Tony DeMaria, M.A.C.C., our JACC editor in chief, recently used his May 19 Editor’s Page to discuss the alarming frequency with which initial clinical trials for novel devices and therapies are being performed outside of the U.S. According to Dr. DeMaria, the situation "clearly raise[s] a question as to whether we in America are exploiting the rest of the world to prematurely test potentially hazardous therapies, or conversely, whether our regulatory and financial environment is stifling access to important new innovations for patients and investigators."

The piece has generated a high volume of responses. “It seems to have struck a chord,” Dr. DeMaria says. One reader notes, “Over the past two decades I have seen an unfortunate gap develop between U.S. and overseas investigations, making us in effect second-tier investigators within the international community. Devices we have invented end up being evaluated, approved and used in general practice well ahead of us ... Percutaneous valves are one the latest example of this dangerous trend/gap!”

I applaud his message. We need to turn this around. Read Dr. DeMaria’s Editor’s Page here. But having just returned from India this week, and after visiting a most amazing 1000 bed CV hospital in Bangalore that produces outcomes comparable to the US (be ready to be stunned) for about 10 % of the cost, I think we need to be aware of the astounding and frankly positive growth of research outside the US that is developing exponentially. One thing the emerging world has going for them is that in environments with no insurance or health care coverage, experimental and novel therapies can be tested in willing patients far more prevalently that in the US or Europe. This will result in a great deal more relevant manuscripts, and in application of new therapies in early stages of illness, that will be considered here only as “compassionate use” therapy in late stages of disease, and only after traditional therapy fails. They will be able to see if new therapy works when started before the patient is near terminal. We won’t. And, as health reform in the US ratchets down the screws on PHARMA, they will go abroad to innovate, taking jobs with them. I’m just trying to cheer everybody up here…

Forty CEO leaders of industry met at Heart House this week to discuss important health care issues. Among the notables were Ron Williams, CEO of Aetna, several regional Blue Cross CEOs, Tony Hooper, CEO of Bristol Myers Squibb, former House Speaker Newt Gingrich (R-Ga.), and many other leaders of insurance, hospital, consumer, health care venture capitalist, consulting, and technology/industry companies. Until recently Nancy Ann DeParle was also a member of this group in her investment banking role (I actually got her plugged in to the group a few years back).

Once again, I had more than dozen overtures about renewed interest in working with ACC and NCDR on quality improvement projects, and I have set up follow up meetings to seek specific pilot concepts. Newt did a terrific job of presenting a view of where the rapidly changing science and technology environment may be heading, and he too will be meeting with us to seek ways to work with his Center for Health Care Transformation.

He emphasized that China and India dynamism is REAL; and that the increasing speed of the advancement of science will transform everything around us faster than anyone sees.

NHLBI is considering several proposals for large randomized controlled trials (RCT) assessing the impact of cardiovascular imaging on health outcomes. The ACC is sending a letter detailing our strong support for such a trial. A large RCT would address one of the major problems in CV care today: the lack of robust outcomes evidence to guide optimal use of new diagnostic imaging technology.

In our letter, we recommend to NHLBI that, “A successful trial will need to take an unbiased approach, emphasize real world effectiveness and compare the full spectrum of usual care with new technology across a variety of clinical practice settings.” We don’t offer specific support for any of the proposals, but it is our hope that NHLBI will fund a trial and that in the future, we will be able to help disseminate the much-needed data to our members.

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!

 

A new report by Paul Ginsburg at the Center for Studying Health System Change concludes medical technology is significantly the culprit for soaring health care costs. AdvaMed and advocates for technology advances strongly disagree.

New technology does contribute to higher costs, and physicians should be careful about how they use it. But that doesn’t mean we shouldn’t use it. Technology, properly used, can avoid more expensive inpatient care and medical complications due to delayed diagnoses. This is where the ACC’s Appropriate Use Criteria and evidence-based guidelines come in. Using advanced technologies appropriately will help save dollars and lives. But, given the growing financial crisis, there will only be more calls to reduce costs, and some of them will be shortsighted in terms of longer term cost savings.

With physician supply problems in cardiovascular care looming, having likely new cuts in Medicare and Medicaid could actually reverse progress in CV morbidity and mortality in the near future. We can’t let that happen.