
Learn from setback – and
Celebrate battles won – and
Enjoy in between
The Rundown
- Senators work to complete legislative language for gun reform package
- Congress is moving ahead with key priorities, including appropriations, despite uncertainty
- Supreme Court rules in favor of hospitals in 340B case
- President Biden issues Executive Order to advance LGBTQI+ equality in healthcare and education
- The latest from our desks
- Join Duke Health Advocacy Network
Federal Updates
Gun violence framework deal (in principle) announced in the Senate
Earlier this week, a bipartisan group led by Senators Chris Murphy (D-CT) and John Cornyn (R-TX) announced that a deal had been reached in principle on a framework for gun safety and public health legislation. The fact that so many qualifying words were necessary in between the words “deal” and “legislation” suggests that the future of a final product remains a little precarious – and it is – but it also should not detract from the possibility of at least incremental progress on gun violence that has eluded federal policymakers for decades.
The agreement was reached with the support and input of 20 senators – 10 Democrats and 10 Republicans, including Senators Thom Tillis (R-NC) and Richard Burr (R-NC) – and includes the following key provisions:
- Enhanced background checks for buyers under 21
- Funding to incentivize states to pass “red flag” laws
- Funding for mental health (including mental health telehealth support) and school safety
- Closing the so-called boyfriend loophole, which presently allows people to buy guns even if they were convicted of domestic violence against a partner they were dating (but not married to).
Work continues on final draft legislation, which congressional leaders hope to pass by the July 4th recess. The 10 Republican “yes” votes will be necessary to overcome procedural hurdles in the Senate, but the final package must also be sold to House and Senate Democrats, some of whom have expressed disappointment that the agreement leaves out further restrictions on assault rifles, among other issues. Senate Finance Committee Chairman Ron Wyden (D-OR) is also working behind the scenes for the committee’s mental health proposals to be included in the bill.
Our team coordinated a call for Duke University Hospital President Tom Owens, MD, to speak with staff of Senator Tillis about the emerging legislation. Dr. Owens thanked staff for their efforts, shared the public health and provider perspective of gun violence in our community, and offered Duke Health as a resource as the process moves forward.
With all deliberate speed: priority schedule update from D.C.
The House and Senate are only scheduled to be in town for one more week this month before heading out for a two-week district/state work period and July 4th recess. Practically, that means barring an emergency, there will likely be no more floor votes after next week until at least the week of July 11th – with the August recess awaiting just a few weeks later. The to-do list hasn’t gotten any shorter. Here’s a quick update on a few priority issues.
Appropriations
There still is no agreement on top-line spending numbers between House and Senate appropriations leaders, despite continuing negotiations. The lack of formal committee instructions has not deterred the House appropriations subcommittees from moving ahead with their ambitious schedule to have worked completed by the upcoming July 4th recess. This week, Subcommittees for Defense, Agriculture, Military Construction and Veterans’ Affairs (Mil-Con VA), Financial Services, and the Legislative Branch marked up their individual appropriations bills, using the President’s FY 2023 budget request as a guidepost where possible.
Of note: the Defense spending bill recommends a substantial increase for the Defense Health Program, which oversees congressionally directed medical research at the Department of Defense (more details will be released with the subcommittee report next week); the Mil-Con VA bill recommends $926 million for VA medical and prosthetic research, an increase of $44 million above current levels; and the Agriculture bill recommends $3.65 billion for the Food and Drug Administration, an increase of $341 million above current levels.
The House Appropriations Subcommittee on Labor, Health and Human Services, and Education (LHHS) is scheduled to markup its bill next week, followed by a full Committee markup the following week. The LHHS bill provides funding for medical research and key federal healthcare programs, including Duke Health priorities advocated for by our office.
The Senate is running a little behind, which is not unexpected given a tighter majority in the upper chamber, as well as even representation between Democrats and Republicans on the committee. We may not see legislative language on the Senate side until July.
Our team is following the appropriations process closely.
NDAA
Work in both the House and Senate on their versions of the National Defense Authorization Act (NDAA) is moving along. The Senate Armed Services Committee is concluding its full committee markup of the annual defense policy bill this week, while the House Armed Services Committee is scheduled to hold its markup next week. 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. Both House and Senate leaders are hoping to resolve any differences between their respective NDAA bills ahead of the midterm elections.
User fees
On Tuesday, the Senate Health, Education, Labor and Pensions (HELP) Committee approved its Food and Drug Administration (FDA) user fee authorization package, the FDA Safety and Landmark Advancements Act. This package continues to include the VALID Act of 2022, which would allow for the FDA to regulate laboratory developed tests (LDTs). The House recently passed its version of a user fee reauthorization bill, which did not include any provisions to regulate LDTs. The Senate will need to reconcile its bill with the House version before the current FDA user fee authorization expires September 30.
Data privacy
This week, the House Energy and Commerce Subcommittee on Consumer Protection and Commerce held a legislative hearing on a bicameral discussion draft of comprehensive data privacy legislation. With some exceptions, the American Data and Privacy Act would cover all entities subject to the Federal Trade Commission’s jurisdiction, supersede most state privacy laws, and create a federal private right of action for consumers. Some roadblocks remain, not the least of which is some policy differences to iron out with the chair of the Senate Commerce Committee, Senator Maria Cantwell (D-WA), who has introduced her own proposal. A markup in the House may be scheduled soon, and we will continue to monitor this issue closely.
BBBA/Reconciliation
The only update here is that, reportedly, talks are continuing between the Biden administration, Senate Majority Leader Chuck Schumer (D-NY), and Senator Joe Manchin (D-WV) on a scaled back reconciliation bill focusing on energy, climate issues, and taxes. Notably missing from these discussions are many (or any) of the healthcare investment provisions included in the House-passed Build Back Better Act – at least for now. Whether or not a deal comes together, time is not on the negotiators side, and a new reconciliation package could mean other priorities get squeezed in the summer session.
Our team will continue to advocate for Duke Health priorities and provide updates on these issues as they become available.
Supreme Court sides with hospitals in 340B case
In a unanimous decision, the Supreme Court this week reversed a DC Circuit Court ruling that had previously upheld the Department of Health and Human Services’ (HHS) $1.6 billion annual cut to 340B drug discount program reimbursement.
The Court found that HHS improperly imposed the cuts without first conducting an assessment of hospitals’ acquisition costs. The case has been remanded to the lower courts, which will help decide the most appropriate remedy. Notably, the decision does not preclude HHS from imposing cuts in the future if appropriate administrative steps are followed; although any such action could be subject to judicial review if challenged.
The initial lawsuit was led by the American Hospital Association (AHA) and other industry partners. AHA said in a statement that it looks forward to “working with the [Biden] administration and the courts to develop a plan to reimburse 340B hospitals affected by these unlawful cuts while ensuring the remainder of the hospital field is not disadvantaged as they also continue to serve their communities.”
Biden administration issues Executive Order to advance equality for LGBTQI+ individuals
This week, the Biden Administration issued an Executive Order on Advancing Equality for Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Individuals. The order is designed to address discrimination and barriers faced by LGBTQI+ individuals and families and directs federal health and education agencies to expand access to gender affirming care and advance LGBTQ-inclusive learning environments at American schools. Among the principal objectives of the order include:
- Addressing discriminatory legislative attacks against LGBTQI+ children and families;
- Preventing so-called “conversion therapy”;
- Safeguarding health care, and programs designed to prevent youth suicide;
- Supporting LGBTQI+ children and families by launching a new initiative to protect foster youth, prevent homelessness, and improve access to federal programs; and
- Taking new, additional steps to advance LGBTQI+ equality
More detailed information is also available in a published White House Fact Sheet.
From our desk(s): Duke Health GR this week
This week, members of our team participated in the Association of American Medical College’s (AAMC’s) Government Relations Representatives meeting in Washington, DC. The two-day meeting included sessions focused on legislative and policy issues affecting medical schools and teaching hospitals.
The Duke Health Government Relations team was pleased to join our colleagues in the Duke State Relations office for a policy presentation with a group of fellows from Duke Health’s Patient Revenue Management Organization (PRMO). We appreciate these opportunities to connect directly with our Duke Health colleagues, share more about our work, and learn about the priorities and issues of importance for various departments and their team members. We’d love to engage more with you, too. If you are interested in having our team join yours for a brief conversation about our work, please contact us at govrelations@dm.duke.edu.
Our team contacted the office of Rep. David Price (D-NC-04) requesting assistance with the Centers for Medicare and Medicaid Services on possible considerations for the exemptions of requirements for out of state Medicaid provider enrollment. Exemptions would help alleviate Medicaid access issues for the treatment of children with Congenital Athymia. Currently, Duke is the only center in the United States with a developed proven treatment for this condition.
We began outreach to members of the NC congressional delegation to cosponsor and support the Safety from Violence for Healthcare Employees (SAVE) Act (H.R. 7961). If passed, the legislation would create the first federal protections for hospital and healthcare workers against violence.
A member of our team joined the inaugural meeting of the National Association of Accountable Care Organizations (NAACO) government relations advocacy virtual meeting to hear updates on legislative priorities and advocacy efforts.
We followed another Supreme Court decision this week involving several states challenging the Biden administration’s decision to not enforce or defend a Trump administration expansion of the public charge rule, which made it more difficult for immigrants receiving certain public benefits to remain in the United States. The Court dismissed the challenge, and the Biden administration has indicated it will issue a new regulatory definition of “public charge” in the future.
A member of our team participated in the American Association for Cancer Research (AACR) and the Association of American Cancer Institutes (AACI) Virtual Hill Day to support robust funding for the National Institutes of Health. Duke Health joined representatives from UNC Health in meetings with the North Carolina congressional offices of Senator Richard Burr, Senator Thom Tillis, and Rep. David Price to raise awareness about the importance of continued investment in medical research.
Our office also participated in coalition and working group meetings on the 340B Drug Pricing Program, telehealth expansion, laboratory developed tests, surprise billing, and Regional Biocontainment Laboratories.
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