ASCO Releases Statement Regarding Home Infusion of Anticancer Therapy

The American Society of Clinical Oncology (ASCO) recently released a statement which raised concerns about home infusion of anticancer therapy and Centers for Medicare & Medicaid Services (CMS) regulations regarding the practice.¹

Overall, the organization indicated that they do not generally support the expansion of anticancer therapy services, as it is not currently believed that the benefits of doing so outweigh the risks.

“We understand that [the coronavirus disease 2019 (COVID-19)] has resulted in treatment challenges in some cases, and that home infusion services have been utilized as an alternative to treatment in outpatient facilities, but it is still unclear if the benefits outweigh the risks of this approach,” ASCO President Lori J. Pierce, MD, FASTRO, FASCO, said in a press release.² “During and beyond this pandemic, patient safety must continue to be the first priority, and the decision to administer anticancer therapy in a home setting should be made only if both the treating physician and patient agree it’s in the patient’s best interest.”

A provision in the 21st Century Cures Act led CMS to finalize a rule in 2019 to create a benefit for home infusion therapy services that will be implemented beginning in 2021. As the COVID-19 pandemic came to fruition, CMS also released numerous regulatory flexibilities to assist health care professionals and patients, including one that allows care to be delivered in the setting most appropriate and safest for an individual patient’s circumstances, which could lead to increase in the use of home infusion for anticancer therapy.

Home infusion of anticancer therapy is different than traditional therapy in that instead of a patient going to an oncology facility to receive their treatment from a qualified member of a care team, typically a nurse goes to the patient’s home to administer the treatment. While this can potentially reduce some obstacles for the patient, home infusion may also add a number of risks that cannot be adequately handled within a patient’s home.

Currently, there is little evidence directly comparing the safety of anticancer therapy infusions in the home versus outpatient settings. However, many established standard and precautions may be difficult or near impossible to uphold during home infusion.

“Our safety principles, for example, emphasize using more than one practitioner to verify and document dosage and infusion volume, safeguards that are designed to minimize errors and prevent patient harm,” Pierce explained in the release. “In an oncology practice, additional trained staff are available to do this, but that is not the case in a home infusion setting.”

With everything considered, ASCO released their own set of recommendations regarding home infusion of anticancer therapy. The recommendations include:

• Public funds should support independent research to evaluate the safety and effectiveness of home infusion of anticancer therapy.
• CMS should not extend the temporary flexibility of home infusion for Part B cancer drugs that was previously approved as part of their response to the COVID-19 pandemic.
• Prior to the implementation of the home infusion benefit in 2021, CMS should consult with oncology experts to ensure that home infusion is only used for certain classes of drugs when deemed to be appropriate by both the physician and patient. Moreover, quality reporting for home infusion therapy services should require the collection of oncology-specific measures to allow for the proper evaluation of safety related to anticancer therapy administration.
• Home infusion benefit policies from public and commercial payers in the context of anticancer therapy should be limited to exceptional circumstances where the benefits of home infusion outweigh the possible risks for patients.
• Any public or commercial payer designing a system to deliver pre-prepared antineoplastic drugs should consult with treating oncologists before implementation of the system.
• Home infusion benefit policies from public and commercial payers should require verification that necessary safety protocols and precautions have been put in place to protect health care personnel, patients, and caregivers.

“Regardless of the setting, any anticancer therapy administration should adhere to ASCO’s infusion safety standards,” ASCO wrote in the released statement. “Importantly, any teleconferences between physicians and nurses administering home infusions to ensure proper oversight should be adequately reimbursed.”

References:

1. ASCO. American Society of Clinical Oncology Position Statement Home Infusion of Anticancer Therapy. ASCO website. Published July 30, 2020. asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020_Home-Infusion-Position-Statement.pdf?cid=DM5714&bid=53107358. Accessed July 31, 2020.

2. Nation’s Cancer Doctors Say Home-Based Anticancer Therapy Without Oncologist Oversight, Safety Protocols, is Not a Safe Alternative to Outpatient Care [news release]. Alexandria, Virginia. Published July 30, 2020. Accessed July 31, 2020.