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Legislation
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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