Her experience includes:

Digital Health

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 represents healthcare industry clients and stakeholders with respect to privacy and security matters, including the development of HIPAA compliance programs, website privacy policies and terms of use, breach investigation and reporting, government investigations and healthcare privacy and security matters arising during the due diligence process. She has extensive knowledge of state health information privacy and security laws and has assisted clients throughout the US in the investigation, remediation, and breach reporting, as required, of privacy and security incidents. She has also defended providers in investigations by the Health and Human Service Office for Civil Rights. She advises clients on privacy and security compliance issues related to big data, health information technology, business associate agreements data use agreements and the use of de-identified data.

340 B Drug Discount Pricing Program

 

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.

Healthcare Transactions

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.