Legal & Regulatory

Infusion: What to Expect in 2023

A review of the most recent CMS guidance pertaining to home infusion therapy.

There are 78 million Baby Boomers who are retiring at the rate of 10,000 per day. Unlike earlier generations, many Boomers will live into their 80s, creating a huge demand for healthcare services. Countered against this demand is a finite amount of money to pay for healthcare.

The costliest place to receive healthcare is in the hospital. It is time-consuming and expensive for patients to receive outpatient infusion therapy in hospitals. As a result, there is a push for infusion therapy to occur outside hospital settings.

Increasingly, DME pharmacies are moving into the infusion space. For example, a pharmacy may sell drugs to, and provide services to, a physician-owned infusion suite; a pharmacy may work with a physician in providing HIT; a pharmacy may own all or a part of a free-standing infusion center. Let’s look at CMS’s most recent guidance (updated in June 2022) pertaining to HIT:

HIT Services Benefit vs. DME Benefit. The HIT services benefit provides a payment that is separate from the payment under the DME benefit (e.g., for the infusion pump, supplies and drugs covered by Part B).

Billing for HIT Services. Only a qualified HIT supplier can bill for services under the HIT services benefit. A qualified HIT supplier must be accredited by a Medicare-approved accrediting organization and must enroll as a Medicare Part B supplier. An HIT supplier is not required to enroll as a DME supplier, but a DME supplier or home health agency may want to consider enrolling as an HIT supplier if it intends to provide HIT beyond what is covered under the DME and home health benefits.

Furnishing of Pump and Drug. The qualified HIT supplier is not required to furnish the infusion pump, home infusion drug, or related pharmacy services. The infusion pump, drug, supplies, and services required to furnish these items (i.e., the compounding and dispensing of the drug) remain covered under the DME benefit.

Patient Eligibility Requirements for HIT. To be eligible to receive services under the HIT benefit, a beneficiary must have Medicare Part B and (i) be under the care of a physician, nurse practitioner or physician assistant) and (ii) be under a physician-established plan of care that meets certain requirements.

HIT Benefit vs. Home Health Benefit. If an HIT patient is also under a home health plan and receives a visit that is unrelated to administering home infusion, then payment for the visit will be covered under the Home Health Prospective Payment System (PPS) and billed on the home health claim. If a home visit includes the provision of home health services in addition to (and separate from) HIT services, the home health agency (also a qualified HIT supplier) submits both a home health claim under the PPS and an HIT services claim under the HIT benefit.

Physician’s Responsibility. The physician establishing the Plan of Care is required to (i) consult with the DME supplier and the HIT supplier and (ii) review the Plan of Care on a regular basis in coordination with the DME supplier and the HIT supplier.

Required Services of the HIT Supplier. The qualified HIT supplier must furnish HIT services to patients with acute or chronic conditions (requiring administration of home infusion drugs) and ensure the safe and effective provision and administration of HIT services seven days per week/24 hours per day.

Patient Training and Education. Qualified HIT suppliers must provide patient training and education not otherwise paid for as DME (e.g., training regarding the provision of home infusion drugs not already required under the DME benefit).

Remote Monitoring. Remote monitoring may be performed through telephone or other electronic communication, based on the Plan of Care and the patient’s preference of communication. An off-site monitoring service may be utilized to communicate abnormal results to the physician for adjustments to the Plan of Care. A qualified HIT supplier may not bill separately for any services furnished via remote monitoring. This service is considered bundled into the payment made for an infusion drug administration calendar day.

Definition of Home Infusion Drugs. “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 through a pump that is an item of DME covered under the Medicare Part B benefit.

Unit of Single Payment. A unit of single payment is a bundled payment is made for items and services furnished by a qualified HIT supplier per payment category for each infusion drug administration calendar day.

Infusion Drug Administration Calendar Day. An “infusion drug administration calendar day” is the day on which HIT services are furnished by skilled professionals in the individual’s home on the day of infusion drug administration.

Medicare Advantage Plans. Medicare Advantage Plans are required to include all Medicare Part B benefits. The HIT service is a Part B benefit. The benefit does not cover drugs but rather the professional (including nursing) services associated with administering certain drugs in the patient’s home. 

About the Author

Jeffrey S. Baird, Esq., is Chairman of the Health Care Group at Brown & Fortunato, a law firm with a national health care practice based in Texas. He represents HME companies, pharmacies, infusion companies, manufacturers and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or