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PART 1: Setting the Stage

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* 1. Can you define clear and compelling public health (documenting prevalence and/or incidence, burden of disease, burden on healthcare system) objectives for securing a new (or revising an existing) ICD code?

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* 2. Are there near-term regulatory or healthcare delivery decisions that would benefit from a new/revised code? (e.g., approval of a new diagnostic tool or therapy for the condition, change in the standard of care, change in the prevalence of the condition)

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* 3. Do you or a member of your team have prior experience revising or applying for a new code?

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* 4. Is there tight agreement among research and medical experts in the field about how to diagnose this condition?

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* 5. Is the subject condition included in the NIH Genetic and Rare Diseases (GARD) Information Center directory of diseases?

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* 6. Does the subject condition have its own or a related World Health Organization (WHO) ICD-11 code?

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