1. The individual’s complex medical status or therapy requires enhanced monitoring and potential interventionabove and beyond the capabilities of the office or home infusion setting; or

2. The individual’s documented history of a significant comorbidity (e.g., cardiopulmonary disorder) or fluid overload status that precludes treatment at an alternative site of care; or

3. Outpatient treatment in the home or office setting presents a health risk due to a clinically significant physical or cognitive impairment; or

4. Difficulty establishing and maintaining patent vascular access; or

5. To initiate, re-initiate products for a short duration (e.g., 4 weeks);

          or

Documentation (e.g., infusion records, medical records) of episodes of severe or potentially life-threatening adverse events (e.g., anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) that have not been responsive to acetaminophen, steroids, diphenhydramine, fluids, infusion rate reductions, or other pre- medications, thereby increasing risk to the individual when administration is in the home or office setting;

or

Initial infusion or re-initiation of therapy after more than 6 months;

or

Homecare or infusion provider has deemed that the individual, home caregiver, or home environment is not suitable for home infusion therapy (if the prescriber cannot infuse in the office setting).

Ongoing outpatient hospital facility-based infusion duration of therapy will be no more than 6 months to allow for reassessment of the individual’s ability to receive therapy at an alternative site of care.