Health law attorney Justin M. Puleo represents both traditional providers of healthcare in their critical transactions and expansions and new entrants in telemedicine, telehealth, and digital medicine. From guidance on a multitude of regulatory obligations to structuring joint ventures and private equity investments, Justin draws from his nearly 15 years of applying regulatory obligations to support healthcare clients’ commercial opportunities and care to patients. He serves as national chair of the Healthcare – Regulatory, Transactional & Telehealth Practice Group.

Justin helps healthcare providers, companies, and innovators maintain business operations and adapt and expand in an era of health reform and unique challenges.

He also guides entrepreneurs, investors, and other market entrants to achieve compliance in the rapid-growth telehealth industry as the parameters of the appropriate use of telemedicine shift. Key areas of Justin’s deal, regulatory, and pre-litigation counsel include:

• Stark Law
• Anti-Kickback Statute
• Telehealth
• Telemedicine
• Corporate Practice of Medicine
• Fee splitting
• Private equity in healthcare
• HIPAA

In addition to brick-and mortar-hospitals, ASCs and practices expanding to multiple states, emerging telehealth companies rely on Justin’s deep understanding of the regulatory landscape and the rules of 50-state licensing and compliance so they can introduce their innovative therapies and products to patients. Justin provides guidance for market entrants, where he highlights key concerns for telemedicine joint ventures and areas of enforcement.  

Health startups look to him to spot issues and protect commercial viability, scalability, and market sustainability. Among Justin’s recent transactions and matters are the design and implementation of 50-state network infrastructure, joint venture agreements, and deal guardrails for telehealth clients focused on mental health, weight loss, health coaching, direct-to-consumer drugs, stem cell therapies, medical marijuana, and others.

Justin is well versed in offering succinct and practical operational advice, earning him a reputation with the C-suite for integrating the worlds of healthcare, business, and the law. He also represents a broad spectrum of healthcare professionals and entities that have been around for decades. These include hospitals, health systems, management service organizations (MSOs), ambulatory surgery centers (ASCs), large physician groups, and long-term care facilities.

Justin is a native of Pinehurst, North Carolina. He sees himself as contributing to his clients’ delivery of patient care, a value he holds closely as a lawyer in a family filled with physicians and healthcare providers. 

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

• Duke University Chapel
• Seven Oaks Swim & Racquet Club, Member 
• Patriot Boot Camp, 2015
• National High School Mock Trial Tournament, Judge, 2015
• Legal Aid of North Carolina, HHS Certified Marketplace Navigator, 2014
• Legal Aid of North Carolina, 7th Annual Bar Awards and Silent Auction, Announcer, 2014
• The Alexander Family YMCA, Hillsborough St. Raleigh, 2013-18

Corporate & Regulatory Experience

Mergers & Acquisitions

• Formulated and established several multiparty healthcare joint venture arrangements.
• Closed deal involving a multistate practice and a newly created MSO supporting the same in the area of stem cell therapy.
• Counseled market leader in telehealth in its affiliation with large physician network. 
• Provided regulatory counsel and closed joint real estate deal between billion dollar hospital system and surgeon.   
• 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 multimillion-dollar corporate merger with a publicly traded company.
• Prepared multimillion-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 multistate 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 multibillion-dollar health system.
• Provided timely, creative, and compliant counsel to radiology practice client dealing with market shortage of radiologists.
• 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.
• Assisting national benefits company enroll nationwide in State Medicaid programs.

Compliance

• Design compliant healthcare 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 Case law.

Pre-Litigation Advocacy

• Resolved physician to physician intra-practice and joint venture disputes regarding compensation, competition, quality, and other issues. 
• Represented individual and institutional healthcare providers in their efforts to regain in-network status with a large private payor.
• Represented healthcare 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, Guidance for Market Entrants in Telemedicine, GRSM50 Healthcare Newsroom, March 2024
• 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, “ASCs: Best Practices from a Legal, Operations, and National Trend Perspective,” presentation before the North Carolina Ambulatory Surgical Center Association, March 15, 2023
• 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