Kristi Kung is Chair of DLA Piper’s Healthcare Regulatory Practice and a partner of the firm’s Healthcare Industry team in the Washington, DC office.
Kristi focuses on the representation of healthcare and life sciences clients in a range of regulatory, compliance and transactional matters. Her practice includes legal advice and counseling with respect to federal and state fraud and abuse matters, billing and reimbursement, health information privacy and security, and digital health engagement. Kristi works with a broad range of healthcare industry stakeholders to evaluate, develop, and implement digital health strategies and advises clients on appropriate use and disclose health data in compliance with law, including with respect to the deployment of artificial intelligence tools to derive insights from data. She also advises on regulatory implications of proposed business models, contracting, acquisitions and investments, internal company investigations, and assists with self-disclosures to various government agencies. Kristi has developed comprehensive compliance programs for a variety of healthcare providers, suppliers, and manufacturers and has served as an independent compliance reviewer for entities under Corporate Integrity Agreements and Deferred Prosecution Agreements.
Kristi is a co-leader of both DLA’s Digital Health Group and Health Privacy Group. She previously served on the Legal Resources Board for the DC-based Center for Telehealth and e-Health Law (CTeL) from 2018-2022 and as an adjunct professor at American University – Washington College of Law, having taught courses in “Health Care Fraud and Abuse” and “Digital Health and Law” from 2014-2020.
Her experience includes:
Kristi has an active digital health practice advising healthcare startups on the appropriate business structuring and strategy to navigate complex and multijurisdictional regulatory challenges. Her background in privacy and security, licensing, reimbursement, fraud and abuse, registration and FDA enforcement and corporate practice of medicine provide her with the unique skillset to effectively guide her clients through the various legal and business obstacles confronting companies looking to develop and implement telehealth, mobile health, artificial intelligence, virtual and augmented reality, and other innovative health technologies. She has assisted clients in the development of regional, national, and international telehealth and mobile health programs and has advised health systems on the implementation of a cohesive telehealth strategy. She has also advised private equity sponsors with respect to digital health ventures and health IT acquisitions.
Healthcare Compliance, Investigations and Regulatory Counseling
Kristi has developed comprehensive compliance programs for a variety of healthcare providers and suppliers, including hospitals, physician practices, laboratories, DMEPOS suppliers, IDTFs, medical device manufacturers and specialty pharmacies. She also advises on the day-to-day healthcare regulatory and compliance matters confronting providers and suppliers in the healthcare industry. Kristi has developed and provided specialized training to her client’s workforces and sales teams concerning fraud and abuse, privacy and security, and other client risk areas. In addition, she has served as an independent compliance reviewer for entities under Corporate Integrity Agreements.
She advises clients on fraud and abuse matters including Stark and Anti-Kickback as well as state law equivalents, HIPAA and other privacy laws, reimbursement and billing, licensing and corporate practice of medicine issues. She assists clients with respect to internal investigations and self-disclosure and refund obligations and has further represented clients under investigation by various federal and state agencies, including the Centers for Medicare and Medicaid Services, the Office of Inspector General for the US Health and Human Services, the Health and Human Service Office for Civil Rights, the Health Resources and Services Administration, the Virginia Department of Health, the North Carolina Department of Health, various Virginia professional licensing boards and the Washington, DC Board of Medicine.
Privacy and Security Compliance, Breach Reporting and Investigations
Kristi has extensive experience advising hospitals, specialty pharmacies and other covered entities with respect to 340B Drug Discount Pricing Program compliance, audits and appeals. She assisted clients in this space with respect to the development of 340B compliance programs, internal audits and investigations, HRSA and drug manufacturer audits and inquiries and the submission of self-disclosures of 340B Program noncompliance to HRSA.
Kristi advises private equity sponsors in their healthcare acquisitions and divestitures, and the on-going representation of their healthcare portfolio companies, regarding healthcare regulatory issues identified in due diligence, including fraud and abuse matters (Stark, AKS, FCA), privacy and security, licensure matters, and Medicare and Medicaid billing issues. Her experience spans a wide range of specialty areas including health IT, specialty pharmacy, laboratory, hospitals, hospice, home health, ASCs, IDTFs, physician practice groups and specialty practices such as ophthalmology, oncology, urology, radiology, and dentistry.
Hospitals and health systems
Kristi represents hospitals and health systems in a wide array of healthcare regulatory and transactional matters with a particular focus on digital health, fraud and abuse counseling, and the development of innovative shared risk arrangements.
Medical groups and physicians
Kristi represents multispecialty physician groups on regulatory matters and acquisitions, including the development of super groups to capture ancillary revenues and working with clients to satisfy their physician compensation goals in a manner that is compliant with the Stark Law and other healthcare regulations. She also assists medical groups and physicians with employment agreements, professional service agreements, administrative service agreements, compliance program development, business associate agreements and a range of other transactional and regulatory matters.
- J.D., Emory University School of Law
- B.S., Michigan State University
- Chambers USA
- Band 4, District of Columbia Healthcare (2022-2023)
- The Legal 500 United States
- Recommended, Healthcare: Service Providers (2020-2023)
- Rising Stars Winner, The National Law Journal (2022)
- Named a Washington, DC Rising Star by Super Lawyers (2016-2022)
- Named a Virginia Rising Star (2010)
- Co-author, "Centers for Medicare & Medicaid Services Issues First HCPCS Code and Medicare DME Benefit Category Determination for Therapeutic Virtual Reality Device," The Journal of Federal Agency Action (July–August, 2023)
- "How Will Telehealth Change After the Pandemic?," HealthTech, June 5, 2020
- "New York Settles EmblemHealth Breach for $575,000," Eye on Privacy Blog, March 2018
- "HHS-OCR Closes 2017 with Six Figure Settlement in PHI Data Breach," Eye on Privacy Blog, January 2018
- "Life in the Slow Lane? What Net Neutrality Repeal May Mean for Telehealth Services,"The National Law Review, January 2018
- "Telehealth in 2017: What's Changed and What's Ahead," Law360, December 2018
- "Texas Telemedicine Saga Finally Over?," SMRH Health Law Blog, November 2017
- "New York AG Takes Enforcement Action Against Heart Monitoring Apps: Murmurs of Concern are Heard in mHealth App World," SMRH Health Law Blog, April 2017
- "Is a Truce in the Battle over Telemedicine in Texas Upon Us?," SMRH Health Law Blog, February 2017
- "Recent Relaxation of State-Level Challenges to the Expansion of Telemedicine but Barriers Remain," SMRH Health Law Blog, July 2016
- "CMS Proposes to Limit Site Neutral Payment Exceptions Applicable to Certain Off-Campus Hospital Departments Following Relocation, Service Expansion, or Certain Ownership Changes," SMRH Health Law Blog, July 2016
- "Disclosing 340B Program Non-Compliance and Negotiating Manufacturer Refunds – An Overview and Case Study, American Health Lawyers Association," In-House Counsel Meeting, June 2016
- "Assessing the Legal Risk of Unregulated Yoga Therapy," Law360, January,5 2016
- "Health Care Fraud and Abuse Update," Health Law Handbook, 2014 – 2016 editions
- "340B Omnibus Guidance Would Significantly Narrow the Pool of Eligible Patients," Law360, September 3, 2015
- "FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications," Law360, August 1, 2014
- "OIG Releases Special Bulletin on the Effect of Exclusion from Federal Health Care Programs," E-Alert, AHLA Accreditation, Certification and Enrollment, Affinity Group, May 8, 2013
- "Impact of the American Taxpayer Relief Act of 2012 on Reimbursement for Health Care Services," E-Alert, AHLA Regulation, Accreditation and Payment Practice Group, January 4, 2013
- "Telemedicine Legal Hurdles - An Overview of Lesser Known Challenges," Healthcare IT News – A Publication of the American Health Lawyers Association, Vol. 15, Issue 3, Page. 7, November 2012
- "Qui Tam Counsel Sanctioned for Breaching Ethical Rules Relating to Review of Privileged Material – E-Alert on the Frazier v. IASIS case," AHLA Healthcare Liability & Litigation Practice Group, February 2012
- "CMS Issues Final Rule Updating Payment Policies Under ESRD PPS for CY 2012," E-Alert, AHLA Regulation, Accreditation and Payment Practice Group, November 7, 2011
- "Legal Practice in a HITECH Environment: An Overview of the HITECH Act and its Impact on Lawyers as Business Associates," Defensively Speaking, International Society of Primerus Law Firms, February 12, 2010
- "Annual Survey of Virginia Law: Health Care Law," 44 U. RICH. L. REV. 473, 2009
- Panelist, CTeL Telehealth Spring Summit – "Workshop: Telehealth Claims and Denials Management – Medicare, Medicaid, and Private Payors," The Washington Hilton, Washington, DC, June 13, 2019
- Panelist, Sensus Healthcare - American Academy of Dermatology Annual Meeting Dinner, The Willard Hotel, Washington, DC, March 1, 2019
- Faculty, TMCx Accelerator, Texas Medical Center, "Digital Health Regulation," February 25, 2019, with Danny Tobey
- Presenter, "Mitigating Legal Risks in Digital Health Adoption," with Danny Tobey, November 13, 2018
- "What the Net Neutrality Repeal May Mean for Telehealth," CTeL Executive Telehealth Spring Summit, June 14, 2018
- "Healthcare Disruptions," American University Washington College of Law Summer Health Law Institute Lunch and Learn Panel, June 6, 2018
- "Data Breach Simulation," Association of Corporate Counsel – San Diego Chapter, April 25, 2018
- "Hot Topics in Healthcare Compliance and Regulation," University of Minnesota Master of Business Administration – Healthcare Executive Track, March 2017
- Health Law Panel: "Where We Are and Where We Are Going," District of Columbia Bar Association, Health Law Section, March 2017
- "Hacking Health: Addressing mHealth Privacy and Security Risks," Lorman Webinar, September 2016
- "Specialty Pharmacy and the 340B Program," National Association of Specialty Pharmacy – Legal Day, Washington, DC, September 2016
- "Avoiding Fraud and Abuse Pitfalls Under Expanded Reimbursement for Telehealth Services," mHealth and Telehealth World Congress –, Boston, July 2016
- Co-Presenter, "HIPAA Compliance and the Use of De-Identified Data," June 25, 2016, with Lisa Shuman (Strategic Management Services)
- "Fraud and Abuse Issues in Telehealth," American Health Lawyers Association – Fraud and Compliance Forum, Baltimore, September 2015
- "Exploring the Current State of mHealth Privacy and Security," mHealth and Telehealth World Congress, Boston, July 2015
- "mHealth and Telehealth – Privacy and Security Issues," American University Washington College of Law, Washington, DC April 2015
- "Privacy and Security Issues," mHealth Applications Legal Issues Breakfast Series, Tysons Corner, Virginia, March 2015
- Federal and Virginia laws relating to pharmacy and prescribing; the Virginia State Board of Pharmacy structure, investigation and hearing procedures; risk management and documentation for preventing litigation, Medical College of Virginia, Pharmacy Residency Program, March 2011; April 2010; and March 2009
- "Electronic Health Records in Litigation," Martha Jefferson Hospital, September 2010
- "Moving Beyond HIPAA: Future Trends in Litigation in This New Electronic Age," American Bar Association National Teleconference, January 2010
- "Patients and Practitioners Beware: Mandatory Electronic (Medical) Records and What You Need to Know," American Bar Association - Young Lawyers Division Fall Conference, October 2009
- Moderator and Speaker, The American Recovery and Reinvestment Act, HITECH provisions, Electronic Medical Records and Health Information Exchanges, and the E-Discovery of Electronic Medical Records in Litigation, Lorman Education Services, July 2009
- Health Information Portability and Accountability Act (HIPAA) and Virginia Medical Records Law, Lorman Education Services, October 2008
Law school courses taught:
- Adjunct Professor, American University Washington College of Law, "Healthcare Fraud and Abuse," 2014 - 2016; 2018-2020
- Adjunct Professor, American University Washington College of Law, "Digital Health and the Law," 2015, 2016, 2018, 2019 (summer institute)
- Subject Matter Coach, American University Washington College of Law, Health Law Competition Team, 2015 - 2018
Memberships And Affiliations
- Center for Telehealth and e-Health Law (CTeL), Legal Advisory Board, 2019-2022
- American Health Lawyers Association
- American Telemedicine Association
- American Bar Association – Health Law Section
- DC Bar Association – Health Law Section
My latest insights
OIG releases advisory opinion re-analyzing online healthcare directories
20 July 2023 .12 minute read
Industry organizations establish practical frameworks for digital health and healthcare AI...
22 June 2023 .10 minute read