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

The Department of Justice (DOJ) lost its third jury trial in its mission to secure criminal convictions against companies and executives accused of labor-side antitrust violations on March 22, 2023, when a jury in Maine acquitted four home healthcare staffing executives of violating Section 1 of the Sherman Act. In United States v. Manahe, the DOJ charged Faysal Kalayaf Manahe, Yaser Aali, Ammar Alkinani, and Quasim Saesah with entering into an approximately two-month conspiracy between April and May 2020 not to hire each other’s caretakers and to fix caretaker wages.[1] After the district court declined to dismiss the indictment, holding the DOJ had successfully alleged a per se conspiracy to fix wages and allocate employees, the case proceeded to a two-week trial. At trial, defendants—all immigrants from Iraq, many of whom served as translators for U.S. forces there—admitted that they discussed setting wage levels and refraining from hiring each other’s employees, and even drafted an agreement with signature lines that outlined the terms of defendants’ discussions.[2] Defendants argued that they never reached an agreement in violation of Section 1 because the draft agreement was never signed. Defense counsel emphasized in opening statements that in defendants’ culture, “when dealing with business matters . . . the only way to confirm a commitment is to put it into a formal written contract.” Given the verdict, it appears the jury agreed.

Continue Reading DOJ Loses Third Consecutive Antitrust Labor Trial

Following remarks made on March 2 and March 3, 2023 at the American Bar Association’s 38th Annual National Institute on White Collar Crime, the U.S. Department of Justice (“DOJ”) issued revisions to its Evaluation of Corporate Compliance Programs (“ECCP”). The newly revised ECCP guidance contains two important changes: (1) the DOJ has directed prosecutors to “consider more closely compensation structures and consequence management when evaluating compliance programs”, and (2) the DOJ will consider corporate practices surrounding the use of personal devices, communications platforms, and messaging applications, including ephemeral messaging applications, and the company’s ability to access and produce underlying data.

Continue Reading DOJ Revises Guidance on Evaluation of Corporate Compliance Programs Concerning Compensation and Employee Use of Personal Devices and Personal Messaging Applications

What Happened?

On Friday, February 3, the Department of Justice, Antitrust Division (the “DOJ”) announced its withdrawal of three policy statements on health care antitrust enforcement: (1) The Department of Justice and Federal Trade Commission Antitrust Enforcement Policy Statements in the Healthcare Area (Sept. 15, 1993); (2) The Department of Justice and Federal Trade Commission Statements of Antitrust Enforcement Policy in Healthcare (Aug. 1, 1996); and (3) The Department of Justice and Federal Trade Commission Statement of Antirust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (Oct. 20, 2011) (together, the “Healthcare Statements”). It has been reported that the Federal Trade Commission (the “FTC”), which shares antitrust enforcement authority with the DOJ (together the “Agencies”), intends to withdraw the Healthcare Statements as well. Assuming the FTC follows the DOJ’s lead, the withdrawal of the Healthcare Statements may be the most significant antitrust enforcement development under the Biden Administration to date and is likely the most significant healthcare antitrust development in decades.

Continue Reading Department of Justice Withdraws Key Healthcare Antitrust Policy Statements

Arguments were heard in the case of United States ex rel. Polansky v. Executive Health Resources, Inc., No. 21-1052 to determine whether and on what statutory grounds, the government, after initially declining to intervene, may subsequently intervene and dismiss a qui-tam False Claims Act (“FCA”) suit. The Court’s decision will resolve a dispute regarding the balance of power between an individual whistleblower and the Department of Justice (“DOJ”).

Continue Reading SCOTUS to Decide Whether the Government has the Authority to Dismiss an FCA Suit After Initially Declining to Intervene and, if so, on What Grounds

It is widely reported that healthcare is a top antitrust enforcement priority in the U.S. The healthcare industry has undergone a transformation over the over the last twenty years and now comprises 17.7% of the U.S. gross domestic product and over $3.795 trillion of the U.S. government budget. Mega-deals among national payors and household names have grabbed headlines and been targets of enforcement by the U.S. Department of Justice, Antitrust Division (the “DOJ”) and Federal Trade Commission (“FTC”) (collectively, “the Agencies”). 

Continue Reading Private Equity & Healthcare: Antitrust Enforcement in 2023–PE Roll-Ups in the Cross Hairs

The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the potential for fraud and abuse. In July 2022, the Department of Health and Human Services Office of Inspector General (“OIG”) issue a Special Fraud Alert alerting practitioners to exercise caution when entering into arrangements with telemedicine companies. The issuance of this report is a significant step and reinforces the government’s interest in scrutinizing telehealth arrangements. The Department of Justice (“DOJ”) and the Drug Enforcement Agency (“DEA”) have also launched several high-profile investigations that the industry is monitoring closely. Telehealth providers should carefully review and update their practices given the heightened enforcement climate.

Continue Reading Recent Developments in Telehealth Enforcement

Representing a sizable portion of the American economy, few industries in the United States have received more attention from the press, legislators, and antitrust agencies than the healthcare industry—particularly in recent years. Recent developments at the Federal Trade Commission (“FTC”) and the Department of Justice (“DOJ”) reaffirm that healthcare remains a top antitrust enforcement priorities in the United States.

Continue Reading U.S. Healthcare Industry Remains Antitrust Enforcement Priority

The Emergency Medical Treatment and Labor Act (EMTALA) requires hospitals with emergency departments and participating in Centers for Medicare and Medicaid Services (CMS) programs to provide medical screening, treatment and transfer for patients with emergency medical conditions (EMCs) or women in labor.[1] EMTALA, which was enacted in 1986 to address concerns about patient dumping, went unnoticed for many years, but has garnered heightened attention as a result of the COVID-19 pandemic, and more recently, the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization (Dobbs).[2]

Continue Reading EMTALA in the Post-Dobbs World

On June 21, 2022 the Supreme Court granted certiorari in Polansky v. Exec. Health Res., 17 F.4th 376 (3d Cir. 2021), allowing the Court to review the Department of Justice’s (“DOJ”) authority to dismiss qui tam suits brought under the False Claims Act (“FCA”), over objections by the relators. The case invites the high Court to decide two key issues: (1) whether the DOJ has the authority to dismiss qui tam suits where it declined to intervene, and (2) what standard of review applies to such requests for dismissal. 

Continue Reading Supreme Court To Review DOJ’s Authority to Dismiss Qui Tam FCA Suits Over Objections From Relators

In one of the final cases of a tumultuous term at the Supreme Court, the Justices ruled against DOJ in a decision that could have wide ranging effects not just for physicians and other prescribers, but for drug control laws more generally. In Xiulu Ruan v. U.S., No. 20-1410 (Jun. 27, 2022), the Court considered the convictions of two physicians for violating the Controlled Substances Act, 21 U.S.C. § 841 because, DOJ contended, and the respective juries found, that their prescriptions were “not authorized.” (The relevant statute makes it a federal crime to “[e]xcept as authorized[,]….knowingly or intentionally…dispense…a controlled substance.” Id.). One physician was sentenced to 20 years imprisonment; a second to 25 years. Each, at trial, had contended that their prescriptions were authorized, that they had the requisite credentials to write prescriptions, including DEA and state board registrations, and that they were properly licensed. DOJ, meanwhile, had argued that the physicians were operating “pill mills” and, accordingly, their prescriptions were not “authorized.”

Continue Reading Supreme Court Rules for Physicians in Blow to DOJ