Title: 340B PAUSE Act
Policy area: Health

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.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4710 Introduced in House (IH)]

<DOC>






115th CONGRESS
  1st Session
                                H. R. 4710

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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 21, 2017

Mr. Bucshon (for himself and Mr. Peters) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``340B Protecting Access for the 
Underserved and Safety-net Entities Act'' or the ``340B PAUSE Act''.

SEC. 2. MORATORIUM ON REGISTRATION OF CERTAIN NEW 340B HOSPITALS AND 
              ASSOCIATED SITES.

    Section 340B(a) of the Public Health Service Act (42 U.S.C. 
256b(a)) is amended--
            (1) in paragraph (4)(L), by striking ``A subsection (d) 
        hospital'' and inserting ``Subject to paragraph (11), a 
        subsection (d) hospital''; and
            (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' of such entity) 
                may not be identified under such system as a child site 
                of the covered entity for purposes of this section 
                unless such child site was so identified under such 
                system, with respect to such covered entity, as of the 
                day before the date of the enactment of this 
                paragraph.''.

SEC. 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) is 
amended by adding at the end the following new subsection:
    ``(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.''.
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