Transparency

(a) In general Section 340B(d) of the Public Health Service Act (42 U.S.C. 256b(d)) is amended by adding at the end the following: (5) Reporting of program savings (A) In general Not later than 1 year after the date of enactment of the SUSTAIN 340B Act, and annually thereafter, each covered entity shall report to the Secretary the following information with respect to the covered entity, including with respect to all child sites and contract pharmacy arrangements, for the preceding year: (i) The total number of individuals who were dispensed or administered covered outpatient drugs during such preceding year that were subject to an agreement under subsection (a)(1). (ii) The total number of prescriptions dispensed or administered with covered outpatient drugs purchased under this section and billed to insurance, organized by type of health insurance coverage (as specified by the Secretary, including by the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, the Children’s Health Insurance Program under title XXI of such Act, health insurance coverage offered in the individual or group market or a group health plan (as such terms are defined in section 2791), and uninsured). (iii) (I) The cost incurred at each covered entity for charity care, reported as a fraction, where the numerator is the amount of charity care reported on worksheet S–10 of the Medicare cost report (or any successor), and the denominator is the total operating cost of the covered entity, as reported for the most recent cost reporting period; or (II) in the case of a covered entity that is not required to submit a Medicare cost report, a qualitative description of the charity care provided by the covered entity, to the extent applicable under the scope of the grant for a covered entity described in any of subparagraphs (A) through (O) of subsection (a)(4), in such manner that is not overly burdensome to covered entities, as the Secretary may require. (iv) At the option of the covered entity, information pertaining to under-reimbursed care provided by the covered entity. (v) (I) A description, submitted in a standardized form and manner prescribed by the Secretary, of the covered entity’s use of the savings received through participation in the drug discount program under this section, including a description of health care services or health-related benefits used to benefit the patients and communities served by the covered entity, delineated by categories of services and benefits and populations served, including such services and benefits provided to underserved, uninsured, or medically vulnerable patients and communities; and (II) an attestation by the chief executive officer, chief executive financial officer, or chief operating officer certifying that such savings have been used to benefit the patients and communities served by the covered entity. (vi) The financial demographics of patients of the covered entity, including— (I) the percentage of patients eligible for financial assistance programs and sliding scale fees; (II) the percentage of patients who reside in a health professional shortage area (as defined in section 332) or a medically underserved community (as defined in section 799B); (III) the percentage of patients who reside in or are part of a medically underserved population (as defined in section 330(b)(3)); (IV) the percentage of uninsured patients; (V) the percentage of patients who are Medicaid beneficiaries; and (VI) the percentage of patients who are Children's Health Insurance Program beneficiaries. (vii) Policies of the covered entity to promote access and adherence to prescribed medication. (viii) In the case of a nongovernmental hospital, any contracts between such hospital and a State or local governmental entity, and any modifications to any such contract. (ix) Any third-party administrators in contract with the covered entity for the administration of the drug discount program. (x) The funding shortfall for the covered entity attributable to services provided to Medicare and Medicaid beneficiaries, as reported on the Internal Revenue Service Form 990. (xi) The number of patients using the outpatient services of the covered entity. (xii) Operation costs to the covered entity related to the drug discount program under this section. (B) Records retention A covered entity shall retain records described in subparagraph (A) for a period of at least 3 years and provide such records and reports as the Secretary determines necessary for purposes of carrying out this paragraph. (C) Availability of information (i) In general Not later than 90 days after receiving the information reported by covered entities under paragraph (1), the Secretary shall publish such information on the public website of the Department of Health and Human Services, which may include the website of the 340B Office of Pharmacy Affairs Information System (or a successor to such system). (ii) Format Data published under clause (i) shall be published in an electronic and searchable format that shows each category of data reported both in the aggregate and identified by each type of covered entity described in subsection (a)(4). In carrying out this paragraph, with respect to data reported pursuant to paragraph (1), the Secretary shall ensure that any proprietary information be redacted from contracts submitted pursuant to subparagraph (A)(viii) before posting such contracts. (D) Submission process Not later than 1 year after the date of enactment of the SUSTAIN 340B Act, the Secretary shall establish a process by which the information required to be submitted under subparagraph (A) may be submitted directly to the 340B Office of Pharmacy Affairs Information System (or a successor to such system). (E) Reports to Congress Not later than 1 year after the date of the enactment of the SUSTAIN 340B Act, and annually thereafter, the Secretary shall submit a report to the appropriate committees of Congress on the information collected under subparagraph (A). (F) Regulations The Secretary may promulgate regulations to carry out this paragraph.. (b) Auditing Section 340B(a)(5)(C) of the Public Health Service Act (42 U.S.C. 256b(a)(5)(C)), as amended by section 4(a)(2), is further amended by adding at the end the following: (iv) Audits of program savings records A covered entity shall permit the Secretary to audit, at the Secretary’s expense, the records of the covered entity used for purposes of reporting under subsection (d)(5)(A), including how the discount from drugs subject to an agreement under paragraph (1) is used by the covered entity..