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As Prescribed

YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

The Boston Bar Association held its annual White Collar Crime Conference on May 4, 2023, featuring lawyers from the defense and plaintiffs’ bar and current and former prosecutors from the US Attorney’s Office for the District of Massachusetts (Office) and the Office of the Massachusetts Attorney General.

The conference addressed a wide spectrum of issues and put forth thought leadership in the white collar crime space, discussed recent securities fraud trials brought into the district, provided an informative panel on how to advise clients in the event of a ransomware attack, and covered the Office’s approach to discovery in criminal cases. However, the highlight of the day for stakeholders in the life sciences and healthcare industries was the panel on healthcare fraud—no surprise given the district’s status as one of the preeminent and most prolific healthcare fraud enforcement offices in the United States.

Insights from AUSAs

The healthcare fraud panel addressed several topics, but the primary message from law enforcement panelists was that not much has changed regarding enforcement priorities or methods. Assistant US Attorney (AUSA) and Chief of the Health Care Fraud Unit Kelly Lawrence and AUSA and Chief of Affirmative Civil Enforcement Abraham George reiterated the Office’s commitment to advocating on behalf of patients, investors, and other victims of healthcare fraud and abuse.

They also reinforced that the criminal and civil divisions actively collaborate and that the criminal division reviews all cases. Ms. Lawrence warned the defense bar that even if the criminal division initially decides not to staff a case, it does not mean that the case is not being considered for criminal prosecution.

Enforcement Priorities

Chief of the Medicaid Fraud Division of the Massachusetts Attorney General’s Office Toby Unger told the audience that recently installed Massachusetts Attorney General Andrea Joy Campbell’s enforcement priorities focus on COVID-19 cases and the use of opioids in nursing facilities; the extension of criminal liability under the Massachusetts criminal elder abuse statute regarding poor patient care to nursing facility owners, administrators, directors, and managers; access to care; and patient transport, including both ambulance and nonemergency transport.

From the relator’s perspective, lawyer Sonya Rao observed that she and her colleagues were seeing a lot of not-very-well-disguised old-school kickback cases, an assessment Mr. George echoed saying that the Office has cases involving speaker fees and meals provided by manufacturers to healthcare professionals.

Investigations and Enforcement

The biggest takeaway for stakeholders in the healthcare and life sciences industries came in the form of the Office’s investigative and enforcement methodology. Both Ms. Lawrence and Mr. George told the crowd that data and technology are highly present and that the Office is focused on analyzing data to identify potential hot spots and outliers indicative of potential fraud and abuse, although the defense bar certainly has heard this before from other agencies in other contexts. Subpoenas and civil investigative demands (CIDs) will be issued accordingly, and the criminal division will look to see if a true crime has been committed—not just civil fraud.

Although both Ms. Lawrence and Mr. George made sure to note that the Office still welcomes qui tam complaints as the impetus for investigations and enforcement actions—and Mr. George observed that whistleblower cases inexplicably seem to come in waves—the clear message was that the Office is going to continue to use the vast amount of data it can access to initiate its own cases.

A later panel that should trouble stakeholders and defense counsel covered the US government’s increasing use of the Racketeer Influenced and Corrupt Organizations Act, cooperators, and wiretaps in white collar cases—not just in narcotics cases, as historically has been the case, or in cases involving insider trading.

What does this mean for life sciences and healthcare industry stakeholders? In short, be ready. Not only will the Office continue sending out subpoenas and CIDs—some initiated by a qui tam and others by its own investigations—it also will be armed with pre-identified areas of concern. While not explicitly tied together, this data-driven approach dovetails with the US Department of Justice’s renewed emphasis on corporate self-disclosure of fraud and abuse and its effort to have companies “raise the tide” of corporate compliance.

Corporate Compliance

The Office’s continued focus on data irregularities will, in practice, serve as another avenue of pressure-testing corporate compliance programs. On another panel during the conference, AUSA and Chief of the Criminal Division Amanda Strachan noted that although the Office knows and accepts that corporate compliance programs have failures, it wants defense counsel to come to the Office prepared to explain and acknowledge those failures.

Ms. Lawrence observed during the healthcare fraud panel that defense counsel should approach the Office as soon as they are ready; if companies wait until the Office extends an invitation, it is likely too late to impact any resolution.

Key Takeaway

Stakeholders in the healthcare and life sciences industries, especially those headquartered and/or operating in the Commonwealth of Massachusetts, should consider taking steps to bolster and test their compliance programs, and should be prepared to respond swiftly and strategically to any inquiry from the Office. Effective advocacy at the early stage of an investigation—especially given the Office will likely be armed with data-related concerns—will be crucial.

If you need assistance responding to an inquiry from the Office, contact the authors for more information.