis (Appendix A, Table 5.19) Any of the following: • Graduated compression stockings (GCS). • Intermittent pneumatic compression devices (IPC) 30

31. VTE Prophylaxis Options for Surgery Elective Total Hip Replacement Any of the following started within 24 hours of surgery: • Low molecular weight heparin (LMWH). • Factor Xa Inhibitor (fondaparinux) • Warfarin. Elective Total Hip Replacement Surgery with a reason for not administering Pharmacological prophylaxis Any of the following: • Intermittent pneumatic compression devices (IPC). • Venous foot pump (VFP). Elective Total Knee Replacement Any of the following: • Low molecular weight heparin (LMWH). • Factor Xa Inhibitor (fondaparinux). • Warfarin. • Intermittent pneumatic compression devices (IPC). • Venous foot pump (VFP) 31

32. Q8: What is the impact on patients, physicians, and hospitals when the measures are not met?What liability do physicians and hospitals expose themselves to in not following the recommended VTE prophylaxis? 32

33. Impact of Not Providing Recommended VTE Prophylaxis When the patient does not receive the appropriate VTE prophylaxis, there is significant impact: • Patient is more likely to get a DVT/PE • Physician is not providing evidenced-based medicine • Non-compliant physicians can have a major impact on a hospital’s publicly reported data. • There are potential legal implications for the physician and the hospital when there is non- compliance with the VTE measures, especially if there is an adverse event. 33

34. Hospital-Acquired Conditions— October 2008 Foreign object retained after surgery Air embolism Blood incompatibility Pressure ulcers, stage III and IV Falls and trauma (Fx, dislocations, intracranial injuries, crushing injuries, burns, electric shock 34

35. Hospital-Acquired Conditions— October 2008 (Cont’d) 6.* Manifestations of poor glycemic control (ketoacidosis, nonketotic hyperosmolar coma, hypoglycemic coma, secondary diabetes with ketoacidosis, secondary diabetes with hyperosmolarity) (Forget to order insulin, monitor BS) 7.* Cather-associated UTI 8.* Vascular catheter-associated infection 35

36. Hospital-Acquired Conditions— October 2008 (Cont’d) 9.* Surgical site infection following: • CABG―mediastinitis • Bariatric surgery • Laproscopic gastric bypass • Gastroenterostomy • Laproscopic gastric restrictive surgery • Orthopedic procedures (spine, neck, shoulder, elbow) 10.* DVT/PE • Total knee, hip replacement 36

37. Q9: If a physician determines VTE prophylaxis is not indicated for a particular patient, what should the physician do to help the hospital meet measure guidelines for this case? 37

38. Documentation Is Required • The physician must clearly and legibly document in the medical record specific reasons why the patient should not receive the recommended prophylaxis. If pharmacoprophylaxis is not given, the appropriate mechanical prophylaxis should be ordered.  38

39. VTE Prophylaxis Exclusions • Patients at risk for bleeding or actively bleeding may be excluded from pharmacological prophylaxis • Active bleeding (gastrointestinal, cerebral, retroperitoneal) • Bleeding risk • Patients on continuous IV heparin therapy with 24 hours before or after surgery • Thrombocytopenia • Patient refusal 39

40. Q10: Should VTE prophylaxis continue after hospital discharge? 40

41. Hospital Stays Are Often Shorter Than Recommended Prophylaxis Duration Average Hospital LOS vs. Recommended Duration of Prophylaxis †For chronic obstructive lung disease or congestive heart failure, estimated from >200 New York State hospitals during 1999-2001; ‡for colonic resection; §for major joint procedures, including hip and knee replacement, estimated from >200 New York State hospitals during 1999-2001. 1. LOVENOX® (enoxaparin sodium injection) Prescribing Information. Sanofi-aventis U.S. LLC. June 2007. 2. de Jong JD et al. Health Serv Res. 2006;41:374-394. 3. Basse L et al. Ann Surg. 2000;232:51-57. 41

42. The Take-Home Message • The effectiveness of VTE prophylaxis is well documented. • Most hospitalized patients have at least one VTE risk factor. • VTE prophylaxis is the right thing to do to protect the health of our patients. • Non-compliance can have serious financial, legal, and public reporting implications for physicians and hospitals. 42

43. The Take-Home Message (Cont’d) VTE risk assessment and prophylaxis should be as fundamental to hospital practice as are the measurements of pulse, blood pressure, temperature, height, and weight. For additional SCIP resources, including the supporting documents for this Webinar, go to: Arizona = http://www.hsag.com/azhospitals/scip/resources.aspx California = http://www.hsag.com/cahospitals/scip/resources.aspx Florida = http://www.fmqai.com/PatientSafety-SCIP-Tools.aspx 43

44. Over 1 million drug-related injuries occur every year in health care settings. The Institute of Medicine estimates that at least a quarter of these injuries are preventable. To find out how to prevent medication errors, go to (Florida) http://www.fmqai.com/PatientSafety-FMSI.aspx,(Arizona) http://www.hsag.com/azproviders/drugsafety.aspx, or (California) http://www.hsag.com/caproviders/drugsafety.aspx. www.hsag.com www.fmqai.com This material was prepared by Health Services Advisory Group of California, Inc., the Medicare Quality Improvement Organization for California; Health Services Advisory Group, Inc., the Medicare Quality Improvement Organization for Arizona; and FMQAI, Inc., the Medicare Quality improvement Organization for Florida, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. Publication Nos. CA-9SOW-6.2.3-110409-01, AZ-9SOW-6.2.3-110409-01, FL2009F62ST1611497 44