To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes.

Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532 PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.133: Consolidated Appropriations Act, 2021 S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129:Lower Costs More Cures Act H.R.2279/S.2546: Safe Step Act H.R.6557: MAIL Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557 MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to prescription drug patents and approval process H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act H.R.985: Fair Access for Safe and Timely (FAST) Generics Act H.R.1499: Protecting Consumer Access to Generic Drugs Act H.R.1520: Purple Book Continuity Act H.R.1503: Orange Book Transparency Act S.64: Preserve Access to Affordable Generics and Biosimilars Act S.659: Biologic Patent Transparency Act Issues related to coverage of prescription drugs in the commercial market H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act

Client expense: $2,000,785 · 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), Office of Management & Budget (OMB), SENATE

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Prescription drug pricing transparency H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532: PBM Study Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.133: Consolidated Appropriations Act, 2021 S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D H.R.19/S.3129: Lower Costs More Cures Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557: MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to coverage of prescription drugs in the commercial market H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134, Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs

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

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.

Client expense: $940,000 · Firm income: Not reported

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Prescription drug pricing transparency H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532: PBM Study Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D H.R.19/S.3129: Lower Costs More Cures Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557: MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to coverage of prescription drugs in the commercial market S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act

Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532 PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129:Lower Costs More Cures Act H.R.2279/S.2546: Safe Step Act H.R.6557: MAIL Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557 MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to prescription drug patents and approval process H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act H.R.985: Fair Access for Safe and Timely (FAST) Generics Act H.R.1499: Protecting Consumer Access to Generic Drugs Act H.R.1520: Purple Book Continuity Act H.R.1503: Orange Book Transparency Act S.64: Preserve Access to Affordable Generics and Biosimilars Act S.659: Biologic Patent Transparency Act Issues related to coverage of prescription drugs in the commercial market S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act

Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129: Lower Costs More Cures Act H.R. 2279/S.2546: Safe Step Act H.R.3: Lower Drug Costs Now Act H.R. 6557 MAIL Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.223/S.532: PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557: MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes

Client expense: $2,676,362 · Firm income: Not reported

Formulary placement of generics and biosimilars in Part D, including H.R. 4913; issues related to access to biosimilar biological products in Medicare Part B, including S. 4134, Increasing Access to Biosimilars Act of 2020.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.

Client expense: $850,000 · Firm income: Not reported

Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532 PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129:Lower Costs More Cures Act H.R.2279/S.2546: Safe Step Act H.R.6557: MAIL Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557 MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to prescription drug patents and approval process H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act H.R.985: Fair Access for Safe and Timely (FAST) Generics Act H.R.1499: Protecting Consumer Access to Generic Drugs Act H.R.1520: Purple Book Continuity Act H.R.1503: Orange Book Transparency Act S.64: Preserve Access to Affordable Generics and Biosimilars Act S.659: Biologic Patent Transparency Act Issues related to coverage of prescription drugs in the commercial market S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Prescription drug pricing transparency H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532: PBM Study Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D H.R.19/S.3129: Lower Costs More Cures Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557: MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to coverage of prescription drugs in the commercial market S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act

Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129: Lower Costs More Cures Act H.R. 2279/S.2546: Safe Step Act H.R.3: Lower Drug Costs Now Act H.R. 6557 MAIL Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.223/S.532: PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557: MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes

Client expense: $1,173,453 · Firm income: Not reported

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act

Client expense: $550,000 · Firm income: Not reported

Formulary placement of generics and biosimilars in Part D, including H.R. 4913; issues related to access to biosimilar biological products in Medicare Part B.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act

Client expense: $560,000 · Firm income: Not reported

Issues related to drug pricing H.R.1499 - Protecting Consumer Access to Generic Drugs Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.965/S. 340 - CREATES Act of 2019 H.R.2375/S. 64 - Preserve Access to Affordable Generics and Biosimilars Act H.R.2374/S. 1224 - Stop STALLING Act S.1895 - Lower Health Care Costs Act S.2103 - Affordable Insulin Approvals Now Act S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R.1865 - Further Consolidated Appropriations Act, 2020 H.R.4913 - To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. H.R.6179 - Increasing Access to Biosimilars Act of 2020 H.R.6201 - Families First Coronavirus Response Act H.R.748 - CARES Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Formulary placement of generics and biosimilars in Part D, including H.R. 4913; issues related to access to biosimilar biological products in Medicare Part B.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.2376/S.1227: Prescription Pricing for the People Act H.R.19/S.3129: Lower Costs More Cures Act H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.1035: Prescription Drug Price Transparency Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.3: Lower Drug Costs Now Act H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act S.476: C-THRU Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.3130: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act

Client expense: $1,069,799 · Firm income: Not reported

Issues related to prescription drug coverage and pharmacy benefits Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, manufacturer market and data exclusivity, REMS, accelerated generic approval, biosimilars H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1264/S.801: Payment Commission Data Act H.R.965/S.340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act H.R.2376/S.1227: Prescription Pricing for the People Act H.R. 19/S.3129: Lower Costs More Cures Act H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.1035: Prescription Drug Price Transparency Act H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act H.R.985: Fair Access for Safe and Timely (FAST) Generics Act H.R.1499: Protecting Consumer Access to Generic Drugs Act H.R.1520: Purple Book Continuity Act H.R.1503: Orange Book Transparency Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.3: Lower Drug Costs Now Act H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act S.476: C-THRU Act S.64: Preserve Access to Affordable Generics and Biosimilars Act S.659: Biologic Patent Transparency Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.3130: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1264/S.801: Payment Commission Data Act H.R.19/S.3129: Lower Costs More Cures Act H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.1035: Prescription Drug Price Transparency Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.3: Lower Drug Costs Now Act H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.3130: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act

Client expense: $1,069,799 · Firm income: Not reported

H.R. 4913 - Ensuring seniors can get access to affordable medication by making sure that generic and biosimilar drugs are being covered and placed on the correct formulary tier in Part D S. 2103 Affordable Insulin Approvals Now Act Health Care Issues, Issues Related to Drug Pricing, Issues Related to the FDA S. 3548 - CARES Act: Issues related to Buy America provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.

Client expense: $940,000 · Firm income: Not reported

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models H.R. 3925: Reducing Barriers to Substance Use Treatment Act - Provisions related to prior authorization requirements H.R. 4178: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates H.R. 4455: BIOSIM Act - Provisions related to biosimilar approval and reimbursement H.R. 4619: Pharmaceutical Rebates for Excessive Pricing Above Inflation Act - Provisions related to Part D and manufacturer rebates H.R. 4628: Better Tools to Lower Costs Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4649: Capping Drug Costs for Seniors Act of 2019 - Provisions related to Part D and patient cost-sharing H.R. 4650: Medicare Dental Act of 2019 - Provisions related to Medicare coverage of dental procedures H.R. 4655: Enhancing Retirement Security for Medicare Beneficiaries Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4663: Freedom from Price Gouging Act - Provisions related to Part B and manufacturer rebates H.R. 4669: Maximizing Drug Coverage for Low-Income Seniors Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4913: Ensuring Access to Lower-Cost Medicines for Seniors Act - Provisions related to Part D prescription drug plans and formularies H.R. 5039: Life-Sustaining Prescription Drug Price Relief Act of 2019 - Provisions related to Part D, prescription drug negotiation, reference pricing and other provisions H.R. 5057: Pass-Through Technical Corrections Act - Provisions related to Medicare prescription drug pass-through payment status S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 709: Prescription Drug Pricing Dashboard Act - Provisions related to prescription drug pricing transparency S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Policy issues related to patient medication information Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tennessee Section 1115 Medicaid waiver Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, 84 Fed. Reg. 55694 (10/17/19)

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act

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

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.2376/S.1227: Prescription Pricing for the People Act H.R.1035: Prescription Drug Price Transparency Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.3: Lower Drug Costs Now Act H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes S.476: C-THRU Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act

Client expense: $1,257,921 · Firm income: Not reported

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1264/S.801: Payment Commission Data Act H.R.1035: Prescription Drug Price Transparency Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.3: Lower Drug Costs Now Act H.R. 4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act

Client expense: $1,257,921 · Firm income: Not reported

Issues related to prescription drug coverage and pharmacy benefits Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, manufacturer market and data exclusivity, REMS, accelerated generic approval, biosimilars H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1264/S.801: Payment Commission Data Act H.R.965/S.340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act H.R.2376/S.1227: Prescription Pricing for the People Act H.R.1035: Prescription Drug Price Transparency Act H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act H.R.985: Fair Access for Safe and Timely (FAST) Generics Act H.R.1499: Protecting Consumer Access to Generic Drugs Act H.R.1520: Purple Book Continuity Act H.R.1503: Orange Book Transparency Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.3: Lower Drug Costs Now Act H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes S.476: C-THRU Act S.64: Preserve Access to Affordable Generics and Biosimilars Act S.659: Biologic Patent Transparency Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models H.R. 3925: Reducing Barriers to Substance Use Treatment Act - Provisions related to prior authorization requirements H.R. 4178: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates H.R. 4455: BIOSIM Act - Provisions related to biosimilar approval and reimbursement H.R. 4619: Pharmaceutical Rebates for Excessive Pricing Above Inflation Act - Provisions related to Part D and manufacturer rebates H.R. 4628: Better Tools to Lower Costs Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4649: Capping Drug Costs for Seniors Act of 2019 - Provisions related to Part D and patient cost-sharing H.R. 4650: Medicare Dental Act of 2019 - Provisions related to Medicare coverage of dental procedures H.R. 4655: Enhancing Retirement Security for Medicare Beneficiaries Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4663: Freedom from Price Gouging Act - Provisions related to Part B and manufacturer rebates H.R. 4669: Maximizing Drug Coverage for Low-Income Seniors Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4913: Ensuring Access to Lower-Cost Medicines for Seniors Act - Provisions related to Part D prescription drug plans and formularies H.R. 5039: Life-Sustaining Prescription Drug Price Relief Act of 2019 - Provisions related to Part D, prescription drug negotiation, reference pricing and other provisions H.R. 5057: Pass-Through Technical Corrections Act - Provisions related to Medicare prescription drug pass-through payment status H.R. 5242: Opioid Settlement Accountability Act - Provisions related to Medicaid and opioid litigation related funds H.R. 5364: End Price Gouging for Insulin Act - Provisions related to prescription drug international reference pricing S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 709: Prescription Drug Pricing Dashboard Act - Provisions related to prescription drug pricing transparency S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Policy issues related to patient medication information Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tennessee Section 1115 Medicaid waiver Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, 84 Fed. Reg. 55694 (10/17/19)

Formulary placement of generics and biosimilars in Part D, including H.R. 4913.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.937 - Right Rebate Act of 2019 Medicare Part A H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.1035 - Prescription Drug Price Transparency Act H.R.1384 - Medicare for All Act of 2019 H.R.1788 - Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act H.R.4628 - Better Tools to Lower Costs Act of 2019 H.R.4649 - Capping Drug Costs for Seniors Act of 2019 - Provisions related to Medicare coverage of dental procedures H.R.4655 - Enhancing Retirement Security for Medicare Beneficiaries Act of 2019 H.R.4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act - Provisions related to Part D prescription drug plans and formularies H.R.5039 - Life-Sustaining Prescription Drug Price Relief Act of 2019

Client expense: $620,000 · Firm income: Not reported

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. H.R.5381: International Pharmaceutical Transparency Act of 2019. Drug Compounding. Drug Shortages. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. FDA Citizen Petitions. H.R.2387: STOP GAMES Act of 2019. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. S.475: RxCAP Act of 2019. 180-Day Exclusivity. H.R.2455/S.1169: Ensuring Timely Access to Generics Act of 2019. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.2376: Prescription Pricing for the People Act of 2019. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. S.1805: Better Tools for Healthy Living Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA).

Issues related to drug pricing H.R.1499 - Protecting Consumer Access to Generic Drugs Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.965/S. 340 - CREATES Act of 2019 H.R.2375/S. 64 - Preserve Access to Affordable Generics and Biosimilars Act H.R.2374/S. 1224 - Stop STALLING Act S.1895 - Lower Health Care Costs Act S.2103 - Affordable Insulin Approvals Now Act S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R.1865 - Further Consolidated Appropriations Act, 2020 H.R.4913 - To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4913 - To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. S. 2103 Affordable Insulin Approvals Now Act Health Care Issues, Issues Related to Drug Pricing, Issues Related to the FDA

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE