With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On July 7, 2025, the National Institutes of Health (NIH) Office of Policy for Extramural Research issued NOT-OD-25-128, titled “Guidance on Enforcement of Closeout Requirements During the Appeals Process” (the Notice). The...more
WHAT: A Massachusetts federal judge blocked the National Institutes of Health (NIH) from cutting hundreds of programs that provide grants to universities, hospitals, and other organizations. The judge found that NIH offered...more
THIS WEEK’S DOSE - - Senate Finance Committee Releases Reconciliation Text. The language is subject to change as negotiations continue and the Byrd rule process plays out. - CMS Releases MA Risk Adjustment Audit Methodology...more
The National Institutes of Health (NIH) issued a notice on June 12, 2025, rescinding recent civil rights–related changes to the terms and conditions governing federally funded research (the Rescission). Effective immediately,...more
On April 21, 2025, the National Institutes of Health (NIH) announced a new civil rights term and condition of award for NIH grants, cooperative agreements and other transaction awards. The new term states that recipients of...more
When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more
The National Institutes of Health (NIH) on April 21, 2025, published a notice (the NIH Notice) updating the civil rights provisions of the NIH Grants Policy Statement and creating new requirements that federally funded...more
The National Institutes of Health (NIH) announced on April 21, 2025, a significant change to the terms and conditions governing federal funding (the Notice) applicable to all NIH grants, cooperative agreements and other...more
A group of 16 Democratic AGs, led by Massachusetts AG Andrea Joy Campbell, filed a lawsuit alleging that the National Institute of Health’s (NIH) delays in the review and approval of grant applications and terminations of...more
In just over two months since President Donald Trump assumed office, the Department of Health and Human Services (HHS), now under the leadership of Secretary Robert F. Kennedy Jr., has undergone a profound shift in its...more
An edict issued without warning in February 2025 by the National Institutes of Health (NIH), having the effect of slashing funding by the NIH across the board, has been put on a nationwide hold for now by a federal court in...more
Judge Angel Kelley of the U.S. District Court for the District of Massachusetts on March 12, 2025, issued a nationwide preliminary injunction halting the implementation, application or enforcement of the National Institutes...more
Welcome to our second issue of The Academic Advisor for 2025. In this edition, we cover the following topics of interest for schools, institutions of higher education, and other education-focused organizations: - the...more
On March 5, 2025, a US district court in Massachusetts issued a preliminary injunction blocking the National Institutes of Health (NIH) from implementing a February 7, 2025, “Supplemental Guidance” notice that would establish...more
On March 5, 2025, Judge Angel Kelley, a federal district court judge sitting in Massachusetts, granted a nationwide preliminary injunction which serves to temporarily block the Trump Administration’s attempt to cap the...more
Our Government Contracts Group examines how companies can prepare for the Trump Administration’s Rate Change Notice despite the uncertainty of the temporary restraining order that put it on hold....more
The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more
If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more
On January 27th, the Trump administration issued an order (the January 27th order) freezing all federal grants and loans, which would have cut billions of dollars of federal funding, largely to research universities....more
Over the past few weeks, the Trump administration has introduced sweeping changes across the federal government that have impacted the federal grantee and contractor community. Adding to these changes, the National Institutes...more
Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more