Anna D Kraus

Anna Durand Kraus has a multi-disciplinary practice advising clients on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and health information privacy. Ms. Kraus is co-chair of the firm’s Health Care Industry practice group. Ms. Kraus regularly advises clients on Medicare reimbursement matters, particularly those arising under Medicare Part B and the Medicare Part D outpatient prescription drug benefit. She also has extensive experience with the Medicaid Drug Rebate program. She has assisted numerous pharmaceutical and device manufacturers, health care providers, pharmacy benefit managers, and other health care industry stakeholders to navigate the challenges and opportunities presented by the Affordable Care Act. Ms. Kraus is also a trusted adviser on health information privacy issues, including those arising under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and the Health Information Technology for Clinical and Economic Health (“HITECH”) Act. Her background in this area dates back to the promulgation of the original HIPAA privacy regulations. Ms. Kraus' clients depend on her to guide them through the complex issues relating to compliance with the Anti-Kickback statute, the Stark regulations, and other laws designed to reduce fraud and abuse in the health care industry. Her deep knowledge of the fraud and abuse laws has made her an important component of the firm’s representation of several pharmaceutical companies and health care organizations under federal criminal and civil investigation or facing allegations under the False Claims Act. In addition, clients contemplating a major acquisition in the health care sector frequently rely on her to guide due diligence efforts. REPRESENTATIVE MATTERS Assisted a major pharmaceutical manufacturer in conducting an internal audit of its price reporting function and determining the necessity for submitting restated price reports. Assisted a pharmaceutical company in obtaining Medicare Part D coverage for its previously excluded product. Assisted several pharmaceutical manufacturers in modifying their price reporting functions to comply with requirements imposed by the Deficit Reduction Act and the Affordable Care Act. Assisted numerous pharmaceutical manufacturers to ensure that their research activities conform to HIPAA and HITECH privacy requirements (for example, by conducting internal audits and by preparing investigator disclosure documents, contract research organization (CRO) agreements, clinical trial agreements, service provider agreements, informed consents and authorizations). Assisted several device manufacturers to assess their status as business associates under HIPAA and HITECH and to develop appropriate compliance plans, policies and procedures. PREVIOUS EXPERIENCE U.S. Department of Health and Human Services, Deputy General Counsel (1993-2001) HONORS AND RANKINGS Washington DC Super Lawyer, Health Care (2013) LMG Life Sciences, “Life Science Star” (2012) PUBLICATIONS AND SPEECHES “Q&A With Covington's Anna Kraus,” Law360 (6/12/2012) "CMS Issues Final Rule to Implement the Sunshine Act," Covington E-Alert (2/13/2013), Co-Author "HHS Issues Long-Awaited Final HITECH Omnibus Rule," Covington Advisory (2/7/2013), Co-Author "Supreme Court Rules on the Constitutionality of the Affordable Care Act," Covington Advisory (6/29/2012), Co-Author