The three criteria are supervision, a qualified supplier, and 12 infusions a year
What the document says“``(2) A qualified home infusion therapy supplier (as defined in subsection (iii)(3)(D)) administers or supervises the administration of the drug or biological in a safe and effective manner in the patient's home (as defined in subsection (iii)(3)(B)).”
The three criteria are that the prescribing information approved by the Food and Drug Administration says the drug should be given by or under the supervision of a health care professional, that a qualified home infusion therapy supplier gives or supervises the drug safely and effectively in the patient's home, and that the prescribing information calls for at least 12 infusions a year, either into a vein or under the skin or at rates the Secretary finds would need an external pump.
What the document actually says“``(2) A qualified home infusion therapy supplier (as defined in subsection (iii)(3)(D)) administers or supervises the administration of the drug or biological in a safe and effective manner in the patient's home (as defined in subsection (iii)(3)(B)).”
A qualified home infusion supplier gives the drug or watches over it. This happens in the patient's home. It must be done in a safe way.
The first test is what the drug label says. The second is who runs the pump. The third is how often the drug is given in a year.
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