By: Dane Christiansen, Washington Representative

January 24, 2025

The new Congress was sworn in on Friday, January 3^rd and convened to certify the election on Monday January 6^th. The broader government was suspended or working from home that week due to a blizzard and activities related to commemorating the life of former President Jimmy Carter. For the remainder of the month, the 119^th Congress worked quickly to realign committees with new members and begin organizing activities. The Senate worked to advance consideration of various nominees to head federal agencies and confirmed former Senator Marco Rubio as Secretary of State with a 99 – 0 vote. During the final week of January, the Senate is set to consider the nomination of Robert F. Kennedy, Jr.to head the Department of Health and Human Services and the House is not in session.

Donald Trump was inaugurated as the 47^th President for his second, non-consecutive term on January 20^th. He immediately signed a flurry of executive orders and, true to form, many were headline grabbing with dubious legal standing and potentially de minimis impact. Below, please find a summary of the most notable actions, which have already galvanized the advocacy community for further outreach (although specific efforts are still emerging):

• The administration issued a memo calling for a temporary pause on all grant funding and federal aid until agencies could conduct a review and ensure projects being supported align with the administration’s values. The memo is notably sparse on details and appears to violate foundational constitutional and legal elements regarding the separation of powers and the ability of Congress to direct tax dollars for federal purposes. Additional information can be found here.

• The administration issued a directive for HHS agencies to cease all external communications and travel, along with many internal activities (including grant review panels, grant submission portals, and Advisory Council activities at NIH) until February 1^st. Additional information can be found here.
• The administration issued a directive to address anything it considers to be associated with Diversity, Equity, and Inclusion (DEI) and Diversity, Equity, Inclusion, and Accessibility (DEIA). This has already impacted the ability to view public information on health equity and health disparities and disrupted many grants and supplements at NIH along with public health activities. Additional information can be found here, and the advocacy community (and I expect legal community) is already mobilizing to respond with congressional champions and further engagement with policymakers.
• The White House issued an Executive Order withdrawing from the World Health Organization citing concerns over the COVID-19 pandemic. Additional information can be found here. The order initiates a 12-month withdraw process but potentially suspends financial contributions in the meantime (we will keep you posted as there will be further developments).
• The White House rescinded various Executive Orders too, including a Biden era initiative to study opportunities to lower drug prices. Additional information can be found here.

The new administration announced that Dr. Matthew Memoli would serve as Acting NIH Director until a new Director can be confirmed.

In a poignant reminder of the whipsaw-nature of the legislative process during the previous
Trump term, the Fiscal Year (FY) 2025 appropriations process was thrown into disarray at the
11th hour following some late-night tweets. Congress had until midnight on Friday, December
20th to act and pass another Continuing Resolution (CR) to keep the government open and
operating. The measure that was introduced mid-week reflected sustained bipartisan negotiations
and a litany of timely priorities. In addition to extending funding until March 14th, the original
CR addressed Medicare physician reimbursement, coupled supplemental disaster relief with farm
aid, dealt with Medicare extenders, and included many health and higher education provisions.
The deal was derailed the following day as the incoming administration called on rank and file
Republicans to reject the measure and to add in a debt ceiling increase.

The House responded by bringing a bill to the floor that contained only Republican priorities,
which was roundly rejected, thus demonstrating no path forward without bipartisan support.
Rather that resurrect the previous measure though, the House moved on to a third bill, the
American Relief Act. This measure ultimately sailed through the House and Senate, but only
included a CR until March 14th, disaster relief and far aid, and some crucial Medicare extenders.
House Appropriations Chair Tom Cole (R-OK) applauded the work to prevent a government
shutdown and strengthen the Republican negotiating position on final FY 2025 spending bills.

When the 119th Congress convenes on January 3rd, lawmakers will need to once again work to
finalize FY 2025 appropriations before the March 14th deadlines. Simultaneously, the House will
need to begin work on the FY 2026 appropriations process. Meanwhile, the Seante will be
focused on confirming appointees for key agencies and cabinet positions. It is poised to be a
chaotic start to the year compounded by a White House that has often priorities that shift day-today and occasionally clash with a Congress that takes weeks, if not months, to negotiate key
legislative items.

By: Dane Christiansen, Washington Representative

October 25, 2024

With Congress out until November 12^th, legislators are focused on campaigning ahead of the November 5^th elections. Medical research, higher education, and health workforce policy items have not been featured heavily by the campaigns. Prior debates related to basic levels of care and access have given way to debates over reproductive rights and out-of-pocket costs. An emerging topic on Capitol Hill with a political tinge has been redundancy and inefficiency in the federal medical research and public health agencies. The House Fiscal Year (FY) 2025 Labor-HHS-Education Appropriations Bill highlights a proposed reorganization of NIH and the elimination of other agencies and programs. More recently, House Energy and Commerce Committee Republicans published a report on the COVID-19 response that largely accused NIH and CDC of misusing public funds to overstate the seriousness of the pandemic and ultimately undermine confidence in public health agencies.

The pending elections have also caught the attention of former agency officials with an interest in overarching health policy priorities. Former Trump-era FDA Commissioner, Dr. Scott Gottlieb, recently published an article in JAMA Forum titled, “Is it Time to Refocus the Role of CDC”, which picks up many of the aforementioned political themes about redundancy in public health. Meanwhile, Former Biden-era Acting FDA Commissioner, Dr. Janet Woodcock, traveled to Capitol Hill to call for a new approach to treatment development, review, and approval for rare diseases.

A comprehensive overview of current election races, including the presidential race, and Senate and House races that will determine the balance of power in the next Congress can be found here.

A summary of the healthcare policy positions of party platforms and various candidates can be found here. 

By: Dane Christiansen, Washington Representative

September 27, 2024

Congress returned to Capitol Hill on September 9^th with only a handful of legislative days to complete work on key items and set up final activity for the lame duck session that will start in mid-November, after the elections. Most crucially, lawmakers need to pass a Continuing Appropriations Resolution (CR) to ensure the government stays open and operating past the October 1^st start of the fiscal year. Recent funding cycles have seen brinkmanship and even government shutdowns. Congressional plans to quickly pass a clean CR so members could return to the campaign trail grew more complicated when the Speaker of the House, Congressman Mike Johnson (R-LA), announced surprise plans for a six-month CR that included polarizing policy riders.

Ultimately, the Speakers emerging plan drew a strong rebuke (including from his own caucus). After the measure was defeated, Congress moved on quickly to pass a three-month clean CR that extends federal funding until December 20^th and includes additional resources for the Secret Service. The House and Senate both passed the short-term CR on the same day and, after considering some additional business, Congress then adjourned until after the election.

Lawmakers will next return to Capitol Hill on November 12^th for the lame duck session. Before the end of the year, they will need to decide final FY 2025 appropriations, how to dispense with supplemental emergency funding, and what other healthcare legislative items will be considered and passed with limited time. With the current bipartisan tone, polarizing proposals like the NIH reorganization put forward by the House are not expected to be part of legislative discussions. However, final top line funding levels for federal agencies along with annual funding for key programs is very much up for debate. Presently, the House and Senate are far apart on allocations for medical research and public health programs. Timely advocacy will be needed to ensure the best possible allocations for CCTS priorities, including NCATS, CTSAs, IDeA, and other efforts. 

CCTS Newsletter Copy

By: Dane Christiansen, Washington Representative

April 26, 2024

Congressman Tom Cole (R-OK) has been installed as the new Chairman of the House Appropriations Committee following the resignation from the post of former Chairwoman Kay Granger (R-TX) at the end of the Fiscal Year (FY) 2024 appropriations process. Chairman Cole is a veteran appropriator known for pragmatism and dealmaking. He has already announced an intention to consider and advance all FY 2025 appropriations bills to ensure the House fully participates in the current appropriations process. Meanwhile, the Senate continues to diligently and bipartisanly complete its work on annual appropriations.

To date, both the House and Senate have heard from many agency officials on FY 2025 budget requests to Congress. Moreover, both the House and Senate have announced the opportunity for Outside Witness Testimony. CCTS provides testimony on annual spending priorities each year and we feature local research success stories that highlight the value and impact of federal funding. If you would like to contribute a brief anecdote, please share it as soon as possible. The House deadline for Labor-HHS-Education testimony this year is May 3^rd, but the Senate deadline is not until May 24^th.

Democrats and moderate Republicans in the House worked together to break a months-long logjam and finally pass supplemental emergency funding for Ukraine, Israe, and Southeast Asia. The package totals nearly $95 billion and also included a potential ban on “TikTok”. Once the House had cleared the measure, the Senate was able to pass the package with an overwhelming 78-19 vote and send it to the President. The bipartisan House coalition represents a new dynamic where (at least for now) the business of the country superseded election year politics. The collaboration also bodes well for FY 2025 appropriations and, potentially, additional supplemental appropriations packages that can bypass budget caps enacted for FY 2025.

By: Dane Christiansen, Washington Representative

March 25, 2024

March was a busy month for budget and appropriations activity. Congress sought to complete work on FY 2024 appropriations with final spending bills. The administration released its FY 2025 budget request before the FY 2024 process was completed (flagging policy proposals and priorities, but ensuring the document lacked an accurate comparison between proposed funding and current funding). Advocacy efforts are now fully underway to ensure the largest possible increases for the full spectrum of medical research and key programs during the FY 2025 process.

The administration’s FY 2025 budget request to Congress calls for:

• $3.86 billion in discretionary budget authority for the Food and Drug Administration (FDA).
• $16.64 billion in discretionary budget authority for the Health Resources and Services Administration (HRSA).
• $8.93 billion in discretionary budget authority for the Indian Health Services (IHS).
• $11.51 billion in discretionary budget authority for the Centers for Disease Control and Prevention (CDC).
• $49.79 billion in discretionary budget authority for the National Institutes of Health (NIH) and $50.1 billion in total funding. Most of the proposed additional funding is dedicated to the National Cancer Institute and the Office of the Director with modest increases for most Institutes and Centers.
• $8.16 billion in discretionary budget authority for the Substance Abuse and Mental Health Services Administration (SAMHSA).
• $387 million in discretionary budget authority for the Agency for Healthcare Research and Quality (AHRQ).

The final FY 2024 appropriations bills provide:

• $8.88 billion for the Health Resources and Services Administration, a reduction of $577.19 million from FY 2023. 

By: Dane Christiansen, Washington Representative

February 26, 2024

Congress continues to work on final Fiscal Year (FY) 2024 appropriations bills ahead of the expiration of a laddered continuing appropriations resolution (CR) funding core parts of the federal government until March 1^st and March 8^th. At this point, negotiations are largely focused on thorny policy riders and divisive political issues, and largely taking place at the leadership level between the parties and the chambers. The Freedom Caucus recently called on House Speake Mike Johnson (R-LA) to dig in his heels and fight for maintaining polarizing issues in the final measure or adopting a year-long CR as an alternative. Historically though, final spending bills have been “clean” and avoided issues beyond funding. Moreover, political and process demands require that any final FY 2024 spending bill has strong bipartisan support to move forward.

The Ad Hoc Group for Medical Research, the Friends of AHRQ (FAHRQ), and other advocacy coalitions have already begun making their funding recommendation for FY 2025 (even though FY 2024 remains unfinished). The community’s request of a $3.6 billion increase for NIH to bring total annual funding up to $51.3 billion annually largely assumes the agency will be near level funded in any final FY 2024 measure. Similarly, the FAHRQ is asking for $500 million for the Agency for Healthcare Research and Quality, which mirrors the consensus request that was made for FY 2024.

It is important to note that FY 2025 community funding recommendations are presently being made in response to congressional office deadlines for submitting such feedback to advance the next appropriations process. These recommendations are being made without the benefit of final FY 2024 levels and without knowing the administration’s FY 2025 budget request to Congress, which is scheduled to be released on March 11^th, following the March 7^th State of the Union Address. Tweaks can certainly be made to any specific numbers that medical research and public health advocates are making moving forward, and leading organizations certainly seem more optimistic for positive outcomes through the FY 2025 process (as opposed to the protracted FY 2024 process). 

By: Dane Christiansen, Washington Representative

January 25, 2024

The 118^th Congress convened earlier this month for its second session and largely picked up where unresolved items were left at the end of the first session. Most notably, Fiscal Year (FY) 2024 appropriations have not been completed and another short-term Continuing Resolution (CR) was enacted before the first tranche of agency funding was scheduled to run out on January 19^th (which would have triggered a partial government shutdown).

The new House Speaker, Mike Johnson (R-LA) negotiated a budget framework with the White House and other congressional leaders that largely mirrored the existing Fiscal Responsibility Act deal, but scored some concessions on handshake deals that had been established between the former Speaker and other congressional leaders. With overall allocations in place for Defense and Non-Defense programs, appropriators are now crafting FY 2024 spending bills and deciding how to provide funds for individual line items while maintain the 3% increase for defense and near-level funding for non-defense. To buy time to complete this effort and align the votes necessary for final passage, Congress passed another CR that provides funding until March 1^st and March 8^th for federal programs.

The Speaker’s new deal was met with a stern rebuke from the usual suspects on the far-right in the House. Deep funding cuts pushed by conservatives and polarizing policy riders are likely out of the process at this point (and it is important to note that current Senate FY24 bills generally reflect the new budget guidelines). The far-right and some progressive members voted against the new CR, but the measure easily passed with support from a broad bipartisan coalition of moderates.

The Speaker also invited President Biden to the House for the Sate of the Union on March 7^th. With the FY 2024 appropriations process potentially completed by March 1^st, the President may take the opportunity to highlight new priorities and initiatives for FY 2025 in the absence of a formal budget request. Given the current political and funding environment, it will be particularly crucial to advocate for meaningful funding increase for the full spectrum of medical research in 2024!

By: Dane Christiansen, Washington Representative

December 22, 2023

Over the past decade, the end of the calendar year and congressional session has been characterized by a hectic effort on Capitol Hill to pass the annual appropriations measures and other must-pass bills ahead of the holidays. This year is an exception. Lawmakers are still debating a foreign policy-focused emergency supplemental appropriations package. While the Senate stayed in session an extra week, there was no breakthrough on negotiations, though the extra time was used to confirm military promotions that had been delayed for nearly the entire year. The lack of progress on the supplemental package delayed further negotiations on final FY 2024 spending measures. Some federal programs are on a continuing resolution (CR) until January 19^th, while most programs are on a CR until February 2^nd, which means lawmakers will have limited time to pass a final package when the convene early next year (and may need to pass another short-term CR).

The House adjourned for the year well ahead of the Senate after passing the annual National Defense Authorization Act. The measure had been delayed for some time due to protracted negotiations over polarizing policy riders pushed by the House. Ultimately, the final bill jettisoned policy riders and was very similar to the measure initially advanced by the Senate. The measure passed the House with more than two-thirds support, bypassing an open amendment process, and securing votes from a broad coalition of Democrats and Republicans (in a manner similar to the current CR).

Next year looks to be a dynamic time on Capitol Hill. The November elections (presidential in particular) are already unprecedented even though campaign season has barely begun. A tremendous number of veteran lawmakers have already announced their retirements setting up a notable changing of the guard for the 119^th Congress, which will convene in 2025. The current Congress will consider some critical legislative items early next year, and work to finalize many others in the lame duck session after the election. We encourage every interested individual to join the CCTS advocacy efforts to ensure a critical mass of support for the full spectrum of medical research remains on Capitol Hill.

By: Dane Christiansen, Washington Representative

November 30, 2023

Congress gave Americans a much-needed break from partisan gridlock and brinksmanship ahead of the Thanksgiving holiday by passing a clean, two-tiered Continuing Resolution (CR) to keep the government open and operating before the previous CR expired on November 17^th. Four of the twelve annual appropriations bills; Transportation/Housing, Military Construction/Veterans, Agriculture/FDA, and Energy are funded until January 19^th while the other eight bills (including Labor-HHS-Education) are funded until February 2^nd.

The bipartisan and drama-free funding extension marks a win for new House Speaker Mike Johnson (R-LA) despite similarities to the approach taken by ousted former Speaker Kevin McCarthy (R-CA). Negotiations are underway to craft a final Fiscal Year (FY) 2024 spending package and avoid the need for yet another CR (or CRs). The House has also started to warm to the reality that the Senate bills, with their modest increases for most programs and consistency with the parameters outlined by the Fiscal Responsibility Act, are more likely to reflect the framework of a final package.

However, there has been some grumbling from hardline conservatives in the House about the ongoing move to bipartisanship in the appropriations process and the lack of commitment to aggressive tactics for spending reductions. Historically, final appropriations bills have been supported by both parties and jettisoned polarizing policy riders and divisive items. It remains unclear how the shifting dynamics in the House and an unruly majority caucus might impact a final spending bill, bills, or CR. 

In another show of bipartisanship, the Senate confirmed Dr. Monica Bertagnolli as the next NIH Director. HELP Committee Chair, Bernie Sanders (I-VT), continued to symbolically oppose the nomination to make a point about further action on drug pricing, but did not obstruct the overall process and his opposition was facilitated by sufficient Republican support for the confirmation. Dr. Bertagnolli takes the helm of NIH and an unprecedented time, both in terms of opportunities to advance the full spectrum of medical research and a time when public trust in science is unusually low and unfortunately polarized.  

By: Dane Christiansen, Washington Representative

October 27, 2023

On Capitol Hill, the month of October was particularly chaotic (even by Congressional standards). The month started with Congress passing a short-term Continuing Resolution (CR) to keep the government open and operating while legislators work to finalize Fiscal Year (FY) 2024 appropriations, the conservative wing of the Republican Caucus then responded by ousting Speaker Kevin McCarthy (R-CA) for supporting a bipartisan CR package, and the month ended with Republicans electing Congressman Mike Johnson (R-LA) as the new Speaker.

The Speaker is a constitutional position and with the chamber leaderless for weeks, all legislative business in the House was effectively frozen. Even now, it is unclear what path the new House leadership team and Committee Chairs will take on appropriations and other legislative items. What is known is that lawmakers will need to finalize FY 2024 funding bills before the current CR expires ahead of Thanksgiving (which seems unlikely) or pass another CR to buy more time (and will require the support of the Seante and the White House).

The Senate made it clear early on that the situation in the would not be a distraction and continued to work on a bipartisan basis to advance the business of the chamber. Senate leadership announced a plan to begin bringing FY 2024 spending bills to the floor and passing them through a series of minibus packages. Further, the Senate HELP Committee advanced the nomination of Dr. Monica Bertagnolli to serve as the next Director of the National Institutes of Health in a bipartisan vote of 15-6. The nomination will now move to the floor of the Senate for a final confirmation vote (though the timetable is unclear).

The National Center for Advancing Translational Sciences at NIH is currently crafting its next Strategic Plan for 2024 – 2029 and inviting community input through an RFI process. More information will be available moving forward, but the effort can be tracked here: https://ncats.nih.gov/about/ncats-overview/strategic-plan

By: Dane Christiansen, Washington Representative

September 25, 2023

With the federal fiscal year ending on September 30^th, Congress remains on a collision course over annual spending and a continuing appropriations resolution or “CR”. Traditionally, passing a CR to keep the government open and operating is a routine annual affair with legislators not completing work on the appropriations bills until the end of the calendar year (or start of the next year). However, ongoing tension between the conservative and moderate wings of the Republican party have stymied efforts to move (any) legislation through the House of Representatives.

Conservatives are calling for deep funding cuts to discretionary programs, partisan policy riders on hot-button issues, and not including emergency supplemental funding for Ukraine in any must-pass legislation. Not only is this approach a non-starter in the Senate and with the White House, but moderate House Republicans are resistant as well. Given the extremely slim majority in the House, the result is a stalemate with House Speaker McCarthy still looking for an off-ramp.

If no CR is enacted, the government will shutdown resulting in many federal programs and mechanisms grinding to a halt. While Social Security, the VA, and the military are considered mandatory or essential programs, most parts of the nation’s medical research and patient care enterprise is considered discretionary and prone to disruption from even a brief shutdown.

The Senate continues to work in a bipartisan fashion and appears to simply be waiting for the House to get its house in order. The Senate has advanced all twelve annual appropriations bills with overwhelming bipartisan support and is interested in an emergency supplemental spending package that includes disaster relief and Ukraine aid. The Senate has also expressed its preference for a “clean” CR that maintains funding for federal programs and does not include policy riders. The Senate has also indicated the HELP Committee will hold a hearing to advance the nomination of Dr. Monica Bertagnolli as the next NIH Director in October (though the specific date and time could be impacted by a shutdown on October 1^st).

CCTS Newsletter Copy

By: Dane Christiansen, Washington Representative

August 24, 2023

As legislators prepare to return to Capitol Hill in early September, following the August congressional recess, they will be faced with a handful of timely, pressing items. Most notably, Congress will need to pass a Continuing Resolution (CR) to keep the government operating past the September 30^th end of the current fiscal year. While this is normally a mundane task to buy time to ultimately finalize annual spending measures in December, staunch conservatives in the House are seeking to leverage the opportunity to push for funding cuts and concessions on hot-button policy issues. With a majority of only a few votes, House Speaker Kevin McCarthy (R-CA) will need to find a way to balance the needs and interests of his entire caucus or pass a consensus bill that gains Democratic support. If Congress does not pass a CR before the end of September, lawmakers risk a damaging government shutdown.

The ongoing partisanship and tension in the House has led to slower than normal progress on annual items. House lawmakers have struggled with the National Defense Authorization Act (NDAA) and military support while also advancing only a few of the FY 2024 appropriations bills. In fact, so much funding was cut from the House appropriations bills to placate conservatives that moderate Republicans communicated they could no longer support the measures. The House is currently at an impasse with some Republicans in the majority calling for further cuts while others would like to see recent proposed cuts rolled back; there is no clear path forward at this time.

Across the Capitol, the Senate has worked diligently on its FY 2024 appropriations bills even reporting all twelve bills out of committee with strong bipartisan support. The Senate has been critical of the House approach of focusing on divisive policy riders and deep funding cuts, and is seeking a traditional process with nominal funding increases and no policy riders. The Senate has also expressed a strong interest in using supplemental emergency appropriations (for Ukraine, disaster relief, etc) to enhance modest FY 2024 funding for many federal programs. For any spending bills to become law though, they will need to pass both the House and Senate, and then be signed by the President.  

By: Dane Christiansen, Washington Representative

July 24, 2023

Heading into the August congressional recess, all eyes in the political world are on the U.S. Senate. Currently, the Senate Appropriations Committee is planning to mark up Fiscal Year (FY) 2024 spending bills for Labor, Health and Human Services, and Education (L-HHS), the Department of Defense (DOD), and a few others. Meanwhile, the Senate Finance Committee is advancing work on Pharmacy Benefit Manager (PBM) reform, which is quickly becoming a vehicle for other health and patient care policy items. Similarly, the Senate Health, Education, Labor and Pensions (HELP) Committee is working on a reauthorization of the Pandemic All Hazards Preparedness and Response Act and pulling in additional items related to medical research and patient care.

The House has continued to mark up FY 2024 appropriations bills that feature deep cuts to non-defense federal programs. While the House FY24 DoD and VA spending bills enhance, or at least maintain, the investment in medical research programs, other bills (such as those focused on FDA or global health) see deep cuts to overall and program-level spending. The House spending bills have also featured a number of hot-button policy riders dealing with polarizing social issues, which are traditionally not part of the appropriations process beyond narrow and limited instances. The House has yet to release official information on the FY 2024 L-HHS bill, but previously telegraphed that the bill will include deep cuts for NIH, CDC, ARHQ, and other agencies (though it appears NCATS and CTSAs will be level-funded).

The Senate Appropriations Committee has taken a bipartisan approach on spending and regularly criticized House activity. Senators from both sides of the aisle have called for additional investment in both Defense and non-Defense programs. The House bills have also been referred to as not serious, but both chambers and the White House will ultimately need to reach agreement on final FY 2024 funding and a Continuing Resolution to keep the government operating at the start of October. The Senate Appropriations Committee is expected to release information on the FY 2024 L-HHS and DOD bills ahead of the August recess. 

By: Dane Christiansen, Washington Representative

June 26, 2023

With the debt ceiling, budget, and spending deal in place (the Fiscal Responsibility Act, P.L. 118-5), the House and Senate are moving forward with marking up their respective appropriations bills. The House, in an effort to placate the more-conservative elements of the Republican majority, announced that it would mark up non-Defense bills at levels lower than those recently negotiated by Congress and the Administration. Meanwhile, Senate appropriators bemoaned the low spending levels for both Defense and Non-Defense programs and indicated an interest in innovative efforts to provide supplemental funding for Fiscal Year (FY) 2024 appropriations.

Thus far, the House has marked up key FY24 spending bills for the Department of Defense (DOD); Military Construction, Veterans Affairs, and Related Programs (MilConVA); and Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (AgFDA). The DOD and MilConVA bills include funding increases, and some additional funding for medical research programs. The AgFDA bill is cut below the FY23 funding level in the House proposal, but user fees and other budget gimmicks are used to minimize program reductions. The Senate has marked up its MilConVA Bill and AgFDA, with modest increases for both Defense and Non-Defense programs. It is also important to note that the House bills are full of partisan policy riders, which have traditionally been removed when final spending measures are negotiated.

Traditionally, bills with broad bipartisan support are considered early, while more contentious appropriations bills, such as the Labor-HHS-Education measure, are considered later in the process. Neither the House nor Senate markup for medical research and public health programs through the Labor-HHS-Education Appropriations Bill has been announced at this time. Appropriations in both the House and Senate though are already acknowledging the need to pass a Continuing Appropriations Resolution (CR) at the start of FY 2024 (October 1^st) and then work on finalizing appropriations before the end of calendar year 2023.   

By: Dane Christiansen, Washington Representative

May 25, 2023

Negotiations between the White House and the Republican leadership of the House of Representatives over raising the nation’s debt ceiling has stymied the annual budget and appropriations process on Capitol Hill. The House had previously announced subcommittee and full committee markups of its twelve annual appropriations bills, starting in May. Spending measures with favorable allocations and funding increases, such as the annual Military Construction and Veterans Affairs appropriations bills, where scheduled to be marked up first with bill expected to face deep cuts, such as the Labor-Health and Human Services-Education (L-HHS) appropriations measure, set to move forward at later (not yet announced) dates. However, progress between negotiators working on a fluid package to address federal spending, revenue, and raising the debt ceiling led to the postponement of all House appropriations activity.

If a deal is struck on the federal budget, it will likely have a direct impact on the annual appropriations measures and House and Senate appropriators will adjust their proposed Fiscal Year (FY) 2024 spending measures accordingly. The Senate previously announced it would hold its subcommittee and full committee markups of FY 2024 spending measures beginning “in June”. With the U.S Treasury repeatedly warning that the nation could default on its debt obligations as soon as early June, the Senate markup schedule may not be impacted, but the clock is certainly ticking for debt ceiling negotiators to finalize the framework of any budget deal.

The National Center for Advancing Translational Sciences (NCATS) has pushed froward with plans to hold a series of roundtable discussions and otherwise gather stakeholder input as it works to develop a 5-to-10-year research plan. To date, these discussions have almost exclusively focused on NCATS role in the rare disease space and efforts to advance treatment development for rare conditions. It is unclear how a forthcoming research plan will reconcile NCATS broad responsibilities in advancing clinical and translational science for the nation and all healthcare communities with its narrower roles in the rare disease space.

The Biden Administration officially nominated the Director of the National Cancer Institute, Dr. Monica Bertagnolli, for ascension to the post of NIH Director. The NIH Director position requires Senate confirmation, and the political fight is expected to be more highly charged than previous NIH Director appointments. If confirmed, NIH would have a Director with a historically unique appreciation for the full spectrum of medical research. 

By: Dane Christiansen, Washington Representative

April 25, 2023

In mid-April, nearly 250 volunteer advocates participated in the Coalition for Clinical and Translational Sciences (CCTS) 2023 Capitol Hill Advocacy Day. Advocates represented 32 states, the District of Columbia, and Puerto Rico, and visited the offices of their House Representatives and U.S. Senators.

The CCTS advocacy visits were well-timed as Congress is currently making key decisions about Fiscal Year (FY) 2024 funding levels for federal medical research and public health programs. Moreover, there are dozens of new legislators in the House and Senate and the Hill Day was an excellent opportunity for elected officials to form local connections with the community while learning about the value and impact of the full spectrum of medical research. Specifically, CCTS advocates asked congressional offices to support the following community funding priorities:

• Please provide the National Institutes of Health (NIH) with at least $50.9 billion, an increase of $3.5 billion over FY 2023.
• Please provide the National Center for Advancing Translational Science (NCATS) at NIH with at least $975 million, an increase of $67 million over FY 2023, including:

• At least $664.56 million in dedicated, line-item funding for the flagship Clinical and Translational Science Awards (CTSA) program, an increase of $35 million over FY 2023. The CTSA program is central to ongoing efforts to modernize and enhance the full spectrum of medical research at NIH, and annual funding increases provided by bolstering the established CTSA budget line-item are essential to maintaining this progress.  
• At least $90 million in appropriated funding for the Cures Acceleration Network (CAN), an increase of at least $20 million over FY 2023.

• Please advance the full spectrum of medical research along with training and career development activities at NIH by providing proportional funding increases for Research Centers in Minority Institutions, Institutional Development Awards, and related programs.

• Please provide the Centers for Disease Control and Prevention (CDC) with $11.58 billion, an increase of $2.37 billion over FY 2023.
• Please provide the Agency for Healthcare Research and Quality (AHRQ) with at least $500 million, an increase of $126.7 million over FY 2023.

The outreach was well received, and the House Labor-HHS-Education Appropriations Subcommittee even asked Acting NIH Director Dr. Larry Tabak a question about the significance of the Clinical and Translational Science Awards (CTSA) program during an FY 2024 budget hearing the following day. Dr. Tabak respond with a positive assessment of CTSAs and the networks contributions to community access and engagement and rural care.

(a portion of the group of CCTS advocates that traveled to Capitol Hill for the 2023 Advocacy Day). 

By: Dane Christiansen, Washington Representative

March 31, 2023

In mid-March, the Biden administration kicked off the ceremonially start to the annual budget and appropriations process with the release for the Fiscal Year (FY) 2024 President’s Budget Request to Congress. The non-binding document serves to outline administration priorities as Congress works on corresponding spending bills. This year, the request outlines a reinvigoration of the Cancer Moonshot while calling for further funding for medical research and public heath programs (though skewing that request toward public health due to the fact that medical research continues to have strong bipartisan support on Capitol Hill). A summary of key items from the FY 204 budget request to Congress is listed below.

• $11.6 billion in discretionary, Prevention and Public Health Fund, and Public Health Service Evaluation funds for the Centers for Disease Control and Prevention (CDC), an increase of $2.4 billion over FY 2023.

   

• $48.6 billion program level for the National Institutes of Health (NIH), an increase of $920 million over FY 2023. The NIH increase is applied unevenly among NIH Institutes and Centers, with many receiving no increase.

   

  • $3.24 billion for the National Institute of General Medical Sciences (NIGMS), level with FY 2023.
    • $425.96 million for the Institutional Development Awards (IDeA) program, level with FY 2023.

   

  • $525.14 million for the National Institute on Minority Health and Health Disparities (NIMHD), level with FY 2023.
    • $83.20 million for Research Centers at Minority Institutions (RCMIs), level with FY 2023.

   

  • $923.32 million for the National Center for Advancing Translational Sciences (NCATS), level with FY 2023.
    • $629.56 million for the Clinical and Translational Science Awards (CTSA) Program, level with FY 2023 (line-item funding for CTSAs is requested through the budget request).

   

• $2.5 billion for the Advanced Research Projects Agency for Health (ARPA-H), an increase of $1 billion over FY 2023.

   

• $447 million for the Agency for Healthcare Research and Quality (AHRQ), an increase of $74 million over FY 2023.

By: Dane Christiansen, Washington Representative

February 24, 2023

Traditionally, the appropriations process begins on Capitol Hill with the releases of the administration’s annual non-biding budget request to Congress. The tentative date for this is at the start of February, but with the Fiscal Year (FY) 2023 process not completed until the end of December last year, the Biden Administration has pushed back the release of its FY 2024 proposal until mid-March. While simply guidance, the document will outline the administration’s priorities for ARPA-H and related agencies in a broad sense as well as feedback on the CTSA program and other activities, specifically.

Congress is not waiting for the administration to being its annual appropriations work. The House, in particular, has already announced public witness hearings for the FY 2024 Labor-HHS-Education Appropriations Bill. Both the House and Senate are accepting input on annual priorities and funding recommendations from community stakeholders. As the appropriations process advances on Capitol Hill with little fanfare, the partisan political jockeying on issues related to spending, the deficit, and debt ceiling has already begun. Both chambers and both parties are drawing lines on defense, non-defense, and entitlements, but clear consensus messages and negotiating points have yet to crystalize.

The community is also moving forward with annual appropriations advocacy ahead of the release of the administration’s budget request. Most notably, the Ad Hoc Group for Medical Research has announced that the stakeholder community’s FY24 funding request for NIH will be, “at least $50.924 billion for NIH’s foundational work, a $3.465 billion increase over the comparable FY 2023 program level”. CCTS will carry this request to Capitol Hill along with specific funding recommendations for CTSAs and the full spectrum of medical research along with investments in public health and research training and career development during Translational Science 2023’s volunteer advocacy day.

By: Dane Christiansen, Washington Representative

January 20, 2022

The 118^th Congress convened with an uneven start. The Senate has been relatively uneventful with the chamber convening briefly to swear in a handful of newly elected Senators. On the other hand, the House struggled to elect a Speaker for nearly a week in a protracted political fight between moderate and far-right Republicans. While the leadership of key congressional committees has been announced, both chambers have yet to release complete committee rosters and to begin regular business.

The ceremonial start to the annual budget and appropriations process is the release of the President’s Budget Request to Congress. The Fiscal Year (FY) 2024 budget request is scheduled for the start of February, but the exact date might slip a little considering the final FY 2023 spending bills were not completed until the end of December. With saber-rattling over the debt ceiling, the deficit, and federal spending already underway on Capitol Hill there is growing concern among advocates over headwinds that could blunt federal investments in medical research and public health programs.

With a split government, dealmaking will be crucial to advancing the FY 2024 appropriations bills and resolving pressing policy items. Last year, Congress ultimately enacted an FY 2023 omnibus package that included notable funding increases for key priorities (NIH, CTSAs, ARPA-H, etc,) as well as policy items such as addressing Medicare cuts, facilitating access to clinical trials, and lowering out-of-pocket costs for patients. With continued advocacy and meaningful congressional outreach, this community should have every expectation that our elected representatives can negotiate and deliver a similar positive result for FY 2024.

CCTS Newsletter Copy

By: Dane Christiansen, Washington Representative

December 23, 2022

Following protracted negotiations, lawmakers on Capitol Hill reached a bipartisan and bicameral deal to finalize the Fiscal Year (FY) 2023 appropriations process. While not as generous toward medical research and public health as prior proposals, the final omnibus package still provides meaningful funding increases for many key agencies and programs. Lawmakers were also working to dispense with critical and timely health policy items and used the omnibus as a comprehensive vehicle to advance legislative provisions, in addition to providing funding. A summary of key items from the FY 2023 omnibus appropriations package is included below.

FY 2023 Funding

• $47.459 billion program level for the National Institutes of Health (NIH), an increase of $2.5 billion over FY 2022.

• $3.24 billion for the National Institute of General Medical Sciences (NIGMS), an increase of $147.31 million over FY 2022.
  • $425.96 million for the Institutional Development Awards (IDeA) program, an increase of $15.50 million over FY 2022.
• $524.4 million for the National Institute on Minority Health and Health Disparities (NIMHD), an increase of $65.34 million over FY 2022.
  • $88.77 million for Research Centers at Minority Institutions (RCMIs), an increase of $4 million over FY 2022.
• $923.32 million for the National Center for Advancing Translational Sciences (NCATS), an increase of $41.06 million over FY 2022.

• $629.56 million for the Clinical and Translational Science Awards (CTSA) Program, an increase of $22.91 million over FY 2022.

CCTS Newsletter Copy

Dale Dirks and Dane Christiansen

November 28, 2022

Lawmakers returned to Washington, DC, after the Thanksgiving recess with a growing list of critical legislative items to address before the end of the calendar year and the conclusion of the 117^th Congress. Chief among them, negotiating topline spending numbers and finalizing the Fiscal Year (FY) 2023 appropriations bills. At this point in the process, both the House and Senate annual funding proposals call for notable increases for medical research, public health, and patient care programs. However, the bills also largely reflect Democratic priorities and Republican concerns over the balance between defense and non-defense spending will need to be resolved (among other issues) for a final deal to be reached in time. It is likely that lawmakers will need to pass another short-term continuing appropriations resolution (CR) to keep the government operating when the current CR expires on December 16^th, but if a longer-term CR is enacted and FY 2023 appropriations spill over into the next Congress, then any pending funding increases will be in jeopardy.

Following the November elections, the Biden-Harris Administration sent an emergency funding request to Congress for supplemental spending for COVID, infectious diseases, and aide to Ukraine. Lawmakers are presently working to address this request within the context of final FY 2023 appropriations. The proposal has been met with some skepticism as some congressional leader’s question accountability and transparency for previously provided COVID resources.

Congress is also working to address a number of authorizing and policymaking priorities within the flurry of lame duck legislative activity. For example, Congress still needs to complete work on the FY 2023 National Defense Authorization Act, which provides annual support to the military. Lawmakers are also working to address pending scheduled cuts to Medicare reimbursement before they take effect at the start of next year. Finally, lawmakers are also working to advance bipartisan provisions left out of the user fee reauthorization legislation for the Food and Drug Administration was well as authorizing legislation for the Advanced Research Projects Agency for Health.

The situation remains fluid on Capitol Hill, but the resolution of key annual legislative priorities should become apparent in the near future.

Dale Dirks and Dane Christiansen

October 21, 2022

Congress spent the month of October in recess, with Representatives and Senators on the campaign trail ahead of the November elections. One of the last actions by Congress was to pass a Continuing Resolution to keep federal agencies operating at their current level until December 16^th so legislators can continue to work to finalize the Fiscal Year (FY) 2023 spending bills by the end of the year. Presently, Congress plans to use the Lame Duck session following the election to finalize FY 2023 appropriations and to pass any critical outstanding bills. The results of the election will have some bearing on how Congress finalizes the annual spending bills and the allocations for key programs, even if the new Congress will not adjourn until January of next year.

One of the key items left to be resolved through the end of the year appropriations process is the authorizing legislation and funding provisions for the Advanced Research Projects Agency for Health (ARPA-H). The House and Senate currently have differing funding levels as well as divergent authorizing legislation, but persistent issues are expected to be resolved in a timely fashion. Moreover, the initial funding provided by Congress for ARPA-H in FY 2022 is already being used to establish the agency, identify its leadership, and stand-up grant making and related activities without delay.

For the remainder of the year, CCTS encourages advocates to reach out to congressional contacts and encourage support the community’s annual funding recommendations (listed below). There will be ample opportunity to educate new members during the next Congress, but for now there is a tangible opportunity to secure pending FY 2023 funding. 

Dale Dirks and Dane Christiansen

September 26^th, 2022

Congress is working swiftly to enact a continuing appropriations resolution (CR) before the October 1^st start of Fiscal Year (FY) 2023 (and before adjourning to campaign throughout October). Lawmakers plan to use the additional time allowed by the CR to finalize the FY 2023 appropriations bills, likely moving to pass any bill(s) during the “Lame Duck” session following the November elections. The CR is expected to be light on policy riders, and while it should include supplement emergency funding for Ukraine, it is not expected to include additional requested funding for the ongoing COVID response. Due to the large funding increases for medical research and public health programs funding in the current FY 2023 bills, the community continues to engage Capitol Hill to ensure legislators understand the importance of finalizing and enacting the pending bills as quickly as possible (and certainly before the current Congress adjourns at the end of December).

Congress is also working to pass a reauthorization of user-fees for the Food and Drug Administration (FDA) before October 1^st. Earlier in the year, the House and Senate had each outlined ambitious proposals to modernize FDA and launch new initiatives. However, with time running out, it is likely that Congress will only be able to pass as a “clean” reauthorization light on new efforts, and that any reauthorization will likely be tied in with the CR. One of the items that Congress hoped to address through the FDA bill was the location of the Advanced Research Projects Agency for Health (ARPA-H), both within the government and within the country. It is unclear how Congress will move the ARPA-H reauthorization forward and reconcile any outstanding items, but this will remain a priority in the Lame Duck session.

While Congress is still working to authorize ARPA-H and provide FY23 funding, White House has announced that the first Director of ARPA-H will be Dr. Renee Wegryn. ARPA-H was modeled on the Defense Advanced Research Projects Agency (DARPA) and the Intelligence Advanced Research Projects Agency (IARPA), two entities that Dr. Wegryn has extensive experience working within. The community continues to look to the administration for announcements on the next NIH and NCATS Directors. 

Dale Dirks and Dane Christiansen

August 25^th, 2022

Lawmakers continued working into the August recess to pass a package of environmental, tax, and healthcare budget provisions known as the Inflation Reduction Act. The legislation includes a number of items of interest to patient and professional healthcare advocates, including a three-year extension of enhanced ACA (exchange) premium subsidies and a $2,000 out of pocket cap with a smoothing mechanism for Medicare Part D that will take effect 2025. When Congress returns in September, lawmakers will need to pass a Continuing Resolution to keep the government operating along with a Food and Drug Administration (FDA) user-fee package to keep the FDA operating before the October 1^st start of the Fiscal Year. Congress is scheduled to be out during October and through the November elections before returning for a Lame Duck session to (hopefully) finalize the Fiscal Year 2023 spending bills and any critical legislation before the end of the year.

As the Biden-Harris Administration was celebrating the enactment of the Inflation Reduction Act, the country learned that NIAID Director Anthony Fauci plans to step down from his role as the nation’s top infectious disease specialist at the end of the year. The announcement caps off fifty years in medical research and public service for Dr. Facui and marks a new phase for NIAID and the ongoing COVID-19 response. Dr. Fauci’s announcement comes at a time when both NIH and NCATS are awaiting new Directors as well (the NIH positions requires Senate confirmation while the leadership for the individual institutes does not).

The House and Senate have released their FY 2023 appropriations bills and both chambers are calling for meaningful funding increases for medical research programs (including CTSAs, CAN, IDeA, and RCMI). CCTS will be working throughout the fall to advocate with key congressional offices on Capitol Hill in an effort to secure the largest possible annual increases for community priorities.