Thomas J. Sommer, President, MassMEDIC

1. PUBLIC POLICY IMPACTS ON THE
MEDTECH SECTOR
Boston BIOMEDevice
March 27, 2014

2. MASSMEDIC
Largest Exclusively MedTech
Organization in the US
Three Objectives
 Access
 Networking
 Informational Seminars
 Advocacy
 State
 Federal
 Small Company Development
 MedTech IGNITE
 MedTech Investors Conference

3. ADVOCACY
Federal
 Medical Device ExciseTax
 User Fee Negotiations/ Sequestration
 ACA Implementation
 Payment Reform/ACO
 Sunshine Act Reporting
 FDA Appropriations
State
 Payment Reform
 Chemical Substance Restrictions
 Non-compete Legislation
 Economic Development Bill
 Angel Investment Incentive

4. MEDICAL DEVICE EXCISETAX
 2.3% ExciseTax on Most Device Marketed in the U.S.
 Repeal Efforts
 Since 2009
 House of Representatives
 Senate
 Tax Reform
 Major Overhaul of U.S.Tax Code
 Vehicle for MDET Repeal?
 R&DTax Credit Extension?
 House Plan – Senate?

5. MEDICAL DEVICE USER FEES
 2012 – Industry/Agency Agreement
 Doubles Fees - $600 million per year
 510(k) - $5,200 – PMA - $258,00
 New funds to pay for technology assessment, new hires, training
 Sequestration
 Agency prohibited from spending additional funds
 December 2013 – Budget passes
 CDRH free to spend funds in escrow
 VC Impact

6. PAYMENT REFORM – MASSACHUSETTS
 End of Fee-for-Service Model
 Accountable Care Organizations
 Bundled Payments
 Role of New MedicalTechnologies?
 Language to Protect
 National Implications – ACA
 Paradigm Shift
 Design
 Manufacturing
 Marketing & Sales

7. EUROPEAN UNION
 Poly Implant Prothèse Scandal
 EU seeks to reform product review process
 Bill Pending – More clinical trial data required -- CE Process
 EU Elections –
 Eucomed – National organizations – lobby against enhanced review process
 Action later this year?

8. WHAT’S AHEAD….
 Mid-Term Elections – Senate/House
 Tax Reform – Next Months Critical
 Improvements in FDA ReviewTimes?
 EU process review
 New Healthcare Economy – long-term impact on medtech sector