{"description":"Documents matching 'research transplantation kidneys livers donors'","count":223,"total_pages":12,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=research+transplantation+kidneys+livers+donors&format=json&page=2","results":[{"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":"example, while a <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> from a <span class=\"match\">donor</span> with HIV no longer is required to be conducted in accordance with the <span class=\"match\">Research</span> Criteria, a dual heart-<span class=\"match\">kidney</span> or dual lung-<span class=\"match\">kidney</span> <span class=\"match\">transplant</span> with organs from <span class=\"match\">donors</span> with HIV is required to be conducted in accordance with the <span class=\"match\">Research</span> Criteria and in accordance with an IRB-approved <span class=\"match\">research</span> protocol. A dual <span class=\"match\">liver</span>-<span class=\"match\">kidney</span> <span class=\"match\">transplant</span> with from <span class=\"match\">donors</span> with HIV is not required to be conducted in accordance with the <span class=\"match\">Research</span> Criteria, as neither <span class=\"match\">liver</span> <span class=\"match\">transplants</span> nor <span class=\"match\">kidney</span> <span class=\"match\">transplants</span> from <span class=\"match\">donors</span> with HIV are"},{"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":"Act <span class=\"match\">transplants</span>, each of which contributed to the recommendation the OPTN provided to the Secretary: (1) the <span class=\"match\">research</span> results of two pilot studies evaluating HOPE Act <span class=\"match\">kidney</span> <span class=\"match\">transplants</span> and <span class=\"match\">liver</span> <span class=\"match\">transplants</span>, and the progress of two ongoing NIH-funded clinical trials evaluating HOPE Act <span class=\"match\">kidney</span> <span class=\"match\">transplants</span> and <span class=\"match\">liver</span> <span class=\"match\">transplants</span>, (2) the <span class=\"match\">research</span> results of an older clinical trial analyzing safety and efficacy of <span class=\"match\">kidney</span> <span class=\"match\">transplants</span> in a small cohort of <span class=\"match\">transplant</span> recipients with HIV, and (3) OPTN data on the outcomes of all HOPE Act <span class=\"match\">transplants</span>. \n"},{"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 <span class=\"match\">research</span> subject to the 2015 <span class=\"match\">Research</span> Criteria and to continue to further the goals shared in 2015 with respect to HOPE Act <span class=\"match\">transplants</span> of other organs from <span class=\"match\">donors</span> with HIV that remain subject to the <span class=\"match\">Research</span> Criteria. NIH proposes to remove requirements from the <span class=\"match\">Research</span> Criteria applicable to HOPE Act <span class=\"match\">kidney</span> and <span class=\"match\">liver</span> <span class=\"match\">transplants</span>. \n \n NIH also proposes other changes to the 2015 NIH <span class=\"match\">Research</span> Criteria for conducting HOPE Act <span class=\"match\">transplants</span> of organs other than <span class=\"match\">kidneys</span> and <span class=\"match\">livers</span> (primarily heart and lung <span class=\"match\">transplants</span>) in IRB-approved <span class=\"match\">research</span>. The"},{"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":"prospective multicenter pilot study of <span class=\"match\">liver</span> <span class=\"match\">transplantation</span> from <span class=\"match\">donors</span> with HIV to recipients with HIV. Am J <span class=\"match\">Transplant</span>. 2022 Mar;22(3):853-864.\n \n \n Ongoing Clinical Trials \n \n Two NIH-funded studies on <span class=\"match\">kidney</span> and <span class=\"match\">liver</span> HOPE Act <span class=\"match\">transplants</span> are ongoing. The NIH-funded U01 HOPE Act <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> clinical trial is designed to analyze rejection and long-term outcomes of <span class=\"match\">kidney</span> <span class=\"match\">transplantation</span> for recipients with HIV. The study will compare outcomes of 100 HOPE Act <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> recipients to 100 <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> recipients with HIV who received"},{"title":"Modification of Living Organ Donation Reimbursement Program Eligibility Guidelines in Response To Honor Our Living Donors Act","type":"Notice","abstract":"HRSA proposes to modify the eligibility guidelines for the Living Organ Donation Reimbursement Program (LODRP) to align with the Honor Our Living Donors (HOLD) Act, enacted on February 3, 2026. The HOLD Act prohibits consideration of the income of the organ transplant recipient in determining eligibility for reimbursement of qualifying non-medical expenses related to living organ donation under LODRP. Consistent with this statutory requirement, HRSA proposes to revise the LODRP eligibility guidelines to eliminate recipient income as a factor in eligibility determinations and to establish a donor-focused eligibility framework based on donor household income and financial need. HRSA will continually monitor the effectiveness and availability of funds for LODRP and further modify the eligibility guidelines in the future if needed.","document_number":"2026-13250","html_url":"https://www.federalregister.gov/documents/2026/07/01/2026-13250/modification-of-living-organ-donation-reimbursement-program-eligibility-guidelines-in-response-to","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-01/pdf/2026-13250.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13250.pdf?1782823512","publication_date":"2026-07-01","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"excerpts":"after all requests for expenses incurred by the <span class=\"match\">donor</span>, and expenses for persons accompanying or assisting the <span class=\"match\">donor</span> for qualifying expenses for travel, housing, meals, and incidental expenses, have been processed under all four preference categories. \n Maximum Number of Prospective <span class=\"match\">Donors</span> per Recipient \n \n • \n <span class=\"match\">Kidney</span>: \n One <span class=\"match\">donor</span> at a time, with a maximum of three <span class=\"match\">donors</span>.\n \n \n • \n <span class=\"match\">Liver</span>: \n One <span class=\"match\">donor</span> at a time, with a maximum of five <span class=\"match\">donors</span>.\n \n \n • \n Lung: \n Two <span class=\"match\">donors</span> at a time, with a maximum of six <span class=\"match\">donors</span>.\n \n Special Provisions \n Many factors may prevent"},{"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 would also be removed from the organ <span class=\"match\">transplantation</span> rate outcome measure. <span class=\"match\">Research</span> activity would no longer count as a <span class=\"match\">transplant</span> for purposes of certification and re-certification.\n \n \n Medically Complex Organs and <span class=\"match\">Donors</span>. \n Organs from <span class=\"match\">donors</span> that fall outside the generally accepted standards for <span class=\"match\">transplantation</span> due to <span class=\"match\">donor</span> age or health status are underutilized. However, <span class=\"match\">research</span> has indicated that many of these organs can be successfully <span class=\"match\">transplanted</span> when appropriately placed with a <span class=\"match\">transplant</span> candidate.\n 2 \n  \n 3 \n \n We propose to define"},{"title":"Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model","type":"Rule","abstract":"This final rule will update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2. This final rule also includes a technical correction to the regulatory text.","document_number":"2026-10890","html_url":"https://www.federalregister.gov/documents/2026/06/01/2026-10890/medicare-program-alternative-payment-model-updates-and-the-increasing-organ-transplant-access-iota","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-01/pdf/2026-10890.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10890.pdf?1779999311","publication_date":"2026-06-01","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":"and avoid burden on <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> hospitals that furnish a smaller number of <span class=\"match\">kidney</span> <span class=\"match\">transplants</span>. Finally, a commenter suggested CMS should only use the number of Medicare <span class=\"match\">kidney</span> <span class=\"match\">transplants</span> to determine eligibility, rather than 11 <span class=\"match\">kidney</span> <span class=\"match\">transplants</span> across all payers. Additionally, as described at 89 FR 96308 a commenter expressed concerns about the impact of the IOTA Model on small <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> hospitals if participation was made mandatory. The commenter suggested that a low volume threshold of 100 <span class=\"match\">kidney</span> <span class=\"match\">transplants</span>, regardless of payer"},{"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":"Relative to dialysis, a <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> can improve survival, reduce avoidable health care utilization and hospital acquired conditions, improve quality of life, and lower Medicare expenditures.\n 4 5 \n \n However, despite these benefits of <span class=\"match\">kidney</span> <span class=\"match\">transplantation</span>, evidence shows low rates of ESRD patients placed on <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> hospitals' waitlists, a decline in living <span class=\"match\">donors</span> over the past 20 years, and underutilization of available <span class=\"match\">donor</span> <span class=\"match\">kidneys</span>, coupled with increasing rates of <span class=\"match\">donor</span> <span class=\"match\">kidney</span> discards, and wide variation in <span class=\"match\">kidney</span> offer acceptance"},{"title":"Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110-Revision","type":"Notice","abstract":"In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.","document_number":"2026-09804","html_url":"https://www.federalregister.gov/documents/2026/05/15/2026-09804/agency-information-collection-activities-proposed-collection-public-comment-request-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-15/pdf/2026-09804.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09804.pdf?1778762725","publication_date":"2026-05-15","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"excerpts":"Pancreas Post-<span class=\"match\">Transplant</span> Malignancy Form \n 127 \n 0.724 \n 92 \n 0.6 \n 55.17 \n \n \n 45 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Candidate Registration \n 127 \n 13.35 \n 1,695 \n 0.6 \n 1,017.27 \n \n \n 46 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Recipient Registration \n 127 \n 6.34 \n 805 \n 1.2 \n 966.22 \n \n \n 47 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Recipient Follow Up (6 Month-5 Year) \n 127 \n 35.55 \n 4,515 \n 0.5 \n 2,257.43 \n \n \n \n 48 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Recipient Follow Up (Post 5 Year) \n 127 \n 68.19 \n 8,660 \n 0.6 \n 5,196.08 \n \n \n 49 \n <span class=\"match\">Kidney</span>/Pancreas Post-<span class=\"match\">Transplant</span> Malignancy Form"},{"title":"Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network","type":"Notice","abstract":"In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.","document_number":"2025-11668","html_url":"https://www.federalregister.gov/documents/2025/06/25/2025-11668/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-25/pdf/2025-11668.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11668.pdf?1750769114","publication_date":"2025-06-25","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"excerpts":"Post-<span class=\"match\">Transplant</span> Malignancy Form \n 123 \n 0.76 \n 93.48 \n 0.60 \n 56.09 \n \n \n 45 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Candidate Registration \n 123 \n 12.94 \n 1,591.62 \n 0.60 \n 954.97 \n \n \n 46 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Recipient Registration \n 123 \n 6.59 \n 810.57 \n 1.20 \n 972.68 \n \n \n 47 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Recipient Follow Up (6-month-5 year) \n 123 \n 38.12 \n 4,688.76 \n 0.50 \n 2,344.38 \n \n \n 48 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Recipient Follow Up (Post 5 year) \n 123 \n 66.63 \n 8,195.49 \n 0.60 \n 4,917.29 \n \n \n 49 \n <span class=\"match\">Kidney</span>/Pancreas Post-<span class=\"match\">Transplant</span> Malignancy"},{"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":"sessions or a <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> is required for survival. Relative to dialysis, a <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> can improve survival, reduce avoidable health care utilization and hospital acquired conditions, improve quality of life, and lower Medicare expenditures.\n 3 \n  \n 4 \n \n However, despite these benefits, evidence shows low rates of ESRD patients placed on <span class=\"match\">kidney</span> <span class=\"match\">transplant</span> hospitals' waitlists, a decline in living <span class=\"match\">donors</span> over the past 20 years, and underutilization of available <span class=\"match\">donor</span> <span class=\"match\">kidneys</span>, coupled with increasing rates of <span class=\"match\">donor</span> <span class=\"match\">kidney</span> discards, and"},{"title":"Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network","type":"Notice","abstract":"In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.","document_number":"2024-25506","html_url":"https://www.federalregister.gov/documents/2024/11/01/2024-25506/agency-information-collection-activities-proposed-collection-public-comment-request-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-01/pdf/2024-25506.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25506.pdf?1730378735","publication_date":"2024-11-01","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"excerpts":"Pancreas Post-<span class=\"match\">Transplant</span> Malignancy Form \n 123 \n 0.76 \n 93 \n 0.60 \n 56.09 \n \n \n 45 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Candidate Registration \n 123 \n 12.94 \n 1,592 \n 0.60 \n 954.97 \n \n \n 46 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Recipient Registration \n 123 \n 6.59 \n 811 \n 1.20 \n 972.68 \n \n \n 47 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Recipient Follow Up (6 Month-5 Year) \n 123 \n 38.12 \n 4,689 \n 0.50 \n 2,344.38 \n \n \n 48 \n <span class=\"match\">Kidney</span>/Pancreas <span class=\"match\">Transplant</span> Recipient Follow Up (Post 5 Year) \n 123 \n 66.63 \n 8,195 \n 0.60 \n 4,917.29 \n \n \n 49 \n <span class=\"match\">Kidney</span>/Pancreas Post-<span class=\"match\">Transplant</span> Malignancy Form"},{"title":"Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157-Revision","type":"Notice","abstract":"In compliance with of the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.","document_number":"2023-12719","html_url":"https://www.federalregister.gov/documents/2023/06/14/2023-12719/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-06-14/pdf/2023-12719.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-12719.pdf?1686660327","publication_date":"2023-06-14","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"excerpts":"\n 0.40 \n 337.60 \n \n \n Intestine Post-<span class=\"match\">Transplant</span> Malignancy Form \n 21 \n 0.62 \n 13 \n 1.00 \n 13.00 \n \n \n <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> Candidate Registration \n 234 \n 177.00 \n 41,418 \n 0.80 \n 33,134.40 \n \n \n <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> Recipient Registration \n 234 \n 105.40 \n 24,664 \n 1.20 \n 29,596.80 \n \n \n <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> Recipient Follow Up (6 Month—5 Year) \n 234 \n 517.12 \n 121,006 \n 0.90 \n 108,905.40 \n \n \n <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> Recipient Follow Up (Post 5 Year) \n 234 \n 525.10 \n 122,873 \n 0.50 \n 61,436.50 \n \n \n <span class=\"match\">Kidney</span> Post-<span class=\"match\">Transplant</span> Malignancy Form \n 234 \n 24.47 \n 5,726"},{"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":"following <span class=\"match\">transplant</span> MS-LTC-DRGs: Heart <span class=\"match\">Transplant</span> or Implant of Heart Assist System with MCC (MS-LTC-DRG 001); Heart <span class=\"match\">Transplant</span> or Implant of Heart Assist System without MCC (MS-LTC-DRG 002); <span class=\"match\">Liver</span> <span class=\"match\">Transplant</span> with MCC or Intestinal <span class=\"match\">Transplant</span> (MS-LTC-DRG 005); <span class=\"match\">Liver</span> <span class=\"match\">Transplant</span> without MCC (MS-LTC-DRG 006); Lung <span class=\"match\">Transplant</span> (MS-LTC-DRG 007); Simultaneous Pancreas, Islet Cell and <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> (MS-LTC-DRG 008); Simultaneous Pancreas, Islet Cell and <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> with Hemodialysis (MS-LTC-DRG 019); Pancreas or Islet Cell <span class=\"match\">Transplant</span> (MS-LTC-DRG"},{"title":"Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157-Revision","type":"Notice","abstract":"In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.","document_number":"2022-21119","html_url":"https://www.federalregister.gov/documents/2022/09/29/2022-21119/agency-information-collection-activities-proposed-collection-public-comment-request-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-09-29/pdf/2022-21119.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-21119.pdf?1664369129","publication_date":"2022-09-29","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"excerpts":"Heart/Lung Post-<span class=\"match\">Transplant</span> Malignancy Form \n 70 \n 0.290 \n 20 \n 0.40 \n 8 \n \n \n <span class=\"match\">Liver</span> <span class=\"match\">Transplant</span> Candidate Registration \n 143 \n 96.920 \n 13,860 \n 0.80 \n 11,088 \n \n \n <span class=\"match\">Liver</span> <span class=\"match\">Transplant</span> Recipient Registration \n 143 \n 64.580 \n 9,235 \n 1.20 \n 11,082 \n \n \n <span class=\"match\">Liver</span> <span class=\"match\">Transplant</span> Recipient Follow-Up (6 Month-5 Year) \n 143 \n 320.266 \n 45,798 \n 1.00 \n 45,798 \n \n \n <span class=\"match\">Liver</span> <span class=\"match\">Transplant</span> Recipient Follow-Up (Post 5 Year) \n 143 \n 384.320 \n 54,958 \n 0.50 \n 27,479 \n \n \n <span class=\"match\">Liver</span> Recipient Explant Pathology Form \n 143 \n 7.300 \n 1,044 \n 0.60 \n 626 \n \n \n <span class=\"match\">Liver</span> Post-<span class=\"match\">Transplant</span> Malignancy"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 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":"2025-06271","html_url":"https://www.federalregister.gov/documents/2025/04/30/2025-06271/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-30/pdf/2025-06271.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-06271.pdf?1744402510","publication_date":"2025-04-30","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":"following <span class=\"match\">transplant</span> MS-LTC-DRGs: Heart <span class=\"match\">Transplant</span> or Implant of Heart Assist System with MCC (MS-LTC-DRG 001); Heart <span class=\"match\">Transplant</span> or Implant of Heart Assist System without MCC (MS-LTC-DRG 002); <span class=\"match\">Liver</span> <span class=\"match\">Transplant</span> with MCC or Intestinal <span class=\"match\">Transplant</span> (MS-LTC-DRG 005); <span class=\"match\">Liver</span> <span class=\"match\">Transplant</span> without MCC (MS-LTC-DRG 006); Lung <span class=\"match\">Transplant</span> (MS-LTC-DRG 007); Simultaneous Pancreas and <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> (MS-LTC-DRG 008); Simultaneous Pancreas and <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> with Hemodialysis (MS-LTC-DRG 019); Pancreas <span class=\"match\">Transplant</span> (MS-LTC-DRG 010); <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> (MS-LTC-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 <span class=\"match\">kidney</span> replacement therapy.\n \n \n \n 213 \n  American <span class=\"match\">Kidney</span> Fund. All about the <span class=\"match\">kidneys</span>. Stages of <span class=\"match\">kidney</span> disease (CKD). \n https://www.kidneyfund.org/all-about-<span class=\"match\">kidneys</span>/stages-<span class=\"match\">kidney</span>-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 <span class=\"match\">Kidney</span> Fund. All about the <span class=\"match\">kidneys</span>. Stages of <span class=\"match\">kidney</span> disease (CKD). \n https://www"},{"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":"following <span class=\"match\">transplant</span> MS-LTC-DRGs: Heart <span class=\"match\">Transplant</span> or Implant of Heart Assist System with MCC (MS-LTC-DRG 001); Heart <span class=\"match\">Transplant</span> or Implant of Heart Assist System without MCC (MS-LTC-DRG 002); <span class=\"match\">Liver</span> <span class=\"match\">Transplant</span> with MCC or Intestinal <span class=\"match\">Transplant</span> (MS-LTC-DRG 005); <span class=\"match\">Liver</span> <span class=\"match\">Transplant</span> without MCC (MS-LTC-DRG 006); Lung <span class=\"match\">Transplant</span> (MS-LTC-DRG 007); Simultaneous Pancreas and <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> (MS-LTC-DRG 008); Simultaneous Pancreas and <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> with Hemodialysis (MS-LTC-DRG 019); Pancreas <span class=\"match\">Transplant</span> (MS-LTC-DRG 010); <span class=\"match\">Kidney</span> <span class=\"match\">Transplant</span> (MS-LTC-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":"Proposed Rule","abstract":"This major proposed 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, and proposing 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.","document_number":"2024-14828","html_url":"https://www.federalregister.gov/documents/2024/07/31/2024-14828/medicare-and-medicaid-programs-cy-2025-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-31/pdf/2024-14828.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14828.pdf?1720642528","publication_date":"2024-07-31","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 successful adult <span class=\"match\">liver</span> <span class=\"match\">transplant</span>: 2012 practice guideline by the American Association for the Study of <span class=\"match\">Liver</span> Diseases and the American Society of <span class=\"match\">Transplantation</span>. <span class=\"match\">Liver</span> Transpl. 2013 Jan;19(1):3-26. doi: 10.1002/lt.23566.\n \n \n \n \n 282 \n  Nelson J, Alvey N, Bowman L, et al. Consensus recommendations for use of maintenance immunosuppression in solid organ <span class=\"match\">transplantation</span>: Endorsed by the American College of Clinical Pharmacy, American Society of <span class=\"match\">Transplantation</span>, and the International Society for Heart and Lung <span class=\"match\">Transplantation</span>. \n Pharmacotherapy"},{"title":"Medicare and Medicaid Programs and the Children's Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes","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); and makes other policy- related changes.","document_number":"2024-17021","html_url":"https://www.federalregister.gov/documents/2024/08/28/2024-17021/medicare-and-medicaid-programs-and-the-childrens-health-insurance-program-hospital-inpatient","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-28/pdf/2024-17021.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-17021.pdf?1722960072","publication_date":"2024-08-28","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 <span class=\"match\">transplant</span> cases that were used to establish the relative weights for heart and heart-lung, <span class=\"match\">liver</span> and/or intestinal, and lung <span class=\"match\">transplants</span> (MS-DRGs 001, 002, 005, 006, and 007, respectively) were limited to those Medicare-approved <span class=\"match\">transplant</span> centers that have cases in the FY 2023 MedPAR file. (Medicare coverage for heart, heart-lung, <span class=\"match\">liver</span> and/or intestinal, and lung <span class=\"match\">transplants</span> is limited to those facilities that have received approval from CMS as <span class=\"match\">transplant</span> centers.) \n • Organ acquisition costs for <span class=\"match\">kidney</span>, heart, heart-lung, <span class=\"match\">liver</span>, lung,"}]}