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Calla Simeone

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Calla Simeone is an associate in the Business Trial Practice Group in the firm's Washington, D.C. office and a member of the firm’s Healthcare Team.

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Federal enforcement of the False Claims Act (FCA) against healthcare and pharmaceutical companies—especially based on alleged Anti-Kickback Statute (AKS) violations—continues to change, with the Regeneron Pharmaceuticals case at the forefront of recent developments. Recall that in Regeneron, the government alleges that the pharmaceutical company is illegally subsidizing copayments for Medicare beneficiaries by making large donations to third party foundations offering copay assistance to strategically steer patients to its high-cost specialty drug, Eylea, instead of lower-cost alternatives, resulting in alleged FCA liability based on an AKS violation. After the First Circuit held that a FCA plaintiff in an AKS-based FCA case must prove “actual causality, which in ordinary course takes the form of but-for causation,” United States v. Regeneron Pharms., Inc., 128 F.4th 324, 330 (1st Cir. 2025), the government is trying—again—to avoid having to prove a causal link between the alleged AKS violation and damages (i.e., financial harm to a government program). The government’s recent summary judgment brief in the United States District Court for the District of Massachusetts provides a detailed look at both its evolving legal theory and the practical compliance lessons for pharmaceutical manufacturers, providers, and health systems.Continue Reading Regeneron, the False Claims Act, and a New Era in Government Enforcement

The inexorable expansion of the False Claims Act (“FCA”) to cover virtually all types of cybersecurity breaches and violations – to include allegedly poor practices and failure to fully adhere to security controls – continues. At one time, an organization might have thought that it was unlikely to face a potential FCA investigation and litigation relating to its cybersecurity practices. That day is long past. Two recent FCA settlements illustrate the expansion: one is the first cybersecurity FCA settlement relating to healthcare Quality System Regulations (“QSR”) and the other involves the first settlement with a defense contractor that also pulls in its private equity owner.Continue Reading The Expanding Scope of FCA-Cybersecurity Liability

On Wednesday, a federal court in Texas stayed provisions of the Centers for Medicare & Medicaid Services’ (“CMS”) contract year 2025 Final Rule that amended the longstanding Medicare Advantage (“MA”) and Part D agent and broker compensation methodology and prohibited certain terms in contracts with third party marketing organizations (“TPMOs”). This decision follows two lawsuits filed against CMS and the Department of Health and Human Services (“HHS”) arguing that the Final Rule exceeds CMS’s statutory authority, is arbitrary and capricious, and was promulgated without complying with procedural requirements.[1] The Texas federal judge stayed the effective date of the “Fixed Fee” and “Contract-Terms Restriction” (i.e., 42 C.F.R. § 422.2274(a), (c), (d), (e) and § 423.2274(a), (c), (d), (e)) of the Final Rule during the pendency of the lawsuits, and chose not to remand to the agency, instead promising an expeditious ruling on the merits at the parties’ request.Continue Reading Texas Court Stays CMS CY2025 Final Rule on Agent and Broker Compensation and Contract Term Restrictions

In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across the country. Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine et al., No. 23-235 and Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, et al., No. 23-236. The Court ultimately decided the case on procedural grounds, holding that the plaintiffs lacked standing to bring suit.Continue Reading Supreme Court Unanimously Preserves Access to Mifepristone

Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed payments set by Medicare, as well as, in some cases, significant additional payments from health plans. Concerned over the potential for abuse, these arrangements have been the subject of Congressional scrutiny and an enforcement priority for both the Department of Justice (“DOJ”) and the Department of Health and Human Services Office of the Inspector General (“HHS OIG”). The Biden Administration and the Centers for Medicare & Medicaid Services (“CMS”) are tackling this issue head-on in a recently published final rule that addresses both marketing tactics and compensation methodologies used by Medicare Advantage organizations (“MAOs”) to pay MA agents or brokers.[1]Continue Reading Increased Scrutiny into Agents & Brokers in the Medicare Advantage Space

Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. Despite rejecting Judge Matthew Kacsmaryk’s blanket suspension of the drug’s approval, the federal appeals court found that the FDA overstepped its authority in expanding access and loosening restrictions on the drug in 2016 and 2021. Specifically, the Fifth Circuit agreed with the lower court’s ruling to invalidate the FDA’s modifications that increased the gestational age and relaxed dispensing requirements such as allowing the drug to be dispensed through the mail and ordered by a non-physician. The 96-page ruling issued by the conservative three-judge panel will likely not have any immediate legal effect, and Mifepristone will remain broadly available due to the Supreme Court’s stay implemented earlier this year.Continue Reading Fifth Circuit Rules to Reinstate Abortion Pill Restrictions

For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. On review, the Fifth Circuit held that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail, temporarily suspending more recent modifications to the FDA’s approval. Continue Reading Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. Although the Fifth Circuit did grant temporary, albeit limited, relief, the court maintained that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail. Continue Reading Access to Abortion Pill in Limbo: Navigating the Intricacies of Conflicting Federal Court Rulings in Texas and Washington State