Title: Prostate Cancer Misdiagnosis Elimination Act of 2017
Policy area: Health

Summary:
This bill provides for Medicare coverage of a DNA Specimen Provenance Assay clinical diagnostic laboratory test following a positive prostate cancer biopsy.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2067 Introduced in Senate (IS)]

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115th CONGRESS
  1st Session
                                S. 2067

To amend title XVIII of the Social Security Act to provide for coverage 
  under the Medicare program of certain DNA Specimen Provenance Assay 
                 clinical diagnostic laboratory tests.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            November 2, 2017

   Mr. Crapo introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to provide for coverage 
  under the Medicare program of certain DNA Specimen Provenance Assay 
                 clinical diagnostic laboratory tests.

    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 ``Prostate Cancer Misdiagnosis 
Elimination Act of 2017''.

SEC. 2. COVERAGE OF CERTAIN DNA SPECIMEN PROVENANCE ASSAY CLINICAL 
              DIAGNOSTIC LABORATORY TESTS UNDER MEDICARE.

    (a) Coverage.--Section 1862(a)(1) of the Social Security Act (42 
U.S.C. 1395y(a)(1)) is amended--
            (1) in subparagraph (O), by striking ``and'' at the end;
            (2) in subparagraph (P), by striking the semicolon at the 
        end and inserting ``, and''; and
            (3) by adding at the end the following new subparagraph:
            ``(Q) in the case of a DNA Specimen Provenance Assay 
        clinical diagnostic laboratory test (DSPA test) furnished on or 
        after the date specified in section 1834A(j)(4), unless the 
        DSPA test is furnished to an individual enrolled under part B 
        who has had a prostate cancer biopsy the results of which are 
        positive, the DSPA test is furnished with respect to such 
        biopsy, and the DSPA test is ordered by the physician who 
        furnished the prostate cancer biopsy that obtained the specimen 
        tested;''.
    (b) Temporary Payment Amount for Certain Tests Furnished Before 
2028 and Related Requirements.--Section 1834A of the Social Security 
Act (42 U.S.C. 1395m-1) is amended--
            (1) in subsection (b)(1)(A), by striking ``and (d)'' and 
        inserting ``, (d), and (j)''; and
            (2) by adding at the end the following new subsection:
    ``(j) DNA Specimen Provenance Assay Clinical Diagnostic Laboratory 
Tests.--
            ``(1) Temporary payment amount for certain tests furnished 
        before 2028.--With respect to a DNA Specimen Provenance Assay 
        clinical diagnostic laboratory test furnished on or after the 
        date specified in paragraph (4) and before January 1, 2028, the 
        payment amount under this section for such test shall be equal 
        to $200.
            ``(2) HCPCS code and modifier assignment.--
                    ``(A) In general.--The Secretary shall assign one 
                or more HCPCS codes to the DNA Specimen Provenance 
                Assay clinical diagnostic laboratory test and may use a 
                modifier to facilitate making payment under this 
                section with respect to such test.
                    ``(B) Identification of dna match on claim.--The 
                Secretary shall require an indication on a claim for a 
                DNA Specimen Provenance Assay clinical diagnostic 
                laboratory test of whether the DNA of the prostate 
                biopsy specimen for such test matches the DNA of the 
                individual with respect to whom the test was ordered. 
                Such indication may be made through use of a HCPCS 
                code, a modifier, or other means, as determined 
                appropriate by the Secretary.
            ``(3) DNA match review.--
                    ``(A) In general.--The Secretary shall review at 
                least three years of claims under part B for DNA 
                Specimen Provenance Assay clinical diagnostic 
                laboratory tests to identify whether the DNA of the 
                prostate biopsy specimens for such tests matched the 
                DNA of the individuals with respect to whom such tests 
                were ordered.
                    ``(B) Posting on internet website.--Not later than 
                July 1, 2024, the Secretary shall post on the Internet 
                website of the Centers for Medicare & Medicaid Services 
                the findings of the review conducted under subparagraph 
                (A).
            ``(4) Date specified.--For purposes of paragraph (1) and 
        section 1862(a)(1)(Q), the date specified in this paragraph is 
        the first day of the second calendar quarter that begins at 
        least 180 days after the date of the enactment of this 
        subsection.''.
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