May 9, 2023
NHIA applauds the guidance issued by FDA to allow for decentralized clinical trials, including in patients’ homes. NHIA first commented on this topic to CMS in our letter regarding the National Coverage Analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease on Jan. 11, 2022, which would have limited studies to hospital outpatient settings. As NHIA noted in its letter, during the COVID-19 public health emergency, several manufacturers successfully conducted clinical trials in remote settings, including patients’ homes.
NHIA believes that allowing decentralized clinical trials will improve the representation of a wider range of patients in trials. According to the FDA guidance, “remote clinical trial visits and clinical trial-related activities are important strategies to make trials more convenient and more accessible” and “sponsors should strive for diversity and inclusiveness in trial populations.”
The FDA also shares guidance for enabling in-person visits and trial-related activities to be provided by HCPs close to trial participants’ homes but are not a part of the trial personnel as well as collecting informed consent remotely.
The National Home Infusion Association (NHIA) applaudes the introduction of bipartisan legislation in the U.S. Senate that will ensure Medicare patients can receive the intravenous (IV) medications they need while at home.
The National Home Infusion Association (NHIA) is pleased to hold its second annual one-day Payor Summit. The event, designed to bring together representatives from commercial health insurance plans with home and specialty infusion leaders, will take place August 23, 2023 in Dallas, TX.
The National Home Infusion Association (NHIA) applauds the introduction of the “Expanding Care in the Home Act,” (H.R.2853) which would expand coverage for home-based services, such as home infusion, dialysis, diagnostic imaging, and personal care services for Medicare beneficiaries.
