{"description":"Documents matching 'audit reports certain medical device'","count":2675,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=audit+reports+certain+medical+device&format=json&page=2","results":[{"title":"Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community","type":"Rule","abstract":"The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule revoking the regulations entitled \"Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community.\" FDA is taking this action because the regulations at 21 CFR part 26 have been superseded in part by the \"United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)\" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.","document_number":"2026-03286","html_url":"https://www.federalregister.gov/documents/2026/02/19/2026-03286/revocation-of-regulations-regarding-the-mutual-recognition-of-pharmaceutical-good-manufacturing","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-19/pdf/2026-03286.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03286.pdf?1771422319","publication_date":"2026-02-19","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":"parties would recognize certain drug and device inspection/evaluation reports of the other, in order to more effectively allocate limited inspection resources (Mutual Recognition of Pharmaceutical Good Manufacturing Practice Inspection Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports Between the United States and the European Community, 63 FR 60122 at 60141 (November 6, 1998)). Subparts A and B of part 26 substantially reflect the 1998 MRA's pharmaceutical and medical device sectoral annexes,"},{"title":"Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, Agency, or we) is proposing to revoke the regulations entitled \"Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community.\" FDA is proposing this action because the existing regulations have been superseded in part by the \"United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)\" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.","document_number":"2024-21559","html_url":"https://www.federalregister.gov/documents/2024/09/20/2024-21559/revocation-of-regulations-regarding-the-mutual-recognition-of-pharmaceutical-good-manufacturing","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-20/pdf/2024-21559.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21559.pdf?1726749947","publication_date":"2024-09-20","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":"parties would recognize certain drug and device inspections/evaluation reports of the other, in order to more effectively allocate limited inspection resources (Mutual Recognition of Pharmaceutical Good Manufacturing Practice Inspection Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports Between the United States and the European Community, 63 FR 60122 at 60141 (November 6, 1998)). Subparts A and B of part 26 substantially reflect the 1998 MRA's pharmaceutical and medical device sectoral annexes,"},{"title":"Medical Device User Fee Amendments; Public Meeting; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing a hybrid public meeting titled \"Medical Device User Fee Amendments.\" The purpose of the public meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2028 through 2032. MDUFA authorizes FDA to collect fees and use them for the process for the review of device applications. The current legislative authority for MDUFA expires September 30, 2027. At that time, new legislation will be required for FDA to continue collecting device user fees in future fiscal years. Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.","document_number":"2026-13778","html_url":"https://www.federalregister.gov/documents/2026/07/08/2026-13778/medical-device-user-fee-amendments-public-meeting-request-for-comments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-08/pdf/2026-13778.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13778.pdf?1783428315","publication_date":"2026-07-08","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":"regarding performance reporting can be found in Section V of the draft commitment letter. \n \n Additional commitments not summarized above are described in the full MDUFA VI commitment letter, available at: \n https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa-fees/medical-device-user-fee-amendments-2028-mdufa-vi \n .\n \n \n FDA will post the agenda approximately 5 days before the meeting at: \n https://www.fda.gov/medical-devices/medical-devices-news-and-events/register-fdas-public-meeting-reauthorization-medical-device-user-fee-amendments-08052026"},{"title":"Prohibition on Creditors and Consumer Reporting Agencies Concerning Medical Information (Regulation V)","type":"Rule","abstract":"The Consumer Financial Protection Bureau (CFPB) is issuing a final rule amending Regulation V, which implements the Fair Credit Reporting Act (FCRA), concerning medical information. The FCRA prohibits creditors from considering medical information in credit eligibility determinations. The CFPB is removing a regulatory exception that had permitted creditors to obtain and use information on medical debts notwithstanding this statutory limitation. The final rule also provides that a consumer reporting agency generally may not furnish to a creditor a consumer report containing information on medical debt that the creditor is prohibited from using.","document_number":"2024-30824","html_url":"https://www.federalregister.gov/documents/2025/01/14/2024-30824/prohibition-on-creditors-and-consumer-reporting-agencies-concerning-medical-information-regulation-v","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-14/pdf/2024-30824.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-30824.pdf?1736775917","publication_date":"2025-01-14","agencies":[{"raw_name":"Consumer Financial Protection Bureau","name":"Consumer Financial Protection Bureau","id":573,"url":"https://www.federalregister.gov/agencies/consumer-financial-protection-bureau","json_url":"https://www.federalregister.gov/api/v1/agencies/573","parent_id":null,"slug":"consumer-financial-protection-bureau"}],"excerpts":"consumer reporting agency's medical debt information reporting responsibilities are impacted when creditors are prohibited from obtaining or using medical debt information. As discussed in more detail in part IV.C, \n Limits on a Consumer Reporting Agency's Disclosure of Medical Debt Information, \n final § 1022.38 provides that a consumer reporting agency is permitted to include medical debt information in a consumer report furnished to a creditor for credit eligibility purposes only if the following criteria are met: (1) the consumer reporting agency"},{"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device","type":"Rule","abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the whole exome sequencing constituent device 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 whole exome sequencing constituent device'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":"2024-20550","html_url":"https://www.federalregister.gov/documents/2024/09/11/2024-20550/medical-devices-immunology-and-microbiology-devices-classification-of-the-whole-exome-sequencing","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-11/pdf/2024-20550.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20550.pdf?1725972341","publication_date":"2024-09-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"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":"design verification and validation, including certain clinical studies; and Certain labeling information, including certain performance information and device limitations. \n \n \n User error and improper use of the device \n Certain design verification and validation, including certain analytical studies and clinical studies; and Certain labeling information, including certain performance information and device limitations. \n \n \n FDA has determined that special controls, in combination with the general controls, address these risks to health and provide"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2027 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 proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. There are no changes to the Rural Emergency Hospital Quality Reporting Program. We propose to expand the prior authorization requirement to include additional Botulinum Toxin Injection services. We also propose to implement certain provisions of the Consolidated Appropriations Act, 2026, for off-campus outpatient departments of a provider. In addition, this proposed rule announces notices of closure of teaching hospitals and opportunities to apply for available slots. This rule also requests information regarding potential approaches to improve comparability and standardization, particularly for complex contracting methodologies, of the HPT information reported in machine- readable files and consumer-friendly displays. We propose hospital AOs with deeming authority to assess compliance with certain Emergency Medical Treatment and Labor Act (EMTALA) administrative requirements during accreditation and reaccreditation surveys. Finally, we are soliciting comments on a potential separate payment under the Inpatient Prospective Payment System (IPPS) for domestic procurement of personal protective equipment and essential medicines.","document_number":"2026-13656","html_url":"https://www.federalregister.gov/documents/2026/07/07/2026-13656/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-07/pdf/2026-13656.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13656.pdf?1782996328","publication_date":"2026-07-07","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":"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":"families from the IPO list for CY 2027.\n \n \n • \n Cross-Program Updates for the Hospital Outpatient Quality Reporting and Ambulatory Surgical Center Quality Reporting Programs: \n We propose to remove the Appropriate Follow-Up Interval for Normal Colonoscopy in Average Risk Patients measure from the Hospital Outpatient Quality Reporting and Ambulatory Surgical Center Quality Reporting Programs.\n \n \n • \n Hospital Outpatient Quality Reporting Program: \n In addition to the cross-program proposal to remove the Appropriate Follow-Up Interval for Normal"},{"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":"postmarketing safety reporting, and labeling that apply to certain medical gases, and to establish regulations regarding certification of designated medical gases (87 FR 31302). This rule satisfies the requirement in section 756 of the Consolidated Appropriations Act, 2017 (Pub. L. 115-31) that FDA issue final regulations revising the Federal drug regulations with respect to medical gases by July 15, 2017. \n By tailoring certain labeling, CGMP, certification, and postmarketing safety reporting requirements more narrowly to medical gases, FDA intends"},{"title":"Amendment to Existing Controls on Russia and Belarus Under the Export Administration Regulations (EAR) Adding New License Exception Medical Devices (MED); Corrections","type":"Rule","abstract":"In this final rule, the Bureau of Industry and Security (BIS) makes changes to the Russia and Belarus sanctions under the Export Administration Regulations (EAR) to add a new license exception for EAR99 medical devices and related parts, components, accessories, and attachments for use in or with medical devices that are destined for both countries and the temporarily occupied Crimea region of Ukraine, or the covered regions of Ukraine. The purpose of this final rule is to authorize under a license exception certain exports, reexports, and transfers (in-country) of \"medical devices\" that are being regularly approved and that advance U.S. national security and foreign policy interests. In addition, this final rule makes two corrections to the EAR related to Russia-related rules published in January, and March, 2024 by correcting an end-user control and adding a cross-reference correction.","document_number":"2024-09076","html_url":"https://www.federalregister.gov/documents/2024/04/29/2024-09076/amendment-to-existing-controls-on-russia-and-belarus-under-the-export-administration-regulations-ear","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-29/pdf/2024-09076.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09076.pdf?1714049149","publication_date":"2024-04-29","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"Bureau of Industry and Security","name":"Industry and Security Bureau","id":241,"url":"https://www.federalregister.gov/agencies/industry-and-security-bureau","json_url":"https://www.federalregister.gov/api/v1/agencies/241","parent_id":54,"slug":"industry-and-security-bureau"}],"excerpts":"Export Administration Regulations (EAR) to add a new license exception for EAR99 medical devices and related parts, components, accessories, and attachments for use in or with medical devices that are destined for both countries and the temporarily occupied Crimea region of Ukraine, or the covered regions of Ukraine. The purpose of this final rule is to authorize under a license \n \n exception certain exports, reexports, and transfers (in-country) of “medical devices” that are being regularly approved and that advance U.S. national security and foreign"},{"title":"Privacy Act of 1974; System of Records","type":"Notice","abstract":"Pursuant to the Privacy Act of 1974, notice is hereby given that VA is modifying the system of records titled \"Patient Medical Records-VA\" (24VA10A7). This system is used for ongoing treatment of individuals and patients; documentation of treatment provided; payment; health care operations such as producing various management and patient follow-up reports; responding to patient and other inquiries; for epidemiological research and other health care related studies; statistical analysis, resource allocation, and planning; providing clinical and administrative support to patient medical care; and determining entitlement and eligibility for VA benefits.","document_number":"2026-13454","html_url":"https://www.federalregister.gov/documents/2026/07/02/2026-13454/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-02/pdf/2026-13454.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13454.pdf?1782909925","publication_date":"2026-07-02","agencies":[{"raw_name":"DEPARTMENT OF VETERANS AFFAIRS","name":"Veterans Affairs Department","id":520,"url":"https://www.federalregister.gov/agencies/veterans-affairs-department","json_url":"https://www.federalregister.gov/api/v1/agencies/520","parent_id":null,"slug":"veterans-affairs-department"}],"excerpts":"security personnel. Access to patient medical records is restricted to VA employees who have a need for information in the performance of their official duties. Sensitive patient medical records, including employee patient medical records, records of public figures, or other sensitive patient medical records are generally stored in separate locked files or a similar electronically controlled access environment. Strict control measures are enforced to ensure that access to and disclosures from these patient medical records are limited. \n 2. Access to"},{"title":"Medical Devices; Quality System Regulation Amendments","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). We are doing so by incorporating by reference an international standard specific for device quality management systems. Through this rulemaking we also establish additional requirements and make conforming edits to clarify the device CGMP requirements for such products. This action will continue our efforts to align our regulatory framework with that used by regulatory authorities in other jurisdictions to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.","document_number":"2024-01709","html_url":"https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-02/pdf/2024-01709.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-01709.pdf?1706708714","publication_date":"2024-02-02","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":"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":"Systems—Fundamentals and Vocabulary—ISO 9000:2015. \n \n \n ISO 14971 \n Medical Devices—Application of Risk Management to Medical Devices. \n \n \n MDR \n Medical Device Reporting. \n \n \n MDSAP \n Medical Device Single Audit Program. \n \n \n OMB \n Office of Management and Budget. \n \n \n QMS \n Quality Management System. \n \n \n QMSR \n Quality Management System Regulation. \n \n \n QS \n Quality System. \n \n \n QSIT \n Quality System Inspection Technique. \n \n \n UDI \n Unique Device Identifier/Unique Device Identification. \n \n \n III. Background \n A. Introduction \n \n QMSs specify"},{"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":"Laboratory Developed Test. \n \n \n LGBTQIA+ \n Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, and Asexual. \n \n \n LoQ \n Limit of Quantitation. \n \n \n MAF \n Master File. \n \n \n MDA \n Medical Device Amendments of 1976. \n \n \n MDAC \n Medical Devices Advisory Committee. \n \n \n MDR \n Medical Device Report. \n \n \n MDUFA \n Medical Device User Fee Amendments. \n \n \n MolDx \n Molecular Diagnostic Services. \n \n \n NCBI \n National Center for Biotechnology Information. \n \n \n NDA \n New Drug Application. \n \n \n NGS \n Next Generation Sequencing. \n \n \n NIFLA \n National Institute"},{"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":"determining deviations excluded from the analytical sample. \n \n As always, we encourage providers to fill out the Medicare cost reports as accurately as possible. We note that there are efforts to monitor cost reports if there are concerns over the reported information. CMS audits home health cost reports through the Medicare Administrative Contractors (MACs) and the Center for Program Integrity (CPI). The cost report certification and associated penalties generally encourages HHAs to accurately represent the incurred costs of providing home health"},{"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":"Proposed Rule","abstract":"This proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule proposes permanent and temporary behavior adjustments and proposes to recalibrate the case-mix weights and update the functional impairment levels; comorbidity subgroups; and low-utilization payment adjustment (LUPA) thresholds for CY 2026. Lastly, this proposed rule proposes policy changes to the face-to-face encounter policy. It also proposes changes to the Home Health Quality Reporting Program (HH QRP) and the expanded Health Value-Based Purchasing (HHVBP) Model requirements. In addition, it would update the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). Lastly it proposes: 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":"2025-12347","html_url":"https://www.federalregister.gov/documents/2025/07/02/2025-12347/medicare-and-medicaid-programs-calendar-year-2026-home-health-prospective-payment-system-hh-pps-rate","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-02/pdf/2025-12347.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-12347.pdf?1751314517","publication_date":"2025-07-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"rolling quarters and would be publicly reported for all HHAs with 40 or more completed surveys over the reporting period. Star Ratings are updated every quarter. To determine what impact the changes to the survey measures would have on public reporting, CMS considered the nature of the measure change. As Talk About Home Safety, Review Medicines, and Talk About Medicine Side Effects are new measures for the HHCAHPS Survey, since they would be reported individually, we would have to wait to introduce public reporting until we have four quarters of data"},{"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":"add-on payments for high-cost new medical services and technologies (including public input, as directed by \n \n the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) Public Law 108-173, obtained in a town hall meeting for applications not submitted under an alternative pathway) with proposals for certain FDA market authorized technologies, and a discussion of the proposed status of FY 2027 new technology applicants under the alternative pathways for certain medical devices and certain antimicrobial products.\n \n • A proposal"},{"title":"Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program","type":"Rule","abstract":"This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2026 benefit year user fee rates for issuers that participate in the HHS-operated risk adjustment program and the 2026 benefit year user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes requirements related to modifications to the calculation of the Basic Health Program (BHP) payment; and changes to the Initial Validation Audit (IVA) sampling approach and Second Validation Audit (SVA) pairwise means test for HHS-RADV. It also addresses HHS' authority to engage in compliance reviews of and take enforcement action against lead agents of insurance agencies for violations of HHS' Exchange standards and requirements; HHS' system suspension authority to address noncompliance by agents and brokers; an optional fixed-dollar premium payment threshold; permissible plan-level adjustment to the index rate to account for cost-sharing reductions (CSRs); reconsideration standards for certification denials; changes to the approach for conducting Essential Community Provider (ECP) certification reviews; a policy to publicly share aggregated, summary- level Quality Improvement Strategy (QIS) information on an annual basis; and revisions to the medical loss ratio (MLR) reporting and rebate requirements for qualifying issuers that meet certain standards.","document_number":"2025-00640","html_url":"https://www.federalregister.gov/documents/2025/01/15/2025-00640/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2026-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-15/pdf/2025-00640.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-00640.pdf?1736802922","publication_date":"2025-01-15","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"clinically significant, chronic or systematic medical condition, and therefore, any enrollees with HCCs, regardless of if they are in a lower-risk stratum or higher risk stratum, have conditions that should have supporting medical records.\n 139 \n \n Furthermore, if it is more burdensome to retrieve medical records for enrollees from lower-risk strata, any increase in burden from retrieving these medical records would be offset, at least in part, by the decrease in burden from retrieving fewer medical records for enrollees from higher-risk strata"},{"title":"Medicare Program; Ensuring Safety Through Domestic Security With Made in America Personal Protective Equipment (PPE) and Essential Medicine Procurement by Medicare Participating Hospitals","type":"Proposed Rule","abstract":"This advance notice of proposed rulemaking solicits public comment on potential options we may consider for Medicare participating hospitals to help foster a more resilient supply chain for American- made personal protective equipment and essential medicines to secure our nation's health and safety and to reflect the additional resource costs incurred when procuring these domestically manufactured items. We seek input on a possible new \"Secure American Medical Supplies\" friendly designation that could be earned by hospitals that demonstrate their commitment to domestic procurement. In addition, we seek input on potential ways such a designation could facilitate the creation of new, streamlined payment policies to support hospitals in their efforts. We are also seeking input on a potential new structural quality measure as part of the Hospital Inpatient Quality Reporting (IQR) Program that could promote hospital commitments to invest in domestic procurement to secure our nation's health and safety.","document_number":"2026-01730","html_url":"https://www.federalregister.gov/documents/2026/01/29/2026-01730/medicare-program-ensuring-safety-through-domestic-security-with-made-in-america-personal-protective","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-29/pdf/2026-01730.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-01730.pdf?1769465709","publication_date":"2026-01-29","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":"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":"modifications that could increase effectiveness. For FY 2024, less than 100 hospitals reported the information necessary to determine the payment adjustment on their cost reports. This low adoption rate may be partially attributable to administrative reporting burden concerns raised by stakeholders. \n \n As noted in the CY 2023 OPPS/ASC final rule with comment period, we received many comments urging us to expand this policy to cover other forms of PPE and critical medical supplies. A few commenters stated that other forms of PPE are susceptible to shortages"},{"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":"surveys, federal reports, and studies, including a multi-year survey conducted by the American Medical Association (AMA) about delays in care and medical risks to patients due to issues with prior authorization (89 FR 8859).\n 114 \n \n Concerns about prior authorization processes have remained the same. According to a 2024 AMA report, 29 percent of physicians reported that prior authorization had led to a severe adverse event for a patient in their care, including hospitalization, permanent impairment, or death, and 94 percent reported that prior authorization"},{"title":"Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Policies","type":"Proposed Rule","abstract":"This proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule discusses the behavior adjustment and proposes a temporary behavior adjustment and proposes to recalibrate the case-mix weights and update the functional impairment levels; comorbidity subgroups; and low- utilization payment adjustment (LUPA) thresholds for CY 2027. Additionally, this proposed rule discusses the provision of home health palliative care services and includes a request for information (RFI) on a home health specific wage index. This rule would also propose changes to the Home Health Quality Reporting Program (HH QRP) and summarizes potential initiatives to improve alignment between the HH QRP and expanded Home Health Value Based Purchasing (HHVBP) Model. Lastly, the rule would--clarify the application of the DMEPOS face-to- face encounter requirements for the replacement of DMEPOS items; make changes to the provider and supplier enrollment requirements; make changes regarding DME benefit expansion for infusion pumps and drugs; and discuss collection of information requirement changes regarding the DMEPOS Competitive Bidding Program (CBP) country of origin.","document_number":"2026-13602","html_url":"https://www.federalregister.gov/documents/2026/07/06/2026-13602/calendar-year-2027-home-health-prospective-payment-system-hh-pps-rate-update-requirements-for-the-hh","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-06/pdf/2026-13602.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13602.pdf?1782936912","publication_date":"2026-07-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"have seen cases where the medical director or administrator is very far from the physical hospice facility; several instances, in fact, involved the hospice and medical director being on opposite sides of the country (for instance, the medical director is in New York, and the hospice is in California). This, too, generates significant concerns about the individual's oversight of the hospice. \n Third, certain hospices have been using medical directors with inactive licenses. Section 418.22(c), as noted, requires the medical director who initially certifies"},{"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":"a policy that hospitals will be required to report certain market-based payment rate information on their Medicare cost report for cost reporting periods ending on or after January 1, 2026, to be used in a finalized change to the methodology for calculating the IPPS MS-DRG relative weights to reflect \n \n relative market-based pricing. Specifically, we are finalizing a requirement for facilities to report market-based rate information on the Medicare cost report; the hospital will be required to report the median of the payer-specific negotiated"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the tracking of medical devices.","document_number":"2023-16933","html_url":"https://www.federalregister.gov/documents/2023/08/08/2023-16933/agency-information-collection-activities-proposed-collection-comment-request-medical-devices-device","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-08-08/pdf/2023-16933.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-16933.pdf?1691412332","publication_date":"2023-08-08","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":"(referred to as a “tracked implant”), or (3) the device is life-sustaining or life-supporting (referred to as a “tracked l/s-l/s device”) and is used outside a device user facility. Tracked device information is collected to facilitate identifying the current location of medical devices and patients possessing those devices, to the extent that patients permit the collection of identifying information. Manufacturers and FDA (where necessary) use the data to: (1) expedite the recall of distributed medical devices that are dangerous or defective and (2) facilitate"}]}