Federal Register Vol 84, No. 217 released November 8, 2019

Section 4: Home Infusion Therapy (HIT) Provisions

  • The new Medicare home Infusion services benefit is provided in a Medicare beneficiary’s home. The beneficiary must be currently under the care of a physician, nurse practitioner or physician’s assistant. (Section 1861(iii)(3)(A)).
  • CMS defines which drugs are approved for home infusion. The medication must be a parenteral drug or biological administered intravenously or subcutaneously for an administration period of 15 minutes or more using an external pump that is a CMS-approved item of durable medical equipment.
    • The requirement of an external infusion pump excludes insulin pump systems and any drugs or biologicals on the DME MAC local coverage decision (LCD) self-administered drug exclusion list. This list can and does change.
    • Self-administered = a drug that is self-administered by more than 50% of Medicare beneficiaries based on MAC analysis of Medicare claims data.
  • Eligible Home Infusion Therapy (HIT) Suppliers as of January 1, 2021 include: a hospital, critical access hospital (CAH), an outpatient comprehensive rehabilitation facility, home health agency, hospice, pharmacy, physician or other provider of services or supplier licensed in the State in which they supply services.
    • A qualified HIT supplier meets the CMS health and safety standards and is accredited by an organization recognized (approved) by CMS. NOTE there is no state survey available, CHAP is under review by CMS to be a recognized AO.
    • Home Infusion Services eligible for Medicare payment are furnished to individuals with acute or chronic conditions requiring the administration of drugs approved for home infusion.
    • Qualified HIT suppliers ensure the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
    • Note: a qualified home infusion therapy supplier does NOT need to furnish the pump or related supplies, home infusion drug, or related pharmacy services (42 CFR part 486)