Enforcement

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In the last year, the Department of Justice (DOJ) has brought more than 100 criminal cases relating to Paycheck Protection Program (PPP) Fraud.  These criminal prosecutions started at a blistering pace, with the first indictments coming within the very first months of the program’s inception. This wave of criminal prosecutions and convictions related to some of the more flagrant abuses – individuals who fraudulently obtained funds from the program and then went on spending sprees for things like Lamborghinis, mansions, and private jet travel.

These prosecutions focused on individuals and organized groups who obtained or used PPP funds fraudulently, often including charges for false statements (18 U.S.C. § 1001), aggravated identify theft (18 U.S.C. § 1028A(a)(1)), false statements in a loan application (18 U.S.C. § 1014), wire fraud (18 U.S.C. § 1343), bank fraud (18 U.S.C. § 1344), and Title 26 tax charges. Along with these prosecutions came significant resources, including new fraud coordinators and data analytics teams across the country.

Now, we are starting to see the first civil enforcement actions relating to the program. This signals a new phase of enforcement for the DOJ and all organizations who benefited from the program must pay close attention.Continue Reading PPP Investigations, Settlements and Litigation on the Horizon

Improper billing for electro-acupuncture using a “P-Stim” device (or peri-auricular stimulation device) has been the subject of two False Claims Act (FCA) settlements already in 2021, following a trend of such enforcement actions within the past year.

Each of the recent settlements, detailed further below, involve providers billing federal healthcare programs for acupuncture using P-Stim devices under HCPCS Code L8649.  Unlike P-Stim devices, though, which are attached to the ears of a patient using needles and adhesives without surgery or anesthesia, HCPCS Code L8649 applies to a product that is surgically implanted into a patient using anesthesia. Medicare, TRICARE and the Federal Employees Health Benefit Program (FEHBP) do not reimburse for acupuncture devices like P-Stim, nor do they reimburse for P-Stim as a neurostimulator or an implantation of neurostimulator electrodes.  In addition to P-Stim, the brand names for these devices include ANSiStim, E-pulse, Stivax and NeuroStim.

Notably, none of these enforcement actions originated from qui tam whistleblowers but rather were the product of affirmative government investigations by the U.S. Department of Justice, U.S. Attorneys’ Offices, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), and CMS’s Center for Program Integrity. These settlements—coming from different jurisdictions and concerning different types of providers and practices—demonstrate the government’s ongoing, nationwide effort to investigate the improper billing of electro-acupuncture devices:Continue Reading Improper Billing of “P-Stim” Devices is Focus of Recent FCA Settlements

As developments related to COVID-19 continue to unfold, Bass, Berry & Sims attorneys are monitoring the situation and providing guidance through a series of video chats entitled, “COVID-19 Compliance Conversations.”

In this episode, Lindsey Fetzer and John Kelly provide a brief overview of compliance considerations related to conducting internal investigations remotely. Watch the video…

As the impact of the COVID-19 pandemic continues to spread, the federal government is preparing to take unprecedented action to curb its effects on the nation’s health and economy by freeing up federal dollars for private businesses, manufacturers and healthcare entities of all types. But, those receiving these dollars, directly or indirectly, should continue to monitor updates to and maintain compliance with all applicable laws and regulations as this unprecedented economic response comes with heightened scrutiny and potential enforcement and regulatory risk.

DOJ Prioritizes COVID-19 Wrongdoing

On March 16, the United States Attorney General issued a memorandum to all U.S. Attorneys prioritizing the detection, investigation and prosecution of wrongdoing “related to the current pandemic.”  Attorney General Barr also issued a press release on March 20 urging the public to report suspected fraud schemes related to COVID-19. Among the schemes, Attorney General Barr encouraged the public to report were any medical providers “fraudulently bill[ing]” tests and procedures.Continue Reading COVID-19 and the False Claims Act

Bass, Berry & Sims and the Tennessee Hospital Association invite you to join us for a complimentary day-long CLE program featuring leading government officials, industry experts and experienced counsel as we discuss the most significant fraud and abuse issues currently facing the healthcare industry. Our panelists will cover topics including:

  • Year in Review: Looking Back on Healthcare Fraud Issues in 2019
  • Medicaid Enforcement Update
  • Enforcement Considerations for a Value-Based World
  • Managed Care Enforcement
  • A View from the U.S. Attorney’s Offices
  • DOJ Cooperation Guidance
  • When the News Gets Out: Crisis Management for Investigations
  • HR Implications of FCA Investigations
  • Settlement Considerations for Enforcement Matters
  • Effectively Managing Internal Investigations

Continue Reading Join Us | Nashville Healthcare Fraud Conference | December 5, 2019

In addition to the United States Department of Justice’s recently issued guidelines related to cooperation in FCA enforcement actions, the Department of Justice (DOJ)’s Criminal Division recently revised its guidance pertaining to assessment of corporate compliance programs.  The revised guidance will inform DOJ’s approach to criminal investigations, charging decisions, plea agreements, and sentencing in cases involving alleged corporate noncompliance or wrongdoing.

DOJ previously published guidance on its evaluation of corporate compliance programs in 2017.  As with the previous version, the revised guidance eschews a “rigid formula” for assessing compliance programs.Continue Reading DOJ Asks “Fundamental Questions” of Corporate Compliance Programs

We wrote an article examining recent enforcement actions by the government within the long-term care industry for McKnight’s Long-Term Care News. In the article, we point out that “recent cases reinforce the notion that long-term care providers should pay particular attention to the government’s efforts to police arrangements and business practices that implicate the…

The U.S. Department of Justice (DOJ) routinely encourages the subjects of False Claims Act (FCA) enforcement actions to make voluntary disclosures and fully cooperate with the government on the premise that cooperation leads to reduced liability. The DOJ recently issued guidance on the types of activities that will earn “cooperation credit.” But how much is cooperation worth, in terms of actual dollars? According to recent data and an analysis by Seton Hall Law School Professor Jacob T. Elberg, perhaps not much.

Discretion over Damages Multiplier Incentivizes Cooperation

The government’s basis for incentivizing cooperation lies primarily in its discretion in seeking damages and penalties allowable under the FCA. A defendant can be liable under the FCA for three times the amount of damages the government sustains, plus a civil penalty for each false claim. But such severe damages and penalties are not required, particularly where the government and a defendant negotiate a settlement to resolve FCA allegations without a court judgment or any finding of liability.Continue Reading Mixed Messages: DOJ Releases New FCA Cooperation Guidelines, while Study Questions Whether Cooperation Actually Garners Credit

In December 2018, the Department of Justice (DOJ) updated its Justice Manual to add Title 1-20.000 et seq., Limitation on Use of Guidance Documents in Litigation. This addition formalizes guidance provided in two previous internal DOJ memoranda—the Sessions Memo and the Brand Memo—each discussing limiting the use of guidance documents and advisory opinions in both criminal and civil enforcement actions.

The Sessions and Brand Memos

The Sessions Memo, authored by then-Attorney General Jeff Sessions in November 2017, prohibited the DOJ from promulgating guidance documents “that purport to create rights or obligations binding on persons or entities outside the Executive Branch[.]” It also prohibited the DOJ from creating binding standards that could then be used to determine a person or entity’s compliance with applicable federal statutes or regulations. Importantly, the memo noted that such guidance documents were not produced through a notice-and-comment rulemaking process and were not promulgated by the agency charged with the constitutional authority to do so.Continue Reading DOJ Formalizes Previous Directives Regarding Limiting Use of Guidance Documents to Prove Violations of Law

A recent piece of federal legislation intended to address the opioid crisis across the United States may have some unintended consequences. In attempting to prohibit “patient brokering” in the narrow context of addiction treatment and recovery centers, Congress may have unwittingly passed an unprecedented expansion of federal prosecutorial authority over payment arrangements between providers and referral sources for private-pay patients. For the reasons discussed in this blog post, any individual or entity who provides services relating to addiction treatment or recovery (as well as all clinical laboratories, regardless of whether they provide any addiction treatment or recovery services) should examine their arrangements with all referral sources for private-pay patients, even those who do not refer patients for addiction treatment or recovery services.

On October 24, 2018, the President signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the “SUPPORT Act”), as discussed here. The SUPPORT Act consolidated a number of opioid-related bills, including the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), which was intended to address the problem of “patient brokering” in the context of treatment centers and sober homes.Continue Reading The Eliminating Kickbacks in Recovery Act: An Unprecedented Expansion of Anti-kickback Liability to Private-Pay Referrals?

From the Bass, Berry & Sims Blog Network
From the Bass, Berry & Sims Blog Network

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