Advocacy News

NASPGHAN, AGA Tell Congress Integrity of NIH Research Must be Upheld

Senate lawmakers had an opportunity to question National Institutes of Health (NIH) Director Jay Bhattacharya, MD, PhD, during a hearing convened by the Health, Education, Labor and Pensions (HELP) Committee on February 3. NIH modernization was the intended focus of the hearing, although lawmakers used it as an opportunity to question Dr. Bhattacharya on a range of issues including  the Administration’s new vaccine policies and disruption last year of NIH research and clinical trials.

NASPGHAN and the American Gastroenterological Association submitted a statement to the Committee for the hearing record. The statement underscored the importance of digestive disease research funded through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the need for NIH research to be free from political interference.

Dr. Bhattacharya’s remarks during the hearing centered on re-establishing public trust in the NIH, which Committee Chair Bill Cassidy, MD (R-LA) challenged by questioning whether the Administration’s vaccine policies are having the opposite effect. Speaking specifically to suggestions the MMR vaccine should be split into three separate vaccines, Cassidy said “It will decrease trust and decrease immunization rates.”

Dr. Bhattacharya also claimed without evidence that changes in the childhood immunization schedule will lead to more, not fewer, children being vaccinated.

The idea of delinking NIH research facility support from projects was also suggested by Dr. Bhattacharya, an idea that Sens. Cassidy and Jim Banks (R-IN) embraced as a way to disrupt the geographic and institutional concentration of NIH funding.

It is expected President Trump’s Fiscal Year (FY) 2027 budget will again include cuts to NIH funding and reduce the number of institutes and centers. The Administration’s FY 2026 budget proposed to consolidate the current 25 institutes and centers to just eight. The NIDDK would have been consolidated with the National Heart, Lung, and Blood Institute, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases into a new National Institute on Body Systems.

Spending Bill Boosts NIH Funding; Includes PBM and PREA Reforms

Last week, House and Senate appropriators released a bipartisan, bicameral fiscal year (FY) 2026 spending bill which includes funding for the Department of Health and Human Services. The House passed the spending bill on January 22, and it was on track for Senate adoption before the current federal continuing resolution for six spending bills expires on January 30. Recent events in Minneapolis, however, have increased the chance the January 30 deadline could lapse without passage of the bills, which would result in a partial government shutdown. Among the departments and agencies that would be impacted by a partial shutdown include the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC).

The bill provides $48.7 billion for the National Institutes of Health (NIH), a $415 million (0.9 percent) increase above the FY2025 level. By contrast, the President’s FY 2026 budget would have cut the NIH by $18 billion. Importantly, the bill also preserves NIH facilities and administrative (F&A) costs.

NASPGHAN joined nearly 150 groups in a letter to Congress for full-year appropriations and to fund the NIH at $48.7 billion. The letter also opposed the imposition of arbitrary caps on F&A rates.

Overall, the legislation represents a positive, compromise outcome that avoids drastic cuts proposed by the President.

The bill includes a number of other significant health measures:

• Requires more transparency from pharmacy benefit managers (PBMs) and requires them to pass through rebates to commercial plans in an attempt to reduce incentives for PBMs to favor higher-priced drugs that can obtain higher rebates.
• Allocates $4.6 billion in additional funding for community health centers through
• Reauthorizes the PREEMIE (Prematurity Research Expansion and Education for Mothers who deliver Infants Early) Act which renews a federal commitment to address preterm birth through federal research, promoting known interventions, and promoting community initiatives. NASPGHAN is on record in support of the PREEMIE Act.

The bill also includes some of the provisions found in the Innovation in Pediatric Drugs Act of 2025, legislation supported by NASPGHAN. Specifically, the provisions in the spending bill under consideration:

• Amend the Pediatric Research Equity Act (PREA) to give the Food and Drug Administration (FDA) the authority it needs to ensure that legally required pediatric studies are completed in a timely way.
• Require the FDA to report on PREA enforcement, including an evaluation of industry compliance with deadlines provided for in deferrals and deferral extensions.

NASPGHAN Meets with FDA; Submits Comments on Biosimilarity Guidance

On January 15 physicians representing NASPGHAN, the American Academy of Pediatrics, the American Gastroenterological Association, Improve Care Now and the Crohn’s and Colitis Foundation met with FDA officials to discuss improving pathways for securing pediatric indications for IBD treatments. The meeting was a follow-up to comments sent by the organizations to the Food and Drug Administration (FDA) in 2024 in response to draft industry guidance for developing drugs for treatment of pediatric IBD. The meeting covered the use of extrapolation from adult studies, challenges with enrolling children and adolescents in clinical trials, and insurance barriers that impede access to biologic therapies that lack pediatric indications. NASPGHAN and the other participating societies are currently assessing next steps with the goal of continued engagement with the FDA.

In related news, this week NASPGHAN submitted a letter to the FDA in response to draft industry guidance on assessing the need for comparative effectiveness studies for demonstrating biosimilarity to a reference product. Separately, the FDA has stated it plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics to achieve “massive cost reductions” for advanced treatments for cancer, autoimmune diseases, and rare disorders.

NASPGHAN is concerned that efforts by the FDA to make it easier for biosimilars to be developed as interchangeable with brand-name biologics will increase the practice of payer- or pharmacy-driven biologic substitution. In its letter, NASPGHAN called for pediatric patient protections against non-medical switching, instead requiring explicit approval of the treating physician before a switch is made.

The letter pointed out that when pharmacists swap biologic products without the advanced knowledge or approval of the treating physician, it does not afford the provider the opportunity to educate the patient/family about or adjust for things like different injection devices or citrate-free formulations. NASPGHAN also highlighted that non-medical switching without proper education and notice can disrupt copay assistance programs and lead to nocebo effects.

NASPGHAN Member Advocacy Leads to Positive Change in Colorado

Effective Jan. 1, 2026, Colorado Medicaid will pay an enhanced dispensing fee for total parenteral nutrition (TPN) pharmacy claims. The change follows efforts led by NASPGHAN member Lindsey Gumer, MD who advocated for increased infusion pharmacy reimbursement to preserve access to TPN for pediatric patients.

Pharmacies will now receive an extra $73.21 per TPN claim in addition to their standard dispensing fee.

Dr. Gumer began advocating for legislation to improve reimbursement for home PN when she realized that pediatric patients who depend on PN could suddenly find themselves without care because home infusion companies were exiting the state.

“When I saw the number of private infusion companies caring for our patients on home PN with Colorado Medicaid drop from four to just one, I realized we were facing a near crisis,” said Dr. Gumer.

Working with Children’s Hospital Colorado, Dr. Gumer guided the development of bipartisan legislation and provided compelling testimony before state lawmakers. The bill was signed into law by Colorado Governor Jared Polis (D) on May 28, 2025.

NASPGHAN supported the advocacy effort by leading a letter to the Centers for Medicare and Medicaid Services (CMS) asking for approval of Colorado’s Medicaid State Plan Amendment to allow for the enhanced dispensing fees. The letter was signed by 11 other national and state organizations. CMS approved the enhanced dispensing fee in October 2025.

Since the bill took effect, a second infusion company has opened its doors to Colorado patients. “Seeing the tangible, positive impact this legislation has had on our patients and their families has been truly incredible,” said Dr. Gumer.

Administration Changes Childhood Vaccine Schedule

Health and Human Services (HHS) Deputy Secretary Jim O’Neill, who is currently acting as the Center for Disease Control and Prevention’s leader, signed a decision memo on January 5, making dramatic changes to the childhood vaccine schedule. In making these changes, the Administration bypassed its own vaccine advisory body.

The move comes after President Trump directed HHS Secretary Robert F. Kennedy Jr. in December to review the childhood schedule and consider revising it to align with those of other developed countries, most of which recommend fewer shots.

A statement led by the National Foundation for Infectious Diseases and signed by NASPGHAN called on policymakers and public health leaders to

“reaffirm their commitment to a transparent, evidence-based immunization policy process and to ensure that U.S. childhood vaccination recommendations remain grounded in U.S. data, expert consensus, and rigorous scientific review.”

The statement was critical of comparing the U.S. childhood immunization schedule to other countries, which ignore differences in population size, diversity, health care access and infectious disease risk.

According to an HHS fact sheet, diseases covered by the previous immunization schedule will still be available to anyone who wants them through Affordable Care Act insurance plans and federal insurance programs, including Medicaid, the Children’s Health Insurance Program, and the Vaccines for Children program.

Read the HHS press release here.

CDC Adopts ACIP Hepatitis B Vaccine Recommendations

The Centers for Disease Control and Prevention (CDC) has thrown out the recommendation for a universal birth hepatitis B vaccine dose and replaced it with the position that the first hepatitis B vaccine should be delayed until two months of age for infants born to mothers who test negative for the virus. Parents, in consultation with their health care provider, can still decide when or if their child will begin the hepatitis B vaccine series.  Read the CDC press release here.

For infants born to mothers who test positive for hepatitis B or whose status is unknown, the currently recommended birth dose of hepatitis B vaccine continues with no change.  The change reflects recommendations approved by newly appointed members of the Advisory Committee on Immunization Practices (ACIP).

The CDC says “consistency of coverage” of the hepatitis B vaccine will be maintained through all payment mechanisms, including the Vaccines for Children Program, Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal Health Insurance Marketplace.

The CDC is still reviewing ACIP’s recommendation that subsequent vaccine doses should be evaluated after anti-HBs serology testing.

In a November letter to ACIP, NASPGHAN urged the panel to maintain the birth-dose recommendation. Following the December ACIP vote, NASPGHAN joined a statement led by the American Association for the Study of Liver Diseases calling on the Trump Administration to uphold the birth dose for all infants.

NASPGHAN Asks Administration for Exception to H-1B Policy

In a December letter to Department of Homeland Security Secretary Kristi Noem, NASPGHAN urged that an exception be provided to H-1B physicians from the Proclamation, “Restriction on Entry of Certain Nonimmigrant Workers,” issued by President Trump on Sept. 19, 2025.

The Proclamation orders prospective employers to pay an additional $100,000 fee for new H-1B petitions for workers abroad, effective Sept. 21, 2025. There is no exception for physicians; although the Secretary of Homeland Security has the authority to grant exceptions to the fee in “extraordinarily rare” circumstances.

The NASPGHAN letter emphasized that H-1B physicians are necessary to meet patient demand for pediatric specialists, and that any exception for physicians from the new fee should be applied evenly and fairly among employers across the country.

Rep. McGovern Submits Testimony on Medical Foods and Formulas

Congressman Jim McGovern (D-MA) submitted testimony to the House Energy and Commerce Committee on December 12 in support of the Medical Foods and Formula Access Act (H.R. 5684). The testimony was for a “Member Day” hearing, which allows House lawmakers an opportunity to testify on issues within the Committee's jurisdiction, including specific legislation or topics of importance to them, their district, and their constituents.

In his testimony, Rep. McGovern urged that H.R. 5684 be included in a hearing “so that the House may pass this important legislation during the 119th Congress.” Rep. McGovern introduced H.R. 5684 in October. Read the press release here.

H.R. 5684 is endorsed by NASPGHAN and the Patients and Providers for Medical Nutrition Equity — a coalition founded NASPGHAN. NASPGHAN members are encouraged to contact their Senate and House lawmakers through the NASPGHAN Action Center and ask them to cosponsor H.R. 5684.

ACIP Upends Hepatitis B Vaccine Recommendation

NASPGHAN Members Urged to Take Action

On December 5, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to drop the recommendation for a universal birth hepatitis B vaccine dose and replaced it with a recommendation that the first hepatitis B vaccine should be delayed until two months of age for infants born to mothers who test negative for the virus.

Under the recommendations, only infants born to mothers who test positive for hepatitis B or whose status is unknown would still receive the birth dose. Additionally, ACIP voted that subsequent vaccine doses should be evaluated after anti-HBs serology testing, moving away from a recommendation for the full three-dose series.

In a November letter to ACIP, NASPGHAN urged the panel to maintain the birth-dose recommendation.

Following the vote, NASPGHAN joined a statement led by the American Association for the Study of Liver Diseases (AASLD) calling on the Trump Administration to uphold the birth dose for all infants. CDC Acting Director Jim O’Neil must approve ACIP’s new recommendations.

NASPGHAN is urging its members to take action by posting a message on X in favor of the universal birth dose. Taking action is easy through the NASPGHAN Action Center.

In related news, on December 5, President Trump signed a memorandum to begin the process to align U.S. core childhood vaccine recommendations with “best practices from peer, developed countries,” which, seemingly would bypass ACIP.

Medical Nutrition Bill Reintroduced in Congress

Legislation has been reintroduced in the Senate and House that would improve access to specialized foods and formulas for those with gastrointestinal and metabolic diseases and disorders. NASPGHAN members are encouraged to ask their members of Congress to cosponsor the bill. Take action now.

The bipartisan “Medical Foods and Formulas Access Act” (S.3304, H.R. 5684) is being led by Sens. Roger Wicker (R-MS), Amy Klobuchar (D-MN), Chuck Grassley (R-IA), and Sheldon Whitehouse (D-RI) in the Senate and by Reps. Jim McGovern (D-MA), John Rutherford (R-FL) and Debbie Dingell (D-MI) in the House. Read the press release here with quotes from the bill co-leads.

Introduction of the bill occurred under NASPGHAN’s leadership and with the endorsement of 50 organizations including the Patients and Providers for Medical Nutrition Equity Coalition, the American Academy of Pediatrics and the American Gastroenterological Association.

The legislation would require coverage of “medically necessary food” for those covered by Medicaid, SCHIP, Medicare and the Federal Employees Health Benefits Program.

On December 4, the Advisory Committee on Immunization Practices (ACIP) will convene and among its agenda items is discussion about the timeline for administration of the Hepatitis B vaccine in infants. In a letter to the Committee, NASPGHAN asked that the universal hepatitis B birth-dose recommendation be maintained.

The panel previously met in September, and, during that meeting, tabled a vote to change current Hepatitis B vaccine recommendations. As drafted, the recommendation is to delay the first vaccine dose until a child is at least one month old if the birth mother tests negative for Hepatitis B. Infants could still receive a dose of Hepatitis B vaccine before one month, but that would be based on shared clinical decision-making.

While NASPGHAN favors more widespread Hepatitis B testing of pregnant women, testing is insufficient and delaying the first vaccine in the series to one month or later creates a window of susceptibility. NASPGHAN further noted even though changes to the vaccine recommendations being discussed by ACIP sound small, “they are not grounded in new evidence and would undo more than three decades of a prevention strategy that has nearly eliminated early childhood hepatitis B in the United States.”

Organizations Ask Lawmakers to Increase NIH Funding

More than 450 organizations, including NASPGHAN, are asking congressional appropriators to provide at least $47.2 billion for the National Institutes of Health (NIH), as well as funding for the Advanced Research Projects Agency for Health (ARPA-H), for fiscal year 2026 — the amount approved by the Senate Appropriations Committee earlier this year.

On November 12, President Trump signed into law legislation ending the government shutdown. That package temporarily extends federal funding through Jan. 30, 2026 for nine of the 12 annual appropriations bills, including the Labor, Health and Human Services, and Education bill, which funds the NIH, while lawmakers complete work on those bills.

White House Reaches Deal to Cut Price of GLP-1s 

On November 6, President Trump announced Eli Lilly and Novo Nordisk will offer their GLP-1 weight-loss drugs at a significant discount. As part of the deal, consumers will be able to buy the companies’ products at a significant discount on TrumpRx when it launches. Ozempic and Wegovy will cost $350, and Zepbound and Orforglipron will be $346. If the Food and Drug Administration approves oral GLP-1 drugs manufactured by either company, their cost will be $150 a month through TrumpRx.

The Medicare prices for Ozempic, Wegovy, Mounjaro, and Zepbound will be $245. State Medicaid programs will also have access to these medications at the Medicare prices.

In exchange for the pricing deal, Eli Lilly and Novo Nordisk are expected to receive a three-year tariff exemption.

NASPGHAN is Listening!  Take our Policy & Advocacy Survey

NASPGHAN is your voice and the leading advocate for pediatric GI. NASPGHAN is updating its national advocacy platform to ensure its advocacy and policy efforts, but first we need to hear from you. Please take a moment to complete a short survey about what you think NASPGHAN’s advocacy and policy priorities should be. The feedback you provide will be instrumental in guiding how NASPGHAN approaches its policy work and will ensure your perspective is heard. Please give NASPGHAN five minutes of your time by completing this important survey.

Organizations Respond to FDA RFI on Defining Ultra-Processed Foods 

In October, NASPGHAN joined with other organizations in sending a letter to the Food and Drug Administration (FDA) as the agency contemplates developing a uniform definition of ultra-processed foods.

The letter emphasized the importance of specialized nutrition products, such as medical foods and formulas, and asked the FDA to not categorize them in the same manner as non-nutrient-dense, conventional foods when considering a definition of ultra-processed foods.

FDA Issues Draft Guidance for Demonstrating Biosimilarity

New draft industry guidance from the Food and Drug Administration (FDA) suggests the agency will change its approach to biosimilar review and no longer require comparative efficacy studies as part of an application for review.

The guidance states that if comparative analytical assessment (CAA) supports a demonstration the proposed biosimilar is highly similar to its reference product, “an appropriately designed human pharmacokinetic similarity study and an assessment of immunogenicity may be sufficient to evaluate whether there are clinically meaningful differences between the proposed biosimilar and the reference product in terms of safety, purity, and potency.”

The FDA has also stated its goal to make it easier for biosimilars to be developed as interchangeable with brand-name biologics.

NASPGHAN is reviewing the guidance which will be open for public comment for 60 days after the draft guidance is published in the Federal Register. Publication has been delayed due to the federal government shutdown.

Administration Issues Clarifying Guidance on H-1B Petitions

On Oct. 20, 2025, U.S. Citizenship and Immigration Services (USCIS) published additional guidance regarding H-1B petitions following the issuance of a proclamation by President Trump on Sept. 19, 2025 that orders prospective employers to pay an additional $100,000 fee for new H-1B petitions for workers abroad, effective Sept. 21, 2025. There is no exception for physicians. The proclamation grants the Secretary of Homeland Security the authority to grant exceptions to the fee in “extraordinarily rare” circumstances. It is unclear whether the Administration will provide exceptions to physicians.

The updated guidance clarifies the proclamation applies to new H-1B petitions and does not prevent any holder of a current H-1B visa, or any alien beneficiary following petition approval, from traveling in and out of the United States.

A federal lawsuit challenging the proclamation was filed October 3. The lawsuit was brought by Global Nurse Force and nine other groups.

NASPGHAN Backs New Indirect Research Cost Model

NASPGHAN, alongside nearly 300 organizations, is asking Congress to support a new model for ensuring that institutions’ essential scientific research costs are adequately supported. The groups are hoping Congress will embrace the work of the Joint Associations Group on Indirect Costs (JAG) and will stop the Office of Management and Budget from instituting arbitrary caps on “indirect costs” or “facilities and administration” (F&A) support for National Institutes of Health (NIH) grants.

On Feb. 7, 2025, the Trump Administration announced it would dramatically cut NIH grants by capping the rate grants pay for “indirect funding” at 15 percent. The abrupt change was opposed by NASPGHAN and others in the medical community. Litigation halted implementation of the policy, although the federal government has appealed the case.

The new model put forward by the JAG  — the Financial Accountability in Research (FAIR) Model — centers on improved transparency and better alignment of indirect cost reimbursement with specific research project needs. The way indirect costs are spread across research at an institution has been targeted by critics who say it allows institutions to evade accountability on how federal dollars are spent.

NASPGHAN Letter to Sens. Cassidy and VanHollen Endorsing the Cure Hepatitis C Act (S. 1941) 

July 28, 2025

NASPGHAN has endorsed the bipartisan Cure Hepatitis C Act (S. 1941), introduced by Sens. Bill Cassidy, MD (R-LA) and Chris Van Hollen (D-MD), that establishes a national program within the U.S. Department of Health and Human Services (HHS) to eliminate hepatitis C (HCV).

The legislation calls upon the Secretary of Health and Human Services to create a national strategy and implementation plan for the elimination of HCV in the United States, which includes the formation of an advisory committee comprised of clinicians, state and local public health officials, patients and other key stakeholders.

The bill creates an innovative purchasing model that authorizes the Secretary of HHS to enter agreements with drug manufacturers for the purchase of hepatitis C treatments. Drugs purchased under those agreements would be provided to registered pharmacies and other dispensing sites and made available to covered populations, including children enrolled in the Children’s Health Insurance Programs (CHIP), without cost-sharing.

The bill also authorizes funding for activities such as outreach to covered populations and screening for HCV.

In its letter, NASPGHAN wrote that early treatment for HCV in children is effective and cost-saving, and that the bill “ensures equitable and uninterrupted access to life-saving therapies during critical windows of early childhood.”

Thank you to Amal Aqul, MD, chair of the NASPGHAN Hepatology Committee, for her valuable contributions to NASPGHAN’s endorsement letter.

Take action now by asking your senator to cosponsor the legislation.

NASPGHAN Responds to FDA RFI on Infant Formula

NASPGHAN has provided extensive input to a request for information from the Food and Drug Administration (FDA) as the agency begins its review of the nutrient content in infant formula. There has not been a comprehensive assessment of nutrient requirements for infant formula since 1998.

In its September 10 letter, NASPGHAN encouraged harmonization between U.S. and European infant formula nutritional standards, including through U.S. adoption of a staged approach that requires different formula nutrient levels at different ages. NASPGHAN suggested the FDA consider a joint panel of European and North American pediatric nutrition experts to provide scientific input to the European Food Safety Authority and to the FDA to accomplish better alignment.

NASPGHAN also provided input on individual formula nutrients and key ingredients, including iron, protein, fats, DHA and ARA, and sources of carbohydrates.

In the letter, NASPGHAN urged the FDA to reinforce with the American public that infant formulas currently marketed in the United States are safe and asked the FDA to also review and update guidance on infant formula labeling and marketing.

In related news, NASPGHAN also recently commented on a draft Agency for Healthcare Research and Quality (AHRQ) comparative effectiveness review: Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid (PUFA) Intake and Child Growth and Development Outcomes. In its letter, NASPGHAN underscored, as significant limitations of the AHRQ systematic review, the exclusion of relevant studies and the variability of study methodologies, as well as the lack of focused findings on important subgroups (e.g., preterm infants, individuals with chronic disease, overweight/obesity).

Step Therapy Legislation Reintroduced in Congress

The Safe Step Act  (S. 2903 / H.R. 5509) has been reintroduced in Congress and lawmakers need to hear from you, their constituents, about why their co-sponsorship support of the bill is needed. The legislation would create a clear, timely and transparent process for a patient or physician to request an exception to step therapy protocols in certain situations, including when a patient is already stable on the prescription drug selected by his or her provider. Contact your members of Congress through the NASPGHAN Action Center. It only takes a few minutes to send an email to your lawmakers using a template letter created for you by NASPGHAN. Take Action Now.