Help Center -Department of Managed Care This I my appeal letter to ask that you reconsider and approve the Sleeve Gastrectomy Weight Loss Surgery that was denied by Anthem Blue Cross because they consider the procedure investigational. I believe this surgery is exactly the tool I need to improve my health and the quality of the rest of my life. I have been told by several of Anthem Blue Cross customer service representatives that 43775 is a covered procedure and that as long as my HMO approved they would pay for the surgery. This is not what I am being told now. I have been getting the runaround on this for two months. I received a letter from my HMO dated 2/6/10(copy enclosed) stating this is not a denial of service but Anthem considers this procedure experimental and has to go to the Utilization Dept for a decision. The number to call this department was on the letter. I called this Dept. a minimum of 5 times and was told they don’t know what I am talking about, this dept. doesn’t handle HMO. So I call my HMO and they say “oh you have to appeal” so I send my appeal letter to Anthem on 2/16 and wait the 30 days for a decision. On the 28th day they inform me that I cannot appeal because I haven’t been denied, oh and the people in the Utilization Dept. don’t know that their department handles this?? So they send it back to the Utilization Dept and now I have officially been denied. This part of this process has taken two months, very frustrating. I. PATIENT BACKGROUND My name is Jeani Xxxxxxx and I am insured under group plan xxxxxxxxxx. My member ID # xxxxxxxxxxxxx. I am now 59 years old. I am 5/5 tall and at this time I weigh 233 lbs. I am seeking approval for weight loss surgery. I have been overweight to one degree or another since I was a young child and was advised by my pediatrician to diet at age 10. I have made numerous efforts at weight loss throughout my teenage years and adult life. I dieted frequently as a teenager and young adult. Numerous times I have lost 40-80 pounds or more but eventually the weight returns. Weight loss programs I tried include juice fasts, traditional calorie counting on quite a few occasions, Weight Watchers, Slim Fast, Nurti-system, the Atkins diet, Cabbage soup, Mayo Clinic diet, the Zone, gym membership, lap swimming, weight training, water aerobics, walking programs, various buddy-system diets and individual, self hypnosis, ”Think yourself Thin” “ Think yourself Thin Automatically, tape you listen to in the car” Dexatrim, Metabalite, Hoodia, Green Tea Extract, and numerous other fad diets. In all cases I lost weight but each time the weight crept back, usually with a little more. Eventually I realized that traditional dieting seemed to actually cause weight gain due to increased hunger that seems to occur after significant weight loss. I believe science is only now beginning to understand the reasons for this phenomenon which is consistently reported by clinically obese people. Studies also show that genetics plays a larger role than once thought and there are morbidly obese people in my family as well as slim people. My co-morbidities include high blood pressure, high triglycerides, low good cholesterol, have had abnormal EKGs, borderline diabetes, and osteoarthritis in my hip, which my doctor said weight loss would help significantly. I have also had sever back pain most of my life. I take hydrochlorothiazide and verapamil for high blood pressure which is effective. I take medicine, Niacin for high triglycerides. I have a family history of cancer as well as strokes, heart disease and severe arthritis. I take nabumetone almost daily and ibuprofen to help with severe leg pain related to arthritis in my hip. I have taken ibuprofin for back pain that i have had most of my life even when I was not overweight. I believe I will need NSAIDS even after WLS which is why I need the sleeve as this is the only WLS that you can still take anti-inflammatory medications. I buy over the counter ibuprofen as I can get 500-200mg pills for $10.00 which last over 6 months, whereas when getting prescription I only get 30 -800 milligrams for a co-payment of $10 which only last a month. My excess weight and other health issues makes everyday activities difficult including housework, shopping, standing, walking significant distances, working and recreation. It effectively makes my world smaller limiting the number of things I can do each day. I have lived with obesity for years and strongly wish to change this aspect of my life. I fear the consequences of my high triglycerides especially considering the family history i have of heart disease. Many members of my family died of heart attack and stroke. I was stunned to learn that my weight is in the obese category but heartened to learn of this newer treatment with fewer side effects and shorter recovery. I am highly motivated to succeed with VSG and understand that food intake will be significantly limited for the rest of my life and that I must continue to exercise to be successful. Before I found out about the arthritis, which is the result of a subtle fracture at some point in my life that affected the curvature and angle of my right hip bone (this was found by an MRI that was done after pain medication didn’t help and physical therapy made the pain worst), I used to walk a minimum of 30-60 minutes a day at least 5 days a week. Since this pain in my leg as a result of the hip arthritis I no longer can do that and I am afraid that the weight will just continue to creep up on me. My particular problem is in volume eating. I eat good food, lots of chicken and turkey, lots of fruits and vegetables, the thing is I am always hungry and I eat until I am full. Having a smaller stomach and feeling full sooner seems like exactly the kind of help I need. I had given up on traditional dieting as it always resulted in failure and am pleased to have found the VSG surgical option which appears to be the only tool offering a realistic possibility of lifelong weight control for me. I believe VSG is the best surgery for me because it offers restriction like the lap-band and the RNY but without the malabsorption of the RNY. The RNY is not an option because I very much need regular doses of nabumetone and ibuprofen for the leg pain related to my hip pain and even once I lose the weight believe I will still need ibuprofen for my back pain which I have suffered with most of my adult life. Tylenol is not effective for me. I am allergic to codeine, vicodin, any pain medication of that type I cannot take. Narcotic pain relievers make my head seem fuzzy but do not help with pain. I have the same concern about the lap band. I also understand that as many as 27 percent of lap band patients require band removal and weight loss is often unsatisfactory (I think the number is even higher now). Most importantly, the VSG removal of a large portion of the stomach removes many of the cells that produce the hormone ghrelin which is known to cause hunger and appetite. The RNY and lap band don’t have this advantage. At age 59 I am concerned about the side effects of the RNY and do not want to spend 6 or more months with dumping syndrome and feeling rotten. I also worry about the ability to take and absorb other medications I might need in the future as I age. The VSG appears to offer the fastest recovery, weight loss similar to the RNY and the least amount of side effects. One recent publication, “The Best Bariatric Operation for Older Patients “ by Drs Lee, Cirangle, Taller, Feng and Jossart, 2005, concludes that “These data suggest that the best bariatric operation for older patients may be the laparoscopic VG because it achieves the greatest weight loss with the shortest operative time and the fewest complications”. I have investigated this procedure very thoroughly including attending support groups and talking with others who have had it. I have completed most of the preoperative testing and strongly believe this is the best procedure for my circumstances II. THE VSG SHOULD NO LONGER BE CONSIDERED INVESTIGATIONAL The only stated reason for denying approval for the VSG is that it is investigational and …” current available medical studies do not show that this service improves health outcomes, is as good as or better than standard alternatives, or shows improvement outside the research setting”. It is respectfully submitted that this conclusion is incorrect. The conclusion ignores the 36 studies now available on the effectiveness of VSG which indicate that excess weight loss is similar to the RNY and that complications from surgery are actually lower than RNY. It also ignores the fact that the VSG is now widely performed and is routine for many bariatric surgeons and has long been performed outside the research setting. Anthem’s policy on Surgery for Clinically Severe Obesity is set forth in a document with an effective date of April 22, 2009. This document reviews the various forms of bariatric surgery and explains when weight loss surgery is considered medically necessary. VSG is excluded from ever being medically necessary because it is designated as investigational and that “…there is insufficient convincing evidence in the peer reviewed medical literature, in terms of safety, to support the use of …sleeve gastrectomy…other than biliopancreatic bypass with duodenal switch, in individuals with clinically severe obesity.”. Nevertheless, the lap band and Realize band procedures are approved as medically necessary in this same document based upon what appears to be two three year studies involving 219 and 352 patients respectively. There is now a considerable body of data and studies supporting the safety and effectiveness of the VSG as a primary procedure for weight loss. The June 2009 Supplement to Bariatric Times reporting on the Second International Consensus Summit on Sleeve Gastrectomy (available at www.bariatrictimes.com) includes 10 papers pertaining to the safety and effectiveness of the VSG presented by leading bariatric surgeons. In Reducing Risk in Bariatric Surgery: Rational for Sleeve Gastrectomy, Dr. Eric J. DeMaria concludes that “A growing body of evidence suggests sleeve gastrectomy may be an appropriate primary bariatric surgical procedure primarily due to low risk and ease of surgical revision when required.” In the paper presented by Drs Jossart and Cirangle, four years of data showed a 68% excess weight loss by VSG patients, a figure not largely different than RNY patients of the same time range. Most significantly, in Debates and Consensus: a Summary by Dr. Michael Gagner, important questions concerning the VSG were debated and conclusions reached by the 400 conference participants. Question 6 was as follows: “Question 6: In your opinion, is there currently enough published data to support the sleeve gastrectomy as a primary procedure to treat morbid obesity on par with adjustable gastric banding and Roux-en-Y gastric bypass? Several groups presented cohorts of patients with follow-up periods of 4 to 8 years the day before. Jossart and colleagues in San Francisco presented eight years’ experience including 1,200 cases, whereas at more than four years, weight loss resulted in a similar curve to gastric bypass. At higher BMI (greater than 55kg/m2) a plateau of nearly 40kg/m2 demanded a second stage, but below a BMI of 55, the operation was terrific. Schauer and colleagues assessed the literature from 35 reports, studied more than 3,000 published sleeve gastrectomy cases, and found an extremely low mortality rate (near 0.12%). Results have shown excellent weight loss and co morbidity reduction that is comparable to or exceeds other bariatric operations and that the sleeve gastrectomy is safe and efficacious. Himpens of Belgium analyzed his patients from 2001 through 2002(sic) to attain six-year follow-up. Sixty-five percent of 46 patients were considered a “success” (%EWL greater than 50 ) at two years. At six years the success rate was maintained at 59 percent. Weiner from Frankfurt and MacMahon of Leeds, who started in 2000, also had similar results. *** Certainly, the audience thought there was enough evidence published to support the sleeve gastrectomy as a primary procedure to treat morbid obesity on par with adjustable gastric banding and Roux-en-Y gastric bypass with a yes vote of 77 percent. This is perhaps the strongest contribution to this second consensus conference.” A review article entitled “Systematic Review of Sleeve Gastrectomy as Staging and Primary Bariatric Procedure” was recently posted on the web site of the American Society of Bariatric and Metabolic Surgeons dated May 26, 2009. The authors are Drs Brethaur and Schaur and Jeffrey Hammel M.S. of the Bariatric and Metabolic Institute of the Cleveland Clinic, Cleveland, Ohio. Thirty-six studies involving 2570 patients who had the VSG procedure were analyzed. Their conclusion was: “From the current evidence, including 36 studies and 2570 patients, LSG is an effective weight loss procedure that can be performed safely as a first stage or primary procedure. From this large volume of case series data, a matched cohort analysis and 2 randomized trials, LSG results in excellent weight loss and co-morbidity reductions that exceeds , or is comparable to, that of other accepted bariatric procedures. The postoperative major complication rates and mortality rates have been acceptably low. Long-term data are limited but the 3- and 5- year follow up data have demonstrated the durability of the SG procedure. “ To date ten thousand patients have had the VSG surgery with good success. Many are going to Mexico or other foreign countries because their insurers refuse to pay for the VSG even though it is less expensive than the RNY procedure, the so called “gold standard” of weight loss surgery which takes several hours and requires a hospital stay of 3 or 4 days. The VSG can be completed in one hour by a skilled surgeon and most patients stay only one night in the hospital. While there is certainly follow up care, the repeated fill and unfill procedures required by gastric banding are unneeded for the VSG. Nutritional supplements are much less of a problem than with the RNY. Many insurance companies are recognizing the value and cost effectiveness of the VSG and have approved the VSG for at least some patients, including BSBC Federal, Tri-west Tri-care Prime, United Healthcare, the Veterans Administration, Aetna, Blue Care Network HMO, Healthnet, Anthem BC of Connecticut, Definity Health/United Healthcare, PPO, Empire Blue Cross Anthem, and UHC. The VSG sleeve gastrectomy is now routinely offered by Kaiser Permanente to all patients that qualify for Weight Loss Surgery and would not do so if this surgery was not proven to work. I don’t think it is fair that if you have five people, one with Kaiser, one with United, one with Aetna, one with Cigna and me with Anthem Blue Cross of California, the other four will be offered the sleeve and I will not. The California Department of Insurance has recognized that VSG is widely accepted by the American Society for Metabolic and Bariatric Surgery as a standard procedure at medical centers for excellence. In Decision #EI09-9645 the physician reviewers reversed the health plan’s denial of the patient’s VSG request and concluded that VSG was the most appropriate option for the patient. The same conclusion was also reached in EI06-5882 though the patient had significantly more co-morbidities. That decision noted the important fact that the VSG is nothing more than the first part of the duodenal switch operation which includes the second step of intestinal modification and as such, the VSG portion has been performed for many years as part of the DS procedure. Some patients have the VSG first as part of a two stage procedure and find that they do not need the second stage. Thus, the VSG is not as new and investigational as Anthem’s conclusions seem to imply. Anthem does cover the DS procedure which includes the VSG as one part. According to an article published in the Detroit Free Press on August 17, 2009, Blue Cross Blue Shield of Michigan, in conjunction with the University of Michigan, has been compiling a large detailed data base on bariatric surgery in order to improve surgical outcomes and provide cost savings. In three years of data collection, it appears that the VSG now accounts for as much as 12% of all bariatric procedures. This percentage indicates that the procedure is far beyond investigational status. This data base indicates that 10,000 VSG procedures are known to have been performed. My Anthem group policy excludes investigational procedures and defines that term as procedures: “ 1) that have progressed to limited use on humans, but which are not generally accepted as proven and effective procedures within the organized medical community; or 2) that do not have final approval from the appropriate governmental regulatory body; or 3) that are not supported by scientific evidence which permits conclusions concerning the effect of the service, drug or device on health outcomes; or 4) that do not improve the health outcome of the patient treated; or 5) that are not as beneficial as any established alternative; or 6) whose results outside the investigational setting cannot be demonstrated or duplicated; or 7) that are not generally approved or used by Physicians in the medical community. It appears that the VSG, based upon the articles cited above, has been performed on thousands of patients, has been accepted by a consensus of participating members of an international conference devoted to this subject, is widely accepted by the ASMBS, does not require FDA or similar government approval, is in fact supported by at least 36 studies analyzed by highly respected physicians, is as effective as the RNY and more effective than gastric banding in terms of percentage of excess weight loss, has fewer complications than the RNY, has as good or better reduction of co morbidities as other procedures, and has results that are similar in studies by both United States and foreign physicians. The VSG therefore no longer falls within the definition of investigational procedures excluded from coverage. The conclusions stated in the previously cited Anthem Policy on Surgery for Clinically Severe Obesity are simply no longer correct and that policy should be updated to include VSG coverage or disregarded. With the VSG patients lose about 68% of excess weight and lower BMI patients like me often do much better. Weight loss will most certainly help my back and hip pain and improve ability to exercise. High triglycerides, high blood pressure, and borderline diabetes are corrected in about 76 percent of WLS cases and I am hoping for this result. It is therefore highly likely that my health will be improved by this procedure and I respectfully ask for your reversal of this denial. I am a mother and soon to be a Grandmother and I want to improve the quality of my life so that I will be healthier and able to help raise my grandchildren and be able to take an active role in their life.Thank you for your review of this matter. I greatly appreciate the fact that the state of California has a procedure to help insured patients who find themselves in disagreement with their insurance companies. I strongly believe this decision will greatly affect the quality of the rest of my life. Thank you for your time. I eagerly await your decision regarding this. I can be reached as indicated below if further information is needed. Enclosed is a copy of my denial letter from Anthem Blue Cross My HMO is Healthcare Partners Primary Care Provider is xxxxxxxxxxxxx Gastric Surgeon xxxxxxxxxxxxx Sports Medicine xxxxxxxxxxxx who ordered MRI and diagnosed arthritis Cardiologist xxxxxxxxxxxxx did my last EKG and stress test All these doctors agree Weight Loss Surgery is a good option for me. Respectfully yours, Jeani Anderson xxxxxxxxxxxxxxx xxxxxxxxxxxxxxx (xxx) xxx-xxxx Work info: xxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxx CA 91101 (xxx)xxx-xxxx ext. 244