[Congressional Record Volume 143, Number 107 (Friday, July 25, 1997)]
[Senate]
[Page S8153]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. HUTCHISON (for herself, Mr. Cochran, Mr. Faircloth, and 
        Mr. Nickles):
  S. 1068. A bill to amend section 353 of the Public Health Service Act 
to exempt physician office laboratories from the clinical laboratories 
requirements of that section; to the Committee on Labor and Human 
Resources.


       THE CLINICAL LABORATORY IMPROVEMENT ACT AMENDMENTS OF 1997

  Mrs. HUTCHISON. Mr. President, I rise today to introduce legislation 
that is critically needed to reduce the regulatory burdens on our 
doctor's offices today.
  In 1988, Congress passed the Clinical Laboratory Improvement Act as a 
reaction to reports about laboratories that inaccurately analyzed PAP 
smears. CLIA 1988 was intended to address the quality of laboratory 
test performance. Unfortunately, the regulations enacted as a result of 
the CLIA 1988 legislation did not reflect the intent of the act. What 
in effect happened following the passage of CLIA 1988 was a series of 
regulations that substantially increased the amount of paperwork to be 
performed in physician offices and now ultimately increases the cost of 
health care to the patients. There has been little, if any, 
documentation that the CLIA 1988 reforms resulted in an improvement in 
patient care.
  In fact, a Texas Medical Association study showed that the annual 
cost of the labor and administrative overhead added by CLIA averages 
$4,435 per physician. This is in addition to the cost of registration, 
controls, proficiency testing, and inspection or accreditation. At a 
time when the entire health care industry is under pressure to control 
health care costs, the CLIA regulations not only subject physicians to 
increased administrative costs but also decrease the amount of time 
devoted to patient care.
  One Texas physician describes his CLIA inspection as being left with 
a feeling that nothing of any real value was accomplished. Dr. McBrayer 
from the Texas Panhandle relates the inspection:

       We were written up for such monumental things as the fact 
     that I had not signed the procedure manual for one of our lab 
     machines. Therefore, everything done on that machine, 
     including the training, was out of compliance. The fact that 
     the manufacturer's rep had come and trained the staff was to 
     no avail. Everything was out of compliance because I didn't 
     sign it. It didn't matter that they had learned how to use 
     it. That was irrelevant.

  The CLIA amendments I am introducing will reduce the burdens on 
physicians who perform laboratory tests in their offices and thereby 
free up resources and time to dedicate to patient care. In Texas alone, 
of the physicians who provided testing services in their offices prior 
to CLIA, 27 percent have closed their office labs, and another 31 
percent have discounted some type of testing, as a direct result of the 
CLIA 1988 reforms. This has resulted in some areas of Texas 
experiencing physician shortages. Many physicians are concerned about 
the possible consequences to patients caused by the decreased access to 
testing or the delay in obtaining results. In the wake of the health 
care reform debate, it is important to promote quality-driven cost-
effective ways of delivery care.
  Mr. President, the CLIA 1997 amendments will not jeopardize the 
quality of laboratory testing. This bill will exempt physician office 
lab tests from the CLIA 1988 restrictions that have caused many 
physicians to discontinue simple laboratory tests due to the excessive 
amounts of regulation involved in the performance of these tests. The 
CLIA 1997 amendments that I am introducing today in the Senate will 
have the narrow purpose of ensuring that essential laboratory testing 
performed by physicians remain a viable diagnostic option for 
physicians and their patients without the excessive rules and 
administratively complex requirements that currently exist, and, most 
importantly, eliminate the strain the CLIA 1988 legislation is placing 
on patients in rural areas who are losing access to necessary testing 
and care.
  I hope that all my colleagues will join me in supporting this 
legislation, which will reduce health care costs and improve the 
ability of patients to receive laboratory tests in a timely fashion 
while providing the much needed regulatory relief to physicians all 
over the country.
                                 ______