Justin M. Puleo has been practicing health law for over ten years and is national co–chair of the Health Care Regulatory and Transactional Practice Group. His work focuses primarily in this area (see practice area link). He routinely manages corporate health care deals involving joint ventures (at times with private equity investment) and counsels health care providers and clinical researchers to identify and resolve regulatory compliance issues. All of the above is done with a view to maintain business operations in the era of health reform and during the unique challenges presented by COVID-19 States of Emergency. He is deeply knowledgeable in the areas of Stark Law, Anti-Kickback Statute, EKRA, Corporate Practice of Medicine, False Claims Act, HIPAA, Medicare Conditions of Participation, Certificate of Need, Joint Commission requirements, and OIG investigations, among other areas.

Typically working directly with practice leaders and health care CEOs, drawing from his decade-plus of experience, Justin is well versed in offering succinct and practical operational advice.  He has represented a broad spectrum of health care professionals and entities, including but not limited to: hospitals, health systems, management service organizations, long-term care facilities, assisted living facilities, home health agencies, hospices, federally qualified health centers, rural health centers, behavioral health facilities, large physician practices, medical spas, ambulatory surgery centers, imaging facilities, solo physicians, and other health care providers. In addition to his focus on health law, Justin has counseled multiple clinical research entities regarding FDA requirements and is also a registered patent attorney and DRC Certified Mediator (inactive) and can identify issues for clients in these areas.

Justin is a native of Pinehurst, North Carolina and comes from a family of health care providers. Both of his parents are physicians, his sisters are a dentist and a psychologist respectively, his aunt and sister-in-law are physician assistants, his grandmother was a nurse, and his grandfather was a veterinarian. Justin’s wife, Merab, is also an attorney and is Associate Director of Global Investigator Contract Solutions at IQVIA.  They live in Northwest Raleigh with their daughter Annabelle, son Jenkins, and dog Obie.

Admissions

• North Carolina
• North Carolina Dispute Resolution Commission, Certified Mediator (inactive)
• U.S. Patent and Trademark Office
• U.S. District Court, Eastern District of North Carolina

Memberships

• American Health Lawyers Association
• North Carolina Bar Association, Health Law Section Leadership Council (2017-2020)
• Tenth Judicial District Bar and Wake County Bar Association

Community Involvement

• Ongoing participation in various charity drives and benefits 
• Seven Oaks Swim & Racquet Club, member since 2021
• Patriot Boot Camp, assisted in obtaining mentors and sponsorship for Chapel Hill event helping military families form startup companies, July 2015
• Judge, National High School Mock Trial Tournament, May 2015
• Alumnus Feature in UNC School of Law Pro Bono Program Newsletter for work as an HHS Certified Marketplace Navigator with Legal Aid of North Carolina, 2014
• Announcer, 7th Annual Bar Awards and Silent Auction, helped raise $53,000.00 to benefit Legal Aid of North Carolina, October 2014
• The Alexander Family YMCA, Hillsborough St. Raleigh, 2013-18

Corporate & Regulatory Experience

Mergers & Acquisitions

• Successfully formulated and established several multi-party health care joint venture arrangements.
• Assisted a multi-campus hospital system with its corporate reorganization to achieve economies of scale; prepared corporate documents effectuating the change and arranged for necessary licensure and payor filings.
• Closed transaction valued at $15 million between large dermatology practice and private equity backed entity. 
• Conducted due diligence and prepared stockholder communications pursuant to pharmacy chain’s multi-million dollar corporate merger with a publicly-traded company.
• Prepared multi-million dollar private placement for investment in an out of network private pay hospital.   
• Closed sale of oral surgery practice involving complex scope of practice and financing considerations. 
• Closed $3.5 million sale of home health agency with multi-state entity.  
• Served as buyers counsel in deal acquiring home health company with $15 million in annual revenue.
• Served as sellers counsel in a $250 million blended stock and asset purchase involving multiple parties and over two dozen skilled nursing facilities in two states.
• Representing a 1,000-plus member IPA in potential sale discussions at a nine-digit valuation.

Operational

• Serving as day to day outside counsel to multi-location diagnostic imaging company that is wholly owned by a multi-billion dollar health system.
• Drafted physician employment and vendor contracts on behalf of hospital entities; negotiated same on physician-side for matters involving different parties.
• Negotiated TPA agreement on behalf of IPA client with multiple facilities to optimize operations.
• Reviewed and negotiated clinical trial agreements and other research related agreements on behalf of sponsors and sites; addressed related intellectual property issues.
• Closed $400 million line of credit transaction for borrower client to fund growth of operations.

Compliance

• Routinely design compliant health care joint ventures with a view towards Stark Law, AKS, EKRA, and corporate practice of medicine considerations. 
• Reviewing existing agreements strained by COVID-19 States of Emergency to address fair market value and sustainability in a compliant fashion. 
• Advising of key opinion leaders regarding clinical research and consulting activities with respect to FDA, CMS, and other related regulation. 
• Amended hospital medical staff bylaws to mirror best practices in light of current NC Appellate Caselaw.

Pre-Litigation Advocacy

• Resolved physician to physician intra-practice and joint venture disputes regarding compensation, competition, quality, and other issues. 
• Represented individual and institutional health care providers in their efforts to regain in-network status with a large private payor.
• Represented health care providers before the North Carolina Medical Board and North Carolina Dental Board pursuant to public complaints and accompanied providers to interviews with Board investigators.
• Settled disputes with NC DHHS on behalf of clients pursuant to OAH Contested Case Hearings.
• Worked with NC DHSR to resolve licensure and enrollment issues on behalf of providers.
• Prepared CON applications and counseled clients with respect to CON disputes.
• Represented large regional hospital systems in numerous pre-litigation complex business disputes.

Publications

• Author, The Five W’s of Intellectual Property Assets in Health Care Business Transactions, Health Care Pulse and IP Blitz, January 18, 2018
• Author, Increased Scrutiny On Provider enrollment Under the ACA: How the New CMS Proposed Rule Creates Additional Considerations for Heath Care Transactions, Health Care Law Note, March 24, 2016
• Author, Recent IRS Publication of Final Rule for Tax-Exempt Hospitals Serves as a Reminder of Lesser-Known ACA Compliance Requirements, Health Care Law Note, January 22, 2015
• Author, "The Affordable Care Act – A Mid-2014 Update," Prognosis, June 2014

Presentations

• Speaker, “What Every First Year Associate Should Know about a Health Care Transaction,” presentation before the NCCU School of Law on behalf of the NCBA Health Law Section, January 31, 2017
• Speaker, “King v. Burwell and the Employer Mandate,” presentation before CFOs, HR Directors, and Benefits Administrators at the ACA Reporting Compliance Seminar sponsored by Mass Mutual, August 6, 2015
• Speaker, “ACA Enrollment, Coverage, Mandates, and the Navigator Program,” presentation at the 6th Annual FUNdamentals CLE before the Florida Bar, September 19, 2014
• Speaker, “ACA Enrollment, Coverage, Mandates, and the Navigator Program,” presentation at Campbell Law School before the Wake County Bar Association breakfast CLE series, September 17, 2014
• Speaker, “The Affordable Care Act: Implications for Senior Lawyers,” presentation before the Senior Lawyers Division of the North Carolina Bar Association, May 3, 2014
• Speaker, “The Admissibility of Medical Review Committee Materials: History, Law, and Practical Guidance regarding the Peer Review ‘Privilege,’” prepared presentation for the North Carolina Judicial College seminar at the UNC School of Government, March 27, 2014