Eligible for reimbursement or not...

[Guest MSMA]

Here is a claim I haven't run into before...

FSA participant (from the U.S.) went to Canada and filled a prescription for Seldane and wants to be reimbursed. However, the US FDA has banned it from US because of the danger of strokes. The claimant's prescription plan has denied payment for the medication.

Can this be reimbursed through the medical FSA?

Thanks!

[JanetM]

would say since it is not lawful drug it can't be covered.

[Lisa Hand]

I agree, not legal in the US, it would fall under the category of illegal drugs as detailed in IRS Publication 502 and would not be eligible.

[GBurns]

Where did you ever hear that seldane or Seldane D were ever banned by the FDA?

As I remember the FDA asked that a warning be placed on it re contraindications with certain other medications. Later the indicated that they would consider further action now that alternatives (then considered safer) were available.

It was a voluntary withdrawal by the 2 manufacturers not a ban and there was no illegality that exists as far as I remember.

However, it might no longer be on most formularies and that is most likely why it was not covered. It probably has nothing to do with illegality. That is also why a Dr issued the prescription for the medication, unless you do think that the Dr would prescribe an illegal substance, in the first place, especially when the patient has coverage from which to seek reimbursement.

If there is no illegality issue, then it should not matter where a valid prescription was filled unless your PD states US only.

[Guest MSMA]

The plan participant went to a Canadian doctor and filled this script there as well. However, his other scripts were written & filled in the U.S.

http://www.fda.gov/cder/fdama/10898.pdf

[GBurns]

If your plan provides coverage in Canada then it is covered because it is legal in Canada.

Re your link:

1. It is Proposed Rulemaking. Therefore not law until after the comment period and issuance of Rule/Regulation or Final Rule/Regulation. This was never done.

2. In the link it clearly states that the removal was voluntarily done by the manufacturer not by FDA ruling or directive.

Therefore is was never banned nor declared illegal.

[Guest MSMA]

I was also provided with these 2 links that seem to very clearly state the ban....but...as it turns out, the claimant has maxxed out his account and this issue becomes moot as far as we're concerned at this point. Thanks to everyone who responded!

http://www.findarticles.com/cf_dls/mOISW/2...713/print.jhtml

and

http://www.biomedcentral.com/news/20001220/02/

[GBurns]

Just because someone writes something in an article does not make it true.

The FDA clearly stated their position in the Federal Register. A list of their actions are also on their website.

Nothing from the FDA or the manufacturers use the term ban, instead the terms "voluntarily" and "by the manufacturer" are used.

I personally do not believe that everything that I see in articles or on websites are true or factual and when I see statements that are contradictory or in conflict I try to determine which is the authority. In this case I would choose the FDA wording in the Federal Register and elsewhere as the governing authority over misc articles written by misc persons.