Sec. 3. Increasing price transparency of clinical diagnostic laboratory tests under the medicare program

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Section 2718 of the Public Health Service Act ( 42 U.S.C. 300gg–18 ) is amended by adding at the end the following: Beginning January 1, 2025, any applicable laboratory that receives payment from a group health plan or health insurance issuer for furnishing any specified clinical diagnostic laboratory test shall— 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; and ensure that such information is updated not less frequently than annually. 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 following: A plain language description of each item or service, accompanied by any applicable billing codes, including modifiers, using commonly recognized billing code sets, including the Current Procedural Terminology code, the Healthcare Common Procedure Coding System code, the diagnosis-related group, the National Drug Code, and other nationally recognized identifier. The gross charge, as applicable, expressed as a dollar amount, for each such item or service. The discounted cash price, as applicable, expressed as a dollar amount, for each such item or service (or, in the case no discounted cash price is available for an item or service, the minimum cash price accepted by the laboratory from self-pay individuals for such item or service when provided in such settings for the previous three years, expressed as a dollar amount, as well as, with respect to prices made public pursuant to subparagraph (A)(ii), a link to a consumer-friendly document that clearly explains the laboratory’s charity care policy). The laboratory shall accept the discounted cash price as payment in full from any patient that chooses to pay in cash without regard to the patient’s coverage. The payer-specific negotiated charges, expressed as a dollar amount and clearly associated with the name of the applicable third party payer and name of each plan, that apply to each such item or service when provided in, as applicable, the inpatient setting and outpatient department setting. If the charges are based on an algorithm, percentage of another amount, or other formula or criteria, the clinical diagnostic laboratory also shall disclose such algorithm, percentage, formula, or criteria as set forth in its contract and any other terms, schedules, exhibits, data, or other information referenced in any such contract as shall be required to determine and disclose the negotiated charge. The de-identified maximum and minimum negotiated charges, as applicable, for each such item or service, expressed as a non-zero dollar amount. Any other additional information the Secretary may require for the purpose of improving the accuracy of, or enabling consumers to easily understand and compare, standard charges and prices for an item or service, except information that is duplicative of any other reporting requirement under this subsection. In the case of standard charges and prices for an item or service included as part of a bundled, per diem, episodic, or other similar arrangement, the information described in this subparagraph shall be made available as determined appropriate by the Secretary. Not later than January 1, 2025, 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— shall include a machine-readable spreadsheet format containing the information described in paragraph

(2)for all items and services furnished by each laboratory; may be similar to any template made available by the Centers for Medicare & Medicaid Services (as described in subsection (e)); shall meet such standards as determined appropriate by the Secretary in order to ensure the accessibility and usability of such information; and shall be updated as determined appropriate by the Secretary, in consultation with stakeholders. Any price or rate for a specified clinical diagnostic laboratory test available to be furnished by an applicable laboratory made publicly available in accordance with paragraph

(1)shall include the price or rate (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. In the case that the Secretary determines that an applicable laboratory is not in compliance with paragraph (1)— not later than 30 days after such determination, the Secretary shall notify such laboratory of such determination; and 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 (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. In applying this paragraph with respect to violations occurring in 2025 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). The provisions of section 1128A of the Social Security Act (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. 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. In this subsection: 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 a hospital pursuant to subsection (e). The term discounted cash price means the charge that applies to an individual who pays cash, or cash equivalent, for an item or service. The term gross charge means the charge for an individual item or service that is reflected on an applicable laboratory’s chargemaster, absent any discounts. The term payer-specific negotiated charge means the charge that an applicable laboratory has negotiated with a third party payer for an item or service. 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 subsection (e)), other than such a test that is only available to be furnished by a single provider of services or supplier. The term third party payer means an entity that is, by statute, contract, or agreement, legally responsible for payment of a claim for a health care item or service. .

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42 USC 300gg–18

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Sec. 3

Increasing price transparency of clinical diagnostic laboratory tests under the medicare program

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