Morning Briefing
Summaries of health policy coverage from major news organizations
Covid Vaccine 'Injury Table' In The Works As Shot Compensation Overhaul Continues
Stat: RFK Jr. Proposes Creating Covid-19 Vaccine Injury Table
Health secretary Robert F. Kennedy Jr. is preparing to make it easier for people to claim that they were injured by a Covid-19 vaccine and receive compensation. (Cirruzzo, 7/8)
From the Centers for Medicare & Medicaid Services —
Modern Healthcare: CMS' Outpatient Rule Proposal Revives 340B Hospital Payment Fight
A pair of 340B Drug Pricing Program proposals is reviving a complicated, years-long battle between safety-net hospitals and the federal government. The Centers for Medicare and Medicaid Services aims to slash Medicare reimbursements for 340B drugs and hasten a convoluted multibillion dollar clawback and redistribution process dating to 2017, when CMS first tried cutting payments. The agency laid out its plan last week in the hospital outpatient reimbursement proposed rule for 2027. (Early, 7/8)
Becker's Hospital Review: CMS Scraps ‘Fast-Track’ Process For Certain Medicaid Waivers: 6 Things To Know
CMS has rescinded a decade-old “fast-track” review process for certain Medicaid Section 1115 demonstration waiver extensions as the agency prepares to implement new federal budget neutrality requirements that take effect in 2027. The July 7 informational bulletin formally withdraws 2015 guidance that allowed eligible states to use an expedited review process when renewing some Section 1115 demonstrations. CMS said the change is necessary because new statutory requirements will require the agency’s chief actuary to certify that Medicaid demonstrations will not increase federal spending before they can be approved, renewed or amended beginning Jan. 1, 2027. (Condon, 7/8)
Regarding federal grants —
Axios: Trump's Federal Grant Overhaul Proposal Draws Massive Pushback
Academic scientists, biotech executives and investors, and patient advocacy groups are sounding alarms over the Trump administration's plans to add political reviews to the process for making research grants. (Owens, 7/9)
MedPage Today: Republican Senator Blasts Proposed Changes To Federal Grantmaking Process
A Republican senator criticized a proposed rule from the White House's budget office that would substantially change how federal grants are managed, arguing that it has the potential to harm patients and set back biomedical research. In a July 6 letter, Sen. Susan Collins (R-Maine), chair of the Senate Appropriations Committee, wrote that "the rule would impose new, burdensome requirements on award recipients that would harm small and rural communities, undermine scientific and biomedical research, and conflict with Congress' control over the federal funding process." (Firth, 7/8)
NPR: Funding For Prevention Of Teen Pregnancy Cut By Trump’s HHS
Last July, the Trump administration issued a notice to the dozens of organizations receiving Teen Pregnancy Prevention Program grants. "Program materials are expected [to] reflect the immutable biological reality of sex, not radical gender ideology, and may not promote anti-American ideologies such as discriminatory equity ideology," the document reads, listing five executive orders organizations needed to comply with to keep their grants. "Programs with such unauthorized content are not eligible for federal funding." (Simmons-Duffin, 7/8)
From the Food and Drug Administration —
Stat: Shortlist For New FDA Commissioner Now In Hands Of White House
The top contenders to lead the Food and Drug Administration have been sent to the White House for a final review and decision, according to a person familiar with the process. The finalists include Heidi Overton, a White House adviser; Jeffrey Vacirca, an oncologist and health system executive; and Stephen Ferrara, a health affairs official at the Defense Department. (Payne, 7/8)
The Hill: Gene Therapy For Children With Sickle Cell Disease Approved By FDA
A new treatment for children aged 2 or older with sickle cell disease has been approved by the Food & Drug Administration (FDA). In a Wednesday news release, the FDA announced it had approved Casgevy, the first gene therapy for children with the disease. “Casgevy is a gene therapy consisting of the patient’s own (autologous) hematopoietic (blood) stem cells, administered as a one-time single dose for intravenous infusion,” the release noted. (Djordjevic, 7/8)
NBC News: FDA Releases Report On Toxic Metals In Tampons And Potential Health Risks
The FDA has determined that various metals found in tampons don’t pose health risks to women. (Alvino, 7/8)
Also —
Stat: Trump Officials Push To Onshore Generic Drug Manufacturing
Last week, pharmaceutical leaders filed into a meeting room in the Eisenhower Executive Office Building, next to the White House, for a meeting with Secretary of State Marco Rubio, health secretary Robert F. Kennedy Jr., and HHS Chief Counsel Chris Klomp. The administration officials had a message for the industry: It’s time to bring production of essential medications back to the U.S. — or at least closer to home. (Payne, 7/8)
Stat: Lessons Learned: OMB Changes Tactics In Control Of Science
Thousands of federal civil servants who academic researchers see as partners in conducting their work were fired. An unprecedented number of scientific projects funded by previous administrations were terminated. Universities were pressured to abandon diversity programs and work to curb health disparities. On a Friday evening, the government tried to push through a dramatic change to how it reimburses universities for research overhead. (Oza, 7/8)
