LittleMissSunshine

VSG Appeal Letter: The Waiting is the Hardest Part

May 05, 2011

Special thanks to Sleeve Genie and WVLoser for letting me use your appeal letters to base mine on... you ladies saved me hours of research!

In addition to the epic novel below (they asked for it!) I also printed off copies of the research found at the following links and included it in the envelope with my appeal:

New Data on Weight Gain After Bariatric Surgery  (Upadate to add this lnk and section 3.1 in the letter below on 5/29... not included in my original appeal, but may be helpful for others being urged to consider RNY).
Bariatric Times Supplement
ASMBS Statement 
Blind Study Comparing VSG with RNY
Another Study Comparing VSG with RNY
Study Comparing VSG with the Band and RNY
(Click "Download PDF" for the printable version)
VSG as Sole and Definitive Procedure (5 year study) (Click "Download PDF" for the printable version)
VSG Early Results and Complications (Click "Download PDF" for the printable version)
Preliminary Outcomes 1 Year Out from VSG (Click "Download PDF" for the printable version)

In the letter below, I pulled out specifics and replaced them with general terms like "Insurance Provider" and "Dr. Surgeon" in red to make it easy for anyone else who needs this letter to customize it to suit their needs.

My husband just dropped it in the mail... I'll post an update as soon as I have one.

Thanks for "listening" :-).

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                                                                                                                                                                           Firstname Lastname
                                                                                                                                                                           Street Address 
                                                                                                                                                                           City, State Zip  

May 3rd, 2011


Appeals Coordinator 

Insurance Provider
PO Box 123
City, State Zip
 
Re: Sleeve Gastrectomy Decision Appeal Name: Firstname Lastname

Group Name: Blah
Group #: XXXXXXX
Subscriber ID: XXXXXXXXX
Reference No: XXXXXXX  

Dear Sir or Madam,

This is my appeal letter to ask that you reconsider and approve my request for coverage of the Vertical Sleeve Gastrectomy (VSG) weight loss surgery (WLS) submitted on my behalf by Dr. Surgeon's office.

If you review my call history with Insurance Provider, you’ll find that I was told by not one, but two different representatives that code 43775 (VSG) is a covered procedure as long as I met the criteria of having a BMI over 40—or 35 with at least 2 co-morbidities—and had completed a 6 month long, medically supervised weight loss program. Further review of my file will show that my BMI is well over 40, I do have co-morbidities (sleep apnea, high BP) and have also completed the required pre-requisite program through Yadda Yadda offered by the City, State location. 

Despite my verifying coverage not once, but twice, prior to my initial consult with Dr. Surgeon—I didn’t want to waste my time or his if the VSG was not covered—I received a rejection letter not because I don’t meet the criteria, as I clearly do, but on the basis that Insurance Provider considers this procedure investigational.  In this letter, I intend to illustrate why I believe this assertion is erroneous as there is sizeable body of data providing the efficacy of this procedure to treat morbid obesity.  


      I.              Personal Information & Background  

I am 35 years old, 5’7 tall and at the writing of this letter, weigh 341lbs (down from 360 just a few months ago, my highest weight ever), putting me at a BMI of 53.4. I have been overweight since age 10 and have made numerous attempts at weight loss throughout my teenage years and adult life, but eventually the lost pounds come back and bring friends with them. You’ll find a documented history of my past weight loss attempts in the information Dr. Surgeon's office sent.

My excess weight makes everyday activities like housework, shopping, standing, walking significant distances, working and recreation more of a challenge than they should be for a 35 year old woman. As the mother of a four year old boy, I’m sure you can imagine how heartbreakingly limited my abilities to keep up with him are.

In addition to the aching joints and lower back discomfort common to most super morbidly obese patients, I currently have obstructive sleep apnea; the doctor said that based on my jaw and soft palate structure, he believes it will clear up entirely once I lose the weight. I also have high blood pressure, though thankfully it’s not dangerous enough to warrant medication… yet. My mother was on BP meds for as long as I can remember when she was alive, so I believe it’s only a matter of time until I need these maintenance meds as well unless I can drop my excess weight. 

It’s worth mentioning that my mother died at 72 following cancer, a stroke AND a heart attack in the span of just 4 years due to her having been morbidly obese her entire adult life. My father died of late-onset diabetes, which is also on my mother’s side (her grandmother had it). I have been fairly lucky with my health thus far, as was my mother when she was my age, but I know someday these high-risk factors from my weight catch up to me.

In addition to those risks listed above, there is also a history of severe arthritis in my family; both my mother and grandmother had it. Given that I am already beginning to notice aching in my joints, especially in my hands, I believe at some point I may need to begin a regular regimen of NSAIDS, the VSG is the only WLS where you can still take anti-inflammatory medications. 

I want to do something about the risk factors I can avoid falling victim to by losing weight now while I’m still young enough to not only bounce back from the surgery, but to enjoy my life and be a participant in my son’s life, not a spectator on the sidelines as my mother was with me.  


     II.            Decision Making Process  

In December of 2010, I began to consider and research surgical weight loss options. At the beginning of this process, I had considered the gastric band procedure as a possible option and had even pursued it to the point of having the surgery scheduled through Previous Surgeon's Office (you’ll find this documentation in my file). As I waited for the big day to arrive, I began to frequent the support forums on ObesityHelp.com for banded patients to prepare myself for what was to come. 

Doing so raised red flags for me as it seemed the vast majority of posts were from people experiencing difficulties ranging from needing corrective surgery to being unable to eat without vomiting.  Reading those posts started me on a path of research around the range and risks of complications that ultimately resulted in my canceling the surgery, where I discovered the following:

2.1        Recent studies show that the gastric band procedure has a significantly high failure rate.

2.2        Allergan, the manufacturer of the Lap Band, published the following as part of their Patient Safety Information. “In the United States clinical study, with 3-year follow-up reported, 88% of the 299 patients had one or more adverse events, ranging from mild, moderate, to severe. Nausea and vomiting (51%), gastroesophageal reflux (regurgitation) (34%), band slippage/pouch dilatation (24%) and stoma obstruction (stomach-band outlet blockage) (14%) were the most common post-operative complications. In the study, 25% of the patients had their band systems removed, two-thirds of which were following adverse events.”

2.3        Published in the journal Obesity Surgery in 2008, the study Long-Term Results of Bariatric Restrictive Procedures: A Prospective Study lap band failure rates were documented at 54% with the most frequent complications being pouch dilatation (21%) and anterior slippage (17%). Forty-four percent (44%) of the patients required repair or revision.

2.4        In the study Analysis of Poor Outcomes After Laparoscopic Adjustable Gastric Banding published in June of 2010 by George Washington University, the authors indicate a high complication rate for gastric banding procedures including reoperation for 16.7% of the patients in the study. The majority of the patients also failed to achieve a 50% excess weight loss. They also noted that 11% of the patients in the study required revision to the sleeve gastrectomy.

2.5        In another study that included patients observed over 9 years, long-term results and complications following adjustable gastric banding 52.9% patients had at least one complication requiring reoperation and the band was removed for 28.6%.

2.6        Most significant is a recent study which included a 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates. In this study, a group of physicians from Switzerland led by Dr. M. Suter, MD, PD, FACS, examined the long-term complications related to LapBand weight-loss surgery. The study demonstrated that LapBand long-term complications increase over time. Overall, 33.1% of patients had at least one long-term complication related to gastric banding. This study concludes:

“LGB appeared promising during the first few years after its introduction, but results worsen over time, despite improvements in the operative technique and material. Only about 60% of the patients without major complication maintain an acceptable EWL in the long term. Each year adds 3-4% to the major complication rate, which contributes to the total failure rate. With a nearly 40% 5-year failure rate, and a 43% 7-year success rate (EWL >50%), LGB should no longer be considered as the procedure of choice for obesity. Until reliable selection criteria for patients at low risk for long-term complications are developed, other longer lasting procedures should be used.”


As my research continued and evolved with the start of 2011, I read several articles and documented studies on the traditional gastric bypass as well as the duodenal switch. 


Due to the high probability that I will need to take NSAIDS for arthritis coupled with the reasons indicated below, neither the gastric bypass nor the duodenal switch are surgical options for me:

3.1        Recent studies have shown that patients who had gastric bypass surgery are more likely to regain weight years later due to the absense of the pyloric valve resulting in reactive hypoglycemia (see attached documentation for details).

3.2         A malabsorptive procedure such as the Roux en Y gastric bypass or the duodenal switch is deemed unnecessarily risky because certain patients are successful with a restrictive-only procedure.

3.3        In general, studies show that malabsorptive procedures carry a significantly higher risk of complications and death. The complication rate for the gastric bypass ranges from 6.5% to 14.5% (depending upon how the procedure is performed) as compared to 1.5% for the sleeve gastrectomy.

3.4        The duodenal switch procedure carries with it a high rate of surgical complications, significant malabsorption leading to anemia, protein deficiency and metabolic bone disease has been found in up to 5% of patients.

Finally in March of 2011, I determined that the Vertical Sleeve Gastrectomy was the best possible solution for me and my life long battle with obesity. The VSG is considered one of the safest procedures while still achieving a high percentage of weight loss. The VSG also removes many of the cells that produce the hormone ghrelin, which is known to cause hunger and appetite. This procedure also has a very fast recovery period. The following documentation supports my findings:

4.1        Recent studies indicate that the sleeve gastrectomy is a safe weight loss surgery with statistically high success rate and a reasonably low rate of complications.

4.2        In a position statement from 2009, the American Society for Metabolic and Bariatric Surgery (ASMBS) determined that sleeve gastrectomy is an "approved bariatric surgical procedure" based on 35 studies covering 2,400 patients (see enclosed).

4.3        Five-year results from one of the longest ongoing studies were presented in 2007. That study, Laparoscopic Vertical Sleeve Gastrectomy for Morbid Obesity: a Report of a Five-Year Experience with 750 Patients presented by Lee, Cirangle and Jossart concludes that: “Laparoscopic VSG demonstrates comparable weight loss to the Gastric Bypass after three years with 0% mortality. Long term morbidity is almost nonexistent compared to the Gastric Bypass.”

4.4        In the study, Laparoscopic Sleeve Gastrectomy: a Retrospective Review of 1- and 2-year Results published in the journal Surgical Endoscopy in 2009 the authors conclude that: “Our results show that LSG is a safe and effective weight-loss procedure with results similar to those of gastric bypass.”

4.5        The study, Laparoscopic Sleeve Gastrectomy as a Single-Stage Bariatric Procedure published in 2009 concludes that: “laparoscopic sleeve gastrectomy has achieved satisfactory weight loss results with an acceptable complication rate in the medium-term.”

4.6        In a study published through the University of Rome in 2010 entitled Laparoscopic Sleeve Gastrectomy as First Stage or Definitive Intent in 300 Consecutive Cases the authors conclude: “SG is a safe and effective treatment for morbid obesity at mid-term follow-up. SG is effective for comorbidities resolution, especially for the treatment of diabetes.”

4.7        In a 5 year study published in 2009 entitled Sleeve Gastrectomy as Sole and Definitive Bariatric Procedure: 5-Year Results for Weight Loss and Ghrelin, the authors report success with mean excess weight loss at nearly 60% after 5 years as well as post-operative ghrelin levels which also remained low during the 5 year study period.

4.8        In Spain, a National Registry has been created to track outcomes of the sleeve gastrectomy. In a study of the registry, entitled: The Study Short-And Mid-Term Outcomes of Sleeve Gastrectomy for Morbid Obesity, the results of 540 patients studied found the resolution of morbid obesity to be 81%. It concluded that sleeve gastrectomy “provides good short- and mid-term results with a low morbid-mortality rate.”

4.9        In Sleeve Gastrectomy: a New Surgical Approach for Morbid Obesity presented by the University of Vermont College of Medicine, the authors stated:

“An extensive literature review was conducted and the information currently available surrounding LSG, such as history, indications and contraindications, mechanism of weight loss, technique and outcomes and controversial issues are discussed, LSG is an accepted procedure for the surgical management of morbid obesity. It is gaining popularity as a primary, staged and revisional operation for its proven safety and simplicity, as well as short-term and mid-term efficiency. Excess weight loss and remission of comorbidities have been reported to take place and is comparable with other well-established procedures.”


4.10      In the study, A Prospective Randomized Study Between Laparoscopic Gastric Banding and Laparoscopic Isolated Sleeve Gastrectomy, the authors concluded that after 1 and 3 years: “Weight loss and loss of feeling of hunger after 1 year and 3 years are better after sleeve gastrectomy than gastric banding. In that study the date is compelling, showing weight loss at 1 and 3 years out with the gastric sleeve at nearly double the weight loss with gastric banding”. 

4.11      In the study. Weight Loss Over Time for Adjustable Gastric Bands, Roux-en-Y Gastric Bypasses, and Sleeve Gastrectomies: A Comparative Analysis published by the American Society of Metabolic and Bariatric Surgery, researcher Snyder reported on data from an analysis of almost 7,000 patients who underwent Roux-en-Y gastric bypass, adjustable gastric banding, or sleeve gastrectomy over a five-year period. Analysis of weight loss over time showed gastric banding to have the lowest rate of weight loss (0.16/day average over 302 days), which was significantly less compared with 0.41/day over 226 days with gastric bypass and 0.39/day over 99 days with sleeve gastrectomy (P less than 0.001). Bypass and sleeve gastrectomy achieved comparable weight loss (P=0.34).

4.12      Recent studies also indicate that the sleeve gastrectomy is a medically appropriate revision procedure for former gastric band patients.

4.13      In the paper, Laparoscopic Sleeve Gastrectomy presented in 2009 by the Bariatric & Metabolic Institute of the Cleveland Clinic the authors stated: “In conclusion, LSG can be performed with minor complications and low mortality. It has been demonstrated to be a safe and effective procedure in the short and midterm and an adequate alternative for failed LAGB.”

Ø The June 2009 Supplement to Bariatric Times reporting on the Second International Consensus Summit on Sleeve Gastrectomy (see enclosed) 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.”   

Ø 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.    

Ø 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:    

“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.”    

Ø 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. “       


     III.           The VSG Should No Longer Be Considered Investigational  

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. This data base indicates that 10,000 VSG procedures are known to have been performed. 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. Based upon the articles cited above, the VSG has the following qualities:

·        
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 approved as a standalone procedure by the ASMBS (highlighted in enclosed)
·         Is, in fact, supported by at least 36 studies analyzed by highly respected physicians
·         Is as effective as the gastric bypass and more effective than gastric banding in terms of percentage of excess weight loss
·         Has fewer complications than the gastric bypass
·         Has as good or better reduction of co-morbidities as other procedures
·         Has results that are similar in studies by both United States and European physicians

Therefore, the experimental/investigational conclusions stated in my rejection letter are, for lack of a better word, outdated and this decision should be overturned.

To date, more than ten thousand patients have had the VSG surgery with great 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 gastric bypass procedure, the so called “gold standard” of weight loss surgery which takes several hours, requires a hospital stay of 3 or 4 days and has the highest mortality rate of the three WLS procedures. The VSG can be completed in one hour by a skilled surgeon, most patients stay only one night in the hospital and the mortality rates are on par with those of the LAPBAND.

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 gastric bypass. Many insurance companies are recognizing the value and cost effectiveness of the VSG and have approved the VSG for at least some patients, including (but not limited to):

·         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
·         Empire Blue Cross Anthem
·         UHC  

The VSG is now routinely offered by Kaiser Permanente to all patients that qualify for WLS; this would not be the case 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 Tri-Care and me with Employer’s supposedly Cadillac coverage through Insurance Provider, the other four will be offered the sleeve and I would not.    

Insurance Provider’s claim that the VSG is investigational was surprising given that it is covered under the Federal BCBS benefits plan. According to my research, Federal BCBS began considering VSG a covered procedure in 2008, which leads me to believe in the possibility that the investigational determination is most likely the result of a simple communication or processing error. Because Federal BCBS covers VSG, it should not be necessary to present evidence regarding the efficacy and safety of the procedure.

A recently updated position statement and standard of care in regards to the VSG from the American Society of Metabolic and Bariatric Surgeons (ASMBS) reads as follows… you’ll find the full statement (and other supporting documentation) enclosed:

Ultimately, various treatment modalities are appropriate for each patient, and surgeons must use their judgment in selecting from among the different feasible treatment options…The ultimate judgment regarding the appropriateness of any specific procedure or course of action must be made by the physician in light of all the circumstances presented 

If the ASMBS recognizes that different treatment options can be applied to different patients, why shouldn’t the surgical decision be left up to the person who wants the surgery and their doctor? My surgeon is recognized as one of the best in his field, a fact proven by his winning the Top Docs award for the past 3 years in a row… why isn’t his assessment good enough to warrant my approval?

As stated in the bullet points above, VSG patients typically lose about 68% of their excess weight. Not only will this surgery improve my health and my quality of life, it will reduce my risk of future health issues as well… something that’s surely in your best interest as my insurance provider. I respectfully ask, as a leading healthcare provider in this industry, to reverse your previous decision to deny me coverage for the VSG.

I am highly motivated to succeed with the 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. As my particular problem in rooted in volume eating, a smaller stomach and feeling full sooner seems like exactly the kind of help I need.

Given that it is highly likely that my health will be improved by this procedure, I respectfully ask for your reversal of this denial.   As a wife, mother and career woman, I want to improve the quality of my life so that I will be healthier and able to meet the challenges of those obligations, which I am falling far short of now.

Thank you for your review of this matter, I eagerly await your decision. If you have any questions or need additional information, please don’t hesitate to call or email me.

Home: XXX-XXX-XXXX
Cell: XXX-XXX-XXXX
Work: XXX-XXX-XXXX
Email: [email protected]                                                                                                              

                                                                                                                              Sincerely,
                                                                                                                                                                                (Handwritten signature)

                                                                                                                              
                                                                                                                               Firstname Lastname

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About Me
48.7
BMI
VSG
Surgery
05/23/2011
Surgery Date
Mar 17, 2011
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