Summary
With the COVID-19 public health emergency (PHE) declaration currently set to end on July 15, today is the deadline for the Department of Health and Human Services (HHS) to provide states at least 60 days’ notice that the PHE will expire or terminate. On the congressional front, several committees will convene hearings on various topics, including mental health, fiscal year 2023 appropriations, abortion, and cybersecurity.
As discussed in our latest WynneSights blog, the general consensus is that it seems more likely that the PHE will not be renewed. There has been some discussion about continuing the PHE to maintain temporary flexibilities another 90 days given the increase in cases due to Omicron and its subvariants, as well as the administrative ease of continuing COVID-19 flexibilities through the fiscal year (a renewal of the PHE declaration would extend it to October 13, 2022). However, the Biden administration is likely interested in moving on from the PHE ahead of the midterm elections in November so it can focus voters on what has been accomplished to date and its vision for the future. To aid in a post-PHE transition, WHG has compiled a chart that delineates a comprehensive set of temporary flexibilities pursuant to the COVID-19 PHE, available here.
This week, the House Energy and Commerce Committee is expected to mark-up a slate of six bipartisan bills related to Food and Drug Administration (FDA) user fees, mental health, cardiovascular health, and health research. All of the bills were favorably reported out of the Health Subcommittee last week (WHG Summary). Committee leaders are pushing to pass the Food and Drug Amendments of 2022 (H.R. 7667) coupled with the Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R. 7666) by July. The FDA user fee amendments will need to be passed by the end of the end of the fiscal year on September 30, 2022.
- Food and Drug Amendments of 2022 (H.R. 7667) (WHG Summary)
- Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R. 7666) (WHG Summary)
- Keeping Incarceration Discharges Streamlined for Children and Accommodating Resources in Education Act or “KIDS CARES Act” (H.R. 7233)
- Gabriella Miller Kids First Research Act 2.0 (H.R. 623)
- South Asian Heart Health Awareness Act of 2021 (H.R. 3771)
- Advanced Research Projects Agency-Health Act or the “ARPA-H Act” (H.R. 5585)
Tomorrow, the Senate Appropriations Committee hearings will continue with directors from the National Institute of Health testifying on the FY 2023 budget proposal. On Thursday, FDA Commissioner Robert Califf will field questions on the FY 2023 budget request for FDA before the House Appropriations Committee.
On Wednesday, the House Judiciary Committee will hold a hearing on abortion care access, which has become a top priority for congressional Democrats ahead of the anticipated Supreme Court decision overturning Roe v. Wade. Congress is currently unable to codify abortion rights given its political makeup, as demonstrated by the failed Senate vote (49-51) on abortion rights legislation last week. The House hearing is likely intended to provide fodder for the midterm elections.
Also on Wednesday, the Senate Committee on Health, Education, Labor and Pensions (HELP) will convene a hearing on cybersecurity in the health and education sectors. The PREVENT Pandemics Act (S. 3799), introduced by Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) includes two provisions mentioning cybersecurity: (1) requires the HHS Secretary to include privacy and cybersecurity protections in interagency data use agreements with HHS for public health emergencies; and (2) requires the HHS Secretary to include recommendations for protection of clinical trial participants data against cybersecurity threats in guidance clarifying the use of digital health technologies in clinical trials.