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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

On February 4, 2021, the Department of Justice (“DOJ”), Office of Public Affairs, issued a Press Release (the “DOJ Press Release”) announcing that Kelly Wolfe, President of Regency, Inc., a medical billing company located in Florida, pleaded guilty to conspiracy to commit healthcare fraud through a “pernicious telefraud scheme”[1] involving fraudulent Medicare and CHAMPVA (Civilian Health and Medical Program of the Department of Veterans Affairs) claims for medically unnecessary durable medical equipment (“DME”) supplies.  As a result of Wolfe’s criminal plea, Wolfe could face up to 13 years in federal prison. 
Continue Reading OIG Warns Telehealth Industry: “With Great Power Comes Great Responsibility”

As we discussed in our April 27, 2020 blog post, nursing homes have become the focus of significant attention during the COVID-19 crisis.  In many respects, the attention is well deserved:

  1. Nursing homes traditionally serve seniors who often struggle with chronic health conditions. As a result, nursing home residents are particularly vulnerable to coronavirus infection due to both their age and health status;
  2. Nursing homes residents are highly interactive with each other. The close proximity of nursing home rooms/beds and the personal relationships often formed among nursing home residents make social distancing hard to maintain;
  3. In order to relieve pressure on hospitals that need to reserve their beds for the most acute COVID-19 patients, nursing homes are under significant pressure to accept COVID-19 patients who have been discharged from hospitals because they no longer require an acute level of care but still may be symptomatic and require isolation and treatment; and
  4. Most importantly, the above three factors and others have turned many nursing homes across the country into hot spots for coronavirus infection and, in some cases, COVID-19 fatalities. Overwhelming data as to the dangers found in nursing homes is highlighted in the blog article referenced above.

Continue Reading Nursing Home Liability Waivers and Nursing Home Investigations and Enforcement: A Delicate Balance During the COVID-19 Pandemic