{"description":"Documents matching 'must include patient population federal'","count":5932,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=must+include+patient+population+federal&format=json&page=2","results":[{"title":"CAUTI Events Among Patients With Spinal Cord Injury-Associated Neurogenic Bladder (SCI-NB); Request for Information: Reopening of Comment Period","type":"Notice","abstract":"The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), is reopening the public comment period for a request for information (RFI) that was initially published on September 8, 2025, regarding Catheter-associated Urinary Tract Infections (CAUTIs) among patients with Spinal Cord Injury-associated Neurogenic Bladder (SCI- NB). We want to understand better the burden of CAUTIs among this patient population and any implications related to reporting within the CDC National Healthcare Safety Network (NHSN) device-associated urinary tract infection (UTI) event module. This docket provides an opportunity for professionals who work with this patient population, as well as those who conduct NHSN UTI surveillance, to offer feedback related to our approach.","document_number":"2025-23450","html_url":"https://www.federalregister.gov/documents/2025/12/19/2025-23450/cauti-events-among-patients-with-spinal-cord-injury-associated-neurogenic-bladder-sci-nb-request-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23450.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23450.pdf?1766065526","publication_date":"2025-12-19","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":"Centers for Disease Control and Prevention","name":"Centers for Disease Control and Prevention","id":44,"url":"https://www.federalregister.gov/agencies/centers-for-disease-control-and-prevention","json_url":"https://www.federalregister.gov/api/v1/agencies/44","parent_id":221,"slug":"centers-for-disease-control-and-prevention"}],"excerpts":"(CAUTIs) among <span class=\"match\">patients</span> with Spinal Cord Injury-associated Neurogenic Bladder (SCI-NB). We want to understand better the burden of CAUTIs among this <span class=\"match\">patient</span> <span class=\"match\">population</span> and any implications related to reporting within the CDC National Healthcare Safety Network (NHSN) device-associated urinary tract infection (UTI) event module. This docket provides an opportunity for professionals who work with this <span class=\"match\">patient</span> <span class=\"match\">population</span>, as well as those who conduct NHSN UTI surveillance, to offer feedback related to our approach.\n \n \n \n DATES: \n Comments <span class=\"match\">must</span> be received"},{"title":"CAUTI Events Among Patients With Spinal Cord Injury-Associated Neurogenic Bladder (SCI-NB); Request for Information","type":"Notice","abstract":"The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), is seeking information regarding Catheter-associated Urinary Tract Infections (CAUTIs) among patients with Spinal Cord Injury-associated Neurogenic Bladder (SCI- NB). We want to understand better the burden of CAUTIs among this patient population and any implications related to reporting within the CDC National Healthcare Safety Network (NHSN) device-associated urinary tract infection (UTI) event module. This docket provides an opportunity for professionals who work with this patient population, as well as those who conduct NHSN UTI surveillance, to offer feedback related to our approach.","document_number":"2025-17118","html_url":"https://www.federalregister.gov/documents/2025/09/08/2025-17118/cauti-events-among-patients-with-spinal-cord-injury-associated-neurogenic-bladder-sci-nb-request-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-08/pdf/2025-17118.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-17118.pdf?1757076312","publication_date":"2025-09-08","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":"Centers for Disease Control and Prevention","name":"Centers for Disease Control and Prevention","id":44,"url":"https://www.federalregister.gov/agencies/centers-for-disease-control-and-prevention","json_url":"https://www.federalregister.gov/api/v1/agencies/44","parent_id":221,"slug":"centers-for-disease-control-and-prevention"}],"excerpts":"(CAUTIs) among <span class=\"match\">patients</span> with Spinal Cord Injury-associated Neurogenic Bladder (SCI-NB). We want to understand better the burden of CAUTIs among this <span class=\"match\">patient</span> <span class=\"match\">population</span> and any implications related to reporting within the CDC National Healthcare Safety Network (NHSN) device-associated urinary tract infection (UTI) event module. This docket provides an opportunity for professionals who work with this <span class=\"match\">patient</span> <span class=\"match\">population</span>, as well as those who conduct NHSN UTI surveillance, to offer feedback related to our approach. \n \n \n DATES: \n Comments <span class=\"match\">must</span> be received"},{"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","document_number":"2026-09335","html_url":"https://www.federalregister.gov/documents/2026/05/12/2026-09335/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-12/pdf/2026-09335.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09335.pdf?1778503521","publication_date":"2026-05-12","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"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":"documentation and performance results from a clinical study that <span class=\"match\">includes</span> prospective (sequentially collected) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study <span class=\"match\">must</span> be performed on a study <span class=\"match\">population</span> consistent with the intended use <span class=\"match\">population</span> and compare the device performance to results obtained using a comparator method that FDA has determined to be appropriate. Detailed documentation <span class=\"match\">must</span> <span class=\"match\">include</span> the clinical study protocol (including a predefined statistical"},{"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","document_number":"2026-11739","html_url":"https://www.federalregister.gov/documents/2026/06/11/2026-11739/medical-devices-immunology-and-microbiology-devices-classification-of-the-simple-point-of-care","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11739.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11739.pdf?1781095520","publication_date":"2026-06-11","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":"from the intended use <span class=\"match\">population</span> for each claimed specimen type. Results <span class=\"match\">must</span> be obtained from a geographically diverse <span class=\"match\">population</span>, such that the performance of the test device is appropriately representative of all present, circulating strains of the target respiratory virus, at the time of the study and submission. The clinical study <span class=\"match\">must</span> be consistent with and support the intended use <span class=\"match\">population</span> and intended operators (as applicable) and <span class=\"match\">must</span> be conducted in a representative intended use setting. The clinical study <span class=\"match\">must</span> compare the results of"},{"title":"Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases-Questions and Answers; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers.\" This guidance assists in the clinical development of new antibacterial drugs to treat serious bacterial diseases in patients with unmet medical needs, including patients with a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance entitled \"Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1)\" issued on May 24, 2022.","document_number":"2025-11928","html_url":"https://www.federalregister.gov/documents/2025/06/27/2025-11928/antibacterial-therapies-for-patients-with-an-unmet-medical-need-for-the-treatment-of-serious","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-27/pdf/2025-11928.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11928.pdf?1750941919","publication_date":"2025-06-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"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":"industry entitled “Antibacterial Therapies for <span class=\"match\">Patients</span> With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases—Questions and Answers.” This guidance assists in the clinical development of new antibacterial drugs to treat serious bacterial diseases in <span class=\"match\">patients</span> with unmet medical needs, including <span class=\"match\">patients</span> with a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance entitled “Antibacterial Therapies for <span class=\"match\">Patients</span> With an Unmet Medical Need for the Treatment"},{"title":"Continuity of Care via Telemedicine for Veterans Affairs Patients","type":"Rule","abstract":"This final rule authorizes Department of Veterans Affairs (VA) practitioners acting within the scope of their VA employment to prescribe controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation. VA practitioners are permitted to prescribe controlled substances to VA patients if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient, subject to certain conditions.","document_number":"2025-01044","html_url":"https://www.federalregister.gov/documents/2025/01/17/2025-01044/continuity-of-care-via-telemedicine-for-veterans-affairs-patients","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01044.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-01044.pdf?1736948756","publication_date":"2025-01-17","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"},{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"practitioner <span class=\"match\">must</span> limit the prescription to a 7-day supply and <span class=\"match\">must</span> later review both the VA <span class=\"match\">patient's</span> VA EHR (to <span class=\"match\">include</span> the internal prescription database) and the PDMP data for the state in which the <span class=\"match\">patient</span> is located at the time of the telemedicine encounter for prescriptions of controlled substances issued to the <span class=\"match\">patient</span> before continuing to prescribe controlled substances to the <span class=\"match\">patient</span> via telemedicine. If no PDMP program exists for the state in which the VA <span class=\"match\">patient</span> is located at the time of the telemedicine encounter the practitioner <span class=\"match\">must</span> review"},{"title":"Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients","type":"Rule","abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients 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 coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients' 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, in part by reducing regulatory burdens.","document_number":"2025-08151","html_url":"https://www.federalregister.gov/documents/2025/05/09/2025-08151/medical-devices-hematology-and-pathology-devices-classification-of-the-coagulation-system-for-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-09/pdf/2025-08151.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-08151.pdf?1746708319","publication_date":"2025-05-09","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":"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":"output). Further, the study <span class=\"match\">must</span> meet all of the following criteria: \n (A) The study <span class=\"match\">must</span> be performed in the intended use <span class=\"match\">population</span> and <span class=\"match\">include</span> representation from all <span class=\"match\">patient</span> <span class=\"match\">populations</span> for whom the device is intended to be used. Potential endogenous and exogenous interferents for each target <span class=\"match\">patient</span> <span class=\"match\">population</span> <span class=\"match\">must</span> be evaluated or known prior to the study; \n (B) The study <span class=\"match\">must</span> be conducted at a minimum of three external sites representative of the intended use setting by the intended operators; \n (C) Test samples <span class=\"match\">must</span> be collected at time intervals"},{"title":"Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is classifying the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies 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 fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies' 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, in part by reducing regulatory burdens.","document_number":"2025-11793","html_url":"https://www.federalregister.gov/documents/2025/06/26/2025-11793/medical-devices-hematology-and-pathology-devices-classification-of-the-fluorescence-in-situ","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-26/pdf/2025-11793.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11793.pdf?1750855518","publication_date":"2025-06-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Code of <span class=\"match\">Federal</span> Regulations. The change was made in accordance with the Office of <span class=\"match\">Federal</span> Register's (OFR) interpretations of the \n <span class=\"match\">Federal</span> Register \n Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook.\n \n \n FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. \n \n Table 1—Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From <span class=\"match\">Patients</span> With Hematologic"},{"title":"Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program","type":"Rule","abstract":"This final rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2027 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 provisions related to civil money penalties (CMPs) for noncompliant issuers and other responsible entities; standards governing agents, brokers, and web-brokers; the expansion and codification of hardship exemption eligibility; implementation of the State Exchange Improper Payment Measurement (SEIPM); provider access standards and essential community provider standards for QHP certification; QHP certification of non-network plans; a prohibition on issuers from including routine non-pediatric dental services as an Essential Health Benefit (EHB); requirements related to defrayal for the cost of any State-required benefits in addition to the EHB; cost- sharing flexibilities for catastrophic and individual market bronze plans; establishment of catastrophic plans with plan terms of up to 10 consecutive plan years; QHP issuer quality improvement strategies (QISs); and revisions affecting which enrollees are included in Federal Basic Health Program (BHP) payment calculations to States. This final rule also includes amendments to implement certain provisions of the Working Families Tax Cut (WFTC) legislation.","document_number":"2026-10050","html_url":"https://www.federalregister.gov/documents/2026/05/20/2026-10050/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2027-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-20/pdf/2026-10050.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10050.pdf?1779135308","publication_date":"2026-05-20","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":"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":"in the March 11, 2014 \n <span class=\"match\">Federal</span> Register \n (79 FR 13743), the May 27, 2014 \n <span class=\"match\">Federal</span> Register \n (79 FR 30339), the February 27, 2015 \n <span class=\"match\">Federal</span> Register \n (80 FR 10749), the March 8, 2016 \n <span class=\"match\">Federal</span> Register \n (81 FR 12203), the December 22, 2016 \n <span class=\"match\">Federal</span> Register \n (81 FR 94183), the April 17, 2018 \n <span class=\"match\">Federal</span> Register \n (83 FR 16930), the May 14, 2020 \n <span class=\"match\">Federal</span> Register \n (85 FR 29164), the May 5, 2021 \n <span class=\"match\">Federal</span> Register \n (86 FR 24140), the May 6, 2022 \n <span class=\"match\">Federal</span> Register \n (87 FR 27208), and the January 15, 2025 \n <span class=\"match\">Federal</span> Register \n (90 FR 4424)"},{"title":"Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment","type":"Rule","abstract":"The \"Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (the SUPPORT Act),\" which became law on October 24, 2018, amended the Controlled Substances Act to expand the conditions a practitioner must meet to provide medication-assisted treatment for opioid use disorder and expand the options available for a physician to be considered a qualifying physician. The SUPPORT Act also allowed a pharmacy to deliver prescribed controlled substances to a practitioner's registered location for the purpose of maintenance or detoxification treatment to be administered under certain conditions by a practitioner. The Drug Enforcement Administration promulgated an interim final rule with request for comments in November 2020 to amend its regulations to make them consistent with the SUPPORT Act and implement its requirements. On December 29, 2022, the Restoring Hope for Mental Health and Well-Being Act of 2022 removed many of the statutory provisions of the SUPPORT Act. This final rule adopts the provisions of the interim final rule that are still applicable as final, with minor changes. In addition, this final rule implements the related provisions of the Restoring Hope for Mental Health and Well-Being Act of 2022.","document_number":"2026-11526","html_url":"https://www.federalregister.gov/documents/2026/06/09/2026-11526/implementation-of-the-substance-use-disorder-prevention-that-promotes-opioid-recovery-and-treatment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-09/pdf/2026-11526.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11526.pdf?1780922715","publication_date":"2026-06-09","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"providers from treating these <span class=\"match\">patients</span>. A commenter expressed concern that the 14-day limit could lead to overdose due to <span class=\"match\">patients</span> not being able to access the medication the remaining 16 days of the month. Commenters mentioned that <span class=\"match\">patients</span> have difficulty keeping appointments for reasons such as <span class=\"match\">patient</span> needs, insecure housing, transportation issues, problems with insurance, and holidays. They stated that the 14-day restriction puts an undue burden on the use of the valuable product because often times a <span class=\"match\">patient</span> is unable to schedule or reschedule"},{"title":"Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program","type":"Proposed Rule","abstract":"This proposed rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2027 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 proposed rule also includes provisions related to civil money penalties (CMPs) for noncompliant issuers and other responsible entities; standards governing agents, brokers, and web-brokers; the expansion and codification of hardship exemption eligibility; implementation of the State Exchange Improper Payment Measurement (SEIPM); provider access standards and essential community provider standards for QHP certification; QHP certification of non-network plans; a prohibition on issuers from including routine non-pediatric dental services as an Essential Health Benefit (EHB); cost-sharing flexibilities for catastrophic and individual market bronze plans; establishment of catastrophic plans with plan terms of up to 10 consecutive years; QHP issuer quality improvement strategies (QISs); revisions affecting which enrollees are included in Federal Basic Health Program (BHP) payment calculations to States; and seeks comment on potential adjustments to other Federal standards, including the Federal medical loss ratio (MLR) standard in the individual market. This proposed rule also includes amendments to implement certain provisions of the Working Families Tax Cut (WFTC) legislation.","document_number":"2026-02769","html_url":"https://www.federalregister.gov/documents/2026/02/11/2026-02769/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2027-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-11/pdf/2026-02769.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02769.pdf?1770671709","publication_date":"2026-02-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"amended in final rules published in the March 11, 2014 \n <span class=\"match\">Federal</span> Register \n (79 FR 13743), the May 27, 2014 \n <span class=\"match\">Federal</span> Register \n (79 FR 30339), the February 27, 2015 \n <span class=\"match\">Federal</span> Register \n (80 FR 10749), the March 8, 2016 \n <span class=\"match\">Federal</span> Register \n (81 FR 12203), the December 22, 2016 \n <span class=\"match\">Federal</span> Register \n (81 FR 94183), the April 17, 2018 \n <span class=\"match\">Federal</span> Register \n (83 FR 16930), the May 14, 2020 \n <span class=\"match\">Federal</span> Register \n (85 FR 29164), the May 5, 2021 \n <span class=\"match\">Federal</span> Register \n (86 FR 24140), and the May 6, 2022 \n <span class=\"match\">Federal</span> Register \n (87 FR 27208), and an interim final rule"},{"title":"Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting applications from patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum coordinated through the FDA's Patient Affairs Staff, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner at FDA, and is hosted by CTTI. Through the PEC, the patient community and FDA staff are able to discuss an array of topics related to increasing meaningful patient engagement with diverse populations in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patient, caregiver, and patient advocate perspectives can inform medical product development and regulatory discussions.","document_number":"2024-15008","html_url":"https://www.federalregister.gov/documents/2024/07/09/2024-15008/request-for-applications-for-new-members-of-the-clinical-trials-transformation-initiativefood-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-09/pdf/2024-15008.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-15008.pdf?1720442730","publication_date":"2024-07-09","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":"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":"Initiative (CTTI), is requesting applications from <span class=\"match\">patient</span> advocates interested in participating on the <span class=\"match\">Patient</span> Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum coordinated through the FDA's <span class=\"match\">Patient</span> Affairs Staff, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner at FDA, and is hosted by CTTI. Through the PEC, the <span class=\"match\">patient</span> community and FDA staff are able to discuss an array of topics related to increasing meaningful <span class=\"match\">patient</span> engagement with diverse <span class=\"match\">populations</span> in medical product development and regulatory"},{"title":"Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program","type":"Proposed Rule","abstract":"This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2027. As required by statute, this proposed 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 2027. It also continues the third year of the 3-year phaseout of the rural adjustment, which began in FY 2025. This proposed rule includes a solicitation for public comments on alternative data sources for the IRF PPS wage index; proposes to require all therapy treatments or therapy evaluations to begin within 36-hours from midnight on the day of admission; proposes to require a patient's current functional status be documented on the preadmission screening; proposes requirements for the initial Interdisciplinary Team meeting; and includes a request for information on potential future IRF PPS payment reform. Additionally, the proposed rule includes updates to the IRF Quality Reporting Program. Furthermore, the proposed rule includes changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program.","document_number":"2026-06642","html_url":"https://www.federalregister.gov/documents/2026/04/06/2026-06642/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-06/pdf/2026-06642.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06642.pdf?1775160907","publication_date":"2026-04-06","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":"severity of the IRF <span class=\"match\">patient</span> <span class=\"match\">population</span> and the associated costs of caring for these <span class=\"match\">patients</span> in the IRF setting. The CMG relative weights are updated each year based on the most recent available data for the full <span class=\"match\">population</span> of IRF Medicare fee-for-service beneficiaries. This ensures that the IRF case-mix system is as reflective as possible of changes in the IRF <span class=\"match\">patient</span> <span class=\"match\">populations</span> and the associated coding practices and ensures that IRF payments appropriately reflect the relative costs of caring for all types of IRF <span class=\"match\">patients</span>. \n V. FY 2027 IRF PPS"},{"title":"Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishment of a Public Docket; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled \"Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population.\" The purpose of the hybrid public meeting is to seek public input on the clinical use and safety concerns associated with the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population. The public meeting will be facilitated by the Reagan-Udall Foundation for the FDA. FDA is establishing a docket for public comment on this topic.","document_number":"2025-10943","html_url":"https://www.federalregister.gov/documents/2025/06/16/2025-10943/use-of-orally-ingestible-unapproved-prescription-drug-products-containing-fluoride-in-the-pediatric","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-10943.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-10943.pdf?1749818723","publication_date":"2025-06-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"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":"prevention in the pediatric <span class=\"match\">population</span>. What factors do clinicians consider when prescribing such drug products for the pediatric <span class=\"match\">population</span>? \n 2. Please comment on the safety concerns associated with these drug products, taking into account the amount of fluoride they provide when used as directed for prevention of tooth decay prevention in the pediatric <span class=\"match\">population</span>. \n 3. Based on the totality of the data available today, please comment on the continued use of these drug products for tooth decay prevention in the pediatric <span class=\"match\">population</span> considering the additional"},{"title":"Registering Emergency Medical Services Agencies Under the Protecting Patient Access to Emergency Medications Act of 2017","type":"Rule","abstract":"The \"Protecting Patient Access to Emergency Medications Act of 2017,\" (the Act) which became law on November 17, 2017, amended the Controlled Substances Act (CSA) to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances. In addition, the Act allows emergency medical services professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional pursuant to a valid standing or verbal order. The Drug Enforcement Administration is publishing this final rule to conform its regulations to the statutory amendments of the CSA and to otherwise implement its requirements. This final rule adopts, with minor modifications, the notice of proposed rulemaking published on October 5, 2020.","document_number":"2026-02288","html_url":"https://www.federalregister.gov/documents/2026/02/05/2026-02288/registering-emergency-medical-services-agencies-under-the-protecting-patient-access-to-emergency","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-05/pdf/2026-02288.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02288.pdf?1770153307","publication_date":"2026-02-05","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"substances. This definition would <span class=\"match\">include</span> instances when an EMS vehicle is responding to an emergency, is transporting <span class=\"match\">patients</span>, or is on call. “On call” means that personnel are ready and available to respond, but may not be responding to an emergency at that precise moment. EMS vehicles and personnel are considered “on call” when they are prepared to respond to emergencies, even if they are not actively engaged in an emergency call. This <span class=\"match\">includes</span> periods when the vehicle is on standby for the next call, which may <span class=\"match\">include</span> waiting in designated standby"},{"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":"use specific terms applicable to individuals covered under that program. Also, when we discuss <span class=\"match\">patients</span>, the term <span class=\"match\">includes</span>, where applicable, a <span class=\"match\">patient's</span> personal representative. For example, a <span class=\"match\">patient</span> or their personal representative may access certain types of information under the proposals in this proposed rule. However, when we refer to a <span class=\"match\">patient's</span> medical needs or health records, we do not <span class=\"match\">include</span> the medical needs or health records of the <span class=\"match\">patient's</span> personal representative. Pursuant to the “Standards for Privacy of Individually Identifiable"},{"title":"Proposed Data Collection Submitted for Public Comment and Recommendations","type":"Notice","abstract":"The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled STI Surveillance Network (SSuN). This information collection request is designed to strengthen national and local surveillance capacity for incident, new, and emerging sexually transmitted infections (STIs) by collecting information on patients at risk for STIs and providing more accurate estimates of the burden of disease, incidence of STIs, trends and impact of STIs at the population level.","document_number":"2025-22009","html_url":"https://www.federalregister.gov/documents/2025/12/05/2025-22009/proposed-data-collection-submitted-for-public-comment-and-recommendations","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-05/pdf/2025-22009.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22009.pdf?1764855916","publication_date":"2025-12-05","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 Disease Control and Prevention","name":"Centers for Disease Control and Prevention","id":44,"url":"https://www.federalregister.gov/agencies/centers-for-disease-control-and-prevention","json_url":"https://www.federalregister.gov/api/v1/agencies/44","parent_id":221,"slug":"centers-for-disease-control-and-prevention"}],"excerpts":"Telephone: 404-639-7570; Email: \n omb@cdc.gov. \n \n \n \n \n SUPPLEMENTARY INFORMATION: \n \n Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), <span class=\"match\">federal</span> agencies <span class=\"match\">must</span> obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires <span class=\"match\">federal</span> agencies to provide a 60-day notice in the \n <span class=\"match\">Federal</span> Register \n concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information"},{"title":"Announcement of Requirements and Registration for “EHIgnite Challenge”","type":"Notice","abstract":"The EHIgnite Challenge addresses data usability challenges in single patient electronic health information (EHI) exports. This challenge seeks to incentivize the development of tools, platforms, and workflows that transform single patient EHI exports into usable, readable, and actionable information that supports clinical care, patient engagement, and informed decision-making.","document_number":"2026-10068","html_url":"https://www.federalregister.gov/documents/2026/05/20/2026-10068/announcement-of-requirements-and-registration-for-ehignite-challenge","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-20/pdf/2026-10068.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10068.pdf?1779117307","publication_date":"2026-05-20","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"}],"excerpts":"Single <span class=\"match\">Patient</span> EHI Export: \n \n —Export EHI for a single <span class=\"match\">patient</span> at any time the user (or user's representative) chooses without Developer assistance \n —The export <span class=\"match\">must</span> be created in a timely fashion \n —<span class=\"match\">Must</span> <span class=\"match\">include</span> all EHI for a single <span class=\"match\">patient</span> \n —<span class=\"match\">Must</span> be electronic and in a computable format \n —<span class=\"match\">Must</span> <span class=\"match\">include</span> a publicly accessible hyperlink of the export's format \n —Certified Health IT Module <span class=\"match\">must</span> be able to limit users who can perform an EHI export \n \n <span class=\"match\">Patient</span> <span class=\"match\">Population</span> EHI Export: \n \n —<span class=\"match\">Must</span> <span class=\"match\">include</span> all EHI for a <span class=\"match\">patient</span> <span class=\"match\">population</span> \n —<span class=\"match\">Must</span> be electronic"},{"title":"Privacy Act of 1974; System of Records","type":"Notice","abstract":"In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Centers for Medicare & Medicaid Services (CMS), titled \"Home Health Agency (HHA) Outcome and Assessment Information Set (OASIS),\" System No. 09-70-0522. This system of records covers information about patients receiving home health services from a Medicare and/or Medicaid approved HHA. Home health agencies required to comply with Medicare Conditions of Participation (CoP) are now mandated to collect OASIS on patients with any payer source, instead of just patients with Medicare/Medicaid pay sources. The amended System of Records Notice (SORN) includes other modifications which are explained in the Supplementary Information section, below.","document_number":"2025-13004","html_url":"https://www.federalregister.gov/documents/2025/07/11/2025-13004/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-11/pdf/2025-13004.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13004.pdf?1752151518","publication_date":"2025-07-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"example, the <span class=\"match\">patient's</span> name; date of birth; state of residence and zip code; sex, ethnicity, and race; and Social Security number (SSN), Medicare Beneficiary Identifier (MBI), or Medicaid number, as applicable. Clinical status data <span class=\"match\">include</span>, \n e.g., \n the reason for the assessment; dates of the <span class=\"match\">patient's</span> admission, discharge, or transfer to a facility, and the type of facility; the <span class=\"match\">patient's</span> medications, treatments, procedures, health conditions, and diagnoses; and assessments of the <span class=\"match\">patient's</span> hearing, speech, vision, cognitive patterns, mood, behavior"},{"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, \"National Patient Databases-VA\" (121VA10). VA provides health care services to many Veterans through VHA. During the course of providing health care, VHA collects medical and health information about Veterans under their care. This system is used for planning, distribution, and utilization of resources; monitoring the performance of VHA programs and Veteran population health; and statistical analysis of clinical and administrative support provided within VHA.","document_number":"2025-15587","html_url":"https://www.federalregister.gov/documents/2025/08/15/2025-15587/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-15/pdf/2025-15587.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15587.pdf?1755175532","publication_date":"2025-08-15","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":"and correlating <span class=\"match\">patients</span>. This information may <span class=\"match\">include</span> Veteran identifiers and demographic information (\n e.g., \n name, Social Security Number, address, date of birth).\n \n 28. To the Centers for Disease Control and Prevention and/or their designee or other <span class=\"match\">Federal</span> or state public health authorities in response to its request or at the initiation of VA, in connection with disease-tracking, <span class=\"match\">patient</span> outcomes, bio-surveillance, or other health information required for program accountability. \n 29. To another <span class=\"match\">Federal</span> agency or <span class=\"match\">Federal</span> entity, when VA"}]}