Rosemary Maxwell focuses on healthcare compliance and public policy issues, Medicare and Medicaid coverage and reimbursement (including the Medicare Part D prescription drug benefit), Medicaid rebate calculations and related price reporting requirements, healthcare privacy law, and related regulatory issues affecting pharmaceutical and medical device manufacturers. Rosemary has represented drug and device manufacturers in preparing submissions to the Centers for Medicare & Medicaid Services, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), and other HHS agencies; in conducting compliance reviews and preparing compliance policies; in litigation matters involving allegations of fraud against Medicare and Medicaid; in internal investigations; and in a wide variety of counseling matters.
Rosemary has written on topics such as the civil and criminal fraud statutes, Medicare and Medicaid drug reimbursement, Medicare coverage issues, State initiatives to control healthcare spending, and First Amendment commercial speech principles in the healthcare arena. She is the co-author, with Grant Bagley, of the Medicare Drug Reimbursement Guide published by FDC Reports.
Experience
- Developing and revising for pharmaceutical clients policies and procedures on calculation of government pricing metrics, and on various compliance-related issues such as grant awards.
- Preparing submissions to HHS-OIG, including requests for new or revised anti-kickback safe harbors and for advisory opinions.
- Providing substantive advice on Medicare Part D issues.
- Analyzing Medicare reimbursement issues and prospects for new products.
- Comments to CMS and other HHS agencies for major pharmaceutical clients on the Inflation Reduction Act (IRA) drug-related issues, Medicaid rebate calculations, ASP calculations, Section 340B drug discount program issues, and Medicare coverage and payment issues.
Perspectives
Credentials
Education
- J.D., The George Washington University Law School, 1987, summa cum laude, with highest honors
- M.A., Economics, State University of New York, 1984
- B.A., State University of New York, 1981
Admissions
- District of Columbia
- Virginia