1. Medtech in Transition: Where Are We Now and What Lies Ahead
State of Coverage With Evidence Development in 2017 and Future Directions
Mitchell Sugarman
Anchor Bay Consulting

2. Mitchell Sugarman, MBA Disclosure Statement of Financial Interest
I hold stock in multiple medical device and pharmaceutical companies
I am a consultant for multiple medical device companies to provide expertise in health economics and reimbursement

3. Progress Towards Achieving Better Care, Smarter Spending, Healthier People
Jan 26, 2015 By: Sylvia Mathews Burwell, HHS Secretary
“Today, for the first time, we are setting clear goals – and establishing a clear timeline – for moving from volume to value in Medicare payments.”
Burwell SM. Setting value-based payment goals--HHS efforts to improve U.S. health care. N Engl J Med Mar 5;372(10): doi: /NEJMp Epub 2015 Jan 26. PMID:

4. Coverage With Evidence Development (CED)
Coverage in the context of approved clinical studies or with the collection of additional clinical data
Allows for positive coverage when evidence is insufficient for a more favorable decision
Without CED, the item or service would be non-covered
May involve randomized controlled trials, observational studies, registries and claims data

5. Why CED?
Provide access to promising technology for which the evidence base may be immature.
Help identify the circumstances in which patients are most likely to benefit and potentially accelerate access to innovations
Will lead to the production of evidence complementary to existing medical evidence
The NCD process, in general, is a transparent one…
Requesters may meet with CMS and frequent, informal contact is possible.  A tracking sheet is posted on the CMS website that allows interested individuals to participate in and monitor the progress of the review.  A proposed decision is issued for public comment within six months of opening the NCD review. 
…But improvements on CED process may be useful
The 30-day comment period on proposed NCDs may be insufficient to fully incorporate stakeholder views and arrive at well-balanced CED requirements for specific therapies. Modifications that allow for broader stakeholder input would improve the process.

6. CED is Becoming More Frequent for New, Innovative Technologies
Transcatheter Aortic Valve Replacement (TAVR) – 2012
Registry
Transcatheter Mitral Valve Repair (MitraClip) – 2014
Left Atrial Appendage Closure (Watchman) – 2016
Percutaneous Image-Guided Lumbar Decompression (PILD) – 2016
Longitudinal claims analysis
Leadless Pacemaker (Micra) – 2017

7. The Path to CED is an NCD
Not all NCDs will result in CED
But, any CED will have gone through an NCD
Know the difference between an NCD and an LCD
Hope that LCDs don’t start to ask for CED!

8. What’s Next?
Evidence will continue to remain the key to any coverage decision.
It’s likely that CMS and other payers will continue the trend away from FFS towards paying for value (PFV).
As accountability for clinical and economic outcomes shifts downstream in PFV, growing importance will be placed on meeting the evidentiary needs for therapy/technology adoption at the provider level.