II 115th CONGRESS 1st Session S. 2067 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.

1. Short title This Act may be cited as the Prostate Cancer Misdiagnosis Elimination Act of 2017 . 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. .