CMS Pub. 100-08, ch. 10, § 10.2.2.2

Home infusion therapy suppliers are a supplier type that enroll via the Form CMS-855B.

A. General Background Information

Section 5012 of the 21st Century Cures Act (“the Cures Act”) (Pub. L. 114-255), which amended

sections 1861(s)(2) and 1861(iii) of the Act, established a new Medicare home infusion therapy

services benefit. The Medicare home infusion therapy services benefit covers the professional

services, including nursing services, furnished in accordance with the plan of care, patient

training and education (not otherwise covered under the durable medical equipment benefit),

remote monitoring, and monitoring services for the provision of home infusion therapy and home

infusion drugs furnished by a qualified home infusion therapy supplier. This benefit will ensure

consistency in coverage for home infusion benefits for all Medicare beneficiaries.

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

supplies or services are furnished. A qualified home infusion therapy supplier must: (1)furnish

infusion therapy to individuals with acute or chronic conditions requiring administration of home

infusion drugs; (2) ensure the safe and effective provision and administration of home infusion

therapy on a 7-day-a-week, 24-hour-a-day basis; (3) be accredited by an organization designated

by the Secretary; and (4) meet other such requirements as the Secretary deems appropriate,

taking into account the standards of care for home infusion therapy established by Medicare

Advantage plans under Part C and in the private sector.

B. Home Infusion Therapy Supplier Eligibility and Enrollment Requirements

An entity that wishes to furnish home infusion therapy services to Medicare beneficiaries must

enroll as a home infusion therapy supplier. The supplier must meet the following requirements:

• Obtain and maintain a valid tax identification number and National Provider Identifier at

the organizational level.

• Be currently and validly accredited as such by a CMS-recognized home infusion therapy

supplier accreditation organization in order to enroll and remain enrolled in Medicare.

The CMS-recognized home infusion therapy supplier accreditation organizations include

the Joint Commission (TJC), the Utilization Review Accreditation Commission (URAC),

the Accreditation Commission for Health Care (ACHC), the Community Health

Accreditation Partner (CHAP), the National Association Boards of Pharmacy (NABP),

and the Compliance Team (TCT).

• Submit documentation containing an effective date of accreditation as well as the

locations accredited for home infusion therapy with its application. (This may, but is not

required to be, a copy of the accreditation certification and/or accreditation approval

letter.)

• Be compliant with § 414.1515 and all provisions of 42 CFR Part 486, subpart I in order

to enroll and maintain Medicare enrollment.

• Certify via the Form CMS-855B application that it meets and will continue to meet the

specific requirements for enrollment described in 42 CFR § 424.68 and 42 CFR Part 424,

subpart P.

• Successfully complete application screening at the limited categorical risk level per §

424.518(a).

• Pay an application fee at initial enrollment, revalidation, and when adding a practice

location.

• Enroll in each state in which it has an accredited practice location. The supplier may

provide services in patients’ homes across state borders as long as it is appropriately

licensed (if the state requires licensure); the supplier must be appropriately licensed (if

the state requires licensure) in each state in which it furnishes home infusion therapy

services in patients’ homes. (See section 10.3 of this chapter for certain PECOS

application submission policies with respect to enrolling in multiple states within one

contractor jurisdiction.)

The supplier completes Section 4D (Rendering Services in Patients Homes) of the Form CMS-

855B application to report all locations where health care services are rendered in patients’

homes. This includes locations across state borders. As an illustration, suppose the supplier has

two accredited practice locations in Arkansas and furnishes home infusion therapy services in

patients’ homes in Arkansas and in Oklahoma; here, the supplier only needs to enroll in

Arkansas. If, however, this same supplier wants to add another accredited practice location in

Texas, it would have to enroll in in Texas.