PUBLIC POLICY IMPACTS ON THE
MEDTECH SECTOR
Boston BIOMEDevice
March 27, 2014
MASSMEDIC
Largest Exclusively MedTech
Organization in the US
Three Objectives
 Access
 Networking
 Informational Semina...
ADVOCACY
Federal
 Medical Device ExciseTax
 User Fee Negotiations/ Sequestration
 ACA Implementation
 Payment Reform/A...
MEDICAL DEVICE EXCISETAX
 2.3% ExciseTax on Most Device Marketed in the U.S.
 Repeal Efforts
 Since 2009
 House of Rep...
MEDICAL DEVICE USER FEES
 2012 – Industry/Agency Agreement
 Doubles Fees - $600 million per year
 510(k) - $5,200 – PMA...
PAYMENT REFORM – MASSACHUSETTS
 End of Fee-for-Service Model
 Accountable Care Organizations
 Bundled Payments
 Role o...
EUROPEAN UNION
 Poly Implant Prothèse Scandal
 EU seeks to reform product review process
 Bill Pending – More clinical ...
WHAT’S AHEAD….
 Mid-Term Elections – Senate/House
 Tax Reform – Next Months Critical
 Improvements in FDA ReviewTimes?
...
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Public policy’s impact on the medtech sector

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Thomas J. Sommer, President, MassMEDIC

Published in: Government & Nonprofit
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Public policy’s impact on the medtech sector

  1. 1. PUBLIC POLICY IMPACTS ON THE MEDTECH SECTOR Boston BIOMEDevice March 27, 2014
  2. 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. 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. 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. 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. 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. 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. 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

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