PUBLIC POLICY IMPACTS ON THE
March 27, 2014
Largest Exclusively MedTech
Organization in the US
Small Company Development
MedTech Investors Conference
Medical Device ExciseTax
User Fee Negotiations/ Sequestration
Sunshine Act Reporting
Chemical Substance Restrictions
Economic Development Bill
Angel Investment Incentive
MEDICAL DEVICE EXCISETAX
2.3% ExciseTax on Most Device Marketed in the U.S.
House of Representatives
Major Overhaul of U.S.Tax Code
Vehicle for MDET Repeal?
R&DTax Credit Extension?
House Plan – Senate?
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
Agency prohibited from spending additional funds
December 2013 – Budget passes
CDRH free to spend funds in escrow
PAYMENT REFORM – MASSACHUSETTS
End of Fee-for-Service Model
Accountable Care Organizations
Role of New MedicalTechnologies?
Language to Protect
National Implications – ACA
Marketing & Sales
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?
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