Health care providers, suppliers, manufacturers, Medicare Advantage organizations, and other participants in Federal health care programs that uncover potentially criminal billing, kickback, or excluded-person conduct inside their own operations now face a materially different—and less forgiving—self-disclosure roadmap.

On October 15, 2026, the Justice Department’s National Fraud Enforcement Division (“Fraud Division”) and the HHS Office of Inspector General (“HHS-OIG”) issued a joint Policy on Coordination of Voluntary Self-Disclosure in Health Care Fraud Matters (the Policy), and HHS-OIG simultaneously updated its Health Care Fraud Self-Disclosure Protocol (“SDP”). See also the DOJ press release (Oct. 15, 2026).

The government touts the consolidation as offering simplification: a single qualifying voluntary self-disclosure to the Fraud Division’s Health Care Fraud Section now earns the benefits of both DOJ’s Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP) and the HHS-OIG SDP, with no duplicate submission through the OIG portal. The less-advertised—but arguably more consequential—change runs the other way. HHS-OIG has expressly closed the SDP to disclosure of Federal crimes, and a disclosure made only to HHS-OIG generally will not qualify as a voluntary self-disclosure to DOJ or support a CEP declination. For organizations that historically treated the SDP as the default first call, the choice of which door to knock on first now carries real criminal-exposure consequences.

What the Joint Policy Does

The Policy establishes the following core rules:

• One disclosure, two sets of benefits. A company that makes a voluntary self-disclosure to the Health Care Fraud Section “within the meaning of the CEP,” relating to conduct involving a Federal health care program as defined in 42 U.S.C. § 1320a-7b(f), receives the benefits of the HHS-OIG SDP. Only one disclosure is required to obtain both CEP and SDP benefits. (Policy § I, ¶ 1; § III.A).
• DOJ forwards the disclosure to OIG. The Health Care Fraud Section will promptly provide HHS-OIG a copy of the disclosure upon receipt. (Policy § III.B).
• OIG-only disclosure generally does not count with DOJ. Consistent with footnote 5 of the CEP, a disclosure made only to HHS-OIG under the SDP generally does not qualify as a voluntary self-disclosure to the Fraud Division and generally will not satisfy the criteria for a Part I CEP declination. Such a disclosure may still be considered as part of a company’s cooperation and remediation credit. (Policy § I, ¶ 2; § III.C).
• Good-faith disclosure to another DOJ component still qualifies. Quoting the CEP, the Policy confirms that good-faith disclosure to one DOJ component, where the matter is later brought to another appropriate component, also qualifies. (Policy n.3).
• Effective date. The Policy applies to voluntary self-disclosures of potential criminal violations affecting one or more Federal health care programs made to the Fraud Division on or after October 15, 2026. (Policy § III.A).
• Submission channel. DOJ directs self-disclosures to corporate.enforcement@usdoj.gov. (DOJ press release).

Important Limits Buried in the Footnotes

Several qualifications in the Policy should temper any expectation that a DOJ disclosure resolves everything:

• Mandatory exclusion is not covered. The SDP benefits conferred through a DOJ disclosure do not include resolution of mandatory exclusion under 42 U.S.C. § 1320a-7(a). (Policy n.4). Organizations whose conduct could result in a conviction triggering mandatory exclusion must plan for that exposure separately.
• Declination remains discretionary. Fraud Division prosecutors retain discretion to recommend a declination after weighing the severity of the circumstances against the company’s self-disclosure, cooperation, and remediation. (Policy n.5).
• No enforceable rights. The Policy expressly disclaims creating any right or benefit enforceable at law or in equity. (Policy n.1).
• The CEP’s definition controls. A disclosure qualifies only if it is made to the Fraud Division (or another qualifying DOJ component) and satisfies every element of the CEP’s definition of voluntary self-disclosure. (Policy § II.A; CEP).

What Changed in the Updated HHS-OIG SDP

HHS-OIG’s October 15, 2026 SDP update implements the Policy and makes several operational changes providers should note:

• Federal crimes are now expressly ineligible. The SDP adds a fifth category of ineligible conduct: it is not available for disclosure of Federal crimes, which should be disclosed to DOJ. Any criminal disclosure that does come through the SDP will be referred to DOJ for resolution. (SDP §§ 2.C, 6).
• The 90-day clock now runs from submission. Disclosing parties expected to complete their internal investigation and damages calculation now have 90 days from the date of the initial submission—not from acceptance into the SDP, as before. (SDP §§ 1.B, 3.A). This effectively front-loads the investigation and damages work before filing.
• Benefits for qualifying civil/administrative matters remain. These include a presumption against requiring integrity agreement obligations in exchange for a release of permissive exclusion, a general minimum multiplier of 1.5 times single damages, and suspension of the 60-day overpayment report-and-return obligation under 42 U.S.C. § 1320a-7k(d) upon OIG’s acknowledgment of a timely submission (see 42 C.F.R. § 401.305(b)(2)(i)). (SDP § 1.B).
• Minimum settlements are unchanged. OIG continues to require a $100,000 minimum settlement for kickback-related submissions and $20,000 for all others. (SDP § 8).
• Physician self-referral-only conduct still goes to CMS. Arrangements implicating only the physician self-referral law, without accompanying Anti-Kickback Statute (AKS) exposure, remain outside the SDP and belong in CMS’s Self-Referral Disclosure Protocol. (SDP §§ 2.C, 7).

The Parallel Civil Track: The DOJ–HHS FCA Self-Disclosure Pilot Program

The Policy does not stand alone. DOJ’s Civil Division and HHS (the Office of the General Counsel, OIG, and CMS) have also launched a Healthcare Self-Disclosure Pilot Program (FCA SDPP), announced October 22, 2026, for potential False Claims Act violations previously unknown to the government (HHS press release (Oct. 22, 2026)). Key features include a coordinated civil release with no factual admissions; a repayment of 1.25–1.6 times a “Base Self-Disclosure Repayment”; no Corporate Integrity Agreement as part of any resolution of OIG’s permissive exclusion authorities; and CMS’s agreement not to impose civil monetary penalties or seek revocation in pilot resolutions. Submissions must be made to FCA-SDPP@usdoj.gov by 11:59 p.m. on April 22, 2027; late or partial submissions will not be reviewed. (FCA SDPP §§ II–III).

The FCA SDPP dovetails with the criminal Policy: it is limited to potentially civil conduct, routes potentially criminal conduct to the Fraud Division, and provides that a company that has made a qualifying criminal disclosure to the Fraud Division need not make a duplicative FCA SDPP submission, with supplementation requested only as needed if the company also seeks a civil FCA release. (FCA SDPP n.1).

Why the Timing Matters: A Rapidly Escalating Enforcement Environment

The Policy is one piece of a deliberate build-out. DOJ created the Fraud Division on April 7, 2026 (DOJ press release). On October 1, 2026, Assistant Attorney General Colin M. McDonald issued Directive 26-12: Corporate Enforcement in the Fight Against Fraud. Then, on October 20, 2026, DOJ launched the Fraud Whistleblower Incentive Program (WHIP), which pays tipsters $10,000 to $30,000 upon the filing of criminal charges—rather than after final resolution—for information relating to Federal health care offenses and fraud on specified Federal programs. For health care, WHIP prioritizes hospice, home health care, day care, and special services fraud. (WHIP press release; WHIP terms).

The practical message is unmistakable: employees, contractors, and business partners now have a faster financial incentive to go directly to DOJ, while the window in which an organization can still claim a voluntary disclosure is shrinking. Delay spent debating where to disclose—or defaulting to an OIG-only filing for conduct that may be criminal—can forfeit declination eligibility altogether.

Analysis: The Hard Part Is the Triage

The Policy simplifies where to file once an organization concludes conduct may be criminal. It does not simplify the threshold judgment itself. The same arrangement—an illegal remuneration arrangement, billing for medically unnecessary services, or employment of an excluded person—can support criminal, civil FCA, and administrative CMP theories simultaneously, and the government’s own documents describe these as overlapping. Organizations should expect the following pressure points:

• Criminal versus civil characterization. The AKS is a criminal statute that also triggers CMP and FCA liability. An organization that characterizes knowing kickback conduct as purely civil and files only with OIG risks losing CEP credit if DOJ later views the conduct as criminal.
• Required admissions. The SDP requires disclosing parties to acknowledge a potential violation and identify the specific laws implicated; equivocal statements can lead to removal. (SDP § 2.B). Counsel must coordinate these acknowledgments with criminal exposure analysis before anything is filed with any agency.
• Individuals are not protected by the entity’s disclosure. The Policy and CEP address corporate resolutions. Executives, physicians, and employees involved in the conduct may have separate and divergent interests, which raises Upjohn-warning, separate-counsel, and indemnification/advancement questions.
• Employment-law crosscurrents. Internal reporters may simultaneously be WHIP tipsters or potential qui tam relators. Discipline or termination decisions involving anyone connected to the reported conduct must be reviewed for retaliation exposure, including under the FCA’s anti-retaliation provision, 31 U.S.C. § 3730(h).
• The 60-day overpayment suspension may not travel with a DOJ-first disclosure. CMS’s regulation suspends the Medicare Part A/B report-and-return deadline only when (i) OIG acknowledges receipt of an SDP submission, (ii) CMS acknowledges receipt of a Self-Referral Disclosure Protocol submission, (iii) the provider requests an extended repayment schedule, or (iv) the provider is conducting a timely, good-faith investigation of related overpayments—a suspension that ends no later than 180 days after the initial overpayment was identified. (42 C.F.R. § 401.305(b)(2)–(3)). A disclosure to DOJ is not among the listed triggers. Neither the Policy nor the updated SDP addresses how the suspension applies when the Health Care Fraud Section forwards a disclosure to OIG and no SDP submission is made; the SDP continues to describe the suspension as arising when OIG acknowledges receipt of an SDP submission. (SDP § 1.B). When CMS adopted the regulation, it reportedly declined commenters’ requests to extend the suspension to disclosures made to DOJ or Medicaid Fraud Control Units. (81 Fed. Reg. 7654 (Feb. 12, 2016)). [verify pin cite for the DOJ/MFCU comment response in the 2016 preamble] The regulation also covers only Medicare Parts A and B; the statutory 60-day obligation for Medicaid overpayments under 42 U.S.C. § 1320a-7k(d) has no corresponding regulatory suspension. Until DOJ, OIG, or CMS speaks to the question, a DOJ-first discloser should not assume the SDP’s overpayment suspension attaches automatically.
• Precaution: As of November 11, 2026, we found no DOJ, HHS-OIG, or CMS guidance on whether the 60-day overpayment suspension applies when a disclosure goes to DOJ first. As written, the regulation does not cover that route. (42 C.F.R. § 401.305(b)(2)). Organizations disclosing to the Fraud Division should not assume the suspension applies and should plan for the 60-day report-and-return obligation accordingly.

Action Items by Stakeholders

Boards and senior leadership should:

• Obtain training or education about Federal Sentencing Guidelines organizational and person exposure for criminal actions and best practices for preventing and mitigating these risks.
• Confirm that the organization’s disclosure-decision framework assigns clear authority and timelines for deciding whether, when, and where to disclose, and that it reflects the DOJ-first rule for potentially criminal conduct.
• Require periodic reporting on hotline volume, investigation aging, and disclosure decisions, recognizing that WHIP compresses the time available to act voluntarily.

Compliance Officers should:

• Update self-disclosure policies, investigation protocols, and escalation matrices that currently direct federal program issues to the OIG SDP by default.
• Build a documented triage step that screens every substantiated matter for potential criminal exposure before choosing among the Fraud Division, the OIG SDP, the CMS SRDP, the FCA SDPP, or a routine contractor refund.
• Refresh exclusion screening (including full-workforce LEIE screening, which the SDP requires before disclosing an excluded-person matter) and AKS arrangement reviews, particularly in hospice, home health, and day care service lines that WHIP prioritizes. (SDP § 3.C).

General Counsel should work with qualified outside counsel to:

• Tighten compliance controls and documentation.
• Structure internal investigations under privilege from the outset, with criminal-exposure assessment by counsel experienced in DOJ health care fraud matters.
• Calendar the FCA SDPP’s April 22, 2027 deadline for potentially civil-only matters, and evaluate whether any pending matters should be routed through the Fraud Division to capture both CEP and SDP benefits.
• Assess mandatory-exclusion risk separately, as the Policy does not resolve it.
• For DOJ-first disclosures involving quantified Medicare or Medicaid overpayments, request written confirmation from the Health Care Fraud Section and HHS-OIG at the time of disclosure as to whether OIG will treat the forwarded disclosure as an acknowledged SDP submission for purposes of 42 C.F.R. § 401.305(b)(2)(i). Absent confirmation, track the 180-day investigation suspension and evaluate, in coordination with the government, whether to return quantified overpayments through the MAC or an extended repayment schedule; OIG credits pre-resolution refunds toward settlement but is not bound by amounts repaid outside the SDP. (SDP § 10).

Human Resources should work with employment counsel experienced with health care and other Federal Sentencing Guidelines risk management to:

• Strengthen training and compliance oversight and enforcement.
• Tighten internal reporting channels and non-retaliation messaging so employees see internal reporting as credible and safe.
• Route any adverse employment action involving a reporter, witness, or implicated employee through legal review before implementation, and ensure investigation interviews include appropriate Upjohn warnings.
• Review separation, confidentiality, and release templates to confirm they do not purport to restrict reporting to government agencies.

Billing, Revenue Cycle, and Finance leaders should:

• Preserve claims, payment, and arrangement data needed to support the SDP’s damages methodologies (including statistically valid sampling of at least 100 items) or the FCA SDPP’s Base Self-Disclosure Repayment. (SDP § 3.B; FCA SDPP § II).
• Coordinate any overpayment refunds with counsel before processing, since repayments outside the SDP do not bind OIG and may affect the disclosure strategy. (SDP § 10).

Bottom Line

For potentially criminal health care conduct, the default first call is now DOJ’s Fraud Division, not HHS-OIG. The Policy reduces duplication for organizations that get the triage right, but it raises the cost of getting it wrong. Health care organizations should update their disclosure frameworks now, before a hotline report or a WHIP tip forces the decision on a compressed timeline.

For Help or More Information

The author of this update, Cynthia Marcotte Stamer has decades of experience advising and assisting health industry clients to design, audit, and defend their organizations and practices including conducting audits and investigations, designing and updating compliance and risk management programs, responding to government investigations, conducting transaction, governance, and other due diligence, and assisting with other legal and operational compliance and risk management and legislative and regulatory affairs. She is available to assist your organization in assessing the impact of these developments and navigating the compliance and strategic steps that follow. For more information about these or other health care, managed care and other health benefits, or other health industry laws or concerns, contact Ms. Stamer via e-mail or via telephone at (214) 452 -8297.

About the Author

Peer recognized as “Top Rated Lawyer” and “LEGAL LEADER™ “Top Rated Lawyer” and “Best Lawyer” for her work in Health Care Law, Labor and Employment Law; ERISA & Employee Benefits,” and “Business and Commercial Law,” Cynthia Marcotte Stamer is an A Martindale-Hubble “AV-Preeminent” (Top 1%) attorneys board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on PBM, pharmacy and pharmaceutical and other health care, managed care, insurance, and insured and self-insured contracting, design, administration and regulation.. 

Author of numerous highly regarded works on health care fraud and other compliance, risk management and operations,  Chair of the Tort Trial and Insurance Practice Section Medicine and Law Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, the ABA International Section Life Sciences Committee and the former Group Chair and Welfare Benefit Committee Co-Chair of the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health industry legal, public policy and operational concerns. 

Ms. Stamer’s work throughout her career has focused heavily on working with hospitals, health care systems, long term care, rehabilitation, home health, hospice, clinics, and other health care organizations; physician and other provider organizations and practitioners; accreditation, medical staff, peer review, and quality committees and organizations; billing, audit, practice management, utilization management, EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors and services organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; DME; health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations; consultants; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies on billing and reimbursement, government investigations and enforcement, and other legal and operational compliance and risk management, performance and workforce management, regulatory and public policy, and other legal and operational concerns. 

Author of a multitude of highly regarded publications and presentations,  Ms. Stamer is widely recognized for her thought leadership on these and other health care, managed care and other health plan,and other health industry matters.  In addition, Ms. Stamer contributes her time and leadership to numerous policy, professional, civil and other organizations including service as the, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources. 

Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any  fact or law specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2026 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.