I 116TH CONGRESS 1ST SESSION H. R. 3584 To amend title XVIII of the Social Security Act to provide for certain amendments relating to reporting requirements with respect to clinical diagnostic laboratory tests, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JUNE 27, 2019 Mr. PETERS (for himself, Mr. PASCRELL, Mr. HUDSON, Mr. HOLDING, and Mr. SCHRADER) 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 certain amendments relating to reporting require- ments with respect to clinical diagnostic laboratory tests, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Laboratory Access for 4 Beneficiaries Act’’ or the ‘‘LAB Act’’. 5 VerDate Sep 11 2014 23:49 Jul 09, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3584.IH H3584 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 3584 IH SEC. 2. AMENDMENTS RELATING TO REPORTING REQUIRE- 1 MENTS WITH RESPECT TO CLINICAL DIAG- 2 NOSTIC LABORATORY TESTS. 3 (a) REVISED REPORTING PERIOD FOR REPORTING 4 OF PRIVATE SECTOR PAYMENT RATES FOR ESTABLISH- 5 MENT OF MEDICARE PAYMENT RATES.—Section 6 1834A(a) of the Social Security Act (42 U.S.C. 1395m– 7 1(a)) is amended— 8 (1) in paragraph (1)— 9 (A) by striking ‘‘Beginning January 1, 10 2016’’ and inserting the following: 11 ‘‘(A) GENERAL REPORTING REQUIRE- 12 MENTS.—Subject to subparagraph (B), begin- 13 ning January 1, 2016’’; and 14 (B) by adding at the end the following: 15 ‘‘(B) REVISED REPORTING PERIOD.—In 16 the case of reporting with respect to clinical di- 17 agnostic laboratory tests that are not advanced 18 diagnostic laboratory tests, the Secretary shall 19 revise the reporting period under subparagraph 20 (A) such that— 21 ‘‘(i) no reporting is required during 22 the period beginning January 1, 2020, and 23 ending January 1, 2021; 24 VerDate Sep 11 2014 23:49 Jul 09, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3584.IH H3584 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 3584 IH ‘‘(ii) reporting is required during the 1 period beginning January 1, 2021, and 2 ending March 31, 2021; and 3 ‘‘(iii) reporting is required every three 4 years after the period described in clause 5 (ii).’’; and 6 (2) in paragraph (4)— 7 (A) by striking ‘‘In this section’’ and in- 8 serting the following: 9 ‘‘(A) IN GENERAL.—Subject to subpara- 10 graph (B), in this section’’; and 11 (B) by adding at the end the following: 12 ‘‘(B) EXCEPTION.—In the case of report- 13 ing during the period described in paragraph 14 (1)(B)(ii) with respect to clinical diagnostic lab- 15 oratory tests that are not advanced diagnostic 16 laboratory tests, the term ‘data collection pe- 17 riod’ means the period beginning January 1, 18 2019, and ending June 30, 2019.’’. 19 (b) CORRECTIONS RELATING TO PHASE-IN OF RE- 20 DUCTIONS FROM PRIVATE PAYOR RATE IMPLEMENTA- 21 TION.—Section 1834A(b)(3) of the Social Security Act 22 (42 U.S.C. 1395m–1(b)(3)) is amended— 23 (1) in subparagraph (A), by striking ‘‘through 24 2022’’ and inserting ‘‘through 2023’’; and 25 VerDate Sep 11 2014 23:49 Jul 09, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3584.IH H3584 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 3584 IH (2) in subparagraph (B)— 1 (A) in clause (i), by striking ‘‘through 2 2019’’ and inserting ‘‘through 2020’’; and 3 (B) in clause (ii), by striking ‘‘2020 4 through 2022’’ and inserting ‘‘2021 through 5 2023’’. 6 SEC. 3. STUDY AND REPORT BY NATIONAL ACADEMY OF 7 MEDICINE. 8 (a) IN GENERAL.—Not later than 90 days after the 9 date of the enactment of this Act, the Administrator of 10 the Centers for Medicare & Medicaid Services (referred to 11 in this section as the ‘‘Administrator’’) shall enter into an 12 agreement with the National Academies of Sciences, Engi- 13 neering, and Medicine (referred to in this section as the 14 ‘‘National Academies’’) to conduct a study to review the 15 methodology the Administrator has implemented for the 16 private payor rate-based clinical laboratory fee schedule 17 under the Medicare program under title XVIII of the So- 18 cial Security Act (42 U.S.C. 1395 et seq.). 19 (b) SCOPE OF STUDY.—In carrying out the study de- 20 scribed in subsection (a), the National Academies shall 21 consider the following: 22 (1) How best to implement the least burden- 23 some data collection process required under section 24 VerDate Sep 11 2014 23:49 Jul 09, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3584.IH H3584 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 3584 IH 1834A(a)(1) of such Act (42 U.S.C. 1395m–1(a)(1)) 1 that would— 2 (A) result in a representative and statis- 3 tically valid data sample of private market rates 4 from all laboratory market segments, including 5 hospital outreach laboratories, physician office 6 laboratories, and independent laboratories; and 7 (B) consider the variability of market seg- 8 ments by laboratory procedure code. 9 (2) Appropriate statistical methods for esti- 10 mating rates that are representative of the market. 11 (c) REPORT TO CONGRESS.—Not later than the date 12 that is 18 months after the Administrator enters into the 13 agreement described in subsection (a) with the National 14 Academies, the National Academies shall submit to the 15 Administrator, the Committee on Finance of the Senate, 16 and the Committees on Ways and Means and Energy and 17 Commerce of the House of Representatives a report that 18 includes— 19 (1) conclusions about the methodology de- 20 scribed in such subsection; and 21 (2) recommendations on ways to improve such 22 methodology. 23 Æ VerDate Sep 11 2014 23:49 Jul 09, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H3584.IH H3584 pamtmann on DSKBFK8HB2PROD with BILLS