Lowering Drug Costs for American Families Act

S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act S. 5021/HR. 7635 - 340B PATIENTS Act of 2024 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. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Drug Shortages Supply Chain Integrity and Traceability Drug Patenting 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 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. 2630/S. 652: SAFE STEP Act H.R. 5378: Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications 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. 2880: Protecting Patients Against PBM Abuses 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 Artificial intelligence policy issues S. 2305: Biosimilar Red Tape Elimination Act IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies

Client expense: $720,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products 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. 2630/S. 652: SAFE STEP Act H.R. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) Lower Costs, More Cures Act Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544/H.R. 1199: Facilitating Innovative Nuclear Diagnostics Act of 2023

Client expense: $720,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, 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 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)

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

Prescription drug industry issues relating to domestic construction and maintenance, prescription drug pricing, supply chain issues, pharmacy benefit managers transparency issues and employment issues, generally; S.127 - Pharmacy Benefit Manager Transparency Act of 2023; S.113 - Prescription Pricing for the People Act of 2023; H.R.830 - HELP Copays Act; S. 1542 - Delinking Revenue from Unfair Gouging Act (a/k/a The DRUG Act"); HR 4895 - H.R. 4895: Lowering Drug Costs for American Families Act; H.R. 2880: Protecting Patients Against PBM Abuses Act; HR 6283 - The Drug Act; HR 5378 - Lower Costs, More Transparency Act; HR 10545, American Relief Act, 2025.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription drug industry issues relating to domestic construction and maintenance, and prescription drug pricing S.127 - Pharmacy Benefit Manager Transparency Act of 2023; S.113 - Prescription Pricing for the People Act of 2023; H.R.830 - HELP Copays Act; S. 1542 - Delinking Revenue from Unfair Gouging Act (a/k/a The DRUG Act"); HR 4895 - H.R. 4895: Lowering Drug Costs for American Families Act; H.R. 2880: Protecting Patients Against PBM Abuses Act; HR 6283 - The Drug Act; HR 5378 - Lower Costs, More Transparency Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Expand Patient Access and Telehealth: Urged Congress to pass H.R.2630/S. 652, the Safe Step Act, which requires insurers to implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol. The bill lays out five exceptions to fail first protocols and requires that a group health plan grant an exemption. Pharmacy Benefit Managers (PBMs) and group health insurers have developed a series of price management tools to curb the rising cost of prescription drugs. Supported H.R. 2829, the Chronic Care Management Improvement Act of 2023, that would remove the co-pay charged to patients who utilize chronic care management services. It would waive the beneficiary coinsurance to manage chronic care conditions and improve patients health. Supported the Protecting Rural Telehealth Access Act, H.R. 3440 and S. 1636. This bipartisan legislation would ensure rural and underserved community healthcare providers can permanently offer telehealth services, including audio-only telehealth appointments, that are set to expire in December 2024. The legislation would: 1) allow payment parity for audio-only health services for clinically appropriate appointments; 2) permanently waive the geographic restriction allowing patients to be treated from their homes; 3) permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services; 4) lift the restrictions on store and forward technologies for telehealth; and 5) allow Critical Access Hospitals (CAHs) to directly bill for telehealth services. Supported the Preserving Telehealth, Hospital, and Ambulance Access Act, which would extend these flexibilities for two years until the end of 2026. Also supported the Protecting Rural Telehealth Access Act, H.R. 3440, and the Telehealth Modernization Act of 2024, H.R. 7623, which facilitate access to care via telehealth permanently. Supported CONNECT for Health Act of 2023, H.R. 4189 and S. 2016, to permanently remove all geographic restrictions on telehealth services and expand originating sites to include the home and other sites. That legislation would: 1) help providers transition to the goals of the Medicare Access and CHIP Reauthorization Act (MACRA) and the Merit-based Incentive Payment System (MIPS) through using telehealth and remote patient monitoring (RPM) without most of the 42 U.S.C. Section 1834(m) telehealth restrictions; 2) allow telehealth and RPM to be used by qualifying participants in alternative payment models, without most of the 1834(m) restrictions; 3) permit the use of remote patient monitoring for certain patients with chronic conditions; 4) allow, as originating sites, telestroke evaluation and management sites, Native American health service facilities, and dialysis facilities for home dialysis patients in certain cases; and 5) permit further telehealth and RPM in community health centers and rural health clinics. Medicare Payments to Physicians (H.R. 2474): Urged Congress to pass H.R. 2474, the Strengthening Medicare for Patients and Providers Act, which preserves access to care for Medicare beneficiaries by providing an annual inflation update equal to the Medicare Economic Index (MEI) for Medicare physician payments. Unlike other health care sectors, Medicare payment rates for physicians have not been updated based on the MEI. As a result, from 2001 to 2021, Medicare physician payments have decreased by 20 percent when adjusted for inflation. Supported H.R. 6545, the Physician Fee Schedule Update and Improvements Act before the House Energy and Commerce Committee. This bill includes an important provision that would allocate 3 percent to the 2024 Medicare conversion factor, which would represent a 1.75 percent increase to the approved level. H.R. 6545 also includes several provisions from H.R. 6371, the Provider Reimbursement Stability Act of 2023, that ACP supports. It would raise the budget neutrality threshold to $53 million and would use cumulative increases in the Medicare Economic Index (MEI) to update the threshold every five years afterwards. Supported H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023. That bill averts a 3.4 percent across-the-board cut to physician payment for 2024. ACP supports a similar bill, S. 5035, introduced by Sen. Boozman. ACP supported extending the work geographic practice costs index to improve the accuracy of geographic adjustment factors. Supported H.R. 6366 that would extend the work geographic practice costs index for another year to 1.00 for any locality where the index would be less than 1.00. We support aspects of legislation recently introduced by Senators Whitehouse and Cassidy, the Pay Primary Care Physicians (PCPs) Act, S. 4338, that would expand and accelerate the adoption of a hybrid per member per month (PMPM) payment model outside of the PFS. We believe this type of model can enhance innovation and improve the delivery of chronic care in primary care practices. ACP supported Dr. Michael C. Burgess Preventive Health Savings Act, H.R. 766, to enable CBO to capture cost-savings associated with preventive health care legislation beyond existing 10-year window, for two additional 10-year periods. Support Value-Based Care: Urged support of the Value in Health Care Act of 2023. The bill provides a multi-year commitment to reforming care delivery by extending MACRAs 5 percent advanced alternative payment models (APM) incentives that are scheduled to expire at the end of the year. It also gives the Centers for Medicare & Medicaid Services (CMS) authority to adjust APM qualifying thresholds so that the current one-size-fits-all approach does not serve as a disincentive to including rural, underserved, primary care or specialty practices in APMs. The bill removes revenue-based distinctions that disadvantage rural and safety net providers, which is critical to improving access to care and improving health equity. The bill also improves financial benchmarks so that APM participants are not penalized for their own success. To allow more clinicians to continue the transition to value, the bill establishes a voluntary track for accountable care organizations (ACOs) in the Medicare Shared Savings Program to take on higher levels of risk and provides technical assistance for clinicians new to APMs. Lastly, the bill seeks to provide parity between APMs and the Medicare Advantage (MA) program by studying ways to increase alignment that will ease burdens on physicians and ensure that both APMs and MA are attractive and sustainable options. ACP supports extending incentive payments for participation in eligible alternative payment models through 2026. This approach would help to maintain incentives that support physicians transition from a volume-based fee-for-service health care system to one that is based on the value and quality outcomes of health care delivered to the patient. Supported H.R. 6369 by Rep. Kim Schrier to extend incentive payments for participation in eligible alternative payment models. ACP supports H.R. 5395, the SURS Extension Act, which would extend the Quality Payment Program-Small Practice, Underserved, and Rural Support (QPP-SURS) program for fiscal years 2024-2029. This program was established under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and has provided direct assistance to eligible clinicians required to participate in MIPS. ACP supports efforts to streamline the number of quality measures physicians must report on and enhance stakeholder engagement. Supported the Fewer Burdens for Better Care Act of 2023, which would emphasize multi-stakeholder input, with a 30-day comment period for stakeholders to comment on the removal of measures from the Medicare program. Pricing Transparency/Consolidation: Supported several provisions of H.R. 5378, Lower Costs, More Transparency Act, which are consistent with our policy and would improve access to and affordability of health care for patients. This bill brings together H.R. 4822, Health Care Price Transparency Act of 2023, H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023 and other related bills reported out of Ways and Means, Energy and Commerce and Education and Workforce Committees. Supported requiring disclosure of changes in hospital or health facility ownership to reveal when private equity firms acquire hospitals, larger physician practices or nursing homes, promote price transparency among hospitals, health plans and pharmacy benefit managers and promote site neutrality for Medicare and Medicare beneficiaries. We further supported the reauthorization and funding increases included for the Teaching Health Center Graduate Medical Education program, Community Health Center program and National Health Service Corps. Supported Section 4 of H.R. 2880, the Protecting Patients Against PBM Abuses Act, which aims to increase PBM data reporting to enhance transparency for Medicare Part D. Specifically, it would set out new requirements for PBMs to report data on rebates and administrative fees to HHS. It would also require that HHS deidentify the data and make it publicly available so that policy makers and the public will have a better understanding of how rebates and administrative fees impact the costs of drug plans. The Affordable Care Act (P.L. 111-148, P.L. 111-152): Urged legislation to extend permanently the premium tax subsidies afforded under the ACA. Supported H.R. 1692, the Health Care Affordability Act of 2023, by Rep. Underwood to permanently extend the premium tax credit subsidies under the ACA. The law provides consumers with subsidies (premium tax credits) that lower costs for households with incomes between 100 percent and 400 percent of the federal poverty level (FPL). It expands the Medicaid program to cover all adults with income below 138 percent of the FPL. Supportive of S. 8, Improving Health Insurance Affordability Act to expand the eligibility of taxpayers for the refundable tax credit for coverage under a qualified health plan and increase cost-sharing subsidies under the ACA. We support similar legislation introduced by Sen. Shaheen in the Senate. FY2025 Appropriations: Urged Congress to support funding for the Centers for Disease Control and Prevention's programs in the FY 2025 Labor, Health and Human Services, Education and Related Agencies Appropriations bill as well as funding shared evenly between the U.S. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to conduct public health research into firearm morbidity and mortality prevention. Advocated for funding for the Health Resources Services Administration (HRSA); Title Vi, Section 747, Primary Care Training and Enhancement (PCTE), Health Resources and Services Administration (HRSA); National Health Service Corps (NHSC); Agency for Healthcare Research and Quality (AHRQ); the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH). Urged Congress to include report language in the FY2025 Labor HHS appropriations bill to direct the GAO to conduct a study encompassing the last decade of CMS estimates of new and revised code utilizations. ACP believes CMS has overestimated utilizations, thus adversely affecting available funds in the Medicare physician fee schedule for other code usage. While the House and Senate bills included language, we prefer the stronger House version language. Urged Congress to support year-end Continuing Resolution (CR) that contained PBM reform, averting Medicare physician payment cuts by 2.5%, provided bonus payment to physicians participating in APMs, and extended telehealth flexibilities adopted during the COVID-19 pandemic for 2 years. Also advocated that streamlined prior authorization process for Medicare Advantage plans be included in the CR. Women's Health: Urged HHS to support Title X funding and ensure unencumbered access to affordable, comprehensive, evidence-based reproductive health care; eliminate medically unnecessary restrictions and inappropriate political interference in the patient-physician relationship; and protect funding for and ensures consistent treatment of qualified service sites. Supported H.R. 459 and S. 323, the Secure Access for Essential Reproductive (SAFER) Health Act. This legislation would strengthen current health privacy laws to ensure that abortion-related health data cannot be shared without patient consent. It prohibits health care providers and insurance plans from disclosing in legal proceedings an individual's personal health information related to an abortion or pregnancy without the individual's valid authorization. The prohibition applies to federal, state, local, and tribal proceedings, including civil, criminal, administrative, and legislative proceedings. The bill provides limited exceptions such as if the information is necessary to investigate physical harm to the individual. We support the Senate Title X spending for pregnancy and family planning over the Houses bill, which eliminates funding in its bill. Primary Care and the Physician Workforce: Urged members of Congress to cosponsor and pass H.R. 2389, the Resident Physician Shortage Reduction Act of 2023, which increases the number of Medicare supported direct graduate medical education (DGME) and indirect medical education (IME) positions by 14,000 over seven years; Support efforts of the bipartisan Senate Working Group to add 10,000 GME slots in legislation; Cosponsor and pass S. 665, the Conrad State 30 and Physician Access Reauthorization Act, to allow states to sponsor foreign-trained physicians to work in medically underserved areas in exchange for a waiver of the physicians' two-year foreign residence requirement; Cosponsor and pass H.R. 1202/S. 704, the Resident Education Deferred Interest (REDI) Act, to make it possible for residents to defer interest on their loans; Support inclusion in FY2024 appropriations legislation funding for Title VII Primary Care and Training Enhancement (PCTE) at $71 million to support and expand the pipeline for individuals training in primary care. Supported H.R.4986/S. 2577, which would refinance the interest rate for all existing federal student loans to zero percent. Further, it would cap interest rates for future student loan borrowers, while considering their financial needs. Prescription Drug Reform: Reviewed proposals to implement guidance by HHS for implementation of Inflation Reduction Act's prescription drug negotiation provisions. Supported H.R. 4895, the Lowering Drug Costs for American Families Act, to expand the number of prescription drugs which Medicare can negotiate under the Inflation Reduction Act from 20 to 50 starting in 2029. Supported H.R. 5385, the Medicare PBM Accountability Act. This legislation aims to lower the costs of prescription drugs for seniors covered by Medicare Part D and Medicare Advantage plans. It would require PBMs to submit annual reports to the Secretary of HHS on PBMs cost savings incurred from rebates, discounts, and price concessions. Supported H.R. 1352, the Increasing Access to Biosimilars Act of 2023. This legislation would encourage adoption of biosimilars in Medicare and improve biosimilar accessibility, by establishing a new pilot program - a voluntary, shared savings demonstration program - for providers of biosimilars in Medicare Part B. Supported H.R. 5386, the Cutting Copays Act. This legislation would eliminate cost-sharing for generic drugs for LIS beneficiaries, helping to incentivize the use of generic drugs. Supported H.R. 3009/S. 2362, the Drug Shortage Prevention Act of 2023, to require that manufacturers of over-the-counter and prescription drugs notify Food & Drug Administration when they are unlikely to meet demand. Social Determinants of Healthcare/DEI: Opposed the Educate Act, H.R. 7725/S. 4115, that will amend the Higher Education Act of 1965 to prohibit graduate medical schools from receiving Federal financial assistance if such schools adopt certain policies and requirements relating to diversity, equity, and inclusion. Firearm Safety: (S.117): Urged Congress to support the Handgun Permit to Purchase Act (S. 117), legislation that would authorize grants to states to support handgun purchaser licensing programs. To qualify for the grants, states must require gun purchasers to be at least the age of 2I and be subject to a criminal background check. Urged Congress to support the Bipartisan Background Checks Act, H.R. 715, and the Background Check Expansion Act, S. 494 and Ethans Law, H.R. 660 and S. 173, requiring gun owners to safely and securely store their firearms. Supported the Keep Americans Safe Act, H.R. 625 and S. 298, which would ban the importation, sale, manufacture, transfer, or possession of high-capacity gun magazines that hold more than fifteen rounds. Supported the Extreme Risk Protection Order Expansion Act, H.R. 768 and S. 247 empowering family members and law enforcement to prevent gun violence by petitioning a court to temporarily separate an at-risk individual from firearms. Supported the FY2024 funding gun violence prevention research contained in FY24 Senate Labor-HHS-Ed appropriations bill for inclusion in any final FY24 appropriations bills. Administrative Burden: Urged Congress to codify many of these proposed improvements to the prior authorization process in the reintroduced the Improving Seniors' Timely Access to Care Act, S.4532. This legislation was passed by the House in the last Congress and would reduce burdens associated with prior authorization in Medicare Advantage (MA) by: l) protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans; 2) requiring all MA plans adopt electronic prior authorization capabilities to streamline the process for prior authorization approval; and 3) standardizing the process and procedures for reporting electronic prior authorization criteria to MA plans. Urged members of Congress to cosponsor and pass H.R.2630/S. 652, the Safe Step Act, to ensure patient access to appropriate treatments based on clinical decision-making and medical necessity rather than arbitrary step therapy protocols. Data Privacy: Supported American Privacy Rights Act, H.R. 8818, nations first comprehensive federal consumer data privacy framework. Bill was considered by House Energy and Commerce and would expand data privacy protections to entities not currently subject to HIPAA privacy protections. ACP asked for provisions enabling consumers to opt-out of allowing companies to use algorithms based on their personal data, allow states to further protect their residents and fully inform subjects of the nature and risks of the research. Scope of Practice: Opposed the Equitable Community Access to Pharmacist Services Act, H.R. 1770/ S. 2477, which would expand Medicare coverage to permanently include select services provided by a pharmacist. Healthcare Worker Safety: Supported H.R. 6364, the Medicare Telehealth Privacy Act of 2023. This bill would ensure that HHS will not publicly post the addresses of participating telehealth practitioners to provide privacy protections for physicians so that they can effectively treat and care for patients via telehealth. Clinical Labs: Supported the provision in H.R. 6366 that would delay payment reductions and data reporting periods for the Clinical Laboratory Fee Schedule under the Protecting Access to Medicare Act (PAMA). Legislation could improve patient access to laboratory tests used to diagnose, monitor, prevent, and manage diseases for Medicare beneficiaries. Cures 2.0: Reviewed and supported Cures 2.0 legislation.

Client expense: $242,106 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

Expand Patient Access and Telehealth: Urged Congress to pass H.R.2630/S. 652, the Safe Step Act, which requires insurers to implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol. The bill lays out five exceptions to fail first protocols and requires that a group health plan grant an exemption. Pharmacy Benefit Managers (PBMs) and group health insurers have developed a series of price management tools to curb the rising cost of prescription drugs. Supported H.R. 2829, the Chronic Care Management Improvement Act of 2023, that would remove the co-pay charged to patients who utilize chronic care management services. It would waive the beneficiary coinsurance to manage chronic care conditions and improve patients health. Supported the Protecting Rural Telehealth Access Act, H.R. 3440 and S. 1636. This bipartisan legislation would ensure rural and underserved community healthcare providers can permanently offer telehealth services, including audio-only telehealth appointments, that are set to expire in December 2024. The legislation would: 1) allow payment parity for audio-only health services for clinically appropriate appointments; 2) permanently waive the geographic restriction allowing patients to be treated from their homes; 3) permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services; 4) lift the restrictions on store and forward technologies for telehealth; and 5) allow Critical Access Hospitals (CAHs) to directly bill for telehealth services. Supported the Preserving Telehealth, Hospital, and Ambulance Access Act, which would extend these flexibilities for two years until the end of 2026. Also supported the Protecting Rural Telehealth Access Act, H.R. 3440, and the Telehealth Modernization Act of 2024, H.R. 7623, which facilitate access to care via telehealth permanently. Supported CONNECT for Health Act of 2023, H.R. 4189 and S. 2016, to permanently remove all geographic restrictions on telehealth services and expand originating sites to include the home and other sites. That legislation would: 1) help providers transition to the goals of the Medicare Access and CHIP Reauthorization Act (MACRA) and the Merit-based Incentive Payment System (MIPS) through using telehealth and remote patient monitoring (RPM) without most of the 42 U.S.C. Section 1834(m) telehealth restrictions; 2) allow telehealth and RPM to be used by qualifying participants in alternative payment models, without most of the 1834(m) restrictions; 3) permit the use of remote patient monitoring for certain patients with chronic conditions; 4) allow, as originating sites, telestroke evaluation and management sites, Native American health service facilities, and dialysis facilities for home dialysis patients in certain cases; and 5) permit further telehealth and RPM in community health centers and rural health clinics. Medicare Payments to Physicians (H.R. 2474): Urged Congress to pass H.R. 2474, the Strengthening Medicare for Patients and Providers Act, which preserves access to care for Medicare beneficiaries by providing an annual inflation update equal to the Medicare Economic Index (MEI) for Medicare physician payments. Unlike other health care sectors, Medicare payment rates for physicians have not been updated based on the MEI. As a result, from 2001 to 2021, Medicare physician payments have decreased by 20 percent when adjusted for inflation. Supported H.R. 6545, the Physician Fee Schedule Update and Improvements Act before the House Energy and Commerce Committee. This bill includes an important provision that would allocate 3 percent to the 2024 Medicare conversion factor, which would represent a 1.75 percent increase to the approved level. H.R. 6545 also includes several provisions from H.R. 6371, the Provider Reimbursement Stability Act of 2023, that ACP supports. It would raise the budget neutrality threshold to $53 million and would use cumulative increases in the Medicare Economic Index (MEI) to update the threshold every five years afterwards. Supported H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023. That bill averts a 3.4 percent across-the-board cut to physician payment for 2024. ACP supports a similar bill, S. 5035, introduced by Sen. Boozman. ACP supported extending the work geographic practice costs index to improve the accuracy of geographic adjustment factors. Supported H.R. 6366 that would extend the work geographic practice costs index for another year to 1.00 for any locality where the index would be less than 1.00. We support aspects of legislation recently introduced by Senators Whitehouse and Cassidy, the Pay Primary Care Physicians (PCPs) Act, S. 4338, that would expand and accelerate the adoption of a hybrid per member per month (PMPM) payment model outside of the PFS. We believe this type of model can enhance innovation and improve the delivery of chronic care in primary care practices. ACP supported Dr. Michael C. Burgess Preventive Health Savings Act, H.R. 766, to enable CBO to capture cost-savings associated with preventive health care legislation beyond existing 10-year window, for two additional 10-year periods. Support Value-Based Care: Urged support of the Value in Health Care Act of 2023. The bill provides a multi-year commitment to reforming care delivery by extending MACRAs 5 percent advanced alternative payment models (APM) incentives that are scheduled to expire at the end of the year. It also gives the Centers for Medicare & Medicaid Services (CMS) authority to adjust APM qualifying thresholds so that the current one-size-fits-all approach does not serve as a disincentive to including rural, underserved, primary care or specialty practices in APMs. The bill removes revenue-based distinctions that disadvantage rural and safety net providers, which is critical to improving access to care and improving health equity. The bill also improves financial benchmarks so that APM participants are not penalized for their own success. To allow more clinicians to continue the transition to value, the bill establishes a voluntary track for accountable care organizations (ACOs) in the Medicare Shared Savings Program to take on higher levels of risk and provides technical assistance for clinicians new to APMs. Lastly, the bill seeks to provide parity between APMs and the Medicare Advantage (MA) program by studying ways to increase alignment that will ease burdens on physicians and ensure that both APMs and MA are attractive and sustainable options. ACP supports extending incentive payments for participation in eligible alternative payment models through 2026. This approach would help to maintain incentives that support physicians transition from a volume-based fee-for-service health care system to one that is based on the value and quality outcomes of health care delivered to the patient. Supported H.R. 6369 by Rep. Kim Schrier to extend incentive payments for participation in eligible alternative payment models. ACP supports H.R. 5395, the SURS Extension Act, which would extend the Quality Payment Program-Small Practice, Underserved, and Rural Support (QPP-SURS) program for fiscal years 2024-2029. This program was established under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and has provided direct assistance to eligible clinicians required to participate in MIPS. ACP supports efforts to streamline the number of quality measures physicians must report on and enhance stakeholder engagement. Supported the Fewer Burdens for Better Care Act of 2023, which would emphasize multi-stakeholder input, with a 30-day comment period for stakeholders to comment on the removal of measures from the Medicare program. Pricing Transparency/Consolidation: Supported several provisions of H.R. 5378, Lower Costs, More Transparency Act, which are consistent with our policy and would improve access to and affordability of health care for patients. This bill brings together H.R. 4822, Health Care Price Transparency Act of 2023, H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023 and other related bills reported out of Ways and Means, Energy and Commerce and Education and Workforce Committees. Supported requiring disclosure of changes in hospital or health facility ownership to reveal when private equity firms acquire hospitals, larger physician practices or nursing homes, promote price transparency among hospitals, health plans and pharmacy benefit managers and promote site neutrality for Medicare and Medicare beneficiaries. We further supported the reauthorization and funding increases included for the Teaching Health Center Graduate Medical Education program, Community Health Center program and National Health Service Corps. Supported Section 4 of H.R. 2880, the Protecting Patients Against PBM Abuses Act, which aims to increase PBM data reporting to enhance transparency for Medicare Part D. Specifically, it would set out new requirements for PBMs to report data on rebates and administrative fees to HHS. It would also require that HHS deidentify the data and make it publicly available so that policy makers and the public will have a better understanding of how rebates and administrative fees impact the costs of drug plans. The Affordable Care Act (P.L. 111-148, P.L. 111-152): Urged legislation to extend permanently the premium tax subsidies afforded under the ACA. Supported H.R. 1692, the Health Care Affordability Act of 2023, by Rep. Underwood to permanently extend the premium tax credit subsidies under the ACA. The law provides consumers with subsidies (premium tax credits) that lower costs for households with incomes between 100 percent and 400 percent of the federal poverty level (FPL). It expands the Medicaid program to cover all adults with income below 138 percent of the FPL. Supportive of S. 8, Improving Health Insurance Affordability Act to expand the eligibility of taxpayers for the refundable tax credit for coverage under a qualified health plan and increase cost-sharing subsidies under the ACA. We support similar legislation introduced by Sen. Shaheen in the Senate. FY2025 Appropriations: Urged Congress to support funding for the Centers for Disease Control and Prevention's programs in the FY 2025 Labor, Health and Human Services, Education and Related Agencies Appropriations bill as well as funding shared evenly between the U.S. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to conduct public health research into firearm morbidity and mortality prevention. Advocated for funding for the Health Resources Services Administration (HRSA); Title Vi, Section 747, Primary Care Training and Enhancement (PCTE), Health Resources and Services Administration (HRSA); National Health Service Corps (NHSC); Agency for Healthcare Research and Quality (AHRQ); the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH). Urged Congress to include report language in the FY2025 Labor HHS appropriations bill to direct the GAO to conduct a study encompassing the last decade of CMS estimates of new and revised code utilizations. ACP believes CMS has overestimated utilizations, thus adversely affecting available funds in the Medicare physician fee schedule for other code usage. While the House and Senate bills included language, we prefer the stronger House version language. Urged Congress to support year-end Continuing Resolution (CR) that contained PBM reform, averting Medicare physician payment cuts by 2.5%, provided bonus payment to physicians participating in APMs, and extended telehealth flexibilities adopted during the COVID-19 pandemic for 2 years. Also advocated that streamlined prior authorization process for Medicare Advantage plans be included in the CR. Women's Health: Urged HHS to support Title X funding and ensure unencumbered access to affordable, comprehensive, evidence-based reproductive health care; eliminate medically unnecessary restrictions and inappropriate political interference in the patient-physician relationship; and protect funding for and ensures consistent treatment of qualified service sites. Supported H.R. 459 and S. 323, the Secure Access for Essential Reproductive (SAFER) Health Act. This legislation would strengthen current health privacy laws to ensure that abortion-related health data cannot be shared without patient consent. It prohibits health care providers and insurance plans from disclosing in legal proceedings an individual's personal health information related to an abortion or pregnancy without the individual's valid authorization. The prohibition applies to federal, state, local, and tribal proceedings, including civil, criminal, administrative, and legislative proceedings. The bill provides limited exceptions such as if the information is necessary to investigate physical harm to the individual. We support the Senate Title X spending for pregnancy and family planning over the Houses bill, which eliminates funding in its bill. Primary Care and the Physician Workforce: Urged members of Congress to cosponsor and pass H.R. 2389, the Resident Physician Shortage Reduction Act of 2023, which increases the number of Medicare supported direct graduate medical education (DGME) and indirect medical education (IME) positions by 14,000 over seven years; Support efforts of the bipartisan Senate Working Group to add 10,000 GME slots in legislation; Cosponsor and pass S. 665, the Conrad State 30 and Physician Access Reauthorization Act, to allow states to sponsor foreign-trained physicians to work in medically underserved areas in exchange for a waiver of the physicians' two-year foreign residence requirement; Cosponsor and pass H.R. 1202/S. 704, the Resident Education Deferred Interest (REDI) Act, to make it possible for residents to defer interest on their loans; Support inclusion in FY2024 appropriations legislation funding for Title VII Primary Care and Training Enhancement (PCTE) at $71 million to support and expand the pipeline for individuals training in primary care. Supported H.R.4986/S. 2577, which would refinance the interest rate for all existing federal student loans to zero percent. Further, it would cap interest rates for future student loan borrowers, while considering their financial needs. Prescription Drug Reform: Reviewed proposals to implement guidance by HHS for implementation of Inflation Reduction Act's prescription drug negotiation provisions. Supported H.R. 4895, the Lowering Drug Costs for American Families Act, to expand the number of prescription drugs which Medicare can negotiate under the Inflation Reduction Act from 20 to 50 starting in 2029. Supported H.R. 5385, the Medicare PBM Accountability Act. This legislation aims to lower the costs of prescription drugs for seniors covered by Medicare Part D and Medicare Advantage plans. It would require PBMs to submit annual reports to the Secretary of HHS on PBMs cost savings incurred from rebates, discounts, and price concessions. Supported H.R. 1352, the Increasing Access to Biosimilars Act of 2023. This legislation would encourage adoption of biosimilars in Medicare and improve biosimilar accessibility, by establishing a new pilot program - a voluntary, shared savings demonstration program - for providers of biosimilars in Medicare Part B. Supported H.R. 5386, the Cutting Copays Act. This legislation would eliminate cost-sharing for generic drugs for LIS beneficiaries, helping to incentivize the use of generic drugs. Supported H.R. 3009/S. 2362, the Drug Shortage Prevention Act of 2023, to require that manufacturers of over-the-counter and prescription drugs notify Food & Drug Administration when they are unlikely to meet demand. Social Determinants of Healthcare/DEI: Opposed the Educate Act, H.R. 7725/S. 4115, that will amend the Higher Education Act of 1965 to prohibit graduate medical schools from receiving Federal financial assistance if such schools adopt certain policies and requirements relating to diversity, equity, and inclusion. Firearm Safety: (S.117): Urged Congress to support the Handgun Permit to Purchase Act (S. 117), legislation that would authorize grants to states to support handgun purchaser licensing programs. To qualify for the grants, states must require gun purchasers to be at least the age of 2I and be subject to a criminal background check. Urged Congress to support the Bipartisan Background Checks Act, H.R. 715, and the Background Check Expansion Act, S. 494 and Ethans Law, H.R. 660 and S. 173, requiring gun owners to safely and securely store their firearms. Supported the Keep Americans Safe Act, H.R. 625 and S. 298, which would ban the importation, sale, manufacture, transfer, or possession of high-capacity gun magazines that hold more than fifteen rounds. Supported the Extreme Risk Protection Order Expansion Act, H.R. 768 and S. 247 empowering family members and law enforcement to prevent gun violence by petitioning a court to temporarily separate an at-risk individual from firearms. Supported the FY2024 funding gun violence prevention research contained in FY24 Senate Labor-HHS-Ed appropriations bill for inclusion in any final FY24 appropriations bills. Administrative Burden: Urged Congress to codify many of these proposed improvements to the prior authorization process in the reintroduced the Improving Seniors' Timely Access to Care Act, S.4532. This legislation was passed by the House in the last Congress and would reduce burdens associated with prior authorization in Medicare Advantage (MA) by: l) protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans; 2) requiring all MA plans adopt electronic prior authorization capabilities to streamline the process for prior authorization approval; and 3) standardizing the process and procedures for reporting electronic prior authorization criteria to MA plans. Urged members of Congress to cosponsor and pass H.R.2630/S. 652, the Safe Step Act, to ensure patient access to appropriate treatments based on clinical decision-making and medical necessity rather than arbitrary step therapy protocols. Data Privacy: Supported American Privacy Rights Act, H.R. 8818, nations first comprehensive federal consumer data privacy framework. Bill was considered by House Energy and Commerce and would expand data privacy protections to entities not currently subject to HIPAA privacy protections. ACP asked for provisions enabling consumers to opt-out of allowing companies to use algorithms based on their personal data, allow states to further protect their residents and fully inform subjects of the nature and risks of the research. Scope of Practice: Opposed the Equitable Community Access to Pharmacist Services Act, H.R. 1770/ S. 2477, which would expand Medicare coverage to permanently include select services provided by a pharmacist. Healthcare Worker Safety: Supported H.R. 6364, the Medicare Telehealth Privacy Act of 2023. This bill would ensure that HHS will not publicly post the addresses of participating telehealth practitioners to provide privacy protections for physicians so that they can effectively treat and care for patients via telehealth. Clinical Labs: Supported the provision in H.R. 6366 that would delay payment reductions and data reporting periods for the Clinical Laboratory Fee Schedule under the Protecting Access to Medicare Act (PAMA). Legislation could improve patient access to laboratory tests used to diagnose, monitor, prevent, and manage diseases for Medicare beneficiaries. Cures 2.0: Reviewed and supported Cures 2.0 legislation.

Client expense: $124,919 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

Congressional outreach and monitoring regarding the following: -Healthcare and hospital workforce budget and appropriations, generally; -340B Drug Discount Program & HRSA/CMS policies; -CMS Wage Index; -Medicare reimbursement rates, generally; -H.R. 2584 / S. 2768, Safety From Violence for Healthcare Employees Act; -H.R.4895, Lowering Drug Costs for American Families Act; -H.R. 7635 / S. 3922, The 340B PATIENTS Act of 2024.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and 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. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act 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. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 5021: The 340B PATIENTS Act of 2024 BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Health Equity Inflation Reduction Act of 2022 (P.L. 117-169), Implementation IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $1,540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; 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. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R.7535, Prescription Drug Supply Chain Pricing Transparency Act; S. 2780, Medication Affordability and Patent Integrity Act; S. 2305, Biosimilar Red Tape Elimination Act; H.R. 6986/S.3583, to address patent thickets; H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); H.R. 8574, 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act); S.150, the Affordable Prescription Drug for Patients Act; S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.

Client expense: $1,720,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $740,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act S. 476/H.R. 5547: Maintaining Investments in New Innovation 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. 142: Preserve Access to Affordable Generics and Biosimilars Act PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Average Manufacturers Price Calculations Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products 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. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) In-Home Administration of Part B Drugs Lower Costs, More Cures Act National Coverage Determination Protected Classes Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-Based Purchasing (VBP) Rule H.R. 3421: Medicare for All Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544/H.R. 1199: Facilitating Innovative Nuclear Diagnostics Act of 2023

Client expense: $740,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

HR 830/S 1375 - HELP Copays Act S 127 - Pharmacy Benefit Manager Transparency Act HR 2630/ S 652 - Safe Step Act HR 1770/S 2477 - Equitable Community Access to Pharmacist Services Act HR 2407/S 2085 - Medicare Multi-Cancer Early Detection Screening Coverage Act S 1246/HR 4895 - SMART Prices Act HR 4818/S 2407 - Treat and Reduce Obesity Act of 2023 Continuation of the Inflation Reduction Act Discussions regarding Health ACCESS Act (Health Accelerating Consumers Care by Expediting Self-Scheduling)

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

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 ---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)

Client expense: $1,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

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)

Client expense: $1,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

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. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and 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. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act 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. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 5021: 340B PATIENTS Act of 2024 BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Artificial intelligence policy issues Cybersecurity policy issues

Client expense: $6,880,000 · Firm income: Not reported

Government targets: Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

Prescription drug industry issues relating to domestic construction and maintenance, and prescription drug pricing S.127 - Pharmacy Benefit Manager Transparency Act of 2023; S.113 - Prescription Pricing for the People Act of 2023; H.R.830 - HELP Copays Act; S. 1542 - Delinking Revenue from Unfair Gouging Act (a/k/a The DRUG Act"); HR 4895 - H.R. 4895: Lowering Drug Costs for American Families Act; H.R. 2880: Protecting Patients Against PBM Abuses Act; HR 6283 - The Drug Act; HR 5378 - Lower Costs, More Transparency Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 4724, HR 9101- 9/11 Responder and Survivor Health Funding Correction Act of 2024 HR 5378- Lower Costs, More Transparency Act HR 4895- Lowering Drug Costs for American Families HR 5796- Protecting Rural Seniors Access to Care Act HR 7513- Protecting America's Seniors Access to Care Act HR 485- Protecting Health Care for All Patients Act S 3679- Lorna Breen Health Care Provider Protection Reauthorization Act HJ Res 139, SJ Res 91- CRA to rescind nursing home staffing rule HR 468, HR 9067- Building America's Health Care Workforce Act HR 3227- Ensuring Seniors' Access to Quality Care Act HJ Res 181- CRA to rescind the Association Health Plan Rule S 4671- Capping Prescription Costs Act S 4804, HR 9156- Health Over Wealth Act

Client expense: $720,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription drug industry issues relating to domestic construction and maintenance, prescription drug pricing, supply chain issues and employment issues, generally; S.127 - Pharmacy Benefit Manager Transparency Act of 2023; S.113 - Prescription Pricing for the People Act of 2023; H.R.830 - HELP Copays Act; S. 1542 - Delinking Revenue from Unfair Gouging Act (a/k/a The DRUG Act"); HR 4895 - H.R. 4895: Lowering Drug Costs for American Families Act; H.R. 2880: Protecting Patients Against PBM Abuses Act; HR 6283 - The Drug Act; HR 5378 - Lower Costs, More Transparency Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Expand Patient Access and Telehealth: Urged Congress to pass H.R.2630/S. 652, the Safe Step Act, which requires insurers to implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol. The bill lays out five exceptions to fail first protocols and requires that a group health plan grant an exemption. Pharmacy Benefit Managers (PBMs) and group health insurers have developed a series of price management tools to curb the rising cost of prescription drugs. Supported H.R. 2829, the Chronic Care Management Improvement Act of 2023, that would remove the co-pay charged to patients who utilize chronic care management services. It would waive the beneficiary coinsurance to manage chronic care conditions and improve patients health. Supported the Protecting Rural Telehealth Access Act, H.R. 3440 and S. 1636. This bipartisan legislation would ensure rural and underserved community healthcare providers can permanently offer telehealth services, including audio-only telehealth appointments, that are set to expire in December 2024. The legislation would: 1) allow payment parity for audio-only health services for clinically appropriate appointments; 2) permanently waive the geographic restriction allowing patients to be treated from their homes; 3) permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services; 4) lift the restrictions on store and forward technologies for telehealth; and 5) allow Critical Access Hospitals (CAHs) to directly bill for telehealth services. Supported the Preserving Telehealth, Hospital, and Ambulance Access Act, which would extend these flexibilities for two years until the end of 2026. Also supported the Protecting Rural Telehealth Access Act, H.R. 3440, and the Telehealth Modernization Act of 2024, H.R. 7623, which facilitate access to care via telehealth permanently. Supported CONNECT for Health Act of 2023, H.R. 4189 and S. 2016, to permanently remove all geographic restrictions on telehealth services and expand originating sites to include the home and other sites. That legislation would: 1) help providers transition to the goals of the Medicare Access and CHIP Reauthorization Act (MACRA) and the Merit-based Incentive Payment System (MIPS) through using telehealth and remote patient monitoring (RPM) without most of the 42 U.S.C. Section 1834(m) telehealth restrictions; 2) allow telehealth and RPM to be used by qualifying participants in alternative payment models, without most of the 1834(m) restrictions; 3) permit the use of remote patient monitoring for certain patients with chronic conditions; 4) allow, as originating sites, telestroke evaluation and management sites, Native American health service facilities, and dialysis facilities for home dialysis patients in certain cases; and 5) permit further telehealth and RPM in community health centers and rural health clinics. Medicare Payments to Physicians (H.R. 2474): Urged Congress to pass H.R. 2474, the Strengthening Medicare for Patients and Providers Act, which preserves access to care for Medicare beneficiaries by providing an annual inflation update equal to the Medicare Economic Index (MEI) for Medicare physician payments. Unlike other health care sectors, Medicare payment rates for physicians have not been updated based on the MEI. As a result, from 2001 to 2021, Medicare physician payments have decreased by 20 percent when adjusted for inflation. Supported H.R. 6545, the Physician Fee Schedule Update and Improvements Act before the House Energy and Commerce Committee. This bill includes an important provision that would allocate 3 percent to the 2024 Medicare conversion factor, which would represent a 1.75 percent increase to the approved level. H.R. 6545 also includes several provisions from H.R. 6371, the Provider Reimbursement Stability Act of 2023, that ACP supports. It would raise the budget neutrality threshold to $53 million and would use cumulative increases in the Medicare Economic Index (MEI) to update the threshold every five years afterwards. Supported H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023. That bill averts a 3.4 percent across-the-board cut to physician payment for 2024. ACP supports a similar bill, S. 5035, introduced by Sen. Boozman. ACP supported extending the work geographic practice costs index to improve the accuracy of geographic adjustment factors. Supported H.R. 6366 that would extend the work geographic practice costs index for another year to 1.00 for any locality where the index would be less than 1.00. We support aspects of legislation recently introduced by Senators Whitehouse and Cassidy, the Pay Primary Care Physicians (PCPs) Act, S. 4338, that would expand and accelerate the adoption of a hybrid per member per month (PMPM) payment model outside of the PFS. We believe this type of model can enhance innovation and improve the delivery of chronic care in primary care practices. ACP supported the Dr. Michael C. Burgess Preventive Health Savings Act, H.R. 766, to enable CBO to capture cost-savings associated with preventive health care legislation beyond existing 10-year window, for two additional 10-year periods. Support Value-Based Care: Urged support of the Value in Health Care Act of 2023. The bill provides a multi-year commitment to reforming care delivery by extending MACRAs 5 percent advanced alternative payment models (APM) incentives that are scheduled to expire at the end of the year. It also gives the Centers for Medicare & Medicaid Services (CMS) authority to adjust APM qualifying thresholds so that the current one-size-fits-all approach does not serve as a disincentive to including rural, underserved, primary care or specialty practices in APMs. The bill removes revenue-based distinctions that disadvantage rural and safety net providers, which is critical to improving access to care and improving health equity. The bill also improves financial benchmarks so that APM participants are not penalized for their own success. To allow more clinicians to continue the transition to value, the bill establishes a voluntary track for accountable care organizations (ACOs) in the Medicare Shared Savings Program to take on higher levels of risk and provides technical assistance for clinicians new to APMs. Lastly, the bill seeks to provide parity between APMs and the Medicare Advantage (MA) program by studying ways to increase alignment that will ease burdens on physicians and ensure that both APMs and MA are attractive and sustainable options. ACP supports extending incentive payments for participation in eligible alternative payment models through 2026. This approach would help to maintain incentives that support physicians transition from a volume-based fee-for-service health care system to one that is based on the value and quality outcomes of health care delivered to the patient. Supported H.R. 6369 by Rep. Kim Schrier to extend incentive payments for participation in eligible alternative payment models. ACP supports H.R. 5395, the SURS Extension Act, which would extend the Quality Payment Program-Small Practice, Underserved, and Rural Support (QPP-SURS) program for fiscal years 2024-2029. This program was established under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and has provided direct assistance to eligible clinicians required to participate in MIPS. ACP supports efforts to streamline the number of quality measures physicians must report on and enhance stakeholder engagement. Supported the Fewer Burdens for Better Care Act of 2023, which would emphasize multi-stakeholder input, with a 30-day comment period for stakeholders to comment on the removal of measures from the Medicare program. Pricing Transparency/Consolidation: Supported several provisions of H.R. 5378, Lower Costs, More Transparency Act, which are consistent with our policy and would improve access to and affordability of health care for patients. This bill brings together H.R. 4822, Health Care Price Transparency Act of 2023, H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023 and other related bills reported out of Ways and Means, Energy and Commerce and Education and Workforce Committees. Supported requiring disclosure of changes in hospital or health facility ownership to reveal when private equity firms acquire hospitals, larger physician practices or nursing homes, promote price transparency among hospitals, health plans and pharmacy benefit managers and promote site neutrality for Medicare and Medicare beneficiaries. We further supported the reauthorization and funding increases included for the Teaching Health Center Graduate Medical Education program, Community Health Center program and National Health Service Corps. Supported Section 4 of H.R. 2880, the Protecting Patients Against PBM Abuses Act, which aims to increase PBM data reporting to enhance transparency for Medicare Part D. Specifically, it would set out new requirements for PBMs to report data on rebates and administrative fees to HHS. It would also require that HHS deidentify the data and make it publicly available so that policy makers and the public will have a better understanding of how rebates and administrative fees impact the costs of drug plans. The Affordable Care Act (P.L. 111-148, P.L. 111-152): Urged legislation to extend permanently the premium tax subsidies afforded under the ACA. Supported H.R. 1692, the Health Care Affordability Act of 2023, by Rep. Underwood to permanently extend the premium tax credit subsidies under the ACA. The law provides consumers with subsidies (premium tax credits) that lower costs for households with incomes between 100 percent and 400 percent of the federal poverty level (FPL). It expands the Medicaid program to cover all adults with income below 138 percent of the FPL. Supportive of S. 8, Improving Health Insurance Affordability Act to expand the eligibility of taxpayers for the refundable tax credit for coverage under a qualified health plan and increase cost-sharing subsidies under the ACA. We support similar legislation introduced by Sen. Shaheen in the Senate. FY2025 Appropriations: Urged Congress to support funding for the Centers for Disease Control and Prevention's programs in the FY 2025 Labor, Health and Human Services, Education and Related Agencies Appropriations bill as well as funding shared evenly between the U.S. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to conduct public health research into firearm morbidity and mortality prevention. Advocated for funding for the Health Resources Services Administration (HRSA); Title Vi, Section 747, Primary Care Training and Enhancement (PCTE), Health Resources and Services Administration (HRSA); National Health Service Corps (NHSC); Agency for Healthcare Research and Quality (AHRQ); the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH). Urged Congress to include report language in the FY2025 Labor HHS appropriations bill to direct the GAO to conduct a study encompassing the last decade of CMS estimates of new and revised code utilizations. ACP believes CMS has overestimated utilizations, thus adversely affecting available funds in the Medicare physician fee schedule for other code usage. While the House and Senate bills included language, we prefer the stronger House version language. Women's Health: Urged HHS to support Title X funding and ensure unencumbered access to affordable, comprehensive, evidence-based reproductive health care; eliminate medically unnecessary restrictions and inappropriate political interference in the patient-physician relationship; and protect funding for and ensures consistent treatment of qualified service sites. Supported H.R. 459 and S. 323, the Secure Access for Essential Reproductive (SAFER) Health Act. This legislation would strengthen current health privacy laws to ensure that abortion-related health data cannot be shared without patient consent. It prohibits health care providers and insurance plans from disclosing in legal proceedings an individual's personal health information related to an abortion or pregnancy without the individual's valid authorization. The prohibition applies to federal, state, local, and tribal proceedings, including civil, criminal, administrative, and legislative proceedings. The bill provides limited exceptions such as if the information is necessary to investigate physical harm to the individual. We support the Senate Title X spending for pregnancy and family planning over the Houses bill, which eliminates funding in its bill. Primary Care and the Physician Workforce: Urged members of Congress to cosponsor and pass H.R. 2389, the Resident Physician Shortage Reduction Act of 2023, which increases the number of Medicare supported direct graduate medical education (DGME) and indirect medical education (IME) positions by 14,000 over seven years; Support efforts of the bipartisan Senate Working Group to add 10,000 GME slots in legislation; Cosponsor and pass S. 665, the Conrad State 30 and Physician Access Reauthorization Act, to allow states to sponsor foreign-trained physicians to work in medically underserved areas in exchange for a waiver of the physicians' two-year foreign residence requirement; Cosponsor and pass H.R. 1202/S. 704, the Resident Education Deferred Interest (REDI) Act, to make it possible for residents to defer interest on their loans; Support inclusion in FY2024 appropriations legislation funding for Title VII Primary Care and Training Enhancement (PCTE) at $71 million to support and expand the pipeline for individuals training in primary care. Supported H.R.4986/S. 2577, which would refinance the interest rate for all existing federal student loans to zero percent. Further, it would cap interest rates for future student loan borrowers, while considering their financial needs. Prescription Drug Reform: Reviewed proposals to implement guidance by HHS for implementation of Inflation Reduction Act's prescription drug negotiation provisions. Supported H.R. 4895, the Lowering Drug Costs for American Families Act, to expand the number of prescription drugs which Medicare can negotiate under the Inflation Reduction Act from 20 to 50 starting in 2029. Supported H.R. 5385, the Medicare PBM Accountability Act. This legislation aims to lower the costs of prescription drugs for seniors covered by Medicare Part D and Medicare Advantage plans. It would require PBMs to submit annual reports to the Secretary of HHS on PBMs cost savings incurred from rebates, discounts, and price concessions. Supported H.R. 1352, the Increasing Access to Biosimilars Act of 2023. This legislation would encourage adoption of biosimilars in Medicare and improve biosimilar accessibility, by establishing a new pilot program - a voluntary, shared savings demonstration program - for providers of biosimilars in Medicare Part B. Supported H.R. 5386, the Cutting Copays Act. This legislation would eliminate cost-sharing for generic drugs for LIS beneficiaries, helping to incentivize the use of generic drugs. Supported H.R. 3009/S. 2362, the Drug Shortage Prevention Act of 2023, to require that manufacturers of over-the-counter and prescription drugs notify Food & Drug Administration when they are unlikely to meet demand. Social Determinants of Healthcare/DEI: Opposed the Educate Act, H.R. 7725/S. 4115, that will amend the Higher Education Act of 1965 to prohibit graduate medical schools from receiving Federal financial assistance if such schools adopt certain policies and requirements relating to diversity, equity, and inclusion. Firearm Safety: (S.117): Urged Congress to support the Handgun Permit to Purchase Act (S. 117), legislation that would authorize grants to states to support handgun purchaser licensing programs. To qualify for the grants, states must require gun purchasers to be at least the age of 2I and be subject to a criminal background check. Urged Congress to support the Bipartisan Background Checks Act, H.R. 715, and the Background Check Expansion Act, S. 494 and Ethans Law, H.R. 660 and S. 173, requiring gun owners to safely and securely store their firearms. Supported the Keep Americans Safe Act, H.R. 625 and S. 298, which would ban the importation, sale, manufacture, transfer, or possession of high-capacity gun magazines that hold more than fifteen rounds. Supported the Extreme Risk Protection Order Expansion Act, H.R. 768 and S. 247 empowering family members and law enforcement to prevent gun violence by petitioning a court to temporarily separate an at-risk individual from firearms. Supported the FY2024 funding gun violence prevention research contained in FY24 Senate Labor-HHS-Ed appropriations bill for inclusion in any final FY24 appropriations bills. Administrative Burden: Urged Congress to codify many of these proposed improvements to the prior authorization process in the reintroduced the Improving Seniors' Timely Access to Care Act, S.4532. This legislation was passed by the House in the last Congress and would reduce burdens associated with prior authorization in Medicare Advantage (MA) by: l) protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans; 2) requiring all MA plans adopt electronic prior authorization capabilities to streamline the process for prior authorization approval; and 3) standardizing the process and procedures for reporting electronic prior authorization criteria to MA plans. Urged members of Congress to cosponsor and pass H.R.2630/S. 652, the Safe Step Act, to ensure patient access to appropriate treatments based on clinical decision-making and medical necessity rather than arbitrary step therapy protocols. Data Privacy: Supported American Privacy Rights Act, H.R. 8818, nations first comprehensive federal consumer data privacy framework. Bill was considered by House Energy and Commerce and would expand data privacy protections to entities not currently subject to HIPAA privacy protections. ACP asked for provisions enabling consumers to opt-out of allowing companies to use algorithms based on their personal data, allow states to further protect their residents and fully inform subjects of the nature and risks of the research. Scope of Practice: Opposed the Equitable Community Access to Pharmacist Services Act, H.R. 1770/ S. 2477, which would expand Medicare coverage to permanently include select services provided by a pharmacist. Healthcare Worker Safety: Supported H.R. 6364, the Medicare Telehealth Privacy Act of 2023. This bill would ensure that HHS will not publicly post the addresses of participating telehealth practitioners to provide privacy protections for physicians so that they can effectively treat and care for patients via telehealth. Clinical Labs: Supported the provision in H.R. 6366 that would delay payment reductions and data reporting periods for the Clinical Laboratory Fee Schedule under the Protecting Access to Medicare Act (PAMA). Legislation could improve patient access to laboratory tests used to diagnose, monitor, prevent, and manage diseases for Medicare beneficiaries.

Client expense: $243,888 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

Expand Patient Access and Telehealth: Urged Congress to pass H.R.2630/S. 652, the Safe Step Act, which requires insurers to implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol. The bill lays out five exceptions to fail first protocols and requires that a group health plan grant an exemption. Pharmacy Benefit Managers (PBMs) and group health insurers have developed a series of price management tools to curb the rising cost of prescription drugs. Supported H.R. 2829, the Chronic Care Management Improvement Act of 2023, that would remove the co-pay charged to patients who utilize chronic care management services. It would waive the beneficiary coinsurance to manage chronic care conditions and improve patients health. Supported the Protecting Rural Telehealth Access Act, H.R. 3440 and S. 1636. This bipartisan legislation would ensure rural and underserved community healthcare providers can permanently offer telehealth services, including audio-only telehealth appointments, that are set to expire in December 2024. The legislation would: 1) allow payment parity for audio-only health services for clinically appropriate appointments; 2) permanently waive the geographic restriction allowing patients to be treated from their homes; 3) permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services; 4) lift the restrictions on store and forward technologies for telehealth; and 5) allow Critical Access Hospitals (CAHs) to directly bill for telehealth services. Supported the Preserving Telehealth, Hospital, and Ambulance Access Act, which would extend these flexibilities for two years until the end of 2026. Also supported the Protecting Rural Telehealth Access Act, H.R. 3440, and the Telehealth Modernization Act of 2024, H.R. 7623, which facilitate access to care via telehealth permanently. Supported CONNECT for Health Act of 2023, H.R. 4189 and S. 2016, to permanently remove all geographic restrictions on telehealth services and expand originating sites to include the home and other sites. That legislation would: 1) help providers transition to the goals of the Medicare Access and CHIP Reauthorization Act (MACRA) and the Merit-based Incentive Payment System (MIPS) through using telehealth and remote patient monitoring (RPM) without most of the 42 U.S.C. Section 1834(m) telehealth restrictions; 2) allow telehealth and RPM to be used by qualifying participants in alternative payment models, without most of the 1834(m) restrictions; 3) permit the use of remote patient monitoring for certain patients with chronic conditions; 4) allow, as originating sites, telestroke evaluation and management sites, Native American health service facilities, and dialysis facilities for home dialysis patients in certain cases; and 5) permit further telehealth and RPM in community health centers and rural health clinics. Medicare Payments to Physicians (H.R. 2474): Urged Congress to pass H.R. 2474, the Strengthening Medicare for Patients and Providers Act, which preserves access to care for Medicare beneficiaries by providing an annual inflation update equal to the Medicare Economic Index (MEI) for Medicare physician payments. Unlike other health care sectors, Medicare payment rates for physicians have not been updated based on the MEI. As a result, from 2001 to 2021, Medicare physician payments have decreased by 20 percent when adjusted for inflation. Supported H.R. 6545, the Physician Fee Schedule Update and Improvements Act before the House Energy and Commerce Committee. This bill includes an important provision that would allocate 3 percent to the 2024 Medicare conversion factor, which would represent a 1.75 percent increase to the approved level. H.R. 6545 also includes several provisions from H.R. 6371, the Provider Reimbursement Stability Act of 2023, that ACP supports. It would raise the budget neutrality threshold to $53 million and would use cumulative increases in the Medicare Economic Index (MEI) to update the threshold every five years afterwards. Supported H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023. That bill averts a 3.4 percent across-the-board cut to physician payment for 2024. ACP supports a similar bill, S. 5035, introduced by Sen. Boozman. ACP supported extending the work geographic practice costs index to improve the accuracy of geographic adjustment factors. Supported H.R. 6366 that would extend the work geographic practice costs index for another year to 1.00 for any locality where the index would be less than 1.00. We support aspects of legislation recently introduced by Senators Whitehouse and Cassidy, the Pay Primary Care Physicians (PCPs) Act, S. 4338, that would expand and accelerate the adoption of a hybrid per member per month (PMPM) payment model outside of the PFS. We believe this type of model can enhance innovation and improve the delivery of chronic care in primary care practices. ACP supported the Dr. Michael C. Burgess Preventive Health Savings Act, H.R. 766, to enable CBO to capture cost-savings associated with preventive health care legislation beyond existing 10-year window, for two additional 10-year periods. Support Value-Based Care: Urged support of the Value in Health Care Act of 2023. The bill provides a multi-year commitment to reforming care delivery by extending MACRAs 5 percent advanced alternative payment models (APM) incentives that are scheduled to expire at the end of the year. It also gives the Centers for Medicare & Medicaid Services (CMS) authority to adjust APM qualifying thresholds so that the current one-size-fits-all approach does not serve as a disincentive to including rural, underserved, primary care or specialty practices in APMs. The bill removes revenue-based distinctions that disadvantage rural and safety net providers, which is critical to improving access to care and improving health equity. The bill also improves financial benchmarks so that APM participants are not penalized for their own success. To allow more clinicians to continue the transition to value, the bill establishes a voluntary track for accountable care organizations (ACOs) in the Medicare Shared Savings Program to take on higher levels of risk and provides technical assistance for clinicians new to APMs. Lastly, the bill seeks to provide parity between APMs and the Medicare Advantage (MA) program by studying ways to increase alignment that will ease burdens on physicians and ensure that both APMs and MA are attractive and sustainable options. ACP supports extending incentive payments for participation in eligible alternative payment models through 2026. This approach would help to maintain incentives that support physicians transition from a volume-based fee-for-service health care system to one that is based on the value and quality outcomes of health care delivered to the patient. Supported H.R. 6369 by Rep. Kim Schrier to extend incentive payments for participation in eligible alternative payment models. ACP supports H.R. 5395, the SURS Extension Act, which would extend the Quality Payment Program-Small Practice, Underserved, and Rural Support (QPP-SURS) program for fiscal years 2024-2029. This program was established under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and has provided direct assistance to eligible clinicians required to participate in MIPS. ACP supports efforts to streamline the number of quality measures physicians must report on and enhance stakeholder engagement. Supported the Fewer Burdens for Better Care Act of 2023, which would emphasize multi-stakeholder input, with a 30-day comment period for stakeholders to comment on the removal of measures from the Medicare program. Pricing Transparency/Consolidation: Supported several provisions of H.R. 5378, Lower Costs, More Transparency Act, which are consistent with our policy and would improve access to and affordability of health care for patients. This bill brings together H.R. 4822, Health Care Price Transparency Act of 2023, H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023 and other related bills reported out of Ways and Means, Energy and Commerce and Education and Workforce Committees. Supported requiring disclosure of changes in hospital or health facility ownership to reveal when private equity firms acquire hospitals, larger physician practices or nursing homes, promote price transparency among hospitals, health plans and pharmacy benefit managers and promote site neutrality for Medicare and Medicare beneficiaries. We further supported the reauthorization and funding increases included for the Teaching Health Center Graduate Medical Education program, Community Health Center program and National Health Service Corps. Supported Section 4 of H.R. 2880, the Protecting Patients Against PBM Abuses Act, which aims to increase PBM data reporting to enhance transparency for Medicare Part D. Specifically, it would set out new requirements for PBMs to report data on rebates and administrative fees to HHS. It would also require that HHS deidentify the data and make it publicly available so that policy makers and the public will have a better understanding of how rebates and administrative fees impact the costs of drug plans. The Affordable Care Act (P.L. 111-148, P.L. 111-152): Urged legislation to extend permanently the premium tax subsidies afforded under the ACA. Supported H.R. 1692, the Health Care Affordability Act of 2023, by Rep. Underwood to permanently extend the premium tax credit subsidies under the ACA. The law provides consumers with subsidies (premium tax credits) that lower costs for households with incomes between 100 percent and 400 percent of the federal poverty level (FPL). It expands the Medicaid program to cover all adults with income below 138 percent of the FPL. Supportive of S. 8, Improving Health Insurance Affordability Act to expand the eligibility of taxpayers for the refundable tax credit for coverage under a qualified health plan and increase cost-sharing subsidies under the ACA. We support similar legislation introduced by Sen. Shaheen in the Senate. FY2025 Appropriations: Urged Congress to support funding for the Centers for Disease Control and Prevention's programs in the FY 2025 Labor, Health and Human Services, Education and Related Agencies Appropriations bill as well as funding shared evenly between the U.S. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to conduct public health research into firearm morbidity and mortality prevention. Advocated for funding for the Health Resources Services Administration (HRSA); Title Vi, Section 747, Primary Care Training and Enhancement (PCTE), Health Resources and Services Administration (HRSA); National Health Service Corps (NHSC); Agency for Healthcare Research and Quality (AHRQ); the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH). Urged Congress to include report language in the FY2025 Labor HHS appropriations bill to direct the GAO to conduct a study encompassing the last decade of CMS estimates of new and revised code utilizations. ACP believes CMS has overestimated utilizations, thus adversely affecting available funds in the Medicare physician fee schedule for other code usage. While the House and Senate bills included language, we prefer the stronger House version language. Women's Health: Urged HHS to support Title X funding and ensure unencumbered access to affordable, comprehensive, evidence-based reproductive health care; eliminate medically unnecessary restrictions and inappropriate political interference in the patient-physician relationship; and protect funding for and ensures consistent treatment of qualified service sites. Supported H.R. 459 and S. 323, the Secure Access for Essential Reproductive (SAFER) Health Act. This legislation would strengthen current health privacy laws to ensure that abortion-related health data cannot be shared without patient consent. It prohibits health care providers and insurance plans from disclosing in legal proceedings an individual's personal health information related to an abortion or pregnancy without the individual's valid authorization. The prohibition applies to federal, state, local, and tribal proceedings, including civil, criminal, administrative, and legislative proceedings. The bill provides limited exceptions such as if the information is necessary to investigate physical harm to the individual. We support the Senate Title X spending for pregnancy and family planning over the Houses bill, which eliminates funding in its bill. Primary Care and the Physician Workforce: Urged members of Congress to cosponsor and pass H.R. 2389, the Resident Physician Shortage Reduction Act of 2023, which increases the number of Medicare supported direct graduate medical education (DGME) and indirect medical education (IME) positions by 14,000 over seven years; Support efforts of the bipartisan Senate Working Group to add 10,000 GME slots in legislation; Cosponsor and pass S. 665, the Conrad State 30 and Physician Access Reauthorization Act, to allow states to sponsor foreign-trained physicians to work in medically underserved areas in exchange for a waiver of the physicians' two-year foreign residence requirement; Cosponsor and pass H.R. 1202/S. 704, the Resident Education Deferred Interest (REDI) Act, to make it possible for residents to defer interest on their loans; Support inclusion in FY2024 appropriations legislation funding for Title VII Primary Care and Training Enhancement (PCTE) at $71 million to support and expand the pipeline for individuals training in primary care. Supported H.R.4986/S. 2577, which would refinance the interest rate for all existing federal student loans to zero percent. Further, it would cap interest rates for future student loan borrowers, while considering their financial needs. Prescription Drug Reform: Reviewed proposals to implement guidance by HHS for implementation of Inflation Reduction Act's prescription drug negotiation provisions. Supported H.R. 4895, the Lowering Drug Costs for American Families Act, to expand the number of prescription drugs which Medicare can negotiate under the Inflation Reduction Act from 20 to 50 starting in 2029. Supported H.R. 5385, the Medicare PBM Accountability Act. This legislation aims to lower the costs of prescription drugs for seniors covered by Medicare Part D and Medicare Advantage plans. It would require PBMs to submit annual reports to the Secretary of HHS on PBMs cost savings incurred from rebates, discounts, and price concessions. Supported H.R. 1352, the Increasing Access to Biosimilars Act of 2023. This legislation would encourage adoption of biosimilars in Medicare and improve biosimilar accessibility, by establishing a new pilot program - a voluntary, shared savings demonstration program - for providers of biosimilars in Medicare Part B. Supported H.R. 5386, the Cutting Copays Act. This legislation would eliminate cost-sharing for generic drugs for LIS beneficiaries, helping to incentivize the use of generic drugs. Supported H.R. 3009/S. 2362, the Drug Shortage Prevention Act of 2023, to require that manufacturers of over-the-counter and prescription drugs notify Food & Drug Administration when they are unlikely to meet demand. Social Determinants of Healthcare/DEI: Opposed the Educate Act, H.R. 7725/S. 4115, that will amend the Higher Education Act of 1965 to prohibit graduate medical schools from receiving Federal financial assistance if such schools adopt certain policies and requirements relating to diversity, equity, and inclusion. Firearm Safety: (S.117): Urged Congress to support the Handgun Permit to Purchase Act (S. 117), legislation that would authorize grants to states to support handgun purchaser licensing programs. To qualify for the grants, states must require gun purchasers to be at least the age of 2I and be subject to a criminal background check. Urged Congress to support the Bipartisan Background Checks Act, H.R. 715, and the Background Check Expansion Act, S. 494 and Ethans Law, H.R. 660 and S. 173, requiring gun owners to safely and securely store their firearms. Supported the Keep Americans Safe Act, H.R. 625 and S. 298, which would ban the importation, sale, manufacture, transfer, or possession of high-capacity gun magazines that hold more than fifteen rounds. Supported the Extreme Risk Protection Order Expansion Act, H.R. 768 and S. 247 empowering family members and law enforcement to prevent gun violence by petitioning a court to temporarily separate an at-risk individual from firearms. Supported the FY2024 funding gun violence prevention research contained in FY24 Senate Labor-HHS-Ed appropriations bill for inclusion in any final FY24 appropriations bills. Administrative Burden: Urged Congress to codify many of these proposed improvements to the prior authorization process in the reintroduced the Improving Seniors' Timely Access to Care Act, S.4532. This legislation was passed by the House in the last Congress and would reduce burdens associated with prior authorization in Medicare Advantage (MA) by: l) protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans; 2) requiring all MA plans adopt electronic prior authorization capabilities to streamline the process for prior authorization approval; and 3) standardizing the process and procedures for reporting electronic prior authorization criteria to MA plans. Urged members of Congress to cosponsor and pass H.R.2630/S. 652, the Safe Step Act, to ensure patient access to appropriate treatments based on clinical decision-making and medical necessity rather than arbitrary step therapy protocols. Data Privacy: Supported American Privacy Rights Act, H.R. 8818, nations first comprehensive federal consumer data privacy framework. Bill was considered by House Energy and Commerce and would expand data privacy protections to entities not currently subject to HIPAA privacy protections. ACP asked for provisions enabling consumers to opt-out of allowing companies to use algorithms based on their personal data, allow states to further protect their residents and fully inform subjects of the nature and risks of the research. Scope of Practice: Opposed the Equitable Community Access to Pharmacist Services Act, H.R. 1770/ S. 2477, which would expand Medicare coverage to permanently include select services provided by a pharmacist. Healthcare Worker Safety: Supported H.R. 6364, the Medicare Telehealth Privacy Act of 2023. This bill would ensure that HHS will not publicly post the addresses of participating telehealth practitioners to provide privacy protections for physicians so that they can effectively treat and care for patients via telehealth. Clinical Labs: Supported the provision in H.R. 6366 that would delay payment reductions and data reporting periods for the Clinical Laboratory Fee Schedule under the Protecting Access to Medicare Act (PAMA). Legislation could improve patient access to laboratory tests used to diagnose, monitor, prevent, and manage diseases for Medicare beneficiaries.

Client expense: $124,919 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

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. 766: Dr. Michael C. Burgess Preventive Health Savings Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1770: Equitable Community Access to Pharmacist Services Act H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program Bayh-Done march in rights policy issues H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 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. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act 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 H.R. 7024: Tax Relief for American Families and Workers Act of 2024 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 8333 BIOSECURE Act H.R.8818 American Privacy Rights Act of 2024; Provisions related to pharmaceutical industry 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. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs; Transparency provisions, Medicare Part D Delinking; Commerical Marketplace Delinking S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Vaccine provisions of the inflation reduction Act Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $1,510,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

HR 830/S 1375 - HELP Copays Act S 127 - Pharmacy Benefit Manager Transparency Act HR 2630/ S 652 - Safe Step Act HR 1770/S 2477 - Equitable Community Access to Pharmacist Services Act HR 2407/S 2085 - Medicare Multi-Cancer Early Detection Screening Coverage Act S 1246/HR 4895 - SMART Prices Act HR 4818/S 2407 - Treat and Reduce Obesity Act of 2023 Continuation of the Inflation Reduction Act

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; 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. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act; H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R.7535, Prescription Drug Supply Chain Pricing Transparency Act; H.R. 6986/S.3583, to address patent thickets; S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act); H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); H.R. 8574, 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act; S.150, the Affordable Prescription Drug for Patients Act; S. 148, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act); S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.

Client expense: $2,200,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 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. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act 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 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act 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. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $6,960,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Government Accountability Office (GAO), 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)

Client expense: $1,790,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

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)

Client expense: $1,790,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), 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

S 4445- The Right to IVF Act HR 6283- Delinking Revenue from Unfair Gouging (DRUG) Act HR 5378- Lower Costs, More Transparency Act HR 4895- Lowering Drug Costs for American Families HR 5796- Protecting Rural Seniors Access to Care Act HR 7513- Protecting America's Seniors Access to Care Act HR 485- Protecting Care for All Patients Care Act S 3679- Lorna Breen Health Care Provider Protection Reauthorization Act HJ Res 139, SJ Res 91- CRA to rescind nursing home staffing rule

Client expense: $680,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340 Drug Discount Program 340B Accountability Act PROTECT 340B Act H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act H.R. 4895: Lowering Drug Costs for American Families Act H.R. 5539: ORPHAN Cures Act H.R. 6283: DRUG Act S. 476/H.R. 5547: Maintaining Investments in New Innovation 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 PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Average Manufacturers Price Calculations Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products 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. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) In-Home Administration of Part B Drugs Lower Costs, More Cures Act National Coverage Determination Protected Classes Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-Based Purchasing (VBP) Rule H.R. 3421: Medicare for All Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544 - 118th Congress (2023-2024) Facilitating Innovative Nuclear Diagnostics Act of 2023 H.R.1199 - 118th Congress (2023-2024) Facilitating Innovative Nuclear Diagnostics Act of 2023

Client expense: $1,010,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

340B Drug Discount Program - 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight 340B Drug Discount Program - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B 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 COVID-19 Pricing Related Provisions 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 H.R. 5378: Lower Costs, More Transparency Act CMMI Authority 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 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program 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

Client expense: $1,010,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Expand Patient Access and Telehealth: Urged Congress to pass H.R.2630/S. 652, the Safe Step Act, which requires insurers to implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol. The bill lays out five exceptions to fail first protocols and requires that a group health plan grant an exemption. Pharmacy Benefit Managers (PBMs) and group health insurers have developed a series of price management tools to curb the rising cost of prescription drugs. Supported H.R. 2829, the Chronic Care Management Improvement Act of 2023, that would remove the co-pay charged to patients who utilize chronic care management services. It would waive the beneficiary coinsurance to manage chronic care conditions and improve patients health. Supported the Protecting Rural Telehealth Access Act, H.R. 3440 and S. 1636. This bipartisan legislation would ensure rural and underserved community healthcare providers can permanently offer telehealth services, including audio-only telehealth appointments, that are set to expire in December 2024. The legislation would: 1) allow payment parity for audio-only health services for clinically appropriate appointments; 2) permanently waive the geographic restriction allowing patients to be treated from their homes; 3) permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services; 4) lift the restrictions on store and forward technologies for telehealth; and 5) allow Critical Access Hospitals (CAHs) to directly bill for telehealth services. Supported the Preserving Telehealth, Hospital, and Ambulance Access Act, which would extend these flexibilities for two years until the end of 2026. Also supported the Protecting Rural Telehealth Access Act, H.R. 3440, and the Telehealth Modernization Act of 2024, H.R. 7623, which facilitate access to care via telehealth permanently. Supported CONNECT for Health Act of 2023, H.R. 4189 and S. 2016, to permanently remove all geographic restrictions on telehealth services and expand originating sites to include the home and other sites. That legislation would: 1) help providers transition to the goals of the Medicare Access and CHIP Reauthorization Act (MACRA) and the Merit-based Incentive Payment System (MIPS) through using telehealth and remote patient monitoring (RPM) without most of the 42 U.S.C. Section 1834(m) telehealth restrictions; 2) allow telehealth and RPM to be used by qualifying participants in alternative payment models, without most of the 1834(m) restrictions; 3) permit the use of remote patient monitoring for certain patients with chronic conditions; 4) allow, as originating sites, telestroke evaluation and management sites, Native American health service facilities, and dialysis facilities for home dialysis patients in certain cases; and 5) permit further telehealth and RPM in community health centers and rural health clinics. Medicare Payments to Physicians (H.R. 2474): Urged Congress to pass H.R. 2474, the Strengthening Medicare for Patients and Providers Act, which preserves access to care for Medicare beneficiaries by providing an annual inflation update equal to the Medicare Economic Index (MEI) for Medicare physician payments. Unlike other health care sectors, Medicare payment rates for physicians have not been updated based on the MEI. As a result, from 2001 to 2021, Medicare physician payments have decreased by 20 percent when adjusted for inflation. Supported H.R. 6545, the Physician Fee Schedule Update and Improvements Act before the House Energy and Commerce Committee. This bill includes an important provision that would allocate 3 percent to the 2024 Medicare conversion factor, which would represent a 1.75 percent increase to the approved level. H.R. 6545 also includes several provisions from H.R. 6371, the Provider Reimbursement Stability Act of 2023, that ACP supports. It would raise the budget neutrality threshold to $53 million and would use cumulative increases in the Medicare Economic Index (MEI) to update the threshold every five years afterwards. Supported H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023. That bill averts a 3.4 percent across-the-board cut to physician payment for 2024. ACP supported extending the work geographic practice costs index to improve the accuracy of geographic adjustment factors. Supported H.R. 6366 that would extend the work geographic practice costs index for another year to 1.00 for any locality where the index would be less than 1.00. We support aspects of legislation recently introduced by Senators Whitehouse and Cassidy, the Pay Primary Care Physicians (PCPs) Act, S. 4338, that would expand and accelerate the adoption of a hybrid per member per month (PMPM) payment model outside of the PFS. We believe this type of model can enhance innovation and improve the delivery of chronic care in primary care practices. ACP supported the Dr. Michael C. Burgess Preventive Health Savings Act, H.R. 766, to enable CBO to capture cost-savings associated with preventive health care legislation beyond existing 10-year window, for two additional 10-year periods. Support Value-Based Care: Urged support of the Value in Health Care Act of 2023. The bill provides a multi-year commitment to reforming care delivery by extending MACRAs 5 percent advanced alternative payment models (APM) incentives that are scheduled to expire at the end of the year. It also gives the Centers for Medicare & Medicaid Services (CMS) authority to adjust APM qualifying thresholds so that the current one-size-fits-all approach does not serve as a disincentive to including rural, underserved, primary care or specialty practices in APMs. The bill removes revenue-based distinctions that disadvantage rural and safety net providers, which is critical to improving access to care and improving health equity. The bill also improves financial benchmarks so that APM participants are not penalized for their own success. To allow more clinicians to continue the transition to value, the bill establishes a voluntary track for accountable care organizations (ACOs) in the Medicare Shared Savings Program to take on higher levels of risk and provides technical assistance for clinicians new to APMs. Lastly, the bill seeks to provide parity between APMs and the Medicare Advantage (MA) program by studying ways to increase alignment that will ease burdens on physicians and ensure that both APMs and MA are attractive and sustainable options. ACP supports extending incentive payments for participation in eligible alternative payment models through 2026. This approach would help to maintain incentives that support physicians transition from a volume-based fee-for-service health care system to one that is based on the value and quality outcomes of health care delivered to the patient. Supported H.R. 6369 by Rep. Kim Schrier to extend incentive payments for participation in eligible alternative payment models. ACP supports H.R. 5395, the SURS Extension Act, which would extend the Quality Payment Program-Small Practice, Underserved, and Rural Support (QPP-SURS) program for fiscal years 2024-2029. This program was established under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and has provided direct assistance to eligible clinicians required to participate in MIPS. ACP supports efforts to streamline the number of quality measures physicians must report on and enhance stakeholder engagement. Supported the Fewer Burdens for Better Care Act of 2023, which would emphasize multi-stakeholder input, with a 30-day comment period for stakeholders to comment on the removal of measures from the Medicare program. Pricing Transparency/Consolidation: Supported several provisions of H.R. 5378, Lower Costs, More Transparency Act, which are consistent with our policy and would improve access to and affordability of health care for patients. This bill brings together H.R. 4822, Health Care Price Transparency Act of 2023, H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023 and other related bills reported out of Ways and Means, Energy and Commerce and Education and Workforce Committees. Supported requiring disclosure of changes in hospital or health facility ownership to reveal when private equity firms acquire hospitals, larger physician practices or nursing homes, promote price transparency among hospitals, health plans and pharmacy benefit managers and promote site neutrality for Medicare and Medicare beneficiaries. We further supported the reauthorization and funding increases included for the Teaching Health Center Graduate Medical Education program, Community Health Center program and National Health Service Corps. Supported Section 4 of H.R. 2880, the Protecting Patients Against PBM Abuses Act, which aims to increase PBM data reporting to enhance transparency for Medicare Part D. Specifically, it would set out new requirements for PBMs to report data on rebates and administrative fees to HHS. It would also require that HHS deidentify the data and make it publicly available so that policy makers and the public will have a better understanding of how rebates and administrative fees impact the costs of drug plans. The Affordable Care Act (P.L. 111-148, P.L. 111-152): Urged legislation to extend permanently the premium tax subsidies afforded under the ACA. Supported H.R. 1692, the Health Care Affordability Act of 2023, to permanently extend the premium tax credit subsidies under the ACA. The law provides consumers with subsidies (premium tax credits) that lower costs for households with incomes between 100 percent and 400 percent of the federal poverty level (FPL). It expands the Medicaid program to cover all adults with income below 138 percent of the FPL. Supportive of S. 8, Improving Health Insurance Affordability Act to expand the eligibility of taxpayers for the refundable tax credit for coverage under a qualified health plan and increase cost-sharing subsidies under the ACA. FY2025 Appropriations: Urged Congress to support funding for the Centers for Disease Control and Prevention's programs in the FY 2025 Labor, Health and Human Services, Education and Related Agencies Appropriations bill as well as funding shared evenly between the U.S. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to conduct public health research into firearm morbidity and mortality prevention. Advocated for funding for the Health Resources Services Administration (HRSA); Title Vil, Section 747, Primary Care Training and Enhancement (PCTE), Health Resources and Services Administration (HRSA); National Health Service Corps (NHSC); Agency for Healthcare Research and Quality (AHRQ); the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH). Urged Congress to include report language in the FY2025 Labor HHS appropriations bill to direct the GAO to conduct a study encompassing the last decade of CMS estimates of new and revised code utilizations. ACP believes CMS has overestimated utilizations, thus adversely affecting available funds in the Medicare physician fee schedule for other code usuage. Women's Health: Urged HHS to support Title X funding and ensure unencumbered access to affordable, comprehensive, evidence-based reproductive health care; eliminate medically unnecessary restrictions and inappropriate political interference in the patient-physician relationship; and protect funding for and ensures consistent treatment of qualified service sites. Supported H.R. 459 and S. 323, the Secure Access for Essential Reproductive (SAFER) Health Act. This legislation would strengthen current health privacy laws to ensure that abortion-related health data cannot be shared without patient consent. It prohibits health care providers and insurance plans from disclosing in legal proceedings an individual's personal health information related to an abortion or pregnancy without the individual's valid authorization. The prohibition applies to federal, state, local, and tribal proceedings, including civil, criminal, administrative, and legislative proceedings. The bill provides limited exceptions such as if the information is necessary to investigate physical harm to the individual. Primary Care and the Physician Workforce: Urged members of Congress to cosponsor and pass H.R. 2389, the Resident Physician Shortage Reduction Act of 2023, which increases the number of Medicare supported direct graduate medical education (DGME) and indirect medical education (IME) positions by 14,000 over seven years; Support efforts of the bipartisan Senate Working Group to add 10,000 GME slots in legislation; Cosponsor and pass S. 665, the Conrad State 30 and Physician Access Reauthorization Act, to allow states to sponsor foreign-trained physicians to work in medically underserved areas in exchange for a waiver of the physicians' two-year foreign residence requirement; Cosponsor and pass H.R. 1202/S. 704, the Resident Education Deferred Interest (REDI) Act, to make it possible for residents to defer interest on their loans; Support inclusion in FY2024 appropriations legislation funding for Title VII Primary Care and Training Enhancement (PCTE) at $71 million to support and expand the pipeline for individuals training in primary care. Supported H.R.4986/S. 2577, which would refinance the interest rate for all existing federal student loans to zero percent. Further, it would cap interest rates for future student loan borrowers, while considering their financial needs. Prescription Drug Reform: Reviewed proposals to implement guidance by HHS for implementation of Inflation Reduction Act's prescription drug negotiation provisions. Supported H.R. 4895, the Lowering Drug Costs for American Families Act, to expand the number of prescription drugs which Medicare can negotiate under the Inflation Reduction Act from 20 to 50 starting in 2029. Supported H.R. 5385, the Medicare PBM Accountability Act. This legislation aims to lower the costs of prescription drugs for seniors covered by Medicare Part D and Medicare Advantage plans. It would require PBMs to submit annual reports to the Secretary of HHS on PBMs cost savings incurred from rebates, discounts, and price concessions. Supported H.R. 1352, the Increasing Access to Biosimilars Act of 2023. This legislation would encourage adoption of biosimilars in Medicare and improve biosimilar accessibility, by establishing a new pilot program - a voluntary, shared savings demonstration program - for providers of biosimilars in Medicare Part B. Supported H.R. 5386, the Cutting Copays Act. This legislation would eliminate cost-sharing for generic drugs for LIS beneficiaries, helping to incentivize the use of generic drugs. Supported H.R. 3009/S. 2362, the Drug Shortage Prevention Act of 2023, to require that manufacturers of over-the-counter and prescription drugs notify Food & Drug Administration when they are unlikely to meet demand. Social Determinants of Healthcare/DEI: Opposed the Educate Act, H.R. 7725/S. 4115, that will amend the Higher Education Act of 1965 to prohibit graduate medical schools from receiving Federal financial assistance if such schools adopt certain policies and requirements relating to diversity, equity, and inclusion. Firearm Safety: (S.117): Urged Congress to support the Handgun Permit to Purchase Act (S. 117), legislation that would authorize grants to states to support handgun purchaser licensing programs. To qualify for the grants, states must require gun purchasers to be at least the age of 2I and be subject to a criminal background check. Urged Congress to support the Bipartisan Background Checks Act, H.R. 715, and the Background Check Expansion Act, S. 494 and Ethans Law, H.R. 660 and S. 173, requiring gun owners to safely and securely store their firearms. Supported the Keep Americans Safe Act, H.R. 625 and S. 298, which would ban the importation, sale, manufacture, transfer, or possession of high-capacity gun magazines that hold more than fifteen rounds. Supported the Extreme Risk Protection Order Expansion Act, H.R. 768 and S. 247 empowering family members and law enforcement to prevent gun violence by petitioning a court to temporarily separate an at-risk individual from firearms. Supported the FY2024 funding gun violence prevention research contained in FY24 Senate Labor-HHS-Ed appropriations bill for inclusion in any final FY24 appropriations bills. Administrative Burden: Urged Congress to codify many of these proposed improvements to the prior authorization process by reintroducing and passing the Improving Seniors' Timely Access to Care Act. This legislation was passed by the House in the last Congress and would reduce burdens associated with prior authorization in Medicare Advantage (MA) by: l) protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans; 2) requiring all MA plans adopt electronic prior authorization capabilities to streamline the process for prior authorization approval; and 3) standardizing the process and procedures for reporting electronic prior authorization criteria to MA plans. Urged members of Congress to cosponsor and pass H.R.2630/S. 652, the Safe Step Act, to ensure patient access to appropriate treatments based on clinical decision-making and medical necessity rather than arbitrary step therapy protocols. Data Privacy: Supported American Privacy Rights Act, H.R. 8818, nations first comprehensive federal consumer data privacy framework. Bill was considered by House Energy and Commerce and would expand data privacy protections to entities not currently subject to HIPAA privacy protections. ACP asked for provisions enabling consumers to opt-out of allowing companies to use algorithms based on their personal data, allow states to further protect their residents and fully inform subjects of the nature and risks of the research. Scope of Practice: Opposed the Equitable Community Access to Pharmacist Services Act, H.R. 1770/ S. 2477, which would expand Medicare coverage to permanently include select services provided by a pharmacist. Healthcare Worker Safety: Supported H.R. 6364, the Medicare Telehealth Privacy Act of 2023. This bill would ensure that HHS will not publicly post the addresses of participating telehealth practitioners to provide privacy protections for physicians so that they can effectively treat and care for patients via telehealth. Clinical Labs: Supported the provision in H.R. 6366 that would delay payment reductions and data reporting periods for the Clinical Laboratory Fee Schedule under the Protecting Access to Medicare Act (PAMA). Legislation could improve patient access to laboratory tests used to diagnose, monitor, prevent, and manage diseases for Medicare beneficiaries.

Client expense: $485,577 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

Expand Patient Access and Telehealth: Urged Congress to pass H.R.2630/S. 652, the Safe Step Act, which requires insurers to implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol. The bill lays out five exceptions to fail first protocols and requires that a group health plan grant an exemption. Pharmacy Benefit Managers (PBMs) and group health insurers have developed a series of price management tools to curb the rising cost of prescription drugs. Supported H.R. 2829, the Chronic Care Management Improvement Act of 2023, that would remove the co-pay charged to patients who utilize chronic care management services. It would waive the beneficiary coinsurance to manage chronic care conditions and improve patients health. Supported the Protecting Rural Telehealth Access Act, H.R. 3440 and S. 1636. This bipartisan legislation would ensure rural and underserved community healthcare providers can permanently offer telehealth services, including audio-only telehealth appointments, that are set to expire in December 2024. The legislation would: 1) allow payment parity for audio-only health services for clinically appropriate appointments; 2) permanently waive the geographic restriction allowing patients to be treated from their homes; 3) permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services; 4) lift the restrictions on store and forward technologies for telehealth; and 5) allow Critical Access Hospitals (CAHs) to directly bill for telehealth services. Supported the Preserving Telehealth, Hospital, and Ambulance Access Act, which would extend these flexibilities for two years until the end of 2026. Also supported the Protecting Rural Telehealth Access Act, H.R. 3440, and the Telehealth Modernization Act of 2024, H.R. 7623, which facilitate access to care via telehealth permanently. Supported CONNECT for Health Act of 2023, H.R. 4189 and S. 2016, to permanently remove all geographic restrictions on telehealth services and expand originating sites to include the home and other sites. That legislation would: 1) help providers transition to the goals of the Medicare Access and CHIP Reauthorization Act (MACRA) and the Merit-based Incentive Payment System (MIPS) through using telehealth and remote patient monitoring (RPM) without most of the 42 U.S.C. Section 1834(m) telehealth restrictions; 2) allow telehealth and RPM to be used by qualifying participants in alternative payment models, without most of the 1834(m) restrictions; 3) permit the use of remote patient monitoring for certain patients with chronic conditions; 4) allow, as originating sites, telestroke evaluation and management sites, Native American health service facilities, and dialysis facilities for home dialysis patients in certain cases; and 5) permit further telehealth and RPM in community health centers and rural health clinics. Medicare Payments to Physicians (H.R. 2474): Urged Congress to pass H.R. 2474, the Strengthening Medicare for Patients and Providers Act, which preserves access to care for Medicare beneficiaries by providing an annual inflation update equal to the Medicare Economic Index (MEI) for Medicare physician payments. Unlike other health care sectors, Medicare payment rates for physicians have not been updated based on the MEI. As a result, from 2001 to 2021, Medicare physician payments have decreased by 20 percent when adjusted for inflation. Supported H.R. 6545, the Physician Fee Schedule Update and Improvements Act before the House Energy and Commerce Committee. This bill includes an important provision that would allocate 3 percent to the 2024 Medicare conversion factor, which would represent a 1.75 percent increase to the approved level. H.R. 6545 also includes several provisions from H.R. 6371, the Provider Reimbursement Stability Act of 2023, that ACP supports. It would raise the budget neutrality threshold to $53 million and would use cumulative increases in the Medicare Economic Index (MEI) to update the threshold every five years afterwards. Supported H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023. That bill averts a 3.4 percent across-the-board cut to physician payment for 2024. ACP supported extending the work geographic practice costs index to improve the accuracy of geographic adjustment factors. Supported H.R. 6366 that would extend the work geographic practice costs index for another year to 1.00 for any locality where the index would be less than 1.00. We support aspects of legislation recently introduced by Senators Whitehouse and Cassidy, the Pay Primary Care Physicians (PCPs) Act, S. 4338, that would expand and accelerate the adoption of a hybrid per member per month (PMPM) payment model outside of the PFS. We believe this type of model can enhance innovation and improve the delivery of chronic care in primary care practices. ACP supported the Dr. Michael C. Burgess Preventive Health Savings Act, H.R. 766, to enable CBO to capture cost-savings associated with preventive health care legislation beyond existing 10-year window, for two additional 10-year periods. Support Value-Based Care: Urged support of the Value in Health Care Act of 2023. The bill provides a multi-year commitment to reforming care delivery by extending MACRAs 5 percent advanced alternative payment models (APM) incentives that are scheduled to expire at the end of the year. It also gives the Centers for Medicare & Medicaid Services (CMS) authority to adjust APM qualifying thresholds so that the current one-size-fits-all approach does not serve as a disincentive to including rural, underserved, primary care or specialty practices in APMs. The bill removes revenue-based distinctions that disadvantage rural and safety net providers, which is critical to improving access to care and improving health equity. The bill also improves financial benchmarks so that APM participants are not penalized for their own success. To allow more clinicians to continue the transition to value, the bill establishes a voluntary track for accountable care organizations (ACOs) in the Medicare Shared Savings Program to take on higher levels of risk and provides technical assistance for clinicians new to APMs. Lastly, the bill seeks to provide parity between APMs and the Medicare Advantage (MA) program by studying ways to increase alignment that will ease burdens on physicians and ensure that both APMs and MA are attractive and sustainable options. ACP supports extending incentive payments for participation in eligible alternative payment models through 2026. This approach would help to maintain incentives that support physicians transition from a volume-based fee-for-service health care system to one that is based on the value and quality outcomes of health care delivered to the patient. Supported H.R. 6369 by Rep. Kim Schrier to extend incentive payments for participation in eligible alternative payment models. ACP supports H.R. 5395, the SURS Extension Act, which would extend the Quality Payment Program-Small Practice, Underserved, and Rural Support (QPP-SURS) program for fiscal years 2024-2029. This program was established under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and has provided direct assistance to eligible clinicians required to participate in MIPS. ACP supports efforts to streamline the number of quality measures physicians must report on and enhance stakeholder engagement. Supported the Fewer Burdens for Better Care Act of 2023, which would emphasize multi-stakeholder input, with a 30-day comment period for stakeholders to comment on the removal of measures from the Medicare program. Pricing Transparency/Consolidation: Supported several provisions of H.R. 5378, Lower Costs, More Transparency Act, which are consistent with our policy and would improve access to and affordability of health care for patients. This bill brings together H.R. 4822, Health Care Price Transparency Act of 2023, H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023 and other related bills reported out of Ways and Means, Energy and Commerce and Education and Workforce Committees. Supported requiring disclosure of changes in hospital or health facility ownership to reveal when private equity firms acquire hospitals, larger physician practices or nursing homes, promote price transparency among hospitals, health plans and pharmacy benefit managers and promote site neutrality for Medicare and Medicare beneficiaries. We further supported the reauthorization and funding increases included for the Teaching Health Center Graduate Medical Education program, Community Health Center program and National Health Service Corps. Supported Section 4 of H.R. 2880, the Protecting Patients Against PBM Abuses Act, which aims to increase PBM data reporting to enhance transparency for Medicare Part D. Specifically, it would set out new requirements for PBMs to report data on rebates and administrative fees to HHS. It would also require that HHS deidentify the data and make it publicly available so that policy makers and the public will have a better understanding of how rebates and administrative fees impact the costs of drug plans. The Affordable Care Act (P.L. 111-148, P.L. 111-152): Urged legislation to extend permanently the premium tax subsidies afforded under the ACA. Supported H.R. 1692, the Health Care Affordability Act of 2023, to permanently extend the premium tax credit subsidies under the ACA. The law provides consumers with subsidies (premium tax credits) that lower costs for households with incomes between 100 percent and 400 percent of the federal poverty level (FPL). It expands the Medicaid program to cover all adults with income below 138 percent of the FPL. Supportive of S. 8, Improving Health Insurance Affordability Act to expand the eligibility of taxpayers for the refundable tax credit for coverage under a qualified health plan and increase cost-sharing subsidies under the ACA. FY2025 Appropriations: Urged Congress to support funding for the Centers for Disease Control and Prevention's programs in the FY 2025 Labor, Health and Human Services, Education and Related Agencies Appropriations bill as well as funding shared evenly between the U.S. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to conduct public health research into firearm morbidity and mortality prevention. Advocated for funding for the Health Resources Services Administration (HRSA); Title Vil, Section 747, Primary Care Training and Enhancement (PCTE), Health Resources and Services Administration (HRSA); National Health Service Corps (NHSC); Agency for Healthcare Research and Quality (AHRQ); the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH). Urged Congress to include report language in the FY2025 Labor HHS appropriations bill to direct the GAO to conduct a study encompassing the last decade of CMS estimates of new and revised code utilizations. ACP believes CMS has overestimated utilizations, thus adversely affecting available funds in the Medicare physician fee schedule for other code usuage. Women's Health: Urged HHS to support Title X funding and ensure unencumbered access to affordable, comprehensive, evidence-based reproductive health care; eliminate medically unnecessary restrictions and inappropriate political interference in the patient-physician relationship; and protect funding for and ensures consistent treatment of qualified service sites. Supported H.R. 459 and S. 323, the Secure Access for Essential Reproductive (SAFER) Health Act. This legislation would strengthen current health privacy laws to ensure that abortion-related health data cannot be shared without patient consent. It prohibits health care providers and insurance plans from disclosing in legal proceedings an individual's personal health information related to an abortion or pregnancy without the individual's valid authorization. The prohibition applies to federal, state, local, and tribal proceedings, including civil, criminal, administrative, and legislative proceedings. The bill provides limited exceptions such as if the information is necessary to investigate physical harm to the individual. Primary Care and the Physician Workforce: Urged members of Congress to cosponsor and pass H.R. 2389, the Resident Physician Shortage Reduction Act of 2023, which increases the number of Medicare supported direct graduate medical education (DGME) and indirect medical education (IME) positions by 14,000 over seven years; Support efforts of the bipartisan Senate Working Group to add 10,000 GME slots in legislation; Cosponsor and pass S. 665, the Conrad State 30 and Physician Access Reauthorization Act, to allow states to sponsor foreign-trained physicians to work in medically underserved areas in exchange for a waiver of the physicians' two-year foreign residence requirement; Cosponsor and pass H.R. 1202/S. 704, the Resident Education Deferred Interest (REDI) Act, to make it possible for residents to defer interest on their loans; Support inclusion in FY2024 appropriations legislation funding for Title VII Primary Care and Training Enhancement (PCTE) at $71 million to support and expand the pipeline for individuals training in primary care. Supported H.R.4986/S. 2577, which would refinance the interest rate for all existing federal student loans to zero percent. Further, it would cap interest rates for future student loan borrowers, while considering their financial needs. Prescription Drug Reform: Reviewed proposals to implement guidance by HHS for implementation of Inflation Reduction Act's prescription drug negotiation provisions. Supported H.R. 4895, the Lowering Drug Costs for American Families Act, to expand the number of prescription drugs which Medicare can negotiate under the Inflation Reduction Act from 20 to 50 starting in 2029. Supported H.R. 5385, the Medicare PBM Accountability Act. This legislation aims to lower the costs of prescription drugs for seniors covered by Medicare Part D and Medicare Advantage plans. It would require PBMs to submit annual reports to the Secretary of HHS on PBMs cost savings incurred from rebates, discounts, and price concessions. Supported H.R. 1352, the Increasing Access to Biosimilars Act of 2023. This legislation would encourage adoption of biosimilars in Medicare and improve biosimilar accessibility, by establishing a new pilot program - a voluntary, shared savings demonstration program - for providers of biosimilars in Medicare Part B. Supported H.R. 5386, the Cutting Copays Act. This legislation would eliminate cost-sharing for generic drugs for LIS beneficiaries, helping to incentivize the use of generic drugs. Supported H.R. 3009/S. 2362, the Drug Shortage Prevention Act of 2023, to require that manufacturers of over-the-counter and prescription drugs notify Food & Drug Administration when they are unlikely to meet demand. Social Determinants of Healthcare/DEI: Opposed the Educate Act, H.R. 7725/S. 4115, that will amend the Higher Education Act of 1965 to prohibit graduate medical schools from receiving Federal financial assistance if such schools adopt certain policies and requirements relating to diversity, equity, and inclusion. Firearm Safety: (S.117): Urged Congress to support the Handgun Permit to Purchase Act (S. 117), legislation that would authorize grants to states to support handgun purchaser licensing programs. To qualify for the grants, states must require gun purchasers to be at least the age of 2I and be subject to a criminal background check. Urged Congress to support the Bipartisan Background Checks Act, H.R. 715, and the Background Check Expansion Act, S. 494 and Ethans Law, H.R. 660 and S. 173, requiring gun owners to safely and securely store their firearms. Supported the Keep Americans Safe Act, H.R. 625 and S. 298, which would ban the importation, sale, manufacture, transfer, or possession of high-capacity gun magazines that hold more than fifteen rounds. Supported the Extreme Risk Protection Order Expansion Act, H.R. 768 and S. 247 empowering family members and law enforcement to prevent gun violence by petitioning a court to temporarily separate an at-risk individual from firearms. Supported the FY2024 funding gun violence prevention research contained in FY24 Senate Labor-HHS-Ed appropriations bill for inclusion in any final FY24 appropriations bills. Administrative Burden: Urged Congress to codify many of these proposed improvements to the prior authorization process by reintroducing and passing the Improving Seniors' Timely Access to Care Act. This legislation was passed by the House in the last Congress and would reduce burdens associated with prior authorization in Medicare Advantage (MA) by: l) protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans; 2) requiring all MA plans adopt electronic prior authorization capabilities to streamline the process for prior authorization approval; and 3) standardizing the process and procedures for reporting electronic prior authorization criteria to MA plans. Urged members of Congress to cosponsor and pass H.R.2630/S. 652, the Safe Step Act, to ensure patient access to appropriate treatments based on clinical decision-making and medical necessity rather than arbitrary step therapy protocols. Data Privacy: Supported American Privacy Rights Act, H.R. 8818, nations first comprehensive federal consumer data privacy framework. Bill was considered by House Energy and Commerce and would expand data privacy protections to entities not currently subject to HIPAA privacy protections. ACP asked for provisions enabling consumers to opt-out of allowing companies to use algorithms based on their personal data, allow states to further protect their residents and fully inform subjects of the nature and risks of the research. Scope of Practice: Opposed the Equitable Community Access to Pharmacist Services Act, H.R. 1770/ S. 2477, which would expand Medicare coverage to permanently include select services provided by a pharmacist. Healthcare Worker Safety: Supported H.R. 6364, the Medicare Telehealth Privacy Act of 2023. This bill would ensure that HHS will not publicly post the addresses of participating telehealth practitioners to provide privacy protections for physicians so that they can effectively treat and care for patients via telehealth. Clinical Labs: Supported the provision in H.R. 6366 that would delay payment reductions and data reporting periods for the Clinical Laboratory Fee Schedule under the Protecting Access to Medicare Act (PAMA). Legislation could improve patient access to laboratory tests used to diagnose, monitor, prevent, and manage diseases for Medicare beneficiaries.

Client expense: $122,264 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

Expand Patient Access and Telehealth: Urged Congress to pass H.R.2630/S. 652, the Safe Step Act, which requires insurers to implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol. The bill lays out five exceptions to fail first protocols and requires that a group health plan grant an exemption. Pharmacy Benefit Managers (PBMs) and group health insurers have developed a series of price management tools to curb the rising cost of prescription drugs. Supported H.R. 2829, the Chronic Care Management Improvement Act of 2023, that would remove the co-pay charged to patients who utilize chronic care management services. It would waive the beneficiary coinsurance to manage chronic care conditions and improve patients health. Supported the Protecting Rural Telehealth Access Act, H.R. 3440 and S. 1636. This bipartisan legislation would ensure rural and underserved community healthcare providers can permanently offer telehealth services, including audio-only telehealth appointments, that are set to expire in December 2024. The legislation would: 1) allow payment parity for audio-only health services for clinically appropriate appointments; 2) permanently waive the geographic restriction allowing patients to be treated from their homes; 3) permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services; 4) lift the restrictions on store and forward technologies for telehealth; and 5) allow Critical Access Hospitals (CAHs) to directly bill for telehealth services. Supported the Preserving Telehealth, Hospital, and Ambulance Access Act, which would extend these flexibilities for two years until the end of 2026. Also supported the Protecting Rural Telehealth Access Act, H.R. 3440, and the Telehealth Modernization Act of 2024, H.R. 7623, which facilitate access to care via telehealth permanently. Supported CONNECT for Health Act of 2023, H.R. 4189 and S. 2016, to permanently remove all geographic restrictions on telehealth services and expand originating sites to include the home and other sites. That legislation would: 1) help providers transition to the goals of the Medicare Access and CHIP Reauthorization Act (MACRA) and the Merit-based Incentive Payment System (MIPS) through using telehealth and remote patient monitoring (RPM) without most of the 42 U.S.C. Section 1834(m) telehealth restrictions; 2) allow telehealth and RPM to be used by qualifying participants in alternative payment models, without most of the 1834(m) restrictions; 3) permit the use of remote patient monitoring for certain patients with chronic conditions; 4) allow, as originating sites, telestroke evaluation and management sites, Native American health service facilities, and dialysis facilities for home dialysis patients in certain cases; and 5) permit further telehealth and RPM in community health centers and rural health clinics. Medicare Payments to Physicians (H.R. 2474): Urged Congress to pass H.R. 2474, the Strengthening Medicare for Patients and Providers Act, which preserves access to care for Medicare beneficiaries by providing an annual inflation update equal to the Medicare Economic Index (MEI) for Medicare physician payments. Unlike other health care sectors, Medicare payment rates for physicians have not been updated based on the MEI. As a result, from 2001 to 2021, Medicare physician payments have decreased by 20 percent when adjusted for inflation. Supported H.R. 6545, the Physician Fee Schedule Update and Improvements Act before the House Energy and Commerce Committee. This bill includes an important provision that would allocate 3 percent to the 2024 Medicare conversion factor, which would represent a 1.75 percent increase to the approved level. H.R. 6545 also includes several provisions from H.R. 6371, the Provider Reimbursement Stability Act of 2023, that ACP supports. It would raise the budget neutrality threshold to $53 million and would use cumulative increases in the Medicare Economic Index (MEI) to update the threshold every five years afterwards. Supported H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023. That bill averts a 3.4 percent across-the-board cut to physician payment for 2024. ACP supported extending the work geographic practice costs index to improve the accuracy of geographic adjustment factors. Supported H.R. 6366 that would extend the work geographic practice costs index for another year to 1.00 for any locality where the index would be less than 1.00. We support aspects of legislation recently introduced by Senators Whitehouse and Cassidy, the Pay Primary Care Physicians (PCPs) Act, S. 4338, that would expand and accelerate the adoption of a hybrid per member per month (PMPM) payment model outside of the PFS. We believe this type of model can enhance innovation and improve the delivery of chronic care in primary care practices. ACP supported the Dr. Michael C. Burgess Preventive Health Savings Act, H.R. 766, to enable CBO to capture cost-savings associated with preventive health care legislation beyond existing 10-year window, for two additional 10-year periods. Support Value-Based Care: Urged support of the Value in Health Care Act of 2023. The bill provides a multi-year commitment to reforming care delivery by extending MACRAs 5 percent advanced alternative payment models (APM) incentives that are scheduled to expire at the end of the year. It also gives the Centers for Medicare & Medicaid Services (CMS) authority to adjust APM qualifying thresholds so that the current one-size-fits-all approach does not serve as a disincentive to including rural, underserved, primary care or specialty practices in APMs. The bill removes revenue-based distinctions that disadvantage rural and safety net providers, which is critical to improving access to care and improving health equity. The bill also improves financial benchmarks so that APM participants are not penalized for their own success. To allow more clinicians to continue the transition to value, the bill establishes a voluntary track for accountable care organizations (ACOs) in the Medicare Shared Savings Program to take on higher levels of risk and provides technical assistance for clinicians new to APMs. Lastly, the bill seeks to provide parity between APMs and the Medicare Advantage (MA) program by studying ways to increase alignment that will ease burdens on physicians and ensure that both APMs and MA are attractive and sustainable options. ACP supports extending incentive payments for participation in eligible alternative payment models through 2026. This approach would help to maintain incentives that support physicians transition from a volume-based fee-for-service health care system to one that is based on the value and quality outcomes of health care delivered to the patient. Supported H.R. 6369 by Rep. Kim Schrier to extend incentive payments for participation in eligible alternative payment models. ACP supports H.R. 5395, the SURS Extension Act, which would extend the Quality Payment Program-Small Practice, Underserved, and Rural Support (QPP-SURS) program for fiscal years 2024-2029. This program was established under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and has provided direct assistance to eligible clinicians required to participate in MIPS. ACP supports efforts to streamline the number of quality measures physicians must report on and enhance stakeholder engagement. Supported the Fewer Burdens for Better Care Act of 2023, which would emphasize multi-stakeholder input, with a 30-day comment period for stakeholders to comment on the removal of measures from the Medicare program. Pricing Transparency/Consolidation: Supported several provisions of H.R. 5378, Lower Costs, More Transparency Act, which are consistent with our policy and would improve access to and affordability of health care for patients. This bill brings together H.R. 4822, Health Care Price Transparency Act of 2023, H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023 and other related bills reported out of Ways and Means, Energy and Commerce and Education and Workforce Committees. Supported requiring disclosure of changes in hospital or health facility ownership to reveal when private equity firms acquire hospitals, larger physician practices or nursing homes, promote price transparency among hospitals, health plans and pharmacy benefit managers and promote site neutrality for Medicare and Medicare beneficiaries. We further supported the reauthorization and funding increases included for the Teaching Health Center Graduate Medical Education program, Community Health Center program and National Health Service Corps. Supported Section 4 of H.R. 2880, the Protecting Patients Against PBM Abuses Act, which aims to increase PBM data reporting to enhance transparency for Medicare Part D. Specifically, it would set out new requirements for PBMs to report data on rebates and administrative fees to HHS. It would also require that HHS deidentify the data and make it publicly available so that policy makers and the public will have a better understanding of how rebates and administrative fees impact the costs of drug plans. The Affordable Care Act (P.L. 111-148, P.L. 111-152): Urged legislation to extend permanently the premium tax subsidies afforded under the ACA. Supported H.R. 1692, the Health Care Affordability Act of 2023, to permanently extend the premium tax credit subsidies under the ACA. The law provides consumers with subsidies (premium tax credits) that lower costs for households with incomes between 100 percent and 400 percent of the federal poverty level (FPL). It expands the Medicaid program to cover all adults with income below 138 percent of the FPL. Supportive of S. 8, Improving Health Insurance Affordability Act to expand the eligibility of taxpayers for the refundable tax credit for coverage under a qualified health plan and increase cost-sharing subsidies under the ACA. FY2025 Appropriations: Urged Congress to support funding for the Centers for Disease Control and Prevention's programs in the FY 2025 Labor, Health and Human Services, Education and Related Agencies Appropriations bill as well as funding shared evenly between the U.S. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to conduct public health research into firearm morbidity and mortality prevention. Advocated for funding for the Health Resources Services Administration (HRSA); Title Vil, Section 747, Primary Care Training and Enhancement (PCTE), Health Resources and Services Administration (HRSA); National Health Service Corps (NHSC); Agency for Healthcare Research and Quality (AHRQ); the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH). Urged Congress to include report language in the FY2025 Labor HHS appropriations bill to direct the GAO to conduct a study encompassing the last decade of CMS estimates of new and revised code utilizations. ACP believes CMS has overestimated utilizations, thus adversely affecting available funds in the Medicare physician fee schedule for other code usuage. Women's Health: Urged HHS to support Title X funding and ensure unencumbered access to affordable, comprehensive, evidence-based reproductive health care; eliminate medically unnecessary restrictions and inappropriate political interference in the patient-physician relationship; and protect funding for and ensures consistent treatment of qualified service sites. Supported H.R. 459 and S. 323, the Secure Access for Essential Reproductive (SAFER) Health Act. This legislation would strengthen current health privacy laws to ensure that abortion-related health data cannot be shared without patient consent. It prohibits health care providers and insurance plans from disclosing in legal proceedings an individual's personal health information related to an abortion or pregnancy without the individual's valid authorization. The prohibition applies to federal, state, local, and tribal proceedings, including civil, criminal, administrative, and legislative proceedings. The bill provides limited exceptions such as if the information is necessary to investigate physical harm to the individual. Primary Care and the Physician Workforce: Urged members of Congress to cosponsor and pass H.R. 2389, the Resident Physician Shortage Reduction Act of 2023, which increases the number of Medicare supported direct graduate medical education (DGME) and indirect medical education (IME) positions by 14,000 over seven years; Support efforts of the bipartisan Senate Working Group to add 10,000 GME slots in legislation; Cosponsor and pass S. 665, the Conrad State 30 and Physician Access Reauthorization Act, to allow states to sponsor foreign-trained physicians to work in medically underserved areas in exchange for a waiver of the physicians' two-year foreign residence requirement; Cosponsor and pass H.R. 1202/S. 704, the Resident Education Deferred Interest (REDI) Act, to make it possible for residents to defer interest on their loans; Support inclusion in FY2024 appropriations legislation funding for Title VII Primary Care and Training Enhancement (PCTE) at $71 million to support and expand the pipeline for individuals training in primary care. Supported H.R.4986/S. 2577, which would refinance the interest rate for all existing federal student loans to zero percent. Further, it would cap interest rates for future student loan borrowers, while considering their financial needs. Prescription Drug Reform: Reviewed proposals to implement guidance by HHS for implementation of Inflation Reduction Act's prescription drug negotiation provisions. Supported H.R. 4895, the Lowering Drug Costs for American Families Act, to expand the number of prescription drugs which Medicare can negotiate under the Inflation Reduction Act from 20 to 50 starting in 2029. Supported H.R. 5385, the Medicare PBM Accountability Act. This legislation aims to lower the costs of prescription drugs for seniors covered by Medicare Part D and Medicare Advantage plans. It would require PBMs to submit annual reports to the Secretary of HHS on PBMs cost savings incurred from rebates, discounts, and price concessions. Supported H.R. 1352, the Increasing Access to Biosimilars Act of 2023. This legislation would encourage adoption of biosimilars in Medicare and improve biosimilar accessibility, by establishing a new pilot program - a voluntary, shared savings demonstration program - for providers of biosimilars in Medicare Part B. Supported H.R. 5386, the Cutting Copays Act. This legislation would eliminate cost-sharing for generic drugs for LIS beneficiaries, helping to incentivize the use of generic drugs. Supported H.R. 3009/S. 2362, the Drug Shortage Prevention Act of 2023, to require that manufacturers of over-the-counter and prescription drugs notify Food & Drug Administration when they are unlikely to meet demand. Social Determinants of Healthcare/DEI: Opposed the Educate Act, H.R. 7725/S. 4115, that will amend the Higher Education Act of 1965 to prohibit graduate medical schools from receiving Federal financial assistance if such schools adopt certain policies and requirements relating to diversity, equity, and inclusion. Firearm Safety: (S.117): Urged Congress to support the Handgun Permit to Purchase Act (S. 117), legislation that would authorize grants to states to support handgun purchaser licensing programs. To qualify for the grants, states must require gun purchasers to be at least the age of 2I and be subject to a criminal background check. Urged Congress to support the Bipartisan Background Checks Act, H.R. 715, and the Background Check Expansion Act, S. 494 and Ethans Law, H.R. 660 and S. 173, requiring gun owners to safely and securely store their firearms. Supported the Keep Americans Safe Act, H.R. 625 and S. 298, which would ban the importation, sale, manufacture, transfer, or possession of high-capacity gun magazines that hold more than fifteen rounds. Supported the Extreme Risk Protection Order Expansion Act, H.R. 768 and S. 247 empowering family members and law enforcement to prevent gun violence by petitioning a court to temporarily separate an at-risk individual from firearms. Supported the FY2024 funding gun violence prevention research contained in FY24 Senate Labor-HHS-Ed appropriations bill for inclusion in any final FY24 appropriations bills. Administrative Burden: Urged Congress to codify many of these proposed improvements to the prior authorization process by reintroducing and passing the Improving Seniors' Timely Access to Care Act. This legislation was passed by the House in the last Congress and would reduce burdens associated with prior authorization in Medicare Advantage (MA) by: l) protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans; 2) requiring all MA plans adopt electronic prior authorization capabilities to streamline the process for prior authorization approval; and 3) standardizing the process and procedures for reporting electronic prior authorization criteria to MA plans. Urged members of Congress to cosponsor and pass H.R.2630/S. 652, the Safe Step Act, to ensure patient access to appropriate treatments based on clinical decision-making and medical necessity rather than arbitrary step therapy protocols. Data Privacy: Supported American Privacy Rights Act, H.R. 8818, nations first comprehensive federal consumer data privacy framework. Bill was considered by House Energy and Commerce and would expand data privacy protections to entities not currently subject to HIPAA privacy protections. ACP asked for provisions enabling consumers to opt-out of allowing companies to use algorithms based on their personal data, allow states to further protect their residents and fully inform subjects of the nature and risks of the research. Scope of Practice: Opposed the Equitable Community Access to Pharmacist Services Act, H.R. 1770/ S. 2477, which would expand Medicare coverage to permanently include select services provided by a pharmacist. Healthcare Worker Safety: Supported H.R. 6364, the Medicare Telehealth Privacy Act of 2023. This bill would ensure that HHS will not publicly post the addresses of participating telehealth practitioners to provide privacy protections for physicians so that they can effectively treat and care for patients via telehealth. Clinical Labs: Supported the provision in H.R. 6366 that would delay payment reductions and data reporting periods for the Clinical Laboratory Fee Schedule under the Protecting Access to Medicare Act (PAMA). Legislation could improve patient access to laboratory tests used to diagnose, monitor, prevent, and manage diseases for Medicare beneficiaries.

Client expense: $82,388 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

Expand Patient Access and Telehealth: Urged Congress to pass H.R.2630/S. 652, the Safe Step Act, which requires insurers to implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol. The bill lays out five exceptions to fail first protocols and requires that a group health plan grant an exemption. Pharmacy Benefit Managers (PBMs) and group health insurers have developed a series of price management tools to curb the rising cost of prescription drugs. Supported H.R. 2829, the Chronic Care Management Improvement Act of 2023, that would remove the co-pay charged to patients who utilize chronic care management services. It would waive the beneficiary coinsurance to manage chronic care conditions and improve patients health. Supported the Protecting Rural Telehealth Access Act, H.R. 3440 and S. 1636. This bipartisan legislation would ensure rural and underserved community healthcare providers can permanently offer telehealth services, including audio-only telehealth appointments, that are set to expire in December 2024. The legislation would: 1) allow payment parity for audio-only health services for clinically appropriate appointments; 2) permanently waive the geographic restriction allowing patients to be treated from their homes; 3) permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services; 4) lift the restrictions on store and forward technologies for telehealth; and 5) allow Critical Access Hospitals (CAHs) to directly bill for telehealth services. Supported the Preserving Telehealth, Hospital, and Ambulance Access Act, which would extend these flexibilities for two years until the end of 2026. Also supported the Protecting Rural Telehealth Access Act, H.R. 3440, and the Telehealth Modernization Act of 2024, H.R. 7623, which facilitate access to care via telehealth permanently. Supported CONNECT for Health Act of 2023, H.R. 4189 and S. 2016, to permanently remove all geographic restrictions on telehealth services and expand originating sites to include the home and other sites. That legislation would: 1) help providers transition to the goals of the Medicare Access and CHIP Reauthorization Act (MACRA) and the Merit-based Incentive Payment System (MIPS) through using telehealth and remote patient monitoring (RPM) without most of the 42 U.S.C. Section 1834(m) telehealth restrictions; 2) allow telehealth and RPM to be used by qualifying participants in alternative payment models, without most of the 1834(m) restrictions; 3) permit the use of remote patient monitoring for certain patients with chronic conditions; 4) allow, as originating sites, telestroke evaluation and management sites, Native American health service facilities, and dialysis facilities for home dialysis patients in certain cases; and 5) permit further telehealth and RPM in community health centers and rural health clinics. Medicare Payments to Physicians (H.R. 2474): Urged Congress to pass H.R. 2474, the Strengthening Medicare for Patients and Providers Act, which preserves access to care for Medicare beneficiaries by providing an annual inflation update equal to the Medicare Economic Index (MEI) for Medicare physician payments. Unlike other health care sectors, Medicare payment rates for physicians have not been updated based on the MEI. As a result, from 2001 to 2021, Medicare physician payments have decreased by 20 percent when adjusted for inflation. Supported H.R. 6545, the Physician Fee Schedule Update and Improvements Act before the House Energy and Commerce Committee. This bill includes an important provision that would allocate 3 percent to the 2024 Medicare conversion factor, which would represent a 1.75 percent increase to the approved level. H.R. 6545 also includes several provisions from H.R. 6371, the Provider Reimbursement Stability Act of 2023, that ACP supports. It would raise the budget neutrality threshold to $53 million and would use cumulative increases in the Medicare Economic Index (MEI) to update the threshold every five years afterwards. Supported H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023. That bill averts a 3.4 percent across-the-board cut to physician payment for 2024. ACP supported extending the work geographic practice costs index to improve the accuracy of geographic adjustment factors. Supported H.R. 6366 that would extend the work geographic practice costs index for another year to 1.00 for any locality where the index would be less than 1.00. We support aspects of legislation recently introduced by Senators Whitehouse and Cassidy, the Pay Primary Care Physicians (PCPs) Act, S. 4338, that would expand and accelerate the adoption of a hybrid per member per month (PMPM) payment model outside of the PFS. We believe this type of model can enhance innovation and improve the delivery of chronic care in primary care practices. ACP supported the Dr. Michael C. Burgess Preventive Health Savings Act, H.R. 766, to enable CBO to capture cost-savings associated with preventive health care legislation beyond existing 10-year window, for two additional 10-year periods. Support Value-Based Care: Urged support of the Value in Health Care Act of 2023. The bill provides a multi-year commitment to reforming care delivery by extending MACRAs 5 percent advanced alternative payment models (APM) incentives that are scheduled to expire at the end of the year. It also gives the Centers for Medicare & Medicaid Services (CMS) authority to adjust APM qualifying thresholds so that the current one-size-fits-all approach does not serve as a disincentive to including rural, underserved, primary care or specialty practices in APMs. The bill removes revenue-based distinctions that disadvantage rural and safety net providers, which is critical to improving access to care and improving health equity. The bill also improves financial benchmarks so that APM participants are not penalized for their own success. To allow more clinicians to continue the transition to value, the bill establishes a voluntary track for accountable care organizations (ACOs) in the Medicare Shared Savings Program to take on higher levels of risk and provides technical assistance for clinicians new to APMs. Lastly, the bill seeks to provide parity between APMs and the Medicare Advantage (MA) program by studying ways to increase alignment that will ease burdens on physicians and ensure that both APMs and MA are attractive and sustainable options. ACP supports extending incentive payments for participation in eligible alternative payment models through 2026. This approach would help to maintain incentives that support physicians transition from a volume-based fee-for-service health care system to one that is based on the value and quality outcomes of health care delivered to the patient. Supported H.R. 6369 by Rep. Kim Schrier to extend incentive payments for participation in eligible alternative payment models. ACP supports H.R. 5395, the SURS Extension Act, which would extend the Quality Payment Program-Small Practice, Underserved, and Rural Support (QPP-SURS) program for fiscal years 2024-2029. This program was established under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and has provided direct assistance to eligible clinicians required to participate in MIPS. ACP supports efforts to streamline the number of quality measures physicians must report on and enhance stakeholder engagement. Supported the Fewer Burdens for Better Care Act of 2023, which would emphasize multi-stakeholder input, with a 30-day comment period for stakeholders to comment on the removal of measures from the Medicare program. Pricing Transparency/Consolidation: Supported several provisions of H.R. 5378, Lower Costs, More Transparency Act, which are consistent with our policy and would improve access to and affordability of health care for patients. This bill brings together H.R. 4822, Health Care Price Transparency Act of 2023, H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023 and other related bills reported out of Ways and Means, Energy and Commerce and Education and Workforce Committees. Supported requiring disclosure of changes in hospital or health facility ownership to reveal when private equity firms acquire hospitals, larger physician practices or nursing homes, promote price transparency among hospitals, health plans and pharmacy benefit managers and promote site neutrality for Medicare and Medicare beneficiaries. We further supported the reauthorization and funding increases included for the Teaching Health Center Graduate Medical Education program, Community Health Center program and National Health Service Corps. Supported Section 4 of H.R. 2880, the Protecting Patients Against PBM Abuses Act, which aims to increase PBM data reporting to enhance transparency for Medicare Part D. Specifically, it would set out new requirements for PBMs to report data on rebates and administrative fees to HHS. It would also require that HHS deidentify the data and make it publicly available so that policy makers and the public will have a better understanding of how rebates and administrative fees impact the costs of drug plans. The Affordable Care Act (P.L. 111-148, P.L. 111-152): Urged legislation to extend permanently the premium tax subsidies afforded under the ACA. Supported H.R. 1692, the Health Care Affordability Act of 2023, to permanently extend the premium tax credit subsidies under the ACA. The law provides consumers with subsidies (premium tax credits) that lower costs for households with incomes between 100 percent and 400 percent of the federal poverty level (FPL). It expands the Medicaid program to cover all adults with income below 138 percent of the FPL. Supportive of S. 8, Improving Health Insurance Affordability Act to expand the eligibility of taxpayers for the refundable tax credit for coverage under a qualified health plan and increase cost-sharing subsidies under the ACA. FY2025 Appropriations: Urged Congress to support funding for the Centers for Disease Control and Prevention's programs in the FY 2025 Labor, Health and Human Services, Education and Related Agencies Appropriations bill as well as funding shared evenly between the U.S. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to conduct public health research into firearm morbidity and mortality prevention. Advocated for funding for the Health Resources Services Administration (HRSA); Title Vil, Section 747, Primary Care Training and Enhancement (PCTE), Health Resources and Services Administration (HRSA); National Health Service Corps (NHSC); Agency for Healthcare Research and Quality (AHRQ); the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH). Urged Congress to include report language in the FY2025 Labor HHS appropriations bill to direct the GAO to conduct a study encompassing the last decade of CMS estimates of new and revised code utilizations. ACP believes CMS has overestimated utilizations, thus adversely affecting available funds in the Medicare physician fee schedule for other code usuage. Women's Health: Urged HHS to support Title X funding and ensure unencumbered access to affordable, comprehensive, evidence-based reproductive health care; eliminate medically unnecessary restrictions and inappropriate political interference in the patient-physician relationship; and protect funding for and ensures consistent treatment of qualified service sites. Supported H.R. 459 and S. 323, the Secure Access for Essential Reproductive (SAFER) Health Act. This legislation would strengthen current health privacy laws to ensure that abortion-related health data cannot be shared without patient consent. It prohibits health care providers and insurance plans from disclosing in legal proceedings an individual's personal health information related to an abortion or pregnancy without the individual's valid authorization. The prohibition applies to federal, state, local, and tribal proceedings, including civil, criminal, administrative, and legislative proceedings. The bill provides limited exceptions such as if the information is necessary to investigate physical harm to the individual. Primary Care and the Physician Workforce: Urged members of Congress to cosponsor and pass H.R. 2389, the Resident Physician Shortage Reduction Act of 2023, which increases the number of Medicare supported direct graduate medical education (DGME) and indirect medical education (IME) positions by 14,000 over seven years; Support efforts of the bipartisan Senate Working Group to add 10,000 GME slots in legislation; Cosponsor and pass S. 665, the Conrad State 30 and Physician Access Reauthorization Act, to allow states to sponsor foreign-trained physicians to work in medically underserved areas in exchange for a waiver of the physicians' two-year foreign residence requirement; Cosponsor and pass H.R. 1202/S. 704, the Resident Education Deferred Interest (REDI) Act, to make it possible for residents to defer interest on their loans; Support inclusion in FY2024 appropriations legislation funding for Title VII Primary Care and Training Enhancement (PCTE) at $71 million to support and expand the pipeline for individuals training in primary care. Supported H.R.4986/S. 2577, which would refinance the interest rate for all existing federal student loans to zero percent. Further, it would cap interest rates for future student loan borrowers, while considering their financial needs. Prescription Drug Reform: Reviewed proposals to implement guidance by HHS for implementation of Inflation Reduction Act's prescription drug negotiation provisions. Supported H.R. 4895, the Lowering Drug Costs for American Families Act, to expand the number of prescription drugs which Medicare can negotiate under the Inflation Reduction Act from 20 to 50 starting in 2029. Supported H.R. 5385, the Medicare PBM Accountability Act. This legislation aims to lower the costs of prescription drugs for seniors covered by Medicare Part D and Medicare Advantage plans. It would require PBMs to submit annual reports to the Secretary of HHS on PBMs cost savings incurred from rebates, discounts, and price concessions. Supported H.R. 1352, the Increasing Access to Biosimilars Act of 2023. This legislation would encourage adoption of biosimilars in Medicare and improve biosimilar accessibility, by establishing a new pilot program - a voluntary, shared savings demonstration program - for providers of biosimilars in Medicare Part B. Supported H.R. 5386, the Cutting Copays Act. This legislation would eliminate cost-sharing for generic drugs for LIS beneficiaries, helping to incentivize the use of generic drugs. Supported H.R. 3009/S. 2362, the Drug Shortage Prevention Act of 2023, to require that manufacturers of over-the-counter and prescription drugs notify Food & Drug Administration when they are unlikely to meet demand. Social Determinants of Healthcare/DEI: Opposed the Educate Act, H.R. 7725/S. 4115, that will amend the Higher Education Act of 1965 to prohibit graduate medical schools from receiving Federal financial assistance if such schools adopt certain policies and requirements relating to diversity, equity, and inclusion. Firearm Safety: (S.117): Urged Congress to support the Handgun Permit to Purchase Act (S. 117), legislation that would authorize grants to states to support handgun purchaser licensing programs. To qualify for the grants, states must require gun purchasers to be at least the age of 2I and be subject to a criminal background check. Urged Congress to support the Bipartisan Background Checks Act, H.R. 715, and the Background Check Expansion Act, S. 494 and Ethans Law, H.R. 660 and S. 173, requiring gun owners to safely and securely store their firearms. Supported the Keep Americans Safe Act, H.R. 625 and S. 298, which would ban the importation, sale, manufacture, transfer, or possession of high-capacity gun magazines that hold more than fifteen rounds. Supported the Extreme Risk Protection Order Expansion Act, H.R. 768 and S. 247 empowering family members and law enforcement to prevent gun violence by petitioning a court to temporarily separate an at-risk individual from firearms. Supported the FY2024 funding gun violence prevention research contained in FY24 Senate Labor-HHS-Ed appropriations bill for inclusion in any final FY24 appropriations bills. Administrative Burden: Urged Congress to codify many of these proposed improvements to the prior authorization process by reintroducing and passing the Improving Seniors' Timely Access to Care Act. This legislation was passed by the House in the last Congress and would reduce burdens associated with prior authorization in Medicare Advantage (MA) by: l) protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans; 2) requiring all MA plans adopt electronic prior authorization capabilities to streamline the process for prior authorization approval; and 3) standardizing the process and procedures for reporting electronic prior authorization criteria to MA plans. Urged members of Congress to cosponsor and pass H.R.2630/S. 652, the Safe Step Act, to ensure patient access to appropriate treatments based on clinical decision-making and medical necessity rather than arbitrary step therapy protocols. Data Privacy: Supported American Privacy Rights Act, H.R. 8818, nations first comprehensive federal consumer data privacy framework. Bill was considered by House Energy and Commerce and would expand data privacy protections to entities not currently subject to HIPAA privacy protections. ACP asked for provisions enabling consumers to opt-out of allowing companies to use algorithms based on their personal data, allow states to further protect their residents and fully inform subjects of the nature and risks of the research. Scope of Practice: Opposed the Equitable Community Access to Pharmacist Services Act, H.R. 1770/ S. 2477, which would expand Medicare coverage to permanently include select services provided by a pharmacist. Healthcare Worker Safety: Supported H.R. 6364, the Medicare Telehealth Privacy Act of 2023. This bill would ensure that HHS will not publicly post the addresses of participating telehealth practitioners to provide privacy protections for physicians so that they can effectively treat and care for patients via telehealth. Clinical Labs: Supported the provision in H.R. 6366 that would delay payment reductions and data reporting periods for the Clinical Laboratory Fee Schedule under the Protecting Access to Medicare Act (PAMA). Legislation could improve patient access to laboratory tests used to diagnose, monitor, prevent, and manage diseases for Medicare beneficiaries.

Client expense: $327,208 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

Prescription drug industry issues relating to domestic construction and maintenance, prescription drug pricing, and employment issues, generally; S.127 - Pharmacy Benefit Manager Transparency Act of 2023; S.113 - Prescription Pricing for the People Act of 2023; H.R.830 - HELP Copays Act; S. 1542 - Delinking Revenue from Unfair Gouging Act (a/k/a The DRUG Act"); HR 4895 - H.R. 4895: Lowering Drug Costs for American Families Act; H.R. 2880: Protecting Patients Against PBM Abuses Act; HR 6283 - The Drug Act; HR 5378 - Lower Costs, More Transparency Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription drug industry issues relating to domestic construction and maintenance, prescription drug pricing, and employment issues, generally; S.127 - Pharmacy Benefit Manager Transparency Act of 2023; S.113 - Prescription Pricing for the People Act of 2023; H.R.830 - HELP Copays Act; S. 1542 - Delinking Revenue from Unfair Gouging Act (a/k/a The DRUG Act"); HR 4895 - H.R. 4895: Lowering Drug Costs for American Families Act; H.R. 2880: Protecting Patients Against PBM Abuses Act; HR 6283 - The Drug Act; HR 5378 - Lower Costs, More Transparency Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Coronavirus (COVID-19) Pandemic ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---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. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Drug Pricing ---FY 2024 Appropriations ---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.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures 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 ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations 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 ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---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 ---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 ---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 2024 Appropriations ---FY 2025 Appropriations ---H.R.2630/S.652: SAFE STEP Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Client expense: $1,760,000 · Firm income: Not reported

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

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 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 ---American Pandemic Preparedness Plan (AP3) ---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 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---Interchangeability and Pharmacy Substitution ---Reimbursement Coronavirus (COVID-19) Pandemic ---COVID-19 Lessons Learned ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Implementation of Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---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. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy 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 ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---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 ---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 ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---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.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures 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 ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---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 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---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 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry 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 ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency 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 Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 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 ---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 ---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 2024 Appropriations ---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 2024 Appropriations ---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)

Client expense: $1,760,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 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 ---American Pandemic Preparedness Plan (AP3) ---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 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---Interchangeability and Pharmacy Substitution ---Reimbursement Coronavirus (COVID-19) Pandemic ---COVID-19 Lessons Learned ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Implementation of Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---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. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy 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 ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---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 ---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 ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---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.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures 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 ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---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 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---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 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry 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 ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency 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 Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 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 ---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 ---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 2024 Appropriations ---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 2024 Appropriations ---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)

Client expense: $1,760,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Coronavirus (COVID-19) Pandemic ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---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. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Drug Pricing ---FY 2024 Appropriations ---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.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures 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 ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations 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 ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---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 ---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 ---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 2024 Appropriations ---FY 2025 Appropriations ---H.R.2630/S.652: SAFE STEP Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Client expense: $1,760,000 · Firm income: Not reported

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

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications 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. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act 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 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 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. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response 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. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern__ Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues H.R.7024 - Tax Relief for American Families and Workers Act of 2024 Vaccine provisions of the Inflation Reduction Act

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

HR 830/S 1375 - HELP Copays Act S 127 - Pharmacy Benefit Manager Transparency Act HR 2630/ S 652 - Safe Step Act HR 1770/S 2477 - Equitable Community Access to Pharmacist Services Act HR 2407/S 2085 - Medicare Multi-Cancer Early Detection Screening Coverage Act S 1246/HR 4895 - SMART Prices Act HR 4818/S 2407 - Treat and Reduce Obesity Act of 2023 Continuation of the Inflation Reduction Act

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussions regarding health equity H.R.830, HELP Copays Act of 2023 H.R.3561, The PATIENT Act H.R.4895, Lowering Drug Costs for American Families Act Biosimilars reimbursement issues International Reference Pricing/Most Favored Nation, regarding all bio-pharmaceutical issues Ensuring Pathways to Innovation Cures (EPIC) Act ORPHAN Act Implementation of Inflation Reduction Act of 2022 MINI Act

Client expense: $600,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 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. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications 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. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act 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 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 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. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response 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. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $9,600,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE