Emergency Access to Insulin Act of 2023

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: $5,294,628 · 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. 3134: Emergency Access to Insulin Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act of 2023 H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Nomination of Dr. Monica Bertagnolli as NIH director Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Anticounterfeiting policy issues Artificial intelligence policy issues

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

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

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 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: $3,973,758 · 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