Jeffrey B. Miller, Esq.

Senior Counsel

Jeffrey B. Miller, Esq. is a skilled and experienced transactional, commercial, regulatory, and compliance attorney who provides trusted advice and support to clients involved in healthcare and the life sciences, as well as other areas of business. He is a member of the firm’s Corporate Healthcare and Life Sciences, Mergers and Acquisitions, Risk Mitigation and Safety and Internal Investigations groups. Jeff also provides support to the firm’s Commercial Litigation team.

With nearly 25 years of experience, Jeff represents and advises organizations across healthcare and the life sciences spectrums, including hospitals and health systems, physician practices, and other healthcare providers, as well as management service organizations, medical device companies, pharmaceutical companies, and healthcare-related supplier and services companies. Often working with organization’s financial backers, including private equity, Jeff’s work includes evaluating and designing M&A transactions, including strategic planning, execution and due diligence, designing and negotiating commercial transactions, developing and executing executive and professional agreements and relationships, addressing a wide variety of regulatory matters, counseling clients on information privacy and security matters, and establishing and/or improving corporate ethics and compliance efforts. In this regard he helps to prepare organizations for sale, to perform due diligence activities, and to address other transaction-related activities, including closing and post-closing matters.

As part of his practice, Jeff addresses matters pertaining to government compliance such as the Health Insurance Portability and Accountability Act (HIPAA) and related Office of Civil Rights mandates, Federal and state false claims acts and anti-kickback statutes, the Foreign Corrupt Practices Act, Federal and state conflicts of interest-related requirements, including the Stark Law, and other legal and regulatory requirements. Jeff provides advice and representation to organizations involved with government agency or commercial payor legal actions, investigations, audits and reviews, including matters involving the U.S. Department of Justice (DOJ), the Food and Drug Administration (FDA), the Department of Health and Human Services, Office of Inspector General (OIG), and the Office of Civil Rights (OCR), among other federal and state authorities. Further, Jeff assists clients in avoiding potential legal and regulatory entanglements by providing experienced counsel on the design, development and implementation of effective and efficient legal and regulatory compliance programs that satisfy applicable guidelines while enhancing company operations and value.

Prior to joining Saxton & Stump, Jeff held professional and executive-level positions at healthcare and life sciences companies, including Mercy Health System of Southeastern Pennsylvania, a non-profit regional integrated delivery system, and DermOne, LLC, a multi-state, private equity backed management service organization, where he served as general counsel, and compliance and privacy officer. Jeff served for nearly 10 years as vice president and chief compliance officer for Synthes, a leading international medical device company, which was acquired by Johnson & Johnson in 2012 and combined with DePuy to form The DePuy Synthes Companies, part of the Johnson & Johnson family of companies, the world’s largest orthopedic and neurological businesses. Most recently, he served as a managing director at a financial and economic consulting firm that concentrated in forensics, valuation, intellectual property and performance optimization.

Jeff is regularly invited to present at global, national, regional and local organizations including the U.S. National Academy of the Sciences, the Ethisphere Institute, the American Bar Association, the American Health Lawyers Association, the Health Care Compliance Association, the Society of Corporate Compliance and Ethics and Temple University. He is also a faculty member at the Pennsylvania Bar Institute, the continuing legal education arm of the Pennsylvania Bar Association, where he instructs attorneys and non-attorney compliance officers on transactional, commercial, regulatory and compliance-related topics.

Jeff also serves as Director-in-Charge for Granite GRC Consulting, a firm that provides governance, risk and compliance services.

EDUCATION
Widener University School of Law, J.D., 1995

The Pennsylvania State University, B.S. in Operations Management, 1991

BAR ADMISSIONS
Pennsylvania
COURT ADMISSIONS

Supreme Court of Pennsylvania

U.S. Courts of Appeals for the Third Circuit

U.S. District Court for the Eastern District of Pennsylvania

MEMBERSHIPS
Wolters Kluwer, Health Law Advisory Board Member

Pennsylvania Bar Association, Member

American Health Lawyers Association, Member

Institute for Business Ethics, Establishing Member of the European Network of Integrity and Compliance Officers

Open Compliance and Ethics Group, Member, GRC capability model task force, 2007 – 2009

American Academy of Family Physicians, Member, Panel of Consultants, 2002 – 2004

COMMUNITY INVOLVEMENT
Love INC. of Lancaster County, Board Member

Manheim Township Marching Band Boosters, Board Member, 2014 – 2019

United Way of Lancaster, Member of the 2-1-1 Volunteer Center Advisory Committee, 2016 – 2017

Hunger Free Lancaster County, Service Committee member and Chair of the Volunteer and Event Planning Task Force, 2015 – 2017

Junior Achievement of Central Pennsylvania, teacher, 2009 – 2013

SELECTED PUBLICATIONS

A Prescription for Compliance Officer Burnout from the Psychoneurotic Institute for the Very, Very Nervous, Wolters Kluwer Legal and Regulatory Solutions U.S. Law & Health Blog, November 2015  

Strategic Perspectives: Learning from the Past and Building for the Future: Corporate Integrity Agreements in the Life Sciences Industry, Wolters Kluwer Health Law Daily, October 2014  

No Picnics in the Park for Responsible Corporate Officers: An Update and Overview of Individual Prosecutions in the Life Sciences Industry, Health Care Compliance Letter, Wolters Kluwer, Vol. 14, Issue 6, June 2011  

The Narrowing Landscape of Manufacturer-Physician Relationships, Physicians News Digest, Physician’s News Digest, Incorporated, July 2009   

Teaching Under the Influence? Manufacturer Support of Continuing Medical Education Programs, Health Care Compliance Letter, Wolters Kluwer, Vol. 11, Issue 1, January 2008  

Keeping Your Friends Close and Your Business Partners Closer: Legal Dynamics in the Relationships Among Hospitals, Physicians and Manufacturers, Health Care Compliance Letter, Wolters Kluwer, Vol. 10, Issue 1, January 2007 

SELECTED SPEAKING ENGAGEMENTS

COVID-19, Telehealth and Cybersecurity, Warehaus Speaker Series, April 17, 2020

Risky Business – Advancing Your Assessments and Analyses Beyond that Old Time Rock and Roll, Pennsylvania Bar institute 25th Annual Health Law Institute, March 12, 2020

Medical Device Liability – A Case Perspective, National Academy of the Sciences, Biomedical Engineering Materials Applications Roundtable, March 25, 2019

Compliance Program Efficiency and Effectiveness, Pennsylvania Bar Institute 23rd Annual Health Law Institute, March 15, 2017

Compliance and Conflicts of Interest, Health Care Compliance Association Philadelphia Regional Conference, June 3, 2016

A Prescription for Compliance Officer Burnout from the Psychoneurotic Institute for the Very, Very Nervous, Health Care Compliance Association Philadelphia Regional Conference, June 3, 2016

The Fundamentals of Designing, Implementing and Maintaining Corporate Compliance Programs, Pennsylvania Bar Institute 22nd Annual Health Law Institute, March 15, 2016

Living in the Tempest: Studying Trends in Corporate Integrity Agreements for Better Future Compliance, Pennsylvania Bar Association, Pennsylvania Bar Institute, 20th Annual Health Law Institute, March 13, 2014

Ambien Anyone? The Issues that Keep Compliance Officers Awake at Night, American Bar Association, Health Law Section, 15th Annual Conference on Emerging Issues in Healthcare Law, February 28, 2014

Highly Regulated Industries, The Ethisphere Institute, 2013 Global Ethics Summit, March 6, 2013

The Legal Impact of Misdemeanor Liability and the Responsible Corporate Officer Doctrine, Center for Business Intelligence, Second Annual Life Sciences In-House Legal Counsel Congress, September 21, 2012

Implications of FCPA and Ex-U.S. Anti-Corruption Operations – How the Enforcement Environment is Evolving, Center for Business Intelligence, Second Annual Life Sciences In-House Legal Counsel Congress, September 21, 2012

Ethics as Organizational Culture; Government as Stakeholders, Temple University, Fox School of Business and Management, March 2010

TEACHING
Adjunct Professor, Villanova University Charles Widger School of Law

Faculty Member, Pennsylvania Bar Institute

Media Mentions and Op-Ed Articles

How to make the most of an online doctor’s visit. Jeffrey B. Miller. Lancaster Newspaper. (May 3, 2020)

Recognitions
Yale University School of Management, Rising Star of Corporate Governance Award, 2008
Relevant Experience
Led and managed a multi-state management service organization’s response to an investigation by the Department of Justice (DOJ)/U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG), negotiated a settlement that protected the private equity investor, limited liability to one entity within the platform and avoided a Corporate Integrity Agreement (CIA)

Designed, built and led global compliance function program from scratch – designed, developed and led compliance infrastructures, processes, activities and staff worldwide

Designed and performed legal and compliance diligence for potential M&A transactions, addressing a variety of Federal and state legal and compliance regulatory matters

Prepared and led the compliance function program through a $2.1 billion acquisition

Supported organizations through periods of transition and crisis, including preparing for and managing through M&A-related activities, expansions, downsizing, and the integration of complex functional and business operations

Co-led the negotiation of criminal and civil settlement agreements with the DOJ, HHS, OIG and U.S. Food and Drug Administration (FDA) resulting in the continued distribution of a company’s key product line and the use of an internal motioning function instead of government-driven external audits

Performed or oversaw more than 500 compliance investigations, including investigations of executive-level employees

Assessed and mitigated risks through the design and implementation of more than 50 ethics and compliance programs across healthcare and the life sciences, including some of the first ethics and compliance programs for long-term care facilities in Pennsylvania

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