II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prostate Cancer Mis5 diagnosis Elimination Act of 2017’’. 


SSpencer on DSKBBV9HB2PROD with BILLS
2 

•S 2067 IS

1 SEC. 2. COVERAGE OF CERTAIN DNA SPECIMEN PROVE2 NANCE ASSAY CLINICAL DIAGNOSTIC LAB3 ORATORY TESTS UNDER MEDICARE. 

4 (a) COVERAGE.—Section 1862(a)(1) of the Social Se5 curity Act (42 U.S.C. 1395y(a)(1)) is amended— 

6 (1) in subparagraph (O), by striking ‘‘and’’ at 

7 the end; 

8 (2) in subparagraph (P), by striking the semi9 colon at the end and inserting ‘‘, and’’; and 

10 (3) by adding at the end the following new sub11 paragraph: 

12 ‘‘(Q) in the case of a DNA Specimen Prove13 nance Assay clinical diagnostic laboratory test 

14 (DSPA test) furnished on or after the date specified 

15 in section 1834A(j)(4), unless the DSPA test is fur16 nished to an individual enrolled under part B who 

17 has had a prostate cancer biopsy the results of 

18 which are positive, the DSPA test is furnished with 

19 respect to such biopsy, and the DSPA test is or20 dered by the physician who furnished the prostate 

21 cancer biopsy that obtained the specimen tested;’’. 

22 (b) TEMPORARY PAYMENT AMOUNT FOR CERTAIN

23 TESTS FURNISHED BEFORE 2028 AND RELATED RE24 QUIREMENTS.—Section 1834A of the Social Security Act 

25 (42 U.S.C. 1395m–1) is amended— 


SSpencer on DSKBBV9HB2PROD with BILLS
3 

•S 2067 IS

1 (1) in subsection (b)(1)(A), by striking ‘‘and 

2 (d)’’ and inserting ‘‘, (d), and (j)’’; and 

3 (2) by adding at the end the following new sub4 section: 

5 ‘‘(j) DNA SPECIMEN PROVENANCE ASSAY CLINICAL

6 DIAGNOSTIC LABORATORY TESTS.— 

7 ‘‘(1) TEMPORARY PAYMENT AMOUNT FOR CER8 TAIN TESTS FURNISHED BEFORE 2028.—With re9 spect to a DNA Specimen Provenance Assay clinical 

10 diagnostic laboratory test furnished on or after the 

11 date specified in paragraph (4) and before January 

12 1, 2028, the payment amount under this section for 

13 such test shall be equal to $200. 

14 ‘‘(2) HCPCS CODE AND MODIFIER ASSIGN15 MENT.— 

16 ‘‘(A) IN GENERAL.—The Secretary shall 

17 assign one or more HCPCS codes to the DNA 

18 Specimen Provenance Assay clinical diagnostic 

19 laboratory test and may use a modifier to facili20 tate making payment under this section with 

21 respect to such test. 

22 ‘‘(B) IDENTIFICATION OF DNA MATCH ON

23 CLAIM.—The Secretary shall require an indica24 tion on a claim for a DNA Specimen Prove25 nance Assay clinical diagnostic laboratory test 


SSpencer on DSKBBV9HB2PROD with BILLS
4 

•S 2067 IS

1 of whether the DNA of the prostate biopsy 

2 specimen for such test matches the DNA of the 

3 individual with respect to whom the test was or4 dered. Such indication may be made through 

5 use of a HCPCS code, a modifier, or other 

6 means, as determined appropriate by the Sec7 retary. 

8 ‘‘(3) DNA MATCH REVIEW.— 

9 ‘‘(A) IN GENERAL.—The Secretary shall 

10 review at least three years of claims under part 

11 B for DNA Specimen Provenance Assay clinical 

12 diagnostic laboratory tests to identify whether 

13 the DNA of the prostate biopsy specimens for 

14 such tests matched the DNA of the individuals 

15 with respect to whom such tests were ordered. 

16 ‘‘(B) POSTING ON INTERNET WEBSITE.— 

17 Not later than July 1, 2024, the Secretary shall 

18 post on the Internet website of the Centers for 

19 Medicare & Medicaid Services the findings of 

20 the review conducted under subparagraph (A). 

21 ‘‘(4) DATE SPECIFIED.—For purposes of para22 graph (1) and section 1862(a)(1)(Q), the date speci23 fied in this paragraph is the first day of the second 


SSpencer on DSKBBV9HB2PROD with BILLS
5 

•S 2067 IS

1 calendar quarter that begins at least 180 days after 

2 the date of the enactment of this subsection.’’. 

Æ 


SSpencer on DSKBBV9HB2PROD with BILLS