| R. Lewis Dark:
Era of Digitized Pathology Systems Approaches
SURGICAL PATHOLOGISTS SHOULD GET READY! I predict that they will soon have
the opportunity to purchase and use fully digital, automated pathology systems
that can perform primary diagnosis.When that happens, it will mark
the final cycle of the era when the principal method of diagnosing tissue was
that of eyeballs fixed to microscopes, scanning cells as glass slides are pushed
around the stage.
The introduction of digital pathology systems capable of primary diagnosis
will likely be the single most disruptive event to anatomic pathology in the past
two decades. That’s because automation of the primary diagnosis of tissue will
upend current work flow and clinical practices in surgical pathology.
I make this prediction, based on two market developments in anatomic
pathology. One development is the success of Aperio Technologies, Inc., in
placing fully digital pathology systems in as many as 375 laboratories in 25
countries. This company is finding a ready market for its digital solutions
that support existing pathology work flow and clinical practices.
The second market development is the long-awaited entry of General
Electric into laboratory medicine. As you will read on pages 9-11, GE
Healthcare is partnering with some of the best minds in digital pathology at
the University of Pittsburgh Medical Center (UPMC) to create Omnyx,
LLC. The aim is to develop digital pathology systems that can integrate the
transmission and use of digitized pathology images across the care continuum,
support improved workflow, and contribute to increased clinical quality—
as well as automate primary diagnosis. The two partners estimate that
the market for digitized pathology systems will be about $2 billion per year.
I suspect GE is making this move now because it believes it has digital and
other technologies that can be transformational to anatomic pathology. It wants
to leverage its experience at digitizing radiology and evolving radiologists into a
fully digital work flow by doing the same in anatomic pathology. In the 1990s,
such companies as NeoPath, Inc., and Neuromedical Systems, Inc., privately showed THE DARK REPORT how digital cytology systems and software algorithms
could do accurate, automated primary diagnosis on a variety of tissue types. Now
the question is: are surgical pathologists ready to accept digital pathology systems
that can move them away from microscopes and in front of computer screens? GE's
entry into thismarketplace is evidence that it believes the answer is: "Yes!"
NPI Rules Slow Payments
To Pathology Groups, Labs
Private payers and Medicare carriers kick out
high volume of claims for incorrect NPI compliance
CEO SUMMARY: New rules requiring use of National Provider
Identification (NPI) numbers took effect on May 23. Since then,
Medicare carriers and payers nationwide have rejected claims from
pathologists and other providers that do not comply with the new
NPI rules. A missing NPI on just one claim will result in the front end
rejection of the entire submission file to Medicare. Cash flow to
some pathology groups and other physicians has dropped. It may
be another month or more before normal cash flow is restored.
GE, UPMC Create Company
For Digital Path Imaging
Joint venture estimates market potential is
$2 billion for fully-digitized pathology systems
CEO SUMMARY: It's a new joint venture with the potential to
transform surgical pathology. General Electric Healthcare has
extensive experience at supporting physicians' work flow with digitized
imaging systems, plus ample experience with molecular biomarkers.
The University of Pittsburgh Medical Center's pathology
department is a world leader in whole-slide imaging and digitized
pathology systems. Together, the two partners hope to gain FDA
approval for a fully digitized pathology system in about two years.
New Senate Bills Include
Repeal of Competitive Bid
Bills would kill lab competitive bidding demo,
eliminate cut to physician fees, and extend TC
CEO SUMMARY: One proposed Senate bill would repeal the
laboratory competitive bidding demonstration project, replace the
10.1% cut to physician fees with a 1.1% increase, and extend the
so-called technical component (TC) grandfather clause. Senator
Max Baucus (D-Montana), Chairman of the Senate Finance
Committee, is sponsor of the bill (called S 3101). Congress is
under pressure to pass a Medicare funding bill before July 1,
2008, when the 10.1% reduction in physician fees will occur.
ISO 15189 Work Advances
At Meeting in Vancouver
Delegates to ISO Technical Committee 212
gathered for their annual working session
CEO SUMMARY: Laboring quietly out of the public eye, an
international work team of professionals, including representatives
from the CDC, the FDA, and global in vitro diagnostics (IVD)
manufacturers, has spent the past 14 years developing an important
series of quality and safety standards for medical (clinical)
laboratories. Here’s a report on events at the most recent international
assembly of ISO Technical Committee 212, which
gathered earlier this month in Vancouver, British Columbia.
CMS Expected to Revise
Condo Lab & TC/PC Rules
Rule changes could come this summer
and may also involve physician self-referral
CEO SUMMARY: Expectations are that the Centers for
Medicare & Medicaid Services (CMS) will take further action to
rein in anatomic pathology arrangements used by physicians to
capture revenue from their patient referrals. This may happen as
soon as next month, when CMS publishes the 2009 Medicare
Physician Fee Schedule (MPFS) Update and requests public comment
on proposed new rules. Attorneys tracking these developments
believe that both anatomic pathology condo labs and TC/PC
arrangements are likely to be the subject of these new rules.
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