This is the second part of this month's guest blog post from ACC Vice President Ralph Brindis, M.D., F.A.C.C. Dr. Brindis is the Senior Advisor for Cardiovascular Disease for Northern California Kaiser and a Clinical Professor of Medicine at the University of California-San Francisco, and has been a leader within the College's NCDR for years.

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CMS is increasingly looking to “Coverage with Evidence Development” as a means of improving patient value and ensuring the most cost-effective care. CMS established CED in 2006 as a way to allow the agency to offer conditional national coverage for new technologies while requiring the collection of additional patient data to supplement standard claims data, either through participation in registry or clinical trial.  CED, then, would allow and encourage the diffusion of new technology into the marketplace and the CV community through its coverage and reimbursement component. Even more importantly, if appropriately applied, it would promote the acquisition and collection of key outcomes and other patient data to allow clinicians and payers alike to best understand not only issues surrounding safety and efficacy, but also the true role of a new technology. The CED strategy has been successfully implemented in NCDR’s partnership with CMS for our ICD Registry.

Unfortunately, there often is resistance to the concept of CED by payers and also at times by practicing physicians. Payers balk at its implementation, feeling the technology is not “mature” enough to justify coverage and reimbursement even through the CED mechanism. Clinicians sometimes balk at CED implementation, feeling the technology already has a substantial “evidence base” justifying coverage through clinical trials and the premarket approval process, and that participating in a CED mandate is extra work. There are also “behind the scenes” political pressures exerted by lobbyists representing competing professional or industry interests that stymie CED implementation. The losers, unfortunately, in this situation are our patients and our CV science.

The NCDR is well positioned to play an active role in any future CED mandate – but only if payers and clinicians alike are able to embrace the terrific opportunity and mechanism for new technology assessment offered by CED.

- By Ralph Brindis, M.D., F.A.C.C., ACC Vice President

* Dr. Brindis' post is the second in a new monthly series of guest posts by ACC leadership. Check back next month to see which ACC leader is sharing his or her thoughts on health care reform!

 

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