HealthTrek Weighing in on a High-Risk Procedure September 2006 Introduction Bariatric surgery is a relatively high-risk procedure once used strictly as a treatment of last resort for obesity. Newspaper and magazine articles, television reality shows, documentaries and an avalanche of advertising over the past few years have made this procedure seem almost commonplace. While more options, improved techniques and better understanding of post-operative care have provided solutions for treating a population that is increasingly obese, the mainstream interest has greatly increased the demand for the procedure and thus created significant liability and insurance challenges for medical professionals and institutions providing bariatric services. It is no secret that the prevalence of obesity has increased significantly in the past two decades. A landmark national survey concluded that the incidence of obesity in adults increased from 15 percent in the late 1970s to 30.9 percent in 1999 1. Obesity is a known risk factor for leading causes of mortality and morbidity, including diabetes, heart disease, stroke, hypertension, gallbladder disease, osteoarthritis, respiratory problems and some forms of cancer. In the US alone, the cost of managing health issues associated with obesity was estimated to be $92 billion in 2002 2. Medicare and other insurance providers have recognized the link between obesity and the higher cost of morbidity management and have included bariatric surgery as a covered treatment option in certain patient populations 3. Mounting patient demand, favorable reimbursement policies and increased acceptance among the surgical community have led many hospitals across the country to start bariatric surgery programs or contemplate doing so. Although bariatric surgery has gained wider acceptance within the underwriting community, hospitals seeking Professional Liability insurance or self-insurance options can still face significant challenges in managing bariatric risk. Bariatric Surgical Procedures and Risks In its early days, bariatric surgery employed one of two procedure types: restrictive and malabsorption 4. Restrictive procedures involve reducing the size of the functional stomach by the creation of a smaller pouch, simply restricting the amount of food that can be taken in. These procedures include gastric binding as well as vertical banded gastroplasty. Malabsorption procedures involve the creation of a bypassed small intestine to limit food absorption. These procedures are rarely performed today due to the By Jacqueline Bezaire, RN, JD Senior Vice President Willis Healthcare Practice Willis North America 09/06
significant side effects associated with them, including fluid and electrolyte imbalances, vitamin deficiencies and fatty infiltration of the liver. Each procedure carries its own set of unique risks and because of this, combination procedures have been developed that have greatly increased the potential for successful long-term surgical outcomes. Bariatric procedures currently used include the following. Roux-en-Y Bariatric This is the most commonly performed weight loss surgery, involving both restrictive and malabsorptive components. Biliopancreatic Diversion This is a malabsorption operation in which portions of the stomach are removed. Vertical Banded Gastroplasty This is a restrictive procedure but has no malabsorptive effect. Laparoscopic Adjustable Gastric Banding Introduced in 2001, this has become increasingly popular and involves the use of an adjustable silicone band around the upper stomach placed during a laparoscopic procedure 5. Liability Issues Organizations offering bariatric surgery services are vulnerable to litigation, not only because of the elevated morbidity and mortality rates associated with the procedure, but also because these cases may represent high damage potential and can be attractive to plaintiff attorneys. The Agency for Healthcare Research and Quality has estimated that about 40 percent of bariatric patients will experience significant complications within 180 days of surgery 6. One of the main selection criteria for bariatric surgery candidates is age, with candidates in their 30s and 40s predicted to have the best outcomes. On the other hand, these patients represent a greater liability if there is a poor outcome allegedly due to malpractice. These claims will be the most costly owing to the significant remaining lifespan and associated lost income of these relatively young individuals. Verdicts and settlements involving bariatric surgery range from $20,000 to $4 million. Below are some examples that illustrate the types of problems that can occur. Organizations offering bariatric surgery services are vulnerable to litigation [in part due to] the elevated morbidity and mortality associated with the procedure... Ohio $1,200,000 Plaintiff Verdict, 2005 Allegations: Death of 33-year-old man, due to failure to diagnose and treat a post-operative anastamosis leak that was not discovered for four days following bariatric surgery. The patient became septic and died. Defendants claimed that the leak was a risk of the procedure 7. Massachusetts $2,000,000 Plaintiff Verdict, 2000 Allegations: Malnutrition, neuropathy and excessive weight loss following bariatric surgery in a 36-year-old man 8. 2 Willis North America 09/06
Ohio $3,000,000 Plaintiff Verdict, 2004 Allegations: Failure to treat bowel spillage, peritonitis, abdominal abscess and sepsis in 38-year-old man, resulting in three subsequent surgeries and two months in ICU 9. California $275,000 Plaintiff Verdict, 2001 Allegations: Failure to obtain informed consent, specifically in terms of the reversibility of the procedure, negligent laparoscopic Roux-en-Y surgical technique leading to stricture in the anastomosis, resulting in nine months of IV nutrition 10. California $4,300,000 Plaintiff Verdict, 2003 Allegations: Failure to diagnose anastomosis leak in a 39-yearold woman, leading to sepsis and death 11. Average Indemnity Payment A study performed by the Physician Insurers Association of America (PIAA), reported that most claims are settled during litigation for an average indemnity payment of $186,925 12. Risk Management Techniques Floor nurses experienced in respiratory care, management of nasogastric and abdominal wall drainage tubes, and ambulation of the morbidly obese patient, knowledge of common perioperative complications and ability to recognize intravascular volume, cardiac, diabetic and vascular problems Availability of specialists in cardiology, pulmonology, rehabilitation and psychiatry 16 Operating Room Equipment Special operating room tables and equipment to accommodate morbidly obese patients Retractors suitable for bariatric surgical procedures Specifically designed stapling instruments Appropriately long surgical instruments Other special supplies unique to the procedure 17 Hospital Facilities Recovery room capable of providing critical care to obese patients Available intensive care unit with similar capabilities Hospital beds, commodes, chairs and wheelchairs to accommodate the morbidly obese Radiology, endoscopy and other diagnostic equipment capable of handling obese patients Long-term follow-up care facilities including rehabilitation facilities, psychiatric care, nutritional counseling and support groups 18 The keys to reducing risks related to bariatric surgery include the development of a comprehensive bariatric program and the use of dedicated and well qualified physicians and staff. Risk management techniques for bariatric surgery are set forth by the American College of Surgeons 13 as well as the Guidelines for Granting Privileges in Bariatric Surgery offered by the American Society for Bariatric Surgery 14. Further, board certification in bariatric surgery for physicians and modified consent forms should be considered 15. Staffing Should Include: A bariatric surgery team comprised of experienced and committed surgeons, anesthesiologists, nurses and nutritionists Recovery room staff experienced in difficult ventilatory and respiratory support Credentialing The skill of the surgeons involved in bariatric surgery is a key factor in preventing claims and providing good outcomes. The American College of Bariatric Surgery recommends the following credentialing guidelines for bariatric surgeons 19. 3 Willis North America 09/06
Credentials from a facility accredited to perform gastrointestinal and biliary surgery Documentation that the physician is working within an integrated program for the care of the morbidly obese patient that provides ancillary services such as specialized nursing care, dietary instruction, counseling, support groups, exercise training and psychological assistance as needed Documentation that there is a program in place to prevent, monitor and manage short-term and long-term complications Documentation that there is a system in place to provide and encourage follow-up for all patients. Include documentation of the educational materials used Clearly document the patient s understanding of all aspects of the procedure Include documentation of discussions with the patient on alternatives to the procedure contemplated Give consideration to including the family in discussions regarding potential outcomes and the necessary care and follow-up after surgery 22 Follow-up visits should either be directly supervised by the bariatric surgeon of record or other healthcare professionals who are appropriately trained in perioperative management of bariatric patients and part of the integrated program. Physicians must demonstrate adequate patient education regarding the importance of follow-up as well as adequate access to follow-up. Operative Experience The operative experience necessary for granting privileges in bariatric surgery varies according to the bariatric procedure contemplated. The American Society for Bariatric Surgery has recommended that the surgeon perform a certain number of bariatric procedures, be proctored during the procedures and document evidence of good surgical outcomes. The specific requirements will vary according to whether the procedure is open or laparoscopic 20. Board Certification in Bariatric Surgery Board certification is now available for bariatric surgeons. The American Board of Bariatric Medicine (ABBM) offers certification in bariatric surgery for those physicians who: Meet licensure and experience qualifications Pass a written examination Complete a patient care review administered by the Board of Bariatric Medicine Are approved by a two-thirds vote of the ABBM Board of Directors 21 Informed Consent Development of a specialized consent process/form for bariatric patients should be considered and should: Document the specific risks and benefits of bariatric surgery and long-term possible outcomes Submission Considerations Bariatric surgery has historically been an area that has made many Professional Liability underwriters nervous due to the high morbidity rates. This seems to be changing as more underwriters become comfortable with the risk. Obtaining reasonable Professional Liability insurance is a function of presenting a well developed bariatric program to the underwriter. The following information should be considered for inclusion in the Professional Liability submission: Evidence of a well documented, multidisciplinary bariatric program Accreditation by the American College of Surgeons Credentialing documentation according to American Board of Bariatric Medicine guidelines Physician Board Certification in Bariatric Surgery by the American College of Surgeons Physician loss histories Evidence of participation in a bariatric surgery outcomes database 4 Willis North America 09/06
Conclusion For any institution offering bariatric surgery, a well documented, comprehensive program, in compliance with the recommendations set forth by the American Board of Bariatric Medicine, the American Society for Bariatric Surgery and the American College of Surgeons, will reduce risk and create a favorable impression on healthcare Professional Liability underwriters. Adherence to these standards will help establish best practices for patient care as well as assist in obtaining the best possible insurance premium prices. Contacts For further information, please contact any of the following: Kevin J. Downs Frank Castro Executive Vice President Senior Vice President and Practice Leader Los Angeles,CA Chicago, IL Tel: 213 607 6304 Tel: 312 621 4812 frank.castro@willis.com kevin.downs@willis.com Jennifer R. Rutecky Paul A. Greve, Jr. Healthcare Practice Principal/ Senior Vice President/ Senior Vice President Senior Consultant Atlanta, GA Nashville, TN Tel: 404 224 5095 Tel: 615 872 3320 jennifer.rutecky@willis.com paul.greve@willis.com Jacqueline Bezaire, RN, JD David C. Wynstra Senior Consultant Executive Vice President Los Angeles, CA San Francisco, CA Tel: 213 607 6343 Tel: 415 955 0233 jacqueline.bezaire@willis.com dave.wynstra@willis.com ASHRM 2006 The Willis Healthcare Practice looks forward to seeing you at ASHRM s 2006 Annual Conference and Exhibition in San Diego, October 29-31. Footnotes: 1. K.M. Flegal, M.D. Carroll, C.L. Ogden, C.L. Johnson, Prevalence and Trends in Obesity Among US Adults, JAMA,1999-2000 2. E.A. Finkelstein, I.C. Flebelkorn, G. Wang, National Medical Spending Attributable to Overweight and Obesity: How Much and Who s Paying, Health Affairs Web Exclusive, May 14, 2003 3. US Department of Health and Human Services, Center for Medicare and Medicaid Services, Medical Coverage Data Base, 8/9/2006, http://www.cms.hhs.gov/med/vicwdecisionmemo.asp 4 Types of Surgeries, 2006, Academy of Bariatric Surgeons, http://www.obesityhelp.com/abs/surgerytypes.html 5. Ibid, p. 3 6. Obesity Surgery Complication Rates, 2006, Agency for Healthcare Research and Quality, http://ahrq.gov/news/press/pr2006 7. Ohio Trial Reported, JAS Publications, 2006, Vol. 20, No. 9 8. Case No. CV-97-1348-C, Medical Alert, 2000, Jury Verdict Review Publications, Inc. 9. Case No. 507681, Verdicts, Settlements & Tactics, January 2004, West Group 10. Case No. 729970, Medical Litigation Alert, 2001, Jury Verdict Review Publications, Inc. 11. Case No. GC 027757, Verdicts, Settlements & Tactics, October, 2003, West Group 12. Bariatric Surgery Claims, PIAA Research Notes, Winter 2005, p. 3 13. Recommendations for Facilities Performing Bariatric Surgery, September 2000, American College of Surgeons 14 Guidelines for Granting Privileges in Bariatric Surgery, October 2005, American Society for Bariatric Surgery 15. Policies and Procedures for Certification, American Board of Bariatric Medicine, http://www.abbmcertification.org 16. Recommendations for Facilities Performing Bariatric Surgery, September 2000, American College of Surgeons 17. Ibid p. 1 18. Ibid p. 1 19. Bariatric Surgery Center Network, American College of Surgeons, www.facs.org/cqi/bscm/overview/html 20. Ibid p. 4 21. Policies and Procedures for Certification, American Board of Bariatric Medicine, http://www.abbmcertification.org 22. Recommendations for Facilities Performing Bariatric Surgery, September 2000, American College of Surgeons, p. 6 Please visit us at booth #211. 5 Willis North America 09/06