ALEXANDRIA, Va. — One of the nation’s leading cancer organizations says home infusion of anticancer therapy is currently not a safe alternative to outpatient treatment. The American Society of Clinical Oncology (ASCO)—which has recently issued a guide to cancer care delivery during the COVID-19 pandemic and, previously, standards on the safe handling of hazardous drugs—released a position statement today that raises concerns about home infusion of anticancer therapy and Centers for Medicare & Medicaid Services (CMS) regulations regarding the practice.
“We understand that 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,” said ASCO President Lori J. Pierce, MD, FASTRO, FASCO. “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.”
Home infusion of anticancer therapy differs from traditional outpatient therapy in that instead of going to an oncology facility for treatment, a qualified member of the care team, typically a nurse, comes to the patient’s home to administer the treatment. While this reduces some hurdles for the patient, home infusion adds a number of risks for both patients and care team members, including concerns around the safe handling of anticancer therapy in the home and the potential lack of coordination with the treating oncologist. Further, adverse side effects from anticancer therapy may quickly escalate and become life-threatening emergencies that may not be able to be adequately resolved in the patient’s home.
A provision in the 21st Century Cures Act prompted 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 crisis evolved into a pandemic, 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. This could lead to increases in the use of home infusion for anticancer therapy.
In 2016, ASCO and the Oncology Nursing Society (ONS) published updated chemotherapy administration safety standards
designed to minimize the risk of errors in chemotherapy ordering, preparation, and administration. ASCO’s 2019 standards
focus on the safe handling of hazardous oncology drugs in the workplace, and the ASCO Special Report: A Guide to Cancer Care Delivery During the COVID-19 Pandemic
provides pandemic-specific guidance to oncology practices on the immediate and short-term steps that could be taken to help protect the safety of patients and health care staff before resuming more routine care operations during the COVID-19 public health crisis.
There is very little evidence directly comparing the safety of anticancer therapy infusions in the home versus outpatient settings. Many established standards and precautions may be difficult, if not impossible, to meet 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,” said Dr. Pierce. “In an oncology practice, additional trained staff are available to do this, but that is not the case in a home infusion setting.”
ASCO’s position statement states that the decision to administer anticancer therapy in a home setting should be made by the treating physician in consultation with the patient, and only after consideration of the availability of necessary precautions to protect medical staff, patients, and caregivers during infusion and disposal. It also lays out the following six recommendations:
- Publicly funded independent research should be conducted to evaluate the safety and effectiveness of home infusion of anticancer therapy.
- CMS should not extend the temporary flexibility related to home infusion for Part B cancer drugs that was approved as part of their response to the public health emergency.
- CMS should consult closely with oncology experts prior to implementation of its home infusion benefit in 2021, to ensure that it is only used when the treating physician and patient determine that home infusion is the most appropriate setting based on the patient’s need and treatment plan. Quality reporting for home infusion therapy services should require collection of oncology-specific measures to enable the evaluation of safety in anticancer therapy administration.
- With anticancer therapy, home infusion benefit policies from public and commercial insurance providers should be strictly limited to exceptional circumstances where the benefits of home infusion outweigh the potential risks to patients.
- Any insurance provider designing a system to deliver pre-prepared antineoplastic drugs to clinical staff should consult with treating oncologists prior to implementation.
- Home infusion benefit policies from public and commercial insurance providers should require verification that necessary safety protocols and precautions are in place to protect health care personnel, patients, and caregivers.
More information about anticancer therapy is available at ASCO’s patient information website, Cancer.Net