Q&A: Andy Fish,
Access to the latest and best diag- nostics technology is one of the hallmarks of a strong healthcare
system, but it’s not always easy to get governments and third-party payers to understand why that is. With getting that
message out in
mind, more than 70
firms have formed
AdvaMedDx, an advocacy group that
aims to communicate the value of innovative diagnostics
promote policies that expand patient access to it. The group is an offshoot of the
Advanced Medical Technology Association (AdvaMed), based in Washington,
D.C. Andy Fish, the executive director of
AdvaMedDx, spoke to Medical Product
Outsourcing about some of the challenges
facing the industry.
MPO: How has the economic slowdown impacted the diagnostic industry? Is the effect different from that of
the medical device industry?
Fish: Certainly, it is a challenging time for
the economy as a whole, and others are
better positioned to speak to the overall
economic circumstances and prospects of
the diagnostic industry. While policy challenges remain, including the need to
modernize payment systems, the industry
is well positioned to deliver the technology advances and innovations in diagnostics that increasingly are recognized as
a key driver of effective healthcare.
MPO: Are procedures using new diagnostics technologies being properly
reimbursed in the United States and
around the world? In cases where they
are not, what are the obstacles?
Fish: We have longstanding concerns
about the way new diagnostic tests are
reimbursed in the United States.
Medicare, whose policies also guide
other payers, often ties payment rates to
a set of lab charges that were developed
in 1983. Medicare also does not factor
into payment rates the value these technologies provide in terms of management of patient care and overall benefit
to the healthcare system. This means
that payment rates do not recognize
continued innovation and the technology breakthroughs in diagnostics that
are helping to transform healthcare.
Payment systems for diagnostics must
be modernized to ensure that robust investment continues to deliver innovative new diagnostic technologies that
are the key to prevention, early detection, accurate diagnosis, effective treatment, and successful management of
Diagnostic tests are reimbursed in
many different ways in various countries. In emerging markets, patients
often pay out-of-pocket because of lack
of government reimbursement or private insurance. In developed countries,
like Japan and Europe (where each
county has its own payment system), diagnostic tests often face the same challenges as in the United States. Payment
rates do not reflect recent innovation
and the value that new technologies
bring to patient care.
MPO: AdvaMed has made a strong effort to publicize the benefits of new
diagnostic technologies. What has
that campaign achieved? What challenges remain?
Fish: The world’s leading diagnostic
manufacturers recently established Ad-
vaMedDx as a new advocacy organiza-
tion focused on creating a stronger
understanding of the value of diagnos-
tics and advocating for healthcare sys-
tems that support robust innovation
and ensure timely access to safe and ef-
fective in-vitro diagnostic tests. With a
membership of nearly 70 companies
and growing, AdvaMedDx is making it
a priority to partner with a wide range
of stakeholder organizations to advance
our mutual goals of promoting well-
ness, improving patient outcomes, and
advancing public health in the United
States and abroad. To help build these
partnerships, AdvaMedDx is sponsor-
ing a day-long symposium on the use
of diagnostic technologies and their im-
pact on patient care and public health.
This symposium will take place on June
22 in Washington, D.C., featuring key
leaders from industry, patient advocacy
organizations, healthcare professional
societies, government and academia.
MPO: In the next few years, what do
you think will be the biggest issues
facing U.S. diagnostics companies?
Fish: To ensure that patients in the U.S.
have access to the latest advances in diagnostic technologies, as well as to fully
realize the promises of personalized
medicine, we must have a competitive
industry supported by an efficient regulatory process that supports innovation.
We also must have a payment system
that recognizes the full value of diagnostics to patient care and to the
Patients in the U.S. continue to wait,
often for years, for access to breakthrough diagnostics that are approved in
other countries much earlier than in the
U.S. AdvaMedDx has long advocated for
a modernized, risk-based approach to
the regulation of all in-vitro diagnostic
tests to assure timely patient access to
safe and effective diagnostics. This flexible, transparent approach would better
align submission requirements, focus
[U.S. Food and Drug Administration] resources on novel technology with the
highest risks, and support the overall