Attorney Brad Byars routinely advises pediatric and adult providers on regulatory compliance and reimbursement/repayment matters relating to the Stark Law, the Anti-kickback Statute, the False Claims Act, and Medicare and state Medicaid payment statutes and regulations. Brad has experience in advising pharmacy benefit managers in areas such as rebates/discounts, specialty pharmacy contracting, and group purchasing.
In addition, Brad is experienced in drafting and negotiating documents related to hospital-physician affiliations, with specific attention to employment, professional services, physician recruitment, and clinical co-management agreements. He also assists his clients with corporate structure and governance issues, franchise matters, and strategic business considerations. Brad represents healthcare providers in civil and criminal fraud investigations and self-disclosures with the U.S. Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and the Centers for Medicare & Medicaid Services (CMS).
• Served as in-house counsel for a national physician group.
• Assisted with complex CHOW applications for numerous facilities related to a large acquisition of health care facilities and successfully worked with CMS representatives to navigate the PECOS and paper documents required for a timely and smooth transition.
• Navigated complex federal and state licensing and credentialing laws related to the development of an integrative medicine clinic with medical, fitness, cosmetic, and spa services; assisted with the project from ground up and provided structural and strategic guidance based on federal and state licensing considerations.
• Directed comprehensive audit and regulatory analysis of physician contracts at a community hospital and submitted a Stark Law disclosure to CMS under the self-referral disclosure protocol. Provided operational and corrective action recommendations related to audit findings.
• Assisted with the settlement of a Stark Law violation with the DOJ and the OIG for the Department of Health and Human Services, after assisting with internal investigation, self-disclosure, and extensive negotiations.
• Represented a large health system in the development of a new system-wide physician employment agreement model and compensation methodology and facilitated the transition of more than 100 employed physicians to the new model.
• Advised a multi-hospital health system on all aspects of physician contracting, including contract development and negotiation, regulatory analysis and operational considerations.
• Assisted with development and structuring of primary care medicine concierge practice to address federal and state healthcare, reimbursement, insurance and privacy/data security issues.
• Represented various healthcare businesses to evaluate and develop medical franchise strategy and associated disclosure documents/ancillary agreements.
• Assisted with an evaluation of a multi-site cloud-based patient information access portal proposed by a concierge medicine franchise.
• Evaluated various quality bonus programs for employed and contracted, including facilitating valuation efforts and the development of quality initiatives, benchmarks and bonus methodology.
• Assisted with an operational practice/staffing review and the development of a comprehensive compensation model for the exclusive anesthesia provider of a large hospital.
• Collaborated with valuation experts to apply fair market value principles to pediatric employment, professional services, and other affiliation arrangements.
• Assisted with evaluating compliance with federal research regulations (informed consent/IRB issues), NIH Grants Policy Statement, and related federal regulations and investigations in the area of pediatric and adult research.
• Developed a comprehensive compliance plan effectiveness audit tool used by various healthcare providers across the Midwest.
• Represented the Compensation Committee of a healthcare system to ensure compliance with Internal Revenue Service and healthcare regulatory requirements, including presentation of educational sessions for Committee members and the hospital’s executive leadership team.