[Congressional Record Volume 158, Number 127 (Wednesday, September 19, 2012)]
[House]
[Pages H6140-H6142]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
TAKING ESSENTIAL STEPS FOR TESTING ACT OF 2012
Mr. PITTS. Mr. Speaker, I move to suspend the rules and pass the bill
(H.R. 6118) to amend section 353 of the Public Health Service Act with
respect to suspension, revocation, and limitation of laboratory
certification.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 6118
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Taking Essential Steps for
Testing Act of 2012''.
SEC. 2. SUSPENSION, REVOCATION, AND LIMITATION OF LABORATORY
CERTIFICATION.
Section 353 of the Public Health Service Act (42 U.S.C.
263a) is amended--
(1) in subsection (d)(1)(E), by inserting ``, except that
no proficiency testing sample shall be referred to another
laboratory for analysis as prohibited under subsection
(i)(4)'' before the period at the end; and
(2) in subsection (i)--
(A) in paragraph (3), by inserting before the period at the
end of the first sentence the following: ``, except that if
the revocation occurs pursuant to paragraph (4) the Secretary
may substitute intermediate sanctions under subsection (h)
instead of the 2-year prohibition against ownership or
operation which would otherwise apply under this paragraph'';
and
(B) in paragraph (4), by striking ``shall'' the first place
it appears and inserting ``may''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Pennsylvania (Mr. Pitts) and the gentlewoman from California (Mrs.
Capps) each will control 20 minutes.
The recognizes the gentleman from Pennsylvania.
General Leave
Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days in which to revise and extend their remarks and
insert extraneous materials into the Record on H.R. 6118.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Pennsylvania?
There was no objection.
Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today to support H.R. 6118, the Taking Essential
Steps for Testing Act of 2012.
H.R. 6118 would give the Centers for Medicare and Medicaid Services
much needed regulatory flexibility to enforce prohibitions against
improper referrals of proficiency testing under the clinical laboratory
improvement amendments.
In order to operate as a business, laboratories must adhere to CMS
procedures for processing samples, must share testing results with CMS
periodically and are prohibited from intentionally referring testing
samples to any other lab.
Currently the Centers for Medicare and Medicaid Services is required
under statute to revoke the CLIA certificate of any laboratory that
intentionally refers its proficiency testing samples to another
laboratory for testing for a period of 1 year.
In addition, the statute requires that a person who has owned or
operated a laboratory which has had its CLIA certification revoked,
including those owning multiple labs, may not own or operate a
laboratory for a period of 2 years following such revocation.
However, there have been instances where a hospital or independent
laboratory has accidently referred a PT sample to another lab due to
mistakes by employees or through automated systems. In such instances
CMS is not allowed by law to consider the circumstances under which the
test was accidently referred or if the lab acted in good faith to
report and address the incident.
[[Page H6141]]
H.R. 6118 would address these issues by amending section 353 of the
Public Health Service Act to allow the Secretary discretion to
determine whether the 1-year ban on laboratories should be applied and
the flexibility to levy immediate sanctions instead of the 2-year
prohibition against ownership or operation of the lab.
The legislation enjoys bipartisan support among this body as well as
numerous organizations, including the American Clinical Laboratory
Association, the American Hospital Association, the College of American
Pathologists, and the Clinical Laboratory Management Association, among
others.
I would like to thank Congressman Grimm and Congressman Roskam for
their work on this legislation, and I urge Members to support the bill.
I reserve the balance of my time.
{time} 2110
Mrs. CAPPS. Mr. Speaker, I yield myself 5 minutes.
Mr. Speaker, the Taking Essential Steps for Testing Act is a
bipartisan, sensible bill which will provide the Centers for Medicare
and Medicaid Services the flexibility it needs in imposing penalties on
clinical laboratories that violate certain recertification procedures.
While not commonly discussed, the Clinical Laboratory Improvement
Amendments of 1988, or CLIA, is an important law that ensures all labs
operating in the United States can be trusted. Under CLIA, all labs
must be certified to prove they are qualified to perform clinical tests
while meeting quality and safety standards. We can all agree this is a
good thing.
Labs are periodically retested to keep their CLIA certification. To
do this, labs are required to perform proficiency tests which measure
the quality and competency of a lab's work. Unlike some tests that come
to a lab that can be sent out to other labs, proficiency tests must be
performed in-house. Currently, if a lab is found to have referred a
proficiency test to another lab, the Secretary of HHS must revoke that
lab's certificate for at least 1 year. This prevents it from
participating in Medicare or Medicaid for that period. In addition, the
operator of any lab that has had its certificate revoked is barred from
owning or operating any certified labs for 2 years.
However, current law does not allow the Secretary any flexibility in
imposing these penalties for labs that improperly refer proficiency
tests--even when it's an unintentional referral. This has led to labs
that are being shut down across the country, potentially affecting
patient care and access, even when their actions are not worthy of such
a sanction. This is especially pronounced when the sanction occurs on
just one lab that is part of a larger health care system, as the
penalties apply to the entire system, even if all the other labs happen
to be in compliance.
So this legislation would help address these problems by allowing CMS
the flexibility to institute lesser sanctions to really address the
problem instead of penalizing an entire system for unintentional
proficiency test referrals. The bill does so without changing the
accountability within the law or making our labs less reliable. And CMS
still will be required and able to hold so-called ``bad actors''
accountable.
This bill is a very commonsense reform to CLIA, and I'm pleased to
support it. I urge my colleagues to do so as well.
I reserve the balance of my time.
Mr. PITTS. Mr. Speaker, at this time I yield 4 minutes to the
gentleman from New York (Mr. Grimm).
Mr. GRIMM. Thank you for yielding me time.
Today, I rise in strong support of this legislation, H.R. 6118, the
Taking Essential Steps for Testing Act. I would like to thank Chairman
Upton for his leadership, Ranking Member Waxman, as well as the Health
Subcommittee and their entire staff for their support and dedication to
this important bill.
The TEST Act is a bipartisan and bicameral solution to an issue that
threatens Americans' access to health care. Under the Clinical
Laboratory Improvement Amendments, CLIA, any lab that conducts human
specimen testing must have a CLIA certificate and comply with the law's
proficient testing, or PT, requirements. CLIA requires labs to treat PT
samples as it would a patient sample. However, the law explicitly
prohibits a lab from referring a PT sample to another laboratory,
although this may be normal for patient procedures. The purpose of this
prohibition is to ensure labs submit their own results for PT samples.
I believe that this does clearly promote continued patient safety,
accurate results, and that a lab is not getting reimbursed for tests it
does not or cannot perform.
The concern is that labs which have accidentally referred a PT sample
to another lab and self-reported this mistake are being told by CMS
that CLIA does not provide any flexibility and therefore their
certificates must be revoked. As a result, labs that make a mistake and
proactively try to correct it are treated identically to labs that
knowingly and in bad faith violate the law.
Without a CLIA certificate, as we have heard, labs are unable to
conduct any human specimen testing. For hospitals, this could mean
choosing between shutting down essentially all services such as the ER
and the operating room or paying millions of dollars to bring in an
outside lab for 2 years. Both of these options result in reduced access
to health care and other related services for patients.
The TEST Act gives CMS discretion to not revoke a CLIA certificate
for a PT referral if it is determined that the lab was acting in good
faith. And for labs which are bad actors, the TEST Act does nothing to
alter CMS's ability to punish those labs and revoke their certificate.
H.R. 6118 also gives CMS the discretion to not apply the revocation to
an entire hospital network or other owner-operators based on the facts
of a particular case.
In determining whether or not to revoke a CLIA certificate, I urge
CMS to consider factors such as the nature of the violation, the lab's
history of compliance and past PT experience, whether or not the lab
voluntarily reported the referral, any remedial actions taken by the
lab, and any recommendations made by the State or applicable
accrediting organization.
I would like to end by saying thank you to all of my colleagues that
helped support this legislation and urge all my colleagues to vote in
favor of H.R. 6118. It's commonsense legislation that ultimately puts
patients first.
Mrs. CAPPS. May I ask the chairman if he has any other speakers?
Mr. PITTS. We have no further speakers.
Mrs. CAPPS. Mr. Speaker, in closing, the Taking Essential Steps for
Testing Act is a straightforward bill with bipartisan support. It will
give CMS tools to effectively deal with labs that unintentionally refer
out their proficiency tests, maintain sanctions for labs that
intentionally flaunt the law, and ensure that certified clinical labs
are there for us when we need them.
I urge support for this bill, and I yield back the balance of my
time.
Mr. PITTS. Mr. Speaker, I urge support for this commonsense,
bipartisan bill, H.R. 6118, and I yield back the balance of my time.
Mr. WAXMAN. Mr. Speaker, I am pleased that we are taking up H.R.
6118, a bipartisan, non-controversial bill that will provide the
Centers for Medicare & Medicaid Services (CMS) with additional
flexibility in imposing and enforcing penalties on clinical
laboratories under the Public Health Service Act.
The Committee on Energy and Commerce has a long history of being
vigilant with respect to quality and safety standards for clinical
laboratories. In fact, the Public Health Service Act standards for labs
originated in this Committee when John Dingell, Ed Madigan, Ron Wyden
and I sponsored the legislation in the 1980's.
All laboratories in the United States must be certified and meet
certain quality and safety standards. To maintain certification,
laboratories must periodically perform proficiency tests, which measure
the quality of a lab's work. These proficiency tests must be performed
in-house--as the test is intended to measure that specific lab's
quality and competency.
If a lab is found to have intentionally referred a proficiency
testing sample to another laboratory, the Secretary of HHS must revoke
that lab's CLIA certificate for at least 1 year (thereby preventing it
from billing Medicare or Medicaid for that period). In addition, the
owner or operator of any lab that has had its CLIA certificate revoked
is barred from owning or operating any CLIA-certified laboratory for 2
years.
Current law does not allow the Secretary any flexibility in imposing
these penalties for
[[Page H6142]]
labs that improperly refer proficiency tests--even for an unintentional
referral.
Equally importantly, there have been a number of changes in the
organization and delivery of health care since these penalties
provisions were enacted. In particular--the growth of health systems
that have many providers joining together to operate under the same
umbrella. In the case of laboratories, one hospital system may own and
operate a number of labs. If one lab is found to have a proficiency
testing violation, all of the labs under the hospital's system would be
barred from Medicare--even if those labs had no quality or proficiency
testing issues.
This is not a sensible result. This legislation would address that
problem.
First, H.R. 6118 ensures the statute is clear on the point that no
proficiency testing sample may be referred to another laboratory even
if such referral would be part of the testing lab's standard procedure
for patient specimens (a point of existing law on which some providers
have been confused).
Second, it grants the Secretary discretion in determining whether to
revoke a lab's CLIA certificate for improper referrals of PT testing
samples--to account for the case of unintentional error.
Finally, the bill would grant the Secretary discretion to apply
alternate sanctions in lieu of the 2-year owner/operator ban if a CLIA
certificate has been revoked due to an improper proficiency testing
referral, correcting the problem of having to ban all labs in a health
system, even if the others had no known problems.
The Taking Essential Steps for Testing Act would address that issue,
striking a balance to ensure quality protections remain, yet giving the
Secretary the flexibility to more appropriately tailor penalties for
violations of the law. I'm pleased to support this bill today.
Mr. UPTON. Mr. Speaker, H.R. 6118, the Taking Essential Steps for
Testing (TEST) Act of 2012, is an important measure that grants CMS the
necessary flexibility to enforce its rules without unnecessarily
punishing employers for unintentional acts.
Under current law, laboratories must adhere to CMS procedures for
processing testing samples in order to do business under the Clinical
Laboratory Improvement Amendments (CLIA) law. In addition, they are
prohibited from intentionally referring testing samples to other labs.
Unfortunately, CMS is not allowed to look at the circumstances under
which labs refer samples, and must levy the same penalties for those
operating in good faith as those knowingly and willfully breaking the
law. These penalties include the loss of a lab's certification for a
year and a prohibition against the owner operating any lab for a period
of two years.
In instances where a hospital or independent laboratory has
accidentally referred a sample due to mistakes by employees or through
automated systems, these penalties can be needlessly harsh and threaten
the livelihood of American workers. H.R. 6118 would address these
issues by allowing the Secretary discretion when determining penalties.
The legislation has received bipartisan support among this body as
well as numerous organizations. I would like to commend Congressmen
Grimm and Roskam for their work and urge Members to support its
passage.
Mr. ROSKAM. Mr. Speaker, I rise today to express my support for H.R.
6118, the ``Taking Essential Steps for Testing Act of 2012'' or TEST
Act. This legislation will give the Centers for Medicare and Medicaid
(CMS) greater leeway when dealing with hospitals and laboratories
across the nation.
Last year I was contacted by a hospital in my Congressional District
who informed me that they had unintentionally referred a proficiency
test to an outside lab because the lab technician was following patient
procedure. They informed me that because of this error they would be
forced to potentially close the lab and essentially fire the lab
director. Upon further investigation, I was troubled to learn that the
same problem was occurring across the country because CMS lacked the
authority to handle these cases in any other fashion.
This is why I was happy to work with my good friend from New York,
Mr. Grimm, and Mr. Ross from Arkansas, as well as Senators Boozman,
Klobuchar, and Shaheen, to come up with a simple, commonsense solution
to the problem. While working with CMS and our friends across the
aisle, we were able to demonstrate that this institution is still
capable of recognizing problems and pursuing solutions for the people
we represent back home.
It is my hope that the Senate will quickly take up this legislation
and send it to the President for signature so we can help provide
regulatory relief to our nation's hospitals and labs.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Pennsylvania (Mr. Pitts) that the House suspend the
rules and pass the bill, H.R. 6118.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill was passed.
A motion to reconsider was laid on the table.
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