Brian D. Bewley

Partner

Manatt Health

Contact

bbewley@manatt.com
Phone: 202.624.3334

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Profile

Health care and life sciences companies look to Brian Bewley to navigate complex regulatory, strategic and transactional matters and find pragmatic solutions. This includes advising on compliance with myriad federal and state laws, providing transactional guidance and managing regulatory due diligence, and assisting with their response to government audits and investigations. Brian’s clients include medical device and pharmaceutical manufacturers, hospitals and health systems, digital health companies, managed care organizations, long-term and post-acute care providers, specialty pharmacies, pharmacy benefit managers, and private equity investors that support these health care and life sciences companies.

In addition to counseling companies on regulatory compliance, business strategies and transactional matters, Brian has successfully defended several for-profit and not-for-profit health care and life sciences companies in matters alleging violations of the False Claims Act (FCA) and the Civil Monetary Penalties Law, as well as with audits conducted by the Department of Health and Human Services Office of Inspector General (HHS OIG) and the Centers for Medicare & Medicaid Services. Brian’s deep experience includes matters involving federal and state Anti-Kickback Statute and Stark Law concerns, allegations of inflated average wholesale prices for drugs and drug ingredients, and Medicare and Medicaid reimbursement and coverage criteria. Brian has also negotiated corporate integrity agreements with the HHS OIG and advised companies operating under these agreements.

Previously, Brian served as senior counsel at the HHS OIG, where he was team leader for the Boston, Miami, Dallas and San Francisco regions. He was also accepted into the highly competitive Department of Justice U.S. Attorney General’s Honors Program and was appointed as a special assistant U.S. attorney by a former U.S. attorney and current federal judge. In these roles, Brian represented the government in matters brought under the FCA, the Anti-Kickback Statute and the Stark Law, Medicare and Medicaid reimbursement rules, and off-label marketing restrictions.

Given his deep experience, Brian is a frequent presenter for several national industry associations. From 1999 to 2001, Brian served as a volunteer in the U.S. Peace Corps, where he was a science teacher (in the French language) for a school located in a remote village in Burkina Faso, West Africa.

Experience

Serves as outside regulatory and fraud and abuse counsel to publicly traded Fortune 500 health care and life science corporation.*

Lead counsel for private equity backed portfolio provider and its management company in a voluntary disclosure to the HHS-OIG.*

Lead regulatory counsel for private equity investment firm on its financing of a complex buyout and restructuring of a physician management and radiation oncology services company.*

Lead regulatory counsel to a private equity investment firm on its multi-billion dollar bid to take a publicly traded health care IT company private.*

Represented pharmaceutical manufacturer in restructuring of its corporate compliance program.*

Lead counsel for global pharmaceutical ingredient supplier and its wholly-owned subsidiaries in an investigation and subsequent settlement under the FCA concerning inflated average wholesale prices, kickbacks to physicians, and waivers of co-pay.*

Lead defense counsel for long term care company in two FCA matters, one of which settled after a protracted multi-year civil and criminal investigation, and another resulting in a declination by both the Department of Justice and respective State Attorney General’s Office.*

Lead counsel for a large pharmacy benefit manager in two separate investigations under the FCA, both of which were subsequently closed by DOJ without any further action.*

Lead counsel for regional health system resulting in a declination by DOJ of a qui tam alleging false claims based on provider-based billing and 340B.*

Represented several large not-for-profit health systems in various regulatory and fraud and abuse issues.*

Represented a hospice services entity in a complex post-sale dispute with a private-equity backed national hospice company. After buyer self-disclosed to OIG, and sued the seller in arbitration for the proposed settlement amount with OIG, Mr. Bewley persuaded OIG that its client was the party-of-interest and negotiated a resolution with OIG for almost $10 million less than originally proposed.*

Represented numerous entities operating under Corporate Integrity Agreements with HHS-OIG.*

_{*Denotes experience prior to joining Manatt.}

Speaking Engagements

Speaker, “Medical Necessity and Civil and Criminal Liability,” Health Care Compliance Association (HCCA), Healthcare Enforcement Compliance Conference, November 2020.

Speaker, “Use of the Travel Act in Prosecutions of Healthcare Fraud,” 15th Annual American Bar Association (ABA) Washington Health Law Summit, December 2017.

Speaker, “Health Care Compliance Issues – Year in Review,” HCCA Kansas City Regional Conference, September 2017.

Speaker, “The Business of Health Care Fraud Enforcement: A Pragmatic Discussion and Assessment,” HCCA 21st Annual Compliance Institute, March 2017.

Speaker, “Hot Topics in Healthcare Fraud and Abuse,” Tennessee Society of Certified Public Accountants (TSCPA) Health Care Conference, November 2016.

Speaker, “Fraud and Abuse – Year in Review,” HCCA web conference, January 2016.

Speaker, “Responding to a Government Investigation: Best Practices for Achieving a Favorable Outcome,” HCCA Compliance Institute, March 2014.

Speaker, “Hone in on Home and Hospice Compliance and Quality: The Government Is Watching,” American Health Lawyers Association (AHLA) Long-Term Care and the Law Conference, February 2014.

Speaker, “Marketing/Anti-kickback Issues in Healthcare – So What Are the Rules These Days?,” AHLA webinar, February 2014.

Speaker, “Risk Areas for Hospice Providers – OIG Enforcement Initiatives,” Colorado Center for Hospice & Palliative Care 2013 Fall Conference, October 2013.

Honors & Awards

Nashville Medical News, “InCharge Healthcare,” 2017–20

Super Lawyers, “Rising Star,” 2014

Inspector General Exceptional Achievement Award, 2009–12

U.S. Attorney General Honors Attorney, 2004

Washington University Law Review, Executive Notes Editor

Memberships

Program Chair, Health Care Compliance Association (HCCA), Midwest Region Conference (2013–17)

Member, American Health Law Association (AHLA), Fraud & Abuse Practice Group, Advisory Opinion Task Force

Member, American Bar Association (ABA), Health Law Practice Group

Admitted to practice in the state of Tennessee

Admitted to practice in the District of Columbia

Admitted to practice in the state of Maryland

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Brian's Events and Webinars

What’s Past Is Present: Key Regulatory Trends Impacting Health ...