DOJ Announces Corporate Enforcement and Voluntary Self-Disclosure Policy for All Criminal Cases
Headlines that Matter for Companies and Executives in Regulated Industries
DOJ Announces Corporate Enforcement and Voluntary Self-Disclosure Policy for All Criminal Cases
On March 10, the US Department of Justice (DOJ) announced its Corporate Enforcement and Voluntary Self-Disclosure Policy (the Department CEP), a first-of-its-kind uniform corporate enforcement policy. While it is similar to the prior policy issued by the Criminal Division, last revised in May of 2025 (the Criminal Division CEP), the Department CEP introduces key changes, including modifications to the resolution framework and other policy shifts relating to self-disclosure requirements, cooperation standards, and credit, and the Corporate Whistleblower Awards Pilot Program.
The Department CEP governs all corporate criminal matters resolved with the DOJ, except for criminal antitrust matters, and “supersed[es] all component-specific or U.S. Attorney’s Office-specific corporate enforcement policies currently in effect.” Like prior CEPs, the Department CEP’s purpose is to incentivize companies to voluntarily self-disclose misconduct, cooperate with investigations, and remediate wrongdoing.
All corporate resolutions must be approved by the relevant Assistant Attorney General or US Attorney in coordination with the Office of the Deputy Attorney General and the Criminal Division, as required by the Justice Manual. Like the Criminal Division CEP, the Department CEP is divided into three parts to describe various outcomes if a company self-reports: (1) declinations, (2) “near miss” voluntary self-disclosures, and (3) other resolutions. It also includes a similar flowchart illustrating the possible outcomes based on key factors.
Stay tuned for our forthcoming alert that will provide greater detail and practical implications of the Department CEP.
Aetna Agrees to Pay $117 Million to Resolve FCA Allegations
On March 10, the US Attorney’s Office for the Eastern District of Pennsylvania announced a $117.7 million resolution with Aetna Inc.
The settlement resolves allegations that Aetna violated the False Claims Act (FCA) by submitting or failing to withdraw inaccurate diagnosis codes for Medicare Advantage Plan enrollees to inflate payments from the Centers for Medicare & Medicaid Services (CMS). According to the government, Aetna operated a “chart review” program for the 2015 payment year. Under that program, Aetna allegedly retrieved medical records from healthcare providers, retained diagnosis coders to identify medical conditions, and submitted additional diagnosis codes to CMS that providers had not reported to obtain increased payments. When those same chart reviews revealed that previously submitted diagnosis codes were unsupported, Aetna allegedly failed to delete or withdraw the inaccurate codes, as doing so would have required it to reimburse CMS.
The settlement also resolves separate allegations that, for payment years 2018 through 2023, Aetna knowingly submitted or failed to delete inaccurate diagnosis codes for morbid obesity where enrollees’ recorded body mass index (BMI) was inconsistent with that diagnosis. The morbid-obesity allegations stem from a whistleblower lawsuit filed under the FCA’s qui tam provisions by a former Aetna risk-adjustment coding auditor, who will receive a $2,012,500 share of the recovery. The qui tam case is captioned United States ex rel. Mary Melette Thomas v. Aetna Inc., et. al., No. 24-cv-339 (E.D. Pa.).
Read the DOJ’s press release here.
Three Individuals Convicted of $32 Million Dental Fraud and Racketeering Scheme
On March 9, following a six-week trial and nearly four days of deliberation, a federal jury in Reading, Pennsylvania, convicted three individuals — brothers Bhaskar and Arun Savani, and Aleksandra “Ola” Radomiak — of multiple charges relating to a scheme to defraud Medicaid by submitting fraudulent reimbursement claims, installing unapproved dental implants, and visa fraud. Three co-defendants (Niranjan Savani, accountant Sunil Philip, and chemist Bharatkumar Parasana) were acquitted of all charges.
According to prosecutors, over the course of a decade, the Savani brothers used an entity called “the Savani Group” to obtain more than $32 million from Pennsylvania Medicaid through nominee-owned dental practices to fraudulently bill Medicaid after the Savani Group’s own Medicaid contracts had been terminated. Bhaskar Savani, a dentist by training, controlled the group’s dental practices, while Arun Savani managed the group’s finances and real property holdings. Radomiak served as a senior employee and executive who allegedly facilitated the conspiracy to defraud Medicaid. Prosecutors alleged the defendants used the fraud proceeds to purchase luxury vehicles, fund trips, and pay for family members’ college tuition, while also evading nearly $1 million in taxes.
All three individuals were convicted on a wide range of charges, most notably including conspiracy to conduct a racketeering enterprise, health care fraud, and conspiracy to commit health care fraud. Sentencings are scheduled for July of this year.
Read the DOJ’s press release here.
Ninth Circuit Hears Oral Argument on Validity of QueerDoc Subpoena
On March 6, a Ninth Circuit panel heard oral arguments in a DOJ appeal seeking to revive a subpoena issued to QueerDoc, a telehealth provider of gender-affirming medical care.
The subpoena, issued in summer 2025, sought extensive patient records, including Social Security numbers and home addresses, ostensibly to investigate potential violations of the Food, Drug, and Cosmetic Act related to misbranding and off-label promotion. In October 2025, a US District Judge quashed the subpoena, finding the government was using the investigation as a pretext to further the administration’s stated goal of eliminating gender-affirming care.
During oral argument, the government argued that the District Court erred by focusing on the “timeline” of the political climate, rather than the government’s traditionally broad subpoena authority, and warned that upholding the ruling would lead to regular judicial interference in federal investigations. QueerDoc, on the other hand, argued that the subpoena was an improper use of the government’s subpoena power and was being used to intimidate providers of legal medical care.
The subpoena issued to QueerDoc was one of 20 that were issued to providers nationwide in 2025. According to QueerDoc, seven of those subpoenas have been challenged and either limited or quashed on similar grounds, and appeals are also pending in the First, Third, and Fourth Circuits.
The panel took the matter under submission without issuing a ruling.
Listen to the oral argument here.
ExThera Enters Into Deferred Prosecution Agreement With DOJ
On March 5, the DOJ announced that ExThera Medical Corporation entered into a three-year deferred prosecution agreement (DPA) for failure to file adverse event reports with the intent to defraud or mislead the US Food and Drug Administration (FDA). ExThera is a Northern California-based medical technology company that manufactures a blood filtration device designed to remove pathogens from patients’ bloodstreams.
Under the DPA, ExThera admitted that, through its former chief regulatory officer, Sanja Ilic, the company acted with intent to defraud and mislead the FDA by concealing reportable adverse events, including the deaths of two cancer patients treated with the device at a clinic in Antigua, in or around 2024. The company agreed to pay a criminal penalty of $750,000 and consented to the entry of a forfeiture order of $5,694,750.
Separately, Ilic was charged with one count of failure to report adverse events with the intent to defraud or mislead the FDA and has agreed to plead guilty. According to the government, Ilic suppressed critical information about patient deaths and other adverse events, understanding that disclosure could trigger FDA scrutiny, cause clinical trial partners to withdraw, and jeopardize a recently secured investment in the company and potential future distribution agreements. A plea hearing has not yet been scheduled.
Read the DOJ’s press release here.
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