Drug Origin Transparency Act of 2026

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

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

Childrens Hospitals Graduate Medical Education (CHGME) program - Urged increased funding in FY 2027 to fund CHGME with the same priority as other federal physician training programs Continued healthcare access - Advocated for a more resilient healthcare infrastructure and policies that provide the staffing and technological infrastructure necessary to maintain essential services Continued monitoring and encouraged passage of the Biosimilar Red Tape Elimination Act (S.1954) Continued monitoring and encouraged passage of the Improving Seniors' Timely Access to Care Act (H.R. 3514/S.1816) Continued monitoring and encouraged passage of the Mapping Americas Pharmaceutical Supply (MAPS) Act (S.1784/H.R.4191) Continued monitoring and encouraged passage of the Protect Medicaid and Rural Hospitals Act (S.2279) Continued monitoring and encouraged passage of the Protecting Health Care and Lowering Costs Act (S.2556) Continued monitoring and encouraged passage of the Resident Physician Shortage Reduction Act of 2025 (S.2439/H.R.3890/H.R.4731) Continued monitoring and encouraged passage of the Save Healthcare Workers Act (S.1600/H.R.3178). Drug shortages - Supported elements to increase transparency in prescription drug supply chain and increase reimbursement for generic prescription drugs; issues related to compounding; issues related to buffer inventory. Encouraged improved stakeholder communication and increased notification by manufacturers for surges in demand Endorsed and encouraged passage of the Drug Origin Transparency Act of 2026 (HR.8339) Hospital Data and Analytics - Provided education and information on the types of clinical, operational, financial and quality data hospitals collect and monitor to improve patient care. Hospital Group Purchasing - Advocated to highlight the value that hospital group purchasing organizations (GPOs) provide to hospitals and suppliers. Provided education on how GPOs work in the healthcare supply chain and the role they play in delivering value to healthcare providers, as well as key differences between traditional GPOs and PBMs. Supply Assurance - Responded to a Senate Special Committee on Aging inquiry on vulnerabilities in the U.S. pharmaceutical supply chain highlighting the work done by GPOs to improve supply chain resiliency and encouraging additional healthcare supply chain visibility. Urged passage of legislation to reauthorize The Pandemic and All-Hazards Preparedness Act (PAHPA) Telehealth - Encouraged the adoption of additional permanent telehealth policies to extend certain telemedicine flexibilities beyond their current expiration date. United States Core Data for Interoperability Draft Version 7 - Respond to the Office of the National Coordinator for Health Information Technology Policy (ONC) on issues raised in Standards Bulletin 2026-1 (SB26-1) and offered comments to constructively improve certain data elements of Draft USCDI v7. Offered recommendations for future iterations of USCDI standards. Workforce - Advocated for strengthening the health workforce and preventing workforce shortages through policies that support education, training, recruitment and retention efforts.

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

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