ERISA APPEAL

Appeals Coordinator
Premera Blue Cross
PO Box 91102
Seattle, WA 98111-9202

Service requested: Biliopancreatic Bypass with Duodenal Switch (BPD/DS)

On June 20^th, 2008, Premera Blue Cross denied coverage for a Biliopancreatic Bypass with Duodenal Switch (BPD/DS). The letter stated that I qualified for surgical treatment of my morbid obesity, but that "Evaluation of reliable evidence indicates that additional research is necessary before this service can be classified as equally or more effective when compared to conventional therapeutic interventions."

I wish to appeal this decision based on the vast amount of peer-reviewed literature attesting to the safety and efficacy of this procedure, and on its specific merits for my post-operative quality of life.

Effectiveness compared to conventional therapeutic interventions

Scopinaro () reports on the BPD/DG procedure an excess weight loss of 74% at 2 years increasing to 78% at 12 years. Scopinaro also states that the results of the BPD procedure have shown little or no weight regain even out to 18 years (World J Surg 1998). Other reports on BPD/DG yield similar results: Clare () reports excess weight loss at 3 years of 77% using a 250 cm alimentary limb, and 71% using equal length bilio and alimentary limbs (Obes Surg 1993). Vassallo () and Totte report 79.6% and 76.2% excess weight loss respectively at 3 years (Vassallo Obes Surg 1997; Totte, Obes Surg 1999). Lemmens reports a 69% excess weight loss at 7 years (Obes Surg 1993). Nanni reported 78% excess weight loss at 2 years (Obes Surg 1997).

Other reports of the efficacy of BPD/DS are similar. Hess reported excess weight loss of 80% at 2 years and 70% at 8 years (Obes Surg 1998). Marceau also adopted the duodenal switch procedure and reported 73% excess weight loss at 51 months (World J Surg 1998). Baltasar reported excess weight loss of 70.1% at 1 year, 75% at 2 years, 75% at 3 years and 81.2% at 4 years (Obes Surg 2001). Rabkin reported a mean excess weight loss of 73% at 4 years (Obes Surg 1998).

In the April 2005 JAMA article Bariatric surgery: a systematic review and meta-analysis () showed effectiveness rates of 47.5% (40.7%-54.2%) for patients who underwent gastric banding; 61.6% (56.7%-66.5%), gastric bypass; 68.2% (61.5%-74.8%), gastroplasty; and 70.1% (66.3%-73.9%), biliopancreatic diversion or duodenal switch. These percentages are in line with other studies, all showing similar relative degrees of efficacy.

The (BPD/DS) has been approved by Medicare. In Medicare's "Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R)" dated February 21, 2006, () the report states

"The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is adequate to conclude that open and laparoscopic Roux-en-Y gastric bypass (RYGBP), laparoscopic adjustable gastric banding (LAGB), and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS), are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) > 35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity.

CMS has determined that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006)."

This report lists numerous reports and sources for the determination of the safety and effectiveness of this procedure for sustained weight loss.

The report also states the importance of that these procedures be performed only at facilities that are certified as a Bariatric Surgery Center of Excellence. Dr. Srikanth is a Board Certified Bariatric Surgeon and is a designated ASBS Center of Excellence surgeon. He has performed over 1,600 Bariatric surgical procedures and over 800 laparoscopic Bariatric surgical procedures. The Center for Weight Loss Surgery is an ASBS Bariatric Surgery Center of Excellence.

In summary, the BG and BPD/DS have the best reported long-term weight loss; in the range of 69%-80%. The efficacy of the BPD and BPD/DS procedures cannot be questioned. The BPD/DG and BPD/DS are the most effective procedures for weight loss in existence today.

Sufficiency of Data Regarding the Biliopancreatic Bypass with Duodenal Switch

While the BPD/DG procedure is rarely performed in the US, the BPD/DS procedure is frequently performed.

This procedure has been performed thousands of times since its inception. The metabolic complication rates have dropped dramatically now that it is common practice to make the alimentary limb length 40-50% of the total intestinal length.

Scopinaro () published a paper in 1998 based on over 2000 patients who underwent the BPD/DG. His report includes following patients for up to 20 years, and he notes that this is the longest longitudinal study on weight-loss surgery ever reported on in the literature at that time. By comparison, Mitchell () completed the longest study of the RNY gastric bypass in August of 2001, and it covers only 15 years. Sileo (), in his long-term study of the BPD/DG states: "In conclusion, biliopancreatic bypass surgery enables a significant weight loss to be achieved together with an improved glycolipid status without leading to nutritional deficiencies" (Minerva Gastroenterol Dietol 1995).

Since BPD/DS is newer than the BPD/DG procedure, the lengths of the studies are shorter. However, in 1998 Hess () reported on a series of 440 patients who underwent BPD/DS followed up to 8 years. Marceau's 1998 report () covered 465 patients who underwent BPD/DS a mean of 4.1 years prior to his report. His 2001 () report include 909 BPD/DS patients studied over 10 years. Baltasar's 2001 report () covers 125 patients who underwent BPD/DS, and Rabkin () in 1998 reports on 105 patients who underwent BPD/DS.

More recently, in November 2007, Marceau et al published () the results of 15 years experience with DS procedures on 1,423 patients from 1992 to 2005, concluding "In the long-term, DS was very efficient in terms of cure rate for morbid obesity and its comorbidities. In terms of risk/benefit, DS was very successful with an appropriate system of follow-up." In his 2008 follow-up () he concludes "The DS greatly improved the BPD, as it was initially proposed. The use of the DS increased weight loss, decreased the need for revision, resulted in fewer side effects and improved the absorption of nutrients."

Several thousand patients have been reported on with follow-ups as long as 20 years. Over the last 18 years there have been numerous peer-reviewed articles showing the long-term safety and efficacy of this procedure. Those that claim otherwise are either confusing the procedure with the old Jejunal-Ileal Bypass or are unaware of the more recent data that provides empirical evidence of the safety of BPD.

A large body of evidence now exists to show that the Biliopancreatic Diversion is a safe and effective procedure.

Quality of Life and Appropriateness for This Patient

With the BPD/DS procedure the pyloric valve remains intact, permitting the flow of gastric juices and keeping dumping syndrome from occurring after surgery. This leads to a huge reduction in side effects such as stomal ulcer, stoma blockage and dumping syndrome which are commonly found with the RNY procedures. This procedure also allows for more 'normal' eating habits such as drinking liquids with your meals, and more normal portions at meals.

The most common side effects; foul-smelling stool or gas are often easily controlled with diet change. Concerns due to mal-absorption are handled through daily vitamins and calcium, and are similar in effect to the more common Medial RNY procedures.

In a profession that is dependent on mental acuity for top performance, I believe that the distractions, severely changed eating habits, and side effects, including dumping, stoma blockage and purging associated with Roux-en-Y procedures would have strong negative impact on my work.

Summary:

BPD/DS is a proven safe and effective means of sustained weight loss. In repeated peer reviewed studies over the last 15 years, this procedure has been shown to be more effective than Roux-en-Y (RNY) and Laparoscopic band procedures. The side effects of this surgery when compared to RNY procedures allow for more 'normal' eating habits with less impact on quality of life.

When going through the expense and time of major surgery, I want the best chance for long term weight loss with lifestyle changes that will not impact the quality of my work. The BPD/DS procedure provides me this chance.