Feels otherwise - but
It’s not all existential
Just one foot, one step
The Rundown
- September schedule update
- President Biden provides updates on the Cancer Moonshot Initiative
- Senator Thom Tillis visits Duke University Hospital
- President Biden names first ARPA-H director
- Heard on the Hill: congressional hearings update
- Biden administration officially revises public charge rule
- The latest from our desks
- Join Duke Health Advocacy Network
Federal Updates
Earth, wind, fire, and ba-dee-ya big expectations
Both chambers are back in session, and a familiar ear worm is beginning to play on repeat once again. We mentioned last week that scope, more so than size, seemed to best characterize this month’s schedule. That may have been a little premature. You’d think we’d “remember” that this is how it goes sometimes in an election-year “September.”
- FY 2023 appropriations – As of publication time, there is still no agreement on top line spending for FY 2023 appropriations, nor is there a clear framework for a developing continuing resolution (CR) to keep the federal government funded beyond the September 30th end of the current fiscal year. Early reports suggest that a CR would run through the November elections until mid-December. The White House continues to press for supplemental funding for COVID and monkeypox response and once again signaled it would support the inclusion of certain Medicare-related policies, including efforts to avert scheduled year-end payment cuts. That may be a non-starter for congressional Republicans, at least right now. How “clean” will this temporary federal funding extension be once the ink is dry on a final deal? It’s an open question. Neither side of the negotiating table is eager for even a temporary shutdown ahead of the midterm elections, but as we noted last week, this is really “it” until November-December. What hangs on will require significant bipartisan support. We’re following closely and advocating strongly for Duke Health priorities over the next few weeks.
- FDA user fees – The current Food and Drug Administration (FDA) user fee agreement also expires on September 30th. A relatively straightforward user fee extension is among the items in discussion for attachment to the CR. Congressional leaders would much rather reach a more comprehensive agreement, but time is short – and a potential lapse would be disastrous for FDA.
- Medicare legislation – It’s been a big week for Medicare. Rep. Ami Bera, MD (D-CA) and Rep. Larry Buschon, MD (R-IN) introduced legislation that would mitigate the Centers for Medicare and Medicaid Services’ (CMS) proposed physician fee schedule cuts for 2023 by increasing the conversion factor by 4.42 percent. This would effectively hold off the proposed cuts for at least a year. It’s a step in the direction of more closely aligning payment policies with costs, but it’s also just one of a number of issues requiring attention. Stakeholders, including Duke Health, are also advocating that Congress waive upcoming statutory PAYGO cuts to Medicare reimbursement, revisit the current 2 percent sequester, and extend enhanced Accountable Care Organization (ACO) payment policies. There is a chance that some of these issues could be addressed with the CR, but resolution in the expected lame duck session seems more likely. Read below for updates on Medicare Advantage legislation and efforts to extend Medicare telehealth flexibilities.
- NDAA – The National Defense Authorization Act has been passed by Congress “on time” every year for over 60 years. That streak is once again on the line in 2022. The NDAA formally authorizes broad programmatic and spending initiatives at the Department of Defense (DOD), including the Defense Health Program, which supports and funds DOD medical research, as well as the Defense-supported medical workforce. The House has passed its version of the NDAA, while the Senate has yet to hold a floor vote on its version – and there may not be enough time to do so this month before the chamber’s expected recess for the midterms. That would leave November-December – which will already be crowded with other “must-pass” priorities – to iron out a deal. Keeping lines of communication open will be critical, even if Congress is out of session again in a few weeks.
President Biden provides updates on the Cancer Moonshot Initiative
On Monday, President Biden delivered a speech at the Kennedy Presidential Library in Boston, outlining the progress on his Cancer Moonshot initiative, including actions to close the screening gap, mitigate impact of environmental exposure, explore opportunities for telehealth in treating cancer, decrease the impact of preventable cancers, and bring the latest research to patients and communities. The speech also highlighted the new Cancer Moonshot Scholars program, which aims to “advance cancer science while also diversifying the pool of researchers and the approaches to cancer research that the National Cancer Institute (NCI) funds. The program seeks to diversify the NCI R01 portfolio by enhancing the number of applications submitted by Early Stage Investigators from diverse backgrounds, including those from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences research workforce. In addition, the program seeks to increase the diversity of thought and approach to cancer research. Individuals from underrepresented groups are especially encouraged to work with their respective institutions to apply.” The FOA is currently open.
This speech follows Biden’s revitalization of the Cancer Moonshot initiative in February, which pledged goals of cutting cancer deaths in half in the next 25 years and improving the experience of those living with and surviving cancer. The February announcement also included the creation of a Cancer Cabinet that incorporated different corners of the government to work toward these goals.
Separately, President Biden signed an Executive Order Monday that aims to boost biotechnology and biomanufacturing to ensure that cutting-edge technologies like those needed to fight cancer will be developed and made in the United States.
More information about the status of the Cancer Moonshot is available here.
Dr. Renee Wegrzyn named inaugural director of ARPA-H
This week, President Biden announced that he plans to appoint Dr. Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health (ARPA-H). Dr. Wegrzyn is currently vice president of business development at Ginkgo Bioworks and Head of Innovation at Concentric by Ginkgo. In his statement, President Biden noted Dr. Wegrzyn’s experience working for two of the institutions that inspired the creation of ARPA-H: the Defense Advanced Research Projects Agency (DARPA) and Intelligence Advanced Research Projects Activity (IARPA).
Senator Thom Tillis visits Duke University Hospital
Senator Thom Tillis (R-NC) visited Duke University Hospital last week to meet with Duke University Hospital President Tom Owens, MD, Duke University School of Medicine Dean Mary Klotman, MD and DUHS Vice President for Administration and Duke University School of Medicine Associate Dean of Veterans’ Affairs Monte Brown, MD.
As a member of the Senate Committee on Veterans’ Affairs, Senator Tillis was eager to learn more about Duke’s longstanding partnership with the Durham VA Medical Center, the importance of VA-supported research, and current regulatory issues affecting the partnership between VA medical centers and academic affiliates. The group also discussed challenges and opportunities facing the Duke Health workforce and access to care, as well as solutions to combat a growing epidemic of violence against healthcare workers.
Our team was pleased to coordinate the conversation and will continue our work with Senator Tillis’s staff on the issues highlighted in the meeting.
Heard on the Hill: congressional hearings recap
On Wednesday, the House Energy and Commerce Subcommittee on Health held a markup of five healthcare bills, including the “Improving Senior’s Timely Access to Care Act of 2021”(H.R. 3173). The bill would streamline the prior authorization process under the Medicare Advantage (MA) program, including establishing an electronic prior authorization program that meets specified standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved. In an atypical process involving suspension of normal House rules, the bill left the committee and was considered on the House floor just a few hours later, quickly advancing to the Senate.
The legislation has a Senate companion, cosponsored by Senator Tillis, and enjoys broad bipartisan support. Congressional leaders are positioning it for inclusion in an anticipated year-end legislative package.
Another Duke Health priority adopted by the Committee in Wednesday’s markup is the “Improving Trauma Systems Emergency Care Act” (H.R. 8163), which would reauthorize and modernize federal trauma grant programs in the Department of Health and Human Services.
On Wednesday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, “Stopping the Spread of Monkeypox: Examining the Federal Response.” The Committee heard from witnesses from the Biden administration, including Dr. Rochelle Walensky, Director for the Centers for Disease Control and Prevention; Dr. Anthony Fauci, Director for the National Institute of Allergy and Infectious Diseases at the National Institutes of Health; Dr. Robert Califf, Commissioner for the FDA; and Dawn O'Connell, Assistant Secretary for Preparedness and Response at the Administration for Strategic Preparedness and Response.
Both Democratic and Republican committee members expressed concerns with the monkeypox response, while acknowledging falling case rates. Ranking member Richard Burr (R-NC) said in his statement that our public health agencies should have been better prepared, especially given our experience with current public health emergency, calling the response a “catastrophic failure.” Ranking member Burr also suggested that the PREVENT Pandemics Act, legislation he co-leads with Chairwoman Murray, is needed and could improve future responses.
Also on Wednesday, the Senate Judiciary Subcommittee on Immigration, Citizenship, and Border Security held a hearing entitled, “Flatlining Care: Why Immigrants are Crucial to Bolstering our Health Care Workforce.” In his opening statement, subcommittee member Senator Tillis referenced his recent visit to Duke University Hospital when discussing the workforce challenges facing health systems in NC and across the country. Our team has been in touch with Senator Tillis’s staff about the health system’s ongoing international and domestic healthcare worker recruitment efforts.
Biden administration officially modifies public charge rule
Last week, the Biden administration issued a final regulation governing the public charge rule, formally rescinding policy changes made by the Trump administration.
The public charge rule, which has been a part of U.S. immigration law since 1882 but more formally defined in 1999, allows authorities to deny the issuance of a visa or green card if the applicant is “primarily dependent on the Government for subsistence, as demonstrated by either the receipt of public cash assistance for income maintenance or institutionalization for long-term care at Government expense.”
The Trump administration expanded the interpretation of the rule in 2019 to include non-cash benefits such as food assistance and Medicaid, as well as extended the requirements to other family members outside of the primary applicant.
The Biden administration stopped enforcing the modified rule in March 2021, and the newly issued final rule reverts the public charge interpretation back to the guidance in place before the prior administration.
The final rule is set to go into effect December 23, 2022.
From our desk(s): Duke Health GR this week
On September 9, our office coordinated a meeting for Dr. Dev Sangvai, Vice President of Population Health Management and Executive Director for Duke Connected Care (DCC), and Dan Costello, Administrative Director for DCC, with Rep. Greg Murphy, MD (R-NC-03). The purpose of the meeting was to discuss legislation that would, among other provisions, extend the 5 percent Advanced Alternative Payment Model incentive payment, which is set to expire at the end of the year. In addition, our office joined other NC members of the National Association of ACOs in advocacy visits to inform congressional offices about the work of ACOs in North Carolina and to support extending the incentive payment.
Our team coordinated Duke Health joining over 370 organizations and institutions across the country in a letter to Senate leadership, urging support for and a vote on H.R. 4040, “Advancing Telehealth Beyond COVID-19 Act”, which passed the House in an overwhelming bipartisan vote this summer. The legislation would extend for two years, through December 31, 2024, critical PHE Medicare telehealth flexibilities. While Duke Health strongly supports permanence for many pandemic flexibilities, the two-year extension has the best opportunity to pass Congress this year. The letter has been shared in follow up with our Senate offices.
Our team also coordinated Duke Health’s response to the CY 2023 Outpatient Prospective Payment System (OPPS) proposed rule in support of restoring full Part B payment rates for 340B drugs in 2023 and repaying hospitals for pay cuts in place since 2018. The Biden administration is currently determining how to proceed after a U.S. Supreme Court decision that the payment reductions were unlawful.
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