1. Washington Update PACT Medical Device Group March 7, 2013 Mark Leahey
President & CEO
Medical Device Manufacturers Association (MDMA)

2. About MDMA
Founded in 1992 by handful of smaller medical device executives seeking a voice in Washington
Today MDMA represents nearly 300 member companies
Leverage collective resources to provide top-tier advocacy and educational assistance to companies
Track record of success

3. The Year Ahead
2013 presents significant opportunities and challenges (ex. device tax repeal, FDASIA implementation, cost of care, value of technology)
Your engagement is vital to the success of our efforts
Collectively, we will succeed

4. Agenda FDA ACA Implementation (device tax, Sunshine Law, ACOs)
Cost of Care/Value of Technology
Other Issues

5. FDA The past 3 years lead to the MDUFA 3 agreement and FDASIA
Total time goals
Earlier FDA interaction
IDE reform
510(k) Modifications Guidance
Other FDA “reforms”
Benefit-Risk Guidance
Network of Experts
Key in 2013 will be FDA execution
Monitoring FDA performance
3rd Party assessment

6. FDA (Cont.) UDI Implementation
Likely phased in over the next 2-5 years
Enhanced Focus on Post-Market Surveillance
Potential expansion of De Novo Process
Congressional oversight likely to continue

7. ACA Device Tax Physician Payment Sunshine ACOs & Bundling
Continue to push for full repeal in 2013
Bipartisan, bicameral bills introduced last month
Explore variety of vehicles for repeal
Leverage increasing bipartisan support
Will require your input to succeed
Physician Payment Sunshine
CMS recently issued final regulations
Companies must start tracking payments on August 1, 2013
First reports due to CMS by March 31, 2014
ACOs & Bundling
Additional ACOs being announced around the country
CMS Innovation Center continuing research and testing of bundled payments for episodes of care

8. The BIG ISSUE - Entitlements
1962 = 14 cents of every federal dollar not going to interest payments spent on entitlement programs
Today = 47 cents of every dollar
2030 = 61 cents of every noninterest dollar will be spent on entitlements.
MEDICARE is the biggest portion of these expenditures
The Reality – MASSIVE change is coming

10. Cost of Care will be Major Battle in 2013
Great macro data demonstrating devices less than 6% of total healthcare spending
Device costs increases (<1%) below rate of medical CPI (approx 4%)
Medical services increase much more significant driver of increased costs
Other groups that are heavily engaging (AHIP, AHA, AMA, etc) 

12. We Need More Examples of Micro Data
Specific examples of how medical technologies save overall costs
Less expensive products
Shorter hospitalization 
Less invasive

13. We Need More Patient Advocates to Engage
You are close to your patients
Identify those with compelling message willing to discuss the value of technology
Expand geographic footprint beyond your corporate profile

14. We Need Industry Engagement
MDMA members have ALWAYS stepped up on behalf of innovators and patients
Some of the biggest threats lie ahead
We will succeed if we all actively engage to shape the narrative

16. Ultimate Objective:
Change narrative to:  Medical Technology is the solution to healthcare costs, not the problem

17. Coverage with Evidence Development (CED)
CED is a policy where CMS covers a new medical device used in a clinical trial so more evidence can be developed for CMS to make an informed decision on coverage
New guidance in 2013
CMS may use CED more frequently
Local Medicare contractors may initiate data-collection conditions
No specific guidance on time-lap of when CED ends and Medicare coverage begins, if at all

18. CPT Coding Reform
Ongoing concerns over growing trend of Category III codes, lack of transparency on CPT Editorial Panel
Recent AMA Enhancements:
New guidelines for specialty societies (March 2012)
Allowed earlier and more meaningful engagement during specific CPT code change proposals
Additional reforms expected in 2013

19. Value of Engagement
Success on key issues relies upon the collective effort of the industry
Association engagement provides an effective and efficient way for you voice to be heard

20. Questions?
(202)