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Draft Response to Aetna CPB #157

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To all Aetna people and those with other insurance companies denying

coverage for the BPD/DS based on it being " investigational " : I have

prepared a counter response. I just had my consultation and am

hoping to get approved, but I am so outraged the Aetna, Blue

Cross/Blue Shield, and United Healthcare are denying coverage on this

basis that I have put together a formal response.

You can find Aetna's policy bulliten #157 at:

http://www.aetnaushc.com/cpb/data/CPBA0157.html

Please feel free to comment, as this is a draft response:

Hull

Dear Aetna,

Regarding the biliopancreatic diversion with duodenal switch (BPD/DS)

procedure being " investigational " . As I understand it, a procedure

is investigational if it is not proven to be both safe and

effective. I will deal with the efficacy issue first.

You own policy bulletin #157 admits that the BPD/DS is

effective: " this procedure is reported to have a higher rate of

weight loss " . In addition, all of the seven references included

report equal or better weight loss with the BPD/DS procedure when

compared to the standard Rouy-n-Y (RNY) gastric bypass. Results of

the BPD procedure without DS have shown no weight regain even out to

20 years [1]. So the efficacy of the BPD and BPD/DS procedures

cannot be questioned.

Regarding the safety of the procedure, I believe that much of the

information from the sited references is out of date. In your

policy bulletin it is stated that " There is only a 50 cm common

absorptive alimentary tract. " While this was true with the original

Socpinaro procedure, most surgeons use 75-100cm common tracts, and

this dramatically reduces side effects [2],[5].

It is also stated " … this … is rarely performed in the United States

due to the high risk of various metabolic complications. " This is

incorrect. Currently there are 30 US surgeons performing this

procedure with 18 performing it as their primary procedure.

Thousands of BPD/DS procedures are done each year. 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.

Your policy bulletin states that " (the distal RNY procedure) combines

the least - desirable features of the gastric bypass with the most

troublesome aspects of the biliopancreatic diversion " .

Yet it also states that " Although patients can have increased

frequency of bowel movements, increased fat in their stools, and

impaired absorption of vitamins, recent studies have reported good

results (for the distal RNY). Since it is admitted that the

most " troublesome " aspects of the BPD/DS procedure are shared by the

distal RNY procedure than it follows that if the distal RNY procedure

has had good results then so too will the BPD/DS procedure. The

references show it is indeed the case.

Your reference #12 from the policy bulletin is now 9 years out of

date. Scopinaro published a paper 3 years ago based on over 2000

patients. He reports that as more has been learned about BPD, the

morbidity rates have dropped substantially [1].

Your reference #13 describes a singular case of hepatic failure out

of thousands of procedures done over the years by Scopinaro, Marceau,

Hess et all. While obese patients are at increased risk of liver

failure under any weight loss surgery, There is no evidence to

suggest that the rate is higher for the BPD procedure. I believe

that the concern of some physicians is based on outcomes of a long

outmoded malabsorption procedure known as JIB. It is clearly stated

by Hess that liver failure is not a problem with this procedure [2].

Many surgeons when first starting to do the BPD/DS procedure have

higher morbidity rates initially. However, as they learn the

procedure, morbidity rates drop dramatically [3],[4]

There now exists a large body of evidence to show that the

Billiopancreatic diversion (with or without duodenal switch) is safe

and effective. Several thousand patients have been reported on with

follow-ups as long as 20 years. The author of your policy bulletin

effectively admits that it is as safe and effective as distal RNY

(which is an approved procedure) and more effective than proximal

RNY. Over the last 3 years there have been numerous articles showing

the long-term safety and efficacy of this procedure. Those that

claim otherwise are either confusing the procedure with JIB or are

unaware of the more recent data.

References:

1. Scopinaro N; Adami GF; Marinari GM; Gianetta E; Traverso E;

Friedman D; Camerini G; Baschieri G; Simonelli A, Biliopancreatic

diversion, World J Surg 1998 Sep;22(9):936-46

2. Hess DS; Hess DW, Biliopancreatic diversion with a duodenal

switch, Obes Surg 1998 Jun;8(3):267-82

3. Baltasar A; del Rio J; Escriva C; Arlandis F; ez R;

Serra C, Preliminary results of the duodenal switch, Obes Surg 1997

Dec;7(6):500-4

4. Baltasar A; Bou R; Bengochea M; Arlandis F; Escriva C; Mir J;

ez R; N, Duodenal switch: an effective therapy for morbid

obesity--intermediate results, Obes Surg 2001 Feb;11(1):54-8

5. Marceau P; Hould FS; Simard S; Lebel S; Bourque RA; Potvin M;

Biron S, Biliopancreatic diversion with duodenal switch, World J Surg

1998 Sep;22(9):947-54

6. Marceau P; Hould FS; Potvin M; Lebel S; Biron S,

Biliopancreatic diversion (doudenal switch procedure), Eur J

Gastroenterol Hepatol 1999 Feb;11(2):99-103

7. Rabkin RA et all, Distal gastric bypass/duodenal switch

procedure, Roux-en-Y gastric bypass and biliopancreatic diversion in

a community practice, Obes Surg 1998 Feb;8(1):53-9

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