Entity DossierGovernment Body

Health and Human Services Department

Federal agency. Imported from federalregister.gov (slug: health-and-human-services-department).

pharmaceuticals

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Regulatory Capture Assessment

Regulatory capture occurs when a regulatory agency advances the interests of the industry it is meant to oversee. The indicators below track evidence of capture for this agency. According to the academic literature (Stigler 1971, Carpenter & Moss 2013), captured agencies exhibit declining enforcement, revolving door personnel pipelines, and rule-making that favors incumbents over public interest.

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Relationships

Type	Connected To	Details	Source
issued_rule	Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications	Issued the rule.	Source
issued_rule	Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity	Issued the rule.	Source
issued_rule	Global Benchmark for Efficient Drug Pricing (GLOBE) Model	Issued the rule.	Source
issued_rule	Transparency in Coverage	Issued the rule.	Source
shaped_policy	Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Withdrawal	Withdrew the rulemaking before finalizing it.	Source
issued_rule	Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model	Issued the rule.	Source
issued_rule	Medicaid Program; Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children	Issued the rule.	Source
issued_rule	COVID-19 Mitigation Policy Requirement in Head Start Programs; Recission	Issued the rule.	Source
issued_rule	Medicare and Medicaid Programs; Hospital Condition of Participation: Prohibiting Sex-Rejecting Procedures for Children	Issued the rule.	Source
issued_rule	Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance	Issued the rule.	Source
issued_rule	Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits	Amended an existing rule.	Source
issued_rule	Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program; Correction	Issued the rule.	Source
issued_rule	Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model	Issued the rule.	Source
issued_rule	Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts	Issued the rule.	Source
issued_rule	Expiration of Interim Final Rule: Control of Communicable Diseases; Foreign Quarantine	Issued the rule.	Source
issued_rule	Medical Devices; Quality Management System Regulation Technical Amendments	Issued the rule.	Source
shaped_policy	Medicare and Medicaid Programs; Repeal of Minimum Staffing Standards for Long-Term Care Facilities	Repealed or rescinded the rule.	Source
issued_rule	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	Issued the rule.	Source
issued_rule	Medicare Program; Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program	Issued the rule.	Source
shaped_policy	Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal	Withdrew the rulemaking before finalizing it.	Source
issued_rule	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; Correction	Issued the rule.	Source
issued_rule	Green Innovation GmbH; Filing of Food Additive Petition (Animal Use)	Issued the rule.	Source
issued_rule	Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device	Amended an existing rule.	Source
issued_rule	Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments	Amended an existing rule.	Source
issued_rule	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	Issued the rule.	Source
issued_rule	Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath	Amended an existing rule.	Source
issued_rule	Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model	Issued the rule.	Source
issued_rule	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	Issued the rule.	Source
issued_rule	Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date	Amended an existing rule.	Source
issued_rule	Revocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Date	Issued the rule.	Source
issued_rule	Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur	Issued the rule.	Source
shaped_policy	New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction	Withdrew the rulemaking before finalizing it.	Source
issued_rule	Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions	Issued the rule.	Source
issued_rule	Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE)-Finalization of Format Provider Directories for Medicare Plan Finder	Issued the rule.	Source
shaped_policy	Proposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages	Repealed or rescinded the rule.	Source
issued_rule	Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices	Amended an existing rule.	Source
issued_rule	Radiological Health Regulations; Technical Amendments	Issued the rule.	Source
issued_rule	Standards of Conduct; Revocation of Superseded Regulations; Revision of Residual Provisions; Correction	Issued the rule.	Source
shaped_policy	Advisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees	Repealed or rescinded the rule.	Source
issued_rule	Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements; Correction	Issued the rule.	Source
issued_rule	Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide	Amended an existing rule.	Source
issued_rule	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	Issued the rule.	Source
issued_rule	Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and Streptococcus thermophilus	Amended an existing rule.	Source
issued_rule	Biomin GmbH; Filing of Food Additive Petition (Animal Use)	Issued the rule.	Source
issued_rule	Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date	Amended an existing rule.	Source
issued_rule	Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices	Amended an existing rule.	Source
issued_rule	Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System	Amended an existing rule.	Source
issued_rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System	Amended an existing rule.	Source
issued_rule	Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date	Amended an existing rule.	Source
issued_rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System	Amended an existing rule.	Source
issued_rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis	Amended an existing rule.	Source
issued_rule	Terminating National Institutes of Health Minority Biomedical Research Support Program and Rescinding the Program's Related Regulation	Issued the rule.	Source
issued_rule	Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System	Amended an existing rule.	Source
issued_rule	Standards of Conduct; Revocation of Superseded Regulations; Revision of Residual Provisions	Issued the rule.	Source
issued_rule	Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices	Amended an existing rule.	Source
issued_rule	Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA), National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard; Updates to Compliance and Other Related Dates	Issued the rule.	Source
issued_rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms	Amended an existing rule.	Source
issued_rule	Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox	Amended an existing rule.	Source
shaped_policy	New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address	Withdrew the rulemaking before finalizing it.	Source
issued_rule	Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date	Amended an existing rule.	Source
issued_rule	Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool	Amended an existing rule.	Source
issued_rule	Medical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens	Amended an existing rule.	Source
issued_rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System	Amended an existing rule.	Source
issued_rule	Evonik Corporation; Filing of Food Additive Petition (Animal Use)	Issued the rule.	Source
issued_rule	Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule; Correction	Issued the rule.	Source
issued_rule	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; Correction	Issued the rule.	Source
issued_rule	Food Standards of Identity Modernization; Pasteurized Orange Juice	Issued the rule.	Source
issued_rule	Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization	Issued the rule.	Source
issued_rule	Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program	Issued the rule.	Source
issued_rule	Medicare Program; FY 2026 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update	Issued the rule.	Source
issued_rule	Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2026	Issued the rule.	Source
issued_rule	Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension	Issued the rule.	Source
issued_rule	Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Correction	Amended an existing rule.	Source
issued_rule	Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements	Issued the rule.	Source
issued_rule	Spoonbill Foundation; Filing of Food Additive Petition	Issued the rule.	Source
issued_rule	Regulatory Hearing Before the Food and Drug Administration	Issued the rule.	Source
issued_rule	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	Issued the rule.	Source
issued_rule	APIX Biosciences US LLC; Filing of Food Additive Petition (Animal Use)	Issued the rule.	Source
issued_rule	Revocation of Food Standards for 11 Products Not Currently Sold	Issued the rule.	Source
issued_rule	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	Issued the rule.	Source
issued_rule	Proposal To Revoke 18 Standards of Identity for Dairy Products	Issued the rule.	Source
issued_rule	Proposal To Revoke 23 Standards of Identity for Foods	Issued the rule.	Source
issued_rule	Revocation of Food Standards for 11 Products Not Currently Sold	Issued the rule.	Source
issued_rule	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	Issued the rule.	Source
issued_rule	Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue	Amended an existing rule.	Source
issued_rule	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	Issued the rule.	Source
issued_rule	Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model	Issued the rule.	Source
issued_rule	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	Issued the rule.	Source
issued_rule	Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies	Amended an existing rule.	Source
issued_rule	Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability	Issued the rule.	Source
issued_rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervous System Infections	Amended an existing rule.	Source
issued_rule	Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test	Amended an existing rule.	Source
issued_rule	Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System	Amended an existing rule.	Source
issued_rule	Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products	Issued the rule.	Source
shaped_policy	New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor	Withdrew the rulemaking before finalizing it.	Source
issued_rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Selected Microbial Agents That Cause Acute Febrile Illness	Amended an existing rule.	Source
issued_rule	Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation	Amended an existing rule.	Source
issued_rule	Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Draft Guidance for Industry; Availability	Issued the rule.	Source
issued_rule	Supporting the Head Start Workforce and Consistent Quality Programming	Issued the rule.	Source
issued_rule	Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers	Amended an existing rule.	Source