{"description":"Documents matching 'expressed concern could adopting tefca'","count":64,"total_pages":4,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=expressed+concern+could+adopting+tefca&format=json&page=2","results":[{"title":"Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (TEFCA)","type":"Rule","abstract":"This final rule has finalized certain proposals from a proposed rule published in August 2024 and in doing so advances interoperability and supports the access, exchange, and use of electronic health information. Specifically, this final rule amends the information blocking regulations by including definitions related to the Trusted Exchange Framework and Common Agreement (TEFCA) Manner Exception. It also implements provisions related to the TEFCA, which will support the reliability, privacy, security, and trust within TEFCA. Lastly, this final rule includes corrections and updates to current regulatory provisions of the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program.","document_number":"2024-29163","html_url":"https://www.federalregister.gov/documents/2024/12/16/2024-29163/health-data-technology-and-interoperability-trusted-exchange-framework-and-common-agreement-tefca","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-16/pdf/2024-29163.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-29163.pdf?1733924732","publication_date":"2024-12-16","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":"Office of the Secretary"}],"excerpts":"voluntary exchange framework. We remind all interested parties that participation in TEFCA is voluntary, and no actor is required to join TEFCA.\n \n \n Comments. \n Some commenters expressed concerns that the TEFCA Manner Exception could have unintended consequences. For example, one commenter expressed concern that the TEFCA Manner Exception could tip the scales to prioritize TEFCA exchange over all other interoperability pathways and noted that TEFCA does not offer solutions to all needs, including, for example, write-back capabilities and non-EHI data"},{"title":"Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability","type":"Proposed Rule","abstract":"This proposed rule seeks to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information through proposals for: standards adoption; adoption of certification criteria to advance public health data exchange; expanded uses of certified application programming interfaces, such as for electronic prior authorization, patient access, care management, and care coordination; and information sharing under the information blocking regulations. It proposes to establish a new baseline version of the United States Core Data for Interoperability. The proposed rule would update the ONC Health IT Certification Program to enhance interoperability and optimize certification processes to reduce burden and costs. The proposed rule would also implement certain provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA), which would support the reliability, privacy, security, and trust within TEFCA.","document_number":"2024-14975","html_url":"https://www.federalregister.gov/documents/2024/08/05/2024-14975/health-data-technology-and-interoperability-patient-engagement-information-sharing-and-public-health","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-05/pdf/2024-14975.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14975.pdf?1721825115","publication_date":"2024-08-05","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":"Office of the Secretary"}],"excerpts":"update for public health and USCDI v4 could help capture more accurate and complete patient characteristics that are reflective of patient diversity and could potentially help data users address disparities in health outcomes for all patients, including those who may be marginalized and underrepresented. This could also support data users' abilities to identify, assess, and analyze gaps in care, which could in turn be used to inform and address the quality of healthcare through interventions and strategies. This could lead to better patient care, experiences"},{"title":"Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity","type":"Proposed Rule","abstract":"This proposed rule focuses on deregulatory actions identified in HHS regulations regarding Health information technology standards, implementation specifications, and certification criteria and certification programs for health information technology, and information blocking. This proposed rule seeks to reduce burden, offer flexibility to both developers and providers, and support innovation through the removal and revisions of certain certification criteria and regulatory provisions. This proposed rule also seeks to address reported misuse and abuse of information blocking definitions and exceptions.","document_number":"2025-23896","html_url":"https://www.federalregister.gov/documents/2025/12/29/2025-23896/health-data-technology-and-interoperability-astponc-deregulatory-actions-to-unleash-prosperity","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23896.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23896.pdf?1766438109","publication_date":"2025-12-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"supports.\n \n We note that removing the TEFCA Manner Exception would not remove any obligations an actor may have as a QHIN, Participant, or Sub-participant in TEFCA to fulfill TEFCA requirements. The TEFCA Manner Exception does not create, reduce, or otherwise affect any obligations any actor may have as a QHIN, Participant, or Sub-participant in TEFCA to fulfill TEFCA requirements. \n \n Finally, we remind readers that removing this exception would \n not \n mean that a practice that would have been covered by the TEFCA Manner Exception would automatically"},{"title":"Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures","type":"Rule","abstract":"This final rule implements requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, enacted on March 30, 2010--collectively, the Affordable Care Act. Specifically, this final rule adopts standards for health care claims attachments transactions, which will support health care claims transactions, and a standard for electronic signatures to be used in conjunction with health care claims attachments transactions.","document_number":"2026-05676","html_url":"https://www.federalregister.gov/documents/2026/03/24/2026-05676/administrative-simplification-adoption-of-standards-for-health-care-claims-attachments-transactions","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-24/pdf/2026-05676.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05676.pdf?1774037709","publication_date":"2026-03-24","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":"Office of the Secretary"}],"excerpts":"elements to identify the specific attachment information. A commenter expressed their appreciation for Version 6020 being tested and implemented in real-world settings.\n \n \n Response: \n We thank commenters for their feedback and support of Version 6020 of the standards as a business case in adopting a health care claims attachments transaction standard.\n \n \n Comment: \n Multiple commenters expressed concern about HHS's proposal to adopt Version 6020 and, instead, recommended that we adopt a newer version of the X12N attachments standards, such as Version"},{"title":"Request for Information; Health Technology Ecosystem","type":"Notice","abstract":"Effective and responsible adoption of technology can empower patients to make better decisions for their health and well-being. This request for information (RFI) seeks input from the public regarding the market of digital health products for Medicare beneficiaries as well as the state of data interoperability and broader health technology infrastructure. Responses to this RFI may be used to inform CMS and ASTP/ONC efforts to lead infrastructure progress to cultivate this market, increasing beneficiary access to effective digital capabilities needed to make informed health decisions, and increasing data availability for all stakeholders contributing to health outcomes.","document_number":"2025-08701","html_url":"https://www.federalregister.gov/documents/2025/05/16/2025-08701/request-for-information-health-technology-ecosystem","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-16/pdf/2025-08701.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-08701.pdf?1747149309","publication_date":"2025-05-16","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":"Exchange Framework and Common Agreement\n TM \n (TEFCA\n TM \n ) currently helping to advance patient access to health information in the real world?\n \n a. Please provide specific examples. \n b. What changes would you suggest? \n c. What use cases could have a significant impact if implemented through TEFCA? \n d. What standards are you aware of that are currently working well to advance access and existing exchange purposes? \n e. What standards are you aware of that are not currently in wide use, but could improve data access and integration? \n f. Are"},{"title":"Notice of Publication of Common Agreement for Nationwide Health Information Interoperability (Common Agreement) Version 2.1","type":"Notice","abstract":"This notice fulfills an obligation under the Public Health Service Act (PHSA). The act requires the National Coordinator for Health Information Technology to publish on the Office of the National Coordinator for Health Information Technology's public internet website, and in the Federal Register, the trusted exchange framework and common agreement developed under the PHSA. This notice is for publishing an updated version of the Common Agreement (Version 2.1).","document_number":"2024-27554","html_url":"https://www.federalregister.gov/documents/2024/11/26/2024-27554/notice-of-publication-of-common-agreement-for-nationwide-health-information-interoperability-common","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-26/pdf/2024-27554.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-27554.pdf?1732283134","publication_date":"2024-11-26","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":"Office of the Secretary"}],"excerpts":"days of receiving such record(s) from its Participant(s). \n \n 9. \n TEFCA Exchange Activities. \n \n \n 9.1 \n Utilization of TEFCA Exchange. \n Signatory may only utilize Designated Network Services for purposes of facilitating TEFCA Exchange. TEFCA Exchange may only be utilized for an XP. To the extent there are limitations on what types of Participants or Subparticipants may transact TEFCA Information for a specific XP, such limitations will be set forth in the applicable SOP(s). All TEFCA Exchange is governed by and must comply with the Framework Agreements"},{"title":"Health Data, Technology, and Interoperability: Protecting Care Access","type":"Rule","abstract":"This final rule has finalized certain proposals from the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability Proposed Rule (HTI-2 Proposed Rule) and in doing so supports the access, exchange, and use of electronic health information. Specifically, this final rule amends the information blocking regulations to revise two existing information blocking exceptions and establish an additional reasonable and necessary activity that does not constitute information blocking referred to as the Protecting Care Access Exception.","document_number":"2024-29683","html_url":"https://www.federalregister.gov/documents/2024/12/17/2024-29683/health-data-technology-and-interoperability-protecting-care-access","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-17/pdf/2024-29683.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-29683.pdf?1734356733","publication_date":"2024-12-17","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":"Office of the Secretary"}],"excerpts":"condition.\n \n \n Another commenter expressed concerns that including the § 171.202 Privacy Exception cross-reference in its entirety could inadvertently create challenges for third-party companies to \n \n access and utilize patient data, and result in incentives to limit the development of health care solutions that could improve experiences for providers, patients, and payers.\n \n \n Response. \n We thank commenters for their input addressing the alternative proposal. After consideration of the comments received, we have not adopted the alternative proposal"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization","type":"Rule","abstract":"This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hospitals; updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); updates and makes changes to requirements for certain quality programs; and makes other policy- related changes. We are also finalizing the provisions of the interim final action with comment period regarding the changes to the FY 2025 IPPS rates due to the court decision in Bridgeport Hosp. v. Becerra. Lastly, it finalizes certain updates to the ONC Health Information Technology (IT) Certification Program.","document_number":"2025-14681","html_url":"https://www.federalregister.gov/documents/2025/08/04/2025-14681/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-ipps-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-04/pdf/2025-14681.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14681.pdf?1753992911","publication_date":"2025-08-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"our comment solicitation and will continue to monitor CAR T-cell therapy claims for such potential anomalies.\n \n \n Comment: \n Some commenters expressed concern that CMS no longer uses the $373,000 threshold to identify clinical trial cases and requested that CMS continue to refine its methodology to also consider standardized drug charges to correctly identify clinical trial cases. Commenters expressed concern that due to incorrect coding or incorrect application of condition codes, cases below the $373,000 threshold may be identified as clinical trials"},{"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":"efficiency adjustment policy.\n \n \n Comment: \n A commenter expressed concern regarding the new supply item, Plaque Characterization Analysis Software, that lists a per-patient fee of $1500 for the plaque data analysis summary generated by the vendor. They stated that this is a high-cost supply item and expressed concerns that a crosswalk is an ad hoc approach that could lead to instability if it is changed in future years.\n \n \n Response: \n We acknowledge the commenter's broader policy concerns regarding the supply-item, Plaque Characterization Analysis"},{"title":"Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing","type":"Rule","abstract":"This final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program). This final rule also makes several updates to certification criteria and standards recognized by the Program. The Program updates include revised certification criteria for \"decision support interventions,\" \"patient demographics and observations,\" and \"electronic case reporting,\" as well as a new baseline version of the United States Core Data for Interoperability (USCDI) standard to Version 3. Additionally, this final rule provides enhancements to support information sharing under the information blocking regulations. The implementation of these provisions advances interoperability, improves algorithm transparency, and supports the access, exchange, and use of electronic health information (EHI). This final rule also updates numerous technical standards in the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs for health IT developers and users of health IT.","document_number":"2023-28857","html_url":"https://www.federalregister.gov/documents/2024/01/09/2023-28857/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-01-09/pdf/2023-28857.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-28857.pdf?1704230116","publication_date":"2024-01-09","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":"Office of the Secretary"}],"excerpts":"is a new data class as compared to USCDI v1. \n \n Comments. \n One commenter expressed specific agreement and support of the Encounter Information data class. Several comments expressed concerns, including regarding a lack of standards. One commenter recommended only adopting the Encounter Diagnosis data element since it does have a standard. One commenter expressed concern that Encounter Information would identify information about pregnancy termination services that could be misused and lead to administrative or criminal investigations of patients"},{"title":"Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2026","type":"Rule","abstract":"This final rule finalizes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year 2026. This final rule also updates the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program.","document_number":"2025-14679","html_url":"https://www.federalregister.gov/documents/2025/08/04/2025-14679/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-04/pdf/2025-14679.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14679.pdf?1753992908","publication_date":"2025-08-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Comment: \n A few commenters expressed concerns with the proposed reclassification of certain conditions from a given clinical category to a Return to Provider status, suggesting changing the clinical categories could potentially lead to increased claims denials and corrections, increased administrative burdens, delays in care, or restrictions in patient access to skilled care by remapping codes from the Medical Management clinical category to Return to Provider.\n \n \n Response: \n We appreciate the comments and concerns raised by the commenters. As"},{"title":"Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges","type":"Proposed Rule","abstract":"These proposals are intended to improve the electronic exchange of health care data and streamline processes related to prior authorization by increasing the interoperability of systems used across the health care industry. We are proposing new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs), including issuers that offer small group market QHPs on the Federally-facilitated Small Business Health Options Program (FF- SHOP) Exchanges (hereinafter referred to as \"small group market QHP issuers on the FF-SHOPs\") (collectively \"impacted payers\"), to make available electronic prior authorization for drugs. We are also proposing to extend many existing interoperability requirements for the prior authorization of non-drug items and services to include prior authorizations for drugs to further reduce patient and provider burden. We are also proposing to require impacted payers to report their application programming interfaces (API) endpoints and related information for the Patient Access, Provider Directory, Provider Access, Payer-to-Payer, and Prior Authorization APIs to CMS. To help assess the impact of our policies, we are proposing to collect API usage metrics. In addition, we are proposing to apply the existing interoperability requirements to small group market QHP issuers on the FF-SHOPs as impacted payers. To improve impacted payers' ability to exchange health information while continuing CMS's drive toward interoperability, we are proposing to require certain Health Level Seven (HL7[supreg]) Fast Healthcare Interoperability Resources (FHIR[supreg]) implementation guides (IGs) that are currently recommended. In addition, HHS is proposing to adopt the HL7 FHIR base standard and certain associated specifications and IGs as the Health Insurance Portability and Accountability Act of 1996 (hereinafter referred to as \"HIPAA\") (Pub. L. 104-191, enacted Aug. 21, 1996) standards for dental, professional, and institutional \"referral certification and authorization\" transactions and \"eligibility for a health plan\" transactions associated with prior authorization. We are proposing to add a definition for \"failure to report,\" which would allow CMS to impose a civil monetary penalty (CMP) on applicable manufacturers or applicable group purchasing organizations (GPOs) if those entities fail to grant CMS timely access to documents for the purposes of an audit. Finally, ONC is using this rulemaking to propose to adopt updated versions of certain health information technology (health IT) standards and specifications for HHS use, such as CMS's interoperability requirements, to support a more robust health IT infrastructure.","document_number":"2026-07205","html_url":"https://www.federalregister.gov/documents/2026/04/14/2026-07205/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-standards","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-14/pdf/2026-07205.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07205.pdf?1775852111","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"the PHSA, the Secretary adopts standards for HHS use, including those adopted in 45 CFR 170.215. We are proposing to require impacted payers to implement and maintain their required FHIR APIs in conformance with certain applicable standards adopted in 45 CFR 170.215, without specifying versions of each required standard, which would allow impacted payers to use unexpired versions of the required standards, as the Secretary adopts updated versions in 45 CFR 170.215. Where more than one unexpired version of a standard is adopted in 45 CFR 170.215, impacted"},{"title":"Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program","type":"Rule","abstract":"This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2026. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2026. It also continues the second year of the 3-year phaseout of the rural adjustment, which began in FY 2025. Additionally, the final rule includes updates to the IRF Quality Reporting Program.","document_number":"2025-14780","html_url":"https://www.federalregister.gov/documents/2025/08/05/2025-14780/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-05/pdf/2025-14780.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14780.pdf?1754079306","publication_date":"2025-08-05","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":"with this expectation.\n \n Many commenters expressed concerns about a reduction in the data submission timeframe. Several cited increased provider burden as a key concern. These commenters noted that a reduced timeline could make it more difficult to meet data completion and accuracy thresholds within a shortened timeframe. Several commenters expressed concerns that there would be increased risk of compromised quality of data and a decrease in the number of completed assessments. Several commenters had concerns about the potential for increased compliance"},{"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":"transmission of a FHIR-based assessment to CMS? \n \n • How could the Trusted Exchange Framework and Common Agreement\n TM \n (TEFCA\n TM \n ) support CMS quality programs' adoption of FHIR-based assessment submissions consistent with the FHIR® Roadmap (available at \n https://rce.sequoiaproject.org/three-year-fhir-roadmap-for-tefca/) \n ? How might patient assessment data hold secondary uses for treatment or other TEFCA exchange purposes?\n \n • What other information should we consider, that could facilitate successful adoption and integration of FHIR-based"},{"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":"December 2022 OIG report identified BFSFs as an area where CMS could provide additional guidance to manufacturers and further stated that manufacturers expressed that competitors may be taking disparate approaches when applying CMS's four-part test to make these determinations. In some cases, BFSFs that are very high could mask price concessions that are passed on by the entity performing the bona fide service so that the product's ASP can remain high. Conversely, certain fees that are BFSFs could be incorrectly classified as a price concession to reduce"},{"title":"Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements","type":"Proposed Rule","abstract":"This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2026. This rule also proposes changes to the admission to hospice regulations and the hospice face-to-face attestation requirements under the certification of terminal illness regulations. This proposed rule also includes a technical correction to the regulatory text and provides updates to the Hospice Quality Reporting Program requirements. Finally, this proposed rule solicits comments regarding requests for information surrounding future measure concepts for Hospice Quality Reporting Program.","document_number":"2025-06317","html_url":"https://www.federalregister.gov/documents/2025/04/30/2025-06317/medicare-program-fy-2026-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reporting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-30/pdf/2025-06317.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-06317.pdf?1744402509","publication_date":"2025-04-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"for example, testing a FHIR-based assessment submission to CMS? \n \n • How could the Trusted Exchange Framework and Common Agreement\n TM \n (TEFCA\n TM \n ) \n 10 \n \n support CMS quality programs' adoption of FHIR-based assessment submissions consistent with the FHIR Roadmap (available at \n https://rce.sequoiaproject.org/three-year-fhir-roadmap-for-tefca/ \n )? How might patient assessment data hold secondary uses for treatment or other TEFCA exchange purposes?\n \n \n \n 10 \n TEFCA\n TM \n , outlines a common set of principles, terms, and conditions to support"},{"title":"Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies","type":"Rule","abstract":"This final rule sets forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this final rule finalizes permanent and temporary behavior adjustments and recalibrates the case- mix weights and update the functional impairment levels; comorbidity subgroups; and low-utilization payment adjustment (LUPA) thresholds for CY 2026. This final rule also finalizes changes to the face-to-face encounter policy and changes to the Home Health Quality Reporting Program (HH QRP) and the expanded Health Value-Based Purchasing (HHVBP) Model requirements. In addition, it updates the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). Lastly it finalizes: a technical change to the HH conditions of participation; updates to DMEPOS supplier conditions of payment; updates to provider and supplier enrollment requirements; and changes to DMEPOS accreditation requirements.","document_number":"2025-21767","html_url":"https://www.federalregister.gov/documents/2025/12/02/2025-21767/medicare-and-medicaid-programs-calendar-year-2026-home-health-prospective-payment-system-hh-pps-rate","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-02/pdf/2025-21767.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21767.pdf?1764364516","publication_date":"2025-12-02","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":"health payment rates. \n \n \n Comment: \n Several commenters expressed concern with the wage index values assigned to their specific geographic areas. A commenter recommended that the wage index value for rural Hawaii match or exceed the wage index value assigned to rural California. A few commenters expressed concern with the wage index value assigned to rural Puerto Rico after the adoption of the delineations from OMB Bulletin No. 23-01.\n \n \n Response: \n We appreciate the concerns expressed by commenters regarding wage index values in specific geographic"},{"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":"mandatory and our responses: \n \n Comment: \n Several commenters expressed support for requiring mandatory participation in the IOTA Model. Some commenters expressed that mandatory participation would help increase access to kidney transplants and improve kidney transplant outcomes.\n \n \n Response: \n We thank the commenters for their support.\n \n \n Comment: \n Several commenters expressed concern with making participation in the IOTA Model mandatory. Commenters shared that mandatory participation could negatively impact patients. A commenter stated that CMS"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital- related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); update and make changes to requirements for certain quality programs; and make other policy-related changes.","document_number":"2025-06271","html_url":"https://www.federalregister.gov/documents/2025/04/30/2025-06271/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-30/pdf/2025-06271.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-06271.pdf?1744402510","publication_date":"2025-04-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"CABG-related care, including the use of DuraGraft®. In the FY 2025 IPPS/LTCH PPS final rule (89 FR 69149), we expressed concern that the Marizyme Internal Study (2023), which has the same content as Caliskan et al. (2024), only reported all-cause mortality and does not specify how many patients had mortality due to other causes that could not be attributed to use of a vein preservation solution other than DuraGraft®. We continue to have the concern that all-cause mortality may include deaths resulting from other conditions rather than heart diseases."},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots","type":"Rule","abstract":"This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2026 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, this final rule with comment period announces the closure of a teaching hospital and the opportunity to apply for available slots, and updates and refines the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency, as well as summarizes comments received in response to a request for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for the OQR, REHQR, and ASCQR programs.","document_number":"2025-20907","html_url":"https://www.federalregister.gov/documents/2025/11/25/2025-20907/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-25/pdf/2025-20907.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20907.pdf?1763759710","publication_date":"2025-11-25","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":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"Comment: \n A commenter expressed concern about payment disparities between traditional surgical arteriovenous fistula (AVF) creation and endovascular procedures. The commenter noted that ASC payment for endovascular creation can be substantially higher than traditional fistula creation, despite the benefits that surgical AVFs may offer to both patients and providers, particularly the greater versatility that surgical AVFs can offer in placement locations when compared to endovascular AVFs. The commenter expressed concern that low payment may cause"}]}