Alliance to HHS: Eliminate CED, Long-Stay Antipsychotic Medication Quality Measure
Published July 14, 2025
Today, the Alliance for Aging Research submitted comments to the U.S. Department of Health and Human Services (HHS) in response to the agency’s Request for Information, “Ensuring Lawful Regulation and Unleashing Innovation to Make American Healthy Again.”
The comments focus on two key issues:
First, the Alliance urges elimination of Coverage with Evidence Development (CED) policy and related guidances. The Alliance used our typical arguments against CED under the framework of deregulation, arguing that CED creates unlawful and burdensome barriers to Medicare beneficiaries’ access to FDA-approved treatments and that the policy requires additional clinical trials or registries, imposing costs, administrative complexity, and delays that harm patients and stifle innovation, while lacking statutory authority under Medicare law.
Second, the Alliance continued our work on Project PAUSE, echoing PAUSE’s response to the same RFI, which recommends removing the Long-Stay Antipsychotic Medication quality measure from the Nursing Home Five-Star Rating System, noting it penalizes facilities for clinically appropriate use, conflicts with psychiatric guidelines, misleads consumers, and interferes with medical best practice. Instead, we propose modernizing the Minimum Data Set to better distinguish appropriate from inappropriate use. These reforms would repeal nearly 30 regulations, in alignment with the Administration’s goals, reduce administrative burden, and protect patient access to needed care.