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Prior to her legal career, Olivia earned a B.A. in Economics from Harvard University and spent five years as an investment banker.\u003c/p\u003e","slug":"olivia-radin","email":"oradin@kslaw.com","phone":null,"matters":["\u003cp\u003eAdvising one of the world's largest technology companies across matters relating to Russia and the impact of sanctions and other international response to Russia\u0026rsquo;s military actions.\u003c/p\u003e","\u003cp\u003eAdvising one of the world's largest technology companies on investigations relating to the U.S., France, Hungary, South Africa, the UK and other countries.\u003c/p\u003e","\u003cp\u003eAdvising one of the world's largest technology companies on other key strategic regulatory risks.\u003c/p\u003e","\u003cp\u003eRepresenting a global mining company on an internal investigation.\u003c/p\u003e","\u003cp\u003eAdvising a Fortune 100 company on a data security incident.\u003c/p\u003e","\u003cp\u003eAdvising a Canadian pension fund in connection with risks relating to its investments and other matters.\u003c/p\u003e","\u003cp\u003eLeading an investigation on behalf of a board in connection with allegations regarding disclosures.\u003c/p\u003e","\u003cp\u003eLeading a board investigation into allegations of misconduct by senior management.\u003c/p\u003e","\u003cp\u003eRepresenting VW in connection with its resolution with DOJ relating to VW's diesel emissions case.\u003c/p\u003e","\u003cp\u003eRepresenting current and former employees of a global auto manufacturer in diesel-related regulatory investigations.\u003c/p\u003e","\u003cp\u003eRepresenting one of the world\u0026rsquo;s largest banks in investigations by multiple enforcement authorities into an alleged scheme to manipulate the setting of LIBOR, EURIBOR and other fixed-income reference rates.\u003c/p\u003e","\u003cp\u003eRepresenting a global financial institution with the largest share of the FX market in investigations by the Department of Justice, the CFTC, the FCA and the NYSDFS into allegations of manipulation and collusion in the setting of global foreign-exchange benchmarks.\u003c/p\u003e","\u003cp\u003eAdvising multiple clients on FCPA, AML and Sanctions risks in connection with strategic acquisitions.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":11,"guid":"11.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":118,"guid":"118.capabilities","index":2,"source":"capabilities"},{"id":111,"guid":"111.capabilities","index":3,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":4,"source":"capabilities"},{"id":128,"guid":"128.capabilities","index":5,"source":"capabilities"},{"id":803,"guid":"803.smart_tags","index":6,"source":"smartTags"},{"id":780,"guid":"780.smart_tags","index":7,"source":"smartTags"},{"id":1327,"guid":"1327.smart_tags","index":8,"source":"smartTags"},{"id":766,"guid":"766.smart_tags","index":9,"source":"smartTags"},{"id":687,"guid":"687.smart_tags","index":10,"source":"smartTags"},{"id":699,"guid":"699.smart_tags","index":11,"source":"smartTags"},{"id":102,"guid":"102.capabilities","index":12,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":13,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":14,"source":"smartTags"},{"id":1188,"guid":"1188.smart_tags","index":15,"source":"smartTags"},{"id":106,"guid":"106.capabilities","index":16,"source":"capabilities"},{"id":750,"guid":"750.smart_tags","index":17,"source":"smartTags"},{"id":14,"guid":"14.capabilities","index":18,"source":"capabilities"},{"id":984,"guid":"984.smart_tags","index":19,"source":"smartTags"},{"id":1199,"guid":"1199.smart_tags","index":20,"source":"smartTags"}],"is_active":true,"last_name":"Radin","nick_name":"Olivia","clerkships":[{"name":"Law Clerk, Judge Honorable Robert D. Sack, U.S. Court of Appeals for the Second Circuit","years_held":"2004 - 2005"}],"first_name":"Olivia","title_rank":9999,"updated_by":202,"law_schools":[{"id":485,"meta":{"degree":"J.D.","honors":"James Kent Scholar","is_law_school":"1","graduation_date":"2004-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"“Recommended” for Dispute Resolution – White Collar Criminal Defense","detail":"The Legal 500 United States"},{"title":"“Rising Star” ","detail":"Legal 500"},{"title":"“Rising Stars” ","detail":"Who’s Who Legal"},{"title":"Notable Women in Law ","detail":"Crain’s New York"}],"linked_in_url":"https://www.linkedin.com/in/olivia-radin-06543073/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eOlivia Radin is a partner in the Special Matters \u0026amp; Government Investigations practice who advises on high-risk global crises, regulatory investigations, and litigation matters. Olivia acts as global strategic counsel for her clients, helping them address risks arising from geopolitical tensions, resolve global investigations and allegations of misconduct, and manage\u0026nbsp;global\u0026nbsp;litigation threats. In the course of this work, she develops a full understanding of key inflection points and an effective response to them; runs teams that include numerous specialists, local counsel, experts and others; and supports clients\u0026rsquo; PR and public policy efforts.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eOlivia represents clients in the technology, energy, financial services, and other industries. She has deep experience advising clients on litigation and investigations arising from global crises, geopolitical tensions or changing regulations and in investigating and remediating allegations of bias, fraud, sanctions and anti-money laundering violations, theft of trade secrets and other issues. She has extensive experience working with money transmitters on BSA/AML risks and fraud detection.\u003c/p\u003e\n\u003cp\u003eOlivia represents clients in affirmative and defensive litigation and defends clients before the Department of Justice, the Securities and Exchange Commission, State Attorneys General, the New York State Department of Financial Services, the Public Company Accounting Oversight Board and other regulators.\u003c/p\u003e\n\u003cp\u003eOlivia has served as a member of the Development Committee of the Board of the Women\u0026rsquo;s White Collar Defense Association. She is also a fellow of the American Bar Foundation and the Federal Bar Council Inn of Court. Olivia has been recognized by\u0026nbsp;\u003cem\u003eCrain\u0026rsquo;s New York\u003c/em\u003e\u0026nbsp;Business Notable Women in Law,\u0026nbsp;\u003cem\u003eLegal 500\u003c/em\u003e\u0026nbsp;and\u0026nbsp;\u003cem\u003eWho\u0026rsquo;s Who Legal\u003c/em\u003e\u0026nbsp;for her work.\u003c/p\u003e\n\u003cp\u003ePrior to joining King \u0026amp; Spalding, Olivia was the New York managing partner of a large law firm and a member of its global board. Olivia earned her J.D. from Columbia Law School, where she was a Kent Scholar and served as a Managing Editor of the\u0026nbsp;\u003cem\u003eColumbia Law Review\u003c/em\u003e. Upon graduation, she served as a law clerk to the Honorable Robert D. Sack of the United States Court of Appeals for the Second Circuit. Prior to her legal career, Olivia earned a B.A. in Economics from Harvard University and spent five years as an investment banker.\u003c/p\u003e","matters":["\u003cp\u003eAdvising one of the world's largest technology companies across matters relating to Russia and the impact of sanctions and other international response to Russia\u0026rsquo;s military actions.\u003c/p\u003e","\u003cp\u003eAdvising one of the world's largest technology companies on investigations relating to the U.S., France, Hungary, South Africa, the UK and other countries.\u003c/p\u003e","\u003cp\u003eAdvising one of the world's largest technology companies on other key strategic regulatory risks.\u003c/p\u003e","\u003cp\u003eRepresenting a global mining company on an internal investigation.\u003c/p\u003e","\u003cp\u003eAdvising a Fortune 100 company on a data security incident.\u003c/p\u003e","\u003cp\u003eAdvising a Canadian pension fund in connection with risks relating to its investments and other matters.\u003c/p\u003e","\u003cp\u003eLeading an investigation on behalf of a board in connection with allegations regarding disclosures.\u003c/p\u003e","\u003cp\u003eLeading a board investigation into allegations of misconduct by senior management.\u003c/p\u003e","\u003cp\u003eRepresenting VW in connection with its resolution with DOJ relating to VW's diesel emissions case.\u003c/p\u003e","\u003cp\u003eRepresenting current and former employees of a global auto manufacturer in diesel-related regulatory investigations.\u003c/p\u003e","\u003cp\u003eRepresenting one of the world\u0026rsquo;s largest banks in investigations by multiple enforcement authorities into an alleged scheme to manipulate the setting of LIBOR, EURIBOR and other fixed-income reference rates.\u003c/p\u003e","\u003cp\u003eRepresenting a global financial institution with the largest share of the FX market in investigations by the Department of Justice, the CFTC, the FCA and the NYSDFS into allegations of manipulation and collusion in the setting of global foreign-exchange benchmarks.\u003c/p\u003e","\u003cp\u003eAdvising multiple clients on FCPA, AML and Sanctions risks in connection with strategic acquisitions.\u003c/p\u003e"],"recognitions":[{"title":"“Recommended” for Dispute Resolution – White Collar Criminal Defense","detail":"The Legal 500 United States"},{"title":"“Rising Star” ","detail":"Legal 500"},{"title":"“Rising Stars” ","detail":"Who’s Who Legal"},{"title":"Notable Women in Law ","detail":"Crain’s New York"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":11192}]},"capability_group_id":2},"created_at":"2026-01-09T22:41:56.000Z","updated_at":"2026-01-09T22:41:56.000Z","searchable_text":"Radin{{ FIELD }}{:title=\u0026gt;\"“Recommended” for Dispute Resolution – White Collar Criminal Defense\", :detail=\u0026gt;\"The Legal 500 United States\"}{{ FIELD }}{:title=\u0026gt;\"“Rising Star” \", :detail=\u0026gt;\"Legal 500\"}{{ FIELD }}{:title=\u0026gt;\"“Rising Stars” \", :detail=\u0026gt;\"Who’s Who Legal\"}{{ FIELD }}{:title=\u0026gt;\"Notable Women in Law \", :detail=\u0026gt;\"Crain’s New York\"}{{ FIELD }}Advising one of the world's largest technology companies across matters relating to Russia and the impact of sanctions and other international response to Russia’s military actions.{{ FIELD }}Advising one of the world's largest technology companies on investigations relating to the U.S., France, Hungary, South Africa, the UK and other countries.{{ FIELD }}Advising one of the world's largest technology companies on other key strategic regulatory risks.{{ FIELD }}Representing a global mining company on an internal investigation.{{ FIELD }}Advising a Fortune 100 company on a data security incident.{{ FIELD }}Advising a Canadian pension fund in connection with risks relating to its investments and other matters.{{ FIELD }}Leading an investigation on behalf of a board in connection with allegations regarding disclosures.{{ FIELD }}Leading a board investigation into allegations of misconduct by senior management.{{ FIELD }}Representing VW in connection with its resolution with DOJ relating to VW's diesel emissions case.{{ FIELD }}Representing current and former employees of a global auto manufacturer in diesel-related regulatory investigations.{{ FIELD }}Representing one of the world’s largest banks in investigations by multiple enforcement authorities into an alleged scheme to manipulate the setting of LIBOR, EURIBOR and other fixed-income reference rates.{{ FIELD }}Representing a global financial institution with the largest share of the FX market in investigations by the Department of Justice, the CFTC, the FCA and the NYSDFS into allegations of manipulation and collusion in the setting of global foreign-exchange benchmarks.{{ FIELD }}Advising multiple clients on FCPA, AML and Sanctions risks in connection with strategic acquisitions.{{ FIELD }}Olivia Radin is a partner in the Special Matters \u0026amp; Government Investigations practice who advises on high-risk global crises, regulatory investigations, and litigation matters. Olivia acts as global strategic counsel for her clients, helping them address risks arising from geopolitical tensions, resolve global investigations and allegations of misconduct, and manage global litigation threats. In the course of this work, she develops a full understanding of key inflection points and an effective response to them; runs teams that include numerous specialists, local counsel, experts and others; and supports clients’ PR and public policy efforts. \nOlivia represents clients in the technology, energy, financial services, and other industries. She has deep experience advising clients on litigation and investigations arising from global crises, geopolitical tensions or changing regulations and in investigating and remediating allegations of bias, fraud, sanctions and anti-money laundering violations, theft of trade secrets and other issues. She has extensive experience working with money transmitters on BSA/AML risks and fraud detection.\nOlivia represents clients in affirmative and defensive litigation and defends clients before the Department of Justice, the Securities and Exchange Commission, State Attorneys General, the New York State Department of Financial Services, the Public Company Accounting Oversight Board and other regulators.\nOlivia has served as a member of the Development Committee of the Board of the Women’s White Collar Defense Association. She is also a fellow of the American Bar Foundation and the Federal Bar Council Inn of Court. Olivia has been recognized by Crain’s New York Business Notable Women in Law, Legal 500 and Who’s Who Legal for her work.\nPrior to joining King \u0026amp; Spalding, Olivia was the New York managing partner of a large law firm and a member of its global board. Olivia earned her J.D. from Columbia Law School, where she was a Kent Scholar and served as a Managing Editor of the Columbia Law Review. Upon graduation, she served as a law clerk to the Honorable Robert D. Sack of the United States Court of Appeals for the Second Circuit. Prior to her legal career, Olivia earned a B.A. in Economics from Harvard University and spent five years as an investment banker. Partner “Recommended” for Dispute Resolution – White Collar Criminal Defense The Legal 500 United States “Rising Star”  Legal 500 “Rising Stars”  Who’s Who Legal Notable Women in Law  Crain’s New York Harvard University Harvard Law School Columbia University Columbia University School of Law New York Development Committee of the Women’s White Collar Defense Association Fellow of the American Bar Foundation Member of the Federal Bar Council and New York City Bar Association Law Clerk, Judge Honorable Robert D. Sack, U.S. Court of Appeals for the Second Circuit Advising one of the world's largest technology companies across matters relating to Russia and the impact of sanctions and other international response to Russia’s military actions. Advising one of the world's largest technology companies on investigations relating to the U.S., France, Hungary, South Africa, the UK and other countries. Advising one of the world's largest technology companies on other key strategic regulatory risks. Representing a global mining company on an internal investigation. Advising a Fortune 100 company on a data security incident. Advising a Canadian pension fund in connection with risks relating to its investments and other matters. Leading an investigation on behalf of a board in connection with allegations regarding disclosures. Leading a board investigation into allegations of misconduct by senior management. Representing VW in connection with its resolution with DOJ relating to VW's diesel emissions case. Representing current and former employees of a global auto manufacturer in diesel-related regulatory investigations. Representing one of the world’s largest banks in investigations by multiple enforcement authorities into an alleged scheme to manipulate the setting of LIBOR, EURIBOR and other fixed-income reference rates. Representing a global financial institution with the largest share of the FX market in investigations by the Department of Justice, the CFTC, the FCA and the NYSDFS into allegations of manipulation and collusion in the setting of global foreign-exchange benchmarks. Advising multiple clients on FCPA, AML and Sanctions risks in connection with strategic acquisitions.","searchable_name":"Olivia Radin","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":445247,"version":1,"owner_type":"Person","owner_id":7299,"payload":{"bio":"\u003cp\u003eA partner in the firm\u0026rsquo;s Healthcare practice, Renee Rayne represents public hospitals, private hospitals and physician groups in regulatory compliance and transactional matters, particularly related to participation in federal and state reimbursement programs. Approaching each transaction with an analytical eye, Renee identifies issues and risk tolerance to help clients solve problems and reach their goals.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eRenee advises hospital systems across a wide-range of regulatory compliance and reimbursement matter, including compliance with the Stark Law, federal and state anti-kickback statutes, HIPAA, compliance issues related to participation in Medicaid and Medicare programs, regulatory audits and appeals, along with other related regulatory requirements. She has significant experience representing public, investor-owned, non-profit, children\u0026rsquo;s, psychiatric, and rural hospitals along with healthcare provider associations.\u003c/p\u003e\n\u003cp\u003eAdditionally, Renee has assisted in the development, implementation, and operation of new Medicaid reimbursement programs in several states, including managed care directed payment programs and Upper Payment Limit (UPL) programs. She analyzes hospital data to model the reimbursement impacts of federal and state policy changes, as well as operational modifications within hospital systems.\u003c/p\u003e\n\u003cp\u003eRenee takes a collaborative approach to matters, strategically partnering with clients to navigate complex negotiations. Her advocacy includes working with state regulatory agencies and facilitating coalitions of industry stakeholders to advocate to state and federal lawmakers for improved reimbursement opportunities.\u003c/p\u003e\n\u003cp\u003eWhen away from the office, Renee enjoys spending time with family and attending concerts.\u003c/p\u003e\n\u003cp\u003eRenee earned her J.D. from the University of Texas School of Law and her B.A. from Vanderbilt University. Renee interned with the Honorable E. Clifton Knowles, Magistrate Judge of the U.S. District Court for the Middle District of Tennessee, and was a recipient of the Dean\u0026rsquo;s Achievement Award for Academic Excellence and William Ellis Woods Endowed Presidential Scholarship.\u003c/p\u003e","slug":"renee-rayne","email":"rrayne@kslaw.com","phone":null,"matters":["\u003cp\u003eAssisting hospitals and state Medicaid agencies in designing state-directed Medicaid managed care payment programs and assisting in responses to CMS inquiries in order to obtain program approval.\u003c/p\u003e","\u003cp\u003eStructuring, developing and assisting hospitals in working with healthcare industry associations, including the Tennessee Hospital Association, to implement a program to address hospitals\u0026rsquo; uncompensated costs of treating uninsured patients.\u003c/p\u003e","\u003cp\u003eDrafting healthcare provider contracts between hospitals, physicians and other healthcare organizations and professionals.\u003c/p\u003e","\u003cp\u003eResearching and drafting briefing materials for hospital intervenors in a disallowance appeal before the Department of Health and Human Services Departmental Appeals Board.\u003c/p\u003e","\u003cp\u003eNegotiating agreements with Medicaid managed care organizations to effectuate hospital participation in a state-directed Medicaid managed care payment program.\u003c/p\u003e","\u003cp\u003eAdvising Texas hospitals related to their participation in the 1115 Medicaid Transformation Waiver and its associated Uncompensated Care and Delivery System Reform Incentive Payment programs.\u003c/p\u003e","\u003cp\u003eAssisting hospitals in obtaining Medicaid managed care incentive payments for developing and implementing initiatives to improve access and quality of care to Medicaid managed care beneficiaries.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":24,"guid":"24.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":2,"source":"capabilities"},{"id":740,"guid":"740.smart_tags","index":3,"source":"smartTags"},{"id":826,"guid":"826.smart_tags","index":4,"source":"smartTags"}],"is_active":true,"last_name":"Rayne","nick_name":"Renee","clerkships":[],"first_name":"Renee","title_rank":9999,"updated_by":34,"law_schools":[{"id":2055,"meta":{"degree":"J.D.","honors":"with honors","is_law_school":"1","graduation_date":"2014-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"“Ones to Watch in America,” Healthcare Law","detail":"Best Lawyers, 2022-2026"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eA partner in the firm\u0026rsquo;s Healthcare practice, Renee Rayne represents public hospitals, private hospitals and physician groups in regulatory compliance and transactional matters, particularly related to participation in federal and state reimbursement programs. Approaching each transaction with an analytical eye, Renee identifies issues and risk tolerance to help clients solve problems and reach their goals.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eRenee advises hospital systems across a wide-range of regulatory compliance and reimbursement matter, including compliance with the Stark Law, federal and state anti-kickback statutes, HIPAA, compliance issues related to participation in Medicaid and Medicare programs, regulatory audits and appeals, along with other related regulatory requirements. She has significant experience representing public, investor-owned, non-profit, children\u0026rsquo;s, psychiatric, and rural hospitals along with healthcare provider associations.\u003c/p\u003e\n\u003cp\u003eAdditionally, Renee has assisted in the development, implementation, and operation of new Medicaid reimbursement programs in several states, including managed care directed payment programs and Upper Payment Limit (UPL) programs. She analyzes hospital data to model the reimbursement impacts of federal and state policy changes, as well as operational modifications within hospital systems.\u003c/p\u003e\n\u003cp\u003eRenee takes a collaborative approach to matters, strategically partnering with clients to navigate complex negotiations. Her advocacy includes working with state regulatory agencies and facilitating coalitions of industry stakeholders to advocate to state and federal lawmakers for improved reimbursement opportunities.\u003c/p\u003e\n\u003cp\u003eWhen away from the office, Renee enjoys spending time with family and attending concerts.\u003c/p\u003e\n\u003cp\u003eRenee earned her J.D. from the University of Texas School of Law and her B.A. from Vanderbilt University. Renee interned with the Honorable E. Clifton Knowles, Magistrate Judge of the U.S. District Court for the Middle District of Tennessee, and was a recipient of the Dean\u0026rsquo;s Achievement Award for Academic Excellence and William Ellis Woods Endowed Presidential Scholarship.\u003c/p\u003e","matters":["\u003cp\u003eAssisting hospitals and state Medicaid agencies in designing state-directed Medicaid managed care payment programs and assisting in responses to CMS inquiries in order to obtain program approval.\u003c/p\u003e","\u003cp\u003eStructuring, developing and assisting hospitals in working with healthcare industry associations, including the Tennessee Hospital Association, to implement a program to address hospitals\u0026rsquo; uncompensated costs of treating uninsured patients.\u003c/p\u003e","\u003cp\u003eDrafting healthcare provider contracts between hospitals, physicians and other healthcare organizations and professionals.\u003c/p\u003e","\u003cp\u003eResearching and drafting briefing materials for hospital intervenors in a disallowance appeal before the Department of Health and Human Services Departmental Appeals Board.\u003c/p\u003e","\u003cp\u003eNegotiating agreements with Medicaid managed care organizations to effectuate hospital participation in a state-directed Medicaid managed care payment program.\u003c/p\u003e","\u003cp\u003eAdvising Texas hospitals related to their participation in the 1115 Medicaid Transformation Waiver and its associated Uncompensated Care and Delivery System Reform Incentive Payment programs.\u003c/p\u003e","\u003cp\u003eAssisting hospitals in obtaining Medicaid managed care incentive payments for developing and implementing initiatives to improve access and quality of care to Medicaid managed care beneficiaries.\u003c/p\u003e"],"recognitions":[{"title":"“Ones to Watch in America,” Healthcare Law","detail":"Best Lawyers, 2022-2026"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":13321}]},"capability_group_id":2},"created_at":"2026-01-26T14:39:50.000Z","updated_at":"2026-01-26T14:39:50.000Z","searchable_text":"Rayne{{ FIELD }}{:title=\u0026gt;\"“Ones to Watch in America,” Healthcare Law\", :detail=\u0026gt;\"Best Lawyers, 2022-2026\"}{{ FIELD }}Assisting hospitals and state Medicaid agencies in designing state-directed Medicaid managed care payment programs and assisting in responses to CMS inquiries in order to obtain program approval.{{ FIELD }}Structuring, developing and assisting hospitals in working with healthcare industry associations, including the Tennessee Hospital Association, to implement a program to address hospitals’ uncompensated costs of treating uninsured patients.{{ FIELD }}Drafting healthcare provider contracts between hospitals, physicians and other healthcare organizations and professionals.{{ FIELD }}Researching and drafting briefing materials for hospital intervenors in a disallowance appeal before the Department of Health and Human Services Departmental Appeals Board.{{ FIELD }}Negotiating agreements with Medicaid managed care organizations to effectuate hospital participation in a state-directed Medicaid managed care payment program.{{ FIELD }}Advising Texas hospitals related to their participation in the 1115 Medicaid Transformation Waiver and its associated Uncompensated Care and Delivery System Reform Incentive Payment programs.{{ FIELD }}Assisting hospitals in obtaining Medicaid managed care incentive payments for developing and implementing initiatives to improve access and quality of care to Medicaid managed care beneficiaries.{{ FIELD }}A partner in the firm’s Healthcare practice, Renee Rayne represents public hospitals, private hospitals and physician groups in regulatory compliance and transactional matters, particularly related to participation in federal and state reimbursement programs. Approaching each transaction with an analytical eye, Renee identifies issues and risk tolerance to help clients solve problems and reach their goals.\nRenee advises hospital systems across a wide-range of regulatory compliance and reimbursement matter, including compliance with the Stark Law, federal and state anti-kickback statutes, HIPAA, compliance issues related to participation in Medicaid and Medicare programs, regulatory audits and appeals, along with other related regulatory requirements. She has significant experience representing public, investor-owned, non-profit, children’s, psychiatric, and rural hospitals along with healthcare provider associations.\nAdditionally, Renee has assisted in the development, implementation, and operation of new Medicaid reimbursement programs in several states, including managed care directed payment programs and Upper Payment Limit (UPL) programs. She analyzes hospital data to model the reimbursement impacts of federal and state policy changes, as well as operational modifications within hospital systems.\nRenee takes a collaborative approach to matters, strategically partnering with clients to navigate complex negotiations. Her advocacy includes working with state regulatory agencies and facilitating coalitions of industry stakeholders to advocate to state and federal lawmakers for improved reimbursement opportunities.\nWhen away from the office, Renee enjoys spending time with family and attending concerts.\nRenee earned her J.D. from the University of Texas School of Law and her B.A. from Vanderbilt University. Renee interned with the Honorable E. Clifton Knowles, Magistrate Judge of the U.S. District Court for the Middle District of Tennessee, and was a recipient of the Dean’s Achievement Award for Academic Excellence and William Ellis Woods Endowed Presidential Scholarship. Partner “Ones to Watch in America,” Healthcare Law Best Lawyers, 2022-2026 Vanderbilt University Vanderbilt University School of Law The University of Texas at Austin The University of Texas School of Law Tennessee Texas Texas State Bar American Health Lawyers Association Assisting hospitals and state Medicaid agencies in designing state-directed Medicaid managed care payment programs and assisting in responses to CMS inquiries in order to obtain program approval. Structuring, developing and assisting hospitals in working with healthcare industry associations, including the Tennessee Hospital Association, to implement a program to address hospitals’ uncompensated costs of treating uninsured patients. Drafting healthcare provider contracts between hospitals, physicians and other healthcare organizations and professionals. Researching and drafting briefing materials for hospital intervenors in a disallowance appeal before the Department of Health and Human Services Departmental Appeals Board. Negotiating agreements with Medicaid managed care organizations to effectuate hospital participation in a state-directed Medicaid managed care payment program. Advising Texas hospitals related to their participation in the 1115 Medicaid Transformation Waiver and its associated Uncompensated Care and Delivery System Reform Incentive Payment programs. Assisting hospitals in obtaining Medicaid managed care incentive payments for developing and implementing initiatives to improve access and quality of care to Medicaid managed care beneficiaries.","searchable_name":"Renee Rayne","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":34,"capability_group_featured":null,"home_page_featured":null},{"id":432953,"version":1,"owner_type":"Person","owner_id":986,"payload":{"bio":"\u003cp\u003eNikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25\u0026nbsp;years of experience.\u0026nbsp; Nikki co-chairs the firm's Government Matters \u0026amp; Regulatory practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas.\u0026nbsp; Nikki previously co-chaired\u0026nbsp;the firm\u0026rsquo;s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450\u0026nbsp;lawyers across seventeen practice areas in the firm.\u0026nbsp; In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence \u0026amp; Power in Law Award for Law Firm Thought Leadership.\u0026nbsp; Nikki is ranked nationally by \u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory from 2021-2025, named a\u0026nbsp;\u003cem\u003eLMG Life Sciences Star\u003c/em\u003e in FDA Pharmaceutical and in FDA Medical Device from 2019-2025, and was named a\u0026nbsp;\u003cem\u003eLaw360 Compliance MVP\u003c/em\u003e\u0026nbsp;in 2020.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs Deputy Chair of our FDA \u0026amp; Life Sciences practice, Nikki advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products.\u0026nbsp; Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.\u0026nbsp; She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits.\u0026nbsp; She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eNikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters.\u0026nbsp; She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance.\u0026nbsp; She routinely advises company executives and board members and represents her clients before federal agencies.\u0026nbsp; She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.\u003c/p\u003e\n\u003cp\u003eNikki leads two pharma and device industry coalitions on transparency and disclosure laws.\u0026nbsp; The\u0026nbsp;\u003cem\u003eAd Hoc Sunshine and State Law Compliance Group\u003c/em\u003e is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws.\u0026nbsp; The \u003cem\u003eInternational Marketing and Disclosure Compliance Group\u003c/em\u003e is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.\u003c/p\u003e\n\u003cp\u003eKing \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice has been named \u003cem\u003eLaw360\u003c/em\u003e Practice Group of the Year from 2017-2020.\u0026nbsp; King \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers.\u0026nbsp; According to\u0026nbsp;\u003cem\u003eChambers USA, sources praise Nikki as being \"thoughtful, quick to respond and available.\" -- Chambers USA\u003c/em\u003e\u0026nbsp;(2022)\u003c/p\u003e\n\u003cp\u003eNikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters.\u0026nbsp; Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board\u0026nbsp;and has served\u0026nbsp;on the\u0026nbsp;Advisory Board for FDAnews and the PCF Pharma Congress planning committee.\u0026nbsp; She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the \u003cem\u003eFDLI Food \u0026amp; Drug Law Journal\u003c/em\u003e and a member of the FDLI Medical Device Committee.\u0026nbsp; Nikki has also served on the Leadership Advisory Board for the National Women\u0026rsquo;s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten\u0026nbsp;years.\u003c/p\u003e\n\u003cp\u003eNikki was elected by her partners in 2017 to serve for three years\u0026nbsp;on the firm\u0026rsquo;s Policy Committee, which is the firm's executive management committee.\u0026nbsp; Nikki served for many years on the firm\u0026rsquo;s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office.\u003c/p\u003e","slug":"nikki-reeves","email":"nreeves@kslaw.com","phone":null,"matters":["\u003cp\u003eAdvised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications.\u003c/p\u003e","\u003cp\u003eAdvised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct.\u003c/p\u003e","\u003cp\u003eAdvised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations.\u003c/p\u003e","\u003cp\u003eConducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.\u003c/p\u003e","\u003cp\u003eStand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program.\u003c/p\u003e","\u003cp\u003eConducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations.\u003c/p\u003e","\u003cp\u003eLed risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":245}]},"expertise":[{"id":81,"guid":"81.capabilities","index":0,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":1,"source":"smartTags"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":3,"source":"capabilities"},{"id":32,"guid":"32.capabilities","index":4,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":5,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":6,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":7,"source":"capabilities"},{"id":970,"guid":"970.smart_tags","index":8,"source":"smartTags"},{"id":109,"guid":"109.capabilities","index":9,"source":"capabilities"},{"id":112,"guid":"112.capabilities","index":10,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":11,"source":"capabilities"},{"id":120,"guid":"120.capabilities","index":12,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":13,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":14,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":15,"source":"smartTags"},{"id":135,"guid":"135.capabilities","index":16,"source":"capabilities"}],"is_active":true,"last_name":"Reeves","nick_name":"Nikki","clerkships":[],"first_name":"Nikki","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Women, Influence \u0026 Power in Law Award for Thought Leadership","detail":"Corporate Counsel 2024"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eNikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25\u0026nbsp;years of experience.\u0026nbsp; Nikki co-chairs the firm's Government Matters \u0026amp; Regulatory practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas.\u0026nbsp; Nikki previously co-chaired\u0026nbsp;the firm\u0026rsquo;s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450\u0026nbsp;lawyers across seventeen practice areas in the firm.\u0026nbsp; In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence \u0026amp; Power in Law Award for Law Firm Thought Leadership.\u0026nbsp; Nikki is ranked nationally by \u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory from 2021-2025, named a\u0026nbsp;\u003cem\u003eLMG Life Sciences Star\u003c/em\u003e in FDA Pharmaceutical and in FDA Medical Device from 2019-2025, and was named a\u0026nbsp;\u003cem\u003eLaw360 Compliance MVP\u003c/em\u003e\u0026nbsp;in 2020.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs Deputy Chair of our FDA \u0026amp; Life Sciences practice, Nikki advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products.\u0026nbsp; Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.\u0026nbsp; She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits.\u0026nbsp; She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eNikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters.\u0026nbsp; She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance.\u0026nbsp; She routinely advises company executives and board members and represents her clients before federal agencies.\u0026nbsp; She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.\u003c/p\u003e\n\u003cp\u003eNikki leads two pharma and device industry coalitions on transparency and disclosure laws.\u0026nbsp; The\u0026nbsp;\u003cem\u003eAd Hoc Sunshine and State Law Compliance Group\u003c/em\u003e is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws.\u0026nbsp; The \u003cem\u003eInternational Marketing and Disclosure Compliance Group\u003c/em\u003e is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.\u003c/p\u003e\n\u003cp\u003eKing \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice has been named \u003cem\u003eLaw360\u003c/em\u003e Practice Group of the Year from 2017-2020.\u0026nbsp; King \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers.\u0026nbsp; According to\u0026nbsp;\u003cem\u003eChambers USA, sources praise Nikki as being \"thoughtful, quick to respond and available.\" -- Chambers USA\u003c/em\u003e\u0026nbsp;(2022)\u003c/p\u003e\n\u003cp\u003eNikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters.\u0026nbsp; Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board\u0026nbsp;and has served\u0026nbsp;on the\u0026nbsp;Advisory Board for FDAnews and the PCF Pharma Congress planning committee.\u0026nbsp; She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the \u003cem\u003eFDLI Food \u0026amp; Drug Law Journal\u003c/em\u003e and a member of the FDLI Medical Device Committee.\u0026nbsp; Nikki has also served on the Leadership Advisory Board for the National Women\u0026rsquo;s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten\u0026nbsp;years.\u003c/p\u003e\n\u003cp\u003eNikki was elected by her partners in 2017 to serve for three years\u0026nbsp;on the firm\u0026rsquo;s Policy Committee, which is the firm's executive management committee.\u0026nbsp; Nikki served for many years on the firm\u0026rsquo;s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office.\u003c/p\u003e","matters":["\u003cp\u003eAdvised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications.\u003c/p\u003e","\u003cp\u003eAdvised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct.\u003c/p\u003e","\u003cp\u003eAdvised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations.\u003c/p\u003e","\u003cp\u003eConducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.\u003c/p\u003e","\u003cp\u003eStand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program.\u003c/p\u003e","\u003cp\u003eConducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations.\u003c/p\u003e","\u003cp\u003eLed risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.\u003c/p\u003e"],"recognitions":[{"title":"Women, Influence \u0026 Power in Law Award for Thought Leadership","detail":"Corporate Counsel 2024"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1139}]},"capability_group_id":2},"created_at":"2025-07-29T16:08:40.000Z","updated_at":"2025-07-29T16:08:40.000Z","searchable_text":"Reeves{{ FIELD }}{:title=\u0026gt;\"Women, Influence \u0026amp; Power in Law Award for Thought Leadership\", :detail=\u0026gt;\"Corporate Counsel 2024\"}{{ FIELD }}Advised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications.{{ FIELD }}Advised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct.{{ FIELD }}Advised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations.{{ FIELD }}Conducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.{{ FIELD }}Stand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program.{{ FIELD }}Conducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations.{{ FIELD }}Led risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.{{ FIELD }}Nikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25 years of experience.  Nikki co-chairs the firm's Government Matters \u0026amp; Regulatory practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas.  Nikki previously co-chaired the firm’s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450 lawyers across seventeen practice areas in the firm.  In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence \u0026amp; Power in Law Award for Law Firm Thought Leadership.  Nikki is ranked nationally by Chambers USA for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory from 2021-2025, named a LMG Life Sciences Star in FDA Pharmaceutical and in FDA Medical Device from 2019-2025, and was named a Law360 Compliance MVP in 2020. \nAs Deputy Chair of our FDA \u0026amp; Life Sciences practice, Nikki advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products.  Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.  She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits.  She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions. \nNikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters.  She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance.  She routinely advises company executives and board members and represents her clients before federal agencies.  She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.\nNikki leads two pharma and device industry coalitions on transparency and disclosure laws.  The Ad Hoc Sunshine and State Law Compliance Group is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws.  The International Marketing and Disclosure Compliance Group is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.\nKing \u0026amp; Spalding’s FDA \u0026amp; Life Sciences Practice has been named Law360 Practice Group of the Year from 2017-2020.  King \u0026amp; Spalding’s FDA \u0026amp; Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers.  According to Chambers USA, sources praise Nikki as being \"thoughtful, quick to respond and available.\" -- Chambers USA (2022)\nNikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters.  Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board and has served on the Advisory Board for FDAnews and the PCF Pharma Congress planning committee.  She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the FDLI Food \u0026amp; Drug Law Journal and a member of the FDLI Medical Device Committee.  Nikki has also served on the Leadership Advisory Board for the National Women’s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten years.\nNikki was elected by her partners in 2017 to serve for three years on the firm’s Policy Committee, which is the firm's executive management committee.  Nikki served for many years on the firm’s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office. Kelly Reeves Partner Women, Influence \u0026amp; Power in Law Award for Thought Leadership Corporate Counsel 2024 North Carolina State University  University of Maryland  North Carolina State University  District of Columbia Maryland Advised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications. Advised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct. Advised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations. Conducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies. Stand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program. Conducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations. Led risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.","searchable_name":"Nikki Reeves","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":445446,"version":1,"owner_type":"Person","owner_id":6346,"payload":{"bio":"\u003cp\u003eMike\u0026rsquo;s practice focuses on complex civil litigation, with a concentration representing\u0026nbsp;food and beverage, dietary supplement and consumer packaged good clients as well as matters involving accounting and financial issues. He has experience in a wide range of litigation, including jury trials, appeals, matters with governmental agencies and internal investigations. Having served as general counsel for a global food company, Mike has a unique perspective that leads to a practical and creative approach to optimize results for clients.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMike began his career trying cases for the U.S. Attorney's Office in the Western District of Virginia, and has focused on representing clients in litigation, regulatory and white-collar matters, and investigations. Mike has regularly practiced in state and federal trial and appellate courts in false advertising and employment class actions, professional liability cases, trade secret misappropriation and other complex litigation, including in actions relating to alleged contaminants in products (heavy metals, glyphosate, PFAS, mycotoxins, phthalates). Mike has also represented clients before FDA and USDA in connection with ingredient labeling, recall-related issues and the National Organic Program.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAfter more than 15 years representing clients in high stakes litigation, Mike transitioned to general counsel of a globally branded food manufacturing company.\u0026nbsp; The company also opened several quick serve restaurant locations during his time there. As part of his role, Mike had responsibility for food safety and regulatory affairs and worked with in-house and outside experts to conduct root cause analyses and develop corrective and preventative actions. This experience provides valuable insight into the daily challenges faced by clients, including developing and executing a strategic approach to litigation and other dispute resolution, as well as developing creative approaches and proactive measures that can be taken to avoid disputes in the first place.\u003c/p\u003e","slug":"michael-resch","email":"mresch@kslaw.com","phone":null,"matters":["\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eKind LLC\u0026nbsp;\u003c/strong\u003ein multiple class actions in New York and Illinois District Courts challenging a product name and ingredient name.\u003c/p\u003e","\u003cp\u003eSecured victory for\u0026nbsp;\u003cstrong\u003eCampbell Soup\u003c/strong\u003e\u0026nbsp;in a false advertising class action in the Northern District of Florida.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eBolthouse Farms\u0026nbsp;\u003c/strong\u003eutilizing preemption defense against organic labeling allegations.\u003c/p\u003e","\u003cp\u003eSuccessfully obtained dismissal for\u0026nbsp;\u003cstrong\u003eChobani\u0026nbsp;\u003c/strong\u003ein the Northern District of California in class action with respect to the labeling of Greek yogurt products.\u003c/p\u003e","\u003cp\u003eDefended a Big 4 accounting firm in arbitration arising out of claims scrutinizing firm's audit.\u003c/p\u003e","\u003cp\u003eSecured victories for\u0026nbsp;\u003cstrong\u003eAmy\u0026rsquo;s Kitchen\u003c/strong\u003e\u0026nbsp;against numerous class actions alleging false advertising based on an ingredient name.\u003c/p\u003e","\u003cp\u003eDefended food manufacturers\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003ein donning/doffing class actions in California state court.\u003c/p\u003e","\u003cp\u003eRepresented more than 10 clients in the food and beverage industry in connection with FDA draft guidance and related written comments.\u003c/p\u003e","\u003cp\u003eUSDA meetings and related written submissions in connection with organic ingredient labeling.\u003c/p\u003e","\u003cp\u003eDeveloped a food manufacturing company's comprehensive Covid-19 response plan, including planning safety, regulatory and litigation strategy and opening a Covid-19 vaccine clinic\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":3,"guid":"3.capabilities","index":1,"source":"capabilities"},{"id":11,"guid":"11.capabilities","index":2,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":3,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":4,"source":"capabilities"},{"id":111,"guid":"111.capabilities","index":5,"source":"capabilities"},{"id":766,"guid":"766.smart_tags","index":6,"source":"smartTags"},{"id":1409,"guid":"1409.smart_tags","index":7,"source":"smartTags"}],"is_active":true,"last_name":"Resch","nick_name":"Michael","clerkships":[],"first_name":"Michael","title_rank":9999,"updated_by":32,"law_schools":[{"id":2484,"meta":{"degree":"J.D.","honors":"cum laude","is_law_school":"1","graduation_date":"1999-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"L.","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eMike\u0026rsquo;s practice focuses on complex civil litigation, with a concentration representing\u0026nbsp;food and beverage, dietary supplement and consumer packaged good clients as well as matters involving accounting and financial issues. He has experience in a wide range of litigation, including jury trials, appeals, matters with governmental agencies and internal investigations. Having served as general counsel for a global food company, Mike has a unique perspective that leads to a practical and creative approach to optimize results for clients.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMike began his career trying cases for the U.S. Attorney's Office in the Western District of Virginia, and has focused on representing clients in litigation, regulatory and white-collar matters, and investigations. Mike has regularly practiced in state and federal trial and appellate courts in false advertising and employment class actions, professional liability cases, trade secret misappropriation and other complex litigation, including in actions relating to alleged contaminants in products (heavy metals, glyphosate, PFAS, mycotoxins, phthalates). Mike has also represented clients before FDA and USDA in connection with ingredient labeling, recall-related issues and the National Organic Program.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAfter more than 15 years representing clients in high stakes litigation, Mike transitioned to general counsel of a globally branded food manufacturing company.\u0026nbsp; The company also opened several quick serve restaurant locations during his time there. As part of his role, Mike had responsibility for food safety and regulatory affairs and worked with in-house and outside experts to conduct root cause analyses and develop corrective and preventative actions. This experience provides valuable insight into the daily challenges faced by clients, including developing and executing a strategic approach to litigation and other dispute resolution, as well as developing creative approaches and proactive measures that can be taken to avoid disputes in the first place.\u003c/p\u003e","matters":["\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eKind LLC\u0026nbsp;\u003c/strong\u003ein multiple class actions in New York and Illinois District Courts challenging a product name and ingredient name.\u003c/p\u003e","\u003cp\u003eSecured victory for\u0026nbsp;\u003cstrong\u003eCampbell Soup\u003c/strong\u003e\u0026nbsp;in a false advertising class action in the Northern District of Florida.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eBolthouse Farms\u0026nbsp;\u003c/strong\u003eutilizing preemption defense against organic labeling allegations.\u003c/p\u003e","\u003cp\u003eSuccessfully obtained dismissal for\u0026nbsp;\u003cstrong\u003eChobani\u0026nbsp;\u003c/strong\u003ein the Northern District of California in class action with respect to the labeling of Greek yogurt products.\u003c/p\u003e","\u003cp\u003eDefended a Big 4 accounting firm in arbitration arising out of claims scrutinizing firm's audit.\u003c/p\u003e","\u003cp\u003eSecured victories for\u0026nbsp;\u003cstrong\u003eAmy\u0026rsquo;s Kitchen\u003c/strong\u003e\u0026nbsp;against numerous class actions alleging false advertising based on an ingredient name.\u003c/p\u003e","\u003cp\u003eDefended food manufacturers\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003ein donning/doffing class actions in California state court.\u003c/p\u003e","\u003cp\u003eRepresented more than 10 clients in the food and beverage industry in connection with FDA draft guidance and related written comments.\u003c/p\u003e","\u003cp\u003eUSDA meetings and related written submissions in connection with organic ingredient labeling.\u003c/p\u003e","\u003cp\u003eDeveloped a food manufacturing company's comprehensive Covid-19 response plan, including planning safety, regulatory and litigation strategy and opening a Covid-19 vaccine clinic\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9733}]},"capability_group_id":2},"created_at":"2026-01-31T22:03:15.000Z","updated_at":"2026-01-31T22:03:15.000Z","searchable_text":"Resch{{ FIELD }}Defended Kind LLC in multiple class actions in New York and Illinois District Courts challenging a product name and ingredient name.{{ FIELD }}Secured victory for Campbell Soup in a false advertising class action in the Northern District of Florida.{{ FIELD }}Defended Bolthouse Farms utilizing preemption defense against organic labeling allegations.{{ FIELD }}Successfully obtained dismissal for Chobani in the Northern District of California in class action with respect to the labeling of Greek yogurt products.{{ FIELD }}Defended a Big 4 accounting firm in arbitration arising out of claims scrutinizing firm's audit.{{ FIELD }}Secured victories for Amy’s Kitchen against numerous class actions alleging false advertising based on an ingredient name.{{ FIELD }}Defended food manufacturers in donning/doffing class actions in California state court.{{ FIELD }}Represented more than 10 clients in the food and beverage industry in connection with FDA draft guidance and related written comments.{{ FIELD }}USDA meetings and related written submissions in connection with organic ingredient labeling.{{ FIELD }}Developed a food manufacturing company's comprehensive Covid-19 response plan, including planning safety, regulatory and litigation strategy and opening a Covid-19 vaccine clinic{{ FIELD }}Mike’s practice focuses on complex civil litigation, with a concentration representing food and beverage, dietary supplement and consumer packaged good clients as well as matters involving accounting and financial issues. He has experience in a wide range of litigation, including jury trials, appeals, matters with governmental agencies and internal investigations. Having served as general counsel for a global food company, Mike has a unique perspective that leads to a practical and creative approach to optimize results for clients.\nMike began his career trying cases for the U.S. Attorney's Office in the Western District of Virginia, and has focused on representing clients in litigation, regulatory and white-collar matters, and investigations. Mike has regularly practiced in state and federal trial and appellate courts in false advertising and employment class actions, professional liability cases, trade secret misappropriation and other complex litigation, including in actions relating to alleged contaminants in products (heavy metals, glyphosate, PFAS, mycotoxins, phthalates). Mike has also represented clients before FDA and USDA in connection with ingredient labeling, recall-related issues and the National Organic Program.  \nAfter more than 15 years representing clients in high stakes litigation, Mike transitioned to general counsel of a globally branded food manufacturing company.  The company also opened several quick serve restaurant locations during his time there. As part of his role, Mike had responsibility for food safety and regulatory affairs and worked with in-house and outside experts to conduct root cause analyses and develop corrective and preventative actions. This experience provides valuable insight into the daily challenges faced by clients, including developing and executing a strategic approach to litigation and other dispute resolution, as well as developing creative approaches and proactive measures that can be taken to avoid disputes in the first place. Partner Pepperdine University Pepperdine University School of Law Washington and Lee University Washington and Lee University School of Law U.S. Court of Appeals for the Federal Circuit U.S. Court of Appeals for the Ninth Circuit U.S. District Court for the Northern District of Illinois U.S. District Court for the Central District of California U.S. District Court for the Eastern District of California U.S. District Court for the Northern District of California U.S. District Court for the Southern District of California U.S. District Court for the District of Columbia California District of Columbia Defended Kind LLC in multiple class actions in New York and Illinois District Courts challenging a product name and ingredient name. Secured victory for Campbell Soup in a false advertising class action in the Northern District of Florida. Defended Bolthouse Farms utilizing preemption defense against organic labeling allegations. Successfully obtained dismissal for Chobani in the Northern District of California in class action with respect to the labeling of Greek yogurt products. Defended a Big 4 accounting firm in arbitration arising out of claims scrutinizing firm's audit. Secured victories for Amy’s Kitchen against numerous class actions alleging false advertising based on an ingredient name. Defended food manufacturers in donning/doffing class actions in California state court. Represented more than 10 clients in the food and beverage industry in connection with FDA draft guidance and related written comments. USDA meetings and related written submissions in connection with organic ingredient labeling. Developed a food manufacturing company's comprehensive Covid-19 response plan, including planning safety, regulatory and litigation strategy and opening a Covid-19 vaccine clinic","searchable_name":"Michael L. Resch","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":32,"capability_group_featured":null,"home_page_featured":null},{"id":442370,"version":1,"owner_type":"Person","owner_id":880,"payload":{"bio":"\u003cp\u003eJohn Richter is a trial and investigations partner in the Special Matters and Investigations Practice Group, and represents and defends companies, Boards of Directors, Board committees, and individuals facing a variety of white-collar criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. John previously served as the Acting Assistant Attorney General in charge of the Criminal Division at the U.S. Department of Justice and as the U.S. Attorney for the Western District of Oklahoma, having been nominated by\u0026nbsp;President George W. Bush\u0026nbsp;and confirmed by unanimous consent of the U.S. Senate.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eLaw360\u003c/em\u003e\u0026nbsp;has named\u0026nbsp;John \"White-Collar MVP of the Year\".\u0026nbsp; He also has been\u0026nbsp;recognized as one of the top 100 trial lawyers in America by\u0026nbsp;\u003cem\u003eBenchmark Litigation\u003c/em\u003e\u0026nbsp;and as a Life Sciences Star for litigation by\u0026nbsp;\u003cem\u003eLMG Life Sciences\u003c/em\u003e.\u0026nbsp; Most recently, he was elected President of the National Association of Former United States Attorneys.\u003c/p\u003e\n\u003cp\u003eDuring his tenure at the Criminal Division, he led investigations, prosecutions, and policy development in many areas of federal criminal law, including healthcare fraud, securities fraud, Foreign Corrupt Practices Act and export violations, bank secrecy and money laundering offenses, public corruption, and organized crime. He served as a member of the President\u0026rsquo;s Corporate Fraud Task Force and oversaw the Enron Task Force. He also served as the Commissioner Ex-Officio to the U.S. Sentencing Commission and represented the Department in matters before the Committee on Foreign Investment in the U.S.\u003c/p\u003e\n\u003cp\u003eAs U.S. Attorney, John served as the chief federal law enforcement officer for the district, tried cases, argued appeals, and oversaw the prosecution and defense of a wide-range of criminal and civil matters on behalf of the U.S., including bank fraud, healthcare fraud, money laundering and other economic and regulatory cases. In 2009, he was awarded the U.S. Department of Health and Human Services\u0026rsquo; Inspector General\u0026rsquo;s Award for Combating Medicare and Medicaid Fraud. He also served as Chairman of the Attorney General\u0026rsquo;s Advisory Committee on Sentencing, and as a member of the Attorney General\u0026rsquo;s Advisory Committee on White Collar Crime.\u003c/p\u003e\n\u003cp\u003eJohn began his career as a federal prosecutor as an Assistant U.S. Attorney in Atlanta and Oklahoma City, during which time he investigated and prosecuted a wide-range of federal cases, including health care, bank, and securities fraud. He began his career as a prosecutor as an Assistant District Attorney in Cobb County, Georgia.\u003c/p\u003e\n\u003cp\u003eIn private practice, John has represented and defended clients in trials and investigations involving U.S. Attorneys\u0026rsquo; Offices in over fifteen different districts around the country, the Criminal and Civil Divisions at the Justice Department, and state attorney general\u0026rsquo;s offices for all 50 states and the District of Columbia. These matters often have also involved parallel proceedings by regulatory agencies and parallel class action or\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;whistleblower litigation.\u003c/p\u003e\n\u003cp\u003eIn addition to tenures as prosecutor and in private practice, John also served as Vice President and Deputy General Counsel at WellCare Health Plans, Inc.,\u0026nbsp;where he led the successful resolution of enterprise-threatening criminal and civil investigations by the U.S. Department of Justice, as well as parallel investigations by other federal and state regulatory agencies, private securities class actions, derivative class actions, and\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;cases.\u003c/p\u003e","slug":"john-richter","email":"jrichter@kslaw.com","phone":null,"matters":["\u003cp\u003eSuccessful defense and full jury acquittal on all charges of Vascular Solutions, Inc., a publicly traded medical device company, in a high-stakes criminal trial in the W.D. Tex., stemming from alleged conspiracy and off-label marketing charges.\u003c/p\u003e","\u003cp\u003eSuccessful dismissal of multi-billion dollar whistleblower lawsuit in the N.D. Cal.,against global telecommunications provider on claims of fraud in connections with wireless services provided to departments and agencies of the federal government.\u003c/p\u003e","\u003cp\u003eIndependent internal investigation on behalf of independent members of the Board of a publicly traded real estate investment trust company into certain financial transactions and activities by management.\u003c/p\u003e","\u003cp\u003eSuccessful negotiation and resolution of enterprise-threatening investigations by DOJ and attorneys general for all 50 states and the District of Columbia against a global medical device manufacturer based on allegations of kickbacks and violations of federal and state false claims acts.\u003c/p\u003e","\u003cp\u003eRepresentation of and successful declination against senior executives of a global pharmaceutical company in DOJ FCPA investigation of the company.\u003c/p\u003e","\u003cp\u003eRepresentation of and successful declination against former Prime Minister of European country in DOJ FCPA investigation.\u003c/p\u003e","\u003cp\u003eSuccessful declination of DOJ criminal and civil investigation of a publicly traded global medical device company based on allegations of off-label marketing and violations of the federal false claims act.\u003c/p\u003e","\u003cp\u003eSuccessful declination of DOJ civil investigation and dismissal of a whistleblower\u0026rsquo;s complaint of publicly traded health insurer based on false claims allegations.\u003c/p\u003e","\u003cp\u003eSuccessful negotiation and resolution of civil investigations by DOJ and 47 state attorneys general against a publicly traded pharmacy service provider based on allegations of violations of federal and state false claims acts.\u003c/p\u003e","\u003cp\u003eSuccessful declinations of numerous DOJ civil investigations against a drug monitoring and testing company based on various allegations of violations of the federal false claims act.\u003c/p\u003e","\u003cp\u003eIndependent internal investigation on behalf of the Board of a publicly traded healthcare intermediary service provider into alleged financial and accounting irregularities.\u003c/p\u003e","\u003cp\u003eInvestigation of and referral to law enforcement for the successful criminal prosecution of a former employee of a global oil and gas services company based on the unlawful intrusion into the company\u0026rsquo;s computer system and theft of trade secret and proprietary information.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":3134}]},"expertise":[{"id":6,"guid":"6.capabilities","index":0,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":1,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":2,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":3,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":4,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":5,"source":"capabilities"},{"id":20,"guid":"20.capabilities","index":6,"source":"capabilities"},{"id":750,"guid":"750.smart_tags","index":7,"source":"smartTags"},{"id":1303,"guid":"1303.smart_tags","index":8,"source":"smartTags"},{"id":766,"guid":"766.smart_tags","index":9,"source":"smartTags"},{"id":780,"guid":"780.smart_tags","index":10,"source":"smartTags"},{"id":11,"guid":"11.capabilities","index":11,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":12,"source":"smartTags"},{"id":984,"guid":"984.smart_tags","index":13,"source":"smartTags"},{"id":1188,"guid":"1188.smart_tags","index":14,"source":"smartTags"},{"id":1199,"guid":"1199.smart_tags","index":15,"source":"smartTags"},{"id":1248,"guid":"1248.smart_tags","index":16,"source":"smartTags"}],"is_active":true,"last_name":"Richter","nick_name":"John","clerkships":[{"name":"Law Clerk, J. Owen Forrester, U.S. District Court for the Northern District of Georgia","years_held":"1992-1994"}],"first_name":"John","title_rank":9999,"updated_by":202,"law_schools":[{"id":2410,"meta":{"degree":"J.D.","honors":null,"is_law_school":1,"graduation_date":"1992-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"C.","name_suffix":"","recognitions":[{"title":"“Richter stands out for his significant capabilities as a trial lawyer”","detail":"Legal 500 - 2024"},{"title":"Elected, President – National Association of Former United States Attorneys (NAFUSA) (2023-2024)","detail":"NAFUSA 2023"},{"title":"Selected,Top 100 Trial Lawyers","detail":"Benchmark Litigation, 2017"},{"title":"Selected, Life Sciences Star","detail":"LMG Life Sciences, 2017"},{"title":"Selected, White Collar Defense MVP","detail":"Law360, 2016"},{"title":"Elected to the Board of Directors, 2017","detail":"National Association of Former United States Attorneys"}],"linked_in_url":null,"seodescription":"John Richter is a trial and investigations partner in the Special Matters and Investigations Practice Group. Find out more about him.","primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eJohn Richter is a trial and investigations partner in the Special Matters and Investigations Practice Group, and represents and defends companies, Boards of Directors, Board committees, and individuals facing a variety of white-collar criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. John previously served as the Acting Assistant Attorney General in charge of the Criminal Division at the U.S. Department of Justice and as the U.S. Attorney for the Western District of Oklahoma, having been nominated by\u0026nbsp;President George W. Bush\u0026nbsp;and confirmed by unanimous consent of the U.S. Senate.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eLaw360\u003c/em\u003e\u0026nbsp;has named\u0026nbsp;John \"White-Collar MVP of the Year\".\u0026nbsp; He also has been\u0026nbsp;recognized as one of the top 100 trial lawyers in America by\u0026nbsp;\u003cem\u003eBenchmark Litigation\u003c/em\u003e\u0026nbsp;and as a Life Sciences Star for litigation by\u0026nbsp;\u003cem\u003eLMG Life Sciences\u003c/em\u003e.\u0026nbsp; Most recently, he was elected President of the National Association of Former United States Attorneys.\u003c/p\u003e\n\u003cp\u003eDuring his tenure at the Criminal Division, he led investigations, prosecutions, and policy development in many areas of federal criminal law, including healthcare fraud, securities fraud, Foreign Corrupt Practices Act and export violations, bank secrecy and money laundering offenses, public corruption, and organized crime. He served as a member of the President\u0026rsquo;s Corporate Fraud Task Force and oversaw the Enron Task Force. He also served as the Commissioner Ex-Officio to the U.S. Sentencing Commission and represented the Department in matters before the Committee on Foreign Investment in the U.S.\u003c/p\u003e\n\u003cp\u003eAs U.S. Attorney, John served as the chief federal law enforcement officer for the district, tried cases, argued appeals, and oversaw the prosecution and defense of a wide-range of criminal and civil matters on behalf of the U.S., including bank fraud, healthcare fraud, money laundering and other economic and regulatory cases. In 2009, he was awarded the U.S. Department of Health and Human Services\u0026rsquo; Inspector General\u0026rsquo;s Award for Combating Medicare and Medicaid Fraud. He also served as Chairman of the Attorney General\u0026rsquo;s Advisory Committee on Sentencing, and as a member of the Attorney General\u0026rsquo;s Advisory Committee on White Collar Crime.\u003c/p\u003e\n\u003cp\u003eJohn began his career as a federal prosecutor as an Assistant U.S. Attorney in Atlanta and Oklahoma City, during which time he investigated and prosecuted a wide-range of federal cases, including health care, bank, and securities fraud. He began his career as a prosecutor as an Assistant District Attorney in Cobb County, Georgia.\u003c/p\u003e\n\u003cp\u003eIn private practice, John has represented and defended clients in trials and investigations involving U.S. Attorneys\u0026rsquo; Offices in over fifteen different districts around the country, the Criminal and Civil Divisions at the Justice Department, and state attorney general\u0026rsquo;s offices for all 50 states and the District of Columbia. These matters often have also involved parallel proceedings by regulatory agencies and parallel class action or\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;whistleblower litigation.\u003c/p\u003e\n\u003cp\u003eIn addition to tenures as prosecutor and in private practice, John also served as Vice President and Deputy General Counsel at WellCare Health Plans, Inc.,\u0026nbsp;where he led the successful resolution of enterprise-threatening criminal and civil investigations by the U.S. Department of Justice, as well as parallel investigations by other federal and state regulatory agencies, private securities class actions, derivative class actions, and\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;cases.\u003c/p\u003e","matters":["\u003cp\u003eSuccessful defense and full jury acquittal on all charges of Vascular Solutions, Inc., a publicly traded medical device company, in a high-stakes criminal trial in the W.D. Tex., stemming from alleged conspiracy and off-label marketing charges.\u003c/p\u003e","\u003cp\u003eSuccessful dismissal of multi-billion dollar whistleblower lawsuit in the N.D. Cal.,against global telecommunications provider on claims of fraud in connections with wireless services provided to departments and agencies of the federal government.\u003c/p\u003e","\u003cp\u003eIndependent internal investigation on behalf of independent members of the Board of a publicly traded real estate investment trust company into certain financial transactions and activities by management.\u003c/p\u003e","\u003cp\u003eSuccessful negotiation and resolution of enterprise-threatening investigations by DOJ and attorneys general for all 50 states and the District of Columbia against a global medical device manufacturer based on allegations of kickbacks and violations of federal and state false claims acts.\u003c/p\u003e","\u003cp\u003eRepresentation of and successful declination against senior executives of a global pharmaceutical company in DOJ FCPA investigation of the company.\u003c/p\u003e","\u003cp\u003eRepresentation of and successful declination against former Prime Minister of European country in DOJ FCPA investigation.\u003c/p\u003e","\u003cp\u003eSuccessful declination of DOJ criminal and civil investigation of a publicly traded global medical device company based on allegations of off-label marketing and violations of the federal false claims act.\u003c/p\u003e","\u003cp\u003eSuccessful declination of DOJ civil investigation and dismissal of a whistleblower\u0026rsquo;s complaint of publicly traded health insurer based on false claims allegations.\u003c/p\u003e","\u003cp\u003eSuccessful negotiation and resolution of civil investigations by DOJ and 47 state attorneys general against a publicly traded pharmacy service provider based on allegations of violations of federal and state false claims acts.\u003c/p\u003e","\u003cp\u003eSuccessful declinations of numerous DOJ civil investigations against a drug monitoring and testing company based on various allegations of violations of the federal false claims act.\u003c/p\u003e","\u003cp\u003eIndependent internal investigation on behalf of the Board of a publicly traded healthcare intermediary service provider into alleged financial and accounting irregularities.\u003c/p\u003e","\u003cp\u003eInvestigation of and referral to law enforcement for the successful criminal prosecution of a former employee of a global oil and gas services company based on the unlawful intrusion into the company\u0026rsquo;s computer system and theft of trade secret and proprietary information.\u003c/p\u003e"],"recognitions":[{"title":"“Richter stands out for his significant capabilities as a trial lawyer”","detail":"Legal 500 - 2024"},{"title":"Elected, President – National Association of Former United States Attorneys (NAFUSA) (2023-2024)","detail":"NAFUSA 2023"},{"title":"Selected,Top 100 Trial Lawyers","detail":"Benchmark Litigation, 2017"},{"title":"Selected, Life Sciences Star","detail":"LMG Life Sciences, 2017"},{"title":"Selected, White Collar Defense MVP","detail":"Law360, 2016"},{"title":"Elected to the Board of Directors, 2017","detail":"National Association of Former United States Attorneys"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":4491}]},"capability_group_id":2},"created_at":"2025-11-05T05:03:40.000Z","updated_at":"2025-11-05T05:03:40.000Z","searchable_text":"Richter{{ FIELD }}{:title=\u0026gt;\"“Richter stands out for his significant capabilities as a trial lawyer”\", :detail=\u0026gt;\"Legal 500 - 2024\"}{{ FIELD }}{:title=\u0026gt;\"Elected, President – National Association of Former United States Attorneys (NAFUSA) (2023-2024)\", :detail=\u0026gt;\"NAFUSA 2023\"}{{ FIELD }}{:title=\u0026gt;\"Selected,Top 100 Trial Lawyers\", :detail=\u0026gt;\"Benchmark Litigation, 2017\"}{{ FIELD }}{:title=\u0026gt;\"Selected, Life Sciences Star\", :detail=\u0026gt;\"LMG Life Sciences, 2017\"}{{ FIELD }}{:title=\u0026gt;\"Selected, White Collar Defense MVP\", :detail=\u0026gt;\"Law360, 2016\"}{{ FIELD }}{:title=\u0026gt;\"Elected to the Board of Directors, 2017\", :detail=\u0026gt;\"National Association of Former United States Attorneys\"}{{ FIELD }}Successful defense and full jury acquittal on all charges of Vascular Solutions, Inc., a publicly traded medical device company, in a high-stakes criminal trial in the W.D. Tex., stemming from alleged conspiracy and off-label marketing charges.{{ FIELD }}Successful dismissal of multi-billion dollar whistleblower lawsuit in the N.D. Cal.,against global telecommunications provider on claims of fraud in connections with wireless services provided to departments and agencies of the federal government.{{ FIELD }}Independent internal investigation on behalf of independent members of the Board of a publicly traded real estate investment trust company into certain financial transactions and activities by management.{{ FIELD }}Successful negotiation and resolution of enterprise-threatening investigations by DOJ and attorneys general for all 50 states and the District of Columbia against a global medical device manufacturer based on allegations of kickbacks and violations of federal and state false claims acts.{{ FIELD }}Representation of and successful declination against senior executives of a global pharmaceutical company in DOJ FCPA investigation of the company.{{ FIELD }}Representation of and successful declination against former Prime Minister of European country in DOJ FCPA investigation.{{ FIELD }}Successful declination of DOJ criminal and civil investigation of a publicly traded global medical device company based on allegations of off-label marketing and violations of the federal false claims act.{{ FIELD }}Successful declination of DOJ civil investigation and dismissal of a whistleblower’s complaint of publicly traded health insurer based on false claims allegations.{{ FIELD }}Successful negotiation and resolution of civil investigations by DOJ and 47 state attorneys general against a publicly traded pharmacy service provider based on allegations of violations of federal and state false claims acts.{{ FIELD }}Successful declinations of numerous DOJ civil investigations against a drug monitoring and testing company based on various allegations of violations of the federal false claims act.{{ FIELD }}Independent internal investigation on behalf of the Board of a publicly traded healthcare intermediary service provider into alleged financial and accounting irregularities.{{ FIELD }}Investigation of and referral to law enforcement for the successful criminal prosecution of a former employee of a global oil and gas services company based on the unlawful intrusion into the company’s computer system and theft of trade secret and proprietary information.{{ FIELD }}John Richter is a trial and investigations partner in the Special Matters and Investigations Practice Group, and represents and defends companies, Boards of Directors, Board committees, and individuals facing a variety of white-collar criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. John previously served as the Acting Assistant Attorney General in charge of the Criminal Division at the U.S. Department of Justice and as the U.S. Attorney for the Western District of Oklahoma, having been nominated by President George W. Bush and confirmed by unanimous consent of the U.S. Senate. \nLaw360 has named John \"White-Collar MVP of the Year\".  He also has been recognized as one of the top 100 trial lawyers in America by Benchmark Litigation and as a Life Sciences Star for litigation by LMG Life Sciences.  Most recently, he was elected President of the National Association of Former United States Attorneys.\nDuring his tenure at the Criminal Division, he led investigations, prosecutions, and policy development in many areas of federal criminal law, including healthcare fraud, securities fraud, Foreign Corrupt Practices Act and export violations, bank secrecy and money laundering offenses, public corruption, and organized crime. He served as a member of the President’s Corporate Fraud Task Force and oversaw the Enron Task Force. He also served as the Commissioner Ex-Officio to the U.S. Sentencing Commission and represented the Department in matters before the Committee on Foreign Investment in the U.S.\nAs U.S. Attorney, John served as the chief federal law enforcement officer for the district, tried cases, argued appeals, and oversaw the prosecution and defense of a wide-range of criminal and civil matters on behalf of the U.S., including bank fraud, healthcare fraud, money laundering and other economic and regulatory cases. In 2009, he was awarded the U.S. Department of Health and Human Services’ Inspector General’s Award for Combating Medicare and Medicaid Fraud. He also served as Chairman of the Attorney General’s Advisory Committee on Sentencing, and as a member of the Attorney General’s Advisory Committee on White Collar Crime.\nJohn began his career as a federal prosecutor as an Assistant U.S. Attorney in Atlanta and Oklahoma City, during which time he investigated and prosecuted a wide-range of federal cases, including health care, bank, and securities fraud. He began his career as a prosecutor as an Assistant District Attorney in Cobb County, Georgia.\nIn private practice, John has represented and defended clients in trials and investigations involving U.S. Attorneys’ Offices in over fifteen different districts around the country, the Criminal and Civil Divisions at the Justice Department, and state attorney general’s offices for all 50 states and the District of Columbia. These matters often have also involved parallel proceedings by regulatory agencies and parallel class action or qui tam whistleblower litigation.\nIn addition to tenures as prosecutor and in private practice, John also served as Vice President and Deputy General Counsel at WellCare Health Plans, Inc., where he led the successful resolution of enterprise-threatening criminal and civil investigations by the U.S. Department of Justice, as well as parallel investigations by other federal and state regulatory agencies, private securities class actions, derivative class actions, and qui tam cases. john richter Partner “Richter stands out for his significant capabilities as a trial lawyer” Legal 500 - 2024 Elected, President – National Association of Former United States Attorneys (NAFUSA) (2023-2024) NAFUSA 2023 Selected,Top 100 Trial Lawyers Benchmark Litigation, 2017 Selected, Life Sciences Star LMG Life Sciences, 2017 Selected, White Collar Defense MVP Law360, 2016 Elected to the Board of Directors, 2017 National Association of Former United States Attorneys Emory University Emory University School of Law University of Virginia University of Virginia School of Law Supreme Court of the United States U.S. Court of Appeals for the Fourth Circuit U.S. Court of Appeals for the Tenth Circuit U.S. Court of Appeals for the Eleventh Circuit U.S. District Court for the Western District of Oklahoma U.S. District Court for the Northern District of Georgia District of Columbia Georgia Oklahoma President, National Association of Former United States Attorneys Law Clerk, J. Owen Forrester, U.S. District Court for the Northern District of Georgia Successful defense and full jury acquittal on all charges of Vascular Solutions, Inc., a publicly traded medical device company, in a high-stakes criminal trial in the W.D. Tex., stemming from alleged conspiracy and off-label marketing charges. Successful dismissal of multi-billion dollar whistleblower lawsuit in the N.D. Cal.,against global telecommunications provider on claims of fraud in connections with wireless services provided to departments and agencies of the federal government. Independent internal investigation on behalf of independent members of the Board of a publicly traded real estate investment trust company into certain financial transactions and activities by management. Successful negotiation and resolution of enterprise-threatening investigations by DOJ and attorneys general for all 50 states and the District of Columbia against a global medical device manufacturer based on allegations of kickbacks and violations of federal and state false claims acts. Representation of and successful declination against senior executives of a global pharmaceutical company in DOJ FCPA investigation of the company. Representation of and successful declination against former Prime Minister of European country in DOJ FCPA investigation. Successful declination of DOJ criminal and civil investigation of a publicly traded global medical device company based on allegations of off-label marketing and violations of the federal false claims act. Successful declination of DOJ civil investigation and dismissal of a whistleblower’s complaint of publicly traded health insurer based on false claims allegations. Successful negotiation and resolution of civil investigations by DOJ and 47 state attorneys general against a publicly traded pharmacy service provider based on allegations of violations of federal and state false claims acts. Successful declinations of numerous DOJ civil investigations against a drug monitoring and testing company based on various allegations of violations of the federal false claims act. Independent internal investigation on behalf of the Board of a publicly traded healthcare intermediary service provider into alleged financial and accounting irregularities. Investigation of and referral to law enforcement for the successful criminal prosecution of a former employee of a global oil and gas services company based on the unlawful intrusion into the company’s computer system and theft of trade secret and proprietary information.","searchable_name":"John C. Richter","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":426281,"version":1,"owner_type":"Person","owner_id":2105,"payload":{"bio":"\u003cp\u003eJessica Ringel advises\u0026nbsp;medical device, pharmaceutical, HCT/P, and cosmetics manufacturers\u0026nbsp;and distributors\u0026nbsp;on matters involving FDA regulation. Jessica\u0026rsquo;s post-market practice focuses on safety and quality matters, including responses to FDA inspections and enforcement actions, recall and adverse event matters, and advertising and promotion. Her pre-market practice includes advising on regulatory strategy and marketing applications. Jessica\u0026rsquo;s transactional practice involves conducting due diligence evaluations of life sciences targets for manufacturers, private equity firms, and investment banks.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s device regulatory practice spans the entire FDA regulatory lifecycle.\u0026nbsp; She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.\u0026nbsp; After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.\u0026nbsp; She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.\u0026nbsp; Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.\u0026nbsp; She further assists life sciences clients with the review and development of compliant marketing strategies and materials.\u0026nbsp; She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.\u0026nbsp; Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA\u0026rsquo;s electronic product radiation control program. Further, Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.\u0026nbsp; She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance.\u003c/p\u003e","slug":"jessica-ringel","email":"jringel@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":81,"guid":"81.capabilities","index":0,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":3,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":4,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":5,"source":"smartTags"}],"is_active":true,"last_name":"Ringel","nick_name":"Jessica","clerkships":[],"first_name":"Jessica","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eJessica Ringel advises\u0026nbsp;medical device, pharmaceutical, HCT/P, and cosmetics manufacturers\u0026nbsp;and distributors\u0026nbsp;on matters involving FDA regulation. Jessica\u0026rsquo;s post-market practice focuses on safety and quality matters, including responses to FDA inspections and enforcement actions, recall and adverse event matters, and advertising and promotion. Her pre-market practice includes advising on regulatory strategy and marketing applications. Jessica\u0026rsquo;s transactional practice involves conducting due diligence evaluations of life sciences targets for manufacturers, private equity firms, and investment banks.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s device regulatory practice spans the entire FDA regulatory lifecycle.\u0026nbsp; She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.\u0026nbsp; After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.\u0026nbsp; She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.\u0026nbsp; Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.\u0026nbsp; She further assists life sciences clients with the review and development of compliant marketing strategies and materials.\u0026nbsp; She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.\u0026nbsp; Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA\u0026rsquo;s electronic product radiation control program. Further, Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.\u0026nbsp; She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1146}]},"capability_group_id":2},"created_at":"2025-05-26T04:50:06.000Z","updated_at":"2025-05-26T04:50:06.000Z","searchable_text":"Ringel{{ FIELD }}Jessica Ringel advises medical device, pharmaceutical, HCT/P, and cosmetics manufacturers and distributors on matters involving FDA regulation. Jessica’s post-market practice focuses on safety and quality matters, including responses to FDA inspections and enforcement actions, recall and adverse event matters, and advertising and promotion. Her pre-market practice includes advising on regulatory strategy and marketing applications. Jessica’s transactional practice involves conducting due diligence evaluations of life sciences targets for manufacturers, private equity firms, and investment banks.\nJessica’s device regulatory practice spans the entire FDA regulatory lifecycle.  She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.  After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.  She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.  Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.  She further assists life sciences clients with the review and development of compliant marketing strategies and materials.  She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.  Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA’s electronic product radiation control program. Further, Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA.   \nJessica’s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.  She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance. Partner Cornell University Cornell Law School Georgetown University Georgetown University Law Center District of Columbia Maryland","searchable_name":"Jessica Ringel","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":436445,"version":1,"owner_type":"Person","owner_id":4001,"payload":{"bio":"\u003cp\u003eKim Roberts represents global corporates and large employers on their employment law and data privacy strategy in the U.K. and across Europe. She has particular experience with international clients headquartered outside the U.K., specifically those in the U.S. with global operations.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eKim is an experienced employment law practitioner and advises across the full range of employment matters both contentious and non-contentious, including counselling, High-Court and Tribunal matters, executive recruitment and termination, board disputes, competition and restraint of trade matters, employment issues on transactions, data protection issues, downsizing and collective consultation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eKim also advises on data protection and privacy issues.\u0026nbsp; She has extensive experience in advising cross border European clients on their data privacy obligations, data privacy policies and employee data management.\u0026nbsp; Kim advises clients on developing law and practice in the EU including the GDPR and on obligations when transferring data between the EU and the U.S., including advice on Model Clauses and the Privacy Shield.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eKim speaks regularly at client events and seminars and commentates in the U.K. national press on employment law and data privacy matters and developments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecognition\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eRecommended in Legal 500\u003c/li\u003e\n\u003c/ul\u003e","slug":"kim-roberts","email":"kroberts@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":6,"guid":"6.capabilities","index":0,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":1,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":2,"source":"capabilities"},{"id":15,"guid":"15.capabilities","index":3,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":4,"source":"smartTags"}],"is_active":true,"last_name":"Roberts","nick_name":"Kim","clerkships":[],"first_name":"Kim","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eKim Roberts represents global corporates and large employers on their employment law and data privacy strategy in the U.K. and across Europe. She has particular experience with international clients headquartered outside the U.K., specifically those in the U.S. with global operations.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eKim is an experienced employment law practitioner and advises across the full range of employment matters both contentious and non-contentious, including counselling, High-Court and Tribunal matters, executive recruitment and termination, board disputes, competition and restraint of trade matters, employment issues on transactions, data protection issues, downsizing and collective consultation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eKim also advises on data protection and privacy issues.\u0026nbsp; She has extensive experience in advising cross border European clients on their data privacy obligations, data privacy policies and employee data management.\u0026nbsp; Kim advises clients on developing law and practice in the EU including the GDPR and on obligations when transferring data between the EU and the U.S., including advice on Model Clauses and the Privacy Shield.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eKim speaks regularly at client events and seminars and commentates in the U.K. national press on employment law and data privacy matters and developments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecognition\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eRecommended in Legal 500\u003c/li\u003e\n\u003c/ul\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":4589}]},"capability_group_id":2},"created_at":"2025-09-02T04:54:16.000Z","updated_at":"2025-09-02T04:54:16.000Z","searchable_text":"Roberts{{ FIELD }}Kim Roberts represents global corporates and large employers on their employment law and data privacy strategy in the U.K. and across Europe. She has particular experience with international clients headquartered outside the U.K., specifically those in the U.S. with global operations. \nKim is an experienced employment law practitioner and advises across the full range of employment matters both contentious and non-contentious, including counselling, High-Court and Tribunal matters, executive recruitment and termination, board disputes, competition and restraint of trade matters, employment issues on transactions, data protection issues, downsizing and collective consultation. \nKim also advises on data protection and privacy issues.  She has extensive experience in advising cross border European clients on their data privacy obligations, data privacy policies and employee data management.  Kim advises clients on developing law and practice in the EU including the GDPR and on obligations when transferring data between the EU and the U.S., including advice on Model Clauses and the Privacy Shield. \nKim speaks regularly at client events and seminars and commentates in the U.K. national press on employment law and data privacy matters and developments.\nRecognition\n\nRecommended in Legal 500\n Partner Law Society of England \u0026amp; Wales (admitted 3/9/2001; reg. # 277966)","searchable_name":"Kim Roberts","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":426313,"version":1,"owner_type":"Person","owner_id":2422,"payload":{"bio":"\u003cp\u003eAdam Robison focuses on a wide range of matters involving healthcare providers and suppliers. A partner in our Healthcare practice, Adam represents healthcare clients in a variety of regulatory and transactional matters.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAdam represents public and private hospital systems, academic medical centers, medical schools, children's hospitals, hospices, laboratories, physicians and suppliers in various regulatory and transactional matters.\u003c/p\u003e\n\u003cp\u003eAdam counsels clients concerning False Claims Act and Civil Monetary Penalty investigations, fraud and abuse, along with anti-kickback and physician self-referral issues, including physician contracting. He has also worked with clients on Medicare and Medicaid administrative overpayment appeals; Medicare and Medicaid self-disclosures; and compliance with the 60-day overpayment rule; as well as on Medicaid supplemental payment and 1115 Waiver programs.\u003c/p\u003e\n\u003cp\u003eIn addition, Adam advises clients on a variety of transactional matters, including hospital joint operating company agreements, merger and acquisition agreements, and academic affiliation agreements.\u003c/p\u003e","slug":"adam-robison","email":"arobison@kslaw.com","phone":"+1-832-714-8015","matters":["\u003cp\u003eLitigation/Administrative Appeals\u003cbr /\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea large healthcare company\u003c/strong\u003e in obtaining an $18 million arbitration award against the sellers of a hospice pursuant to claims for indemnification and fraud related to a self-disclosure audit that Adam also facilitated.\u003c/p\u003e","\u003cp\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea drug testing laboratory\u003c/strong\u003e in reducing a $31 million Medicare overpayment resulting in more than a $29 million overpayment reduction.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ean oncologist\u003c/strong\u003e before the Administrative Law Judge in a Medicare overpayment case resulting in the full reversal of the alleged multimillion-dollar overpayment.\u003c/p\u003e","\u003cp\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea coalition of children\u0026rsquo;s hospitals\u003c/strong\u003e in connection with dispute involving cost-settling certain Medicaid primary care case management payments resulting in multimillion-dollar settlements.\u003c/p\u003e","\u003cp\u003eNegotiated a $6 million settlement agreement for \u003cstrong data-redactor-tag=\"strong\"\u003ea children\u0026rsquo;s hospital\u003c/strong\u003e in connection with a dispute involving cost-settling certain Medicaid primary care case management payments.\u003c/p\u003e","\u003cp\u003eFalse Claims Act Matters and Settlements\u003cbr /\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea county-owned hospital\u003c/strong\u003e in an approximate $21.75 million settlement of a federal False Claims Act \u003cem data-redactor-tag=\"em\"\u003equi tam\u003c/em\u003e lawsuit involving allegations of Stark Law and Anti-Kickback Statute violations without a Corporate Integrity Agreement.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea nursing home chain\u003c/strong\u003e in a $4 million settlement of federal and state False Claims Act lawsuit and negotiation of a Corporate Integrity Agreement related to ambulance arrangement allegations.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea hospital district\u003c/strong\u003e in a favorable $3.3 million settlement of federal and state False Claims Act lawsuit involving physician billing without a Corporate Integrity Agreement.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea national hospice\u003c/strong\u003e in negotiating an approximate $25 million settlement and negotiated Corporate Integrity Agreement based on allegations of lack of medically necessary services.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea county hospital district\u003c/strong\u003e in negotiating an approximate $15 million settlement and negotiated corporate compliance agreement related to allegations of lack of Medicare Secondary Payer issues and claims for prisoners.\u003c/p\u003e","\u003cp\u003eTransactions\u003cbr /\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea medical school\u003c/strong\u003e in negotiating $100 plus million joint operating company and physician clinically integrated network agreements.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea medical school\u003c/strong\u003e in the annual negotiation of $220 plus million physician coverage and academic affiliation agreements.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea state university/academic medical center\u003c/strong\u003e in the successful negotiation of a $338 million agreement with the state\u0026rsquo;s department of criminal justice for the provision of correctional healthcare services to state inmates.\u003c/p\u003e","\u003cp\u003eHealth Regulatory and Self-Disclosures\u003cbr /\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea state medical school\u003c/strong\u003e in obtaining provider-based on-campus designation for its $66 million radiation oncology facility resulting in millions of dollars of additional reimbursement per year.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea state medical school\u003c/strong\u003e in obtaining a favorable advisory opinion from the Office of Inspector General related to the medical school\u0026rsquo;s prenatal care programs.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ean academic medical center hospital\u003c/strong\u003e in obtaining retroactive listing as a covered entity under the 340B drug discount program, resulting in $4.5 plus million in drug savings.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003emultiple hospital systems and providers\u003c/strong\u003e in self-disclosing overpayments to Medicare Administrative Contractors, the Office of Inspector General (self-disclosure protocol) and various state Medicaid agencies.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003evarious participants\u003c/strong\u003e regarding the development and implementation of Medicaid supplemental payment/1115 Waiver programs to provide enhanced Medicaid payments to hospitals and other providers located in multiple counties in Texas.\u003c/p\u003e","\u003cp\u003eReviewed and analyzed physician and referral arrangements on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003emultiple financial institutions\u003c/strong\u003e in connection with hospital public finance transactions to determine compliance with the Anti-Kickback Statute and Stark Law.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea multi-hospital system\u003c/strong\u003e in voluntarily disclosing pursuant to the OIG through the OIG Self-Disclosure Protocol its employment of individuals excluded from participation in federal healthcare programs.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":6,"guid":"6.capabilities","index":0,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":1,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":2,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":3,"source":"capabilities"},{"id":32,"guid":"32.capabilities","index":4,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":5,"source":"capabilities"},{"id":826,"guid":"826.smart_tags","index":6,"source":"smartTags"},{"id":952,"guid":"952.smart_tags","index":7,"source":"smartTags"},{"id":114,"guid":"114.capabilities","index":8,"source":"capabilities"}],"is_active":true,"last_name":"Robison","nick_name":"Adam","clerkships":[],"first_name":"Adam","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Top Ranked Lawyer, Healthcare","detail":"Chambers USA, Texas (2019-2022)"},{"title":"\"Adam Robison has a very deep understanding of the specificities of healthcare transactions.\"","detail":"Chambers USA (2022)"},{"title":"Healthcare Super Lawyer: Texas","detail":"Super Lawyers, 2013–2016"},{"title":"Rising Star: Texas","detail":"Super Lawyers, 2010–2012"}],"linked_in_url":"https://www.linkedin.com/in/adam-robison-03538125/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eAdam Robison focuses on a wide range of matters involving healthcare providers and suppliers. A partner in our Healthcare practice, Adam represents healthcare clients in a variety of regulatory and transactional matters.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAdam represents public and private hospital systems, academic medical centers, medical schools, children's hospitals, hospices, laboratories, physicians and suppliers in various regulatory and transactional matters.\u003c/p\u003e\n\u003cp\u003eAdam counsels clients concerning False Claims Act and Civil Monetary Penalty investigations, fraud and abuse, along with anti-kickback and physician self-referral issues, including physician contracting. He has also worked with clients on Medicare and Medicaid administrative overpayment appeals; Medicare and Medicaid self-disclosures; and compliance with the 60-day overpayment rule; as well as on Medicaid supplemental payment and 1115 Waiver programs.\u003c/p\u003e\n\u003cp\u003eIn addition, Adam advises clients on a variety of transactional matters, including hospital joint operating company agreements, merger and acquisition agreements, and academic affiliation agreements.\u003c/p\u003e","matters":["\u003cp\u003eLitigation/Administrative Appeals\u003cbr /\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea large healthcare company\u003c/strong\u003e in obtaining an $18 million arbitration award against the sellers of a hospice pursuant to claims for indemnification and fraud related to a self-disclosure audit that Adam also facilitated.\u003c/p\u003e","\u003cp\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea drug testing laboratory\u003c/strong\u003e in reducing a $31 million Medicare overpayment resulting in more than a $29 million overpayment reduction.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ean oncologist\u003c/strong\u003e before the Administrative Law Judge in a Medicare overpayment case resulting in the full reversal of the alleged multimillion-dollar overpayment.\u003c/p\u003e","\u003cp\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea coalition of children\u0026rsquo;s hospitals\u003c/strong\u003e in connection with dispute involving cost-settling certain Medicaid primary care case management payments resulting in multimillion-dollar settlements.\u003c/p\u003e","\u003cp\u003eNegotiated a $6 million settlement agreement for \u003cstrong data-redactor-tag=\"strong\"\u003ea children\u0026rsquo;s hospital\u003c/strong\u003e in connection with a dispute involving cost-settling certain Medicaid primary care case management payments.\u003c/p\u003e","\u003cp\u003eFalse Claims Act Matters and Settlements\u003cbr /\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea county-owned hospital\u003c/strong\u003e in an approximate $21.75 million settlement of a federal False Claims Act \u003cem data-redactor-tag=\"em\"\u003equi tam\u003c/em\u003e lawsuit involving allegations of Stark Law and Anti-Kickback Statute violations without a Corporate Integrity Agreement.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea nursing home chain\u003c/strong\u003e in a $4 million settlement of federal and state False Claims Act lawsuit and negotiation of a Corporate Integrity Agreement related to ambulance arrangement allegations.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea hospital district\u003c/strong\u003e in a favorable $3.3 million settlement of federal and state False Claims Act lawsuit involving physician billing without a Corporate Integrity Agreement.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea national hospice\u003c/strong\u003e in negotiating an approximate $25 million settlement and negotiated Corporate Integrity Agreement based on allegations of lack of medically necessary services.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea county hospital district\u003c/strong\u003e in negotiating an approximate $15 million settlement and negotiated corporate compliance agreement related to allegations of lack of Medicare Secondary Payer issues and claims for prisoners.\u003c/p\u003e","\u003cp\u003eTransactions\u003cbr /\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea medical school\u003c/strong\u003e in negotiating $100 plus million joint operating company and physician clinically integrated network agreements.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea medical school\u003c/strong\u003e in the annual negotiation of $220 plus million physician coverage and academic affiliation agreements.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea state university/academic medical center\u003c/strong\u003e in the successful negotiation of a $338 million agreement with the state\u0026rsquo;s department of criminal justice for the provision of correctional healthcare services to state inmates.\u003c/p\u003e","\u003cp\u003eHealth Regulatory and Self-Disclosures\u003cbr /\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea state medical school\u003c/strong\u003e in obtaining provider-based on-campus designation for its $66 million radiation oncology facility resulting in millions of dollars of additional reimbursement per year.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea state medical school\u003c/strong\u003e in obtaining a favorable advisory opinion from the Office of Inspector General related to the medical school\u0026rsquo;s prenatal care programs.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ean academic medical center hospital\u003c/strong\u003e in obtaining retroactive listing as a covered entity under the 340B drug discount program, resulting in $4.5 plus million in drug savings.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003emultiple hospital systems and providers\u003c/strong\u003e in self-disclosing overpayments to Medicare Administrative Contractors, the Office of Inspector General (self-disclosure protocol) and various state Medicaid agencies.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003evarious participants\u003c/strong\u003e regarding the development and implementation of Medicaid supplemental payment/1115 Waiver programs to provide enhanced Medicaid payments to hospitals and other providers located in multiple counties in Texas.\u003c/p\u003e","\u003cp\u003eReviewed and analyzed physician and referral arrangements on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003emultiple financial institutions\u003c/strong\u003e in connection with hospital public finance transactions to determine compliance with the Anti-Kickback Statute and Stark Law.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea multi-hospital system\u003c/strong\u003e in voluntarily disclosing pursuant to the OIG through the OIG Self-Disclosure Protocol its employment of individuals excluded from participation in federal healthcare programs.\u003c/p\u003e"],"recognitions":[{"title":"Top Ranked Lawyer, Healthcare","detail":"Chambers USA, Texas (2019-2022)"},{"title":"\"Adam Robison has a very deep understanding of the specificities of healthcare transactions.\"","detail":"Chambers USA (2022)"},{"title":"Healthcare Super Lawyer: Texas","detail":"Super Lawyers, 2013–2016"},{"title":"Rising Star: Texas","detail":"Super Lawyers, 2010–2012"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":89}]},"capability_group_id":2},"created_at":"2025-05-26T04:50:47.000Z","updated_at":"2025-05-26T04:50:47.000Z","searchable_text":"Robison{{ FIELD }}{:title=\u0026gt;\"Top Ranked Lawyer, Healthcare\", :detail=\u0026gt;\"Chambers USA, Texas (2019-2022)\"}{{ FIELD }}{:title=\u0026gt;\"\\\"Adam Robison has a very deep understanding of the specificities of healthcare transactions.\\\"\", :detail=\u0026gt;\"Chambers USA (2022)\"}{{ FIELD }}{:title=\u0026gt;\"Healthcare Super Lawyer: Texas\", :detail=\u0026gt;\"Super Lawyers, 2013–2016\"}{{ FIELD }}{:title=\u0026gt;\"Rising Star: Texas\", :detail=\u0026gt;\"Super Lawyers, 2010–2012\"}{{ FIELD }}Litigation/Administrative AppealsSuccessfully represented a large healthcare company in obtaining an $18 million arbitration award against the sellers of a hospice pursuant to claims for indemnification and fraud related to a self-disclosure audit that Adam also facilitated.{{ FIELD }}Successfully represented a drug testing laboratory in reducing a $31 million Medicare overpayment resulting in more than a $29 million overpayment reduction.{{ FIELD }}Represented an oncologist before the Administrative Law Judge in a Medicare overpayment case resulting in the full reversal of the alleged multimillion-dollar overpayment.{{ FIELD }}Successfully represented a coalition of children’s hospitals in connection with dispute involving cost-settling certain Medicaid primary care case management payments resulting in multimillion-dollar settlements.{{ FIELD }}Negotiated a $6 million settlement agreement for a children’s hospital in connection with a dispute involving cost-settling certain Medicaid primary care case management payments.{{ FIELD }}False Claims Act Matters and SettlementsRepresented a county-owned hospital in an approximate $21.75 million settlement of a federal False Claims Act qui tam lawsuit involving allegations of Stark Law and Anti-Kickback Statute violations without a Corporate Integrity Agreement.{{ FIELD }}Represented a nursing home chain in a $4 million settlement of federal and state False Claims Act lawsuit and negotiation of a Corporate Integrity Agreement related to ambulance arrangement allegations.{{ FIELD }}Represented a hospital district in a favorable $3.3 million settlement of federal and state False Claims Act lawsuit involving physician billing without a Corporate Integrity Agreement.{{ FIELD }}Represented a national hospice in negotiating an approximate $25 million settlement and negotiated Corporate Integrity Agreement based on allegations of lack of medically necessary services.{{ FIELD }}Represented a county hospital district in negotiating an approximate $15 million settlement and negotiated corporate compliance agreement related to allegations of lack of Medicare Secondary Payer issues and claims for prisoners.{{ FIELD }}TransactionsRepresented a medical school in negotiating $100 plus million joint operating company and physician clinically integrated network agreements.{{ FIELD }}Represented a medical school in the annual negotiation of $220 plus million physician coverage and academic affiliation agreements.{{ FIELD }}Represented a state university/academic medical center in the successful negotiation of a $338 million agreement with the state’s department of criminal justice for the provision of correctional healthcare services to state inmates.{{ FIELD }}Health Regulatory and Self-DisclosuresRepresented a state medical school in obtaining provider-based on-campus designation for its $66 million radiation oncology facility resulting in millions of dollars of additional reimbursement per year.{{ FIELD }}Represented a state medical school in obtaining a favorable advisory opinion from the Office of Inspector General related to the medical school’s prenatal care programs.{{ FIELD }}Represented an academic medical center hospital in obtaining retroactive listing as a covered entity under the 340B drug discount program, resulting in $4.5 plus million in drug savings.{{ FIELD }}Represented multiple hospital systems and providers in self-disclosing overpayments to Medicare Administrative Contractors, the Office of Inspector General (self-disclosure protocol) and various state Medicaid agencies.{{ FIELD }}Represented various participants regarding the development and implementation of Medicaid supplemental payment/1115 Waiver programs to provide enhanced Medicaid payments to hospitals and other providers located in multiple counties in Texas.{{ FIELD }}Reviewed and analyzed physician and referral arrangements on behalf of multiple financial institutions in connection with hospital public finance transactions to determine compliance with the Anti-Kickback Statute and Stark Law.{{ FIELD }}Represented a multi-hospital system in voluntarily disclosing pursuant to the OIG through the OIG Self-Disclosure Protocol its employment of individuals excluded from participation in federal healthcare programs.{{ FIELD }}Adam Robison focuses on a wide range of matters involving healthcare providers and suppliers. A partner in our Healthcare practice, Adam represents healthcare clients in a variety of regulatory and transactional matters.\nAdam represents public and private hospital systems, academic medical centers, medical schools, children's hospitals, hospices, laboratories, physicians and suppliers in various regulatory and transactional matters.\nAdam counsels clients concerning False Claims Act and Civil Monetary Penalty investigations, fraud and abuse, along with anti-kickback and physician self-referral issues, including physician contracting. He has also worked with clients on Medicare and Medicaid administrative overpayment appeals; Medicare and Medicaid self-disclosures; and compliance with the 60-day overpayment rule; as well as on Medicaid supplemental payment and 1115 Waiver programs.\nIn addition, Adam advises clients on a variety of transactional matters, including hospital joint operating company agreements, merger and acquisition agreements, and academic affiliation agreements. Partner Top Ranked Lawyer, Healthcare Chambers USA, Texas (2019-2022) \"Adam Robison has a very deep understanding of the specificities of healthcare transactions.\" Chambers USA (2022) Healthcare Super Lawyer: Texas Super Lawyers, 2013–2016 Rising Star: Texas Super Lawyers, 2010–2012 Brigham Young University J. Reuben Clark Law School South Texas College of Law South Texas College of Law Texas Litigation/Administrative AppealsSuccessfully represented a large healthcare company in obtaining an $18 million arbitration award against the sellers of a hospice pursuant to claims for indemnification and fraud related to a self-disclosure audit that Adam also facilitated. Successfully represented a drug testing laboratory in reducing a $31 million Medicare overpayment resulting in more than a $29 million overpayment reduction. Represented an oncologist before the Administrative Law Judge in a Medicare overpayment case resulting in the full reversal of the alleged multimillion-dollar overpayment. Successfully represented a coalition of children’s hospitals in connection with dispute involving cost-settling certain Medicaid primary care case management payments resulting in multimillion-dollar settlements. Negotiated a $6 million settlement agreement for a children’s hospital in connection with a dispute involving cost-settling certain Medicaid primary care case management payments. False Claims Act Matters and SettlementsRepresented a county-owned hospital in an approximate $21.75 million settlement of a federal False Claims Act qui tam lawsuit involving allegations of Stark Law and Anti-Kickback Statute violations without a Corporate Integrity Agreement. Represented a nursing home chain in a $4 million settlement of federal and state False Claims Act lawsuit and negotiation of a Corporate Integrity Agreement related to ambulance arrangement allegations. Represented a hospital district in a favorable $3.3 million settlement of federal and state False Claims Act lawsuit involving physician billing without a Corporate Integrity Agreement. Represented a national hospice in negotiating an approximate $25 million settlement and negotiated Corporate Integrity Agreement based on allegations of lack of medically necessary services. Represented a county hospital district in negotiating an approximate $15 million settlement and negotiated corporate compliance agreement related to allegations of lack of Medicare Secondary Payer issues and claims for prisoners. TransactionsRepresented a medical school in negotiating $100 plus million joint operating company and physician clinically integrated network agreements. Represented a medical school in the annual negotiation of $220 plus million physician coverage and academic affiliation agreements. Represented a state university/academic medical center in the successful negotiation of a $338 million agreement with the state’s department of criminal justice for the provision of correctional healthcare services to state inmates. Health Regulatory and Self-DisclosuresRepresented a state medical school in obtaining provider-based on-campus designation for its $66 million radiation oncology facility resulting in millions of dollars of additional reimbursement per year. Represented a state medical school in obtaining a favorable advisory opinion from the Office of Inspector General related to the medical school’s prenatal care programs. Represented an academic medical center hospital in obtaining retroactive listing as a covered entity under the 340B drug discount program, resulting in $4.5 plus million in drug savings. Represented multiple hospital systems and providers in self-disclosing overpayments to Medicare Administrative Contractors, the Office of Inspector General (self-disclosure protocol) and various state Medicaid agencies. Represented various participants regarding the development and implementation of Medicaid supplemental payment/1115 Waiver programs to provide enhanced Medicaid payments to hospitals and other providers located in multiple counties in Texas. Reviewed and analyzed physician and referral arrangements on behalf of multiple financial institutions in connection with hospital public finance transactions to determine compliance with the Anti-Kickback Statute and Stark Law. Represented a multi-hospital system in voluntarily disclosing pursuant to the OIG through the OIG Self-Disclosure Protocol its employment of individuals excluded from participation in federal healthcare programs.","searchable_name":"Adam Robison","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":436367,"version":1,"owner_type":"Person","owner_id":2254,"payload":{"bio":"\u003cp\u003eKim Roeder focuses on the healthcare sector, particularly with regard to compliance, investigations and transactions. As a partner in our Healthcare practice, Kim represents individual and institutional healthcare providers, along with suppliers, in a wide range of matters.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eKim advises healthcare suppliers and providers, including hospital systems, academic medical centers and physician practice groups, on implementing compliance programs as well as conducting compliance assessments and internal investigations. She frequently represents healthcare providers in responding to Department of Justice and Office of Inspector General investigations and\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;actions, and in voluntary disclosures through agency programs.\u003c/p\u003e\n\u003cp\u003eIn addition, Kim has extensive experience advising clients on Medicare and Medicaid reimbursement issues; federal and state self-referral and anti-kickback laws; delivery system reform; accountable care organizations; shared savings and incentive payment arrangements; clinically integrated networks; and hospital-physician employment relationships and other affiliations.\u003c/p\u003e\n\u003cp\u003eKim is an Adjunct Professor at the Georgia State University College of Law. A frequent author and speaker before professional and trade groups, Kim is a member of the American Health Lawyers Association and the Health Care Compliance Association, and a former president of the Georgia Academy of Healthcare Attorneys.\u003c/p\u003e\n\u003cp\u003eKim holds a top ranking among Georgia healthcare lawyers in\u0026nbsp;\u003cem\u003eChambers USA,\u003c/em\u003e\u0026nbsp;and has been recognized for more than 10 years as one of\u0026nbsp;\u003cem\u003eThe\u003c/em\u003e\u0026nbsp;\u003cem\u003eBest Lawyers in America\u003c/em\u003e\u0026nbsp;for Healthcare Law. In addition, she has been selected as a Georgia Super Lawyer by\u0026nbsp;\u003cem\u003eSuper Lawyers\u003c/em\u003e\u0026nbsp;since 2004, and named an Outstanding Healthcare Fraud and Compliance Lawyer in\u0026nbsp;\u003cem\u003eNightingale\u0026rsquo;s Healthcare News.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u0026ldquo;The Stark Law and Regulations,\u0026rdquo;\u0026nbsp;\u003cem\u003eCompliance Manual\u003c/em\u003e, Healthcare Compliance Association (2009, 2011 and 2016 updates)\u003c/li\u003e\n\u003cli\u003eAmerican Health Lawyers Association, Business Law and Governance Practice Group,\u0026nbsp;\u003cem\u003eExecutive Summary\u003c/em\u003e\u0026nbsp;(December 2009), \u0026ldquo;The New Healthcare Delivery System:\u0026nbsp; What are Accountable Care Organizations and Medical Homes?\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eAmerican Health Lawyers Association, Business Law and Governance Practice Group, Business Law Update (September 9, 2009), \u0026ldquo;Healthcare Reform Will Challenge Providers\u0026rsquo; Business Structures\u0026rdquo;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSpeaking Engagements\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eAmerican Health Lawyers Association, Physicians and Hospitals Law Institute, February 10-12, 2020, \u0026ldquo;The Regulatory Sprint to Coordinated Care:\u0026nbsp; Are We There Yet?\u0026rdquo;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eKing \u0026amp; Spalding Roundtable Webinars, November 7, 2019 and November 20, 2019: Recalculating:\u0026nbsp; Are the Major Stark, Anti-Kickback and CMP Proposed Rule Changes Taking Us in a New Direction?\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eABA Health Law Section Webinar, \u0026ldquo;Head Start:\u0026nbsp; What You Need to Know Now About the Newly Proposed AKS Regulations,\u0026rdquo; November 5, 2019.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e26th Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2017: \u0026nbsp;Participation in Panel Presentation, \u0026ldquo;Fulfilling Campaign Promises:\u0026nbsp; ACA Repeal and Replace\u0026rdquo;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eAICPA Health Care Industry Conference, November 2016:\u0026nbsp; \u0026ldquo;ACA Update: Where are We and What\u0026rsquo;s Coming?\u0026rdquo;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eKing \u0026amp; Spalding Roundtable Program, December 2014:\u0026nbsp; \u0026ldquo;The New \u0026lsquo;Selfie\u0026rsquo;: Self Disclosures and Voluntary Repayments under Medicare\u0026rdquo;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e22nd Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2013:\u0026nbsp; Panel Presentation \u0026ndash; \u0026ldquo;Healthcare Reform Countdown\u0026rdquo;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003eArkansas Hospital Association, August 2012:\u0026nbsp; \u0026ldquo;Update on Delivery System and Payment Reforms\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eKing \u0026amp; Spalding Roundtable Program, August 2012:\u0026nbsp; \u0026ldquo;Recent Medicaid Developments from the Implementation of the Supreme Court\u0026rsquo;s Ruling on PPACA, Enforcement Activities and Other Medicaid Reforms\u0026rdquo;\u003c/li\u003e\n\u003cli\u003e21st Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2012:\u0026nbsp; Panel Presentation, \u0026ldquo;Delivery System Evolution:\u0026nbsp; Competing on Cost and Quality\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eHCCA Southeast Regional Annual Conference, January 2012:\u0026nbsp; \u0026ldquo;Compliance Issues in Accountable Care: Shared Savings, Bundled Payments and other Innovations\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eGeorgia State University College of Law and Center for Law, Health and Society, January 2012:\u0026nbsp; \u0026ldquo;Update -- The Progress of Healthcare Delivery System Reform\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eKing \u0026amp; Spalding Roundtable Program, November 2011:\u0026nbsp; \u0026ldquo;Qualifying as an Accountable Care Organization in the CMS Shared Savings Program:\u0026nbsp; Overview of the Final Rule and Agency Announcements\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eTennessee Hospital Association Fall Compliance Conference, October 2011:\u0026nbsp; \u0026ldquo;Compliance Issues in Accountable Care Organizations and Innovative Payment Arrangements\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eGeorgia Bio/Georgia Association of Healthcare Executives, October 2011:\u0026nbsp; \u0026ldquo;Technology That Will Create Accountable Care:\u0026nbsp; Legal Framework for Accountable Care Organizations and Innovative Payment Arrangements\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eGeorgia Healthcare Financial Management Association, July 2011:\u0026nbsp; Accountable Care Organizations\u003c/li\u003e\n\u003cli\u003eKing \u0026amp; Spalding Roundtable Program, April 2011:\u0026nbsp; \u0026ldquo;Planning to Qualify as an Accountable Care Organization:\u0026nbsp; Proposed Rule and Agency Notices\u0026rdquo;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cul\u003e\n\u003cli\u003eEast Tennessee Healthcare Fraud Working Group, April 2011:\u0026nbsp; \u0026ldquo;Health Care Reform and Compliance Issues\u0026rdquo;\u003c/li\u003e\n\u003cli\u003e20th Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2011:\u0026nbsp; \u0026ldquo;Legal and Regulatory Conflicts in PPACA\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eAmerican Health Lawyers Association, June 2010:\u0026nbsp; \u0026ldquo;Quality-Based Compensation in a New Era of Health Reform\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eGeorgia Academy of Healthcare Attorneys, May 2010:\u0026nbsp; \u0026ldquo;Hospital-Physician Alignment\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eKing \u0026amp; Spalding Roundtable Program, May 2010:\u0026nbsp; \u0026ldquo;Reform Driven Strategies and Tactics\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eAmerican Health Lawyers Association, Moderator of national teleconference, April 2010, regarding Care Coordination Models\u003c/li\u003e\n\u003cli\u003eKing \u0026amp; Spalding Roundtable Program, April 2010:\u0026nbsp; \u0026ldquo;Healthcare Reform Legislation -- Medicare, Medicaid and Delivery System Reform\u0026rdquo;\u003c/li\u003e\n\u003c/ul\u003e","slug":"kim-roeder","email":"kroeder@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[{"id":97}]},"expertise":[{"id":23,"guid":"23.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":2,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":3,"source":"capabilities"},{"id":826,"guid":"826.smart_tags","index":4,"source":"smartTags"}],"is_active":true,"last_name":"Roeder","nick_name":"Kim","clerkships":[],"first_name":"Kim","title_rank":9999,"updated_by":174,"law_schools":[],"middle_name":"H.","name_suffix":"","recognitions":[{"title":"Top ranking among Georgia healthcare lawyers ","detail":"Chambers USA"},{"title":"Healthcare Law ","detail":"The Best Lawyers in America, 10+ years"},{"title":"Georgia Super Lawyer ","detail":"Super Lawyers"},{"title":"Outstanding Healthcare Fraud and Compliance Lawyer ","detail":"Nightingale’s Healthcare News"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eKim Roeder focuses on the healthcare sector, particularly with regard to compliance, investigations and transactions. As a partner in our Healthcare practice, Kim represents individual and institutional healthcare providers, along with suppliers, in a wide range of matters.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eKim advises healthcare suppliers and providers, including hospital systems, academic medical centers and physician practice groups, on implementing compliance programs as well as conducting compliance assessments and internal investigations. She frequently represents healthcare providers in responding to Department of Justice and Office of Inspector General investigations and\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;actions, and in voluntary disclosures through agency programs.\u003c/p\u003e\n\u003cp\u003eIn addition, Kim has extensive experience advising clients on Medicare and Medicaid reimbursement issues; federal and state self-referral and anti-kickback laws; delivery system reform; accountable care organizations; shared savings and incentive payment arrangements; clinically integrated networks; and hospital-physician employment relationships and other affiliations.\u003c/p\u003e\n\u003cp\u003eKim is an Adjunct Professor at the Georgia State University College of Law. A frequent author and speaker before professional and trade groups, Kim is a member of the American Health Lawyers Association and the Health Care Compliance Association, and a former president of the Georgia Academy of Healthcare Attorneys.\u003c/p\u003e\n\u003cp\u003eKim holds a top ranking among Georgia healthcare lawyers in\u0026nbsp;\u003cem\u003eChambers USA,\u003c/em\u003e\u0026nbsp;and has been recognized for more than 10 years as one of\u0026nbsp;\u003cem\u003eThe\u003c/em\u003e\u0026nbsp;\u003cem\u003eBest Lawyers in America\u003c/em\u003e\u0026nbsp;for Healthcare Law. In addition, she has been selected as a Georgia Super Lawyer by\u0026nbsp;\u003cem\u003eSuper Lawyers\u003c/em\u003e\u0026nbsp;since 2004, and named an Outstanding Healthcare Fraud and Compliance Lawyer in\u0026nbsp;\u003cem\u003eNightingale\u0026rsquo;s Healthcare News.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u0026ldquo;The Stark Law and Regulations,\u0026rdquo;\u0026nbsp;\u003cem\u003eCompliance Manual\u003c/em\u003e, Healthcare Compliance Association (2009, 2011 and 2016 updates)\u003c/li\u003e\n\u003cli\u003eAmerican Health Lawyers Association, Business Law and Governance Practice Group,\u0026nbsp;\u003cem\u003eExecutive Summary\u003c/em\u003e\u0026nbsp;(December 2009), \u0026ldquo;The New Healthcare Delivery System:\u0026nbsp; What are Accountable Care Organizations and Medical Homes?\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eAmerican Health Lawyers Association, Business Law and Governance Practice Group, Business Law Update (September 9, 2009), \u0026ldquo;Healthcare Reform Will Challenge Providers\u0026rsquo; Business Structures\u0026rdquo;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSpeaking Engagements\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eAmerican Health Lawyers Association, Physicians and Hospitals Law Institute, February 10-12, 2020, \u0026ldquo;The Regulatory Sprint to Coordinated Care:\u0026nbsp; Are We There Yet?\u0026rdquo;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eKing \u0026amp; Spalding Roundtable Webinars, November 7, 2019 and November 20, 2019: Recalculating:\u0026nbsp; Are the Major Stark, Anti-Kickback and CMP Proposed Rule Changes Taking Us in a New Direction?\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eABA Health Law Section Webinar, \u0026ldquo;Head Start:\u0026nbsp; What You Need to Know Now About the Newly Proposed AKS Regulations,\u0026rdquo; November 5, 2019.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e26th Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2017: \u0026nbsp;Participation in Panel Presentation, \u0026ldquo;Fulfilling Campaign Promises:\u0026nbsp; ACA Repeal and Replace\u0026rdquo;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eAICPA Health Care Industry Conference, November 2016:\u0026nbsp; \u0026ldquo;ACA Update: Where are We and What\u0026rsquo;s Coming?\u0026rdquo;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eKing \u0026amp; Spalding Roundtable Program, December 2014:\u0026nbsp; \u0026ldquo;The New \u0026lsquo;Selfie\u0026rsquo;: Self Disclosures and Voluntary Repayments under Medicare\u0026rdquo;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e22nd Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2013:\u0026nbsp; Panel Presentation \u0026ndash; \u0026ldquo;Healthcare Reform Countdown\u0026rdquo;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003eArkansas Hospital Association, August 2012:\u0026nbsp; \u0026ldquo;Update on Delivery System and Payment Reforms\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eKing \u0026amp; Spalding Roundtable Program, August 2012:\u0026nbsp; \u0026ldquo;Recent Medicaid Developments from the Implementation of the Supreme Court\u0026rsquo;s Ruling on PPACA, Enforcement Activities and Other Medicaid Reforms\u0026rdquo;\u003c/li\u003e\n\u003cli\u003e21st Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2012:\u0026nbsp; Panel Presentation, \u0026ldquo;Delivery System Evolution:\u0026nbsp; Competing on Cost and Quality\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eHCCA Southeast Regional Annual Conference, January 2012:\u0026nbsp; \u0026ldquo;Compliance Issues in Accountable Care: Shared Savings, Bundled Payments and other Innovations\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eGeorgia State University College of Law and Center for Law, Health and Society, January 2012:\u0026nbsp; \u0026ldquo;Update -- The Progress of Healthcare Delivery System Reform\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eKing \u0026amp; Spalding Roundtable Program, November 2011:\u0026nbsp; \u0026ldquo;Qualifying as an Accountable Care Organization in the CMS Shared Savings Program:\u0026nbsp; Overview of the Final Rule and Agency Announcements\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eTennessee Hospital Association Fall Compliance Conference, October 2011:\u0026nbsp; \u0026ldquo;Compliance Issues in Accountable Care Organizations and Innovative Payment Arrangements\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eGeorgia Bio/Georgia Association of Healthcare Executives, October 2011:\u0026nbsp; \u0026ldquo;Technology That Will Create Accountable Care:\u0026nbsp; Legal Framework for Accountable Care Organizations and Innovative Payment Arrangements\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eGeorgia Healthcare Financial Management Association, July 2011:\u0026nbsp; Accountable Care Organizations\u003c/li\u003e\n\u003cli\u003eKing \u0026amp; Spalding Roundtable Program, April 2011:\u0026nbsp; \u0026ldquo;Planning to Qualify as an Accountable Care Organization:\u0026nbsp; Proposed Rule and Agency Notices\u0026rdquo;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cul\u003e\n\u003cli\u003eEast Tennessee Healthcare Fraud Working Group, April 2011:\u0026nbsp; \u0026ldquo;Health Care Reform and Compliance Issues\u0026rdquo;\u003c/li\u003e\n\u003cli\u003e20th Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2011:\u0026nbsp; \u0026ldquo;Legal and Regulatory Conflicts in PPACA\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eAmerican Health Lawyers Association, June 2010:\u0026nbsp; \u0026ldquo;Quality-Based Compensation in a New Era of Health Reform\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eGeorgia Academy of Healthcare Attorneys, May 2010:\u0026nbsp; \u0026ldquo;Hospital-Physician Alignment\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eKing \u0026amp; Spalding Roundtable Program, May 2010:\u0026nbsp; \u0026ldquo;Reform Driven Strategies and Tactics\u0026rdquo;\u003c/li\u003e\n\u003cli\u003eAmerican Health Lawyers Association, Moderator of national teleconference, April 2010, regarding Care Coordination Models\u003c/li\u003e\n\u003cli\u003eKing \u0026amp; Spalding Roundtable Program, April 2010:\u0026nbsp; \u0026ldquo;Healthcare Reform Legislation -- Medicare, Medicaid and Delivery System Reform\u0026rdquo;\u003c/li\u003e\n\u003c/ul\u003e","recognitions":[{"title":"Top ranking among Georgia healthcare lawyers ","detail":"Chambers USA"},{"title":"Healthcare Law ","detail":"The Best Lawyers in America, 10+ years"},{"title":"Georgia Super Lawyer ","detail":"Super Lawyers"},{"title":"Outstanding Healthcare Fraud and Compliance Lawyer ","detail":"Nightingale’s Healthcare News"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":11804}]},"capability_group_id":2},"created_at":"2025-09-02T04:50:41.000Z","updated_at":"2025-09-02T04:50:41.000Z","searchable_text":"Roeder{{ FIELD }}{:title=\u0026gt;\"Top ranking among Georgia healthcare lawyers \", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"Healthcare Law \", :detail=\u0026gt;\"The Best Lawyers in America, 10+ years\"}{{ FIELD }}{:title=\u0026gt;\"Georgia Super Lawyer \", :detail=\u0026gt;\"Super Lawyers\"}{{ FIELD }}{:title=\u0026gt;\"Outstanding Healthcare Fraud and Compliance Lawyer \", :detail=\u0026gt;\"Nightingale’s Healthcare News\"}{{ FIELD }}Kim Roeder focuses on the healthcare sector, particularly with regard to compliance, investigations and transactions. As a partner in our Healthcare practice, Kim represents individual and institutional healthcare providers, along with suppliers, in a wide range of matters.\nKim advises healthcare suppliers and providers, including hospital systems, academic medical centers and physician practice groups, on implementing compliance programs as well as conducting compliance assessments and internal investigations. She frequently represents healthcare providers in responding to Department of Justice and Office of Inspector General investigations and qui tam actions, and in voluntary disclosures through agency programs.\nIn addition, Kim has extensive experience advising clients on Medicare and Medicaid reimbursement issues; federal and state self-referral and anti-kickback laws; delivery system reform; accountable care organizations; shared savings and incentive payment arrangements; clinically integrated networks; and hospital-physician employment relationships and other affiliations.\nKim is an Adjunct Professor at the Georgia State University College of Law. A frequent author and speaker before professional and trade groups, Kim is a member of the American Health Lawyers Association and the Health Care Compliance Association, and a former president of the Georgia Academy of Healthcare Attorneys.\nKim holds a top ranking among Georgia healthcare lawyers in Chambers USA, and has been recognized for more than 10 years as one of The Best Lawyers in America for Healthcare Law. In addition, she has been selected as a Georgia Super Lawyer by Super Lawyers since 2004, and named an Outstanding Healthcare Fraud and Compliance Lawyer in Nightingale’s Healthcare News.\nPublications\n\n“The Stark Law and Regulations,” Compliance Manual, Healthcare Compliance Association (2009, 2011 and 2016 updates)\nAmerican Health Lawyers Association, Business Law and Governance Practice Group, Executive Summary (December 2009), “The New Healthcare Delivery System:  What are Accountable Care Organizations and Medical Homes?”\nAmerican Health Lawyers Association, Business Law and Governance Practice Group, Business Law Update (September 9, 2009), “Healthcare Reform Will Challenge Providers’ Business Structures”\n\nSpeaking Engagements\n\n\nAmerican Health Lawyers Association, Physicians and Hospitals Law Institute, February 10-12, 2020, “The Regulatory Sprint to Coordinated Care:  Are We There Yet?”\n\n\nKing \u0026amp; Spalding Roundtable Webinars, November 7, 2019 and November 20, 2019: Recalculating:  Are the Major Stark, Anti-Kickback and CMP Proposed Rule Changes Taking Us in a New Direction?\n\n\nABA Health Law Section Webinar, “Head Start:  What You Need to Know Now About the Newly Proposed AKS Regulations,” November 5, 2019.\n\n\n26th Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2017:  Participation in Panel Presentation, “Fulfilling Campaign Promises:  ACA Repeal and Replace”\n\n\nAICPA Health Care Industry Conference, November 2016:  “ACA Update: Where are We and What’s Coming?”\n\n\nKing \u0026amp; Spalding Roundtable Program, December 2014:  “The New ‘Selfie’: Self Disclosures and Voluntary Repayments under Medicare”\n\n\n22nd Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2013:  Panel Presentation – “Healthcare Reform Countdown”\n\nArkansas Hospital Association, August 2012:  “Update on Delivery System and Payment Reforms”\nKing \u0026amp; Spalding Roundtable Program, August 2012:  “Recent Medicaid Developments from the Implementation of the Supreme Court’s Ruling on PPACA, Enforcement Activities and Other Medicaid Reforms”\n21st Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2012:  Panel Presentation, “Delivery System Evolution:  Competing on Cost and Quality”\nHCCA Southeast Regional Annual Conference, January 2012:  “Compliance Issues in Accountable Care: Shared Savings, Bundled Payments and other Innovations”\nGeorgia State University College of Law and Center for Law, Health and Society, January 2012:  “Update -- The Progress of Healthcare Delivery System Reform”\nKing \u0026amp; Spalding Roundtable Program, November 2011:  “Qualifying as an Accountable Care Organization in the CMS Shared Savings Program:  Overview of the Final Rule and Agency Announcements”\nTennessee Hospital Association Fall Compliance Conference, October 2011:  “Compliance Issues in Accountable Care Organizations and Innovative Payment Arrangements”\nGeorgia Bio/Georgia Association of Healthcare Executives, October 2011:  “Technology That Will Create Accountable Care:  Legal Framework for Accountable Care Organizations and Innovative Payment Arrangements”\nGeorgia Healthcare Financial Management Association, July 2011:  Accountable Care Organizations\nKing \u0026amp; Spalding Roundtable Program, April 2011:  “Planning to Qualify as an Accountable Care Organization:  Proposed Rule and Agency Notices”\n\n\nEast Tennessee Healthcare Fraud Working Group, April 2011:  “Health Care Reform and Compliance Issues”\n20th Annual King \u0026amp; Spalding Health Law and Policy Forum, March 2011:  “Legal and Regulatory Conflicts in PPACA”\nAmerican Health Lawyers Association, June 2010:  “Quality-Based Compensation in a New Era of Health Reform”\nGeorgia Academy of Healthcare Attorneys, May 2010:  “Hospital-Physician Alignment”\nKing \u0026amp; Spalding Roundtable Program, May 2010:  “Reform Driven Strategies and Tactics”\nAmerican Health Lawyers Association, Moderator of national teleconference, April 2010, regarding Care Coordination Models\nKing \u0026amp; Spalding Roundtable Program, April 2010:  “Healthcare Reform Legislation -- Medicare, Medicaid and Delivery System Reform”\n Kim H Roeder Partner Top ranking among Georgia healthcare lawyers  Chambers USA Healthcare Law  The Best Lawyers in America, 10+ years Georgia Super Lawyer  Super Lawyers Outstanding Healthcare Fraud and Compliance Lawyer  Nightingale’s Healthcare News Cornell University Cornell Law School Case Western Reserve University Case Western Reserve University School of Law Georgia Health Care Compliance Association Georgia Academy of Healthcare Attorneys, Past President and Board Member American Bar Association, Health Law Section, Business and Corporate Section State Bar of Georgia, Health Law Section, Corporate Law Section Adjunct Professor, Georgia State University College of Law American Health Lawyers Association, Former Co-Chair of the Transactions Affinity Group of the Business Law and Governance Practice Group","searchable_name":"Kim H. Roeder","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":174,"capability_group_featured":null,"home_page_featured":null},{"id":445647,"version":1,"owner_type":"Person","owner_id":3646,"payload":{"bio":"\u003cp\u003eKristin Roshelli is a partner in King \u0026amp; Spalding\u0026rsquo;s Houston Healthcare practice. Kristin\u0026rsquo;s practice focuses on corporate and regulatory matters in the healthcare and life sciences industries.\u0026nbsp; She represents a broad range of prominent healthcare and life science\u0026nbsp;clients\u0026nbsp;on mergers and acquisitions, affiliations, general health law questions, and complex corporate governance and contracting matters. She has extensive experience structuring transactions, particularly as to complex arrangements involving health systems, physician practices, and academic medical centers.\u0026nbsp; Kristin has helped establish the legal and operational framework in connection with the startup of three new medical schools and multiple new health systems.\u0026nbsp; She is also a go-to lawyer for\u0026nbsp;leading pharmaceutical,\u0026nbsp;biotech, organ procurement and other large companies for assistance with complex collaboration arrangements with third parties and in establishing and negotiating\u0026nbsp;their supply chain and other key contracts.\u0026nbsp;\u0026nbsp;Her life sciences work often involves advising on product supply and manufacturing agreements, licensing arrangements, commercialization and distribution agreements, specialty pharmacy agreements,\u0026nbsp;research agreements and other complex collaboration arrangements and\u0026nbsp;key service and supply contracts.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eShe is Chambers-ranked for healthcare in Texas\u0026nbsp;and has been\u0026nbsp;recognized by \u003cem\u003eLegal 500\u003c/em\u003e as a \u0026ldquo;Recommended Key Lawyer,\u0026rdquo; by \u003cem\u003eTexas\u0026nbsp;Super Lawyers\u003c/em\u003e as a healthcare rising star,\u0026nbsp;and by\u0026nbsp;\u003cem\u003eTexas Lawyers\u003c/em\u003e with an \u0026ldquo;On the Rise Award,\u0026rdquo; which recognizes lawyers under the age of 40 who have wielded influence in their practice areas in Texas and beyond.\u0026nbsp; Prior to entering the legal field, Kristin served as a nurse in the United States Air Force, worked in the general counsel\u0026rsquo;s office of a large academic medical center, and practiced as a registered nurse in a medical intensive care unit.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e2016 Health Care Fraud and Abuse Top Ten List Reimbursement Advisor, Vol 32, No. 6, February 2017\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;The Plot Thickens for the Medicare Narrative Requirement,\u0026rdquo; Law360, February 2015\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;When is a Hospital a \u0026lsquo;New Hospital?,\u0026rsquo;\u0026rdquo; Reimbursement Advisor, Vol. 30, No. 4, December 2014\u003c/li\u003e\n\u003c/ul\u003e","slug":"kristin-roshelli","email":"kroshelli@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[{"id":3777}]},"expertise":[{"id":24,"guid":"24.capabilities","index":0,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":1,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":2,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":3,"source":"capabilities"},{"id":826,"guid":"826.smart_tags","index":4,"source":"smartTags"},{"id":32,"guid":"32.capabilities","index":5,"source":"capabilities"}],"is_active":true,"last_name":"Roshelli","nick_name":"Kristin","clerkships":[{"name":"Law Clerk, P. Kevin Castel, U.S. District Court for the Southern District of New York","years_held":"2010-2011"}],"first_name":"Kristin","title_rank":9999,"updated_by":202,"law_schools":[{"id":2724,"meta":{"degree":"J.D.","honors":"cum laude","is_law_school":"1","graduation_date":"2010-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"M.","name_suffix":"","recognitions":[{"title":"\"Kristin is very calm and intelligent, and extremely responsive. I always enjoy working with her.\"","detail":"Chambers USA"},{"title":"\"She is extremely knowledgeable, responsive and always able to navigate the most complex matters\"","detail":"Chambers USA"},{"title":"\"Kristin really understands our business well. She doesn't miss anything and is highly responsive.\"","detail":"Chambers USA"},{"title":"On the Rise Award","detail":"Texas Lawyer, 2020"},{"title":"Top Ranked Lawyer, Healthcare","detail":"Chambers USA, Texas (2021-2025)"},{"title":"\"She's very wise with her advice, as well as being detail-oriented and organized.\"","detail":"Chambers USA"}],"linked_in_url":null,"seodescription":"Kristin M. Roshelli is a lawyer of our Government Matters \u0026 Regulation Practice Group. Read more.","primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eKristin Roshelli is a partner in King \u0026amp; Spalding\u0026rsquo;s Houston Healthcare practice. Kristin\u0026rsquo;s practice focuses on corporate and regulatory matters in the healthcare and life sciences industries.\u0026nbsp; She represents a broad range of prominent healthcare and life science\u0026nbsp;clients\u0026nbsp;on mergers and acquisitions, affiliations, general health law questions, and complex corporate governance and contracting matters. She has extensive experience structuring transactions, particularly as to complex arrangements involving health systems, physician practices, and academic medical centers.\u0026nbsp; Kristin has helped establish the legal and operational framework in connection with the startup of three new medical schools and multiple new health systems.\u0026nbsp; She is also a go-to lawyer for\u0026nbsp;leading pharmaceutical,\u0026nbsp;biotech, organ procurement and other large companies for assistance with complex collaboration arrangements with third parties and in establishing and negotiating\u0026nbsp;their supply chain and other key contracts.\u0026nbsp;\u0026nbsp;Her life sciences work often involves advising on product supply and manufacturing agreements, licensing arrangements, commercialization and distribution agreements, specialty pharmacy agreements,\u0026nbsp;research agreements and other complex collaboration arrangements and\u0026nbsp;key service and supply contracts.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eShe is Chambers-ranked for healthcare in Texas\u0026nbsp;and has been\u0026nbsp;recognized by \u003cem\u003eLegal 500\u003c/em\u003e as a \u0026ldquo;Recommended Key Lawyer,\u0026rdquo; by \u003cem\u003eTexas\u0026nbsp;Super Lawyers\u003c/em\u003e as a healthcare rising star,\u0026nbsp;and by\u0026nbsp;\u003cem\u003eTexas Lawyers\u003c/em\u003e with an \u0026ldquo;On the Rise Award,\u0026rdquo; which recognizes lawyers under the age of 40 who have wielded influence in their practice areas in Texas and beyond.\u0026nbsp; Prior to entering the legal field, Kristin served as a nurse in the United States Air Force, worked in the general counsel\u0026rsquo;s office of a large academic medical center, and practiced as a registered nurse in a medical intensive care unit.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e2016 Health Care Fraud and Abuse Top Ten List Reimbursement Advisor, Vol 32, No. 6, February 2017\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;The Plot Thickens for the Medicare Narrative Requirement,\u0026rdquo; Law360, February 2015\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;When is a Hospital a \u0026lsquo;New Hospital?,\u0026rsquo;\u0026rdquo; Reimbursement Advisor, Vol. 30, No. 4, December 2014\u003c/li\u003e\n\u003c/ul\u003e","recognitions":[{"title":"\"Kristin is very calm and intelligent, and extremely responsive. I always enjoy working with her.\"","detail":"Chambers USA"},{"title":"\"She is extremely knowledgeable, responsive and always able to navigate the most complex matters\"","detail":"Chambers USA"},{"title":"\"Kristin really understands our business well. She doesn't miss anything and is highly responsive.\"","detail":"Chambers USA"},{"title":"On the Rise Award","detail":"Texas Lawyer, 2020"},{"title":"Top Ranked Lawyer, Healthcare","detail":"Chambers USA, Texas (2021-2025)"},{"title":"\"She's very wise with her advice, as well as being detail-oriented and organized.\"","detail":"Chambers USA"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":11456}]},"capability_group_id":2},"created_at":"2026-02-06T21:25:46.000Z","updated_at":"2026-02-06T21:25:46.000Z","searchable_text":"Roshelli{{ FIELD }}{:title=\u0026gt;\"\\\"Kristin is very calm and intelligent, and extremely responsive. I always enjoy working with her.\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"\\\"She is extremely knowledgeable, responsive and always able to navigate the most complex matters\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"\\\"Kristin really understands our business well. She doesn't miss anything and is highly responsive.\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"On the Rise Award\", :detail=\u0026gt;\"Texas Lawyer, 2020\"}{{ FIELD }}{:title=\u0026gt;\"Top Ranked Lawyer, Healthcare\", :detail=\u0026gt;\"Chambers USA, Texas (2021-2025)\"}{{ FIELD }}{:title=\u0026gt;\"\\\"She's very wise with her advice, as well as being detail-oriented and organized.\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}Kristin Roshelli is a partner in King \u0026amp; Spalding’s Houston Healthcare practice. Kristin’s practice focuses on corporate and regulatory matters in the healthcare and life sciences industries.  She represents a broad range of prominent healthcare and life science clients on mergers and acquisitions, affiliations, general health law questions, and complex corporate governance and contracting matters. She has extensive experience structuring transactions, particularly as to complex arrangements involving health systems, physician practices, and academic medical centers.  Kristin has helped establish the legal and operational framework in connection with the startup of three new medical schools and multiple new health systems.  She is also a go-to lawyer for leading pharmaceutical, biotech, organ procurement and other large companies for assistance with complex collaboration arrangements with third parties and in establishing and negotiating their supply chain and other key contracts.  Her life sciences work often involves advising on product supply and manufacturing agreements, licensing arrangements, commercialization and distribution agreements, specialty pharmacy agreements, research agreements and other complex collaboration arrangements and key service and supply contracts. \nShe is Chambers-ranked for healthcare in Texas and has been recognized by Legal 500 as a “Recommended Key Lawyer,” by Texas Super Lawyers as a healthcare rising star, and by Texas Lawyers with an “On the Rise Award,” which recognizes lawyers under the age of 40 who have wielded influence in their practice areas in Texas and beyond.  Prior to entering the legal field, Kristin served as a nurse in the United States Air Force, worked in the general counsel’s office of a large academic medical center, and practiced as a registered nurse in a medical intensive care unit. \nPublications\n\n2016 Health Care Fraud and Abuse Top Ten List Reimbursement Advisor, Vol 32, No. 6, February 2017\n“The Plot Thickens for the Medicare Narrative Requirement,” Law360, February 2015\n“When is a Hospital a ‘New Hospital?,’” Reimbursement Advisor, Vol. 30, No. 4, December 2014\n Kristin Roshelli lawyer Partner \"Kristin is very calm and intelligent, and extremely responsive. I always enjoy working with her.\" Chambers USA \"She is extremely knowledgeable, responsive and always able to navigate the most complex matters\" Chambers USA \"Kristin really understands our business well. She doesn't miss anything and is highly responsive.\" Chambers USA On the Rise Award Texas Lawyer, 2020 Top Ranked Lawyer, Healthcare Chambers USA, Texas (2021-2025) \"She's very wise with her advice, as well as being detail-oriented and organized.\" Chambers USA University of Pennsylvania University of Pennsylvania Law School St. John's University St. John's University School of Law U.S. District Court for the Eastern District of New York U.S. District Court for the Southern District of New York New Jersey New York Texas American Bar Association (2014) American Health Lawyers Association (2011) New York State Bar Association (2011) Houston Young Lawyers Association (2014) Law Clerk, P. Kevin Castel, U.S. District Court for the Southern District of New York","searchable_name":"Kristin M. Roshelli","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":443985,"version":1,"owner_type":"Person","owner_id":6913,"payload":{"bio":"\u003cp\u003eAs a partner in our FDA and Life Sciences practice, Lauren leverages nearly two decades of experience in legal practice and senior roles at the FDA to advise clients on legal, regulatory, and compliance matters across FDA-regulated industries. Most recently, as FDA\u0026rsquo;s Associate Commissioner for Policy, Lauren played a key role in all major policy initiatives. Lauren translates her experience to help clients navigate the complex issues facing their businesses at the intersections of law, science, and policy.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eLauren brings a breadth of experience advising senior public officials and life sciences companies on legal, regulatory, and policy matters. As the Associate Commissioner for Policy from 2019-2024, Lauren led the Commissioner\u0026rsquo;s Office of Policy (OP), supervising issuance of all FDA regulations and guidance documents. She advised agency, HHS, and Administration officials on high priority and novel matters, including implementation of new authorities for drugs, devices, food, and cosmetics. She also served as FDA\u0026rsquo;s lead negotiator for the fifth medical device user fee agreement, playing a pivotal role in shaping current policies and practices related to premarket review, digital health, patient engagement, and use of real-world evidence.\u003c/p\u003e\n\u003cp\u003ePreviously, Lauren was a Senior Advisor to FDA\u0026rsquo;s Chief of Staff (2017-2019) and the Associate Director for Strategy and Regulatory Operations within the Center for Devices and Radiological Health (2016-2017). In those roles, she advised on regulatory, legislative, and compliance matters, including strategic initiatives on device safety and tobacco product regulation.\u003c/p\u003e\n\u003cp\u003eBefore joining FDA, Lauren served as Assistant General Counsel to an association of the United States\u0026rsquo;s leading manufacturers of innovative pharmaceutical products, Pharmaceutical Research and Manufacturers of America (PhRMA). She advised the association on issues related to government enforcement of healthcare fraud and abuse laws, corporate compliance programs, patient adherence and access programs, and drug distribution channels.\u003c/p\u003e\n\u003cp\u003eIn private practice, Lauren advised companies on compliance with healthcare regulations, including the Federal Food, Drug, and Cosmetic Act; the False Claims Act; the anti-kickback statute; and exclusion and debarment laws. She also guided healthcare companies in government investigations (criminal and civil) and conducted internal investigations to analyze legal risk and compliance issues.\u003c/p\u003e\n\u003cp\u003eLauren earned her J.D. from the University of Virginia, where she served as an Articles Editor for the\u003cem\u003e Virginia Law Review.\u003c/em\u003e\u003c/p\u003e","slug":"lauren-roth","email":"lroth@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":1,"source":"capabilities"},{"id":118,"guid":"118.capabilities","index":2,"source":"capabilities"},{"id":133,"guid":"133.capabilities","index":3,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":4,"source":"smartTags"},{"id":1202,"guid":"1202.smart_tags","index":5,"source":"smartTags"}],"is_active":true,"last_name":"Roth","nick_name":"Lauren","clerkships":[],"first_name":"Lauren","title_rank":9999,"updated_by":35,"law_schools":[{"id":2410,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"2007-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"K.","name_suffix":"","recognitions":[{"title":"FDA Award of Merit","detail":"2023"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eAs a partner in our FDA and Life Sciences practice, Lauren leverages nearly two decades of experience in legal practice and senior roles at the FDA to advise clients on legal, regulatory, and compliance matters across FDA-regulated industries. Most recently, as FDA\u0026rsquo;s Associate Commissioner for Policy, Lauren played a key role in all major policy initiatives. Lauren translates her experience to help clients navigate the complex issues facing their businesses at the intersections of law, science, and policy.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eLauren brings a breadth of experience advising senior public officials and life sciences companies on legal, regulatory, and policy matters. As the Associate Commissioner for Policy from 2019-2024, Lauren led the Commissioner\u0026rsquo;s Office of Policy (OP), supervising issuance of all FDA regulations and guidance documents. She advised agency, HHS, and Administration officials on high priority and novel matters, including implementation of new authorities for drugs, devices, food, and cosmetics. She also served as FDA\u0026rsquo;s lead negotiator for the fifth medical device user fee agreement, playing a pivotal role in shaping current policies and practices related to premarket review, digital health, patient engagement, and use of real-world evidence.\u003c/p\u003e\n\u003cp\u003ePreviously, Lauren was a Senior Advisor to FDA\u0026rsquo;s Chief of Staff (2017-2019) and the Associate Director for Strategy and Regulatory Operations within the Center for Devices and Radiological Health (2016-2017). In those roles, she advised on regulatory, legislative, and compliance matters, including strategic initiatives on device safety and tobacco product regulation.\u003c/p\u003e\n\u003cp\u003eBefore joining FDA, Lauren served as Assistant General Counsel to an association of the United States\u0026rsquo;s leading manufacturers of innovative pharmaceutical products, Pharmaceutical Research and Manufacturers of America (PhRMA). She advised the association on issues related to government enforcement of healthcare fraud and abuse laws, corporate compliance programs, patient adherence and access programs, and drug distribution channels.\u003c/p\u003e\n\u003cp\u003eIn private practice, Lauren advised companies on compliance with healthcare regulations, including the Federal Food, Drug, and Cosmetic Act; the False Claims Act; the anti-kickback statute; and exclusion and debarment laws. She also guided healthcare companies in government investigations (criminal and civil) and conducted internal investigations to analyze legal risk and compliance issues.\u003c/p\u003e\n\u003cp\u003eLauren earned her J.D. from the University of Virginia, where she served as an Articles Editor for the\u003cem\u003e Virginia Law Review.\u003c/em\u003e\u003c/p\u003e","recognitions":[{"title":"FDA Award of Merit","detail":"2023"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12437}]},"capability_group_id":2},"created_at":"2025-12-05T05:02:19.000Z","updated_at":"2025-12-05T05:02:19.000Z","searchable_text":"Roth{{ FIELD }}{:title=\u0026gt;\"FDA Award of Merit\", :detail=\u0026gt;\"2023\"}{{ FIELD }}As a partner in our FDA and Life Sciences practice, Lauren leverages nearly two decades of experience in legal practice and senior roles at the FDA to advise clients on legal, regulatory, and compliance matters across FDA-regulated industries. Most recently, as FDA’s Associate Commissioner for Policy, Lauren played a key role in all major policy initiatives. Lauren translates her experience to help clients navigate the complex issues facing their businesses at the intersections of law, science, and policy.\nLauren brings a breadth of experience advising senior public officials and life sciences companies on legal, regulatory, and policy matters. As the Associate Commissioner for Policy from 2019-2024, Lauren led the Commissioner’s Office of Policy (OP), supervising issuance of all FDA regulations and guidance documents. She advised agency, HHS, and Administration officials on high priority and novel matters, including implementation of new authorities for drugs, devices, food, and cosmetics. She also served as FDA’s lead negotiator for the fifth medical device user fee agreement, playing a pivotal role in shaping current policies and practices related to premarket review, digital health, patient engagement, and use of real-world evidence.\nPreviously, Lauren was a Senior Advisor to FDA’s Chief of Staff (2017-2019) and the Associate Director for Strategy and Regulatory Operations within the Center for Devices and Radiological Health (2016-2017). In those roles, she advised on regulatory, legislative, and compliance matters, including strategic initiatives on device safety and tobacco product regulation.\nBefore joining FDA, Lauren served as Assistant General Counsel to an association of the United States’s leading manufacturers of innovative pharmaceutical products, Pharmaceutical Research and Manufacturers of America (PhRMA). She advised the association on issues related to government enforcement of healthcare fraud and abuse laws, corporate compliance programs, patient adherence and access programs, and drug distribution channels.\nIn private practice, Lauren advised companies on compliance with healthcare regulations, including the Federal Food, Drug, and Cosmetic Act; the False Claims Act; the anti-kickback statute; and exclusion and debarment laws. She also guided healthcare companies in government investigations (criminal and civil) and conducted internal investigations to analyze legal risk and compliance issues.\nLauren earned her J.D. from the University of Virginia, where she served as an Articles Editor for the Virginia Law Review. Partner FDA Award of Merit 2023 University of Virginia  University of Virginia University of Virginia School of Law District of Columbia Food \u0026amp; Drug Law Institute","searchable_name":"Lauren K. Roth","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":35,"capability_group_featured":null,"home_page_featured":null},{"id":436477,"version":1,"owner_type":"Person","owner_id":5088,"payload":{"bio":"\u003cp\u003eNeal J. Reynolds is a senior counsel in the firm\u0026rsquo;s international trade and litigation practice group.\u0026nbsp; He has more than twenty-five years of experience in international trade policy and litigation, with extensive experience in U.S. antidumping, countervailing duty, and safeguards investigations and reviews. \u0026nbsp;At King and Spalding, Neal focuses on international trade litigation and international trade policy.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eBefore joining King and Spalding, Neal was an international trade lawyer at the U.S. International Trade Commission for 22 years.\u0026nbsp; At the Commission, Neal provided legal and policy advice to the Commission and its staff in antidumping and countervailing duty proceedings and safeguard investigations.\u0026nbsp; He also represented the agency in litigation matters and provided advice to the Commission on a variety of trade policy issues.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFrom 2005 to 2014, Neal supervised the Commission\u0026rsquo;s legal staff in appeals of the agency\u0026rsquo;s trade remedy determinations, representing the Commission in a large number of appeals at the U.S. Court of International Trade, the U.S. Court of Appeals for the Federal Circuit, other Federal district and circuit courts, the World Trade Organization, and North American Free Trade Agreement dispute panels.\u0026nbsp; From 2014 to 2016, Neal was the Commission\u0026rsquo;s Chief of Staff, managing all of the agency\u0026rsquo;s operational and administrative activities.\u003c/p\u003e\n\u003cp\u003eBefore joining the Commission, Neal was a trade lawyer in the private sector for six years, representing clients before the Commission, the Department of Commerce, the Court of International Trade, and the Court of Appeals for the Federal Circuit.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring his career, Neal has worked on matters involving a variety of products, including carbon steel flat products, pipe and tube products, stainless steel products, wire and wire rod products, advanced electronic and consumer goods, tires, chemicals, bearings products, solar panels, large civil aircraft, cement, lumber, paper products, bedroom furniture, brass sheet and strip, flooring, uranium, wind towers, and agricultural products (such as beef, sugar and shrimp).\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBecause of his long experience in the area, Neal possesses a strong understanding of the trade remedy process and the Commission\u0026rsquo;s decision-making process. Neal has a strong track record of developing successful litigation strategies in litigation involving the Commission\u0026rsquo;s trade determinations.\u003c/p\u003e\n\u003cp\u003eNeal was a member of the Board of Directors of the Federal Circuit Bar Association from 2013 to 2017.\u0026nbsp; He was also Co-Chairman and Vice Chairman of the Federal Circuit Bar Association\u0026rsquo;s International Trade Committee from August 2010 to May 2013.\u0026nbsp;\u0026nbsp; Neal has spoken frequently on international trade issues and published a number of articles on trade remedy issues.\u003c/p\u003e","slug":"neal-reynolds","email":"nreynolds@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":25,"guid":"25.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":579,"guid":"579.smart_tags","index":2,"source":"smartTags"},{"id":124,"guid":"124.capabilities","index":3,"source":"capabilities"}],"is_active":true,"last_name":"Reynolds","nick_name":"Neal","clerkships":[],"first_name":"Neal","title_rank":9999,"updated_by":34,"law_schools":[{"id":755,"meta":{"degree":"J.D.","honors":null,"is_law_school":1,"graduation_date":"1986-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"J.","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":77,"translated_fields":{"en":{"bio":"\u003cp\u003eNeal J. Reynolds is a senior counsel in the firm\u0026rsquo;s international trade and litigation practice group.\u0026nbsp; He has more than twenty-five years of experience in international trade policy and litigation, with extensive experience in U.S. antidumping, countervailing duty, and safeguards investigations and reviews. \u0026nbsp;At King and Spalding, Neal focuses on international trade litigation and international trade policy.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eBefore joining King and Spalding, Neal was an international trade lawyer at the U.S. International Trade Commission for 22 years.\u0026nbsp; At the Commission, Neal provided legal and policy advice to the Commission and its staff in antidumping and countervailing duty proceedings and safeguard investigations.\u0026nbsp; He also represented the agency in litigation matters and provided advice to the Commission on a variety of trade policy issues.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFrom 2005 to 2014, Neal supervised the Commission\u0026rsquo;s legal staff in appeals of the agency\u0026rsquo;s trade remedy determinations, representing the Commission in a large number of appeals at the U.S. Court of International Trade, the U.S. Court of Appeals for the Federal Circuit, other Federal district and circuit courts, the World Trade Organization, and North American Free Trade Agreement dispute panels.\u0026nbsp; From 2014 to 2016, Neal was the Commission\u0026rsquo;s Chief of Staff, managing all of the agency\u0026rsquo;s operational and administrative activities.\u003c/p\u003e\n\u003cp\u003eBefore joining the Commission, Neal was a trade lawyer in the private sector for six years, representing clients before the Commission, the Department of Commerce, the Court of International Trade, and the Court of Appeals for the Federal Circuit.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring his career, Neal has worked on matters involving a variety of products, including carbon steel flat products, pipe and tube products, stainless steel products, wire and wire rod products, advanced electronic and consumer goods, tires, chemicals, bearings products, solar panels, large civil aircraft, cement, lumber, paper products, bedroom furniture, brass sheet and strip, flooring, uranium, wind towers, and agricultural products (such as beef, sugar and shrimp).\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBecause of his long experience in the area, Neal possesses a strong understanding of the trade remedy process and the Commission\u0026rsquo;s decision-making process. Neal has a strong track record of developing successful litigation strategies in litigation involving the Commission\u0026rsquo;s trade determinations.\u003c/p\u003e\n\u003cp\u003eNeal was a member of the Board of Directors of the Federal Circuit Bar Association from 2013 to 2017.\u0026nbsp; He was also Co-Chairman and Vice Chairman of the Federal Circuit Bar Association\u0026rsquo;s International Trade Committee from August 2010 to May 2013.\u0026nbsp;\u0026nbsp; Neal has spoken frequently on international trade issues and published a number of articles on trade remedy issues.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":5623}]},"capability_group_id":2},"created_at":"2025-09-02T04:55:31.000Z","updated_at":"2025-09-02T04:55:31.000Z","searchable_text":"Reynolds{{ FIELD }}Neal J. Reynolds is a senior counsel in the firm’s international trade and litigation practice group.  He has more than twenty-five years of experience in international trade policy and litigation, with extensive experience in U.S. antidumping, countervailing duty, and safeguards investigations and reviews.  At King and Spalding, Neal focuses on international trade litigation and international trade policy.\nBefore joining King and Spalding, Neal was an international trade lawyer at the U.S. International Trade Commission for 22 years.  At the Commission, Neal provided legal and policy advice to the Commission and its staff in antidumping and countervailing duty proceedings and safeguard investigations.  He also represented the agency in litigation matters and provided advice to the Commission on a variety of trade policy issues. \nFrom 2005 to 2014, Neal supervised the Commission’s legal staff in appeals of the agency’s trade remedy determinations, representing the Commission in a large number of appeals at the U.S. Court of International Trade, the U.S. Court of Appeals for the Federal Circuit, other Federal district and circuit courts, the World Trade Organization, and North American Free Trade Agreement dispute panels.  From 2014 to 2016, Neal was the Commission’s Chief of Staff, managing all of the agency’s operational and administrative activities.\nBefore joining the Commission, Neal was a trade lawyer in the private sector for six years, representing clients before the Commission, the Department of Commerce, the Court of International Trade, and the Court of Appeals for the Federal Circuit. \nDuring his career, Neal has worked on matters involving a variety of products, including carbon steel flat products, pipe and tube products, stainless steel products, wire and wire rod products, advanced electronic and consumer goods, tires, chemicals, bearings products, solar panels, large civil aircraft, cement, lumber, paper products, bedroom furniture, brass sheet and strip, flooring, uranium, wind towers, and agricultural products (such as beef, sugar and shrimp).       \nBecause of his long experience in the area, Neal possesses a strong understanding of the trade remedy process and the Commission’s decision-making process. Neal has a strong track record of developing successful litigation strategies in litigation involving the Commission’s trade determinations.\nNeal was a member of the Board of Directors of the Federal Circuit Bar Association from 2013 to 2017.  He was also Co-Chairman and Vice Chairman of the Federal Circuit Bar Association’s International Trade Committee from August 2010 to May 2013.   Neal has spoken frequently on international trade issues and published a number of articles on trade remedy issues. Senior Counsel Harvard University Harvard Law School Georgetown University Georgetown University Law Center U.S. Court of International Trade District of Columbia Massachusetts Federal Circuit Bar Association District of Columbia Bar Association Massachusetts Bar Association","searchable_name":"Neal J. Reynolds","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":34,"capability_group_featured":null,"home_page_featured":null}]}}