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FDA authorization has nothing to do with insurance coverage. I know of a small manufacturer that's had an authorized product on the market for over 3 years, no
by capnkap 3y ago
FDA authorization has nothing to do with insurance coverage. I know of a small manufacturer that's had an authorized product on the market for over 3 years, not a single insurance company will cover it.
Insurance coverage is basically a waiting game between manufacturers and insurance companies. If you have enough capital to wait it out and schmooze executives, then you can get coverage. If not, good luck to you.
- ethanbond 3y agoFDA authorization definitely does have something to do with insurance coverage, it just isn’t a necessary nor sufficient condition.
- jxf 3y agoIt is a necessary condition for a number of treatments and insurance companies, but not all of them.
- notQuiteEither 3y agoFDA approval makes it considerably easier, and in many cases possible at all, to get reimbursement for these tests. I work in the field and this is a constant hurdle to overcome.
- nradov 3y agoIn many cases medical insurers outsource decisions on what tests to cover to care guideline vendors such as MCG and Change Healthcare (Optum). Those vendors periodically update their guidelines based on medical research and evidence-based medicine protocols. For a new test to be covered it generally has to demonstrate some clear benefit in terms of improved patient outcomes.