CMS Pub. 100-02, ch. 15, § 320.3

Section 1861(iii)(3)(D)(i) of the Act defines a qualified home infusion therapy supplier as

a pharmacy, physician, or other provider of services or supplier licensed by the State in

which the pharmacy, physician, or provider of services or supplier furnishes items or

services.

The qualified home infusion therapy supplier must:

A. Furnish home infusion therapy services to individuals with acute or chronic

conditions requiring administration of home infusion drugs;

B. Ensure the safe and effective provision and administration of home infusion

therapy services on a 7-day-a-week, 24-hour a-day basis;

C. Be accredited by an organization designated by the Secretary; and meet such other

requirements as the Secretary determines appropriate.

The supplier may subcontract with a pharmacy, physician, other qualified supplier or

provider of medical services, in order to meet these requirements. Additionally, section

1861(u) of the Act defines “provider of services” to mean a hospital, critical access

hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home

health agency, hospice program, or, for purposes of sections 1814(g) and 1835(e) of the

Act, a fund. Therefore, any of the previously noted entities who meet the Medicare

accreditation requirements for home infusion therapy suppliers is eligible to enroll as a

qualified home infusion therapy supplier.

In the case that a home health agency also becomes accredited as a home infusion therapy

supplier, the HHA would continue to meet the requirements under the Home Health

Conditions of Participation (CoPs) as well as the home infusion therapy supplier

requirements as set out in 42 CFR 486 Subpart I, of which DME services, including

pharmacy services associated with the preparation and dispensing of home infusion drugs

are not included.

The qualified home infusion therapy supplier is not required to furnish the infusion pump,

home infusion drug, or related pharmacy services. The infusion pump, drug, other

supplies, and the services required to furnish these items (that is, the compounding and

dispensing of the drug) remain covered under the DME benefit. Pharmacy services,

remote or otherwise, furnished by a Medicare enrolled DMEPOS supplier, associated

with the preparation and dispensing of home infusion drugs are covered under the DME

benefit and are not part of this specific home infusion therapy services benefit.