Billy Wynne

OIG Examines Reporting Delays and Data Gaps in CDC and SAMHSA Submissions for the National Drug Control Strategy The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a report examining the challenges faced by the Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health…

OIG Audit Finds Gaps in Office of Civil Rights’ HIPAA Oversight The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a report evaluating the effectiveness of the Office for Civil Rights’ (OCR) HIPAA audit program. This audit was prompted by increasing concerns about cyberattacks on healthcare organizations and the…

Two Manufacturer Participants for Cell and Gene Therapy Access Model Announced The Centers for Medicare and Medicaid Services (CMS) announced that two manufacturers of sickle cell disease treatments will participate in the Center for Medicaid and Medicaid Innovation (CMMI) Cell and Gene Therapy (CGT) Access Model. Additional details follow. Manufacturer Participants: CMS details that bluebird…

Increasing Organ Transplant Access (IOTA) Final Model The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) Innovation Center, finalized the Increasing Organ Transplant Access (IOTA) Model (press release/ fact sheet/full proposal).  The IOTA Model aims to increase access to life-saving kidney transplants for patients living with…

Agency Releases Resources to Address the Mental Health Impact of Gun Violence The Substance Abuse and Mental Health Services Administration (SAMHSA) released new resources to help address the trauma caused by and mental health impact of gun violence. These resources include guides for coping with grief, behavioral health best practices for trauma-informed care, and lessons…

Draft Guidance Issued on Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Comments are Due February 2 The Food and Drug Administration (FDA) released draft guidance entitled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an…

Task Force Requests Comments on Draft Recommendation Statement and Evidence Review on Screening for Syphilis in Pregnancy; Due December 23 The US Preventive Services Task Force (USPSTF) is requesting comments on a draft recommendation statement and draft evidence review on screening for syphilis infection in pregnant persons. The Task Force recommends that all pregnant individuals…

Agency Requests Public Comment on Proposed Definitions for Crisis Response Services, Comments Due December 5th The Substance Abuse and Mental Health Services Administration (SAMHSA) is requesting public comment on a new draft publication, Model Behavioral Health Crisis Services Definitions. According to the agency, this document was designed to provide clarity for providers, state and local…

Committee Addresses Disaster Funding Needs in Bipartisan Hearing The Senate Appropriations Committee convened a hearing to address the urgent federal funding needs for communities affected by recent natural disasters. The session highlighted the bipartisan commitment to providing relief despite the challenges posed by post-election transitions and ongoing work to finalize fiscal year (FY) 2025 appropriations…

Senate Subcommittee on Economic Policy Discusses the Failed Reality of the TCJA and Cautions Against Future Proposals The Senate Committee on Banking, Housing, and Urban Affairs Subcommittee on Economic Policy convened a hearing to examine the future of tax policy as the country approaches 2025. The discussion centered on the consequences of the 2017 Tax…