Medicaid VBPs for Patients Act

H.R.7384/S.4583, Creating Hope Reauthorization Act H.R.2666/S.4204, Medicaid VBPs for Patients (MVP) Act H.R.9184, Patient Access Act of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocate on issues related to regulation of, access to, and reimbursement for regenerative medicine companies and products. Value Based Payment legislation. CMS policies regarding Value Based legislation. FDA appropriations. FDA staffing. Prescription Drug User Fee Act (PDUFA). Medicaid reimbursement. Provider credentialing. Medicare reimbursement. NTAP. Medicaid VBPs for Patients (MVP) Act (H.R.2666/S.4204). Accelerating Kids Access to Care Act (S.2372/H.R.4758). MDRP. CMMI. Creating Hope Reauthorization Act of 2024 (H.R.7384/S.4583). Rare Pediatric Disease Designation and Priority Review Voucher (PRV) Programs. Preventive Health Savings Act (H.R.766/S.114). Patient Access Act of 2024 (H.R.9184).

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

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

Monitored implementation of P.L. 117-169, the Inflation Reduction Act, as it relates to drug pricing. Monitored issues related to Ambulatory Surgical Centers. H.R. 2666, the Medicaid VBPs for Patients (MVP) Act. Issues related to preventative services. Issues related to pharmacy benefit management. Issues related to the Medicaid Drug Rebate Program. Monitored issues related to Medicare physician payment. H.R. 10445, Furthering Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025, as it relates to pharmacy benefit management. H.R. 10545, The American Relief Act of 2025.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Monitored the implementation of P.L. 117-169, the Inflation Reduction Act, as it relates to drug pricing. H.R. 2666, the Medicaid VBPs for Patients (MVP) Act, and issues related to value-based payment arrangements. Issues related to Medicaid Drug Rebate Program. H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023. Issues concerning cybersecurity. H.R. 10445, Furthering Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025, as it relates to access to home infusion and pharmacy benefit management reforms. H.R. 10545, The American Relief Act of 2025.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 485 - Protecting Health Care For All Patients Act of 2023 - Rep. McMorris Rodgers, Cathy - federal programs using prices based on quality-adjusted life years H.R. 824 - Telehealth Benefit Expansion for Workers Act of 2023 - Rep. Walberg, Tim - telehealth and ERISA amendments H.R. 830 - HELP Copays Act - Rep. Carter, Earl - health insurers responsibility for payments made by or on behalf of a plan enrollee toward a plans cost-sharing requirements H.R. 1488 - Affordable Insulin Now Act of 2023 - Rep. Craig, Angie - cost-sharing for insulin products H.R. 2666 - MVP Act - Rep. Guthrie, Brett - value-based purchasing arrangements under Medicaid program and reforms to price reporting H.R. 2691 - Transparent Price Act - Rep. McMorris Rodgers, Cathy - health insurer price transparency H.R. 2813 - Self-Insurance Protection Act - Rep. Good, Bob - ERISA amendments H.R. 2868 - Association Health Plans Act - Rep. Walberg, Tim - ERISA amendments H.R. 3305 - Black Maternal Health Momnibus Act - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 3561 - PATIENT Act - Rep. McMorris Rodgers, Cathy - PBM transparency, PBM contract design, health insurance transparency, hospital transparency H.R. 3799 - Custom Health Option and Individual Care Expense Arrangement Act- Rep. Hern, Kevin - health reimbursement arrangements H.R. 7623 - Telehealth Modernization Act of 2024- Rep. Carter, Buddy - including requirements for Part D plan contracts with PBMs including transparency and delinking provisions H.R. 7858 - Telehealth Enhancement for Mental Health Act of 2024 - Rep. James, John - Medicare, behavioral health, telehealth H.R. 9572 - Enhanced Enforcement of Health Coverage Act - Rep. Murphy, Gregory - increased penalties of surprise billing violations H.R. 10445 - Further Continuing Appropriations and Disaster Relief Supplement Appropriations Act, 2025 - Rep. Cole, Tom - to fund the federal government through March 14, 2025 as well as extension of several health care policies S. 3393 - SUPPORT for Patients and Communities Reauthorization Act. - Sen. Sanders, Bernie - SUD treatment S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 - Sen. Wyden, Ron - mental health, telehealth, health workforce S. 3612 - Access to Family Building Act- Sen. Duckworth, Tammy- right to access reproductive technology (ex. IVF) S. 3805 - A bill to amend title XI of the Social Security Act to prohibit health plans from imposing fees on health care providers for electronic funds transfers and health care payment and remittance advice transactions, and for other purposes. - Sen. Cassidy, Bill - SSA, healthcare, electronic funds, payments, remittance S. 4357 - Comprehensive Dental Reform Act of 2024- Sen. Sanders, Bernie - promotes access to oral health care S. 4358 - Preventing and Treating Substance Use Disorders Among Older Adults Act- Sen. Casey, Robert - SAMHSA grant program for SUDs S. 4554 - Reproductive Freedom for Women Act- Sen. Murray, Patty - protecting abortion and reproductive rights Issues related to broadband and public health infrastructure; mental health and telehealth; behavioral health; rural health; substance use disorder treatments; Health Savings Accounts; provider directories; artificial intelligence and privacy; insurance industry response to and support for providers regarding the Change Healthcare cyberattack and broader cyber security issues; ACA Marketplace; and Mental Health Parity Proposed Rule.

Client expense: $2,610,000 · Firm income: Not reported

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

H.R.7384/S.4583, Creating Hope Reauthorization Act H.R.2666/S.4204, Medicaid VBPs for Patients (MVP) Act H.R.9184, Patient Access Act of 2024

Client expense: Not reported · Firm income: Not reported

H.R. 2666/S. 4204, the Medicaid VBPs for Patients (MVP) Act; Center for Medicare and Medicaid Innovations (CMMI) Cell and Gene Therapy Access Model; H.R. 4758/S. 2372, Accelerating Kids Access to Care Act; H.R. 7384, Creating Hope Reauthorization Act of 2024; H.R. 10545, American Relief Act, 2025

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

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. 2691, Transparent 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. 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); S.150, the Affordable Prescription Drug for Patients Act; S. 142, the Preserve Access to Affordable Generics and Biosimilars Act; S. 5503, H.R. 10362, the Patients Before Monopolies (PBM) Act; P.L. No: 118-158 and draft FY2025 Continuing Resolution, issues related to PBMs.

Client expense: $1,420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2666: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); ALL PROVISIONS OF THE BILL HR 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL HR 6094: PROVIDING REALISTIC OPPORTUNITY TO EQUAL AND COMPARABLE TREATMENT FOR RARE ACT (PROTECT RARE ACT); ALL PROVISIONS OF THE BILL S 4204: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); ALL PROVISIONS OF THE BILL S 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING MEDICAID ACCESS TO RARE DISEASE THERAPIES AND ACCESS TO OUT OF STATE PROVIDER TELEHEALTH

Client expense: $490,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS OF THE BILL HR 2630: SAFE STEP ACT; ALL PROVISIONS OF THE BILL HR 2666: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); PROVISIONS RELATED TO OUTCOME BASED ARRANGEMENTS (OBA) AND VALUE BASED ARRANGEMENTS (VBA) HR 4758: ACCELERATING KIDS' ACCESS TO CARE ACT: ALL PROVISIONS OF THE BILL HR 7384: CREATING HOPE REAUTHORIZATION ACT OF 2024; ALL PROVISIONS OF THE BILL HR 8574: 340B AFFORDABLE CARE FOR COMMUNITIES AND ENSURING A STRONG SAFETY-NET (ACCESS) ACT; ALL PROVISIONS OF THE BILL HR 9184: PATIENT ACCESS ACT OF 2024; ALL PROVISIONS OF THE BILL S 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL S 4583: CREATING HOPE REAUTHORIZATION ACT OF 2024; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING GENETIC SCREENING, LONG TERM FOLLOW UP, CURES 3.0, AND ORPHAN DRUG ACT

Client expense: $490,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2666/S. 4204 - MVP Act, all provisions. H.R. 10445 - Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025, issues related to PRV and the Accelerating Kids Access to Care Act. Issues related to the CMMI demonstration on Gene and Cell Therapy.

Client expense: $250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1613, Drug Price Transparency in Medicaid Act of 2023 H.R. 2666, Medicaid VBPs for Patients (MVP) Act H.R. 7174, 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. 7635, The 340B PATIENTS Act of 2024 Issues relating to, Medicare; Medicare Part B and D drug pricing issues; 340B program integrity; 340B of the Public Health Services Act; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; FY-2024 Budget and Appropriations Legislation; Medicaid drug rebate program (MDRP); Medicare coverage of COVID antiviral medicines.

Client expense: $1,730,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Issues related to plasma therapies. H.R. 6465 / S.4741, Preserving Life-saving Access to Specialty Medicines in America (PLASMA) Act. Issues related to gene therapies. H.R. 2666, the Medicaid VBPs for Patients (MVP) Act and issues related to value-based payments. Issues related to drug shortages. Issues related to the Medicaid Drug Rebate Program. Monitored implementation of P.L. 117-169, the Inflation Reduction Act, as it relates to plasma derived products and drug pricing. Monitored issues related to pharmacy benefit management.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitored implementation of P.L. 117-169, the Inflation Reduction Act, as it relates to drug pricing. Monitored issues related to Ambulatory Surgical Centers. H.R. 2666, the Medicaid VBPs for Patients (MVP) Act. Issues related to preventative services. Issues related to pharmacy benefit management. Issues related to the Medicaid Drug Rebate Program. Monitored issues related to Medicare physician payment. H.R. 10445, Furthering Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 and H.R. 10545, The American Relief Act of 2025, as they relate to pharmacy benefit management.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Issues related to the development of gene therapies for rare diseases S. 4204/ H.R. 2666 MVP ACT

Client expense: Not reported · Firm income: $60,000

Reimbursement for hemophilia services and treatments in Medicare Reimbursement for hemophilia services and treatments in Medicaid Issues related to 1115 Waivers in Medicaid Preserving and expanding access to Medicaid Providing Realistic Opportunity to Equal and Comparable Treatment (PROTECT) for Rare Act (H.R. 6094) The Menstrual Equity for All Act (H.R. 3646) Medicaid VBPs for Patients (MVP) Act (H.R. 2666/S.4204) Accelerating Kids Access to Care Act (S. 2372)

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

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

Transparency Policy Issues, Medicare Part D, Coverage Gap, Rebate Reform, Out-of-Pocket Costs; H.R. 1825/S. 2821 PSA Screening for HIM Act; Issues related to IRA (Pub. L 117-169); Issues pertaining to Current Procedural Terminology (CPT) codes (no specific bills); H.R. 2666, MVP Act.

Client expense: $670,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to managed care pharmacists; H.R. 1458/S.723 - Access to Prescription Digital Therapeutics Act of 2023; H.R. 2666/S. 4204 - the Medicaid VBPs for Patients (MVP).

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2666/S 4204 - Medicaid Value-Based Payments for Patients (MVP) Act HR 4758/S 2372 - Accelerating Kids' Access to Care Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Value-based pricing arrangements; MVP Act - HR 2666

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues and legislation related to access to gene therapies and treatment of rare diseases; the Medicaid VBPs for Patients (MVP) Act (H.R. 2666); Creating Hope Reauthorization Act (H.R. 7384 / S. 4583); Patient Access Act (H.R. 9184)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Issues and legislation related to access to gene therapies and treatment of rare diseases; the Medicaid VBPs for Patients (MVP) Act (H.R. 2666); Creating Hope Reauthorization Act (H.R. 7384 / S. 4583); Patient Access Act (H.R. 9184)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Q4 Lobbying Report (Oct.1 -Dec. 31) HCR Transparency (surprise medical bills; public posting of hospital charges) 340B Drug Pricing Program Resident Physician Shortage Act of 2023 (H.R. 2389) No Surprises Act regulations Food and Drug Amendments No Surprise Bills for New Moms Act (H.R. 3387) Securing the U.S. Organ Procurement and Transplantation Network Act (H.R. 2544) Promoting Access to Treatments and Increasing Extremely Needed Transparency Act (H.R. 3561) Medicaid VBPs for Patients (MVP) Act (H.R. 2666) Providers and Payers COMPETE Act (H.R. 3284) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program (H.R. 3290) Transparent PRICE Act (H.R. 3281/H.R. 2691)) Resident Physician Shortage Reduction (S. 1302) Medical Student Education Authorization Act (H.R. 3046) Save Americas Rural Hospitals Act (H.R. 833) Chronic Care Management Improvement Act (H.R. 2829) Safety From Violence for Healthcare Employees Act (H.R. 2584) Supporting Safety Net Hospitals Act (H.R. 2665) Patient Access to Higher Quality Health Care Act (H.R. 977/S.470) FEMA re: COVID-19 related reimbursement Public Health Guidance Transparency and Accountability Act of 2023 (H.R. 4529) Public Health Emergency Congressional Review Act (H.R. 4381) CDC Leadership Accountability Act of 2023 (H.R. 3813) Preparing for All Hazards and Pathogens Reauthorization Act (H.R. 4421) Preparedness and Response Reauthorization Act (H.R. 4420) Childrens Hospital GME Support Reauthorization Act of 2023 (H.R. 3887) Health Care Price Transparency Act of 2023 (H.R. 4822) Providers and Payers COMPETE Act (H.R. 3284) Lower Costs, More Transparency Act (H.R. 5378 Transparency in Coverage Act (H.R. 4507) GOLD Card Act of 2023 (H.R. 4968) No Fees for EFTs Act (H.R.6487) Rural Health Care Facilities Revitalization Act (H.R. 5989) Dr. Lorna Breen Health Care Provider Protection Reauthorization Act (H.R. 7153) To amend title XVIII of the Social Security Act to establish a definition of essential health system in statute (H.R. 7397) Substance Use Disorder Workforce Act (H.R. 7050) 340B PATIENTS Act (H.R. 7635) The 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act (H.R. 8574) Improving Seniors Access to Timely Care Act (H.R. 8702/S.4532) The Preserving Emergency Access in Key Sites (PEAKS) Act (H.R. 7931) Rural Health Care Facilities Revitalization Act (H.R. 5989) MMM Accelerated and Advance Payment Program repayment flexibility Graduate Medical Education (GME) funding Telehealth flexibilities and payment Annual Prospective Payment System Rules Organ acquisition payment policies Californias Medicaid Hospital Quality Assurance Fee Program Medicare Advantage BUD FY 2025 Appropriations bills Nursing and allied health workforce funding FY 2025 budget request Further Continuing Appropriations and Other Extensions Act (H.R. 6363) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R. 5894) Tax Relief for American Families and Workers Act of 2024 (H.R. 7024) Extension of Continuing Appropriations and Other Matters Act, 2024 (H.R. 7463) Submitted Comments Regulatory Comment Letters SUBJECT: CMS-10913, Medicare Part C Utilization Management Annual Data Submission and Audit Protocol Data Request; Notice, Agency Information Collection Activities: Proposed Collection; Comment Request; Federal Register (Vol 89, No 145), September 10, 2024

Client expense: $300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Social Security Administration (SSA)

CMS policies and federal legislation regarding Value Based payment legislation; Promote policies to support value based payment; Accelerating Kids Access to Care Act (S. 2372/ HR 4758); MVP Act (HR 2666).

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

CMS policies and federal legislation regarding Value Based payment legislation; Promote policies to support value based payment; Accelerating Kids Access to Care Act (S. 2372/ HR 4758); MVP Act (HR 2666).

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Access for inpatient gene therapies Monitor newborn screening issues. Pediatric Review Reauthorization. H.R.2666/S.4204 - MVP Act. H.R.4758/S.2372 - Accelerating Kids Access to Care Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the implementation of H.R.5547/S.476 - Maintaining Investments in New Innovation Act and H.R.7384 - Creating Hope Reauthorization Act of 2024. Pediatric Review Reauthorization. H.R.5539/S.3131 - ORPHAN Cures Act. H.R.2666/S.4204 - MVP Act. H.R.4758/S.2372 - Accelerating Kids Access to Care Act.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

VICP Reform and Excise Tax Inflation Reduction Act (IRA) HR7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Part D Payer Utilization Management Drug Shortages S2916 - Prescription Information Modernization Act of 2023 Vaccines, Clinical Trials and Coverage S2305 - Biosimilar Red Tape Elimination Act Biosimilar Access and Interchangeability HR 2666 - Medicaid Value Based Payments for Patients (MVP) Act HR 4758 - Accelerating Kids Access to Care Act HR 7384 - Rare Pediatric Disease Priority Review (PRV) Voucher Trade-Related Aspects of Intellectual Property Rights March-in Framework Guidance and Policies S.79 - Interagency Patent Coordination and Improvement Act of 2023 S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.150 - Affordable Prescriptions for Patients Act of 2023 S.2780 - Medication Affordability and Patent Integrity Act Digital: Data Flows and Digital Trade

Client expense: $1,070,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE

HR 2666 - MVP Act HR 7384 - Creating Hope Reauthorization Act of 2024 Safe Labor Draft Legislation

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access to Prescription Digital Therapeutics Act of 2023 (S. 723/H.R. 1458) - To create a benefit category under Medicare and Medicaid allowing for the coverage of prescription digital therapeutics Medicaid VBPs for Patients Act (H.R. 2666) - To codify the existing Medicaid "multiple best price" rule related to value-based purchasing arrangements for drug therapies in Medicaid programs, to expand the use of value-based arrangements to drugs covered under Medicaid administered in an inpatient setting, and to make technical changes to pharmaceutical manufacturer report requirements to CMS related to these changes. Equitable Community Access to Pharmacy Services Act (H.R. 1770) - To make permanent certain emergency authorizations from the COVID-19 public health emergency related to pharmacist-provided care for COVID-19, RSV, and influenza (such as testing and immunization) and to allow reimbursement for these services under Medicare Part B. Also to automatically implement these authorizations for future public health emergencies declared under either the Public Health Service Act or the PREP Act.

Client expense: $100,000 · 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), SENATE

Access to Prescription Digital Therapeutics Act of 2023 (S. 723/H.R. 1458) - To create a benefit category under Medicare and Medicaid allowing for the coverage of prescription digital therapeutics Medicaid VBPs for Patients Act (H.R. 2666) - To codify the existing Medicaid "multiple best price" rule related to value-based purchasing arrangements for drug therapies in Medicaid programs, to expand the use of value-based arrangements to drugs covered under Medicaid administered in an inpatient setting, and to make technical changes to pharmaceutical manufacturer report requirements to CMS related to these changes. Equitable Community Access to Pharmacy Services Act (H.R. 1770) - To make permanent certain emergency authorizations from the COVID-19 public health emergency related to pharmacist-provided care for COVID-19, RSV, and influenza (such as testing and immunization) and to allow reimbursement for these services under Medicare Part B. Also to automatically implement these authorizations for future public health emergencies declared under either the Public Health Service Act or the PREP Act.

Client expense: $100,000 · 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), SENATE

H.R. 485 - Protecting Health Care For All Patients Act of 2023 - Rep. McMorris Rodgers, Cathy - federal programs using prices based on quality-adjusted life years H.R. 824 - Telehealth Benefit Expansion for Workers Act of 2023 - Rep. Walberg, Tim - telehealth and ERISA amendments H.R. 830 - HELP Copays Act - Rep. Carter, Earl - health insurers responsibility for payments made by or on behalf of a plan enrollee toward a plans cost-sharing requirements H.R. 1488 - Affordable Insulin Now Act of 2023 - Rep. Craig, Angie - cost-sharing for insulin products H.R. 2666 - MVP Act - Rep. Guthrie, Brett - value-based purchasing arrangements under Medicaid program and reforms to price reporting H.R. 2691 - Transparent Price Act - Rep. McMorris Rodgers, Cathy - health insurer price transparency H.R. 2813 - Self-Insurance Protection Act - Rep. Good, Bob - ERISA amendments H.R. 2868 - Association Health Plans Act - Rep. Walberg, Tim - ERISA amendments H.R. 2872 - Further Additional Continuing Appropriations and Other Extensions Act, 2024 - Rep. Graves, Garret - extends FY24 funding and program authorities through March 8, 2024 H.R. 2882 - Further Consolidated Appropriations Act, 2024 - Rep. Ciscomani, Juan - provides annual funding through September 30, 2024, for the Departments of Labor, Health and Human Services, and Education, and Related Agencies H.R. 3305 - Black Maternal Health Momnibus Act - Rep. Underwood, Lauren - maternal health including in Medicaid and CHIP H.R. 3561 - PATIENT Act - Rep. McMorris Rodgers, Cathy - PBM transparency, PBM contract design, health insurance transparency, hospital transparency H.R. 3799 - Custom Health Option and Individual Care Expense Arrangement Act- Rep. Hern, Kevin - health reimbursement arrangements H.R. 3801 - Employer Reporting Improvement Act - Rep. Smith, Adrian - ACA reporting requirements H.R. 6956 - Opioid Settlement Accountability Act - Rep. Kaptur, Marcy - funding for opioid prevention and treatment services, training, equipment, and social support services H.R. 6960 - Emergency Medical Services for Children Reauthorization Act of 2024 - Rep. Carter, Earl L. Buddy - funding for emergency medical services for children program H.R. 7513 - Protecting Americas Seniors Access to Care Act - Rep. Fischbach, Michelle - regarding minimum staffing for nursing facilities H.R. 7623 - Telehealth Modernization Act of 2024- Rep. Carter, Buddy - including requirements for Part D plan contracts with PBMs including transparency and delinking provisions H.R. 7858 - Telehealth Enhancement for Mental Health Act of 2024 - Rep. James, John - Medicare, behavioral health, telehealth H.R. 7899 - To direct the Attorney General, in consultation with the Secretary of Health and Human Services, to promulgate the final regulations relating to special registration for telemedicine. - Rep. Ezell, Mike - telehealth H.R. 7907 - Welcome Back to the Health Care Workforce Act - Rep. Krishnamoorthi, Raja- grants/funding, health care workforce H.R. 7929 - Nursing Home Workforce Support and Expansion Act of 2024 - Rep. Horsford, Steven - grants/funding, health care workforce H.R. 7994 - Long-Term Care Workforce Support Act - Rep. Dingell, Debbie - health care workforce H.R. 8444 - Mental Health in Schools Act - Rep. Napolitano, Grace - grant to promote mental health S. 1606 - A bill to end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes. - Sen. Booker, Cory - maternal mortality S. 3393 - SUPPORT for Patients and Communities Reauthorization Act. - Sen. Sanders, Bernie - SUD treatment S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 - Sen. Wyden, Ron - mental health, telehealth, health workforce S. 3612 - Access to Family Building Act- Sen. Duckworth, Tammy- right to access reproductive technology (ex. IVF) S. 3756 - At HOME Services Act of 2024- Sen. Rubio, Marco- pilot program for outpatient observation, acute care at home S. 3775 - BOLD Infrastructure for Alzheimers Reauthorization Act of 2024- Sen. Collins, Susan - healthcare infrastructure, Alzheimers S. 3805 - A bill to amend title XI of the Social Security Act to prohibit health plans from imposing fees on health care providers for electronic funds transfers and health care payment and remittance advice transactions, and for other purposes. - Sen. Cassidy, Bill - SSA, healthcare, electronic funds, payments, remittance S. 3847 - Improving Social Determinants of Health Act of 2024- Sen. Smith, Tina- CDC authorization S. 4088 - Welcome Back to the Health Care Workforce Act - Sen. Kaine, Tim - grants/funding, health care workforce S. 4120 - Long-Term Care Workforce Support Act - Sen. Casey, Robert P., Jr. - health care workforce S. 4195 - Childhood Diabetes Reduction Act of 2024 - Sen. Sanders, Bernie - nutrition labeling S. 4357 - Comprehensive Dental Reform Act of 2024- Sen. Sanders, Bernie - promotes access to oral health care S. 4358 - Preventing and Treating Substance Use Disorders Among Older Adults Act- Sen. Casey, Robert - SAMHSA grant program for SUDs S. 4554 - Reproductive Freedom for Women Act- Sen. Murray, Patty - protecting abortion and reproductive rights Issues related to broadband and public health infrastructure; mental health and telehealth; behavioral health; rural health; substance use disorder treatments; Health Savings Accounts; provider directories; artificial intelligence and privacy; insurance industry response to and support for providers regarding the Change Healthcare cyberattack and broader cyber security issues; ACA Marketplace; and Mental Health Parity Proposed Rule.

Client expense: $2,560,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Advocate on issues related to regulation of, access to, and reimbursement for regenerative medicine companies and products. Value Based Payment legislation. CMS policies regarding Value Based legislation. FDA appropriations. FDA staffing. Prescription Drug User Fee Act (PDUFA). Medicaid reimbursement. Provider credentialing. Medicare reimbursement. NTAP. Medicaid VBPs for Patients (MVP) Act (H.R.2666/S.4204). Accelerating Kids Access to Care Act (S.2372/H.R.4758). MDRP. CMMI. Creating Hope Reauthorization Act of 2024 (H.R.7384/S.4583). Rare Pediatric Disease Designation and Priority Review Voucher (PRV) Programs. Preventive Health Savings Act (H.R.766/S.114). Patient Access Act of 2024 (H.R.9184).

Client expense: $150,000 · Firm income: Not reported

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

H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act H.R. 8261: Preserving Telehealth, Hospital, and Ambulance Access Act S. 1450: Cutting Medicare Prescription Drug Prices in Half 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 Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY 2026 and Maximum Fair Prices policy issues CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P) Medicaid Drug Rebate Program Final rule (CMS-2434-F)

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

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

HR 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS OF THE BILL HR 2630: SAFE STEP ACT; ALL PROVISIONS OF THE BILL HR 2666: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); PROVISIONS RELATED TO OUTCOME BASED ARRANGEMENTS (OBA) AND VALUE BASED ARRANGEMENTS (VBA) HR 7384: CREATING HOPE REAUTHORIZATION ACT OF 2024; ALL PROVISIONS OF THE BILL HR 8574: 340B AFFORDABLE CARE FOR COMMUNITIES AND ENSURING A STRONG SAFETY-NET (ACCESS) ACT; ALL PROVISIONS OF THE BILL HR 9184: PATIENT ACCESS ACT OF 2024; ALL PROVISIONS OF THE BILL S 4583: CREATING HOPE REAUTHORIZATION ACT OF 2024; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING GENETIC SCREENING, LONG TERM FOLLOW UP, CURES 3.0

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2666: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); ALL PROVISIONS OF THE BILL HR 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL HR 6094: PROVIDING REALISTIC OPPORTUNITY TO EQUAL AND COMPARABLE TREATMENT FOR RARE ACT (PROTECT RARE ACT); ALL PROVISIONS OF THE BILL S 4204: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); ALL PROVISIONS OF THE BILL S 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING MEDICAID ACCESS TO RARE DISEASE THERAPIES AND ACCESS TO OUT OF STATE PROVIDER TELEHEALTH

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Amending Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169); e-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions; Value-based payment arrangements; CMMI; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Efforts to improve coding, coverage, and access for rare disease therapies; Medicaid Drug Rebate Program proposed rule, specifically the stacking rule; Medicare patient access to rare disease therapies, Part B and Part D drugs; Centers for Medicare and Medicaid Innovation (CMMI) policy issues; Center for Medicare and Medicaid Innovation models; General issues related to diagnostic reimbursement; H.R. 5539/S. 3131 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act; HR1503/S2916 Prescription Information Modernization Act; H.R. 3876 Access to Genetic Counselor Services Act of 2023; H.R. 2666 Medicaid VBPs for Patients Act.

Client expense: $650,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office

HR 2666 - Medicaid Value-Based Payments for Patients (MVP) Act S 4204 - Medicaid Value-Based Payments for Patients (MVP) Act HR 4758 - Accelerating Kids' Access to Care Act Medicaid Program: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434-P)

Client expense: $60,000 · Firm income: Not reported

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

Issues related to plasma therapies. H.R. 6465 / S.4741, Preserving Life-saving Access to Specialty Medicines in America (PLASMA) Act. Issues related to gene therapies. H.R. 2666, the Medicaid VBPs for Patients (MVP) Act and issues related to value-based payments. Issues related to drug shortages. Issues related to the Medicaid Drug Rebate Program. Monitored implementation of P.L. 117-169, the Inflation Reduction Act, as it relates to plasma derived products and drug pricing. Monitored issues related to pharmacy benefit management.

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

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