CMS-R-131 Comment #6

BIOLOGICAL TECHNOLOGY
LABORATORY, INC.
10114 Woodfield Lane St. Louis, MO 63132
(314) 432-5030 (800) 737-5030
I

I

I

June 22,2007
Centers f o r Medicare & Medicaid Services
O f f ice of Strategic Operations and Regulatory Affairs
Division o f Regulations Development - C
Attention: Bonnie L. Harkless
Room C4-26-05
7500 Security Boulevard
Baltimore, MD 21244-1850

Faxed to: Carolyn Lovett (202) 395-6974

RE: Comments on Revised CMS Advance Beneficiary Notice (ABN)
bear Ms. Harkless:
Our company, Biological Technology Laboratory, Inc., (BioTech Lab) is a regional
laboratory serving over 300 nursing facilities as well as many physicians and outpatients. We respectfully submit the following comments relating t o the Notice
dated May 25,2007 f o r additional public comment on the revised Advance
Beneficiary Notice (ABN) (CMS-R-131). We welcome the opportunity t o partner
with the Centers f o r Medicare & Medicaid Services (CMS), other laboratories,
providers, and Medicare carriers in seeking t o develop and implement the most
effective ABN and associated instructions for all relevant stakeholders.
Proper instructions for ABN use are essential in order t o communicate the possible
denial o f Medicare coverage t o beneficiaries in the most clear and concise fashion
possible. Beneficiaries also need and deserve significant advance notice about
Medicare coverage t o allow them t o make an informed decision about whether t o
BioTech Lab Comments to CMS

Revised ABN
Page 1of 3

proceed with a particular course o f medical care. We are pleased that CMS
decided t o keep a specific ABN f o r clinical laboratory services; however, we
continue t o have other specific concerns about the notice.
First, we would like t o express concern with the addition o f another ABN, bringing
the total number of options t o three. BioTech Lab often serves patients who have
their blood drawn a t another outpatient laboratory. I t is possible another lab
might use a different version o f the ABN. This already has caused confusion among
beneficiaries who do not understand why they are signing a new and different ABN.
By adding a third, "generic" ABN, there is the possibility of even further confusion.
Second, the new ABN form does not provide sufficient space t o list all o f the tests
that are subject t o National Coverage Determinations ("NCDs") and Local
Determinations ("LCDsn). The current ABN provides enough space f o r a laboratory
t o list all of the NCD or LCD tests. Having them listed allows staff t o simply circle
the NCD and/or LCD test when the medical necessity does not support the test
being ordered. Filling in each o f the tests will create an unnecessary and timeconsuming step. We believe that this is an important point due t o the fact that
coverage determinations a f f e c t the results of an ABN.
Third, we recommend that CMS maintain the heading f o r the NCD tests that have
frequency parameters. The old ABN included the heading 'Medicare does not pay
f o r these tests as often as this (denied as too frequent)." Certain tests, such as
the Hemoglobin AlC, are considered medically necessary by Medicare t o be
performed only once every three months. I n many cases a laboratory has no way o f
knowing how many times the patient has received the test in the past. Since the
patient may have already met the frequency parameters without our knowledge, we
may not have him or her sign an ABN and will end up paying f o r the test. The
heading for the NCD tests provides a simple explanation t o the Medicare
beneficiary that this test has frequency parameters that might not have been met
yet but if they have, the beneficiary will be responsible f o r payment.
Fourth, though CMS claims that there will not be a cost associated with the new
ABN, there will be a cost associated with training staff t o understand and
sufficiently explain the new ABN t o Medicare beneficiaries. While we appreciate
CMS' willingness t o ensure that the concerns of the clinical laboratory community
are met, we are not convinced that there will be a significant positive outcome for
patients by creating a new ABN.
BioTech Lob Conunents to CMS
Revised ABN
Page 2 of 3

Fimrlly, we believe that there should be an exception f o r clinical laboratories from
the ABN requirement. Clinical laboratories are unique from other providers
because we do not order any tests - they must be ordered by the treating
physician. Therefore, the laboratory has no access t o additional information a t the
time o f service. While we appreciate CMS' recognition o f this with a lab-only ABN,
the fact that laboratories are not in the same category as physicians or other
providers remains unaddressed.
BioTech Lab is ready t o work with CMS and other stakeholders t o ensure that both
the clinical laboratory ABN and i t s associated instructions meet the needs o f
Medicare beneficiaries, providers, carriers, and laboratories. I f you have any
questions about our comments, please do not hesitate t o contact me.

Tamara Schwartz, Executive Vice President

BioTech Lab Comments to CMS
Revised ABN
Page 3 o f 3