Biosimilar Red Tape Elimination Act

Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.

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

Issues related to drug pricing and reimbursement for prescription drugs; Issues related to H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act; Issues related to H.R. 5526/S. 1954, Biosimilar Red Tape Elimination Act; Issues related to Senate Finance Dear Colleague process; H.R. 10628/S. 5571, Biosimilars Access and Affordability Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- H.R. 1539, Medical Device Electronic Labeling Act, regarding all provisions - H.R. 929/S. 266, the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, regarding all provisions - H.R. 946 ORPHAN Cures Act, regarding all provisions - S.864, HELP Copays Act, regarding all provisions - H.R. 2214, Delinking Revenue from Unfair Gouging (DRUG) Act, regarding all provisions - H.R. 1492/S. 832, Ensuring Pathways to Innovative Cures (EPIC) Act, regarding all provisions - S. 1954/ H.R. 5526 Biosimilar Red Tape Elimination Act, regarding all provisions - H.R.2527, Early Detection of Vision Impairments for Children Act of 2025, regarding all provisions - PL117-169 The Inflation Reduction Act, regarding all provisions related to drug pricing and implementation - H.R.5343/S. 1717, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, regarding all provisions - H.R.4282, Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act, regarding all provisions - S.1399 / H.R. 6197, the Health Tech Investment Act, regarding all provisions - H.R. 3521, the Clinical Trial Modernization Act, regarding all provisions - H.R. 3006 / S.1776, the Medicare Beneficiary Co-Pay Fairness Act, regarding all provisions - H.R. 3514, the Improving Seniors Timely Access to Care Act of 2025, regarding all provisions - H.R. 6549, the VA Contracting and Procurement Act, regarding all provisions - H.R. 5509 / S. 2903, Safe Step Act, regarding all provisions - H.R. 5256, 340B ACCESS Act, regarding all provisions - H.R. 7391, Community Health Center Drug Pricing Protection Act, regarding all provisions - H.R. 3953 / S. 1874 Title VIII Nursing Workforce Reauthorization Act, regarding all provisions Issues related to - direct to consumer advertising - clinical trial modernization - biosimilars - cardiovascular health - 340B and 340B Rebate Pilot - Heart Recovery Awareness Day & H.Res. 1301, designating February 20th Heart Recovery Awareness Day - MFN - Foreign Reference Pricing - CMS Outpatient Prospective Payment System rule - peripheral artery disease (PAD) - PBM and Insurer Reforms

Client expense: $2,220,000 · Firm income: Not reported

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

H.R. 5526 - Biosimilar Red Tape Elimination Act; all provisions. S. 1414 - Expedited Access to Biosimilars Act; all provisions. S. 2658 - Medication Affordability and Patent Integrity Act; all provisions.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare reimbursement issues. FDA regulations of biosimilars. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. Inflation Reduction Act implementation. H.R.5526/S.1954 - Biosimilar Red Tape Elimination Act. H.R.9661/S.1414 - Expedited Access to Biosimilars Act.

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549 Chronic Care Management Act of 2026ﾠHR 8261 Prior Authorization Reform for Autoimmune & Blood Disorders ActﾠHR 9192 Patient Access to Autoimmune Treatments ActﾠHR 5467 Patients First Act H.R. 9693 Expedited Access to Biosimilars Act H.R. 9661/ S. 1414 Protecting Approved Care Act H.R. 10394 Doctors Not AI Act of 2026 H.R. 10210 Protecting Patients from Automatic Denials Act H.R. 9734

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549 Chronic Care Management Act of 2026ﾠHR 8261 Prior Authorization Reform for Autoimmune & Blood Disorders ActﾠHR 9192 Patient Access to Autoimmune Treatments ActﾠHR 5467 Patients First Act H.R. 9693 Expedited Access to Biosimilars Act H.R. 9661/ S. 1414 Protecting Approved Care Act H.R. 10394 Doctors Not AI Act of 2026 H.R. 10210 Protecting Patients from Automatic Denials Act H.R. 9734

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549 Chronic Care Management Act of 2026ﾠHR 8261 Prior Authorization Reform for Autoimmune & Blood Disorders ActﾠHR 9192 Patient Access to Autoimmune Treatments ActﾠHR 5467 Patients First Act H.R. 9693 Expedited Access to Biosimilars Act H.R. 9661/ S. 1414 Protecting Approved Care Act H.R. 10394 Doctors Not AI Act of 2026 H.R. 10210 Protecting Patients from Automatic Denials Act H.R. 9734

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

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

HJRes 197 / SJRes 197, CRA related to the 2027 NBPP; HR 247 / S 46, Health Care Affordability Act; HR 6867 / S 3562, the NIH Clinical Trial Integrity Act; HR 3521 / S 4440, the Clinical Trial Modernization Act; HR 4710 / S 2420, No Surprises Act Enforcement Act; HR 5526 / S 1954, Biosimilar Red Tape Elimination Act; HR 5582 / S 2355, the Patients Deserve Price Tags Act; HR 6248 / S 4027, Healthy Competition for Better Care Act HR 6485 / S 43, Skinny Labels, Big Savings Act; HR 6867 / S 3562, NIH Clinical Trial Integrity Act; HR 7895, the PBM Kickback Prohibition Act; HR 8879 / S 4509, Patients Before Monopolies Act; HR 8908, the STOP GAMES Act; HR 9393, Lower Costs, More Transparency Act; HR 9396, the Prior Authorization Accountability Act; HR 9397, the Premium Transparency Act; HR 9645, the Health Care Price Certainty for All Americans Act; HR 9661 / S 1414, the Expedited Access to Biosimilars Act; HR 10370, the AIM to Cure Kids with Cancer Act; HR 10788, the Lower Premiums, Faster Payments Act; S 976, the Insurance Fraud Accountability Act; S 1041, Affordable Prescriptions for Patients Act; S 1095, Stop STALLING Act; S 1096, Preserve Access to Affordable Generics & Biosimilars Act S 1097, Interagency Patent Coordination & Improvements Act; S 2658, Medication Affordability & Patent Integrity Act; S 3014, Ensuring Timely Access to Generics Act; S 3822, the Break Up Big Medicine Act Policies to address the expiration of the enhanced Advanced Premium Tax Credits; Policies to improve transparency in hospital and insurer costs and finances; Policies to streamline pediatric patient access to subspecialist care via telemedicine; Policies to protect patients and consumers from junk insurance, including short-term limited duration insurance; Policies related to modernization of clinical trials; Policies related to the 2027 FDA user fee agreements; Implementation of the No Surprises Act; Policies related to oversight of insurance agents and brokers; Oversight and patient impact of the 340B program; Policies related to consolidation within the healthcare sector;

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies

Client expense: $630,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, White House Office

Prescription drug pricing issues. H.R. 1843/S. 1032 - Increasing Transparency in Generic Drug Applications Act. S. 1954/H.R. 5526 - Biosimilar Red Tape Elimination Act; S. 1095 - Stop Stalling Act S. 2630 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R.1262 - Mikaela Naylon Give Kids a Chance Act. S. 3014 - Ensuring Timely Access to Generics Act of 2025 S. 1414 - Expedited Access to Biosimilars Act

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

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

Issues related to pharmaceutical manufacturing supply chain. S. 1040 - Drug Competition Enhancement Act; H.R. 5526/S. 1954 -Biosimilar Red tape Elimination Act; H.R. 3269 - ETHIC Act; S. 43 - Skinny Labels, Big Savings Act; H.R. 1843/S. 1302- Increasing Transparency in Generic Drug Applications Act; Country of origin labeling. H.R. 9661/S. 1414 - Expediated Access to Biosimilars Act.

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

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

Issues related to the 340B Program - Public Health Service Act (PL 78-410); Issues related to H.R. 5526/S. 1954 - Biosimilar Red Tape Elimination Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 7148 (now Public Law 119-75) The Consolidated Appropriations Act provisions regulating pharmacy benefit manager practices S. 2355 Patients Deserve Price Tags Act provisions related to drug price transparency and patient transparency tools S. 3822 Break Up Big Medicine Act provisions related to insurer/PBM ownership or pharmacies S. 1954/HR 5526 The Biosimilar Red Tape Elimination Act - provisions related to interchangeability of biosimilars H.R.9393 Lower Costs, More Transparency Act of 2026

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 7148 (now Public Law 119-75) The Consolidated Appropriations Act provisions regulating pharmacy benefit manager practices S. 2355 Patients Deserve Price Tags Act provisions related to drug price transparency and patient transparency tools S. 3822 Break Up Big Medicine Act provisions related to insurer/PBM ownership or pharmacies S. 1954/HR 5526 The Biosimilar Red Tape Elimination Act - provisions related to interchangeability of biosimilars H.R.9393 Lower Costs, More Transparency Act of 2026

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and regulation regarding pharmaceutical pricing, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S.1954, H.R.5526 - Biosimilar Red Tape Elimination Act S.1414 - Expedited Access to Biosimilars Act S.2780, H.R.5429 - Medication Affordability and Patent Integrity Act S. 2620 - Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY Act) S.2276, H.R. 3269 - Eliminating Thickets to Increase Competition Act (ETHIC Act) S.3014 - Ensuring Timely Access to Generics Act S.43 - Skinny Labels, Big Savings Act

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

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

H.R. 6423/S. 864: HELP Copays Act - requires health insurers to count third-party financial assistance toward patients' cost-sharing obligations, including deductibles and copays, for prescription drugs, with changes effective for plan years beginning January 1, 2026. S. 526: PBM Transparency Act - prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs H.R. 4191/S. 1784: MAPS Act - requires federal agencies to regularly update a list of essential medicines, assess and report on supply chain risks, map pharmaceutical supply chains, and enhance coordination and cybersecurity to protect public health and national security. H.R. 3955/S.2062: RAPID Reserve Act - establishes a $500 million program to create and maintain domestic reserves of critical drugs and their ingredients, prioritizing domestic manufacturing and supply chain resilience to prevent shortages during public health emergencies. H.R. 8339: Drug Origin Transparency Act to amend the Federal Food, Drug, and Cosmetic Act to enhance drug manufacturing amount information reporting H.R. 5526/S. 1954: Biosimilar Red Tape Elimination Act - streamlines the approval process for biosimilar biological products by automatically deeming them interchangeable with reference products, subject to certain exclusivity protections, and requires updated regulatory guidance to reflect these changes. H.R. 4101: Cancer Drug Parity Act of 2025 - requires group health plans to provide cost-sharing for oral anticancer drugs that is at least as favorable as for provider-administered anticancer medications, with protections against increased patient costs and a mandated GAO study on the law's impact. H.R. 3521/S. 4440: Clinical Trials Modernization Act - Increase clinical trial participation among underrepresented populations by providing grants, permitting certain participant reimbursements, and offering tax exclusions, while ensuring compliance with existing legal protections. S. 705: Innovation in Pediatric Drugs Act of 2025 - amends existing laws to enhance pediatric cancer research, mandates compliance measures, allocates funding for pediatric studies, and sets guidelines for orphan drugs, with specific timelines for implementation and evaluation. H.R. 5509/S. 2903: Safe Step Act - to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes. H.R. 4425/S. 2287: Palliative Care and Hospice Education and Training Act - expands federal support for workforce development, education, public awareness, and research in palliative and hospice care, with targeted funding and statutory changes to improve care for patients with serious or life-threatening illnesses. H.R. 8839/S. 5052: Lainie Jones Comprehensive Cancer Survivorship Act of 2026 to address the health of cancer survivors.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug pricing. H.R. 5526 & S. 1954 Biosimilar Red Tape Elimination Act. S. 1095 Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics Act. S. 3014 Ensuring Timely Access to Generics Act of 2025 S. 1414 Expedited Access to Biosimilars Act S. 1032/H.R. 1843 Increasing Transparency in Generic Drug Applications Act. S. 2630, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.1262 Mikaela Naylon Give Kids a Chance Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 7837Most Favored Patient Act HRSA-2026-03042340B Rebate Model HR 8293Abolish CMMI Act S 2658Medication Affordability and Patent Integrity Act HR 5526, S. 1954Biosimilar Red Tape Elimination Act

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

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

Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549 Chronic Care Management Act of 2026ﾠHR 8261 Prior Authorization Reform for Autoimmune & Blood Disorders ActﾠHR 9192 Patient Access to Autoimmune Treatments ActﾠHR 5467

Client expense: $180,000 · Firm income: Not reported

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549 Chronic Care Management Act of 2026ﾠHR 8261 Prior Authorization Reform for Autoimmune & Blood Disorders ActﾠHR 9192 Patient Access to Autoimmune Treatments ActﾠHR 5467

Client expense: $180,000 · Firm income: Not reported

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549 Chronic Care Management Act of 2026ﾠHR 8261 Prior Authorization Reform for Autoimmune & Blood Disorders ActﾠHR 9192 Patient Access to Autoimmune Treatments ActﾠHR 5467

Client expense: $180,000 · Firm income: Not reported

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

Draft, the Expedited Access to Biosimilars Act (no bill number) - Rep. Langworthy, Nick - Biosimilar approval requirements H.R. 1 - One Big Beautiful Bill Act - Rep. Arrington, Jodey - Medicaid eligibility and state financing, Marketplace coverage and enrollment, Health Savings Account expansion, Pharmacy Benefit Manager financing and regulation H.R. 843 - Prompt Approval of Safe Generic Drugs Act - Rep. Barragan, Nanette Diaz - Generic drugs applications and approvals H.R. 946 - ORPHAN Cures Act - Rep. Joyce, John - Medicare Drug Negotiation Program H.R. 950 - Saving Seniors Money on Prescriptions Act - Rep. Landsman, Greg - PBM reporting requirements for MA/Part D plans. H.R. 1117 - Responsibility in Drug Advertising Act - Rep. DeLauro, Rosa - Direct-to-consumer ads H.R. 1244 - Reducing Drug Prices for Seniors Act - Rep. Davis, Donald - Coinsurance for Part D drugs H.R. 2214 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 2450 - Prescription Drug Transparency and Affordability Act - Rep. McDonald Rivet, Kristen - PBM transparency H.R. 3493 - Global Fairness in Drug Pricing Act - Rep. Khanna, Ro - Prescription drug international reference pricing H.R. 3546 - Prescription Drug Price Relief Act - Rep. Khanna, Ro - Prescription drug patent reform H.R. 3775 - Fair Prescription Drug Prices for Americans Act - Rep. Van Drew, Jefferson - Prescription drug and biological product international reference pricing H.R. 3789 - DTC Act - Rep. Taylor, David - Direct-to-consumer prescription advertising transparency H.R. 4139 - Cutting Copays Act - Rep. McGarvey, Morgan - Medicare cost-sharing for generic drugs H.R. 4231 - Treat and Reduce Obesity Act - Rep. Kelly, Mike - Medicare coverage of obesity drugs H.R. 4317 - PBM Reform Act - Rep. Carter, Earl L. Buddy - PBM contracting requirements and transparency H.R. 4605 - End Prescription Drug Ads Now Act - Rep. Nadler, Jerrold - Ban on DTC drug ads H.R. 4623 - Plain Prescription Prices Act - Rep. Williams, Nikema - Transparency requirements for DTC drug ads H.R. 5094 - Protect Patients from Costly Care Act - Rep. Pappas, Chris - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program H.R. 5197 - Protect Beneficiaries from Middlemen Act - Rep. Malliotakis, Nicole - Medicare cost-sharing limit for drugs H.R. 5526 - Biosimilar Red Tape Elimination Act - Rep. Pfluger, Austin - Biosimilars approval procedures H.R. 6255 - Affordable Insulin Now Act - Rep. Craig, Angie - require cost-sharing for certain insulin products H.R. 7837 - Most Favored Patient Act - Rep. Meuser, Daniel - MFN demonstration H.R. 8779 - PBM Act - Rep. Harshbarger, Diana - PBM ownership requirements S. 229 - DTC Act - Sen. Durbin, Richard - Drug advertising requirements S. 483 - Responsibility in Drug Advertising Act - Sen. King, Angus - Drug advertising requirements S. 526 - Pharmacy Benefit Manager Transparency Act of 2025 - Sen. Grassley, Chuck - PBM reporting requirements S. 529 - Capping Prescription Costs Act - Sen. Warnock, Raphael - Drug copay caps S. 652 - Protecting Patients from Deceptive Drugs Ads Act - Sen. Durbin, Richard - Drug advertising requirements S. 882 - Patients Before Middlemen Act - Sen. Blackburn, Marsha - PBM reforms S. 891 - Bipartisan Health Care Act - Sen. Wyden, Ron - PBM reforms and transparency S. 1040 - Drug Competition Enhanced Act - Sen. Cornyn, John - Drug patent reform S. 1041 - Affordable Prescriptions for Patients Act - Sen. Cornyn, John - Patent issues S. 1095 - Stop STALLING Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen. Hawley, Josh - Prescription drug international reference pricing S. 1753 - End Price Gouging for Medications Act - Sen. Merkley, Jeff - Prescription drug international reference pricing S. 1818 - Prescription Drug Price Relief Act - Sen. Sanders, Bernard - Prescription drug patent reform S. 1954 - Biosimilar Red Tape Elimination Act - Sen. Lee, Mike - Biological product assessment and approval S. 1973 - Treat and Reduce Obesity Act - Sen. Cassidy, Bill - Medicare coverage for obesity drugs S. 2345 - Short on Competition Act - Sen. Klobuchar, Amy - Expedited approval for generic drugs S. 2447 - Repealing the Trump Sick Tax Act - Sen. Welch, Peter - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program S. 2620 - REMEDY Act - Sen. Durbin, Richard - Expedited approvals for certain drug approvals S. 2658 - Medication Affordability and Patient Integrity Act - Sen. Hassan, Margaret - FDA and USPTO coordination S. 3014 - Ensuring Timely Access to Generics Act - Sen. Shaheen, Jeanne - Generic drug approval S. 4332 - Medication Competition Act - Sen. Hassan, Maggie - Pharmaceutical exclusivity periods S. 4355 - Drug Deal Disclosure Act - Sen. Wyden, Ron - Federal MFN agreement transparency S. 4509 - PBM Act - Sen. Warren, Elizabeth - PBM ownership requirements Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; cost-sharing and coverage of weight loss drugs/GLP-1s; high priced drugs; patent reforms; generic approval; Pharmacy Benefit Managers; PBM-related issues; step therapy; copay caps; insulin costs; and copay coupons.

Client expense: $3,010,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.

Client expense: $870,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), 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.1954, H.R.5526 - Biosimilar Red Tape Elimination Act S.1414 - Expedited Access to Biosimilars Act S.2780, H.R.5429 - Medication Affordability and Patent Integrity Act S. 2620 - Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY Act) H. R. 3269 - Eliminating Thickets to Increase Competition Act (ETHIC Act) S.3014 - Ensuring Timely Access to Generics Act S.43 - Skinny Labels, Big Savings Act

Client expense: $530,000 · Firm income: Not reported

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

S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act Section 301 Investigation re: Germany Issues Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines PTAB Proposed Rule - Discretionary Denials and One and Done Federal Procurement Preferences for Domestic Medicines Drug Shortages and Supply Chain Resilience

Client expense: $580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Use of Industrial Chemicals in Medical Devices Drug Shortages and Supply Chain Resilience Employee Benefits Security Administration (EBSA) Proposed Rule Re: Broker/Consultant Transparency to Employer Plans Section 301 Investigation re: Germany Issues PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency

Client expense: $580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

HR 247 / S 46, Health Care Affordability Act; S 2420, No Surprises Act Enforcement Act; HR 3521, the Clinical Trial Modernization Act; HR 5526, Biosimilar Red Tape Elimination Act; HR 5582, S 2355, the Patients Deserve Price Tags Act; HR 6248 / S 4027, Healthy Competition for Better Care Act HR 6485 / S 43, Skinny Labels, Big Savings Act; HR 6867 / S 3562, NIH Clinical Trial Integrity Act; HR 7895, the PBM Kickback Prohibition Act; HR 8908, the STOP GAMES Act; HR 9393, Lower Costs, More Transparency Act; HR 9396, the Prior Authorization Accountability Act; HR 9397, the Premium Transparency Act; HR 9661, Expedited Access to Biosimilars Act; S 1041, Affordable Prescriptions for Patients Act; S 1095, Stop STALLING Act; S 1096, Preserve Access to Affordable Generics & Biosimilars Act S 1097, Interagency Patent Coordination & Improvements Act; S 2658, Medication Affordability & Patent Integrity Act; S 3014, Ensuring Timely Access to Generics Act; S 4509, Patients Before Monopolies Act; Policies to address the expiration of the enhanced Advanced Premium Tax Credits; Policies to improve transparency in hospital and insurer costs and finances; Policies to streamline pediatric patient access to subspecialist care via telemedicine; Policies to protect patients and consumers from junk insurance, including short-term limited duration insurance; Policies related to the modernization of clinical trials; Policies related to the 2027 FDA user fee agreements; Implementation of the No Surprises Act; Policies related to oversight of insurance agents and brokers; Oversight and patient impact of the 340B program;

Client expense: $590,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- H.R. 1539, Medical Device Electronic Labeling Act, regarding all provisions - H.R. 929/S. 266, the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, regarding all provisions - H.R. 946 ORPHAN Cures Act, regarding all provisions - S.864, HELP Copays Act, regarding all provisions - H.R. 2214, Delinking Revenue from Unfair Gouging (DRUG) Act, regarding all provisions - H.R. 1492/S. 832, Ensuring Pathways to Innovative Cures (EPIC) Act - S. 1954/ H.R. 5526 Biosimilar Red Tape Elimination Act, regarding all provisions - H.R.2527, Early Detection of Vision Impairments for Children Act of 2025, regarding all provisions - PL117-169 The Inflation Reduction Act, regarding all provisions related to drug pricing and implementation - H.R.5343/S. 1717, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, regarding all provisions - H.R.4282, Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act, regarding all provisions - S.1399 / H.R. 6197, the Health Tech Investment Act, regarding all provisions - H.R. 3521, the Clinical Trial Modernization Act, regarding all provisions - H.R. 3006 / S.1776, the Medicare Beneficiary Co-Pay Fairness Act, regarding all provisions - H.R. 3514, the Improving Seniors Timely Access to Care Act of 2025, regarding all provisions - H.R. 6549, the VA Contracting and Procurement Act, regarding all provisions - H.R. 5509 / S. 2903, Safe Step Act, regarding all provisions - H.R. 5256, 340B ACCESS Act, regarding all provisions - H.R. 7391, Community Health Center Drug Pricing Protection Act, regarding all provisions Issues related to - direct to consumer advertising - clinical trial modernization - biosimilars - cardiovascular health - 340B and 340B Rebate Pilot - Heart Recovery Awareness Day & H.Res. 1301, designating February 20th Heart Recovery Awareness Day - obesity treatments - MFN - Foreign Reference Pricing - CMS Outpatient Prospective Payment System rule - peripheral artery disease (PAD) - PBM and Insurer Reforms

Client expense: $1,440,000 · Firm income: Not reported

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

Prescription drug pricing issues. H.R. 1843/S. 1032 - Increasing Transparency in Generic Drug Applications Act. S. 1954/H.R. 5526 - Biosimilar Red Tape Elimination Act; S. 1095 - Stop Stalling Act S. 2630 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R.1262 - Mikaela Naylon Give Kids a Chance Act. S. 3014 - Ensuring Timely Access to Generics Act of 2025 S. 1414 - Expedited Access to Biosimilars Act

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

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

Issues related to drug pricing and reimbursement for prescription drugs; Issues related to H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act; Issues related to H.R. 5526/S. 1954, Biosimilar Red Tape Elimination Act; Issues related To S. 5459, The Biosimilar Access and Affordability Act; Issues related to Senate Finance Dear Colleague process

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Rebuild Americas Health Care Schools Act (H.R. 1708/S. 1087), issues related to pharmacy residency funding. Issues related to FDA authority to manage drug shortages, regulation of pharmacy compounding, and implementation of the Drug Quality and Security Act. The Biosimilar Red Tape Elimination Act (H.R. 5526/S. 1954) and Expedited Access to Biosimilars Act (H.R. 9661), issues related to increased patient access to essential biosimilar medications. Issues related to pharmacy benefit manager (PBM) abuses and transparency (generally, no specific legislation). The 340B PATIENTS Act (H.R. 4581/S. 2372), issues related to 340B program nondiscrimination and contract pharmacy arrangements. Issues related to manufacturer attempts to undercut the 340B program, including conversion of the program to a rebate model (generally, no specific legislation). Issues related to drug price negotiations and patient out-of-pocket costs (generally, no specific legislation). Issues related to patient access to antipsychotic medication in long-term care settings (generally, no specific legislation). The Stop Pills That Kill Act (H.R. 8005), PRESS Act (H.R. 7184), and Fight Illicit Pill Presses Act (H.R. 5880), issues related to halting the unlawful production and availability of fentanyl, fentanyl analogues, and fentanyl-related substances. The States Handling Access to Reciprocity for Employment (SHARE) Act of 2025 (H.R. 4122), issues related to the Federal Bureau of Investigation (FBI) providing criminal history records to state licensing agencies under interstate compacts, which would help pharmacists and other healthcare professionals to more easily work across state lines.

Client expense: $260,000 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

Vaccine Coverage and Coverage Executive Order 14297 - Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients Codification and Sec. 301 trade investigations FDA User Fee Agreements: 2027 PDUFA Cycle H.R. 7837 - Most Favored Patient Act of 2026 H.R. 7391 - Community Health Center Drug Pricing Protection Act 340B Program Reform Inflation Reduction Act (IRA) H.R. 8646 - Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriates Act, 2027 H.R. 9260 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2027 H.R. 5178 - Sickle Cell Disease Comprehensive Care Act H.R. 5526 - Biosimilars Red Tape Elimination Act H.R. 4930 - To Expand the Sharing of Information with Respect to Suspected Violations of Intellectual Property Rights in Trade H.R. 4299 - Protecting Patient Access to Cancer and Complex Therapies Act: IRA reforms Prior Authorization Step Therapy Practices FDA Modernization and Reforms Drug Pricing PBM Reform Direct-to-Patient Prescription Drug Purchase Platforms and Insurance Coverage

Client expense: $1,880,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 5526/S. 1954, the Biosimilar Red Tape Elimination Act, provisions relating to deeming a biosimilar interchangeable with its reference product immediately upon approval.

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

Government targets: HOUSE OF REPRESENTATIVES

Medicare reimbursement issues. FDA regulations of biosimilars. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. Inflation Reduction Act implementation. H.R.5526/S.1954 - Biosimilar Red Tape Elimination Act.

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

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

Issues related to the 340B Program - Public Health Service Act (PL 78-410); Issues related to H.R. 5526/S. 1954 - Biosimilar Red Tape Elimination Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmaceutical manufacturing supply chain. S. 1040 - Drug Competition Enhancement Act; H.R. 5526/S. 1954 -Biosimilar Red tape Elimination Act; H.R. 3269 - ETHIC Act; S. 43 - Skinny Labels, Big Savings Act; H.R. 1843/S. 1302- Increasing Transparency in Generic Drug Applications Act; Country of origin labeling.

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

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

H.R. 7148 (now Public Law 119-75) The Consolidated Appropriations Act provisions regulating pharmacy benefit manager practices S. 2355 Patients Deserve Price Tags Act provisions related to drug price transparency and patient transparency tools S. 3822 Break Up Big Medicine Act provisions related to insurer/PBM ownership or pharmacies S. 1954/HR 5526 The Biosimilar Red Tape Elimination Act - provisions related to interchangeability of biosimilars Department of Labors Notice of Proposed Rulemaking, Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure (RIN 1210-AB37) H.R.9393 Lower Costs, More Transparency Act of 2026

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

Government targets: HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE

H.R. 6423/S. 864: HELP Copays Act - requires health insurers to count third-party financial assistance toward patients' cost-sharing obligations, including deductibles and copays, for prescription drugs, with changes effective for plan years beginning January 1, 2026. S. 526: PBM Transparency Act - prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs H.R. 4191/S. 1784: MAPS Act - requires federal agencies to regularly update a list of essential medicines, assess and report on supply chain risks, map pharmaceutical supply chains, and enhance coordination and cybersecurity to protect public health and national security. H.R. 3955/S.2062: RAPID Reserve Act - establishes a $500 million program to create and maintain domestic reserves of critical drugs and their ingredients, prioritizing domestic manufacturing and supply chain resilience to prevent shortages during public health emergencies. H.R. 8339: Drug Origin Transparency Act to amend the Federal Food, Drug, and Cosmetic Act to enhance drug manufacturing amount information reporting H.R. 5526/S. 1954: Biosimilar Red Tape Elimination Act - streamlines the approval process for biosimilar biological products by automatically deeming them interchangeable with reference products, subject to certain exclusivity protections, and requires updated regulatory guidance to reflect these changes. H.R. 4101: Cancer Drug Parity Act of 2025 - requires group health plans to provide cost-sharing for oral anticancer drugs that is at least as favorable as for provider-administered anticancer medications, with protections against increased patient costs and a mandated GAO study on the law's impact. H.R. 3521/S. 4440: Clinical Trials Modernization Act - Increase clinical trial participation among underrepresented populations by providing grants, permitting certain participant reimbursements, and offering tax exclusions, while ensuring compliance with existing legal protections. S. 705: Innovation in Pediatric Drugs Act of 2025 - amends existing laws to enhance pediatric cancer research, mandates compliance measures, allocates funding for pediatric studies, and sets guidelines for orphan drugs, with specific timelines for implementation and evaluation. H.R. 5509/S. 2903: Safe Step Act - to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes. H.R. 4425/S. 2287: Palliative Care and Hospice Education and Training Act - expands federal support for workforce development, education, public awareness, and research in palliative and hospice care, with targeted funding and statutory changes to improve care for patients with serious or life-threatening illnesses. H.R. 8839: Lainie Jones Comprehensive Cancer Survivorship Act of 2026 to address the health of cancer survivors.

Client expense: $480,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug pricing. H.R. 5526 & S. 1954 Biosimilar Red Tape Elimination Act. S. 1095 Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics Act. S. 3014 Ensuring Timely Access to Generics Act of 2025 S. 1414 Expedited Access to Biosimilars Act S. 1032/H.R. 1843 Increasing Transparency in Generic Drug Applications Act. S. 2630, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.1262 Mikaela Naylon Give Kids a Chance Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549

Client expense: $40,000 · 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 Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062: RAPID Reserve Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.

Client expense: $840,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE