More than seven months after the effective date of the new Medicare Part B Home Infusion Therapy (HIT) services, opportunities abound for pharmacies registered as qualified HIT providers. But challenges remain, mainly at the state level, as the adaptation of state regulatory structures has been delayed despite the promulgation of federal legislation establishing the benefit in 2016 and the promulgation of final implementing regulations at the end of 2020. With new payment rates for HIT offered by the Centers for Medicare and Medicaid Services (CMS) and a new Medicare enrollment protocol for HIT providers implemented in June 2021, however, the federal framework for delivery is fully established and will allow states to make further changes to their own licensing and regulatory structures. to take into account the new service.
The genesis of the Medicare HIT benefit can be found in section 5012 of 21st Century Cures Act, which amended several sections of the Social Security Act1 (the “Act”) and was enacted in 2016. Licensed pharmacies enrolled in the Medicare Part B Durable Medical Equipment (DME) program have been permitted to bill HIT for a transition period from 2019 to 2020.2 In November 2020, CMS promulgated a final rule to implement the registration requirements for the benefit, which came into effect on January 1, 2021.
Simply put, the HIT service covers (a) professional services, including nursing services, provided in accordance with a care plan, (b) training and education of patients not covered by the EMR service, (c) remote monitoring, and (d) other monitoring services for the delivery of HIT and home infusion medications provided by a qualified HIT provider, which are provided to the patient’s home.
Relevant definitions3 applicable to the service include:
- Home – A place of residence serving as domicile for an individual, including an institution serving as domicile other than a hospital, critical access hospital, or skilled nursing facility. It can therefore be assumed that these services can be provided in environments such as assisted living facilities, personal care homes and other collective settings.
- Home infusion medicine – A parenteral or biological drug administered intravenously, or subcutaneously for a period of administration of 15 minutes or more, to the home of an individual via a pump which is part of an EMR. The term does not include insulin pump systems or a self-administered or biological drug on a self-administered drug exclusion list.
- Qualified Home Infusion Therapy Provider – A pharmacy, doctor or other service provider or provider approved by the national home infusion therapy provider who:
- Provides infusion therapy to people with acute or chronic conditions requiring home infusion medication;
- Ensures the safe and efficient delivery and administration of home infusion therapy 7 days a week, 24 hours a day;
- is accredited by an organization designated by the secretary of the Ministère de la Santé et des Services sociaux (the “secretary”);4 and
- Meets such other 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.
The qualified TIH provider should ensure that the patient is under the care of a physician, nurse practitioner, or medical assistant and has a plan of care from a physician that prescribes the type, amount, and duration infusion therapy services to be provided.5 The care plan should be reviewed periodically by the doctor6 in coordination with the supply of home infusion medicines.
The existing EMR benefit covers the infusion pump, associated supplies and equipment, and the drug for infusion, as well as some services needed to provide these items, such as pharmacy services, delivery and installation of the drug. equipment, and education / training related to EMR items. As indicated above, the HIT service covers professional services, education / training not covered by the EMR service and patient follow-up. Under the Act, a single payment unit corresponds to each “calendar day of administration of the drug by infusion” at the patient’s home.7 In addition, the payment received will vary depending on the use of nursing services by type of infusion therapy to reflect factors such as patient acuity and the complexity of drug administration. There are currently three payment categories. This payment is separate from the payment for the DME service.
A pharmacy that wishes to become a home infusion therapy provider for Medicare billing purposes must do so on CMS-855B, which came into effect on June 22, 2021. As part of the registration process, the provider must register. ” register in each state in which it has an accredited place of practice. The provider may provide services to patients’ homes across state borders as long as they are properly licensed in all states of service. Authorization to practice in the service record will generally take the form of a non-resident pharmacy license. For non-resident pharmacy licenses, state pharmacy licensing laws often require that the pharmacist responsible for the out-of-state pharmacy be licensed in the serving state. The pharmacy may also need to obtain a home health agency license depending on state law and the provider’s structure and business model vis-à-vis the nursing component, or even licensed for home infusion therapy from the state. Another consideration is whether various state nursing practice laws allow some or all of Medicare HIT professional functions to be performed by a licensed practical or licensed practical nurse, or whether a registered nurse must perform those functions.
Ultimately, states will adapt their legislative and regulatory frameworks to better adapt to the new service. Until then, however, pharmacies intending to establish a Medicare HIT footprint in multiple states should be prepared to do their homework, navigate a multitude of state regulatory issues, and be flexible enough to find. a business model that works in all of these states. .
 More specifically, Articles 1834 (u), 1861 (s) (2) and 1861 (iii).
 See article 50401 of the 2018 budget balancing law (Pub. L. 115-123).
 See Section 1861 (iii) of the Social Security Act and 42 CFR § 486.505.
 Currently, CMS recognizes the following organizations to provide HIT accreditation: Joint Commission (TJC), Accreditation Commission for Use Examination (URAC), Accreditation Commission for Healthcare (ACHC), Community Health Accreditation Partner (CHAP), National Association Boards of Pharmacy (NABP) and Compliance Team (TCT). CMS, Ed. 100-08 Integrity Handbook for Healthcare Providers, CMS Pub. 100-08, Medicare Provider Integrity Manual, § 10.2.2.8.B.
 42 CFR §486.520.
 Section 1834 (u) (1) (A) (ii) of the Act. Under 42 CFR § 486.505, “calendar day for drug administration by infusion” is defined as “the day on which home infusion therapy services are provided by qualified professionals in the individual’s home on day of administration of the drug by infusion. The skilled services provided on this day must be so inherently complex that they can only be performed safely and efficiently by, or under the supervision of, professional or technical personnel.