image
Issues for the Bariatric & Metabolic Professional

A Case-by-Case Approach; Some Early Success; National Coverage Still the Hope

By Christina Frangou

The Centers for Medicare & Medicaid Services (CMS) will give local Medicare contractors the right to cover laparoscopic sleeve gastrectomy (LSG) on a case-by-case basis.

In a June 27 letter announcing the decision, the CMS said there is not enough evidence to warrant a broad approval of coverage of LSG.

But, the agency said, individual patients may benefit from this procedure. Local contractors are “in a better position” to consider the characteristics of individual beneficiaries and the performance of eligible bariatric centers within their jurisdiction, according to the CMS statement.

image “Taking into consideration the seriousness of obesity, the possibility of benefit in highly selected patients in qualified centers, we believe that local Medicare contractor determination on a case-by-case basis balances these considerations in the interests of our beneficiaries.”

The decision only relates to the laparoscopic approach and to a sleeve gastrectomy done as a “stand-alone” procedure.

The American Society for Metabolic and Bariatric Surgery (ASMBS) said the decision will make LSG an option for more Americans.

“On behalf of our patients, ASMBS is very pleased and gratified that CMS has recognized the true value and compelling need for coverage of this procedure,” said the ASMBS in a statement.

Right now, LSG is the fastest growing in popularity of all bariatric procedures and is covered by all major insurers other than CMS.

The ASMBS said that the organization would have preferred a broad national approval of LSG. The partial go-ahead will require additional work at the regional level to secure coverage.

The national Medicare program is divided into 10 Medicare Administrative Contractor (MAC) jurisdictions, and each jurisdiction will have the power to decide on LSG coverage.

John M. Morton, MD, associate professor and director of bariatric surgery and surgical quality at Stanford School of Medicine, in Stanford, Calif., said the ASMBS has identified a “local champion” in each region who will work with Medicare administrators.

So far, a number of ASMBS members have reported that local authorities have already cleared patients for an LSG.

“We’ve heard very positive feedback and believe everything will work out. It looks like it will take some time and effort but, at the end of the day, Medicare beneficiaries are going to enjoy the same level of coverage as the rest of America,” said Dr. Morton.

The ASMBS still hopes to achieve national CMS coverage for the LSG.

The recent announcement from CMS comes after a proposed decision from the agency in March in which CMS said it would not cover sleeve gastrectomy outside of randomized clinical trials, calling for more long-term studies and more randomized studies.

The ASMBS appealed the decision immediately, citing several recently published clinical studies on sleeve gastrectomy, including two randomized trials and one prospective cohort study.

“These studies provide clear and compelling evidence that the laparoscopic vertical sleeve gastrectomy is safe and effective on a randomized trial basis with both medical therapy and CMS-covered bariatric surgeries as controls,” the ASMBS wrote in a letter appealing the decision.

In the month following the CMS’ proposed decision, hundreds of surgeons and patients wrote in to comment on the decision. The overwhelming majority argued for full coverage, although two bariatric surgeons and one manufacturer of a gastric band device agreed with the CMS proposal; all three said that although short-term outcomes were available, there are insufficient medium and long-term data.

At the ASMBS annual meeting in June, just prior to the CMS announcement, researchers presented more evidence to support the agency’s full coverage of laparoscopic sleeve gastrectomy. The data was submitted to CMS in advance of the meeting.

In the largest reported series to date, Dr. Morton and his colleagues showed that the sleeve gastrectomy has a safety and efficacy profile that fits in between the two CMS-sanctioned bariatric procedures, gastric bypass and laparoscopic gastric banding.

Table. Key End Points of Study From the Bariatric Outcomes Longitudinal Databasea
Gastric Bypass,
%
Gastric Banding,
%
Sleeve Gastrectomy,
%
30-day serious complication rate 1.25 0.25 0.96
Death rate 0.14 0.03 0.08
Weight loss (% BMI lost) 40 20 30
BMI, body mass index
a Presented at the 2012 annual meeting of the American Society of Metabolic and Bariatric Surgery

The researchers studied nearly 270,000 metabolic and bariatric operations performed between 2007 and 2010, and recorded in the Bariatric Outcomes Longitudinal Database (BOLD). Nearly 16,000 of the procedures were sleeve gastrectomies, which had a 30-day serious complication rate of 0.96% compared with a rate of 1.25% for gastric bypass and 0.25% for gastric banding. Deaths were extremely rare following all three procedures, at 0.03, 0.14 and 0.08 for adjustable gastric banding, gastric bypass and sleeve gastrectomy, respectively (Table).

Similarly, in terms of weight loss, sleeve gastrectomy was associated with outcomes that fell in between those for gastric bypass and gastric banding. Sleeve gastrectomy patients experienced a 30% drop in body mass index (BMI), from 47.5 to 31.2 kg/m2. It was less than the 40% reduction associated with gastric bypass (47.7 to 31.2 kg/m2), but more than the 20% for adjustable gastric banding (45.1 to 31.2 kg/m2).

All major series of LSG report similar outcomes, said Matthew Hutter, MD, assistant professor in surgery at Harvard Medical School in Boston.

“It’s remarkable how consistent this is in showing the validity of the data. It shows that the sleeve gastrectomy, a brand new, very complex procedure, can be introduced safely and effectively when performed at a standard bariatric accreditation program.”

The CMS decision was one of several developments in obesity treatment over a one-week period this summer.

On June 25, the United States Preventive Services Task Force (USPSTF) recommended that clinicians not only screen adults for obesity but offer or refer patients with a BMI of 30 kg/m2 or higher to intensive, multicomponent behavioral interventions for 12 to 26 sessions a year. The guideline did not mention bariatric surgery as an intervention. Dr. Morton said surgery is not typically included in USPSTF recommendations because the task force generally considers it preventive care.

“As a surgeon who treats obese patients, I welcome that [the USPSTF] endorsed counseling and treatment for the obese patient. I anticipate that, in the future, the task force will endorse bariatric surgery given its special role as the only effective and enduring treatment for the seriously obese.”

Two days later, the FDA approved the first new drug to treat obesity in 13 years, giving a go-ahead to Belviq (lorcaserin hydrochloride), which was developed by Arena Pharmaceuticals (story, page 30).

On July 1, the Cleveland Clinic Health Plan in Ohio, announced it would expand coverage for employees with type 2 diabetes and BMI between 30 and 35 kg/m2 who are not optimally managed with medical therapy. The decision marks the first time in the United States or internationally that an insurance health plan has agreed to cover bariatric surgery for patents with BMI less than 35 kg/m2.

“This means that many patients with poorly controlled diabetes will now have access to surgical treatment that will provide them with an opportunity to achieve glycemic control and reduce complications of type 2 diabetes such as renal failure, blindness, heart attack and stroke,” said the ASMBS in a statement.