340B PAUSE Act

To amend the Public Health Service Act to establish a moratorium on the registration of certain new 340B hospitals and associated sites, and for other purposes. 1. Short title This Act may be cited as the 340B Protecting Access for the Underserved and Safety-net Entities Act 340B PAUSE Act 2. Moratorium on registration of certain new 340 Section 340B(a) of the Public Health Service Act ( 42 U.S.C. 256b(a) (1) in paragraph (4)(L), by striking A subsection (d) hospital Subject to paragraph (11), a subsection (d) hospital (2) by adding at the end the following new paragraph: (11) Moratorium on registration of certain hospitals and associated sites of such hospitals During the period beginning on the date of the enactment of this paragraph, and ending on the date that is 2 years after such date of enactment— (A) an entity described in paragraph (4)(L) shall not be considered a covered entity under this section unless such entity had been identified as a covered entity under the system established under subsection (d)(2)(B)(iv) as of the day before the date of the enactment of this paragraph; and (B) in the case of an entity described in paragraph (4)(L) that is identified as a covered entity under such system, an off-site outpatient facility, clinic, eligible off-site location, or associated site of such entity (in this paragraph and subsection (f) referred to as a potential child site . 3. Data reporting to improve the transparency regarding how 340B hospital covered entities provide care for patients Section 340B of the Public Health Service Act ( 42 U.S.C. 256b (f) Data reporting To improve the transparency regarding how hospital covered entities provide care for patients (1) In general Beginning on the date that is 14 months after the date of the enactment of this subsection, and annually thereafter, subject to subparagraph (C), a covered entity described in subparagraph (L) or (M) of subsection (a)(4), unless otherwise indicated, shall report on the following, with respect to the previous year, in such a manner and form as specified by the Secretary: (A) The following information: (i) With respect to such covered entity and with respect to each child site of such entity (as referenced in paragraph (11)), the number and percentage of individuals who are dispensed or administered drugs that are subject to an agreement under this section, organized by form of health insurance coverage of such individuals (including at least by the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX 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). (ii) With respect to each such child site of such entity, the total costs incurred 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. (B) The aggregate amount of gross reimbursement received by each such covered entity (including child sites of such entity) described in such subparagraph (L) or (M) for all drugs purchased that are subject to an agreement under this section and the entity’s aggregate acquisition cost for such drugs. (C) In the case of covered entity described in subparagraph (L) of subsection (a)(4), at the time of application and recertification (and at least annually thereafter), the contract that is the basis for eligibility under the requirement under clause (i) of such subparagraph and any modifications to such contract for purposes of review by the Secretary. (D) With respect to such covered entity and with respect to each child site of such entity, the name of all third-party vendors or other similar entities that the covered entity contracts with to provide services associated with the program under this section. (2) Availability of information (A) In general The Secretary shall make data reported by covered entities under subparagraphs (A), (C), and (D) of paragraph (1) available 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: (B) Format Data made available under subparagraph (A) shall be made available in a manner that shows each category of data reported both in the aggregate and identified by covered entities described in subparagraphs (L) and (M) of subsection (a)(4) and child sites of such covered entities. In carrying out this paragraph, with respect to data reported pursuant to paragraph (1)(C), the Secretary shall ensure that any proprietary information shall be redacted from contracts submitted pursuant to such paragraph (1)(C) before posting such data. (3) Interim final regulations The Secretary shall issue interim final regulations no later than the date that is 6 months after the date of the enactment of this subsection, to carry out this subsection and shall finalize such regulations prior to the end of the moratorium period to which subsection (a)(11) applies. (4) Reports to Congress (A) OIG report Not later than 2 years after the date of the enactment of this subsection, the Office of the Inspector General shall submit to Congress a final report on the level of charity care provided by covered entities described in subparagraphs (L) and (M) of subsection (a)(4) and separately by child sites of such covered entities, as reported in paragraph (1)(A). (B) GAO reports (i) Initial report Not later than 1 year after the date of the enactment of this subsection, the Comptroller General of the United States shall submit to Congress a report— (I) analyzing the State and local government contracts intended to satisfy the requirement under subsection (a)(4)(L)(i) for a covered entity to qualify as an entity described in subparagraph (L) of subsection (a)(4); (II) assessing the amount of care such contracts obligate such entity to provide to low-income individuals ineligible for Medicare under title XVIII of the Social Security Act and Medicaid under title XIX of such Act; and (III) analyzing how these contracts define low-income individuals and whether the Secretary reviews such determinations. (ii) Subsequent report Not later than 2 years after the date of the enactment of this subsection, the Comptroller General of the United States shall submit to Congress a final report on the information collected under paragraph (1)(B) regarding the difference between the aggregate gross reimbursement and aggregate acquisition costs received by each such covered entity (including child sites of such entity) for drugs subject to an agreement under this section. .

Summary: 340B Protecting Access for the Underserved and Safety-net Entities Act or the 340B PAUSE Act This bill amends the Public Health Service Act to suspend for two years the registration of certain hospitals in the 340B drug pricing program, which requires drug manufacturers to offer discounts on outpatient drugs to registered health care entities. The bill requires certain registered hospitals to report to the Department of Health and Human Services specified information, including the number of individuals receiving discounted drugs and associated costs.