Billy Wynne

ASTP/ONC Releases Limited HTI-2 Final Rule to Advance Interoperability Through TEFCA The Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP), released the Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (TEFCA) final rule (HTI-2 final rule) (press release). What…

Policy Round-Up: CBO, GAO Reports on ACA Premium Tax Credits; DACA Marketplace Eligibility In this update, we highlight recent developments regarding ACA Marketplace and enhanced premium tax credits (PTCs). The ongoing negotiations for the lame duck health package appear unlikely to include an extension of enhancements to premium tax credits, which expire at the end…

Recent SAMHSA Behavioral Health Updates Below please find highlights of recent activity from the Biden Administration related to behavioral health. SAMHSA Requests Public Comment on Draft Guidelines for Behavioral Health Coordinated System of Crisis Care The Substance Abuse and Mental Health Services Administration (SAMHSA) is accepting public comments on updated national guidelines for a coordinated…

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…