John W. Jones, Jr.
John W. Jones, Jr. is a partner in the Commercial Department of Pepper Hamilton LLP, resident in the Philadelphia office. He also is chair of the firm’s Group Purchasing and Buying Cooperative Practice Group, Long-Term Care Organizations Group and Pharmacy Industry Group, co-chair of the Health Care Services Practice and a member of the White Collar and Corporate Investigations Practice Group. Mr. Jones concentrates his practice in corporate and health care matters.
Specifically, Mr. Jones represents public and private companies, including, private equity funds and their portfolio companies, venture capital firms, pharmaceutical manufacturers, medical device companies, hospitals and health systems, medical staffs, ambulatory surgery centers (ASCs), specialty hospitals, outpatient diagnostic centers, including MRI and lithotripsy centers, physician groups, long-term care organizations, retail, specialty compounding and long-term care pharmacies, biotechnology companies, research institutions and laboratories, contract research organizations (CROs), medical suppliers, group purchasing organizations (GPOs), software vendors, including information technology companies, management and consulting companies, third-party administrators, staffing companies and other health care organizations. Mr. Jones has been representing health care providers, including pharmacies, on the transactional and regulatory side for 15 years. Additional details regarding representative pharmacy engagements including buy and sell-side pharmacy transactions may be found at http://www.pepperlaw.com/PracticeArea_preview.aspx?PracticeAreaKey=81. Details regarding representative GPO and buying cooperative engagements may be found at http://www.pepperlaw.com/PracticeArea_preview.aspx?PracticeAreaKey=82.
Mr. Jones also counsels health care companies on company formation, organization, governance and risk management issues. Additionally, his practice includes counseling these organizations on corporate planning, finance and structuring of transactions, including mergers, acquisitions (including platform add-ons and roll-up acquisitions) and dispositions, joint ventures, restructuring and reorganizations, and collaborations, partnering arrangements and strategic alliances. He has significant experience in regulatory issues impacting commercial health care transactions as well as those affecting members in the medical and pharmaceutical supply chains, including pharmaceutical medical device manufacturers and suppliers, hospitals, physicians, GPOs, outsourcing companies and other providers. These generally include issues under fraud and abuse laws, (including the federal Anti-Kickback Statute), Stark, civil monetary penalties law, false claims act, health care fraud statutes, HIPAA, as well as billing, reimbursement and claims issues, including issues under Medicare Parts A, B & D, Medicaid and commercial payor requirements. Regarding reimbursement, Mr. Jones also counsels health systems and physician groups on corporate compliance, national and local coverage decisions, GME and teaching physician rules, documentation issues, assignment and reassignment rules, supervision requirements, “incident to” rules, E&M guidelines, private contracting, independent contractors and reimbursement appeals.
Mr. Jones also has experience with traditional health care issues, such as hospital-physician relations, including exclusive contracts and medical staff privileges and credentialing (including economic credentialing and pay-for-performance issues), certificates of need and licensure, professional courtesy and patient rights issues, including care access and delivery issues. Additionally, Mr. Jones represents providers and suppliers in connection with negotiating and drafting managed care agreements. He also has experience with the unique issues facing academic medical centers and nonprofit health care institutions and with the legal issues presented by new health records and electronic medical information technologies, including informatics and e-commerce, telemedicine, electronic health records and electronic medical communications. Mr. Jones counsels product manufacturers and life science companies, including biotechnology companies on a range of investment, governance, contractual and regulatory issues and represents sponsors, academic institutions, researchers, investigative sites, and CROs in the preparation of protocols, informed consent and authorization forms, collaborative research agreements and counseling these organizations on compliance issues under applicable HIPAA and FDA requirements.
Mr. Jones’ representative engagements include the following:
- counseling financial and strategic investors on transactional and health care regulatory issues impacting mergers, acquisitions and dispositions and private placements
- advising start-ups and emerging health care businesses on corporate formation, structure and governance issues
- establishing buy-sell arrangements for various corporations and partnerships, including health care providers and suppliers
- structuring strategic alliances, partnering arrangements and collaborations both in traditional health care and biotechnology space
- advising boards of directors and management on investments, including asset acquisition and company growth, company life cycle issues and exit strategies.
- counseling hospital on affiliations, acquisitions and dispositions
- counseling health systems, physician groups, long-term care facilities, and other providers on regulatory mattes, including fraud and abuse, Stark, facility licensure and operations, reimbursement, including Medicare and Medicaid payment, managed care contracting, physician credentialing and termination, and contract issues, including exclusive contracts
- counseling private equity fund regarding exit strategies and disposition of equity interest in managed care organization joint venture
- advising physician groups in establishing independent physician association, hospital-physician joint ventures, provider networks, multi-service organizations and ancillary service corporations
- counseling pharmaceutical manufacturers regarding fraud and abuse issues, including those presented under sales and marketing arrangements, consulting agreements and arrangements with health care professionals
- advising ASCs, specialty hospitals and outpatient diagnostic centers on regulatory compliance issues under federal and state fraud and abuse laws (including the federal Anti-Kickback Statute), anti-referral laws (including Stark), licensure and securities laws arising from physician and non-physician, including hospital, ownership of these centers and related real estate acquired through a private offering of partnership interests
- advising product developer on health care regulatory issues through acquisition, private placement, public offering and commercialization matters
- counseling suppliers and vendors in connection with fraud and abuse and health care regulatory issues impacting their businesses and arrangements with other health care organizations and individual providers
- advising hospitals and other health care organizations in connection with establishing and/or joining group purchasing organizations
- advising public medical transcription services company on health care regulatory issues impacting its business, including issues under the federal Anti-Kickback Statute and civil monetary penalties law
- counseling rehabilitation center on formation and structural issues and state and federal health care regulations, including fraud and abuse, anti-referral laws, professional licensure regulations and fee splitting statutes
- representing hospitals and health systems in connection with managed care payment issues, standard of care, and utilization review procedures
- assisting health systems, physicians and other providers in formulating and executing managed care business strategies, purchase and sale of physician practices, formation and operation of ancillary joint ventures, and mergers and acquisitions
- counseling private equity fund on health care regulatory issues impacting disposition of equity interest in group purchasing organization
- counseling private equity fund on health care regulatory issues impacting acquisition of third-party administrator and underwriting and claims services company add-on
- counseling medical device manufacturer of health care regulatory issues in connection with initial public offering
- counseling physician and non-physician investors in multi-specialty ASC private placement
- advising health care staffing company regarding structure, formation and contractual issues, as well as health care regulatory and malpractice matters
- counseling second largest dialysis provider in the world on payment and reimbursement issues under government and commercial payment programs
- advising lenders in connection with certain health care regulatory issues (including Stark, fraud and abuse and HIPAA) impacting acquisitions and joint ventures
- counseling largest long-term care pharmacy GPO on fraud and abuse issues, safe harbor regulations, and regulatory issues impacting its relationships with other members in the medical supply chain, including manufacturers, suppliers and pharmacies
- advising Medicare Part D pharmacy network manager on rebate, discount and PDP issues under Medicare Prescription Drug, Improvement, and Modernization Act of 2003
- counseling multi-specialty physician group on development of specialty hospital and private placement
- counseling national retail and long-term care pharmacy chain regarding state and federal health care regulatory issues impacting its business and negotiate and draft agreements with vendors and suppliers
- counseling private multi-site radiology practice on federal and state fraud and abuse, Stark, fee splitting, licensure and government and private payor reimbursement issues
- advising providers, including hospitals, physician groups and medical device companies on billing and claims issues, draft corporate compliance programs and procedures and assist with implementing plan and monitoring compliance
- advising manufacturers, medical device companies, physician practice groups, hospitals and other providers and suppliers on the federal Anti-Kickback Statute and Stark (and safe harbors) in connection with marketing programs, physician recruitment deals and discount and rebate arrangements
- counseling nonprofit hospital on disposition of its equity interest in cancer center
- advising specialty multi-physician groups on fraud and abuse and marketing guidelines, including structuring plans and programs under civil monetary penalties law and federal Anti-Kickback Statute
- counseling physician and non-physician investors in connection with MRI joint venture private placement.
Privacy, Security and Information Technology
- counseling academic institutions, research organizations and biotechnology companies on clinical research issues
- counseling research sponsors in connection with clinical trials, research and development procedures and compliance with FDA and HIPAA regulations
- drafting clinical trial documents and agreements, including master services agreements, clinical study agreements, protocols, agreements with CROs, confidentiality agreements, informed consent and authorization forms
- preparing and negotiate collaborative research agreements between researchers and academic institutions
- counseling emerging life science business on raising funds in private placement and additional rounds of financing
- advising research organizations on indemnification, regulatory compliance and safe harbor issues under fraud and abuse and anti-referral laws
- counseling biotechnology companies on strategic alliances and partnering arrangements with “big pharma.”
- advising health care systems, providers and vendors in connection with interpretation and implementation of HIPAA privacy, security and transaction and code set regulations, including development of privacy policies, notices, authorizations, and business associate and data use agreements
- assisting software vendors in structuring and developing tools for transactions and claims processing and electronically exchanging protected health information in compliance with HIPAA and development of direct data entry systems
- assisting in structuring and developing of systems (including debit card payment systems) for health care payment in compliance with HIPAA
- counseling hospitals and health systems, providers and suppliers on e-commerce issues, including health care regulatory issues (such as fraud and abuse) impacting Web-site development and hosting arrangements
- advising parties concerning complex commercial transactions involving research and development, product launch and product life cycle
- advising vendors on development and commercialization of technology innovations, including disease management, charity care, prescription drug plan and electronic health records tools
- structuring business process outsourcing transactions, including accounting, billing and practice management
- advising software vendors on HIPAA and state law privacy and confidentiality compliance issues impacting electronic health records and the nuances presented by HIV/AIDS, mental health and drug and alcohol records
- assisting CROs and product and device manufacturers in development of protocols, research and investigator agreements and informed consent and authorizations in compliance with HIPAA
- counseling educational institutions regarding obligations under HIPAA privacy regulations
- advising health care systems on privacy and security aspects of computer systems, networks and data, including HIPAA review and drafting policies and procedures in connection with use of technology
- counseling hospitals and physicians on telemedicine, including reimbursement, licensure and malpractice issues as well as privacy and other legal issues presented by electronic medical communications.
Mr. Jones is a member of the adjunct faculty at Drexel University Earle Mack School of Law, and teaches the Health Law Practicum in the Health Law Concentration, to upper level students. He also is a member of the Health Law Concentration's Board of Advisors.
Mr. Jones speaks and writes frequently on health-related topics. He is a contributing editor to Physicians News Digest, a regular contributor to AHLA’s Health Law Digest, and he was a contributing author to Guide to Medical Privacy and HIPAA (Thomas Publishing Group, 2002). He has been on the faculty of the Pennsylvania Bar Institute, the Health Law Institute, Medical Education Services, the Medical Records Institute and Lorman Education Services for programs on HIPAA privacy and security.
Mr. Jones’ recent speaking engagements include:
Mr. Jones’ recent articles include:
- “Risk Management for the LTC Pharmacy Owner-Operator,” 2013 ASCP Executive Summit, Seattle, Washington (November 19, 2013)
- “Reinforcing Compliance Systems – Avoiding Anti-Kickback Allegations in a Heightened Enforcement Environment,” American Conference Institute: Reducing Legal Risks in the Sales & Marketing of Medical Devices, Chicago, Illinois (April 30, 2013)
- “Fraud and Abuse and Enforcement Issues Impacting Pharmacies,” Wagreens Corporation, Deerfiled, Illinois (April 29, 2013)
- “Institutional Pharmacy Audits in the LTC Setting,” MHA 10th Annual Business Summit (February 27, 2013)
- “Navigating Legal Challenges of Health Information Technology,” The Wharton School, Health Care Management 867 – Health Care Entrepreneurship (February 14, 2013)
- “Hot Button Issues in Pharmacy and LTC - Creating Value While Minimizing Risk,” The 2012 ASCP Spring Conference and Exhibition (May 2012)
- “Addressing and Overcoming Kickback Allegations in Dealings with Clinicians and Other Healthcare Professionals,” American Conference Institute’s 12th National Forum on Fraud and Abuse in the Sale and Marketing of Drugs (March 2012)
- “Episode 1: Pepper Hamilton on Midmarket Pharma, Health Care Deals,” Podcast in The Deal (February 2010)
- Group Purchasing Arrangements Coming Under Government Scrutiny-Are These Harbors Still Safe?, Pennsylvania Bar Institute, 11th Annual Health Law Institute, Philadelphia, Pennsylvania, March 2005.
- HIPAA’s Impact on Drug Manufacturers, CROs, Vendors and Other Non-Covered Entities Engaged in Research, Pennsylvania Bar Institute, 10th Annual Health Law Institute, Philadelphia, Pennsylvania March 2004.
- Privacy and Security Issues Under HIPAA, e-Health Legal Forum, TEPR ’03, San Antonio, Texas, 2003.
Mr. Jones was quoted in Physician Financial News concerning HMO denial of care and in Modern Physician regarding physician liability, physician ownership and management of managed care plans. He recently was interviewed regarding the pros and cons of e-mail communications between providers and patients, and he also was quoted in Psychiatric Times concerning legal issues regarding electronic communications between physicians and patients.
- “Medicine and Law: Legal Implications of Physician Relationships with Medical Supply and Distribution Companies,” Physicians News Digest (April 2012)
- “Legal Implications of Physician as Marketer,” Pepper Hamilton LLP Health Care Law Alert (February 10, 2010)
- “Legal Implications of Economic Credentialing,” Physicians News Digest, April 2006
- “Physician-Owned GPOs: Complying with the Federal Anti-Kickback Statute,” Physicians News Digest, October 2005
- “Implications of Malpractice Insurance Subsidies,” Physicians News Digest, July 2005
- “Member-Owned Group Purchasing Organizations: What You Need to Know,” Pepper Hamilton LLP, Health Care Law Alert, April 2005 and Martindale-Hubbell, April 2005
- “GPO Arrangements Coming Under Government Scrutiny: Are These Harbors Still Safe?” Pepper Hamilton LLP Health Care Law Alert, April 2005
- “So You Want to Try Internet Prescribing,” Pennsylvania Psychiatrist, April 2005
- “Medical Device Manufacturer Relationships,” Physicians News Digest, March 2005.
Mr. Jones was a contributor to the Guide to Medicaid Privacy and HIPAA, Thompson Publishing (2001) and The Health Laws of Pennsylvania, Pennsylvania Bar Institute (2000). During law school, Mr. Jones worked as a law clerk and as a health policy intern at the Pennsylvania Department of Health, where he co-wrote “Department of Health – Powers and Duties under Pennsylvania Law” (rev. 1996).
During law school, Mr. Jones received the D. Arthur Magaziner Human Services Award, Jack M. Mumford Memorial Health Law Scholarship, the Monroe E. Trout Law and Medicine Award, the Excellence for the Future, Consumer Protection Award and the Excellence for the Future, State Securities Regulation Award. Mr. Jones is a member of the Pennsylvania bar.
B.A. 1993, cum laude, University of Delaware
J.D. 1997 Dickinson School of Law; associate editor, Dickinson Journal of International Law
M.S.W. 1997 University of Pennsylvania
Admitted to practice in Pennsylvania