Amanda Grimm Wiegrefe
932 Whitstable Blvd., Arnold,MD
Summary
Highly motivated healthcare policy professional with extensive experience working with federal and private sector organizations to inform and assure positive change in public health. Knowledgeable in regulatory policies with emphasis on Food and Drug Administration and extensive experience in the member- driven, association landscape. Known for personal and professional integrity and dedication to ensure the highest quality of patient care.
Overview
16
16
years of professional experience
Work History
Associate Director, Government Relations
AmericanSociety of Cataract and Refractive Surgery
01.2024 - Current
- Developed relationships with policymakers, specifically within the FDA
- Actively participated in industry interactions
- Coordinated policy analysis on major Medicare physician payment efforts, including the Physician Fee Schedule
Director, Regulatory Affairs
American College Of Rheumatology
11.2019 - Current
- Lead the development of all ACR regulatory policies, including updating biosimilar position statements, Medicare physician reimbursement, and telehealth policies
- Established relationships with key regulatory agencies, including FDA, CMS, and NIH
- Serve as subject matter expert on drug pricing, biosimilars, drug shortages, and vaccines for the immunocompromised patient population
- Serve as the key contact with the White House COVID-19 Task Force during the public health emergency
- Collaborate with the Federal and state advocacy teams on overlapping issues, including pharmacy benefit management reform, telehealth policies following the public health emergency, and drug pricing
- Collaborate with the Marketing and Communications colleagues to disseminate pertinent policy changes to ACR members and other interested stakeholders
Assistant Director, Government Relations
The Society of Thoracic Surgeons
05.2017 - 10.2019
- Working with the Advocacy team and physician leaders, assisted with the development of legislative priorities while monitoring legislative and administrative actions that impact cardiothoracic surgeons
- Analyze policy, including proposed legislation and administrative rules, to determine the potential impact on cardiothoracic surgeons
- Lead the drafting of comments on the Medicare Physician Fee Schedule, the Acute Inpatient Prospective Payment System, and the Hospital Outpatient Prospective Payment System
- Developed strong working relationships with physician associations to identify and collaborate on legislation and policy proposals of mutual interest
- Represent The Society in coalitions, such as the MACRA Alliance, a coalition aimed to improve the Medicare Access and CHIP Reauthorization Act (MACRA) statute
- Assist the Director in identifying the appropriate pathway for cardiothoracic surgeons to participate in Alternative Payment Models (APMs) and collaborating with other professional societies on the development of APMs
- Assist the Director in communication with the Centers for Medicare and Medicaid Innovation (the Innovation Center) on appropriate clinical episodes and quality measures to be included in upcoming APMs
Associate Director, Practice Management and Delivery Systems Policy
American Psychiatric Association
03.2016 - 05.2017
- Identify patient privacy issues in health information technology with a focus on mental health and substance abuse disorders
- Collaborate with policy team to understand and analyze various healthcare delivery system models
- Lead all APA efforts on FDA issues, including risk evaluation and mitigation strategies (REMS), the FDA's efforts on combating the opioid abuse epidemic, medical device reclassification, and the Precision Medicine Initiative
- Lead APA efforts to understand current pharmacologic issues related to formulary and drug pricing concerns in the mental health community
Manager, Federal Policy
Cystic Fibrosis Foundation
10.2015 - 02.2016
- Served as team lead on all issues related to the FDA
- Represented the Foundation before Members of Congress
- Served as liaison with the House of Representatives Cystic Fibrosis Caucus
Senior Associate
Leavitt Partners Collaborative Advocates
04.2015 - 10.2015
- Managed projects for the coalition seeking legislative and regulatory solution for oversight of laboratory-developed tests
- Led research on client engagement, focusing on legislative and regulatory policies and partnering opportunities for stroke research
Manager, Regulatory and Public Policy
American Academy of Dermatology Association
12.2008 - 04.2015
- Liaised between the FDA, CDC, NIH, industry partners, Pharmaceutical Research and Manufacturers of America (PhRMA), and Biotechnology Industry Organization (BIO) on efforts to provide education on biologics, biosimilars, and interchangeability
- Represented the Academy in a number of biosimilar focused coalitions, including the Biologics Coalition and Alliance for Safe Biologic Medicines
- Served as Advocacy and Public Policy lead on Academy skin cancer awareness/prevention initiatives and public health/regulatory policy
- Led a workgroup of legislative, state, and research colleagues to identify and shape public policy positions on issues regarding biosimilars, sunscreen labeling, indoor tanning, compounding, drug shortages, and risk evaluation and mitigation strategies
- Led an interdepartmental team in providing research on the dangers of tanning bed devices to the FDA, and encouraged reclassification of tanning bed devices
- Identified dermatology-specific drug shortages and work with FDA to rectify access to drugs
- Worked with physicians and staff to encourage drug development for rare diseases under the Best Pharmaceutical for Children Act
- Monitored and analyzed key issues regarding regulatory issues and the impact on the practice and medicine, particularly with regard to approval pathway for biosimilars
- Summarized, analyzed, and interpreted proposed and final rules from the FDA, NIH, and Agency for Health Research and Quality
Education
Masters of Science - Health Sciences Regulatory Affairs
The George Washington University
Washington, DC2012
Bachelor of Arts - Political Science; Focus on Public Policy
The George Washington University
Washington, DC2008
Skills
- FDA policies and regulatory framework
- Pharmaceutical and device approval process
- Access to care issues, including drug pricing and formulary design
- Policies related to physician reimbursement and practice
- Alternative health delivery system initiatives
- Ensuring quality patient care
- Analytical problem solving
- Relationship building with key stakeholders
- Teamwork
Accomplishments
- Led a cross-functional team in advocating for the reclassification of sunlamps and sunlamp products by including a black box warning.
- Partnered with Centers for Disease Control and Prevention (CDC), Office of the Surgeon General (OSG), and other stakeholders to unveil the Surgeon General's Call to Action on Skin Cancer Prevention.
- Collaborated with Congressional policy colleagues during the drafting and passage of the Drug Quality and Safety Act and Sunscreen Innovation Act.
- Served as the primary contact for all regulatory telehealth flexibilities, drug shortage issues, and regulatory implications related to the Public Health Emergency on the Coronavirus
- Served as primary contact for the White House COVID-19 Task Force
Publications
Ernst, A., Grimm, A., and Lim, H. W. (2015). Tanning lamps: Health effects and reclassification by the Food and Drug Administration. Journal of the American Academy of Dermatology,72(1), 175-180. doi:10.1016/j.jaad.2014.10.016
Professional Development
- Leading Women in Associations Workshop
- Communication Matters Executive Coaching and Training
Timeline
Associate Director, Government Relations
AmericanSociety of Cataract and Refractive Surgery
01.2024 - Current
Director, Regulatory Affairs
American College Of Rheumatology
11.2019 - Current
Assistant Director, Government Relations
The Society of Thoracic Surgeons
05.2017 - 10.2019
Associate Director, Practice Management and Delivery Systems Policy
American Psychiatric Association
03.2016 - 05.2017
Manager, Federal Policy
Cystic Fibrosis Foundation
10.2015 - 02.2016
Senior Associate
Leavitt Partners Collaborative Advocates
04.2015 - 10.2015
Manager, Regulatory and Public Policy
American Academy of Dermatology Association
12.2008 - 04.2015
Masters of Science - Health Sciences Regulatory Affairs
The George Washington University
Bachelor of Arts - Political Science; Focus on Public Policy
The George Washington University