Staff by Issue

Contact Main Office: 202- 783-8700 Direct Dial: 202-434-7###

510(k) Ruey Dempsey X220

ACOs & Bundling Richard Price X227

AdvaMedDx Tharini Sathiamoorthy X279

AdvaMedDx Andy Fish X222

Advertising & Promotion Khatereh Calleja X267

Advisory Panels (Nominations) Zach Rothstein X224

Advisory Panels (General) Sharon Segal X243

Ambulatory Surgical Centers DeChane Dorsey X218

APEC Code of Ethics Initiative Nancy Travis X275

Automatic Identification (UDI) Zach Rothstein X224

Best Practices of Code of Ethics Terry Chang X214

Blood Regulation Ruey Dempsey X220

Brazil Steven Bipes X205

Business Development Ashley McMaster X245

California PAC Colin Canavan X215

China Zach Helzer X104

China Charitable Giving Nancy Travis

Ralph Ives X275/X270

CLIA Khatereh Calleja X267

Clinical Trials Tara Federici X208

Coding DeChane Dorsey X218

Combination Products Sharon Segal X243

Comparative Effectiveness Research Chandra Branham X219

Competitive Bidding Richard Price X227

Compliance Terry Chang X214

Congressional Advocacy JC Scott X242

Congressional Advocacy Colin Canavan X215

Coverage (Medicare) Chandra Branham X219

Custom Devices Tara Federici X208

Device & Diagnostics Compliance Terry Chang X214

Device Pricing Richard Price X227

Device Tax Christopher White X217

Diagnostics: Government Affairs Duane Wright X278

Diagnostics: Regulatory Khatereh Calleja X267

Diagnostics: Payment and Coverage Chandra Branham X219

Direct HCP Sponsorship Terry Chang X214

Domestic Device & Diagnostics Terry Chang X214

Durable Medical Equipment (Medicare) Richard Price X227

Dx Compliance Terry Chang X214

Accel Ashley Wallin X221

Accel: Government Affairs Elizabeth Pika Sharp X241

Accel: Public Affairs Wanda Moebius X240

Accel: Legal & Compliance Terry Chang X214

Electronic Submissions Sharon Segal X243

Enforcement Zach Rothstein X224

Environmental Health & Safety Awareness Ruey Dempsey X220

Ethics and Health Care Compliance Committee Christopher White X217

EU-15 Initial Members Joe Gatewood X274

European Union Joe Gatewood X274

European Union Code of Ethics Nancy Travis X275

Evidence-Based Value in Orthopedics Richard Price X227

FCPA Christopher White X217

FDA Strategy Janet Trunzo X228

FDA Vendor Days Ruey Dempsey X220

Fly-Ins Ryan Strandlund X206

Fundraising Colin Canavan X215

Germany Joe Gatewood X274

Global Harmonization Janet Trunzo

Christopher White X228/X217

Global Policy & Trade: Government Affairs Duane Wright X278

Global Policy & Trade: Public Affairs Jon Dobson X272

Grassroots Ryan Strandlund X206

HCIR Credentialing Terry Chang X214

Digital Medical Technology Zach Rothstein X224

Heart Valves Ruey Dempsey X220

Home Use Tara Federici X208

Humanitarian Use Tara Federici X208

IDE Tara Federici X208

IDE: Coverage Chandra Branham X219

Implantable Cardioverter/Defibrillators Ruey Dempsey X220

India Abby Pratt X277

Infusion Pumps Tara Federici X208

Inpatient Hospital Payments Richard Price X227

Inspections Sharon Segal X243

Intellectual Property Terry Chang X214

International Board Committee Ralph Ives X270

International Trade Policies Ralph Ives X270

International Policy Working Group Ralph Ives X270

Interventional Cardiology Ruey Dempsey X220

InVitro Diagnostics Tharini Sathiamoorthy X279

Invoices Chelsea Shin X252

Italy Joe Gatewood X274

Japan Phil Agress X210

Labeling Zach Rothstein X224

Latin America Code of Ethics

Nancy Travis

Christopher White

Steven Bipes

X275

X217

X205

Legal Committee Christopher White X217

Legal: Government Affairs Elizabeth Pika Sharp X241

Legal: Public Affairs Jon Dobson X272

Life Changing Innovation Danielle Blake X233

Marketing Rachel Johnson X235

Medical Device Tax Repeal Riley Swinehart X209

Medical Device User Fee Implementation Janet Trunzo X228

MedTech Veterans Program Ashley McMaster X245

Member Retention Ashley McMaster X245

Middle East Abby Pratt X277

Nominating and Governance Committee Nancy Travis X275

Ophthalmic Devices Sharon Segal X243

Orphan Devices Tara Federici X208

Orthopedic: T&R Tara Federici X208

Orthopedic: Payment Richard Price X227

Outpatient Prospective Payment System DeChane Dorsey X218

PAC Colin Canavan X215

Pacemakers Ruey Dempsey X220

Pediatrics Tara Federici X208

Physician Payment DeChane Dorsey X218

PMA Sharon Segal X243

Postmarket Policy Zach Rothstein X224

Preparedness Sharon Segal X243

Quality: Payment Steve Brotman X207

Quality: T&R Sharon Segal X243

Recalls Zach Rothstein X224

Reclassification Khatereh Calleja X267

Registration & Listing Zach Rothstein X224

Reportable Events (MDRs) Zach Rothstein X224

Reuse Tara Federici X208

Russia Abby Pratt X277

South East Asia Phil Agress X210

Software Zach Rothstein X224

State Affairs Tom Tremble X216

Standards Sharon Segal X243

Standards: Diagnostics Khatereh Calleja X267

State Government Relations Representative (Eastern U.S.) Tom Tremble X216

State Government Relations Representative (Western U.S.) Carrie Hartgen X265

State Medical Technology Alliance (SMTA) Carrie Hartgen X265

Statistics Ruey Dempsey X220

Sunshine Implementation Christopher White X217

Taiwan Zach Helzer X104

Technology & Regulatory: Government Affairs Elizabeth Pika Sharp X241

Technology & Regulatory: Public Affairs Marker Brager X244

Tier I Markets Ralph Ives X270

Tissue Engineering Sharon Segal X243

Transmissible spongiform encephalopathy TSE Ruey Dempsey X220

UK Joe Gatewood X274

User Fees Janet Trunzo X228

Warning Letters Zach Rothstein X224

Website Management Elyse Petroni X271

Wound Management DeChane Dorsey X218

AdvaMed Issues by Department

Government Affairs

JC Scott

Senior Executive Vice President, Government Affairs

202-434-7242

Strategic Planning on all federal and state advocacy issues

Department Management

Congressional Advocacy

Elizabeth Pika Sharp

Senior Vice President & Managing Director, Federal Government Affairs

202-434-7241

Technology and Regulatory

MDUFA

FDASIA oversight & implementation

510(k)

UDI

Post-market Surveillance

FDA Funding Issues

Mobile medical apps

All other FDA regulatory issues

Legal

Patent Reform

Preemption

Accel & Small Business Issues

Tax reform incentives for investment in small companies

Working Groups

FDA Advocacy Work Group(FDA-AWG)

Duane Wright

Vice President, Government Affairs

202-434-7278

Diagnostics

Regulatory

Lab Developed Tests (LDTs)

Payment Reform

Payment

Imaging

Deficit Reduction

Price Transparency

Competitive Bidding

ACOs and other alternative payment models

All other legislative policy related to CMS

Working Groups

Payment Advocacy Work Group (PAWG)

Riley Swinehart

Vice President, Government Affairs

202-434-7209

Medical Device Tax Repeal

Legal Policy

Sunshine

Debarment

Foreign Corrupt Practices Act (FCPA)

Physician Owned Distributors

Global Policy and Trade

TWG

TIPP

Transatlantic Trade and International Partnership (TTIP)

ITA

Working Groups

Trade Advocacy Work Group (TAWG)

Device Tax Advocacy Work Group

Tom Tremble

Vice President & Managing Director, State Government Affairs

202-434-7216

State Government Relations Representative (Eastern U.S.)

Payment reform cost containment efforts

o Technology Assessment and Transparency

Mandates on Disposal of Needles, Syringes, and other Medical Sharps

Extended producer responsibility and chemical restrictions

State Competitiveness Agenda, a proactive initiative advocating a set of beneficial public policies

Working Groups

State Affairs Working Group

Carrie Hartgen

Vice President, State Government Relations and Regional Affairs

202-434-7216

State Government Relations Representative (Western U.S.)

Payment reform cost containment efforts

o Technology Assessment and Transparency

Mandates on Disposal of Needles, Syringes, and other Medical Sharps

Extended producer responsibility and chemical restrictions

State Competitiveness Agenda, a proactive initiative advocating a set of beneficial public policies

Health Technology Assessment

o Viscosupplementation Coalition

State Medical Technology Alliance

Alliance of state medtech trade associations

Working Groups

State Affairs Working Group

Colin Canavan

Director, PAC and Political Advocacy

202-434-7215

Fundraising

PAC event planning

PAC fundraising

Compliance / Federal Election Commission

California PAC

Compliance

Ryan Strandlund

Manager, Grassroots and Member Engagement

202-434-7206

Grassroots/Member Engagement

Grassroots action alerts

Communications

Capitol Hill Fly-Ins

Life Changing Innovation

Employee education on engaging in advocacy activities

Event Planning

Technology and Regulatory Affairs

Janet Trunzo

Senior Executive Vice President, Technology and Regulatory Affairs

202-434-7228

Working Groups

Global Harmonization Working Group

FDA Strategy Working Group

T&R Regulatory Working Group

Other Regulatory Topics

Medical Device User Fee Implementation (MDUFA)

Ruey Dempsey

Vice President, Technology and Regulatory Affairs

202-434-7220

FDA Vendor Days

FDASIA requirements to hold two vendor days a year

Promote interaction of FDA & industry

Active Working Groups

510(k) Working Group

o New 510(k) for device modifications

o Use of symbols

o Color Additives

Blood FDA Working Group

Environmental, Health & Safety Awareness Working Group

Interventional Cardiology Working Group

o AF Ablation Catheters

o Cardiac Assist Devices

o Drug eluting stents

Pacemaker & Implantable Defibrillator Working Group

Heart Valve Working Group

Statistics Working Group

o Annual FDA/AdvaMed Statistics Workshop

Monitoring Working Groups

Radiation Therapy Working Group

TSE Working Group

EMC Working Group

Transmissible spongiform encephalopathy (TSE)

Khatereh Calleja

Senior Vice President, Technology and Regulatory Affairs

202-434-7267

Active Working Groups

Advertising and Promotion Working Group

Diagnostics Task Force Working Group

Diagnostics Blood Glucose Monitoring (BGM) Working Group

Diagnostics CLIA Working Group

Diagnostics Exemptions Working Group

Diagnostics Labeling Working Group

Diagnostics PRE-IDE Working Group

Personalized Medicine & Molecular Diagnostics Working Group

Ad-Hoc Groups

Appeals

Notice to Industry

Emerging Diagnostics

Zach Rothstein

Associate Vice President, Technology and Regulatory Affairs

202-434-7224

Active Working Groups

Automatic Identification (UDI) Working Group

o Conforming Amendments

o Direct Marking

o Kits

Digital Medical Technology

Postmarket Policy Working Group

o Postmarket Surveillance

o Recalls

o Adverse Events (MDRs)

Software Working Group

o Cybersecurity

Ad-Hoc Groups

Dental Products Working Group

Registries

Other Regulatory Topics

Enforcement

Inspections

Warning Letters

Tara Federici

Vice President, Technology and Regulatory Affairs

202-434-7208

Active Working Groups

Clinical Trials Working Group

Infusion Pump Working Group

Orthopedic Compliance Working Group

Orthopedic Products Working Group

Orthopedic Spine Working Group

Pediatric Working Group

Reuse Working Group

Orthopedic POC Project Team

Ad Hoc Groups

Home Use Working Group

UDI/Orthopedic Trays Working Group

Battery Working Group

Sectors

Orthopedics

Other Regulatory Topics

Custom Devices

Humanitarian Use

IDE

Orphans

Sharon Segal

Vice President, Technology and Regulatory Affairs

202-434-7243

Working Groups

Combination Products Working Group

PMA Working Group

o 30-Day Notice

o Advisory Panels

o Benefit Risk

Quality Systems Working Group

o Case for Quality Working Group

Design Control CtQs

Supplier Quality-Purchasing Controls

Success Metrics-Governance

Monitoring Working Groups

Preparedness Working Group

Tissue Engineering Products Working Group

Nanotechnology

Ad HOC Working Groups

Biocompatibility Working Group

Sector

Ophthalmic Devices

Global

Ralph Ives

Executive Vice President, Global Strategy and Analysis

202-434-7270

Strategic Planning

Country Responsibilities

International Strategy

Tier I Markets

International Trade Policies

Working Groups

International Board Committee

International Policy Working Group

Non Member International Policy Working Group

Phil Agress

Senior Vice President, Global Strategy and Analysis (Asian Region)

202-434-7210

Japan

Reimbursement & Regulation

o Revision of Reimbursement rates

o Foreign Average Pricing Rules (FAP)

Regulatory

o Action Program for Speedy Approval of Medical Devices

Quality Management Systems (QMS)

Medical Device Promotion Law

Revised Pharma Affairs Law (PAL)

South East Asia

ASEAN-Association of South East Asian Nations

Regulatory Harmonization

Working Groups

Trans-Pacific Partnership FTA

Commerce Department Manufacturing Council

Export Now!

Australia

New Zealand

Joe Gatewood

Vice President, Global Strategy and Analysis

202-434-7274

Country Responsibilities

UK

MedTech Group & Advocacy

Technology uptake

Health care reform

Germany

Reimbursement

Advocacy

o Ketchum Pleon

o Aktion Meditech

o Med Insight Germany Journal

Italy

Health Care Reform

Assobiomedia

Embassy of Italy

EU- 15 Initial Members

Regulatory Issues

HTA

European Union

MDD/IVD

Coordination with Eucomed

Korea

KORUS Free Trade (KFT)

Policy Responsibilities

Reimbursement

Health Technology Assessment

Procurement

Compliance

Global Reimbursement

Pan EU Regulatory

Working Groups

UK Working Group

Korea Working Group

Germany Working Group

Italy Working Group

France Working Group

EU Regulatory Working Group

Steven Bipes

Associate Vice President, Global Strategy and Analysis

202-434-7205

Brazil

ABIIS (Brazilian Alliance of Innovative Health Industry)

LATAM Annual Compliance Conference

CEO Delegation

Best Practices on regulatory, reimbursement, standards and compliance

Brazil FCPA

Working Groups

Latin American Working Groups

o Brazil Working Group – Regulatory, Reimbursement and Standards

o Brazil Compliance Working Group

o Colombia Working Group

o Mexico Working Group

o Latin America Compliance Working Group

Zach Helzer

Associate Vice President, Global Strategy and Analysis

202-434-7104

China

Promoting value & representing device industry

China Council Task Force

Regulatory Issues & Politics

China Ethical Business Compliance

WTO Technical Business Compliance

Taiwan

TAMTA

TIFA

Working Groups

China Working Group

Hong Kong Working Group

Taiwan Working Group

Abby Pratt

Vice President, Global Strategy and Analysis

202-434-7277

India

Medical device regulation

Government processes around reimbursement and pricing

PR Activities to create awareness about the medical device industry

Russia

Localization barriers to trade

Medical Device regulation

Coordination with IMEDA

Middle East

New Regulatory & Reform Process

Medomed

Best Practices

Registered new products

Working Groups

India Working Group

Turkey Working Group

Russia Working Group

Middle East Working Group

WHO

Legal

Christopher White

Senior Executive Vice President, General Counsel

202-434-7217

Legal Policy

Device Tax

Sunshine Implementation / Engagement with CMS

Debarment bill to expand OIG permissive exclusion authority

FCPA Industry Guidance to Mitigate Risk

Global Code Harmonization o Asia Pacific Economic Corporation (APEC) o Latin America

Committees

Legal Committee

Board Committee on Ethics & HealthCare Compliance

GMTCC- International Compliance Conference

Working Groups

Joint AdvaMed-Eucomed Distributor Working Group

Legal Committee Exclusion Working Group

Sunshine Implementation Working Group

Sunshine Communications Working Group

Global Compliance Officers Working Group

Global Compliance Steering Group

Legal Affairs Group

Terry Chang

Associate General Counsel & Director, Medical and Legal Affairs

202-434-7214

Legal Policy

Intellectual Property

Direct HCP Sponsorship

Administer Committee on Ethics & Health Care Compliance

Best Practices of Code of Ethics

Manage Spring Device & Diagnostics Compliance Group (DDCG)

Compliance

Dx Compliance

DxIP

InVitro Diagnostics

Healthcare Industry Representation Compliance

Healthcare Industry Compliance

Dx Legal Affairs

Domestic Device & Diagnostics

Accel Legal & Compliance

Lead Dental Compliance

Working Groups

HCIR Credentialing Working Group

Intellectual Property Working Group

Device & Diagnostics Compliance Working Group

CVS Task Force

Off-Label Compliance Working Group

Industry Management Working Group

Inventory Management Working Group

Dental Compliance Working Group

Nancy Travis

Vice President, International Compliance and Governance

202-434-7275

Legal Policy

China Charitable Giving

Compliance

International Code of Ethics Compliance

APEC Code of Ethics Initiative

Global Compliance & Code Harmonization

Latin America Code of Ethics Initiative

European Union Code of Ethics Initiative

Working Groups

Asia-Pacific Compliance Working Group

Asia-Pacific Regulatory Working Group

APEC Healthcare Association Working Group

Nominating and Governance Committee

Payment and Health Care Delivery Policy

Don May Executive Vice President, Payment and Health Care Delivery Policy 202-434-7203

Strategic Planning Department Management

Working Groups

Payment Policy Working Group Chandra Branham Vice President, Payment and Health Care Delivery Policy 202-434-7219 Coverage

Medicare Coverage Issues

Coverage with Evidence Development

National & Local Coverage Determinations

Diagnostic Coding and Payment Issues

Clinical Laboratory Fee Schedule

Rate-setting

Diagnostic Evidence Issues

Diagnostic Payment Coding Reforms

Comparative Effectiveness Research (CER)

Patient-Centered Outcomes Research Institute (PCORI)

Working Groups

Diagnostics Payment Work Group (DPWG)

Coverage and Coding Work Group

Steven Brotman, M.D., J.D. Senior Vice President, Payment and Health Care Delivery Policy 202-434-7207 Quality Measures

Value-Based Purchasing/Pay-for-Performance

o Hospital Inpatient Value-Based Purchasing Program

o Physician Value-Based Payment Modifier (Physician Modifier)

o Accountable Care Organization (ACO)/Medicare Shared Savings Program (MSSP)

Quality Reporting Programs / Pay-for-Reporting Programs

o Inpatient Quality Reporting (IQR) Program

o Hospital Outpatient Quality Reporting (OQR) Program

o Ambulatory Surgical Quality Reporting Program

o Physician Quality Reporting System (PQRS)

Pre-Rulemaking Quality Measures

o Measure Applications Partnership (MAP)

MAP Coordinating Committee

Measure Selection Criteria

MAP Workgroups Hospital, Clinician, PAC/LTC, and Dual Eligible

Beneficiaries

MAP Task Forces

Measure Development

o Identification of Measure Gap Areas

o Measure Specifications, Testing & Evidence Criteria

o NQF Measure Incubator Program

Measure Endorsement

o NQF Consensus Development Process (CDP)

o NQF Evaluation/Endorsement Criteria

o NQF Standing Committee Musculoskeletal Disorders

NQF Supplier-Industry Council

AdvaMed Workgroups

o Quality Workgroup

o Chief Medical Officers Group

DeChane Dorsey Vice President, Payment and Health Care Delivery Policy 202-434-7218

Ambulatory Surgical Centers

ASC Comments

Payment Policies

Procedure List

Coding

HCPCS Coding Process

CPT Process and Policy Issues

Pathology Coding Caucus

ICD-10

Outpatient Prospective Payment System

Charge Compression

Annual Outpatient Prospective Payment Comments

External Data

New Technology Pass-through

Payment Improvements

Physician Payment Issues

Annual Fee Schedule Comments

Practice Expense

Physician Payment Issues

Annual Fee Schedule Comments

Payment Policies Wound

Various Payment Policy Concerns

Coding issues

Work Groups

Wound Healing & Tissue Regeneration Sector

Coverage and Coding Workgroup (coding piece)

Radiation Therapy

Imaging

Quality of Life

Richard Price Senior Vice President, Payment and Health Care Delivery Policy 202-434-7218

Competitive Bidding

Payment Issues

Regulation Analysis and Response

Inpatient Hospital Payments

Annual Inpatient Prospective Payment System Comments

New Technology Add-On Payments

Short Stay Payment Policy

ACOs & Bundling

CMMI (Innovation Center)

Medicare Shared Savings Program

Pioneer ACOs

Bundling Models

Shared savings and gainsharing rewards

Quality

Orthopedic Sector

Gainsharing

Spine Reimbursement Issues

Inpatient Payment Hospital Issues

Warranties

Device Pricing

Price Transparency

Trends in Prices of Implantable Devices

Device Price Increase vs. CPI Increase

Trends in Device Spending as a Share of National Health Expenditures

Work Groups

Competitive Bidding

IPPS

Orthopedic Reimbursement

AdvaMed Accel

Ashley Wallin

Executive Director and Senior Vice President, AdvaMed Accel

202-434-7241

AdvaMed Accel Board of Directors

Emerging and Early-Growth Company Strategy

Tax Reform and Capital Formation

o Tax Reform incentives for investment in small companies

o JOBS Act

Technology & Regulatory

o Small Company “US Submission Program”

o Innovation Pathway

Legal and Compliance

o Compliance for Small Companies – Policy Development & Programming

o Patent Reform

Working Groups

Accel Tax Reform Working Group