DOJ National Fraud Enforcement Division (NFED): How Providers Should Prepare for Civil and Criminal Investigations

In 2026, the U.S. Department of Justice (DOJ) reorganized how it fights fraud against federal programs. On January 8, 2026, the White House announced plans for a new National Fraud Enforcement Division within DOJ, and on April 7, 2026, the Department of Justice formally announced the creation of the National Fraud Enforcement Division, often called the NFED or the "Fraud Division." DOJ describes the division as focused on investigating and prosecuting those who commit fraud against the American people, and its work supports the White House Task Force to Eliminate Fraud established by Executive Order 14395.

Health care is one of the largest areas of the division's work. The Health Care Fraud Section, which brings criminal health care fraud cases across the country, is part of the National Fraud Enforcement Division. Since its creation, the division has led the 2026 National Health Care Fraud Takedown, expanded its Health Care Fraud Strike Forces into new regions, entered data-sharing agreements with CMS and other agencies, and announced a joint self-disclosure policy with the HHS Office of Inspector General (HHS-OIG).

For healthcare providers, these developments raise practical questions. What is the National Fraud Enforcement Division? How do civil and criminal health care fraud investigations begin? What should an organization do if it receives a subpoena, a civil investigative demand, or a visit from federal agents? And what can providers do now to reduce risk and be ready to respond?

This article provides a neutral, educational overview of the NFED, the laws most often involved in health care fraud investigations, the differences between civil and criminal matters, and practical steps providers can take to prepare. It is not legal advice, and any organization facing an investigation should consult qualified legal counsel.

What Is the National Fraud Enforcement Division?

The National Fraud Enforcement Division is a DOJ component dedicated to fraud enforcement. According to the Congressional Research Service (CRS), the division is responsible for enforcing federal criminal and civil laws against those who target federal government programs, federally funded benefits, businesses, nonprofits, and private citizens, and it is charged with overseeing multi-district and multi-agency fraud investigations and working to dismantle organized fraud schemes that cross jurisdictions.

The division is led by an Assistant Attorney General. DOJ press releases identify Colin M. McDonald as Assistant Attorney General for the National Fraud Enforcement Division.

The Health Care Fraud Section

Within the division, the Health Care Fraud Section focuses on criminal health care fraud. DOJ describes the section as made up of more than 75 experienced white-collar prosecutors dedicated to prosecuting complex health care fraud matters and the illegal prescribing and dispensing of opioids and other controlled substances. The section works with dedicated data analysts to identify, investigate, and prosecute cases using data analytics, and DOJ states that it conducts more trials than any other component of the Department.

The section uses a Strike Force model that brings together prosecutors, data analysts, and federal and state law enforcement. According to DOJ, the Health Care Fraud Strike Force program, currently made up of nine strike forces, has charged more than 6,200 defendants who collectively billed federal health care programs and private insurers more than $45 billion since 2007.

Strike Force Expansion in 2026

In 2026, the division expanded the geographic reach of its Strike Forces. DOJ announced:

• The formation of a West Coast Health Care Fraud Strike Force covering the District of Arizona, the District of Nevada, and the Northern District of California. DOJ stated that data showed a significant and accelerating increase in health care fraud in those districts.

• Expansions to the District of Massachusetts and the District of Minnesota.

• An expansion of the Northeast Health Care Fraud Strike Force to Philadelphia, Pennsylvania, with a focus on Medicaid fraud, including Medicaid home health aide schemes.

Data and Interagency Partnerships

The division has placed heavy emphasis on data. In connection with the 2026 National Health Care Fraud Takedown, DOJ announced that the Fraud Division and CMS had entered an agreement under which the division will receive cloud computing space in the CMS Integrated Data Repository environment to deploy advanced data analytics algorithms and artificial intelligence tools. DOJ also announced agreements with the Department of Homeland Security and the Federal Trade Commission aimed at breaking down data silos.

DOJ also announced the launch of a National Fraud Detection Center, a prosecutor-led, multi-agency team designed to investigate those defrauding federal programs, including actors operating schemes across multiple programs. Its inaugural members include the FBI, IRS Criminal Investigation, the Treasury Department, and the offices of inspector general for many agencies, including the Department of Health and Human Services.

In addition, the division has announced federal-state partnerships, including a partnership with Ohio that includes access to state corporate registrant data to help identify ownership links among clinics, laboratories, and billing entities, and cooperation agreements with several southeastern states.

Enforcement Results

The division's first major health care showcase was the 2026 National Health Care Fraud Takedown, announced on June 23, 2026, which resulted in charges against 455 defendants, including 90 doctors and other licensed medical professionals, in schemes involving more than $6.5 billion in alleged false claims. DOJ reported that the Takedown included 295 Medicaid fraud defendants and more than $518 million in alleged false Medicaid claims, the largest number of Medicaid fraud defendants and Medicaid fraud loss charged in Department history.

DOJ has also emphasized trial work. In one announcement, DOJ reported that the Health Care Fraud Unit secured jury convictions in six trials in under three weeks, involving more than $1.1 billion in fraud losses across six schemes.

How Health Care Fraud Investigations Begin

Understanding where investigations come from helps providers understand their risks. Common sources include:

• Data analytics. DOJ, HHS-OIG, and CMS use claims data to identify statistical outliers. DOJ has described cases in which its Data Analytics Team identified a provider as a statistical extreme compared with peers.

• Whistleblowers. Current or former employees, business partners, competitors, or patients may report concerns to the government or file a qui tam lawsuit under the False Claims Act.

• CMS and contractor referrals. CMS, Unified Program Integrity Contractors (UPICs), and Medicare Administrative Contractors may refer suspected fraud to HHS-OIG and DOJ. CMS reported that law enforcement accepted 372 CMS fraud referrals in 2025.

• State referrals. State Medicaid agencies refer cases to Medicaid Fraud Control Units (MFCUs), which may work with federal prosecutors.

• Patient complaints. Beneficiaries may report services they did not receive.

• Financial intelligence. DOJ and its partners use financial data to trace health care fraud proceeds.

Many investigations begin quietly. A provider may not know it is under review until it receives a document request, a subpoena, or a visit from agents.

Key Laws in Health Care Fraud Investigations

The False Claims Act

The civil False Claims Act (31 U.S.C. 3729 to 3733) imposes liability on anyone who knowingly submits, or causes the submission of, a false or fraudulent claim for payment to the federal government. "Knowingly" includes actual knowledge, deliberate ignorance, and reckless disregard of the truth. Liability can include treble damages and per-claim civil penalties that are adjusted for inflation. The False Claims Act also applies to knowingly retaining an identified overpayment.

The False Claims Act allows private individuals, known as relators, to file qui tam lawsuits on behalf of the United States under 31 U.S.C. 3730 and to share in any recovery. Section 6 of Executive Order 14395 directs the Attorney General to promote the meritorious pursuit of qui tam actions involving fraud in federal benefit programs.

The Anti-Kickback Statute

The federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) makes it a crime to knowingly and willfully offer, pay, solicit, or receive anything of value to induce or reward referrals of items or services payable by federal health care programs. Claims resulting from violations may also create False Claims Act liability.

The Physician Self-Referral Law

The physician self-referral law, often called the Stark Law (42 U.S.C. 1395nn), generally prohibits physicians from referring Medicare patients for certain designated health services to entities with which they have a financial relationship, unless an exception applies.

Criminal Health Care Fraud Statutes

Federal criminal statutes used in health care cases include the health care fraud statute (18 U.S.C. 1347), conspiracy statutes, wire fraud, false statements relating to health care matters, aggravated identity theft, money laundering, and obstruction.

Administrative Remedies

HHS-OIG may impose civil monetary penalties under the Civil Monetary Penalties Law (42 U.S.C. 1320a-7a) and exclude individuals and entities from federal health care programs under 42 U.S.C. 1320a-7. CMS may suspend payments and revoke Medicare enrollment.

Civil vs. Criminal Investigations: Understanding the Difference

Health care fraud matters can proceed on civil, criminal, and administrative tracks, sometimes at the same time. These are often called parallel proceedings.

Civil Investigations

Civil investigations are usually handled by DOJ's Civil Division or civil attorneys in U.S. Attorneys' Offices, often working with HHS-OIG. The most common civil tool is the civil investigative demand (CID) under 31 U.S.C. 3733, which can require documents, written answers to interrogatories, and oral testimony. Civil matters often begin with a qui tam complaint filed under seal, and the government investigates before deciding whether to intervene. Civil matters typically resolve through settlement, sometimes with a corporate integrity agreement with HHS-OIG.

Criminal Investigations

Criminal investigations are handled by federal prosecutors, such as the Health Care Fraud Section of the National Fraud Enforcement Division or U.S. Attorneys' Offices, working with agents from HHS-OIG, the FBI, and other agencies. Tools include grand jury subpoenas, search warrants, interviews, undercover operations, and financial tracing. Individuals may receive target or subject letters. Criminal cases can result in indictments, plea agreements, trials, prison sentences, restitution, and forfeiture.

Signs a Matter May Be Criminal

Indicators that a matter may have a criminal component include a grand jury subpoena, a search warrant, unannounced agent interviews of employees, or communications from a criminal prosecutor. Any of these warrants immediate involvement of experienced counsel.

How to Prepare Before an Investigation

The best time to prepare for an investigation is before one starts.

1. Maintain an Effective Compliance Program

HHS-OIG's General Compliance Program Guidance describes the elements of an effective compliance program, including written policies and procedures, compliance leadership and oversight, training and education, effective lines of communication, enforcing standards, risk assessment, auditing and monitoring, and responding to detected offenses. DOJ also considers the effectiveness of a company's compliance program when evaluating corporate cases.

• Designate a compliance officer with real authority and access to leadership.

• Report regularly to the board or owners on compliance risks and activities.

• Conduct an annual risk assessment that considers current enforcement priorities, such as Medicaid, laboratory testing, wound care and skin substitutes, durable medical equipment, hospice, home health, telehealth, and behavioral health.

2. Audit Your Highest-Risk Areas

• Conduct regular internal audits of claims in high-risk and high-volume service lines.

• Compare your billing patterns with peers where data is available, because enforcement agencies use data to identify statistical outliers.

• Investigate and document the reasons for significant changes in billing volume or patterns.

3. Review Financial Relationships

• Inventory all arrangements with referral sources, marketers, vendors, and physicians.

• Confirm that each arrangement is in writing, reflects fair market value, and does not vary with the volume or value of referrals.

• Review arrangements for compliance with the Anti-Kickback Statute and the Stark Law with qualified counsel.

4. Handle Overpayments Promptly

Under 42 CFR 401.305, Medicare providers must report and return identified overpayments. CMS amended the rule effective January 1, 2025, to allow the 60-day deadline to be suspended for up to 180 days while a provider conducts a timely, good-faith investigation of related overpayments. Knowingly retaining an identified overpayment can create False Claims Act liability.

5. Encourage Internal Reporting

Because many cases begin with whistleblowers, organizations benefit from making it easy and safe for employees to raise concerns internally.

• Maintain a confidential or anonymous hotline.

• Adopt and enforce a non-retaliation policy.

• Investigate every report promptly and document the outcome.

6. Screen for Exclusions

Screen employees, contractors, and vendors against the HHS-OIG List of Excluded Individuals and Entities, SAM.gov, and state Medicaid exclusion lists. Schemes that conceal an excluded provider are among the conduct DOJ has identified in its self-disclosure guidance.

7. Build Records Management and Preservation Practices

• Maintain records according to the longest applicable federal and state retention requirements.

• Make sure records can be retrieved quickly, including emails, text messages, and data held by vendors.

• Prepare a process for issuing a legal hold that suspends routine deletion when an investigation is anticipated.

8. Prepare a Response Plan for Government Contact

Every organization should have a written plan for responding to subpoenas, civil investigative demands, search warrants, and agent visits. The plan should identify who to call, including legal counsel, and who is authorized to speak for the organization.

Responding to Specific Types of Government Contact

Subpoenas and Civil Investigative Demands

• Contact legal counsel immediately.

• Note the return date and any deadlines.

• Issue a legal hold to preserve all potentially relevant documents and electronic data.

• Do not destroy, alter, or backdate any records. DOJ has prosecuted obstruction in cases where providers fabricated or backdated records after receiving a subpoena.

• Work through counsel to discuss scope, timing, and the format of production with the government.

• Keep a complete record of everything produced.

Search Warrants

• Remain calm and cooperative, and do not obstruct agents.

• Ask for a copy of the warrant and identify the lead agent.

• Contact legal counsel immediately.

• Designate a point person to accompany agents and take notes on what is searched and seized, without interfering.

• Ask for an inventory of items seized.

• Understand that employees may choose whether to speak with agents and may have counsel present, but the organization should not instruct employees not to cooperate or discourage them from speaking with the government.

Agent Interviews

Agents from HHS-OIG, the FBI, or other agencies may contact current or former employees at work or at home. Organizations should consult counsel about how to inform employees of their rights in a lawful and non-coercive way. Statements to federal agents must be truthful, because false statements can be a separate crime.

Payment Suspensions and Other Administrative Actions

An investigation may be accompanied by a CMS payment suspension under 42 CFR 405.371, often based on a credible allegation of fraud. Providers generally may submit a rebuttal statement under 42 CFR 405.374. State Medicaid programs must suspend payments when there is a credible allegation of fraud under 42 CFR 455.23, subject to good-cause exceptions.

Self-Disclosure and Cooperation

The 2026 Joint Self-Disclosure Policy

On October 15, 2026, the National Fraud Enforcement Division and HHS-OIG announced a policy under which a company that voluntarily self-discloses potential criminal conduct affecting a federal health care program to the Fraud Division's Health Care Fraud Section can receive the benefits of both DOJ's Corporate Enforcement Policy and HHS-OIG's Health Care Fraud Self-Disclosure Protocol, without a separate submission to HHS-OIG. DOJ gave examples of conduct that may be covered, including illegal kickbacks, schemes to bill Medicare for medically unnecessary services, and schemes to conceal an excluded provider.

HHS-OIG updated its Self-Disclosure Protocol to clarify that criminal health care matters should be disclosed to DOJ. DOJ stated that a company that discloses only to HHS-OIG generally will not have made a voluntary self-disclosure to the Department and generally will not qualify for a declination on that basis. DOJ also stated that companies that come forward, cooperate fully, and remediate can expect clear and predictable benefits, while those that conceal misconduct should expect a very different outcome.

DOJ also reported that the Fraud Division announced the first declination of a health care company under the Department-wide Corporate Enforcement Policy, which resulted from a voluntary self-disclosure.

Other Disclosure Options

• The HHS-OIG Health Care Fraud Self-Disclosure Protocol remains available for conduct that may violate civil or administrative law.

• The CMS Voluntary Self-Referral Disclosure Protocol is available for potential Stark Law violations.

• Routine overpayments are generally reported and returned through the Medicare Administrative Contractor under 42 CFR 401.305.

Choosing the right disclosure path is a significant legal decision. Organizations should involve experienced counsel before making any disclosure.

Protecting Individuals and the Organization

DOJ has emphasized accountability for individuals, including owners, executives, and others involved in the business side of health care fraud schemes. Organizations should understand that the interests of the organization and its individual employees or executives may differ in an investigation. Counsel for the organization represents the organization, and individuals may need separate counsel. Organizations should review indemnification, advancement of legal fees, and insurance coverage, such as directors and officers insurance, before an investigation arises.

An Investigation-Readiness Checklist

• Written compliance program aligned with HHS-OIG General Compliance Program Guidance.

• Annual compliance risk assessment reflecting current DOJ and HHS-OIG priorities.

• Regular internal and periodic external claims audits.

• Inventory and legal review of all referral and financial arrangements.

• Written overpayment policy consistent with 42 CFR 401.305.

• Confidential hotline and non-retaliation policy.

• Monthly exclusion screening of workforce, contractors, and vendors.

• Records retention and legal hold procedures, including electronic communications.

• Written protocol for subpoenas, civil investigative demands, search warrants, and agent visits.

• Designated legal counsel experienced in health care fraud matters.

• Leadership training on the self-disclosure options and decision-making process.

• Review of insurance coverage and indemnification policies.

Frequently Asked Questions

Is the National Fraud Enforcement Division only focused on health care?

No. The division addresses fraud against many federal programs, including benefits programs, small business loans, housing assistance, and tax fraud. Health care is one of its largest areas of work.

What is the difference between a subpoena and a civil investigative demand?

A grand jury subpoena is issued in a criminal investigation. A civil investigative demand is a civil tool under the False Claims Act that can require documents, written answers, and testimony. HHS-OIG can also issue subpoenas. Each requires prompt attention and legal advice.

Can a civil matter become a criminal matter?

Yes. Civil, criminal, and administrative matters can proceed in parallel, and information developed in one may be shared with others as permitted by law.

Does a compliance program prevent investigations?

No compliance program can guarantee that an investigation will not occur. However, an effective compliance program helps organizations find and fix problems early, and DOJ considers compliance program effectiveness when evaluating corporate cases.

Should we self-disclose if we find a problem?

It depends on the facts. Many billing errors are overpayments that should be returned through normal channels. Potential fraud or kickback issues may warrant self-disclosure to DOJ or HHS-OIG. This decision should be made with experienced legal counsel.

Conclusion

The DOJ National Fraud Enforcement Division represents a more centralized, data-driven, and coordinated federal approach to fraud enforcement. For healthcare providers, the division's expanded Strike Forces, data partnerships with CMS and other agencies, focus on Medicaid, and new self-disclosure policy signal an environment in which compliance problems may be identified quickly and handled across civil, criminal, and administrative tracks.

Providers can prepare by maintaining an effective compliance program, auditing high-risk areas, reviewing financial relationships, handling overpayments promptly, encouraging internal reporting, preserving records, and adopting a clear response plan for government contact. Preparation helps organizations respond calmly and effectively if an investigation arises, and it often helps prevent problems from becoming investigations at all.

How HealthBridge Can Help

HealthBridge is a healthcare management consulting firm that specializes in compliance, program integrity, and investigation readiness for healthcare providers. We help organizations assess compliance risks, conduct internal audits, review documentation and billing practices, build response protocols for government contact, and coordinate with legal counsel during reviews. If you would like help preparing your organization for civil or criminal health care fraud investigations, please get in touch with us. We will be happy to help you with this topic.

References

• U.S. Department of Justice, Office of Public Affairs. National Health Care Fraud Takedown Results in 455 Defendants Charged in Connection with Over $6.5 Billion in Alleged Fraud (June 23, 2026). https://www.justice.gov/opa/pr/national-health-care-fraud-takedown-results-455-defendants-charged-connection-over-65

• U.S. Department of Justice, Office of Public Affairs. National Fraud Enforcement Division and the Department of Health and Human Services Announce Self-Disclosure Protocol for Criminal Health Care Fraud (October 15, 2026). https://www.justice.gov/opa/pr/national-fraud-enforcement-division-and-department-health-and-human-services-announce-self

• U.S. Department of Justice, National Fraud Enforcement Division. Health Care Fraud Section. https://www.justice.gov/fraud/health-care-fraud-section

• U.S. Department of Justice, National Fraud Enforcement Division. Speeches and Videos. https://www.justice.gov/fraud/speeches-and-videos

• U.S. Department of Justice, Office of Public Affairs. The Fraud Division Launches West Coast Strike Force to Target Health Care Fraud Schemes Across Arizona, Nevada, and Northern California. https://www.justice.gov/opa/pr/fraud-division-launches-west-coast-strike-force-target-health-care-fraud-schemes-across

• U.S. Department of Justice, Office of Public Affairs. The Fraud Division Announces Charges Against 19 Defendants for Medicaid Home Health Aid Schemes. https://www.justice.gov/opa/pr/fraud-division-announces-charges-against-19-defendants-medicaid-home-health-aid-schemes

• U.S. Department of Justice, Office of Public Affairs. National Fraud Enforcement Division's Healthcare Fraud Unit Secures Six Trial Convictions Involving over $1.1 Billion in Fraud. https://www.justice.gov/opa/pr/national-fraud-enforcement-divisions-healthcare-fraud-unit-secures-six-trial-convictions

• U.S. Department of Justice, Office of Public Affairs. Department of Justice Announces Launch of National Fraud Detection Center to Combat Fraud Against Taxpayer-Funded Programs. https://www.justice.gov/opa/pr/department-justice-announces-launch-national-fraud-detection-center-combat-fraud-against

• U.S. Department of Justice, Office of Public Affairs. Fraud Division Announces Federal-State Partnership in Ohio to Prosecute Fraud. https://www.justice.gov/opa/pr/fraud-division-announces-federal-state-partnership-ohio-prosecute-fraud

• U.S. Department of Justice, Office of Public Affairs. Justice Department's Fraud Division Announces Unprecedented Fraud Enforcement Actions in Southeast Resulting from Federal-State Partnerships. https://www.justice.gov/opa/pr/justice-departments-fraud-division-announces-unprecedented-fraud-enforcement-actions

• Congressional Research Service. Executive Order 14395, "Establishing the Task Force to Eliminate Fraud," IF13229 (May 19, 2026). https://www.congress.gov/crs-product/IF13229

• The White House. Establishing the Task Force to Eliminate Fraud, Executive Order 14395 (March 16, 2026). https://www.whitehouse.gov/presidential-actions/2026/03/establishing-the-task-force-to-eliminate-fraud/

• Centers for Medicare & Medicaid Services, Center for Program Integrity. Crushing Fraud: Annual Report 2025. https://www.cms.gov/files/document/crushing-fraud-annual-report.pdf

• U.S. Department of Health and Human Services, Office of Inspector General. General Compliance Program Guidance. https://oig.hhs.gov/compliance/general-compliance-program-guidance/

• U.S. Department of Health and Human Services, Office of Inspector General. Health Care Fraud Self-Disclosure. https://oig.hhs.gov/compliance/self-disclosure-info/

• U.S. Department of Health and Human Services, Office of Inspector General. Exclusions Program and LEIE Database. https://oig.hhs.gov/exclusions/

• U.S. Code. 31 U.S.C. 3729, False Claims. https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3729&num=0&edition=prelim

• U.S. Code. 31 U.S.C. 3730, Civil Actions for False Claims. https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3730&num=0&edition=prelim

• U.S. Code. 31 U.S.C. 3733, Civil Investigative Demands. https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3733&num=0&edition=prelim

• U.S. Code. 42 U.S.C. 1320a-7b, Criminal Penalties for Acts Involving Federal Health Care Programs. https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320a-7b&num=0&edition=prelim

• U.S. Code. 42 U.S.C. 1395nn, Limitation on Certain Physician Referrals. https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395nn&num=0&edition=prelim

• U.S. Code. 18 U.S.C. 1347, Health Care Fraud. https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1347&num=0&edition=prelim

• Electronic Code of Federal Regulations. 42 CFR 401.305, Requirements for Reporting and Returning of Overpayments. https://www.ecfr.gov/current/title-42/section-401.305

• Electronic Code of Federal Regulations. 42 CFR 405.371, Suspension, Offset, and Recoupment of Medicare Payments. https://www.ecfr.gov/current/title-42/section-405.371

• Electronic Code of Federal Regulations. 42 CFR 455.23, Suspension of Payments in Cases of Fraud. https://www.ecfr.gov/current/title-42/section-455.23