RFK Jr. launches new vaccine injury initiative

HHS Secretary Robert F. Kennedy Jr. recently announced the launch of a vaccine injury initiative, which includes a new research clinic at NIH and a new billing code to reimburse doctors for filing reports of serious vaccine side effects.

HHS announced the opening of the clinic last week, saying the clinic is dedicated to studying "patients experiencing health problems following vaccination."

"We must listen to patients and families who report vaccine injuries — not dismiss or gaslight them," Kennedy said in a statement. "President Trump and I are building a health system that takes them seriously, follows the evidence, and uses what we learn to make vaccines safer. This is how we earn back trust in our public health institutions."

In addition, HHS said it would propose reimbursing physicians who report any suspected vaccine-related injuries to the Vaccine Adverse Event Reporting System. The agency would also require a patient's electronic health records be included in vaccine-related adverse event reports.

Vaccine experts said that while they're skeptical of Kennedy's focus on vaccines in well-studied areas like autism and metals, they acknowledged the need for additional vaccine safety research.

"I do think that we do need to take these adverse events more seriously, and I think that we need to build that into how we fund scientific research in the future," said Helen Chu, a former member of CDC's Advisory Committee on Immunization Practices.

Daniel Salmon, who leads the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health, agreed. "More research in vaccine safety would be very helpful," he said, adding that "it needs to be rigorous science."

(Stolberg, New York Times, 10/7; Choi, The Hill, 10/8)

Hospitals sue to block 340B rebate pilot (again)

The hospital industry has launched a new lawsuit aimed at blocking HHS' revamped 340B rebate pilot that would require providers to pay upfront for drugs and seek rebates later.

In recent years, several drugmakers have attempted to implement a rebate model for 340B drug discounts. Instead of receiving upfront discounts for drugs, hospitals would have to pay the full price and then apply for a rebate later.

Several drugmakers, including Johnson & Johnson, Eli Lilly, Bristol Myers Squibb, Novartis AG, and Sanofi, have tried to implement 340B rebate programs, but were blocked by the Health Resources and Services Administration (HRSA) under the Biden administration.

However, HRSA later approved its own 340B Rebate Model Pilot Program in November 2025. The rebate program was originally intended to begin Jan. 1, 2026, and run for one year, but the American Hospital Association (AHA), the Maine Hospital Association (MHA), and four safety-net hospitals filed a lawsuit against HRSA to block the 340B rebate pilot program. In the lawsuit, Judge Lance Walker of the U.S. District Court of Maine ruled against HRSA, saying that the program would likely violate the Administrative Procedure Act and could potentially harm hospitals.

In August, HRSA announced a revised version of its 340B Rebate Model Pilot Program. Under the program, covered entities will have up to 45 days after dispensation to submit claims data for a rebate, and drug manufacturers must pay all rebates within 10 days of a completed data submission. Manufacturers must also provide "rationale and specific documentation for reasons claims are denied," HRSA said. 

In the new lawsuit, AHA, MHA, and three community-based providers claim that HHS and HRSA illegally ignored their feedback on the substantial expenses that would be borne by providers and suggestions for alternate approaches to the rebate program.

In a letter sent to Kennedy, Oregon Gov. Tina Kotek (D), California Gov. Gavin Newsom (D), Maine Gov. Janet Mills (D), New Mexico Gov. Michelle Grisham (D), and Virginia Gov. Abigail Spanberger (D) asked HHS to use its enforcement discretion to tie the compliance date to demonstrated state readiness instead of a fixed calendar date.

According to the governors, CMS' June 1 interim final rule reversed guidance the agency had provided states over the past year. Specifically, they called out three changes: a definition of medical frailty that goes beyond the new statute, new compliance activities that require form and system changes, and a verification hierarchy that requires states to determine a person's work status before they evaluate compliance or exceptions. Given these changes, the governors argued that notices and staff training cannot be built out and tested in time.

These Medicaid work requirements were originally established as part of the One Big Beautiful Bill Act, which passed and became law last year.

The work requirements will apply to adults enrolled in Medicaid through the program's expansion under the Affordable Care Act and to those with lower incomes who are not also enrolled in Medicare. There are several exceptions to the requirements, including for individuals who are pregnant or postpartum, disabled or medically frail, and parents and caretakers of children under the age of 14.

Under CMS' final rule, those who aren't exempt must prove they spent at least 80 hours per month working, performing community service, or engaged in education at least half-time.

(Cass, Becker's Hospital Review, 10/2)

US rejects UN declaration pledging collaboration on future pandemics

The United States last month rejected a declaration by member countries of the United Nations pledging international collaboration and solidarity preparing for and responding to any future pandemics.

The declaration, which was produced in a high-level UN meeting on pandemic preparedness, is not legally binding nor does it set any rules for what countries should do during pandemics.

The Trump administration objected to the declaration. CDC Director Erica Schwartz represented the United States at the session and said that, despite some meaningful revisions, the document included "divisive ideologies that lack definitional consensus" and that the United States "is not in a position to support this text in full."

Although Schwartz didn't clarify what those ideologies were, an early draft obtained by the New York Times showed the United States asked to delete mentions of equality, solidarity, and universal access to sexual and reproductive healthcare services. An official who spoke to the Times on condition of anonymity said that U.S. officials suggested edits throughout the process that would've made the Trump administration more comfortable with the language.

Meanwhile, the European Union also objected to the declaration, saying parts of it crossed "explicit red lines" on intellectual property protections, and that "technology transfer must be voluntary and on mutually agreed terms."

In a statement, a spokesperson said that the EU "supports the important overarching objective of the declaration — strengthening pandemic prevention, preparedness, and response and its many useful elements — while not agreeing with the elements in the declaration that set us back in the achievement of that objective."

(Mandavilli, New York Times, 9/25)