Health Care Policy Update - Weekly Wrap-up and What's Ahead - August 12, 2024

What’s Ahead: This Week

Hearings and Markups – No notable hearings this week. Congress is not in session.

Notable Policy Events –

Thursday, August 15
- Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), “Health IT Advisory Committee.” Free, Virtual. Additional Information
- National Academies of Sciences, Engineering, and Medicine (NASEM), “Strategies to Better Align Investments in Innovations for Therapeutic Development with Disease Burden and Unmet Needs.” Free, Virtual. Additional Information
- National Council for Mental Wellbeing, “Innovation in Behavioral Health Model Clinic-Centered Informational Session.” Free, Virtual. Additional Information

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

Medicare & Medicaid –

On August 5, CMS announced that Virginia submitted an extension request to its Building and Transforming Coverage, Services, and Supports for a Healthier Virginia (BTCSSHV) section 1115 demonstration to extend the substance use disorder (SUD) program and continue coverage for Former Foster Care Youth (FFCY). The comment period is open through September 4, 2024. Pending Application Submit Comments
On August 7, CMS issued a final procedural notice outlining the Transitional Coverage for Emerging Technologies (TCET) pathway. The pathway would allow CMS to achieve more timely and predictable access to certain new medical technologies for Medicare beneficiaries. Final Notice Press Release
On August 8, the Government Accountability Office (GAO) published a report reviewing the implementation of Medicare’s immunosuppressive drug benefit. Report
Also on August 8, CMS issued an informational bulletin, which summarized state obligations related to Medicaid coverage of family planning services and supplies. Bulletin

Health IT, Privacy, & Digital Health –

On August 5, FDA released a discussion paper on health equity in the context of medical devices and a request for input from the public. Comments are due October 4, 2024. Announcement Discussion Paper Submit Comments
On August 7, FDA updated the list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. With this update, FDA has authorized 950 AI/ML-enabled medical devices. List
On August 9, HHS released a proposed rule, which would implement standards in its contracts for health information technology. Comments are due October 8. Press Release Proposed Rule

Mental Health & Substance Use Disorder –

On August 6, CDC released data, which showed improvements in mental health among some United States teens. Press Release Report
On August 7, HHS issued a report and an issue brief on developing a database of SUD treatment needs. Issue Brief Press Release Report
Also on August 7, the HHS Office of Inspector General (OIG) issued a report finding that opioid treatment programs in Washington State did not fully comply with federal and state requirements. One-Pager Press Release Report
On August 8, HHS published an evaluation of the Assisted Outpatient Treatment (AOT) program for individuals with serious mental illness (SMI). Press Release Report

Prescription Drugs & Health Innovation –

On August 5, FDA published a frequently asked questions (FAQ) about compounded drugs. FAQ
On August 6, Senate Finance Committee Ranking Member Crapo (R-ID), House Ways & Means Committee Chair Smith (R-MO), and House Energy & Commerce Committee Chair Rodgers (R-WA) sent a letter to GAO requesting it review the Medicare Part D Premium Stabilization Demonstration. Letter Press Release

SDOH & Health Equity –

On August 8, HRSA announced $8.1 million in federal funding for the HRSA Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program in Kentucky, an initiative providing in-home services to expectant families and families with young children. MIECHV Program Press Release
Also on August 8, HHS issued division-specific language access plans from across the department. Press Release

Health Systems & Health Care Workforce –

On August 5, HRSA released data showing over 31 million patients were served at HRSA-funded health centers in 2023. HRSA Health Center Program Press Release
Also on August 5, the HHS Office for Civil Rights (OCR) settled a complaint with a New Jersey imaging network to resolve a disability complaint filed under federal civil rights law. Press Release Settlement Agreement
On August 7, HHS awarded nearly $9 million to 18 health centers to improve access to cancer screenings in underserved communities. Press Release

Legislative Activity –

Introduced Legislation –

On August 6, Reps. Caraveo (D-CO) and Wilson (R-SC) introduced the Stomach Cancer Prevention and Early Detection Act (H.R. 9304), which would conduct a review of the current state of stomach cancer incidence, prevention, screening, awareness, and future public health importance. Bill Text Press Release
Also on August 6, Reps. Slotkin (D-MI) and Bacon (R-NE) introduced the American Made Pharmaceuticals Act (H.R. 9321), which would conduct a demonstration program to test providing preferential treatment under the Medicare, Medicaid, and CHIP programs for certain drugs and biologicals manufactured in the United States. Press Release
Also on August 6, Reps. Womack (R-AR) and Bishop (D-GA) introduced the Protecting Veteran Access to Telemedicine Services Act (H.R. 9324), which would authorize certain health care professionals employed by the Department of Veterans Affairs (VA) to deliver, distribute, or dispense to veterans certain controlled medications via telemedicine under certain conditions. Bill Text Press Release

Health Care Policy Update – Weekly Wrap-up and What’s Ahead – August 12, 2024