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Professionals

Kathie McDonald-McClure

Partner

P 502-562-7526 F 502-589-0309

500 West Jefferson Street
Suite 2800
Louisville, KY 40202

 

Kathie McDonald-McClure is a member of the Firm's Health Care and Data Privacy & Security Practice Groups. She concentrates her practice on provider compliance with applicable fraud, waste and abuse laws; HIPAA; pharmacy board licensure; Medicare reimbursement, payment methodologies, audits and overpayment demands (e.g., ZPIC, RAC); Medicare secondary payer rules; Medicare and Medicaid enrollment; clinical trial contracting and regulatory compliance; Medicare meaningful use and other quality data initiatives.

Ms. McDonald-McClure also assists clients with information security incidents. She is the editor of the Wyatt HITECH Law Blog (wyatthitechlaw.com), which focuses on legal developments related to the privacy and security of confidential consumer and business information.  She also assists clients with the development, review and maintenance of effective compliance program and with risk and insurance issues.

Her healthcare clients include medical device manufacturers, hospitals, nursing homes, physicians, group purchasing organizations, behavioral health providers, home health providers, physical and occupational therapy providers, long-term care pharmacies, among others. Her non-healthcare clients include public school districts and colleges and universities and a non-profit, managed care insurance entity.

Kathie  McDonald-McClure

Location

500 West Jefferson Street
Suite 2800
Louisville, KY 40202

Representative Matters

  • Advising on compliance with HIPAA, HITECH, FERPA, FTC, drug, alcohol and behavioral health privacy and security regulations and standards including data breach response and remediation
  • Reviewing arrangements between providers for compliance under Stark Law and Anti-Kickback Statute
  • Assisting with Medicare and Medicaid audits and overpayment demands (ZPIC, RAC, OIG, DOJ)
  • Negotiating clinical trial research agreements between industry and health care providers, advising on regulatory compliance (e.g., FDA, IRB, False Claims Act, Anti-Kickback Statute, Stark Law), and developing research related policies
  • Advising on Medicare reimbursement rules (including NCDs/LCDs) applicable to a variety of provider and supplier types (e.g., IPPS, OPPS, DRGs, RUGs, APCs, HCPCS codes, etc.)
  • Advising on ACO Contracts
  • Structuring clinical integration arrangements for behavioral health, primary care and insurance
  • Assisting with state pharmacy board matters including licensure and complaints
  • Structuring compliant discount programs for sales of health care products and services
  • Preparing nursing home medical director, rehab and other ancillary services contracts
  • Structuring and advising on group purchasing organization member and vendor arrangements
  • Advising hospitals and physicians on "meaningful use" compliance under the HITECH Act, PQRS and other Medicare quality initiatives
  • Developing and auditing compliance programs and related education and training
  • Preparing enrollment and change of information packages for Medicare and Medicaid programs, and advising on ownership and adverse action disclosure matters
  • Advising plaintiff and defense counsel on, and assisting providers and self-insured entities with, compliance under the Medicare Secondary Payer law and mandatory insurance reporting requirements related to liability claims involving Medicare beneficiaries
  • Advising durable medical equipment (DME) suppliers on compliance with Medicare’s DME standards, billing and competitive bidding program rules
  • Developing policies and advising on Identity Theft Programs and the FTC Red Flags Rule
  • Assisting with government surveys, citations, subpoenas, warrants, and civil investigative demands
  • Advising on DOJ and OIG settlements and exclusionary issues
  • Developing false claims education under the Deficit Reduction Act of 2005
  • Interpreting liability insurance policy coverage and defense terms
  • Negotiating insurance and indemnity provisions
  • Representing health care professionals before licensing boards
  • Developing defense and tort reform strategies for long-term care negligence claims

Professional Experience

  • Enjoyed 12-year tenure as in-house counsel with Kindred Healthcare, LLC, a national long-term care company operating nursing homes, hospitals and other healthcare services in over 40 states. Was responsible for day-to-day legal advice in the areas of healthcare, employment, liability and risk management culminating in a position as Vice President and Counsel of Liability Claims with responsibility for administration of general and professional liability claims and management of a staff of lawyers and legal professionals.
  • Prior to in-house counsel position with Kindred, was with Greenebaum Doll & McDonald for six years, representing local, regional and national corporations before state and federal courts in commercial, insurance, employment and copyright and trademark protection cases.
  • Before joining Wyatt, served as an independent healthcare liability consultant and claims mediator.

Honors

Best Lawyers Generic Honor Logo

  • Highest Professional AV Rating by Martindale-Hubbell Law Directory. Peer references stated that, “Her ability to navigate an extremely complicated area of the law and then communicate with clients in a plain-spoken, easy to understand manner is admirable. Kathie practices with high ethical standards and is always very responsive to client concerns and schedules.” “Kathie is an excellent attorney, a true advocate for her clients and a model for legal ethics."
  • Woodward/White’s The Best Lawyers in America® Health Care Law, 2009-2017
  • Selected as a "Partner in Healthcare" by Business First, 2008-2016

Education

1985 - J.D., University of Louisville; Executive Editor of the Journal of Family Law, 1984-1985

1982 - B.S.B.A. (Business Administration and Marketing), with highest honors, University of Louisville

Presentations

Ms. McDonald-McClure has given over 50 presentations on a variety of healthcare and data privacy and security topics, including the Anti-Kickback Statute, False Claims Act, Affordable Care Act, Physicians Payments Sunshine Act, the HITECH Act of 2009 (e.g., the Meaningful Use Rule, Security Rule Risk Assessments, HIPAA Omnibus Rule), state data breach notification laws, Medicare reimbursement and payment methodologies, hospital in-patient 2-midnight rule, Medicare Secondary Payer law and the MMSEA Section 111 mandatory insurance reporting requirements, the Deficit Reduction Act of 2005’s education requirements related to False Claims Acts, behavioral health and more.  She also presents in-house seminars for legal, operations, sales, risk and insurance personnel of clients, either in person or through the use of the firm's webinar technology.

Professional Activities and Memberships

  • Louisville, Kentucky and American Bar Associations' Healthcare, Litigation, Tort & Insurance Sections
  • Louisville Bar Association, 2005 Chair of Health Law Section, 1991 Chair Litigation Section Mock Trial Seminar, Past Member of Board of Directors, Past Member of Publications Committee
  • American Health Lawyers Association (AHLA), including membership in the following groups: Life Sciences; Fraud & Abuse; Hospitals and Health Systems; Payors, Plans, and Managed Care; and Post Acute and Long Term Care Services
  • Health Care Compliance Association (HCCA), Certification in Healthcare Compliance (CHC)
  • Healthcare Financial Management Association (HFMA)
  • Kentucky and American Societies of Healthcare Risk Management (KSHRM and ASHRM)
  • American Society for Pharmacy Law (ASPL)
  • International Association of Privacy Professionals (IAPP)
  • Association for Conflict Resolution (ACR), Member 2003-2016
  • Chair of the Washington, D.C. based American Health Care Association's Medical Liability Subcommittee from December 2001 through July 2003

Admissions

  • Kentucky

Civic Involvement

  • Member of the Advisory Board for the Greater Louisville Inc. (GLI) Health Enterprises Network (HEN), 2007-present, and Executive Committee, 2008-present
  • Vice-Chair, HEN Nominating Committee, 2016-present
  • Vice-Chair, HEN Policy Forum, 2010-2014
  • Member, 2017 American Heart Association Executive Leadership Team, 25th Anniversary Heart Ball (fundraiser for heart and stroke research)  
  • Honorary Chair, ElderServe's 2012 Champion for the Aging Awards Luncheon
  • HEN Fellows Class of 2006
  • Co-Chair, Local Organizing Committee for the first ever US Figure Skating's Regional Championships in Louisville, KY, 2006-2007 
  • Member, Board of Directors, Louisville Skating Academy, 2007-2008
  • Member, Board of Directors, Court Appointed Special Advocates (CASA), 1994-1995

Publications

Ms McDonald-McClure has written or edited over 100 articles for the Wyatt HITECH Law Blog, a blog that she created soon after passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 to track legal developments related to health information technology, privacy and security.  The blog's scope was expanded in 2015 to report legal developments and enforcement actions regarding the privacy and security of sensitive data of individuals, businesses and organizations in all industry sectors.

Other publications include:

  • Risk Management in Health Care Institutions: Limiting Liability and Enhancing Care, Chapter 16, “Risk Management in Long Term Care Institutions and Services” (2014 3rd Ed.)
  • Valeo Communications: OCR Steps Up HIPAA Audits (July 2011)
  • HCCA Compliance Today, “Medicare’s New Mandatory Reporting Requirements for Liability Insurers, Including Self-Insured Entities” (July 2009)
  • LBA Bar Briefs, “Mandatory Reporting of Liability Settlements:  Law to Shine Spotlight on Attorney’s and Their Clients’ Pocketbooks” (June 2009)
  • “Enforcement Activities By Investigating Authorities and Responding to Investigations,” Chp. 5, Kentucky Health Law (2009 5th Ed.)(co-author with R. Benvenuti, III)
  • HCCA Compliance Today, “Outpatient Therapy Clinics and Their Referring Physicians: Fraud and Abuse Risks” (April 2008)
  • HFMA Kentucky Chapter Financial Scene, “Deficit Reduction Act Update” (January 2007)
  • HFMA Kentucky Chapter Financial Scene, “The DRA’s New False Claims Requirements” (June – July, 2006)
  • HFMA Kentucky Chapter Financial Scene, “US Supreme Court Limits Medicaid Recoveries in Personal Injuries Settlements” (June – July, 2006)
  • HCCA Compliance Today, “Compliance 101, Clinical Trials Primer” (June 2006)

Blog

Ms. McDonald-McClure is the creator and editor of the Wyatt HITECH Law Blog. The HITECH Law blog focuses on legal developments related to the privacy and security of confidential consumer and business information in today’s “high tech” world.  Since 2009, the year this blog was created, there has been an explosion in consumer and business electronic data privacy and security issues, beyond healthcare, HIPAA and the Health Information Technology for Economic and Clinical Health Act of 2009 (aka “The HITECH Act”, the original impetus for the blog).  This compelled us to expand the blog’s scope in late 2015 to cover legal developments regarding the creation, access, collection, maintenance or transmission of confidential information regarding an individual, business or organization in all industry sectors.

Representative Matters

  • Advising on compliance with HIPAA, HITECH, FERPA, FTC, drug, alcohol and behavioral health privacy and security regulations and standards including data breach response and remediation
  • Reviewing arrangements between providers for compliance under Stark Law and Anti-Kickback Statute
  • Assisting with Medicare and Medicaid audits and overpayment demands (ZPIC, RAC, OIG, DOJ)
  • Negotiating clinical trial research agreements between industry and health care providers, advising on regulatory compliance (e.g., FDA, IRB, False Claims Act, Anti-Kickback Statute, Stark Law), and developing research related policies
  • Advising on Medicare reimbursement rules (including NCDs/LCDs) applicable to a variety of provider and supplier types (e.g., IPPS, OPPS, DRGs, RUGs, APCs, HCPCS codes, etc.)
  • Advising on ACO Contracts
  • Structuring clinical integration arrangements for behavioral health, primary care and insurance
  • Assisting with state pharmacy board matters including licensure and complaints
  • Structuring compliant discount programs for sales of health care products and services
  • Preparing nursing home medical director, rehab and other ancillary services contracts
  • Structuring and advising on group purchasing organization member and vendor arrangements
  • Advising hospitals and physicians on "meaningful use" compliance under the HITECH Act, PQRS and other Medicare quality initiatives
  • Developing and auditing compliance programs and related education and training
  • Preparing enrollment and change of information packages for Medicare and Medicaid programs, and advising on ownership and adverse action disclosure matters
  • Advising plaintiff and defense counsel on, and assisting providers and self-insured entities with, compliance under the Medicare Secondary Payer law and mandatory insurance reporting requirements related to liability claims involving Medicare beneficiaries
  • Advising durable medical equipment (DME) suppliers on compliance with Medicare’s DME standards, billing and competitive bidding program rules
  • Developing policies and advising on Identity Theft Programs and the FTC Red Flags Rule
  • Assisting with government surveys, citations, subpoenas, warrants, and civil investigative demands
  • Advising on DOJ and OIG settlements and exclusionary issues
  • Developing false claims education under the Deficit Reduction Act of 2005
  • Interpreting liability insurance policy coverage and defense terms
  • Negotiating insurance and indemnity provisions
  • Representing health care professionals before licensing boards
  • Developing defense and tort reform strategies for long-term care negligence claims

Professional Experience

  • Enjoyed 12-year tenure as in-house counsel with Kindred Healthcare, LLC, a national long-term care company operating nursing homes, hospitals and other healthcare services in over 40 states. Was responsible for day-to-day legal advice in the areas of healthcare, employment, liability and risk management culminating in a position as Vice President and Counsel of Liability Claims with responsibility for administration of general and professional liability claims and management of a staff of lawyers and legal professionals.
  • Prior to in-house counsel position with Kindred, was with Greenebaum Doll & McDonald for six years, representing local, regional and national corporations before state and federal courts in commercial, insurance, employment and copyright and trademark protection cases.
  • Before joining Wyatt, served as an independent healthcare liability consultant and claims mediator.

Honors

Best Lawyers Generic Honor Logo

  • Highest Professional AV Rating by Martindale-Hubbell Law Directory. Peer references stated that, “Her ability to navigate an extremely complicated area of the law and then communicate with clients in a plain-spoken, easy to understand manner is admirable. Kathie practices with high ethical standards and is always very responsive to client concerns and schedules.” “Kathie is an excellent attorney, a true advocate for her clients and a model for legal ethics."
  • Woodward/White’s The Best Lawyers in America® Health Care Law, 2009-2017
  • Selected as a "Partner in Healthcare" by Business First, 2008-2016

Education

1985 - J.D., University of Louisville; Executive Editor of the Journal of Family Law, 1984-1985

1982 - B.S.B.A. (Business Administration and Marketing), with highest honors, University of Louisville

Presentations

Ms. McDonald-McClure has given over 50 presentations on a variety of healthcare and data privacy and security topics, including the Anti-Kickback Statute, False Claims Act, Affordable Care Act, Physicians Payments Sunshine Act, the HITECH Act of 2009 (e.g., the Meaningful Use Rule, Security Rule Risk Assessments, HIPAA Omnibus Rule), state data breach notification laws, Medicare reimbursement and payment methodologies, hospital in-patient 2-midnight rule, Medicare Secondary Payer law and the MMSEA Section 111 mandatory insurance reporting requirements, the Deficit Reduction Act of 2005’s education requirements related to False Claims Acts, behavioral health and more.  She also presents in-house seminars for legal, operations, sales, risk and insurance personnel of clients, either in person or through the use of the firm's webinar technology.

Professional Activities and Memberships

  • Louisville, Kentucky and American Bar Associations' Healthcare, Litigation, Tort & Insurance Sections
  • Louisville Bar Association, 2005 Chair of Health Law Section, 1991 Chair Litigation Section Mock Trial Seminar, Past Member of Board of Directors, Past Member of Publications Committee
  • American Health Lawyers Association (AHLA), including membership in the following groups: Life Sciences; Fraud & Abuse; Hospitals and Health Systems; Payors, Plans, and Managed Care; and Post Acute and Long Term Care Services
  • Health Care Compliance Association (HCCA), Certification in Healthcare Compliance (CHC)
  • Healthcare Financial Management Association (HFMA)
  • Kentucky and American Societies of Healthcare Risk Management (KSHRM and ASHRM)
  • American Society for Pharmacy Law (ASPL)
  • International Association of Privacy Professionals (IAPP)
  • Association for Conflict Resolution (ACR), Member 2003-2016
  • Chair of the Washington, D.C. based American Health Care Association's Medical Liability Subcommittee from December 2001 through July 2003

Admissions

  • Kentucky

Civic Involvement

  • Member of the Advisory Board for the Greater Louisville Inc. (GLI) Health Enterprises Network (HEN), 2007-present, and Executive Committee, 2008-present
  • Vice-Chair, HEN Nominating Committee, 2016-present
  • Vice-Chair, HEN Policy Forum, 2010-2014
  • Member, 2017 American Heart Association Executive Leadership Team, 25th Anniversary Heart Ball (fundraiser for heart and stroke research)  
  • Honorary Chair, ElderServe's 2012 Champion for the Aging Awards Luncheon
  • HEN Fellows Class of 2006
  • Co-Chair, Local Organizing Committee for the first ever US Figure Skating's Regional Championships in Louisville, KY, 2006-2007 
  • Member, Board of Directors, Louisville Skating Academy, 2007-2008
  • Member, Board of Directors, Court Appointed Special Advocates (CASA), 1994-1995

Publications

Ms McDonald-McClure has written or edited over 100 articles for the Wyatt HITECH Law Blog, a blog that she created soon after passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 to track legal developments related to health information technology, privacy and security.  The blog's scope was expanded in 2015 to report legal developments and enforcement actions regarding the privacy and security of sensitive data of individuals, businesses and organizations in all industry sectors.

Other publications include:

  • Risk Management in Health Care Institutions: Limiting Liability and Enhancing Care, Chapter 16, “Risk Management in Long Term Care Institutions and Services” (2014 3rd Ed.)
  • Valeo Communications: OCR Steps Up HIPAA Audits (July 2011)
  • HCCA Compliance Today, “Medicare’s New Mandatory Reporting Requirements for Liability Insurers, Including Self-Insured Entities” (July 2009)
  • LBA Bar Briefs, “Mandatory Reporting of Liability Settlements:  Law to Shine Spotlight on Attorney’s and Their Clients’ Pocketbooks” (June 2009)
  • “Enforcement Activities By Investigating Authorities and Responding to Investigations,” Chp. 5, Kentucky Health Law (2009 5th Ed.)(co-author with R. Benvenuti, III)
  • HCCA Compliance Today, “Outpatient Therapy Clinics and Their Referring Physicians: Fraud and Abuse Risks” (April 2008)
  • HFMA Kentucky Chapter Financial Scene, “Deficit Reduction Act Update” (January 2007)
  • HFMA Kentucky Chapter Financial Scene, “The DRA’s New False Claims Requirements” (June – July, 2006)
  • HFMA Kentucky Chapter Financial Scene, “US Supreme Court Limits Medicaid Recoveries in Personal Injuries Settlements” (June – July, 2006)
  • HCCA Compliance Today, “Compliance 101, Clinical Trials Primer” (June 2006)

Blog

Ms. McDonald-McClure is the creator and editor of the Wyatt HITECH Law Blog. The HITECH Law blog focuses on legal developments related to the privacy and security of confidential consumer and business information in today’s “high tech” world.  Since 2009, the year this blog was created, there has been an explosion in consumer and business electronic data privacy and security issues, beyond healthcare, HIPAA and the Health Information Technology for Economic and Clinical Health Act of 2009 (aka “The HITECH Act”, the original impetus for the blog).  This compelled us to expand the blog’s scope in late 2015 to cover legal developments regarding the creation, access, collection, maintenance or transmission of confidential information regarding an individual, business or organization in all industry sectors.

Kathie  McDonald-McClure