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. Ms. Maxwell has represented drug and device manufacturers in preparing submissions to the Centers for Medicare and Medicaid Services, the US Department of Health and Human Services (HHS) Office of Inspector General, 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.

Ms. Maxwell 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 the HHS Office of Inspector General, including requests for new or revised anti-kickback safe harbors and for advisory opinions.
  • Providing substantive advice on Medicare Part D issues in litigation.
  • Analyzing Medicare reimbursement issues and prospects for new products.
  • Comments to CMS and other HHS agencies for major pharmaceutical clients on Medicaid rebate calculations, ASP calculations, Section 340B drug discount program issues, and Medicare coverage and payment issues.

Perspectives

21st Century Cures Act: What Life Sciences Companies Need To Know
Arnold & Porter LLP
The 21st Century Cures Act
Arnold & Porter Advisory
HRSA Releases Proposed Rule Governing the 340B Administrative Dispute Resolution Process
Arnold & Porter Advisory
CMS Delays Enforcement of 5i AMP Provisions
Legal Alert
CMS Releases Final Medicaid Rebate Rule
Arnold & Porter Advisory
More

Credentials

Education
  • JD, The George Washington University Law School, 1987, summa cum laude, with highest honors
  • MA, Economics, State University of New York, 1984
  • BA, State University of New York, 1981
Admissions
  • District of Columbia
  • Virginia
Overview

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