HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
HHS OIG’s Nursing Facility: Industry Segment-Specific Compliance Program Guidance
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care
New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy - Thought Leaders in Health Law®
Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
HHS Office for Civil Rights Director Melanie Fontes Rainer on Progress and News at OCR
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Hospice Insights Podcast - A Refresh: What’s New in the New OIG General Compliance Program Guidance
The Presumption of Innocence Podcast: Special Edition | Episode 36 - Rolling Change: The DEA Turns Over a New Leaf on Marijuana Scheduling
Understanding the HHS OIG’s General Compliance Program Guidance
OMG. . .The OIG is at it Again
The FTC's Health Privacy Enforcement Actions
Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
The Proposed Arrangement - On August 7, 2025, the OIG issued Advisory Opinion 25-09.1 In this instance, the Requestor was a medical device developer, manufacturer, and seller of certain medical devices related to emergency...more
Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more
On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more
The Executive Order aims to bolster the resilience of the United States’s pharmaceutical supply chain by stockpiling Active Pharmaceutical Ingredients (“APIs”) for critical medicines in the Strategic Active Pharmaceutical...more
On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more
Reestablishes the Presidential Fitness Test and revitalizes the President's Council on Sports, Fitness, and Nutrition to promote youth participation in sports, improve national health, and address rising rates of obesity and...more
On July 29, 2025, Uri Monson, Secretary for the Pennsylvania Governor’s Office of the Budget issued a letter to its “partners in health and human services,” notifying them that since they work for a human services...more
ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS) to enforce the False Claims Act...more
Senate Steers Toward Summer Break - With the House already on August recess, the Senate will consider several of President Trump’s nominees, including Gustav Chiarello III to be an assistant secretary of the US Department of...more
In the end, the final termination letter arrived in the mail on July 18. For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D.,...more
In the early days of the second Trump Administration, several federal funding agencies announced caps to indirect cost (“IDC”) rates for federally funded research awards. In many cases, these caps would substantially reduce...more
As we reported in our recent client alert, the Trump administration has made clear that it is committed to using the False Claims Act (FCA) to prosecute healthcare fraud. Two recent Trump administration moves give important...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
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 2, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced the formation of the DOJ-HHS False Claims Act Working Group to strengthen “their ongoing collaboration to advance...more
On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more
On June 27, 2025, the Supreme Court in Kennedy v. Braidwood Management, Inc. upheld the structure of the U.S. Preventive Services Task Force (USPSTF, or “Task Force”), overturning a Fifth Circuit decision that had ruled that...more
The government has announced a renewed and expanded focus on False Claims Act (FCA) enforcement, doubling down on traditional health care priorities like kickbacks and drug pricing while signaling increased scrutiny of...more
Last week, in a 6-3 decision, the Supreme Court overturned a Fifth Circuit decision holding that HHS-appointed United States Preventative Task Force (USPTF) members are inferior officers that do not need to be approved by the...more
Federal regulators have paused enforcement of the 2024 Mental Health Parity and Addiction Equity Act (“MHPAEA”) Final Rule (the “2024 Final Rule”, published September 23, 2024) while they reconsider the rule and defend...more
Two recent U.S. Supreme Court rulings support provisions of the Affordable Care Act, one directly and one indirectly....more
On June 25, 2025, the Office of the Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) released a short video containing the highlights of the Medicaid Fraud Control Units (“MFCUs”) Annual...more
Since the Dobbs v. Jackson Women’s Health Organization decision (which overturned the landmark Roe v. Wade decision), the healthcare industry has continued to grapple with renewed concerns over patient privacy and...more
On June 18, 2025, in Purl v. U.S. Dep't of Health and Human Services, the U.S. District Court for the Northern District of Texas vacated the 2024 amendments to the HIPAA Privacy Rule that enhanced certain privacy protections...more