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Donna S. Clark

Donna Clark is a partner in the Baker Hostetler Healthcare Practice Group. She represents healthcare providers in federal and state regulatory matters, with an emphasis on compliance with referral laws. Her clients include hospitals and hospital systems, physicians and physician groups, academic medical centers, imaging facilities, pharmaceutical and medical device manufacturers, ambulatory surgery centers, home health agencies and dialysis providers.

Ms. Clark has advised numerous clients regarding the structuring of joint venture and contractual relationships in compliance with federal and state laws governing referral relationships, including the illegal remuneration, Stark and civil money penalties laws. She has assisted clients in obtaining governmental approval for particular transactions under these laws through the advisory opinion process. Ms. Clark has performed internal audits and investigations for healthcare providers examining relationships with referral sources for compliance with the requirements of the referral laws and for compliance with Medicare and Medicaid program billing requirements. She has represented various healthcare provider entities in self-disclosure of potential violations to the Department of Justice and Office of Inspector General, as well as representing healthcare provider entities in investigations initiated by such entities.

Ms. Clark has represented academic medical centers in developing compensation models for faculty physicians and implementing time studies to support faculty physician compensation. She has structured outpatient clinics and diagnostic facilities for academic medical centers, with consideration of reimbursement and referral law issues. She has significant experience in Medicare and Medicaid reimbursement for the services of physician practices in both private and academic settings.

Ms. Clark is a member of the American Health Lawyers Association and the American Bar Association (Health Law Section). She is listed in The Best Lawyers in America in healthcare law (2006 through the present), named one of Houston’s Top Lawyers in Health Law in 2010 by H Texas Magazine and has been named a Texas Super Lawyer since 2007 by Law & Politics and the publishers of Texas Monthly magazine. In addition, Ms. Clark was named one of the Top 100 Houston Super Lawyers in 2010 and has been recognized as one of the Top 50 Women Texas Super Lawyers since 2009.

Ms. Clark is a frequent speaker and writer on a range of topics affecting health industry clients, including compliance with the referral laws. She is also an adjunct professor at the University of Houston Law Center teaching Healthcare, Fraud and Abuse.

Her representative matters include:

• Conducted review of all physician contracts for hospital system with large physician group for compliance with Stark/Anti-Kickback Law requirements.
• Obtained advisory opinion from Office of Inspector General for medical school approving donation of medical office building by for-profit hospital to medical school for use as family practice residency program clinic.
• Performed Anti-Kickback analysis of lease arrangement between hospital and physician group and negotiated settlement for payment of back rent and expenses.
• Analyzed Stark/Anti-Kickback implications of proposed cardiac cath joint venture and contractual relationship with hospital, including analysis of procedure coverage implications of alternative Medicare provider types.
• Restructured cardiac cath management agreement to comply with new Stark requirements.
• Restructured gamma knife equipment lease to comply with new Stark requirements.
• Analyzed fraud and abuse implications of payment by pharmaceutical manufacturer of cost sharing obligations for Medicare beneficiaries participating in clinical trials.
• Analyzed fraud and abuse implications of hospital accepting donations from charitable foundation directed to pay expenses of hospital’s transplant patients.
• Analyzed Stark/Anti-Kickback implications of gainsharing and pay-for-performance proposals for medical school to propose to affiliated teaching institutions.
• Drafted numerous physician recruitment, medical director and hospital-based physician agreements and assisted hospitals in addressing issues arising under the agreements (e.g., collection of amounts owed to hospital after departure from community of recruited physician or failure to provide adequate radiology coverage).
• Negotiated academic institution affiliation agreement with medical school.
• Analyzed allowability under Stark Law of proposed allocation method for ancillary service revenue for large physician group.

Ms. Clark’s most recent speaking engagements include: 

• UT School of Law Health Law Conference: Stark Law Self-Disclosure and Recent Developments (April 15, 2011)
• Texas Hospital Association: Stark/Anti-Kickback Update (October 10, 2011)
• THA/SBA Health Law Conference: Fraud and Abuse Update (October 11-12, 2010)
• University of Texas School of Public Health - Houston, Legal Issues in Health Care Administration: Federal Government Investigation and Enforcement (September 9, 2010)
• University of Texas Health Law Conference: Stark and Fraud and Abuse Hot Spots: Self Reporting, Disclosure and Compliance Issues (April 7-8, 2010)
• Texas Hospital Association/State Bar of Texas: Fraud and Abuse and Stark Law Update (October 12, 2009)
• University of Texas Masters of Public Health: Federal Government Investigation and Enforcement (September 17, 2009)
• Houston Bar Association: Stark Law Developments (July 8, 2009)
• UT Health Law Conference: Setting the Legal GPS System: Stark and Fraud and Abuse Developments (April 15-17, 2009)
• HFMA Texas State Conference: Physician Issues—Stark (March 30, 2009)