[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1220 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                S. 1220

 To require that certain complex diagnostic laboratory tests performed 
 by an independent laboratory after a hospital outpatient encounter or 
 inpatient stay during which the specimen involved was collected shall 
 be treated as services for which payment may be made directly to the 
   laboratory under part B of title XVIII of the Social Security Act.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 9, 2009

Mr. Specter (for himself and Mr. Wyden) introduced the following bill; 
     which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
 To require that certain complex diagnostic laboratory tests performed 
 by an independent laboratory after a hospital outpatient encounter or 
 inpatient stay during which the specimen involved was collected shall 
 be treated as services for which payment may be made directly to the 
   laboratory under part B of title XVIII of the Social Security Act.

    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 ``Patient Access to Critical Lab Tests 
Act''.

SEC. 2. FINDINGS; SENSE OF CONGRESS.

    (a) Findings.--The Congress finds as follows:
            (1) Timely access to laboratory testing is essential to 
        ensure quality of care for patients.
            (2) Genetic and molecular laboratory testing are the new 
        cornerstones of high-quality, cost-effective preventive 
        medicine.
            (3) The completion of the Human Genome Project in 2003 
        paved the way for a more sophisticated understanding of disease 
        causation, which has contributed to the advent of 
        ``personalized medicine''.
            (4) Personalized medicine is the application of genomic and 
        molecular data to better target the delivery of health care, 
        facilitate the discovery and clinical testing of new products, 
        and help determine a patient's predisposition to a particular 
        disease or condition.
            (5) Personalized medicine offers the promise of smarter, 
        more effective, and safer care as physicians and patients 
        become equipped with better information to guide treatment 
        decisions.
            (6) Some of the most encouraging personalized medicine 
        developments involve highly specialized laboratory tests that, 
        using biomarkers and vast stores of historical data, provide 
        individualized information that enable physicians and patients 
        to develop personalized treatment plans.
            (7) Several outdated Medicare regulations for laboratory 
        billing are obstructing access to highly specialized laboratory 
        tests and delaying patients' diagnoses and treatments. These 
        same rules are discouraging investments in development of new 
        tests.
            (8) Realizing the promise of personalized medicine will 
        require improved regulation that appropriately encourages 
        development of and access to these specialized tests.
    (b) Sense of Congress.--It is the sense of Congress that--
            (1) where practical, Medicare regulations and policies 
        should be written to promote development of and access to the 
        highly specialized laboratory tests referred to in subsection 
        (a)(6); and
            (2) the Medicare regulation described in section 414.510 of 
        title 42, Code of Federal Regulations, is one such regulation 
        that should be revised to permit laboratories furnishing 
        certain specialized tests to bill for and be paid directly by 
        Medicare for furnishing such tests.

SEC. 3. TREATMENT OF CERTAIN COMPLEX DIAGNOSTIC LABORATORY TESTS.

    (a) In General.--Notwithstanding sections 1862(a)(14) and 
1866(a)(1)(H)(i) of the Social Security Act (42 U.S.C. 1395y(a)(14) and 
1395cc(a)(1)(H)(i)), in the case that a laboratory performs a covered 
complex diagnostic laboratory test, with respect to a specimen 
collected from an individual during a period in which the individual is 
a patient of a hospital, if the test is performed after such period the 
Secretary of Health and Human Services shall treat such test, for 
purposes of providing direct payment to the laboratory under section 
1833(h) or 1848 of such Act (42 U.S.C. 1395l(h) or 1395w-4), as if such 
specimen had been collected directly by the laboratory.
    (b) Covered Complex Diagnostic Laboratory Test Defined.--For 
purposes of this section, the term ``covered complex diagnostic 
laboratory test'' means an analysis--
            (1) of DNA, RNA, chromosomes, proteins, or metabolites that 
        detects, identifies, or quantitates genotypes, mutations, 
        chromosomal changes, biochemical changes, cell response, 
        protein expression, or gene expression or similar method or is 
        a cancer chemotherapy sensitivity assay or similar method, but 
        does not include methods principally comprising routine 
        chemistry or routine immunology;
            (2) that is described in section 1861(s)(3) of the Social 
        Security Act (42 U.S.C. 1395x(s)(3));
            (3) that is developed and performed by a laboratory which 
        is independent of the hospital in which the specimen involved 
        was collected and not under any arrangements (as defined in 
        section 1861(w)(1) of such Act (42 U.S.C. 1395x(w)(1)); and
            (4) that is not furnished by the hospital where the 
        specimen was collected to a patient of such hospital, directly 
        or under arrangements (as defined in section 1861(w)(1) of such 
        Act (42 U.S.C. 1395x(w)(1))) made by such hospital.

SEC. 4. EFFECTIVE DATE.

    The provisions of section 3 shall apply to tests furnished on or 
after the date of the enactment of this Act.
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