Springtime; renewal
And time to reset, refocus
Clock starts on Q2
The Rundown
- PHE extended – but for how long?
- CMS releases FY 2023 IPPS proposed rule
- ARPA-H transferred to NIH to begin operations
- Post-recess schedule and priority update
- Week of hearings highlighted by HHS Sec. Becerra at Energy and Commerce
- The latest from our desks
- Join Duke Health Advocacy Network
Federal Updates
PHE renewed through mid-July; what happens now?
We’re back - and still under a federal public health emergency (PHE) determination, at least through mid-July. On April 12, the Biden administration announced it was renewing the PHE for an additional 90 days, meaning that a number of pandemic-related flexibilities will remain in place, as well as the federal government’s expanded authority to respond broadly to ongoing COVID-related challenges. Although cases are rising in many places around the country, the rate of hospitalizations and deaths continue to fall precipitously from last fall and winter. Could this most recent extension be the last since the PHE was first declared over two years ago?
The answer is complicated and the outlook unclear. The president’s own chief medical advisor Dr. Anthony Fauci seemed to suggest this week that the U.S. has, for now, moved beyond the “acute” pandemic phase but later clarified his comments that COVID remains a global pandemic threat. The White House has promised governors at least 60 days-notice before winding down the PHE, which means we could be getting some early signs about the administration’s decision making in the next two weeks. While a growing chorus of policymakers seem eager to move on from the PHE, the eventual, gradual drawdown comes with it the disentanglement of temporary regulatory changes and would also start the clock on the current five-month extension of Medicare telehealth waivers and flexibilities.
We will continue to monitor this issue closely and report any new developments from the administration.
CMS releases FY 2023 IPPS proposed rule
The Centers for Medicare & Medicaid Services (CMS) released the fiscal year (FY) 2023 hospital Inpatient Prospective Payment System (IPPS) proposed rule on April 18. The proposed rule includes changes related to increasing operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the hospital Inpatient Quality Reporting (IQR) program.
Additionally, the proposed rule contains two graduate medical education (GME) proposals and several health equity requests for information. One is related to addressing the impact of climate change on health equity. The RFI seeks comments from hospitals on how to better prepare for the harmful impacts of climate change and how CMS can support hospitals. The second is related to assessing healthcare quality disparities across Medicare programs. Finally, CMS is seeking feedback to update program scoring to help hospitals improve performance for socially at-risk populations.
Our team is reaching out to Duke Health leadership and experts on various provisions of the proposed rule to coordinate and inform a potential health system comment letter.
ARPA-H transferred to NIH for FY 2022
Last week a notice appeared in the Federal Register indicating that the Secretary of the Department of Health and Human Services (HHS) authorized the transfer of the Advanced Research Projects Agency for Health (ARPA-H) to the National Institutes of Health (NIH). Currently, both the House and Senate have drafted legislation to independently establish the ARPA-H agency; however, the Consolidated Appropriations Act of 2022 (omnibus) provided $1 billion for ARPA-H ahead of the formal authorization. The omnibus included a provision that allowed the HHS Secretary to transfer ARPA-H to any HHS agency/office within 30 days of enactment to begin utilizing the appropriated funds. The Director of NIH will oversee ARPA-H until an ARPA-H Director is appointed.
To learn more about ARPA-H, check out this report from the Congressional Research Service entitled “Advanced Research Projects Agency for Health (ARPA-H): Congressional Action and Selected Policy Issues.”
The post-recess stretch
Congress also returned this week, but several COVID cases among Democratic leaders have delayed timing on anticipated votes in the Senate and jumbled the schedule. Both the House and Senate are scheduled to be in session through late May before a brief break around Memorial Day. Here’s the latest on a few priority issues:
- FY 2023 federal budget and appropriations - This week was the deadline for funding requests to be submitted to the House Labor, Health and Human Services, and Education (LHHS-ED) Appropriations Subcommittee. Once Members of Congress submit their programmatic and community project funding requests to the Committee, staff will begin drafting funding legislation with the expectation of having them approved, at least through the Appropriations Committee, by mid-summer with hopes of wrapping up work by the August recess. The "four corners" House and Senate Appropriations leadership are reportedly discussing top-line spending targets for both defense and non-defense discretionary spending. While there is no agreement yet, both Democratic and Republican leaders are optimistic that a deal can be reached in the next few weeks.
Our office worked with our NC congressional offices over the last few weeks to garner support for Duke Health funding priorities, including increasing funding for the NIH. Our office coordinated Duke Health joining with nearly 320 organizations in a FY 2023 funding letter, led by the Ad Hoc Group for Medical Research, requesting a program level of at least $49.048 billion for the NIH base budget, which would represent an increase of $4.1 billion above the comparable FY 2022 funding level. To date, Reps. G.K. Butterfield (D-NC-01), Kathy Manning (D-NC-06), David Price (D-NC-04), Deborah Ross (R-NC-02), and Richard Hudson (R-NC-08) have signed the letter.
Our office also requested support for a letter to the House Labor-HHS-Education Appropriations Subcommittee requesting $530 million for the Nursing Workforce Development Programs at the Health Resources and Services Administration (HRSA), a significant increase above the FY 2022 level. Separately our office also requested support for another letter requesting $980 million for Title VII health professions education and training programs at HRSA. Further, we worked in coalition with other stakeholders on congressional letters of support for the National Child Traumatic Stress Network and Defense medical research, including Peer-Reviewed Reconstructive Transplant.
We will provide an update on the NC delegation members who signed those letters next week.
- COVID supplemental – After the derailing of the $10 billion COVID supplemental funding deal two weeks ago over disagreements on potential amendment votes, observers had hoped that the two-week recess would allow Senators to return with a plan to move forward on the package. It doesn’t seem like we’re there yet. Democratic leaders are considering an attempt to pair COVID supplemental funding with aid for Ukraine. It’s worth noting that the scaled back supplemental does not include any resources to replenish programs supporting the uninsured for testing and treatments.
The White House has repeatedly warned lawmakers that the federal government’s COVID response would be limited absent additional funding – and another COVID supplemental bill may be needed again later this summer.
Our office continues to advocate for swift passage of COVID funding.
- Medicare sequester – Stakeholders are ramping up efforts to push Congress to address the current phased-in 2 percent Medicare payment cut after the prior moratorium was allowed to expire at the beginning of this month. While the American Hospital Association recently issued a report highlighting rising input costs and inflationary pressures facing hospitals and health systems, policymakers have been reluctant to take up a legislative fix. Although the Medicare cuts can be reversed retroactively, making the case to do so becomes more difficult each day past the end of the moratorium.
- “Skinny” reconciliation – Are we even doing a second round of reconciliation at this point? Build Back Better is no more, and lingering talks on separate legislation between Senate leadership and Senator Joe Manchin (D-WV) have focused on Manchin’s insistence that there should be a bipartisan effort to lower inflation and reduce the deficit. The current posture from Senator Manchin has been met with some opposition from Democratic colleagues, so it remains unclear how Democrats can successfully repackage a number of the administration’s key priorities.
- Innovation legislation – House and Senate negotiators have taken a critical step of appointing conferees to begin finding agreement toward a final Bipartisan Innovation Act, a legislative package aimed at boosting research, including for STEM disciplines, and innovation in the United States. This is an important administration priority that could require not so insignificant amount of capital from the White House to see the legislation cross the finish line. The timeline, which some Members believe could be the end of summer, will have ripple effects for a number of other agenda items. There’s only so much calendar and so much time before Congress will turn greater attention to the midterm elections.
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.
Committee hearings take center stage again this week
This week, HHS Secretary Xavier Becerra appeared before the House Energy and Commerce (E&C) Subcommittee on Health at a hearing examining the Administration’s FY 2023 HHS budget request. As you may recall from previous newsletters, the President’s budget request proposes funding and policies that represent the administration’s priorities, but the “power of the purse” belongs to Congress, which will take the President’s requests into consideration.
During his testimony, Secretary Becerra stated that “the Budget demonstrates the administration’s commitment to reinvesting in public health, research, and development to drive growth and shared prosperity for all Americans by making major investments in priority areas, including overdose prevention, mental health, maternal health, cancer, and HIV/AIDS.” He also stressed the focus of the budget to advance equity. Subcommittee member Rep. GK Butterfield (D-NC-01) asked Secretary Becerra about the mental and substance disorder crisis facing families and the increases proposed in the administration’s budget to address this crisis. He specifically asked about which communities and activities the administration would plan to target with these increased resources.
The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing with leadership from the Food and Drug Administration (FDA) on user fees for medical product innovation and regulation as the committee works toward crafting user fee reauthorization legislation this year.
The Senate Veterans’ Affairs Committee held a nomination hearing for Dr. Shereef Elnahal to be Under Secretary for Health. Dr. Elnahal is a former chief quality and safety officer of the Veterans’ Health Administration, Commissioner of the NJ Department of Health, and more recently President and CEO of University Hospital in Newark.
Also this week, the House Appropriations Subcommittee on Military Construction, Veterans Affairs, and Related Agencies held a hearing entitled “Meeting Veterans’ Full Needs: Update on Women’s Health, Mental Health, Homelessness, and Other Programs”. Among the invited witnesses was Benjamin Kligler MD, MPH, executive director of the Office of Patient Centered Care & Cultural Transformation at the VA and a core faculty member of the Leadership Program in Integrative Healthcare at Duke. The hearing’s scope was in response to the president’s FY 2023 budget request, which includes recommendations for increased investment in Veterans’ healthcare.
From our desk(s): Duke Health GR this week
Congress may have been away from D.C. for a couple of weeks, but as noted above, our team has been busy with the FY 2023 appropriations cycle and connecting with staff and Members of the NC congressional delegation on Duke Health priorities.
A member of our team attended the American Hospital Association Annual Membership Meeting, where key health leaders discussed important topics including health equity, workforce, the impact of inflation on hospitals, COVID-19, and other issues and challenges.
We coordinated a meeting for Michael Pencina, Director of Duke AI Health, to talk with staff of Rep. Greg Murphy, MD (R-NC-03) about opportunities, innovation, and regulatory challenges for healthcare AI. Rep. Murphy serves on the House Ways and Means Subcommittee on Health, which is beginning to explore this issue in more detail.
We also coordinated an opportunity for Dr. Moira Rynn, Chair of the Department of Psychiatry and Behavioral Sciences at Duke University School of Medicine, to meet with committee staff for Senator Richard Burr (R-NC). Senator Burr serves as Ranking Member of the Senate HELP Committee and as a member of the Senate Finance Committee. Both Committees are considering mental and behavioral health legislation. Dr. Rynn shared her expertise to inform policy development, and serve as a resource to staff and a number of issues.
We continue to press lawmakers, independently and in collaboration with other stakeholders, to provide even greater certainty for telehealth expansion following the end of the PHE. We are working with the offices of Rep. Richard Hudson (R-NC) and Rep. Cindy Axne (D-IA) to build support for House legislation that would extend telehealth flexibilities under Medicare for two years after the PHE to give Congress and CMS more time to collect data and make permanent policy decisions. The Telehealth Extension and Evaluation Act (H.R. 7573) is the companion to Senate legislation introduced in February that in addition to a broad extension of telehealth flexibilities also includes an extension of policy that allows controlled substances to be prescribed via telehealth.
Our team is monitoring a four-day public hearing of the Occupational Safety and Health Administration (OSHA) on potential revisions to its COVID-19 healthcare worker temporary standard ahead of a potential final rule to be issued this summer. Comments from health systems and providers have largely opposed the need for a new, COVID-specific standard, instead arguing that slight modifications to current regulatory framework for protection against infectious diseases would be sufficient.
Finally, we are also monitoring a new White House initiative to ease the burden of medical debt for millions of Americans. This effort comes as the administration is reportedly preparing a final rule related to the No Surprises Act ban on certain surprise medical billing practices.
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