Clinical Laboratory Improvement Act Amendments of 1999

Clinical Laboratory Improvement Act Amendments of 1999 - Exempts a physician clinical office laboratory from Public Health Service Act certification requirements, except when such laboratory performs a pap smear (Papanicolaou Smear) analysis.

[Congressional Bills 106th Congress]
[From the U.S. Government Printing Office]
[H.R. 528 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 528

    To amend section 353 of the Public Health Service Act to exempt 
     physician office laboratories from the clinical laboratories 
                     requirements of that section.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 3, 1999

  Mr. Archer introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 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.

    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 ``Clinical Laboratory Improvement Act 
Amendments of 1999''.

SEC. 2. EXEMPTION OF PHYSICIAN OFFICE LABORATORIES.

    Section 353(d) of the Public Health Service Act (42 U.S.C. 263a(d)) 
is amended--
            (1) by redesignating paragraphs (2), (3), and (4) as 
        paragraphs (3), (4), and (5) and by adding after paragraph (1) 
        the following:
            ``(2) Exemption of physician office laboratories.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), a clinical laboratory in a 
                physician's office (including an office of a group of 
                physicians) which is directed by a physician and in 
                which examinations and procedures are either performed 
                by a physician or by individuals supervised by a 
                physician solely as an adjunct to other services 
                provided by the physician's office is exempt from this 
                section.
                    ``(B) Exception.--A clinical laboratory described 
                in subparagraph (A) is not exempt from this section 
                when it performs a pap smear (Papanicolaou Smear) 
                analysis.
                    ``(C) Definition.--For purposes of subparagraph 
                (A), the term `physician' has the same meaning as is 
                prescribed for such term by section 1861(r) of the 
                Social Security Act (42 U.S.C. 1395x(r)).'';
            (2) in paragraph (3) (as so redesignated) by striking 
        ``(3)'' and inserting ``(4)''; and
            (3) in paragraphs (4) and (5) (as so redesignated) by 
        striking ``(2)'' and inserting ``(3)''.
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