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