Areas Of Emphasis

Health Law and Business Transactions

Amy structures business transactions and advises clients on complex health care industry strategic, reimbursement and transactional matters. Amy handles a variety of business transactions including structuring strategic alliances and negotiating technology contracts, licenses, joint ventures, supplier contracts, distribution agreements, leases, group purchasing and other commercial contract negotiations.

Regulatory Compliance

She spearheads our compliance practice and regularly advises clients on federal and state regulatory and reimbursement matters, managing regulatory vulnerabilities and effective corporate compliance.  Amy is certified in Healthcare Compliance (CHC) and has provided compliance and HIPAA training to dozens of hospitals.

Health IT

Amy has a special interest in technology development and licensing and privacy and security issues. Amy leads the HIMSS Legal Aspects of the Enterprise Task Force and is Vice Chair of the AHLA Health Information Technology Practice Group. She served on the Certification Commission for Health Information Technology (CCHIT) Health Information Exchange (HIE) Certification Work Group to develop standards for health information exchanges.

Hospital and Physician Relations

Amy has worked extensively on physician alignment and structuring physician relationships on behalf of hospitals, physician groups, IPAs and managed care organizations.

Her Experience Includes:

• Counseling hospitals, physicians, ancillary service providers, entrepreneurs and facilities on state and federal licensing, payment, privacy and technology issues
  
  
• Outside counsel to health care industry service providers, including manufacturers, distributors, software and online medical education and publishing and ancillary companies
  
  
• Drafting and negotiating technology and software licensing agreements, pharma and device supplier contracts, distribution agreements, sponsor agreements, outsourcing, leasing, group purchasing and other commercial contracts
  
  
• Developing ownership structures and negotiating agreements among hospitals, physicians, surgery centers, retail clinics, and health information exchanges
  
  
• Analyzing legal and regulatory issues associated with uses and disclosures of health information

• Structuring strategic alliances and business transactions to avoid fraud and abuse and self-referral landmines
  
  
• Developing and implementing corporate compliance plans for billing, HIPPA privacy and security, antitrust and regulatory requirements for health care providers, health plans, and their business associates
  
  
• Special counsel in government investigations (DOJ, CMS, OIG, FDA) and false claims act litigation
  
  
• Representing providers in numerous Medicare coverage and payment appeals before hearing officers and administrative law judges

Professional & Community Associations

• American Bar Association - Health Care and Intellectual Property Sections
  

• American Health Lawyers Association - Vice Chair, Health IT Practice Group, Leader, eHealth and Telemedicine Affinity Group, RHIO and EHR Toolkit, Speaker

• Cleveland Metropolitan Bar Association - Secretary and Executive Council, Women in the Law Section and Former member Health Law Council, 1999 - 2003

• Alcohol, Drug Addiction, and Mental Health Board of Cuyahoga County - Trustee, Vice Chair, Finance Committee

• Village Foundation, Trustee, Bylaws Committee

• Case Western Reserve University Law-Medicine Center - Professional Advisory Committee

• Ohio Health Information Security and Privacy Collaboration (HISPC) Legal Working Group

• West Virginia Bar Association

Recent Presentations

• "Privacy and Security: Compliance in the ARRA Era," Healthcare Stimulus Exchange Conference, Chicago, Illinois, June 23, 2010 (with David Mayer)

• "Enforcement from the Defense Perspective: Criminal, Civil and Self-Reporting," Health Care Compliance Association Regional Meeting, Columbus, Ohio May 7, 2010 (with Steve Sozio)

• "The Meaningful Use NPRM: An Overview and Path to EHR Incentive Payments," American Health Lawyers Ass'n teleconference, March 4, 2010

• "HIPAA 2.0, HITECH and the Road Ahead for Clinical Research," Great Lakes Higher Education Symposium, Feb. 2, 2010

• "HITECH Act," Cleveland Metropolitan Bar Association, Health Care Law Section Presentation, January 20, 2010

• "Legal Strategies on the Road to Meaningful Use," HIMSS Dallas Conference ("Takin' HIT To The Streets: The ARRA Era"), December 4, 2009, Dallas Texas

• "Organ and Tissue Donation Awareness in Your Hospital," Ohio Hospital Association 2009 Annual Meeting, Columbus, Ohio, June 15, 2009

• "2009 Compliance Update," for Cleveland Clinic Physician Organization Board, June 11, 2009

• "Regulations of PHRs and Legal Issues on the Horizon," Northern Ohio HIMSS Spring Conference, June 5, 2009

• "e-HR and Health Information Exchange under HITECH," Lorman program on Medical Records law, April 30, 2009

• "e-HR Adoption, HIT Stimulus, and an Update on HIT Donation Rules," Academy of Medicine of Cleveland and Northern Ohio (AMCNO), April 8 & April 15, 2009

• "Mergers, Joint Ventures, Networks and Affiliation Agreements," Medtrade Spring 2009, Las Vegas, NV, March 24-26, 2009
  

• "HITECH Part I - The First Take," American Health Lawyers Ass'n (AHLA) video conference, March 17, 2009

• "Legal Issues in Electronic Health Records and Health Information Exchange," Lorman Seminar on "Medical Records Law in Ohio," Independence, Ohio, 2009
  
  
• "Hospital Regulatory Update:  What's Hot, What's Not," Ohio Society of CPAs, Healthcare Meeting, November 12, 2008
  
  
• "Joint Ventures, Networks and other Affiliations," Medtrade, Fall 2008, Atlanta, GA
  

• "Electronic Health Records and Technology Issues," Academy of Medicine of Cleveland and Northern Ohio (AMCNO), April 2 & April 9, 2008
  
  
• "Hospital/Physician Alignment Trends and Strategies," Ohio Hospital Association 2007 Fall Conference and Annual Meeting, September 28, 2007
  
  
• National Employee Benefits Web Summit, "What Electronic Health Records (EHRs) Mean to Employers", June 20, 2007
  
  
• "Healthcare and Information Technology: Policy, Legal and Strategic Issues in Northeast Ohio," Cleveland Bar Association, Health Law Institute, May 4, 2007
  
  
• "Compliance Update," Cleveland Clinic Health System, Physician Organization Board meeting, May 3, 2007
  
  
• "Competitive Bidding," Medtrade Spring, Las Vegas, NV April 26, 2007 (with Bob Crump)
  
  
• "Privacy and Legal Issues, Update on Health IT Laws and Regulations," Academy of Medicine of Cleveland and Northern Ohio, March 9, 2007
  
  
• "Intellectual Property Primer for Physicians," 47th Annual Meeting of American College of Legal Medicine, Orlando, March 4, 2007
  
  
• "Data Issues in Health Information Exchange," Lexwork teleconference, February 6, 2007
  
  
• "The Entrepreneurial MD: Healthcare and Intellectual Property Considerations for Physician Entrepreneurs," Oakstone Medical Publishing teleconference, December 6, 2006
  
  
• "HIPAA Medical Privacy and Security: An In-Depth Exploration of Internal Enforcement," American Health Lawyers Association teleconference, May 18, 2006
  
  
• "Effective Assistance of Counsel: What Criminal & Health Care Lawyers Need to Know," Cleveland Bar Association, April 6, 2006
  
  
• "Regulatory Issues in Distribution Agreements," Medtrade Fall 2005 Meeting, Atlanta
  
  
• "Physician Contracting: Legal and Regulatory Issues," American College of Legal Medicine 2005 Annual Meeting, San Diego
  
  
• "The HIPAA Privacy Rule," Cuyahoga County Bar Association, 2005
  
  
• "Recruiting, Retaining, and Compensating Physicians and Executives: Trends, Legal Issues and Strategies," AHLA 2004 Annual Meeting, New York City
  
  
• "HIPAA in a Nutshell: The Security Rule," National Business Institute, 2004
  
  
• "Managing Conflicts of Interest between Physicians and Industry," Cleveland Clinic Health System, Fairview Hospital Surgery, 2002
  
  
• "Medicare Appeals," AHLA 2002 Physician Organizations Law Institute, New Orleans

Education

Case Western Reserve University School of Law, J.D., 1995
University of Alabama at Birmingham, M.S. Health Services Administration, 1983
Auburn University, B.S., 1981

Licensed to Practice

• Ohio and West Virginia

Awards & Recognitions Named a "Woman of Professional Excellence" by the YWCA of Greater Cleveland, in recognition of her high professional standards, significant contributions to the operations of the firm and willingness to support and mentor others. - April 2010 Received Compliance Certification Board's "CHC" designation, in recognition of her completion of the Certified in Healthcare Compliance Examination; this board recognizes individuals who meet the criteria used to measure competence in the practice of healthcare compliance. Amy was named to the "Health Information Exchange (HIE) Certification Work Group" formed by the Certification Commission for Health Information Technology (CCHIT), an independent, non-profit, federally-recognized certification body that develops standards for health information technology AV rated by Martindale-Hubbell Listed in "Best Lawyers in America ". Health Care Law, 2006 through 2011 Chair, Health Care Law Committee, Ohio State Bar Association 2002-2004 Ohio State Bar Foundation - Fellow, Class of 2003

Articles by Amy S. Leopard March/April 2010 - "The Proposed Pathway for Achieving 'Meaningful Use' and EHR Stimulus Payments," Northern Ohio Physician March 2010 - "Ten Things Lawyers Should Know about the New HITECH Act," Cleveland Metropolitan Bar Journal November/December 2009 - "'Meaningful Use' for EHR Stimulus Payments - an Update," Northern Ohio Physician June 2009 - "HIT in a HITECH World: An Analysis of the HITECH Act" (AHLA Member Briefing Co-Author) May/June 2009 - "Stimulus Package Promotes Health IT Adoption;" Northern Ohio Physician January/February 2009 – "CMS Updates the Stark Physician Self Referral Rule;" Northern Ohio Physician November 2007 – "Adapting to Changes in Physician Relationships with Hospitals and Industry;" Northern Ohio Physician July 2007– OIG: Compliance Auditing Is Key Factor for CCAs; Huge Settlements Diminish Chances Published in the Report on Medicare Compliance. May 2007– " Bid Adieu to Bucks". Published in Crain's Cleveland Business March 2007 – NEO RHIO: Pioneering Health Information Exchange in Northeast Ohio Published in the March/April 2007 issue of Northern Ohio Physician Magazine. Spring / Summer 2007 – "Personal Health Records: Legal, Business and Contractual Issues for Employers" (AHLA HMOs and Health Plans newsletter). November/December 2006 – Technology Donations to Physicians: New Health IT Rules in Play Published in the Health Information Technology section of the Northern Ohio Physician Magazine. October 2006 – The DRA takes on Medicaid abuse:  Get ready to update your compliance plan Published in the Contemporary Long-Term Care Magazine. Spring 2006 – "Obtaining A Medicare Coverage Decision For New Telehealth Services" Published in AHLA Health Information and Technology News. January 2006 – System changes prompt Medicare providers to pay attention to appeals: Published in Crain's Cleveland Business, January 9-15, 2006, at 14. December 2004 – Client Briefing on Health Care: Health Care Regulatory Update. 2001 and 2004 – Coauthored three chapters on Healthcare Compliance Guidance for Matthew Bender Health Care Compliance Manual. 2004 – "The Medicare Modernization Act of 2003," authored sections on Medicare regulatory reforms, audits, appeals and coverage determinations for AHLA Member Briefing. October 2003 – Client Briefing On Health Care Law: Recent Developments. July 2001 – "Stark II Rules Break Out of the Gate," Cleveland Physician, July, 2004 and "Final Stark II Rules: New Opportunities and Challenges," Cleveland Physician. Spring 2001 – "New Exceptions for Academic Medical Centers Under the Final Stark II Rules," AHLA Physician Organizations. March 2001 – Client Briefing on Health Care Law: HCFA Issues Final Stark Rules. June 2000 – Client Briefing on Health Care Law: New OIG Guidance on Physician Groups; Time to Reevaluate Your Compliance Program

Areas of Practice

Information Technology Law
Bioscience
Health Care
Business Services