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.

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

Client expense: $1,330,000 · Firm income: Not reported

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

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

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

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

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

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

Client expense: $300,000 · Firm income: Not reported

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

Client expense: $1,330,000 · Firm income: Not reported