Billy Wynne

Information Requested on Challenges to the Development of Cell and Gene Therapies; Comments Due Dec. 13 The Food and Drug Administration issued a request for information (RFI) on the critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs). The agency notes that an improved understanding of the molecular…

OIG Finds that SAMHSA’s Policies for Awarding and Monitoring CCHC-E Grants Were Not Adequate The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a report on the Substance Abuse and Mental Health Services Administration’s (SAMHSA’s) policies and procedures for awarding Certified Community Behavioral Health Clinic Expansions (CCHBC-E) grants. In…

Agency Issues Final Rule on Streamlining Medicaid; Medicare Savings Program Eligibility Determination and Enrollment Today, the Centers for Medicare and Medicaid Services (CMS) released a final rule to streamline enrollment and retention in Medicare Savings Program (MSP) coverage (press release; fact sheet). This final rule is intended to leverage data from other programs and eliminate…

CMS and HRSA Announce Organ Transplant Affinity Group Action Plan The Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) announced the action plan for the Organ Transplant Affinity Group (OTAG).OTAG is a collaboration between CMS and HRSA that seeks to drive improvements in donations, clinical outcomes, system improvement,…

GAO Advises HHS to Protect Against Political Interference The Government Accountability Office (GAO) released a report detailing safeguards that Department of Health and Human Services (HHS) agencies could take to protect against political interference. GAO has previously made recommendations to HHS and its agencies about preventing political interference, and uses this report to examine further…

House E&C Health Subcommittee Members Seek Bipartisan Solutions to Address Drug Shortages The House Energy & Commerce Health Subcommittee convened a legislative hearing to consider five pieces of proposed legislation to address the drug shortage crisis. The hearing featured witnesses from the American Society of Health Systems Pharmacists, Healthcare Supply Chain Association, Healthcare Distribution Alliance,…

Senate HELP Committee Chairman Sanders and Senator Marshall Release Bipartisan Workforce Legislation and Schedule Markup on Three Additional Bills Today, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) and Senator Roger Marshall (R-KS) unveiled the Bipartisan Primary Care and Health Workforce Act (bill text/section by section). The bill will be marked…

Policymakers Discuss Telehealth Research and Policies at the HRSA National Telehealth Conference The Health Resources and Services Administration (HRSA) held the second National Telehealth Conference to convene policymakers and stakeholders to discuss telehealth best practices. The conference included several different panel discussions with Administration officials and representatives of stakeholder organizations. Topics of discussion included the…

Cancer Moonshot Announces New Initiatives and Partnerships to Revolutionize Cancer Care As part of President Biden’s Unity Agenda, the White House Cancer Moonshot announced new actions and commitments to advance the mission of reducing the cancer death rate in the United States by at least half by 2047 and improving the cancer patient experience. The…

COVID-19 Booster Recommended for All Persons Ages 6 Months and Older The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 to recommend the 2023-2024 monovalent, XBB containing COVID-19 vaccines as authorized under the FDA’s Emergency Use Authorization (EUA) or approved by Biologics License Application (BLA) for all persons ages 6 months and older.  Yesterday, the FDA approved the…