{"description":"Documents matching 'outpatient compliance'","count":2593,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=outpatient+compliance&format=json&page=2","results":[{"title":"Medicare Program; Announcement of the Advisory Panel on Hospital Outpatient Payment Meeting-August 24, 2026","type":"Notice","abstract":"This notice announces the virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) on Monday, August 24, 2026. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital Outpatient Prospective Payment System and the Ambulatory Surgical Center payment system, and supervision of hospital outpatient therapeutic services. The meeting is open to the public.","document_number":"2026-13793","html_url":"https://www.federalregister.gov/documents/2026/07/08/2026-13793/medicare-program-announcement-of-the-advisory-panel-on-hospital-outpatient-payment-meeting-august-24","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-08/pdf/2026-13793.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13793.pdf?1783428317","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":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"the virtual meeting of the Advisory Panel on Hospital <span class=\"match\">Outpatient</span> Payment (the Panel) on Monday, August 24, 2026. The purpose of the Panel is to advise the Secretary of the Department of Health \n \n and Human Services on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital <span class=\"match\">Outpatient</span> Prospective Payment System and the Ambulatory Surgical Center payment system, and supervision of hospital <span class=\"match\">outpatient</span> therapeutic services. The meeting is open to the public"},{"title":"Medicare Program; Announcement of the Advisory Panel on Hospital Outpatient Payment Meeting-August 25, 2025","type":"Notice","abstract":"This meeting notice announces the virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) on Monday, August 25, 2025. The purpose of the Panel is to advise the Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital Outpatient Prospective Payment System and the Ambulatory Surgical Center payment system, and supervision of hospital outpatient therapeutic services.","document_number":"2025-13428","html_url":"https://www.federalregister.gov/documents/2025/07/17/2025-13428/medicare-program-announcement-of-the-advisory-panel-on-hospital-outpatient-payment-meeting-august-25","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-17/pdf/2025-13428.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13428.pdf?1752669918","publication_date":"2025-07-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"meeting notice announces the virtual meeting of the Advisory Panel on Hospital <span class=\"match\">Outpatient</span> Payment (the Panel) on Monday, August 25, 2025. The purpose of the Panel is to advise the Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital <span class=\"match\">Outpatient</span> Prospective Payment System and the Ambulatory Surgical Center payment system, and supervision of hospital <span class=\"match\">outpatient</span> therapeutic services. \n \n \n DATES: \n \n \n Virtual Meeting Dates: \n Monday, August"},{"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":"Transfer/Admission measure.\n \n \n • \n Expansion of Category for Hospital <span class=\"match\">Outpatient</span> Department Prior Authorization Process: \n We are adding Botulinum Toxin Injection codes to the existing category of services subject to the Hospital <span class=\"match\">Outpatient</span> Department prior authorization process for dates of service on or after July 1, 2027.\n \n \n • Partial Hospitalization and Intensive <span class=\"match\">Outpatient</span> Programs: \n We propose to update the Partial Hospitalization Program (PHP) and Intensive <span class=\"match\">Outpatient</span> Program (IOP) payment rates for CY 2027 using the methodology we finalized"},{"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":"email at \n Scott.Talaga@cms.hhs.gov \n .\n \n \n Graduate Medical Education (GME) Accreditation, contact \n DAC@cms.hhs.gov \n .\n \n \n Hospital <span class=\"match\">Outpatient</span> Quality Reporting (OQR) Program policies, contact Kimberly Go via email at \n Kimberly.Go@cms.hhs.gov \n .\n \n \n Hospital <span class=\"match\">Outpatient</span> Quality Reporting (OQR) Program measures, contact Kristina Rabarison via email at \n Kristina.Rabarison@cms.hhs.gov \n .\n \n \n Hospital <span class=\"match\">Outpatient</span> Visits (Emergency Department Visits and Critical Care Visits), contact Elise Barringer via email at \n Elise.Barringer@cms.hhs.gov \n "},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency","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 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. This proposed rule would also update and refine 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. This rule also contains requests for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for all three programs (OQR, REHQR, and ASCQR; expanding the method to control for unnecessary increases in the volume of covered OPD services to on- campus clinic visits; software as a service; and adjusting payment under the OPPS for services predominately performed in the ambulatory surgical center or physician office settings.","document_number":"2025-13360","html_url":"https://www.federalregister.gov/documents/2025/07/17/2025-13360/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-17/pdf/2025-13360.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13360.pdf?1752610509","publication_date":"2025-07-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"administration codes 15272, 15274, 15276, and 15278 would still be packaged in the hospital <span class=\"match\">outpatient</span> setting, because add-on codes are generally packaged in the hospital <span class=\"match\">outpatient</span> setting, we anticipate that many of the concerns expressed by presenters at previous meetings of the Advisory Panel on Hospital <span class=\"match\">Outpatient</span> Payment (HOP Panel) and by public commenters on previous rules that providers are discouraged from treating larger wounds in the hospital <span class=\"match\">outpatient</span> setting (89 FR 94247) would be addressed by our proposal to pay separately for codes describing"},{"title":"Medicare Program; Announcement of the Advisory Panel on Hospital Outpatient Payment Meeting-August 26-27, 2024","type":"Notice","abstract":"This meeting notice announces the virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) on Monday, August 26, 2024 and Tuesday, August 27, 2024. The purpose of the Panel is to advise the Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital Outpatient Prospective Payment System and the Ambulatory Surgical Center payment system, and supervision of hospital outpatient therapeutic services.","document_number":"2024-15393","html_url":"https://www.federalregister.gov/documents/2024/07/15/2024-15393/medicare-program-announcement-of-the-advisory-panel-on-hospital-outpatient-payment-meeting-august","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-15/pdf/2024-15393.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-15393.pdf?1720798329","publication_date":"2024-07-15","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":"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":"announces the virtual meeting of the Advisory Panel on Hospital <span class=\"match\">Outpatient</span> Payment (the Panel) on Monday, August 26, 2024 and Tuesday, August 27, 2024. The purpose of the Panel is to advise the Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital <span class=\"match\">Outpatient</span> Prospective Payment System and the Ambulatory Surgical Center payment system, and supervision of hospital <span class=\"match\">outpatient</span> therapeutic services. \n \n \n DATES: \n \n \n Virtual Meeting Dates: "},{"title":"Medicare and Medicaid Programs: Approval of Application From the American Association for Accreditation of Ambulatory Surgery Facilities dba QUAD A for Continued CMS-Approval of Its Outpatient Physical Therapy (OPT) Accreditation Program","type":"Notice","abstract":"This notice acknowledges the approval of an application from the American Association for Accreditation of Ambulatory Surgery Facilities dba QUAD A for continued recognition as a national accrediting organization for Outpatient Physical Therapy programs that wish to participate in the Medicare or Medicaid programs.","document_number":"2025-02914","html_url":"https://www.federalregister.gov/documents/2025/02/21/2025-02914/medicare-and-medicaid-programs-approval-of-application-from-the-american-association-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-02-21/pdf/2025-02914.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-02914.pdf?1740059112","publication_date":"2025-02-21","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":"recognition as a national accrediting organization for <span class=\"match\">Outpatient</span> Physical Therapy programs that wish to participate in the Medicare or Medicaid programs. \n \n \n DATES: \n The decision announced in this notice is applicable April 4, 2025 to April 4, 2030. \n \n \n FOR FURTHER INFORMATION CONTACT: \n Caecilia Andrews, (410) 786-2190. \n \n \n \n SUPPLEMENTARY INFORMATION: \n I. Background \n A healthcare provider may enter into an agreement with Medicare to participate in the program as a provider of <span class=\"match\">outpatient</span> physical therapy (OPT) provided certain requirements"},{"title":"Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities dba QUAD A for Continued CMS-Approval of Its Outpatient Physical Therapy (OPT) Accreditation Program","type":"Notice","abstract":"This notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, dba QUAD A, for continued recognition as a national accrediting organization for outpatient physical therapy providers that wish to participate in the Medicare or Medicaid programs.","document_number":"2024-23930","html_url":"https://www.federalregister.gov/documents/2024/10/17/2024-23930/medicare-and-medicaid-programs-application-from-the-american-association-for-accreditation-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-17/pdf/2024-23930.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-23930.pdf?1729082723","publication_date":"2024-10-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"\n Notice with request for comment. \n \n \n SUMMARY: \n This notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, dba QUAD A, for continued recognition as a national accrediting organization for <span class=\"match\">outpatient</span> physical therapy providers that wish to participate in the Medicare or Medicaid programs. \n \n \n DATES: \n To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on November 18, 2024. \n \n \n ADDRESSES: \n In commenting"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities","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 2025 based on our continuing experience with these systems. We 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 system. Also, this final rule updates the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, and Hospital Inpatient Quality Reporting Program. We also summarize information received in response to a Request for Information on potential modifications to the Safety of Care measure group in the Overall Hospital Quality Star Rating methodology. In this final rule, we are also finalizing our proposal to narrow the description of \"custody\" in the Medicare payment exclusion rule and to revise the special enrollment period criteria for formerly incarcerated individuals. We are also finalizing our Medicaid and Children's Health Insurance Program (CHIP) continuous eligibility provisions. We are also finalizing the proposal to reduce the review timeframe for standard prior authorization requests for certain covered outpatient department services paid under the OPPS from 10-business days to 7-calendar days. Further, this rule finalizes updates to the Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAHs) in an effort to advance the health and safety of pregnant, birthing, and postpartum women. This rule also finalizes our proposed policy to separately pay Indian Health Service (IHS) and Tribal hospitals for high-cost drugs furnished in hospital outpatient departments through an add-on payment in addition to the all-inclusive rate (AIR) under the authorities used to calculate the AIR starting January 1, 2025. Finally, we are finalizing exceptions to the Medicaid clinic services four walls requirement for IHS and Tribal clinics, and, at state option, for behavioral health clinics and clinics located in rural areas.","document_number":"2024-25521","html_url":"https://www.federalregister.gov/documents/2024/11/27/2024-25521/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-27/pdf/2024-25521.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25521.pdf?1730492130","publication_date":"2024-11-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"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":"gov \n .\n \n \n Hospital <span class=\"match\">Outpatient</span> Quality Reporting (OQR) Program policies, contact Kimberly Go via email at \n Kimberly.Go@cms.hhs.gov \n .\n \n \n Hospital <span class=\"match\">Outpatient</span> Quality Reporting (OQR) Program measures, contact Janis Grady via email at \n Janis.Grady@cms.hhs.gov \n .\n \n \n Hospital <span class=\"match\">Outpatient</span> Visits (Emergency Department Visits and Critical Care Visits), contact Elise Barringer via email at \n Elise.Barringer@cms.hhs.gov \n .\n \n \n IHS <span class=\"match\">Outpatient</span> Encounter Rate available to all American Indian and Alaska Native (AI/AN) <span class=\"match\">Outpatient</span> Programs Request for"},{"title":"Notice of Availability of Draft Programmatic Environmental Assessment for the Build-To-Suit Lease Program","type":"Notice","abstract":"The U.S. Department of Veterans Affairs (VA) announces the availability of the Draft Programmatic Environmental Assessment (PEA) for the Build-to-Suit Lease Program. The Draft PEA analyzes lease actions which include construction, renovation, repair, and operation of outpatient clinics, community living centers, and other similar leased medical facilities identified under the VA Office of Real Property build-to-suit program. VA is requesting comments on the Draft PEA.","document_number":"2025-07324","html_url":"https://www.federalregister.gov/documents/2025/04/29/2025-07324/notice-of-availability-of-draft-programmatic-environmental-assessment-for-the-build-to-suit-lease","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-29/pdf/2025-07324.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-07324.pdf?1745844311","publication_date":"2025-04-29","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":"Centers is not an easily accessible option. \n The PEA aims to provide a streamlined NEPA <span class=\"match\">compliance</span> process for those recurring, predictable, and low-impact construction, renovation, or repair projects that would result in less than significant impacts. Use of the PEA would expedite the NEPA analysis and documentation process for those build-to-suit lease projects that meet the conditions identified within the PEA. VA will complete additional NEPA <span class=\"match\">compliance</span> as required on projects outside the parameters of the PEA. The geographic scope of the PEA"},{"title":"Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; 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 \"Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.\" Although the public health emergency declared by the Department of Health and Human Services under section 319 of the Public Health Services Act has ended, COVID-19 remains an ongoing public health problem with continued prevention and treatment efforts. FDA is issuing this guidance to provide sponsors and investigators with considerations for approaches on how common COVID- 19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects. This guidance supersedes the guidance of the same name issued on September 29, 2020.","document_number":"2024-03622","html_url":"https://www.federalregister.gov/documents/2024/02/22/2024-03622/assessing-covid-19-related-symptoms-in-outpatient-adult-and-adolescent-subjects-in-clinical-trials","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-22/pdf/2024-03622.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-03622.pdf?1708523126","publication_date":"2024-02-22","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":"the availability of a final guidance for industry entitled “Assessing COVID-19-Related Symptoms in <span class=\"match\">Outpatient</span> Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.” This guidance provides considerations for how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in <span class=\"match\">outpatient</span> adult and adolescent subjects. \n \n This guidance supersedes the guidance of the same name issued"},{"title":"Medicare Program: Appeal Rights for Certain Changes in Patient Status","type":"Rule","abstract":"This final rule implements an order from the Federal district court for the District of Connecticut in Alexander v. Azar that requires HHS to establish appeals processes for certain Medicare beneficiaries who are initially admitted as hospital inpatients but are subsequently reclassified as outpatients receiving observation services during their hospital stay and meet other eligibility criteria.","document_number":"2024-23195","html_url":"https://www.federalregister.gov/documents/2024/10/15/2024-23195/medicare-program-appeal-rights-for-certain-changes-in-patient-status","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-15/pdf/2024-23195.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-23195.pdf?1728677721","publication_date":"2024-10-15","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":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"the hospital as an <span class=\"match\">outpatient</span> receiving “observation services”; \n 4 \n \n \n \n \n 4 \n  For the purposes of these procedures, a beneficiary is considered an <span class=\"match\">outpatient</span> receiving observation services when the hospital changes a beneficiary's status from inpatient to <span class=\"match\">outpatient</span> while the beneficiary is in the hospital and the beneficiary subsequently receives observation services following a valid order for such services (see 42 CFR 405.931(h)).\n \n \n \n • Have received or will have received an initial determination or Medicare <span class=\"match\">Outpatient</span> Observation Notice"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities","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 2025 based on our continuing experience with these systems. In this proposed rule, we 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 system. Also, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, and Hospital Inpatient Quality Reporting Program. This proposed rule would request information on options being considered for future changes to the Overall Hospital Quality Star Rating methodology. The proposed rule would narrow the description of \"custody\" for purposes of Medicare's no legal obligation to pay payment exclusion. The proposed rule would revise the eligibility requirements in the special enrollment period (SEP) for formerly incarcerated individuals to tie the eligibility for this SEP to the determination made by the Social Security Administration that they are no longer incarcerated for releases that occur on and after January 1, 2025. This rule also proposes to codify the requirement in the Consolidated Appropriations Act, 2023 (CAA, 2023) to provide 12 months of continuous eligibility to children under the age of 19 in Medicaid and CHIP, with limited exceptions. Further, this proposed rule would provide updates to the Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAHs) in an effort to advance the health and safety of pregnant, birthing, and postpartum patients. This rule proposes to separately pay IHS and tribal hospitals for high-cost drugs furnished in hospital outpatient departments through an add-on payment in addition to the AIR under the authorities used to calculate the AIR starting January 1, 2025. This rule also requests further information related to a Tribal Technical Advisory Group request to apply the Indian Health Service encounter rate to all outpatient tribal clinics. Finally, the proposed rule would provide exceptions to the Medicaid clinic services benefit four walls requirement for Indian Health Service and Tribal clinics, and, at state option, for behavioral health clinics and clinics located in rural areas.","document_number":"2024-15087","html_url":"https://www.federalregister.gov/documents/2024/07/22/2024-15087/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-22/pdf/2024-15087.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-15087.pdf?1720615525","publication_date":"2024-07-22","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":"ngozi.uzokwe@cms.hhs.gov. \n \n \n Hospital <span class=\"match\">Outpatient</span> Quality Reporting (OQR) Program policies, contact Kimberly Go via email \n Kimberly.Go@cms.hhs.gov. \n \n \n Hospital <span class=\"match\">Outpatient</span> Quality Reporting (OQR) Program measures, contact Janis Grady via email \n Janis.Grady@cms.hhs.gov. \n \n \n Hospital <span class=\"match\">Outpatient</span> Visits (Emergency Department Visits and Critical Care Visits), contact Abby Cesnik via email at \n Abigail.Cesnik@cms.hhs.gov \n or Nate Vercauteren via email at \n Nathan.Vercauteren@cms.hhs.gov. \n \n \n \n IHS <span class=\"match\">Outpatient</span> Encounter Rate available to all American"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction","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 2024 based on our continuing experience with these systems. In this final rule, we 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 system. Also, this final rule updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Rural Emergency Hospital Quality Reporting (REHQR) Program. In this final rule, we are also establishing a payment for certain intensive outpatient services under Medicare, beginning January 1, 2024. In addition, this final rule updates and refines requirements for hospitals to make public their standard charge information and enforcement of hospital price transparency. We are finalizing changes to the community mental health center (CMHC) Conditions of Participation (CoPs) to provide requirements for furnishing intensive outpatient (IOP) services, and we are finalizing the proposed personnel qualifications for mental health counselors (MHCs) and marriage and family therapists (MFTs). Additionally, we are finalizing the removal of discussion of the inpatient prospective payment system (IPPS) Medicare Code Editor (MCE) from the annual IPPS rulemakings, beginning with the fiscal year (FY) 2025 rulemaking. Finally, we are finalizing a technical correction to the Rural Emergency Hospital (REH) CoPs under the standard for the designation and certification of REHs.","document_number":"2023-24293","html_url":"https://www.federalregister.gov/documents/2023/11/22/2023-24293/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-22/pdf/2023-24293.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-24293.pdf?1698959177","publication_date":"2023-11-22","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":"Payment for Intensive <span class=\"match\">Outpatient</span> Programs: \n Beginning in CY 2024, we are finalizing payment for intensive <span class=\"match\">outpatient</span> program (IOP) services under Medicare. We are finalizing the scope of benefits, physician certification requirements, coding and billing, and payment rates under the IOP benefit. IOP services may be furnished in hospital <span class=\"match\">outpatient</span> departments, community mental health centers (CMHCs), federally qualified health centers (FQHCs), and rural health clinics (RHCs). We also are finalizing payment for intensive <span class=\"match\">outpatient</span> services provided"},{"title":"Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915-0327-Revision","type":"Notice","abstract":"In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.","document_number":"2026-00179","html_url":"https://www.federalregister.gov/documents/2026/01/08/2026-00179/agency-information-collection-activities-proposed-collection-public-comment-request-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-08/pdf/2026-00179.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-00179.pdf?1767793516","publication_date":"2026-01-08","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"excerpts":"Pricing Agreement (PPA) with manufacturers of covered <span class=\"match\">outpatient</span> drugs. Manufacturers are also required by section 1927(a)(5)(A) of the Social Security Act to enter into agreements with the Secretary of HHS (Secretary) that comply with section 340B of the PHS Act if they participate in the Medicaid Drug Rebate Program. When a drug manufacturer signs a PPA, it is opting into the 340B Drug Pricing Program (340B Program), and it agrees to the statutory requirement that prices charged for covered <span class=\"match\">outpatient</span> drugs to covered entities will not exceed statutorily"},{"title":"Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915-0327-Revision","type":"Notice","abstract":"In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.","document_number":"2025-14955","html_url":"https://www.federalregister.gov/documents/2025/08/07/2025-14955/agency-information-collection-activities-proposed-collection-public-comment-request-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-07/pdf/2025-14955.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14955.pdf?1754484309","publication_date":"2025-08-07","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"excerpts":"Pricing Agreement (PPA) with manufacturers of covered <span class=\"match\">outpatient</span> drugs. Manufacturers are also required by section 1927(a)(5)(A) of the Social Security Act to enter into agreements with the Secretary of HHS (Secretary) that comply with section 340B of the PHS Act if they participate in the Medicaid Drug Rebate Program. When a drug manufacturer signs a PPA, it is opting into the 340B Drug Pricing Program (340B Program), and it agrees to the statutory requirement that prices charged for covered <span class=\"match\">outpatient</span> drugs to covered entities will not exceed statutorily"},{"title":"Medicare Program; Announcement of the Advisory Panel on Hospital Outpatient Payment Meeting-August 21-22, 2023-and New Panel Members","type":"Notice","abstract":"This notice announces the dates and times of a virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) in August of 2023. In addition, it announces 8 new membership appointments to the Panel. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center payment system; and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as we prepare the annual update for the OPPS.","document_number":"2023-15254","html_url":"https://www.federalregister.gov/documents/2023/07/19/2023-15254/medicare-program-announcement-of-the-advisory-panel-on-hospital-outpatient-payment-meeting-august","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-07-19/pdf/2023-15254.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-15254.pdf?1689365721","publication_date":"2023-07-19","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 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":"meeting of the Advisory Panel on Hospital <span class=\"match\">Outpatient</span> Payment (the Panel) in August of 2023. In addition, it announces 8 new membership appointments to the Panel. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare &amp; Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital <span class=\"match\">Outpatient</span> Prospective Payment System (OPPS) and the Ambulatory"},{"title":"Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: 340B Rebate Model Pilot Program Application, Implementation, and Evaluation, OMB Number 0906-NEW","type":"Notice","abstract":"In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.","document_number":"2026-03833","html_url":"https://www.federalregister.gov/documents/2026/02/26/2026-03833/agency-information-collection-activities-proposed-collection-public-comment-request-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-26/pdf/2026-03833.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03833.pdf?1772027112","publication_date":"2026-02-26","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"excerpts":"submissions will enhance 340B Program <span class=\"match\">compliance</span> monitoring and reduce lag time in assessing 340B Program metrics. The monthly data will also support the ongoing assessment of any 340B Rebate Model Pilot Program.\n \n \n Collection of Data Submitted by Covered Entities to Manufacturers: \n In a potential 340B Rebate Model Pilot Program, covered entities will be required to provide specific data to participating manufacturers for the manufacturers to provide rebates to effectuate the 340B price on the entities' covered <span class=\"match\">outpatient</span> drug purchases. OPA expects that"},{"title":"Proposed Collection; Comment Request","type":"Notice","abstract":"In compliance with the Paperwork Reduction Act of 1995, the DHA announces proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.","document_number":"2026-08803","html_url":"https://www.federalregister.gov/documents/2026/05/06/2026-08803/proposed-collection-comment-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-06/pdf/2026-08803.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08803.pdf?1777985114","publication_date":"2026-05-06","agencies":[{"raw_name":"DEPARTMENT OF DEFENSE","name":"Defense Department","id":103,"url":"https://www.federalregister.gov/agencies/defense-department","json_url":"https://www.federalregister.gov/api/v1/agencies/103","parent_id":null,"slug":"defense-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"ACTION: \n 60-Day information collection notice. \n \n \n SUMMARY: \n \n In <span class=\"match\">compliance</span> with the \n Paperwork Reduction Act of 1995, \n the DHA announces proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance"},{"title":"Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for immediate implementation entitled \"Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry.\" The purpose of this guidance is to provide FDA's recommendations to blood establishments for the submission of a Biologics License Application (BLA) for the manufacture of COVID-19 convalescent plasma intended for transfusion in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. The guidance also provides FDA's recommendations for investigational new drug applications (INDs) for investigational COVID- 19 convalescent plasma for transfusion.","document_number":"2024-16046","html_url":"https://www.federalregister.gov/documents/2024/07/22/2024-16046/recommendations-for-investigational-and-licensed-covid-19-convalescent-plasma-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-22/pdf/2024-16046.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16046.pdf?1721393124","publication_date":"2024-07-22","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":"immunosuppressive treatment in either the <span class=\"match\">outpatient</span> or inpatient setting. The purpose of this guidance is to provide FDA's recommendations on two regulatory pathways for the manufacture of COVID-19 convalescent plasma. Specifically, the guidance provides recommendations to blood establishments for the submission of a BLA for the manufacture of COVID-19 convalescent plasma for transfusion intended to treat patients with immunosuppressive disease or receiving immunosuppressive treatment in either the <span class=\"match\">outpatient</span> or inpatient setting. The guidance also"}]}