By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The U.S. Department of Justice (DOJ) announced significant revisions to its Justice Manual on September 18, 2026, aimed at strengthening enforcement of the federal False Claims Act (FCA). The changes clarify how federal attorneys may use agency guidance in enforcement cases and when the DOJ may seek dismissal of whistleblower or qui tam lawsuits.
These changes are especially important for physicians, pharmacies, hospitals, medical practices, healthcare executives, and other providers that bill Medicare, Medicaid, TRICARE, or other federally funded healthcare programs. Although the revisions may provide defendants with additional protections in certain FCA cases, they do not signal a reduction in federal enforcement of healthcare fraud.
DOJ Limits the Use of Nonbinding Agency Guidance.
One of the most significant revisions concerns “sub-regulatory guidance.” Healthcare professionals routinely encounter guidance from the Centers for Medicare & Medicaid Services (CMS), the Office of Inspector General (OIG), Medicare Administrative Contractors (MACs), and other federal agencies.
Such materials may include manuals, bulletins, FAQs, policy statements, advisory documents, billing instructions, and other agency publications. However, agency guidance does not have the same legal force as a federal statute or regulation.
The DOJ’s revised policy clarifies that agency guidance cannot impose legal obligations beyond statutes or regulations, and that individuals and businesses should be held accountable only for violating binding law (e.g., statutes and duly enacted regulations or rules).
Agency Guidance Can Still Be Important Evidence.
The revised DOJ policy does not permit healthcare providers to ignore agency manuals or guidance documents, which may still be used as evidence of knowledge, professional standards, scientific processes, compliance, and relevant factual or legal context.
This is especially significant under the FCA because the government must address whether a defendant acted with the required level of knowledge, often referred to as scienter. Therefore, even when a guidance document does not independently create a binding legal requirement, a provider’s awareness of that guidance could potentially become evidence in an FCA investigation or lawsuit.
Healthcare providers should continue to carefully review and document their responses to CMS manuals, billing guidance, compliance notices, Medicare Administrative Contractor instructions, and other government materials.
The second major revision concerns False Claims Act qui tam lawsuits, in which whistleblowers sue on the federal government’s behalf over alleged false claims for government funds. After investigating the allegations, the DOJ may decide to intervene and take primary responsibility for pursuing the lawsuit. Alternatively, the government may decline intervention and allow the whistleblower to continue pursuing the case.
Declining to intervene, however, does not necessarily mean the DOJ believes the allegations have no merit.
What This Means for Healthcare Providers Facing FCA Allegations.
The revisions may provide healthcare providers and their attorneys with additional arguments when defending certain FCA cases. For example, allegations based on nonbinding CMS guidance should be checked against binding statutes, regulations, or contractual requirements.
Similarly, healthcare providers defending declined qui tam lawsuits may wish to demonstrate to the DOJ why further litigation would not serve government interests. However, these revisions do not signal a decrease in federal healthcare fraud enforcement. Instead, the DOJ views these changes as a way to strengthen FCA enforcement by focusing resources on violations of legal and contractual obligations and cases that benefit the United States.
The DOJ’s latest revisions may change how certain FCA allegations are evaluated, but they do not eliminate the risks associated with inaccurate claims, improper billing practices, false certifications, kickbacks, medically unnecessary services, or other conduct that may trigger federal scrutiny.
Contact Health Law Attorneys Experienced in Handling Health Care Fraud Investigations and Other Legal Proceedings.
The Health Law Firm represents healthcare providers in Medicare and Medicaid audits, and in RAC audits throughout Florida and across the U.S. We also represent health providers in civil and administrative litigation by government agencies and insurance companies attempting to recoup claims that have been paid.
The Health Law Firm’s attorneys routinely represent physicians, dentists, pharmacists, psychotherapists, medical groups, clinics, pharmacies, assisted living facilities (ALFs), home health agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.
To contact The Health Law Firm please call (407) 331-6620 or toll-free at (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.
Sources:
Setty, Ganesh. “DOJ Revises Policies Over False Claims Act Suits.” Law360, (September 18, 2026). Web.
Office of Public Affairs. “DOJ Revises Justice Manual to Strengthen False Claims Act Enforcement.” U.S. Department of Justice. (September 18, 2026). Web.
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law; he is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.
Keywords: CMS manuals, sub-regulatory guidance, False Claims Act healthcare representation, DOJ False Claims Act defense lawyer, False Claims Act attorney, healthcare fraud attorney, qui tam healthcare lawsuit defense, DOJ qui tam dismissal, Medicare fraud investigation lawyer, Medicaid fraud investigation defense attorney, healthcare whistleblower representation, CMS compliance lawyer, healthcare fraud defense attorney, FCA healthcare attorney, healthcare fraud investigation representation, and False Claims Act defense, DOJ healthcare enforcement representation, reviews of The Health Law Firm, The Health Law Firm attorney reviews
“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999. Copyright © 2026 George F. Indest III, The Health Law Firm. All rights reserved. No part of this work may be reproduced in any way in any medium without the written permission of the copyright owner. The author of this work reserves the right to have his name associated with any use or publication of this work or any part of it.
