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Denise Barnes counsels clients in high-stakes matters related to fraud allegations, including in healthcare, federal contract procurement, and securities and financial services. A former trial attorney with the U.S. Department of Justice (DOJ), she has extensive experience handling issues related to compliance, white-collar and regulatory investigations, and complex commercial litigation. Denise represents businesses in public and non-public investigations, regulatory inquiries, and proceedings involving federal and state agencies. She frequently assists clients navigating government investigations related to allegations arising under the False Claims Act (FCA), Anti-Kickback Statute (AKS), Stark Law, and Financial Institutions Reform, Recovery, and Enforcement Act (FIRREA). Notably, during her tenure at the DOJ, she spearheaded numerous multi-district investigations that resulted in over $2.7 billion in recoveries for federal taxpayers.

Guidance remains relevant as evidence, particularly in healthcare. While guidance cannot establish the underlying legal duty, CMS manuals, Local Coverage Determinations, and similar materials may still be used to prove scienter, notice, industry standards, and medical necessity in FCA cases.

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Continue Reading Guidance Out, Dismissals In: DOJ Rewrites the False Claims Act Playbook with Justice Manual Revisions on Sub-Regulatory Guidance and Qui Tam Dismissals

On August 5, the U.S. Department of Justice (DOJ) announced that a federal grand jury in the District of Nevada returned a six-count indictment charging Stephen Dubin, M.D., of Henderson, Nevada, with conspiracy to commit healthcare fraud and five counts of healthcare fraud. The charges against Dr. Dubin arise from an alleged scheme to defraud Medicare of approximately $95 million through the billing of medically unnecessary amniotic wound allografts to elderly Medicare beneficiaries as well as alleged kickbacks and rebates from two allograft distributors; sham full-price invoices; and, as to one distributor, a pass-through bank account held in the name of a shell company. According to DOJ, Medicare paid over $54 million on the allegedly fraudulent claims.
Continue Reading What Happens in Vegas…Gets DOJ’s Attention: $95M Wound Care Fraud Indictment

The Department of Justice (DOJ) recently announced the largest National Health Care Fraud Takedown in its history, charging 455 defendants—including 90 physicians and other licensed medical professionals—in schemes involving more than $6.5 billion in alleged false claims.

Continue Reading DOJ’s $6.5 Billion National Health Care Fraud Takedown Signals a New Era of Data-Driven Enforcement

As procurement fraud enforcement continues to be a priority for the Department of Justice and other federal agencies, we take a look back at significant 2025 enforcement developments affecting government contractors, grant recipients and participants in federal programs in our 2025 Procurement Fraud Review.

Continue Reading Procurement Fraud Enforcement Trends Continue Into 2026

Skin substitutes, bioengineered or natural materials designed to promote healing by replacing or supporting damaged skin, have become a key component of advanced wound care. But the significant Medicare reimbursement of these products commanded over the last few years has made them a prime target for enforcement by the Department of Justice and the Department of Health and Human Services Office of Inspector General (OIG).  

Continue Reading Federal Court Seizes $2 Million from Wound Care Clinic: What Providers, Distributors, and Manufacturers Need to Know

I provided insight for Law360 on the government’s recent settlement with IBM to settle allegations into the company’s diversity, equity and inclusion (DEI) practices. The IBM deal is the first of its kind involving a company and alleged violations of the False Claims Act related to DEI practices. The article suggests this deal may signal the Department of Justice’s (DOJ) focus on enforcement actions involving DEI and the potential fines incurred.

Continue Reading Takeaways from IBM’s DEI Settlement

I recently shared my perspective on President Trump’s newest executive order, which is designed to restrict federal contractors from participating in what the administration characterizes as “racially discriminatory” DEI efforts. Under this order, certain DEI‑related activities could put a contractor’s eligibility for future federal work at risk.

Continue Reading Understanding the False Claims Act Implications of Trump’s Latest DEI Order for Federal Contractors

On September 9, the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) released a major report (Report) regarding the fraud risks currently associated with skin substitute products billed to Medicare.

Continue Reading HHS-OIG’s Latest Wound Care Report Warrants Careful Scrutiny

The federal government’s growing use of the False Claims Act (FCA) to pursue customs fraud signals a new era of trade enforcement, with importers facing heightened scrutiny and increased risk of whistleblower actions.

Continue Reading Cracking Down on Customs Fraud: How the False Claims Act Raises the Stakes for Importers

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 designed to promote healing by replacing or supporting damaged skin. While these innovations hold great promise for the future of wound care, they have also come under increased scrutiny by regulatory agencies and the Department of Justice (DOJ).

Continue Reading Wound Care in the Crosshairs: Reimbursements Risks Amid Skin Substitute Fraud Investigations