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is Vertical Sleeve FDA approved?



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um, i am pretty sure that the surgery has to be approved by the fda in order to be done here. i had no problem getting it covered by blue cross blue shield of california.

some insurance companys consider it to be experimental still because it is still new, but that is so they dont have to pay for it. insurance company's get away with that all the time. good luck :)

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I don't think the FDA approves surgical procedures that do not involve implanting medical devices or some other material in your body. This is what I found:

The FDA is responsible for protecting and promoting public health through the regulationand supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications),vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The lap band had to be FDA approved and if your doctor uses mesh to reinforce the staple line it would also need to be approved. If your doctor uses a laser for surgery, the laser needs to be approved.

I'll be interested in knowing if someone else has different information.

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Insurance companies can consider procedures experimental or unproven - that's pretty common with a newer procedure and that changes as other insurance companies begin making it a covered service.

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I would suggest speaking with your doc's office and asking them the code they use to bill it and make sure its covered....if that code isnt billable, trust me, there's another one that is, that Medicaid will cover.

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I heard that FDA has not approved Sleeve and therefore not coveted my Florida Medicaid, is this true?

Hi Mariposa!! My hubby is on Medicare and he wanted to get the sleeve but the doctor said Medicare doesn't cover the sleeve but will cover the RNY Surgery. I don't know what the Medicaid system requires though. Hope that helps.

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It's not a drug or device so the FDA doesn't have anything to do with it.

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Hi Mariposa!! My hubby is on Medicare and he wanted to get the sleeve but the doctor said Medicare doesn't cover the sleeve but will cover the RNY Surgery. I don't know what the Medicaid system requires though. Hope that helps.

Medicare approval of a procedure is a major milestone toward general acceptance - when Medicare started covering the DS a few years ago, that created a cascade of policy revisions on the part of the insurance companies, as they could no longer claim that a procedure covered by Medicare was "investigational" or "experimental". Currently with the VSG, more insurance companies seem to be covering it so that should be a tweak toward Medicare covering it - eventually. How long that could be is anybody's guess, given the pace of government action on such things.

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I think...and I may be wrong (highly likely)... that the FDA recently (in the past year) approved it for a lower BMI than they had in the past, therefore more surgeries are being approved by insurance companies.

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I think...and I may be wrong (highly likely)... that the FDA recently (in the past year) approved it for a lower BMI than they had in the past, therefore more surgeries are being approved by insurance companies.

I pray you are right, I've gained 70 lbs in the last 2 yrs, way too much. I'm 5'1 or 5'2", way too short for that weight. I'm glad they lowered the bmi. Thanks.

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It was my understanding that the FDA approves products, not procedures.

This is correct. I had this come up in my approval process as well. The FDA does not approve procedures.

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I think...and I may be wrong (highly likely)... that the FDA recently (in the past year) approved it for a lower BMI than they had in the past, therefore more surgeries are being approved by insurance companies.

The companies that make the lap bands (Johnson & Johnson and Allergan) lobbied the FDA to get the BMI lowered to 30 for their band products; whether or when the insurance companies will follow that recommendation is anybody's guess. As far as I know, the standard 35/40 BMI standards still generally rule amongst the insurance companies for general bariatric surgery approval, with some companies demanding higher BMIs for some procedures (including the VSG, strangely enough.).

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Living in Fla and being in the Medical field I can tell you that Florida Medicaid does not cover it because it is NOT covered by Medicare- Florida Medicaid. Having said that there are some things that Medicare covers and Medicaid doesnt for example some types of medical equipment, supplies, proecdures, tests etc...

Unfortunately every patient I know on Medicaid has had to go out of the country to be able to afford it because a) if you are able to save and have it here in the US you run the risk of losing your benefits because obviously you can cover the cost of your care and b)it is less expensive and follow up is hard to get done because very few specialists accept the plan which is why most medicaid recipients utilize the ER for their care. It's a catch 22.

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