Claims modifiers; covered entity data submission

Section 340B(a)(5) of the Public Health Service Act (42 U.S.C. 256b(a)(5)) is further amended by adding at the end the following: (J) Claims modifier and covered entity data submission (i) Claims modifier All claims submitted to a payor, including, without limitation, Medicare and Medicaid, by a covered entity or a contract pharmacy under a contract with a covered entity in compliance with subparagraph (F) for reimbursement of a unit of a covered outpatient drug purchased under the program under this section shall include the relevant 340B modifier established by the Secretary under Medicare Part B (that is JG, TB, or any successor modifier) or the Submission Clarification Code of 20 or any successor modifier developed by the National Council for Prescription Drug Programs (NCPDP) to identify claims for covered outpatient drugs purchased under such program. All claims submitted by a covered entity or a contract pharmacy described in this clause to a payor, including, without limitation, Medicare and Medicaid, for reimbursement of a unit of a covered outpatient drug not purchased under such program shall also include a relevant non-340B modifier, which shall be established by the Secretary, or a non-340B modifier developed by the NCPCP to identify such claims. (ii) Covered entity data submission A covered entity described in paragraph (4) shall (and shall cause any entity acting on its behalf to) furnish to the clearinghouse described in subsection (d)(2)(C) the data described in clause (iii), in a machine-readable format, with respect to each covered outpatient drug dispensed, furnished, or administered by the covered entity (including such drugs dispensed by a contract pharmacy under contract with such covered entity in compliance with subparagraph (F)), for which such covered entity seeks or has received discounted pricing under this section. Such covered entity shall provide, or cause to be provided, such data to the clearinghouse within 45 days after the date on which the covered outpatient drug was dispensed, furnished, or administered (or such shorter time period as may be specified by the Secretary through notice-and-comment rulemaking) in an electronic format specified by the Secretary. The covered entity shall require (and shall cause any entity acting on its behalf to require) that data on pharmacy-dispensed drugs described in this subparagraph be submitted to the clearinghouse directly by the pharmacy dispensing such drug. (iii) Claim level data elements The data described in this clause shall include the following, as applicable: (I) Self-administered drugs With respect to a self-administered drug dispensed at a pharmacy, by a mail order service, or by another dispenser— (aa) prescription number; (bb) prescribed date; (cc) prescription fill date; (dd) national drug code (NDC) of the drug; (ee) quantity dispensed; (ff) bank identification number, processor control number, and group number of the plan receiving the claim (as applicable); (gg) national provider identifier (NPI) of the prescriber; (hh) NPI of the dispensing pharmacy; (ii) name and 340B identifier of the covered entity dispensing the drug, or on whose behalf the drug is dispensed; (jj) 340B/non-340B claim modifier; (kk) wholesaler invoice number; and (ll) an indicator, which shall be specified by the clearinghouse or the Secretary, denoting that the drug was or was not dispensed as a result of care coordination described in subsection (b)(3). (II) Provider-administered drugs With respect to a drug furnished or administered by a physician or other provider of services or a supplier— (aa) drug billing and payment code/HCPCS code; (bb) NDC of the drug; (cc) claim number; (dd) Medicare provider number of prescriber (as applicable); (ee) NPI of the prescriber; (ff) name and 340B identifier of the covered entity furnishing or administering the drug; (gg) date drug furnished or administered; (hh) claim adjudication date; (ii) quantity furnished or administered; (jj) 340B/non-340B claim modifier; and (kk) an indicator, which shall be specified by the clearinghouse or the Secretary, denoting that the drug was or was not furnished or administered as a result of care coordination described in subsection (b)(3). (iv) Information privacy and security A covered entity described in paragraph (4) shall provide the data specified in clause (iii) to the clearinghouse in a secure manner, consistent with such entity’s obligations under the Security Standards for the Protection of Electronic Protected Health Information described in part 164 of subpart C of title 45, Code of Federal Regulations (or any successor regulations). A covered entity shall not be required to obtain an individual authorization under part 164 of subpart E of title 45, Code of Federal Regulations (or any successor regulations) for its reporting of such data to the clearinghouse. (v) Standardization of reported data elements; prohibition on modifications A covered entity described in paragraph (4) shall take reasonable steps to ensure the data specified in clause (iii) submitted to the clearinghouse fully complies with the data submission standards (including field descriptors and definitions) specified by the clearinghouse or the Secretary following consultation with relevant stakeholders, including manufacturers of covered outpatient drugs. A covered entity described in paragraph (4) is prohibited, and shall prohibit any entity acting on its behalf (including any affiliate of such entity), from taking or refraining from taking any action that would cause such information to no longer comply with the standards described in this clause. In specifying the data submission standards described in this clause, the clearinghouse and the Secretary, as applicable, shall seek to minimize administrative burden on covered entities while ensuring such data satisfies the intent of this subparagraph. (vi) Covered entities that fail to report A covered entity that fails to furnish the information as required under this subparagraph shall be subject to a civil monetary penalty in the amount of $2,500 for each day of such violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics. The provisions of section 1128A of the Social Security Act (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this clause in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). The Office of Inspector General of the Department of Health and Human Services shall carry out the provisions of this clause..