```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4882 Introduced in House (IH)]

<DOC>

118th CONGRESS
  1st Session
                                H. R. 4882

 To amend title XVIII of the Social Security Act to promote laboratory 
             price transparency under the Medicare program.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             July 25, 2023

 Mrs. Miller of West Virginia introduced the following bill; which was 
  referred to the Committee on Ways and Means, and in addition to the 
   Committee on Energy and Commerce, 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 promote laboratory 
             price transparency under the Medicare program.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Clinical Laboratory Price 
Transparency Act of 2023''.

SEC. 2. PROMOTING LABORATORY PRICE TRANSPARENCY UNDER THE MEDICARE 
              PROGRAM.

    Part E of title XVIII of the Social Security Act (42 U.S.C. 1395x 
et seq.) is amended by adding at the end the following new section:

``SEC. 1899C. LABORATORY PRICE TRANSPARENCY REQUIREMENT.

    ``(a) In General.--Beginning January 1, 2025, each applicable 
laboratory that receives payment under this title for furnishing a 
specified clinical diagnostic laboratory test shall--
            ``(1) make publicly available (in a manner and form 
        specified by the Secretary) on an Internet website the 
        information described in subsection (b) with respect to each 
        such specified clinical diagnostic laboratory test that such 
        laboratory is so available to furnish; and
            ``(2) ensure that such information is updated not less 
        frequently than annually.
    ``(b) Information Described.--For purposes of subsection (a), the 
information described in this subsection is, with respect to an 
applicable laboratory and a specified clinical diagnostic laboratory 
test, the following:
            ``(1) The discounted cash price for such test (or, if no 
        such price exists, the gross charge for such test).
            ``(2) If required by the Secretary, the deidentified 
        minimum negotiated rate in effect between such laboratory and 
        any group health plan or group or individual health insurance 
        coverage for such test and the deidentified maximum negotiated 
        rate in effect between such laboratory and any such plan or 
        coverage for such test.
    ``(c) Method and Format.--Not later than January 1, 2028, the 
Secretary shall establish one or more methods and formats for each 
provider of services and supplier to use in compiling and making public 
standard charges and prices (as applicable) pursuant to subsection (a). 
Any such method and format--
            ``(1) may be similar to any template made available by the 
        Centers for Medicare & Medicaid Services as of the date of the 
        enactment of this subsection;
            ``(2) shall meet such standards as determined appropriate 
        by the Secretary in order to ensure the accessibility and 
        usability of such charges and prices; and
            ``(3) shall be updated as determined appropriate by the 
        Secretary, in consultation with stakeholders.
    ``(d) Monitoring Compliance.--The Secretary shall, through notice 
and comment rulemaking and in consultation with the Inspector General 
of the Department of Health and Human Services, establish a process to 
monitor compliance with this section.
    ``(e) Enforcement.--
            ``(1) In general.--In the case that the Secretary 
        determines that an applicable laboratory is not in compliance 
        with subsection (a)--
                    ``(A) not later than 30 days after such 
                determination, the Secretary shall notify such 
                laboratory of such determination;
                    ``(B) upon request of the Secretary, such 
                laboratory shall submit to the Secretary, not later 
                than 45 days after such request is sent, a corrective 
                action plan to comply with such subsection; and
                    ``(C) if such laboratory continues to fail to 
                comply with such paragraph after the date that is 90 
                days after such notification is sent (or, in the case 
                of such a laboratory that has submitted a corrective 
                action plan described in subparagraph (B) in response 
                to a request so described, after the date that is 90 
                days after such submission), the Secretary may impose a 
                civil monetary penalty in an amount not to exceed $300 
                for each subsequent day during which such failure to 
                comply is ongoing.
            ``(2) Increase authority.--In applying this paragraph with 
        respect to violations occurring in 2027 or a subsequent year, 
        the Secretary may through notice and comment rulemaking 
        increase the amount of the civil monetary penalty under 
        paragraph (1)(C).
            ``(3) 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 subsection in the same manner as such provisions apply to 
        a civil monetary penalty imposed under subsection (a) of such 
        section.
            ``(4) Authority to waive or reduce penalty.--The Secretary 
        may waive or reduce any penalty otherwise applicable with 
        respect to an applicable laboratory under this paragraph if the 
        Secretary determines that imposition of such penalty would 
        result in a significant hardship for such laboratory (such as 
        in the case of an applicable laboratory located in a rural or 
        underserved area where imposition of such penalty may result 
        in, or contribute to, a lack of access to care for individuals 
        in such area).
            ``(5) Clarification of nonapplicability of other 
        enforcement provisions.--Notwithstanding any other provision of 
        this title, this subsection shall be the sole means of 
        enforcing the provisions of this section.
    ``(f) Definitions.--In this section:
            ``(1) Applicable laboratory.--The term `applicable 
        laboratory' has the meaning given such term in section 414.502, 
        of title 42, Code of Federal Regulations (or any successor 
        regulation).
            ``(2) Group health plan; group health insurance coverage; 
        individual health insurance coverage.--The terms `group health 
        plan', `group health insurance coverage', and `individual 
        health insurance coverage' have the meaning given such terms in 
        section 2791 of the Public Health Service Act.
            ``(3) 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 pursuant to section 180.60 of 
        title 45, Code of Federal Regulations (or a successor 
        regulation), other than such a test that is an advanced 
        diagnostic laboratory test (as defined in section 
        1834A(d)(5)).''.
                                 <all>
```