Maine, New Hampshire, & Vermont Remain DOJ Health Care Enforcement Priorities: Targeted Federal Enforcement Presents Serious Risk
The United States Department of Justice (DOJ) has recently emphasized that Maine, New Hampshire, and Vermont are priorities for health care investigations and anticipated significant enforcement. Even well-managed (and compliant) organizations and law-abiding practitioners may find themselves responding to government investigators and should proceed with caution anytime the government comes knocking.
Enforcement will focus on improper opioid prescribing but will be broad and could encompass investigations into allegations of health care fraud, suspected overbilling, allegations of services not provided or not provided at the claimed level, and telehealth. The DOJ also will increase its scrutiny of clinical labs, nursing homes, compliance programs, and compliance with Drug Enforcement Administration (DEA) Diversion protocols. It is critical to consult with experienced government enforcement lawyers, like those at Verrill, any time the government is involved.
Speaking at the September 2022 conference of the American Health Lawyers Association in Baltimore, Maryland, DOJ Assistant Attorney General (AAG) Kenneth A. Polite, Jr., touted the DOJ’s newest strike force focusing on Northern New England and announced that the DOJ is already anticipating significant enforcement activity in the region. Nationally, AAG Polite oversees a team of over 600 prosecutors, more than 80 of whom focus on health care fraud and related investigations. AAG Polite’s focus on Northern New England as a top DOJ priority is telling and demonstrates how serious the DOJ is about taking actions in the region. AAG Polite referenced telehealth, interstate prescribing of opioid medications, and pharmaceutical wholesalers and distributors as specific areas of DOJ interest. AAG Polite touted the need for robust compliance programs and noted that the newly installed Chief of the DOJ’s Health Care Fraud unit is a former chief compliance officer. The AAG also strongly encouraged all health care organizations to ensure they have proper staffing to review their own data and respond to observations as needed. At that same conference, the Inspector General for the Department of Health & Human Services (HHS OIG), the Honorable Christi A. Grimm, reported that nursing homes are among the very highest priorities for her organization, which often works hand in hand with the DOJ.
In a June 2022 alert, Verrill reported that the DOJ assembled a task force called the New England Prescription Opioid Strike Force (NEPO). According to the DOJ, NEPO’s mission is to follow the data and pursue potential diversion of controlled substances, including opioids. The DOJ will likely scrutinize the claims data and prescribing records to flag issues for further investigation. Hospital systems, clinical labs, health care practice groups, and practitioners would be well advised to monitor and review their own data—looking for trends, spikes, and outliers—because the DOJ is likely already reviewing this data.
The DOJ has compared the newly formed NEPO to the Appalachian Regional Prescription Opioid Strike Force (ARPO), which remains the government’s most successful regional task force and recently celebrated its five-year anniversary. ARPO’s first enforcement action occurred approximately six months after inception, when ARPO charged 60 individuals, including 53 medical professionals with a number of offenses. In conjunction with the criminal prosecutions, ARPO also worked to exclude providers from participation in Medicare, Medicaid, and all other government health care programs. The DEA issued several suspension orders, orders to show cause, and received voluntary surrenders of controlled substance registrations. Since its inception in 2018, ARPO has conducted so-called “takedowns” every six months or so, resulting in numerous criminal charges, administrative actions, and civil settlements.
Many, but not all, of DOJ enforcement actions will target bad actors who are engaged in intentional wrongdoing—not law-abiding systems, providers, or practitioners. Nevertheless, the DOJ and its task forces cast a wide net and even law-abiding corporate citizens and practitioners may find themselves interacting with NEPO and responding to investigations or inquiries. While seemingly benign, every interaction with the government should be carefully considered and managed in consultation with experienced government enforcement counsel.
- The DOJ and its task forces cast a wide net. Even the most law-abiding organizations and individuals may experience government enforcement interactions and should always proceed with caution.
- The DOJ is actively reviewing historical and likely real-time claims data and prescribing records for practitioners of all types in Maine, New Hampshire, and Vermont.
- Review your own data—look for trends, spikes, and outliers. Examine the findings to identify potential issues and determine appropriate response(s), if any.
- Carefully and quickly consider how to address overpayments or suspected overpayments.
- Investigate whistleblower or employee hotline complaints and document your findings. Consider retaining outside counsel to investigate allegations as necessary.
- Providers, individuals, or entities who are contacted should seek experienced government enforcement counsel. Verrill lawyers have extensive experience in this area and early consultation with counsel is recommended.
David G. Lazarus, a former DOJ health care prosecutor, is a Health Care & White-Collar Defense Partner at Verrill Dana LLP. Dave represents individuals and companies in federal and state government enforcement matters including False Claims Act defense, subpoena response, all types of civil, criminal, and administrative litigation, internal investigations, and provides regulatory advice and compliance services, including in New England.
Jeffrey A. Smagula, Counsel to Verrill Dana LLP, former Chief Compliance Officer of a large health plan, is an experienced compliance, regulatory, and privacy lawyer. Jeff provides compliance and regulatory guidance, privacy advice, conducts internal investigations, and assists in all types of litigation.