340B Accountability Act of 2023

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---H.R.6973: Generic Drug Application Review Reforms ---S.148: Stop STALLING Act ---S.4351: Enhanced Access to Affordable Medicines Act Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4758: Accelerating Kids Access to Care Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433: Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1067: Ensuring Timely Access to Generics ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART) Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety from Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 6833, Continuing Appropriations Act of 2023 HR 9747, Continuing Appropriations and Extensions Act, 2025 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support Reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower Costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 HR 7635 The 340B Pharmaceutical Access to Invest in Essential, Needed Treatments & Support Act of 2024 HR 8574 340B Affording Care for Communities and Ensuring a Strong Safety-net Act HR 8260, Hospital Inpatient Services Modernization Act S 2768, Hospital Inpatient Services Modernization Act HR 10545 American Relief Act of 2025 S 2372 Accelerating Kids Access to Care Act HR 4758 Accelerating Kids Access to Care Act CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $40,000 · Firm income: Not reported

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety from Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 6833, Continuing Appropriations Act of 2023 HR 9747, Continuing Appropriations and Extensions Act, 2025 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support Reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower Costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 HR 7635 The 340B Pharmaceutical Access to Invest in Essential, Needed Treatments & Support Act of 2024 HR 8574 340B Affording Care for Communities and Ensuring a Strong Safety-net Act HR 8260, Hospital Inpatient Services Modernization Act S 2768, Hospital Inpatient Services Modernization Act HR 10545 American Relief Act of 2025 S 2372 Accelerating Kids Access to Care Act HR 4758 Accelerating Kids Access to Care Act CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $40,000 · Firm income: Not reported

The 340B Drug Pricing Program; H.R. 2534, The Protect 340B Act; FY24 and FY25 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations bills. HR 3290,to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R.3561 - PATIENT Act of 2023, The Stop Drug Shortages Act (Draft legislation- House), H.R. 5378: Lower Costs, More Transparency Act, S. 1182: 340B Reporting and Accountability Act; S.1133: 340B Accountability Act of 2023,S.1038: Drug Price Transparency in Medicaid Act of 2023,H.R.1613: Drug Price Transparency in Medicaid Act of 2023,H.R.198: Drug Pricing Transparency and Accountability Act; S. 2973: Modernizing and Ensuring PBM Accountability Act, Draft Senate legislation the SUSTAIN 340B Act, HR 7635 and S. 5021, the 340B PATIENTS Act.H.R. 8574, 340B ACCESS Act: H.R.8144 - Rural 340B Access Act of 2024

Client expense: $260,046 · Firm income: Not reported

S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 HR. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Alternative Funding Programs Drug Shortages Supply Chain Integrity and Traceability Drug Patenting S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S. 4667 Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S. 2780 Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.4351: Enhanced Access to Affordable Medicines Act ---H.R 6973: Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433 - Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---American Pandemic Preparedness Plan (AP3) ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---HR 8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.2780 - Medication Affordability and Patent Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

The 340B Drug Pricing Program; H.R. 2534, The Protect 340B Act; FY24 and FY25 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations bills. HR 3290,to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R.3561 - PATIENT Act of 2023, The Stop Drug Shortages Act (Draft legislation- House), H.R. 5378: Lower Costs, More Transparency Act, S. 1182: 340B Reporting and Accountability Act; S.1133: 340B Accountability Act of 2023,S.1038: Drug Price Transparency in Medicaid Act of 2023,H.R.1613: Drug Price Transparency in Medicaid Act of 2023,H.R.198: Drug Pricing Transparency and Accountability Act; S. 2973: Modernizing and Ensuring PBM Accountability Act, Draft Senate legislation the SUSTAIN 340B Act, HR 7635 and S. 5021, the 340B PATIENTS Act.H.R. 8574, 340B ACCESS Act: H.R.8144 - Rural 340B Access Act of 2024

Client expense: $345,454 · Firm income: Not reported

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 6833, Continuing Appropriations Act of 2023 HR 9747, Continuing Appropriations and Extensions Act, 2025 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 HR 7635 The 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024 HR 8574 340B Affording Care for Communities and Ensuring a Strong Safety-net Act HR 8260, Hospital Inpatient Services Modernization Act S 2768, Hospital Inpatient Services Modernization Act CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $45,000 · Firm income: Not reported

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 6833, Continuing Appropriations Act of 2023 HR 9747, Continuing Appropriations and Extensions Act, 2025 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 HR 7635 The 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024 HR 8574 340B Affording Care for Communities and Ensuring a Strong Safety-net Act HR 8260, Hospital Inpatient Services Modernization Act S 2768, Hospital Inpatient Services Modernization Act CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $45,000 · Firm income: Not reported

340B Program; H.R.2534 Protect 340B Act; 340B Transparency and Oversight H.R.3290/S.1133; The PATIENT Act H.R.3561; Resident Physician Shortage Reduction Act H.R.2389; Preventive Health Savings Act S.114/H.R.766; Safety from Violence for Healthcare Employees "SAVE" Act H.R.2584; H.R.5378 Lower Costs, More Transparency Act; Stop Drug Shortages Act; H.R.5378 Lower Costs, More Transparency Act; Senate 340B RFI - responded; 340B Access Act;

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---HR 8818: American Privacy Rights Act of 2024 ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

340B Program; H.R.2534 Protect 340B Act; 340B Transparency and Oversight H.R.3290/S.1133; The PATIENT Act H.R.3561; Resident Physician Shortage Reduction Act H.R.2389; Preventive Health Savings Act S.114/H.R.766; Safety from Violence for Healthcare Employees "SAVE" Act H.R.2584; H.R.5378 Lower Costs, More Transparency Act; Stop Drug Shortages Act; H.R.5378 Lower Costs, More Transparency Act; Senate 340B RFI - responded; 340B Access Act;

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The 340B Drug Pricing Program; H.R. 2534, The Protect 340B Act; FY24 and FY25 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations bills. HR 3290,to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R.3561 - PATIENT Act of 2023, The Stop Drug Shortages Act (Draft legislation- House), H.R. 5378: Lower Costs, More Transparency Act, S. 1182: 340B Reporting and Accountability Act; S.1133: 340B Accountability Act of 2023,S.1038: Drug Price Transparency in Medicaid Act of 2023,H.R.1613: Drug Price Transparency in Medicaid Act of 2023,H.R.198: Drug Pricing Transparency and Accountability Act; S. 2973: Modernizing and Ensuring PBM Accountability Act, Draft Senate legislation the SUSTAIN 340B Act, HR 7635, the 340B PATIENTS Act.H.R. 8574, 340B ACCESS Act

Client expense: $315,115 · Firm income: Not reported

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 HR 7635 The 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024 HR 8574 340B Affording Care for Communities and Ensuring a Strong Safety-net Act CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $40,000 · Firm income: Not reported

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 HR 7635 The 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024 HR 8574 340B Affording Care for Communities and Ensuring a Strong Safety-net Act CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $40,000 · Firm income: Not reported

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $110,000 · Firm income: Not reported

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $110,000 · Firm income: Not reported

The 340B Drug Pricing Program; H.R. 2534, The Protect 340B Act; FY24 and FY25 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations bills. HR 3290,to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R.3561 - PATIENT Act of 2023, The Stop Drug Shortages Act (Draft legislation- House), H.R. 5378: Lower Costs, More Transparency Act, S. 1182: 340B Reporting and Accountability Act; S.1133: 340B Accountability Act of 2023,S.1038: Drug Price Transparency in Medicaid Act of 2023,H.R.1613: Drug Price Transparency in Medicaid Act of 2023,H.R.198: Drug Pricing Transparency and Accountability Act; S. 2973: Modernizing and Ensuring PBM Accountability Act, Draft Senate legislation the SUSTAIN 340B Act, HR 7635, the 340B PATIENTS Act.

Client expense: $391,233 · Firm income: Not reported

340B Program; H.R.2534 Protect 340B Act; 340B Transparency and Oversight H.R.3290/S.1133; The PATIENT Act H.R.3561; Resident Physician Shortage Reduction Act H.R.2389; Preventive Health Savings Act S.114/H.R.766; Safety from Violence for Healthcare Employees "SAVE" Act H.R.2584; H.R.5378 Lower Costs, More Transparency Act; Stop Drug Shortages Act; H.R.5378 Lower Costs, More Transparency Act; Senate 340B RFI - responded;

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures Act 2.0 340B Contract Pharmacy Policy 340B Drug Discount Program Accelerated Approval Alternative Funding Programs Buy American Executive Order Cancer Moonshot CBO modeling Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 2534, PROTECT 340B Act of 2023 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 4822, Health Care Price Transparency Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 5378, Lower Costs, More Transparency Act H.R. 5416, The Give Kids a Chance Act H.R. 830/S. 1375, HELP Co-pays Act Health industry vertical integration Inflation Reduction Act Implementation Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Reauthorization of PAHPA S. 1131, Drug Price Transparency Act S. 1133, 340B Accountability Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542/H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2837, 340B Accountability Act 2021 S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 Step Therapy The Medicaid VBPs for Patients (MVP) Act Transparency policy issues

Hospital Group Purchasing - Advocated to highlight the value that hospital group purchasing organizations provide to hospitals and suppliers. Provided education on how GPOs work in the healthcare supply chain and the role they play in delivering value to healthcare providers. Endorsed passage of Connecting Our Medical Providers with Links to Expand Tailored and Effective (COMPLETE) Care Act (H.R. 5819/S.1378). Preparing for All Hazards and Pathogens Reauthorization Act (H.R. 4421) and Preparedness and Response Reauthorization Act (H.R. 4420) - Supported passage of legislation to reauthorize the Pandemic and All Hazards Preparedness Act. Advocated for including provisions to increase transparency in the healthcare supply chain and improve hospital and health system emergency preparedness. Payer-mandated White Bagging - Urged support for policy updates related to payer-mandated white bagging for medications. Drug shortages -Supported elements to increase transparency in prescription drug supply chain and increase reimbursement for generic prescription drugs; issues related to compounding; issues related to buffer inventory. Endorsed passage of the Drug Origin Transparency Act (H.R. 3810). Endorsed passage of the Biosimilar Red Tape Elimination Act (S. 2305). Supported passage of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (S. 1355/H.R. 2940). Supported passage of the Biologics Competition Act (H.R. 1790). Endorsed passage of Biosimilar Red Tape Elimination Act (S.2305) 340B Drug Pricing Program - Continued to urge action to ensure covered entities have access to 340B discounted prices through contract pharmacies. Highlighted critical importance of the 340B program for hospitals. Endorsed passage of the Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act (H.R. 2534). Opposed legislation (H.R. 3290/S. 1133) that would place cumbersome reporting obligations on 340B covered entities. Buffer inventory - Engagements with CMS on reimbursement for hospitals that stockpile buffer supplies of essential medicines Mental and Behavioral Health - Highlighted during congressional briefing how hospitals are providing mental and behavioral health treatment and support for their communities. Highlighted the need for legislation to address significant challenges to mental and behavioral health treatment, including increased demand for services, limited access to treatment, and clinician shortages. Healthcare Workforce - Supported passage of the Resident Physician Shortage Reduction Act (H.R. 2389 / S. 1302), the Safety from Violence for Healthcare Employees (SAVE) Act (H.R. 2584/S. 2768) and the Healthcare Workforce Resilience Act (H.R 6205/S. 3211); Monitored development and introduction of the Bipartisan Primary Care and Health Workforce Act (S.2840) Children's Hospital Graduate Medical Education (CHGME) - Urged Congress to reauthorize CHGME program through the Childrens Hospital GME Support Reauthorization Act of 2023 (H.R. 3887). Offered support for providing $738 million in funding the CHGME program. Unique Device Identification (UDI) - Continued engagement to improve data standards and validation and support opportunities for the improved use of unique device identification and the Global UDI database (GUDID). Telehealth - Continued supporting passage of the CONNECT for Health Act (S. 2016/H.R. 4189). Continued to advocate for the adoption of permanent telehealth policies to extend flexibilities beyond the current 2024 expiration date. Social Determinants of Health - Encouraged Congress and agencies to ensure tools like the Vizient Vulnerability Index are being utilized to understand and identify social drivers of health at the neighborhood level. Medical Device Sterilization - Conducted education and outreach on the potential negative impact on the healthcare supply chain of pending regulations limiting the use of Ethylene Oxide as a medical device sterilant. Issues related to pharmacy benefit managers

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $40,000 · Firm income: Not reported

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $40,000 · Firm income: Not reported

21st Century Cures Act 2.0 340B Contract Pharmacy Policy 340B Drug Discount Program Accelerated Approval Alternative Funding Programs Buy American Executive Order Cancer Moonshot CBO modeling Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 2534, PROTECT 340B Act of 2023 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 4822, Health Care Price Transparency Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 5378, Lower Costs, More Transparency Act H.R. 5416, The Give Kids a Chance Act H.R. 830/S. 1375, HELP Co-pays Act Health industry vertical integration Inflation Reduction Act Implementation Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Reauthorization of PAHPA S. 1131, Drug Price Transparency Act S. 1133, 340B Accountability Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542/H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2837, 340B Accountability Act 2021 S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 Step Therapy The Medicaid VBPs for Patients (MVP) Act Transparency policy issues

Higher education healthcare related issues, generally Monitor the following: Hospital at Home Program, Entirety Graduate Medical Education (GME) Medicare Wage Index Disproportionate Share Hospital (DSH) Payments Alabama Area Health Education Centers (AHEC) Medicare Reimbursement related issues H.R.3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, Entirety S.1133, 340B Accountability Act of 2023, Entirety S.1182, 340B Reporting and Accountability Act, Entirety H.R.2534, PROTECT 340B Act of 2023, Entirety Medicaid Provider Hold Harmless Arrangements Low Volume Hospitals and Medicare Dependent Hospitals CMS Hospital Payment, Provider relief issues

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor the following: Telehealth reimbursement issues Hospital Acquisition and Billing The Hospital Inpatient Payment Systems for Acute Care Hospitals and Long Term care Hospital Prospective Payment System (IPPS), Proposed Rule changes Disproportionate share hospital payments Graduate Medical Education (GME) issues Medicaid and Medicare Reform H.R.3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, Entirety S.1133, 340B Accountability Act of 2023, Entirety S.1182, 340B Reporting and Accountability Act, Entirety H.R.2534, PROTECT 340B Act of 2023, Entirety

Client expense: Not reported · Firm income: $40,000

The 340B Drug Pricing Program; The Protect 340B Act; FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations bill. HR 3290,to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R.3561 - PATIENT Act of 2023, The Stop Drug Shortages Act (Draft legislation- House), H.R. 5378: Lower Costs, More Transparency Act, S. 1182: 340B Reporting and Accountability Act; S.1133: 340B Accountability Act of 2023,S.1038: Drug Price Transparency in Medicaid Act of 2023,H.R.1613: Drug Price Transparency in Medicaid Act of 2023,H.R.198: Drug Pricing Transparency and Accountability Act; S. 2973: Modernizing and Ensuring PBM Accountability Act

Client expense: $249,606 · Firm income: Not reported

340B Program; H.R.2534 Protect 340B Act; 340B Transparency and Oversight H.R.3290/S.1133; The PATIENT Act H.R.3561; Resident Physician Shortage Reduction Act H.R.2389; Preventive Health Savings Act S.114/H.R.766; Safety from Violence for Healthcare Employees "SAVE" Act H.R.2584; H.R.5378 Lower Costs, More Transparency Act; Stop Drug Shortages Act; H.R.5378 Lower Costs, More Transparency Act;

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Hospital Group Purchasing - Advocated to highlight the value that hospital group purchasing organizations provide to hospitals and suppliers. Provided education on how GPOs work in the healthcare supply chain and the role they play in delivering value to healthcare providers. Drug shortages - Opposed provisions in House Energy and Commerce Committee discussion draft on drug shortages that would exempt sterile injectable products from the 340B Drug Pricing Program, and increase reporting obligations for hospitals as a and group purchasing organizations. Supported elements to increase transparency in prescription drug supply chain and increase reimbursement for generic prescription drugs. Endorsed passage of the Drug Origin Transparency Act (H.R. 3810). Endorsed passage of the Biosimilar Red Tape Elimination Act (S. 2305). Pandemic and All Hazard Preparedness Act (H.R. 4421 and H.R. 4420) - Supported timely passage of legislation to reauthorize the Pandemic and All Hazards Preparedness Act. Advocated for including provisions to increase transparency in the healthcare supply chain and improve hospital and health system emergency preparedness. 340B Drug Pricing Program - Endorsed passage of the Protect 340B Act (H.R. 2534). Opposed legislation (H.R. 3290/S. 1133) that would place cumbersome reporting obligations on 340B covered entities. Continued to urge action to ensure covered entities have access to 340B discounted prices through contract pharmacies. Highlighted critical importance of the 340B program for hospitals. Social Determinants of Health - Highlighted during congressional briefing how hospitals are investing in social determinants of health to support the health of their community. Highlighted the need for federal agencies to utilize a more comprehensive social needs index like the Vizient Vulnerability Index to identify community health needs and other social drivers of health. Healthcare Workforce - Urged passage of the Safety from Violence for Healthcare Employees (SAVE) Act (H.R. 2584/S. 2768). Continued to highlight the need to improve healthcare staffing through investments and reauthorization of critical workforce programs, expanding access to unused visas for healthcare workers. Monitored development and introduction of the Bipartisan Primary Care and Health Workforce Act (S.2840). Children's Hospital Graduate Medical Education (CHGME) - Urged Congress to reauthorize CHGME program (H.R. 3887). Offered support for providing $738 million in funding the CHGME program. Unique Device Identification (UDI) - Supported improved data standards and validation to improve accuracy of medical device information in the Global Unique Device Identification Database. Telehealth - Supported passage of the CONNECT for Health Act (S. 2016/H.R. 4189). Continued to advocate for the adoption of permanent telehealth policies to extend flexibilities beyond the current 2024 expiration date. Medical Device Sterilization - Conducted education and outreach on the potential negative impact on the healthcare supply chain of pending regulations limiting the use of Ethylene Oxide as a medical device sterilant. Supported passage of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)Act (S. 1355/H.R. 2940). Supported passage of the Biologics Competition Act (H.R. 1790). Payer-mandated White Bagging - Urged support for policy updates to place limits on payer-mandated white bagging for medications.

Pharmacy Benefit Manager Reform Act (S. 1339) The Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023 (S. 3561) Lower Costs, More Transparency Act (H.R. 5378) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program (H.R. 3290) 340B Accountability Act of 2023 (S. 1133) Pharmacy Benefits Manager Accountability Act (H.R. 2679) To amend title XXVII of the Public Health Service Act to limit cost sharing for prenatal services in certain circumstances. Black Maternal Health Momnibus Act (H.R. 3305/S. 1606) Modernizing and Ensurging PBM Accountability Act (MEPA Act) Medicare PBM Accountability Act (Discussion Draft) Senate Bi-Partisan 340B RFI National Drug Rebate Clearinghouse Proposal Pandemic and All Hazards Preparedness Act (PAHPA) (S. 2333) Bipartisan Primary Care and Health Workforce Act (S. 2840) Jeanette Acosta Invest in Womens Health Act (not yet introduced) Health Equity and Accountability Act (not yet introduced) Caring for Grieving Families Act

Client expense: $306,810 · Firm income: Not reported

340B Drug Discount Program H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 2534, PROTECT 340B Act of 2023 340B Contract Pharmacy Policy S. 1133, 340B Accountability Act Accelerated Approval Advanced Research Projects Agency for Health (ARPA-H) Alternative Funding Programs Biosimilar approval and reimbursement policy issues Buy American Executive Order Cancer Moonshot Cell, gene and radioligand therapies Co-pay accumulator programs Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 2534, Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 5376, Inflation Reduction Act H.R. 4822, Health Care Price Transparency Act of 2023 Inflation Reduction Act Implementation H.R. 5416, The Give Kids a Chance Act The Medicaid VBPs for Patients (MVP) Act H.R. 830/S. 1375, HELP Co-pays Act H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Priority Review Voucher (PRV) Reauthorization of PAHPA Regulatory efficiencies policy issues S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 S. 2837, 340B Accountability Act 2021 S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act H.R. 5539, ORPHAN Cures Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542, Delinking Reveue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act H.R. 5378, Lower Costs, More Transparency Act H.R. 2880, Protecting Patients Against PBM Abuses Act Step Therapy Transparency policy issues Utilization management issues Health industry vertical integration CBO modeling 340B Program Implementation & Oversight 340B Accountability Act S. 1182: The 340B Reporting and Accountability Act H.R.2534: PROTECT 340B Act of 2023 H.R.2408: Access to Innovative Treatments Act of 2023 H.R.1790: Biologics Competition Act of 2023 S.113: Prescription Pricing for the People Act of 2023 S.150: Affordable Prescriptions for Patients Act of 2023 Drug Benefit Design

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization

Client expense: $50,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization

Client expense: $50,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

Monitor the following: Hospital at Home Program, Entirety Graduate Medical Education (GME) Medicare Wage Index Disproportionate Share Hospital (DSH) Payments Alabama Area Health Education Centers (AHEC) Medicare Reimbursement related issues H.R.3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, Entirety S.1133, 340B Accountability Act of 2023, Entirety S.1182, 340B Reporting and Accountability Act, Entirety H.R.2534, PROTECT 340B Act of 2023, Entirety Medicaid Provider Hold Harmless Arrangements Low Volume Hospitals and Medicare Dependent Hospitals CMS Hospital Payment, Provider relief issues

Client expense: Not reported · Firm income: $30,000

The 340B Drug Pricing Program; The Protect 340B Act; FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations bill. HR 3290,to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R.3561 - PATIENT Act of 2023, The Stop Drug Shortages Act (Draft legislation- House), H.R. 5378: Lower Costs, More Transparency Act, S. 1182: 340B Reporting and Accountability Act; S.1133: 340B Accountability Act of 2023,S.1038: Drug Price Transparency in Medicaid Act of 2023,H.R.1613: Drug Price Transparency in Medicaid Act of 2023,H.R.198: Drug Pricing Transparency and Accountability Act; S. 2973: Modernizing and Ensuring PBM Accountability Act

Client expense: $313,537 · Firm income: Not reported

Monitor the following: Telehealth reimbursement issues Hospital Acquisition and Billing The Hospital Inpatient Payment Systems for Acute Care Hospitals and Long Term care Hospital Prospective Payment System (IPPS), Proposed Rule changes Disproportionate share hospital payments Graduate Medical Education (GME) issues Medicaid and Medicare Reform H.R.3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, Entirety S.1133, 340B Accountability Act of 2023, Entirety S.1182, 340B Reporting and Accountability Act, Entirety H.R.2534, PROTECT 340B Act of 2023, Entirety

Client expense: Not reported · Firm income: $30,000

340B Program; H.R.2534 Protect 340B Act; 340B Transparency and Oversight H.R.3290/S.1133; The PATIENT Act H.R.3561; Resident Physician Shortage Reduction Act H.R.2389; Preventive Health Savings Act S.114/H.R.766; Safety from Violence for Healthcare Employees "SAVE" Act H.R.2584;H.R.5378 Lower Costs, More Transparency Act; Stop Drug Shortages Act;

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Real Education and Access for Healthy Youth Act (H.R. 3583/S. 1697) Supporting the goals and ideals of the month of May as Sex Ed For All Month: Equity and Access for All (H. Res. 432) Personal Responsibility Education Program (PREP) Reauthorization Title V Abstinence-Only-Until-Marriage (AOUM) Program Jeanette Acosta Invest in Women's Health Act (not yet introduced) The Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023 (H.R. 3561) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program (H.R. 3290) The Medicaid VBPs for Patients (MVP) Act (H.R. 2666) Pharmacy Benefits Manager Accountability Act (H.R. 2679) Pharmacy Benefit Manager Reform Act (S. 1339) Medicare PBM Accountability Act (Discussion Draft) 340B Accountability Act of 2023 (S. 1133) DEA Temporary and Proposed Rule for prescribing controlled substances via telehealth. (Jayapal and Markey) Gender Affirming Care Access Research for Equity (CARE) Act (S.2246) A bill to provide enhanced funding for family planning services (S.2207) Combating Illicit Xylazine Act (H.R.1839)

Client expense: $203,670 · Firm income: Not reported

Hospital Group Purchasing - Advocated to highlight the value that hospital group purchasing organizations provide to hospitals and suppliers. Provided education on how GPOs work in the healthcare supply chain and the role they play in delivering value to healthcare providers. Drug shortages - Engaged to highlight how GPOs act to prevent and mitigate drug shortages. Urged greater transparency in the healthcare supply chain related to geographic locations for manufacturing, active pharmaceutical ingredients and other critical sources. Debt Ceiling Negotiations (H.R. 3746) - Opposed inclusion of work and community engagement requirements or further cuts in hospital reimbursement in debt ceiling negotiations. Pandemic and All Hazard Preparedness Act - Supported including provisions in the reauthorization of the Pandemic and All Hazards Preparedness Act that would provide greater authority to require reporting of geographic locations for sourcing of critical materials, active pharmaceutical ingredients, manufacturing, sterilization and finishing of critical medical products. Advocated for policies that would improve hospital and health system emergency preparedness. Supported improvements in transparency for the Strategic National Stockpile, greater government engagement with private sector stakeholders, automated reporting and reduced administrative burden for providers in emergencies and urged steps to support greater supply chain resilience. 340B Drug Pricing Program - Endorsed passage of the Protect 340B Act (H.R. 2534). Opposed legislation (H.R. 3290/S. 1133) that would place cumbersome reporting obligations on 340B covered entities. Continued to urge action to ensure covered entities have access to 340B discounted prices through contract pharmacies. Highlighted critical importance of the 340B program for hospitals. Healthcare Workforce - Urged passage of the Safety from Violence for Healthcare Employees (SAVE) Act (H.R. 2584). Continued to highlight the need to improve healthcare staffing through investments and reauthorization of critical workforce programs, expanding access to unused visas for healthcare workers, and review of staffing agency activities during the COVID-19 pandemic. Children's Hospital Graduate Medical Education (CHGME) - Offered support for providing $738 million in funding the CHGME program. Urged Congress to reauthorize CHGME program (H.R. 3887). Telehealth - Endorsed passage of the CONNECT for Health Act(S. 2016/H.R. 4189). Continued to advocate for the adoption of permanent telehealth policies that would extend flexibilities offered during the declared public health emergency and beyond the current 2024 expiration date. Medical Device Sterilization - conducted education and outreach on the potential negative impact on the healthcare supply chain of pending regulations limiting the use of Ethylene Oxide as a medical device sterilant. Endorsed passage of the Pioneering Antimicrobial Subscriptions To End Upsurging Resistance (PASTEUR)Act (S. 1355/H.R. 2940). Endorsed passage of the Biologics Competition Act (H.R. 1790) Payer Mandated "white bagging" - Raised concerns about health plan restrictions requiring medications to be acquired through payer-affiliated pharmacies.

Monitor the following: Telehealth reimbursement issues Hospital Acquisition and Billing The Hospital Inpatient Payment Systems for Acute Care Hospitals and Long Term care Hospital Prospective Payment System (IPPS), Proposed Rule changes Disproportionate share hospital payments Graduate Medical Education (GME) issues Medicaid and Medicare Reform H.R.3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, Entirety S.1133, 340B Accountability Act of 2023, Entirety S.1182, 340B Reporting and Accountability Act, Entirety H.R.2534, PROTECT 340B Act of 2023, Entirety

Client expense: Not reported · Firm income: $40,000

Monitor the following: Hospital at Home Program, Entirety Graduate Medical Education (GME) Medicare Wage Index Disproportionate Share Hospital (DSH) Payments Alabama Area Health Education Centers (AHEC) Agency for Healthcare Research and Quality related issues IDeA program related issues Medicare Reimbursement related issues H.R.3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, Entirety S.1133, 340B Accountability Act of 2023, Entirety S.1182, 340B Reporting and Accountability Act, Entirety H.R.2534, PROTECT 340B Act of 2023, Entirety Medicaid Provider Hold Harmless Arrangements Low Volume Hospitals and Medicare Dependent Hospitals CMS Hospital Payment, Provider relief issues

Client expense: Not reported · Firm income: $80,000

Monitor the following: Hospital at Home Program, Entirety Graduate Medical Education (GME) Medicare Wage Index Disproportionate Share Hospital (DSH) Payments Alabama Area Health Education Centers (AHEC) Agency for Healthcare Research and Quality related issues IDeA program related issues Medicare Reimbursement related issues H.R.3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, Entirety S.1133, 340B Accountability Act of 2023, Entirety S.1182, 340B Reporting and Accountability Act, Entirety H.R.2534, PROTECT 340B Act of 2023, Entirety Medicaid Provider Hold Harmless Arrangements Low Volume Hospitals and Medicare Dependent Hospitals CMS Hospital Payment, Provider relief issues

Client expense: Not reported · Firm income: $40,000

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety From Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 1613, Drug Price Transparency in Medicaid Act HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support reauthorization Act of 2023 CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization

Client expense: $50,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE