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Questions To Ask Before Deciding About A Treatment

If The Treatment Is A New Device

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Be aware that the FDA approval process for a new device is not the same as for a new drug. The FDA approves new drugs as safe and effective. However, with respect to most devices, there is a fast-track review in which regulators simply determine if the device does what its maker says it does. The FDA does not determine whether the device is effective or whether it poses any undue safety risks. It also may be in the doctor's financial interest to recommend a new device since Medicare and many private insurers offer additional compensation to the doctor for using a new device on the theory that it takes time to learn about a new procedure.

If a new device is recommended, it is advisable to ask the following questions:

  • What is my diagnosis?
  • What is the device you are recommending?  
    • Do you have a sample to show me?
    • How does it work? 
  • What is the goal of using the device? 
  • What are the chances the goal will be achieved?
  • What medical evidence exists with respect to the effectiveness and safety of the device?
  • What are the alternatives?
    • If there alternatives, why do you recommend the one you recommend?
  • What will be the effect on my daily life? Work life?
  • Is there a financial incentive for the doctor to use the device?
  • What has the doctor's experience been with the device? (for example, number of patients and the results).
  • Does using the new device prevent me from other treatments in the future?
  • Is the device covered by my insurance?
    • If not, what is the least expensive way for me to obtain the device?
    • For additional information, see Uninsured.
  • Where can I find more information about the device?

If the device will be inserted by surgery, see: Questions To Ask Before Agreeing To Surgery

If you are a member of an HMO or other managed care health insurance plan, ask:
  • Does the insurer provide financial incentives for doctors to use a preferred treatment?
  • Is the doctor prohibited from informing you about treatment options other than the one or ones approved by the managed care company? This is a practice known as "gagging."  Gagging is supposed to be a thing of the past. However, it is still worth confirming that you have been advised of all of your treatment options.
  • Does the plan limit your doctor's choice to order treatments and make referrals if a patient's needs go beyond the plan's protocols?

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