FacultyFaculty/Author Profile

Vicky G. Gormanly

Arnold & Porter LLP

Washington, DC, USA


Vicky Gormanly is an Associate in the FDA and Healthcare group in the New York office, supporting the needs of a variety of pharmaceutical and other healthcare industry clients. She has particular expertise in representing pharmaceutical companies on a broad range of complex regulatory issues (for example, Medicaid Drug Rebate Program, 340B, Tricare, State Pharmaceutical Assistance Programs, State Supplemental Rebate Programs, Medicare and Medicaid reimbursement, Anti-Kickback Statute), as well as product coverage, coding, payment, and reimbursement issues. Ms. Gormanly also counsels clients in the negotiation of rebate agreements between pharmaceutical manufacturers and pharmacy benefit managers, managed care companies, and group purchasing agreements.

Ms. Gormanly formerly worked as the Medicaid Program Manager for a major pharmaceutical company, where she managed various aspects of government pricing, including calculation methodology, submissions, and regulatory implementation. She led and served on multifunctional team projects related to risk assessment audits, state supplemental rebate programs, and health care reform. Prior to that role, she was the Medicaid Administrator at another pharmaceutical manufacturer, where she managed government pricing and resolved Medicaid Drug Rebate Program disputes.

Ms. Gormanly serves in an advisory capacity with The Focus Approach Law Review, where she advises, mentors, and educates students about the Law School Admission Test, the law school admissions application process, and the challenges of being a 1L. Ms. Gormanly also assists Focus with its diversity initiatives.

Experience

Life Sciences and Healthcare Regulatory

  • Advises pharmaceutical manufacturers on drug pricing issues under the 340B program, Medicaid, Medicare, and the Department of Veterans Affairs healthcare program; prepares drug price reporting policies and reasonable assumptions; provides guidance on internal audits and price recalculation projects.
  • Counsels pharmaceutical manufacturers on compliance with federal laws relating to healthcare fraud and abuse, including the Anti-Kickback Act and the False Claims Act.
  • Drafts comments to CMS and other HHS agencies on behalf of drug manufacturers and industry associations on proposed rules and guidance regarding drug reimbursement and price reporting issues.
  • Advises pharmaceutical manufacturers on coverage and reimbursement issues relating to Medicaid and Medicare.
  • Counsels pharmaceutical manufacturers on implementation of recent health care reform legislation.


Perspectives

 
April 1, 2016
CMS Delays Enforcement of 5i AMP Provisions
Legal Alert

January 25, 2016
CMS Releases Final Medicaid Rebate Rule
Arnold & Porter Advisory

December 1, 2015
Pharmaceutical and Medical Device Compliance Update: Management of Critical and Emerging Legal Challenges
Arnold & Porter Seminar/Conference

September 1, 2015
HRSA Issues Proposed "Omnibus 340B Guidance"
Arnold & Porter Advisory

June 18, 2015
HRSA Issues Proposed Rule on 340B Ceiling Price Calculations and Manufacturer Civil Monetary Penalties
Arnold & Porter Advisory

July 29, 2013
HRSA Issues Final Rule on Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program
Arnold & Porter Advisory

Credentials

Education

  • JD, Pace Law School, 2009, cum laude
  • BS, Post University, 2005

Admissions

  • New York
  • District of Columbia
  • Connecticut

Focus Areas

Life Sciences and Healthcare Regulatory
Pharmaceutical/Medical Device
Vicky G. Gormanly is associated with the following items:
Answer Book Chapters  Answer Book Chapters Pharmaceutical Price Reporting: The “ABCs” and “123s” of Compliance - Pharmaceutical Compliance and Enforcement Answer Book (2017 Edition), Monday, April 17, 2017
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