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So the latest with my insurance is a letter explaining the denial is due to VSL#3 not being FDA approved. This response came after I submitted my GI's letter to them explaining why I need the probiotic.

Some of you have mentioned VSL#3 DS is sometimes covered, where VSL#3 is not. Is the DS version FDA approved?

I'm guessing it's not, but it would be good to know if I should bother pursuing it or just let it go.

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No it is not. It is not a drug, but is classified as a medical food. Still, products are not required to be FDA approved to be covered by insurance, but many insurance plans use that as a guideline. The first tier is usually the insurance company's formulary. Then there is the non-formulary items that require coding or a physician's statement of medical need. But, generally, these need to be FDA approved. Plus, gray area items like medical foods usually have strict diagnoses that must be documented before there is approval. Once I was prescribed an elemental diet while awaiting my colectomy. I was denied coverage for it because it was only approved for coverage if you had a Crohn's diagnosis. I wound up having to pay a lot out of pocket for 3 weeks worth of prescription diet.

Bottom line is that insurance companies only do what they are required to do, and even then sometimes you have to twist their arm.

Still, it is not as if VSL#3 has a high rate of success, so it is kind of understandable. I doubt your GI could prove that it was better than anything else. It just has a few studies, where the others don't.

If you had no other options (like you were allergic to all the antibiotics), it might be worth pursuing. If it were me, I'd let it go and save your energy for a fight you can win.

http://www.vsl3.com/hcp/faq.asp

Jan Smiler
Jan Dollar
VSL #3 DS does require a prescription, but the FDA doesn't approve probiotics. FWIW, a huge fraction of prescriptions are for "off label" use - the drug is approved by the FDA, but for a different purpose. Running the studies is very expensive, so the drug companies sometimes don't do so.

Jan is probably right about the value of the fight. On the other hand you could try it on your own nickel for 6-8 weeks and see whether it makes a big difference for you.
Scott F
Thanks, all.

I recently finished my box of Culturelle and switched to the VSL#3 samples from my doc. I had the cramping I've heard can happen at first and really haven't felt like fighting through that. I've had enough for now.

So I bought another box of Culturelle and I think I will see how it goes. I'm hoping I get lucky and won't have chronic pouchitis.
K

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