SMART Prices Act

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements, other contemplated "reasonable pricing price controls and patent prize schemes Repeal of Inflation Reduction Act (IRA), Sec. 5000D, drug price controls product price negotiation and 95% inflation penalty and IRA implementation S. 2305 (Biosimilar Red Tape Elimination Act) S. 2780 (Medication Affordability and Patent Integrity Act) S. 2973 (Modernizing and Ensuring PBM Accountability Act) S. 3430 (Mental Health, Lower-Cost Drug and Extenders Package)

Client expense: Not reported · Firm income: $7,600

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Inflation Reduction Act of 2022, H.R. 5376; Affordable Insulin Now Act of 2023, S. 954; Improving Health Insurance Affordability Act of 2023, S. 8; SMART Prices Act, S. 1264; Black Maternal Health Momnibus Act, H.R. 3305; Perinatal Workforce Act, S.1710; CARE for Moms, S.2846; Health Care Affordability Act of 2024, H.R. 9774

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Tax Relief and Reform Tax Relief for American Families and Workers Act of 2024: SBE Council supported U.S. Senate passage (which failed) of the House-passed bill. R&D Tax Credit-Immediate Expensing: Continue to support restoring and making permanent full expensing for R&D expenditures for small businesses. Support "American Innovation and Jobs Act" (S. 866) in the Senate and "American Innovation and R&D Competitiveness Act" (H.R. 2673) in the House. Main Street Tax Certainty Act of 2023 (S. 1706, H.R. 4721): Support House and Senate versions of the legislation to make permanent the 20-percent deduction for small-and individually-owned businesses (Section 199A). Death Tax Repeal Act of 2023 (S. 1108): Support House and Senate bills to permanent repeal the death tax and continue to support action by Congress. Tax Cuts and Jobs Act of 2017: Support extending the expiring provisions of the legislation that terminate in 2025 and have expressed opposition to raising taxes on small businesses. Regulation Regulatory Pause and Review: In light of the Supreme Court decision in Loper Bright Enterprises et al. v. Raimondo, urged President Biden and the Administration to pause all current rulemakings and stop new rules from taking effect until there is a thorough legal review of each agencys constitutional and statutory authority to regulate in the way it proposes. Joint Employer Standard: Supported the specific provision in Fiscal Year 2025 Labor, Health and Human Services, Education and Related Agencies (LHHS) Appropriations Act to prevent federal funds from being used to administer, implement, or enforce the recent National Labor Relations Board (NLRB) rule entitled Standard for Determining Joint Employer Status. Blacklisting: Expressed opposition to the unrelated blacklisting provision in the Workforce Innovation and Opportunity Act (WIOA). Basel III Endgame Implementation: Continue to express concern and opposition to the proposal by the U.S. Federal Reserve and Federal Deposit and Insurance Corporation in regard to the impact on small business capital access and affordability. Save Local Businesses Act (S.1261, HR 2826): Continue to support the legislation. Protecting the Right to Organize (PRO) Act (S. 567): Continue to oppose the legislation. The Protect Small Business and Prevent Illicit Financial Activity Act: SBE Council supports S. 3625 to delay implementation of the Corporate Transparency Act and H.R. 9278, legislation to delay the Corporate Transparency Acts year-end compliance deadline. We have also supported repeal of this measure. Consumer Financial Protection Bureaus (CFPBs) Rule Capping Credit-Card Late Fees: Continue to voice concern about the rules unintended consequences for small businesses. Prove-It Act (H.R. 7198): Continue to support the legislation. Federal Communications Commission (FCC) Safeguarding and Securing the Open Internet Rule: Continues to express concern about intrusive government control of the internet as advanced by the rule and Section 214 regulations under the proposal. The Credit Card Competition Act: Continue to oppose the legislation. Railway Safety Act (S. 576): SBE Council continues to express concern about the legislation as well as proposals to intrusively regulate the railroad industry, which is dominated by small businesses. The Small Business Regulatory Reduction Act: Continue to support full House passage. The Fishery Improvement to Streamline Untimely Regulatory Hurdles post Emergency Situation Act (FISHES Act): Continue to support House and Senate passage of the legislation. Privacy Policy: Continue to express the need for a national regulatory framework, but for Congress to consider a framework that avoids adding to the growing patchwork burden of state privacy laws, and to carefully consider unintended consequences on small businesses. SBE Council expressed opposition to H.R. 8818, the American Rights Privacy Act. Access to Capital Expanding Access to Capital Act (H.R. 2799): SBE Council supported House passage and action by the U.S. Senate. Affordable Health Coverage and Health Care Innovation Continue to voice ongoing concerns about the rising costs of health coverage and lack of choices in many markets. Voiced support for these various reforms: enhancing tax credits for small businesses, expanding and making additional fixes to HSAs, reforming QSEHRAs, and making CARESs Act telehealth provisions permanent. CHOICE Arrangement Act (H.R. 2799): Supported House passage and continue to support Senate action on the legislation. Tax Credit for Small Businesses: Support making reforms to the restrictive and temporary health care tax credit for small businesses to make it more practical for small businesses. HSA Modernization Act (H.R. 5687) and Bipartisan HSA Improvement Act (H.R. 5688): Continue to support full House action. Telehealth Expansion Act of 2023 (H.R. 1843) (S. 1001): Continue to support full House and Senate action. Telehealth Coverage and Extension: Urged Congress to intervene in Drug Enforcement Administrations non-action on allowing virtual prescriptions and other telehealth for a two-year extension. Chronic Disease Flexible Coverage Act (H.R. 3800): Supported full House passage and Senate action. Paperwork Burden Reduction Act (H.R. 3797): Supported full House passage and Senate action. Employer Reporting Improvement Act (H.R. 3801): Supported full House passage and Senate action. Small Business Flexibility Act (H.R. 3798): Support full House passage. Custom Health Option and Individual Care Expense Arrangement Act (H.R. 3799): Support full House passage. SMART Prices Act (S. 1264): Continue to oppose the legislation. Property Rights and IP March-In and the Bayh Dole Act: Continue to express opposition to a regulatory guidance proposal via the National Institutes of Health (NIST) that considers price as a basis for invalidating the patents of research and innovations seeded with federal government dollars. Trade and Global Market Access Digital Trade Principles: Continue to express concern about the U.S. pulling away from these global principles and the need for President Biden to revisit the United State Trade Representatives action to withdraw from for foundational positions on digital trade policy within the World Trade Organization (WTO). Global Trade Agreements and Access to Global Markets: Continue to advocate to the Administration the need to advance a positive and proactive U.S. trade policy that benefits all U.S. enterprises and citizens. Supporting Business Competitiveness and Startup Activity Comprehensive Resources for Entrepreneurs in the Arts to Transform the Economy (CREATE) Act: Support the legislation. Access to Broadband and Next Gen Technology BEAD Program Implementation: Continues to voice concern about the National Telecommunications and Information Administrations rate regulation provisions for broadband internet service that was specifically prohibited by Congress as part of the Infrastructure Investment and Jobs Act. Rural Internet Improvement Act of 2023 (S.130) (H.R. 3216): Continue to support the legislation. Development of a National Spectrum Strategy (NSS): Continue to express support for such a policy and the need for more spectrum to deploy next Gen technologies and 5G. Nominations NLRB Chair Lauren McFerran: Urge the Senate Health, Education, Labor, and Pensions (HELP) Committee to reject Chair Lauren McFerrans re-nomination to the National Labor Relations Board (NLRB), and expressed concern about the fact that there was no confirmation hearing.

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

Government targets: Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, White House Office

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 5021: The 340B PATIENTS Act of 2024 BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Health Equity Inflation Reduction Act of 2022 (P.L. 117-169), Implementation IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

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

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

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. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 8070, National Defense Authorization Act for Fiscal Year 2025 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. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act S. 2780, The Medication Affordability and Patent Integrity Act S.5160, A bill to expand the sharing of information with respect to suspected violations of intellectual property rights in trade Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to digital copyright piracy Potential legislation making omnibus year-end appropriations, with a focus on appropriations for USPTO and the United States Copyright Office Potential legislation related to the NIST Draft Framework on the use of march-in rights for federally funded research. Proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings (Fed. Reg. 28,693-28,706, April 19, 2024) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; modernization of the U.S. Copyright Office; patent examination practices and patent quality; patent filing fees; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; implementation of the NIST draft interagency guidance for the use of march-in rights on federally funded inventions; emerging issues surrounding artificial intelligence, intellectual property, and data protection; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; funding for the Intellectual Property Enforcement Program in FY25 Appropriations Legislation; the Reasonable Price Clause in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); WHOIS policy for .us web domains; march-in rights under the Bayh-Dole Act (P.L. 96-517); inventorship guidance for AI-assisted inventions

Client expense: $14,750,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 5021: 340B PATIENTS Act of 2024 BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Artificial intelligence policy issues Cybersecurity policy issues

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

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

Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act

Client expense: $970,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements, other contemplated "reasonable pricing price controls and patent prize schemes Repeal of Inflation Reduction Act (IRA), Sec. 5000D, drug price controls product price negotiation and 95% inflation penalty and IRA implementation S. 2305 (Biosimilar Red Tape Elimination Act) S. 2780 (Medication Affordability and Patent Integrity Act)

Client expense: Not reported · Firm income: $53,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements, other contemplated "reasonable pricing price controls and patent prize schemes Repeal of Inflation Reduction Act (IRA), Sec. 5000D, drug price controls product price negotiation and 95% inflation penalty and IRA implementation S. 2305 (Biosimilar Red Tape Elimination Act) S. 2780 (Medication Affordability and Patent Integrity Act)

Client expense: Not reported · Firm income: $53,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Inflation Reduction Act of 2022, H.R. 5376; Affordable Insulin Now Act of 2023, S. 954; Improving Health Insurance Affordability Act of 2023, S. 8; SMART Prices Act, S. 1264; Black Maternal Health Momnibus Act, H.R. 3305; Perinatal Workforce Act, S.1710; CARE for Moms, S.2846; Health Care Affordability Act of 2024, H.R. 9774

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Tax Relief and Reform Tax Relief for American Families and Workers Act of 2024 - SBE Council continues to support U.S. Senate passage. R&D Tax Credit-Immediate Expensing: Continue to support restoring and making permanent full expensing for R&D expenditures for small businesses. Support "American Innovation and Jobs Act" (S. 866) in the Senate and "American Innovation and R&D Competitiveness Act" (H.R. 2673) in the House. Main Street Tax Certainty Act of 2023 (S. 1706, H.R. 4721) - Support House and Senate versions of the legislation to make permanent the 20-percent deduction for small-and individually-owned businesses (Section 199A). Death Tax Repeal Act of 2023 (S. 1108): Support House and Senate bills to permanent repeal the death tax and continue to support action by Congress. Regulation Basel III Endgame Implementation - SBE Council has expressed concern and opposition to the proposal by the U.S. Federal Reserve and Federal Deposit and Insurance Corporation in regard to the impact on small business capital access and affordability. Regulation II as Proposed by the Federal Reserve: Opposed the notice of proposed rulemaking to amend Regulation II, which sets standards for debit card fee regulation. Urged the Federal Reserve to withdraw the proposal. Expressed opposition to further lower the cap on debit card interchange fees from 21 cents to 14.4 cents per transaction, which would harm small financial institutions and small business consumers. Congressional Review Act (CRA) Resolution to Overturn the Department of Labors Independent Contractor Rule: SBE Council supported H.J. Res 116 and S.J. Res 63 to nullify the rule. Continue to express concern about the effects of the final rule on entrepreneurship and the economy, and support general efforts in the House and Senate to promote and strengthen independent work and self-employment. DOL's Proposed Overtime Rule: Expressed concern about the final rule, support of the CRA to overturn the rule, and communicated to the Department of Labor Wage and Hour Division about the need to delay implementation due to sudden and painful impact on small businesses and legal challenges to the rule. OSHA Walkaround Rule - Oppose the final rule, and efforts in the Congress to implement the rule. Save Local Businesses Act (S.1261, HR 2826) - Support the legislation. Protecting the Right to Organize (PRO) Act (S. 567) - Continue to oppose the legislation. The Protect Small Business and Prevent Illicit Financial Activity Act - SBE Council supports S. 3625 to delay implementation of the Corporate Transparency Act, and continue to communicate concerns about widespread non-compliance due to lack of knowledge in the small business community. Federal Acquisition Regulation: Use of Project Labor Agreements for Federal Construction Projects - SBE Council opposed the final rule. SBE Council continues to educate lawmakers about the effects of PLA's on small business competition, to taxpayers and the efficacy of completing federal construction and infrastructure projects. Federal Trade Commission (FTC) Hart-Scott-Rodino (HSR) Pre-Merger Reporting Requirement Proposed Rule - SBE Council continue to oppose the rule and to point out that the FTC mistakenly certified that small businesses will not be affected by the significant changes being proposed, therefore the rule needs to be pulled. National Labor Relation Board (NLRB) Funding - SBE Council supports efforts by House and Senate appropriators to hold the line on increased funding for the NLRB. Voiced support for language that would disallow funds to be used for implementation of the final "joint employer" rule. Consumer Financial Protection Bureaus (CFPBs) Rule Capping Credit-Card Late Fees - SBE Council continues to voice concern about the rules unintended consequences for small businesses. Prove-It Act (H.R. 7198) - SBE Council continues to support House passage of the legislation, which gives small businesses a more effectual voice in federal rulemakings and strengthens federal government accountability when proposed regulations impact small businesses. Federal Communications Commission (FCC) Safeguarding and Securing the Open Internet Rule - SBE Council continues to express concerns about intrusive government control of the internet as proposed by the rule and Section 214 regulations under the proposal. The Credit Card Competition Act - SBE Council continues to oppose the legislation. Railway Safety Act (S. 576) - SBE Council continues to express concern about the legislation as well as proposals to further regulate the railroad industry, which is dominated by small businesses. The Small Business Regulatory Reduction Act - Continue to support full House passage. The Fishery Improvement to Streamline Untimely Regulatory Hurdles post Emergency Situation Act (FISHES Act) - Support the legislation in the House and Senate. Privacy Policy - Continue to express the need for a national regulatory framework, but for Congress to consider a framework that avoids adding to the growing patchwork burden of state privacy laws, and to carefully consider unintended consequences on small businesses. SBE Council expressed opposition to H.R. 8818, the American Rights Privacy Act. Access to Capital Expanding Access to Capital Act (H.R. 2799) - SBE Council supported House passage and action by the U.S. Senate. Affordable Health Coverage and Health Care Innovation Voiced ongoing concerns about the rising costs of health coverage, lack of choices, and dwindling choices in many markets against the backdrop of challenging economic conditions. Voiced support for these various reforms: enhancing tax credits for small businesses, expanding and making additional fixes to HSAs, reforming QSEHRAs, and making CARESs Act telehealth provisions permanent. CHOICE Arrangement Act (H.R. 2799) - Supported House passage and continue to support Senate action on the legislation. Tax Credit for Small Businesses: Support making reforms to the restrictive and temporary health care tax credit for small businesses to make it more practical for small businesses. HSA Modernization Act (H.R. 5687) and Bipartisan HSA Improvement Act (H.R. 5688) - Continue to support full House passage. Telehealth Expansion Act of 2023 (H.R. 1843) (S. 1001)- Continue to support full House and Senate passage. Telehealth Coverage: Urged the Drug Enforcement Administration to expedite the release of a revised proposed rule to permit and regulate the prescribing of controlled substances through telehealth, which is crucial for access to mental health, substance use disorder, and other telehealth care. Chronic Disease Flexible Coverage Act (H.R. 3800) - Support full House passage. Paperwork Burden Reduction Act (H.R. 3797) - Supported full House passage. Employer Reporting Improvement Act (H.R. 3801) - Support full House passage. Small Business Flexibility Act (H.R. 3798) - Support full House passage. Custom Health Option and Individual Care Expense Arrangement Act (H.R. 3799) - Support full House passage. SMART Prices Act (S. 1264) - Continue to oppose the legislation. Property Rights and IP Commented on U.S. Patent and Trademark Office (USPTO) Notice of Proposed Rulemaking concerning proposed modifications to the rules of practice for inter partes review (IPR) and post-grant review (PGR) proceedings before the Patent Trial and Appeal Board (PTAB). Urged USPTO to consider the input of small inventors and innovative entrepreneurial firms. Trade and Global Market Access Digital Trade Principles - Continue to express concern about the U.S. pulling away from the principles and the need for President Biden to revisit the United State Trade Representatives action to withdraw from for foundational positions on digital trade policy within the World Trade Organization (WTO). Supporting Business Competitiveness and Startup Activity Comprehensive Resources for Entrepreneurs in the Arts to Transform the Economy (CREATE) Act - SBE Council supports the legislation. Access to Broadband and Next Gen Technology BEAD Program Implementation - SBE Council continues to voice concern about the National Telecommunications and Information Administrations rate regulation provisions for broadband internet service that was specifically prohibited by Congress as part of the Infrastructure Investment and Jobs Act. Rural Internet Improvement Act of 2023 (S.130) (H.R. 3216) - Continue to support the legislation. Development of a National Spectrum Strategy (NSS) - Continue to express support for such a policy and the need for more spectrum to deploy next Gen technologies and 5G.

Client expense: $35,000 · Firm income: Not reported

Government targets: Consumer Financial Protection Bureau (CFPB), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 766: Dr. Michael C. Burgess Preventive Health Savings Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1770: Equitable Community Access to Pharmacist Services Act H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program Bayh-Done march in rights policy issues H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7024: Tax Relief for American Families and Workers Act of 2024 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 8333 BIOSECURE Act H.R.8818 American Privacy Rights Act of 2024; Provisions related to pharmaceutical industry S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs; Transparency provisions, Medicare Part D Delinking; Commerical Marketplace Delinking S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Vaccine provisions of the inflation reduction Act Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

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

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

Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act

Client expense: $1,050,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

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

Government targets: Congressional Budget Office (CBO), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

H.R. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 8070, National Defense Authorization Act for Fiscal Year 2025 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. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act Potential legislation regarding the establishment of a SEP royalty court Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to digital copyright piracy Potential legislation related to proposed reforms of the National Institutes of Health Potential legislation making omnibus year-end appropriations, with a focus on appropriations for USPTO and the United States Copyright Office Potential legislation related to the NIST Draft Framework on the use of march-in rights for federally funded research Proposed Rule, Federal Trade Commission; Petition for Rulemaking of PIRG and iFixit (89 Fed. Reg. 286, January 3, 2024) Request for Comment, United States Patent and Trademark Office, Department of Commerce; Unlocking the Full Potential of Intellectual Property by Translating More Innovation to the Marketplace (89 Fed. Reg. 18,907-18,911 March 15, 2024) Notice of Proposed Rulemaking, United States Patent and Trademark Office, Department of Commerce; Setting and Adjusting Patent Fees During Fiscal Year 2025 (89 Fed. Reg. 23,226-23,291, April 3, 2024) Proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings (Fed. Reg. 28,693-28,706, April 19, 2024) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; modernization of the U.S. Copyright Office; patent examination practices and patent quality; patent filing fees; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; implementation of the NIST draft interagency guidance for the use of march-in rights on federally funded inventions; emerging issues surrounding artificial intelligence, intellectual property, and data protection; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); WHOIS policy for .us web domains; March-In rights under the Bayh-Dole Act (P.L. 96-517); establishment of IP attache position for U.S. Embassy in the Republic of Korea; inventorship guidance for AI-Assisted Inventions

Client expense: $13,930,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program - 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight 340B Drug Discount Program - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Alternative Funding Programs Drug Shortages Supply Chain Integrity and Traceability Drug Patenting S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 COVID-19 Pricing Related Provisions PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act H.R. 5378: Lower Costs, More Transparency Act CMMI Authority Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues

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

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

Issues related to implementation of drug pricing and reimbursement of prescription drugs provision in The Inflation Reduction Act of 2022 (PL 117-169); Issues relating to Medicare Part B Pricing Reform; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of drug pricing and reimbursement of prescription drugs provision in The Inflation Reduction Act of 2022 (PL 117-169); Issues relating to Medicare Part D and Part B Pricing Reform; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of drug pricing and reimbursement of prescription drugs provision in The Inflation Reduction Act of 2022 (PL 117-169); Issues relating to Medicare Part D and Part B Pricing Reform; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of drug pricing and reimbursement for prescription drugs provision in Inflation Reduction Act of 2022 (PL 117-169); Issues related to Medicare Part D drug rebates; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Inflation Reduction Act of 2022, H.R. 5376; Affordable Insulin Now Act of 2023, S. 954; Improving Health Insurance Affordability Act of 2023, S. 8; SMART Prices Act, S. 1264; Black Maternal Health Momnibus Act, H.R. 3305; Perinatal Workforce Act, S.1710; CARE for Moms, S.2846;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements, other contemplated "reasonable pricing price controls and patent prize schemes Repeal of Inflation Reduction Act (IRA), Sec. 5000D, drug price controls product price negotiation and 95% inflation penalty and IRA implementation

Client expense: Not reported · Firm income: $19,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern__ Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues H.R.7024 - Tax Relief for American Families and Workers Act of 2024 Vaccine provisions of the Inflation Reduction Act

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

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

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

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

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

Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Tax Relief and Reform Tax Relief for American Families and Workers Act of 2024 - SBE Council supported U.S. House passage of the legislation and advocated for passage by the U.S. Senate. R&D Tax Credit: Continue to support extending and making permanent full expensing for R&D expenditures for small businesses. Voiced Support for "American Innovation and Jobs Act" (S. 866) in the Senate and "American Innovation and R&D Competitiveness Act" (H.R. 2673) in the House. Main Street Tax Certainty Act of 2023 (S. 1706, H.R. 4721) - Support House and Senate versions of the legislation to make permanent the 20-percent deduction for small-and individually-owned businesses (Section 199A). Death Tax Repeal Act of 2023 (S. 1108): Support House and Senate bills to permanent repeal the death tax and continue to support action by Congress. Capital Gains Tax Indexing - Voiced support for this reform measure and continue to support action by Congress. Regulation Resolution of Disapproval to Overturn NLRBs Joint Employer Rule (HJ. Res 98) - SBE Council supported U.S. House passage and for the U.S. Senate to quickly follow suit. Basel III Endgame Implementation - SBE Council expressed concern and opposition to the proposal to the U.S. Federal Reserve and Federal Deposit and Insurance Corporation regarding the impact on small business capital access and affordability. Congressional Review Act (CRA) Resolution to Overturn the Department of Labors Independent Contractor Rule: SBE Council supported H.J. Res 116 and S.J. Res 63 to nullify the rule. DOL's Proposed Overtime Rule: Continue to express concern about the proposed rule. Save Local Businesses Act (S.1261, HR 2826) - Continue to support the legislation. Protecting the Right to Organize (PRO) Act (S. 567) - Continue to oppose the legislation. The Protect Small Business and Prevent Illicit Financial Activity Act - SBE Council supports S. 3625 to delay implementation of the Corporate Transparency Act. Federal Acquisition Regulation: Use of Project Labor Agreements for Federal Construction Projects - SBE Council opposed the final rule. Federal Trade Commission (FTC) Hart-Scott-Rodino (HSR) Pre-Merger Reporting Requirement Proposed Rule - SBE Council opposes the rule and pointed out that the FTC mistakenly certified that small businesses will not be affected by the significant changes being proposed, therefore the rule needs to be pulled. National Labor Relation Board (NLRB) Funding - SBE Council urged House and Senate appropriators to hold the line on increased funding for the NLRB. Consumer Financial Protection Bureaus (CFPBs) Rule Capping Credit-Card Late Fees - SBE Council voiced concern about the rules unintended consequences. That is, backfiring on small business consumers who use credit responsibly and make their payments on time. Prove-It Act (H.R. 7198) - SBE Council supported House Judiciary Committee action that advanced the legislation, which gives small businesses a more effectual voice in federal rulemakings and strengthens federal government accountability when proposed regulations impact small businesses. Federal Communications Commission (FCC) Safeguarding and Securing the Open Internet Rule - SBE Council continues to express concerns about intrusive government control of the internet as proposed by the rule and Section 214 regulations under the proposal. The Credit Card Competition Act - SBE Council continues to oppose the legislation. Railway Safety Act (S. 576) - SBE Council continues to express concern about the heavy-handedness of the legislation as well as proposals to further regulate the railroad industry, which is dominated by small businesses. Centers for Medicare and Medicaid Services (CMS) Proposal on Medicare Advantage Plans - SBE Council expressed concerns about the proposal that would significantly alter the marketing and broker compensation structures of the plans. The Small Business Regulatory Reduction Act - Continue to supported full House passage. Privacy Policy - Continue to express the need for a national regulatory framework, but for Congress to consider a framework that avoids adding to the growing patchwork burden of state privacy laws, and to carefully consider unintended consequences on small businesses. Access to Capital Expanding Access to Capital Act (H.R. 2799) - SBE Council supported House passage. The Budget Further Consolidated Appropriations Act for 2024 - SBE Council supported House passage. Republican FY 2025 Budget Resolution - SBE Council supported the budget resolution framework. President Bidens Budget Proposal - SBE Council voiced concern about the excessive spending in the proposal as well as the various tax increases that would fall on small businesses, investors and the business community. Affordable Health Coverage and Health Care Innovation Voiced ongoing concerns about the rising costs of health coverage, lack of choices, and dwindling choices in many markets against the backdrop of challenging economic conditions. Voiced support for these various reforms: enhancing tax credits for small businesses, expanding and making additional fixes to HSAs, reforming QSEHRAs, and making CARESs Act telehealth provisions permanent. CHOICE Arrangement Act (H.R. 2799) - Supported House passage and continue to support Senate action on the legislation. Tax Credit for Small Businesses: Support making reforms to the restrictive and temporary health care tax credit for small businesses to make it more practical for small businesses. HSA Modernization Act (H.R. 5687) and Bipartisan HSA Improvement Act (H.R. 5688) - Continue to support full House passage. Telehealth Expansion Act of 2023 (H.R. 1843) (S. 1001)- Continue to support full House and Senate passage. Chronic Disease Flexible Coverage Act (H.R. 3800) - Support full House passage. Paperwork Burden Reduction Act (H.R. 3797) - Support full House passage. Employer Reporting Improvement Act (H.R. 3801) - Support full House passage. Small Business Flexibility Act (H.R. 3798) - Support full House passage. Custom Health Option and Individual Care Expense Arrangement Act (H.R. 3799) - Support full House passage. SMART Prices Act (S. 1264) - Continue to oppose the legislation. Property Rights and IP Submitted Comments to the National Institutes of Standards and Technology (NIST) Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-in Rights-SBE Council urged NIST to withdraw the proposed guidance. Submitted Comments to United States Patent and Trademark Office (USPTO) on WIPO IGC Negotiations on Genetic Resources and Associated Traditional Knowledge - SBE Council expressed concern regarding the IGCs proposed mandatory patent disclosure requirements (PDRs) for the origin of genetic resources and traditional knowledge, which would irreparably harm the startup and small business ecosystems that drive innovation. Trade and Global Market Access Digital Trade - The Moratorium on Customs Duties on Electronic Transmissions permanent during the 13th WTO Ministerial Conference (MC13) - SBE Council urged World Trade Organization members to support an extension of the moratorium. Digital Trade Principles - Continue to express concern about the U.S. pulling away from the principles and the need for President Biden to revisit the United State Trade Representatives action to withdraw from for foundational positions on digital trade policy within the World Trade Organization (WTO). Supporting Business Competitiveness and Startup Activity Comprehensive Resources for Entrepreneurs in the Arts to Transform the Economy (CREATE) Act - SBE Council supported Senate introduction of the bill. Paid Leave Policy in U.S. House: Continue to express support for bipartisan exploration in identifying paid leave policy solutions that help support business owners and working families. Access to Broadband and Next Gen Technology BEAD Program Implementation - SBE Council expressed concern about the National Telecommunications and Information Administrations rate regulation provisions for broadband internet service that was specifically prohibited by Congress as part of the Infrastructure Investment and Jobs Act. Rural Internet Improvement Act of 2023 (S.130) (H.R. 3216) - Continue to support the legislation. Development of a National Spectrum Strategy (NSS) - Continue to express support for such a policy and the need for more spectrum to deploy next Gen technologies and 5G.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Patent & Trademark Office (PTO), President of the U.S., SENATE, U.S. Trade Representative (USTR)

H.R. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 6943, No AI FRAUD Act 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. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Draft legislation titled Nurture Originals, Foster Art, and Keep Entertainment Safe (NO FAKES) Act of 2023 Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to H.R. 5429, Save our Stages Extension Act Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act Potential legislation making omnibus year-end appropriations Potential legislation regarding the establishment of a SEP royalty court Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to right to repair issues in intellectual property rights Proposed Rule, Federal Trade Commission; Petition for Rulemaking of PIRG and iFixit (89 Fed. Reg. 286, January 3, 2024) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; modernization of the U.S. Copyright Office; patent examination practices and patent quality; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; World Trade Organization pending proposal related to pharmaceuticals and intellectual property rights; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Trade Organization; the World Health Organization; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; promoting inclusive innovation and diversity initiatives in the intellectual property system; proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; right-to-repair issues; emerging issues surrounding artificial intelligence, intellectual property, and data protection; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; USPTO's IP Attache Program; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); WHOIS policy for .us web domains;

Client expense: $23,370,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program - 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight 340B Drug Discount Program - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 Artificial Intelligence (AI) 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 S. 148: Stop STALLING Act S. 150: Affordable Prescriptions for Patients Act of 2023 CMMI Aurthority COVID-19 Pricing Related Provisions Implementation of the Inflation Reduction Act (IRA) of 2022 PBM Reform Funding for FDA - FY 2024 Appropriations Funding for FDA - FY 2025 Appropriations 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 Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act H.R. 5378: Lower Costs, More Transparency Act CMMI Authority Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues

Client expense: $3,510,000 · 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

Inflation Reduction Act Medicare Part D 6 Protected Classes H.R.5237, The Reduced Cost and Continued Cures Act SMART Prices Act (S. 1264) Lowering Drug Costs for American Families Act (H.R. 4895) Executive Order on Strengthening Access to Affordable, High Quality Contraception & Family Planning Services Accelerating Kids Access to Care Act (S. 2372, H.R. 4758) The Modernizing and Ensuring PBM Accountability Act (no bill # yet) Medicaid Drug Rebate Proposed Rule

Client expense: $210,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of drug pricing and reimbursement of prescription drugs provision in The Inflation Reduction Act of 2022 (PL 117-169); Issues relating to Medicare Part B Pricing Reform; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of drug pricing and reimbursement of prescription drugs provision in The Inflation Reduction Act of 2022 (PL 117-169); Issues relating to Medicare Part D and Part B Pricing Reform; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of drug pricing and reimbursement of prescription drugs provision in The Inflation Reduction Act of 2022 (PL 117-169); Issues relating to Medicare Part D and Part B Pricing Reform; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of drug pricing and reimbursement for prescription drugs provision in Inflation Reduction Act of 2022 (PL 117-169); Issues related to Medicare Part D drug rebates; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements, other contemplated "reasonable pricing price controls and patent prize schemes Repeal of Inflation Reduction Act (IRA) drug price controls product price negotiation and 95% inflation penalty and IRA implementation

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Inflation Reduction Act of 2022, H.R. 5376; Affordable Insulin Now Act of 2023, S. 954; Improving Health Insurance Affordability Act of 2023, S. 8; SMART Prices Act, S. 1264; Black Maternal Health Momnibus Act, H.R. 3305; Perinatal Workforce Act, S.1710; CARE for Moms, S.2846;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2940/S. 1355: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. Inflation Reduction Act - provisions related to vaccines and pharmaceuticals. H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: Increasing Transparency in Generic Drug Applications Act H.R. 4115: The Lower Drug Costs for Families Act H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging (DRUG) Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Anticounterfeiting policy issues Artificial intelligence policy issues H.R.5143 - Vaccine Access Improvement Act - reform the vaccine injury compensation program H.R. 5142 - Vaccine Injury Compensation Modernization Act -- reform the vaccine injury compensation program S.1542/H.R.6283 - Delinking Revenue from Unfair Gouging Act - commercial delinking of PBM prices Labor HHS Appropriations Inflation Reduction Act of 2022, provisions related to Part D redesign and Medicare negotiation; 340B reform proposals

Client expense: $1,500,000 · Firm income: Not reported

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

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3134: Emergency Access to Insulin Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act of 2023 H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Nomination of Dr. Monica Bertagnolli as NIH director Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Anticounterfeiting policy issues Artificial intelligence policy issues

Client expense: $6,430,000 · Firm income: Not reported

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

H.R. 2670/S. 2226, National Defense Authorization Act H.R. 5475, Prohibiting Adversarial Patents Act of 2023 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. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to H.R. 5429, Save our Stages Extension Act Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act Potential legislation making omnibus year-end appropriations Potential legislation regarding the establishment of a SEP royalty court Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to right to repair issues in intellectual property rights Request for Information, National Institute of Standards and Technology, Department of Commerce; Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (88 Fed. Reg. 85,593-85,605, December 8, 2023) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; modernization of the U.S. Copyright Office; patent examination practices and patent quality; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Trade Organization; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; promoting inclusive innovation and diversity initiatives in the intellectual property system; proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; right to repair issues; emerging issues surrounding artificial intelligence, intellectual property, and data protection; confirmation of NIH Director; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; draft 2022-2026 USPTO strategic plan; USPTOs IP Attache Program; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417)

Client expense: $19,080,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

Taxes and Tax Reform R&D Tax Credit: Continue to support extending and making permanent full expensing for R&D expenditures for small businesses. Voiced Support for "American Innovation and Jobs Act" (S. 866) in the Senate and "American Innovation and R&D Competitiveness Act" (H.R. 2673) in the House. Main Street Tax Certainty Act of 2023 (S. 1706, H.R. 4721) - Support House and Senate versions of the legislation to make permanent the 20-percent deduction for small-and individually-owned businesses (Section 199A). "Small Business Jobs Act" (HR 3937) - Continue to support House passage of the legislation. "Build It in America Act" (HR 3938) - Continue to support House passage of the legislation. "Small Business Investment Act" (H.R. 2767) - Continue to support full House Action. "Death Tax Repeal Act of 2023" (S. 1108): Support House and Senate bills to permanent repeal the death tax and continue to support action by Congress. Capital Gains Tax Indexing - Voiced support for this reform measure and continue to support action by Congress. Affordable Health Coverage and Health Care Innovation "CHOICE Arrangement Act" (H.R. 2799) - Supported House passage and continue to support Senate action on the legislation. Tax Credit for Small Businesses: Support making reforms to the restrictive and temporary health care tax credit for small businesses to make it more practical for small businesses. Voiced ongoing concerns about the rising costs of health coverage, lack of choices, and dwindling choices in many markets against the backdrop of challenging economic conditions. Voiced support for these various reforms: enhancing tax credits for small businesses, expanding and making additional fixes to HSAs, reforming QSEHRAs, and making CARESs Act telehealth provisions permanent. "HSA Modernization Act" (H.R. 5687) and "Bipartisan HSA Improvement Act" (H.R. 5688) - Continue to support full House passage. "Telehealth Expansion Act of 2023" (H.R. 1843) (S. 1001) - Voiced support for Ways and Means Committee passage and continue to support full House and Senate passage. Chronic Disease Flexible Coverage Act (H.R. 3800) - Continue to support full House passage. Paperwork Burden Reduction Act (H.R. 3797) - Continue to support full House passage. Employer Reporting Improvement Act (H.R. 3801) - Continue to support full House passage. Small Business Flexibility Act (H.R. 3798) - Continue to support full House passage. Custom Health Option and Individual Care Expense Arrangement Act (H.R. 3799) - Continue to support full House passage. Preserving Telehealth: Joined coalition comments to the Centers for Medicare and Medicaid Services (CMS) take action on preserving the benefits of telehealth by ensuring telehealth practitioners working from a home-based (or other) location do not need to report that private residence to the federal government for purposes of either enrollment or billing. "Inflation Reduction Act": Continue to express concern about the impact of price controls on drug innovation, especially for small bio-pharmaceutical firms, urging congressional oversight. "SMART Prices Act" (S. 1264) - Continue to oppose the legislation. Access to Broadband and Digital Policy Rural Internet Improvement Act of 2023 (S.130) (H.R. 3216) - Continue to support the legislation. Development of a National Spectrum Strategy (NSS) - Continue to express support for such a policy and the need for more spectrum to deploy next Gen technologies and 5G. Broadband Infrastructure: Continue to support efforts in the Congress to provide oversight and track Broadband Equity, Access and Deployment (BEAD) Program funding to ensure the tens of billions of taxpayer dollars being allocated will be used efficiently to connect those lacking access with high-speed broadband. Also expressed concern to U.S. Commerce about possible price controls for broadband. Access to Capital "Small Business Technological Advancement Act" (S.2330): Support the legislation which would help end the digital gap for many small businesses by allowing SBA Loans to be used for investments in eligible technologies. Basel III Endgame Rule: Provided written testimony to Senate Finance Committee on the downstream negative effects regarding the cost and availability of capital and credit of this proposed Federal Reserve rule. Proposed CFPB Rule on Credit Card Price Caps: Urged the Consumer Financial Protection Bureau and President Biden to pull back on this proposed rule given the negative impact on small business access to credit and small financial institutions. Regulation "Providing Opportunities to Show Transparency via Information Technology Act" (POST IT Act): Supported full House passage of the bill. "The Small Business Regulatory Reduction Act": Continue to supported full House passage. "Regulations from the Executive in Need of Scrutiny (REINS) Act" (H.R. 277) - Supported House passage and continue to support Senate action. Privacy Policy in General: Continue to express the need for a national framework, but for Congress to consider a framework that avoid adding to the growing patchwork burden of state privacy laws, and to carefully consider unintended consequences on small businesses. PLA Mandates for Clean Energy Credits: Joined comments to U.S. Treasury/IRS expressing opposition and concern about the mandated use of Project Labor Agreements (PLAs) in order to qualify for the clean energy tax credit used in conjunction with Inflation Reduction Act projects. "Prove It Act" (S. 1411) - Continue to voice support and passage of this bill requiring agencies to conduct due diligence on how proposed regulations impact small businesses. Filed comments with the North American Securities Administrators Associations (NASAA) on proposed revisions to its model rule on Dishonest or Unethical Business Practices of Broker-Dealers and Agents, expressing concern about impact on small businesses in the sector and the impact on retail investors. Filed comments with the Federal Communications Commission (FCC) opposing the Proposed Rulemaking (NPRM), Safeguarding and Securing the Open Internet, given its negative impact on small providers, costs, investment, innovation and access to affordable broadband. Trade and Globa Market Access EU and Digital Trade: Urged President Biden, ahead of the October 20 U.S.-EU Summit, to push back against regulatory overreach and protectionist actions in Europe that threaten to restrict trade, undermine U.S. competitiveness, and stifle innovation. These actions include one that undermine intellectual property rights and regulatory initiatives that discriminate against U.S. companies. Digital Trade Principles: Urged President Biden to revisit the United State Trade Representatives action to withdraw from for foundational positions on digital trade policy within the World Trade Organization (WTO). Labor and Workforce Policy DOL's Proposed Overtime Rule: Continue to express concern about the proposed rule. "Save Local Businesses Act" (S.1261, HR 2826) - Continue to support the legislation. Paid Leave Policy in U.S. House: Continue to express support for bipartisan exploration in identifying paid leave policy solutions that help support business owners and working families. Proposed Independent Contractor Rules: Continued to express opposition to independent contractor rules being proposed and advanced by the Department of Labor that would disrupt this critical model for entrepreneurship. "Protecting the Right to Organize (PRO) Act" (S. 567) - Continue to oppose the legislation. "Railway Safety Act" (S. 576): Expressed concern about the legislation to all members of Congress.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Labor, Dept of (DOL), President of the U.S., SENATE, Treasury, Dept of

Inflation Reduction Act Medicare Part D 6 Protected Classes H.R.5237, The Reduced Cost and Continued Cures Act SMART Prices Act (S. 1264) Lowering Drug Costs for American Families Act (H.R. 4895) Executive Order on Strengthening Access to Affordable, High Quality Contraception & Family Planning Services Accelerating Kids Access to Care Act (S. 2372, H.R. 4758) The Modernizing and Ensuring PBM Accountability Act (no bill # yet) Medicaid Drug Rebate Proposed Rule

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to patient interests in prescription drug proposals and policies, including in P.L. 117-169, the Inflation Reduction Act. Issues related to patient costs and Pharmacy Benefit Managers. H.R. 830/S. 1375, the HELP Copays Act. H.R. 1770, the Equitable Community Access to Pharmacist Services Act. H.R. 2407/S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act. S. 1264, the SMART Prices Act. H.R. 4895, Lowering Drug Costs for American Families Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of drug pricing and reimbursement of prescription drugs provision in The Inflation Reduction Act of 2022 (PL 117-169); Issues relating to Medicare Part D and Part B Pricing Reform; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of drug pricing and reimbursement of prescription drugs provision in The Inflation Reduction Act of 2022 (PL 117-169); Issues relating to Medicare Part B Pricing Reform; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of drug pricing and reimbursement of prescription drugs provision in The Inflation Reduction Act of 2022 (PL 117-169); Issues relating to Medicare Part D and Part B Pricing Reform; S. 1264 - Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE