{"description":"Documents matching 'research criteria applicable hope kidney'","count":390,"total_pages":20,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=research+criteria+applicable+hope+kidney&format=json&page=2","results":[{"title":"Draft Revised Human Immunodeficiency Virus (HIV) Organ Policy Equity Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV","type":"Notice","abstract":"The HOPE Act requires the Secretary of Health and Human Services (the Secretary) to develop and publish criteria for research involving the transplantation of organs from donors with HIV to recipients with HIV. In 2015, the National Institutes of Health (NIH), and the U.S. Department of Health and Human Services (HHS) published research criteria applicable to such transplants, which have been in effect for all transplants involving organs from donors with HIV as authorized by the HOPE Act. As amended in an HHS final rule published elsewhere in this issue of the Federal Register, the Secretary determined that participation in clinical research should no longer be a requirement for the transplantation of kidneys and livers from donors with HIV to recipients with HIV and amended the HHS regulations governing the operation of the Organ Procurement and Transplantation Network (OPTN) to reflect this determination. As a result, HOPE Act transplants involving kidneys and livers from donors with HIV no longer need to comply with the research criteria. Given this regulatory change, NIH proposes to delete aspects of the research criteria that are specific to kidney and liver transplantation. NIH proposes additional changes to the research criteria based on its review of scientific evidence and in consideration of prior public feedback concerning the criteria, including comments provided in the recent rulemaking procedure that modified the OPTN regulations. NIH invites the public to submit comments regarding the proposed changes to the research criteria.","document_number":"2024-27733","html_url":"https://www.federalregister.gov/documents/2024/11/27/2024-27733/draft-revised-human-immunodeficiency-virus-hiv-organ-policy-equity-act-safeguards-and-research","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-27/pdf/2024-27733.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-27733.pdf?1732628720","publication_date":"2024-11-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"as research subject to the 2015 Research Criteria and to continue to further the goals shared in 2015 with respect to HOPE Act transplants of other organs from donors with HIV that remain subject to the Research Criteria. NIH proposes to remove requirements from the Research Criteria applicable to HOPE Act kidney and liver transplants. \n \n NIH also proposes other changes to the 2015 NIH Research Criteria for conducting HOPE Act transplants of organs other than kidneys and livers (primarily heart and lung transplants) in IRB-approved research. The"},{"title":"Final Revised Human Immunodeficiency Virus (HIV) Organ Policy Equity Act Safeguards and Research Criteria for Transplantation of Organs From Donors With HIV","type":"Notice","abstract":"Kidney and liver transplants from donors with HIV no longer require institutional review board (IRB)-approved research protocols or compliance with HHS research criteria per a November 27, 2024, final rule. Through this notice, the U.S. Department of Health and Human Services (HHS) announces the publication of this accompanying Final Revised Safeguards and Research Criteria for Transplantation of Organs from Donors with HIV to apply to non-kidney and non-liver organs from donors with HIV for transplantation in recipients with HIV. Under the HOPE Act, these transplants must still occur under an IRB-approved research protocol that is compliant with federal regulations governing human subjects' research. The goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of transplants other than liver and kidney, from donors with HIV, thereby expanding access to organs for patients with HIV in need of transplants. HHS published Draft Revised Safeguards and Research Criteria on December 12, 2024. A summary of the public comments and HHS' responses follows. As explained below, NIH adopts revised research criteria as proposed except that NIH removed residual stigmatizing language from the title of the Research Criteria.","document_number":"2024-31265","html_url":"https://www.federalregister.gov/documents/2024/12/30/2024-31265/final-revised-human-immunodeficiency-virus-hiv-organ-policy-equity-act-safeguards-and-research","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-30/pdf/2024-31265.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31265.pdf?1735307160","publication_date":"2024-12-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"remain subject to the Research Criteria. NIH has removed the requirements from the 2015 Research Criteria applicable to HOPE Act kidney and liver transplants. \n \n NIH has also made other changes to the 2015 NIH Research Criteria for conducting HOPE Act transplants of organs other than kidneys and livers (primarily heart and lung transplants) in IRB-approved research. These changes are intended to accelerate research, ensure research participant safety, and maintain stakeholder confidence in clinical research conducted under the HOPE Act. Notable revisions"},{"title":"Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act","type":"Rule","abstract":"The Department of Health and Human Services (HHS) amends the regulations implementing the National Organ Transplant Act of 1984, as amended (NOTA), to remove clinical research and institutional review board (IRB) requirements (\"research and IRB requirements\") for transplantation of kidneys and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. As allowed by the HIV Organ Policy Equity (HOPE) Act, the Secretary of HHS determines that participation in such clinical research should no longer be a requirement for transplantation of kidneys and livers from donors with HIV to recipients with HIV. This final rule serves as publication of the Secretary's determination and amends the regulations to reflect this determination. This final rule also serves as publication of the Secretary's direction to the Organ Procurement and Transplantation Network (OPTN) to adopt and use standards of quality with respect to kidneys and livers from donors with HIV to ensure that HOPE Act kidney and liver transplants are subject to OPTN policies that are consistent with NOTA, and in a way that ensures the revised requirements for transplantation of such organs will not reduce the safety of organ transplantation.","document_number":"2024-27410","html_url":"https://www.federalregister.gov/documents/2024/11/27/2024-27410/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-hope-act","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-27/pdf/2024-27410.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-27410.pdf?1732628714","publication_date":"2024-11-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"revised NIH Research Criteria, and other comments received appear relevant to the content of the Research Criteria. These comments are noted below in both the subheading discussing the comments specifically provided on the Research Criteria, as well as in the subheadings relating to the subject matter of the comment when the commenter did not specifically reference the Research Criteria. All comments relating to the content of the revised Research Criteria were provided to NIH for consideration in the development of the revised Research Criteria."},{"title":"Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act","type":"Proposed Rule","abstract":"The Department of Health and Human Services (HHS) proposes to amend the regulations implementing the National Organ Transplant Act of 1984, as amended (NOTA), to remove clinical research and institutional review board (IRB) requirements (\"research and IRB requirements\") for transplantation of kidney and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. As allowed by the HIV Organ Policy Equity (HOPE) Act, the Secretary of HHS proposes to determine that participation in such clinical research should no longer be a requirement for transplantation of HIV positive kidneys and livers from donors with HIV to recipients with HIV. This proposed rule serves as publication of the Secretary's proposed determination and proposes to amend the regulations to reflect this determination. Consistent with NOTA and current regulatory requirements, the Secretary's proposed determination and the proposed corresponding regulatory revision, if finalized, will necessitate that the Organ Procurement and Transplantation Network (OPTN) adopt and use standards of quality concerning kidneys and livers from donors with HIV, as directed by the Secretary, consistent with NOTA and in a way that ensures the revised requirements for transplantation of such organs will not reduce the safety of organ transplantation.","document_number":"2024-20643","html_url":"https://www.federalregister.gov/documents/2024/09/12/2024-20643/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-hope-act","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-12/pdf/2024-20643.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20643.pdf?1726058732","publication_date":"2024-09-12","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":" Segev DL; HOPE in Action Investigators. HOPE in action: A prospective multicenter pilot study of liver transplantation from donors with HIV to recipients with HIV. Am J Transplant. 2022 Mar;22(3):853-864.\n \n \n Ongoing Clinical Trials \n \n Two NIH-funded studies on kidney and liver HOPE Act transplants are ongoing. The NIH-funded U01 HOPE Act kidney transplant clinical trial is designed to analyze rejection and long-term outcomes of kidney transplantation for recipients with HIV. The study will compare outcomes of 100 HOPE Act kidney transplant recipients"},{"title":"Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, Conditions for Coverage for End-Stage Renal Disease Facilities, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model","type":"Rule","abstract":"This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2025. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule updates requirements for the Conditions for Coverage for ESRD Facilities, ESRD Quality Incentive Program, and ESRD Treatment Choices Model.","document_number":"2024-25486","html_url":"https://www.federalregister.gov/documents/2024/11/12/2024-25486/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-12/pdf/2024-25486.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25486.pdf?1730492128","publication_date":"2024-11-12","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":" ESRD is a kidney impairment that is irreversible and permanent. Dialysis is a process for cleaning the blood and removing excess fluid artificially with special equipment when the kidneys have failed. People with ESRD require either a regular course of dialysis or kidney transplantation to live. Given the high costs and absolute necessity of transplantation or dialysis for people with failed kidneys, Medicare provides health care coverage to qualifying individuals diagnosed with ESRD, regardless of age, including coverage for kidney transplantation"},{"title":"Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model","type":"Rule","abstract":"This final rule describes a new mandatory alternative payment model, the Increasing Organ Transplant Access Model (IOTA Model), that will test whether performance-based upside risk payments or downside risk payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end- stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures. This final rule also adopts standard provisions that will apply to the Radiation Oncology Model, the End-Stage Renal Disease (ESRD) Treatment Choices Model, and mandatory Innovation Center models, including the IOTA Model, whose first performance period begins on or after January 1, 2025. The finalized standard provisions relate to beneficiary protections; cooperation in model evaluation and monitoring; audits and records retention; rights in data and intellectual property; monitoring and compliance; remedial action; model termination by CMS; limitations on review; miscellaneous provisions on bankruptcy and other notifications; and the reconsideration review process.","document_number":"2024-27841","html_url":"https://www.federalregister.gov/documents/2024/12/04/2024-27841/medicare-program-alternative-payment-model-updates-and-the-increasing-organ-transplant-access-iota","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-04/pdf/2024-27841.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-27841.pdf?1732655723","publication_date":"2024-12-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"org/atoz/content/transplant-waitlist \n .\n \n \n \n \n 20 \n \n The kidney transplant waitlist. \n (n.d.). Transplant Living. \n https://transplantliving.org/kidney/the-kidney-transplant-waitlist/ \n .\n \n \n \n \n 21 \n National kidney Foundation. (2019, June 12). \n Understanding the transplant waitlist. \n National Kidney Foundation. \n https://www.kidney.org/content/understanding-transplant-waitlist \n .\n \n \n 22 \n National kidney Foundation. (2016, August 4). \n Multiple Listing for Kidney Transplant. \n National Kidney Foundation. \n https://www.kidney.org/atoz/content/multiple-listing"},{"title":"Office of the Director; Notice of Charter Renewal","type":"Notice","abstract":null,"document_number":"2026-11519","html_url":"https://www.federalregister.gov/documents/2026/06/09/2026-11519/office-of-the-director-notice-of-charter-renewal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-09/pdf/2026-11519.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11519.pdf?1780690508","publication_date":"2026-06-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"duties and authorities, including but not limited to research hospital administration/operations, clinical care, safety and quality, clinical and research compliance, or clinical research, and (b) two individuals who have participated in clinical research studies as patients. Appointed members will be selected from the academic and private sector research community, as well as the general public. \n \n 4. \n List of all other Federal advisory committees of the agency: \n \n • Advisory Committee on Research on Women's Health \n • Advisory Committee to the Director"},{"title":"Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, Conditions for Coverage for End-Stage Renal Disease Facilities, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model","type":"Proposed Rule","abstract":"This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2025. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this proposed rule would update requirements for the Conditions for Coverage for ESRD Facilities, ESRD Quality Incentive Program, and ESRD Treatment Choices Model.","document_number":"2024-14359","html_url":"https://www.federalregister.gov/documents/2024/07/05/2024-14359/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-05/pdf/2024-14359.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14359.pdf?1719519316","publication_date":"2024-07-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":" ESRD is a kidney impairment that is irreversible and permanent. Dialysis is a process for cleaning the blood and removing excess fluid artificially with special equipment when the kidneys have failed. People with ESRD require either a regular course of dialysis or kidney transplantation to live. Given the high costs and absolute necessity of transplantation or dialysis for people with failed kidneys, Medicare provides health care coverage to qualifying individuals diagnosed with ESRD, regardless of age, including coverage for kidney transplantation"},{"title":"Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model","type":"Proposed Rule","abstract":"This proposed rule describes a new mandatory Medicare payment model, the Increasing Organ Transplant Access Model (IOTA Model), that would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end-stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures. This proposed rule also includes standard provisions that would apply to Innovation Center models whose first performance period begins on or after January 1, 2025, and also would apply, in whole or part, to any Innovation Center model whose first performance period begins prior to January 1, 2025 should such model's governing documentation incorporate the provisions by reference in whole or in part. The proposed standard provisions relate to beneficiary protections; cooperation in model evaluation and monitoring; audits and records retention; rights in data and intellectual property; monitoring and compliance; remedial action; model termination by CMS; limitations on review; miscellaneous provisions on bankruptcy and other notifications; and the reconsideration review process.","document_number":"2024-09989","html_url":"https://www.federalregister.gov/documents/2024/05/17/2024-09989/medicare-program-alternative-payment-model-updates-and-the-increasing-organ-transplant-access-iota","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-17/pdf/2024-09989.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09989.pdf?1715199328","publication_date":"2024-05-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"The efficiency domain would assess the kidney organ offer acceptance rate ratio for each IOTA participant. The kidney organ offer acceptance rate ratio measures the number of kidneys an IOTA participant accepts for transplant over the expected value, based on variables such as kidney quality. Points for the kidney organ offer acceptance rate ratio would be determined relative to either the kidney organ offer acceptance rate ratio across all kidney transplant hospitals, or the IOTA participant's own past kidney organ offer acceptance rate ratio, with"},{"title":"Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage","type":"Proposed Rule","abstract":"This proposed rule would revise the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and enable OPOs to make better informed decisions to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. This rule would revise definitions, add new Quality Assessment Performance Improvement (QAPI) requirements related to medically complex organs and donors, revise the designation requirements for OPOs, clarify when an OPO's service area is open for competition, and update the process for appeals. It also includes a discussion of factors we would consider when selecting a successor OPO during a competition under the tiered approach to re-certification. We are committed to holding all OPOs accountable for their performance and this proposed rule does not revise the focus on improving the volume of donors and transplants assessed in the outcome measures or the tier structure used for re- certification and de-certification of OPOs.","document_number":"2026-01833","html_url":"https://www.federalregister.gov/documents/2026/01/30/2026-01833/medicare-and-medicaid-programs-organ-procurement-organizations-conditions-for-coverage-revisions-to","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-30/pdf/2026-01833.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-01833.pdf?1769616910","publication_date":"2026-01-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"pancreata used for islet cell research will have little effect on the rankings of OPOs when calculating the donation outcome measure because the volume of \n bona fide \n pancreatic islet cell research conducted by a qualified researcher, that is bench only research with no transplants, is limited nationwide. By nature of the status of the research field and the requirements needed to move this treatment from research to standard clinical practice, the overall impact of including these pancreata used for islet cell research to implement the requirements"},{"title":"Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650","type":"Notice","abstract":"The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) refusing to approve a new drug application (NDA) submitted by Intarcia Therapeutics, Inc., an i2o Therapeutics Business Unit, (Intarcia) for ITCA 650 (exenatide in DUROS device). FDA has determined that the approval criteria in the FD&C Act have not been met because Intarcia has failed to demonstrate that ITCA 650 is safe for its intended conditions of use.","document_number":"2024-18898","html_url":"https://www.federalregister.gov/documents/2024/08/23/2024-18898/final-decision-on-the-proposal-to-refuse-to-approve-a-new-drug-application-for-itca-650","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-23/pdf/2024-18898.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-18898.pdf?1724330720","publication_date":"2024-08-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"applicants propose acceptance criteria, and FDA may agree or disagree with the proposal, depending on the data. The data submitted by Intarcia are intended to show that the device meets the proposed acceptance criteria to a specific confidence interval. Even if the specific ITCA 650 performance data submitted are within a tighter range than the acceptance criteria proposed by Intarcia, those acceptance criteria are inappropriate because they would allow for manufacture of the device with unacceptably wide criteria. As stated in CDER's proposed order"},{"title":"Notice Regarding the Uyghur Forced Labor Prevention Act Entity List","type":"Notice","abstract":"The U.S. Department of Homeland Security (DHS), as the Chair of the Forced Labor Enforcement Task Force (FLETF), announces the publication and availability of the updated Uyghur Forced Labor Prevention Act (UFLPA) Entity List, a consolidated register of the four lists required to be developed and maintained pursuant to the UFLPA, on the DHS UFLPA website. The updated UFLPA Entity List is also published as an appendix to this notice. This update adds five entities to the section 2(d)(2)(B)(ii) list of the UFLPA and twenty-five entities to the section 2(d)(2)(B)(v) list of the UFLPA. Further, this update includes a technical correction to remove an alias for one entity already on the UFLPA Entity List. Details related to the process for revising the UFLPA Entity List are included in this Federal Register notice.","document_number":"2024-27337","html_url":"https://www.federalregister.gov/documents/2024/11/25/2024-27337/notice-regarding-the-uyghur-forced-labor-prevention-act-entity-list","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-25/pdf/2024-27337.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-27337.pdf?1732283118","publication_date":"2024-11-25","agencies":[{"raw_name":"DEPARTMENT OF HOMELAND SECURITY","name":"Homeland Security Department","id":227,"url":"https://www.federalregister.gov/agencies/homeland-security-department","json_url":"https://www.federalregister.gov/api/v1/agencies/227","parent_id":null,"slug":"homeland-security-department"}],"excerpts":"to, or removals from, the UFLPA Entity List based on criteria described in clauses (i), (ii), (iv), or (v) of section 2(d)(2)(B) of the UFLPA. Any FLETF member agency may submit a recommendation(s) to add, remove or make technical corrections to an entry on the UFLPA Entity List. FLETF member agencies will review and vote on revisions to the UFLPA Entity List accordingly.\n \n Additions to the Entity List \n The FLETF will consider future additions to the UFLPA Entity List based on the criteria described in clauses (i), (ii), (iv), or (v) of section"},{"title":"Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of Nationwide Temporary Moratoria on Enrollment of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Supplier Medical Supply Companies","type":"Notice","abstract":"This notice announces the imposition of a 6-month nationwide moratorium on the Medicare enrollment of DMEPOS supplier medical supply companies.","document_number":"2026-03971","html_url":"https://www.federalregister.gov/documents/2026/02/27/2026-03971/medicare-medicaid-and-childrens-health-insurance-programs-announcement-of-nationwide-temporary","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-27/pdf/2026-03971.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03971.pdf?1772054108","publication_date":"2026-02-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Affordable Care Act added specific moratorium language applicable to Medicaid at section 1902(kk)(4) of the Act, requiring States to comply with any moratorium imposed by the Secretary unless the state determines that the imposition of such moratorium would adversely impact Medicaid beneficiaries' access to care. Section 6401(c) of the Affordable Care Act amended section 2107(e)(1) of the Act to provide that all the Medicaid provisions in sections 1902(a)(77) and 1902(kk) are also applicable to CHIP. \n \n In February 2011, in accordance with the aforementioned"},{"title":"Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements","type":"Proposed Rule","abstract":"This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2027. This proposed rule also includes an analysis of Medicare non-hospice spending, including details regarding a hospice service and spending variation index (SSVI), and proposes to require that hospices provide the hospice election statement addendum to all Medicare beneficiaries at the time of hospice election. Additionally, this rule proposes conforming regulation text changes to discharge from hospice care regulations; regulation text changes to the face-to-face encounter regulations; and includes requests for information on community palliative care services; the construction of a hospice specific wage index; and the overlap between hospice and medical aid in dying (MAID). Finally, this rule proposes changes to the Hospice Quality Reporting Program.","document_number":"2026-06604","html_url":"https://www.federalregister.gov/documents/2026/04/06/2026-06604/medicare-program-fy-2027-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reporting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-06/pdf/2026-06604.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06604.pdf?1775160907","publication_date":"2026-04-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"through the Hospice Outcomes and Patient Evaluation (HOPE) tool and plans for further development. The FY 2026 Hospice Wage Index final rule provided updates on the HOPE instrument and public reporting.\n \n Table 12 shows the current quality measures in effect for the FY 2027 HQRP, which were updated and finalized in the FY 2025 Hospice Wage Index and Payment Rate Update final rule. \n BILLING CODE 4120-01-P \n \n EP06AP26.013 \n \n BILLING CODE 4120-01-C \n 2. Updates Regarding the HOPE Measures \n The HOPE assessment was developed as the new patient assessment"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; and Other Policy Changes","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital- related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); update and make changes to requirements for certain quality programs; and make other policy-related changes.","document_number":"2026-07203","html_url":"https://www.federalregister.gov/documents/2026/04/14/2026-07203/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-ipps-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-14/pdf/2026-07203.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07203.pdf?1775852113","publication_date":"2026-04-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"warranted is to determine if all the criteria is satisfied for a three-way split. In applying the criteria for a three-way split, a base MS-DRG is initially subdivided into the three subgroups: MCC, CC, and NonCC. Each subgroup is then analyzed in relation to the other two subgroups using the volume (Criteria 1 and 2), average cost (Criteria 3 and 4), and reduction in variance (Criteria 5). If the criteria fail, the next step is to determine if the criteria are satisfied for a two-way split. In applying the criteria for a two-way split, a base MS-DRG"},{"title":"Medicare Program; FY 2025 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, and Hospice Quality Reporting Program Requirements","type":"Rule","abstract":"This final rule updates the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2025. This rule also adopts the most recent Office of Management and Budget statistical area delineations, which will impact the hospice wage index. This rule clarifies current policy related to the \"election statement\" and the \"notice of election\", as well as adds clarifying language regarding hospice certification and includes a technical regulation text change to the Conditions of Participation (CoPs). This rule finalizes changes to the Hospice Quality Reporting Program. Finally, this rule summarizes comments received regarding potential implementation of a separate payment mechanism to account for high intensity palliative care services.","document_number":"2024-16910","html_url":"https://www.federalregister.gov/documents/2024/08/06/2024-16910/medicare-program-fy-2025-hospice-wage-index-and-payment-rate-update-hospice-conditions-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-06/pdf/2024-16910.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16910.pdf?1722370514","publication_date":"2024-08-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"hospice best practices. We will continue to monitor the provision and burden of in-person HOPE follow-up visits after HOPE implementation and evaluate whether revisions to the HOPE administration requirements are necessary. If modifications to the HOPE instrument are required, they will be proposed in future rulemaking. \n CMS also reminds commenters that the burden calculations associated with HOPE only reflect the costs of implementation and administration of the HOPE assessment instrument, and do not include costs hospices may incur associated with visits"},{"title":"Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Large Municipal Waste Combustors Voluntary Remand Response and Five-Year Review","type":"Rule","abstract":"The U.S. Environmental Protection Agency (EPA) is finalizing new source performance standards (NSPS) and emission guidelines (EG) for the large municipal waste combustion (MWC) source category. This final rule responds to a voluntary remand of the preceding rule for this source category and announces the results of the non-discretionary review at five-year intervals required by Clean Air Act (CAA) section 129(a)(5), fulfilling the requirements of a consent decree for the source category. The final rule revises the remanded emission limits for cadmium, lead, particulate matter, polychlorinated dibenzodioxins and dibenzofurans, mercury, hydrogen chloride, and sulfur dioxide for all sources subject to the NSPS and EG and the remanded emission limits for nitrogen oxides and carbon monoxide for some sources subject to the EG and all sources subject to the NSPS. This final rule also removes certain startup, shutdown, and malfunction (SSM) exclusions and exemptions. In addition, the EPA is taking this opportunity to streamline regulatory language; revise recordkeeping and reporting requirements; establish electronic notification; reestablish new and existing source applicability dates; eliminate title V requirements for air curtain incinerators that burn only wood waste, yard waste, and clean lumber; close a 2007 proposed reconsideration action; and make certain typographical and technical corrections and clarifications. The EPA estimates this final rule will result in 3,269 tpy reduction in regulated pollutants from existing sources through implementation of the final emission limits.","document_number":"2026-04646","html_url":"https://www.federalregister.gov/documents/2026/03/10/2026-04646/standards-of-performance-for-new-stationary-sources-and-emission-guidelines-for-existing-sources","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-10/pdf/2026-04646.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04646.pdf?1773060312","publication_date":"2026-03-10","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"Changes to the Large MWC EG and NSPS \n 1. Changes to the Applicability Date of the 1995 Large MWC EG and NSPS \n a. What did we propose regarding applicability dates for the large MWC source category? \n The EPA proposed new applicability dates for determining whether units are “existing” or “new” sources. Specifically, we proposed that large MWC units that are currently subject to the NSPS would become existing sources under the proposed amended standards and subject to the revised EG by the applicable compliance date for the revised guidelines. However"},{"title":"Heat Injury and Illness Prevention in Outdoor and Indoor Work Settings","type":"Proposed Rule","abstract":"OSHA is proposing to issue a new standard, titled Heat Injury and Illness Prevention in Outdoor and Indoor Work Settings. The standard would apply to all employers conducting outdoor and indoor work in all general industry, construction, maritime, and agriculture sectors where OSHA has jurisdiction, with some exceptions. It would be a programmatic standard that would require employers to create a plan to evaluate and control heat hazards in their workplace. It would more clearly set forth employer obligations and the measures necessary to effectively protect employees from hazardous heat. OSHA requests comments on all aspects of the proposed rule.","document_number":"2024-14824","html_url":"https://www.federalregister.gov/documents/2024/08/30/2024-14824/heat-injury-and-illness-prevention-in-outdoor-and-indoor-work-settings","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-30/pdf/2024-14824.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14824.pdf?1724935516","publication_date":"2024-08-30","agencies":[{"raw_name":"DEPARTMENT OF LABOR","name":"Labor Department","id":271,"url":"https://www.federalregister.gov/agencies/labor-department","json_url":"https://www.federalregister.gov/api/v1/agencies/271","parent_id":null,"slug":"labor-department"},{"raw_name":"Occupational Safety and Health Administration","name":"Occupational Safety and Health Administration","id":386,"url":"https://www.federalregister.gov/agencies/occupational-safety-and-health-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/386","parent_id":271,"slug":"occupational-safety-and-health-administration"}],"excerpts":"risk of chronic kidney disease and end-stage renal disease, particularly if kidney stones are recurrent (Uribarri, 2020). \n E. Summary \n The available peer-reviewed scientific literature demonstrates occupational heat exposure as a risk factor for kidney stones, in both indoor and outdoor environments. Kidney stones may require medical treatment and in some cases hospitalization. Finally, individuals who develop kidney stones are at increased risk of other kidney diseases. \n III. Acute Kidney Injury \n A. Introduction \n \n Acute kidney injury (AKI) can"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization","type":"Rule","abstract":"This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hospitals; updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); updates and makes changes to requirements for certain quality programs; and makes other policy- related changes. We are also finalizing the provisions of the interim final action with comment period regarding the changes to the FY 2025 IPPS rates due to the court decision in Bridgeport Hosp. v. Becerra. Lastly, it finalizes certain updates to the ONC Health Information Technology (IT) Certification Program.","document_number":"2025-14681","html_url":"https://www.federalregister.gov/documents/2025/08/04/2025-14681/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-ipps-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-04/pdf/2025-14681.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14681.pdf?1753992911","publication_date":"2025-08-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"warranted is to determine if all the criteria is satisfied for a three-way split. In applying the criteria for a three-way split, a base MS-DRG is initially subdivided into the three subgroups: MCC, CC, and NonCC. Each subgroup is then analyzed in relation to the other two subgroups using the volume (Criteria 1 and 2), average cost (Criteria 3 and 4), and reduction in variance (Criteria 5). If the criteria fail, the next step is to determine if the criteria are satisfied for a two-way split. In applying the criteria for a two-way split, a base MS-DRG"},{"title":"Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments","type":"Rule","abstract":"This final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for, the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; updates to the Medicare Diabetes Prevention Program expanded model; payment for dental services inextricably linked to specific covered medical services; updates to drugs and biological products paid under Part B including immunosuppressive drugs and clotting factors; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or a Medicare Advantage Prescription Drug (MA-PD) plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the diabetes payment structure and PHE flexibilities; expansion of colorectal cancer screening and Hepatitis B vaccine coverage and payment; establishing payment for drugs covered as additional preventive services; Medicare Parts A and B Overpayment Provisions of the Affordable Care Act and Medicare Parts C and D Overpayment Provisions of the Affordable Care Act.","document_number":"2024-25382","html_url":"https://www.federalregister.gov/documents/2024/12/09/2024-25382/medicare-and-medicaid-programs-cy-2025-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-09/pdf/2024-25382.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25382.pdf?1730492138","publication_date":"2024-12-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"peritoneal dialysis) or kidney replacement therapy.\n \n \n \n 213 \n American Kidney Fund. All about the kidneys. Stages of kidney disease (CKD). \n https://www.kidneyfund.org/all-about-kidneys/stages-kidney-disease \n (accessed 2024-07-21).\n \n \n \n \n 214 \n Centers for Disease Control and Prevention. About Post-Streptococcal Glomerulonephritis. \n https://www.cdc.gov/group-a-strep/about/post-streptococcal-glomerulonephritis.html \n .\n \n \n \n \n 215 \n Ibid.\n \n \n \n \n 216 \n American Kidney Fund. All about the kidneys. Stages of kidney disease (CKD). \n https://www"}]}