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The Rundown
- Senate HELP Committee completes markup of the PREVENT Pandemics Act (S.3799)
- House E&C holds hearing to examine 22 bills focused on encouraging innovation and improving oversight
- Congress shifts to other priorities following completion of FY 2022 omnibus spending bill
- VA releases report evaluating and recommending changes for its healthcare facilities and infrastructure
- The latest from our desks
Federal Updates
Senate HELP Committee completes markup of PREVENT Pandemics Act (S.3799)
On Tuesday, the Senate Health, Education, Labor and Pensions (HELP) Committee advanced the much anticipated “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act),” which is bipartisan legislation introduced by Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) to strengthen the nation’s public health and medical preparedness and response systems in the wake of the COVID-19 pandemic. The legislation was introduced after lengthy negotiations and input from Committee members and stakeholders, including Duke Health.
A manager’s amendment was introduced ahead of the markup to replace the original bill. Notably, the manger’s amendment included a provision to establish the Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health (NIH), with a director appointed by the President. In addition, ARPA-H could not be headquartered, inside of, or in close proximity to, the National Capital region, and shall not be located on any part of the National Institutes of Health campuses or on any part of the NIH’s campuses. Our office is working to get clarification on what this would mean for RTP as a potential site should the bill become law.
Inclusion of ARPA-H in this bill follows the introduction of a standalone ARPA-H bill from Chair Murray and Ranking Member Burr on March 10. The House Energy and Commerce Committee also considered its ARPA-H bill on Thursday (more details below). The manager’s amendment would also create an Office of Pandemic Preparedness and Response Policy within the Executive Office of the President, with a director appointed by the President.
Further, the amendment included the Bio-Preparedness Workforce Pilot Program “to provide for loan repayment for health professionals with expertise in infectious diseases and emergency preparedness and response activities to ensure an adequate supply of such professionals.” Our office has advocated for this program, and Duke Health’s support was included in comments to the HELP Committee as the bill was being drafted. This effort was championed by the Infectious Diseases Society of America (IDSA) and the HIV Medicine Association.
The PREVENT Pandemics Act advanced out of Committee on a 20-2 vote after consideration of several amendments. In total, 8 amendments were accepted, including an amendment from Senator Bernie Sanders (I-VT) that would provide $177 million in mandatory funding for the Nurse Corps program in FY 2023. The bill also included an amendment from Senator Roger Marshall (R-KS) that would prohibit federally-funded research conducted in a foreign institution involving pathogens of pandemic potential or biological agents or toxins located in a country of concern as identified by the Director of National Intelligence or the head of another relevant Federal department or agency, as appropriate, in consultation with the Secretary of HHS. The text of this amendment was modified from its original text and received support from both Chair Murry and Ranking Member Burr. More information on the bill, markup, and amendments can be viewed here.
An amendment from Senator Rand Paul (R-KY) to include the Verified Innovative Testing in American Laboratories (VITAL) Act, which “shifts the regulation of laboratory-developed testing procedures from the Food and Drug Administration (FDA) to the Centers for Medicare & Medicaid Services (CMS),” was tabled for later consideration by the Committee. Chair Murray noted that this issue would be more appropriate as part of the Committee’s discussions on reauthorization of FDA user fees, which will expire and require legislation this year. She noted she is working with Ranking Member Burr on this issue.
A separate effort by Senator Chris Murphy (D-CT) that would have incorporated language to establish uniform medical licensure for future public health emergencies was withdrawn before submission. HELP leadership indicated that they will work closely with Senator Murphy on emergency licensure issues as part of other legislation.
The bill now moves to consideration of the full Senate, where the path forward is less clear, despite numerous speculations about how this bill could successfully advance through Congress. Our office will continue to be actively engaged on this legislation.
House E&C holds hearing to examine legislation focused on encouraging innovation and improving oversight
On Thursday, the House Energy and Commerce (E&C) Subcommittee on Health held a hearing entitled, "The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight." The hearing focused on 22 bills to “streamline development and approval processes for drugs and therapeutics, strengthen program integrity, and improve diversity and equity in biomedical research.”
Notably, one of the bills discussed at the hearing was H.R. 5585, the “ARPA–H Act,” introduced by Subcommittee Chair Anna Eshoo (D-CA). Like the HELP Committee’s ARPA-H provision in the PREVENT Pandemics Act discussed above, this legislation would establish the new agency within HHS but outside of NIH, with a director appointed by the HHS Secretary. E&C Chairman Frank Pallone (D-NJ) said that “this proposal has the potential to be transformative and bring about medical breakthroughs that have the power to change our society for the better. I was pleased to see that the final omnibus funding bill that Congress passed on a bipartisan basis last week and President Biden signed into law on Tuesday included $1 billion for ARPA-H. Now, this Committee must pass comprehensive legislation to properly establish the agency.”
The hearing also examined H.R. 6000, the “Cures 2.0 Act,” introduced by Reps. Diana DeGette (D-CO) and Fred Upton (R-MI), which we featured in our newsletter in November 2021. This legislation builds on the 21st Century Cures Act of 2016, which aimed to accelerate the approval of healthcare treatments and devices.
A full list of the 22 pieces of legislation can be viewed in the Committee’s hearing memorandum.
Where do go from here? Congressional schedule moving forward after FY 2022 work complete
While much of the first quarter of 2022 has felt like an entire year in of itself at times, one of the biggest priorities for both Congress and the Biden administration is now off the board. The completion of the FY 2022 omnibus spending bill brought greater certainty to federal funding, federal support of expanded telehealth under Medicare for at least some period beyond the public health emergency, and resources for an international ally facing a military and humanitarian crisis. Yet, checking this particular box didn’t happen without complications, which threaten to squeeze an already packed agenda facing limitations around a midterm election year. Let’s take a quick look at where some of our key priorities stand:
- FY 2023 federal spending – We weren’t kidding when we suggested that there would be a tight turnaround from completing work on FY 2022 appropriations to ramping up advocacy for FY 2023. Reports suggest that President Biden’s delayed FY 2023 budget proposal may be released as soon as March 28. This nonbinding statement of the administration’s funding and policy priorities will “officially” kick off the congressional budget season and provide congressional leaders with guideposts to put forward their own recommendations for spending priorities. Typically, there is some space in between the release of the president’s budget and Congress beginning its appropriations work in earnest, so stakeholders have some time to evaluate how best to advocate for their own priorities. This year, that turnaround time to have official funding requests submitted to some congressional offices may be as little as a week after the president’s budget is announced. Granted, these submissions aren’t the only opportunity to advocate for increased federal funding and other policy changes, but an extra boost directly from a congressional office is helpful. Our team has been working across Duke Health over the past several weeks to prepare for this process, and we are anticipating tight windows across the board.
- COVID-19 relief funding – The FY2022 omnibus package originally included $15 billion in additional COVD-19 emergency response funding that had to be stripped at the last minute over objections to a provision that would have paid for the new measures with currently unspent COVID relief funding. This was an unexpected complication for the bipartisan leadership that negotiated the deal and the White House, necessitating some scrambling this week as the major players try to determine what’s next. On Tuesday, the White House sent congressional leadership a letter outlining the ramifications of not providing additional funding, including no additional purchases of monoclonal antibodies sent to states, fewer tests made in America, fewer treatments for the immune compromised, and a risk of running short on vaccines and boosters, leaving the government unequipped to plan for future surges. House Democratic leadership is trying to find new offsets in order to craft a package that has a chance to pass the Senate, while Republicans are opposed to any new COVID package unless the Biden administration accounts for the trillions of dollars in funding already allocated for the crisis. Our office has been in touch with NC delegation members this week expressing our concerns.
- Medicare sequester – Building on the theme of priorities left out of the FY2022 omnibus package, a phased-in Medicare payment sequester is set to begin in less than two weeks if Congress does not act to extend the current moratorium. A 1% cut is set to begin April 1 that will phase into a 2% percent cut on July 1. Efforts are underway urging congressional leaders to prevent the scheduled cuts from taking effect, but we’re running out of time without many viable options. Congress can still take action after April 1 and apply changes retroactively, but there is a real danger in nothing getting done at all if too much time elapses past the deadline.
- SCOTUS – The Senate Judiciary Committee has announced that confirmation hearings will begin next week for Judge Ketanji Brown Jackson’s nomination to the Supreme Court. Monday’s hearing will involve opening statements by the Committee members and Judge Jackson, with questions following on Tuesday and Wednesday. This keeps to the schedule outlined by Senate Democrats to have Judge Jackson on the Supreme Court by mid-April.
- Build Back Better – Congressional leadership are optimistically eyeing the work period between the return from the April recess and Memorial Day as the sweet spot to finally pass a reconciliation bill. Whatever form this legislation takes won’t look anything like the Build Back Better Act, but there is some hope to craft a package that addresses prescription drug costs, tax reforms, climate change, and possibly fixes to the Affordable Care Act.
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.
VA releases report outlining recommendations for its healthcare facilities and infrastructure
This week, the Department of Veterans Affairs (VA) released a much anticipated report reviewing VA healthcare facilities nationwide, offering sweeping recommendations to modernize and invest in healthcare infrastructure for Veterans.
The 2018 VA MISSION Act included a provision requiring the VA to study the current and future healthcare needs of America’s Veterans, evaluate the VA’s healthcare infrastructure, and to ensure the VA has the resources needed to continue to offer high quality care. The VA’s asset and infrastructure (AIR) review process, which has been a multi-year evaluation since the passage of the MISSION Act, will be supported by a nine member AIR Commission appointed by President Biden and confirmed by the Senate Veterans’ Affairs Committee. The AIR Commission is tasked with reviewing the VA’s initial recommendations over the next year while seeking input from stakeholder communities, academic partners, Congress, and others before issuing its own set of final recommendations to President Biden by March 2023. President Biden announced eight of the nine nominees to serve on the AIR Commission last week, with former Secretary of the Army and Pennsylvania Congressman Patrick Murphy nominated to serve as chair.
Among the North Carolina-specific VA healthcare infrastructure recommendations identified in the VA’s report include potentially relocating the current Durham VA Medical Center to a new site geographically closer to the border of Durham and Wake counties. Overall, the initial report recommends the closure (without relocation) of three VA hospitals across the country with major investments in construction and alignment of new facilities.
The VA, in public statements and the report, has attempted to make clear that these recommendations are merely a starting point for a much broader review process, one that will be heavily influenced by public comments, additional AIR Commission evaluation, and scrutiny by Congress and the administration. Leadership of the Senate Veterans’ Affairs Committee, of which Senator Thom Tillis (R-NC) is a member, has also cautioned that they will not support any recommendations that compromise access to care for Veterans.
We will continue to monitor any new developments and opportunities for community and stakeholder engagement as this initiative moves forward.
From our desk(s): Duke Health GR this week
This week, members of our team participated in the Trauma Center Association of America virtual Hill day, connecting with staff of members of the NC and SC congressional delegations to advocate in support of full authorized funding for the MISSION Zero Military-Civilian Trauma grant program for FY 2023 and new legislation introduced to modernize and strengthen federal trauma center grant programs.
Our office also participated in a Research!America alliance member meeting to discuss legislative updates on pandemic preparedness, the FY 2022 omnibus, and other topics of interest to the research community. We also joined other government relations colleagues for the quarterly American Association of Colleges of Nursing University Government Relations Collaborative (UGRC) virtual meeting.
On Thursday, our team joined Duke State Relations in presenting to department heads at Duke University Hospital. We provided an overview of the federal landscape, including healthcare related items from the FY2022 omnibus package, and upcoming priorities for the rest of 2022.
Duke Health Government Relations joined colleagues from other health systems and the business and life sciences communities for a virtual meeting with Rep. Richard Hudson (R-NC-08). Hosted by the Healthcare Leadership Council, participants shared updates on the COVID response, telehealth, and support for the workforce.
Our office also coordinated Duke Health’s support for a letter to House and Senate Appropriators requesting $500 million in FY 2023 funding for the Agency for Healthcare Research and Quality (AHRQ).
Finally, members of our team participated in stakeholder meetings in support of telehealth, immigration, pandemic preparedness, and additional COVID-19 resources and relief. We continue to engage experts and allies on a range of pending regulatory and legislative issues.