{
  "legislationId": "118_S_4469",
  "lastUpdate": "2026-02-10T19:51:04.818Z",
  "history": [
    {
      "timestamp": "2026-02-10T19:51:04.818Z",
      "source_url": "https://www.congress.gov/118/bills/s4469/BILLS-118s4469is.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). 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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. 4469 Introduced in Senate (IS)] <DOC> 118th CONGRESS 2d Session S. 4469 To improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES June 5, 2024 Mr. Cardin (for himself and Mrs. Blackburn) introduced the following bill; which was read twice and referred to the Committee on Finance _______________________________________________________________________ A BILL To improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE; TABLE OF CONTENTS. (a) Short Title.--This Act may be cited as the ``Chronic Kidney Disease Improvement in Research and Treatment Act of 2024''. (b) Table of Contents.--The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. TITLE I--PREVENTING KIDNEY DISEASE BY EXPANDING EDUCATION AND AWARENESS Sec. 101. Expanding Medicare annual wellness benefit to include kidney disease screening. Sec. 102. Increasing access to Medicare kidney disease education benefit. Sec. 103. Understanding the progression of kidney disease and treatment of kidney failure in minority populations. TITLE II--INCENTIVIZING KIDNEY CARE INNOVATION Sec. 201. Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies. Sec. 202. Ensuring Medicare Advantage supports kidney care innovative therapies. Sec. 203. Improving patient lives and quality of care through research and innovation. TITLE III--ADDRESSING THE KIDNEY CARE WORKFORCE CRISIS. Sec. 301. Improving patient decision making and transparency by consolidating and modernizing quality programs. Sec. 302. Ensuring accuracy and stability in kidney care payment. TITLE IV--EXPANDING PATIENT CHOICE OF COVERAGE Sec. 401. Medigap coverage for beneficiaries with end-stage renal disease. TITLE I--PREVENTING KIDNEY DISEASE BY EXPANDING EDUCATION AND AWARENESS SEC. 101. EXPANDING MEDICARE ANNUAL WELLNESS BENEFIT TO INCLUDE KIDNEY DISEASE SCREENING. (a) In General.--Section 1861(ww)(2) of the Social Security Act (42 U.S.C. 1395x(ww)(2)) is amended-- (1) by moving subparagraph (N) 2 ems to the left; (2) by redesignating subparagraph (O) as subparagraph (P); and (3) by inserting after subparagraph (N) the following new subparagraph: ``(O) Chronic kidney disease screening as defined by the Secretary.''. (b) Effective Date.--The amendments made by this section apply to items and services furnished on or after January 1, 2025. SEC. 102. INCREASING ACCESS TO MEDICARE KIDNEY DISEASE EDUCATION BENEFIT. (a) In General.--Section 1861(ggg) of the Social Security Act (42 U.S.C. 1395x(ggg)) is amended-- (1) in paragraph (1)-- (A) in subparagraph (A), by inserting ``or stage V'' after ``stage IV''; and (B) in subparagraph (B), by inserting ``or of a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5)) assisting in the treatment of the individual's kidney condition'' after ``kidney condition''; and (2) in paragraph (2)-- (A) by striking subparagraph (B); and (B) in subparagraph (A)-- (i) by striking ``(A)'' after ``(2)''; (ii) by striking ``and'' at the end of clause (i); (iii) by striking the period at the end of clause (ii) and inserting ``; and''; (iv) by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and indenting appropriately; and (v) by adding at the end the following: ``(C) a renal dialysis facility subject to the requirements of section 1881(b)(1) with personnel who-- ``(i) provide the services described in paragraph (1); and ``(ii) is a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in subsection (aa)(5)).''. (b) Payment to Renal Dialysis Facilities.--Section 1881(b) of the Social Security Act (42 U.S.C. 1395rr(b)) is amended by adding at the end the following new paragraph: ``(15) For purposes of paragraph (14), the single payment for renal dialysis services under such paragraph shall not take into account the amount of payment for kidney disease education services (as defined in section 1861(ggg)). Instead, payment for such services shall be made to the renal dialysis facility on an assignment-related basis under section 1848.''. (c) Effective Date.--The amendments made by this section apply to kidney disease education services furnished on or after January 1, 2025. SEC. 103. UNDERSTANDING THE PROGRESSION OF KIDNEY DISEASE AND TREATMENT OF KIDNEY FAILURE IN MINORITY POPULATIONS. (a) Study.--The Secretary of Health and Human Services (in this section referred to as the ``Secretary'') shall conduct a study on-- (1) the social, behavioral, and biological factors associated with kidney disease onset and progression; (2) efforts to slow the progression of kidney disease in minority populations that are disproportionately affected by such disease; and (3) treatment patterns associated with providing care, under the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, and through private health insurance, to minority populations that are disproportionately affected by kidney disease. (b) Report.--Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the study conducted under subsection (a), together with such recommendations as the Secretary determines to be appropriate. TITLE II--INCENTIVIZING KIDNEY CARE INNOVATION SEC. 201. REFINING THE END-STAGE RENAL DISEASE PAYMENT SYSTEM TO IMPROVE ACCURACY IN PAYMENT AND SUPPORT THERAPIES. (a) In General.--Section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) is amended by adding at the end the following new subparagraph: ``(J) Payment for New and Innovative Drugs, Biologicals, and Devices That Are Renal Dialysis Services.-- ``(i) In general.--For any new renal dialysis drug or biological product that is used to treat or manage a condition for which there is a functional category as defined in section 413.234(a) of title 42, Code of Federal Regulations that received a transitional drug add-on adjustment (referred to in this subparagraph as `TDAPA') under section 413.234(c)(2) of such title, and was furnished on or after January 1, 2024, the Secretary shall establish a permanent add-on adjustment to the base rate for claims submitted on or after January 1, 2025, that includes the administration of such drugs or biologicals. ``(ii) Calculation of the post-tdapa add-on adjustment.--In calculating the add-on adjustment described in clause (i), the Secretary shall-- ``(I) base the calculation on-- ``(aa) except as provided in items (bb) and (cc), the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of average sales price data for such drug or product; ``(bb) if the most recent available full calendar quarter of average sales price data reflects 0 or negative sales, 100 percent of the wholesale acquisition cost (as defined in section 1847A(c)(6)) of such drug or product; or ``(cc) if the wholesale acquisition cost is not available, the drug manufacturer's invoice; ``(II) calculate the post-TDAPA add-on payment adjustment as the expenditures for the new renal dialysis drug or biological product divided by the total number of renal dialysis services during which such drug or biological was administered during the same period; ``(III) set the amount of the add-on adjustment as an amount equal to 65 percent of the amount calculated under subclause (II); ``(IV) update the add-on adjustment annually to account for inflationary changes; and ``(V) apply the add-on adjustment amount immediately upon the expiration of the TDAPA period and availability of the post-TDAPA add-on adjustment. ``(iii) Implementation.--This subparagraph shall not be implemented in a budget neutral manner and shall not be adjusted by any applicable patient-level case-mix adjustments described in section 413.235 of title 42, Code of Federal Regulations (or any successor regulation).''. (b) Extension of Transitional Drug Add-On Adjustment Under the Drug Designation Policy.--The Secretary shall pay the transitional drug add- on adjustment under paragraph (c) of section 413.234 of title 42, Code of Federal Regulations (or a successor regulation) for a total of 3 years for any new renal dialysis drug or biological product that-- (1) is used to treat or manage a condition for which there is a functional category as defined in paragraph (a) of such section; (2) qualifies for such adjustment under paragraph (c)(2) of such section; and (3) is furnished on or after January 1, 2024. (c) New Devices and Other Technologies.-- (1) In general.--As part of the promulgation of the annual rule for the Medicare end-stage renal disease prospective payment system under section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) for calendar year 2026, and in consultation with stakeholders, the Secretary of Health and Human Services (referred to in this subsection as the ``Secretary'') shall-- (A) ensure that the single payment amount is adequate to cover the cost of any new innovative device or other technology with substantial clinical improvement; and (B) increase the single payment amount if the Secretary determines such payment amount is not adequate to cover such cost. (2) Cost and utilization data.--In carrying out paragraph (1), the Secretary shall use the cost and utilization data collected during a 3-year transitional payment period, as described in the final regulation published on November 9, 2020 (85 Fed. Reg. 71398). SEC. 202. ENSURING MEDICARE ADVANTAGE SUPPORTS KIDNEY CARE INNOVATIVE THERAPIES. Section 1853(c) of the Social Security Act (42 U.S.C. 1395w-23(c)) is amended by adding at the end the following new paragraph: ``(8) Treatment of innovative products for enrollees with end stage renal disease.-- ``(A) In general.--The Secretary shall make direct payment adjustments to providers of services or renal dialysis facilities for-- ``(i) any new renal dialysis drug or biological product that receives a transitional drug add-on adjustment under section 413.234(c) of title 42, Code of Federal Regulations; or ``(ii) an item or service that receives a transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of such title. ``(B) Amount of direct payment.--The amount of the adjustment shall equal the amount determined under the end stage renal disease prospective payment system described in section 1881(b)(14). ``(C) Duration of direct payment.--The Secretary shall make payments under subparagraph (A) for the duration of the transitional payment under the end stage renal disease prospective payment system described in such section.''. SEC. 203. IMPROVING PATIENT LIVES AND QUALITY OF CARE THROUGH RESEARCH AND INNOVATION. (a) Study.--The Secretary of Health and Human Services (referred to in this section as the ``Secretary'') shall conduct a study on increasing kidney transplantation rates. Such study shall include an analysis of each of the following: (1) Any disincentives in the payment systems under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) that create barriers to kidney transplants and post-transplant care for beneficiaries with end-stage renal disease. (2) The practices used by donation service areas with higher than average donation rates and whether those practices and policies could be successfully utilized in other donation service areas. (3) Practices and policies that could increase donation rates among minority populations. (4) Whether cultural and policy barriers exist to increasing living donation rates, including an examination of how to better facilitate kidney paired donations. (5) Criteria for transplant recipients for referral and for getting on the waitlist to receive a kidney. (6) Other areas determined appropriate by the Secretary. (b) Report.--Not later than 18 months after the date of enactment of this Act, the Secretary shall submit to Congress a report on the study conducted pursuant to subsection (a), together with such recommendations as the Secretary determines to be appropriate. TITLE III--INCREASING PATIENT ACCESS TO QUALITY PERFORMANCE BY IMPROVING THE ACCURACY AND TRANSPARENCY OF END-STAGE RENAL DISEASE QUALITY PROGRAMS SEC. 301. IMPROVING PATIENT DECISION MAKING AND TRANSPARENCY BY CONSOLIDATING AND MODERNIZING QUALITY PROGRAMS. (a) Measures.--Section 1881(h)(2) of the Social Security Act (42 U.S.C. 1395rr(h)(2)) is amended-- (1) by striking subparagraph (A) and inserting the following: ``(A) The measures specified under this paragraph with respect to the year involved shall be selected by the Secretary in consultation with stakeholders to promote improvement in beneficiary outcomes and shared decision-making with beneficiaries and their caregivers. When selecting measures specified under this paragraph, the Secretary shall take into account clinical gaps in care, underutilization that may lead to beneficiary harm, patient safety, and outcomes.''; (2) in subparagraph (B)(i), by striking ``subparagraph (A)(iv)'' and inserting ``subparagraph (A)''; (3) by striking subparagraph (E); and (4) by adding at the end the following new subparagraphs: ``(E) Weighting limitation.--No single measure specified by the Secretary or individual measure within a composite measure so specified may be weighted less than 10 percent of the total performance score. ``(F) Statistically valid and reliable.--In specifying measures under subparagraph (A), the Secretary shall only specify measures that have been shown to be statistically valid and reliable through testing.''. (b) Endorsement.--Section 1881(h)(2)(B)(ii) of the Social Security Act (42 U.S.C. 1395rr(h)(2)(B)(ii)) is amended by adding at the end the following new sentence: ``The exception under the preceding sentence shall not apply to a measure that the entity with a contract under section 1890(a) (or a similar entity) considered but failed to endorse.''. (e) Effective Date.--The amendments made by this section shall apply to items and services furnished on or after January 1, 2025. TITLE IV--EMPOWERING PATIENTS SEC. 401. MEDIGAP COVERAGE FOR BENEFICIARIES WITH END-STAGE RENAL DISEASE. (a) Guaranteed Availability of Medigap Policies to All ESRD Medicare Beneficiaries.-- (1) In general.--Section 1882(s) of the Social Security Act (42 U.S.C. 1395ss(s)) is amended-- (A) in paragraph (2)-- (i) in subparagraph (A), by striking ``is 65'' and all that follows through the period and inserting the following: ``is-- ``(i) 65 years of age or older and is enrolled for benefits under part B; or ``(ii) entitled to benefits under 226A(b) and is enrolled for benefits under part B.''; and (ii) in subparagraph (D), in the matter preceding clause (i), by inserting ``(or is entitled to benefits under 226A(b))'' after ``is 65 years of age or older''; and (B) in paragraph (3)(B)-- (i) in clause (ii), by inserting ``(or is entitled to benefits under 226A(b))'' after ``is 65 years of age or older''; and (ii) in clause (vi), by inserting ``(or under 226A(b))'' after ``at age 65''. (2) Effective date.--The amendments made by paragraph (1) shall apply to Medicare supplemental policies effective on or after January 1, 2026. (b) Additional Enrollment Period for Certain Individuals.-- (1) One-time enrollment period.-- (A) In general.--In the case of an individual described in subparagraph (B), the Secretary of Health and Human Services shall establish a one-time enrollment period during which such an individual may enroll in any Medicare supplemental policy under section 1882 of the Social Security Act (42 U.S.C. 1395ss) of the individual's choosing. (B) Enrollment period.--The enrollment period established under subparagraph (A) shall begin on January 1, 2026, and shall end June 30, 2026. (2) Individual described.--An individual described in this paragraph is an individual who-- (A) is entitled to hospital insurance benefits under part A of title XVIII of the Social Security Act under section 226A(b) of such Act (42 U.S.C. 426-1); (B) is enrolled for benefits under part B of such title XVIII; and (C) would not, but for the provisions of, and amendments made by, subsection (a) be eligible for the guaranteed issue of a Medicare supplemental policy under paragraph (2) or (3) of section 1882(s) of such Act (42 U.S.C. 1395ss(s)). <all>\n--- SOURCE_TEXT END ---\n\n--- FLAGGED_JSON START ---\n{\n  \"pl_ai_title\": \"Poprawa opieki nad nerkami: badania, edukacja i dostęp do ubezpieczenia Medigap.\",\n  \"pl_summary\": \"Ustawa ma na celu poprawę opieki nad osobami z przewlekłą chorobą nerek (CKD) poprzez rozszerzenie badań przesiewowych w ramach rocznych wizyt Medicare. Zwiększa dostęp do edukacji na temat choroby nerek i zapewnia, że pacjenci z krańcową niewydolnością nerek (ESRD) poniżej 65. roku życia będą mieli gwarantowany dostęp do ubezpieczenia uzupełniającego Medigap. Ponadto, ustawa wprowadza zmiany w systemie płatności Medicare, aby wspierać innowacyjne terapie i leki dla pacjentów dializowanych.\",\n  \"pl_key_points\": [\n    \"Bezpłatne badania przesiewowe w kierunku przewlekłej choroby nerek (CKD) zostaną włączone do corocznych wizyt kontrolnych w ramach programu Medicare (od 1 stycznia 2025 r.).\",\n    \"Pacjenci z krańcową niewydolnością nerek (ESRD) poniżej 65. roku życia uzyskają gwarantowany dostęp do ubezpieczenia uzupełniającego Medigap (od 1 stycznia 2026 r.), co obniży ich koszty leczenia.\",\n    \"Rozszerzenie dostępu do edukacji na temat choroby nerek (KDE) – usługi te będą mogły być świadczone przez większą liczbę specjalistów i placówek dializacyjnych.\",\n    \"Wprowadzenie stałych dodatkowych płatności w Medicare za nowe, innowacyjne leki i produkty biologiczne stosowane w dializach, co ma zachęcać do innowacji w leczeniu.\",\n    \"Nakaz przeprowadzenia badań nad czynnikami wpływającymi na postęp choroby nerek i transplantacje, zwłaszcza w populacjach mniejszościowych.\"\n  ],\n  \"eng_ai_title\": \"Kidney Care Improvement Act: Screening, Innovation, and Medigap Access for ESRD Patients.\",\n  \"eng_summary\": \"This Act aims to enhance care for individuals with Chronic Kidney Disease (CKD) by expanding screening within Medicare's annual wellness visits. It increases access to kidney disease education and ensures that End-Stage Renal Disease (ESRD) patients under 65 are guaranteed access to Medigap supplemental insurance. Furthermore, the legislation modifies Medicare payment systems to support innovative therapies and drugs for dialysis patients.\",\n  \"eng_key_points\": [\n    \"Free chronic kidney disease (CKD) screening will be included in Medicare's annual wellness visits (effective January 1, 2025).\",\n    \"ESRD patients under 65 will gain guaranteed access to Medigap supplemental insurance (effective January 1, 2026), reducing their out-of-pocket costs.\",\n    \"Access to Kidney Disease Education (KDE) is expanded, allowing more professionals and dialysis facilities to provide these services.\",\n    \"Introduction of permanent add-on payments in Medicare for new, innovative drugs and biological products used in dialysis to incentivize treatment innovation.\",\n    \"Mandates studies on factors affecting kidney disease progression and transplantation rates, particularly within minority populations.\"\n  ],\n  \"de_ai_title\": \"Nierenpflege-Verbesserungsgesetz: Screening, Innovation und Medigap für ESRD-Patienten.\",\n  \"de_summary\": \"Dieses Gesetz zielt darauf ab, die Versorgung von Personen mit chronischer Nierenerkrankung (CKD) zu verbessern, indem es das Screening im Rahmen der jährlichen Medicare-Vorsorgeuntersuchungen erweitert. Es verbessert den Zugang zu Aufklärung über Nierenerkrankungen und stellt sicher, dass Patienten mit terminaler Niereninsuffizienz (ESRD) unter 65 Jahren garantierten Zugang zur Medigap-Zusatzversicherung erhalten. Darüber hinaus ändert das Gesetz die Medicare-Zahlungssysteme, um innovative Therapien und Medikamente für Dialysepatienten zu unterstützen.\",\n  \"de_key_points\": [\n    \"Kostenloses Screening auf chronische Nierenerkrankungen (CKD) wird in die jährlichen Medicare-Vorsorgeuntersuchungen aufgenommen (wirksam ab 1. Januar 2025).\",\n    \"ESRD-Patienten unter 65 Jahren erhalten garantierten Zugang zur Medigap-Zusatzversicherung (wirksam ab 1. Januar 2026), was ihre Behandlungskosten senkt.\",\n    \"Der Zugang zur Aufklärung über Nierenerkrankungen (KDE) wird erweitert, sodass mehr Fachkräfte und Dialyseeinrichtungen diese Dienste anbieten können.\",\n    \"Einführung dauerhafter Zusatzzahlungen in Medicare für neue, innovative Medikamente und biologische Produkte, die bei der Dialyse verwendet werden, um Innovationen in der Behandlung zu fördern.\",\n    \"Anordnung von Studien zu Faktoren, die das Fortschreiten von Nierenerkrankungen und die Transplantationsraten beeinflussen, insbesondere in Minderheitenpopulationen.\"\n  ],\n  \"fr_ai_title\": \"Loi sur l'amélioration des soins rénaux: dépistage, innovation et accès Medigap.\",\n  \"fr_summary\": \"Cette loi vise à améliorer les soins pour les personnes atteintes de maladie rénale chronique (MRC) en élargissant le dépistage lors des visites de bien-être annuelles de Medicare. Elle augmente l'accès à l'éducation sur les maladies rénales et garantit que les patients atteints d'insuffisance rénale terminale (IRT) de moins de 65 ans aient un accès garanti à l'assurance complémentaire Medigap. De plus, la législation modifie les systèmes de paiement de Medicare pour soutenir les thérapies et médicaments innovants pour les patients dialysés.\",\n  \"fr_key_points\": [\n    \"Le dépistage gratuit de la maladie rénale chronique (MRC) sera inclus dans les visites de bien-être annuelles de Medicare (à compter du 1er janvier 2025).\",\n    \"Les patients IRT de moins de 65 ans obtiendront un accès garanti à l'assurance complémentaire Medigap (à compter du 1er janvier 2026), réduisant ainsi leurs frais personnels.\",\n    \"L'accès à l'éducation sur les maladies rénales (KDE) est élargi, permettant à davantage de professionnels et d'établissements de dialyse de fournir ces services.\",\n    \"Introduction de paiements supplémentaires permanents dans Medicare pour les nouveaux médicaments et produits biologiques innovants utilisés en dialyse, afin d'encourager l'innovation thérapeutique.\",\n    \"Ordonne des études sur les facteurs affectant la progression de la maladie rénale et les taux de transplantation, en particulier au sein des populations minoritaires.\"\n  ],\n  \"es_ai_title\": \"Ley de Mejora de la Enfermedad Renal: Detección, Innovación y Acceso a Medigap.\",\n  \"es_summary\": \"Esta Ley busca mejorar la atención a las personas con Enfermedad Renal Crónica (ERC) ampliando la detección en las visitas anuales de bienestar de Medicare. Aumenta el acceso a la educación sobre la enfermedad renal y garantiza que los pacientes con Enfermedad Renal en Etapa Terminal (ESRD) menores de 65 años tengan acceso garantizado al seguro suplementario Medigap. Además, la legislación modifica los sistemas de pago de Medicare para apoyar terapias y medicamentos innovadores para pacientes en diálisis.\",\n  \"es_key_points\": [\n    \"La detección gratuita de la enfermedad renal crónica (ERC) se incluirá en las visitas anuales de bienestar de Medicare (a partir del 1 de enero de 2025).\",\n    \"Los pacientes con ESRD menores de 65 años obtendrán acceso garantizado al seguro suplementario Medigap (a partir del 1 de enero de 2026), lo que reducirá sus costos de bolsillo.\",\n    \"Se amplía el acceso a la Educación sobre la Enfermedad Renal (KDE), permitiendo que más profesionales e instalaciones de diálisis brinden estos servicios.\",\n    \"Introducción de pagos adicionales permanentes en Medicare para medicamentos y productos biológicos nuevos e innovadores utilizados en diálisis, para incentivar la innovación en el tratamiento.\",\n    \"Ordena estudios sobre los factores que afectan la progresión de la enfermedad renal y las tasas de trasplante, particularmente en poblaciones minoritarias.\"\n  ],\n  \"it_ai_title\": \"Legge sul Miglioramento della Malattia Renale: Screening, Innovazione e Accesso Medigap.\",\n  \"it_summary\": \"Questa legge mira a migliorare l'assistenza per gli individui con Malattia Renale Cronica (CKD) espandendo lo screening durante le visite annuali di benessere di Medicare. Aumenta l'accesso all'educazione sulla malattia renale e garantisce che i pazienti con Malattia Renale allo Stadio Terminale (ESRD) sotto i 65 anni abbiano accesso garantito all'assicurazione supplementare Medigap. Inoltre, la legislazione modifica i sistemi di pagamento Medicare per sostenere terapie e farmaci innovativi per i pazienti in dialisi.\",\n  \"it_key_points\": [\n    \"Lo screening gratuito per la malattia renale cronica (CKD) sarà incluso nelle visite annuali di benessere di Medicare (a partire dal 1° gennaio 2025).\",\n    \"I pazienti ESRD sotto i 65 anni otterranno l'accesso garantito all'assicurazione supplementare Medigap (a partire dal 1° gennaio 2026), riducendo i loro costi a carico.\",\n    \"L'accesso all'Educazione sulla Malattia Renale (KDE) è ampliato, consentendo a più professionisti e strutture di dialisi di fornire questi servizi.\",\n    \"Introduzione di pagamenti aggiuntivi permanenti in Medicare per farmaci e prodotti biologici nuovi e innovativi utilizzati nella dialisi, per incentivare l'innovazione nel trattamento.\",\n    \"Dispone studi sui fattori che influenzano la progressione della malattia renale e i tassi di trapianto, in particolare nelle popolazioni minoritarie.\"\n  ],\n  \"nl_ai_title\": \"Nierenzorgverbeteringswet: Screening, Innovatie en Medigap-toegang voor ESRD-patiënten.\",\n  \"nl_summary\": \"Deze wet is bedoeld om de zorg voor personen met chronische nierziekte (CKD) te verbeteren door screening uit te breiden binnen de jaarlijkse Medicare-welzijnsbezoeken. Het vergroot de toegang tot nierziekte-educatie en zorgt ervoor dat patiënten met terminale nierziekte (ESRD) onder de 65 jaar gegarandeerde toegang krijgen tot de aanvullende Medigap-verzekering. Bovendien wijzigt de wet de Medicare-betalingssystemen om innovatieve therapieën en medicijnen voor dialysepatiënten te ondersteunen.\",\n  \"nl_key_points\": [\n    \"Gratis screening op chronische nierziekte (CKD) wordt opgenomen in de jaarlijkse Medicare-welzijnsbezoeken (vanaf 1 januari 2025).\",\n    \"ESRD-patiënten onder de 65 jaar krijgen gegarandeerde toegang tot de aanvullende Medigap-verzekering (vanaf 1 januari 2026), wat hun eigen kosten verlaagt.\",\n    \"De toegang tot nierziekte-educatie (KDE) wordt uitgebreid, waardoor meer professionals en dialysefaciliteiten deze diensten kunnen aanbieden.\",\n    \"Introductie van permanente toeslagen in Medicare voor nieuwe, innovatieve medicijnen en biologische producten die bij dialyse worden gebruikt, om innovatie in de behandeling te stimuleren.\",\n    \"Opdracht tot studies naar factoren die de progressie van nierziekte en transplantatiesnelheden beïnvloeden, met name binnen minderheidsgroepen.\"\n  ],\n  \"pt_ai_title\": \"Lei de Melhoria da Doença Renal: Rastreio, Inovação e Acesso ao Medigap.\",\n  \"pt_summary\": \"Esta Lei visa melhorar os cuidados para indivíduos com Doença Renal Crónica (DRC), expandindo o rastreio nas visitas anuais de bem-estar do Medicare. Aumenta o acesso à educação sobre doenças renais e garante que os pacientes com Doença Renal em Estágio Terminal (ESRD) com menos de 65 anos tenham acesso garantido ao seguro suplementar Medigap. Além disso, a legislação modifica os sistemas de pagamento do Medicare para apoiar terapias e medicamentos inovadores para pacientes em diálise.\",\n  \"pt_key_points\": [\n    \"O rastreio gratuito da doença renal crónica (DRC) será incluído nas visitas anuais de bem-estar do Medicare (a partir de 1 de janeiro de 2025).\",\n    \"Pacientes com ESRD com menos de 65 anos terão acesso garantido ao seguro suplementar Medigap (a partir de 1 de janeiro de 2026), reduzindo os seus custos diretos.\",\n    \"O acesso à Educação sobre Doença Renal (KDE) é expandido, permitindo que mais profissionais e instalações de diálise forneçam esses serviços.\",\n    \"Introdução de pagamentos adicionais permanentes no Medicare para medicamentos e produtos biológicos novos e inovadores usados em diálise, para incentivar a inovação no tratamento.\",\n    \"Determina a realização de estudos sobre fatores que afetam a progressão da doença renal e as taxas de transplante, particularmente em populações minoritárias.\"\n  ],\n  \"category\": [\n    \"Health\",\n    \"Benefits\"\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\": \"Poprawa opieki nad nerkami: badania, edukacja i dostęp do ubezpieczenia Medigap\",\n  \"pl_summary\": \"Ustawa ma na celu poprawę opieki nad osobami z przewlekłą chorobą nerek (CKD) poprzez włączenie badań przesiewowych do rocznych wizyt Medicare. Zwiększa dostęp do edukacji na temat choroby nerek i zapewnia, że pacjenci z krańcową niewydolnością nerek (ESRD) poniżej 65. roku życia będą mieli gwarantowany dostęp do ubezpieczenia uzupełniającego Medigap. Ponadto, ustawa wprowadza zmiany w systemie płatności Medicare, aby wspierać innowacyjne terapie i leki dla pacjentów dializowanych.\",\n  \"pl_key_points\": [\n    \"Badania przesiewowe w kierunku przewlekłej choroby nerek (CKD) zostaną włączone do corocznych wizyt kontrolnych w ramach programu Medicare (od 1 stycznia 2025 r.).\",\n    \"Pacjenci z krańcową niewydolnością nerek (ESRD) poniżej 65. roku życia uzyskają gwarantowany dostęp do ubezpieczenia uzupełniającego Medigap (od 1 stycznia 2026 r.).\",\n    \"Rozszerzenie dostępu do edukacji na temat choroby nerek (KDE) – usługi te będą mogły być świadczone przez większą liczbę specjalistów i placówek dializacyjnych.\",\n    \"Wprowadzenie stałych dodatkowych płatności w Medicare za nowe leki i produkty biologiczne stosowane w dializach, które wcześniej otrzymały przejściową korektę płatności.\",\n    \"Nakaz przeprowadzenia badań nad czynnikami wpływającymi na postęp choroby nerek i transplantacje, zwłaszcza w populacjach mniejszościowych.\"\n  ],\n  \"eng_ai_title\": \"Kidney Care Improvement Act: Screening, Innovation, and Medigap Access for ESRD Patients\",\n  \"eng_summary\": \"This Act aims to enhance care for individuals with Chronic Kidney Disease (CKD) by including screening within Medicare's annual wellness visits. It increases access to kidney disease education and ensures that End-Stage Renal Disease (ESRD) patients under 65 are guaranteed access to Medigap supplemental insurance. Furthermore, the legislation modifies Medicare payment systems to support innovative therapies and drugs for dialysis patients.\",\n  \"eng_key_points\": [\n    \"Chronic kidney disease (CKD) screening will be included in Medicare's annual wellness visits (effective January 1, 2025).\",\n    \"ESRD patients under 65 will gain guaranteed access to Medigap supplemental insurance (effective January 1, 2026).\",\n    \"Access to Kidney Disease Education (KDE) is expanded, allowing more professionals and dialysis facilities to provide these services.\",\n    \"Introduction of permanent add-on payments in Medicare for new drugs and biological products used in dialysis that previously received a transitional payment adjustment.\",\n    \"Mandates studies on factors affecting kidney disease progression and transplantation rates, particularly within minority populations.\"\n  ],\n  \"de_ai_title\": \"Nierenpflege-Verbesserungsgesetz: Screening, Innovation und Medigap für ESRD-Patienten\",\n  \"de_summary\": \"Dieses Gesetz zielt darauf ab, die Versorgung von Personen mit chronischer Nierenerkrankung (CKD) zu verbessern, indem es das Screening in die jährlichen Medicare-Vorsorgeuntersuchungen aufnimmt. Es verbessert den Zugang zu Aufklärung über Nierenerkrankungen und stellt sicher, dass Patienten mit terminaler Niereninsuffizienz (ESRD) unter 65 Jahren garantierten Zugang zur Medigap-Zusatzversicherung erhalten. Darüber hinaus ändert das Gesetz die Medicare-Zahlungssysteme, um innovative Therapien und Medikamente für Dialysepatienten zu unterstützen.\",\n  \"de_key_points\": [\n    \"Screening auf chronische Nierenerkrankungen (CKD) wird in die jährlichen Medicare-Vorsorgeuntersuchungen aufgenommen (wirksam ab 1. Januar 2025).\",\n    \"ESRD-Patienten unter 65 Jahren erhalten garantierten Zugang zur Medigap-Zusatzversicherung (wirksam ab 1. Januar 2026).\",\n    \"Der Zugang zur Aufklärung über Nierenerkrankungen (KDE) wird erweitert, sodass mehr Fachkräfte und Dialyseeinrichtungen diese Dienste anbieten können.\",\n    \"Einführung dauerhafter Zusatzzahlungen in Medicare für neue Medikamente und biologische Produkte, die bei der Dialyse verwendet werden und zuvor eine vorübergehende Zahlungsanpassung erhalten haben.\",\n    \"Anordnung von Studien zu Faktoren, die das Fortschreiten von Nierenerkrankungen und die Transplantationsraten beeinflussen, insbesondere in Minderheitenpopulationen.\"\n  ],\n  \"fr_ai_title\": \"Loi sur l'amélioration des soins rénaux: dépistage, innovation et accès Medigap\",\n  \"fr_summary\": \"Cette loi vise à améliorer les soins pour les personnes atteintes de maladie rénale chronique (MRC) en incluant le dépistage dans les visites de bien-être annuelles de Medicare. Elle augmente l'accès à l'éducation sur les maladies rénales et garantit que les patients atteints d'insuffisance rénale terminale (IRT) de moins de 65 ans aient un accès garanti à l'assurance complémentaire Medigap. De plus, la législation modifie les systèmes de paiement de Medicare pour soutenir les thérapies et médicaments innovants pour les patients dialysés.\",\n  \"fr_key_points\": [\n    \"Le dépistage de la maladie rénale chronique (MRC) sera inclus dans les visites de bien-être annuelles de Medicare (à compter du 1er janvier 2025).\",\n    \"Les patients IRT de moins de 65 ans obtiendront un accès garanti à l'assurance complémentaire Medigap (à compter du 1er janvier 2026).\",\n    \"L'accès à l'éducation sur les maladies rénales (KDE) est élargi, permettant à davantage de professionnels et d'établissements de dialyse de fournir ces services.\",\n    \"Introduction de paiements supplémentaires permanents dans Medicare pour les nouveaux médicaments et produits biologiques utilisés en dialyse ayant précédemment reçu un ajustement de paiement transitoire.\",\n    \"Ordonne des études sur les facteurs affectant la progression de la maladie rénale et les taux de transplantation, en particulier au sein des populations minoritaires.\"\n  ],\n  \"es_ai_title\": \"Ley de Mejora de la Enfermedad Renal: Detección, Innovación y Acceso a Medigap\",\n  \"es_summary\": \"Esta Ley busca mejorar la atención a las personas con Enfermedad Renal Crónica (ERC) incluyendo la detección en las visitas anuales de bienestar de Medicare. Aumenta el acceso a la educación sobre la enfermedad renal y garantiza que los pacientes con Enfermedad Renal en Etapa Terminal (ESRD) menores de 65 años tengan acceso garantizado al seguro suplementario Medigap. Además, la legislación modifica los sistemas de pago de Medicare para apoyar terapias y medicamentos innovadores para pacientes en diálisis.\",\n  \"es_key_points\": [\n    \"La detección de la enfermedad renal crónica (ERC) se incluirá en las visitas anuales de bienestar de Medicare (a partir del 1 de enero de 2025).\",\n    \"Los pacientes con ESRD menores de 65 años obtendrán acceso garantizado al seguro suplementario Medigap (a partir del 1 de enero de 2026).\",\n    \"Se amplía el acceso a la Educación sobre la Enfermedad Renal (KDE), permitiendo que más profesionales e instalaciones de diálisis brinden estos servicios.\",\n    \"Introducción de pagos adicionales permanentes en Medicare para nuevos medicamentos y productos biológicos utilizados en diálisis que previamente recibieron un ajuste de pago transitorio.\",\n    \"Ordena estudios sobre los factores que afectan la progresión de la enfermedad renal y las tasas de trasplante, particularmente en poblaciones minoritarias.\"\n  ],\n  \"it_ai_title\": \"Legge sul Miglioramento della Malattia Renale: Screening, Innovazione e Accesso Medigap\",\n  \"it_summary\": \"Questa legge mira a migliorare l'assistenza per gli individui con Malattia Renale Cronica (CKD) includendo lo screening nelle visite annuali di benessere di Medicare. Aumenta l'accesso all'educazione sulla malattia renale e garantisce che i pazienti con Malattia Renale allo Stadio Terminale (ESRD) sotto i 65 anni abbiano accesso garantito all'assicurazione supplementare Medigap. Inoltre, la legislazione modifica i sistemi di pagamento Medicare per sostenere terapie e farmaci innovativi per i pazienti in dialisi.\",\n  \"it_key_points\": [\n    \"Lo screening per la malattia renale cronica (CKD) sarà incluso nelle visite annuali di benessere di Medicare (a partire dal 1° gennaio 2025).\",\n    \"I pazienti ESRD sotto i 65 anni otterranno l'accesso garantito all'assicurazione supplementare Medigap (a partire dal 1° gennaio 2026).\",\n    \"L'accesso all'Educazione sulla Malattia Renale (KDE) è ampliato, consentendo a più professionisti e strutture di dialisi di fornire questi servizi.\",\n    \"Introduzione di pagamenti aggiuntivi permanenti in Medicare per nuovi farmaci e prodotti biologici utilizzati nella dialisi che hanno precedentemente ricevuto un adeguamento transitorio del pagamento.\",\n    \"Dispone studi sui fattori che influenzano la progressione della malattia renale e i tassi di trapianto, in particolare nelle popolazioni minoritarie.\"\n  ],\n  \"nl_ai_title\": \"Nierenzorgverbeteringswet: Screening, Innovatie en Medigap-toegang voor ESRD-patiënten\",\n  \"nl_summary\": \"Deze wet is bedoeld om de zorg voor personen met chronische nierziekte (CKD) te verbeteren door screening op te nemen in de jaarlijkse Medicare-welzijnsbezoeken. Het vergroot de toegang tot nierziekte-educatie en zorgt ervoor dat patiënten met terminale nierziekte (ESRD) onder de 65 jaar gegarandeerde toegang krijgen tot de aanvullende Medigap-verzekering. Bovendien wijzigt de wet de Medicare-betalingssystemen om innovatieve therapieën en medicijnen voor dialysepatiënten te ondersteunen.\",\n  \"nl_key_points\": [\n    \"Screening op chronische nierziekte (CKD) wordt opgenomen in de jaarlijkse Medicare-welzijnsbezoeken (vanaf 1 januari 2025).\",\n    \"ESRD-patiënten onder de 65 jaar krijgen gegarandeerde toegang tot de aanvullende Medigap-verzekering (vanaf 1 januari 2026).\",\n    \"De toegang tot nierziekte-educatie (KDE) wordt uitgebreid, waardoor meer professionals en dialysefaciliteiten deze diensten kunnen aanbieden.\",\n    \"Introductie van permanente toeslagen in Medicare voor nieuwe medicijnen en biologische producten die bij dialyse worden gebruikt en die eerder een tijdelijke betalingsaanpassing ontvingen.\",\n    \"Opdracht tot studies naar factoren die de progressie van nierziekte en transplantatiesnelheden beïnvloeden, met name binnen minderheidsgroepen.\"\n  ],\n  \"pt_ai_title\": \"Lei de Melhoria da Doença Renal: Rastreio, Inovação e Acesso ao Medigap\",\n  \"pt_summary\": \"Esta Lei visa melhorar os cuidados para indivíduos com Doença Renal Crónica (DRC), incluindo o rastreio nas visitas anuais de bem-estar do Medicare. Aumenta o acesso à educação sobre doenças renais e garante que os pacientes com Doença Renal em Estágio Terminal (ESRD) com menos de 65 anos tenham acesso garantido ao seguro suplementar Medigap. Além disso, a legislação modifica os sistemas de pagamento do Medicare para apoiar terapias e medicamentos inovadores para pacientes em diálise.\",\n  \"pt_key_points\": [\n    \"O rastreio da doença renal crónica (DRC) será incluído nas visitas anuais de bem-estar do Medicare (a partir de 1 de janeiro de 2025).\",\n    \"Pacientes com ESRD com menos de 65 anos terão acesso garantido ao seguro suplementar Medigap (a partir de 1 de janeiro de 2026).\",\n    \"O acesso à Educação sobre Doença Renal (KDE) é expandido, permitindo que mais profissionais e instalações de diálise forneçam esses serviços.\",\n    \"Introdução de pagamentos adicionais permanentes no Medicare para novos medicamentos e produtos biológicos usados em diálise que receberam anteriormente um ajuste de pagamento transitório.\",\n    \"Determina a realização de estudos sobre fatores que afetam a progressão da doença renal e as taxas de transplante, particularmente em populações minoritárias.\"\n  ],\n  \"category\": [\n    \"Health\",\n    \"Benefits\"\n  ]\n}"
    },
    {
      "timestamp": "2025-12-30T22:23:03.984Z",
      "source_url": "https://www.congress.gov/118/bills/s4469/BILLS-118s4469is.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 S4469 IS: Chronic Kidney Disease Improvement in Research and Treatment Act of 2024 U.S. Senate 2024-06-05 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. 4469IN THE SENATE OF THE UNITED STATESJune 5, 2024Mr. Cardin (for himself and Mrs. Blackburn) introduced the following bill; which was read twice and referred to the Committee on FinanceA BILLTo improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes.1.Short title; table of contents(a)Short titleThis Act may be cited as the Chronic Kidney Disease Improvement in Research and Treatment Act of 2024.(b)Table of contentsThe table of contents for this Act is as follows:Sec. 1. Short title; table of contents.TITLE I—Preventing kidney disease by expanding education and awarenessSec. 101. Expanding Medicare annual wellness benefit to include kidney disease screening.Sec. 102. Increasing access to Medicare kidney disease education benefit.Sec. 103. Understanding the progression of kidney disease and treatment of kidney failure in minority populations.TITLE II—Incentivizing kidney care innovationSec. 201. Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies.Sec. 202. Ensuring Medicare Advantage supports kidney care innovative therapies.Sec. 203. Improving patient lives and quality of care through research and innovation.TITLE III—Addressing the kidney care workforce crisis.Sec. 301. Improving patient decision making and transparency by consolidating and modernizing quality programs.Sec. 302. Ensuring accuracy and stability in kidney care payment.TITLE IV—Expanding patient choice of coverageSec. 401. Medigap coverage for beneficiaries with end-stage renal disease.IPreventing kidney disease by expanding education and awareness101.Expanding Medicare annual wellness benefit to include kidney disease screening(a)In generalSection 1861(ww)(2) of the Social Security Act (42 U.S.C. 1395x(ww)(2)) is amended—(1)by moving subparagraph (N) 2 ems to the left;(2)by redesignating subparagraph (O) as subparagraph (P); and(3)by inserting after subparagraph (N) the following new subparagraph:(O)Chronic kidney disease screening as defined by the Secretary..(b)Effective dateThe amendments made by this section apply to items and services furnished on or after January 1, 2025.102.Increasing access to Medicare kidney disease education benefit(a)In generalSection 1861(ggg) of the Social Security Act (42 U.S.C. 1395x(ggg)) is amended—(1)in paragraph (1)—(A)in subparagraph (A), by inserting or stage V after stage IV; and(B)in subparagraph (B), by inserting or of a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5)) assisting in the treatment of the individual's kidney condition after kidney condition; and(2)in paragraph (2)—(A)by striking subparagraph (B); and(B)in subparagraph (A)—(i)by striking (A) after (2);(ii)by striking and at the end of clause (i);(iii)by striking the period at the end of clause (ii) and inserting ; and;(iv)by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and indenting appropriately; and(v)by adding at the end the following:(C)a renal dialysis facility subject to the requirements of section 1881(b)(1) with personnel who—(i)provide the services described in paragraph (1); and(ii)is a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in subsection (aa)(5))..(b)Payment to renal dialysis facilitiesSection 1881(b) of the Social Security Act (42 U.S.C. 1395rr(b)) is amended by adding at the end the following new paragraph:(15)For purposes of paragraph (14), the single payment for renal dialysis services under such paragraph shall not take into account the amount of payment for kidney disease education services (as defined in section 1861(ggg)). Instead, payment for such services shall be made to the renal dialysis facility on an assignment-related basis under section 1848..(c)Effective dateThe amendments made by this section apply to kidney disease education services furnished on or after January 1, 2025.103.Understanding the progression of kidney disease and treatment of kidney failure in minority populations(a)StudyThe Secretary of Health and Human Services (in this section referred to as the Secretary) shall conduct a study on—(1)the social, behavioral, and biological factors associated with kidney disease onset and progression;(2)efforts to slow the progression of kidney disease in minority populations that are disproportionately affected by such disease; and(3)treatment patterns associated with providing care, under the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, and through private health insurance, to minority populations that are disproportionately affected by kidney disease.(b)ReportNot later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the study conducted under subsection (a), together with such recommendations as the Secretary determines to be appropriate.IIIncentivizing kidney care innovation201.Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies(a)In generalSection 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) is amended by adding at the end the following new subparagraph:(J)Payment for new and innovative drugs, biologicals, and devices that are renal dialysis services(i)In generalFor any new renal dialysis drug or biological product that is used to treat or manage a condition for which there is a functional category as defined in section 413.234(a) of title 42, Code of Federal Regulations that received a transitional drug add-on adjustment (referred to in this subparagraph as TDAPA) under section 413.234(c)(2) of such title, and was furnished on or after January 1, 2024, the Secretary shall establish a permanent add-on adjustment to the base rate for claims submitted on or after January 1, 2025, that includes the administration of such drugs or biologicals.(ii)Calculation of the Post-TDAPA Add-on adjustmentIn calculating the add-on adjustment described in clause (i), the Secretary shall—(I)base the calculation on— (aa)except as provided in items (bb) and (cc), the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of average sales price data for such drug or product;(bb)if the most recent available full calendar quarter of average sales price data reflects 0 or negative sales, 100 percent of the wholesale acquisition cost (as defined in section 1847A(c)(6)) of such drug or product; or(cc)if the wholesale acquisition cost is not available, the drug manufacturer's invoice;(II)calculate the post-TDAPA add-on payment adjustment as the expenditures for the new renal dialysis drug or biological product divided by the total number of renal dialysis services during which such drug or biological was administered during the same period;(III)set the amount of the add-on adjustment as an amount equal to 65 percent of the amount calculated under subclause (II);(IV)update the add-on adjustment annually to account for inflationary changes; and(V)apply the add-on adjustment amount immediately upon the expiration of the TDAPA period and availability of the post-TDAPA add-on adjustment.(iii)ImplementationThis subparagraph shall not be implemented in a budget neutral manner and shall not be adjusted by any applicable patient-level case-mix adjustments described in section 413.235 of title 42, Code of Federal Regulations (or any successor regulation)..(b)Extension of transitional drug add-On adjustment under the drug designation policyThe Secretary shall pay the transitional drug add-on adjustment under paragraph (c) of section 413.234 of title 42, Code of Federal Regulations (or a successor regulation) for a total of 3 years for any new renal dialysis drug or biological product that—(1)is used to treat or manage a condition for which there is a functional category as defined in paragraph (a) of such section;(2)qualifies for such adjustment under paragraph (c)(2) of such section; and(3)is furnished on or after January 1, 2024.(c)New devices and other technologies(1)In generalAs part of the promulgation of the annual rule for the Medicare end-stage renal disease prospective payment system under section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) for calendar year 2026, and in consultation with stakeholders, the Secretary of Health and Human Services (referred to in this subsection as the Secretary) shall— (A)ensure that the single payment amount is adequate to cover the cost of any new innovative device or other technology with substantial clinical improvement; and (B)increase the single payment amount if the Secretary determines such payment amount is not adequate to cover such cost. (2)Cost and utilization dataIn carrying out paragraph (1), the Secretary shall use the cost and utilization data collected during a 3-year transitional payment period, as described in the final regulation published on November 9, 2020 (85 Fed. Reg. 71398).202.Ensuring Medicare Advantage supports kidney care innovative therapiesSection 1853(c) of the Social Security Act (42 U.S.C. 1395w–23(c)) is amended by adding at the end the following new paragraph:(8)Treatment of innovative products for enrollees with end stage renal disease(A)In generalThe Secretary shall make direct payment adjustments to providers of services or renal dialysis facilities for—(i)any new renal dialysis drug or biological product that receives a transitional drug add-on adjustment under section 413.234(c) of title 42, Code of Federal Regulations; or (ii)an item or service that receives a transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of such title.(B)Amount of direct paymentThe amount of the adjustment shall equal the amount determined under the end stage renal disease prospective payment system described in section 1881(b)(14).(C)Duration of direct paymentThe Secretary shall make payments under subparagraph (A) for the duration of the transitional payment under the end stage renal disease prospective payment system described in such section..203.Improving patient lives and quality of care through research and innovation(a)StudyThe Secretary of Health and Human Services (referred to in this section as the Secretary) shall conduct a study on increasing kidney transplantation rates. Such study shall include an analysis of each of the following:(1)Any disincentives in the payment systems under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) that create barriers to kidney transplants and post-transplant care for beneficiaries with end-stage renal disease.(2)The practices used by donation service areas with higher than average donation rates and whether those practices and policies could be successfully utilized in other donation service areas.(3)Practices and policies that could increase donation rates among minority populations.(4)Whether cultural and policy barriers exist to increasing living donation rates, including an examination of how to better facilitate kidney paired donations.(5)Criteria for transplant recipients for referral and for getting on the waitlist to receive a kidney.(6)Other areas determined appropriate by the Secretary.(b)ReportNot later than 18 months after the date of enactment of this Act, the Secretary shall submit to Congress a report on the study conducted pursuant to subsection (a), together with such recommendations as the Secretary determines to be appropriate.IIIIncreasing patient access to quality performance by improving the accuracy and transparency of end-stage renal disease quality programs301.Improving patient decision making and transparency by consolidating and modernizing quality programs(a)MeasuresSection 1881(h)(2) of the Social Security Act (42 U.S.C. 1395rr(h)(2)) is amended—(1)by striking subparagraph (A) and inserting the following:(A)The measures specified under this paragraph with respect to the year involved shall be selected by the Secretary in consultation with stakeholders to promote improvement in beneficiary outcomes and shared decision-making with beneficiaries and their caregivers. When selecting measures specified under this paragraph, the Secretary shall take into account clinical gaps in care, underutilization that may lead to beneficiary harm, patient safety, and outcomes.;(2)in subparagraph (B)(i), by striking subparagraph (A)(iv) and inserting subparagraph (A);(3)by striking subparagraph (E); and(4)by adding at the end the following new subparagraphs:(E)Weighting limitationNo single measure specified by the Secretary or individual measure within a composite measure so specified may be weighted less than 10 percent of the total performance score.(F)Statistically valid and reliableIn specifying measures under subparagraph (A), the Secretary shall only specify measures that have been shown to be statistically valid and reliable through testing..(b)EndorsementSection 1881(h)(2)(B)(ii) of the Social Security Act (42 U.S.C. 1395rr(h)(2)(B)(ii)) is amended by adding at the end the following new sentence: The exception under the preceding sentence shall not apply to a measure that the entity with a contract under section 1890(a) (or a similar entity) considered but failed to endorse..(e)Effective dateThe amendments made by this section shall apply to items and services furnished on or after January 1, 2025.IVEmpowering patients401.Medigap coverage for beneficiaries with end-stage renal disease(a)Guaranteed availability of Medigap policies to all ESRD Medicare beneficiaries(1)In generalSection 1882(s) of the Social Security Act (42 U.S.C. 1395ss(s)) is amended—(A)in paragraph (2)—(i)in subparagraph (A), by striking is 65 and all that follows through the period and inserting the following: “is—(i)65 years of age or older and is enrolled for benefits under part B; or(ii)entitled to benefits under 226A(b) and is enrolled for benefits under part B.; and(ii)in subparagraph (D), in the matter preceding clause (i), by inserting (or is entitled to benefits under 226A(b)) after is 65 years of age or older; and(B)in paragraph (3)(B)—(i)in clause (ii), by inserting (or is entitled to benefits under 226A(b)) after is 65 years of age or older; and(ii)in clause (vi), by inserting (or under 226A(b)) after at age 65.(2)Effective dateThe amendments made by paragraph (1) shall apply to Medicare supplemental policies effective on or after January 1, 2026.(b)Additional enrollment period for certain individuals(1)One-time enrollment period(A)In generalIn the case of an individual described in subparagraph (B), the Secretary of Health and Human Services shall establish a one-time enrollment period during which such an individual may enroll in any Medicare supplemental policy under section 1882 of the Social Security Act (42 U.S.C. 1395ss) of the individual's choosing.(B)Enrollment periodThe enrollment period established under subparagraph (A) shall begin on January 1, 2026, and shall end June 30, 2026.(2)Individual describedAn individual described in this paragraph is an individual who—(A)is entitled to hospital insurance benefits under part A of title XVIII of the Social Security Act under section 226A(b) of such Act (42 U.S.C. 426–1);(B)is enrolled for benefits under part B of such title XVIII; and(C)would not, but for the provisions of, and amendments made by, subsection (a) be eligible for the guaranteed issue of a Medicare supplemental policy under paragraph (2) or (3) of section 1882(s) of such Act (42 U.S.C. 1395ss(s)).\n\nSUMMARY TO EVALUATE:\nTitle: Kidney Care Improvement Act: Screening, Innovation, and Medigap Access for ESRD Patients.\nSummary: This Act aims to enhance care for individuals with Chronic Kidney Disease (CKD) by expanding screening within Medicare's annual wellness visits. It increases access to kidney disease education and ensures that End-Stage Renal Disease (ESRD) patients under 65 are guaranteed access to Medigap supplemental insurance. Furthermore, the legislation modifies Medicare payment systems to support innovative therapies and drugs for dialysis patients.\nKey Points: Free chronic kidney disease (CKD) screening will be included in Medicare's annual wellness visits (effective January 1, 2025)., ESRD patients under 65 will gain guaranteed access to Medigap supplemental insurance (effective January 1, 2026), reducing their out-of-pocket costs., Access to Kidney Disease Education (KDE) is expanded, allowing more professionals and dialysis facilities to provide these services., Introduction of permanent add-on payments in Medicare for new, innovative drugs and biological products used in dialysis to incentivize treatment innovation., Mandates studies on factors affecting kidney disease progression and transplantation rates, particularly within minority populations.\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": "2025-12-30T15:54:30.430Z",
      "source_url": "https://www.congress.gov/118/bills/s4469/BILLS-118s4469is.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 S4469 IS: Chronic Kidney Disease Improvement in Research and Treatment Act of 2024 U.S. Senate 2024-06-05 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. 4469IN THE SENATE OF THE UNITED STATESJune 5, 2024Mr. Cardin (for himself and Mrs. Blackburn) introduced the following bill; which was read twice and referred to the Committee on FinanceA BILLTo improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes.1.Short title; table of contents(a)Short titleThis Act may be cited as the Chronic Kidney Disease Improvement in Research and Treatment Act of 2024.(b)Table of contentsThe table of contents for this Act is as follows:Sec. 1. Short title; table of contents.TITLE I—Preventing kidney disease by expanding education and awarenessSec. 101. Expanding Medicare annual wellness benefit to include kidney disease screening.Sec. 102. Increasing access to Medicare kidney disease education benefit.Sec. 103. Understanding the progression of kidney disease and treatment of kidney failure in minority populations.TITLE II—Incentivizing kidney care innovationSec. 201. Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies.Sec. 202. Ensuring Medicare Advantage supports kidney care innovative therapies.Sec. 203. Improving patient lives and quality of care through research and innovation.TITLE III—Addressing the kidney care workforce crisis.Sec. 301. Improving patient decision making and transparency by consolidating and modernizing quality programs.Sec. 302. Ensuring accuracy and stability in kidney care payment.TITLE IV—Expanding patient choice of coverageSec. 401. Medigap coverage for beneficiaries with end-stage renal disease.IPreventing kidney disease by expanding education and awareness101.Expanding Medicare annual wellness benefit to include kidney disease screening(a)In generalSection 1861(ww)(2) of the Social Security Act (42 U.S.C. 1395x(ww)(2)) is amended—(1)by moving subparagraph (N) 2 ems to the left;(2)by redesignating subparagraph (O) as subparagraph (P); and(3)by inserting after subparagraph (N) the following new subparagraph:(O)Chronic kidney disease screening as defined by the Secretary..(b)Effective dateThe amendments made by this section apply to items and services furnished on or after January 1, 2025.102.Increasing access to Medicare kidney disease education benefit(a)In generalSection 1861(ggg) of the Social Security Act (42 U.S.C. 1395x(ggg)) is amended—(1)in paragraph (1)—(A)in subparagraph (A), by inserting or stage V after stage IV; and(B)in subparagraph (B), by inserting or of a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5)) assisting in the treatment of the individual's kidney condition after kidney condition; and(2)in paragraph (2)—(A)by striking subparagraph (B); and(B)in subparagraph (A)—(i)by striking (A) after (2);(ii)by striking and at the end of clause (i);(iii)by striking the period at the end of clause (ii) and inserting ; and;(iv)by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and indenting appropriately; and(v)by adding at the end the following:(C)a renal dialysis facility subject to the requirements of section 1881(b)(1) with personnel who—(i)provide the services described in paragraph (1); and(ii)is a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in subsection (aa)(5))..(b)Payment to renal dialysis facilitiesSection 1881(b) of the Social Security Act (42 U.S.C. 1395rr(b)) is amended by adding at the end the following new paragraph:(15)For purposes of paragraph (14), the single payment for renal dialysis services under such paragraph shall not take into account the amount of payment for kidney disease education services (as defined in section 1861(ggg)). Instead, payment for such services shall be made to the renal dialysis facility on an assignment-related basis under section 1848..(c)Effective dateThe amendments made by this section apply to kidney disease education services furnished on or after January 1, 2025.103.Understanding the progression of kidney disease and treatment of kidney failure in minority populations(a)StudyThe Secretary of Health and Human Services (in this section referred to as the Secretary) shall conduct a study on—(1)the social, behavioral, and biological factors associated with kidney disease onset and progression;(2)efforts to slow the progression of kidney disease in minority populations that are disproportionately affected by such disease; and(3)treatment patterns associated with providing care, under the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, and through private health insurance, to minority populations that are disproportionately affected by kidney disease.(b)ReportNot later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the study conducted under subsection (a), together with such recommendations as the Secretary determines to be appropriate.IIIncentivizing kidney care innovation201.Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies(a)In generalSection 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) is amended by adding at the end the following new subparagraph:(J)Payment for new and innovative drugs, biologicals, and devices that are renal dialysis services(i)In generalFor any new renal dialysis drug or biological product that is used to treat or manage a condition for which there is a functional category as defined in section 413.234(a) of title 42, Code of Federal Regulations that received a transitional drug add-on adjustment (referred to in this subparagraph as TDAPA) under section 413.234(c)(2) of such title, and was furnished on or after January 1, 2024, the Secretary shall establish a permanent add-on adjustment to the base rate for claims submitted on or after January 1, 2025, that includes the administration of such drugs or biologicals.(ii)Calculation of the Post-TDAPA Add-on adjustmentIn calculating the add-on adjustment described in clause (i), the Secretary shall—(I)base the calculation on— (aa)except as provided in items (bb) and (cc), the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of average sales price data for such drug or product;(bb)if the most recent available full calendar quarter of average sales price data reflects 0 or negative sales, 100 percent of the wholesale acquisition cost (as defined in section 1847A(c)(6)) of such drug or product; or(cc)if the wholesale acquisition cost is not available, the drug manufacturer's invoice;(II)calculate the post-TDAPA add-on payment adjustment as the expenditures for the new renal dialysis drug or biological product divided by the total number of renal dialysis services during which such drug or biological was administered during the same period;(III)set the amount of the add-on adjustment as an amount equal to 65 percent of the amount calculated under subclause (II);(IV)update the add-on adjustment annually to account for inflationary changes; and(V)apply the add-on adjustment amount immediately upon the expiration of the TDAPA period and availability of the post-TDAPA add-on adjustment.(iii)ImplementationThis subparagraph shall not be implemented in a budget neutral manner and shall not be adjusted by any applicable patient-level case-mix adjustments described in section 413.235 of title 42, Code of Federal Regulations (or any successor regulation)..(b)Extension of transitional drug add-On adjustment under the drug designation policyThe Secretary shall pay the transitional drug add-on adjustment under paragraph (c) of section 413.234 of title 42, Code of Federal Regulations (or a successor regulation) for a total of 3 years for any new renal dialysis drug or biological product that—(1)is used to treat or manage a condition for which there is a functional category as defined in paragraph (a) of such section;(2)qualifies for such adjustment under paragraph (c)(2) of such section; and(3)is furnished on or after January 1, 2024.(c)New devices and other technologies(1)In generalAs part of the promulgation of the annual rule for the Medicare end-stage renal disease prospective payment system under section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) for calendar year 2026, and in consultation with stakeholders, the Secretary of Health and Human Services (referred to in this subsection as the Secretary) shall— (A)ensure that the single payment amount is adequate to cover the cost of any new innovative device or other technology with substantial clinical improvement; and (B)increase the single payment amount if the Secretary determines such payment amount is not adequate to cover such cost. (2)Cost and utilization dataIn carrying out paragraph (1), the Secretary shall use the cost and utilization data collected during a 3-year transitional payment period, as described in the final regulation published on November 9, 2020 (85 Fed. Reg. 71398).202.Ensuring Medicare Advantage supports kidney care innovative therapiesSection 1853(c) of the Social Security Act (42 U.S.C. 1395w–23(c)) is amended by adding at the end the following new paragraph:(8)Treatment of innovative products for enrollees with end stage renal disease(A)In generalThe Secretary shall make direct payment adjustments to providers of services or renal dialysis facilities for—(i)any new renal dialysis drug or biological product that receives a transitional drug add-on adjustment under section 413.234(c) of title 42, Code of Federal Regulations; or (ii)an item or service that receives a transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of such title.(B)Amount of direct paymentThe amount of the adjustment shall equal the amount determined under the end stage renal disease prospective payment system described in section 1881(b)(14).(C)Duration of direct paymentThe Secretary shall make payments under subparagraph (A) for the duration of the transitional payment under the end stage renal disease prospective payment system described in such section..203.Improving patient lives and quality of care through research and innovation(a)StudyThe Secretary of Health and Human Services (referred to in this section as the Secretary) shall conduct a study on increasing kidney transplantation rates. Such study shall include an analysis of each of the following:(1)Any disincentives in the payment systems under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) that create barriers to kidney transplants and post-transplant care for beneficiaries with end-stage renal disease.(2)The practices used by donation service areas with higher than average donation rates and whether those practices and policies could be successfully utilized in other donation service areas.(3)Practices and policies that could increase donation rates among minority populations.(4)Whether cultural and policy barriers exist to increasing living donation rates, including an examination of how to better facilitate kidney paired donations.(5)Criteria for transplant recipients for referral and for getting on the waitlist to receive a kidney.(6)Other areas determined appropriate by the Secretary.(b)ReportNot later than 18 months after the date of enactment of this Act, the Secretary shall submit to Congress a report on the study conducted pursuant to subsection (a), together with such recommendations as the Secretary determines to be appropriate.IIIIncreasing patient access to quality performance by improving the accuracy and transparency of end-stage renal disease quality programs301.Improving patient decision making and transparency by consolidating and modernizing quality programs(a)MeasuresSection 1881(h)(2) of the Social Security Act (42 U.S.C. 1395rr(h)(2)) is amended—(1)by striking subparagraph (A) and inserting the following:(A)The measures specified under this paragraph with respect to the year involved shall be selected by the Secretary in consultation with stakeholders to promote improvement in beneficiary outcomes and shared decision-making with beneficiaries and their caregivers. When selecting measures specified under this paragraph, the Secretary shall take into account clinical gaps in care, underutilization that may lead to beneficiary harm, patient safety, and outcomes.;(2)in subparagraph (B)(i), by striking subparagraph (A)(iv) and inserting subparagraph (A);(3)by striking subparagraph (E); and(4)by adding at the end the following new subparagraphs:(E)Weighting limitationNo single measure specified by the Secretary or individual measure within a composite measure so specified may be weighted less than 10 percent of the total performance score.(F)Statistically valid and reliableIn specifying measures under subparagraph (A), the Secretary shall only specify measures that have been shown to be statistically valid and reliable through testing..(b)EndorsementSection 1881(h)(2)(B)(ii) of the Social Security Act (42 U.S.C. 1395rr(h)(2)(B)(ii)) is amended by adding at the end the following new sentence: The exception under the preceding sentence shall not apply to a measure that the entity with a contract under section 1890(a) (or a similar entity) considered but failed to endorse..(e)Effective dateThe amendments made by this section shall apply to items and services furnished on or after January 1, 2025.IVEmpowering patients401.Medigap coverage for beneficiaries with end-stage renal disease(a)Guaranteed availability of Medigap policies to all ESRD Medicare beneficiaries(1)In generalSection 1882(s) of the Social Security Act (42 U.S.C. 1395ss(s)) is amended—(A)in paragraph (2)—(i)in subparagraph (A), by striking is 65 and all that follows through the period and inserting the following: “is—(i)65 years of age or older and is enrolled for benefits under part B; or(ii)entitled to benefits under 226A(b) and is enrolled for benefits under part B.; and(ii)in subparagraph (D), in the matter preceding clause (i), by inserting (or is entitled to benefits under 226A(b)) after is 65 years of age or older; and(B)in paragraph (3)(B)—(i)in clause (ii), by inserting (or is entitled to benefits under 226A(b)) after is 65 years of age or older; and(ii)in clause (vi), by inserting (or under 226A(b)) after at age 65.(2)Effective dateThe amendments made by paragraph (1) shall apply to Medicare supplemental policies effective on or after January 1, 2026.(b)Additional enrollment period for certain individuals(1)One-time enrollment period(A)In generalIn the case of an individual described in subparagraph (B), the Secretary of Health and Human Services shall establish a one-time enrollment period during which such an individual may enroll in any Medicare supplemental policy under section 1882 of the Social Security Act (42 U.S.C. 1395ss) of the individual's choosing.(B)Enrollment periodThe enrollment period established under subparagraph (A) shall begin on January 1, 2026, and shall end June 30, 2026.(2)Individual describedAn individual described in this paragraph is an individual who—(A)is entitled to hospital insurance benefits under part A of title XVIII of the Social Security Act under section 226A(b) of such Act (42 U.S.C. 426–1);(B)is enrolled for benefits under part B of such title XVIII; and(C)would not, but for the provisions of, and amendments made by, subsection (a) be eligible for the guaranteed issue of a Medicare supplemental policy under paragraph (2) or (3) of section 1882(s) of such Act (42 U.S.C. 1395ss(s)).\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\": \"Poprawa opieki nad nerkami: badania, edukacja i dostęp do ubezpieczenia Medigap.\",\n  \"pl_summary\": \"Ustawa ma na celu poprawę opieki nad osobami z przewlekłą chorobą nerek (CKD) poprzez rozszerzenie badań przesiewowych w ramach rocznych wizyt Medicare. Zwiększa dostęp do edukacji na temat choroby nerek i zapewnia, że pacjenci z krańcową niewydolnością nerek (ESRD) poniżej 65. roku życia będą mieli gwarantowany dostęp do ubezpieczenia uzupełniającego Medigap. Ponadto, ustawa wprowadza zmiany w systemie płatności Medicare, aby wspierać innowacyjne terapie i leki dla pacjentów dializowanych.\",\n  \"pl_key_points\": [\n    \"Bezpłatne badania przesiewowe w kierunku przewlekłej choroby nerek (CKD) zostaną włączone do corocznych wizyt kontrolnych w ramach programu Medicare (od 1 stycznia 2025 r.).\",\n    \"Pacjenci z krańcową niewydolnością nerek (ESRD) poniżej 65. roku życia uzyskają gwarantowany dostęp do ubezpieczenia uzupełniającego Medigap (od 1 stycznia 2026 r.), co obniży ich koszty leczenia.\",\n    \"Rozszerzenie dostępu do edukacji na temat choroby nerek (KDE) – usługi te będą mogły być świadczone przez większą liczbę specjalistów i placówek dializacyjnych.\",\n    \"Wprowadzenie stałych dodatkowych płatności w Medicare za nowe, innowacyjne leki i produkty biologiczne stosowane w dializach, co ma zachęcać do innowacji w leczeniu.\",\n    \"Nakaz przeprowadzenia badań nad czynnikami wpływającymi na postęp choroby nerek i transplantacje, zwłaszcza w populacjach mniejszościowych.\"\n  ],\n  \"eng_ai_title\": \"Kidney Care Improvement Act: Screening, Innovation, and Medigap Access for ESRD Patients.\",\n  \"eng_summary\": \"This Act aims to enhance care for individuals with Chronic Kidney Disease (CKD) by expanding screening within Medicare's annual wellness visits. It increases access to kidney disease education and ensures that End-Stage Renal Disease (ESRD) patients under 65 are guaranteed access to Medigap supplemental insurance. Furthermore, the legislation modifies Medicare payment systems to support innovative therapies and drugs for dialysis patients.\",\n  \"eng_key_points\": [\n    \"Free chronic kidney disease (CKD) screening will be included in Medicare's annual wellness visits (effective January 1, 2025).\",\n    \"ESRD patients under 65 will gain guaranteed access to Medigap supplemental insurance (effective January 1, 2026), reducing their out-of-pocket costs.\",\n    \"Access to Kidney Disease Education (KDE) is expanded, allowing more professionals and dialysis facilities to provide these services.\",\n    \"Introduction of permanent add-on payments in Medicare for new, innovative drugs and biological products used in dialysis to incentivize treatment innovation.\",\n    \"Mandates studies on factors affecting kidney disease progression and transplantation rates, particularly within minority populations.\"\n  ],\n  \"de_ai_title\": \"Nierenpflege-Verbesserungsgesetz: Screening, Innovation und Medigap für ESRD-Patienten.\",\n  \"de_summary\": \"Dieses Gesetz zielt darauf ab, die Versorgung von Personen mit chronischer Nierenerkrankung (CKD) zu verbessern, indem es das Screening im Rahmen der jährlichen Medicare-Vorsorgeuntersuchungen erweitert. Es verbessert den Zugang zu Aufklärung über Nierenerkrankungen und stellt sicher, dass Patienten mit terminaler Niereninsuffizienz (ESRD) unter 65 Jahren garantierten Zugang zur Medigap-Zusatzversicherung erhalten. Darüber hinaus ändert das Gesetz die Medicare-Zahlungssysteme, um innovative Therapien und Medikamente für Dialysepatienten zu unterstützen.\",\n  \"de_key_points\": [\n    \"Kostenloses Screening auf chronische Nierenerkrankungen (CKD) wird in die jährlichen Medicare-Vorsorgeuntersuchungen aufgenommen (wirksam ab 1. Januar 2025).\",\n    \"ESRD-Patienten unter 65 Jahren erhalten garantierten Zugang zur Medigap-Zusatzversicherung (wirksam ab 1. Januar 2026), was ihre Behandlungskosten senkt.\",\n    \"Der Zugang zur Aufklärung über Nierenerkrankungen (KDE) wird erweitert, sodass mehr Fachkräfte und Dialyseeinrichtungen diese Dienste anbieten können.\",\n    \"Einführung dauerhafter Zusatzzahlungen in Medicare für neue, innovative Medikamente und biologische Produkte, die bei der Dialyse verwendet werden, um Innovationen in der Behandlung zu fördern.\",\n    \"Anordnung von Studien zu Faktoren, die das Fortschreiten von Nierenerkrankungen und die Transplantationsraten beeinflussen, insbesondere in Minderheitenpopulationen.\"\n  ],\n  \"fr_ai_title\": \"Loi sur l'amélioration des soins rénaux: dépistage, innovation et accès Medigap.\",\n  \"fr_summary\": \"Cette loi vise à améliorer les soins pour les personnes atteintes de maladie rénale chronique (MRC) en élargissant le dépistage lors des visites de bien-être annuelles de Medicare. Elle augmente l'accès à l'éducation sur les maladies rénales et garantit que les patients atteints d'insuffisance rénale terminale (IRT) de moins de 65 ans aient un accès garanti à l'assurance complémentaire Medigap. De plus, la législation modifie les systèmes de paiement de Medicare pour soutenir les thérapies et médicaments innovants pour les patients dialysés.\",\n  \"fr_key_points\": [\n    \"Le dépistage gratuit de la maladie rénale chronique (MRC) sera inclus dans les visites de bien-être annuelles de Medicare (à compter du 1er janvier 2025).\",\n    \"Les patients IRT de moins de 65 ans obtiendront un accès garanti à l'assurance complémentaire Medigap (à compter du 1er janvier 2026), réduisant ainsi leurs frais personnels.\",\n    \"L'accès à l'éducation sur les maladies rénales (KDE) est élargi, permettant à davantage de professionnels et d'établissements de dialyse de fournir ces services.\",\n    \"Introduction de paiements supplémentaires permanents dans Medicare pour les nouveaux médicaments et produits biologiques innovants utilisés en dialyse, afin d'encourager l'innovation thérapeutique.\",\n    \"Ordonne des études sur les facteurs affectant la progression de la maladie rénale et les taux de transplantation, en particulier au sein des populations minoritaires.\"\n  ],\n  \"es_ai_title\": \"Ley de Mejora de la Enfermedad Renal: Detección, Innovación y Acceso a Medigap.\",\n  \"es_summary\": \"Esta Ley busca mejorar la atención a las personas con Enfermedad Renal Crónica (ERC) ampliando la detección en las visitas anuales de bienestar de Medicare. Aumenta el acceso a la educación sobre la enfermedad renal y garantiza que los pacientes con Enfermedad Renal en Etapa Terminal (ESRD) menores de 65 años tengan acceso garantizado al seguro suplementario Medigap. Además, la legislación modifica los sistemas de pago de Medicare para apoyar terapias y medicamentos innovadores para pacientes en diálisis.\",\n  \"es_key_points\": [\n    \"La detección gratuita de la enfermedad renal crónica (ERC) se incluirá en las visitas anuales de bienestar de Medicare (a partir del 1 de enero de 2025).\",\n    \"Los pacientes con ESRD menores de 65 años obtendrán acceso garantizado al seguro suplementario Medigap (a partir del 1 de enero de 2026), lo que reducirá sus costos de bolsillo.\",\n    \"Se amplía el acceso a la Educación sobre la Enfermedad Renal (KDE), permitiendo que más profesionales e instalaciones de diálisis brinden estos servicios.\",\n    \"Introducción de pagos adicionales permanentes en Medicare para medicamentos y productos biológicos nuevos e innovadores utilizados en diálisis, para incentivar la innovación en el tratamiento.\",\n    \"Ordena estudios sobre los factores que afectan la progresión de la enfermedad renal y las tasas de trasplante, particularmente en poblaciones minoritarias.\"\n  ],\n  \"it_ai_title\": \"Legge sul Miglioramento della Malattia Renale: Screening, Innovazione e Accesso Medigap.\",\n  \"it_summary\": \"Questa legge mira a migliorare l'assistenza per gli individui con Malattia Renale Cronica (CKD) espandendo lo screening durante le visite annuali di benessere di Medicare. Aumenta l'accesso all'educazione sulla malattia renale e garantisce che i pazienti con Malattia Renale allo Stadio Terminale (ESRD) sotto i 65 anni abbiano accesso garantito all'assicurazione supplementare Medigap. Inoltre, la legislazione modifica i sistemi di pagamento Medicare per sostenere terapie e farmaci innovativi per i pazienti in dialisi.\",\n  \"it_key_points\": [\n    \"Lo screening gratuito per la malattia renale cronica (CKD) sarà incluso nelle visite annuali di benessere di Medicare (a partire dal 1° gennaio 2025).\",\n    \"I pazienti ESRD sotto i 65 anni otterranno l'accesso garantito all'assicurazione supplementare Medigap (a partire dal 1° gennaio 2026), riducendo i loro costi a carico.\",\n    \"L'accesso all'Educazione sulla Malattia Renale (KDE) è ampliato, consentendo a più professionisti e strutture di dialisi di fornire questi servizi.\",\n    \"Introduzione di pagamenti aggiuntivi permanenti in Medicare per farmaci e prodotti biologici nuovi e innovativi utilizzati nella dialisi, per incentivare l'innovazione nel trattamento.\",\n    \"Dispone studi sui fattori che influenzano la progressione della malattia renale e i tassi di trapianto, in particolare nelle popolazioni minoritarie.\"\n  ],\n  \"nl_ai_title\": \"Nierenzorgverbeteringswet: Screening, Innovatie en Medigap-toegang voor ESRD-patiënten.\",\n  \"nl_summary\": \"Deze wet is bedoeld om de zorg voor personen met chronische nierziekte (CKD) te verbeteren door screening uit te breiden binnen de jaarlijkse Medicare-welzijnsbezoeken. Het vergroot de toegang tot nierziekte-educatie en zorgt ervoor dat patiënten met terminale nierziekte (ESRD) onder de 65 jaar gegarandeerde toegang krijgen tot de aanvullende Medigap-verzekering. Bovendien wijzigt de wet de Medicare-betalingssystemen om innovatieve therapieën en medicijnen voor dialysepatiënten te ondersteunen.\",\n  \"nl_key_points\": [\n    \"Gratis screening op chronische nierziekte (CKD) wordt opgenomen in de jaarlijkse Medicare-welzijnsbezoeken (vanaf 1 januari 2025).\",\n    \"ESRD-patiënten onder de 65 jaar krijgen gegarandeerde toegang tot de aanvullende Medigap-verzekering (vanaf 1 januari 2026), wat hun eigen kosten verlaagt.\",\n    \"De toegang tot nierziekte-educatie (KDE) wordt uitgebreid, waardoor meer professionals en dialysefaciliteiten deze diensten kunnen aanbieden.\",\n    \"Introductie van permanente toeslagen in Medicare voor nieuwe, innovatieve medicijnen en biologische producten die bij dialyse worden gebruikt, om innovatie in de behandeling te stimuleren.\",\n    \"Opdracht tot studies naar factoren die de progressie van nierziekte en transplantatiesnelheden beïnvloeden, met name binnen minderheidsgroepen.\"\n  ],\n  \"pt_ai_title\": \"Lei de Melhoria da Doença Renal: Rastreio, Inovação e Acesso ao Medigap.\",\n  \"pt_summary\": \"Esta Lei visa melhorar os cuidados para indivíduos com Doença Renal Crónica (DRC), expandindo o rastreio nas visitas anuais de bem-estar do Medicare. Aumenta o acesso à educação sobre doenças renais e garante que os pacientes com Doença Renal em Estágio Terminal (ESRD) com menos de 65 anos tenham acesso garantido ao seguro suplementar Medigap. Além disso, a legislação modifica os sistemas de pagamento do Medicare para apoiar terapias e medicamentos inovadores para pacientes em diálise.\",\n  \"pt_key_points\": [\n    \"O rastreio gratuito da doença renal crónica (DRC) será incluído nas visitas anuais de bem-estar do Medicare (a partir de 1 de janeiro de 2025).\",\n    \"Pacientes com ESRD com menos de 65 anos terão acesso garantido ao seguro suplementar Medigap (a partir de 1 de janeiro de 2026), reduzindo os seus custos diretos.\",\n    \"O acesso à Educação sobre Doença Renal (KDE) é expandido, permitindo que mais profissionais e instalações de diálise forneçam esses serviços.\",\n    \"Introdução de pagamentos adicionais permanentes no Medicare para medicamentos e produtos biológicos novos e inovadores usados em diálise, para incentivar a inovação no tratamento.\",\n    \"Determina a realização de estudos sobre fatores que afetam a progressão da doença renal e as taxas de transplante, particularmente em populações minoritárias.\"\n  ],\n  \"category\": [\n    \"Health\",\n    \"Benefits\"\n  ]\n}"
    },
    {
      "timestamp": "2025-12-26T19:51:13.504Z",
      "source_url": "https://www.congress.gov/118/bills/s4469/BILLS-118s4469is.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 S4469 IS: Chronic Kidney Disease Improvement in Research and Treatment Act of 2024 U.S. Senate 2024-06-05 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. 4469IN THE SENATE OF THE UNITED STATESJune 5, 2024Mr. Cardin (for himself and Mrs. Blackburn) introduced the following bill; which was read twice and referred to the Committee on FinanceA BILLTo improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes.1.Short title; table of contents(a)Short titleThis Act may be cited as the Chronic Kidney Disease Improvement in Research and Treatment Act of 2024.(b)Table of contentsThe table of contents for this Act is as follows:Sec. 1. Short title; table of contents.TITLE I—Preventing kidney disease by expanding education and awarenessSec. 101. Expanding Medicare annual wellness benefit to include kidney disease screening.Sec. 102. Increasing access to Medicare kidney disease education benefit.Sec. 103. Understanding the progression of kidney disease and treatment of kidney failure in minority populations.TITLE II—Incentivizing kidney care innovationSec. 201. Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies.Sec. 202. Ensuring Medicare Advantage supports kidney care innovative therapies.Sec. 203. Improving patient lives and quality of care through research and innovation.TITLE III—Addressing the kidney care workforce crisis.Sec. 301. Improving patient decision making and transparency by consolidating and modernizing quality programs.Sec. 302. Ensuring accuracy and stability in kidney care payment.TITLE IV—Expanding patient choice of coverageSec. 401. Medigap coverage for beneficiaries with end-stage renal disease.IPreventing kidney disease by expanding education and awareness101.Expanding Medicare annual wellness benefit to include kidney disease screening(a)In generalSection 1861(ww)(2) of the Social Security Act (42 U.S.C. 1395x(ww)(2)) is amended—(1)by moving subparagraph (N) 2 ems to the left;(2)by redesignating subparagraph (O) as subparagraph (P); and(3)by inserting after subparagraph (N) the following new subparagraph:(O)Chronic kidney disease screening as defined by the Secretary..(b)Effective dateThe amendments made by this section apply to items and services furnished on or after January 1, 2025.102.Increasing access to Medicare kidney disease education benefit(a)In generalSection 1861(ggg) of the Social Security Act (42 U.S.C. 1395x(ggg)) is amended—(1)in paragraph (1)—(A)in subparagraph (A), by inserting or stage V after stage IV; and(B)in subparagraph (B), by inserting or of a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5)) assisting in the treatment of the individual's kidney condition after kidney condition; and(2)in paragraph (2)—(A)by striking subparagraph (B); and(B)in subparagraph (A)—(i)by striking (A) after (2);(ii)by striking and at the end of clause (i);(iii)by striking the period at the end of clause (ii) and inserting ; and;(iv)by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and indenting appropriately; and(v)by adding at the end the following:(C)a renal dialysis facility subject to the requirements of section 1881(b)(1) with personnel who—(i)provide the services described in paragraph (1); and(ii)is a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in subsection (aa)(5))..(b)Payment to renal dialysis facilitiesSection 1881(b) of the Social Security Act (42 U.S.C. 1395rr(b)) is amended by adding at the end the following new paragraph:(15)For purposes of paragraph (14), the single payment for renal dialysis services under such paragraph shall not take into account the amount of payment for kidney disease education services (as defined in section 1861(ggg)). Instead, payment for such services shall be made to the renal dialysis facility on an assignment-related basis under section 1848..(c)Effective dateThe amendments made by this section apply to kidney disease education services furnished on or after January 1, 2025.103.Understanding the progression of kidney disease and treatment of kidney failure in minority populations(a)StudyThe Secretary of Health and Human Services (in this section referred to as the Secretary) shall conduct a study on—(1)the social, behavioral, and biological factors associated with kidney disease onset and progression;(2)efforts to slow the progression of kidney disease in minority populations that are disproportionately affected by such disease; and(3)treatment patterns associated with providing care, under the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, and through private health insurance, to minority populations that are disproportionately affected by kidney disease.(b)ReportNot later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the study conducted under subsection (a), together with such recommendations as the Secretary determines to be appropriate.IIIncentivizing kidney care innovation201.Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies(a)In generalSection 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) is amended by adding at the end the following new subparagraph:(J)Payment for new and innovative drugs, biologicals, and devices that are renal dialysis services(i)In generalFor any new renal dialysis drug or biological product that is used to treat or manage a condition for which there is a functional category as defined in section 413.234(a) of title 42, Code of Federal Regulations that received a transitional drug add-on adjustment (referred to in this subparagraph as TDAPA) under section 413.234(c)(2) of such title, and was furnished on or after January 1, 2024, the Secretary shall establish a permanent add-on adjustment to the base rate for claims submitted on or after January 1, 2025, that includes the administration of such drugs or biologicals.(ii)Calculation of the Post-TDAPA Add-on adjustmentIn calculating the add-on adjustment described in clause (i), the Secretary shall—(I)base the calculation on— (aa)except as provided in items (bb) and (cc), the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of average sales price data for such drug or product;(bb)if the most recent available full calendar quarter of average sales price data reflects 0 or negative sales, 100 percent of the wholesale acquisition cost (as defined in section 1847A(c)(6)) of such drug or product; or(cc)if the wholesale acquisition cost is not available, the drug manufacturer's invoice;(II)calculate the post-TDAPA add-on payment adjustment as the expenditures for the new renal dialysis drug or biological product divided by the total number of renal dialysis services during which such drug or biological was administered during the same period;(III)set the amount of the add-on adjustment as an amount equal to 65 percent of the amount calculated under subclause (II);(IV)update the add-on adjustment annually to account for inflationary changes; and(V)apply the add-on adjustment amount immediately upon the expiration of the TDAPA period and availability of the post-TDAPA add-on adjustment.(iii)ImplementationThis subparagraph shall not be implemented in a budget neutral manner and shall not be adjusted by any applicable patient-level case-mix adjustments described in section 413.235 of title 42, Code of Federal Regulations (or any successor regulation)..(b)Extension of transitional drug add-On adjustment under the drug designation policyThe Secretary shall pay the transitional drug add-on adjustment under paragraph (c) of section 413.234 of title 42, Code of Federal Regulations (or a successor regulation) for a total of 3 years for any new renal dialysis drug or biological product that—(1)is used to treat or manage a condition for which there is a functional category as defined in paragraph (a) of such section;(2)qualifies for such adjustment under paragraph (c)(2) of such section; and(3)is furnished on or after January 1, 2024.(c)New devices and other technologies(1)In generalAs part of the promulgation of the annual rule for the Medicare end-stage renal disease prospective payment system under section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) for calendar year 2026, and in consultation with stakeholders, the Secretary of Health and Human Services (referred to in this subsection as the Secretary) shall— (A)ensure that the single payment amount is adequate to cover the cost of any new innovative device or other technology with substantial clinical improvement; and (B)increase the single payment amount if the Secretary determines such payment amount is not adequate to cover such cost. (2)Cost and utilization dataIn carrying out paragraph (1), the Secretary shall use the cost and utilization data collected during a 3-year transitional payment period, as described in the final regulation published on November 9, 2020 (85 Fed. Reg. 71398).202.Ensuring Medicare Advantage supports kidney care innovative therapiesSection 1853(c) of the Social Security Act (42 U.S.C. 1395w–23(c)) is amended by adding at the end the following new paragraph:(8)Treatment of innovative products for enrollees with end stage renal disease(A)In generalThe Secretary shall make direct payment adjustments to providers of services or renal dialysis facilities for—(i)any new renal dialysis drug or biological product that receives a transitional drug add-on adjustment under section 413.234(c) of title 42, Code of Federal Regulations; or (ii)an item or service that receives a transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of such title.(B)Amount of direct paymentThe amount of the adjustment shall equal the amount determined under the end stage renal disease prospective payment system described in section 1881(b)(14).(C)Duration of direct paymentThe Secretary shall make payments under subparagraph (A) for the duration of the transitional payment under the end stage renal disease prospective payment system described in such section..203.Improving patient lives and quality of care through research and innovation(a)StudyThe Secretary of Health and Human Services (referred to in this section as the Secretary) shall conduct a study on increasing kidney transplantation rates. Such study shall include an analysis of each of the following:(1)Any disincentives in the payment systems under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) that create barriers to kidney transplants and post-transplant care for beneficiaries with end-stage renal disease.(2)The practices used by donation service areas with higher than average donation rates and whether those practices and policies could be successfully utilized in other donation service areas.(3)Practices and policies that could increase donation rates among minority populations.(4)Whether cultural and policy barriers exist to increasing living donation rates, including an examination of how to better facilitate kidney paired donations.(5)Criteria for transplant recipients for referral and for getting on the waitlist to receive a kidney.(6)Other areas determined appropriate by the Secretary.(b)ReportNot later than 18 months after the date of enactment of this Act, the Secretary shall submit to Congress a report on the study conducted pursuant to subsection (a), together with such recommendations as the Secretary determines to be appropriate.IIIIncreasing patient access to quality performance by improving the accuracy and transparency of end-stage renal disease quality programs301.Improving patient decision making and transparency by consolidating and modernizing quality programs(a)MeasuresSection 1881(h)(2) of the Social Security Act (42 U.S.C. 1395rr(h)(2)) is amended—(1)by striking subparagraph (A) and inserting the following:(A)The measures specified under this paragraph with respect to the year involved shall be selected by the Secretary in consultation with stakeholders to promote improvement in beneficiary outcomes and shared decision-making with beneficiaries and their caregivers. When selecting measures specified under this paragraph, the Secretary shall take into account clinical gaps in care, underutilization that may lead to beneficiary harm, patient safety, and outcomes.;(2)in subparagraph (B)(i), by striking subparagraph (A)(iv) and inserting subparagraph (A);(3)by striking subparagraph (E); and(4)by adding at the end the following new subparagraphs:(E)Weighting limitationNo single measure specified by the Secretary or individual measure within a composite measure so specified may be weighted less than 10 percent of the total performance score.(F)Statistically valid and reliableIn specifying measures under subparagraph (A), the Secretary shall only specify measures that have been shown to be statistically valid and reliable through testing..(b)EndorsementSection 1881(h)(2)(B)(ii) of the Social Security Act (42 U.S.C. 1395rr(h)(2)(B)(ii)) is amended by adding at the end the following new sentence: The exception under the preceding sentence shall not apply to a measure that the entity with a contract under section 1890(a) (or a similar entity) considered but failed to endorse..(e)Effective dateThe amendments made by this section shall apply to items and services furnished on or after January 1, 2025.IVEmpowering patients401.Medigap coverage for beneficiaries with end-stage renal disease(a)Guaranteed availability of Medigap policies to all ESRD Medicare beneficiaries(1)In generalSection 1882(s) of the Social Security Act (42 U.S.C. 1395ss(s)) is amended—(A)in paragraph (2)—(i)in subparagraph (A), by striking is 65 and all that follows through the period and inserting the following: “is—(i)65 years of age or older and is enrolled for benefits under part B; or(ii)entitled to benefits under 226A(b) and is enrolled for benefits under part B.; and(ii)in subparagraph (D), in the matter preceding clause (i), by inserting (or is entitled to benefits under 226A(b)) after is 65 years of age or older; and(B)in paragraph (3)(B)—(i)in clause (ii), by inserting (or is entitled to benefits under 226A(b)) after is 65 years of age or older; and(ii)in clause (vi), by inserting (or under 226A(b)) after at age 65.(2)Effective dateThe amendments made by paragraph (1) shall apply to Medicare supplemental policies effective on or after January 1, 2026.(b)Additional enrollment period for certain individuals(1)One-time enrollment period(A)In generalIn the case of an individual described in subparagraph (B), the Secretary of Health and Human Services shall establish a one-time enrollment period during which such an individual may enroll in any Medicare supplemental policy under section 1882 of the Social Security Act (42 U.S.C. 1395ss) of the individual's choosing.(B)Enrollment periodThe enrollment period established under subparagraph (A) shall begin on January 1, 2026, and shall end June 30, 2026.(2)Individual describedAn individual described in this paragraph is an individual who—(A)is entitled to hospital insurance benefits under part A of title XVIII of the Social Security Act under section 226A(b) of such Act (42 U.S.C. 426–1);(B)is enrolled for benefits under part B of such title XVIII; and(C)would not, but for the provisions of, and amendments made by, subsection (a) be eligible for the guaranteed issue of a Medicare supplemental policy under paragraph (2) or (3) of section 1882(s) of such Act (42 U.S.C. 1395ss(s)).\n\nSUMMARY TO EVALUATE:\nTitle: Kidney Care Improvement: Screening, Innovation Funding, and Medigap Access for ESRD.\nSummary: This Act aims to enhance care for individuals with Chronic Kidney Disease (CKD) by expanding mandatory screening within Medicare annual wellness visits and increasing access to kidney disease education. It introduces permanent add-on payments for innovative dialysis drugs and devices to incentivize the development of new therapies. Crucially, it guarantees access to supplemental Medigap insurance for all Medicare beneficiaries with End-Stage Renal Disease (ESRD), regardless of age, significantly reducing their out-of-pocket costs.\nKey Points: CKD Screening Expansion: Medicare Annual Wellness Visits must include chronic kidney disease screening (effective January 1, 2025)., Guaranteed Medigap Access: Medicare beneficiaries with End-Stage Renal Disease (ESRD) under age 65 will gain guaranteed access to supplemental Medigap policies (effective January 1, 2026)., Funding Innovation: Establishes a permanent add-on payment adjustment (Post-TDAPA) for new and innovative renal dialysis drugs, biologicals, and devices to support better treatment options., Education Access: Expands the Kidney Disease Education (KDE) benefit, allowing renal dialysis facilities to provide these services and receive separate payment., Minority Health Study: Mandates a study on social, behavioral, and biological factors associated with kidney disease progression and treatment patterns in disproportionately affected minority populations.\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}"
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    {
      "timestamp": "2025-12-23T05:12:24.730Z",
      "source_url": "https://www.congress.gov/118/bills/s4469/BILLS-118s4469is.xml",
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      "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 S4469 IS: Chronic Kidney Disease Improvement in Research and Treatment Act of 2024 U.S. Senate 2024-06-05 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. 4469IN THE SENATE OF THE UNITED STATESJune 5, 2024Mr. Cardin (for himself and Mrs. Blackburn) introduced the following bill; which was read twice and referred to the Committee on FinanceA BILLTo improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes.1.Short title; table of contents(a)Short titleThis Act may be cited as the Chronic Kidney Disease Improvement in Research and Treatment Act of 2024.(b)Table of contentsThe table of contents for this Act is as follows:Sec. 1. Short title; table of contents.TITLE I—Preventing kidney disease by expanding education and awarenessSec. 101. Expanding Medicare annual wellness benefit to include kidney disease screening.Sec. 102. Increasing access to Medicare kidney disease education benefit.Sec. 103. Understanding the progression of kidney disease and treatment of kidney failure in minority populations.TITLE II—Incentivizing kidney care innovationSec. 201. Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies.Sec. 202. Ensuring Medicare Advantage supports kidney care innovative therapies.Sec. 203. Improving patient lives and quality of care through research and innovation.TITLE III—Addressing the kidney care workforce crisis.Sec. 301. Improving patient decision making and transparency by consolidating and modernizing quality programs.Sec. 302. Ensuring accuracy and stability in kidney care payment.TITLE IV—Expanding patient choice of coverageSec. 401. Medigap coverage for beneficiaries with end-stage renal disease.IPreventing kidney disease by expanding education and awareness101.Expanding Medicare annual wellness benefit to include kidney disease screening(a)In generalSection 1861(ww)(2) of the Social Security Act (42 U.S.C. 1395x(ww)(2)) is amended—(1)by moving subparagraph (N) 2 ems to the left;(2)by redesignating subparagraph (O) as subparagraph (P); and(3)by inserting after subparagraph (N) the following new subparagraph:(O)Chronic kidney disease screening as defined by the Secretary..(b)Effective dateThe amendments made by this section apply to items and services furnished on or after January 1, 2025.102.Increasing access to Medicare kidney disease education benefit(a)In generalSection 1861(ggg) of the Social Security Act (42 U.S.C. 1395x(ggg)) is amended—(1)in paragraph (1)—(A)in subparagraph (A), by inserting or stage V after stage IV; and(B)in subparagraph (B), by inserting or of a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5)) assisting in the treatment of the individual's kidney condition after kidney condition; and(2)in paragraph (2)—(A)by striking subparagraph (B); and(B)in subparagraph (A)—(i)by striking (A) after (2);(ii)by striking and at the end of clause (i);(iii)by striking the period at the end of clause (ii) and inserting ; and;(iv)by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and indenting appropriately; and(v)by adding at the end the following:(C)a renal dialysis facility subject to the requirements of section 1881(b)(1) with personnel who—(i)provide the services described in paragraph (1); and(ii)is a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in subsection (aa)(5))..(b)Payment to renal dialysis facilitiesSection 1881(b) of the Social Security Act (42 U.S.C. 1395rr(b)) is amended by adding at the end the following new paragraph:(15)For purposes of paragraph (14), the single payment for renal dialysis services under such paragraph shall not take into account the amount of payment for kidney disease education services (as defined in section 1861(ggg)). Instead, payment for such services shall be made to the renal dialysis facility on an assignment-related basis under section 1848..(c)Effective dateThe amendments made by this section apply to kidney disease education services furnished on or after January 1, 2025.103.Understanding the progression of kidney disease and treatment of kidney failure in minority populations(a)StudyThe Secretary of Health and Human Services (in this section referred to as the Secretary) shall conduct a study on—(1)the social, behavioral, and biological factors associated with kidney disease onset and progression;(2)efforts to slow the progression of kidney disease in minority populations that are disproportionately affected by such disease; and(3)treatment patterns associated with providing care, under the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, and through private health insurance, to minority populations that are disproportionately affected by kidney disease.(b)ReportNot later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the study conducted under subsection (a), together with such recommendations as the Secretary determines to be appropriate.IIIncentivizing kidney care innovation201.Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies(a)In generalSection 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) is amended by adding at the end the following new subparagraph:(J)Payment for new and innovative drugs, biologicals, and devices that are renal dialysis services(i)In generalFor any new renal dialysis drug or biological product that is used to treat or manage a condition for which there is a functional category as defined in section 413.234(a) of title 42, Code of Federal Regulations that received a transitional drug add-on adjustment (referred to in this subparagraph as TDAPA) under section 413.234(c)(2) of such title, and was furnished on or after January 1, 2024, the Secretary shall establish a permanent add-on adjustment to the base rate for claims submitted on or after January 1, 2025, that includes the administration of such drugs or biologicals.(ii)Calculation of the Post-TDAPA Add-on adjustmentIn calculating the add-on adjustment described in clause (i), the Secretary shall—(I)base the calculation on— (aa)except as provided in items (bb) and (cc), the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of average sales price data for such drug or product;(bb)if the most recent available full calendar quarter of average sales price data reflects 0 or negative sales, 100 percent of the wholesale acquisition cost (as defined in section 1847A(c)(6)) of such drug or product; or(cc)if the wholesale acquisition cost is not available, the drug manufacturer's invoice;(II)calculate the post-TDAPA add-on payment adjustment as the expenditures for the new renal dialysis drug or biological product divided by the total number of renal dialysis services during which such drug or biological was administered during the same period;(III)set the amount of the add-on adjustment as an amount equal to 65 percent of the amount calculated under subclause (II);(IV)update the add-on adjustment annually to account for inflationary changes; and(V)apply the add-on adjustment amount immediately upon the expiration of the TDAPA period and availability of the post-TDAPA add-on adjustment.(iii)ImplementationThis subparagraph shall not be implemented in a budget neutral manner and shall not be adjusted by any applicable patient-level case-mix adjustments described in section 413.235 of title 42, Code of Federal Regulations (or any successor regulation)..(b)Extension of transitional drug add-On adjustment under the drug designation policyThe Secretary shall pay the transitional drug add-on adjustment under paragraph (c) of section 413.234 of title 42, Code of Federal Regulations (or a successor regulation) for a total of 3 years for any new renal dialysis drug or biological product that—(1)is used to treat or manage a condition for which there is a functional category as defined in paragraph (a) of such section;(2)qualifies for such adjustment under paragraph (c)(2) of such section; and(3)is furnished on or after January 1, 2024.(c)New devices and other technologies(1)In generalAs part of the promulgation of the annual rule for the Medicare end-stage renal disease prospective payment system under section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) for calendar year 2026, and in consultation with stakeholders, the Secretary of Health and Human Services (referred to in this subsection as the Secretary) shall— (A)ensure that the single payment amount is adequate to cover the cost of any new innovative device or other technology with substantial clinical improvement; and (B)increase the single payment amount if the Secretary determines such payment amount is not adequate to cover such cost. (2)Cost and utilization dataIn carrying out paragraph (1), the Secretary shall use the cost and utilization data collected during a 3-year transitional payment period, as described in the final regulation published on November 9, 2020 (85 Fed. Reg. 71398).202.Ensuring Medicare Advantage supports kidney care innovative therapiesSection 1853(c) of the Social Security Act (42 U.S.C. 1395w–23(c)) is amended by adding at the end the following new paragraph:(8)Treatment of innovative products for enrollees with end stage renal disease(A)In generalThe Secretary shall make direct payment adjustments to providers of services or renal dialysis facilities for—(i)any new renal dialysis drug or biological product that receives a transitional drug add-on adjustment under section 413.234(c) of title 42, Code of Federal Regulations; or (ii)an item or service that receives a transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of such title.(B)Amount of direct paymentThe amount of the adjustment shall equal the amount determined under the end stage renal disease prospective payment system described in section 1881(b)(14).(C)Duration of direct paymentThe Secretary shall make payments under subparagraph (A) for the duration of the transitional payment under the end stage renal disease prospective payment system described in such section..203.Improving patient lives and quality of care through research and innovation(a)StudyThe Secretary of Health and Human Services (referred to in this section as the Secretary) shall conduct a study on increasing kidney transplantation rates. Such study shall include an analysis of each of the following:(1)Any disincentives in the payment systems under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) that create barriers to kidney transplants and post-transplant care for beneficiaries with end-stage renal disease.(2)The practices used by donation service areas with higher than average donation rates and whether those practices and policies could be successfully utilized in other donation service areas.(3)Practices and policies that could increase donation rates among minority populations.(4)Whether cultural and policy barriers exist to increasing living donation rates, including an examination of how to better facilitate kidney paired donations.(5)Criteria for transplant recipients for referral and for getting on the waitlist to receive a kidney.(6)Other areas determined appropriate by the Secretary.(b)ReportNot later than 18 months after the date of enactment of this Act, the Secretary shall submit to Congress a report on the study conducted pursuant to subsection (a), together with such recommendations as the Secretary determines to be appropriate.IIIIncreasing patient access to quality performance by improving the accuracy and transparency of end-stage renal disease quality programs301.Improving patient decision making and transparency by consolidating and modernizing quality programs(a)MeasuresSection 1881(h)(2) of the Social Security Act (42 U.S.C. 1395rr(h)(2)) is amended—(1)by striking subparagraph (A) and inserting the following:(A)The measures specified under this paragraph with respect to the year involved shall be selected by the Secretary in consultation with stakeholders to promote improvement in beneficiary outcomes and shared decision-making with beneficiaries and their caregivers. When selecting measures specified under this paragraph, the Secretary shall take into account clinical gaps in care, underutilization that may lead to beneficiary harm, patient safety, and outcomes.;(2)in subparagraph (B)(i), by striking subparagraph (A)(iv) and inserting subparagraph (A);(3)by striking subparagraph (E); and(4)by adding at the end the following new subparagraphs:(E)Weighting limitationNo single measure specified by the Secretary or individual measure within a composite measure so specified may be weighted less than 10 percent of the total performance score.(F)Statistically valid and reliableIn specifying measures under subparagraph (A), the Secretary shall only specify measures that have been shown to be statistically valid and reliable through testing..(b)EndorsementSection 1881(h)(2)(B)(ii) of the Social Security Act (42 U.S.C. 1395rr(h)(2)(B)(ii)) is amended by adding at the end the following new sentence: The exception under the preceding sentence shall not apply to a measure that the entity with a contract under section 1890(a) (or a similar entity) considered but failed to endorse..(e)Effective dateThe amendments made by this section shall apply to items and services furnished on or after January 1, 2025.IVEmpowering patients401.Medigap coverage for beneficiaries with end-stage renal disease(a)Guaranteed availability of Medigap policies to all ESRD Medicare beneficiaries(1)In generalSection 1882(s) of the Social Security Act (42 U.S.C. 1395ss(s)) is amended—(A)in paragraph (2)—(i)in subparagraph (A), by striking is 65 and all that follows through the period and inserting the following: “is—(i)65 years of age or older and is enrolled for benefits under part B; or(ii)entitled to benefits under 226A(b) and is enrolled for benefits under part B.; and(ii)in subparagraph (D), in the matter preceding clause (i), by inserting (or is entitled to benefits under 226A(b)) after is 65 years of age or older; and(B)in paragraph (3)(B)—(i)in clause (ii), by inserting (or is entitled to benefits under 226A(b)) after is 65 years of age or older; and(ii)in clause (vi), by inserting (or under 226A(b)) after at age 65.(2)Effective dateThe amendments made by paragraph (1) shall apply to Medicare supplemental policies effective on or after January 1, 2026.(b)Additional enrollment period for certain individuals(1)One-time enrollment period(A)In generalIn the case of an individual described in subparagraph (B), the Secretary of Health and Human Services shall establish a one-time enrollment period during which such an individual may enroll in any Medicare supplemental policy under section 1882 of the Social Security Act (42 U.S.C. 1395ss) of the individual's choosing.(B)Enrollment periodThe enrollment period established under subparagraph (A) shall begin on January 1, 2026, and shall end June 30, 2026.(2)Individual describedAn individual described in this paragraph is an individual who—(A)is entitled to hospital insurance benefits under part A of title XVIII of the Social Security Act under section 226A(b) of such Act (42 U.S.C. 426–1);(B)is enrolled for benefits under part B of such title XVIII; and(C)would not, but for the provisions of, and amendments made by, subsection (a) be eligible for the guaranteed issue of a Medicare supplemental policy under paragraph (2) or (3) of section 1882(s) of such Act (42 U.S.C. 1395ss(s)).\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\": \"Poprawa opieki nad nerkami: badania, edukacja i ubezpieczenie Medigap dla chorych.\",\n  \"pl_summary\": \"Ustawa ma na celu poprawę opieki nad osobami z przewlekłą chorobą nerek (CKD) poprzez rozszerzenie badań przesiewowych w ramach rocznych wizyt Medicare oraz zwiększenie dostępu do edukacji na temat choroby. Wprowadza stałe dopłaty do innowacyjnych leków i urządzeń dializacyjnych, co ma zachęcać do rozwoju nowych terapii. Kluczową zmianą dla pacjentów jest zagwarantowanie dostępu do ubezpieczenia uzupełniającego Medigap dla wszystkich beneficjentów Medicare z krańcową niewydolnością nerek (ESRD), niezależnie od wieku.\",\n  \"pl_key_points\": [\n    \"Badania przesiewowe CKD: Roczne wizyty kontrolne w ramach Medicare (Annual Wellness Benefit) będą obowiązkowo obejmować badania przesiewowe w kierunku przewlekłej choroby nerek (od 1 stycznia 2025 r.).\",\n    \"Dostęp do Medigap: Beneficjenci Medicare z krańcową niewydolnością nerek (ESRD) poniżej 65. roku życia uzyskają gwarantowany dostęp do ubezpieczenia uzupełniającego Medigap (od 1 stycznia 2026 r.), co obniży ich koszty leczenia.\",\n    \"Innowacje w leczeniu: Wprowadzenie stałych dopłat do innowacyjnych leków, produktów biologicznych i urządzeń stosowanych w dializach (Post-TDAPA Add-on adjustment) ma wspierać rozwój nowych, lepszych terapii.\",\n    \"Edukacja i personel: Rozszerzenie dostępu do edukacji na temat choroby nerek (KDE) oraz umożliwienie placówkom dializacyjnym (renal dialysis facilities) świadczenia tych usług i otrzymywania za nie oddzielnej płatności.\",\n    \"Badania nad mniejszościami: Nakaz przeprowadzenia badań nad czynnikami wpływającymi na postęp choroby nerek i wzorce leczenia w populacjach mniejszościowych, które są nieproporcjonalnie dotknięte tą chorobą.\"\n  ],\n  \"eng_ai_title\": \"Kidney Care Improvement: Screening, Innovation Funding, and Medigap Access for ESRD.\",\n  \"eng_summary\": \"This Act aims to enhance care for individuals with Chronic Kidney Disease (CKD) by expanding mandatory screening within Medicare annual wellness visits and increasing access to kidney disease education. It introduces permanent add-on payments for innovative dialysis drugs and devices to incentivize the development of new therapies. Crucially, it guarantees access to supplemental Medigap insurance for all Medicare beneficiaries with End-Stage Renal Disease (ESRD), regardless of age, significantly reducing their out-of-pocket costs.\",\n  \"eng_key_points\": [\n    \"CKD Screening Expansion: Medicare Annual Wellness Visits must include chronic kidney disease screening (effective January 1, 2025).\",\n    \"Guaranteed Medigap Access: Medicare beneficiaries with End-Stage Renal Disease (ESRD) under age 65 will gain guaranteed access to supplemental Medigap policies (effective January 1, 2026).\",\n    \"Funding Innovation: Establishes a permanent add-on payment adjustment (Post-TDAPA) for new and innovative renal dialysis drugs, biologicals, and devices to support better treatment options.\",\n    \"Education Access: Expands the Kidney Disease Education (KDE) benefit, allowing renal dialysis facilities to provide these services and receive separate payment.\",\n    \"Minority Health Study: Mandates a study on social, behavioral, and biological factors associated with kidney disease progression and treatment patterns in disproportionately affected minority populations.\"\n  ],\n  \"de_ai_title\": \"Nierenpflege-Verbesserung: Screening, Innovationsförderung und Medigap für Nierenkranke.\",\n  \"de_summary\": \"Dieses Gesetz zielt darauf ab, die Versorgung von Menschen mit chronischer Nierenerkrankung (CKD) zu verbessern, indem es das obligatorische Screening im Rahmen der jährlichen Medicare-Vorsorgeuntersuchungen erweitert und den Zugang zu Aufklärung über Nierenerkrankungen verbessert. Es führt dauerhafte Zuschläge für innovative Dialysemedikamente und -geräte ein, um die Entwicklung neuer Therapien zu fördern. Eine wesentliche Änderung ist die Garantie des Zugangs zu Medigap-Zusatzversicherungen für alle Medicare-Begünstigten mit terminaler Niereninsuffizienz (ESRD), unabhängig vom Alter.\",\n  \"de_key_points\": [\n    \"CKD-Screening-Erweiterung: Jährliche Medicare-Vorsorgeuntersuchungen müssen ein Screening auf chronische Nierenerkrankungen beinhalten (wirksam ab 1. Januar 2025).\",\n    \"Garantierter Medigap-Zugang: Medicare-Begünstigte mit terminaler Niereninsuffizienz (ESRD) unter 65 Jahren erhalten garantierten Zugang zu Medigap-Zusatzpolicen (wirksam ab 1. Januar 2026).\",\n    \"Innovationsanreize: Einführung eines dauerhaften Zuschlags (Post-TDAPA) für neue und innovative Dialysemedikamente, Biologika und Geräte zur Unterstützung besserer Behandlungsoptionen.\",\n    \"Forschung zu Minderheiten: Anordnung einer Studie über die Faktoren, die das Fortschreiten von Nierenerkrankungen und Behandlungsmuster in überproportional betroffenen Minderheitenpopulationen beeinflussen.\"\n  ],\n  \"fr_ai_title\": \"Amélioration des soins rénaux: dépistage, innovation et accès Medigap pour l'ESRD.\",\n  \"fr_summary\": \"Cette loi vise à améliorer les soins pour les personnes atteintes de maladie rénale chronique (CKD) en élargissant le dépistage obligatoire lors des visites annuelles de bien-être Medicare et en augmentant l'accès à l'éducation. Elle introduit des paiements supplémentaires permanents pour les médicaments et dispositifs de dialyse innovants afin d'encourager le développement de nouvelles thérapies. Un changement crucial est la garantie d'accès à l'assurance complémentaire Medigap pour tous les bénéficiaires de Medicare atteints d'insuffisance rénale terminale (ESRD), quel que soit leur âge.\",\n  \"fr_key_points\": [\n    \"Élargissement du dépistage CKD: Les visites annuelles de bien-être Medicare incluront obligatoirement le dépistage de la maladie rénale chronique (à partir du 1er janvier 2025).\",\n    \"Accès garanti à Medigap: Les bénéficiaires de Medicare atteints d'insuffisance rénale terminale (ESRD) de moins de 65 ans auront un accès garanti aux polices complémentaires Medigap (à partir du 1er janvier 2026).\",\n    \"Financement de l'innovation: Établissement d'un ajustement de paiement supplémentaire permanent (Post-TDAPA) pour les médicaments, produits biologiques et dispositifs de dialyse nouveaux et innovants.\",\n    \"Éducation et personnel: Augmentation de l'accès aux services d'éducation sur les maladies rénales, permettant aux centres de dialyse de fournir ces services et d'être payés séparément.\",\n    \"Étude sur la transplantation: Mandat pour une étude visant à identifier les obstacles et les pratiques pour augmenter les taux de transplantation rénale.\"\n  ],\n  \"es_ai_title\": \"Mejora de la atención renal: cribado, financiación de innovación y acceso a Medigap.\",\n  \"es_summary\": \"Esta ley busca mejorar la atención a las personas con Enfermedad Renal Crónica (ERC) ampliando el cribado obligatorio en las visitas anuales de bienestar de Medicare y mejorando el acceso a la educación. Introduce pagos adicionales permanentes para medicamentos y dispositivos de diálisis innovadores para fomentar el desarrollo de nuevas terapias. Un cambio fundamental es garantizar el acceso al seguro suplementario Medigap para todos los beneficiarios de Medicare con Enfermedad Renal en Etapa Terminal (ESRD), sin importar su edad.\",\n  \"es_key_points\": [\n    \"Expansión del cribado de ERC: Las visitas anuales de bienestar de Medicare incluirán obligatoriamente el cribado de enfermedad renal crónica (a partir del 1 de enero de 2025).\",\n    \"Acceso garantizado a Medigap: Los beneficiarios de Medicare con ESRD menores de 65 años obtendrán acceso garantizado a las pólizas suplementarias Medigap (a partir del 1 de enero de 2026).\",\n    \"Incentivos a la innovación: Establecimiento de un ajuste de pago adicional permanente (Post-TDAPA) para medicamentos, productos biológicos y dispositivos de diálisis nuevos e innovadores.\",\n    \"Estudio sobre minorías: Se ordena un estudio sobre los factores que influyen en la progresión de la enfermedad renal y los patrones de tratamiento en poblaciones minoritarias desproporcionadamente afectadas.\"\n  ],\n  \"it_ai_title\": \"Miglioramento cura renale: screening, innovazione e accesso Medigap per ESRD.\",\n  \"it_summary\": \"Questa legge mira a migliorare l'assistenza per gli individui con Malattia Renale Cronica (CKD) espandendo lo screening obbligatorio nelle visite annuali Medicare e aumentando l'accesso all'educazione. Introduce pagamenti aggiuntivi permanenti per farmaci e dispositivi dialitici innovativi per incentivare lo sviluppo di nuove terapie. Un cambiamento cruciale è garantire l'accesso all'assicurazione supplementare Medigap per tutti i beneficiari Medicare con Malattia Renale allo Stadio Terminale (ESRD), indipendentemente dall'età.\",\n  \"it_key_points\": [\n    \"Espansione dello screening CKD: Le visite annuali di benessere Medicare includeranno lo screening obbligatorio per la malattia renale cronica (a partire dal 1° gennaio 2025).\",\n    \"Accesso garantito a Medigap: I beneficiari Medicare con ESRD di età inferiore ai 65 anni otterranno l'accesso garantito alle polizze supplementari Medigap (a partire dal 1° gennaio 2026).\",\n    \"Incentivi all'innovazione: Istituzione di un adeguamento di pagamento aggiuntivo permanente (Post-TDAPA) per farmaci, prodotti biologici e dispositivi dialitici nuovi e innovativi.\",\n    \"Educazione e personale: Aumento dell'accesso ai servizi di educazione sulla malattia renale, consentendo alle strutture di dialisi di fornire tali servizi e ricevere un pagamento separato.\"\n  ],\n  \"nl_ai_title\": \"Nierzorgverbetering: Screening, innovatiefinanciering en Medigap-toegang voor ESRD.\",\n  \"nl_summary\": \"Deze wet is bedoeld om de zorg voor mensen met chronische nierziekte (CKD) te verbeteren door verplichte screening uit te breiden binnen de jaarlijkse Medicare-welzijnsbezoeken en de toegang tot nierziekte-educatie te vergroten. Het introduceert permanente toeslagen voor innovatieve dialysegeneesmiddelen en -apparatuur om de ontwikkeling van nieuwe therapieën te stimuleren. Een cruciale verandering is de garantie van toegang tot de aanvullende Medigap-verzekering voor alle Medicare-begunstigden met terminale nierziekte (ESRD), ongeacht hun leeftijd.\",\n  \"nl_key_points\": [\n    \"CKD-screeninguitbreiding: Jaarlijkse Medicare-welzijnsbezoeken moeten screening op chronische nierziekte omvatten (vanaf 1 januari 2025).\",\n    \"Gegarandeerde Medigap-toegang: Medicare-begunstigden met ESRD jonger dan 65 jaar krijgen gegarandeerde toegang tot aanvullende Medigap-polissen (vanaf 1 januari 2026).\",\n    \"Innovatie financieren: Oprichting van een permanente toeslag (Post-TDAPA) voor nieuwe en innovatieve nierdialysegeneesmiddelen, biologische producten en apparaten.\",\n    \"Onderzoek naar minderheden: Opdracht voor een studie naar factoren die de progressie van nierziekte en behandelingspatronen in onevenredig getroffen minderheidsgroepen beïnvloeden.\"\n  ],\n  \"pt_ai_title\": \"Melhoria da Doença Renal: Rastreio, Inovação e Acesso Medigap para ESRD.\",\n  \"pt_summary\": \"Este Ato visa melhorar os cuidados para indivíduos com Doença Renal Crónica (DRC) expandindo o rastreio obrigatório nas visitas anuais de bem-estar do Medicare e aumentando o acesso à educação. Introduz pagamentos adicionais permanentes para medicamentos e dispositivos de diálise inovadores para incentivar o desenvolvimento de novas terapias. Uma mudança crucial é garantir o acesso ao seguro suplementar Medigap para todos os beneficiários do Medicare com Doença Renal em Estágio Terminal (ESRD), independentemente da idade.\",\n  \"pt_key_points\": [\n    \"Expansão do Rastreio de DRC: As Visitas Anuais de Bem-Estar do Medicare devem incluir o rastreio de doença renal crónica (a partir de 1 de janeiro de 2025).\",\n    \"Acesso Garantido ao Medigap: Os beneficiários do Medicare com ESRD com menos de 65 anos terão acesso garantido a apólices suplementares Medigap (a partir de 1 de janeiro de 2026).\",\n    \"Financiamento da Inovação: Estabelecimento de um ajuste de pagamento adicional permanente (Post-TDAPA) para novos e inovadores medicamentos, produtos biológicos e dispositivos de diálise renal.\",\n    \"Estudo sobre Transplantes: Mandato para um estudo sobre o aumento das taxas de transplante renal e a identificação de barreiras no sistema de pagamento do Medicare.\"\n  ],\n  \"category\": [\n    \"Health\",\n    \"Benefits\"\n  ]\n}"
    }
  ]
}