{"description":"Documents matching 'laboratories accredited under program equal'","count":1799,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=laboratories+accredited+under+program+equal&format=json&page=2","results":[{"title":"Announcement of the Approval of COLA as an Accreditation Organization for the Specialty of Histocompatibility Under the Clinical Laboratory Improvement Amendments of 1988","type":"Notice","abstract":"This notice announces the application of the Commission on Laboratory Accreditation (COLA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialty of Histocompatibility. We have determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, we are granting COLA deeming authority for the specialty of Histocompatibility for a period of 5 years.","document_number":"2026-11618","html_url":"https://www.federalregister.gov/documents/2026/06/10/2026-11618/announcement-of-the-approval-of-cola-as-an-accreditation-organization-for-the-specialty-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-10/pdf/2026-11618.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11618.pdf?1781009114","publication_date":"2026-06-10","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":"of part 493 (Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program) specifies the requirements an accreditation organization must meet to be approved by CMS as an accreditation organization under CLIA. \n II. Notice of Approval of COLA for the Specialty of Histocompatibility \n \n In this notice, we approve the Commission on Laboratory Accreditation (COLA) as an organization that may accredit laboratories for purposes of establishing their compliance with CLIA requirements for the specialty"},{"title":"Announcement of the Approval of COLA as an Accreditation Organization for the Specialties of Clinical Cytogenetics and Radiobioassay Under the Clinical Laboratory Improvement Amendments of 1988","type":"Notice","abstract":"This notice announces the application of the Commission on Laboratory Accreditation (COLA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialties of Clinical Cytogenetics and Radiobioassay. We have determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, we are granting COLA deeming authority for the specialties of Clinical Cytogenetics and Radiobioassay for a period of 5 years.","document_number":"2025-23434","html_url":"https://www.federalregister.gov/documents/2025/12/19/2025-23434/announcement-of-the-approval-of-cola-as-an-accreditation-organization-for-the-specialties-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23434.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23434.pdf?1766065524","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 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":"of part 493 (Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program) specifies the requirements an accreditation organization must meet to be approved by CMS as an accreditation organization under CLIA. \n II. Notice of Approval of COLA for the Specialties of Clinical Cytogenetics and Radiobioassay \n \n In this notice, we approve the Commission on Laboratory Accreditation (COLA) as an organization that may accredit laboratories for purposes of establishing their compliance with CLIA requirements"},{"title":"Final Revisions to the National Lead Laboratory Accreditation Program (NLLAP); Notice of Availability","type":"Notice","abstract":"The Environmental Protection Agency (EPA or Agency) is announcing the availability of the document titled \"Laboratory Quality Standards for Recognition (LQSR 4.0)\" under the National Lead Laboratory Accreditation Program (NLLAP), which is a revision to the EPA document titled \"Laboratory Quality System Requirements (LQSR) Revision 3.0,\" dated November 5, 2007. The revised LQSR 4.0 updates and streamlines the guidance by referencing existing laboratory standards already in practice by NLLAP participating laboratories and directly related to laboratory lead analysis; and includes updates to the test and sampling method standards to better complement EPA's lead- based paint program activities.","document_number":"2024-24558","html_url":"https://www.federalregister.gov/documents/2024/10/23/2024-24558/final-revisions-to-the-national-lead-laboratory-accreditation-program-nllap-notice-of-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-23/pdf/2024-24558.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-24558.pdf?1729601132","publication_date":"2024-10-23","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"recognizes the organizations as accrediting organizations through a memorandum of agreement (\n https://www.epa.gov/lead/national-lead-laboratory-accreditation-program-nllap \n ). Once a laboratory successfully meets the requirements of the ELPAT Program and passes an NLLAP system audit, the laboratory is recognized by EPA under the NLLAP.\n \n In 1993, EPA issued its first version of the LQSR, which outlined minimum requirements for NLLAP recognized laboratories. An organization requesting NLLAP recognition shall be a laboratory capable of performing sampling"},{"title":"Notice of Request To Renew an Approved Information Collection: Accredited Laboratories","type":"Notice","abstract":"In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, FSIS is announcing its intention to renew an approved information collection regarding accredited laboratories. There are no changes to the existing information collection. The approval for this information collection will expire on February 28, 2025.","document_number":"2024-20553","html_url":"https://www.federalregister.gov/documents/2024/09/11/2024-20553/notice-of-request-to-renew-an-approved-information-collection-accredited-laboratories","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-11/pdf/2024-20553.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20553.pdf?1725972342","publication_date":"2024-09-11","agencies":[{"raw_name":"DEPARTMENT OF AGRICULTURE","name":"Agriculture Department","id":12,"url":"https://www.federalregister.gov/agencies/agriculture-department","json_url":"https://www.federalregister.gov/api/v1/agencies/12","parent_id":null,"slug":"agriculture-department"},{"raw_name":"Food Safety and Inspection Service","name":"Food Safety and Inspection Service","id":201,"url":"https://www.federalregister.gov/agencies/food-safety-and-inspection-service","json_url":"https://www.federalregister.gov/api/v1/agencies/201","parent_id":12,"slug":"food-safety-and-inspection-service"}],"excerpts":"products and sends them to FSIS laboratories for analysis. These tests are conducted to determine the content of food chemistry components and the presence of pathogens, violative concentrations of veterinary drugs, or other chemical residues to verify whether establishments meet regulatory requirements. In addition, establishments collect samples for analysis at other laboratories, including accredited non-Federal laboratories. \n FSIS accredits non-Federal analytical laboratories under its Accredited Laboratory Program (ALP) (see 9 CFR part 439). The"},{"title":"Medicare Program; Announcement of the Re-Approval of the Joint Commission as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988","type":"Notice","abstract":"This notice announces the application of the Joint Commission for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology; Diagnostic Immunology, including Syphilis Serology, and General Immunology; Chemistry, including Routine Chemistry, Toxicology, and Endocrinology; Hematology, including routine hematology and coagulation; Immunohematology, including ABO Group, D (Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and Antibody Identification; Pathology, including Histopathology, Oral Pathology, and Cytology. We have determined that the Joint Commission meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant the Joint Commission deeming authority for a period of 6 years.","document_number":"2024-11421","html_url":"https://www.federalregister.gov/documents/2024/05/24/2024-11421/medicare-program-announcement-of-the-re-approval-of-the-joint-commission-as-an-accreditation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-24/pdf/2024-11421.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-11421.pdf?1716468320","publication_date":"2024-05-24","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (Pub. L. 100-578) (CLIA). CLIA amended section 353 of the Public Health Service Act. We issued a final rule implementing the accreditation provisions of CLIA on July 31, 1992 (57 FR 33992). Under those provisions, we may grant deeming authority to an accreditation organization if its requirements for laboratories accredited under its program are equal to or more stringent than the applicable CLIA program requirements in 42 CFR part 493 (Laboratory Requirements). Subpart E of part"},{"title":"Announcement of the Re-Approval of AABB (Association for the Advancement of Blood and Biotherapies) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988","type":"Notice","abstract":"This notice announces the application of the Association for the Advancement of Blood and Biotherapies (AABB) for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant AABB deeming authority for a period of 6 years.","document_number":"2024-08809","html_url":"https://www.federalregister.gov/documents/2024/04/25/2024-08809/announcement-of-the-re-approval-of-aabb-association-for-the-advancement-of-blood-and-biotherapies-as","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-25/pdf/2024-08809.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08809.pdf?1713962733","publication_date":"2024-04-25","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"}],"excerpts":"Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578). CLIA amended section 353 of the Public Health Service Act. We issued a final rule implementing the accreditation provisions of CLIA on July 31, 1992 (57 FR 33992). Under those provisions, we may grant deeming authority to an accreditation organization if its requirements for laboratories accredited under its program are equal to or more stringent than the applicable CLIA program requirements in 42 CFR part 493 (Laboratory Requirements). Subpart E of part"},{"title":"Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988","type":"Notice","abstract":"This notice announces the application of COLA for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology; Diagnostic Immunology, including Syphilis Serology, and General Immunology; Chemistry, including Routine Chemistry, Toxicology, and Endocrinology; Hematology, including routine hematology and coagulation; Immunohematology, including ABO Group, D (Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and Antibody Identification; Pathology, including Histopathology, Oral Pathology, and Cytology. We have determined that COLA meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant COLA deeming authority for a period of 6 years.","document_number":"2024-04674","html_url":"https://www.federalregister.gov/documents/2024/03/06/2024-04674/medicare-program-announcement-of-the-re-approval-of-cola-under-the-clinical-laboratory-improvement","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-06/pdf/2024-04674.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-04674.pdf?1709646322","publication_date":"2024-03-06","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":"part 493 (Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program) specifies the requirements an accreditation organization must meet to be approved by CMS as an accreditation organization under CLIA. \n II. Notice of Re-Approval of COLA as an Accreditation Organization \n In this notice, we approve COLA as an organization that may accredit laboratories for purposes of establishing their compliance with CLIA requirements for the following specialty and subspecialty areas under CLIA: \n"},{"title":"Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies","type":"Rule","abstract":"This final rule sets forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this final rule finalizes permanent and temporary behavior adjustments and recalibrates the case- mix weights and update the functional impairment levels; comorbidity subgroups; and low-utilization payment adjustment (LUPA) thresholds for CY 2026. This final rule also finalizes changes to the face-to-face encounter policy and changes to the Home Health Quality Reporting Program (HH QRP) and the expanded Health Value-Based Purchasing (HHVBP) Model requirements. In addition, it updates the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). Lastly it finalizes: a technical change to the HH conditions of participation; updates to DMEPOS supplier conditions of payment; updates to provider and supplier enrollment requirements; and changes to DMEPOS accreditation requirements.","document_number":"2025-21767","html_url":"https://www.federalregister.gov/documents/2025/12/02/2025-21767/medicare-and-medicaid-programs-calendar-year-2026-home-health-prospective-payment-system-hh-pps-rate","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-02/pdf/2025-21767.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21767.pdf?1764364516","publication_date":"2025-12-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"unqualified providers and suppliers out of the Medicare program, which, in turn would prevent improper Medicare payments to such parties. \n 6. DMEPOS Supplier Accreditation Organizations \n \n DMEPOS suppliers are required to be accredited by a CMS-approved accrediting organization to enroll in and bill Medicare. The purpose of accreditation is to confirm, typically through an on-site survey of the supplier, that the supplier meets the DMEPOS quality standards. Regulations promulgating our accreditation requirements were enacted in 2006 but have not been"},{"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":"certain services that are paid under fee schedules or other payment systems. Such excluded services include, for example, the professional services of physicians and nonphysician practitioners paid under the Medicare Physician Fee Schedule (MPFS); certain laboratory services paid under the Clinical Laboratory Fee Schedule (CLFS); services for beneficiaries with end-stage renal disease (ESRD) that are paid under the ESRD prospective payment system; and services and procedures that require an inpatient stay that are paid under the hospital IPPS. In addition"},{"title":"Proposed Revisions to the National Lead Laboratory Accreditation Program (NLLAP); Notice of Availability and Request for Comment","type":"Notice","abstract":"The Environmental Protection Agency (EPA) is announcing the availability of and soliciting comment on proposed revisions to EPA's document titled \"Laboratory Quality System Requirements (LQSR) Revision 3.0\" dated November 5, 2007, under the National Lead Laboratory Accreditation Program (NLLAP). Proposed revisions reflected in the draft document titled, \"Laboratory Quality Standards for Recognition\" (LQSR 4.0),\" are intended to update and streamline the guidance by referencing existing laboratory standards already in practice by NLLAP participating laboratories and directly related to laboratory lead analysis, and to update the test and sampling method standards to better complement EPA's lead-based paint program activities.","document_number":"2023-25141","html_url":"https://www.federalregister.gov/documents/2023/11/15/2023-25141/proposed-revisions-to-the-national-lead-laboratory-accreditation-program-nllap-notice-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-15/pdf/2023-25141.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-25141.pdf?1699969580","publication_date":"2023-11-15","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"conducted by a laboratory accrediting organization recognized by EPA. EPA currently recognizes the organizations as accrediting organizations through a memorandum of agreement (\n https://www.epa.gov/lead/national-lead-laboratory-accreditation-program-nllap \n ). Once a laboratory successfully meets the requirements of the ELPAT Program and passes an NLLAP system audit, the laboratory is recognized by EPA under the NLLAP.\n \n In 1993, EPA issued its first version of the LQSR, which outlined minimum requirements for NLLAP recognized laboratories. An organization"},{"title":"Medical Devices; Laboratory Developed Tests","type":"Rule","abstract":"The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.","document_number":"2024-08935","html_url":"https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08935.pdf?1714398256","publication_date":"2024-05-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Abbreviation/acronym \n What it means \n \n \n 3P510k Review Organization \n Third Party Review Organization Accredited Under FDA's Third Party Review Program \n \n \n 510(k) \n Premarket Notification. \n \n \n AABB \n Association for the Advancement of Blood and Biotherapies. \n \n \n ACGME \n Accreditation Council for Graduate Medical Education. \n \n \n ACLA \n American Clinical Laboratory Association. \n \n \n ADLT \n Advanced Diagnostic Laboratory Test. \n \n \n ACHC \n Accreditation Commission for Health Care. \n \n \n AMC \n Academic Medical Center. \n \n \n AML \n Acute Myeloid Leukemia"},{"title":"Reimagining and Improving Student Education-Federal Student Loan Program Final Regulations","type":"Rule","abstract":"The Secretary amends the regulations for the Federal student loan programs authorized under title IV of the Higher Education Act (HEA) of 1965, as amended (the title IV, HEA programs) to implement the statutory changes to the title IV, HEA programs included in Public Law 119-21, the Working Families Tax Cuts Act signed into law by President Trump on July 4, 2025. The Department previously referred to the Working Families Tax Cuts Act as the \"One Big Beautiful Bill Act,\" including in the Notice of Proposed Rulemaking published on January 30, 2026. These changes include establishing new loan limits for graduate students, professional students, and parents, and phasing out the Graduate PLUS (Grad PLUS) Program. The Working Families Tax Cuts Act also simplifies the current broken and confusing myriad of Federal student loan repayment plans by phasing out the existing Income- Contingent Repayment (ICR) plans, creating a new Tiered Standard repayment plan option, and establishing a new income-driven repayment plan known as the Repayment Assistance Plan. The Working Families Tax Cuts Act also enables borrowers in default who have previously rehabilitated a defaulted loan a second chance to rehabilitate their loan(s) and resume repayment.","document_number":"2026-08556","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08556/reimagining-and-improving-student-education-federal-student-loan-program-final-regulations","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08556.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08556.pdf?1777553126","publication_date":"2026-05-01","agencies":[{"raw_name":"DEPARTMENT OF EDUCATION","name":"Education Department","id":126,"url":"https://www.federalregister.gov/agencies/education-department","json_url":"https://www.federalregister.gov/api/v1/agencies/126","parent_id":null,"slug":"education-department"}],"excerpts":"therapy, social work, graduate-level nursing programs, Doctor of Public Health programs, and similar graduate programs should qualify because they allegedly satisfy the operative elements of the incorporated definition. The Department is not interpreting the cross-referenced definition as a free-standing test under which any graduate program involving advanced study, clinical preparation, licensure-related requirements, accreditation, or occupational responsibility must be treated as a professional degree program. Nor is the Department treating the enumerated"},{"title":"Agency Information Collection Activities: Proposed Collection; Comment Request","type":"Notice","abstract":"The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.","document_number":"2026-07850","html_url":"https://www.federalregister.gov/documents/2026/04/22/2026-07850/agency-information-collection-activities-proposed-collection-comment-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-22/pdf/2026-07850.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07850.pdf?1776775518","publication_date":"2026-04-22","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"}],"excerpts":"State licensure programs for CLIA purposes were published as Subpart E of part 493. These regulations establish that we may approve a private, nonprofit organization as an accreditation organization for clinical laboratories under the CLIA program if the organization's requirements for its accredited laboratories are equal to or more stringent than the applicable CLIA program requirements of part 493. These regulations also provide for the CLIA exemption of laboratories in a State that applies licensure requirements that are equal to or more stringent"},{"title":"Agency Information Collection Activities: Submission for OMB Review; Comment Request","type":"Notice","abstract":"The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.","document_number":"2026-13465","html_url":"https://www.federalregister.gov/documents/2026/07/02/2026-13465/agency-information-collection-activities-submission-for-omb-review-comment-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-02/pdf/2026-13465.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13465.pdf?1782909927","publication_date":"2026-07-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"State licensure programs for CLIA purposes were published as Subpart E of part 493. These regulations establish that we may approve a private, nonprofit organization as an accreditation organization for clinical laboratories under the CLIA program if the organization's requirements for its accredited laboratories are equal to or more stringent than the applicable CLIA program requirements of part 493. These regulations also provide for the CLIA exemption of laboratories in a State that applies licensure requirements that are equal to or more stringent"},{"title":"Reconsideration of the Dust-Lead Hazard Standards and Dust-Lead Post-Abatement Clearance Levels","type":"Rule","abstract":"As part of EPA's high-priority efforts to reduce childhood lead exposure, and in accordance with a U.S. Court of Appeals for the Ninth Circuit 2021 opinion, EPA is finalizing its proposal to lower the dust-lead hazard standards to any reportable level as analyzed by a laboratory recognized by EPA's National Lead Laboratory Accreditation Program (NLLAP). EPA's lead-based paint (LBP) regulations do not compel property owners or occupants to evaluate their property for LBP hazards or to take control actions, but if a LBP activity such as an abatement is performed, then EPA's regulations set requirements for doing so. EPA is also finalizing changes to lower the post-abatement dust-lead clearance levels to 5 micrograms per square foot ([micro]g/ft\\2\\), 40 [micro]g/ft\\2\\, and 100 [micro]g/ft\\2\\ for floors, window sills and troughs respectively, the current levels in New York City. Due to feedback from public comments, EPA is also finalizing changes to the nomenclature to adopt the terms dust-lead reportable levels (DLRL) and dust-lead action levels (DLAL). Given the decoupling of the action levels from the reportable levels, EPA is finalizing revisions to the definition of abatement so that the recommendation for action based on dust-lead applies when dust-lead loadings are at or above the action levels, rather than the hazard standards, as has been the case historically. The dust-lead hazard standards will be described as DLRL moving forward (i.e., after publication of this final rule) and the dust-lead clearance levels will be described as DLAL. Additionally, EPA is finalizing several other amendments, including revising the definition of target housing to conform with the statute.","document_number":"2024-25070","html_url":"https://www.federalregister.gov/documents/2024/11/12/2024-25070/reconsideration-of-the-dust-lead-hazard-standards-and-dust-lead-post-abatement-clearance-levels","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-12/pdf/2024-25070.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25070.pdf?1731073558","publication_date":"2024-11-12","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"(taken using documented methodologies as defined in 40 CFR 745.227(a)(3)) from floors and window sills. Those samples are required to be analyzed by a laboratory that is recognized under NLLAP, which is an EPA program that defines the minimum standards that laboratories must meet to attain EPA recognition as an accredited testing laboratory (the standards for the program are laid out in the Laboratory Quality Standards for Recognition) (Ref. 26). A risk assessor compares the results of the dust wipe samples to the applicable hazard standard (currently"},{"title":"Announcement of the Approval of the Accreditation Commission for Health Care (ACHC) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988","type":"Notice","abstract":"This notice announces the approval of the application of the Accreditation Commission for Health Care (ACHC) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the ACHC meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant the ACHC deeming authority for a period of 6 years.","document_number":"2023-06280","html_url":"https://www.federalregister.gov/documents/2023/03/27/2023-06280/announcement-of-the-approval-of-the-accreditation-commission-for-health-care-achc-as-an","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-27/pdf/2023-06280.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-06280.pdf?1679661935","publication_date":"2023-03-27","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":"of part 493 (Accreditation by a Private, Nonprofit Accreditation Organization or Exemption under an Approved State Laboratory Program) specifies the requirements an accreditation organization must meet to be approved by CMS as an accreditation organization under CLIA. \n II. Notice of Approval of the ACHC as an Accreditation Organization \n In this notice, we approve and grant deeming authority to the Accreditation Commission for Health Care (ACHC) as an organization that may accredit laboratories for purposes of establishing their compliance with CLIA"},{"title":"Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories","type":"Rule","abstract":"This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. This final rule implements a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. We are finalizing the incorporation of limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. We are also finalizing the distribution of the administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees. In addition, we are finalizing the clarification of the methodology used to determine program compliance fees. This final rule ensures the continuing quality and safety of laboratory testing for the public. This final rule also amends histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes. In addition, this final rule amends the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite State monitoring) to allow for the imposition of such sanctions on CoW laboratories.","document_number":"2023-28170","html_url":"https://www.federalregister.gov/documents/2023/12/28/2023-28170/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28170.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-28170.pdf?1703279719","publication_date":"2023-12-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"of all accredited laboratories inspected by the Department of Health & Human Services (HHS), and the findings compared to the findings of the Accreditation Organizations (AOs). The February 1992 final rule stated that all accredited laboratories would share the cost of this activity and that the fees would be the same as for inspections by nonaccredited laboratories. We proposed new § 493.645(a)(1) to clarify that all accredited laboratories share in the validation inspections cost. Under § 493.645(b)(1), the accredited laboratories currently"},{"title":"Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program","type":"Rule","abstract":"This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.","document_number":"2025-19787","html_url":"https://www.federalregister.gov/documents/2025/11/05/2025-19787/medicare-and-medicaid-programs-cy-2026-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-05/pdf/2025-19787.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19787.pdf?1761945018","publication_date":"2025-11-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; update to the Ambulance Fee Schedule regulations;"},{"title":"Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments","type":"Rule","abstract":"This final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for, the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; updates to the Medicare Diabetes Prevention Program expanded model; payment for dental services inextricably linked to specific covered medical services; updates to drugs and biological products paid under Part B including immunosuppressive drugs and clotting factors; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or a Medicare Advantage Prescription Drug (MA-PD) plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the diabetes payment structure and PHE flexibilities; expansion of colorectal cancer screening and Hepatitis B vaccine coverage and payment; establishing payment for drugs covered as additional preventive services; Medicare Parts A and B Overpayment Provisions of the Affordable Care Act and Medicare Parts C and D Overpayment Provisions of the Affordable Care Act.","document_number":"2024-25382","html_url":"https://www.federalregister.gov/documents/2024/12/09/2024-25382/medicare-and-medicaid-programs-cy-2025-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-09/pdf/2024-25382.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25382.pdf?1730492138","publication_date":"2024-12-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; updates to the Medicare Diabetes Prevention Program expanded model; payment for dental services inextricably linked to specific covered medical services; updates to drugs and biological products paid under Part B including immunosuppressive drugs and clotting factors; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to policies for Rural"},{"title":"Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program","type":"Proposed Rule","abstract":"This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.","document_number":"2025-13271","html_url":"https://www.federalregister.gov/documents/2025/07/16/2025-13271/medicare-and-medicaid-programs-cy-2026-payment-policies-under-the-physician-fee-schedule-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-16/pdf/2025-13271.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13271.pdf?1752524111","publication_date":"2025-07-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers update to the Ambulance Fee Schedule regulations;"}]}