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