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Kathrin E. Kudner Member

Ms. Kudner's practice is devoted to the representation of health care providers, payors and biotechnology and life sciences companies in various corporate and regulatory matters. Ms. Kudner is a member of the Firm's Biotechnology and Life Sciences, Dental Service Organizations, and Insurance Teams.

Experience

  • Corporate Transactions. Advise health care providers and payors in structuring businesses and transactions to comply with the law and payor requirements and to maximize reimbursement. Represent providers and payors in mergers and acquisitions, joint ventures, affiliations, conversions and consolidations. Advise clients on the corporate practice of medicine and dentistry.
  • Information Privacy and Security. Counsel providers, managed care organizations, insurance companies, employers and business associates regarding HIPAA compliance. Draft and review HIPAA forms, policies and procedures and business associate agreements. Counsel clients on cybersecurity and data breaches.
  • Biotechnology and Life Science. Counsel manufacturers, distributors and health care providers regarding compliance with FDA requirements, including obtaining required clearances and approvals, labeling, informed consent and IRB. Review and negotiate clinical trial, clinical research organization, collaboration, license and technology transfer contracts and policies and procedures. Advise regarding reimbursement, HIPAA and tax issues related to clinical research, regulatory issues in connection with mobile medical applications and cloud-based services and compliance with the Sunshine Act.
  • Managed Care and Insurance. Counsel regarding licensure and regulatory matters applicable to insurers and managed care organizations. Review and negotiate managed care and insurance contracts on behalf of providers, managed care organizations, commercial insurers, Medicare and Medicaid plans and third party administrators. Counsel regarding formation of ACOs and CINs, including MSSP.
  • Tax Exemption. Advise tax exempt clients regarding governance, private inurement and private benefit, private use, UBIT, and excess benefit transactions. Represent tax exempt organizations in bond financings and commercial loans. Represent tax exempt organizations. 
  • Compliance. Draft and review compliance program manuals and policies and procedures. Advise compliance committees on internal and external audits, investigations and disclosures. Counsel clients regarding voluntary disclosure, overpayments and appeal of Medicare, Medicaid and other third party payor reimbursement decisions.

Prior to her law career, Ms. Kudner was an administrator of a rural medical and dental health care system in Nevada and served as a Peace Corps Volunteer in the Philippines.

Memberships & Involvement

  • American Health Lawyers Association, Member
  • Health Law Council, Michigan Bar Association, Member, 1999-2017; Chair, 2003-2004
  • International Association of Privacy Professionals (IAPP), Member
  • Great Lakes TE/GE Council, Emeritus Member

Community/Civic Activities

  • Evangelical Homes of Michigan Foundation, Board of Directors, Member

Named by Best Lawyers® as Ann Arbor Health Care Law "Lawyer of the Year," 2017

Recognized in Michigan Super Lawyers® for Health Care, FDA, and Business/Corporate, 2006-Present

Recognized in The Best Lawyers in America® for Health Care, 1999-Present. Copyright 2015 by Woodward/White, Inc., Aiken, SC

Named a Michigan Leading Lawyer in the areas of Biotechnology, Health  and Insurance, Insurance Coverage & Reinsurance Law by the Leading Lawyers Network, 2014-2017. Law Bulletin Publishing Company

Named a Top Lawyer by dbusiness Magazine for Health Care Law, 2010-2011, 2015-2016

Recipient of an AV® Preeminent™ Rating by Martindale-Hubbell