{"description":"Documents matching 'transplantation such organs will reduce'","count":750,"total_pages":38,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=transplantation+such+organs+will+reduce&format=json&page=2","results":[{"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":"Increasing <span class=\"match\">Organ</span> <span class=\"match\">Transplant</span> Access (IOTA) Model \n A. Background \n 1. Purpose \n The Increasing <span class=\"match\">Organ</span> <span class=\"match\">Transplant</span> Access (IOTA) Model is a 6-year mandatory alternative payment model tested by the CMS Innovation Center that began on July 1, 2025, and will end on June 30, 2031. The IOTA Model is testing whether performance-based incentives paid to or owed by participating kidney <span class=\"match\">transplant</span> hospitals can increase access to kidney <span class=\"match\">transplants</span> for kidney <span class=\"match\">transplant</span> waitlist patients, while preserving or enhancing quality of care and <span class=\"match\">reducing</span> Medicare expenditures"},{"title":"Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model","type":"Proposed Rule","abstract":"This proposed rule would update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2.","document_number":"2025-22543","html_url":"https://www.federalregister.gov/documents/2025/12/11/2025-22543/medicare-program-alternative-payment-model-updates-and-the-increasing-organ-transplant-access-iota","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-11/pdf/2025-22543.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22543.pdf?1765314907","publication_date":"2025-12-11","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":"FOR FURTHER INFORMATION CONTACT: \n \n \n CMMItransplant@cms.hhs.gov, \n for questions related to the Increasing <span class=\"match\">Organ</span> <span class=\"match\">Transplant</span> Access Model.\n \n Thomas Duvall, (410) 786-8887, for questions related to the Increasing <span class=\"match\">Organ</span> <span class=\"match\">Transplant</span> Access Model. \n Christina McCormick, (410) 786-4012, for questions related to the Increasing <span class=\"match\">Organ</span> <span class=\"match\">Transplant</span> Access Model. \n Lina Gebremariam, (410) 786-8893, for questions related to the Increasing <span class=\"match\">Organ</span> <span class=\"match\">Transplant</span> Access Model. \n \n \n \n SUPPLEMENTARY INFORMATION: \n \n \n Inspection of Public Comments: \n All comments received"},{"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":"non-liver HOPE Act <span class=\"match\">transplants</span>. Since 2019, when the OPTN's HOPE Act policy was expanded to include all solid <span class=\"match\">organs</span>, only three heart <span class=\"match\">transplant</span> programs have received approval to perform HOPE Act <span class=\"match\">transplants</span>. To date, just three heart <span class=\"match\">transplants</span> have been conducted, including one heart-kidney <span class=\"match\">transplant</span>.\n 21 22 \n \n No HOPE Act <span class=\"match\">transplants</span> have been recorded among recipients in need of other <span class=\"match\">organs</span>. The lack of data makes it difficult to assess the safety and outcomes of HOPE Act <span class=\"match\">transplants</span> other than kidney and liver HOPE Act <span class=\"match\">transplants</span>.\n \n \n \n 21"},{"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":"permit <span class=\"match\">transplants</span> of <span class=\"match\">organs</span> from donors with HIV in accordance with the HOPE Act requirements.\n \n \n \n 4 \n  \n Federal Register \n . <span class=\"match\">Organ</span> Procurement and <span class=\"match\">Transplantation</span>: Implementation of the HIV <span class=\"match\">Organ</span> Policy Equity (HOPE) Act. 2015 May:80 FR 26464. \n https://www.federalregister.gov/documents/2015/05/08/2015-11048/<span class=\"match\">organ</span>-procurement-and-<span class=\"match\">transplantation</span>-implementation-of-the-hiv-<span class=\"match\">organ</span>-policy-equity-act. \n \n \n \n The HOPE Act also directs the Secretary to develop and publish criteria for the conduct of research relating to <span class=\"match\">transplantation</span> of <span class=\"match\">organs</span> from"},{"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":"stem cell <span class=\"match\">transplantation</span>. Hum Hered. 2013;76(3-4):178-86. doi: 10.1159/000358798. Epub 2014 May 21. PMID: 24861862.\n \n \n The <span class=\"match\">transplantation</span> rate is calculated as the number of <span class=\"match\">organs</span> <span class=\"match\">transplanted</span> from donors in the DSA as a percentage of the donor potential. <span class=\"match\">Organs</span>, including pancreatic islet cells, <span class=\"match\">transplanted</span> into patients on the <span class=\"match\">Organ</span> Procurement and <span class=\"match\">Transplantation</span> Network (OPTN) waiting list as part of research are included in the <span class=\"match\">organ</span> <span class=\"match\">transplantation</span> rate. Pancreata that are used in islet cell research are also included. The <span class=\"match\">organ</span> transplantation"},{"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":"(PML). \n \n \n <span class=\"match\">Transplant</span> Hospital Criteria \n <span class=\"match\">Transplant</span> hospital with established program for care of subjects with HIV \n <span class=\"match\">Transplant</span> hospital with established program for care of patients with HIV. \n \n \n   \n HIV program expertise on the <span class=\"match\">transplant</span> team \n HIV program expertise on the <span class=\"match\">transplant</span> team. \n \n \n   \n <span class=\"match\">Organ</span>-specific experience with <span class=\"match\">transplants</span> of <span class=\"match\">organs</span> from donors without HIV to recipients with HIV (5 D-/R+ <span class=\"match\">transplant</span> cases over 4 years) \n There is no longer a center specific case experience requirement with <span class=\"match\">transplants</span> of <span class=\"match\">organs</span> from donors"},{"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":"donation of an <span class=\"match\">organ</span>. \n • Donor and recipient of the <span class=\"match\">organ</span> are U.S. citizens or lawfully present in the United States. \n • Donor and recipient have primary residences in the United States or its territories. \n • Travel is originating from the donor's primary residence. \n • Donor and recipient certify that they understand and are in compliance with Section 301 of National <span class=\"match\">Organ</span> <span class=\"match\">Transplant</span> Act (42 U.S.C. 274e) which states in part that it shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human <span class=\"match\">organ</span> for valuable"},{"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":"to as the <span class=\"match\">transplant</span> ecosystem) that comprises a vast network of institutions dedicated to ensuring that patients are evaluated and, if appropriate, placed onto the <span class=\"match\">organ</span> <span class=\"match\">transplant</span> waitlist, and that those on the <span class=\"match\">organ</span> <span class=\"match\">transplant</span> waitlist receive lifesaving <span class=\"match\">organ</span> <span class=\"match\">transplants</span>. <span class=\"match\">Transplantation</span> of livers, hearts, lungs, and other <span class=\"match\">organs</span> is also well established within the U.S. health care system. The <span class=\"match\">transplant</span> ecosystem includes the <span class=\"match\">Organ</span> Procurement and <span class=\"match\">Transplantation</span> Network (OPTN); <span class=\"match\">Organ</span> Procurement Organizations (OPOs); <span class=\"match\">transplant</span> hospitals"},{"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":"1016/j.kint.2018.02.016. \n \n \n 1. The <span class=\"match\">Transplant</span> Ecosystem \n \n Kidney <span class=\"match\">transplantation</span> occurs within an overall <span class=\"match\">organ</span> donation and <span class=\"match\">transplantation</span> system (also known and referred to as the <span class=\"match\">transplant</span> ecosystem) that comprises a vast network of institutions dedicated to ensuring that patients are evaluated and, if appropriate, placed onto the <span class=\"match\">organ</span> <span class=\"match\">transplant</span> waitlist, and that those on the <span class=\"match\">organ</span> <span class=\"match\">transplant</span> waitlist receive lifesaving <span class=\"match\">organ</span> <span class=\"match\">transplants</span>. <span class=\"match\">Transplantation</span> of livers, hearts, lungs, and other <span class=\"match\">organs</span> is also well established within the U"},{"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":"scientific and clinical status of <span class=\"match\">organ</span> <span class=\"match\">transplantation</span>; and (5) perform <span class=\"match\">transplantation</span>-related public health surveillance, including the possible transmission of donor disease. \n HRSA is requesting to make the following changes to improve the OPTN <span class=\"match\">organ</span> matching and allocation process and improve OPTN member compliance with OPTN requirements: \n (1) Adding data collection forms for candidates listed in the OPTN <span class=\"match\">organ</span> <span class=\"match\">transplant</span> waiting list to the existing OMB-approved information collection. These forms allow a <span class=\"match\">transplant</span> center to add, change, or remove"},{"title":"Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Process Data for Organ Procurement and Transplantation Network, OMB No. 0906-xxxx-New","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":"2025-12211","html_url":"https://www.federalregister.gov/documents/2025/07/01/2025-12211/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-01/pdf/2025-12211.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-12211.pdf?1751287523","publication_date":"2025-07-01","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":"the new forms. Both data collections include time-sensitive, life-critical data on <span class=\"match\">transplant</span> candidates and potential <span class=\"match\">organ</span> donor patients, the <span class=\"match\">organ</span> matching process, histocompatibility results, <span class=\"match\">organ</span> labeling and packaging, as well as pre- and post-<span class=\"match\">transplantation</span> data on recipients and donors. The OPTN collects these specific data elements from <span class=\"match\">transplant</span> centers. \n HRSA and the OPTN use this information to (1) facilitate <span class=\"match\">organ</span> placement and match donor <span class=\"match\">organs</span> with recipients; (2) monitor compliance of member organizations with federal laws and"},{"title":"Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Process Data 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 and any other aspect of the ICR.","document_number":"2024-25522","html_url":"https://www.federalregister.gov/documents/2024/11/04/2024-25522/agency-information-collection-activities-proposed-collection-public-comment-request-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-04/pdf/2024-25522.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25522.pdf?1730465120","publication_date":"2024-11-04","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":"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":"on the new forms. Both data collections include time-sensitive, life-critical data on <span class=\"match\">transplant</span> candidates and potential <span class=\"match\">organ</span> donor patients, the <span class=\"match\">organ</span> matching process, histocompatibility results, <span class=\"match\">organ</span> labeling and packaging, and pre-and post-<span class=\"match\">transplantation</span> data on recipients and donors. The OPTN collects these specific data elements from <span class=\"match\">transplant</span> centers. \n HRSA and the OPTN use this information to: (1) facilitate <span class=\"match\">organ</span> placement and match donor <span class=\"match\">organs</span> with recipients; (2) monitor compliance of member organizations with federal laws and"},{"title":"Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation OMB No. 0906-0034-Extension","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. The initial notice was published on November 17, 2023, with a 60-day comment period. No comments were received. OMB will accept comments from the public during the 30-day comment period for this notice. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.","document_number":"2024-03759","html_url":"https://www.federalregister.gov/documents/2024/02/23/2024-03759/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-23/pdf/2024-03759.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-03759.pdf?1708609537","publication_date":"2024-02-23","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":"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":"effort, and the goal is to continue to collect data on living <span class=\"match\">organ</span> donor <span class=\"match\">transplant</span> programs in the United States over time. Monitoring and reporting of long-term health outcomes of living <span class=\"match\">organ</span> donors post-donation will continue to provide useful information to <span class=\"match\">transplant</span> programs for their future donor selection process and to aid potential \n \n living <span class=\"match\">organ</span> donors in their decision to pursue living donation.\n \n \n Likely Respondents: \n Potential and actual living donors, <span class=\"match\">transplant</span> programs, medical and scientific organizations, and public organizations"},{"title":"Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflicts of Interest, and Related Provisions","type":"Rule","abstract":"This final rule with comment period sets forth provisions to strengthen the oversight of Medicare national accrediting organizations by addressing conflicts of interest, establishing consistent standards, processes, and definitions, and updating the validation and performance standards systems. Additionally, this final rule with comment period revises the psychiatric hospital survey process, adds a limitation on terminated deemed providers and suppliers when reentering the program, and provides technical corrections for End-Stage Renal Disease facilities and Transplant Programs.","document_number":"2026-12069","html_url":"https://www.federalregister.gov/documents/2026/06/16/2026-12069/medicare-program-strengthening-oversight-of-accrediting-organizations-aos-and-preventing-ao","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-16/pdf/2026-12069.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12069.pdf?1781295308","publication_date":"2026-06-16","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":"participation. \n There are currently 234 approved <span class=\"match\">transplant</span> centers participating in Medicare with 888 approved <span class=\"match\">transplant</span> programs nationwide. To be approved by Medicare, <span class=\"match\">transplant</span> programs must meet the requirements specified at § 482.72 through § 482.104. A <span class=\"match\">transplant</span> program is located in a Medicare-approved hospital and provides <span class=\"match\">transplantation</span> services for the following types of solid <span class=\"match\">organs</span>: heart, lung, liver, kidney, pancreas, or intestine. In addition to meeting the <span class=\"match\">transplant</span> CoPs, the <span class=\"match\">transplant</span> program must comply with the hospital CoPs"},{"title":"Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation, OMB No. 0906-0034-Extension","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":"2023-25368","html_url":"https://www.federalregister.gov/documents/2023/11/17/2023-25368/agency-information-collection-activities-proposed-collection-public-comment-request-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-17/pdf/2023-25368.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-25368.pdf?1700142351","publication_date":"2023-11-17","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":"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":"the SRTR contractor implemented a pilot living donor registry in which <span class=\"match\">transplant</span> programs registered all potential living <span class=\"match\">organ</span> donors who provided informed consent to participate in the pilot registry. The <span class=\"match\">Organ</span> Procurement and <span class=\"match\">Transplantation</span> Network final rule, 42 CFR part 121, requires <span class=\"match\">organ</span> procurement organizations and <span class=\"match\">transplant</span> hospitals, “as specified from time to time by the Secretary,” to submit to the SRTR, as appropriate, information regarding “donors of <span class=\"match\">organs</span>” and “other information that the Secretary deems appropriate.” 42 CFR 121"},{"title":"Government-Owned Inventions; Availability for Licensing","type":"Notice","abstract":"The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the invention listed below, which is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.","document_number":"2026-06501","html_url":"https://www.federalregister.gov/documents/2026/04/03/2026-06501/government-owned-inventions-availability-for-licensing","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-03/pdf/2026-06501.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06501.pdf?1775133912","publication_date":"2026-04-03","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":"35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration. \n Potential Commercial Applications \n • Development of monoclonal antibody therapies, bispecific antibodies, and antibody-targeted drugs for use in <span class=\"match\">organ</span> <span class=\"match\">transplantation</span>, B-cell lymphomas, and autoimmune conditions. \n Competitive Advantages \n • First fully human IgM antibody that binds to and kills B cells at concentrations as low as 0.01Nm. \n • Versatile antibody that may be used directly, engineered as IgG1 antibody, and possibly"},{"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":"the choice is between solid-<span class=\"match\">organ</span> pancreas <span class=\"match\">transplantation</span> alone or islet <span class=\"match\">transplantation</span>.\n 14 \n \n Islet cell <span class=\"match\">transplantation</span> offers a less invasive established alternative to pancreas <span class=\"match\">transplant</span>, and the procedures are regulated similarly.\n 15 \n \n The goal of both pancreas whole <span class=\"match\">organ</span> <span class=\"match\">transplant</span> and islet cell <span class=\"match\">transplantation</span> is to enable effective, stable glycemic management (often with insulin independence), to improve quality of life, and to <span class=\"match\">reduce</span> secondary complications. Both pancreas and islet cell <span class=\"match\">transplantation</span> require lifelong immunosuppression"},{"title":"Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, 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 2026. 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 rule proposes to update requirements for the ESRD Quality Incentive Program and to terminate and modify requirements for the ESRD Treatment Choices Model.","document_number":"2025-12368","html_url":"https://www.federalregister.gov/documents/2025/07/02/2025-12368/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-02/pdf/2025-12368.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-12368.pdf?1751314516","publication_date":"2025-07-02","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":"spending under the applicable title; <span class=\"match\">reduce</span> spending under the applicable title without <span class=\"match\">reducing</span> the quality of care; or improve the quality of care and <span class=\"match\">reduce</span> spending. Such termination may occur at any time after such testing has begun and before completion of the testing.” \n 24 \n \n \n \n \n 24 \n  42 U.S.C. 1315a.\n \n \n \n ETC Model performance since 2021 has not been shown to enhance the quality-of-care ETC regions on the key model measures of home dialysis modalities, <span class=\"match\">transplant</span> waitlisting, and living donor <span class=\"match\">transplantation</span>. The second Annual Evaluation"},{"title":"Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, 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 2026. This rule also includes updates to the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule updates the requirements for the ESRD Quality Incentive Program and terminates and modifies requirements for the ESRD Treatment Choices Model.","document_number":"2025-20681","html_url":"https://www.federalregister.gov/documents/2025/11/24/2025-20681/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20681.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20681.pdf?1763673309","publication_date":"2025-11-24","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":"under the applicable title; <span class=\"match\">reduce</span> spending under the applicable title without <span class=\"match\">reducing</span> the quality of care; or improve the quality of care and <span class=\"match\">reduce</span> spending. Such termination may occur at any time after \n \n such testing has begun and before completion of the testing.” \n 36 \n \n \n \n \n 36 \n  42 U.S.C. 1315a\n \n \n \n ETC Model performance since 2021 has not been shown to enhance the quality-of-care ETC regions on the key model measures of home dialysis modalities, <span class=\"match\">transplant</span> waitlisting, and living donor <span class=\"match\">transplantation</span>. The third Annual Evaluation"},{"title":"Revised Medical Criteria for Evaluating Cardiovascular Disorders","type":"Rule","abstract":"We are revising the criteria in the Listing of Impairments (listings) that we use to evaluate claims involving cardiovascular disorders in adults and children under titles II and XVI of the Social Security Act (Act). The revisions reflect our adjudicative experience, advances in medical knowledge, and comments we received from the public in response to a notice of proposed rulemaking (NPRM).","document_number":"2026-13420","html_url":"https://www.federalregister.gov/documents/2026/07/02/2026-13420/revised-medical-criteria-for-evaluating-cardiovascular-disorders","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-02/pdf/2026-13420.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13420.pdf?1782909921","publication_date":"2026-07-02","agencies":[{"raw_name":"Social Security Administration","name":"Social Security Administration","id":470,"url":"https://www.federalregister.gov/agencies/social-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/470","parent_id":null,"slug":"social-security-administration"}],"excerpts":"What do we consider when we evaluate heart <span class=\"match\">transplant</span> recipients? \n \n a. After your heart <span class=\"match\">transplant</span>, we will consider you disabled under 4.09 for 1 year following the surgery because there is a greater likelihood of rejection of the <span class=\"match\">organ</span> and infection during the first year. If you develop cardiac allograft vasculopathy after your <span class=\"match\">transplant</span>, we will evaluate this impairment under 4.16. \n b. However, heart <span class=\"match\">transplant</span> patients generally meet our definition of disability before they undergo <span class=\"match\">transplantation</span>. We will determine the onset of your disability"}]}