Anna D. Kraus

Anna Durand Kraus currently chairs the firm's Health Care practice and is resident in the Washington, DC office. She 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. In addition, Ms. Kraus is an expert in health information privacy issues, including those arising under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). She joined the firm after spending seven years as Deputy General Counsel to the U.S. Department of Health and Human Services.

Representative Matters

· Assisted Kos Pharmaceuticals to obtain Medicare Part D coverage for its previously excluded product.

· Assisted several pharmaceutical manufacturers in reinstating Medicaid coverage for products dropped from the program by the Centers for Medicare & Medicaid Services (CMS).

· Assisted numerous pharmaceutical manufacturers to ensure that their research activities conform to HIPAA privacy requirements (activities included preparing investigator disclosure documents, contract research organization (CRO) agreements, clinical trial agreements, service provider agreements, informed consents and authorizations).

Previous Experience

· U.S. Department of Health and Human Services, Deputy General Counsel (1993-2001)

Publications

· "CMS Delays Physician Payments Sunshine Act Data Collection Requirement," Covington E-Alert (5/7/2012), Co-Author

· "From Research to Revenue: Coverage and Reimbursement for Life Sciences Products - When Parallel Review Is Right for You," Bloomberg Law Reports (2/23/2012), Co-Author

· "CMS Issues Proposed Rule to Implement Drug Pricing and Rebate Provisions of the Affordable Care Act," Covington E-Alert (2/10/2012), Co-Author

· "CMS Issues Proposed Rule Implementing Sunshine Act Reports Regarding Ownership or Investment Interests Held by Physicians," Covington E-Alert (1/3/2012), Co-Author

· "CMS Issues Proposed Rule Implementing Sunshine Act: Review, Correction, and Publication of Data on Public Website," Covington E-Alert (12/30/2011), Co-Author

· "CMS Issues Proposed Rule Implementing Sunshine Act," Covington E-Alert (12/23/2011), Co-Author

· "IRS Issues Regulations on Calculation of Branded Prescription Drug Fee," Covington E-Alert (9/1/2011), Co-Author

· "Coverage and Reimbursement Considerations for In Vitro Diagnostics," Bloomberg Health Law Report (June 2011), Co-Author

· "CMS Releases Final Discount Program Model Agreements," Covington E-Alert (8/3/2010), Co-Author

· "HHS Issues Proposed Rule to Implement HITECH Changes to HIPAA," Covington E-Alert (7/26/2010), Co-Author

· "Update on the Medicare Coverage Gap Discount Program," Covington E-Alert (6/3/2010), Co-Author

· "Guide to Applying for Therapeutic Discovery Project Grants and Tax Credits," Covington E-Alert (June 2010), Co-Author

· "CMS Issues Draft Guidance on Medicare Part D Discount Program," Covington E-Alert (5/3/2010), Co-Author

· "Health Care Reform: Annual Fee On Prescription Drug Manufacturers And Excise Tax On Medical Device Manufacturers," Covington E-Alert (4/29/2010), Co-Author

· "Health Care Reform: Medicaid Prescription Drug Reimbursement," Covington E-Alert (April 2010), Co-Author

· "Health Care Reform: Sunshine Provisions," Covington E-Alert (April 2010), Co-Author

· "Health Care Reform: 340B Drug Pricing Program," Covington E-Alert (April 2010), Co-Author

· "Health Care Reform: Medicare Part D Donut Hole and Protected Classes," Covington E-Alert (April 2010), Co-Author

· "Health Care Reform: Therapeutic Discovery Project Tax Credits and Grants for Small Employers," Covington E-Alert (April 2010), Co-Author

· "HHS Issues Rule Implementing Increased Penalties for HIPAA Violations," Covington E-Alert (11/6/2009), Co-Author

· "HHS, FTC Issue Breach Notification Rules for Electronic Health Information," Covington E-Alert (9/1/2009), Co-Author

· "New Maine Law to Restrict Online and Offline Collection, Receipt or Use of Data from Minors for Marketing Purposes," Covington E-Alert (6/19/2009), Co-Author

· "FTC Seeking Comment on Proposed Breach Notification Rule for Electronic Health Information," Covington E-Alert (4/29/2009), Co-Author

· "HHS Issues Guidance and Request for Information on Technologies and Methodologies to Secure Protected Health Information for the Purposes of Breach Notification Provisions," Covington E-Alert (4/29/2009), Co-Author

· "Federal Spending Bill Creates New Categories of Nominal Price Exclusions," Covington E-Alert (3/20/2009), Co-Author

· "Comparative Effectiveness Research Provisions of the American Recovery and Reinvestment Act of 2009," Covington E-Alert (3/6/2009), Co-Author

· "Health Information Technology Provisions in Economic Stimulus Bill Expand Privacy and Security Requirements for Health Information," Covington E-Alert (2/23/2009), Co-Author

· "First Circuit Upholds New Hampshire Law Banning Sale of Prescriber Information," Covington E-Alert (12/1/2008), Co-Author

· "CMS Issues Final Rule to Implement Medicaid Drug Pricing and Reimbursement Provisions of the Deficit Reduction Act," Covington E-Alert (8/7/2007), Co-Author

· "New Hampshire Prescription Data Ban Ruled Unconstitutional," Covington E-Alert (5/17/2007), Co-Author

· "CMS Issues Proposal to Revise Clinical Trial Policy National Coverage Determination," Covington E-Alert (5/3/2007), Co-Author

· "CMS Issues Proposed Rule to Implement Medicaid Drug Pricing and Reimbursement Provisions of the Deficit Reduction Act," Covington E-Alert (1/12/2007), Co-Author

· "California Will Negotiate Drug Prices with Manufacturers in New Discount Drug Program," Covington E-Alert (10/9/2006), Co-Author

· "Employee Education on False Claims Recovery," Covington E-Alert (10/4/2006), Co-Author

· "New HHS Regulations Protect Arrangements Involving Health Information Technology," Covington E-Alert (8/24/2006), Co-Author

· "The Impact of the Deficit Reduction Act of 2005 on Pharmaceutical Manufacturers," Covington E-Alert (3/3/2006), Co-Author

· "CMS Issues Proposed Rule for the Competitive Acquisition Program," Covington E-Alert (4/5/2005), Co-Author

· "Medicare Prescription Drug Benefit: CMS Clarifies Final Rules for Medicare Prescription Drug Benefit Program," Covington E-Alert (4/4/2005), Co-Author

· "Analysis of Final Rule Implementing Medicare Part D Prescription Drug Benefit," Covington E-Alert (2/1/2005), Co-Author

· "Overview of Final Rule Implementing Medicare Part D Prescription Drug Benefit," Covington E-Alert (1/27/2005), Co-Author

· "Medicare Part D: USP Final Model Guidelines," Covington E-Alert (January 2005), Co-Author

· "CMS Establishes PDP and MA Regions," Covington E-Alert (December 2004), Co-Author

· "CMS Issues Ten-Year Record Retention Rule for Medicaid Drug Rebate Program," Covington E-Alert (December 2004), Co-Author

· "Comments Submitted in Response to CMS Medicare Drug Benefit Proposed Rule," Covington E-Alert (December 2004), Co-Author

· "CMS Issues Guidelines for the Review of Part D Formularies and Procedures; Additional Bidding Information Also Provided," Covington E-Alert (December 2004), Co-Author

· "Sponsoring a Medicare Part D Prescription Drug Plan," Covington E-Alert (October 2004), Co-Author

· "Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Final Rule on ASP Calculation Methodology," Covington E-Alert (9/17/2004), Co-Author

· "Key Provisions of the CMS Medicare Drug Benefit Proposed Rule," Covington E-Alert (August 2004), Co-Author

· "Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Interim Final Rule," Covington E-Alert (4/14/2004), Co-Author

· "Average Wholesale Price Reform Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (12/11/2003), Co-Author

· "Prescription Drug Benefit Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (11/26/2003), Co-Author

Judicial Clerkship

· Hon. Harry A. Blackmun, U.S. Supreme Court, 1983-1984

· Hon. Herbert Y.C. Choy, U.S. Court of Appeals, Ninth Circuit, 1982-1983