Creating Hope Reauthorization Act of 2024

Legislation regarding FDA and clinical research, particularly with respect to rare disease and orphan drug development and the accelerated approval pathway, and related legislation regarding FY 2024 Appropriations. FY 2025 appropriations for CDC newborn screening programs. HR 7384/S. 4583, Creating Hope Reauthorization Act to renew PRV program. HR 10445, the Continuing Resolution and provisions related to the PRV program.

Client expense: $100,000 · Firm income: Not reported

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

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

H.R. 7384/S. 4583, the Creating Hope Reauthorization Act of 2024 H.R. 4758/S. 2372, the Accelerating Kids Access to Care Act H.R. 3433, the Give Kids A Chance Act General discussions about ultra-rare disease drug development General discussions about regulatory reform, including scientific-focused drug development meetings H.R. 1092/S. 526, the BENEFIT Act General discussions about mitochondrial diseases H.R. 9979, the Scientific EXPERT Act of 2024 General discussions about ultra-rare diseases FDA Rare Disease Innovation Hub

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

-S. 5353/H.R. 10210, National Plan for Epilepsy Act, support passage. -Support legislation to increase access to home and community-based services. -S. 652/H.R. 2630, Safe Step Act, support passage. -S. 1375/H.R. 830, HELP Copays Act, support passage. -S. 1339, PBM Reform Act, support patient-centric reforms including addition of the Safe Step Act and HELP Copays Act. -H.R. 2880, Protecting Patients Against PBM Abuses Act -Support preservation of Medicare Part Ds Six Protected Classes policy -Reauthorization of the Advance Premium Tax Credits -Support patient-centric implementation of Medicare Part D out-of-pocket cap and the Medicare Prescription Payment Plan -Urge patient priorities like standardized health plans and network adequacy in the 2026 Notice of Benefit and Payment Parameters rule. -Ensure any regulation of cannabis protects safe and legal access -Ensure continued access to needed healthcare via telehealth including prescribing of epilepsy medications that are controlled substances -Requests to join the Congressional Epilepsy Caucus. -H.R. 824, the Telehealth Benefit Expansion for Workers Act, oppose passage. -Support H.R. 670, S. 4174, Think Differently Database Act -Support S. 4325, the Lifespan Respite Care Program Reauthorization Act -Support the parity of coverage of mental health treatments -Support legislation and regulations that incentivize the development of rare disease treatments -Support the Clinical Trial Modernization Act -Support legislation and regulations that help to advance health equity for people with epilepsy -S. 5065/H.R. 9635, Seizure Awareness and Preparedness Act, support passage -Support legislation and regulations that would ban the use of electric shock devices that apply a shock to a persons skin to reduce or cease self-injurious or aggressive behaviors, including supporting the immediate release of a final rule -Supporting legislation and regulations that protect the current structure of the National Institutes of Health -Support legislation and regulations to keep insurance brokers accountable -Support H.R. 7573, Stop Medicaid Recovery Act -Support legislation and regulations on continuous eligibility in Medicaid -Support H.R. 4758/S.2372, Accelerating Kids Access to Care Act -Support legislation and regulations to streamline prior authorization processes -Support the creation of an Office of Caregiving at the Department of Health and Human Services -Comments on Medicare $2 Drug List Model -Support legislation and regulations to reduce the burden of medical debt -Support legislation and regulation on the responsible use of AI in healthcare -Support S.5070, the Ensuring Access to Medicaid Buy-In Programs Act -Support H.R. 7384/S. 4583, The Creating Hope Reauthorization Act -Support the Rare Pediatric Disease Priority Review Voucher Program -Oppose any cuts to Medicaid as part of reconciliation

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of, Veterans Affairs, Dept of (VA)

Extension of Priority Review Vouchers in S 4583; HR 7384 the Creating Hope Reauthorization Act, FDA reforms to improve rare disease patient perspective input and flexibilities; HR 10545 American Relief Act of 2025

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions) H.R. 3433, Give Kids a Chance Act of 2024 (generally, no specific provisions) H.R. 7623, Telehealth Modernization Act of 2024 (generally, no specific provisions) S. 2780, Medication Affordability and Patent Integrity Act (generally, no specific provisions) S. 4583, Creating Hope Reauthorization Act of 2024 (generally, no specific provisions)

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

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. 7384/S.4583, Creating Hope Reauthorization 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

S.4426, Promising Pathway Act 2.0 H.R.7384/S.4583, the Creating Hope Reauthorization Act of 2024 H.R.4758/S.2372, Accelerating Kids Access to Care Act H.R.3433, the Give Kids a Chance Act H.R. 10545, American Relief Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor and engage on legislative and administrative action related to health care policy. Monitor and engage on legislative and administrative action related to womens health issues. Monitor and engage on legislative and administrative action related to over-the-counter consumer care products. Monitor and engage on legislative and administrative action related to dietary supplements. Monitor and engage on legislative and administrative action related to servicing of medical device equipment. Monitor and engage on legislative and administrative action related to FDA monograph reform and user fees. Monitor and engage on legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor and engage on legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor and engage on legislative and administrative action related to 340B drug discount program. Monitor and engage on legislative and administrative action related to drug supply chain issues, including pharmacy benefit manager reform. Monitor and engage on legislative and administrative action related to copay assistance. Monitor and engage on legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor and engage on legislative and administrative action related to long-acting reversable contraception usage. Monitor and engage on legislative and administrative action related to access to treatments for kidney patients. Monitor and engage on legislative and administrative action related to broader insurance coverage of supplemental imaging procedures for women with dense breast tissue. Monitor and engage on legislative and administrative action related to phenylephrine. Monitor and engage on legislative and administrative action related to e-labeling. Monitor and engage on legislative and administrative action related to DEA-determined pseudoephedrine quotas. H.R. 3086, Find It Early Act. H.R. 3433, Give Kids a Chance Act of 2023. H.R. 7384, A bill to amend the Federal Food, Drug, and Cosmetic Act to extend the authority of the Secretary of HHS to issue priority review vouchers to encourage treatments for rare pediatric diseases. H.R. 10545, American Relief Act, 2025, including pharmacy benefit manager reform. S. 4583, Creating Hope Reauthorization Act of 2024.

Client expense: $2,010,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

H.R.485, Protecting Health Care for All Patients Act H.R.5378, Lowering Costs, More Transparency Act H.R.6283/S.1542, DRUG Act H.R.1385/S.1424, DOC Access Act H.R.5608, ACCESS Act H.R.5539/S.3131, ORPHAN Cures Act H.R. 3433, Give Kids a Chance Act of 2024 H.R. 7623, Telehealth Modernization Act of 2024 S. 2780, Medication Affordability and Patent Integrity Act S. 4583, Creating Hope Reauthorization Act of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---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

PAHPA reauthorization (S. 2333 - Pandemic and All-Hazards Preparedness and Response Act; H.R. 4421 - the Preparing for All Hazards and Pathogens Reauthorization Act); Drug pricing issues; PBM reform (S. 2973 -Modernizing and Ensuring PBM Accountability Act and S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023); Rare Pediatric Disease Priority Review Voucher Program reauthorization (H.R. 7384/ S. 4583 - Creating Hope Reauthorization Act); National Vaccine Injury Compensation Program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing and value, generally Issues related to pharmacy benefit managers and drug rebate reform Issues related to drug patents and patent reporting requirements Issues related to march-in rights under the Bayh-Dole Act (Pub. L. 96-517) Creating Hope Reauthorization Act (H.R. 7384/S. 4583) Promising Pathway Act 2.0 (S.4426)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Creating Hope Reauthorization Act of 2024 - H.R. 7384 Give Kids a Chance Act of 2024 - H.R. 3433 Creating Hope Reauthorization Act of 2024 - S. 4583 March-in/Bayh-Dole Act Orphan drug policies Scientific EXPERT Act of 2024 - H.R.9979 H.R.9979 - Scientific EXPERT Act of 2024 H.R.10545 - American Relief Act, 2025

Client expense: $320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to rare disease H. R. 7384/S. 4583 - Creating Hope Reauthorization Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues impacting rare disease treatments, including rare disease research incentives; H.R. 7384/S. 4583 - Creating Hope Reauthorization Act of 2024; H.R. 3433 - Give Kids a Chance Act of 2024; American Relief Act of 2025 (PL 118-158).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Inflation Reduction Act of 2022; Issues Related to the Orphan Drug Tax Credit; Help Copays Act (HR 830 / S 1375); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); The Creating Hope Reauthorization Act (HR 7384 / S 4583) / HR 3433); BIOSECURE Act (HR 7085); The American Recovery Act (HR 10545).

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

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

Establishment of FDA Rare Disease Innovation Hub and related issues pertaining to rare disease therapy applications; reauthorization of the pediatric priority review voucher (H.R. 3433), Promising Pathways Act (S. 4426); Creating Hope Reauthorization Act of 2024 (S.4583).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pandemic preparedness; Antimicrobial resistance; Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization; PASTEUR Act (H.R. 2940, S. 1355); Rare Pediatric Disease Priority Review Voucher reauthorization. (H.R. 3433, HR 7384, S. 4583)

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

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

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act; H.R. 7384, S. 4583 - Creating Hope Reauthorization Act; H.R. 7383, S. 1214 - RARE Act; H.R. 3433 - Give Kids a Chance Act of 2023; H.R. 6664 - Innovation in Pediatric Drugs Act of 2023; H.R. 9979 - Scientific External Process for Educated Review of Therapeutics (EXPERT) Act of 2024; H.R. 3433 - Give Kids a Chance Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the implementation of the Inflation Reduction Act. H.R.5547/S.476 - Maintaining Investments in New Innovation Act. H.R.7384/S.4583 - Creating Hope Reauthorization Act of 2024. H.R.7085 - BIOSECURE Act. H.R. 5539 - ORPHAN Cures Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the implementation of the Inflation Reduction Act. H.R.5547/S.476 - Maintaining Investments in New Innovation Act. H.R.7384/S.4583 - Creating Hope Reauthorization Act of 2024. H.R.7085 - BIOSECURE Act. H.R. 5539 - ORPHAN Cures Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Research into spinal muscular atrophy, timely access to care, treatments, medical devices, and home and community-based services, newborn screening, newborn screening funding, coverage of rare disease treatments, care, and devices, including intermittent catheter (IC) coding, HCBS Access Act (H.R. 1493, S. 762), BENEFIT Act (H.R. 1092, S. 526), Safe Step Act (S. 652, H.R. 2630), Protecting Health Care for All Patients Act of 2023 (H.R. 485), Supporting Our Direct Care Workforce & Family Caregivers Act (S. 1298), Long-Term Care Workforce Support Act (S.4120/H.R.7994); HCBS Relief Act (S. 3118, H.R. 6296); Recognizing the Role of Direct Support Professionals Act (S. 1332), Medicaid unwinding protections for people with SMA and other disabilities, direct care workforce shortage, healthcare discrimination (i.e., quality adjusted life years), Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691); Creating Hope Reauthorization Act (H.R.7384/ S. 4583) - FDA priority review voucher program, healthcare utilization protocols (i.e., prior authorization and step therapy), Patient Protection and Affordable Care Act (111-148), Inflation Reduction Act (P.L. 117-169), Supporting accessible medical diagnostic equipment, Charlotte Woodward Organ Transplant Discrimination Prevention Act (H.R. 2706/S. 1183), Lifespan Respite Reauthorization Act (H.R. 6160), Stop Unfair Medicaid Recoveries Act (H.R. 7573), accessible medical diagnostic equipment, durable medical equipment, intermittent catheter coding, FDA Rare Disease Center of Excellence, Think Differently Database Act (H.R.670/ S. 4174), Accelerating Kids Access to Care Act ((H.R.4758/S.2372); Ensuring Access to Medicaid Buy-In Programs Act (H.R.8107/ S.5070); Defense Health Research Programs (Congressionally Directed Medical Research Programs)

Client expense: $75,000 · 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), Natl Institutes of Health (NIH), SENATE

Medicaid home and community-based services, continuation of HCBS services following the public health emergency, Medicaid unwinding, healthcare access and coverage, including to patient preferred treatment, assistive technology devices, accessible diagnostic equipment, and durable medical equipment, such as power wheelchairs and power wheelchair features such as seat elevators and standing systems, intermittent catheter coding, HCBS Access Act (H.R. 1493, S. 762), HCBS Relief Act (S. 3118, H.R. 6296), Supporting Our Direct Care Workforce & Family Caregivers Act (S. 1298), Recognizing the Role of Direct Support Professionals Act (S.1332), Stop Unfair Medicaid Recoveries Act (H.R. 7573), Long-term Care Workforce Support Act ((S.4120/H.R.7994), Creating Hope Reauthorization Act (H.R.7384/ S. 4583); Think Differently Database Act (H.R.670/ S. 4174); Ensuring Access to Medicaid Buy-In Programs Act (H.R.8107 / S. 5070)

Client expense: $75,000 · Firm income: Not reported

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

Research into spinal muscular atrophy, timely access to care, treatments, medical devices, and home and community-based services, newborn screening, newborn screening funding, coverage of rare disease treatments, care, and devices, including intermittent catheter (IC) coding, HCBS Access Act (H.R. 1493, S. 762), BENEFIT Act (H.R. 1092, S. 526), Safe Step Act (S. 652, H.R. 2630), Protecting Health Care for All Patients Act of 2023 (H.R. 485), Supporting Our Direct Care Workforce & Family Caregivers Act (S. 1298), Long-Term Care Workforce Support Act (S.4120/H.R.7994); HCBS Relief Act (S. 3118, H.R. 6296); Recognizing the Role of Direct Support Professionals Act (S. 1332), Medicaid unwinding protections for people with SMA and other disabilities, direct care workforce shortage, healthcare discrimination (i.e., quality adjusted life years), Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691); Creating Hope Reauthorization Act (H.R.7384/ S. 4583), healthcare utilization protocols (i.e., prior authorization and step therapy), Patient Protection and Affordable Care Act (111-148), Inflation Reduction Act (P.L. 117-169), Supporting accessible medical diagnostic equipment, Charlotte Woodward Organ Transplant Discrimination Prevention Act (H.R. 2706/S. 1183), Lifespan Respite Reauthorization Act (H.R. 6160), Stop Unfair Medicaid Recoveries Act (H.R. 7573), accessible medical diagnostic equipment, durable medical equipment, intermittent catheter coding, FDA Rare Disease Center of Excellence, Think Differently Database Act (H.R.670/ S. 4174), Accelerating Kids Access to Care Act ((H.R.4758/S.2372)

Client expense: $75,000 · 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), Natl Institutes of Health (NIH), SENATE

Medicaid home and community-based services, continuation of HCBS services following the public health emergency, Medicaid unwinding, healthcare access and coverage, including to patient preferred treatment, assistive technology devices, accessible diagnostic equipment, and durable medical equipment, such as power wheelchairs and power wheelchair features such as seat elevators and standing systems, intermittent catheter coding, HCBS Access Act (H.R. 1493, S. 762), HCBS Relief Act (S. 3118, H.R. 6296), Supporting Our Direct Care Workforce & Family Caregivers Act (S. 1298), Recognizing the Role of Direct Support Professionals Act (S.1332), Stop Unfair Medicaid Recoveries Act (H.R. 7573), Long-term Care Workforce Support Act ((S.4120/H.R.7994), Creating Hope Reauthorization Act (H.R.7384/ S. 4583); Think Differently Database Act (H.R.670/ S. 4174)

Client expense: $75,000 · 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. 7384/S. 4583, the Creating Hope Reauthorization Act of 2024 H.R. 4758/S. 2372, the Accelerating Kids Access to Care Act H.R. 3433, the Give Kids A Chance Act General discussions about ultra-rare disease drug development General discussions about regulatory reform, including scientific-focused drug development meetings H.R. 1092/S. 526, the BENEFIT Act General discussions about mitochondrial diseases

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

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: $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

Implementation of the Inflation Reduction Act of 2022; Help Copays Act (HR 830 / S 1375); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); The Creating Hope Reauthorization Act (HR 7384 / S 4583) / HR 3433); BIOSECURE Act (HR 7085).

Client expense: $220,000 · 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

Monitor and engage on legislative and administrative action related to health care policy. Monitor and engage on legislative and administrative action related to womens health issues. Monitor and engage on legislative and administrative action related to over-the-counter consumer care products. Monitor and engage on legislative and administrative action related to dietary supplements. Monitor and engage on legislative and administrative action related to servicing of medical device equipment. Monitor and engage on legislative and administrative action related to FDA monograph reform and user fees. Monitor and engage on legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor and engage on legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor and engage on legislative and administrative action related to 340B drug discount program. Monitor and engage on legislative and administrative action related to drug supply chain issues, including pharmacy benefit manager reform. Monitor and engage on legislative and administrative action related to copay assistance. Monitor and engage on legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor and engage on legislative and administrative action related to long-acting reversable contraception usage. Monitor and engage on legislative and administrative action related to access to treatments for kidney patients. Monitor and engage on legislative and administrative action related to broader insurance coverage of supplemental imaging procedures for women with dense breast tissue. Monitor and engage on legislative and administrative action related to phenylephrine. Monitor and engage on legislative and administrative action related to e-labeling. Monitor and engage on legislative and administrative action related to DEA-determined pseudoephedrine quotas. H.R. 3086, Find It Early Act. H.R. 3433, Give Kids a Chance Act of 2023. H.R. 7384, A bill to amend the Federal Food, Drug, and Cosmetic Act to extend the authority of the Secretary of HHS to issue priority review vouchers to encourage treatments for rare pediatric diseases. S. 4583, Creating Hope Reauthorization Act of 2024.

Client expense: $2,080,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions) H.R. 3433, Give Kids a Chance Act of 2024 (generally, no specific provisions) H.R. 7623, Telehealth Modernization Act of 2024 (generally, no specific provisions) S. 2780, Medication Affordability and Patent Integrity Act (generally, no specific provisions) S. 4583, Creating Hope Reauthorization Act of 2024 (generally, no specific provisions)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---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

Extension of Priority Review Vouchers in S 4583; HR 7384 the Creating Hope Reauthorization Act, FDA reforms to improve rare disease patient perspective input and flexibilities

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.4426, Promising Pathway Act 2.0 H.R.7384/S.4583, the Creating Hope Reauthorization Act of 2024 H.R.4758/S.2372, Accelerating Kids Access to Care Act H.R.3433, the Give Kids a Chance Act H.R. 7623, Telehealth Modernization Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.7384/S.4583, the Creating Hope Reauthorization Act of 2024 H.Res.1307 - Expressing support for the designation of June 20, 2024, as "World FSHD Day". H.R. 7432, Sickle Cell Disease Comprehensive Care Act S. 1852, Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023 H.R. 5539, ORPHAN Cures Act H.R. 4408/S.1644, Promising Pathway Act S.4426,Promising Pathway Act 2.0 H.R. 3100, Sickle Cell Care Expansion Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 830/S. 1375, HELP Copays Act H.R. 2630/S. 652, Safe Step Act H.R.7384/S.4583, the Creating Hope Reauthorization Act of 2024 H.R.4408/S.1906, Promising Pathway Act H.R.8702/S.4532, Improving Seniors Timely Access to Care Act of 2024 S.4905, Innovation in Pediatric Drugs Act H.R.4758/S.2372, Accelerating Kids Access to Care Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE