Tests Make For Smart Selling
tests (kits, strips, and small-ticket instruments) represent
a huge segment of high profit business for medical supply
distributors who focus in this area. Because they're relatively
small-ticket items, they're easy to sell initially, and the
inevitable reorders become the bread-and-butter items that
make up a big portion of your monthly GP. As an added bonus,
they're not often the focus of price squabbles, like table
paper and tongue blades, so you can often maintain a good
GP on them.
Who To Target
105,000 practicing physicians in the U.S. perform office-based lab testing, so waived tests can
be sold to almost every primary care account–even prisons
and schools! In addition, better than one in three patient
visits to primary care practitioners involve laboratory tests.
Group practices perform more testing than solo practices,
of course. Specialties to target include large family, pediatric
and internal medicine practices–the bigger, the better.
Sam often adds to the waived test list, so selling opportunities
are ongoing. Two sure bets are:
Introducing accounts to newly
products to their waived counterparts
How To Sell Them
CLIA-waived tests is a no-brainer, once you've mastered a
few easy concepts. If you begin your presentation with "Do
you have a lab?" you'll likely hear “No,” even when you
can see the boxes of occult blood tests and bottles of urine
dipsticks over the person's shoulder. That's because most
people (with the exception of a handful of lab nerds like
me) imagine labs like they saw in Frankenstein, with bubbling
orange and blue beakers and flasks, or space age-type rooms
with sophisticated instruments. They may not think of simple
“kit” products as lab tests.
simple tests are often overlooked selling opportunities. Because
they’re waived under CLIA, none of the traditional customer
objections to lab testing apply. These tests are almost
unregulated. Assure timid accounts that signing up with
CLIA doesn’t necessarily equate to inviting federal agents
bedecked with trench coats and Uzi's into their practice.
Waived labs don’t even get inspected! To begin testing, all
your accounts need to do is sign up and pay $150 every two
How to Get With The [CLIA] Program
the Centers for Medicare & Medicaid Services number in your state (Table 1) and ask for a
CLIA application form. It will take your account less than
10 minutes to fill out the form and mail it in. They will
be billed $150 every two years and will probably have nothing
more to do with the CLIA program.
Table 1. HOW TO GET A CLIA CERTIFICATE OF WAIVER
STEP 1: Call your state Centers for Medicare & Medicaid
Services (CMS, http://www.cms.hhs.gov/clia/ssa-map.asp) office and request Form #116 and any other forms that
may be required to get a CLIA certificate. For the CMS telephone
number in your state, call 410-786-3531 or visit the CMS
web site at www.hcfa.gov.
STEP 2: Advise the account to complete CMS Form # 116 and check
“Certificate of Waiver” in Section 2.
STEP 3: The account can begin testing once Form # 116 has been
returned to CMS. Once CMS receives their payment, the account
will receive a CLIA identification number that must be included
on all Medicare and Medicaid claims. CLIA certificates (including
fees) are renewed every 2 years.
Who Needs A CLIA Certificate?
place that tests human specimens (this includes blood, urine,
and assorted other unsavory body fluids) to diagnose, treat
or monitor patients has to get with the program, even if they
perform only so-called “simple” tests, such as urine dipsticks
and microscopic tests. Regardless of whether an account bills
Medicare for these tests, they are still required by law to
sign up with CLIA.
…And Who Doesn't?
practices that only draw blood to refer out (and do not perform
urine dipsticks or other in-house testing) or only perform
workplace drug testing are exempt from CLIA. Table 2 indicates
when a CLIA certificate is needed and when it isn't.
Table 2. When to Get A CLIA Certificate
Get A CLIA Certificate If You….
Do Not Get A CLIA Certificate If You….
tests from human body fluids that are used to diagnose,
monitor or treat disease
tests only for research or other purposes (e.g., workplace
simple tests such as blood glucose meters or urine dipsticks
physiological tests only (ECG, spirometry, pulse oximetry,
specimens and refer elsewhere for testing
do autoclave spore checks
Waived Tests On The Rise
number of tests in CLIA’s unregulated category is increasing
daily to include several tests that can be used not only by
physicians and law enforcement, but by patients at home, such
as nicotine and alcohol tests (got teenagers)? The waived
test list now includes most rapid strep tests, several mono
and H. pylori kits, instruments for lipid panels and prothrombin
time, in addition to the original list of dipstick urine,
glucose meters, fecal occult blood, and pregnancy test kits.
To search for a particular test's CLIA classification, go
To see an abbreviated list of CLIA Waived tests, c
Waived List 2005.
accounts have misperceptions about the CLIA regulation and
voice their objections when faced with purchasing lab tests
(Table 3). Waived tests are easy to sell because the only
CLIA quality requirement is that the user follow the manufacturer’s
waived tests, no daily quality control is required (unless
the manufacturer specifically states this, and many don't),
nor is proficiency testing needed. Finally, virtually no waived
site will be inspected. The exception is in a handful of states,
such as Pennsylvania, where some of the recently waived tests are not yet recognized as waived
and are subject
to daily QC and proficiency testing.
Table 3. Fact vs. Fiction about CLIA-Waived Tests
is too much hassle.
only requirement for waived tests is to “follow the
is too expensive.
can recoup the $150 during the first week of testing!
And CLIA fees are only collected every two years.
don’t want to hire a tech.
who can fog a mirror can perform a waived test.
we run our daily quality control we’ll lose money on
QC is not required for waived tests, unless specifically
stated in the manufacturer’s instructions (and it isn’t)
don’t want the feds inspecting my office
that only perform waived tests are not inspected.
Selling Waived Tests To Moderately-Complex POLs
there's an opportunity to save your accounts a lot of money
by switching out their moderately-complex tests with waived
ones, where possible. Why? Because they do not need to perform
quality control and proficiency testing on waived tests. This
can amount to savings of several hundred dollars per year
and you'll be the hero.
bottom line: Keep your accounts abreast of what's on the waived
test list so they can pursue testing opportunities they might
not have considered–and you can be a hero in the process!