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.*
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.