{"description":"Documents matching 'donors labeling products clinical laboratory'","count":385,"total_pages":20,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=donors+labeling+products+clinical+laboratory&format=json&page=2","results":[{"title":"Advisory Committee; Blood Products Advisory Committee; Renewal","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing the renewal of the Blood Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 13, 2028, expiration date.","document_number":"2026-09108","html_url":"https://www.federalregister.gov/documents/2026/05/07/2026-09108/advisory-committee-blood-products-advisory-committee-renewal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-07/pdf/2026-09108.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09108.pdf?1778071535","publication_date":"2026-05-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"appropriate use of blood, <span class=\"match\">products</span> derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and as required, any other <span class=\"match\">products</span> for which FDA has regulatory responsibility. The Committee also advises the Commissioner of Food and Drugs of its findings regarding screening and testing (to determine eligibility) of <span class=\"match\">donors</span> and <span class=\"match\">labeling</span> of the <span class=\"match\">products</span>, on <span class=\"match\">clinical</span> and <span class=\"match\">laboratory</span> studies involving such <span class=\"match\">products</span>, on the affirmation or revocation of biological <span class=\"match\">products</span> licenses. The Committee"},{"title":"Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices","type":"Rule","abstract":"The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.","document_number":"2025-18082","html_url":"https://www.federalregister.gov/documents/2025/09/18/2025-18082/microbiology-devices-reclassification-of-antigen-antibody-and-nucleic-acid-based-hepatitis-b-virus","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-18/pdf/2025-18082.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18082.pdf?1758113115","publication_date":"2025-09-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Radiological Health (CDRH) uses <span class=\"match\">product</span> codes to help categorize and ensure consistent regulation of medical devices. A <span class=\"match\">product</span> code consists of three characters that are assigned at the time a <span class=\"match\">product</span> code is generated and is unique to a <span class=\"match\">product</span> type. The three characters carry no other significance and are not an abbreviation. See FDA guidance entitled, “Medical Device Classification <span class=\"match\">Product</span> Codes” available at \n https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-<span class=\"match\">product</span>-codes-guidance-industry-an"},{"title":"Medical Devices; Laboratory Developed Tests","type":"Rule","abstract":"The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.","document_number":"2024-08935","html_url":"https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08935.pdf?1714398256","publication_date":"2024-05-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Federal Regulations. \n \n \n CGMP \n Current Good Manufacturing Practice. \n \n \n CGT \n Cell and Gene Therapy. \n \n \n CLIA \n <span class=\"match\">Clinical</span> <span class=\"match\">Laboratory</span> Improvement Amendments of 1988. \n \n \n CLIAC \n <span class=\"match\">Clinical</span> <span class=\"match\">Laboratory</span> Improvement Advisory Committee. \n \n \n CLSI \n <span class=\"match\">Clinical</span> and <span class=\"match\">Laboratory</span> Standards Institute. \n \n \n CMS \n Centers for Medicare &amp; Medicaid Services. \n \n \n COLA \n Commission on Office <span class=\"match\">Laboratory</span> Accreditation. \n \n \n CRO \n <span class=\"match\">Clinical</span> Research Organization. \n \n \n Cures Act \n 21st Century Cures Act. \n \n \n DNA \n Deoxyribonucleic Acid. \n \n \n DoD \n Department"},{"title":"Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories","type":"Rule","abstract":"This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. This final rule implements a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. We are finalizing the incorporation of limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. We are also finalizing the distribution of the administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees. In addition, we are finalizing the clarification of the methodology used to determine program compliance fees. This final rule ensures the continuing quality and safety of laboratory testing for the public. This final rule also amends histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes. In addition, this final rule amends the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite State monitoring) to allow for the imposition of such sanctions on CoW laboratories.","document_number":"2023-28170","html_url":"https://www.federalregister.gov/documents/2023/12/28/2023-28170/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28170.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-28170.pdf?1703279719","publication_date":"2023-12-28","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":"/2022-15300/<span class=\"match\">clinical</span>-<span class=\"match\">laboratory</span>-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and. \n The public comment period was extended and closed on September 26, 2022 (87 FR 52712). \n https://www.federalregister.gov/documents/2022/08/29/2022-18558/<span class=\"match\">clinical</span>-<span class=\"match\">laboratory</span>-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and. \n \n \n The February 1992 final rule also stated at § 493.645(b)(1) that <span class=\"match\">laboratories</span> issued a CoA would be assessed a fee to cover the cost of evaluating the individual <span class=\"match\">laboratories</span> to determine"},{"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the SARS- CoV-2 serology test. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","document_number":"2026-12902","html_url":"https://www.federalregister.gov/documents/2026/06/26/2026-12902/medical-devices-immunology-and-microbiology-devices-classification-of-the-sars-cov-2-serology-test","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12902.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12902.pdf?1782391512","publication_date":"2026-06-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"510(k) process, when necessary, to market their device. \n II. De Novo Classification \n On September 20, 2021, FDA received Ortho-<span class=\"match\">Clinical</span> Diagnostics, Inc.'s request for De Novo classification of the VITROS Immunodiagnostic <span class=\"match\">Products</span> Anti-SARS-CoV-2 IgG Reagent Pack and Calibrator. On September 21, 2021, FDA received Ortho-<span class=\"match\">Clinical</span> Diagnostics, Inc.'s request for De Novo classification of the VITROS Immunodiagnostic <span class=\"match\">Products</span> Anti-SARS-CoV-2 Total Reagent Pack and Calibrator. FDA reviewed both requests in order to classify the devices under the criteria"},{"title":"Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Fentanyl to the Department of Transportation's Drug-Testing Panel; Harmonization With Certain Items in the HHS Mandatory Guidelines for Urine and Oral Fluid; and Technical Amendments","type":"Proposed Rule","abstract":"The U.S. Department of Transportation (Department or DOT) proposes to amend its drug-testing program regulation, 49 CFR part 40 (part 40), to add fentanyl (a synthetic opioid) and norfentanyl (a metabolite of fentanyl) to its drug testing panels. The proposed rulemaking would harmonize part 40 with the U.S. Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), which DOT must follow for the minimum list of drugs for which DOT requires testing, and the comprehensive standards for laboratory drug testing per the Omnibus Employee Testing Act of 1991. Adding fentanyl and norfentanyl is also in the interest of transportation safety, given compelling information regarding the number of overdose deaths in the United States involving fentanyl. The Department also proposes to amend certain provisions of part 40 to harmonize, as appropriate, with the current HHS Mandatory Guidelines using urine (UrMG) and oral fluid (OFMG). This NPRM also proposes to clarify certain existing part 40 drug testing program provisions and to make technical amendments.","document_number":"2025-16720","html_url":"https://www.federalregister.gov/documents/2025/09/02/2025-16720/procedures-for-transportation-workplace-drug-and-alcohol-testing-programs-addition-of-fentanyl-to","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-02/pdf/2025-16720.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-16720.pdf?1756471542","publication_date":"2025-09-02","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"Testing—Proposal To Adjust the <span class=\"match\">Laboratory</span> Morphine Confirmatory Cutoff and Remove the Additional Requirement for MROs To Look for <span class=\"match\">Clinical</span> Evidence of Illegal Opioid Use \n \n Currently, for a <span class=\"match\">laboratory</span> to report a positive codeine/morphine \n 21 \n \n result for a urine specimen, the <span class=\"match\">laboratory</span>-confirmed result must be greater than or equal to 2,000 ng/mL.\n 22 \n \n In our December 19, 2000 final rule (65 FR 79462), the Department established a process to address a <span class=\"match\">laboratory</span>-reported positive result, which depends on the <span class=\"match\">laboratory</span>-reported codeine/morphine"},{"title":"Advisory Committee; Blood Products Advisory Committee; Renewal","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing the renewal of the Blood Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 13, 2026, expiration date.","document_number":"2024-17518","html_url":"https://www.federalregister.gov/documents/2024/08/08/2024-17518/advisory-committee-blood-products-advisory-committee-renewal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-08/pdf/2024-17518.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-17518.pdf?1723034761","publication_date":"2024-08-08","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other <span class=\"match\">product</span> for which FDA has regulatory responsibility. The Committee also advises the Commissioner of Food and Drugs of its findings regarding screening and testing (to determine eligibility) of <span class=\"match\">donors</span> and <span class=\"match\">labeling</span> of the <span class=\"match\">products</span>, on <span class=\"match\">clinical</span> and <span class=\"match\">laboratory</span> studies involving such <span class=\"match\">products</span>, on the affirmation or revocation of biological <span class=\"match\">products</span> licenses, and on the quality and relevance of FDA's research program, which provides the scientific support"},{"title":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.","document_number":"2024-13190","html_url":"https://www.federalregister.gov/documents/2024/06/18/2024-13190/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-18/pdf/2024-13190.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13190.pdf?1718628314","publication_date":"2024-06-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"including: \n • General considerations, including general support, definitions, timing of the rule, and the effective date; \n \n • <span class=\"match\">Labeling</span> requirements, including <span class=\"match\">labeling</span> statements and the applicability of <span class=\"match\">labeling</span> provisions to different types of containers;\n \n \n • CGMP requirements, including buildings and facilities, equipment, control of incoming <span class=\"match\">products</span>, packaging and <span class=\"match\">labeling</span> control, holding and distribution, <span class=\"match\">laboratory</span> controls, records, and returned medical gases; \n • Certification requirements, including annual reporting, withdrawal, and the"},{"title":"Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management","type":"Rule","abstract":"The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a postamendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification.","document_number":"2024-21616","html_url":"https://www.federalregister.gov/documents/2024/09/23/2024-21616/microbiology-devices-reclassification-of-cytomegalovirus-deoxyribonucleic-acid-quantitative-assay","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-23/pdf/2024-21616.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21616.pdf?1726836315","publication_date":"2024-09-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"healthcare professionals in conjunction with other relevant <span class=\"match\">clinical</span> and <span class=\"match\">laboratory</span> findings.\n \n \n (b) \n Classification. \n Class II (special controls). The special controls for this device are:\n \n (1) The <span class=\"match\">labeling</span> required under §  809.10(b) of this chapter must include: \n (i) A prominent statement that the device is not intended for use as a <span class=\"match\">donor</span> screening test for the presence of CMV DNA in blood or blood <span class=\"match\">products</span>. \n (ii) Limitations, which must be updated to reflect current <span class=\"match\">clinical</span> practice. The limitations must include, but are not limited"},{"title":"Medical Devices; Laboratory Developed Tests","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is proposing a policy under which FDA intends to phase out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA is proposing this phaseout to better protect the public health by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.","document_number":"2023-21662","html_url":"https://www.federalregister.gov/documents/2023/10/03/2023-21662/medical-devices-laboratory-developed-tests","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-03/pdf/2023-21662.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-21662.pdf?1695991649","publication_date":"2023-10-03","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":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"diagnostic <span class=\"match\">laboratory</span> test,” which is defined in part as a <span class=\"match\">clinical</span> diagnostic <span class=\"match\">laboratory</span> test “that is offered and furnished only by a single <span class=\"match\">laboratory</span> and not sold for use by a <span class=\"match\">laboratory</span> other than the original developing <span class=\"match\">laboratory</span> (or a successor owner)” (section 216(a) of PAMA). If such <span class=\"match\">laboratory</span> tests were not devices, the 510(k) clearance and premarket approval provisions would not apply to them and the inclusion of such provisions would be pointless and ineffectual. In addition, Congress indicated that <span class=\"match\">clinical</span> <span class=\"match\">laboratory</span> tests are devices"},{"title":"Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative HBV antibody assays and quantitative assays that detect anti-HBs (antibodies to HBV surface antigen (HBsAg)), and quantitative HBV nucleic acid-based assays, all of which are postamendments class III devices, into class II (general controls and special controls), subject to premarket notification. FDA is also proposing three new device classification regulations along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for each device.","document_number":"2024-21932","html_url":"https://www.federalregister.gov/documents/2024/09/25/2024-21932/microbiology-devices-reclassification-of-antigen-antibody-and-nucleic-acid-based-hepatitis-b-virus","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-25/pdf/2024-21932.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21932.pdf?1727181930","publication_date":"2024-09-25","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":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"use as a <span class=\"match\">donor</span> screening assay for the presence of HBV nucleic acids in blood, blood <span class=\"match\">products</span>, plasma, cells, or tissue <span class=\"match\">donors</span>, or as a diagnostic assay to confirm the presence of HBV infection.\n \n \n (b) \n Classification. \n Class II (special controls). The special controls for this device are:\n \n (1) <span class=\"match\">Labeling</span> required under § 809.10(b) of this chapter must include: \n (i) A prominent statement that the assay is not intended for use as a screening assay for the presence of HBV DNA in blood or blood <span class=\"match\">products</span>, plasma, cells, or tissue <span class=\"match\">donors</span>, or as a"},{"title":"Modernizing Security Requirements","type":"Proposed Rule","abstract":"The U.S. Nuclear Regulatory Commission (NRC) is proposing to revise its regulations to modernize security and fitness-for-duty requirements to enhance efficiency, consistent with Executive Order 14300, \"Ordering the Reform of the Nuclear Regulatory Commission.\" The proposed revisions are intended to reduce regulatory burden, where appropriate, while continuing to provide reasonable assurance that safety and security will be adequately maintained at NRC-licensed facilities.","document_number":"2026-12989","html_url":"https://www.federalregister.gov/documents/2026/06/26/2026-12989/modernizing-security-requirements","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12989.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12989.pdf?1782391523","publication_date":"2026-06-26","agencies":[{"raw_name":"NUCLEAR REGULATORY COMMISSION","name":"Nuclear Regulatory Commission","id":383,"url":"https://www.federalregister.gov/agencies/nuclear-regulatory-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/383","parent_id":null,"slug":"nuclear-regulatory-commission"}],"excerpts":"performed by the HHS-certified <span class=\"match\">laboratory</span> that a licensee or other entity uses to perform testing under contract. In each calendar quarter, BPTSs must be submitted to the <span class=\"match\">laboratory</span> for each drug or drug metabolite that must be tested in <span class=\"match\">donor</span> specimens and for each validity test performed to identify subversion attempts. A licensee or other entity must prepare BPTSs to appear as <span class=\"match\">donor</span> specimens to the <span class=\"match\">laboratory</span>, and BPTSs must be submitted along with <span class=\"match\">donor</span> specimens throughout the calendar quarter to evaluate <span class=\"match\">laboratory</span> performance. \n Each year, operating"},{"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":"when the new version of the PE worksheet introduced the activity codes for <span class=\"match\">clinical</span> labor, there was a need to translate old <span class=\"match\">clinical</span> labor tasks into the new activity codes, and that a prior <span class=\"match\">clinical</span> labor task was split into two of the new <span class=\"match\">clinical</span> labor activity codes: CA007 (\n Review patient <span class=\"match\">clinical</span> extant information and questionnaire \n ) in the preservice period, and CA014 (\n Confirm order, protocol exam \n ) in the service period. Commenters stated that the same <span class=\"match\">clinical</span> labor from the old PE worksheet was now divided into the CA007 and CA014"},{"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management","type":"Rule","abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the quantitative viral nucleic acid test for transplant patient management into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the quantitative viral nucleic acid test for transplant patient management's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.","document_number":"2024-21086","html_url":"https://www.federalregister.gov/documents/2024/09/17/2024-21086/medical-devices-immunology-and-microbiology-devices-classification-of-the-quantitative-viral-nucleic","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-17/pdf/2024-21086.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21086.pdf?1726490731","publication_date":"2024-09-17","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":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"healthcare professionals in conjunction with other relevant <span class=\"match\">clinical</span> and <span class=\"match\">laboratory</span> findings.\n \n \n (b) \n Classification. \n Class II (special controls). The special controls for this device are:\n \n (1) The <span class=\"match\">labeling</span> required under § 809.10(b) of this chapter must include: \n (i) A prominent statement that the device is not intended for use as a <span class=\"match\">donor</span> screening test for the presence of viral nucleic acid in blood or blood <span class=\"match\">products</span>. \n (ii) Limitations which must be updated to reflect current <span class=\"match\">clinical</span> practice. These limitations must include, but are not limited"},{"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":"when the new version of the PE worksheet introduced the activity codes for <span class=\"match\">clinical</span> labor, there was a need to translate old <span class=\"match\">clinical</span> labor tasks into the new activity codes, and that a prior <span class=\"match\">clinical</span> labor task was split into two of the new <span class=\"match\">clinical</span> labor activity codes: CA007 (\n Review patient <span class=\"match\">clinical</span> extant information and questionnaire \n ) in the preservice period, and CA014 (\n Confirm order, protocol exam \n ) in the service period. Commenters stated that the same <span class=\"match\">clinical</span> labor from the old PE worksheet was now divided into the CA007 and CA014"},{"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":"CAHPS measure \n 15.00 \n \n \n Care Coordination Measure Domain \n 30.00 \n \n \n SHR <span class=\"match\">clinical</span> measure \n 7.50 \n \n \n SRR <span class=\"match\">clinical</span> measure \n 7.50 \n \n \n PPPW measure \n 7.50 \n \n \n <span class=\"match\">Clinical</span> Depression Screening and Follow-Up measure \n 7.50 \n \n \n <span class=\"match\">Clinical</span> Care Measure Domain \n 35.00 \n \n \n Kt/V Dialysis Adequacy Measure Topic \n 11.00 \n \n \n Long-Term Catheter Rate <span class=\"match\">clinical</span> measure \n 12.00 \n \n \n STrR <span class=\"match\">clinical</span> measure \n 12.00 \n \n \n Safety Measure Domain \n 10.00 \n \n \n NHSN BSI <span class=\"match\">clinical</span> measure \n 10.00 \n \n \n Reporting Measure Domain \n 10.00 \n \n \n Hypercalcemia reporting"},{"title":"Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program","type":"Rule","abstract":"This major 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; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.","document_number":"2025-19787","html_url":"https://www.federalregister.gov/documents/2025/11/05/2025-19787/medicare-and-medicaid-programs-cy-2026-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-05/pdf/2025-19787.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19787.pdf?1761945018","publication_date":"2025-11-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"when the new version of the PE worksheet introduced the activity codes for <span class=\"match\">clinical</span> labor, there was a need to translate old <span class=\"match\">clinical</span> labor tasks into the new activity codes, and that a prior <span class=\"match\">clinical</span> labor task was split into two of the new <span class=\"match\">clinical</span> labor activity codes: CA007 (\n Review patient <span class=\"match\">clinical</span> extant information and questionnaire \n ) in the preservice period, and CA014 (\n Confirm order, protocol exam \n ) in the service period. Commenters stated that the same <span class=\"match\">clinical</span> labor from the old PE worksheet was now divided into the CA007 and CA014"},{"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":"identified as <span class=\"match\">clinical</span> trial cases in calculating the national average standardized cost per case that is used to calculate the relative weights for all MS-DRGs and for purposes of budget neutrality and outlier simulations. We calculate this adjustor by dividing the average cost for cases that we identify as <span class=\"match\">clinical</span> trial cases by the average cost for cases that we identify as non-<span class=\"match\">clinical</span> trial cases, with the additional refinements that (a) when the CAR T-cell therapy <span class=\"match\">product</span> is purchased in the usual manner, but the case involves a <span class=\"match\">clinical</span> trial of"},{"title":"Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program","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 establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.","document_number":"2025-13271","html_url":"https://www.federalregister.gov/documents/2025/07/16/2025-13271/medicare-and-medicaid-programs-cy-2026-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-16/pdf/2025-13271.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13271.pdf?1752524111","publication_date":"2025-07-16","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":"when the new version of the PE worksheet introduced the activity codes for <span class=\"match\">clinical</span> labor, there was a need to translate old <span class=\"match\">clinical</span> labor tasks into the new activity codes, and that a prior <span class=\"match\">clinical</span> labor task was split into two of the new <span class=\"match\">clinical</span> labor activity codes: CA007 (\n Review patient <span class=\"match\">clinical</span> extant information and questionnaire \n ) in the preservice period, and CA014 (\n Confirm order, protocol exam \n ) in the service period. Commenters stated that the same <span class=\"match\">clinical</span> labor from the old PE worksheet was now divided into the CA007 and CA014"},{"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":"shows low rates of ESRD patients placed on kidney transplant 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> kidneys, coupled with increasing rates of <span class=\"match\">donor</span> kidney discards, and wide variation in kidney offer acceptance rates and <span class=\"match\">donor</span> kidney discards by region and across kidney transplant hospitals.\n 6 7 \n \n Further, there are substantial disparities in both deceased and living <span class=\"match\">donor</span> transplantation rates among structurally disadvantaged populations. Strengthening and improving the performance"}]}