Life Sciences & Health Care Compliance and Investigations

Our experienced attorneys help you navigate the challenges of the ever-changing health care regulatory landscape to get you back to your core business.

Our approach

Prosecutors and regulators have made health care fraud one of their highest priorities.

We help clients navigate the complex maze of regulations covering their day-to-day operations, building compliance programs, conflicts of interest policies and training programs for employees and executives.

When litigation becomes unavoidable, our team of highly skilled trial lawyers achieves favorable results for individuals and companies in some of the nation’s largest and highest profile civil and criminal proceedings—and in all forms of investigations and prosecutions initiated by the Department of Justice, individual U.S. Attorney’s offices and state attorneys general.

We counsel clients on matters including:

  • Early stages of external government investigations, whether informal inquiries or high-profile subpoenas to public companies
  • Off-label promotion
  • Pharmaceutical pricing and reimbursement
  • Good manufacturing practices
  • Average wholesale price
  • Overpayments
  • Payment suspensions
  • Medicare and Medicaid regulation
  • Physician consulting agreements
  • Violations of federal and state laws and regulations, such as the Anti-Kickback Statute, the False Claims Act, the Foreign Corrupt Practices Act, the Stark Law and state gift ban statutes
  • Misbranding and adulteration

We also provide counsel around corporate integrity agreements, and deferred prosecution agreements and other monitorship agreements—helping clients negotiate and, implement and monitor compliance with these agreements and analyzing while managing their impact on our clients’ businesses.

We work with

  • Pharmaceutical companies
  • Medical device manufacturers
  • Durable medical equipment suppliers
  • Hospitals
  • Long-term care facilities
  • Skilled nursing facilities
  • Ambulatory centers
  • Physician practices
  • Labs and clinics

Representative experience

  • Representation of a major pharmaceutical manufacturer in two separate government investigations involving alleged off-label promotion, anti-kickback violations, and improper “Best Price” reporting under the Medicaid Drug Rebate Program. These matters, along with a third investigation, were resolved as part of a global $3 billion criminal and civil settlement with the federal government and certain participating states, the largest health care fraud settlement in U.S. history.
  • Representation of a medical device manufacturer in a federal investigation involving potential False Claims Act violations arising out of the marketing of an orthopedic device.
  • Representation of a large pharmaceutical manufacturer in an action commenced by the Massachusetts Attorney General’s Office alleging that the company violated the Massachusetts Consumer Protection Statute as a result of off-label promotion and the failure to disclose certain product risk information.
  • Representation of a pharmaceutical sales executive targeted in a federal investigation involving allegations of off-label promotion and anti-kickback violations.
  • Representation of multiple institutional dialysis providers in a federal investigation of alleged Medicaid billing violations.
  • Representation of the owner of multiple skilled nursing facilities in a federal investigation involving Medicare billing issues.
  • Representation of a national hospital chain in connection with the federal investigation of the New England Compounding Center and the multistate outbreak of fungal meningitis.
  • Representation of an artificial hip and knee manufacturer in an industry-wide investigation by the U.S. Attorney’s Office for the District of New Jersey alleging violations of the Anti-Kickback Statute. The investigation was resolved through a deferred prosecution agreement, civil settlement, and the imposition of a DOJ-appointed monitor. Our firm represented the company in its dealings with the monitor until the DPA expired and the government dismissed its complaint against the company.
  • Representation of an international pharmaceutical company in an investigation by the Massachusetts Attorney General’s Office involving potential violations of the state gift ban and payment reporting regulations.
  • Representation of a pharmaceutical manufacturer in a federal investigation centering on the company’s sales and marketing practices, including allegations of off-label promotion, and anti-kickback violations. The matter was resolved through a civil-only settlement and a corporate integrity agreement.
  • Representation of a Massachusetts teaching hospital in connection with its voluntary disclosure of Medicare overpayments associated with patients who received observation services.
  • Representation of a physician-hospital organization in an internal investigation of potential anti-kickback violations.
  • Representation of an international pharmaceutical manufacturer in an internal investigation of off-label sales and marketing activities.
  • Representation of a major pharmaceutical manufacturer in a federal investigation involving allegations that the company set an inflated “average wholesale price” for certain products and then promoted those products to physicians based on the “spread” between the AWP-based Medicare and Medicaid reimbursement, and the actual price paid by physicians. The investigation and two related False Claims Act cases were resolved through a civil settlement with no criminal charges against the company. Our attorneys also represented the company in related multidistrict litigation and state court actions brought by various state attorneys general and third-party payors.
  • Representation of a drug company in a federal investigation into the company’s alleged failure to report—as its “Best Price” under the Medicaid Drug Rebate Program—the price of certain products sold to a health maintenance organization that repackaged and relabeled the products under its own NDC numbers. The investigation was resolved through a civil-only settlement with the government.
  • Representation of a prominent academic medical center in a False Claims Act action alleging fraud in connection with Medicare and Medicaid billing and reporting related to federally funded (NIH/NCI) clinical research.
  • Representation of a former regional account manager of a large pharmaceutical company in connection with a federal investigation of alleged anti-kickback violations.
  • Representation of a national pharmaceutical company in an “average wholesale price” investigation by the Department of Justice.

Billionaire pharmaceuticals entrepreneur indicted in alleged fentanyl fraud scheme

Wall Street Journal | October 26, 2017

This article quotes Boston government investigations and white collar defense partner Brian Kelly for representing John Kapoor, the former chief executive of pharmaceutical company Insys Therapeutics, Inc. in an ongoing investigation.

Life Sciences Cases to Watch in the 2nd Half of 2016

Law360 | July 13, 2016

Boston Government Investigations & White Collar Defense partner Brian French, a member of the Life Sciences team, is quoted in this story looking at important cases the industry is monitoring for the remainder of the calendar year. Brian is quoted discussing False Claims Act matters.

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