Pediatric Policy Council Update

The APS and SPR are members of the Pediatric Policy Council (PPC) which actively advocates for children and academic pediatrics at the federal level. SPR representatives to the PPC are Dr. Joyce Javier, Dr. Shetal Shah, and Dr. Ashwini Lakshmanan; Dr. Lisa Chamberlain and Dr. Scott Lorch represent APS.

The PPC also includes representatives from the Academic Pediatric Association (APA) and the Association of Medical School Pediatric Department Chairs (AMSPDC). The PPC is based in the Washington DC office of the American Academy of Pediatrics (AAP), who supplies staff and other support.

The latest advocacy developments are summarized by the PPC below:

PPC CAPITOL CONNECTION

October 31, 2024

What Matters Now in Washington:

  • Congress passed a clean continuing resolution (CR) through the end of December, putting off finalizing FY 2025 appropriations until after the election.
  • CMS has unveiled new guidance on improving access to comprehensive health care for children and youth enrolled in Medicaid.
  • The Senate passed KOSA and COPPA 2.0, and a key House committee has advanced them for full chamber consideration.
  • The All of Us Research Program has begun a limited round of pediatric enrollment of the youngest children, from birth through age 4.
  • The Child Tax Credit expansion measure failed to advance in the Senate.
  • A bipartisan pair of senators introduced a bill to accelerate pediatric rare disease research and treatment advances.
  • PPC members authored policy commentaries in Pediatric Research exploring the intersections of child health policy, advocacy, and pediatric research.
  • Find new funding opportunities, research findings, and more below.
  • See what other developments we’re tracking with implications for child health advocacy.

 

HOUSE AND SENATE APPROVE, PRESIDENT BIDEN SIGNS CONTINUING RESOLUTION THROUGH DECEMBER. On Wednesday, September 25, Congress approved a temporary funding bill that keeps the government open at current spending levels until December 20, buying lawmakers additional time to negotiate a full-year spending bill for Fiscal Year (FY) 2025. President Biden signed the CR into law soon afterwards, averting a government shutdown that otherwise would have occurred at the start of FY 2025 on October 1. This effectively puts off all budget negotiations until after the 2024 elections. Congress has since recessed until after the election and is scheduled to return on November 12, which will give lawmakers roughly five weeks to finalize final FY25 appropriations bills.

The move comes after Speaker Mike Johnson (R-La.) failed to garner majority support within his party for a six-month continuing resolution (CR) paired with a controversial measure known as the Safeguard American Voter Eligibility (SAVE) Act that would require documentary proof of citizenship to vote in federal elections. The inclusion of the SAVE Act, along with a six-month CR timetable, were both nonstarters with congressional Democrats. Moderate Republicans had also come out against inclusion of the SAVE Act, fearing the electoral implications of a possible government shutdown 35 days before the elections. Once it became increasingly clear that Johnson would not have the necessary votes to advance this measure, he pulled this proposal from consideration from the House floor altogether, and instead put forth a clean CR for House consideration.

The bipartisan, clean CR includes the three-month timetable most members were pushing for. The bill does include a provision extending authority for state governments to reimburse Supplemental Nutrition Assistance Program (SNAP) beneficiaries who have had their benefits stolen through skimming – a technique in which criminals copy electronic benefit transfer (EBT) card information at points of purchase. Omitted from the CR was an additional $7.7 billion in funding for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) that was requested by the Biden Administration.

 

—The Senate Appropriations Committee Advanced its FY25 Labor-HHS Spending Legislation Over the Summer. Over the summer, the Senate Appropriations Committee approved its FY 2025 Labor-HHS-Education spending bill. The bipartisan measure, approved on a 25-3 vote, funds the Department of Health and Human Services (HHS) at $122.8 billion, $15 billion more than the funding provided for in the House version that proposed a 7% cut to the department from the FY24 enacted level.

The bill funds the National Institutes of Health (NIH) at $50.224 billion, a $2.05 billion increase over the FY24 level, in contrast to the House bill which kept agency funding flat at $48 billion and had proposed a dramatic restructuring of the agency. This includes a $2 million increase for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The Senate bill also sustains funding of $1.5 billion for the Advanced Research Projects Agency for Health (ARPA-H). In addition, the Senate bill includes $127 million in funding authorized by the 21st Century Cures Act to support NIH’s efforts to advance life-saving biomedical research, including the Cancer Moonshot program.

Crucially, the bill fully restores funding for the All of Us Research Program back to FY22 and FY23 enacted levels of $541 million, amounting to a $184 million increase above FY24 levels. Additionally, the bill included report language acknowledging the lack of robust recruitment of children into All of Us, and strongly encourages NIH to build a diverse pediatric dataset within the program to accelerate health research and medical breakthroughs for children and their families.

In another important funding update, the bill maintains level funding for the Pediatric Specialty Loan Repayment Program (PSLRP) at $10 million. Like the House version of the bill, the Senate committee approved report language directing the Health Resources and Services Administration (HRSA) to work with subspecialty care stakeholders to ensure the program’s application process reflects the realities of pediatric subspecialty practice.

This legislation must still be reconciled with its House counterpart, which eliminates funding for gun violence prevention research and other programs supporting maternal and child health. The significant differences between the House and Senate funding bills will need to be resolved before final spending legislation can be advanced. However, the bipartisan nature of the Senate proposals suggests that the Senate bills may serve as a blueprint for what’s to come when final funding is considered after Congress returns from its recess.

In the months leading up to the funding deadline, the PPC and other child health advocates will continue to urge congressional appropriators to provide robust funding for key child health priorities as the FY 2025 budgetary process continues.

CMS RELEASES NEW MEDICAID EPSDT GUIDANCE FOR STATES. On September 27, the Centers for Medicare and Medicaid Services (CMS) released new guidance aimed at helping to ensure children enrolled in Medicaid have better access to comprehensive health care guaranteed by the Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit.

EPSDT represents the cornerstone health benefit for children, guaranteeing that eligible children and youth are guaranteed access to a wide range of preventive, diagnostic, and therapeutic services ranging from mental health services, dental, vision, and hearing care, and child welfare visits. These regulations are geared towards ensuring that children receive early access to medically necessary health care services, so that potential health complications arising in children are identified and treated as early as possible. However, implementation of the EPSDT benefit has been inconsistent across states, prompting Congress to direct CMS to perform a gap analysis and issue guidance to states as part of the 2022 Bipartisan Safer Communities Act.

The new guidance sent to states highlights a number of strategies and best practices for implementing EPSDT benefit requirements and is divided across three focus areas:

  • Promoting EPSDT awareness and accessibility so eligible families understand their rights
  • Growing the number of pediatricians and other pediatric practitioners participating in the Medicaid program
  • Improving care for children with specialized needs with a focus on children with mental health conditions, children in foster care and children with disabilities or other complex health needs

Additionally, CMS mandates that states provide a full continuum of medically necessary mental and behavioral health services for children with and without a diagnosis in order to meet their EPSDT obligation. The letter also recommends that state mental health systems create a children’s behavioral health benefit package that has a single point of entry and supports children and youth with mild to moderate behavioral health needs in primary care settings. This newly published guidance is a major step forward in guaranteeing that children receive the comprehensive and high-quality care they need, as EPSDT requirements are essential in the long run to achieve health equity by helping to provide access to necessary care for children enrolled in Medicaid and CHIP.

SENATE PASSES KIDS’ ONLINE SAFETY PACKAGE, BUT HOUSE FATE REMAINS UNCLEAR. On July 30, the Senate overwhelmingly passed a package of kids’ online safety and privacy bills in a 91-3 bipartisan vote. The Kids Online Safety and Privacy Act (KOSPA) — which includes both the Kids Online Safety Act (KOSA) and the Children and Teens Online Privacy Protection Act (COPPA 2.0) —would be the first meaningful legislation to protect children online in over 25 years.

KOSA would create a “duty of care” for online platforms that are used by minors, requiring social media companies to implement reasonable safeguards on their platforms in order to shield youth users from certain harms including online bullying, sexual exploitation, drug promotion, and eating disorders. Platforms would also be required to provide new safeguards, including restricting access to minors’ personal data and limiting features that encourage longer use of the apps such as autoplay. COPPA 2.0, which builds on a 1998 children’s privacy law of the same name, would extend privacy protections to those under 17. It would also ban targeted advertising to minors covered by the bill and give young people and their parents the option to delete personal information from social media platforms.

On September 18, the House Energy and Commerce Committee advanced the two bills for consideration by the full chamber, representing a promising development towards passing these bills into law. However, differences between the committee-reported and Senate versions of both KOSA and COPPA 2.0, made by House champions to address concerns from House GOP leadership about KOSA’s “duty of care” provisions, will need to be resolved before the bill can be enacted into law.

Advocates will continue to urge Congress to advance the strongest possible child online safety legislation before the end of the year.

NIH’S ALL OF US RESEARCH PROGRAM BEGINS LIMITED ENROLLMENT OF CHILDREN. On August 1, the National Institutes of Health (NIH) announced that the All of Us Research Program has initiated a limited round of pediatric enrollment for children from birth through age 4, across five partner heath care organizations nationwide.

NIH had been working to include pediatric participants in All of Us since the program’s launch in 2018. The program established a pediatrics branch in 2022 and had updated its protocol to support the participation of children from birth to age 5. Five healthcare provider organizations were selected to participate in an initial assessment of pediatric enrollment. The program began a short pilot phase for pediatric enrollment in late 2023 and modified the enrollment process after inviting feedback from partners and parents. However, following the enactment of the FY24 budget this past March, the program had announced a delay in launching pediatric enrollment citing limited funding capabilities.

With this latest announcement, the program will utilize existing funding with the goal of enrolling a few hundred children total for the remainder of the current calendar year. Since the announcement, All of Us has already enrolled more than 150 children in the research study. The program intends to expand pediatric enrollment to include older children throughout more facilities across the country, contingent on the availability of additional funding. Expanding participation to children will allow the program to achieve its mission of advancing health research across the entire lifespan.

CHILD TAX CREDIT EXPANSION MEASURE FAILS PROCEDURAL VOTE IN SENATE. On August 1, the Senate failed to clear a procedural hurdle invoking cloture for the Tax Relief for American Families and Workers Act (H.R. 7024) in a 48-44 vote. This tax package, which pairs expansions of the Child Tax Credit (CTC) with certain tax deductions for businesses, passed the House with broad bipartisan support in January.

The $79 billion package pairs a $33 billion expansion of the Child Tax Credit with three business provisions that lower corporate tax liabilities worth the same amount. The package to expand the CTC includes an increase of the refundability cap to $1,800 in 2023; $1,900 in 2024; and $2,000 in 2025 to index for inflation, as well as allowing families to use a prior year’s income to calculate their benefits in 2024 and 2025. If passed, the changes to the CTC would give an estimated 16 million children access to the full credit and lift as many as 400,000 children out of poverty in its first year. The American Rescue Plan Act of 2021’s interim implementation of the CTC increase resulted in a significant reduction of child poverty and hunger, as families utilized the additional funds to cover the costs for housing, groceries, and other necessities.

SENATORS INTRODUCE BIPARTISAN INNOVATION IN PEDIATRIC DRUGS ACT. Senators Jack Reed (D-RI) and Shelly Moore Capito (R-WV) introduced the Innovation in Pediatric Drugs Act of 2024, which would ensure that drugs for rare diseases are studied in children and that drug companies are held accountable for completing pediatric study requirements. A House companion of this bill was introduced in December 2023 by Reps. Anna Eshoo (D-CA) and Michael McCaul (R-TX). This bill would help speed up therapies for children who need them by making overdue changes to the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA).

Specifically, this bill would ensure that children with rare diseases can benefit from new and innovative treatments by allowing orphan drugs to be studied in children under PREA. When PREA was first passed in 2003, orphan drugs made up a small minority of annual drug approvals. Yet today, most newly approved drugs are orphan drugs, meaning that the majority of new drugs approved are exempt from pediatric study requirements. The bill would also increase funding for the NIH BPCA program to conduct studies of off-patent drugs used in children to ensure there is better data about older drugs to treat diseases in children. This program has been flat funded at $25 million since its inception in 2002, so this would mark the first funding increase in 22 years.

Several of the provisions of this bill were included in the House-passed H.R. 3433, Give Kids a Chance Act, which was championed by Reps. Eshoo and McCaul. This bill passed the House unanimously in September.

 

PPC POLICY COMMENTARIES. Members of the PPC have authored commentaries detailing the policy implications of research published in Pediatric Research. You can read these PPC-authored commentaries online:

KEY RESEARCH UPDATES FROM NIH

WHAT WE’RE READING: