Thursday, July 29, 2010

Summary Appeal Letter - Studies and Standards

Here is my final letter (I hope) in my year+ insurance appeal. I was finally told that I qualify for a revision but that they need more studies on whether VSG is appropriate after band failure. Sheesh, can't they do a search on PubMed for themselves? At any rate, I put it all together in a huge letter. I'm thinking this letter could help others...

Please forgive the formatting, it didn't cut and past over well...

[Opening paragraph contains specifics about my case and attorney]

The OPM has recommended that this case be re-submitted for further medical review and the information contained in this letter contains additional information as requested by the OPM. In this letter we will also show the following:

A. That a revision surgery is medically necessary and, in fact, that the medical necessity was already established by Regence in October of 2009. Vertical sleeve gastrectomy is a covered procedure.

B. That the Sleeve Gastrectomy is a medically appropriate course of treatment. Of the four weight loss surgeries currently available, the vertical sleeve gastrectomy procedure is the most appropriate given the patient’s history and the study data currently available.

Revision is Medically Necessary

As stated above, revision surgery meets the requirements of medical necessity. Ms. Udy’s lap band failed in early 2009 as confirmed by endoscopy and fluoroscopy procedures. Removal of the failed gastric band and weight loss surgery revision were deemed medically necessary by the patient’s primary care physician and surgeon, Drs. Brogren and Billing.
In addition to physician-established medical necessity, the following must also be considered:

1. Medical necessity for a revision has already been established by Regence when they covered removal of the failed gastric band in October of 2009. As per common medical standards for bariatric surgery, correction of a failed primary bariatric procedure includes revision as well as repair. Revision is necessary to provide continuation of care for the original diagnosis of morbid obesity under which the primary procedure was covered. By covering the explant of the gastric band, Regence has already established medical necessity for a revision; it is not reasonable to claim that medically necessity doesn’t exist as a reason for denying coverage of the second half of the revision process.

2. Federal BCBS plans routinely provide coverage for the sleeve gastrectomy and for weight loss surgery revisions, including revisions from gastric band to a gastric sleeve. (See the appendix for the list of states and surgeons where gastric sleeve procedures have been covered).
As per prior communication with Federal BCBS, vertical sleeve has been a covered gastric restrictive procedure since January of 2008. It is clearly covered under the plan benefits which include:

“Gastric restrictive procedures, gastric malabsorptive procedures, and combination restrictive and malabsorptive procedures to treat morbid obesity.”

Note that there are no exclusions referring to the sleeve gastrectomy -- either as a primary or revisionary procedure.

3. The patient meets the standard medical criteria set forth for weight loss surgery revision.
In 2008 the American Society for Metabolic & Bariatric Surgery presented medical guidelines for bariatric surgery. Recommendation R163 specifically recommends revision of a bariatric surgical procedure if there were medical complications resulting from the initial surgical procedure. Insurance companies appear to have considered this recommendation when developing their own medical policies for bariatric revision.

Regence’s own medical policy for bariatric surgery includes this reference to revision:

“Reoperation to address complications of a bariatric procedure may be considered medically necessary. These include, but are not limited to, staple-line failure, obstruction, stricture, non-absorption resulting in hypoglycemia or malnutrition, weight loss of 20% or more below ideal body weight, band erosion, band migration.”

Nowhere in Regence’s bariatric policy or in the Federal BCBS plan is weight or BMI ever suggested as a possible prerequisite to revision surgery. It would be unreasonable to require a patient to regain all of their weight in order to have coverage to remove a failed lap band just as it would be unreasonable to ask a cardiac patient to have another heart attack before a failed pacemaker is replaced.

Most insurance companies appear to have policies that support this basic bariatric revision guideline: if the primary bariatric procedure fails, revision surgery is deemed medically necessary without re-introduction of the same weight and diet requirements of the initial procedure. Even Medicare, whose policies often set the standard for coverage, clearly states the following:

“Previous gastric restrictive procedures that have failed for anatomic or technical reasons (e.g., obstruction, staple dehiscence, etc.) are determined to be medically appropriate for revision without consideration of the initial preoperative criteria.”
(See additional policy examples in the appendix at the end of this letter.)

Sleeve Gastrectomy is Medically Appropriate

The patient’s surgeon and primary care physician have recommended the following (also refer to letters which were submitted during the appeal process as well as physician notes included in the case file):

· Immediate removal of the failed lap band in order to prevent further damage to the patient’s stomach and esophagus.

· Revision to a different weight loss surgery (specifically sleeve gastrectomy) as necessary to prevent recurrence of morbid obesity and recurrence of comorbidities.

There are four weight loss surgeries currently performed today. Roux en Y bypass and duodenal switch bypass provide both gastric restriction and malabsorption. The remaining two procedures, gastric banding and sleeve gastrectomy provide gastric restriction only.

For Mrs. Udy, the gastric sleeve was determined to be the most appropriate revision procedure of the four procedures routinely covered by Federal BCBS for the following reasons:

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

2. Without revision, patients with a failed lap band regain weight and suffer ongoing morbid obesity.

3. Replacement of the lap band is contraindicated in patients with a slip and/or esophageal dilation.

4. In this case, the patient only requires gastric restriction for successful treatment of morbid obesity.

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

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

7. As per common standards of medical care, the treating physician determines which of the available and approved treatment options is most appropriate for the patient.

8. A malapsoptive procedure such as the Roux en Y gastric bypass or the duodenal switch was deemed unnecessarily risky because the patient was previously successful with a restrictive-only procedure.

The remainder of this letter presents study data and additional information as requested by the OPM for each of the eight reasons listed above.

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

1.1. 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.”

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

1.3. In the study Analysis of poor outcomes after laparoscopic adjustable gastric banding published in June of 2010 by George Washington University[ii], 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.

1.4. In another study that included patients observed over 9 years, Long-Term Results and Complications Following Adjustable Gastric Banding[iii], 52.9% patients had at least one complication requiring reoperation and the band was removed for 28.6%.

1.5. Most significant is a recent study A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates[iv]. 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.”

2. Without revision, patients with a failed lap band regain weight and suffer ongoing morbid obesity. In the study Weight loss and quality of life after gastric band removal or deflation[v], nearly 88% of patients whose lap bands were removed regained weight. This study, like several others, indicate that revision is necessary to treat morbid obesity over the patient’s lifetime.

3. Replacement of the lap band is contraindicated in patients with a slip and/or esophageal dilation. As noted in many of the studies cited above, slips and esophageal dilation are a relatively common complicate for lap band surgery patients – as high as 20% of all patients will suffer from one or the other or both. Because esophageal dilation is not treatable and because it is a progressive disorder, reinstruction of a lap band is contraindicated. The only treatment for lap band slips and esophageal dilation is removal or de-inflation of the lap band which, as shown in item 2 above, results in a return to morbid obesity in 88% of patients studied. Sleeve gastrectomy is the only restrictive revision procedure available for patients who suffer these complications.

4. In this case, the patient only requires gastric restriction for successfully treatment of morbid obesity. Until the failure of the gastric band, the patient had successfully reduced her excess weight by 90% and all of her comorbidities had been resolved. Therefore a revision to the only other gastric restrictive procedure available, the gastric sleeve, was deemed both appropriate and medically necessary.

5. 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.

5.1. 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.

5.2. 5-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.”

5.3. In the study Laparoscopic Sleeve Gastrectomy as Revisional Procedure for Failed Gastric Banding and Vertical Banded Gastroplasty[vi] published in 2009 a study of 41 patients with a failed gastric band concluded that “Conversion of GB and VBG into LSG is feasible and safe. LSG is effective in the short term with a mean %EWL of 42.7% at 13.4 months.”

5.4. 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.”.[vii]

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

5.6. 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[ix], 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.”

5.7. 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[x], 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.

5.8. 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, sleeve gastrectomy[xi] 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.” Another finding showed that the best results “are obtained in younger patients with lowest BMI” – making it an appropriate surgery for Ms. Udy.

5.9. 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 efficacy. Excess weight loss and remission of comorbidities have been reported to take place in a frequency comparable with other well-established procedures.”

5.10. In the study A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: Results after 1 and 3 years[xii] the authors concluded that:

“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.
5.11. In the study Weight loss over time for adjustable gastric bands, Roux-en-Y gastric bypasses, and sleeve gastrectomies: A comparative analysis [xiii] 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).

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

6.1. In the paper Laparoscopic Sleeve Gastrectomy[xiv] 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.”

6.2. The study Two-Year Results on Morbidity, Weight Loss and Quality of Life of Sleeve Gastrectomy as First Procedure, Sleeve Gastrectomy After Failure of Gastric Banding and Gastric Banding[xv] published in 2009 stated in its conclusion:

“Initial BMI was significantly higher in the Sleeve Gastrectomy group but was no longer significantly different from the BMI of the Gastric Banding group at 12 and 24 months. Excess BMI loss was higher after Sleeve Gastrectomy than after Gastric Banding. This reduction of BMI was considered to be a success for Gastric Banding. Thus, results of Sleeve Gastrectomy should be considered as a success. Quality of life was not significantly different between the three groups. These results validated Sleeve Gastrectomy as first procedure or after failure of Gastric Band.”

6.3. The study Feasibility of Laparoscopic Sleeve Gastrectomy as a Revision Procedure for Prior Laparoscopic Gastric Banding[xvi] published in 2006 followed patients for a year following failed gastric banding and concluded that:

“Laproscopic Sleeve Gastrectomy proved to be feasible and safe after Laproscopic Adjustable Gastric Banding”.

6.4. The study Feasibility and technique of laparoscopic conversion of adjustable gastric banding to sleeve gastrectomy[xvii] concludes:

“The results of this study support the safety of LSG in the case of an inadequate %EWL after Laproscopic Adjustable Gastric Banding.”

6.5. Similar outcomes were identified in the study Safety and short-term outcomes of laparoscopic sleeve gastrectomy as a revisional approach for failed laparoscopic adjustable gastric banding in the treatment of morbid obesity.[xviii]

6.6. In the Spanish study cited in section 5 above, Dr. Baltasar specific noted that the sleeve gastrectomy is also indicated “for the patients where the lap-band has given complications such us poor weight lost, perforation and removal or poor QOL.”

7. As per common standards of medical care, the treating physician determines which of the available and approved treatment options is most appropriate for the patient. Sleeve gastrectomy is one of several weight loss surgeries covered by Federal BCBS and is not excluded for primary or revisionary procedures. In Ms. Udy’s case, the surgeon chose sleeve gastrectomy and sleeve gastrectomy is covered. The OPM should not allow Regence to withhold a covered, and medically appropriate, treatment. The patient has the right to any of the procedures covered under her insurance plan for her diagnosis.

8. A malapsoptive procedure such as the Roux en Y gastric bypass or the duodenal switch was deemed unnecessarily risky because the patient was previously successful with a restrictive-only procedure.

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

8.2. The duodenal switch procedure is generally recommended in patients with a BMI of 50 or
above. In addition to a high rate of surgical complications, significant malabsorption leading to anemia, protein deficiency and metabolic bone disease in up to 5% of patients.

In Closing

The OPM has recommended that this case be re-submitted for medical review and has requested that we provide additional information indicating why the sleeve gastrectomy revision should be covered. Study after study, not all of which are cited here, reiterate the finding published by the ASMBMS in 2009 – that the sleeve gastrectomy is an approved and appropriate bariatric procedure. Additional studies verify both the safety and efficacy of the sleeve gastrectomy as well as it’s place in bariatric revisions.

Given the data included in this letter -- as well as all of the other information provided to the OPM since the appeal was submitted in October of 2009 – we request that the OPM immediately overturn Regence’s denial of coverage. To do otherwise is a violation of insurance policy and well documented bariatric standards of care, and will directly affect the patient’s health and well-being.

[closing and signature]

Appendix A
Example list of surgeons with Federal BCBS patients for whom VSG procedures were covered (including revision).

Dr. Andrew Hargroder
1014 West St. Clare Blvd., Ste 1000
Gonzales, LA 70737
1-225-743-2333

Surgical Specialists of Louisiana
Dr. Thomas Lavin
7015 Highway 190 East Service Road, Suite 200
Covington, Louisiana 70433
Phone: 985.234.3000

Oklahoma Weight Loss Options
Dr. Lana Nelson
3400 W Tecumseh Suite 205
Norman, OK 73072
(405) 360-7100

Dr. Andrew Averbach, M.D.
700 Geipe Rd., Suite 274
Catonsville, MD 21228
Phone: 410-368-8725

Dr. James Davidson, M.D.
8210 Walnut Hill Lane
Dallas, TX 75231
214-265-7546

Ashraf A. Hilmy, M.D.
Harlingen, TX 78550

George Eckles
1602 West Northfield Blvd.
Suite 504
Murfreesboro, TN 37129
Phone: (615) 867-1940

Dr. Wade Barker
1151 North Buckner BlvdDallas, Texas 75218Phone: 1-877-923-3227
Bariatric Institute at Cleveland Clinic
Dr. Raul J. Rosenthal
2950 Cleveland Clinic Boulevard
Weston, FL 33331
954.659.5000

Southern Arizona Surgical Weight Loss Center
Dr. Patrick Chiasson, Dr. Stephen E. Burpee
6320 N. La Cholla BLVD, Suite 380
Tucson, AZ 85741
Phone: (520) 219-8690

Dr. Kuldeep Singh, M.D.
7625 Maple Lawn Boulevard, Suite 145
Fulton, MD 20759
Ph: 301-490-2193

Comprehensive Bariatric Surgery Center, Baylor
Dr. Vadim Sherman
6620 Main Street
Houston, TX 77030
(713) 798-5662

Mickey Seger, MD, FACS, FASMBS
9910 Huebner Rd, Ste 250
San Antonio, TX 78240
Phone: (210) 615-8500

Toby Broussard, M.D.
1800 S. Renaissance Blvd
Edmond, OK 73013
Phone: (405) 359-2473
Guillermo Alvarez M.D.
www.EndoBariatric.com
112 Rodrigo Andalon St. Suite A
Piedras Negras, Mexico


Appendix B

Example Bariatric Revision Policies

Example 1 – Aetna Bariatric Revision Policy

Aetna considers repeat bariatric surgery medically necessary for members whose initial bariatric surgery was medically necessary (i.e., who met medical necessity criteria for their initial bariatric surgery), and who meet either of the following medical necessity criteria:
· Conversion to a RYGB or BPD/DS may be considered medically necessary for members who have not had adequate success (defined as loss of more than 50 percent of excess body weight) two years following the primary bariatric surgery procedure and the member has been compliant with a prescribed nutrition and exercise program following the procedure; OR
· Revision of a primary bariatric surgery procedure that has failed due to dilation of the gastric pouch is considered medically necessary if the primary procedure was successful in inducing weight loss prior to the pouch dilation, and the member has been compliant with a prescribed nutrition and exercise program following the procedure.

Example 2 – United Healthcare

Revisional surgeries are covered for patients who have had previous surgical treatment for morbid obesity if the patient had previously met the medical necessity indications at the time of the initial surgery.

Example 3 – ODS Healthplan

Reoperation and Surgical Revision:
Surgical revision may be considered medically necessary when a patient develops complications
from the original surgery (i.e. stricture or obstruction). Medical and surgical complications may
be covered if determined to be medically necessary even if the original surgery was not a covered
benefit.

Example 4 – University of Pittsburgh Medical Center

Repeat or revision bariatric surgery is considered medically necessary for any of the following:
1. To correct complications from surgery such as obstructions or strictures, OR
2. When the primary procedure has failed due to dilation of the gastric pouch, AND
If the primary procedure was successful in inducing weight loss prior to the pouch
dilation, AND The member has been compliant with the prescribed nutrition and exercise
Program.

Example 5 – Blue Care of Michigan

Previous gastric restrictive procedures that have failed for anatomic or technical reasons (for example, obstruction, staple dehiscence, etc.) are determined to be medically appropriate for revision without consideration of the criteria outlined here [ed. note: referring to weight criteria].

Example 6 – WellCare Health Plans

Repeat bariatric surgery is considered medically necessary under the following condition ONLY:
1. A complication has occurred associated with the original procedure

Example 7 – BCBS of Tennessee

Bariatric surgery, for the treatment of morbidly obese individuals 18 years or older, is considered medically appropriate if ANY ONE of the following criteria are met:

An individual who has had a prior bariatric surgical procedure and is requesting / requiring a revision, alteration or reversal must have a related medical or surgical complication of that procedure that is documented by the physician.

Bibliography
[i] Long-Term Results of Bariatric Restrictive Procedures: A Prospective Study
Schouten R, Wiryasaputra DC, van Dielen FM, van Gemert WG, Greve JW.
Obesity Surgery, 2008

[ii] Analysis of poor outcomes after laparoscopic adjustable gastric banding.
Kasza J, Brody F, Vaziri K, Scheffey C, McMullan S, Wallace B, Khambaty F.
Surg Endosc. 2010 Jun 30.

[iii] Long-Term Results and Complications Following Adjustable Gastric Banding.
Lanthaler M, Aigner F, Kinzl J, Sieb M, Cakar-Beck F, Nehoda H.
The Journal of Metabolic Surgery and Allied Care, 2010

[iv] A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates
Suter M, Calmes JM, Paroz A, Giusti V.
Obesity Surgery, 2006

[v] Weight Loss and Quality of Life After Gastric Band Removal or Deflation
Lanthaler M, Strasser S, Aigner F, Margreiter R, Nehoda H.
Obesity Surgery, 2009

[vi] Laparoscopic Sleeve Gastrectomy as Revisional Procedure for Failed Gastric Banding and Vertical Banded Gastroplasty
Iannelli A, Schneck AS, Ragot E, Liagre A, Anduze Y, Msika S, Gugenheim J.
Obesity Surgery, 2009

[vii] Laparoscopic sleeve gastrectomy: a retrospective review of 1- and 2-year results
Jacobs, Bisland, Gomez, Plasencia, Mederos, Celaya and Fogel
Surgical Endoscopy, 2009

[viii] Laparoscopic Sleeve Gastrectomy as a Single-Stage Bariatric Procedure
Tarik Sammour, Andrew G. Hill, Parry Singh, Anudini Ranasinghe, Richard Babor and Habib Rahman
Obesity Surgery, 2010

[ix] Laparoscopic sleeve gastrectomy as first stage or definitive intent in 300 consecutive cases
N. Basso, G. Casella, M. Rizzello, F. Abbatini, E. Soricelli, G. Alessandri, C. Maglio and A. Fantini
Surgical Endoscopy, 2010

[x] Sleeve Gastrectomy as Sole and Definitive Bariatric Procedure: 5-Year Results for Weight Loss and Ghrelin
Arthur Bohdjalian, Felix B. Langer, Soheila Shakeri-Leidenmühler, Lisa Gfrerer, Bernhard Ludvik, Johannes Zacherl and Gerhard Prager
Obesity Surgery, 2010

[xi] Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry.
Sánchez-Santos R, Masdevall C, Baltasar A, Martínez-Blázquez C, García Ruiz de Gordejuela A, Ponsi E, Sánchez-Pernaute A, Vesperinas G, Del Castillo D, Bombuy E, Durán-Escribano C, Ortega L, Ruiz de Adana JC, Baltar J, Maruri I, García-Blázquez E, Torres A.
Obesity Surgery, 2009

[xii] A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years.
Himpens J, Dapri G, Cadière GB.
Obesity Surgery, 2006

[xiii] Weight loss over time for adjustable gastric bands, Roux-en-Y gastric bpasses, and sleeve gastrectomies: A comparative analysis"
Snyder B et al
ASMBS 2010; Abstract PL-311.

[xiv] Laparoscopic Sleeve Gastrectomy
Ismael Court, MD; Omar Bellorin, MD; Fernando Dip, MD; Christopher DuCoin, MD; Samuel Szomstein, MD, FACS; and Raul J. Rosenthal, MD, FACS
Surgical Perspective, Bariatric Times, 2009

[xv] Two-Year Results on Morbidity, Weight Loss and Quality of Life of Sleeve Gastrectomy as First Procedure, Sleeve Gastrectomy After Failure of Gastric Banding and Gastric Banding
Sabbagh, Verhaeghe, Dhahri, Brehant, Fuks, Badaoui and Regimbeau
Obesity Surgery, 2010

[xvi] Feasibility of Laparoscopic Sleeve Gastrectomy as a Revision Procedure for Prior Laparoscopic Gastric Banding
P Bernante, M Foletto, L Busetto, F Pomerri, F Francini Pesenti, MR Pelizzo and D Nitti
Obesity Surgery, 2006

[xvii] Feasibility and technique of laparoscopic conversion of adjustable gastric banding to sleeve gastrectomy.
Dapri G, Cadière GB, Himpens J.
Presented as an oral presentation at the 25th Annual Meeting of the American Society for Metabolic and Bariatric Surgery, Washington, DC, June 15–20, 2008

[xviii] Safety and short-term outcomes of laparoscopic sleeve gastrectomy as a revisional approach for failed laparoscopic adjustable gastric banding in the treatment of morbid obesity.
Acholonu E, McBean E, Court I, Bellorin O, Szomstein S, Rosenthal RJ.
Obesity Surgery, 2009

Tuesday, May 25, 2010

Final Letter - Why revision doesn't require a high BMI

Well it's been over a year and I'm in the final few days of my appeal. It's gone all the way to the Federal Office of Personnel Management in D.C. The basic issue is that even though they already agreed that my lap band failed, enough that they paid to remove it, they want me to get my BMI back up to 40 before they do. Crazy huh? But over the weekend I found policy statements for revision from Regence, Medicare and the ASMBS. I put it all in a letter and sent it off for a "hail Mary" pass at getting them to change their minds.

In case it's useful for anyone, here's the letter...

------------------

In October 2009, I submitted an appeal to the OPM regarding a disputed claim for bariatric surgery revision. As the OPM’s review of my appeal comes to a close, I wanted to take a minute and reiterate the details of my case and why I believe that the revision is medically necessary under the guidelines of Regence’s bariatric revision policy. Your review and immediate consideration of this letter is much appreciated. Given that I’ve waited 7 months for an appeals process that should have been completed within 60 days (as per OPM policy), I believe my request for expediency is fair.

In 2006 I was approved for weight loss surgery and underwent a procedure to insert an adjustable gastric band. The procedure was very successful. The band, along with my compliance to the recommended diet and exercise guidelines, helped me to lose nearly 90% of my excess weight. I far exceeded the 65% excess weight loss average for this type of surgery. It was wonderful experience and it changed my life.

Unfortunately, in late 2008 I suffered a complication and the lap band failed. A band slip with pouch dilation, also referred to as stomach prolapse, was confirmed through endoscopy. A secondary failure, a leak in the band tubing that prevented adjustment and appropriate gastric restriction, was found later. Through no fault of my own, the device I relied on to treat my morbid obesity was no longer functional.

Both my primary care physician and bariatric surgeon advised against replacement of the lap band due to risk of future failure and long-term stomach damage. I was advised to pursue a vertical sleeve gastrectomy which was to be performed as part of the overall revision procedure that included removal of the gastric band. My revision request was partially approved by Regence and the lap band was removed in October of 2009.

At the time of the lap band failure I was within 10 pounds of my goal weight. Now, 13 months after the initial pre-certification request and 7 months after removal of the band, I am only 16 pounds under a BMI of 40. Although my initial surgery was approved with a BMI of 35 and co-morbidities, I’ve been advised that I’ll need to gain weight until I reach a BMI of 40 to be approved for the revision. If I do, I will actually weigh more than I did prior to the initial lap band surgery.

In 2008 the American Society for Metabolic & Bariatric Surgery presented medical guidelines for bariatric surgery. Recommendation R163 specifically recommends revision of a bariatric surgical procedure if there were medical complications resulting from the initial surgical procedure. Insurance companies appear to have considered this recommendation when developing their own medical policies for bariatric revision.

Regence’s medical policy for bariatric surgery includes this reference to revision:
“Reoperation to address complications of a bariatric procedure may be considered medically necessary. These include, but are not limited to, staple-line failure, obstruction, stricture, non-absorption resulting in hypoglycemia or malnutrition, weight loss of 20% or more below ideal body weight, band erosion, band migration.”

Nowhere in Regence’s bariatric policy is weight or BMI even suggested as a possible prerequisite to revision surgery.

Most insurance companies appear to have policies that support this basic bariatric revision guideline: if the primary bariatric procedure fails, revision surgery is deemed medically necessary without re-introduction of the same weight and diet requirements of the initial procedure. Even Medicare, whose policies often set the standard for coverage, clearly states the following:

“Previous gastric restrictive procedures that have failed for anatomic or technical reasons (e.g., obstruction, staple dehiscence, etc.) are determined to be medically appropriate for revision without consideration of the initial preoperative criteria.”
(See additional policy examples at the end of this letter.)

In my research, I reviewed the stories of dozens of revision patients (many covered by Federal BCBS). I couldn’t find a single patient who was required to regain their weight as a prerequisite for revision. I couldn’t actually find any patients who were refused a revision by their insurance company for any reason when their primary procedure failed.

I also consulted with three bariatric surgeons (Billing, Hargroder, Cirangle). Not one would recommend weight gain prior to revision. None expected BMI to be used as a criterion for medical necessity.

What’s more, Regence has already acknowledged medical necessity by covering the removal of the gastric band. As per common bariatric revision policy and medical standards, revision of the failed primary bariatric procedure should have included both repair and reintroduction of gastric restriction. In my case, both procedures were planned as a single surgery. Unfortunately, the surgery plan had to be modified a few days before it was scheduled. Against the medical opinion of my surgeon, Regence dictated that only half of the revision was to be performed. Regence already established medical necessity for a revision; they shouldn’t be allowed to claim later that medical necessity doesn’t exist.

When we made the decision to appeal the denial to the OPM I was initially relieved. Like most Federal employees and their families, I viewed the OPM as my health care champion -- a team able to provide fair and speedy review of my claim against medical standards and insurance policies. It would never have occurred to me that I would be asked to regain all of the weight I’d lost from my first surgery, to actually weigh more than I did before the initial surgery and more than I ever have in my life, before I would be considered for the second half of the revision. And I certainly didn’t expect the 60 day appeals process to take seven months.

My health, weight and well-being have been impacted by the failure of my gastric band and the 13 months I’ve spent pursuing appeals. On all counts I meet the requirements of medically necessity applied to bariatric surgery revision by most insurers in the United States. I was diagnosed with morbid obesity and received covered treatment in the form of a gastric band. Regence has already acknowledged the failure of the gastric band and medical necessity for a revision. The lap band provided gastric restriction until it failed and was removed. My revision cannot be considered complete without restoration of gastric restriction with a vertical sleeve gastrectomy.

Respectfully, I ask that my claim be approved immediately so that the procedure can be performed without further delay. It makes little sense to require that I gain an additional 16 pounds in order to qualify. If the OPM chooses to uphold Regence’s denial, my only recourse will be to file a lawsuit in Federal court. This drastic measure seems completely unnecessary given the facts of the case. A lawsuit would be a poor use of OPM time and taxpayer dollars. All I want, all I’ve ever wanted, is a revision that would repair the damage done by the failed lap band and restore the gastric restriction that I was originally approved for. Please help me bring this case to a quick and satisfactory conclusion.

Respectfully,
Britt Udy


Appendix – Example Bariatric Revision Policies

Example 1 – Aetna Bariatric Revision Policy

Aetna considers repeat bariatric surgery medically necessary for members whose initial bariatric surgery was medically necessary (i.e., who met medical necessity criteria for their initial bariatric surgery), and who meet either of the following medical necessity criteria:

· Conversion to a RYGB or BPD/DS may be considered medically necessary for members who have not had adequate success (defined as loss of more than 50 percent of excess body weight) two years following the primary bariatric surgery procedure and the member has been compliant with a prescribed nutrition and exercise program following the procedure; OR
· Revision of a primary bariatric surgery procedure that has failed due to dilation of the gastric pouch is considered medically necessary if the primary procedure was successful in inducing weight loss prior to the pouch dilation, and the member has been compliant with a prescribed nutrition and exercise program following the procedure.

Example 2 – United Healthcare

Revisional surgeries are covered for patients who have had previous surgical treatment for morbid obesity if the patient had previously met the medical necessity indications at the time of the initial surgery.

Example 3 – ODS Healthplan

Reoperation and Surgical Revision:
Surgical revision may be considered medically necessary when a patient develops complications
from the original surgery (i.e. stricture or obstruction). Medical and surgical complications may
be covered if determined to be medically necessary even if the original surgery was not a covered
benefit.

Example 4 – University of Pittsburgh Medical Center

Repeat or revision bariatric surgery is considered medically necessary for any of the following:
1. To correct complications from surgery such as obstructions or strictures, OR
2. When the primary procedure has failed due to dilation of the gastric pouch, AND
If the primary procedure was successful in inducing weight loss prior to the pouch
dilation, AND The member has been compliant with the prescribed nutrition and exercise
Program.

Example 5 – Blue Care of Michigan

Previous gastric restrictive procedures that have failed for anatomic or technical reasons (for example, obstruction, staple dehiscence, etc.) are determined to be medically appropriate for revision without consideration of the criteria outlined here [ed. note: referring to weight criteria].

Example 6 – WellCare Health Plans

Repeat bariatric surgery is considered medically necessary under the following condition ONLY:
1. A complication has occurred associated with the original procedure

Example 7 – BCBS of Tennessee

Bariatric surgery, for the treatment of morbidly obese individuals 18 years or older, is considered medically appropriate if ANY ONE of the following criteria are met:

An individual who has had a prior bariatric surgical procedure and is requesting / requiring a revision, alteration or reversal must have a related medical or surgical complication of that procedure that is documented by the physician.

Thursday, June 18, 2009

VSG: No Longer Investigational

Partial gastrectomies have been performed to treat medical conditions, such as stomach cancer, for many decades. The vertical sleeve gastrectomy procedure has been used successfully for weight loss (as demonstrated by medical studies) since 1976. The Duodenal Switch (DS) has also been performed for many years and is approved by most Blue Cross plans. The VSG is simply the restrictive portion of the DS without the “switch”, or malabsorptive, portion of the surgery. DS is often done as a two-stage procedure -- the VSG is performed first with a follow up malabsortive procedure performed at a later date (generally after an improvement in health and initial reduction in weight). An interest in the VSG as a standalone procedure appears to have started when reported data began to show a pattern -- a success rate similar to DS or RNY but with a lower rate of complications. So the thinking became, “Why do the riskier second procedure when the sleeve gastrectomy appeared to be working so well on its own?”

While any surgery carries risks, the VSG is not riskier than other weight loss procedures; in fact statistics indicate that it is safer. Documented studies show that it will generate between 60 to 80% of Excess Body Weight Loss (EBWL) in 6 to 12 months and many patients have achieved 90 to 100% EBWL during the same time periods with weight loss of 100lbs to 200lbs. The complication rate of the RNY is 6.5%, and it’s considered the “gold standard.” Compare that to the complication rate of only 1.5% for the VSG in the last 10 years and with similar or better weight loss results. Studies also indicate a lower complication rate for VSG than for the Lap Band which is generally touted as the safest WLS available.

As a result, a significant number of medical experts on the issue of bariatric surgeries are in agreement that the VSG is quickly gaining acceptance when compared to the RNY and is likely to become the surgery of choice for weight loss, Among them Dr John R. Romanelli, MD FACS in his article Laparoscopic Sleeve Gastrectomy: The newest front in the battle against Obesity, published in WLS Lifestyles, fall of 2006.

As of 2008, there were 35 published studies involving over 2,400 patients clearly pointing to the VSG as a procedure with a high success rate and low incidence of side effects. The largest was a 5 year study (ongoing) 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 RGB after three years with 0% mortality. Long term morbidity is almost nonexistent compared to the RGB.”
(see http://www.ssat.com/cgi-bin/abstracts/08ddw/O4.cgi)

Perhaps these studies and statistics were known by Federal BCBS when they decided to consider VSG a covered procedure in 2008? Certainly the data must have something to do with the explosion in the number of doctors who perform VSG – about 15 surgeons considered themselves VSG experts two years ago. Today a conservative count of surgeons who offer VSG would set that number at 3 times as many. And anyone visiting online weight-loss surgery communities such as ObesityHelp.com or even LapBandTalk.com can find an ever-increasing number of patients who’ve had the VSG and are reporting back on great weight loss or weight management results and an amazingly few number of side effects.

As many insurers follow in Federal BCBS’ footsteps and offer VSG as a covered procedure, and as the studies verifying both the efficacy and safety continue to be published, it’s hard to imagine that it won’t eventually overtake RNY and Lap Band in popularity. The VSG also costs less than a Lap Band – and not just the initial procedure -- but a VSG sidesteps the ongoing costs of lap band fills and unfills. There are no adjustments or ongoing medical interventions necessary for the VSG patient. In the long run, I believe that the VSG will prove itself to be a real winner for patients and insurers alike. It cannot and should not be considered experimental or investigational.

Appeal Letter

Dear Sir or Madam,

I am writing this letter to appeal Regence BlueShield’s denial of coverage for removal of a lap band (CTP 43774) and revision to Sleeve Gastrectomy (CTP 43843). Based on the letters of denial dated April 6 2009, the lap band removal was denied because it was "determined that removal of lap band is not medically necessary” and “treatment of morbid obesity does not meet current BMI requirement of FEP (BMI must be greater than 35)”. The second letter stated that Sleeve Gastrectomy “is experimental/investigational”.

Because you may have based your denial on incorrect or incomplete information, I wanted to submit this letter outlining why I disagree with the denial and why I believe surgery should be approved. In this letter I will address each element of the denial individually but would like to start with a clarification that, although the procedures have been submitted and denied individually; the lap band removal, any adhesion or repair procedures deemed necessary on visualization, and revision from a lap band to a vertical sleeve gastrectomy would most likely be done in a single surgery. Dr. Billing does offer them as two separate procedures performed six weeks apart, but I’ve since learned that the current standard of care for lap band removal and revision is for both to be performed in a single surgery. It appears from the separate denial letters that they may have been considered individually rather than as part of a single course of treatment intended to correct and restore the gastric restriction which was achieved when my original lap band procedure was performed in 2006.

Relevant Medical History

I was diagnosed with morbid obesity with multiple co-morbidities in 2006 and underwent lap band surgery with Dr. Neal of Pacific Surgical in Olympia, Washington on August 14, 2006. My surgery was fully covered under Microsoft’s Premera insurance plan as I met the qualifications of a BMI > 35 with 2 or more co-morbidities. On the day of surgery I had a BMI of 38.2.

My lap band procedure was initially successful and I lost ~75 pounds and had resolution of all co-morbidities. Although I still wanted to lose an additional 20 pounds, I maintained the weight loss until early 2009. In February of 2009 I began to experience pain and difficulty eating and could no longer feel restriction. A fluoroscopy with Dr. Neal revealed significant swelling and inflammation. I was told that there was a serious and potentially dangerous stretching of the stomach pouch. My lap band was immediately “unfilled” and I was put on liquids for two weeks pending follow-up.

Because Dr. Neal’s office is almost 3 hours from my home and he is no longer a preferred provider under my plan, I went to see Dr. Peter Billing at Puget Sound Surgical in Edmonds. A second fluoroscopy performed in Dr. Billing’s office confirmed the swelling along with evidence of a recent dilation and/or slip. Although there appeared to be some improvement in the swelling as a result of the liquid diet, evidence of a problem could still be seen so my lap band was not refilled.

Dr. Billing advised me that even a small slip or dilation is generally an indicator of a failed lap band and that surgical correction or revision is usually recommended to prevent a progression of complications over time. A follow-up endoscopy confirmed his findings and I was strongly advised to revise to the vertical sleeve procedure as an alternative gastric restrictive procedure preferable to replacing or repairing my lap band.

After researching the long-term progression of symptoms and risks associated with lap band slips, pouch and/or esophageal dilation I also consulted with Dr. Paul Cirangle of Lap Band Associates of San Francisco. Dr. Cirangle is a nationally recognized bariatric surgeon often considered one of the foremost authorities in lap band revisions and vertical gastrectomy procedures (see curriculum vitae and related publications at http://www.lapsf.com/dr-cirangle-your-bariatric-doctor-for-weight-loss-surgery.php). He confirmed Dr. Billing’s recommendation. As did the office of Dr. Andrew Hargroder in Louisiana -- also well regarded for lap band revisions and sleeve gastrectomies.

After reviewing my Federal BCBS policy and verifying coverage for both procedures over the phone, I proceeded with preparing for surgery by completing the required consultation with a nutritionist and a psychological assessment and was looking forward to setting a surgery date and the subsequent resolution of my physical symptoms. I was very surprised to be notified of the denial.

Lap Band Removal

As mentioned above, part of the denial was related to an assessment that removal of the lap band is not medically necessary. Given the debilitating and constant nature of my problems with the lap band, the only conclusion I can come to about this assessment is a lack of information. So I thought I’d take a minute to describe my current situation.

After following a liquid diet to reduce inflammation and pain I was advised to return slowly to solid foods. Now that I’m eating in the method approved for lap band patients (protein first, chew thoroughly, small portions, etc.) I now suffer from chronic pain – the only way to describe it is as if a ball of sandpaper about the size of a small orange is lodged behind my sternum with a throbbing and burning sensation that also radiates up my throat. This pain is present most of the time, often increasing after meals but sometimes present without apparent cause. During the worst incidents, there’s a feeling akin to a knife turning in my chest. All of the GERD symptoms I suffered prior to surgery have returned. In the morning I am generally unable to eat solids and must stick to protein drinks or other liquids.

Usually I am able to eat around lunch time and do so with caution. Most foods cause some level of discomfort and pressure. Approximately 1-2 times per week I experience an episode with food that results in severe pain and vomiting. These episodes last from 2-4 hours. The onset of vomiting appears to cause additional swelling which, in turn, blocks my stoma. After awhile I am even unable to swallow my own saliva and the pressure and pain increases as the saliva, food, and increased stomach mucus builds up above my closed stoma. It’s becomes a vicious circle because the vomiting increases the swelling and extends the time that the stoma remains closed. Once I am able to resume liquids I stay on a liquid diet for 1-2 days and then slowly return to solid food over the next 1-4 days depending on my pain level.

This has become the regular pattern of my life. It often interferes with my ability to work and/or take care of my children. I’ve had to pull off to the side of the road because I’m worried that the pain is too distracting for me to safely drive with my children in the car. Other times I’ve had to leave work because the need to vomit every 10 to 15 minutes makes it impossible to perform my job effectively. My symptoms are significant and often debilitating. And I can only imagine the kind of long term damage I’m risking as these problems continue. Being told that I cannot have surgery to remove, repair, and revise to the kind of functioning gastric restriction I had with the lap band prior to these complications is incredibly discouraging. It’s hard to imagine having to live this way indefinitely.

Sleeve Gastrectomy as Investigational

Regence’s claim that sleeve gastrectomy is investigational was surprising given how the Federal BCBS benefits statement reads and the verbal confirmation of coverage for CPT 43843 I received in two separate phone calls prior to the doctor’s submission for pre-approval. According to my research, Federal BCBS began considering VSG a covered procedure in 2008. I have identified >20 VSG patients with Federal BCBS coverage who were approved for the procedure upon first submission. In fact, I’m the only person I’m aware of who has been denied for VSG with Federal BCBS under the investigational determination. Listed below are the surgeons with Federal BCBS patients who have had patients with VSG procedures approved.

[Physician names and contact info removed in case there would be confidentiality concerns. I'm happy to share them privately with blog readers if requested.]

I have been told by Regence that Federal plan coverage doesn’t vary from state to state; the benefit guide applies to all participants in all states. Because Federal BCBS is administered by local offices such as Regence, I believe the investigational determination is most likely the result of a simple communication or processing error. Perhaps Regence has inadvertently applied coverage standards for other local BCBS plans (many would deny VSG as investigation even though Federal BCBS does not). I have been confirming coverage with the doctors and local BSBS administrator for the states listed. For example, Dr. Hargroder’s office confirmed that their Fed BCBS patients have been covered. And a supervisor with BCBS Louisiana confirmed that Federal BCBS has been covering VSG since 2008 and that they routinely approve it as a covered bariatric procedure.

The 2009 benefit plan for the Federal BCBS Basic plan covers: “gastric restrictive procedures, gastric malabsorptive procedures, and combination restrictive and malabsorptive procedures to treat morbid obesity.” CTP code 43843 for VSG is listed as a "Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty.” There is nothing stated in the Federal plan that specifically excludes a vertical sleeve gastrectomy. And any reasonable comparison of the plan benefit statement and the CTP code definition could conclude that the procedure definition matches the procedures covered by the plan.

Please note that this letter doesn’t outline why VSG should no longer be classified as investigational. Because Federal BCBS covers VSG it should not be necessary to present evidence regarding the efficacy and safety of the procedure. It does not seem reasonable for Regence to deny one Federal BCBS patient a procedure that is routinely covered for Federal BCBS patients across the country. However, because I would like to be thorough in presenting my appeal, I have attached more information on the VSG procedure should it be helpful during the review of my case. Please see the attached appendix.

Current BMI

Also noted on the denial letter for removal of the lap band, is that I do not meet current BMI requirements (BMI > 35). The fact that this is specifically given as a reason for denying removal of the lap band is odd. In my research I never identified anyone who was denied a lap band removal procedure and found many patients who were at or near a normal BMI when they experienced problems. A lap band could fail at any point after placement, before a patient has lost weight, or after they get to goal, or somewhere in between. The risks of morbid obesity and rapid weight gain are well known. It’s hard to imagine that Regence’s policy would require a patient to regain weight and return to a morbidly obese state before a lap band can be removed and any damage caused by the lap band repaired -- particularly patients with the type of symptoms I’ve been experiencing over the past few months. As happens with most patients that suffer lap-band complications, my weight has increased. My current BMI is 32.3, about 20 pounds short of a 35 BMI. A few of my original co-morbidities have returned. It’s awful to think that the only way I would be approved for lap band removal and repair, the only way to stop the pain and have revised gastric restriction, is to gain another 20 pounds. I’m already doing everything I can to get control over the 40 pounds I’ve regained, especially challenging given how difficult it is to eat healthy proteins and vegetables when almost anything but soft or liquid foods initiates the pain, swelling and vomiting I’ve described above.

Although covered under a different plan, my original weight loss surgery was approved by insurance under the same conditions that apply to Federal BCBS: >35 BMI and co-morbidities. I chose a gastric restrictive procedure at the recommendation of my surgeon to avoid the long-term risks associated with malabsorptive procedures like the bypass. Given that I met the criteria and had covered lap band surgery, it seems logical that any subsequent surgeries to repair or revise the original restrictive procedure would be considered a continuation of the initial treatment.

Although not a perfect analogy… If a Federal BCBS patient were to request breast implants, Regence would appropriately deny the claim because such procedures are not covered by the Federal BCBS plan. But consider a breast cancer patient that has a mastectomy. A year after surgery she requests breast implants as part of reconstructive surgery. At the time of her request, the patient is in remission with no active tumor or cancer. Would she be denied the implant surgery because she no longer suffers from cancer? No. Her surgery would be considered a continuation of treatment related to the original surgery for a covered condition.

I respectfully submit that my request can be viewed in a similar light. I was approved for a gastric restrictive procedure with a BMI > 35 and multiple co-morbidities. The lap band surgery was an appropriate treatment for my diagnosis of morbid obesity. The proof is found in the fact that it treated my morbid obesity by bringing my weight into a healthy category and improving my health and quality of life. The lap band has now failed and I have no gastric restriction, and what’s more, now have recurrent and often debilitating pain and side effects. I am asking that follow-up treatment for the original lap band procedure be approved so that the lap band can be removed, any damage repaired, and the gastric restriction previously achieved with the lap band can be restored by a revision to a vertical sleeve gastrectomy. I can think of no other health condition where correction of a failed procedure would be denied, particular if the original procedure also caused additional health problems. Federal BCBS covers gastric restrictive procedures and has covered VSG as an approved gastric restrictive procedure in every case that I was able to identify in my research.

In summary

Based on the information outlined in this mail, I am asking Regence to reconsider the denial and approve coverage for the surgery. If you need any additional information, please contact me at (425) 273 6006.

Thank you for your time.

Sincerely,

Britt

Introduction

Hi!

My name is Britt. I'm a 41 year old mother of two small boys, part-time software program manager, and a lap band patient. I had my lap band placed in 2006 and had two great years. Then I started gaining weight and found out I had a dilated pouch and probably a small slip. I consulted with three doctors and all agreed the band ought to come out and I should consider revising to a vertical sleeve gastrectomy. I have Federal BCBS, known to cover VSGs, but my local BCBS office disagreed. They say the lap band complications aren't life threatening, it can't come out because I'm not morbidly obese any more and that VSG is investigational (try telling all the other BCBS offices around the country that - they know that Fed BCBS has been covering VSG since 2008).

So what am I going to do? I'm going to fight on appeal. Am I going to win? Well, probably not. But I'm going to try. And then it occurred to me today that the appeal I wrote might help other people too. How do I know? Because someone else helped me. Teresa of thediaryofafatwoman blog here on blogspot. Almost all of the material I submitted in my fight against the investigational claim came from her. And it was great! I just reorginizaed it a little. My main letter covers everything else - why removing my lap band is important, why it's not right to deny VSG when every other Federal BCBS person that requests it gets it, and how my current BMI shouldn't play in to fixing a procedure I qualified for that was covered.

I haven't submitted it yet. Do you enjoy offering advice? I'd sure love to have you read what I wrote and let me know what you think.

Thanks!
Britt