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! |