End Drug Shortages Act

H.R. 2584/ S. 2768, the Safety from Violence for Healthcare Employees (SAVE) Act, all provisions; S. 3211/ H.R. 6205, Healthcare Workforce Resilience Act, all provisions; S.665 / H.R. 4942, Conrad State 30 and Physician Access Reauthorization Act, all provisions; S 3679 / H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions, S. 3770/ H.R. 7266, "The Future Advancement of Academic Nursing (FAAN Act)", all provisions; S. 1176 / H.R. 2663, Workplace Violence Prevention for Health Care and Social Service Workers Act, all provisions, Draft Bill , 340B SUSTAIN Act, all provisions, H.R. 7635, The 340B PATIENTS Act, all provisions; H.R.8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net (340B ACCESS) Act, all provisions; DRAFT Senate / H.R. 5804, Mental Health Infrastructure Improvement Act, all provisions; S. 5368, End Drug Shortages Act, all provisions, H.R. 10362 / S. 5493, To prohibit pharmacy benefit managers and pharmacies from being under common ownership, and for other purposes, all provisions, H.R. 7379, Patient Matching And Transparency in Certified Health IT Act of 2024, all provisions; Health & Human Services (HHS), Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2), Interoperability, improve transparency and electronic access and exchange of electronic health records; Health & Human Services (HHS) & Drug Enforcement Agency (DEA) Telemedicine Waivers for Controlled Substances, Waiver flexibilities for prescribing controlled substances through telemedicine ; Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA), IV Fluid Shortage Impact on Sepsis and Infection Care IV Fluid Shortage Impact on Sepsis and Infection Care; Medical Debt, Issues specific to medical debt incurred by patients and hospital billing and collection practices; Price Transparency, Issues related to hospital price transparency; Rural Health Care Access, Issues to protect access to rural health care; Tax-exempt status, Issues pertaining to not-for-profit hospitals' tax exempt status; Maternal Health and Child Health, Access to maternal and child health care and addressing related workforce shortages, conditions of participation (COP) and impact of recent payment rules; Behavioral Health, Issues related to expanding access to care and reducing regulatory barriers; Health Plan Accountability, Issues specific to prior authorization, patient access to care, adequate provider networks, inappropriate denials, reducing account receivables, prompt pay; Workforce, nurse staffing mandate, workforce development programs; Health Professions Diversity, National health service corps; centers of excellence; health careers opportunity programs; Hospital mergers and acquisitions, Issues pertaining to hospital consolidation, mergers an acquisition, physician practice acquisition; Physician Owned Hospitals Physician-owned hospitals; Supply Chain Issues, Baxter Plant / Hurricane Recovery, Issues pertaining to supply chain issues, IV Fluid Shortages, Baxter Plant, Hurricane Recovery, defense production act, national emergency declaration, Advanced Premium Tax Credits, Extension of Advanced Premium Tax Credits, Cyber Security & Resiliency, Issues pertaining to ongoing cyber risks to the health care field.

Client expense: $6,570,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), SENATE, White House Office

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

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes. HR 6992: Mapping America's Pharmaceutical Supply Act- require the Department of Health and Human Services to update its essential medicines list and create a database to help predict vulnerabilities in the U.S. pharmaceutical supply chain. S 3458: Seniors' Access to Critical Medications Act of 2023 - clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program. HR 8404/S 4330: ROCR Value Based Program Act of 2024 - To amend title XVIII of the Social Security Act to create a Radiation Oncology Case Rate Value Based Payment Program exempt from budget neutrality adjustment requirements, and to amend section 1128A of title XI of the Social Security Act to create a new statutory exception for the provision of free or discounted transportation for radiation oncology patients to receive radiation therapy services. HR 3633: Prevent HPV Cancers ACt of 2023 - To amend the Public Health Service Act to provide for a public awareness campaign with respect to human papillomavirus, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - To amend the Federal Food, Drug, and Cosmetic Act to provide for notification by manufacturers of critical essential medicines of increased demand of such drugs, and for other purposes. S 5368/HR 10239: End Drug Shortages Act - To amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE