After a brief pause
We’ll sprint through May, jog through June
Late spring session’s up.
The Rundown
- Congress returns to work, but without the legislative crises
- FY 2025 appropriations update
- Committee updates – Medicaid access, Change Healthcare attack, and maternal health
- Regulatory update
- What’s up NC delegation
- The latest from our desks
- Join the Duke Health Advocacy Network!
Federal Updates
They’re baaack – for four straight weeks
Congress is back at work in the Capitol, and the overall vibes in the place seem different. That’s because for the first time in months, there’s no big legislative crisis hanging over lawmakers’ heads. The Federal government is now funded through September 30, and Congress just passed a $95 billion foreign aid bill for Ukraine, Israel, and Taiwan.
Now don’t get us wrong. There is still a lot to do. The Federal Aviation Authority (FAA) reauthorization bill expires on May 10, the five-year Farm Bill is up for renewal, and work is continuing on the FY 2025 appropriations bills (more on that below). The FAA bill is one of Congress’ final must-pass agenda items before the election, so there’s a chance some Members of Congress will try to attach some unrelated pieces of legislation to the bill. Currently, we don’t expect any health-related bills will be up for consideration, but we’ll continue watching to see what could get added at the last minute.
In the House, Rep. Marjorie Taylor Greene (R-GA) announced on Wednesday that she’ll bring up the motion to vacate as a privileged matter next week, officially starting the process to remove Speaker Mike Johnson (R-LA) from his role. However, not even that has proven to be too disruptive (for the moment at least), as House Democrats pledged to support tabling the motion, effectively killing off the effort as a procedural matter. What happens after that, and whether Rep. Greene will try again, remains to be seen. But for now, it seems like Speaker Johnson’s job is safe for the time being.
FY 2025 Funding Update
With the FY 2025 appropriations process underway, our office is working diligently to build support for Duke Health priorities. Our office has been urging members of the House NC delegation to sign the NIH Dear Colleague Letter requesting that appropriators provide $51.3 billion for NIH base funding in FY 2025. As a reminder, these letters are an opportunity for Members of Congress to illustrate support for a policy and communicate with Committee leadership. Reps. Alma Adams (D-NC-12), Don Davis (D-NC-01), Kathy Manning (D-NC-06), Wiley Nickel (D-NC-13), and Deborah Ross (D-NC-02) signed the letter. In the Senate, Senator Thom Tillis (R-NC) is co-leading the effort to request that appropriators maintain a strong commitment to funding for NIH in FY 2025.
Related to NIH, our office coordinated outreach on behalf of North Carolina’s three NIH National Cancer Institute (NCI)-Designated Cancer Centers to also support at least $51.303 billion for NIH in FY 2025. The Duke Cancer Institute, UNC Lineberger Comprehensive Cancer Center, and the Atrium Health Levine Cancer Institute joined together to highlight how investments at NIH are advancing innovative research into cancer treatments and care.
Our team also coordinated health system support for a community letter asking Congressional appropriators to fund the Advanced Research Projects Agency for Health (ARPA-H) at a level that enables the agency to expand the scope of its vital work—providing at least $1.7 billion to the agency for FY 2025, in a manner that supplements, rather than supplants, funding for NIH and other research and public health agencies.
Our office joined a meeting with House appropriations staff to advocate for funding for the network of Regional Biocontainment Labs, which receive funding from NIH.
Our office urged NC delegation members to support funding for Title VIII Nursing Workforce Development programs at the Health Resources and Services Administration. We urged our House and Senate members to join their respective Dear Colleague letters in support of $530 million for these programs in FY 2025.
Heard on the Hill: Committee updates
House Energy and Commerce Health Subcommittee
On Tuesday, the House Energy and Commerce Health Subcommittee held a hearing entitled, "Legislative Proposals to Increase Medicaid Access and Improve Program Integrity." Daniel Tsai, Deputy Administrator and Director for the Center for Medicaid and CHIP, served as the witness for the hearing.
While the hearing examined several pieces of bipartisan legislation, some Republican members focused on Medicaid long-term care. While supportive of efforts to improve long-term care, they questioned CMS’s final rule that would require states to ensure a minimum of 80% of Medicaid payments for homemaker, home health aide, and personal care services be spent on compensation for direct care workers furnishing these services. Also discussed, with criticism from Republican members on the Committee, was the nursing home minimum staffing final rule. Two bills discussed at the hearing would block both final rules from being implemented.
House and Senate Committees Question UHG on Change Healthcare Cyberattack
This week, UnitedHealth CEO Andrew Witty testified in two separate hearings on the Change Healthcare Cyberattack, including before the House Energy and Commerce Oversight and Investigations Subcommittee and the Senate Finance Committee. The American Hospital Association sent a letter to the Committee discussing outstanding issues continuing to impact patients, hospitals, and health systems, as well as actions for Congress and the Administration to consider going forward.
HELP Committee Examines Shortage of Minority Health Care Professionals and the Maternal Health Crisis
On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, “What Can Congress Do to Address the Severe Shortage of Minority Health Care Professionals and the Maternal Health Crisis?” The hearing’s two panels included Senator Laphonza Butler (D-CA), who has championed several of the issues discussed at the hearing, Rep. Michael Burgess, MD (R-TX), an OB-GYN and member of the House Energy and Commerce Committee, as well representatives from a range of health providers and institutions.
In his opening remarks, HELP Committee Chair Bernie Sanders (I-VT) highlighted the shortage of providers, the lack of workforce diversity, and the health disparity gaps that exist for Black, Latino, and Native American individuals in the U.S. He noted that research has demonstrated that when these individuals have access to Black, Latino, and Native American doctors, their health outcomes improve, they are more likely to seek preventive care, they are more satisfied with their services, and they are more likely to live longer lives.
Ranking Member Bill Cassidy (R-LA) discussed the shortage of doctors in all areas, especially in underserved areas. He notes that 8 percent of doctors in the United States are Black, citing a figure from the Bureau of Labor Statistics for 2022 was different than Chair Sanders’s figure of 5 percent from the AAMC for 2019 data. Ranking Member Cassidy suggested that progress is being made.
Our team provided background to staff for Senator Ted Budd (R-NC), who serves as a member of the Committee, regarding Duke Health’s work to improve maternal health and health equity.
It rules: regulatory update
If that sound you hear is something announced late on a Friday in the middle of spring, it is highly likely CMS released a new or updated federal regulation. Below are a few that we are tracking.
Section 1557 –Nondiscrimination in healthcare
The Department of Health and Human Services (HHS) released a long-awaited final rule updating the Affordable Care Act’s Section 1557 nondiscrimination protections to include gender identity and sexual orientation. The updated rule also holds that health programs under HHS are subject to the same anti-discrimination rules as those receiving federal financial assistance, clarifies that covered telehealth services must be accessible to those to individuals with limited English proficiency and individuals with disabilities, and expands its application to the use of patient care decision support tools in clinical care. The final rule and additional resources are linked below. The agency is expected to publish and offer additional educational and compliance resources in the coming weeks.
Data Breach Notification Rule
The Federal Trade Commission (FTC) approved modifications that extend the scope of its Health Breach Notification Rule to include personal health information collected by health apps and other technology that fall outside of HIPAA. The rule requires vendors of personal health records and related entities that are not covered by HIPAA to notify individuals, the FTC, and, in some cases, the media of a breach of personally identifiable health information. Third-party service providers vendors of personal health records. are mandated to notify related entities following the discovery of a breach under the updated rule. A press release/summary from FTC and the final rule are linked below.
The final rule is expected to face legal challenges, including that FTC has exceeded its statutory authority in the rule’s development and issuance.
HIPAA and reproductive healthcare privacy
HHS issued a final rule that strengthens the Health Insurance Portability Act of 1996 (HIPAA) Privacy Rule by prohibiting the disclosure of protected health information (PHI) related to lawful reproductive health care in certain circumstances - specifically, when it is sought to investigate or impose liability on individuals, health care providers, or others who seek, obtain, provide, or facilitate legal reproductive healthcare, including abortions. The final rule supports Biden administration Executive Orders on reproductive healthcare in the wake of the Supreme Court’s decision in Dobbs. Links to a fact sheet and the final rule text are below.
Laboratory Developed Tests (LDTs)
The Food and Drug Administration (FDA) issued a final rule governing laboratory developed tests (LDTs). LDTs will now be regulated as medical devices, and the rule provides for a four-year phaseout of the FDA’s current policies. There are also significant enforcement discretion carve-outs for certain categories of tests, including those already on the market and those meeting unmet needs. The development of the final rule has not been without controversy, as some congressional leaders have questioned FDA’s authority to further regulate LDTs. While the rule was undergoing final administrative review, our team coordinated a meeting with officials at the Office of Management and Budget to discuss its potential impact on an academic medical center’s clinical labs. The FDA’s announcement and final rule are linked below.
HHS discrimination protections for people with disabilities
This week, HHS issued a final rule to “advance equity and bolster protections for people with disabilities” under Section 504 of the Rehabilitation Act. Section 504 prohibits discrimination based on disability in programs and activities that receive funding from HHS, and since the law’s enactment over 50 years ago, major legislative actions and judicial decisions have expanded its scope. The final rule addresses discrimination in medical treatment, adds enforceable standards for accessible medical diagnostic equipment, and seeks to ensure more accessible web content and mobile apps. It also updates existing requirements to make them consistent with the American with Disabilities Act (ADA). Links to a fact sheet and the final rule are below.
What’s up, NC Delegation
Rep. Greg Murphy, MD (R-NC-03), along with other House colleagues, reintroduced a bill aimed at permanently expanding access to telehealth services for Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs), which expire at the end of this year. In his press release, Rep. Murphy said, “After practicing medicine in rural eastern North Carolina for the last 25 years, I know that many patients have to travel hours to access healthcare…. They face significant burdens in cost as well as time away from work. Telehealth services are critical for these rural communities who live far from clinics and hospitals. We saw how beneficial this valuable service was for folks during the pandemic and it should continue to be available for all Americans.”
From our desk(s): Duke Health GR this week
Our team coordinated the participation of Michael Cary, PhD, RN, Duke AI Health Equity Scholar and Elizabeth C. Clipp Term Chair of Nursing at the Duke University School of Nursing, in a virtual briefing on bias in artificial intelligence for congressional staff of the Congressional Black Caucus. Dr. Cary presented on addressing AI bias in healthcare and spoke about Duke’s practical and academic leadership on the issue. He was joined on the panel by a representative from the Consumer Financial Protection Bureau and experts on AI bias in policing and private industry.
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