Our words have meaning
But, without nuance, it’s all
Counting syllables
The Rundown
- President Biden calls out health policy priorities in State of the Union
- Congressional hearings focus on federal pandemic response and drug patent reform
- House Energy and Commerce Committee releases work plan priorities for the 118th Congress
- Federal court strikes down surprise billing IDR rules
- The latest from our desks
- Join the Duke Health Advocacy Network!
Federal Updates
President Biden delivers State of the Union address
President Joe Biden delivered his State of the Union address to a joint session of Congress on February 7. This was Biden’s third joint address to Congress since becoming president, and first to the new and divided 118th Congress. The State of the Union is generally an opportunity for the president to outline policy priorities for the upcoming year while also discussing past and present challenges and accomplishments.
President Biden sought to characterize the country as one in transition away from the worst of a debilitating pandemic to a place of growth and new opportunities to “finish the job” on issues impacting the day-to-day lives of people living in the United States, including healthcare progress and access. He also took the opportunity to tout major bipartisan accomplishments from the 117th Congress, including passage of the Inflation Reduction Act infrastructure investment package, the Bipartisan Safer Communities Act gun safety legislation, and the year-end omnibus bill.
Among the health policy priorities mentioned include:
- Drug pricing and access reforms
- Protecting Medicare
- Federal support of reproductive healthcare and abortion
- Mental health and access to care
- Cancer moonshot
- Support for Veterans’ health
Further details of the administration’s plans and priorities for this year and the remainder of its first term are expected as part of the president’s FY 2024 budget proposal scheduled to be released March 9.
Listen up: Hearings focus on federal COVID response and drug patent reform
On Wednesday, the House Energy and Commerce (E&C) Subcommittee on Oversight and Investigations and the Subcommittee on Health held a joint hearing entitled, “The Federal Response to COVID-19.” This hearing marked the second COVID-focused E&C panel in as many weeks as the Oversight and Investigations Subcommittee held a hearing February 1 focused on a report from the Government Accountably Office (GAO), “Pandemic Origins: Technologies and Challenges for Biological Investigations,” which was released in January.
Wednesday’s joint hearing featured witnesses from the Biden administration, including: Dr. Lawrence A. Tabak, Senior Official Performing the Duties of the Director, National Institutes of Health; Dr. Rochelle P. Walensky, Director, Centers for Disease Control and Prevention; and Dr. Robert Califf, Commissioner, U.S. Food and Drug Administration. The agency-focused examination of the nation’s COVID response was among the first promised by the leadership of the new Republican House majority, and the approach to the conversation largely fell along party lines.
Subcommittee on Oversight and Investigations Chairman Rep. Morgan Griffith (R-VA) expressed frustration about what he characterized as a lack of timely response from the administration’s leaders on questions regarding its COVID-19 strategy, while full E&C Committee Chairwoman Cathy McMorris Rodgers (R-WA) outlined specific structural and communications grievances with each of the agencies represented on the panel.
Democratic committee leaders, including full committee ranking member Frank Pallone (D-NJ), were inclined to defend the Biden administration’s actions after taking over the Trump administration’s handling of the first 10 months of the pandemic and decried what they felt was a politicized conversation.
One area of agreement: the federal government must improve our nation’s public health infrastructure to be better prepared for the next public health emergency.
On Thursday, the Senate Judiciary Committee advanced five bipartisan bills that aim to boost generic and biosimilar competition in the pharmaceutical marketplace.
The pieces of legislation, which comprise a drug patent reform package that was also approved by the Committee in the last Congress, would boost coordination between the FDA and the U.S. Patent and Trademark Office, direct the Federal Trade Commission to study the role of pharmacy benefit managers in the supply chain, limit pay-for-delay agreements, deter use of citizen petitions that aim to delay competition, and facilitate competition by addressing product hopping and placing limits on the number of patents biologic manufacturers can assert during what is known as the patent dance.
While the product hopping legislation, in particular, has drawn criticism from the brand drug industry and some committee members by creating a “cloud” of enforcement over potential innovation, committee leadership noted a bipartisan effort to make changes to those provisions to “better balance” competing interests.
The drug patent reform bills will reportedly have an opportunity to be passed by the full Senate, but their fate as a package or individually remains uncertain in the House.
House E&C releases plan for 118th Congress
The House Energy and Commerce (E&C) Committee released it Authorization and Oversight (A&O) plan for the 118th Congress, outlining areas where the Committee plans to examine, hold hearings, and conduct oversight. The authorization and oversight plans were formally mandated as part of the House rules package adopted in January.
The A&O plan includes examining the origins and response to the COVID-19 pandemic, including “the government’s role in Gain-of-Function research and the adequacy of the HHS Potential Pandemic Pathogen Care and oversight (P3CO) framework used to oversee research projects involving experiments that could make dangerous viruses more transmissible or more lethal.”
The plan also states that the “Committee will conduct oversight of the NIH grant making policies and procedures as it relates to approving and monitoring its grants and subgrantees, including the use of indirect costs, to ensure the safe, appropriate, and efficient use of Federal tax dollars.” Other areas for examination include the fentanyl crisis, healthcare affordability, Medicare, and Medicaid-among other healthcare issues.
The full E&C Committee held a markup of the plan on February 9th.
In anticipation of the public release of the A&O plan, our team has been connecting with committee staff and strategically preparing and planning with Duke Health leadership.
Surprise! (again): Federal judge strikes certain balance billing rules
This week, a federal judge in Texas ruled that the federal government’s revised independent dispute resolution (IDR) process for determining payment for out-of-network services under the No Surprises Act skews the arbitration results in commercial insurers’ favor in violation of the compromise Congress reached in the Act.
Specifically at issue is what challengers allege is the rule’s continued over-reliance on the qualified payment amount (QPA) instead of a myriad of other factors outlined in the legislation to reach an interim payment. The Biden administration was previously forced to revise its interim final rule with respect to the IDR before issuing the current rule because a similar court challenge.
The result of the decision vacates portions of the IDR rule nationwide. While the Biden administration is likely to appeal, it is unlikely to receive a more favorable result from the 5th Circuit Court of Appeals.
Senate Health, Education, Labor and Pensions (HELP) Committee ranking member Bill Cassidy, MD (R-LA), who helped craft the No Surprises Act compromise, has suggested that the Department of Health and Human Services “defied the will of Congress” in its final rule and that the administration will likely have to rewrite the rule a third time because of the legal challenges.
We will continue to monitor this issue closely.
From our desk(s): Duke Health GR this week
This week our office joined Dr. Vincent Guilamo-Ramos, Dean of the Duke University School of Nursing (DUSON) and Vice Chancellor for Nursing Affairs, on Capitol Hill for meetings with the North Carolina delegation about the School and federal support for nursing education, research and DUSON priorities.
A member of our team participated in the Trauma Center Association of America (TCAA) Advocacy Committee meetings to discuss federal priorities and strategy for TCAA’s advocacy day events in April in Washington, D.C.
We joined a healthcare AI coalition meeting with the office of Rep. Ted Lieu (D-CA) to discuss innovations in AI health and priorities for the 118th Congress.
Our office also participated in an Ad Hoc Group for Medical Research discussion about Federal FY 2024 funding for NIH.
Join the Duke Health Advocacy Network!
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