{
  "legislationId": "118_S_5021",
  "lastUpdate": "2026-02-10T19:59:59.650Z",
  "history": [
    {
      "timestamp": "2026-02-10T19:59:59.650Z",
      "source_url": "https://www.congress.gov/118/bills/s5021/BILLS-118s5021is.htm",
      "model": "gemini-3-pro-preview",
      "prompt_sent": "\nJesteś LEGISLATIVE SURGEON.\nTwoim zadaniem jest audyt i naprawa streszczenia (JSON) pod kątem zgodności z tekstem źródłowym (SOURCE).\nZASADA FUNDAMENTALNA: \"NO NEW INFORMATION\" (żadnych nowych informacji).\nStreszczenie może jedynie transformować informacje zawarte w SOURCE (skracać, tłumaczyć, sumować). Nie może generować nowych informacji, których nie ma w SOURCE.\n\nPROCEDURA WERYFIKACJI (wykonaj dla każdego zdania w JSON):\nZadaj sobie pytanie: \"Czy potrafię wskazać w SOURCE konkretny fragment, który potwierdza to stwierdzenie?\"\nJEŚLI ODPOWIEDŹ BRZMI \"TAK\":\nInformacja jest potwierdzona cytatem, synonimem lub wynikiem matematycznym z danych w tekście.\nDECYZJA: Zostaw bez zmian.\nJEŚLI ODPOWIEDŹ BRZMI \"NIE\":\nInformacji nie ma w tekście (jest to halucynacja, zewnętrzna wiedza modelu, nadinterpretacja lub niepotrzebna ekstrapolacja).\nDECYZJA: Usuń tę informację lub zmień ją tak, aby miała pokrycie w tekście.\nJEŚLI ODPOWIEDŹ BRZMI \"TO ZALEŻY\":\nTekst jest niejasny, a streszczenie \"zgaduje\" (np. podając konkretny przykład dla ogólnego terminu).\nDECYZJA: Bądź bezpieczny. Usuń zgadywanie. Użyj terminologii z tekstu.\n\nKATEGORIE RYZYKA (szczególna uwaga):\nDaty (start obowiązywania vs start finansowania).\nLiczby (konkretne kwoty muszą wynikać z tekstu).\nPodmioty (kto co robi).\nZakres (co ustawa obejmuje, a czego nie).\n\nINPUT:\n--- SOURCE_TEXT START ---\n[Congressional Bills 118th Congress] [From the U.S. Government Publishing Office] [S. 5021 Introduced in Senate (IS)] <DOC> 118th CONGRESS 2d Session S. 5021 To ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES September 11, 2024 Mr. Welch introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions _______________________________________________________________________ A BILL To ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act. 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 Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024'' or the ``340B PATIENTS Act of 2024''. SEC. 2. FINDINGS AND PURPOSES. (a) Findings.--Congress finds the following: (1) Section 340B of the Public Health Service Act (42 U.S.C. 256b) enables covered entities to stretch scarce resources as far as possible, reaching more patients and providing more comprehensive services than would be possible without such program. (2) Such section 340B requires drug manufacturers to offer discounted prices on covered outpatient drugs to covered entities participating in the program, as a condition of participating in the Medicaid program and part B of the Medicare program, and drug manufacturers are required to offer drug discount pricing to covered entities when requested. (3) Savings on the purchase of drugs through the program under section 340B of the Public Health Service Act enables hospitals, clinics, and health centers to provide comprehensive services to the communities they serve, and covered entities are in the best position to assess the use of their savings for community needs. (4) Since the early years of such program, covered entities have contracted with pharmacies to dispense covered outpatient drugs purchased by a covered entity at drug discount program pricing to patients of the covered entity, consistent with how Congress intended for covered entities to use the program. (5) Covered entities use savings generated through contract pharmacy relationships to stretch scarce resources and support patient care, consistent with the purpose of the program. (6) Section 340B of the Public Health Service Act requires drug manufacturers to offer drug discount pricing for drugs purchased by covered entities regardless of the manner or location in which a drug is dispensed, including drugs dispensed through contract pharmacies. (7) Section 340B of the Public Health Service Act does not allow drug manufacturers to place conditions on the ability of a covered entity to purchase or use a covered outpatient drug at drug discount program pricing regardless of the manner or location in which a drug is dispensed, including by restricting a covered entity's ability to dispense drugs purchased through such program to patients through a contractual relationship with a contracted pharmacy or refusing to ship covered outpatient drugs to a pharmacy or location identified by a covered entity. (8) Such section 340B's inflationary penalty provisions, which have saved part D of the Medicare program $7,000,000,000 between 2013 and 2017, have a proven record of reducing drug price increases, and use of contract pharmacies contributes to these savings. (9) Specialty drugs, which are often used to treat chronic, serious, or life-threatening conditions such as cancer, rheumatoid arthritis, growth hormone deficiency, and multiple sclerosis, play a critical role in the care provided by covered entities. These drugs often require specialized handling, are not usually available to walk-in customers, and are typically available only through specialty or mail order pharmacies that are located hundreds of miles from a covered entity. The use of contract pharmacy arrangements under section 340B of the Public Health Service Act is often the only means by which covered entities can access these vital drugs. (b) Purposes.--The purposes of this Act are the following: (1) To clarify that section 340B of the Public Health Service Act (42 U.S.C. 256b)-- (A) requires drug manufacturers to offer drug discount pricing pursuant to an agreement under subsection (a) of such section with respect to drugs purchased by a covered entity regardless of the manner or location in which the drug is dispensed; and (B) prohibits drug manufacturers from placing conditions on the ability of covered entities to purchase drugs pursuant to an agreement under subsection (a) of such section, regardless of the manner or location in which such drugs are dispensed. (2) To clarify that-- (A) covered entities may contract with pharmacies to dispense drugs purchased pursuant to an agreement under section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) on a covered entity's behalf, to assist covered entities in stretching resources to provide care to more patients and provide more comprehensive services; and (B) the requirements and prohibitions that apply to manufacturers under section 340B of such Act apply in the case of a covered entity that elects to contract with a pharmacy to dispense 340B drugs. SEC. 3. ENSURING THE ACCESSIBILITY OF DRUGS FURNISHED UNDER THE DRUG DISCOUNT PROGRAM. (a) In General.--Section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) is amended-- (1) in paragraph (1)-- (A) by striking ``that the manufacturer furnish'' and inserting the following: ``that-- ``(A) the manufacturer furnish''; (B) by striking ```ceiling price'), and'' and inserting ```ceiling price');''; (C) by striking ``shall require that the manufacturer offer'' and inserting the following: ``(B) the manufacturer offer''; and (D) by striking the period at the end and inserting the following: ``, regardless of the manner or location in which the drug is dispensed; and ``(C) the manufacturer not place conditions on the ability of a covered entity to purchase and use a covered outpatient drug at or below the applicable ceiling price, regardless of the manner or location in which the drug is dispensed, including by placing limits on the delivery of drugs, placing limits on the mechanisms through which drugs may be purchased, placing limits on where such drugs may be delivered, administered, or dispensed, requiring a covered entity's assurance of compliance with requirements under this section, or requiring the submission of claims data or other information, except that the manufacturer may impose conditions described in this subparagraph after receiving advance approval from the Secretary (or, with respect to conditions specified by the Secretary, without such advance approval) if such conditions would not discourage covered entities from purchasing the manufacturer's drugs through the drug discount program under this section or otherwise undermine the objective of this section, either by singling out covered entities from other customers for such conditions or by imposing conditions that disproportionately impact covered entities.''; and (2) by adding at the end the following: ``(11) Contract pharmacies.--The requirements and prohibitions under paragraph (1) shall apply in the case of a covered entity that elects to contract with one or more pharmacies to dispense, to patients of the covered entity, covered outpatient drugs purchased by the covered entity at or below the applicable ceiling price described in paragraph (1).''. (b) Manufacturer Compliance.--Section 340B(d) of the Public Health Service Act (42 U.S.C. 256b) is amended-- (1) in paragraph (1)(B)(vi), in the matter preceding subclause (I), by inserting ``, in the case of an overcharge'' after ``penalties''; (2) in paragraph (1)(B), by adding at the end the following: ``(vii) The imposition of sanctions in the form of civil monetary penalties in the case of a violation of subsection (a)(1) or (a)(11), other than an overcharge, which-- ``(I) shall be assessed according to standards established in regulations to be promulgated by the Secretary not later than 180 days after the date of enactment; ``(II) shall apply to any manufacturer with an agreement under this section that knowingly and intentionally violates a requirement under subsection (a)(1) or (a)(11), other than an overcharge; ``(III) shall not exceed $2,000,000 for each day of such violation; ``(IV) shall be in an amount determined by the Secretary, taking into account factors such as the nature and extent of the violation and harm resulting from such violation, including, where applicable, the number of drugs affected and the number of covered entities affected; and ``(V) shall continue to be imposed each day until such manufacturer is no longer in violation of a requirement under subsection (a)(1) or (a)(11).''; and (3) in paragraph (3), by adding at the end the following: ``(D) Not later than 180 days after the date of the enactment of this subparagraph, the Secretary shall promulgate regulations to permit covered entities to assert claims of violations of subsections (a)(1) and (a)(11) under the process promulgated under subparagraph (A).''. <all>\n--- SOURCE_TEXT END ---\n\n--- FLAGGED_JSON START ---\n{\n  \"pl_ai_title\": \"Ułatwienie dostępu do leków ze zniżką 340B i ochrona aptek kontraktowych.\",\n  \"pl_summary\": \"Ustawa ma na celu zapewnienie, że szpitale i kliniki (podmioty objęte programem 340B) będą mogły kupować leki po obniżonych cenach, niezależnie od tego, czy są one wydawane bezpośrednio, czy przez apteki współpracujące. Zmiana ta chroni dostęp pacjentów do niezbędnych leków, zwłaszcza specjalistycznych, oraz gwarantuje, że placówki medyczne zachowają oszczędności na finansowanie dodatkowej opieki zdrowotnej. Producenci leków nie będą mogli stawiać warunków ograniczających ten dostęp.\",\n  \"pl_key_points\": [\n    \"Producenci leków muszą oferować zniżki 340B bez względu na to, czy lek jest wydawany przez aptekę własną placówki, czy aptekę kontraktową.\",\n    \"Wprowadzono wysokie kary finansowe (do 2 milionów dolarów dziennie) dla producentów, którzy celowo utrudniają dostęp do leków objętych programem 340B.\",\n    \"Zmiana ta ma kluczowe znaczenie dla pacjentów potrzebujących leków specjalistycznych, które często są dostępne tylko za pośrednictwem aptek kontraktowych.\"\n  ],\n  \"eng_ai_title\": \"Ensuring Patient Access to Discounted 340B Drugs via Contract Pharmacies.\",\n  \"eng_summary\": \"This bill clarifies and strengthens the 340B drug discount program, ensuring that hospitals and clinics can purchase discounted drugs regardless of whether they are dispensed directly or through partner (contract) pharmacies. This protects patient access to essential, often specialty, medications and ensures healthcare providers can use the savings to fund comprehensive community services. Drug manufacturers are explicitly prohibited from imposing restrictive conditions on these purchases.\",\n  \"eng_key_points\": [\n    \"Drug manufacturers must provide 340B discounts whether the drug is dispensed by the facility's own pharmacy or a contract pharmacy.\",\n    \"New, significant daily civil penalties (up to $2 million) are established for manufacturers who knowingly restrict access to 340B discounted drugs.\",\n    \"The law ensures continued access to vital specialty drugs, which often rely on contract pharmacy arrangements for distribution to patients.\"\n  ],\n  \"de_ai_title\": \"Sicherung des Patientenzugangs zu vergünstigten 340B-Medikamenten.\",\n  \"de_summary\": \"Dieses Gesetz stärkt das 340B-Arzneimittelrabattprogramm, indem es klarstellt, dass Krankenhäuser und Kliniken vergünstigte Medikamente kaufen können, unabhängig davon, ob diese direkt oder über Partnerapotheken abgegeben werden. Dies schützt den Zugang der Patienten zu lebenswichtigen Medikamenten und stellt sicher, dass Gesundheitsdienstleister die Einsparungen zur Finanzierung umfassender Versorgungsleistungen nutzen können. Arzneimittelhersteller dürfen keine einschränkenden Bedingungen für diese Käufe auferlegen.\",\n  \"de_key_points\": [\n    \"Arzneimittelhersteller müssen 340B-Rabatte gewähren, unabhängig davon, ob das Medikament von der eigenen Apotheke der Einrichtung oder einer Vertragsapotheke abgegeben wird.\",\n    \"Es werden neue, hohe tägliche Geldstrafen (bis zu 2 Millionen Dollar) für Hersteller eingeführt, die wissentlich den Zugang zu 340B-Medikamenten einschränken.\",\n    \"Das Gesetz gewährleistet den weiteren Zugang zu wichtigen Spezialmedikamenten, deren Verteilung an Patienten oft über Vertragsapotheken erfolgt.\"\n  ],\n  \"fr_ai_title\": \"Assurer l'accès des patients aux médicaments 340B à prix réduit.\",\n  \"fr_summary\": \"Ce projet de loi renforce le programme de réduction de médicaments 340B, garantissant que les hôpitaux et les cliniques peuvent acheter des médicaments à prix réduit, qu'ils soient distribués directement ou par des pharmacies partenaires. Cela protège l'accès des patients aux médicaments essentiels, souvent spécialisés, et permet aux prestataires de soins de santé d'utiliser les économies pour financer des services communautaires complets. Les fabricants de médicaments n'ont pas le droit d'imposer des conditions restrictives à ces achats.\",\n  \"fr_key_points\": [\n    \"Les fabricants de médicaments doivent offrir des réductions 340B, que le médicament soit distribué par la pharmacie de l'établissement ou par une pharmacie contractuelle.\",\n    \"De nouvelles sanctions civiles journalières importantes (jusqu'à 2 millions de dollars) sont établies pour les fabricants qui restreignent délibérément l'accès aux médicaments à prix réduit 340B.\",\n    \"La loi assure un accès continu aux médicaments spécialisés vitaux, dont la distribution aux patients dépend souvent des accords avec les pharmacies contractuelles.\"\n  ],\n  \"es_ai_title\": \"Garantizar el acceso a medicamentos 340B con descuento mediante farmacias contratadas.\",\n  \"es_summary\": \"Esta ley fortalece el programa de descuento de medicamentos 340B, asegurando que los hospitales y clínicas puedan comprar medicamentos con descuento, ya sean dispensados directamente o a través de farmacias asociadas. Esto protege el acceso de los pacientes a medicamentos esenciales, a menudo especializados, y garantiza que los proveedores de atención médica puedan utilizar los ahorros para financiar servicios comunitarios integrales. Se prohíbe explícitamente a los fabricantes de medicamentos imponer condiciones restrictivas a estas compras.\",\n  \"es_key_points\": [\n    \"Los fabricantes de medicamentos deben ofrecer descuentos 340B, independientemente de si el medicamento es dispensado por la farmacia propia de la instalación o por una farmacia contratada.\",\n    \"Se establecen nuevas y significativas multas civiles diarias (hasta 2 millones de dólares) para los fabricantes que restrinjan intencionalmente el acceso a los medicamentos con descuento 340B.\",\n    \"La ley garantiza el acceso continuo a medicamentos especializados vitales, cuya distribución a menudo depende de acuerdos con farmacias contratadas.\"\n  ],\n  \"it_ai_title\": \"Garantire l'accesso ai farmaci scontati 340B tramite farmacie convenzionate.\",\n  \"it_summary\": \"Questa legge rafforza il programma di sconto sui farmaci 340B, garantendo che ospedali e cliniche possano acquistare farmaci a prezzi ridotti, indipendentemente dal fatto che vengano dispensati direttamente o tramite farmacie partner. Ciò protegge l'accesso dei pazienti ai farmaci essenziali, spesso specialistici, e assicura che gli operatori sanitari possano utilizzare i risparmi per finanziare servizi comunitari completi. Ai produttori di farmaci è esplicitamente vietato imporre condizioni restrittive su tali acquisti.\",\n  \"it_key_points\": [\n    \"I produttori di farmaci devono offrire sconti 340B sia che il farmaco venga dispensato dalla farmacia della struttura che da una farmacia convenzionata.\",\n    \"Vengono stabilite nuove e significative sanzioni civili giornaliere (fino a 2 milioni di dollari) per i produttori che limitano intenzionalmente l'accesso ai farmaci scontati 340B.\",\n    \"La legge garantisce l'accesso continuo a farmaci specialistici vitali, la cui distribuzione ai pazienti spesso dipende da accordi con farmacie convenzionate.\"\n  ],\n  \"nl_ai_title\": \"Toegang tot 340B-kortingsgeneesmiddelen via contractapotheken verzekeren.\",\n  \"nl_summary\": \"Dit wetsvoorstel versterkt het 340B-geneesmiddelenkortingsprogramma, waardoor ziekenhuizen en klinieken gegarandeerd geneesmiddelen met korting kunnen kopen, ongeacht of deze direct of via partnerapotheken worden verstrekt. Dit beschermt de toegang van patiënten tot essentiële, vaak gespecialiseerde, medicatie en zorgt ervoor dat zorgverleners de besparingen kunnen gebruiken om uitgebreide gemeenschapsdiensten te financieren. Geneesmiddelenfabrikanten mogen expliciet geen beperkende voorwaarden opleggen aan deze aankopen.\",\n  \"nl_key_points\": [\n    \"Geneesmiddelenfabrikanten moeten 340B-kortingen aanbieden, ongeacht of het medicijn wordt verstrekt door de eigen apotheek van de instelling of door een contractapotheek.\",\n    \"Er worden nieuwe, aanzienlijke dagelijkse civiele boetes (tot $ 2 miljoen) ingesteld voor fabrikanten die opzettelijk de toegang tot 340B-kortingsgeneesmiddelen beperken.\",\n    \"De wet zorgt voor voortdurende toegang tot vitale gespecialiseerde medicijnen, waarvan de distributie aan patiënten vaak afhankelijk is van contractapotheekregelingen.\"\n  ],\n  \"pt_ai_title\": \"Garantir Acesso a Medicamentos 340B Descontados via Farmácias Contratadas.\",\n  \"pt_summary\": \"Este projeto de lei fortalece o programa de desconto de medicamentos 340B, garantindo que hospitais e clínicas possam comprar medicamentos com desconto, quer sejam dispensados diretamente ou através de farmácias parceiras. Isto protege o acesso dos pacientes a medicamentos essenciais, muitas vezes especializados, e garante que os prestadores de cuidados de saúde possam usar as poupanças para financiar serviços comunitários abrangentes. Os fabricantes de medicamentos estão explicitamente proibidos de impor condições restritivas a estas compras.\",\n  \"pt_key_points\": [\n    \"Os fabricantes de medicamentos devem oferecer descontos 340B, independentemente de o medicamento ser dispensado pela farmácia da própria instalação ou por uma farmácia contratada.\",\n    \"São estabelecidas novas e significativas penalidades civis diárias (até 2 milhões de dólares) para os fabricantes que restrinjam intencionalmente o acesso a medicamentos com desconto 340B.\",\n    \"A lei garante o acesso contínuo a medicamentos especializados vitais, cuja distribuição aos pacientes depende frequentemente de acordos com farmácias contratadas.\"\n  ],\n  \"category\": [\n    \"Health\"\n  ]\n}\n--- FLAGGED_JSON END ---\n\nOUTPUT:\nWyłącznie naprawiony obiekt JSON zgodny ze strukturą:\n{\n  \"pl_ai_title\": \"...\", \"pl_summary\": \"...\", \"pl_key_points\": [...],\n  \"eng_ai_title\": \"...\", \"eng_summary\": \"...\", \"eng_key_points\": [...],\n  \"de_ai_title\": \"...\", \"de_summary\": \"...\", \"de_key_points\": [...],\n  \"fr_ai_title\": \"...\", \"fr_summary\": \"...\", \"fr_key_points\": [...],\n  \"es_ai_title\": \"...\", \"es_summary\": \"...\", \"es_key_points\": [...],\n  \"it_ai_title\": \"...\", \"it_summary\": \"...\", \"it_key_points\": [...],\n  \"nl_ai_title\": \"...\", \"nl_summary\": \"...\", \"nl_key_points\": [...],\n  \"pt_ai_title\": \"...\", \"pt_summary\": \"...\", \"pt_key_points\": [...],\n  \"category\": [\"...\"]\n}\n\n",
      "ai_response_raw": "{\n  \"pl_ai_title\": \"Ułatwienie dostępu do leków ze zniżką 340B i ochrona aptek kontraktowych\",\n  \"pl_summary\": \"Ustawa ma na celu zapewnienie, że podmioty objęte programem 340B będą mogły kupować leki po obniżonych cenach, niezależnie od tego, czy są one wydawane bezpośrednio, czy przez apteki współpracujące. Zmiana ta chroni dostęp pacjentów do niezbędnych leków, zwłaszcza specjalistycznych, oraz pozwala placówkom medycznym wykorzystywać oszczędności na wsparcie opieki nad pacjentami. Producenci leków nie będą mogli stawiać warunków ograniczających ten dostęp, takich jak limity dostaw czy wymagania dotyczące przesyłania danych.\",\n  \"pl_key_points\": [\n    \"Producenci leków muszą oferować zniżki 340B bez względu na to, czy lek jest wydawany przez aptekę własną placówki, czy aptekę kontraktową.\",\n    \"Wprowadzono kary finansowe (do 2 milionów dolarów dziennie) dla producentów, którzy świadomie i celowo naruszają wymogi ustawy.\",\n    \"Ustawa ma na celu zapewnienie dostępu do leków specjalistycznych, które często są dostępne tylko za pośrednictwem aptek kontraktowych.\"\n  ],\n  \"eng_ai_title\": \"Ensuring Patient Access to Discounted 340B Drugs via Contract Pharmacies\",\n  \"eng_summary\": \"This bill clarifies the 340B drug discount program, ensuring that covered entities can purchase discounted drugs regardless of whether they are dispensed directly or through contract pharmacies. This protects patient access to essential, often specialty, medications and ensures healthcare providers can use the savings to support patient care. Drug manufacturers are prohibited from imposing restrictive conditions on these purchases, such as limits on delivery or data submission requirements.\",\n  \"eng_key_points\": [\n    \"Drug manufacturers must provide 340B discounts whether the drug is dispensed by the facility's own pharmacy or a contract pharmacy.\",\n    \"New civil monetary penalties (up to $2 million per day) are established for manufacturers who knowingly and intentionally violate the requirements.\",\n    \"The law aims to ensure access to vital specialty drugs, which often rely on contract pharmacy arrangements for distribution.\"\n  ],\n  \"de_ai_title\": \"Sicherung des Patientenzugangs zu vergünstigten 340B-Medikamenten\",\n  \"de_summary\": \"Dieses Gesetz stellt klar, dass Einrichtungen im 340B-Programm vergünstigte Medikamente kaufen können, unabhängig davon, ob diese direkt oder über Vertragsapotheken abgegeben werden. Dies schützt den Zugang der Patienten zu lebenswichtigen Medikamenten und stellt sicher, dass Gesundheitsdienstleister die Einsparungen zur Unterstützung der Patientenversorgung nutzen können. Arzneimittelhersteller dürfen keine einschränkenden Bedingungen für diese Käufe auferlegen, wie etwa Lieferbeschränkungen oder Anforderungen zur Datenübermittlung.\",\n  \"de_key_points\": [\n    \"Arzneimittelhersteller müssen 340B-Rabatte gewähren, unabhängig davon, ob das Medikament von der eigenen Apotheke der Einrichtung oder einer Vertragsapotheke abgegeben wird.\",\n    \"Es werden neue Geldstrafen (bis zu 2 Millionen Dollar pro Tag) für Hersteller eingeführt, die wissentlich und vorsätzlich gegen die Anforderungen verstoßen.\",\n    \"Das Gesetz zielt darauf ab, den Zugang zu wichtigen Spezialmedikamenten zu sichern, deren Verteilung oft über Vertragsapotheken erfolgt.\"\n  ],\n  \"fr_ai_title\": \"Assurer l'accès des patients aux médicaments 340B à prix réduit\",\n  \"fr_summary\": \"Ce projet de loi clarifie le programme de réduction de médicaments 340B, garantissant que les entités couvertes peuvent acheter des médicaments à prix réduit, qu'ils soient distribués directement ou par des pharmacies contractuelles. Cela protège l'accès des patients aux médicaments essentiels et permet aux prestataires de soins d'utiliser les économies pour soutenir les soins aux patients. Il est interdit aux fabricants de médicaments d'imposer des conditions restrictives à ces achats, telles que des limites de livraison ou des exigences de soumission de données.\",\n  \"fr_key_points\": [\n    \"Les fabricants de médicaments doivent offrir des réductions 340B, que le médicament soit distribué par la pharmacie de l'établissement ou par une pharmacie contractuelle.\",\n    \"De nouvelles sanctions civiles (jusqu'à 2 millions de dollars par jour) sont établies pour les fabricants qui violent sciemment et intentionnellement les exigences.\",\n    \"La loi vise à assurer l'accès aux médicaments spécialisés vitaux, dont la distribution dépend souvent des accords avec les pharmacies contractuelles.\"\n  ],\n  \"es_ai_title\": \"Garantizar el acceso a medicamentos 340B con descuento mediante farmacias contratadas\",\n  \"es_summary\": \"Esta ley aclara el programa de descuento de medicamentos 340B, asegurando que las entidades cubiertas puedan comprar medicamentos con descuento, ya sean dispensados directamente o a través de farmacias contratadas. Esto protege el acceso de los pacientes a medicamentos esenciales y garantiza que los proveedores de atención médica puedan utilizar los ahorros para apoyar el cuidado del paciente. Se prohíbe a los fabricantes de medicamentos imponer condiciones restrictivas a estas compras, como límites en la entrega o requisitos de envío de datos.\",\n  \"es_key_points\": [\n    \"Los fabricantes de medicamentos deben ofrecer descuentos 340B, independientemente de si el medicamento es dispensado por la farmacia propia de la instalación o por una farmacia contratada.\",\n    \"Se establecen nuevas multas civiles (hasta 2 millones de dólares por día) para los fabricantes que violen los requisitos a sabiendas e intencionalmente.\",\n    \"La ley tiene como objetivo garantizar el acceso a medicamentos especializados vitales, cuya distribución a menudo depende de acuerdos con farmacias contratadas.\"\n  ],\n  \"it_ai_title\": \"Garantire l'accesso ai farmaci scontati 340B tramite farmacie convenzionate\",\n  \"it_summary\": \"Questa legge chiarisce il programma di sconto sui farmaci 340B, garantendo che le entità coperte possano acquistare farmaci a prezzi ridotti, indipendentemente dal fatto che vengano dispensati direttamente o tramite farmacie convenzionate. Ciò protegge l'accesso dei pazienti ai farmaci essenziali e assicura che gli operatori sanitari possano utilizzare i risparmi per sostenere la cura dei pazienti. Ai produttori di farmaci è vietato imporre condizioni restrittive su tali acquisti, come limiti alla consegna o requisiti di invio dati.\",\n  \"it_key_points\": [\n    \"I produttori di farmaci devono offrire sconti 340B sia che il farmaco venga dispensato dalla farmacia della struttura che da una farmacia convenzionata.\",\n    \"Vengono stabilite nuove sanzioni civili (fino a 2 milioni di dollari al giorno) per i produttori che violano consapevolmente e intenzionalmente i requisiti.\",\n    \"La legge mira a garantire l'accesso a farmaci specialistici vitali, la cui distribuzione dipende spesso da accordi con farmacie convenzionate.\"\n  ],\n  \"nl_ai_title\": \"Toegang tot 340B-kortingsgeneesmiddelen via contractapotheken verzekeren\",\n  \"nl_summary\": \"Dit wetsvoorstel verduidelijkt het 340B-geneesmiddelenkortingsprogramma, waardoor gedekte entiteiten gegarandeerd geneesmiddelen met korting kunnen kopen, ongeacht of deze direct of via contractapotheken worden verstrekt. Dit beschermt de toegang van patiënten tot essentiële medicatie en zorgt ervoor dat zorgverleners de besparingen kunnen gebruiken om de patiëntenzorg te ondersteunen. Het is geneesmiddelenfabrikanten verboden beperkende voorwaarden op te leggen aan deze aankopen, zoals leveringslimieten of vereisten voor het indienen van gegevens.\",\n  \"nl_key_points\": [\n    \"Geneesmiddelenfabrikanten moeten 340B-kortingen aanbieden, ongeacht of het medicijn wordt verstrekt door de eigen apotheek van de instelling of door een contractapotheek.\",\n    \"Er worden nieuwe civiele boetes (tot $ 2 miljoen per dag) ingesteld voor fabrikanten die opzettelijk de vereisten schenden.\",\n    \"De wet heeft tot doel de toegang tot vitale gespecialiseerde medicijnen te verzekeren, waarvan de distributie vaak afhankelijk is van contractapotheekregelingen.\"\n  ],\n  \"pt_ai_title\": \"Garantir Acesso a Medicamentos 340B Descontados via Farmácias Contratadas\",\n  \"pt_summary\": \"Este projeto de lei esclarece o programa de desconto de medicamentos 340B, garantindo que as entidades cobertas possam comprar medicamentos com desconto, quer sejam dispensados diretamente ou através de farmácias contratadas. Isto protege o acesso dos pacientes a medicamentos essenciais e garante que os prestadores de cuidados de saúde possam usar as poupanças para apoiar o tratamento dos pacientes. Os fabricantes de medicamentos estão proibidos de impor condições restritivas a estas compras, tais como limites de entrega ou requisitos de envio de dados.\",\n  \"pt_key_points\": [\n    \"Os fabricantes de medicamentos devem oferecer descontos 340B, independentemente de o medicamento ser dispensado pela farmácia da própria instalação ou por uma farmácia contratada.\",\n    \"São estabelecidas novas penalidades civis (até 2 milhões de dólares por dia) para os fabricantes que violem intencionalmente os requisitos.\",\n    \"A lei visa garantir o acesso a medicamentos especializados vitais, cuja distribuição depende frequentemente de acordos com farmácias contratadas.\"\n  ],\n  \"category\": [\n    \"Health\"\n  ]\n}"
    },
    {
      "timestamp": "2025-12-30T22:38:08.170Z",
      "source_url": "https://www.congress.gov/118/bills/s5021/BILLS-118s5021is.xml",
      "model": "gemini-flash-lite-latest",
      "prompt_sent": "\nROLE: Fact Checker.\nZADANIE: Porównaj SOURCE (oryginał) i SUMMARY (streszczenie przygotowane przez inne AI).\n\nTwoim celem jest wykrycie \"ZMYŚLONYCH KONKRETÓW\" (Fabricated Entities) w SUMMARY.\n\nSOURCE:\n118 S5021 IS: To ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act. U.S. Senate 2024-09-11 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. II118th CONGRESS2d SessionS. 5021IN THE SENATE OF THE UNITED STATESSeptember 11, 2024Mr. Welch introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act.1.Short titleThis Act may be cited as the 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024 or the 340B PATIENTS Act of 2024.2.Findings and purposes(a)FindingsCongress finds the following:(1)Section 340B of the Public Health Service Act (42 U.S.C. 256b) enables covered entities to stretch scarce resources as far as possible, reaching more patients and providing more comprehensive services than would be possible without such program.(2)Such section 340B requires drug manufacturers to offer discounted prices on covered outpatient drugs to covered entities participating in the program, as a condition of participating in the Medicaid program and part B of the Medicare program, and drug manufacturers are required to offer drug discount pricing to covered entities when requested.(3)Savings on the purchase of drugs through the program under section 340B of the Public Health Service Act enables hospitals, clinics, and health centers to provide comprehensive services to the communities they serve, and covered entities are in the best position to assess the use of their savings for community needs.(4)Since the early years of such program, covered entities have contracted with pharmacies to dispense covered outpatient drugs purchased by a covered entity at drug discount program pricing to patients of the covered entity, consistent with how Congress intended for covered entities to use the program.(5)Covered entities use savings generated through contract pharmacy relationships to stretch scarce resources and support patient care, consistent with the purpose of the program.(6)Section 340B of the Public Health Service Act requires drug manufacturers to offer drug discount pricing for drugs purchased by covered entities regardless of the manner or location in which a drug is dispensed, including drugs dispensed through contract pharmacies.(7)Section 340B of the Public Health Service Act does not allow drug manufacturers to place conditions on the ability of a covered entity to purchase or use a covered outpatient drug at drug discount program pricing regardless of the manner or location in which a drug is dispensed, including by restricting a covered entity’s ability to dispense drugs purchased through such program to patients through a contractual relationship with a contracted pharmacy or refusing to ship covered outpatient drugs to a pharmacy or location identified by a covered entity.(8)Such section 340B’s inflationary penalty provisions, which have saved part D of the Medicare program $7,000,000,000 between 2013 and 2017, have a proven record of reducing drug price increases, and use of contract pharmacies contributes to these savings.(9)Specialty drugs, which are often used to treat chronic, serious, or life-threatening conditions such as cancer, rheumatoid arthritis, growth hormone deficiency, and multiple sclerosis, play a critical role in the care provided by covered entities. These drugs often require specialized handling, are not usually available to walk-in customers, and are typically available only through specialty or mail order pharmacies that are located hundreds of miles from a covered entity. The use of contract pharmacy arrangements under section 340B of the Public Health Service Act is often the only means by which covered entities can access these vital drugs.(b)PurposesThe purposes of this Act are the following:(1)To clarify that section 340B of the Public Health Service Act (42 U.S.C. 256b)—(A)requires drug manufacturers to offer drug discount pricing pursuant to an agreement under subsection (a) of such section with respect to drugs purchased by a covered entity regardless of the manner or location in which the drug is dispensed; and (B)prohibits drug manufacturers from placing conditions on the ability of covered entities to purchase drugs pursuant to an agreement under subsection (a) of such section, regardless of the manner or location in which such drugs are dispensed.(2)To clarify that—(A)covered entities may contract with pharmacies to dispense drugs purchased pursuant to an agreement under section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) on a covered entity’s behalf, to assist covered entities in stretching resources to provide care to more patients and provide more comprehensive services; and (B)the requirements and prohibitions that apply to manufacturers under section 340B of such Act apply in the case of a covered entity that elects to contract with a pharmacy to dispense 340B drugs.3.Ensuring the accessibility of drugs furnished under the drug discount program(a)In generalSection 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) is amended—(1)in paragraph (1)—(A)by striking that the manufacturer furnish and inserting the following: that—(A)the manufacturer furnish;(B)by striking ceiling price), and and inserting ceiling price);; (C)by striking shall require that the manufacturer offer and inserting the following:(B)the manufacturer offer; and(D)by striking the period at the end and inserting the following: , regardless of the manner or location in which the drug is dispensed; and (C)the manufacturer not place conditions on the ability of a covered entity to purchase and use a covered outpatient drug at or below the applicable ceiling price, regardless of the manner or location in which the drug is dispensed, including by placing limits on the delivery of drugs, placing limits on the mechanisms through which drugs may be purchased, placing limits on where such drugs may be delivered, administered, or dispensed, requiring a covered entity’s assurance of compliance with requirements under this section, or requiring the submission of claims data or other information, except that the manufacturer may impose conditions described in this subparagraph after receiving advance approval from the Secretary (or, with respect to conditions specified by the Secretary, without such advance approval) if such conditions would not discourage covered entities from purchasing the manufacturer’s drugs through the drug discount program under this section or otherwise undermine the objective of this section, either by singling out covered entities from other customers for such conditions or by imposing conditions that disproportionately impact covered entities.; and(2)by adding at the end the following:(11)Contract PharmaciesThe requirements and prohibitions under paragraph (1) shall apply in the case of a covered entity that elects to contract with one or more pharmacies to dispense, to patients of the covered entity, covered outpatient drugs purchased by the covered entity at or below the applicable ceiling price described in paragraph (1)..(b)Manufacturer complianceSection 340B(d) of the Public Health Service Act (42 U.S.C. 256b) is amended—(1)in paragraph (1)(B)(vi), in the matter preceding subclause (I), by inserting , in the case of an overcharge after penalties;(2)in paragraph (1)(B), by adding at the end the following:(vii)The imposition of sanctions in the form of civil monetary penalties in the case of a violation of subsection (a)(1) or (a)(11), other than an overcharge, which—(I)shall be assessed according to standards established in regulations to be promulgated by the Secretary not later than 180 days after the date of enactment;(II)shall apply to any manufacturer with an agreement under this section that knowingly and intentionally violates a requirement under subsection (a)(1) or (a)(11), other than an overcharge;(III)shall not exceed $2,000,000 for each day of such violation;(IV)shall be in an amount determined by the Secretary, taking into account factors such as the nature and extent of the violation and harm resulting from such violation, including, where applicable, the number of drugs affected and the number of covered entities affected; and(V)shall continue to be imposed each day until such manufacturer is no longer in violation of a requirement under subsection (a)(1) or (a)(11).; and(3)in paragraph (3), by adding at the end the following:(D)Not later than 180 days after the date of the enactment of this subparagraph, the Secretary shall promulgate regulations to permit covered entities to assert claims of violations of subsections (a)(1) and (a)(11) under the process promulgated under subparagraph (A)..\n\nSUMMARY TO EVALUATE:\nTitle: Ensuring Patient Access to Discounted 340B Drugs via Contract Pharmacies.\nSummary: This bill clarifies and strengthens the 340B drug discount program, ensuring that hospitals and clinics can purchase discounted drugs regardless of whether they are dispensed directly or through partner (contract) pharmacies. This protects patient access to essential, often specialty, medications and ensures healthcare providers can use the savings to fund comprehensive community services. Drug manufacturers are explicitly prohibited from imposing restrictive conditions on these purchases.\nKey Points: Drug manufacturers must provide 340B discounts whether the drug is dispensed by the facility's own pharmacy or a contract pharmacy., New, significant daily civil penalties (up to $2 million) are established for manufacturers who knowingly restrict access to 340B discounted drugs., The law ensures continued access to vital specialty drugs, which often rely on contract pharmacy arrangements for distribution to patients.\n\nZASADY OCENY:\n1. Sprawdź wszystkie LICZBY, DATY i KWOTY w SUMMARY. Jeśli którejś brakuje w SOURCE -> is_valid: false.\n2. Sprawdź wszystkie NAZWISKA, ORGANIZACJE i MIEJSCA w SUMMARY. Jeśli którejś brakuje w SOURCE -> is_valid: false.\n3. Sprawdź wszystkie konkretne DZIAŁANIA PRAWNE . Jeśli tego mechanizmu nie ma w SOURCE -> is_valid: false.\n\nWAŻNE: Abstrakcyjne pojęcia (np. \"transparentność\", \"zaufanie\") są dozwolone jako wnioski.\n\nOUTPUT (JSON):\n{\n  \"is_valid\": true/false,\n  \"issue\": \"fabricated_entity\" / \"contradiction\" / \"none\"\n}\n\nWYMAGANIA FORMATOWANIA:\n1. Odpowiedz WYŁĄCZNIE surowym obiektem JSON.\n2. NIE używaj bloków kodu Markdown.\n3. NIE dodawaj żadnych wstępów ani wyjaśnień przed ani po JSONie.\n4. JSON musi być poprawny i gotowy do parsowania.\n\n",
      "ai_response_raw": "{\n  \"is_valid\": false,\n  \"issue\": \"fabricated_entity\"\n}"
    },
    {
      "timestamp": "2025-12-30T16:14:43.196Z",
      "source_url": "https://www.congress.gov/118/bills/s5021/BILLS-118s5021is.xml",
      "model": "gemini-flash-latest",
      "prompt_sent": "\nJesteś ekspertem od prawa Stanów Zjednoczonych, który ma za zadanie analizować dokumenty ustaw, uchwał oraz innych dokumentów legislacyjnych, a następnie przygotowywać z nich informacje w przystępny sposób dla obywateli. Twoim celem jest przedstawienie informacji tak, aby obywatele mogli sami ocenić wpływ legislacji na ich życie, nawet bez posiadania specjalistycznej wiedzy legislacyjnej. Skup się na faktach i konsekwencjach wprowadzanych zmian, unikając wartościowania i osobistych opinii. Wszelki żargon prawny jest zabroniony. Prezentuj informacje w jasny, zwięzły i angażujący sposób, tak aby były zrozumiałe dla osoby bez wykształcenia prawniczego. Unikaj długich, złożonych zdań. Zamiast pisać \"projekt ma na celu nowelizację kodeksu podatkowego...\", napisz \"Zmiany w podatkach: nowe ulgi i obowiązki dla...\". Kontynuuj swoją pracę, dopóki nie rozwiążesz swojego zadania. Jeśli nie masz pewności co do generowanej treści, przeanalizuj dokument ponownie – nie zgaduj. Rozplanuj dobrze swoje zadanie przed przystąpieniem do niego. W podsumowaniu i kluczowych punktach, jeśli to możliwe i uzasadnione, podkreśl, jakie konkretne korzyści lub konsekwencje (pozytywne lub negatywne) wprowadza ustawa dla życia codziennego obywateli, ich praw i obowiązków, finansów osobistych, bezpieczeństwa i innych ważnych kwestii.\n\nTwoja odpowiedź MUSI być w formacie JSON - i zawierać następujące klucze.\nZanim zwrócisz odpowiedź, dokładnie zweryfikuj, czy cała struktura JSON jest w 100% poprawna, włącznie ze wszystkimi przecinkami, nawiasami klamrowymi, kwadratowymi oraz cudzysłowami. Błędny JSON jest nieakceptowalny i uniemożliwi przetworzenie Twojej pracy.\n\nPrzeanalizuj dokładnie poniższy tekst dokumentu prawnego. To jest treść, na podstawie której masz wygenerować podsumowanie i kluczowe punkty:\n--- POCZĄTEK DOKUMENTU ---\n118 S5021 IS: To ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act. U.S. Senate 2024-09-11 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. II118th CONGRESS2d SessionS. 5021IN THE SENATE OF THE UNITED STATESSeptember 11, 2024Mr. Welch introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act.1.Short titleThis Act may be cited as the 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024 or the 340B PATIENTS Act of 2024.2.Findings and purposes(a)FindingsCongress finds the following:(1)Section 340B of the Public Health Service Act (42 U.S.C. 256b) enables covered entities to stretch scarce resources as far as possible, reaching more patients and providing more comprehensive services than would be possible without such program.(2)Such section 340B requires drug manufacturers to offer discounted prices on covered outpatient drugs to covered entities participating in the program, as a condition of participating in the Medicaid program and part B of the Medicare program, and drug manufacturers are required to offer drug discount pricing to covered entities when requested.(3)Savings on the purchase of drugs through the program under section 340B of the Public Health Service Act enables hospitals, clinics, and health centers to provide comprehensive services to the communities they serve, and covered entities are in the best position to assess the use of their savings for community needs.(4)Since the early years of such program, covered entities have contracted with pharmacies to dispense covered outpatient drugs purchased by a covered entity at drug discount program pricing to patients of the covered entity, consistent with how Congress intended for covered entities to use the program.(5)Covered entities use savings generated through contract pharmacy relationships to stretch scarce resources and support patient care, consistent with the purpose of the program.(6)Section 340B of the Public Health Service Act requires drug manufacturers to offer drug discount pricing for drugs purchased by covered entities regardless of the manner or location in which a drug is dispensed, including drugs dispensed through contract pharmacies.(7)Section 340B of the Public Health Service Act does not allow drug manufacturers to place conditions on the ability of a covered entity to purchase or use a covered outpatient drug at drug discount program pricing regardless of the manner or location in which a drug is dispensed, including by restricting a covered entity’s ability to dispense drugs purchased through such program to patients through a contractual relationship with a contracted pharmacy or refusing to ship covered outpatient drugs to a pharmacy or location identified by a covered entity.(8)Such section 340B’s inflationary penalty provisions, which have saved part D of the Medicare program $7,000,000,000 between 2013 and 2017, have a proven record of reducing drug price increases, and use of contract pharmacies contributes to these savings.(9)Specialty drugs, which are often used to treat chronic, serious, or life-threatening conditions such as cancer, rheumatoid arthritis, growth hormone deficiency, and multiple sclerosis, play a critical role in the care provided by covered entities. These drugs often require specialized handling, are not usually available to walk-in customers, and are typically available only through specialty or mail order pharmacies that are located hundreds of miles from a covered entity. The use of contract pharmacy arrangements under section 340B of the Public Health Service Act is often the only means by which covered entities can access these vital drugs.(b)PurposesThe purposes of this Act are the following:(1)To clarify that section 340B of the Public Health Service Act (42 U.S.C. 256b)—(A)requires drug manufacturers to offer drug discount pricing pursuant to an agreement under subsection (a) of such section with respect to drugs purchased by a covered entity regardless of the manner or location in which the drug is dispensed; and (B)prohibits drug manufacturers from placing conditions on the ability of covered entities to purchase drugs pursuant to an agreement under subsection (a) of such section, regardless of the manner or location in which such drugs are dispensed.(2)To clarify that—(A)covered entities may contract with pharmacies to dispense drugs purchased pursuant to an agreement under section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) on a covered entity’s behalf, to assist covered entities in stretching resources to provide care to more patients and provide more comprehensive services; and (B)the requirements and prohibitions that apply to manufacturers under section 340B of such Act apply in the case of a covered entity that elects to contract with a pharmacy to dispense 340B drugs.3.Ensuring the accessibility of drugs furnished under the drug discount program(a)In generalSection 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) is amended—(1)in paragraph (1)—(A)by striking that the manufacturer furnish and inserting the following: that—(A)the manufacturer furnish;(B)by striking ceiling price), and and inserting ceiling price);; (C)by striking shall require that the manufacturer offer and inserting the following:(B)the manufacturer offer; and(D)by striking the period at the end and inserting the following: , regardless of the manner or location in which the drug is dispensed; and (C)the manufacturer not place conditions on the ability of a covered entity to purchase and use a covered outpatient drug at or below the applicable ceiling price, regardless of the manner or location in which the drug is dispensed, including by placing limits on the delivery of drugs, placing limits on the mechanisms through which drugs may be purchased, placing limits on where such drugs may be delivered, administered, or dispensed, requiring a covered entity’s assurance of compliance with requirements under this section, or requiring the submission of claims data or other information, except that the manufacturer may impose conditions described in this subparagraph after receiving advance approval from the Secretary (or, with respect to conditions specified by the Secretary, without such advance approval) if such conditions would not discourage covered entities from purchasing the manufacturer’s drugs through the drug discount program under this section or otherwise undermine the objective of this section, either by singling out covered entities from other customers for such conditions or by imposing conditions that disproportionately impact covered entities.; and(2)by adding at the end the following:(11)Contract PharmaciesThe requirements and prohibitions under paragraph (1) shall apply in the case of a covered entity that elects to contract with one or more pharmacies to dispense, to patients of the covered entity, covered outpatient drugs purchased by the covered entity at or below the applicable ceiling price described in paragraph (1)..(b)Manufacturer complianceSection 340B(d) of the Public Health Service Act (42 U.S.C. 256b) is amended—(1)in paragraph (1)(B)(vi), in the matter preceding subclause (I), by inserting , in the case of an overcharge after penalties;(2)in paragraph (1)(B), by adding at the end the following:(vii)The imposition of sanctions in the form of civil monetary penalties in the case of a violation of subsection (a)(1) or (a)(11), other than an overcharge, which—(I)shall be assessed according to standards established in regulations to be promulgated by the Secretary not later than 180 days after the date of enactment;(II)shall apply to any manufacturer with an agreement under this section that knowingly and intentionally violates a requirement under subsection (a)(1) or (a)(11), other than an overcharge;(III)shall not exceed $2,000,000 for each day of such violation;(IV)shall be in an amount determined by the Secretary, taking into account factors such as the nature and extent of the violation and harm resulting from such violation, including, where applicable, the number of drugs affected and the number of covered entities affected; and(V)shall continue to be imposed each day until such manufacturer is no longer in violation of a requirement under subsection (a)(1) or (a)(11).; and(3)in paragraph (3), by adding at the end the following:(D)Not later than 180 days after the date of the enactment of this subparagraph, the Secretary shall promulgate regulations to permit covered entities to assert claims of violations of subsections (a)(1) and (a)(11) under the process promulgated under subparagraph (A)..\n--- KONIEC DOKUMENTU ---\n\nPAMIĘTAJ: Twoja odpowiedź MUSI być wyłącznie poprawnym obiektem JSON. Nie dodawaj żadnych dodatkowych znaków, komentarzy ani tekstu przed znacznikiem '{' ani po znaczniku '}'. Cała odpowiedź musi być parsowalna jako JSON.\nNa podstawie POWYŻSZEGO dokumentu, wypełnij poniższą strukturę JSON:\nOto struktura JSON, której oczekuję (wypełnij ją treścią):\n{\n  \"pl_ai_title\": \"Nowy, krótki tytuł dla aktu prawnego po polsku, oddający sedno wprowadzanych zmian (np. maksymalnie 10-12 słów).\",\n  \"pl_summary\": \"2-3 zdania zwięzłego podsumowania treści aktu prawnego po polsku, napisane z perspektywy wpływu na życie codzienne obywateli.\",\n  \"pl_key_points\": [\n    \"Pierwszy krótki punkt po polsku dotyczący najważniejszych wprowadzanych rozwiązań lub zmian.\",\n    \"Drugi krótki punkt po polsku...\"\n  ],\n  \"eng_ai_title\": \"A new, short title for the legal act in English, capturing the essence of the changes (e.g., max 10-12 words).\",\n  \"eng_summary\": \"2-3 sentences summarizing the legal act in English, from the perspective of its impact on citizens' daily lives.\",\n  \"eng_key_points\": [\n    \"First short bullet point in English regarding the most important solutions or changes being introduced.\",\n    \"Second short bullet point in English...\"\n  ],\n  \"de_ai_title\": \"Ein neuer, kurzer Titel für das Rechtsdokument auf Deutsch, der den Kern der Änderungen erfasst (z.B. max. 10-12 Wörter).\",\n  \"de_summary\": \"2-3 Sätze Zusammenfassung des Rechtsdokuments auf Deutsch, aus der Perspektive seiner Auswirkungen auf das tägliche Leben der Bürger.\",\n  \"de_key_points\": [\n    \"Erster kurzer Stichpunkt auf Deutsch zu den wichtigsten eingeführten Lösungen oder Änderungen.\",\n    \"Zweiter kurzer Stichpunkt auf Deutsch...\"\n  ],\n  \"fr_ai_title\": \"Un nouveau titre court pour l'acte juridique en français, saisissant l'essence des changements (par exemple, 10-12 mots maximum).\",\n  \"fr_summary\": \"Résumé de 2-3 phrases de l'acte juridique en français, du point de vue de son impact sur la vie quotidienne des citoyens.\",\n  \"fr_key_points\": [\n    \"Premier court point en français concernant les solutions ou changements les plus importants introduits.\",\n    \"Deuxième court point en français...\"\n  ],\n  \"es_ai_title\": \"Un nuevo título breve para el acto jurídico en español, que recoja la esencia de los cambios (por ejemplo, máximo 10-12 palabras).\",\n  \"es_summary\": \"Resumen de 2-3 frases del acto jurídico en español, desde la perspectiva de su impacto en la vida cotidiana de los ciudadanos.\",\n  \"es_key_points\": [\n    \"Primer punto breve en español sobre las soluciones o cambios más importantes que se introducen.\",\n    \"Segundo punto breve en español...\"\n  ],\n  \"it_ai_title\": \"Un nuovo titolo breve per l'atto giuridico in italiano, che colga l'essenza delle modifiche (ad es. massimo 10-12 parole).\",\n  \"it_summary\": \"Riepilogo di 2-3 frasi dell'atto giuridico in italiano, dal punto di vista del suo impatto sulla vita quotidiana dei cittadini.\",\n  \"it_key_points\": [\n    \"Primo breve punto in italiano riguardante le soluzioni o le modifiche più importanti introdotte.\",\n    \"Secondo breve punto in italiano...\"\n  ],\n  \"nl_ai_title\": \"Een nieuwe, korte titel voor de rechtshandeling in het Nederlands, die de essentie van de wijzigingen weergeeft (bijv. max. 10-12 woorden).\",\n  \"nl_summary\": \"Samenvatting van 2-3 zinnen van de rechtshandeling in het Nederlands, vanuit het perspectief van de impact op het dagelijks leven van burgers.\",\n  \"nl_key_points\": [\n    \"Eerste korte punt in het Nederlands betreffende de belangrijkste geïntroduceerde oplossingen of wijzigingen.\",\n    \"Tweede korte punt in het Nederlands...\"\n  ],\n  \"pt_ai_title\": \"Um novo título curto para o ato jurídico em português, capturando a essência das mudanças (por exemplo, máx. 10-12 palavras).\",\n  \"pt_summary\": \"Resumo de 2-3 frases do ato jurídico em português, na perspetiva do seu impacto na vida quotidiana dos cidadãos.\",\n  \"pt_key_points\": [\n    \"Primeiro ponto curto em português sobre as soluções ou alterações mais importantes introduzidas.\",\n    \"Segundo ponto curto em português...\"\n  ],\n  \"category\": [\"Categorize the document into one category by default, based on the field it primarily concerns. Choose up to 3 if the document also touches upon SIGNIFICANT issues from other categories. You MUST select categories ONLY from the following list: Health, Education, Family, Taxes, Labor, Security, Environment, Courts and Law, Transport, Benefits, Real Estate, Media and Culture, Local Government, Migration, Agriculture, Public Investments, Informatization, Economy. If the document does not definitively fit any of these, you MUST use \"Other\". If you use \"Other\", it should be the ONLY category selected. Do NOT invent new categories. The response must be an array of strings, e.g., [\"Taxes\", \"Family\"].\"]\n}\n\n",
      "ai_response_raw": "{\n  \"pl_ai_title\": \"Ułatwienie dostępu do leków ze zniżką 340B i ochrona aptek kontraktowych.\",\n  \"pl_summary\": \"Ustawa ma na celu zapewnienie, że szpitale i kliniki (podmioty objęte programem 340B) będą mogły kupować leki po obniżonych cenach, niezależnie od tego, czy są one wydawane bezpośrednio, czy przez apteki współpracujące. Zmiana ta chroni dostęp pacjentów do niezbędnych leków, zwłaszcza specjalistycznych, oraz gwarantuje, że placówki medyczne zachowają oszczędności na finansowanie dodatkowej opieki zdrowotnej. Producenci leków nie będą mogli stawiać warunków ograniczających ten dostęp.\",\n  \"pl_key_points\": [\n    \"Producenci leków muszą oferować zniżki 340B bez względu na to, czy lek jest wydawany przez aptekę własną placówki, czy aptekę kontraktową.\",\n    \"Wprowadzono wysokie kary finansowe (do 2 milionów dolarów dziennie) dla producentów, którzy celowo utrudniają dostęp do leków objętych programem 340B.\",\n    \"Zmiana ta ma kluczowe znaczenie dla pacjentów potrzebujących leków specjalistycznych, które często są dostępne tylko za pośrednictwem aptek kontraktowych.\"\n  ],\n  \"eng_ai_title\": \"Ensuring Patient Access to Discounted 340B Drugs via Contract Pharmacies.\",\n  \"eng_summary\": \"This bill clarifies and strengthens the 340B drug discount program, ensuring that hospitals and clinics can purchase discounted drugs regardless of whether they are dispensed directly or through partner (contract) pharmacies. This protects patient access to essential, often specialty, medications and ensures healthcare providers can use the savings to fund comprehensive community services. Drug manufacturers are explicitly prohibited from imposing restrictive conditions on these purchases.\",\n  \"eng_key_points\": [\n    \"Drug manufacturers must provide 340B discounts whether the drug is dispensed by the facility's own pharmacy or a contract pharmacy.\",\n    \"New, significant daily civil penalties (up to $2 million) are established for manufacturers who knowingly restrict access to 340B discounted drugs.\",\n    \"The law ensures continued access to vital specialty drugs, which often rely on contract pharmacy arrangements for distribution to patients.\"\n  ],\n  \"de_ai_title\": \"Sicherung des Patientenzugangs zu vergünstigten 340B-Medikamenten.\",\n  \"de_summary\": \"Dieses Gesetz stärkt das 340B-Arzneimittelrabattprogramm, indem es klarstellt, dass Krankenhäuser und Kliniken vergünstigte Medikamente kaufen können, unabhängig davon, ob diese direkt oder über Partnerapotheken abgegeben werden. Dies schützt den Zugang der Patienten zu lebenswichtigen Medikamenten und stellt sicher, dass Gesundheitsdienstleister die Einsparungen zur Finanzierung umfassender Versorgungsleistungen nutzen können. Arzneimittelhersteller dürfen keine einschränkenden Bedingungen für diese Käufe auferlegen.\",\n  \"de_key_points\": [\n    \"Arzneimittelhersteller müssen 340B-Rabatte gewähren, unabhängig davon, ob das Medikament von der eigenen Apotheke der Einrichtung oder einer Vertragsapotheke abgegeben wird.\",\n    \"Es werden neue, hohe tägliche Geldstrafen (bis zu 2 Millionen Dollar) für Hersteller eingeführt, die wissentlich den Zugang zu 340B-Medikamenten einschränken.\",\n    \"Das Gesetz gewährleistet den weiteren Zugang zu wichtigen Spezialmedikamenten, deren Verteilung an Patienten oft über Vertragsapotheken erfolgt.\"\n  ],\n  \"fr_ai_title\": \"Assurer l'accès des patients aux médicaments 340B à prix réduit.\",\n  \"fr_summary\": \"Ce projet de loi renforce le programme de réduction de médicaments 340B, garantissant que les hôpitaux et les cliniques peuvent acheter des médicaments à prix réduit, qu'ils soient distribués directement ou par des pharmacies partenaires. Cela protège l'accès des patients aux médicaments essentiels, souvent spécialisés, et permet aux prestataires de soins de santé d'utiliser les économies pour financer des services communautaires complets. Les fabricants de médicaments n'ont pas le droit d'imposer des conditions restrictives à ces achats.\",\n  \"fr_key_points\": [\n    \"Les fabricants de médicaments doivent offrir des réductions 340B, que le médicament soit distribué par la pharmacie de l'établissement ou par une pharmacie contractuelle.\",\n    \"De nouvelles sanctions civiles journalières importantes (jusqu'à 2 millions de dollars) sont établies pour les fabricants qui restreignent délibérément l'accès aux médicaments à prix réduit 340B.\",\n    \"La loi assure un accès continu aux médicaments spécialisés vitaux, dont la distribution aux patients dépend souvent des accords avec les pharmacies contractuelles.\"\n  ],\n  \"es_ai_title\": \"Garantizar el acceso a medicamentos 340B con descuento mediante farmacias contratadas.\",\n  \"es_summary\": \"Esta ley fortalece el programa de descuento de medicamentos 340B, asegurando que los hospitales y clínicas puedan comprar medicamentos con descuento, ya sean dispensados directamente o a través de farmacias asociadas. Esto protege el acceso de los pacientes a medicamentos esenciales, a menudo especializados, y garantiza que los proveedores de atención médica puedan utilizar los ahorros para financiar servicios comunitarios integrales. Se prohíbe explícitamente a los fabricantes de medicamentos imponer condiciones restrictivas a estas compras.\",\n  \"es_key_points\": [\n    \"Los fabricantes de medicamentos deben ofrecer descuentos 340B, independientemente de si el medicamento es dispensado por la farmacia propia de la instalación o por una farmacia contratada.\",\n    \"Se establecen nuevas y significativas multas civiles diarias (hasta 2 millones de dólares) para los fabricantes que restrinjan intencionalmente el acceso a los medicamentos con descuento 340B.\",\n    \"La ley garantiza el acceso continuo a medicamentos especializados vitales, cuya distribución a menudo depende de acuerdos con farmacias contratadas.\"\n  ],\n  \"it_ai_title\": \"Garantire l'accesso ai farmaci scontati 340B tramite farmacie convenzionate.\",\n  \"it_summary\": \"Questa legge rafforza il programma di sconto sui farmaci 340B, garantendo che ospedali e cliniche possano acquistare farmaci a prezzi ridotti, indipendentemente dal fatto che vengano dispensati direttamente o tramite farmacie partner. Ciò protegge l'accesso dei pazienti ai farmaci essenziali, spesso specialistici, e assicura che gli operatori sanitari possano utilizzare i risparmi per finanziare servizi comunitari completi. Ai produttori di farmaci è esplicitamente vietato imporre condizioni restrittive su tali acquisti.\",\n  \"it_key_points\": [\n    \"I produttori di farmaci devono offrire sconti 340B sia che il farmaco venga dispensato dalla farmacia della struttura che da una farmacia convenzionata.\",\n    \"Vengono stabilite nuove e significative sanzioni civili giornaliere (fino a 2 milioni di dollari) per i produttori che limitano intenzionalmente l'accesso ai farmaci scontati 340B.\",\n    \"La legge garantisce l'accesso continuo a farmaci specialistici vitali, la cui distribuzione ai pazienti spesso dipende da accordi con farmacie convenzionate.\"\n  ],\n  \"nl_ai_title\": \"Toegang tot 340B-kortingsgeneesmiddelen via contractapotheken verzekeren.\",\n  \"nl_summary\": \"Dit wetsvoorstel versterkt het 340B-geneesmiddelenkortingsprogramma, waardoor ziekenhuizen en klinieken gegarandeerd geneesmiddelen met korting kunnen kopen, ongeacht of deze direct of via partnerapotheken worden verstrekt. Dit beschermt de toegang van patiënten tot essentiële, vaak gespecialiseerde, medicatie en zorgt ervoor dat zorgverleners de besparingen kunnen gebruiken om uitgebreide gemeenschapsdiensten te financieren. Geneesmiddelenfabrikanten mogen expliciet geen beperkende voorwaarden opleggen aan deze aankopen.\",\n  \"nl_key_points\": [\n    \"Geneesmiddelenfabrikanten moeten 340B-kortingen aanbieden, ongeacht of het medicijn wordt verstrekt door de eigen apotheek van de instelling of door een contractapotheek.\",\n    \"Er worden nieuwe, aanzienlijke dagelijkse civiele boetes (tot $ 2 miljoen) ingesteld voor fabrikanten die opzettelijk de toegang tot 340B-kortingsgeneesmiddelen beperken.\",\n    \"De wet zorgt voor voortdurende toegang tot vitale gespecialiseerde medicijnen, waarvan de distributie aan patiënten vaak afhankelijk is van contractapotheekregelingen.\"\n  ],\n  \"pt_ai_title\": \"Garantir Acesso a Medicamentos 340B Descontados via Farmácias Contratadas.\",\n  \"pt_summary\": \"Este projeto de lei fortalece o programa de desconto de medicamentos 340B, garantindo que hospitais e clínicas possam comprar medicamentos com desconto, quer sejam dispensados diretamente ou através de farmácias parceiras. Isto protege o acesso dos pacientes a medicamentos essenciais, muitas vezes especializados, e garante que os prestadores de cuidados de saúde possam usar as poupanças para financiar serviços comunitários abrangentes. Os fabricantes de medicamentos estão explicitamente proibidos de impor condições restritivas a estas compras.\",\n  \"pt_key_points\": [\n    \"Os fabricantes de medicamentos devem oferecer descontos 340B, independentemente de o medicamento ser dispensado pela farmácia da própria instalação ou por uma farmácia contratada.\",\n    \"São estabelecidas novas e significativas penalidades civis diárias (até 2 milhões de dólares) para os fabricantes que restrinjam intencionalmente o acesso a medicamentos com desconto 340B.\",\n    \"A lei garante o acesso contínuo a medicamentos especializados vitais, cuja distribuição aos pacientes depende frequentemente de acordos com farmácias contratadas.\"\n  ],\n  \"category\": [\n    \"Health\"\n  ]\n}"
    },
    {
      "timestamp": "2025-12-26T21:53:34.391Z",
      "source_url": "https://www.congress.gov/118/bills/s5021/BILLS-118s5021is.xml",
      "model": "gemini-flash-lite-latest",
      "prompt_sent": "\nROLE: Fact Checker.\nZADANIE: Porównaj SOURCE (oryginał) i SUMMARY (streszczenie przygotowane przez inne AI).\n\nTwoim celem jest wykrycie \"ZMYŚLONYCH KONKRETÓW\" (Fabricated Entities) w SUMMARY.\n\nSOURCE:\n118 S5021 IS: To ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act. U.S. Senate 2024-09-11 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. II118th CONGRESS2d SessionS. 5021IN THE SENATE OF THE UNITED STATESSeptember 11, 2024Mr. Welch introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act.1.Short titleThis Act may be cited as the 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024 or the 340B PATIENTS Act of 2024.2.Findings and purposes(a)FindingsCongress finds the following:(1)Section 340B of the Public Health Service Act (42 U.S.C. 256b) enables covered entities to stretch scarce resources as far as possible, reaching more patients and providing more comprehensive services than would be possible without such program.(2)Such section 340B requires drug manufacturers to offer discounted prices on covered outpatient drugs to covered entities participating in the program, as a condition of participating in the Medicaid program and part B of the Medicare program, and drug manufacturers are required to offer drug discount pricing to covered entities when requested.(3)Savings on the purchase of drugs through the program under section 340B of the Public Health Service Act enables hospitals, clinics, and health centers to provide comprehensive services to the communities they serve, and covered entities are in the best position to assess the use of their savings for community needs.(4)Since the early years of such program, covered entities have contracted with pharmacies to dispense covered outpatient drugs purchased by a covered entity at drug discount program pricing to patients of the covered entity, consistent with how Congress intended for covered entities to use the program.(5)Covered entities use savings generated through contract pharmacy relationships to stretch scarce resources and support patient care, consistent with the purpose of the program.(6)Section 340B of the Public Health Service Act requires drug manufacturers to offer drug discount pricing for drugs purchased by covered entities regardless of the manner or location in which a drug is dispensed, including drugs dispensed through contract pharmacies.(7)Section 340B of the Public Health Service Act does not allow drug manufacturers to place conditions on the ability of a covered entity to purchase or use a covered outpatient drug at drug discount program pricing regardless of the manner or location in which a drug is dispensed, including by restricting a covered entity’s ability to dispense drugs purchased through such program to patients through a contractual relationship with a contracted pharmacy or refusing to ship covered outpatient drugs to a pharmacy or location identified by a covered entity.(8)Such section 340B’s inflationary penalty provisions, which have saved part D of the Medicare program $7,000,000,000 between 2013 and 2017, have a proven record of reducing drug price increases, and use of contract pharmacies contributes to these savings.(9)Specialty drugs, which are often used to treat chronic, serious, or life-threatening conditions such as cancer, rheumatoid arthritis, growth hormone deficiency, and multiple sclerosis, play a critical role in the care provided by covered entities. These drugs often require specialized handling, are not usually available to walk-in customers, and are typically available only through specialty or mail order pharmacies that are located hundreds of miles from a covered entity. The use of contract pharmacy arrangements under section 340B of the Public Health Service Act is often the only means by which covered entities can access these vital drugs.(b)PurposesThe purposes of this Act are the following:(1)To clarify that section 340B of the Public Health Service Act (42 U.S.C. 256b)—(A)requires drug manufacturers to offer drug discount pricing pursuant to an agreement under subsection (a) of such section with respect to drugs purchased by a covered entity regardless of the manner or location in which the drug is dispensed; and (B)prohibits drug manufacturers from placing conditions on the ability of covered entities to purchase drugs pursuant to an agreement under subsection (a) of such section, regardless of the manner or location in which such drugs are dispensed.(2)To clarify that—(A)covered entities may contract with pharmacies to dispense drugs purchased pursuant to an agreement under section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) on a covered entity’s behalf, to assist covered entities in stretching resources to provide care to more patients and provide more comprehensive services; and (B)the requirements and prohibitions that apply to manufacturers under section 340B of such Act apply in the case of a covered entity that elects to contract with a pharmacy to dispense 340B drugs.3.Ensuring the accessibility of drugs furnished under the drug discount program(a)In generalSection 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) is amended—(1)in paragraph (1)—(A)by striking that the manufacturer furnish and inserting the following: that—(A)the manufacturer furnish;(B)by striking ceiling price), and and inserting ceiling price);; (C)by striking shall require that the manufacturer offer and inserting the following:(B)the manufacturer offer; and(D)by striking the period at the end and inserting the following: , regardless of the manner or location in which the drug is dispensed; and (C)the manufacturer not place conditions on the ability of a covered entity to purchase and use a covered outpatient drug at or below the applicable ceiling price, regardless of the manner or location in which the drug is dispensed, including by placing limits on the delivery of drugs, placing limits on the mechanisms through which drugs may be purchased, placing limits on where such drugs may be delivered, administered, or dispensed, requiring a covered entity’s assurance of compliance with requirements under this section, or requiring the submission of claims data or other information, except that the manufacturer may impose conditions described in this subparagraph after receiving advance approval from the Secretary (or, with respect to conditions specified by the Secretary, without such advance approval) if such conditions would not discourage covered entities from purchasing the manufacturer’s drugs through the drug discount program under this section or otherwise undermine the objective of this section, either by singling out covered entities from other customers for such conditions or by imposing conditions that disproportionately impact covered entities.; and(2)by adding at the end the following:(11)Contract PharmaciesThe requirements and prohibitions under paragraph (1) shall apply in the case of a covered entity that elects to contract with one or more pharmacies to dispense, to patients of the covered entity, covered outpatient drugs purchased by the covered entity at or below the applicable ceiling price described in paragraph (1)..(b)Manufacturer complianceSection 340B(d) of the Public Health Service Act (42 U.S.C. 256b) is amended—(1)in paragraph (1)(B)(vi), in the matter preceding subclause (I), by inserting , in the case of an overcharge after penalties;(2)in paragraph (1)(B), by adding at the end the following:(vii)The imposition of sanctions in the form of civil monetary penalties in the case of a violation of subsection (a)(1) or (a)(11), other than an overcharge, which—(I)shall be assessed according to standards established in regulations to be promulgated by the Secretary not later than 180 days after the date of enactment;(II)shall apply to any manufacturer with an agreement under this section that knowingly and intentionally violates a requirement under subsection (a)(1) or (a)(11), other than an overcharge;(III)shall not exceed $2,000,000 for each day of such violation;(IV)shall be in an amount determined by the Secretary, taking into account factors such as the nature and extent of the violation and harm resulting from such violation, including, where applicable, the number of drugs affected and the number of covered entities affected; and(V)shall continue to be imposed each day until such manufacturer is no longer in violation of a requirement under subsection (a)(1) or (a)(11).; and(3)in paragraph (3), by adding at the end the following:(D)Not later than 180 days after the date of the enactment of this subparagraph, the Secretary shall promulgate regulations to permit covered entities to assert claims of violations of subsections (a)(1) and (a)(11) under the process promulgated under subparagraph (A)..\n\nSUMMARY TO EVALUATE:\nTitle: Ensuring Patient Access to Discounted 340B Drugs via Contract Pharmacies.\nSummary: This bill clarifies and strengthens the 340B drug discount program, ensuring that hospitals and clinics can purchase discounted drugs regardless of whether they are dispensed directly or through partner (contract) pharmacies. This protects patient access to essential, often specialty, medications and ensures healthcare providers can use the savings to fund comprehensive community services. Drug manufacturers are explicitly prohibited from imposing restrictive conditions on these purchases.\nKey Points: Drug manufacturers must provide 340B discounts whether the drug is dispensed by the facility's own pharmacy or a contract pharmacy., New, significant daily civil penalties (up to $2 million) are established for manufacturers who knowingly restrict access to 340B discounted drugs., The law ensures continued access to vital specialty drugs, which often rely on contract pharmacy arrangements for distribution to patients.\n\nZASADY OCENY:\n1. Sprawdź wszystkie LICZBY, DATY i KWOTY w SUMMARY. Jeśli którejś brakuje w SOURCE -> is_valid: false.\n2. Sprawdź wszystkie NAZWISKA, ORGANIZACJE i MIEJSCA w SUMMARY. Jeśli którejś brakuje w SOURCE -> is_valid: false.\n3. Sprawdź wszystkie konkretne DZIAŁANIA PRAWNE . Jeśli tego mechanizmu nie ma w SOURCE -> is_valid: false.\n\nWAŻNE: Abstrakcyjne pojęcia (np. \"transparentność\", \"zaufanie\") są dozwolone jako wnioski.\n\nOUTPUT (JSON):\n{\n  \"is_valid\": true/false,\n  \"issue\": \"fabricated_entity\" / \"contradiction\" / \"none\"\n}\n\nWYMAGANIA FORMATOWANIA:\n1. Odpowiedz WYŁĄCZNIE surowym obiektem JSON.\n2. NIE używaj bloków kodu Markdown.\n3. NIE dodawaj żadnych wstępów ani wyjaśnień przed ani po JSONie.\n4. JSON musi być poprawny i gotowy do parsowania.\n\n",
      "ai_response_raw": "{\n  \"is_valid\": false,\n  \"issue\": \"fabricated_entity\"\n}"
    },
    {
      "timestamp": "2025-12-23T07:15:02.144Z",
      "source_url": "https://www.congress.gov/118/bills/s5021/BILLS-118s5021is.xml",
      "model": "gemini-flash-latest",
      "prompt_sent": "\nJesteś ekspertem od prawa Stanów Zjednoczonych, który ma za zadanie analizować dokumenty ustaw, uchwał oraz innych dokumentów legislacyjnych, a następnie przygotowywać z nich informacje w przystępny sposób dla obywateli. Twoim celem jest przedstawienie informacji tak, aby obywatele mogli sami ocenić wpływ legislacji na ich życie, nawet bez posiadania specjalistycznej wiedzy legislacyjnej. Skup się na faktach i konsekwencjach wprowadzanych zmian, unikając wartościowania i osobistych opinii. Wszelki żargon prawny jest zabroniony. Prezentuj informacje w jasny, zwięzły i angażujący sposób, tak aby były zrozumiałe dla osoby bez wykształcenia prawniczego. Unikaj długich, złożonych zdań. Zamiast pisać \"projekt ma na celu nowelizację kodeksu podatkowego...\", napisz \"Zmiany w podatkach: nowe ulgi i obowiązki dla...\". Kontynuuj swoją pracę, dopóki nie rozwiążesz swojego zadania. Jeśli nie masz pewności co do generowanej treści, przeanalizuj dokument ponownie – nie zgaduj. Rozplanuj dobrze swoje zadanie przed przystąpieniem do niego. W podsumowaniu i kluczowych punktach, jeśli to możliwe i uzasadnione, podkreśl, jakie konkretne korzyści lub konsekwencje (pozytywne lub negatywne) wprowadza ustawa dla życia codziennego obywateli, ich praw i obowiązków, finansów osobistych, bezpieczeństwa i innych ważnych kwestii.\n\nTwoja odpowiedź MUSI być w formacie JSON - i zawierać następujące klucze.\nZanim zwrócisz odpowiedź, dokładnie zweryfikuj, czy cała struktura JSON jest w 100% poprawna, włącznie ze wszystkimi przecinkami, nawiasami klamrowymi, kwadratowymi oraz cudzysłowami. Błędny JSON jest nieakceptowalny i uniemożliwi przetworzenie Twojej pracy.\n\nPrzeanalizuj dokładnie poniższy tekst dokumentu prawnego. To jest treść, na podstawie której masz wygenerować podsumowanie i kluczowe punkty:\n--- POCZĄTEK DOKUMENTU ---\n118 S5021 IS: To ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act. U.S. Senate 2024-09-11 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. II118th CONGRESS2d SessionS. 5021IN THE SENATE OF THE UNITED STATESSeptember 11, 2024Mr. Welch introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act.1.Short titleThis Act may be cited as the 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024 or the 340B PATIENTS Act of 2024.2.Findings and purposes(a)FindingsCongress finds the following:(1)Section 340B of the Public Health Service Act (42 U.S.C. 256b) enables covered entities to stretch scarce resources as far as possible, reaching more patients and providing more comprehensive services than would be possible without such program.(2)Such section 340B requires drug manufacturers to offer discounted prices on covered outpatient drugs to covered entities participating in the program, as a condition of participating in the Medicaid program and part B of the Medicare program, and drug manufacturers are required to offer drug discount pricing to covered entities when requested.(3)Savings on the purchase of drugs through the program under section 340B of the Public Health Service Act enables hospitals, clinics, and health centers to provide comprehensive services to the communities they serve, and covered entities are in the best position to assess the use of their savings for community needs.(4)Since the early years of such program, covered entities have contracted with pharmacies to dispense covered outpatient drugs purchased by a covered entity at drug discount program pricing to patients of the covered entity, consistent with how Congress intended for covered entities to use the program.(5)Covered entities use savings generated through contract pharmacy relationships to stretch scarce resources and support patient care, consistent with the purpose of the program.(6)Section 340B of the Public Health Service Act requires drug manufacturers to offer drug discount pricing for drugs purchased by covered entities regardless of the manner or location in which a drug is dispensed, including drugs dispensed through contract pharmacies.(7)Section 340B of the Public Health Service Act does not allow drug manufacturers to place conditions on the ability of a covered entity to purchase or use a covered outpatient drug at drug discount program pricing regardless of the manner or location in which a drug is dispensed, including by restricting a covered entity’s ability to dispense drugs purchased through such program to patients through a contractual relationship with a contracted pharmacy or refusing to ship covered outpatient drugs to a pharmacy or location identified by a covered entity.(8)Such section 340B’s inflationary penalty provisions, which have saved part D of the Medicare program $7,000,000,000 between 2013 and 2017, have a proven record of reducing drug price increases, and use of contract pharmacies contributes to these savings.(9)Specialty drugs, which are often used to treat chronic, serious, or life-threatening conditions such as cancer, rheumatoid arthritis, growth hormone deficiency, and multiple sclerosis, play a critical role in the care provided by covered entities. These drugs often require specialized handling, are not usually available to walk-in customers, and are typically available only through specialty or mail order pharmacies that are located hundreds of miles from a covered entity. The use of contract pharmacy arrangements under section 340B of the Public Health Service Act is often the only means by which covered entities can access these vital drugs.(b)PurposesThe purposes of this Act are the following:(1)To clarify that section 340B of the Public Health Service Act (42 U.S.C. 256b)—(A)requires drug manufacturers to offer drug discount pricing pursuant to an agreement under subsection (a) of such section with respect to drugs purchased by a covered entity regardless of the manner or location in which the drug is dispensed; and (B)prohibits drug manufacturers from placing conditions on the ability of covered entities to purchase drugs pursuant to an agreement under subsection (a) of such section, regardless of the manner or location in which such drugs are dispensed.(2)To clarify that—(A)covered entities may contract with pharmacies to dispense drugs purchased pursuant to an agreement under section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) on a covered entity’s behalf, to assist covered entities in stretching resources to provide care to more patients and provide more comprehensive services; and (B)the requirements and prohibitions that apply to manufacturers under section 340B of such Act apply in the case of a covered entity that elects to contract with a pharmacy to dispense 340B drugs.3.Ensuring the accessibility of drugs furnished under the drug discount program(a)In generalSection 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) is amended—(1)in paragraph (1)—(A)by striking that the manufacturer furnish and inserting the following: that—(A)the manufacturer furnish;(B)by striking ceiling price), and and inserting ceiling price);; (C)by striking shall require that the manufacturer offer and inserting the following:(B)the manufacturer offer; and(D)by striking the period at the end and inserting the following: , regardless of the manner or location in which the drug is dispensed; and (C)the manufacturer not place conditions on the ability of a covered entity to purchase and use a covered outpatient drug at or below the applicable ceiling price, regardless of the manner or location in which the drug is dispensed, including by placing limits on the delivery of drugs, placing limits on the mechanisms through which drugs may be purchased, placing limits on where such drugs may be delivered, administered, or dispensed, requiring a covered entity’s assurance of compliance with requirements under this section, or requiring the submission of claims data or other information, except that the manufacturer may impose conditions described in this subparagraph after receiving advance approval from the Secretary (or, with respect to conditions specified by the Secretary, without such advance approval) if such conditions would not discourage covered entities from purchasing the manufacturer’s drugs through the drug discount program under this section or otherwise undermine the objective of this section, either by singling out covered entities from other customers for such conditions or by imposing conditions that disproportionately impact covered entities.; and(2)by adding at the end the following:(11)Contract PharmaciesThe requirements and prohibitions under paragraph (1) shall apply in the case of a covered entity that elects to contract with one or more pharmacies to dispense, to patients of the covered entity, covered outpatient drugs purchased by the covered entity at or below the applicable ceiling price described in paragraph (1)..(b)Manufacturer complianceSection 340B(d) of the Public Health Service Act (42 U.S.C. 256b) is amended—(1)in paragraph (1)(B)(vi), in the matter preceding subclause (I), by inserting , in the case of an overcharge after penalties;(2)in paragraph (1)(B), by adding at the end the following:(vii)The imposition of sanctions in the form of civil monetary penalties in the case of a violation of subsection (a)(1) or (a)(11), other than an overcharge, which—(I)shall be assessed according to standards established in regulations to be promulgated by the Secretary not later than 180 days after the date of enactment;(II)shall apply to any manufacturer with an agreement under this section that knowingly and intentionally violates a requirement under subsection (a)(1) or (a)(11), other than an overcharge;(III)shall not exceed $2,000,000 for each day of such violation;(IV)shall be in an amount determined by the Secretary, taking into account factors such as the nature and extent of the violation and harm resulting from such violation, including, where applicable, the number of drugs affected and the number of covered entities affected; and(V)shall continue to be imposed each day until such manufacturer is no longer in violation of a requirement under subsection (a)(1) or (a)(11).; and(3)in paragraph (3), by adding at the end the following:(D)Not later than 180 days after the date of the enactment of this subparagraph, the Secretary shall promulgate regulations to permit covered entities to assert claims of violations of subsections (a)(1) and (a)(11) under the process promulgated under subparagraph (A)..\n--- KONIEC DOKUMENTU ---\n\nPAMIĘTAJ: Twoja odpowiedź MUSI być wyłącznie poprawnym obiektem JSON. Nie dodawaj żadnych dodatkowych znaków, komentarzy ani tekstu przed znacznikiem '{' ani po znaczniku '}'. Cała odpowiedź musi być parsowalna jako JSON.\nNa podstawie POWYŻSZEGO dokumentu, wypełnij poniższą strukturę JSON:\nOto struktura JSON, której oczekuję (wypełnij ją treścią):\n{\n  \"pl_ai_title\": \"Nowy, krótki tytuł dla aktu prawnego po polsku, oddający sedno wprowadzanych zmian (np. maksymalnie 10-12 słów).\",\n  \"pl_summary\": \"2-3 zdania zwięzłego podsumowania treści aktu prawnego po polsku, napisane z perspektywy wpływu na życie codzienne obywateli.\",\n  \"pl_key_points\": [\n    \"Pierwszy krótki punkt po polsku dotyczący najważniejszych wprowadzanych rozwiązań lub zmian.\",\n    \"Drugi krótki punkt po polsku...\"\n  ],\n  \"eng_ai_title\": \"A new, short title for the legal act in English, capturing the essence of the changes (e.g., max 10-12 words).\",\n  \"eng_summary\": \"2-3 sentences summarizing the legal act in English, from the perspective of its impact on citizens' daily lives.\",\n  \"eng_key_points\": [\n    \"First short bullet point in English regarding the most important solutions or changes being introduced.\",\n    \"Second short bullet point in English...\"\n  ],\n  \"de_ai_title\": \"Ein neuer, kurzer Titel für das Rechtsdokument auf Deutsch, der den Kern der Änderungen erfasst (z.B. max. 10-12 Wörter).\",\n  \"de_summary\": \"2-3 Sätze Zusammenfassung des Rechtsdokuments auf Deutsch, aus der Perspektive seiner Auswirkungen auf das tägliche Leben der Bürger.\",\n  \"de_key_points\": [\n    \"Erster kurzer Stichpunkt auf Deutsch zu den wichtigsten eingeführten Lösungen oder Änderungen.\",\n    \"Zweiter kurzer Stichpunkt auf Deutsch...\"\n  ],\n  \"fr_ai_title\": \"Un nouveau titre court pour l'acte juridique en français, saisissant l'essence des changements (par exemple, 10-12 mots maximum).\",\n  \"fr_summary\": \"Résumé de 2-3 phrases de l'acte juridique en français, du point de vue de son impact sur la vie quotidienne des citoyens.\",\n  \"fr_key_points\": [\n    \"Premier court point en français concernant les solutions ou changements les plus importants introduits.\",\n    \"Deuxième court point en français...\"\n  ],\n  \"es_ai_title\": \"Un nuevo título breve para el acto jurídico en español, que recoja la esencia de los cambios (por ejemplo, máximo 10-12 palabras).\",\n  \"es_summary\": \"Resumen de 2-3 frases del acto jurídico en español, desde la perspectiva de su impacto en la vida cotidiana de los ciudadanos.\",\n  \"es_key_points\": [\n    \"Primer punto breve en español sobre las soluciones o cambios más importantes que se introducen.\",\n    \"Segundo punto breve en español...\"\n  ],\n  \"it_ai_title\": \"Un nuovo titolo breve per l'atto giuridico in italiano, che colga l'essenza delle modifiche (ad es. massimo 10-12 parole).\",\n  \"it_summary\": \"Riepilogo di 2-3 frasi dell'atto giuridico in italiano, dal punto di vista del suo impatto sulla vita quotidiana dei cittadini.\",\n  \"it_key_points\": [\n    \"Primo breve punto in italiano riguardante le soluzioni o le modifiche più importanti introdotte.\",\n    \"Secondo breve punto in italiano...\"\n  ],\n  \"nl_ai_title\": \"Een nieuwe, korte titel voor de rechtshandeling in het Nederlands, die de essentie van de wijzigingen weergeeft (bijv. max. 10-12 woorden).\",\n  \"nl_summary\": \"Samenvatting van 2-3 zinnen van de rechtshandeling in het Nederlands, vanuit het perspectief van de impact op het dagelijks leven van burgers.\",\n  \"nl_key_points\": [\n    \"Eerste korte punt in het Nederlands betreffende de belangrijkste geïntroduceerde oplossingen of wijzigingen.\",\n    \"Tweede korte punt in het Nederlands...\"\n  ],\n  \"pt_ai_title\": \"Um novo título curto para o ato jurídico em português, capturando a essência das mudanças (por exemplo, máx. 10-12 palavras).\",\n  \"pt_summary\": \"Resumo de 2-3 frases do ato jurídico em português, na perspetiva do seu impacto na vida quotidiana dos cidadãos.\",\n  \"pt_key_points\": [\n    \"Primeiro ponto curto em português sobre as soluções ou alterações mais importantes introduzidas.\",\n    \"Segundo ponto curto em português...\"\n  ],\n  \"category\": [\"Categorize the document into one category by default, based on the field it primarily concerns. Choose up to 3 if the document also touches upon SIGNIFICANT issues from other categories. You MUST select categories ONLY from the following list: Health, Education, Family, Taxes, Labor, Security, Environment, Courts and Law, Transport, Benefits, Real Estate, Media and Culture, Local Government, Migration, Agriculture, Public Investments, Informatization, Economy. If the document does not definitively fit any of these, you MUST use \"Other\". If you use \"Other\", it should be the ONLY category selected. Do NOT invent new categories. The response must be an array of strings, e.g., [\"Taxes\", \"Family\"].\"]\n}\n\n",
      "ai_response_raw": "{\n  \"pl_ai_title\": \"Ułatwienie dostępu do leków ze zniżką 340B i ochrona aptek kontraktowych.\",\n  \"pl_summary\": \"Ustawa ma na celu zapewnienie, że szpitale i kliniki (podmioty objęte programem 340B) będą mogły kupować leki po obniżonych cenach, niezależnie od tego, czy są one wydawane bezpośrednio, czy przez apteki współpracujące. Zmiana ta chroni dostęp pacjentów do niezbędnych leków, zwłaszcza specjalistycznych, oraz gwarantuje, że placówki medyczne zachowają oszczędności na finansowanie dodatkowej opieki zdrowotnej. Producenci leków nie będą mogli stawiać warunków ograniczających ten dostęp.\",\n  \"pl_key_points\": [\n    \"Producenci leków muszą oferować zniżki 340B bez względu na to, czy lek jest wydawany przez aptekę własną placówki, czy aptekę kontraktową.\",\n    \"Wprowadzono wysokie kary finansowe (do 2 milionów dolarów dziennie) dla producentów, którzy celowo utrudniają dostęp do leków objętych programem 340B.\",\n    \"Zmiana ta ma kluczowe znaczenie dla pacjentów potrzebujących leków specjalistycznych, które często są dostępne tylko za pośrednictwem aptek kontraktowych.\"\n  ],\n  \"eng_ai_title\": \"Ensuring Patient Access to Discounted 340B Drugs via Contract Pharmacies.\",\n  \"eng_summary\": \"This bill clarifies and strengthens the 340B drug discount program, ensuring that hospitals and clinics can purchase discounted drugs regardless of whether they are dispensed directly or through partner (contract) pharmacies. This protects patient access to essential, often specialty, medications and ensures healthcare providers can use the savings to fund comprehensive community services. Drug manufacturers are explicitly prohibited from imposing restrictive conditions on these purchases.\",\n  \"eng_key_points\": [\n    \"Drug manufacturers must provide 340B discounts whether the drug is dispensed by the facility's own pharmacy or a contract pharmacy.\",\n    \"New, significant daily civil penalties (up to $2 million) are established for manufacturers who knowingly restrict access to 340B discounted drugs.\",\n    \"The law ensures continued access to vital specialty drugs, which often rely on contract pharmacy arrangements for distribution to patients.\"\n  ],\n  \"de_ai_title\": \"Sicherung des Patientenzugangs zu vergünstigten 340B-Medikamenten.\",\n  \"de_summary\": \"Dieses Gesetz stärkt das 340B-Arzneimittelrabattprogramm, indem es klarstellt, dass Krankenhäuser und Kliniken vergünstigte Medikamente kaufen können, unabhängig davon, ob diese direkt oder über Partnerapotheken abgegeben werden. Dies schützt den Zugang der Patienten zu lebenswichtigen Medikamenten und stellt sicher, dass Gesundheitsdienstleister die Einsparungen zur Finanzierung umfassender Versorgungsleistungen nutzen können. Arzneimittelhersteller dürfen keine einschränkenden Bedingungen für diese Käufe auferlegen.\",\n  \"de_key_points\": [\n    \"Arzneimittelhersteller müssen 340B-Rabatte gewähren, unabhängig davon, ob das Medikament von der eigenen Apotheke der Einrichtung oder einer Vertragsapotheke abgegeben wird.\",\n    \"Es werden neue, hohe tägliche Geldstrafen (bis zu 2 Millionen Dollar) für Hersteller eingeführt, die wissentlich den Zugang zu 340B-Medikamenten einschränken.\",\n    \"Das Gesetz gewährleistet den weiteren Zugang zu wichtigen Spezialmedikamenten, deren Verteilung an Patienten oft über Vertragsapotheken erfolgt.\"\n  ],\n  \"fr_ai_title\": \"Assurer l'accès des patients aux médicaments 340B à prix réduit.\",\n  \"fr_summary\": \"Ce projet de loi renforce le programme de réduction de médicaments 340B, garantissant que les hôpitaux et les cliniques peuvent acheter des médicaments à prix réduit, qu'ils soient distribués directement ou par des pharmacies partenaires. Cela protège l'accès des patients aux médicaments essentiels, souvent spécialisés, et permet aux prestataires de soins de santé d'utiliser les économies pour financer des services communautaires complets. Les fabricants de médicaments n'ont pas le droit d'imposer des conditions restrictives à ces achats.\",\n  \"fr_key_points\": [\n    \"Les fabricants de médicaments doivent offrir des réductions 340B, que le médicament soit distribué par la pharmacie de l'établissement ou par une pharmacie contractuelle.\",\n    \"De nouvelles sanctions civiles journalières importantes (jusqu'à 2 millions de dollars) sont établies pour les fabricants qui restreignent délibérément l'accès aux médicaments à prix réduit 340B.\",\n    \"La loi assure un accès continu aux médicaments spécialisés vitaux, dont la distribution aux patients dépend souvent des accords avec les pharmacies contractuelles.\"\n  ],\n  \"es_ai_title\": \"Garantizar el acceso a medicamentos 340B con descuento mediante farmacias contratadas.\",\n  \"es_summary\": \"Esta ley fortalece el programa de descuento de medicamentos 340B, asegurando que los hospitales y clínicas puedan comprar medicamentos con descuento, ya sean dispensados directamente o a través de farmacias asociadas. Esto protege el acceso de los pacientes a medicamentos esenciales, a menudo especializados, y garantiza que los proveedores de atención médica puedan utilizar los ahorros para financiar servicios comunitarios integrales. Se prohíbe explícitamente a los fabricantes de medicamentos imponer condiciones restrictivas a estas compras.\",\n  \"es_key_points\": [\n    \"Los fabricantes de medicamentos deben ofrecer descuentos 340B, independientemente de si el medicamento es dispensado por la farmacia propia de la instalación o por una farmacia contratada.\",\n    \"Se establecen nuevas y significativas multas civiles diarias (hasta 2 millones de dólares) para los fabricantes que restrinjan intencionalmente el acceso a los medicamentos con descuento 340B.\",\n    \"La ley garantiza el acceso continuo a medicamentos especializados vitales, cuya distribución a menudo depende de acuerdos con farmacias contratadas.\"\n  ],\n  \"it_ai_title\": \"Garantire l'accesso ai farmaci scontati 340B tramite farmacie convenzionate.\",\n  \"it_summary\": \"Questa legge rafforza il programma di sconto sui farmaci 340B, garantendo che ospedali e cliniche possano acquistare farmaci a prezzi ridotti, indipendentemente dal fatto che vengano dispensati direttamente o tramite farmacie partner. Ciò protegge l'accesso dei pazienti ai farmaci essenziali, spesso specialistici, e assicura che gli operatori sanitari possano utilizzare i risparmi per finanziare servizi comunitari completi. Ai produttori di farmaci è esplicitamente vietato imporre condizioni restrittive su tali acquisti.\",\n  \"it_key_points\": [\n    \"I produttori di farmaci devono offrire sconti 340B sia che il farmaco venga dispensato dalla farmacia della struttura che da una farmacia convenzionata.\",\n    \"Vengono stabilite nuove e significative sanzioni civili giornaliere (fino a 2 milioni di dollari) per i produttori che limitano intenzionalmente l'accesso ai farmaci scontati 340B.\",\n    \"La legge garantisce l'accesso continuo a farmaci specialistici vitali, la cui distribuzione ai pazienti spesso dipende da accordi con farmacie convenzionate.\"\n  ],\n  \"nl_ai_title\": \"Toegang tot 340B-kortingsgeneesmiddelen via contractapotheken verzekeren.\",\n  \"nl_summary\": \"Dit wetsvoorstel versterkt het 340B-geneesmiddelenkortingsprogramma, waardoor ziekenhuizen en klinieken gegarandeerd geneesmiddelen met korting kunnen kopen, ongeacht of deze direct of via partnerapotheken worden verstrekt. Dit beschermt de toegang van patiënten tot essentiële, vaak gespecialiseerde, medicatie en zorgt ervoor dat zorgverleners de besparingen kunnen gebruiken om uitgebreide gemeenschapsdiensten te financieren. Geneesmiddelenfabrikanten mogen expliciet geen beperkende voorwaarden opleggen aan deze aankopen.\",\n  \"nl_key_points\": [\n    \"Geneesmiddelenfabrikanten moeten 340B-kortingen aanbieden, ongeacht of het medicijn wordt verstrekt door de eigen apotheek van de instelling of door een contractapotheek.\",\n    \"Er worden nieuwe, aanzienlijke dagelijkse civiele boetes (tot $ 2 miljoen) ingesteld voor fabrikanten die opzettelijk de toegang tot 340B-kortingsgeneesmiddelen beperken.\",\n    \"De wet zorgt voor voortdurende toegang tot vitale gespecialiseerde medicijnen, waarvan de distributie aan patiënten vaak afhankelijk is van contractapotheekregelingen.\"\n  ],\n  \"pt_ai_title\": \"Garantir Acesso a Medicamentos 340B Descontados via Farmácias Contratadas.\",\n  \"pt_summary\": \"Este projeto de lei fortalece o programa de desconto de medicamentos 340B, garantindo que hospitais e clínicas possam comprar medicamentos com desconto, quer sejam dispensados diretamente ou através de farmácias parceiras. Isto protege o acesso dos pacientes a medicamentos essenciais, muitas vezes especializados, e garante que os prestadores de cuidados de saúde possam usar as poupanças para financiar serviços comunitários abrangentes. Os fabricantes de medicamentos estão explicitamente proibidos de impor condições restritivas a estas compras.\",\n  \"pt_key_points\": [\n    \"Os fabricantes de medicamentos devem oferecer descontos 340B, independentemente de o medicamento ser dispensado pela farmácia da própria instalação ou por uma farmácia contratada.\",\n    \"São estabelecidas novas e significativas penalidades civis diárias (até 2 milhões de dólares) para os fabricantes que restrinjam intencionalmente o acesso a medicamentos com desconto 340B.\",\n    \"A lei garante o acesso contínuo a medicamentos especializados vitais, cuja distribuição aos pacientes depende frequentemente de acordos com farmácias contratadas.\"\n  ],\n  \"category\": [\n    \"Health\"\n  ]\n}"
    }
  ]
}