Clinical diagnostic laboratory test price transparency

Section 1846 of the Social Security Act (42 U.S.C. 1395w–2) is amended— (1) in the header, by inserting and additional requirements after sanctions; and (2) by adding at the end the following new subsection: (c) Price transparency requirement (1) In general Beginning January 1, 2028, any applicable laboratory that receives payment under this title for furnishing any specified clinical diagnostic laboratory test under this title shall— (A) make publicly available on an internet website the information described in paragraph (2) with respect to each such specified clinical diagnostic laboratory test that such laboratory so furnishes; (B) ensure that such information is updated not less frequently than annually; and (C) include on the website described in subparagraph (A) an attestation that all such information is complete and accurate. (2) Information described For purposes of paragraph (1), the information described in this paragraph is, with respect to an applicable laboratory and a specified clinical diagnostic laboratory test, the discounted cash price for such test (or, if no such price exists, the gross charge for such test). (3) Uniform method and format Not later than January 1, 2028, the Secretary shall establish a standard, uniform method and format for applicable laboratories to use in compiling and making public information pursuant to paragraph (1). Such method and format— (A) may be similar to any template made available by the Centers for Medicare & Medicaid Services (as described in section 1899D(a)(2)(C)(ii)); (B) shall meet such standards as determined appropriate by the Secretary in order to ensure the accessibility and usability of such information; and (C) shall be updated as determined appropriate by the Secretary, in consultation with stakeholders. (4) Inclusion of ancillary services Any price or charge for a specified clinical diagnostic laboratory test furnished by an applicable laboratory made publicly available in accordance with paragraph (1) shall include the price or charge (as applicable) for any ancillary item or service (such as specimen collection services) that would normally be furnished by such laboratory as part of such test, as specified by the Secretary. (5) Enforcement (A) In general In the case that the Secretary determines that an applicable laboratory is not in compliance with paragraph (1)— (i) not later than 30 days after such determination, the Secretary shall notify such laboratory of such determination; and (ii) if such laboratory continues to fail to comply with such paragraph after the date that is 90 days after such notification is sent, the Secretary may impose a civil monetary penalty in an amount not to exceed $300 for each day (beginning with the day on which the Secretary first determined that such laboratory was failing to comply with such paragraph) during which such failure is ongoing. (B) Increase authority In applying this paragraph with respect to violations occurring in 2029 or a subsequent year, the Secretary may through notice and comment rulemaking increase the per day limitation on civil monetary penalties under subparagraph (A)(ii). (C) Application of certain provisions The provisions of section 1128A (other than subsections (a) and (b) of such section) shall apply to a civil monetary penalty imposed under this paragraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection (a) of such section. (6) Provision of technical assistance The Secretary shall, to the extent practicable, provide technical assistance relating to compliance with the provisions of this subsection to applicable laboratories requesting such assistance. (7) Definitions In this subsection: (A) Applicable laboratory The term applicable laboratory has the meaning given such term in section 414.502, of title 42, Code of Federal Regulations (or a successor regulation), except that such term does not include a laboratory with respect to which standard charges and prices for specified clinical diagnostic laboratory tests furnished by such laboratory are made available by— (i) a specified hospital pursuant to section 1899D; (ii) a hospital pursuant to section 2718(f) of the Public Health Service Act; or (iii) an ambulatory surgical center pursuant to section 1834(bb). (B) Discounted cash price The term discounted cash price means the charge that applies to an individual who pays cash, or cash equivalent, for an item or service. (C) Gross charge The term gross charge means the charge for an individual item or service that is reflected on an applicable laboratory’s chargemaster (or similar list of prices), absent any discounts. (D) Specified clinical diagnostic laboratory test the term specified clinical diagnostic laboratory test means a clinical diagnostic laboratory test that is included on the list of shoppable services specified by the Centers for Medicare & Medicaid Services (as described in section 1899D(a)(2)(A)(ii)(I)), other than an advanced diagnostic laboratory test (as defined in section 1834A(d)(5)). (E) Specified hospital The term specified hospital has the meaning given such term in section 1899D..