Diagnostic Lab Testing Transparency Act

I 118TH CONGRESS 1ST SESSION H. R. 3248 To amend title XVIII of the Social Security Act to increase price transparency of clinical diagnostic laboratory tests under the Medicare program. IN THE HOUSE OF REPRESENTATIVES MAY 11, 2023 Mrs. MILLER-MEEKS (for herself and Ms. DEGETTE) 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 sub- sequently 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 increase price transparency of clinical diagnostic laboratory tests under the Medicare program. 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 ‘‘Diagnostic Lab Test- 4 ing Transparency Act’’. 5 VerDate Sep 11 2014 19:03 May 24, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3248.IH H3248 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3248 IH SEC. 2. INCREASING PRICE TRANSPARENCY OF CLINICAL 1 DIAGNOSTIC LABORATORY TESTS UNDER 2 THE MEDICARE PROGRAM. 3 Section 1846 of the Social Security Act (42 U.S.C. 4 1395w–2) is amended— 5 (1) in the header, by inserting ‘‘AND ADDI- 6 TIONAL REQUIREMENTS’’ after ‘‘SANCTIONS’’; 7 and 8 (2) by adding at the end the following new sub- 9 section: 10 ‘‘(c) PRICE TRANSPARENCY REQUIREMENT.— 11 ‘‘(1) IN GENERAL.—Beginning January 1, 12 2025, each provider of services or supplier that is 13 available to furnish any specified clinical diagnostic 14 laboratory test under this title shall— 15 ‘‘(A) make publicly available on an Inter- 16 net website the information described in para- 17 graph (2) with respect to each such specified 18 clinical diagnostic laboratory test that such pro- 19 vider or supplier is so available to furnish; and 20 ‘‘(B) ensure that such information is up- 21 dated not less frequently than annually. 22 ‘‘(2) INFORMATION DESCRIBED.—For purposes 23 of paragraph (1), the information described in this 24 paragraph is, with respect to a provider of services 25 VerDate Sep 11 2014 21:31 May 24, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3248.IH H3248 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3248 IH or supplier and a specified clinical diagnostic labora- 1 tory test, the following: 2 ‘‘(A) The discounted cash price for such 3 test (or, if no such price exists, the gross 4 charge for such test). 5 ‘‘(B) The deidentified minimum negotiated 6 rate in effect between such provider or supplier 7 and any group health plan or group or indi- 8 vidual health insurance coverage for such test. 9 ‘‘(C) The deidentified maximum negotiated 10 rate in effect between such provider or supplier 11 and any such plan or coverage for such test. 12 ‘‘(3) INCLUSION OF ANCILLARY SERVICES.— 13 Any price or rate for a specified clinical diagnostic 14 laboratory test available to be furnished by a pro- 15 vider of services or supplier made publicly available 16 in accordance with paragraph (1) shall include the 17 price or rate (as applicable) for any ancillary item 18 or service (such as specimen collection services) that 19 would normally be furnished by such provider or 20 supplier as part of such test, as specified by the Sec- 21 retary. 22 ‘‘(4) ENFORCEMENT.— 23 ‘‘(A) IN GENERAL.—In the case that the 24 Secretary determines that a provider of services 25 VerDate Sep 11 2014 19:03 May 24, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3248.IH H3248 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3248 IH or supplier is not in compliance with paragraph 1 (1)— 2 ‘‘(i) not later than 30 days after such 3 determination, the Secretary shall notify 4 such provider or supplier of such deter- 5 mination; 6 ‘‘(ii) not later than 90 days after such 7 notification is sent, such provider or sup- 8 plier shall complete a corrective action plan 9 to comply with such paragraph and submit 10 such plan to the Secretary; and 11 ‘‘(iii) if such provider or supplier con- 12 tinues to fail to comply with such para- 13 graph after the date that is 90 days after 14 such notification is sent, the Secretary may 15 impose a civil monetary penalty in an 16 amount not to exceed $300 for each day 17 (beginning with the date that is 91 days 18 after such notification was sent) during 19 which such failure is ongoing. 20 ‘‘(B) APPLICATION OF CERTAIN PROVI- 21 SIONS.—The provisions of section 1128A (other 22 than subsections (a) and (b) of such section) 23 shall apply to a civil monetary penalty imposed 24 under this paragraph in the same manner as 25 VerDate Sep 11 2014 19:03 May 24, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3248.IH H3248 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 3248 IH such provisions apply to a civil monetary pen- 1 alty imposed under subsection (a) of such sec- 2 tion. 3 ‘‘(5) DEFINITIONS.—In this subsection: 4 ‘‘(A) GROUP HEALTH PLAN; GROUP 5 HEALTH INSURANCE COVERAGE; INDIVIDUAL 6 HEALTH INSURANCE COVERAGE.—The terms 7 ‘group health plan’, ‘group health insurance 8 coverage’, and ‘individual health insurance cov- 9 erage’ have the meaning given such terms in 10 section 2791 of the Public Health Service Act. 11 ‘‘(B) SPECIFIED CLINICAL DIAGNOSTIC 12 LABORATORY TEST.—The term ‘specified clin- 13 ical diagnostic laboratory test’ means a clinical 14 diagnostic laboratory test that is included on 15 the list of shoppable services specified by the 16 Centers for Medicare & Medicaid Services (as 17 described in section 180.60 of title 42, Code of 18 Federal Regulations (or a successor regula- 19 tion)).’’. 20 Æ VerDate Sep 11 2014 21:31 May 24, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H3248.IH H3248 kjohnson on DSK79L0C42PROD with BILLS