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

Last week the Federal Trade Commission (FTC) issued a press release highlighting recent and forthcoming actions by the FTC, Department of Justice (DOJ), and the Department of Health and Human Services (HHS), which they say will further promote competition, thereby lowering costs and increasing the quality of care in the U.S. health care market. In addition to highlighting recent actions by each of the agencies (e.g., the FTC’s proposed non-compete rule), the release states that the three agencies are entering into new partnerships to increase interagency cooperation and advance a “whole-of-government” approach to protect health care competition, including:Continue Reading FTC, DOJ, and HHS Announce Interagency Initiatives to Promote Healthcare Competition

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting continued enforcement and recovery actions under the Health Care Fraud and Abuse Control Program (HCFAC). During fiscal year 2022 (FY 2022), over $1.7 billion was returned through HCFAC’s enforcement actions.Continue Reading HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment Centers, Among Other Initiatives

On July 19, 2023, the Federal Trade Commission and Department of Justice jointly published long-anticipated proposed merger guidelines (the “Proposed Merger Guidelines”), which had been expected since President Biden issued an Executive Order Promoting Competition in the American Economy in the summer of 2021. According to the agencies, the Proposed Merger Guidelines “build upon, expand, and clarify” the prior guidance,[1] to keep up with “modern” market realities.[2] In contrast to the previous versions, the Proposed Merger Guidelines cover both horizontal and vertical mergers. They also cite case law for the first time.[3] Reflecting the Biden Administration’s views on federal antitrust merger enforcement, the Proposed Merger Guidelines substantially expand the types of competitive harm the agencies consider grounds for challenging a transaction under Section 7 of the Clayton Act (which prohibits mergers where the effect is “substantially to lessen competition” or “to tend to create a monopoly”).[4]Continue Reading A Big Deal: FTC and DOJ Issue Long-Awaited New Draft Merger Guidelines

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

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