Clinical diagnostic laboratory price transparency

Section 2718A of the Public Health Service Act, as added by section 601, is amended by adding at the end the following: (c) Clinical diagnostic laboratory price transparency (1) In general Beginning January 1 of the year that begins on or after the date that is 1 year after the date of enactment of the Health CARE Act of 2026, an applicable laboratory shall, on a quarterly basis (if there have been any changes to the standard charges described in paragraph (2)) compile and make publicly available on an internet website (without subscription and free of charge)— (A) the standard charges described in paragraph (2) with respect to each specified clinical diagnostic laboratory test that such laboratory so furnishes; and (B) the name and business address for each person or entity that, with respect to the laboratory— (i) has an ownership or investment interest; (ii) has a controlling interest; (iii) is a management services organization; or (iv) is a significant equity investor. (2) Standard charges defined For purposes of paragraph (1), the term standard charges means, with respect to an applicable laboratory and a specified clinical diagnostic laboratory test, the following: (A) A plain language description of each item or service, accompanied by any applicable billing codes (including modifiers that materially change the price for insurers or providers, and that materially change out-of-pocket costs for consumers) using commonly recognized billing code sets, including— (i) the Healthcare Common Procedure Coding System code; (ii) the National Drug Code; or (iii) other applicable identifier as determined by the Secretary (or successor code sets). (B) The gross charge expressed as a dollar amount, for each such test. (C) The discounted cash price. (D) 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 test. If the charges are based on an algorithm, percentage of another amount, or other formula or criteria, the applicable laboratory also shall disclose such algorithm, percentage, formula, or criteria as set forth in its contract and any other information necessary to determine the negotiated charge as a dollar amount. (E) The de-identified maximum and minimum negotiated charges for each such item or service, expressed as a non-zero dollar amount. (F) 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 for an item or service, except information that is duplicative of any other reporting requirement under this section. In the case of standard charges 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. (3) Uniform method and format 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— (A) include a machine-readable format (or a successor technology specified by the Secretary) containing the information described in paragraph (2) for all specified clinical diagnostic laboratory tests furnished by each laboratory and the ownership information described in paragraph (1)(B); (B) meet such standards as determined appropriate by the Secretary in order to ensure the accessibility and usability of such information; and (C) be updated as determined appropriate by the Secretary, in consultation with stakeholders. (4) Monitoring compliance The Secretary shall, in consultation with the Inspector General of the Department of Health and Human Services, establish a process to monitor compliance with this subsection. Such process shall ensure that each applicable laboratory’s compliance with this subsection is reviewed not less frequently than once every year. (5) Inclusion of ancillary services Any charge for a specified clinical diagnostic laboratory test furnished by an applicable laboratory made publicly available in accordance with paragraph (1) shall include the charge for any ancillary item or service (such as specimen collection services, specimen transport, centrifugation, aliquoting, labeling, requisition processing, and standard result reporting services) that would customarily and routinely be furnished by such laboratory as part of such test, as specified by the Secretary. (6) Attestation A senior official from each clinical diagnostic laboratory (the Chief Executive Officer, Chief Financial Officer, or an official of equivalent seniority) shall attest to the accuracy and completeness of the disclosures, and any other attestations as required by the Secretary, made in accordance with the clinical laboratory price transparency requirements based on criteria established by the Secretary. (7) Enforcement (A) In general In the case of an applicable laboratory that fails to comply with the requirements of this subsection— (i) the Secretary shall notify such laboratory of such failure not later than 30 days after the date on which the Secretary determines such failure exists; and (ii) upon request of the Secretary, such laboratory shall submit to the Secretary, not later than 45 days after the date of such request, a corrective action plan to comply with such requirements. (B) Civil monetary penalty (i) In general An applicable laboratory that has received a notification under subparagraph (A)(i) and fails to comply with the requirements of this subsection by the date that is 90 days after such notification (or, in the case of an applicable laboratory that has submitted a corrective action plan described in subparagraph (A)(ii) in response to a request so described, by the date that is 90 days after such submission) shall be subject to a civil monetary penalty of an amount specified by the Secretary for each day (beginning with the day on which the Secretary first determined that such laboratory was not complying with such requirements) during which such failure is ongoing (not to exceed $300 per day). (ii) Increase authority In applying this subparagraph with respect to an applicable laboratory that fails to comply with the requirements of this subsection in 2028 or a subsequent year, the Secretary may through notice and comment rulemaking increase the limitation on the per day amount of any penalty applicable to an applicable laboratory under clause (i). (iii) Application of certain provisions 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 subparagraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection (a) of such section. (iv) No authority to waive or reduce penalty The Secretary shall not grant or extend any waiver, delay, tolling, or other mitigation of a civil monetary penalty for failing to comply with the requirements of this subsection except where the Secretary determines that imposing the maximum civil monetary penalty will disrupt applicable laboratory operations in a manner that impacts patient care. The Secretary may request documentation in such form and manner as the Secretary may require in order to evaluate impact on applicable laboratory operations. (8) 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. (9) Rulemaking (A) In general The Secretary shall implement this subsection through notice and comment rulemaking in accordance with section 553 of title 5, United States Code. (B) Ownership information In promulgating regulations under this paragraph, the Secretary shall define the individuals and organizations that must be disclosed under paragraph (1)(B) in a manner that harmonizes disclosure requirements with requirements established under section 1124 of the Social Security Act and prioritizes the disclosure of individuals and organizations whose ownership or management relationship with a laboratory impacts operational, financial, or clinical decision making for such laboratory..