NHIA submitted comments on a CMS PFS proposed rule (CMS-1784-P) that would affect Medicare classification and coverage of self-administered drugs, certain biologics and coding and billing requirements related to the use of single dose containers and drug waste.

NHIA responded to an FDA request for comment on “Increasing Patient Access to At-Home Use Medical Technologies,” applauding the agency for recognizing the importance of facilitating access to care in the home.

NHIA submitted comments to CMS on the proposed 2024 home health payment rule. CMS did not mention the HIT services benefit in its 2024 rulemaking, however, NHIA believes it is important to continue advocating on behalf of Medicare beneficiaries to improve access to home infusion services.

On Friday June 30, 2023, CMS released proposed updates to the Medicare Home Health Prospective Payment System for CY 2024. The proposed home health rule does not address home infusion therapy (HIT) services other than to describe the potential interaction with the new Home IVIG Items and Service benefit, which replaces the IVIG demonstration starting on January 1, 2024. 

NHIA applauds the guidance issued by FDA to allow for decentralized clinical trials, including in patients’ homes. NHIA believes that allowing decentralized clinical trials will improve the representation 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.”