Goodbye, ‘21
Hardly knew ye – then again
Think we’ve seen enough
This is our final scheduled newsletter of 2021. We will return the week of January 3rd with the opening of the second session of the 117th Congress.
In the meantime, please follow us on Twitter - @DukeGovRel - for breaking news.
The Rundown
- Our thanks to you
- Congress winds down year-end agenda
- Senate HELP Committee holds confirmation hearing for FDA nominee Robert Califf, MD
- Biden administration releases unified regulatory agenda for 2022
- The latest from our desks
Federal Updates
Our thanks to you
While so many of us were just beginning to process an unexpected (we hope you don’t mind that we’ve retired the term “unprecedented” for a while) and difficult 2020, a whole new year seems to have flown by. In very different ways than years prior, and in some the same as always, 2021 was a busy year for federal policy and congressional activity. There were hits and misses, challenges and successes, deep lows and incredible highs. It was a year that we were happy to see through together, as well as one that carried a little extra weight and sense of purpose for all of us.
With so much continuing to evolve, there has always been some comfort in this space, those opportunities to connect with you and distill some of the outside chaos. It’s a privilege that we take seriously because you and the communities served by our institution are our constant, our why – and we sincerely thank you for reading this newsletter each week and taking this journey with us.
We are grateful to be part of Duke Health and to amplify the health system’s collective voice in Washington, D.C. Wishing you a joyous holiday season – and we look forward to even more opportunities to engage with you in 2022.
Catherine, James, Julie, and Brian
What gets done, what gets pushed to 2022?
We know better than to state any predictions about the 117th Congress without a lot of padding and escape clauses. That said, the nightmare December session that many feared in November hasn’t really come to fruition as most of the absolutely must-pass items, including a short-term continuing resolution to keep the federal government operating, were addressed right on time or even a little ahead of schedule. This doesn’t mean that we aren’t still in for some last minute surprises, but how Congress will be spending the last couple of weeks of the year, or not, is coming into clearer focus.
- The debt limit – We can breathe a little easier, as the threat of default has been taken off the table. Thanks to some procedural work-around magic, congressional Democrats (with one Republican joining the "yes" votes in the House) passed a $2.5 trillion debt limit increase, which should allow the federal government to meet its debt obligations through the midterm elections and into early 2023. Of all of the must-do items this month, the solution to this one was the most uncertain. A big and controversial item has been taken off the agenda for now, likely clearing the way for Congress to address other priorities.
- National Defense Authorization Act (NDAA) – The 60 year streak of passing the NDAA in consecutive calendar years remains intact, as the Senate cleared the conferenced and House-passed FY 2022 NDAA this week. The NDAA is a major defense policy bill that, among other provisions, authorizes medical research programs at the Department of Defense.
- Build Back Better Act (BBBA) – A lot of blame for the outward lack of movement on the BBBA in the Senate has been placed on a couple of moderate Democrats who aren’t quite sold on the size and scope of the current package – but there are also some other very human and procedural delays at play. One piece of good news to report is that Senate Finance Committee revisions to the package have removed a House-passed provision to cut Disproportionate Share Hospital (DSH) payments to states that have not expanded Medicaid. Our office joined stakeholders across the country to advocate for this change. As of today, it seems unlikely that the Senate will be able to take up the BBBA before the end of the year and instead will return the week of January 3rd to attempt to make more progress.
What else might be coming up in the first few weeks of 2022? We anticipate that the Biden administration will renew the public health emergency (PHE) for another 90 days, but there is some uncertainty after that point. This likely means that advocacy and activity on any number of policies tied to the PHE, including those for telehealth, hospital at home, and other Medicare flexibilities, will pick up in the first quarter. Democratic leaders are also eager to take up voting rights legislation ahead of the 2022 midterms, negotiations will begin anew for a final deal on FY 2022 spending, and a likely mad dash on other legislative and regulatory items will occur before the end of the summer session.
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 as the federal agenda takes shape for 2022.
Califf hearing signals likely confirmation
This week, Robert Califf, MD, President Biden’s nominee to be the next commissioner of the Food and Drug Administration (FDA), appeared before the Senate Health, Education, Labor and Pensions (HELP) Committee to kick off his confirmation process. This would be the second go round for Dr. Califf if ultimately confirmed, as he previously served as FDA Commissioner in the final year of the Obama administration.
Before joining the FDA, Dr. Califf was a professor of cardiology and vice chancellor for clinical and translational research at Duke. He also served as director of the Duke Translational Medicine Institute, founding director of the Duke Clinical Research Institute, and later became the founding director of Duke Forge.
During the hearing, Dr. Califf pledged to streamline the FDA’s COVID-19 test review process, noted that responding to the current pandemic and preparing for future emergencies, including antimicrobial resistance, would be a top priority, and made clear he supports a Biden administration-favored policy that would allow Medicare to negotiate prescription drug prices. Dr. Califf also faced questions from some Democratic members of the HELP Committee about his ties to pharmaceutical companies and prior handling of the nation’s emerging opioid crisis – with two Democrats signaling that they will not vote to advance his nomination out of committee.
Despite the potential loss of some Democratic votes, Dr. Califf is likely to garner enough support from Senate Republicans to ensure his confirmation, including from HELP Committee ranking member Richard Burr (R-NC), who said of Dr. Califf, “I’m not sure you could write a resume of somebody more qualified to be considered for commissioner of the FDA.”
The relative lack of drama (so far) indicates that Dr. Califf may be confirmed and in place as commissioner as soon as mid-January, but the initial committee vote has yet to be scheduled.
Biden administration releases Unified Agenda: HHS set for a busy 2022
The Biden administration has released its so-called Unified Agenda for FY 2022, which previews the administration’s regulatory priorities for the upcoming year. While some deviation from the plan is inevitable given the likelihood of other emergent policy needs and delays, the agenda does provide some insight into where agencies are preparing to focus their attention. The Department of Health and Human Services (HHS), in particular, has wide-ranging plans through potential rulemaking and policy statements to increase health equity, improve health data security, streamline the application process for Medicaid and the Children’s Health Insurance Program (CHIP), build on HHS’ COVID-19 vaccine mandates, make changes to the 340B program, and develop rules for rural hospitals participating in Medicare and Medicaid.
Among the details of HHS’s agenda include: establishing a rule requiring Medicare Advantage providers, Medicaid-managed care plans, CHIP managed care entities, state Medicaid and CHIP fee-for-service programs, and Qualified Health Plan issuers on the federally facilitated exchanges to standardize data sharing to cut through prior authorization burdens and promote interoperability; developing a rule to promote enforcement of information blocking rules; increasing the scope of Title X programs and authorities to promote health equity; creating a rule to promote retention of Medicaid and CHIP enrollees and ensure those eligible have access to these programs; expanding federal vaccine mandates to Head Start facilities; developing a dispute resolution process for the 340B discount prescription drug program; and drafting a rule creating a new category of rural hospitals participating in Medicare and Medicaid that would allow these facilities to shift their care models to outpatient and emergency-care only.
While there are no timetables for many of the priorities on the agenda, we may begin seeing the announcement policies and proposed rules for public comment as soon as the end of December.
From our desk(s): Duke Health GR this week
This week, our office coordinated with the office of Rep. David Price (D-NC-04) to have the congressman join a small group of state legislators touring the Duke Research and Discovery @RTP campus. The purpose of the visit, which was organized and hosted by Duke State Relations, was to learn more about the School of Medicine’s new research campus in the Research Triangle Park and see firsthand the work being done by federal and state investments in biomedical research.
We shared a Dear Colleague letter being circulated by Senator Bill Cassidy, MD (R-LA) urging the Biden administration to make revisions to the No Surprises Act interim final rule (IFR) part II with the offices of Senators Burr and Thom Tillis (R-NC). Specifically, the letter requests changes to the rule provisions related to the payer-provider independent dispute resolution process so that the language more directly reflects legislative intent. Senator Cassidy was one of the primary drafters of the No Surprises Act. We are grateful to Senator Tillis for signing onto the letter, which will close later today.
We continue to meet with congressional staff and stakeholder partners to build upon advocacy efforts for permanent expansion of telehealth flexibilities, as well as those for the hospital at home program, under Medicare beyond the current public health emergency. The Telehealth Extension Act (H.R. 6202) has now been introduced in the House by leadership of the House Ways and Means Subcommittee on Health. Among other provisions, the bill would permanently extend all current flexibilities for two years beyond the COVID-19 PHE to give the Centers for Medicare and Medicaid Services (CMS) and Congress more time to work out permanent policy solutions. Rep. G.K. Butterfield (D-NC-01) has joined as a cosponsor, and our team is conducting outreach with the broader NC congressional delegation.
On Wednesday, our team had the opportunity to join a virtual event on climate resilience in the health care system, which included conversations with Rep. Lauren Underwood (D-IL-14) and Victor J. Dzau, MD, President of the National Academy of Medicine (NAM) and former CEO of the Duke University Medical Center. Dr. Dzau discussed the fact that the US health sector contributes up to 10% of all US carbon emissions, most of which come from the extended, complex supply chain necessary to support health care organizations. While attention on climate change is focused on environmental impacts and natural disasters, Dr. Dzau argued that most of the effects of climate change will be felt as individual health effects and that it is the responsibility of health care professionals to reorient this perception and raise the issue as a public health crisis. Rep. Underwood pointed to a provision in the Momnibus bill, which is included in the Build Back Better Act that seeks to invest in community-based initiatives to reduce levels of and exposure to climate change-related risks for moms and babies as an example of how the government can help address the public health aspects related to climate change. Our office will continue monitoring this issue as it relates to public health.
We continue to monitor developments related to the Biden administration’s COVID-19 vaccine mandates. A complex decision by the 8th Circuit Court of Appeals has effectively reinstated the CMS vaccine mandate for employees of most health care providers and entities that receive Medicare or Medicaid payments in all but 24 states covered by separate injunctions. North Carolina is among the 26 states where the ban has been lifted for now. Varying opinions on the mandates in jurisdictions across the country make it more likely that the Supreme Court will step in to resolve the issue sooner rather than later.
Finally, we appreciated additional opportunities to meet with our colleagues across the health system, talk about the latest news from D.C., our work, and to learn more about their priorities. If you’d like to learn more about our work and connect on issues most relevant to yours, we’d love love to meet with you in 2022! Please feel free to reach out at govrelations@dm.duke.edu.