The Centers for Medicare and Medicaid Services Declines to Provide Coverage for Laparoscopic Sleeve Gastrectomy: Disappointing News for Patients, Surgeons, and Advocates

| April 18, 2012

Dear Readers of Bariatric Times:

I would like to start this editorial by relaying the disappointing news that the Centers for Medicare and Medicaid Services (CMS) has declined to provide coverage for laparoscopic sleeve gastrectomy (LSG) as valid bariatric treatment modality. It is unfortunate that the ones affected by this decision are the ones that, in my experience, have benefited from this procedure the most, such as elderly patients.

Enough data from collected series have been published demonstrating the safety and effectiveness of LSG, but still, the verdict reads that we need to demonstrate its safety and effectiveness in a “prospective, randomized, controlled trial (RCT).” What will change if LSG proves to be superior or inferior in weight loss to any other proven treatment modality? If there is any reason why I personally would approve the LSG in the elderly it would be the incredibly low incidence of postoperative complications and not the weight loss.

I cannot agree more with those physicians in charge of “panels” who are trying to make decisions based on scientific evidence and trials. But are retrospective series that bad? Do we really need to do a RCT comparing apples and bananas with statistically significant conclusions to acknowledge that a treatment modality is safe?

I remember attending a scientific meeting at Cedars Sinai Medical Center in Los Angeles, California in 1993 celebrating, I believe it was, 25 years of the implementation of the Swan Ganz catheter. I will never forget Jeremy Swan’s comments telling us “that if they (him and Willy Ganz) would have had to relate on the statistical analysis of the Swan Ganz trials, the catheter would have never been released to the market.” Their results were not significant enough and despite all the controversy that is still surrounding the SG catheter, it is still part of the main armamentarium in any critical care unit when hemodynamic instability ensues. I will await guidance from the American Society of Metabolic and Bariatric Surgery (ASMBS) on when and how we should start the RCT so that hopefully by 2015, LSG will be approved by CMS. Until then, we will continue to put in and take out bands and perform Roux-en-Y gastric bypasses (RYGBs) in patients that could do much better if treated with LSG. I cannot wait to see what kind of RCT CMS would like to implement for gastric plication.

In this issue of Bariatric Times, we present the second installment of the Metabolic Applied Research Strategy Initiative (MARS) series. This article discussing body weight and energy balance can be used to reinforce all of the above mentioned. The hypocrisy of those who are running the military rejecting recruits who are overweight, while they themselves have doubled the rates of obesity, seems like something out of a comedy. Energy in should equal energy out. It is that simple and we should all stay slim and fit forever. The science tells us, nevertheless, that if we do not walk two miles a day we gain 10 pounds a year. So, this means it is likely that many, if not most, of those who work long hours and/or have two jobs will become surgical candidates in the next 10 years.

Also in this issue, Dr. Roman Schuman provides an overview on the relevancy of research being conducted related to obesity, surgery, and the inflammatory response.

In this month’s “Surgical Pearls: Techniques in Bariatric Surgery,” Dr. Jaime Ponce, our ASMBS incoming president describes how ports should be secured to the abdominal wall fascia after implantation of a laparoscopic adjustable gastric band (LAGB). Although many people may think of port placement as a simple procedure, port complications are more prevalent than many think and are often the reason for reoperative surgery.
In this month’s “Hot Topics in Integrated Health,” Ms. Tina Napora discusses considerations for laboratory testing, including reimbursement rules, diagnosis codes, and coverage requirements.

We also introduce a new column dedicated to covering topics related to medical weight loss entitled “Medical Methods in Obesity Treatment.” In their debut installment, Drs. Primack and Scinta offer a detailed report on phentermine/topiramate (Qnexa, Vivus Inc., Mountian View, California), a weight loss drug that has garnered a lot of attention recently. On February 22, 2012, a sub-committee of the United States Food and Drug Administration (FDA) voted 22 to 2 to approve the drug, and on July 17, 2012, the full FDA will make a final decision on its approval for market use.

If approved, the drug will hopefully help those low patients with low body mass index (BMI) and those regaining weight after bariatric surgery stay out of the operating room. More importantly, I believe that LAGB combined with an anorectic drug will become headlines in the future.

Let me close my editorial on a happy note. Dr. David Provost, president of the ASMBS Foundation, announces in this month’s “ASMBS Foundation News and Update” that Dr. Kelvin Higa has been selected to receive the 2012 “Outstanding Achievement” award. What a great choice—a master surgeon but more importantly a “mensch.” For those who are not current with the term mensch, it comes from the German language and it means “human being” But it has been used primarily to describe an individual who strives to go above and beyond, demonstrating for instance dexterity in the operating room, professional discipline, and/or forward thinking” What the term mensch really describes is a human being that represents the highest standards of kindness and compassion—someone to admire and emulate. Dr. Kelvin Higa is a devoted father and husband. He is also a great friend whom I consider myself lucky to have. Congrats to Gloria and the whole Higa family on the award. We are looking forward to seeing you in San Diego, California at the annual meeting of the ASMBS and giving Dr. Higa a big round of applause.

Sincerely,
Raul J. Rosenthal, MD, FACS
Editor, Bariatric Times

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