Page 302 - Medicare Benefit Policy Manual

“Home infusion drugs” are defined as parenteral drugs and biologicals administered
intravenously, or subcutaneously for an administration period of 15 minutes or more, in
the home of an individual through a pump that is an item of DME covered under the
Medicare Part B DME benefit, pursuant to and the regulatory definition set out at 42 CFR
486 Subpart I and the statutory definition set out in section 1861(iii)(3)(C) of the Act, and
incorporated by cross reference at section 1834(u)(7)(A)(iii) of the Act.

Section 1861(iii)(3)(C) of the Act also states that such term “home infusion drugs” does
not include insulin pump systems or self-administered drugs or biologicals on a self-
administered drug exclusion list. See section 50.2 of this chapter for instructions
regarding the determination of self-administered drugs or biologicals.

See the Medicare Claims Processing Manual, Chapter 32, Section 411 for a list of drugs
and biologicals that meet the criteria of a home infusion drug. It is important to note that
this list is not static.

The home infusion drugs identified for coverage of home infusion therapy services are
paid under the DME benefit. The related pharmacy services, furnished by a Medicare
enrolled DMEPOS supplier, including the preparation and dispensing of home infusion
drugs, are also paid under the DME benefit and are not part of this specific home infusion
therapy services benefit.

320.7.1 - Determining Qualifying Home Infusion Drugs
(Rev. 10547, Issued: 12-31-20, Effective: 01-01-21, Implementation: 01-04-21)

In general, Medicare Part B covers a limited number of home infusion drugs through the
DME benefit if:
1. the drug is necessary for the effective use of an infusion pump classified as DME
and determined to be reasonable and necessary for administration of the drug; and
2. the drug being used with the pump is itself reasonable and necessary for the
treatment of an illness or injury.

Specifically, under this home infusion therapy services benefit, a home infusion drug
must require infusion through an external infusion pump that is covered under the DME
benefit. If the drug or biological can be infused through a disposable pump or by a
gravity drip, it does not meet this criterion.

Only certain types of infusion pumps are covered under the DME benefit. The Medicare
National Coverage Determinations Manual, Publication 100-03, Chapter 1, Section 280.1
describes the types of infusion pumps that are covered under the DME benefit. The DME
MACs then specify the details of which infusion drugs are covered with these pumps.

The drugs and biologicals identified in the DME Local Coverage Determination (LCD)
for External Infusion Pumps (L33794) qualify as home infusion drugs as long as they are
infused intravenously or subcutaneously over a period of 15 minutes or more, are not
classified as insulin for insulin pump use, and are not on a self-administered drug