• Accelerated FCA Investigative Timeline: The U.S. Department of Justice (DOJ) is taking new steps to implement the directives of Executive Order 14395 of March 16, 2026, “Establishing the Task Force To Eliminate Fraud,” by expediting the review for newly filed False Claims Act (FCA) qui tam actions involving federally funded state-administered benefits programs. The May 27, 2026, memorandum from Assistant Attorney General Brett A. Shumate (“Shumate Memo”) states that all newly filed state-administered benefits program fraud qui tam actions will now be reviewed by DOJ in 60 to 120 days after filing to determine if the government will continue its investigation, permit the whistleblower to proceed, or act to dismiss the case.
• DOJ Reaffirmation of Relator Authority: The Shumate Memo reaffirms DOJ’s position that whistleblowers may “stand in the shoes” of the government and indicates that the agency will let relators lead litigation subject to DOJ’s “oversight and ultimate control.”
• Automatic Criminal and Administrative Referrals: New benefits program fraud qui tam matters will be automatically referred to the Criminal Division and/or the National Fraud Enforcement Division for evaluation of potential criminal violations and to the affected agency for potential administrative action, including payment suspension.

New York’s Shield Law creates substantive protections for reproductive health care, which can be summarized as follows:

This year, DOJ’s Health Care Fraud Unit reported that 324 defendants were charged for their alleged involvement in various health care fraud schemes that involved over $14.6 billion in intended loss—more than doubling the prior record of $6 billion set in 2020 during the first Trump administration. By way of comparison, last year, the 2024 Takedown charged 193 defendants with allegedly committing more than $2.5 billion in fraud. And two years ago, the 2023 Takedown charged 78 defendants with more than $2.5 billion. To say there was a significant increase between the Biden administration and the second Trump administration would be an understatement.  

That this administration would “follow the money” should not come as a surprise. As noted, the prior record was set during President Trump’s first term in 2020. In that Takedown, DOJ and HHS OIG reported 345 defendants allegedly submitted more than $6 billion in false and fraudulent claims to federal health care programs and private payers. The bulk of that 2020 Takedown, $4.5 billion, was related to telehealth.

MFCUs—which investigate and prosecute statewide Medicaid provider fraud, and beneficiary abuse and neglect—recovered $1.4 billion in FY 2024, which equates to $3.46 for every $1 spent. Criminal recoveries were the highest amount in the past 10 years, $961 million, and more than double the rolling 5-year average. HHS OIG attributes this massive increase to the California MFCU, which recovered $513 million on its own.

On June 9, 2025, the governor of Maine signed into law LD558, which amends the Maine Fair Credit Reporting Act to prohibit medical creditors, debt collectors and debt buyers from reporting a consumer’s medical debt to a consumer reporting agency. Under the Maine law, a “medical creditor” is defined as “an entity that provides health care services and to whom a consumer incurs medical debt or an entity that provided health care services to a consumer and to whom the consumer previously owed medical debt if the medical debt has been purchased by one or more debt buyers.” Additionally, the Maine law forbids consumer reporting agencies from reporting medical debt on consumer reports. Consumers whose medical debt is reported in violation of the new amendments can seek civil remedies against the medical creditor, debt collector, debt buyer, or consumer reporting agency that reported the medical debt pursuant to the Maine Fair Credit Reporting Act for actual damages, attorneys’ fees and costs, and either treble damages or statutory damages depending on whether the violation was willful or negligent.

Consumer protection laws can be tempting causes of action for individuals who believe they have been wronged by the healthcare system. Unlike medical malpractice claims, which require expert testimony and may include damages caps, consumer protection statutes often include treble damages, punitive damages, and attorneys’ fees. Consumer protection laws may also offer injunctive relief as a remedy, do not require a plaintiff to prove causation or damages, and have the potential for class action lawsuits. To prevent plaintiffs from reframing a negligence case to sidestep the limitations of medical malpractice cases, some courts and states have drawn boundaries between consumer protection and medical malpractice cases.

1. Focus on High-Impact Waste, Fraud, and Abuse Harming Vulnerable Taxpayers

It should be no surprise that the administration is targeting actors that profit through “waste, fraud, and abuse.” The memo sets clear priorities for its prosecutors to investigate, listing as the #1 priority health care fraud and federal program and procurement fraud.  The memo goes on to provide a top 10 list of “high-impact areas”, with “trade and customs fraud, including tariff evasion” as #2.  Heavy focus is given to fraud perpetrated by foreign actors and conduct threatening U.S. national security. Also listed is fraud victimizing U.S. investors, including elder fraud and Ponzi schemes. Appearing as #8 on the list is violations of the Controlled Substances Act and the Federal Food, Drug and Cosmetic Act, including the creation of counterfeit pills laced with fentanyl and the “unlawful distribution of opioids by medical professionals and companies.”

In doing so, the Court left open the question of what it means to be “entitled to supplementary security income [SSI] benefits . . . under subchapter XVI.” §1395ww(d)(5)(F)(vi)(I).

Today, in Advocate Christ Medical Center v. Kennedy, the Court, in a 7–2 decision (with Justice Barrett writing for the majority and Justice Jackson, joined by Justice Sotomayor, dissenting), held “that a person is entitled to such benefits when she is eligible to receive a cash payment during the month of her hospitalization.” Today’s decision continues the unbroken string of losses that the petitioner hospitals have suffered in this litigation at both the administrative and judicial levels.

In this episode, Epstein Becker Green attorneys Mike Brodlieb, Jim Flynn, Jimmy Oh, and Jack Wenik navigate the complexities of regulatory action and inaction. The conversation dives into the changing administrative landscape and covers how businesses can strategize to challenge regulations, the pros and cons of litigation, and the critical importance of aligning legal goals with practical business objectives.

The panelists also explore how agencies’ evolving processes create both challenges and opportunities, including how internal agency relationships and unexpected legal arguments can shape outcomes. From assembling the right legal team to balancing risk and reward in high-stakes scenarios, they discuss real-world tactics for crafting solutions that address uncertainty while keeping business interests front and center.

Gain insight into how legal professionals are managing the intricate interplay between government regulation, litigation strategies, and client priorities in today’s dynamic environment.

In response, the Centers for Medicare & Medicaid Services (CMS) issued a 2023 Final Rule mandating a retroactive lump-sum reimbursement to 340B participating hospitals for 340B underpayments made between 2018 and 2022. The Supreme Court’s decision, coupled with CMS’s administrative action, has led to significant contractual disputes and regulatory challenges as 340B contract hospitals seek restitution for past financial shortfalls while Medicare Advantage organizations (“MAOs”) grapple with the fiscal implications of these payment adjustments. The stakes are high, with hospitals seeking significant back payments and MAOs pushing back, arguing that their obligations are dictated by contracts, not federal rulemaking. As legal battles unfold, the question remains: Who is financially responsible for correcting these underpayments? This article analyzes these developments, focusing on the litigation between hospitals and MAOs and offering strategic contractual considerations in this shifting landscape.

[1] The court reasoned that vacatur would be highly disruptive due to the complexity of the Medicare system and potential budget neutrality concerns.

The Rule has been published in the Federal Register and is scheduled to become effective March 17, 2024. A recent Executive Order, however, may delay or impact whether the Rule is implemented and, if it is implemented, the timing of when the Rule becomes effective.

As the Third Circuit explained, “[t]he FCA punishes the submission to the Government of fraudulent claims for payment under, for example, the Medicare and Medicaid programs.”  Id. at *1.  While the FCA encourages individuals, known as relators, to report government-related fraud by way of filing a qui tam suit, the public disclosure bar prevents a relator from bringing an FCA qui tam suit “if substantially the same allegations or transactions as alleged in the action or claim were publicly disclosed” in a “Federal report” or “from the news media” unless the relator is “an original source of the information.” 31 U.S.C. § 3730(e)(4)(A).  In the Third Circuit, “the public disclosure bar applies if either Z (fraud) or both X (misrepresented facts) and Y (true facts) are publicly disclosed by way of a listed source.” Stebbins, 2024 WL 4947274, at *2 (quoting U.S. ex rel. Zizic v. Q2Administrators, LLC, 728 F.3d 228, 236 (3d Cir. 2013)). 

In United States ex rel. Stebbins v. Maraposa Surgical Inc. et al., despite having no affiliation whatsoever with the defendants, the relator filed a qui tam action alleging, inter alia, that the defendants fraudulently sought reimbursement for the arteriograms performed in a physician’s office, rather than a licensed ambulatory surgery center, which the relator asserted violates Pennsylvania’s regulations.  Without deciding whether the defendants actually engaged in any wrongdoing, the Third Circuit held that the public disclosure bar prohibited the relator from proceeding with suit because the relator drew each piece of information supporting his FCA allegations from publicly disclosed databases.

On December 10, 2024, the Supreme Court of Ohio issued its decision in Stull v. Summa, a medical negligence case in which the defendants argued that Ohio’s statutory peer-review privilege protected from discovery the file a hospital maintained on a resident physician, which included, among other things, quality reviews and assessments of the resident’s clinical competency and professional conduct. The Supreme Court of Ohio decided one issue: Does the peer-review privilege in R.C. 2305.252 apply to a healthcare entity’s files concerning resident physicians?

This case arose from the medical treatment of head injuries that the patient sustained during a car crash. The patient and his guardians filed a medical negligence lawsuit against the hospital and its employed healthcare professionals, including a resident physician who participated in the patient’s care. The plaintiffs alleged that the resident improperly intubated the patient, causing the patient to sustain a brain injury

On October 28, 2024, by a majority vote of 56 to 17, with four abstentions, the New Jersey General Assembly passed Assembly Bill No. 1848, which, if it goes into effect, will prohibit the sale or delivery of OTC diet pills, weight loss, and muscle building supplements to minors, unless the minor is accompanied by a parent or guardian. Bill No 1848 is an exemplar of efforts intended to combat the misuse and abuse of these products and the potential causal relationship between these dietary supplements and eating disorders. Violators, including employees of retail establishments, may face a civil penalty of not more than $750.

The legislation sets forth that:

“no person, firm, corporation, partnership, association, limited liability company, or other entity shall sell, offer to sell, or offer for promotional purposes, either directly or indirectly by an agent or an employee, any over-the-counter diet pull or dietary supplement for weight loss or muscle building to a minor under 18 years of age, unless the minor is accompanied by a parent or guardian.”

Payors have developed a reputation for underpaying or denying payment to providers altogether. This is especially true for providers who do not have contracts with insurance companies and, as a result, are out-of-network. Meanwhile providers who have contracts with  insurance companies, i.e., in-network providers, are subject to preferential contract rates and in exchange are supposed to be paid in a timely manner. However, many providers have learned this is not what happens. Out-of-network providers, in particular, face an uphill battle to get reimbursed for the medically necessary services rendered to patients. The out-of-network provider in this case experienced just that.

Since there is no contract between the provider and payor in an out-of-network context, the provider submits its billed charges to the payor. Many states have balance billing laws that preclude the provider from seeking payment from the insured directly. Knowing that the provider has limited recourse, insurance companies will often either not pay or pay slowly. St. Charles Surgical Hospital and Center for Restorative Breast Surgery (“St. Charles”) is well-known for its treatment of cancer patients. After not being appropriately reimbursed for the services rendered to patients, St. Charles filed its lawsuit in Louisiana state court in 2017. According to St. Charles, BCBS of Louisiana would authorize surgeries, the providers would perform those surgeries pursuant to the authorizations, and then the insurer would not render the appropriate payment. The case involved about 7,000 procedures that were performed on an out-of-network basis. St. Charles claimed that BCBS of Louisiana only paid approximately 9% of the total amount billed for these services. St. Charles’s claims against the insurance company were for fraud and abuse of rights. The insurance company’s defense included arguments that authorizing medical treatment did not guarantee payment at those rates. Rather, BCBS of Louisiana negotiated individual deals for out-of-network reimbursement with brokers or employers.

What Has Stayed the Same and What Has Changed?

Similar to last year’s all-encompassing “takedown,” this year’s enforcement action charged defendants with schemes related to telemedicine and laboratory fraud; diversion of controlled substances (HIV medications and prescription stimulants); addiction treatment schemes; opioids and other familiar types of health care fraud (such as home health, DME and kickbacks).  However, the “headline” this year was a $900 million case in Arizona involving medically unnecessary amniotic wound grafts.

The 2024 enforcement action charged 193 defendants who allegedly have committed over $2.75 billion in fraud. The cases were brought by 32 different U.S. Attorneys’ Offices and 11 State Attorney Generals’ Offices. Although the dollar figure at issue is slightly higher than the 2023 enforcement action, the number of defendants is strikingly higher, with almost two and a half times as many defendants charged. Similarly, the cases were brought in almost twice as many federal districts as last year, suggesting that the Fraud Section is building more partnerships with U.S. Attorney’s Offices nationwide.