More than seven months in from the effective date of the new Medicare Part B Home Infusion Therapy (HIT) services benefit, opportunities abound for pharmacies enrolled as qualified HIT suppliers. But challenges remain, primarily at the state level, as the adaptation of state regulatory structures has lagged despite the enactment of federal legislation establishing the benefit in 2016 and promulgation of final implementing regulations in late 2020. With new payment rates for HIT proposed by the Centers for Medicare and Medicaid Services (CMS) and a new Medicare enrollment protocol for HIT suppliers implemented in June 2021, however, the federal framework for the benefit is fully established and will allow for states to make any further changes to their own licensing and regulatory structures to accommodate the new benefit.

The genesis of the Medicare HIT benefit can be found in Section 5012 of the 21^st Century Cures Act, which amended several sections of the Social Security Act¹  (the “Act”) and was enacted into law in 2016. Licensed pharmacies enrolled in the Medicare Part B Durable Medical Equipment (DME) program were permitted to bill for HIT during a transitional period from 2019 through 2020.²  In November 2020, CMS promulgated a final rule to implement enrollment requirements for the benefit, which became effective on January 1, 2021.

Put simply, the HIT benefit covers (a) professional services, including nursing services, furnished in accordance with a plan of care, (b) patient training and education not otherwise covered under the DME benefit, (c) remote monitoring, and (d) other monitoring services for the provision of HIT and home infusion drugs furnished by a qualified HIT supplier, which are furnished in the patient’s home.

Relevant definitions³  applicable to the benefit include:

• Home – A place of residence used as the home of an individual, including an institution used as a home other than a hospital, critical access hospital, or skilled nursing facility. Presumably, then, such services can be furnished in such settings as assisted living facilities, personal care homes, and other congregate settings.

• Home infusion drug – A parenteral drug or biological 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. The term does not include insulin pump systems or a self-administered drug or biological on a self-administered drug exclusion list.

• Qualified home infusion therapy supplier – A pharmacy, physician, or other provider of services or supplier that is licensed by the state supplier of home infusion therapy that:
  • Furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs;
  • Ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis;
  • Is accredited by an organization designated by the Secretary of the Department of Health and Human Services (the “Secretary”);⁴  and
  • Meets such other requirements as the Secretary determines 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.

The qualified HIT supplier must ensure that the patient is under the care of a physician, nurse practitioner, or physician’s assistant, and has a physician-established plan of care that prescribes the type, amount, and duration of infusion therapy services to be furnished.⁵  The plan of care must be periodically reviewed by the physician⁶  in coordination with the furnishing of home infusion drugs.

The existing DME benefit covers the infusion pump, related supplies and equipment, and the infusion drug, as well as certain services required to furnish these items, such as pharmacy services, equipment delivery and set up, and education/training relating to the items of DME. As noted above, the HIT benefit covers the professional services, education/training not covered by the DME benefit, and patient monitoring. Under the Act, a unit of single payment is for each “infusion drug administration calendar day” in the patient’s home.⁷  In addition, the payment received will vary according to the utilization of nursing services by infusion therapy type to reflect such factors as patient acuity and complexity of drug administration. There are presently three payment categories. This payment is separate from payment under the DME benefit.

A pharmacy that wishes to become a home infusion therapy supplier for purposes of billing Medicare must do so on CMS-855B, which became effective on June 22, 2021. As part of the enrollment process, the supplier must 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 in all service states. Licensure in service states will generally take the form of a nonresident pharmacy permit. For nonresident pharmacy permits, state pharmacy licensing laws often require that the pharmacist-in-charge of the out-of-state pharmacy be licensed in the service state. The pharmacy may also need to obtain a home health agency license depending on state law and the supplier’s structure and business model vis-à-vis the nursing component, or even a state home infusion therapy license. Another consideration involves whether various state nurse practice acts permit some or all professional functions of Medicare HIT to be provided by a Licensed Practical or Vocational Nurse or whether a Registered Nurse must perform these functions.

Eventually, states will adapt their legislative and regulatory frameworks to better accommodate the new benefit. Until then, however, pharmacies that intend to establish a Medicare HIT footprint in several states, must be prepared to do their homework, navigate a host of state regulatory issues, and be flexible enough to find a business model that works across all of those states.

[1] Specifically, Sections 1834(u), 1861(s)(2), and 1861(iii).

[2] See Section 50401 of the Balanced Budget Act of 2018 (Pub. L. 115-123).

[3] See Section 1861(iii) of the Social Security Act and 42 C.F.R. § 486.505.

[4] Presently, CMS recognizes the following organizations to provide HIT accreditation:  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). CMS, Pub. 100-08 Medicare Provider Integrity Manual, CMS Pub. 100-08, Medicare Provider Integrity Manual, § 10.2.2.8.B.

[5] 42 C.F.R. §486.520.

[6] Id.

[7] Section 1834(u)(1)(A)(ii) of the Act.  Under 42 C.F.R. § 486.505, By regulation, “infusion drug administration calendar day” is defined as “the day on which home infusion therapy services are furnished by skilled professionals in the individual’s home on the day of infusion drug administration. The skilled services provided on such day must be so inherently complex that they can only be safely and effectively performed by, or under the supervision of, professional or technical personnel.”