I 115th CONGRESS 1st Session H. R. 2557 IN THE HOUSE OF REPRESENTATIVES May 19, 2017 Mr. Bucshon (for himself, Mr. Payne , Mr. Carson of Indiana , Mr. Mullin , and Mr. Rush ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Ways and Means , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 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), 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 tests furnished during 2018 through 2020 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 tests furnished during 2018 through 2020 Notwithstanding the payment amount that would otherwise apply under this section, with respect to a DNA Specimen Provenance Assay clinical diagnostic laboratory test furnished on or after January 1, 2018, and before January 1, 2021, the payment amount under this section shall be equal to 85 percent of the amount determined under the fee schedule under section 1833(h)(1) for 2016 for HCPCS code 81265. (2) HCPCS code assignment The Secretary shall assign an HCPCS code to the DNA Specimen Provenance Assay clinical diagnostic laboratory test. (3) Ensuring proper billing and payment (A) Use of modifier to ensure proper payment The Secretary may use a modifier to facilitate making payment under this section with respect to a DNA Specimen Provenance Assay clinical diagnostic laboratory test. (B) Paid claims sample error rate (i) In general The Secretary shall conduct a post-payment review of a sample of not less than 50 claims for DNA Specimen Provenance Assay clinical diagnostic laboratory tests for which payment is made under this part. The sample reviewed under the preceding sentence may be taken from claims paid to more than one supplier. (ii) Posting on Internet website Not later than July 1, 2019, the Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services the number of claims with errors identified based on the reviews conducted under clause (i). . (c) Effective date The amendments made by this section shall apply to DNA Specimen Provenance Assay clinical diagnostic laboratory tests furnished on or after January 1, 2018.