FDA Warning Letters on Exosome Products | Regulatory & Criminal Defense
FDA warning letters to exosome manufacturers cite unapproved drugs, unlicensed biologics, and misbranded products under the FD&C Act and PHS Act. Analysis of enforcement trends from 2024 through 2026, criminal prosecution risks, and the regulatory framework for exosome products. Defense by former senior DOJ officials.
CFTC Oil Futures Investigation: Insider Trading Charges and Defense
Former DOJ Fraud Section prosecutors analyze the CFTC oil futures investigation, Tag 50 exchange data, commodities fraud charges under the CEA, and defenses.
Home Health Certification in Federal Fraud Cases: OASIS, Homebound Status, Face-to-Face Encounter
Analysis of the Medicare home health certification process in federal criminal fraud cases. Covers the face-to-face encounter under 42 C.F.R. 424.22, OASIS assessment scoring under PDGM, homebound status certification, CMS-485 physician certification, LCD compliance, and defense strategies including cross-examination of beneficiary witnesses who received undisclosed kickback payments. By former DOJ Fraud Section prosecutors.
DOJ Creates the National Fraud Enforcement Division: What It Means for Federal Procurement Fraud Defense
On April 7, 2026, Acting Attorney General Todd Blanche established the National Fraud Enforcement Division. Analysis of the new division, recent criminal procurement fraud cases, the statutes DOJ uses, and the key defenses available to individuals facing investigation or indictment.
Operation Never Say Die: Federal Hospice Fraud Arrests and CMS Payment Suspensions
Eight defendants arrested and 221 hospice providers suspended in Operation Never Say Die. Analysis of the federal charges, CMS payment suspension procedures under 42 C.F.R. 405.371, and the strategic risks of responding to a suspension notice while a parallel DOJ criminal investigation may be active.
Clawback Demands: Coming soon from the Goliath Ventures Case
Clawback defense for Goliath Ventures investors, vendors, and professionals. Scott Armstrong and Drew Bradylyons, founders of Armstrong & Bradyylons PLLC and former senior DOJ officials, explain the receiver's theories, challenges, and strongest available defenses.
Injection Fraud Is a Federal Enforcement Priority: Charges, Defenses, and What Providers Need to Know
DOJ and HHS-OIG are aggressively targeting injection fraud in 2025 and 2026. Facet joint injections, Botox, trigger point injections, and epidural steroid injections billed to Medicare are under direct federal scrutiny. This guide covers the key federal charges, defenses, and billing codes at issue. Armstrong & Bradylyons PLLC defends physicians and healthcare executives in federal injection fraud investigations nationwide.
Hospice Fraud: On the Law-Enforcement Horizon
Federal hospice fraud investigations are escalating in 2025 and 2026. Scott Armstrong and Drew Bradylyons, two former Assistant Chiefs at DOJ’s Fraud Section, explain the scrutiny, investigations, and charges that hospice executives and certifying physicians face in these cases.