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What’s Ahead: This Week

Hearings and Markups –

  • There are currently no relevant hearings or markups for this week.

Notable Policy Events –

  • Tuesday, September 5
  • Wednesday, September 6
    • America’s Health Insurance Plans, “Working with Health Systems to Expand Value-Based Care and Engagement.” Additional Information
    • Food and Drug Administration (FDA), Patient Engagement Advisory Committee Meeting, “Advancing Health Equity in Medical Devices.” Additional Information
  • Thursday, September 7
    • American Medical Association, “Value-Based Care and the CPT Code Set.” Additional Information
    • Department of Labor (DOL), “Proposed Rules on Requirements Related to the Mental Health Parity and Addiction Equity Act Webinar.” Additional Information
  • Thursday, September 7-Friday, September 8

Weekly Wrap-Up: Notable Health Care Developments from Last Week

Medicare & Medicaid–

  • On August 29, CMS announced the first 10 drugs covered under Medicare Part D selected for negotiation. The negotiations with participating drug companies will occur in 2023 and 2024, with negotiated prices becoming effective beginning in 2026. Press Release White House Statement HHS Report CMS Fact Sheet
  • On August 30, CMS sent a letter to state Medicaid directors requiring them to determine whether they have issues in their eligibility systems that could cause children to be mistakenly disenrolled from Medicaid or CHIP during the unwinding. Press Release Letter
  • On August 31, CMS released the latest enrollment figures for Medicaid, Medicaid, and CHIP. As of May 2023, 65,954,976 people are enrolled in Medicare and 93,815,749 people are enrolled in Medicaid and CHIP. Enrollment Figures
  • Also on August 31, CMS announced that it is extending the comment period for the proposed rule titled “Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022” until September 11, 2023. Notice
  • Also on August 31, CMS released a rule finalizing requirements for mandatory annual state reporting of three different quality measure sets starting in federal fiscal year 2024: (1) Core Set of Children’s Health Care Quality Measures for Medicaid and CHIP; (2) Behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid; and (3) Core Sets of Health Home Quality Measures for Medicaid. Rule
  • On September 1, CMS released a proposed rule that would establish minimum staffing standards for long-term care facilities. Comments are due November 5, 2023. Proposed Rule Press Release

Public Health Prevention, Preparedness, Surveillance & Data –

  • On August 31, the Rural Housing Service (RHS) within the United States Department of Agriculture (USDA) announced that it is accepting applications for the Community Facilities Technical Assistance and Training Disaster Repair Grant Program to provide technical assistance for repairing essential community facilities damaged by disasters in 2022. The funding amount is up to $2,500,000 and will remain available until expended. Submissions are due on November 29, 2023. Notice

Health IT, Privacy, & Digital Health –

  • On August 28, Rep. Susan DelBene (D-WA) authored an opinion piece in which the Congresswoman argued the need for Congress to pass comprehensive national data privacy legislation to protect Americans’ data privacy and serve as the foundation for laws that can govern emerging technologies such as artificial intelligence (AI). Opinion Piece
  • Also on August 28, it was announced that the Office of the National Coordinator for Health IT (ONC) awarded a non-profit organization, the Sequoia Project, a five-year contract to continue serving as the recognized coordinating entity (RCE) for the implementation of the Trusted Exchange Framework and Common Agreement (TEFCA). Announcement
  • On August 29, ONC published a blog on electronic health information (EHI) export criterion that Health IT Modules that are part of a health IT product that stores EHI are required to certify to and make available to end users by December 31, 2023. Blog
  • Also on August 29, the White House published a blog on key takeaways from an event held earlier this month in which leading AI companies provided their large language models for the first-ever public assessment “red-teaming” event. Blog

Mental Health and Substance Use Disorder Policy –

  • On August 31, the Biden Administration declared September 2023 as National Recovery Month, raising awareness of substance use disorder. Proclamation
  • Also on August 31, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a guide entitled “Best Practices for Successful Reentry From Criminal Justice Settings for People Living With Mental Health Conditions and/or Substance Use Disorders,” examining the types of interventions that support successful reentry for adults with mental health conditions and/or substance use disorders who are leaving jail/prison. Press Release Guide Overview Guide
  • Also on August 31, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a report entitled “Emergency Department (ED) Interventions for Opioid Use Disorder,” about ED efforts across the U.S. in patient identification, approaches to treatment engagement, structure, relationships with community-based organizations, and financing related to opioid use disorder (OUD). Press Release Report
  • Also on August 31, the Biden Administration announced more than $80 million in awards to rural communities in 39 states to support key strategies to respond to the overdose risk from fentanyl and other opioids. Press Release
  • Also on August 31, the Biden Administration announced more than $450 million to strengthen prevention, harm reduction, treatment, and recovery support services and crack down on illicit drug trafficking. Press Release
  • Also on August 31, CDC awarded $279 million to 49 states, the District of Columbia, and 40 local health departments to help stop overdoses within their communities. Press Release
  • Also on August 31, SAMHSA awarded $57.6 million in seven grant programs to connect Americans who misuse substances to recovery and treatment supports. Press Release
  • Also on August 31, FDA Commissioner Califf published a blog highlighting the FDA’s recent actions to promote the prevention and reduction of substance use disorders (SUDs) and overdose deaths. Press Release

Prescription Drugs, Medical Devices, Biomedical Research, & Health Innovation –

  • On August 30, FDA announced the availability of final guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” Announcement Final Guidance
  • On August 31, ASPE published an issue brief that provides an analysis of the current antimicrobial drug market and highlights challenges. Issue Brief

Veterans Health and Military Health  – On August 28, the Department of Veterans Affairs (VA) announced it has permanently housed 26,470 Veterans through July 2023, and announced more than $1 billion in grants to help homeless and at-risk Veterans through the Supportive Services for Veteran Families and Homeless Providers Grant and Per Diem programs. The efforts are built upon the evidence-based “Housing First” approach, which prioritizes getting a Veteran into housing and providing them with the wraparound support they need to stay housed, including health care, job training, legal and education assistance and more. Press Release

Population Health, Public Health & Health Equity – On August 28, the CDC issued a notice calling for nominations for membership on the Lead Exposure and Prevention Advisory Committee (LEPAC). Nominations for membership on the LEPAC must be received no later than September 30, 2023. Notice

Health Systems & Health Care Workforce – On September 1, the Biden Administration published a fact sheet outlining steps to improve safety in nursing homes, including proposed federal minimum staffing requirements, tougher enforcement initiatives, and efforts to expand nursing workforce. Fact Sheet

Misc. –

Legislative Activity –

Introduced Legislation –

  • On August 29, Reps. Manning (D-NC), Thompson (R-PA), and Trone (D-MD) introduced the Supporting Healthy Mothers and Infants Act of 2023 (H.R. 5312), which would support women, infants, and children impacted by substance use disorder. Bill Text Press Release
  • Also on August 29, Reps. Steel (R-CA), Manning (D-NC), and Crenshaw (R-TX) introduced the Flexible Savings Arrangements for a Healthy Robust America (FSA-HRA) Act (H.R. 5317), which would allow distributions from a health flexible spending arrangement or health reimbursement arrangement directly to a health savings account in connection with establishing coverage under a high deductible health plan. Bill Text Press Release