Note: Capitol Associates will not publish Capitol Insights the week of July 1^st in observance of Independence Day. In lieu of a new edition, we encourage you to read the Declaration of Independence.

On Wednesday, June 26^th, the House Ways and Means Subcommittee on Health held a hearing on value-based care. The hearing ended up focusing much more closely on administrative burdens, access to care, and the cost of implementing value-based programs in various communities.

The Presidential Debate between President Joe Biden and former President Donald Trump was held last night in Atlanta, Georgia. While the performances of the candidates were certainly the main takeaway, there were some policy conversations as well. Key health issues discussed include abortion and Medicare.

This morning, the Supreme Court of the United States released its highly awaited decision on Loper Bright v. Raimondo. As anticipated in last week’s edition of Capitol Insights, the decision overruled Chevron Deference, significantly reducing the power of federal regulators to interpret unclear laws. Importantly, Chief Justice John Roberts clarified in his decision that this ruling will not be applied retroactively and will only affect future laws.

Earlier this month, Republicans on the House Energy & Commerce Committee released a plan calling for major changes to the National Institutes of Health (NIH). Historically, the NIH has been a rare area of bipartisanship. Other influential members of Congress, such as Health, Education, Labor and Pensions (HELP) Ranking Member Bill Cassidy (R-LA), have also called for change to the structure of the NIH.

Notably, no structural legislative reforms to the NIH have advanced in nearly 20 years. The report categorizes its recommendations into two main areas: structural reforms and policy reforms.

Structural Reform

The proposal suggests reducing the NIH’s 27 Institutions and Centers (ICs) to 15, arguing that consolidation will eliminate unnecessary spending and bureaucracy. A significant structural change would absorb the Advanced Research Projects Agency for Health (ARPA-H) into the NIH.

Policy Reform

Most of the recommendations provided by the report were included in the Policy section of the proposal. The Policy section is further broken up into three subcategories. Below, is a non-exhaustive list of the main recommendations and themes from the Policy section:

Mission and Leadership Reform:

• Establishing a congressionally mandated commission to conduct a comprehensive review of NIH objectives.
• Bolstering public-private partnerships to foster innovation.
• Implementing five-year term limits for IC directors, with the option for a second term upon appointment by the NIH Director.
• Eliminating silos between NIH ICs.
• Enforcing financial disclosure requirements for NIH donors and partners to enhance transparency.
• Improving policies to address research misconduct.

Funding Reform:

• Granting Congress a more substantial role in directing NIH funding.
• Enhancing transparency on indirect costs to minimize waste and fraud.

Grant Reform:

• Restricting grants to investigators with no more than three ongoing NIH engagements to promote wider distribution of funding.
• Requiring reporting of grant research conducted outside the United States.
• Enhancing accountability measures for grantees.
• Introducing national security reviews for research involving foreign governments designated as adversaries.
• Strengthening efforts to prevent conflicts of interest.

This report establishes a foundation for potential legislative action, however, it remains uncertain whether Congress will advance these concepts into legislation. While this report was drafted by Republicans, many of the objectives could potentially gain bipartisan support, suggesting there could be a plausible path forward.

Stakeholders are invited to provide feedback by August 16 via email at NIHReform@mail.house.gov.

In the coming days, the Supreme Court of the United States (SCOTUS) is expected to issue an opinion on Loper Bright Enterprises v. Raimondo. This case challenges the Chevron deference doctrine, established by the 1984 decision in Chevron U.S.A., Inc. v. Natural Resources Defense Council. For 40 years, Chevron deference has allowed federal agencies to make “reasonable interpretations” of statutes that are “silent or ambiguous.” Federal agencies frequently rely on this precedent when developing regulatory policies. If SCOTUS overturns this precedent, it would significantly change how Congress and federal agencies create and implement policies.

Loper Bright considers whether or not federal agencies should have the power to interpret ambiguous statutes established by Congress. While the substance of this case has nothing to do with health policy, a decision that overturns the Chevron deference precedent would have major implications for healthcare policymaking.

Federal healthcare agencies rely on Chevron regularly to interpret ambiguity in healthcare policy areas. For example, the Centers for Medicare and Medicaid Services (CMS) regularly uses it to interpret major statutes. In one example highlighted in an October 2023 edition of Capitol Insights, CMS interpreted “ambiguity” in the No Surprises Act statute to give the qualified payment amount (QPA) added weight compared to other factors. The Texas Medical Association (TMA) challenged this interpretation in federal court because the NSA statute did not give any factors added weight. CMS defended its decision arguing it had the authority to give the QPA added weight based on the Chevron precedent. The district court disagreed, ruling that the statute was not ambiguous on this matter.

Overturning Chevron will undermine the authority of relevant federal healthcare agencies to interpret ambiguities within complex policy areas. Currently, under Chevron, agencies are empowered to make decisions within the scope of the intention behind policies, and as long as the interpretation is reasonable, courts can defer to that interpretation. If Chevron is overturned, more responsibility would also fall on Congress to define who gets to interpret the ambiguity of federal statutes.

SCOTUS is expected to publish its opinion on Loper Bright by the end of next week.

*Correction: Last week’s edition incorrectly linked the House Energy and Commerce Republican’s proposal to revamp the NIH as covered in this week’s featured topic. The correct link can be found here.

A federal Appeals Court curbed the Affordable Care Act’s preventative care mandate. The ruling only applies to the eight plaintiffs involved

The FDA has approved menthol-flavored electronic cigarettes, soon to hit the market.

A US District Court Judge vacated a 2022 guidance by the HHS Office of Civil Rights that warned against third-party entities collecting hospital website data. The judge stated that HIPAA does not protect against online data from public websites.

A summer COVID-19 wave is hitting with cases likely increasing in 39 states. COVID-19 hospitalizations have risen 25%.

New research suggests that high healthcare costs are one factor that drives up unemployment in the US.

US Surgeon General Vivek Murthy has declared gun violence a public health crisis. The Surgeon General called on congress to enact a ban on assault weapons and universal background checks.

The HHS finalized penalties for providers, ACOs and hospitals that unreasonably block the exchange of health information.

The U.S. Supreme Court declined to hear a case that challenged Connecticut’s ban on religious exemptions for vaccines in schools.

Oracle has launched a new generative AI-powered tool to improve clinical documentation.

House and Senate lawmakers sent a letter to CMS asking for greater oversight of artificial intelligence algorithms in Medicare Advantage prior authorization decisions.

Medicare will be cutting the price of 64 drugs that outpaced inflation. The move is a part of the Biden Administration’s effort to lower pharmaceutical prices through the Inflation Reduction Act.

If ACA subsidies are extended, the number of insured Americans is expected to increase by an average of 3.4 million annually.

Twenty years after a landmark report that chronicled health inequities, little is found to have improved.

The Supreme Court is allowing emergency abortions to continue in Idaho.

The Coalition for Health AI has released a framework on responsible AI use in healthcare. This comes as the federal government moves slower than AI advancement.