On Becoming CEO leaders in the cutting-edge diagnostics space share how their careers developed and the goals and aspirations that motivate them. Andy Fish is the Executive Director of AdvaMedDx, an organization that advocates for the power of medical diagnostic tests to promote wellness, improve patient outcomes, and advance public health in the United States and abroad.

His advocacy organization represents over 75 member companies that produce innovative diagnostic tests performed in laboratories, at the hospital bedside, in doctor’s offices, in medical clinics, and in the home. These tests facilitate evidence-based medicine, improve quality of care, promote wellness, and enable early detection of disease. And, since they ultimately influence as much as 70% of health care decision making, they often reduce health care costs.

As technology advances, a new generation of diagnostics testing that provides insights at the molecular level is delivering on the promise of personalized medicine. Andy Fish works daily with legislators and company leaders to make sure that the industry keeps moving in that direction.

Slone Partners: In diagnostics, what do you think needs the most attention in terms of advocacy?

Andy Fish: Our role as a trade association is to essentially clear the way as far forward as we can for the entire industry to bring its technologies and advances for patients into the health care system.

A couple of issues are really critical for this industry going forward. Regulatory issues are always with us. We are in a constant dialogue with FDA and Congress to make sure the regulatory system keeps pace with technology development and science and continues to expedite clearance and approval as much as possible, while still maintaining a balance with patient safety…

What I’ve seen change over the last two to three years is a growing recognition that an even bigger challenge for industry is payment. In other words, are these products really being disseminated as quickly as they should be for optimum patient care? And in our health care system, are diagnostics being paid for at a level that’s commensurate with the value they’re bringing to patients?

That’s fundamentally a challenge right now because the answer in many cases is no.

We’ve just taken steps with Congress last year that would reform Medicare payment for diagnostics, and we’re hopeful that over time that’s going to result in better payment for advanced technologies.

But this is really a problem that goes far beyond Medicare. It’s necessary now for industry to work with the broader health care system…to ensure that diagnostics value is accurately measured, accounted for, and then paid for appropriately.

Slone Partners: Is there a quick fix to the payment issue, something that could be enacted within a year?

Andy Fish: If someone were “diagnostics czar” and could stroke the pen and do something on the Medicare front, it probably would look something like driving Medicare to a more comprehensive assessment of the returns that diagnostics bring in the health care system and then paying commensurately to that.

But there are a couple of major challenges. There are certainly questions around methodology and health-tech assessment for diagnostics. It’s a really complex field, there is no standard approach to it, so there really needs to be more clarity around how all actors in the space understand the health economic value of diagnostics, which in our view is often under-assessed.

And the other challenge… is that the Medicare system is only part of the puzzle. It really is more complex than being susceptible to a simple policy solution. It’s a case of working with a lot of stakeholders, and to educate and work on better approaches to appropriately value diagnostics.

Slone Partners: Are there any media outlets or conferences that are pushing the envelope and having a progressive conversation about diagnostics?

Andy Fish These challenges in the health-tech assessment space are something that I do not think have gotten a lot of play from a media standpoint. The general challenge of reimbursement certainly gets a lot of play in the trade press in particular, and that tends to be focused on the here-and-now of what’s going on with Medicare… But these broader, systemic questions of how we better value diagnostics in the first place is something that I don’t think is getting a lot of media attention.

…The first time I saw a conference dedicated entirely to reimbursement in diagnostics was just a couple of years ago. Certainly one can now go to some of the commercial conferences and get a lot of this content, but again it tends to be a more practical question of the system as it exists today and how to work within that system to get the most favorable outcomes.

These bigger questions around how to appropriately value diagnostics are somewhat more esoteric. It’s a little harder to cover at these conferences and even for media to pick up on. I think you need to look more to health policy journals and places like managed care conferences to start talking about these issues that are really going to matter for diagnostics going forward.

Slone Partners: What does a typical day look like for you?

Andy Fish: There is probably not a typical day, but there is a typical set of things that I am juggling at any given time. Regularly interacting with our member companies is one of the most important things that I do. Not only do we have a CEO-level board of directors for AdvaMedDx [with whom] we have quarterly board meetings, but we also have a number of workgroups staffed by any of our companies that want to participate. Those are workgroups we interact with sometimes multiple times per week, whether it’s by email, conference call, or in-person meetings. That’s a big part of the engine that drives what we do.

This is not a trade association driven by staff. We serve our member companies and we rely on them heavily for their input on multiple fronts to make sure we understand what challenges they are facing, [and] to understand their experience at FDA and at CMS [the Center for Medicare and Medicaid Services]. And of course we provide a certain level of expert insight as well.

Certainly there is a significant part of my work as well which involves maintaining relationships with other stakeholders, so I spend part of my time keeping those stakeholders up to date on what we are doing and even more importantly collaborating with some of those organizations. For example, we collaborate with a number of patient advocacy organizations to put on programs [such as] Capitol Hill briefings. We are doing a number of community roundtables around the country with the American Cancer Society on personalized medicine. So that’s a really substantial part of our work as well.

How can leaders in healthcare get the knowledge they need to deal effectively with the issues of regulation or reimbursement?

Andy Fish: If you are in an industry or company that has trade associations, to give a very self-interested plug, trade associations really are the nexus between the public sector and the private sector. This is where private sector comes together to really chew on public policy issues. And figure out what public policy is beneficial and what changes in public policy are needed and can be effectively promoted to Congress and other agencies….

When I moved from the administration into the private sector [Mr. Fish was assistant secretary for congressional relations and intergovernmental affairs, U.S. Department of Agriculture, from 1999 to 2001], particularly when I went to the American Cancer Society and later to another trade association, I was somewhat concerned that these positions would be less interesting that working in the government, frankly, because working in the government is being at the intersection of a lot of interesting things going on – you have the ability to effect a lot of significant change.

I was very relieved to find out that working in this private sector intersection with the public sphere, in a trade association or a patient advocacy organization or a professional society, is an incredibly dynamic place. We are spending more time thinking about certain policy issues than anyone on Capitol Hill. So we end up becoming more expert than just about anyone that we work with on Capitol Hill and in some cases within the government agencies.

This interview was condensed and edited. For more information on AdvaMedDx, please visit www.advameddx.org.

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