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.
Experiência
- October 20, 2015
AseraCare Update: Jury Finds Majority of Sampled Claims False, AseraCare Seeks JMOL Following Phase One of Bifurcated Trial, American Health Lawyers Association Practice Group, Email Alert - August 28, 2015
Fifth Circuit Requires Pharmacies to Arbitrate Claims Against Non-Signatories to Arbitration Agreement, American Health Lawyers Association Practice Group Email Alert - December 27, 2013
Another Record Year for Government Recoveries under the False Claims Act, American Health Lawyers Association Practice Group, Email Alert - October 2013
What Hospitals Need to Know About ZPIC Audits, Healthcare Financial Management Association - November 2012
What do you do when a ZPIC comes knocking? Compliance Today, Health Care Compliance Association - August 29, 2012
Beware of the Minefield - The New Survey and Enforcement Landscape for Home Health Agencies, The American Health Lawyers Association's Healthcare Liability and Litigation Health Briefs - February 1, 2012
The Various Weapons in the ZPIC Arsenal, The American Health Lawyers Association's LTC-SIR Advisor - December 22, 2011
Why the Anti-Kickback Statute May Be the Tip of the Iceberg When It Comes to Questionable Vendor Arrangements, The American Health Lawyers Association's LTC-SIR Advisor - May 2011
Nursing Homes May Find Some Solace Amid the Storm of New Regulations Governing the Assessment of CMPs, American Health Lawyers Association's Healthcare Liability and Litigation Practice Group, May 2011 Health Briefs e-Newsletter - June 21, 2010
Has a Trap Been Set? - What Risks Lie Ahead for Nursing Homes Compelled to Disclose Organizational Information under the Patient Protection and Affordable Care Act, American Health Lawyers Association's Healthcare Liability & Litigation Health Briefs - February 17, 2010
New Guidance on the Indicia of Reliability Standard: What Now Faces Potential Relators in False Claims Act Litigation, American Health Lawyers Association's Healthcare Liability & Litigation Health Briefs
- April 21, 2020
Part 2: Opportunities and Risks for Telehealth under HIPAA and State Privacy Responses to the COVID-19 Pandemic,” American Telemedicine Association , COVID-19 Response Webinar Series - April 14, 2020
Part 1: Opportunities and Risks for Telehealth under HIPAA and State Privacy Responses to the COVID-19 Pandemic,” American Telemedicine Association , COVID-19 Response Webinar Series - April 15, 2019
The Evolving Landscape of Telehealth: Politics, Policy, Operations and Oversight, American Telemedicine Association - February 24, 2015
Long Term Care and the Law: Why Long Term Care Providers are Finding New Uses for ADR: Best Practices for an Evolving Landscape, American Health Lawyers Association - February 19, 2015
Due Diligence Reviews in Healthcare Transactions, Jones Day's CLE Academy - December 17, 2013
Advocating Effectively in Health Care Arbitrations, American Health Lawyers Association - November 2011
Beware of the ZPIC - Tips and Tactics from the Trenches, American Health Lawyers Association - Fall 2009
Federal and state efforts to improve patient safety and reduce medical errors, Patient Safety and Never Events
- The George Washington University (J.D. 1998; Moot Court Board; Jessup Moot Court Competition, International Rounds Participant; Research and Writing Dean's Fellow); University of California, Los Angeles (B.A. summa cum laude 1995; Phi Beta Kappa); Oxford University, England (Extension Program, 1994)
- Georgia, U.S. District Courts for the Middle and Northern Districts of Georgia, and U.S. Courts of Appeals for the Sixth and Eleventh Circuits
Best Lawyers in America: health care law (2019-2024)
Chambers USA: health care (2019-2020)
Georgia Super Lawyers "Rising Star" (2006, 2007, 2010)
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