Change only feels quick
When returned for something paid
The exchange matters
The Rundown
- The congressional schedule shifts… again
- FDA user fee legislation introduced in the House
- House Republican Health Futures Task Force releases report on prescription drugs and therapeutics development
- May flowers: opportunities to recognize Duke Health professionals and institutions
- The latest from our desks
- Join Duke Health Advocacy Network
Federal Updates
Hurry up, wait, then hurry up again
It’s been an odd week in Washington, D.C. The House isn’t in session, and some plans were again delayed in the Senate due to cases of COVID-19. There is also the matter of a historic leak of an early draft Supreme Court opinion that, if made final, would have seismic implications for reproductive health rights and women’s healthcare in the United States. That’s a lot – and yet this week could otherwise be characterized as a “holding pattern” of sorts. We’re right on the cusp of some critical decisions, and they are all going to come sooner than it seems. Here’s the latest on a few priority issues:
- FY 2023 federal budget and appropriations – The “four corners” leadership of the House and Senate Appropriations Committees continue to have discussions about settling top-line defense and non-defense discretionary spending numbers, and there is every indication that a deal is on track. The top-lines give the subcommittees the freedom and direction they need to begin working out programmatic and other priority details, and where all the hard work of submitting funding requests and discussions with congressional staff receive prime consideration. The House has a plan to begin marking up its individual appropriations bills in June and July – and that plan is dependent upon the step we mentioned in the beginning coming together as expected. Our team continues to reach out to the NC congressional delegation on Duke Health federal funding priorities, and we look forward to having more updates on the FY 2023 process in the coming weeks.
- COVID supplemental – This is a problem. The White House has repeatedly warned lawmakers that the federal government’s COVID response would be limited absent additional funding – and the $10 billion under consideration likely won’t even be enough to get us through the summer. We feel it important to also note again that the scaled back supplemental does not include any resources to replenish programs supporting the uninsured for testing and treatments. An attempt to attach the $10 billion COVID funding bill to another piece of legislation advancing aid for Ukraine, a strategy favored by House Speaker Nancy Pelosi (D-CA), has run into similar roadblocks that prevented the bill from moving forward before the spring recess. There’s broad agreement the funding is needed and yet no agreement on what will allow a final vote to be scheduled in both chambers.
Our office, independently and in partnership with stakeholders across the country, continues to advocate for swift passage of COVID funding.
- Women’s Health Protection Act – A leaked draft Supreme Court opinion for the Dobbs v. Jackson County Women’s Health Organization case expected to be decided in June suggests that there is a majority of the Court considering overruling Roe v. Wade and Planned Parenthood v. Casey, which established and sustained a 14th amendment federal privacy right to abortion in the United States. Absent this protection, the primary legal authority on abortion and reproductive rights will return to the individual states and legislative bodies. Senate Democratic leadership has announced plans to vote next week on the Women’s Health Protection Act (H.R. 3755/S.1975), which would codify Roe’s decision in law to effectively render moot a potential Supreme Court decision in Dobbs. The bill has already passed in the House, but Democrats do not have the 60 votes necessary to overcome procedural hurdles in the Senate. There is a growing chorus in the Democratic caucus to carve out an exception on this issue to avoid filibuster and allow for a simple majority vote, but as of today, there aren’t enough Democratic votes to make the change. We will continue to monitor this issue closely.
- Innovation legislation – Conferees are now receiving instructions to open negotiations for a final Bipartisan Innovation Act legislative package aimed at boosting research, including for STEM disciplines, and innovation in the United States. This is a big priority for the administration, and we’re following pieces of the discussions along with our campus side government relations colleagues, particularly with respect to research security and how health professions are included, or not, within the context of STEM provisions. There is hope to wrap up negotiations by the end of summer, but Congress will be facing other headwinds and tight timelines on other key issues from appropriations to user fees (discussed more below).
We continue to advocate for Duke Health federal priorities and will stay closely engaged with the NC congressional delegation and our partners in regional and national coalitions.
FDA user fee bill introduced in the House
This week, full House Energy and Commerce Committee leadership, Chairman Frank Pallone (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-WA), and Health Subcommittee leadership, Chairwoman Anna G. Eshoo (D-CA) and Ranking Member Brett Guthrie (R-KY) introduced the “Food and Drug Amendments of 2022.”
This is a comprehensive user fee reauthorization package for the Food and Drug Administration (FDA) and includes the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA). In addition, the legislation has provisions to: strengthen the Accelerated Approval Pathway (mentioned in the article below); enhance generic competition in the market; improve diversity in clinical trials; address issues relating to inspections, address issues relating to research, development and supply chain, including authorizing new programs; and improve transparency, program integrity and regulatory process. According to Health Subcommittee leadership, a markup of the bill will be scheduled next week. The Senate Health, Education, Labor and Pensions (HELP) Committee is reportedly also developing its user fee package with the intent to introduce the legislation soon. A section-by-section summary of the House bill can be viewed here.
House Republicans offer insight into prescription drug solutions for next Congress
Republicans in the House have provided some insight into how they would address the cost of prescription drugs and other related issues if control of the House flips from Democratic control following the November midterm elections.
The announcement comes from the Healthy Future Task Force’s Treatment Subcommittee, which is co-chaired by House Ways and Means Committee member Rep. Brad Wenstrup, DPM (R-OH-2). Some of the provisions of the plan include passing the “Lower Costs, More Cures Act” (H.R. 19) to speed up the FDA approval process by broadening the FDA Accelerated Approval Program. The intent is to expand and streamline the process for Medicare coverage for breakthrough devices, incentivize domestic medical manufacturing of therapies and therapeutics to prepare for the next pandemic, and to build on COVID-19 flexibilities from the public health emergency to make clinical trials more widely available and aid the development of new treatment and cures.
The broader Healthy Futures Taskforce was announced last year by House Republican Leader Kevin McCarthy (R-CA-23) and is co-led by Reps. Brett Guthrie (R-KY-02) and Vern Buchanan (R-FL-16). The group’s membership features Republican members of the Ways and Means and Energy and Commerce Committees, and includes NC Reps. Richard Hudson (R-NC-08) and Greg Murphy, MD (R-NC-03). The focus of the task Force is to “examine policies to modernize and personalize America’s health care system, support innovative treatments, restore the doctor/patient relationship, and provide all Americans more affordable health care options that fit their individual needs. The task force will also aim to make sure the U.S. is prepared for the next pandemic and ensure our country has a more resilient medical supply chain.”
May flowers: opportunities to recognize Duke Health professionals and institutions
In case you missed it, May is Mental Health Awareness month. Our office will look for opportunities to elevate Duke Health’s policies priorities, while also elevating our care, education, research and training in mental and behavioral health. We continue to work with Congress as they work to develop legislation this year to address the mental health crisis facing our country.
Additionally, today kicks off National Nurses Week. Supporting the nursing workforce, education, training and well-being are all priorities for our office, and we are actively engaging with Congress on these issues.
We are also looking forward to celebrating Hospital Week next week (May 8-14) and highlighting the amazing work of our health system, its healthcare workforce, and the innovative and important ways Duke Health supports the community, patients, and families.
If you have anything you would like us to highlight in recognition of these important events, share with our Members of Congress, or other recognition opportunities of which our office may not be aware, please do not hesitate to reach out!
From our desk(s): Duke Health GR this week
This week our office advocated to our Senator’s offices to support $980 million for the Title VII health professions education and training programs at the Health Resources and Services Administration (HRSA) by signing the Dear Colleague letter being circulated by Senator Jack Reed (D-RI).
Our team is following reports that Duke University School of Medicine Dean Mary Klotman, MD is among the top candidates to replace Francis Collins, MD as Director of the National Institutes of Health. Dr. Collins stepped down as director after over 14 years in the role in late 2021. Dr. Lawrence Tabak has served in the interim role since Dr. Collins stepped down. A final decision on the replacement by the Biden administration is expected soon.
We met with coalition groups to discuss ongoing education and advocacy strategies with respect to surprise medical billing rule implementation and permanent expansion of telehealth flexibilities under Medicare.
Duke Health Government Relations joined colleagues from the North Carolina Healthcare Association and other stakeholders from the biotech industry to meet with Rep. Deborah Ross (D-NC-02). Hosted by the Healthcare Leadership Council, participants shared appreciation for her support of the Provider Relief Fund, telehealth, biomedical research, and support for the workforce.
Our office also highlighted the exciting research that was featured in the Duke press release “Investigational Mucosal COVID Vaccine Protects Against Disease and Transmission” with some of our delegation members.
Join the Duke Health Advocacy Network!
Looking for more opportunities to connect with fellow advocates and professionals interested in public policy across the health system? Join the Duke Health Advocacy Teams Channel!
Managed and moderated by Duke Health Government Relations and Duke State Relations, the purpose of the platform is for you to connect with your colleagues throughout the health system who are engaged and/or interested in public policy advocacy. We hope the channel will be used as a space for sharing ideas, collaboration, and engaging with the government relations teams on the issues most important to your work.
We encourage you to explore the channel, as we will post relevant news items, policy updates, questions, advocacy resources, and opportunities for engagement. As importantly, this is your space to do the same and to help grow the community.
Click to Join
(Note: This is only open to Duke Health employees. By joining this teams channel, you acknowledge that the platform and your participation are intended for information sharing and connections/relationship building and is not an inducement by Duke Health Government Relations and Duke State Relations, or the channel’s participants, to act as an unauthorized advocacy and/or lobbying representative of Duke Health or Duke University).