Ensuring covered entity transparency

(a) In general 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: (L) Reporting (i) In general During the first year beginning on or after the date that is 14 months after the date of enactment of this subparagraph and during each subsequent year, each covered entity described in subparagraph (L) of paragraph (4) (and any other covered entity specified by the Secretary) shall report to the Secretary (at a time and in a form and manner specified by the Secretary) the following information with respect to the preceding year: (I) With respect to such covered entity and each child site, as applicable, of such entity— (aa) the total number of individuals who were dispensed or administered covered outpatient drugs during such preceding year that were subject to an agreement under this section; and (bb) the number of such individuals described in a category specified in clause (iii), broken down by each such category. (II) With respect to such covered entity and each child site, as applicable, of such entity— (aa) the percentage of the total number of individuals furnished items and services during such preceding year who were dispensed or administered covered outpatient drugs during such preceding year that were subject to an agreement under this section; and (bb) for each category specified in clause (iii), the percentage of the total number of individuals described in such category furnished items and services during such preceding year who were dispensed or administered covered outpatient drugs during such preceding year that were subject to an agreement under this section. (III) With respect to such covered entity and each child site, as applicable, of such entity, the total costs incurred during the year at each such site and the cost incurred at each such site for charity care (as defined in line 23 of worksheet S–10 to the Medicare cost report, or in any successor form). (IV) With respect to such covered entity and each child site, as applicable, of such entity, the costs incurred during the year of furnishing items and services at each such entity or site to patients of such entity who were entitled to benefits under part A of title XVIII of the Social Security Act or enrolled under part B of such title, enrolled in a State plan under title XIX of such Act (or a waiver of such plan), or who were uninsured for services, minus the sum of— (aa) payments under title XVIII of such Act for such items and services (including any cost sharing for such items and services); (bb) payments under title XIX of such Act for such items and services (including any cost sharing for such items and services); and (cc) payments by uninsured patients for such items and services. (V) With respect to such covered entity and each child site, as applicable, of such entity, the margin (as defined in clause (iv)) generated on covered outpatient drugs subject to an agreement under this section dispensed or furnished by such entity or site (and any entity pharmacy or contract pharmacy dispensing such drugs on behalf of such entity in accordance with subparagraph (F)), with each component of the margin calculation described in item (aa) through (cc) of such clause listed as a separate line item. (VI) To the extent the Secretary requires covered entities described in one of subparagraphs (A) through (K) of paragraph (4) to report information pursuant to this subparagraph, with respect to each such covered entity, use of margin (as defined in clause (iv)) generated on covered outpatient drugs subject to an agreement under this section in the following categories of expenditures, if applicable, which the Secretary shall define in interim final regulations in a manner consistent with reporting under the Health Resources and Services Administration Uniform Data System (UDS)— (aa) medical care; (bb) dental care; (cc) mental health; (dd) pharmaceuticals, which shall include margin used to provide free and discounted covered outpatient drugs subject to an agreement under this section dispensed or furnished to eligible patients (as defined in subparagraph (H)), notwithstanding any UDS reporting requirement that may limit or interfere with the inclusion of margin used for such purpose; (ee) sliding fee discounts; (ff) case management; (gg) transportation; (hh) patient and community education; (ii) community health workers; (jj) outreach; (kk) eligibility assistance; and (ll) nutritional assessment and referral. (ii) Publication The Secretary shall publish data reported under clause (i) with respect to a year annually on the public website of the Department of Health and Human Services in an electronic and searchable format, which may include the 340B Office of Pharmacy Affairs Information System (or a successor to such system), in a manner that shows each category of data reported in the aggregate and identified by the specific covered entity submitting such data. The Secretary shall include in such publication the disproportionate patient percentage (as defined in section 1886(d)(5)(F)(vi) of the Social Security Act) of each such covered entity (if applicable) for each cost reporting period occurring during such year. (iii) Categories specified For purposes of clause (i), the categories specified in this clause are the following: (I) Individuals covered under a group health plan or group or individual health insurance coverage (as such terms are defined in section 2791). (II) Individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act. (III) Individuals enrolled under a State plan under title XIX of such Act (or a waiver of such plan). (IV) Individuals enrolled under a State child health plan under title XXI of such Act (or a waiver of such plan). (V) Individuals not described in any preceding subclause and not covered under any Federal health care program (as defined in section 1128B of such Act but including the program established under chapter 89 of title 5, United States Code). (iv) Definitions In this subparagraph: (I) Child site The term child site shall have the meaning given such term in subparagraph (E). (II) Entity pharmacy The term entity pharmacy shall have the meaning given such term in subparagraph (F). (III) Margin The term margin means, with respect to covered outpatient drugs purchased by a covered entity under an agreement under this section, the following amount for such drugs dispensed, furnished, or administered to an individual by such entity or a child site of such entity (and any entity pharmacy or contract pharmacy dispensing such drugs on behalf of such entity in accordance with subparagraph (F))— (aa) aggregate payments received by the covered entity for such drugs from individuals (including cost-sharing amounts) and third parties, including government and private payors; (bb) aggregate costs to acquire such drugs at either the ceiling price described in paragraph (1) or any voluntary subceiling price at which the covered entity purchased such drug or drugs, as applicable; minus (cc) aggregate costs incurred by the covered entity that are necessary for such entity to participate in the program under this section and to comply with such program’s requirements, including program-related compliance, legal, educational, and administrative costs (such costs shall be determined in accordance with Generally Accepted Accounting Principles), and compensation paid to third-party administrators or contract pharmacies to carry out program-related functions.. (b) Rulemaking Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall issue an interim final rule to carry out section 340B(a)(5)(L) of the Public Health Service Act, as added by subsection (a).