Wednesday, September 27, 2017

Medicare panel gives low vote of confidence to weight-loss treatments

By Virgil Dickson  | August 30, 2017

A panel that advises the CMS on Medicare coverage decisions said there wasn't enough information available on whether weight-loss surgeries and devices are beneficial for the program's enrollees, making it unlikely Medicare will expand coverage for more of the treatments.

The Medicare Evidence Development & Coverage Advisory Committee, or MEDCAC, voted Wednesday that it had low confidence that current weight-loss interventions are successful in treating the Medicare population.

The vote took place after hours of public presentations on the available clinical data for weight-loss surgeries and devices. The panel overall voiced confidence that there was evidence that weight-loss surgeries such as gastric bypass, lap bands and gastric sleeve surgeries were helpful in treating obese patients, but said the benefits for individuals 65 and older are still unclear.

"There didn't seem to be clear data presented on the Medicare population today," said Martha Betz, a panel member and biomedical engineer at the Food and Drug Administration.

The panel's vote is likely bad news for weight-loss providers who went into the meeting hoping MEDCAC would sway the CMS to expand Medicare coverage for weight-loss surgeries and new devices such as gastric balloons, which are not covered at all.

MEDCAC doesn't make coverage decisions, but it is historically an influential voice for the CMS on reimbursement for weight-loss treatments. The agency began covering weight-loss surgeries in 2006 following a recommendation from the advisory panel.

Hospitals are now reimbursed between $10,000 and $17,000 by Medicare for weight-loss surgeries and physicians on average receive $1,500.

The agency now covers weight-loss surgery for only certain beneficiaries who have a body mass index of 35 or greater and at least one co-morbidity such as high blood pressure or diabetes.

The patient also has to prove that they participated in at least one physician-supervised program in which they failed to lose weight.

Clinicians that specialize in weight loss estimate that about 2 million Medicare beneficiaries are eligible for the surgeries now. They hoped that CMS would expand the coverage to people with a BMI as low as 30, which would make an additional 1 million enrollees eligible.

There is evidence that people with a lower BMI number have greater long-term health benefits than those that have a higher one, as they tend to have fewer or less severe chronic illnesses, according to Dr. John Morton, chief of bariatric and minimally invasive surgery at Stanford School of Medicine.

If Medicare were to lower the eligible BMI for surgery, health insurance companies would likely follow suit, which could mean millions more could become eligible for coverage for weight-loss procedures.

As things are now, most insurance companies cover weight-loss surgeries for people with BMIs 40 or greater, or a BMI of 35 if there are significant medical problems associated with that person's weight, such as diabetes or heart disease.

"Medicare coverage decisions are very influential," Morton said. "If CMS' sneezes, the rest of insurers get a cold."

While it wasn't a specific voting question, several panelists mentioned they were especially unsure what clinical benefit gastric balloons provided.

"The evidence I heard today was not compelling," said Dr. Marcel Salive, panel member and health scientist administrator in the National Institute of Health's Division of Geriatrics and Clinical Gerontology.

Doctors say these devices are a low-risk alternative for patients whose health is too frail for surgeries.

The balloons are inserted into the stomach through an endoscopic procedure. A doctor fills the balloon with saline solution to create a feeling of fullness, so patients lose the urge to overeat. After six months, it's deflated and removed.

The FDA approved balloons from two different companies in 2015, but no insurers cover their use. On average, the total cost of the gastric balloon procedure is $8,150.

If the CMS does decide to expand the population eligible for weight-loss surgeries or cover gastric balloons, it should create a registry to better track implications for the Medicare populations, panel members said.

"Without coverage, we're not going to get the data that we need for this population," said Dr. Doug Campos-Outcalt, medical director for the Mercy Care Plan.

Virgil Dickson reports from Washington on the federal regulatory agencies. His experience before joining Modern Healthcare in 2013 includes serving as the Washington-based correspondent for PRWeek and as an editor/reporter for FDA News. Dickson earned a bachelor's degree from DePaul University in 2007.

 http://www.modernhealthcare.com/article/20170830/NEWS/170839991?utm_source=modernhealthcare&utm_medium=email&utm_content=20170830-NEWS-170839991&utm_campaign=financedaily

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