G-2
Laboratory Institute Report
October
10-13, 2007
By:
John W. Sherer, MT(AMT)
Chair,
AMT Federal Government Affairs Committee
John Sherer, MT(AMT) has graciously offered the
following synopsis of the first three speakers at the 2007 G-2 Lab
Institute. For the full report, go to AMT’s Website-
www.AMT1.com.
10/10/07- Dennis Weissman, President of
Washington G-2 Reports in his welcome and address opened the
session giving an overview of the lab industry over the 25 years since
G-2 first started. He stated that in the 80’s, it was all reimbursement
concerns, in the 90’s it was on fraud, abuse, and compliance, and in the
21st century, these issues continue with lots of industry
restructuring, still growing in technology, and innovation. He stated we
are in a world economy and must be competitive in this new arena. He
predicts that within the next 3-5 years, we’ll see some variety of
universal health care and medical care will double in the next 2
decades.
10/10/07 5:45 PM – Where is the U.S. Lab
Market Going? Dr. Colin Goldschmidt, CEO & Managing Director of
Sonic Health Care, an Australian lab operation, who has acquired
Bioscienta labs in Germany, labs in Switzerland, United Kingdom, and in
2005 bought Clinical Pathology Labs (CPL) labs in Texas and in 2007
SunSet Labs in N.Y. City. They are now the largest international lab at
$2.1 billion with over $400 million in the USA market. They have 8 hub
labs in the USA including one in Toledo, Ohio. Their formula for success
is a Happy Staff, Happy Customers, and Happy Shareholders and core
values Service excellence, honesty & integrity, Responsibility &
accountability, continuous improvement, and confidentiality. They try to
capture the same passion noted in small labs.
10/10/07 6:30PM – Mara Aspinald, President
Genzyme-Topic- “Brave New World: Personalized Medicine & the marriage
between Diagnostics and Therapeutics”. She stated we must get
the message across, “The medical system can not practice personalized
medicine without lab tests”. Tests save lives just like drugs save
lives.”
Old paradigm-Trial and error medicine. Doctor
observation of problem, try something and ask, did it work? This is
experimental but worked in some cases.
New paradigm- Linking tests to action and therapy.
Now Doctor observation, orders tests, leads to action with predictable
response breaking the cycle of trial and error medicine. She said we
need the right drug for the right patient and explained that some people
benefit with no toxicity, others get no benefit but have toxicity, and
others must have the correct dose to have optimal benefit with low
toxicity. Today in USA we have 2.2 million people with adverse events in
care annually. Medical errors are now the 6th leading cause
of death so we need tests to increase drug efficacy. FDA is part
of the problem in that they only require lab tests for 2 approved drugs.
There are 3 where they recommend testing and 121 where there are no
requirements for testing. She indicated physicians are overwhelmed by
the volume of data available on testing that should be done to monitor
drugs and patients also need to be educated so she suggest three things:
More education, more data, change policies by changing standards for
drug test utilization, getting FDA to require testing with the approval
process, promote testing as part of Doctors pay for performance and
reform reimbursement system tying it to pay for performance standards.
Legislative
Alert
Support House and Senate Bills to Repeal Competitive Bidding Demo for
Medicare Lab Services
Immediate Contact Needed to Members of Congress
At
the urging of the Clinical Laboratory Coalition, legislation has been
introduced in both the U.S. House of Representatives and the Senate to
halt the Centers for Medicare & Medicaid Services (CMS) clinical
laboratory services competitive bidding demonstration project. The
bills would repeal the section of the Medicare law that requires CMS to
conduct the demo in two metropolitan areas.
The House bill, H.R. 3453, was
introduced August 4, 2007, by Rep. Nydia Velazquez (D-NY), Chairwoman of
the House Small Business Committee. The Senate version,
S. 2099, was introduced September
26, 2007, by Senators Ken Salazar (D-CO), Pat Roberts (R-KS), and Maria
Cantwell (D-WA).
Each of the bills would repeal subsection 1847(e) of the Social Security
Act (42 U.S.C. § 1395w‑3(e)),
which requires CMS to conduct the demo. CMS is otherwise expected to
announce the locations and final details of the demo at any time.
HERE’s WHAT TO DO:
Go to the
websites of your U.S. Senators and your Congressional Representative.
You can find links to those websites by going to
www.congress.org, then entering your zip code where indicated. Once
you have accessed your legislators’ website, find the feature that
allows you to send an e-mail message to their office directly through
the web page (look for a menu item that says “Contact Us” or “E-mail the
Senator,” or a similar link).
When contacting your Senators and Representative, urge them
to
support
H.R. 3453
(in the House) and
S. 2099
(in the Senate). Tell them the bill
will repeal a misguided provision of the Medicare Prescription Drug,
Improvement and Modernization Act of 2003 that requires CMS to conduct a
competitive bidding demonstration for Medicare laboratory services.
Tell them the demo is a bad concept and deserves to be repealed
because:
-
It will harm beneficiaries by limiting their choices of labs, and in
many cases requiring seniors to travel to new, unfamiliar and
inconvenient patient service centers to have their blood drawn
-
By completely excluding non-winning labs from Medicare, the demo
will drive some labs out of business – especially smaller labs –
thereby decreasing overall competition in the demo areas.
-
Laboratory services are not fungible commodities like wheel chairs,
canes, and beds. They are complex medical services that can vary
depending upon the setting, patient acuity, the required turnaround
time, and a host of other factors.
-
Lab services are not overpriced. Medicare pays for them under a fee
schedule that has been reduced by about 40% in inflation-adjusted
terms since 1984. Lab services account for only about 1.6% of
Medicare spending, but lab results are used in 70% of medical
decision-making.
With your help, the Medicare competitive bidding demonstration can be
defeated. Please write your Congressional Representatives and Senators
today!
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