Kristen Pollock McDonald

Kristen McDonald defends providers in False Claims Act litigation brought by federal and state agencies and qui tam whistleblowers. Her civil fraud experience involves billing, coding, medical necessity, eligibility, physician compensation, and potential liability under the Stark Law and Anti-Kickback Statute. Kristen defends providers in government extrapolated audits, and she conducts internal investigations including assistance with repayments and self-disclosures. Additionally, she conducts internal investigations associated with HIPAA/HITECH concerns and defends providers in OCR (Office of Civil Rights) investigations. Kristen also represents organ transplant programs under review by the Organ Procurement & Transplantation Network (OPTN) and its Membership & Professional Standards Committee (MPSC).

In addition, she has extensive experience conducting health care due diligence reviews for mergers, acquisitions, investments, and banking matters, focusing on fraud and abuse and other regulatory and compliance concerns. Kristen routinely advises health care and life science companies and related investors on fraud and abuse analyses, telemedicine services and reimbursement, HCP (health care professionals) arrangements, conditions of payment, and compliance program effectiveness reviews.

Kristen has represented hospitals/health systems; hospice, home health, skilled nursing, and other post-acute care providers; life science companies including pharmaceutical, medical device, and biologics manufacturers and distributors; telehealth companies; AI companies; diagnostic imaging; ambulance suppliers; DME (durable medical equipment) suppliers; financial institutions; and private equity investors.

Kristen is a member of the American Health Law Association and served as chair of AHLA's Health Care Liability and Litigation Practice Group.

Kristen has written and spoken extensively on health care issues, including telemedicine, cybersecurity, program integrity audits, government recoveries, risks in post-acute care, and strategies for diligence.