Expanding Access to Low-Cost Generics Act of 2023

Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R.9070 - Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN]

Client expense: Not reported · Firm income: Not reported

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

H.R. 661, MIRACLE Medical Technology Act of 2025 H.R. 1650/S. 763, Telehealth Expansion Act of 2025 Potential legislation similar to H.R. 1843/S. 1001, Telehealth Expansion Act of 2023 Potential legislation similar to H.R. 2868, Association Health Plans Act Potential legislation similar to H.R. 3800, Chronic Disease Flexible Coverage Act Potential legislation similar to H.R. 4307/S. 2115, Medical Supply Chain Resiliency Act Potential legislation similar to H.R. 6363, Further Continuing Appropriations and Other Extensions Act of 2024, and issues pertaining to H.R. 1843/S. 1001, The Telehealth Expansion Act of 2023 Potential legislation similar to H.R. 6860, Restore Protections for Dialysis Patients Act Potential legislation similar to H.R. 9029, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 Potential legislation similar to S. 142, Preserve Access to Affordable Generics and Biosimilars Act Potential legislation similar to S. 150, Affordable Prescriptions for Patients Act of 2023 Potential legislation similar to S. 1067, Ensuring Timely Access to Generics Act of 2023 Potential legislation similar to S. 1114, Expanding Access to Low-Cost Generics Act of 2023 Potential legislation similar to S. 2624, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 Potential legislation similar to S. 2780, The Medication Affordability and Patent Integrity Act Final Rule, Mental Health Parity and Addiction Equity Act (89 Fed. Reg. 77,586-77,751, September 23, 2024) Various issues relating to the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, health savings account (HSAs), health reimbursement account (HRAs), employer mandate; implementation of the American Rescue Plan Act (P.L. 117-2); implementation of the Inflation Reduction Act (P.L. 117-169); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; legislative proposals to tax employer-provided health care coverage; artificial price caps on providing insulin; Reasonable Price Clause in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); ERISA preemption protections including information on constructive changes/modifications to ERISA; efforts to reform the World Health Organizations (WHO) engagement with private sector; continued U.S. membership to the World Health Organization (WHO); support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health systems strengthening; promote greater harmonization of standards and investment in digital health; health-related policy issues in the G20/G7 forums and other multilateral forums; support for improving access to health products and technologies globally, including via regulatory alignment, addressing trade barriers, strengthening the global supply chain, and raising awareness on potential pitfalls of local manufacturing; combatting anti-microbial resistance; support for continued and reformed U.S. foreign assistance, including in global health; Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, U.S. Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (2025 Advance Notice, January 31, 2024)

Client expense: $19,340,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR)

340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R.9070 - Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN]

Client expense: $1,200,000 · Firm income: Not reported

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

Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R.9070 - Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN]

Client expense: $28,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R.9070 - Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN]

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

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

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Client expense: $269,075 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.4741 - PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Sen. Tillis, Thomas [R-NC] HR 6465 PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Rep. Hudson, Richard [R-NC-9] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

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

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

Affordable Care Act--extending enhanced APTCs (H.R. 9774, S. 5194) and unauthorized enrollments in Marketplace plans (S. 4767), Affordability (H.R. 3589), Behavioral Health, Employer-Provided Health Coverage, Health Equity, Maternal Health, Surprise Billing, Health IT, Cybersecurity, Interoperability, Health Care Innovation, Telehealth-extending flexibilities, Transparency & PBMs (S. 127, S. 1339, S. 3430, H.R. 3651, H.R. 4507, H.R. 4508, H.R. 4509, H.R. 4527, H.R. 4822, H.R. 5378), Provider Directories (S. 3430), Prescription Drugs (S. 150, S. 1067, S. 1114, S. 2305), Preventative Services

Client expense: $640,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1264, Commonsense Reporting Act of 2023 H.R. 2813, Self-Insurance Protection Act H.R. 2868, Association Health Plans Act H.R. 3800, Chronic Disease Flexible Coverage Act H.R. 4307/S. 2115, Medical Supply Chain Resiliency Act H.R. 6363, Further Continuing Appropriations and Other Extensions Act of 2024, and issues pertaining to H.R. 1843/S. 1001, The Telehealth Expansion Act of 2023 H.R. 6860, Restore Protections for Dialysis Patients Act H.R. 9029, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 S. 127, Pharmacy Benefit Manager Transparency Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 148, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 1067, Ensuring Timely Access to Generics Act of 2023 S. 1114, Expanding Access to Low-Cost Generics Act of 2023 S. 1214, Retaining Access and Restoring Exclusivity (RARE) Act S. 1339, Pharmacy Benefit Manager Reform Act S. 2624, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 S. 2780, The Medication Affordability and Patent Integrity Act Proposed Rule, Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department; Requirements Related to the Mental Health Parity and Addiction Equity Act (88 Fed. Reg. 51,552-51,669, August 3, 2023) Proposed Rule, Employee Benefits Security Administration, Department of Labor; Definition of Employer-Association Health Plans (88 Fed. Reg. 87,968-87,981, December 20, 2023) Various issues relating to the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, health savings account (HSAs), health reimbursement account (HRAs), employer mandate; Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2026, and Solicitation of Comments; implementation of the American Rescue Plan Act (P.L. 117-2); implementation of the Inflation Reduction Act (P.L. 117-169); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; legislative proposals to tax employer-provided health care coverage; artificial price caps on providing insulin; Reasonable Price Clause in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); over-the-counter preventive services; ERISA preemption protections including information on constructive changes/modifications to ERISA; efforts to reform the World Health Organizations (WHO) engagement with private sector; support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health systems strengthening; promote greater harmonization of standards and investment in digital health; health-related policy issues in the G20/G7 forums and other multilateral forums; support for improving access to health products and technologies globally, including via regulatory alignment, addressing trade barriers, strengthening the global supply chain, and raising awareness on potential pitfalls of local manufacturing; combatting anti-microbial resistance; Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, U.S. Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (2025 Advance Notice, January 31, 2024)

Client expense: $22,410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR)

340B Program/Transparency; generics access S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Client expense: $5,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.

Client expense: $800,000 · Firm income: Not reported

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

Prescription Drug Affordability S775 Increasing Transparency in Generic Drug Application to provide for increased transparency in generic drug application Sen Hassan, Margaret Wood (D-NH) HR9070, Affordable Prescriptions for Patients Act of 2024 to amend title 35, United States Code, to prohibit product hopping, and for other purposes Sen. Cornyn, John (R-TX) Insulin Out of Pocket Charges; Finance PBNM Framework Proposals; Covid Vaccines S. 150 - Affordable Prescriptions for Patients Act of 2023 A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. John Cornyn (R-TX) S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 A bill to prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Maria Cantwell (D-WA) S.1067 - Ensuring Timely Access to Generics Act of 2023 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1114 - Expanding Access to Low-Cost Generics Act of 2023 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S.1269 - INSULIN Act of 2023 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S.2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT]

Client expense: $31,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B drug discount program; drug pricing; importation of biopharmaceuticals; direct-to-consumer (DTC) advertising; transparency; international pharmaceutical supply chain; antimicrobial resistance legislation; insulin price cap; DoD TRICARE Pharmacy Benefits Program, H.R.8070/S.4638, National Defense Authorization Act for Fiscal Year 2025; H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169) implementation; Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; H.R.830, HELP Copays Act; S.127, Pharmacy Benefit Manager Transparency Act of 2023; H.R.3285, Fairness for Patient Medications Act; S.1339, Pharmacy Benefit Manager Reform Act; S.1067, Ensuring Timely Access to Generics Act of 2023; S.1114, Expanding Access to Low-Cost Generics Act of 2023; S.1214, RARE Act; H.R.5378, Lower Costs, More Transparency Act; S.2840, Bipartisan Primary Care and Health Workforce Act; S.3430, Better Mental Health Care Lower-Cost Drugs and Health Extenders Act; S.2973, Modernizing and Ensuring PBM Accountability Act; H.R.6283, DRUG Act; S.2305, Biosimilar Red Tape Elimination Act; S.2780, Medication Affordability and Patent Integrity Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Use of Section viii statements in pharmaceutical labeling. FDAs approval of over-the-counter naloxone nasal spray. Changes to Hatch-Waxmans 180-day exclusivity incentive. Changes to FDA approval process for pharmaceuticals. Implementation of the Inflation Reduction Act. Drug pricing proposals. Oversight and reform efforts affecting pharmacy benefit managers, including Pharmacy Benefit Manager Transparency Act (S. 127), Prescription Pricing for the People Act (S. 113), and Drug Price Transparency in Medicaid Act of 2023 (H.R. 1613), and Lower Costs, More Transparency Act (H.R. 5378). Patent reform, including the Preserve Access to Affordable Generics and Biosimilars Act (S.142), Affordable Prescriptions for Patients Act (S.150). Proposals related to drug shortages. Reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). S. 1067, Ensuring Timely Access to Generics Act. S. 1339, Pharmacy Benefit Manager Reform Act. S. 1114, Expanding Access to Low-Cost Generics Act of 2023. S. 1552, A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable. S. 1543, A bill to require regulations concerning the disclosure of direct and indirect compensation from entities providing pharmacy benefit management services or third-party administration services. Biosimilar Red Tape Elimination Act (S. 2305). Appeal of a decision regarding the CTPAT Program (DHS).

Client expense: $360,000 · Firm income: Not reported

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

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.4741 - PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Sen. Tillis, Thomas [R-NC] HR 6465 PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Rep. Hudson, Richard [R-NC-9] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

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

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

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.4741 - PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Sen. Tillis, Thomas [R-NC] HR 6465 PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Rep. Hudson, Richard [R-NC-9] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Client expense: $140,000 · Firm income: Not reported

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

Legislation and regulation regarding pharmaceutical pricing, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S.2140 - Patent Eligibility Restoration Act of 2023 H.R. 2679, the PBM Accountability Act H.R.3285 - To establish patient protections with respect to highly rebated drugs S. 1067, the Ensuring Timely Access to Generics Act of 2023 S. 1114, the Expanding Access to Low-Cost Generics Act of 2023 S.1269 - INSULIN Act of 2023 S. 1909 Pharmacy DIR Reform to Reduce Senior Drug Costs Act S. 1967 The Patients Before Middlemen Act (the PBM Act) S. 1339 The Pharmacy Benefit Managers Reform Act S. 127, the Pharmacy Benefit Manager Transparency Act of 2023 H.R. 485, the Protecting Health Care for All Patients Act of 2023 S. 2780 & H.R. 5429 - Medication Affordability and Patent Integrity Act S. 2305 - Biosimilar Red Tape Elimination Act S.150 & H.R. 9070 - Affordable Prescriptions for Patients Act of 2023 S. 5503 and H.R. 10362 - The Patients Before Monopolies Act

Client expense: $220,000 · Firm income: Not reported

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

S.2140 - Patent Eligibility Restoration Act of 2023 H.R. 2679, the PBM Accountability Act H.R.3285 - To establish patient protections with respect to highly rebated drugs S. 1067, the Ensuring Timely Access to Generics Act of 2023 S. 1114, the Expanding Access to Low-Cost Generics Act of 2023 S.1269 - INSULIN Act of 2023 S. 1909 Pharmacy DIR Reform to Reduce Senior Drug Costs Act S. 1967 The Patients Before Middlemen Act (the PBM Act) S. 1339 The Pharmacy Benefit Managers Reform Act Legislation and regulation regarding pharmaceutical pricing, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S. 127, the Pharmacy Benefit Manager Transparency Act of 2023 H.R. 485, the Protecting Health Care for All Patients Act of 2023

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

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

H.R. 1264, Commonsense Reporting Act of 2023 H.R. 2813, Self-Insurance Protection Act H.R. 2868, Association Health Plans Act H.R. 3800, Chronic Disease Flexible Coverage Act H.R. 4307/S. 2115, Medical Supply Chain Resiliency Act H.R. 6860, Restore Protections for Dialysis Patients Act H.R. 9029, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 S. 127, Pharmacy Benefit Manager Transparency Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 148, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 1067, Ensuring Timely Access to Generics Act of 2023 S. 1114, Expanding Access to Low-Cost Generics Act of 2023 S. 1214, Retaining Access and Restoring Exclusivity (RARE) Act S. 1339, Pharmacy Benefit Manager Reform Act S. 2624, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 S. 2780, The Medication Affordability and Patent Integrity Act Proposed Rule, Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department; Requirements Related to the Mental Health Parity and Addiction Equity Act (88 Fed. Reg. 51,552-51,669, August 3, 2023) Proposed Rule, Employee Benefits Security Administration, Department of Labor; Definition of Employer-Association Health Plans (88 Fed. Reg. 87,968-87,981, December 20, 2023) Various issues relating to the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, health savings account (HSAs), health reimbursement account (HRAs), employer mandate; Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191-1198 of the Social Security Act for Initial Price Applicability Year 2026, and Solicitation of Comments; implementation of the American Rescue Plan Act (P.L. 117-2); implementation of the Inflation Reduction Act (P.L. 117-169); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; legislative proposals to tax employer-provided health care coverage; artificial price caps on providing insulin; Reasonable Price Clause in reauthorization draft of the Pandemic and All Hazards Preparedness Act(PAHPA, P.L. 109-417); over-the-counter preventive services; ERISA preemption protections including information on constructive changes/modifications to ERISA; efforts to reform the World Health Organizations (WHO) engagement with private sector; support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health systems strengthening; promote greater harmonization of standards and investment in digital health; health-related policy issues in the G20/G7 forums and other multilateral forums; support for improving access to health products and technologies globally, including via regulatory alignment, addressing trade barriers, strengthening the global supply chain, and raising awareness on potential pitfalls of local manufacturing; Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, U.S. Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (2025 Advance Notice, January 31, 2024)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR)

Issues related to prescription drug coverage and pharmacy benefits Issues related to the prescription drug marketplace, patents, and competition Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits S.113 - Prescription Pricing for the People Act S.127 - Pharmacy Benefit Manager Transparency Act S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.148 - Stop STALLING Act S.652 - Safe Step Act S.775 - Increasing Transparency in Generic Drug Applications Act S.1067 - Ensuring Timely Access to Generics Act S.1114 - Expanding Access to Low-Cost Generics Act S.1120 - Improved Access to Affordable Medications Act S.1128 - Ensuring Access to Generic Medications Act S.1339 - Pharmacy Benefit Manager Reform Act S.1542/H.R.6283 - Delinking Revenue from Unfair Gouging (DRUG) Act S.2973 - Modernizing and Ensuring PBM Accountability Act S.3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act S.150 - Affordable Prescriptions for Patients Act of 2023 H.R.1352 - Increasing Access to Biosimilars Act H.R.1790 - Biologics Competition Act H.R.2880 - Protecting Patients Against PBM Abuses Act H.R.4881 - To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program H.R.5378 - Lower Costs More Transparency Act H.R.5385 - Medicare PBM Accountability Act H.R. 8261- Preserving Telehealth, Hospital, and Ambulance Access Act, Sec. 302 H.R.7623- Telehealth Modernization Act of 2024 H.R.4758- Accelerating Kids Access to Care Act AINS Sec. 3 H.R.9096- Pharmacists Fight Back Act Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation

Client expense: $4,165,073 · Firm income: Not reported

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

Gene therapies; Prescription drug affordability S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, the Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R. 6094 - PROTECT Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

Client expense: $1,910,000 · Firm income: Not reported

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

340B drug discount program; drug pricing; importation of biopharmaceuticals; direct-to-consumer (DTC) advertising; transparency; international pharmaceutical supply chain; antimicrobial resistance legislation; insulin price cap; DoD TRICARE Pharmacy Benefits Program, H.R.8070/S.4638, National Defense Authorization Act for Fiscal Year 2025; H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169) implementation; Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; H.R.830, HELP Copays Act; S.127, Pharmacy Benefit Manager Transparency Act of 2023; H.R.3285, Fairness for Patient Medications Act; S.1339, Pharmacy Benefit Manager Reform Act; S.1067, Ensuring Timely Access to Generics Act of 2023; S.1114, Expanding Access to Low-Cost Generics Act of 2023; S.1214, RARE Act; H.R.5378, Lower Costs, More Transparency Act; S.2840, Bipartisan Primary Care and Health Workforce Act; S.3430, Better Mental Health Care Lower-Cost Drugs and Health Extenders Act; S.2973, Modernizing and Ensuring PBM Accountability Act; H.R.6283, DRUG Act; S.2305, Biosimilar Red Tape Elimination Act; S.2780, Medication Affordability and Patent Integrity Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Affordability S775 Increasing Transparency in Generic Drug Application to provide for increased transparency in generic drug application Sen Hassan, Margaret Wood (D-NH) HR9070, Affordable Prescriptions for Patients Act of 2024 to amend title 35, United States Code, to prohibit product hopping, and for other purposes Sen. Cornyn, John (R-TX) Insulin Out of Pocket Charges; Finance PBNM Framework Proposals; Covid Vaccines S. 150 - Affordable Prescriptions for Patients Act of 2023 A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. John Cornyn (R-TX) S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 A bill to prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Maria Cantwell (D-WA) S.1067 - Ensuring Timely Access to Generics Act of 2023 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1114 - Expanding Access to Low-Cost Generics Act of 2023 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S.1269 - INSULIN Act of 2023 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S.2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT]

Client expense: $31,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues Generics access; Cell & Gene therapy; Step Therapy Bills H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] " S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] H.R. 6094 - PROTECT Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S. 142 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Amy Klobuchar (D-MN) S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

Client expense: $31,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Use of Section viii statements in pharmaceutical labeling. FDAs approval of over-the-counter naloxone nasal spray. Changes to Hatch-Waxmans 180-day exclusivity incentive. Changes to FDA approval process for pharmaceuticals. Implementation of the Inflation Reduction Act. Drug pricing proposals. Oversight and reform efforts affecting pharmacy benefit managers, including Pharmacy Benefit Manager Transparency Act (S. 127), Prescription Pricing for the People Act (S. 113), and Drug Price Transparency in Medicaid Act of 2023 (H.R. 1613), and Lower Costs, More Transparency Act (H.R. 5378). Patent reform, including the Preserve Access to Affordable Generics and Biosimilars Act (S.142), Affordable Prescriptions for Patients Act (S.150). Proposals related to drug shortages. Reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). S. 1067, Ensuring Timely Access to Generics Act. S. 1339, Pharmacy Benefit Manager Reform Act. S. 1114, Expanding Access to Low-Cost Generics Act of 2023. S. 1552, A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable. S. 1543, A bill to require regulations concerning the disclosure of direct and indirect compensation from entities providing pharmacy benefit management services or third-party administration services. Biosimilar Red Tape Elimination Act (S. 2305). Appeal of a decision regarding the CTPAT Program (DHS).

Client expense: $310,000 · Firm income: Not reported

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

Affordable Care Act--extending enhanced APTCs (H.R. 9774) and unauthorized enrollments in Marketplace plans (S. 4767), Affordability (H.R. 3589), Behavioral Health, Health Equity, Maternal Health, Surprise Billing, Health IT, Cybersecurity, Interoperability, Value-Based Care, Health Care Innovation, Telehealth-extending flexibilities, Transparency & PBMs (S. 127, S. 1339, S. 3430, H.R. 3651, H.R. 4507, H.R. 4508, H.R. 4509, H.R. 4527, H.R. 4822, H.R. 5378), Provider Directories (S. 3430, Sec. 109), Prescription Drugs (S. 150, S. 1067, S. 1114, S. 2305)

Client expense: $660,000 · Firm income: Not reported

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

Generics access; Cell & Gene therapy; Step Therapy H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] " S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] H.R. 6094 - PROTECT Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S. 142 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Amy Klobuchar (D-MN) S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA]

Client expense: $1,430,000 · Firm income: Not reported

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

Issues related to prescription drug coverage and pharmacy benefits Issues related to the prescription drug marketplace, patents, and competition Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits S.113 - Prescription Pricing for the People Act S.127 - Pharmacy Benefit Manager Transparency Act S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.148 - Stop STALLING Act S.652 - Safe Step Act S.775 - Increasing Transparency in Generic Drug Applications Act S.1067 - Ensuring Timely Access to Generics Act S.1114 - Expanding Access to Low-Cost Generics Act S.1120 - Improved Access to Affordable Medications Act S.1128 - Ensuring Access to Generic Medications Act S.1339 - Pharmacy Benefit Manager Reform Act S.1542/H.R.6283 - Delinking Revenue from Unfair Gouging (DRUG) Act S.2973 - Modernizing and Ensuring PBM Accountability Act S.3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act S.150 - Affordable Prescriptions for Patients Act of 2023 H.R.1352 - Increasing Access to Biosimilars Act H.R.1790 - Biologics Competition Act H.R.2880 - Protecting Patients Against PBM Abuses Act H.R.4881 - To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program H.R.5378 - Lower Costs More Transparency Act H.R.5385 - Medicare PBM Accountability Act H.R. 8261- Preserving Telehealth, Hospital, and Ambulance Access Act, Sec. 302 H.R.7623- Telehealth Modernization Act of 2024 H.R.4758 - Accelerating Kids Access to Care Act AINS Sec. 3 Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation

Client expense: $3,581,756 · Firm income: Not reported

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

S.2140 - Patent Eligibility Restoration Act of 2023 H.R. 2679, the PBM Accountability Act H.R.3285 - To establish patient protections with respect to highly rebated drugs S. 1067, the Ensuring Timely Access to Generics Act of 2023 S. 1114, the Expanding Access to Low-Cost Generics Act of 2023 S.1269 - INSULIN Act of 2023 S. 1909 Pharmacy DIR Reform to Reduce Senior Drug Costs Act S. 1967 The Patients Before Middlemen Act (the PBM Act) S. 1339 The Pharmacy Benefit Managers Reform Act Legislation and regulation regarding pharmaceutical pricing, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S. 127, the Pharmacy Benefit Manager Transparency Act of 2023 H.R. 485, the Protecting Health Care for All Patients Act of 2023

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

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

H.R. 1264, Commonsense Reporting Act of 2023 H.R. 2813, Self-Insurance Protection Act H.R. 2868, Association Health Plans Act H.R. 4307/S. 2115, Medical Supply Chain Resiliency Act H.R. 6860, Restore Protections for Dialysis Patients Act S. 127, Pharmacy Benefit Manager Transparency Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 148, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 1067, Ensuring Timely Access to Generics Act of 2023 S. 1114, Expanding Access to Low-Cost Generics Act of 2023 S. 1214, Retaining Access and Restoring Exclusivity (RARE) Act S. 1339, Pharmacy Benefit Manager Reform Act S. 2624, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 Draft legislation titled Fiscal Year 2025 Labor, Health and Human Services, Education, and Related Agencies Appropriations Act Request for Extension of Time for Comments, on Proposed Rule, Consumer Financial Protection Bureau; Prohibition on Creditors and Consumer Reporting Agencies Concerning Medical Information (Regulation V) (89 Fed. Reg. 51,682-51,736, June 18, 2024) Proposed Rule, Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department; Requirements Related to the Mental Health Parity and Addiction Equity Act (88 Fed. Reg. 51,552-51,669, August 3, 2023) Proposed Rule, Employee Benefits Security Administration, Department of Labor; Definition of Employer-Association Health Plans (88 Fed. Reg. 87,968-87,981, December 20, 2023) Various issues relating to the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, health savings account (HSAs), health reimbursement account (HRAs), employer mandate; Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2026, and Solicitation of Comments; implementation of the American Rescue Plan Act (P.L. 117-2); implementation of the Inflation Reduction Act (P.L. 117-169); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; legislative proposals to tax employer-provided health care coverage; artificial price caps on providing insulin; Reasonable Price Clause in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); over-the-counter preventive services; ERISA preemption protections including information on constructive changes/modifications to ERISA; artificial price caps on providing insulin; efforts to reform the World Health Organizations (WHO) engagement with private sector; continued U.S. membership to the World Health Organization (WHO); support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health systems strengthening; promote greater harmonization of standards and investment in digital health; health-related policy issues in the G20/G7 forums and other multilateral forums; support for improving access to health products and technologies globally, including via regulatory alignment and addressing trade barriers; Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, U.S. Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (2025 Advance Notice, January 31, 2024)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR)

340B drug discount program; drug pricing; importation of biopharmaceuticals; direct-to-consumer (DTC) advertising; transparency; international pharmaceutical supply chain; antimicrobial resistance legislation; insulin price cap; DoD TRICARE Pharmacy Benefits Program, FY2025 National Defense Authorization Act, H.R.8070; H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169) implementation; Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; H.R.830, HELP Copays Act; S.127, Pharmacy Benefit Manager Transparency Act of 2023; H.R.3285, Fairness for Patient Medications Act; S.1339, Pharmacy Benefit Manager Reform Act; S.1067, Ensuring Timely Access to Generics Act of 2023; S.1114, Expanding Access to Low-Cost Generics Act of 2023; S.1214, RARE Act; H.R.5378, Lower Costs, More Transparency Act; S.2840, Bipartisan Primary Care and Health Workforce Act; S.3430, Better Mental Health Care Lower-Cost Drugs and Health Extenders Act; S.2973, Modernizing and Ensuring PBM Accountability Act; H.R.6283, DRUG Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (extending enhanced APTCs, unauthorized enrollments in Marketplace plans), Affordability, Behavioral Health, Health Equity, Maternal Health, Surprise Billing, Health IT, Cybersecurity, Interoperability, Value-Based Care, Health Care Innovation, Telehealth-extending flexibilities, Transparency & PBMs (S. 127, S. 1339, S. 3430, H.R. 3651, H.R. 4507, H.R. 4508, H.R. 4509, H.R. 4527, H.R. 4822, H.R. 5378), Provider Directories (S. 3430, Sec. 109), Insulin Affordability (S. 1269, S. 954), Prescription Drugs (S. 150, S. 1067, S. 1114, S. 2305)

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

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

Insulin Out of Pocket Charges; Finance PBNM Framework Proposals; Covid Vaccines S. 150 - Affordable Prescriptions for Patients Act of 2023 A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. John Cornyn (R-TX) S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 A bill to prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Maria Cantwell (D-WA) S.1067 - Ensuring Timely Access to Generics Act of 2023 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1114 - Expanding Access to Low-Cost Generics Act of 2023 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S.1269 - INSULIN Act of 2023 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S.2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT]

Client expense: $31,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues Generics access; Cell & Gene therapy; Step Therapy Bills H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] " S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] H.R. 6094 - PROTECT Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S. 142 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Amy Klobuchar (D-MN) S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

Client expense: $31,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Generics Access; Cell and Gene Therapy; Step Therapy HR 6094, PROTECT Rare Act, by Rep. Doris Matsui (D-CA). To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. HR 7312, EPCS 2.0 Act, by Rep. Ann Kuster (D-NH). To provide requirements for electronic prescribing for controlled substances under group health plans and group and individual health insurance coverage. S 127, Pharmacy Benefit Manager Transparency Act of 2023, by Sen. Maria Cantwell (D-WA). To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. S 142, Preserve Access to Affordable Generics and Biosimilars Act, by Sen. Amy Klobuchar (D-MN). A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. S 148, Stop STALLING Act, by Sen. Amy Klobuchar (D-MN). A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. S 150, Affordable Prescriptions for Patients Act of 2023, by Sen. John Cornyn (R-TX). To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. S 1114, Expanding Access to Low-Cost Generics Act, by Sen. Tina Smith (D-MN). To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. S 1339, Pharmacy Benefit Manager Reform Act, by Sen. Bernie Sanders (I-VT). To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. S 1542, DRUG Act, by Sen. Roger Marshall (R-KS). To improve services provided by pharmacy benefit managers. S 2305, Biosimilar Red Tape Elimination Act, by Sen. Mike Lee (R-UT). To improve the requirements for making a determination of interchangeability of a biological product and its reference product. S 2666, EPCS 2.0 Act, by Sen. Margaret Wood Hassan (D-NH). To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage.

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

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

Issues Generics access; Cell & Gene therapy; Step Therapy Bills S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] " S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Amy Klobuchar (D-MN) S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

Client expense: $269,075 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Generics Access; Cell and Gene Therapy; Step Therapy HR 6094, PROTECT Rare Act, by Rep. Doris Matsui (D-CA). To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. HR 7312, EPCS 2.0 Act, by Rep. Ann Kuster (D-NH). To provide requirements for electronic prescribing for controlled substances under group health plans and group and individual health insurance coverage. S 127, Pharmacy Benefit Manager Transparency Act of 2023, by Sen. Maria Cantwell (D-WA). To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. S 142, Preserve Access to Affordable Generics and Biosimilars Act, by Sen. Amy Klobuchar (D-MN). A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. S 148, Stop STALLING Act, by Sen. Amy Klobuchar (D-MN). A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. S 150, Affordable Prescriptions for Patients Act of 2023, by Sen. John Cornyn (R-TX). To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. S 1114, Expanding Access to Low-Cost Generics Act, by Sen. Tina Smith (D-MN). To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. S 1339, Pharmacy Benefit Manager Reform Act, by Sen. Bernie Sanders (I-VT). To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. S 1542, DRUG Act, by Sen. Roger Marshall (R-KS). To improve services provided by pharmacy benefit managers. S 2305, Biosimilar Red Tape Elimination Act, by Sen. Mike Lee (R-UT). To improve the requirements for making a determination of interchangeability of a biological product and its reference product. S 2666, EPCS 2.0 Act, by Sen. Margaret Wood Hassan (D-NH). To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage.

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

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

Use of Section viii statements in pharmaceutical labeling. FDAs approval of over-the-counter naloxone nasal spray. Changes to Hatch-Waxmans 180-day exclusivity incentive. Changes to FDA approval process for pharmaceuticals. Implementation of the Inflation Reduction Act. Drug pricing proposals. Oversight and reform efforts affecting pharmacy benefit managers, including Pharmacy Benefit Manager Transparency Act (S. 127), Prescription Pricing for the People Act (S. 113), and Drug Price Transparency in Medicaid Act of 2023 (H.R. 1613), and Lower Costs, More Transparency Act (H.R. 5378). Patent reform, including the Preserve Access to Affordable Generics and Biosimilars Act (S.142), Affordable Prescriptions for Patients Act (S.150). Block, Report, and Suspend Suspicious Shipments Act (H.R. 501). Proposals related to drug shortages. Reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). S. 1067, Ensuring Timely Access to Generics Act. S. 1339, Pharmacy Benefit Manager Reform Act. S. 1114, Expanding Access to Low-Cost Generics Act of 2023. S. 1552, A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable. S. 1543, A bill to require regulations concerning the disclosure of direct and indirect compensation from entities providing pharmacy benefit management services or third-party administration services. Biosimilar Red Tape Elimination Act (S. 2305). Appeal of a decision regarding the CTPAT Program (DHS).

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

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

S.2140 - Patent Eligibility Restoration Act of 2023 H.R. 2679, the PBM Accountability Act H.R.3285 - To establish patient protections with respect to highly rebated drugs S. 1067, the Ensuring Timely Access to Generics Act of 2023 S. 1114, the Expanding Access to Low-Cost Generics Act of 2023 S.1269 - INSULIN Act of 2023 S. 1909 Pharmacy DIR Reform to Reduce Senior Drug Costs Act S. 1967 The Patients Before Middlemen Act (the PBM Act) S. 1339 The Pharmacy Benefit Managers Reform Act Legislation and regulation regarding pharmaceutical pricing, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S. 127, the Pharmacy Benefit Manager Transparency Act of 2023 H.R. 485, the Protecting Health Care for All Patients Act of 2023

Client expense: $140,000 · Firm income: Not reported

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

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

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

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

Issues related to prescription drug coverage and pharmacy benefits Issues related to the prescription drug marketplace, patents, and competition Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits S.113 - Prescription Pricing for the People Act S.127 - Pharmacy Benefit Manager Transparency Act S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.148 - Stop STALLING Act S.150 - Affordable Prescriptions for Patients Act S.652 - Safe Step Act S.655 - Chronic Disease Management Act S.727 - Insulin for All Act S.775 - Increasing Transparency in Generic Drug Applications Act S.954 - Affordable Insulin Now Act S.1038 - Drug Price Transparency in Medicaid Act S.1067 - Ensuring Timely Access to Generics Act S.1114 - Expanding Access to Low-Cost Generics Act S.1120 - Improved Access to Affordable Medications Act S.1128 - Ensuring Access to Generic Medications Act S.1130 - Health Care PRICE Transparency Act S.1131 - Drug Price Transparency Act S.1217 - Ending the Prescription Drug Kickback Act S.1218 - Fair Prescription Drug Prices for Americans Act S.1269 - INSULIN Act S.1339 - Pharmacy Benefit Manager Reform Act S.1375 - HELP Copays Act S.1497 - Emergency Access to Insulin Act S.1491 - Pharmacy and Medically Underserved Areas Enhancement Act S.1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S.1543 - A bill to require regulations concerning the disclosure of direct and indirect compensation from entities providing pharmacy benefit management services or third party administration services S.1967 - Patients Before Middlemen (PBM) Act S.2052 - Protect Patient Access to Pharmacies Act S.2129 - Ensuring Access to Lower-Cost Medicines for Seniors Act S.2254 - Medicare PBM Accountability Act S.2405 - Strengthening Pharmacy Access for Seniors Act S.2406 - PBM Oversight Act S.2408 - IMPROVE Part D Regulations Act S.2436 - Neighborhood Options for Patients Buying Medicines (NO PBM) Act S.2456 - Protecting Seniors from High Drug Costs Act S.2474 - Share the Savings with Seniors Act S.2477 - Equitable Community Access to Pharmacist Services Act S.2493 - PBM Reporting Transparency Act S.2666 - EPCS 2.0 Act S.2840 - Bipartisan Primary Care and Health Workforce Act (Bruan Amendment #3 - Price Transparency Requirements) S.2939 - Pharmacy Access Oversight and Reporting Act S.2973 - Modernizing and Ensuring PBM Accountability Act S.3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act H.R.830 - HELP Copays Act H.R.1352 - Increasing Access to Biosimilars Act H.R.1488 - Affordable Insulin Now Act H.R.1587 - Making Insulin Affordable for All Children Act H.R.1613 - Drug Price Transparency in Medicaid Act H.R.1770 - Equitable Community Access to Pharmacists Act H.R.1790 - Biologics Competition Act H.R.2630 - Safe Step Act H.R.2666 - Medicaid VBPs for Patients (MVP) Act H.R.2670 - PBM Accountability Act H.R.2691 - Transparent PRICE Act H.R.2880 - Protecting Patients Against PBM Abuses Act H.R.3030 - Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act H.R.3134 - Emergency Access to Insulin Act H.R.3262 - to amend title XI of the Social Security Act to increase transparency of certain health-related ownership information H.R.3281 - Transparent PRICE Act H.R.3282 - Promoting Transparency and Health Competition in Medicare Act H.R.3285 - Fairness for Patient Medications H.R.3561- Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act H.R.3800 - Chronic Disease Flexible Coverage Act H.R.4011 - Timely Access to Clinical Treatment Act H.R.4507 - Transparency in Coverage Act H.R.4508 - Hidden Fee Disclosure Act H.R.4509 - Transparency in Billing Act H.R.4527 - Health Data Act H.R.4712 - Patient Right to Shop Act H.R.4822 - Health Care Price Transparency Act H.R.4846 - To amend the Internal Revenue Code of 1986, title XXVII of the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to provide for oversight of pharmacy benefit manager services H.R.4881 - To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program H.R.4883 - Medicare Common Ownership Transparency Act H.R.5372 - Expanding Seniors Access to Lower Cost Medicines Act H.R.5376 - Share the Savings with Seniors Act H.R.5378 - Lower Costs More Transparency Act H.R.5384 - Advancing Enrollment and Reducing Drug Costs Act H.R.5385 - Medicare PBM Accountability Act H.R.5386 - Cutting Copays Act H.R.5393 -Transparency and Fairness for Pharmacies Act H.R.5400 - Neighborhood Options for Patients Buying Medicines (NO PBM) Act H.R.5461 - Ensuring Access to Lower-Cost Medicines for Seniors Act Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation

Client expense: $4,803,802 · Firm income: Not reported

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

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

340B drug discount program; drug pricing; importation of biopharmaceuticals; direct-to-consumer (DTC) advertising; transparency; international pharmaceutical supply chain; antimicrobial resistance legislation; insulin price cap; DoD TRICARE Pharmacy Benefits Program, FY2024 National Defense Authorization Act, H.R.2670/S.2226/P.L.118-31; H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169) implementation; Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; H.R.830, HELP Copays Act; S.127, Pharmacy Benefit Manager Transparency Act of 2023; H.R.3285, Fairness for Patient Medications Act; S.1339, Pharmacy Benefit Manager Reform Act; S.1067, Ensuring Timely Access to Generics Act of 2023; S.1114, Expanding Access to Low-Cost Generics Act of 2023; S.1214, RARE Act; H.R.5378, Lower Costs, More Transparency Act; S.2840, Bipartisan Primary Care and Health Workforce Act; S.3430, Better Mental Health Care Lower-Cost Drugs and Health Extenders Act; S.2973, Modernizing and Ensuring PBM Accountability Act; H.R.6283, DRUG Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1264, Commonsense Reporting Act of 2023 H.R. 2813, Self-Insurance Protection Act H.R. 2868, Association Health Plans Act H.R. 4307/S. 2115, Medical Supply Chain Resiliency Act H.R. 6860, Restore Protections for Dialysis Patients Act S. 127, Pharmacy Benefit Manager Transparency Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 148, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 1067, Ensuring Timely Access to Generics Act of 2023 S. 1114, Expanding Access to Low-Cost Generics Act of 2023 S. 1214, Retaining Access and Restoring Exclusivity (RARE) Act S. 1339, Pharmacy Benefit Manager Reform Act S. 2624, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 Proposed Rule by the Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department; Requirements Related to the Mental Health Parity and Addiction Equity Act (88 Fed. Reg. 51,552-51,669, August 3, 2023) Proposed Rule, Employee Benefits Security Administration, Department of Labor; Definition of Employer-Association Health Plans (88 Fed. Reg. 87,968-87,981, December 20, 2023) Various issues relating to the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, health savings account (HSAs), health reimbursement account (HRAs), employer mandate; Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2026, and Solicitation of Comments; implementation of the American Rescue Plan Act (P.L. 117-2); implementation of the Inflation Reduction Act (P.L. 117-169); "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; Over-the-counter preventive services; ERISA preemption protections including information on constructive changes/modifications to ERISA; artificial price caps on providing insulin; efforts to reform the World Health Organizations (WHO) engagement with private sector; continued U.S. membership to the World Health Organization (WHO); support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health systems strengthening; promote greater harmonization of standards and investment in digital health; health-related policy issues in the G20/G7 forums and other multilateral forums; support for improving access to health products and technologies globally, including via regulatory alignment and addressing trade barriers; Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, U.S. Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (2025 Advance Notice, January 31, 2024)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR)

Covid Therapeutics; Cell & Gene therapy; Step Therapy H.R.5372 - Expanding Seniors' Access to Lower Cost Medicines Act of 2023 To amend Title XVIII of the Social Security Act to facilitate midyear formulary changes for biosimilars. Sponsor: Rep. Joyce, John [R-PA-13] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] H.R.5376 - Inflation Reduction Act of 2022 Prescription Drug Pricing Reform Sponsor: Rep. Yarmuth, John A. [D-KY-3] S. 1067 Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] " S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] HR 6094 PROTECT Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7]

Client expense: $1,940,000 · Firm income: Not reported

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