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  • Brian D. Bewley
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Brian D. Bewley

Partner

Manatt Health
Contact
  • bbewley@manatt.com
  • Phone: 202.624.3334
  • Download vCard
  • Washington, D.C.
Bar Admissions
  • Maryland

    Tennessee

    Washington, D.C.

Education
  • Washington University in St. Louis School of Law, J.D., 2004

    Drury University, B.A., Biology, 1998

Services
  • False Claims Act
  • Government and Regulatory
  • Health Care Litigation
  • Health Care Transactions
  • Manatt for Entrepreneurs
Industries
  • Digital Health
  • Manatt Health

Show Full Bio

  • Profile
  • Experience
  • Speaking Engagements
  • Honors & Awards
  • Memberships
  • Publications
Profile

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

Experience

Health Care Providers

Lead attorney representing one of largest non-profit health systems in an audit conducted by the Office of Audit Services for the Office of Inspector General to the Department of Health and Human Services. Brian’s representation resulted in a reduction in the original Medicare overpayment determination of over $8 million to a little over $1 million – of which is presently on appeal with the Office of Medicare Hearings and Appeal.

Lead counsel to large non-profit health system in complex internal investigation of contractual arrangements with certain cardiology groups that implicated the Stark and Anti-Kickback laws.  Representation resulted in a voluntary disclosure to, and favorable settlement with, the Office of Counsel to the Inspector General.

Lead counsel to large non-profit health system in dissolution of professional services agreement with independent specialty physician practice and then subsequent conversion of this physician practice to employment model with health system.

Acts as primary compliance consultant for one of the largest public-owned hospital districts.

Lead counsel for prestigious pediatric hospital in complex investigation involving Stark law compliance with several independent physician practices.  Representation included disclosure to the Centers for Medicare and Medicaid under its Self-Referral Disclosure Protocol.

Lead counsel to a Special Health Care District serving one the largest counties in the United States on its comprehensive agreement with the largest multi-specialty physician group in the state covering all clinical, administrative, research, and teaching functions. Representation of this Special Health Care District includes ensuring compliance with this agreement that is valued, minimally, at $150 million/year.

Lead counsel to one of the nation’s largest not-for-profit health plans in an internal investigation of its compliance with network adequacy requirements under Medicare regulations and sub-regulatory guidance.

Lead compliance counsel for large long-term care company operating under a Corporate Integrity Agreement with OIG-HHS.

Representing several nonprofit health care systems on hospital-physician compensation structures and alignment, and compliance with reimbursement regulations.

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

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

Pharmaceutical, Medical Device, and Digital Therapeutics

Longstanding outside regulatory and fraud and abuse counsel to Fortune 100 multinational medical device and health care corporation.

Regulatory counsel for emerging medical device company as it prepares to go to market upon receiving clearance of its device from the U.S Food and Drug Administration.

Lead regulatory and compliance counsel to pharmaceutical manufacturer with a rare disease drug. Representation includes advising the manufacturer on its go-to market commercial strategy in the United States to ensure compliance with various federal and state laws.

Lead counsel for European-based digital therapeutics company on its market access strategy in the United States. Representation included negotiating large affiliation agreements with Pfizer, AstraZeneca, Eli Lilly, and Anthem.

Lead counsel for Fagron Holding USA LLC and its wholly-owned subsidiaries in a global settlement with the Department of Justice based on two False Claims Act cases alleging inflated average wholesale prices, kickbacks to physicians, and waivers of co-pay.  United States ex rel. Hueseman v. PSI et al., (WDTX) and United States ex rel. Sten v. Midwest Compounders, et al., (NDIA)

Advised pharmaceutical manufacturer in restructuring of its corporate compliance program.

On behalf of a medical device corporation, conducted comprehensive review of its corporate compliance program.

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.*

Private Equity/Investors

Lead regulatory counsel to Vivo Fusion, a nationally recognized provider of ambulatory infusion care launched by InTandem Capital Partners, in the acquisition of Infusion Center of Pennsylvania (ICPA), the largest nonhospital infusion provider in the Philadelphia area.

Lead regulatory counsel for private equity and growth capital firm—with over $100 billion in managed assets—in its bid to take a large public health care company private.

Lead legal and regulatory counsel to InTandem Capital Partners, a health care services-focused private equity firm, in its formation of Vivo Infusion, a leading ambulatory infusion services provider, through the recapitalization and combination of two infusion centers.

Lead regulatory counsel for private equity investment firm on its acquisition of California-based fertility practices.

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.*

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.*

*Denotes experience prior to joining Manatt.

Speaking Engagements

Speaking Engagements

Speaker, “Internal Investigation, Repayment and Self-Disclosure,” Healthcare Enforcement Compliance Conference, Health Care Compliance Association, November 9, 2022.

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

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

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

Publications

Publications

Quoted, “Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate,” Pink Sheet, April 11, 2022.

Quoted, “Beyond Aduhelm: OIG Review Will Put FDA’s Entire Accelerated Approval Program Under Microscope,” Pink Sheet, August 4, 2021.

Featured, “People on the Move: Brian Bewley,” Washington Business Journal, June 16, 2021.

Co-authored, “HHS Advisory Highlights Need For Anti-Kickback Law Update,” Law360, May 21, 2021.

Brian in the News

  • 09.20.22

    Manatt Serves as Regulatory Counsel to Vivo Infusion in Acquisition ...

    A team led by Manatt Health Partner Brian Bewley and including Counsel Katie Dunn and Associates Michael Herrmann, Krusheeta Patel and Marisa ...

  • 04.11.22

    Sher and Bewley Quoted in Pink Sheet on OIG’s Review of FDA Approval ...

    Manatt Health Partners Rachel Sher and Brian Bewley were quoted in Pink Sheet on the Office of Inspector General’s (OIG) review of the ...

  • 04.07.22

    Manatt Advises InTandem Capital Partners on Formation of Infusion ...

    Manatt Health provided legal and regulatory counsel to InTandem Capital Partners in its formation of Vivo Infusion through the recapitalization and...

  • 10.20.21

    Manatt Adds Seasoned Physician and Researcher to Expanding Health ...

    Senior Advisor Amy Salerno adds to firm’s integrated legal and consulting health care capabilities, bringing significant clinical, financial ...

Show More

Brian's Articles

  • 05.21.21

    HHS Advisory Highlights Need For Anti-Kickback Law Update

    Manatt Health Partner Brian Bewley and Associate Kaitlyn Dunn co-authored an article for Law360 analyzing the U.S. Department of Health and ...



Brian's Newsletters

  • 01.09.23

    OIG Advisory Opinion Offers a Cautionary Tale on Utilization of ...

    On December 19, 2022, the Office of Inspector General of the U.S. Department of Health & Human Services issued an advisory opinion blessing the ...

  • 04.28.22

    OIG Advisory Opinion Recognizes Legitimacy of Certain Physician-Owned ...

    After years of government skepticism and enforcement activity targeting physician-owned medical device companies, a recent favorable advisory opinion ...

  • 02.08.22

    Manatt Provides Input to OIG on Opportunities for Modernizing ...

    On January 31, 2022, Manatt, Phelps & Phillips, LLP, submitted a formal response to the Request for Information issued by the U.S. Department of ...

  • 05.12.21

    New OIG Advisory Opinion Begs the Question: Is It Time to Reform the ...

    On April 26, 2021, the Office of Inspector General of the U.S. Department of Health and Human Services issued a favorable advisory opinion involving ...



Brian's Events and Webinars

  • 11.09.22

    Bewley and Dunn to Speak at HCCA’s Healthcare Enforcement Compliance ...

    Manatt Health Partner Brian Bewley and Counsel Katie Dunn will speak at the annual Healthcare Enforcement Compliance Conference hosted by the ...



  • 02.23.22

    Prepare for More Health Care Investigations: A Primer on Navigating ...

    In FY 2020, the Department of Justice opened 1,079 new civil health care fraud investigations and had 1,498 civil health care fraud matters ...



  • 03.23.21

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

    From Pricing to Compliance to Coordinated Care, a Wide Range of Critical Areas Saw Regulatory Changes in 2020 That Will Impact the Health Care and ...

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