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Thread: Non FDA approved procedure

  1. #1
    Join Date
    Apr 2007
    New Port Richey & Clearwater

    Default Non FDA approved procedure

    AAPC: Back to School
    My doctors are getting ready to start doing a Non FDA approved treatment for MS. My question is can I still bill the insurance if it is not FDA approved their ICD9s are 340 & 459.2, but we are treating their MS symptoms?

  2. #2
    Join Date
    Apr 2007


    I'm assuming you are talking about commercial carriers and not government (Medicare, Medicaid) carriers. If a treatment is not FDA approved an insurance company would probably consider the treatment investigational; most insurance policies state that investigational, unproven treatment is not a covered benefit. If I were you, I would ask the patient's insurance carrier about their coverage policy for this specific treatment before you provide the service and see what they say and get their answer in writing (good luck with that!).

    I would also make sure the patient clearly understands that the treatment may not be covered and they may be held personally responsible for the bill. You might want to use something similar to an ABN waiver so you can prove you informed the patient about the cost and possible non-coverage so they can make an informed decision about the expenditures and the fact that it's not FDA approved. Does your malpractice carrier know your MD's are providing this treatment? and do they approve?

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