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H.R. 9599IntroducedHouse · nowSenatePresidentLawIn committee
Sec. 11 · H.R. 9599

Studies and reports

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(a) Cost of dispensing studies and report (1) Study Not later than 1 year after the date of the enactment of this section, the Secretary shall conduct a study on dispensing fees and reimbursements that health plans and pharmacy benefit managers pay to pharmacies, separated by each category of payer (at a minimum, Medicare, Medicaid, and commercial payors) and whether the drug is purchased under section 340B. The Secretary shall repeat this study not less than every 24 months thereafter. (2) Report Not later than 90 days after the completion of each study conducted under paragraph (1), the Secretary shall submit to Congress a report containing the results of such study, including— (A) the amount of dispensing fees for covered outpatient drugs purchased under section 340B and covered outpatient drugs not purchased under section 340B; (B) whether such fees are reasonable; and (C) any recommendations for further Congressional action with respect to dispensing fees and the establishment of acceptable standards for dispensing fees. (b) Comptroller general study and report on 340 B discount (1) Study Not later than 1 year after the date of the enactment of this section, the Comptroller General of the United States shall conduct a study of the 340B discount (the unit rebate amount referenced in section 340B(a)(1) of the Public Health Service Act) that is retained by— (A) contract pharmacies; (B) health plans; (C) pharmacy benefit managers; (D) third-party vendors; (E) patients; and (F) covered entities. (2) Report Not later than 2 years after enactment, the Comptroller General of the United States shall submit to Congress a report detailing the results of this study. (A) Information shall be aggregated for each type of covered entity, and by arrangements the covered entity has with each different entity specified in subparagraphs (A) through (D) of paragraph (1), describing the amount of the 340B discount retained by the covered entity and the entities specified in subparagraphs (A) through (D) of paragraph (1). (B) The report shall include recommendations to Congress on a standardized set of definitions to collect this information and a calculation methodology. (c) GAO report Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on the debt collection practices of hospitals, including hospitals that participate in the drug discount program under section 340B of the Public Health Service Act (42 U.S.C. 256b) as covered entities described in subparagraphs (L) through (O) of subsection (a)(4)of such section. (d) Reports to congress (1) 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 a report to Congress on the following: (A) analyzing such contracts between State and local governments and covered entities described in subparagraph (L), (M), (N), or (O) of subsection (a)(4) that claim to be eligible for the drug discount program under this section by virtue of being a private non-profit hospital that has a contract with a State or local government to provide health care services to low-income individuals who are not eligible for Medicaid or Medicare; (B) assessing the amount of care the contracts described in subparagraph (A) obligate the covered entity to provide to individuals at or below 400 percent of the Federal Poverty Level, who are ineligible for Medicare under title XVIII of the Social Security Act and Medicaid under title XIX of such Act; (C) assessing the amount of charity care and uncompensated care covered entities reporting under this section provide to individuals earning at or below 400 percent of the Federal Poverty Level; (D) analyzing the difference between the aggregate gross reimbursement and aggregate acquisition costs received by each covered entity for covered outpatient drugs purchased under the 340B program; (E) analyzing the degree to which Federally Qualified Health Centers, as such term is defined in subsection (a)(4)(A), are subject to the violations under section 2730(b) of the Public Health Service Act, and the effect of these violations on Federally Qualified Health Centers’ ability to provide affordable care to underserved populations; and (F) analyzing how the contracts described in subparagraph (A) define low-income individuals and whether the Secretary reviews such determinations. (2) 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) regarding the difference between the aggregate payment received by each such covered entity (including child sites of such entity and adding information on all sources of payment received by the covered entity and its child sites) for drugs purchased under this section and the aggregate costs paid by the covered entity (including its child sites) to acquire such drugs. (3) Clarification When submitting these reports, the Comptroller General of the United States shall not provide copies of unredacted contracts or any work materials to Congress or any other parties.

Sec. 11: Studies and reports · Public Law Tracker