From the Editor’s Desk: Compliance Week’s Insights and Reflections from July to August 2025
AI and the False Claims Act
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
The Trend of Threatening Physicians for Personal Gain
Daily Compliance News: June 17, 2025, The JBS Goes Public Edition
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Daily Compliance News: June 16, 2025, The Golden Share Edition
Hospice Insights Podcast - Still Number One: Healthcare Fraud Remains Central in DOJ’s White Collar Enforcement Plan
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
Daily Compliance News: May 16, 2025, The Ethics Nightmare Edition
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
False Claims Act Insights - DOJ’s Reliance on FCA to Pursue Covid-Related Fraud
UPIC Audits
Criminal Health Care Fraud Enforcement: Projections for 2025 and Beyond – Diagnosing Health Care Video Podcast
AGG Talks: Home Health & Hospice Podcast - Episode 10: Anti-Kickback Compliance for Hospice and Skilled Nursing Providers
False Claims Act Insights - Stranger Than Fiction? An FCA April Fools’ Day Episode
The Presumption of Innocence Podcast: Episode 53 - Diagnosis: Innocent – A Doctor’s Journey to Acquittal
False Claims Act Insights - Reality Checks: How to Approach Healthcare Transactions Without Triggering FCA Liability
On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more
The Ninth Circuit recently affirmed two decisions that provide additional guidance regarding how arrangements with marketing agents implicate and violate the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220(a)(EKRA)....more
In June 2025, the Department of Justice announced the largest coordinated healthcare fraud takedown in U.S. history. The numbers were staggering: 324 individuals were charged and more than $14.6B in alleged fraud, more than...more
On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more
There’s always a “but” when it comes to AI. It has great potential, but there’s always the risk of bad things happening. In the case of the False Claims Act and healthcare, that’s very much the case. In a recent article for...more
The medical spa industry is thriving, but with growth comes complexity, particularly in New Jersey where healthcare and professional licensing rules intersect with business and real-estate regulations. For physicians, nurses,...more
On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more
On June 30, the Department of Justice (DOJ) announced the largest coordinated health care fraud enforcement effort in U.S. history, involving criminal charges against over 300 defendants and over $14.6 billion in health care...more
If you’re preparing to launch an audit within your healthcare organization, pause for a moment and consider this: how well you plan before the audit begins can significantly affect the outcome—and your risk exposure. This...more
If you’re trying to strengthen your organization’s compliance program, one of the most important recommendations from the Office of Inspector General’s (OIG) General Compliance Program Guidance is to integrate quality and...more
In an audit, election statement deficiencies can be costly. Auditors deny all claims covered by the problematic election statement, and those costs can multiply if more than one patient was affected. In this episode, Husch...more
Effective wound care is critical for patients recovering from surgery or managing chronic or non-healing wounds. Advances in treatment have led to the development of skin substitutes—bioengineered or natural materials...more
As we hit the halfway point of 2025, now is the perfect time to revisit your compliance work plan. While it’s always good practice to assess whether your organization is meeting its compliance goals, this year presents a...more
In this new episode of the HealthLaw HotSpot podcast, host Ericka Adler is joined by Roetzel litigation shareholder Michael Scotti to explore a growing and deeply concerning issue in health care: patients using threats, such...more
Welcome to the Daily Compliance News. Each day, Tom Fox, the Voice of Compliance, brings you compliance-related stories to start your day. Sit back, enjoy a cup of morning coffee, and listen in to the Daily Compliance News....more
On May 21, 2025, the Centers for Medicare & Medicaid Services (CMS) announced an aggressive plan (Plan) to expand its efforts to address fraud, waste, and abuse in Medicare Advantage (MA)....more
In today’s complex healthcare landscape, whistleblower claims are a major source of regulatory and legal risk for organizations. Last year saw a record number of “qui tam” claims filed under the False Claims Act. While...more
On May 21, 2025, CMS announced that it plans to increase its auditing efforts for Medicare Advantage (MA) plans. Effective immediately, CMS will audit all eligible MA contracts for each payment year in all newly initiated...more
On May 12, 2025, the Head of the Criminal Division for the Department of Justice (DOJ) issued a memorandum outlining its enforcement priorities. In this episode, Husch Blackwell’s Meg Pekarske and Jonathan Porter break down...more
Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more
In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more
On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans....more
Host Jonathan Porter welcomes to the show Husch Blackwell partner Bryan Nowicki, a Madison-based member of the firm’s Healthcare group, to discuss payment suspensions involving the Centers for Medicare & Medicaid Services...more
Welcome to the Daily Compliance News. Each day, Tom Fox, the Voice of Compliance brings to you compliance related stories to start your day. Sit back, enjoy a cup of morning coffee and listen in to the Daily Compliance News....more
In a recent False Claims Act case, a long-term care pharmacy and consulting services provider was found liable for submitting false claims to the government, resulting in a jury verdict of over $135 million in damages. The...more