Page 298 - Medicare Benefit Policy Manual

The plan of care plays an integral part in care coordination between providers,
particularly when the physician ordering the home infusion drug is not the same
physician establishing the home infusion therapy services plan of care. Coordination
between the physician ordering the home infusion drug, the physician establishing the
plan of care for the home infusion therapy services, and the DME supplier furnishing the
home infusion drug is imperative in providing safe and effective home infusion therapy.
Coordination would likely include review of the patient assessment and evaluation,
including interpretation of lab results as they pertain to changes in medication type, dose,
or frequency. A current home infusion therapy services plan of care is essential in order
to ensure that the qualified home infusion therapy supplier is providing the appropriate
professional services, including patient monitoring, to ensure that medication
administration is safe and effective.

As coordination is required between the DME supplier responsible for furnishing the
infusion drug, and both the physician establishing the home infusion therapy services
plan of care and the prescriber of the home infusion drug, all entities are expected to be
involved in this care coordination process.

320.6 - Professional Services, Including Nursing Services, for Home
Infusion Therapy
(Rev. 10547, Issued: 12-31-20, Effective: 01-01-21, Implementation: 01-04-21)

In order to ensure that patients have access to expert clinical knowledge and advice to
safely and effectively manage all aspects of treatment, especially in the event of an urgent
or emergent infusion-related situation, the qualified home infusion therapy supplier must
provide the following services on a 7-day-a-week, 24-hour-a-day basis, in accordance
with the plan of care:

A. Professional services, including nursing services.

B. Patient training and education not otherwise paid for as durable medical
equipment as described in 42 CFR 424.57(c)(12).

C. Remote monitoring and monitoring services for the provision of home infusion
therapy services and home infusion drugs.

D. All home infusion therapy suppliers must provide home infusion therapy services
in accordance with nationally recognized standards of practice, and in accordance
with all applicable state and federal laws and regulations. This could include the
applicable provisions in the Federal Food, Drug, and Cosmetic Act.

Professional services, including nursing services, are skilled services which may be
necessary for an individual patient or particular therapy or course of treatment, as
determined by the physician responsible for the plan of care. The skilled services
provided on an infusion drug administration calendar day must be so inherently complex
that they can only be safely and effectively performed by, or under the supervision of,