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Sara Morgan

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Sara Morgan works closely with various companies, including many hospitals and healthcare providers, on a wide range of litigation matters related to healthcare fraud and abuse, products liability, and general business litigation matters. She represents several healthcare companies in fraud and abuse litigation and investigations stemming from claims brought under the False Claims Act, Anti-Kickback Statute, the Stark Law, Medicare and Medicaid reimbursement rules, and various other federal and state healthcare statutes and regulations.

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While the government is writing checks to companies to cope with recent pandemic losses, it simultaneously updated its internal guidance for scrutinizing a company’s corporate compliance program.  Earlier this week, the Department of Justice (DOJ) issued to prosecutors an update to its guidance document for the “Evaluation of Corporate Compliance Programs.”  DOJ counsel has long considered the existence and adequacy of a company’s corporate compliance program when determining whether, and to what extent, charges should be brought against that company, as well as how investigations should be resolved.

This guidance document, originally published in 2017, assists government counsel with that evaluation process.  While primarily intended for use in the criminal context, the same guidance could undoubtedly be considered during a civil investigation against a company, such as in a False Claims Act investigation.  The guidance document and its updates are excellent resources for a company to use in the company’s ongoing evaluation of its compliance program.

Purposefully tailoring the compliance program to your company.  Many DOJ updates reinforce the notion that a company should create a corporate compliance program that is tailored to that specific company, based upon its evaluation of its particular risks and anecdotes.  For instance, the update clarifies that government counsel should consider “the company’s size, industry, geographic footprint, regulatory landscape, and other factors, both internal and external to the company’s operations, that might impact its compliance program.”  And when evaluating whether the compliance program is well designed for a particular company, government counsel is directed “to understand why the company has chosen to set up the compliance program the way that it has, and why and how the company’s compliance program has evolved over time.”Continue Reading DOJ Updates Guidance for Evaluating Corporate Compliance Programs as a Record Number of Companies are Receiving Federal Funding

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

DOJ recently announced a settlement agreement in one of its first cases against an electronic health records (EHR) vendor—eClinicalWorks (eCW). According to the terms of the settlement, eCW and three of its founders will pay $154.92 million to the government to settle claims alleging that eCW falsified the certification of its software and thereby caused physician practices to submit claims for payment that were materially false. Three other eCW employees—a software developer and two project managers—will pay between $15,000 and $50,000 each for their roles.

Practitioners Get Financial Incentives for Making “Meaningful Use” of Certified EHR Technology

eCW is an EHR vendor that develops and sells software for  physician practices to use in maintaining EHR for their patients. To incentivize physician practices to make use of the EHR technology, the U.S. Department of Health and Human Services (HHS) established the Meaningful Use Program under the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. The HITECH Meaningful Use Program gives medical practitioners monetary incentives for submitting claims for payment that make “meaningful use” of certified EHR technology. To become certified, the HITECH Act requires that software companies, such as eCW, submit their EHR programs for testing.Continue Reading Electronic Health Records Vendor Must Pay Over $150 Million in FCA Settlement

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

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