Phair Relief Act of 2019

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

Client expense: $2,676,362 · 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 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

H.R. 1614 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S. 724 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S.340 CREATES Act of 2019 H.R. 985 FAST Generics Act of 2019 S.640 Phair Pricing Act of 2019 S. 97 Affordable and Safe Prescription Drug Importation Act S. 61 Safe and Affordable Drugs from Canada Act of 2019 H.R. 1034 Phair Pricing Act of 2019 H.R. 965 CREATES Act of 2019 H.R. 1478 Affordable Insulin Act of 2019 H.R. 447 Affordable and Safe Prescription Drug Importation Act H.R. 1499 Protecting Consumer Access to Generic Drugs Act H.R. 3417 The Beneficiary Education Tools, Telehealth, and Extenders Re-authorization Act of 2019 H.R. 2296 Fair Accountability and Innovative Research Drug Pricing (FAIR Drug Pricing) Act of 2019 H.R. 1607 Fairness to Pet Owners Act H.R. 3379 Priced Relief, Innovation, and Competition for Essential Drugs (PRICED) Act H.R. 478 Safe and Affordable Drugs from Canada Act of 2019 H.R. 3 Lower Drug Costs Now Act of 2019 H.R. 275 Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448 Medicare Drug Price Negotiation Act H.R. 1046 Medicare Negotiation and Competitive Licensing Act of 2019 H.R. 5304 PBM Transparency in Prescription Drug Costs Act H.R. 5172 NOPAIN Act S. 2543 Prescription Drug Pricing Reduction Act of 2019 S. Rept. 116-120 Prescription Drug Pricing Reduction Act of 2019 S. 2247 Phair Relief Act of 2019 S. 3070 Preventing Pill Mills Through Data Sharing Act H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 19 Lower Costs, More Cures Act on 2019 S. 3129 Lower Costs, More Cures Act on 2019 H.R. 748 Coronavirus Aid, Relief, and Economic Security Act or the CARES Act H.R. 6573 Help our Heroes Access Medicine Act of 2020 H.R. 6557 MAIL Act S. 3979 A bill to amend title 10, United States Code, to authorize the Secretary of Defense to temporarily waive cost-sharing amounts under the TRICARE pharmacy benefits program during certain declared emergencies. H.R.6395 - William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 H.R. 4806 DEBAR Act of 2019 H.R. 3878 Block, Report, and Suspend Suspicious Shipments Act of 2019 H.R. 4812 Ensuring Compliance Against Drug Diversion Act H.R. 4814 Suspicious Order Identification Act of 2019 H.R. 8061 Community Immunity During COVID-19 Act S. 3548 The CARES Act H.R. 6800 The HEROES 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 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

Medicare Direct and Indirect Remuneration H.R. 1034, S.640 Phair Pricing Act of 2019, S. 2247 Phair Relief Act Medicare coverage of home infusion access

Client expense: Not reported · Firm income: $120,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 1614 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S. 724 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S.340 CREATES Act of 2019 H.R. 985 FAST Generics Act of 2019 S.640 Phair Pricing Act of 2019 S. 97 Affordable and Safe Prescription Drug Importation Act S. 61 Safe and Affordable Drugs from Canada Act of 2019 H.R. 1034 Phair Pricing Act of 2019 H.R. 965 CREATES Act of 2019 H.R. 1478 Affordable Insulin Act of 2019 H.R. 447 Affordable and Safe Prescription Drug Importation Act H.R. 1499 Protecting Consumer Access to Generic Drugs Act H.R. 3417 The Beneficiary Education Tools, Telehealth, and Extenders Re-authorization Act of 2019 H.R. 2296 Fair Accountability and Innovative Research Drug Pricing (FAIR Drug Pricing) Act of 2019 H.R. 1607 Fairness to Pet Owners Act H.R. 3379 Priced Relief, Innovation, and Competition for Essential Drugs (PRICED) Act H.R. 478 Safe and Affordable Drugs from Canada Act of 2019 H.R. 3 Lower Drug Costs Now Act of 2019 H.R. 275 Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448 Medicare Drug Price Negotiation Act H.R. 1046 Medicare Negotiation and Competitive Licensing Act of 2019 H.R. 5304 PBM Transparency in Prescription Drug Costs Act H.R. 5172 NOPAIN Act S. 2543 Prescription Drug Pricing Reduction Act of 2019 S. Rept. 116-120 Prescription Drug Pricing Reduction Act of 2019 S. 2247 Phair Relief Act of 2019 S. 3070 Preventing Pill Mills Through Data Sharing Act H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 19 Lower Costs, More Cures Act on 2019 S. 3129 Lower Costs, More Cures Act on 2019 H.R. 748 Coronavirus Aid, Relief, and Economic Security Act or the CARES Act H.R. 6573 Help our Heroes Access Medicine Act of 2020 H.R. 6557 MAIL Act S. 3979 A bill to amend title 10, United States Code, to authorize the Secretary of Defense to temporarily waive cost-sharing amounts under the TRICARE pharmacy benefits program during certain declared emergencies. H.R.6395 - William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021

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. 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 S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and prescription drug price negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification 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. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 2650: Medicare Prescription Drug Savings and Choice Act of 2019 - Provisions related to Part D and prescription drug pricing S. 2817: End Price Gouging for Insulin Act - Provisions related to prescription drug international reference pricing S. 2911: Seniors Prescription Drug Relief Act of 2019 - Provisions related to Part D and patient cost-sharing S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3457: Preserving Patient Access to Home Infusion Act - Provisions related to Medicare and prescription drug access 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 CMS Healthy Adult Opportunity (HAO) initiative and related policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P)

Medicare Direct and Indirect Remuneration H.R. 1034, S.640 Phair Pricing Act of 2019, S. 2247 Phair Relief Act Medicare coverage of home infusion

Client expense: Not reported · Firm income: $120,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

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. 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 S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and prescription drug price negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification 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. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 2650: Medicare Prescription Drug Savings and Choice Act of 2019 - Provisions related to Part D and prescription drug pricing S. 2817: End Price Gouging for Insulin Act - Provisions related to prescription drug international reference pricing S. 2911: Seniors Prescription Drug Relief Act of 2019 - Provisions related to Part D and patient cost-sharing S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3457: Preserving Patient Access to Home Infusion Act - Provisions related to Medicare and prescription drug access 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 CMS Healthy Adult Opportunity (HAO) initiative and related policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P)

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. 1614 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S. 724 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S.340 CREATES Act of 2019 H.R. 985 FAST Generics Act of 2019 S.640 Phair Pricing Act of 2019 S. 97 Affordable and Safe Prescription Drug Importation Act S. 61 Safe and Affordable Drugs from Canada Act of 2019 H.R. 1034 Phair Pricing Act of 2019 H.R. 965 CREATES Act of 2019 H.R. 1478 Affordable Insulin Act of 2019 H.R. 447 Affordable and Safe Prescription Drug Importation Act H.R. 1499 Protecting Consumer Access to Generic Drugs Act H.R. 3417 The Beneficiary Education Tools, Telehealth, and Extenders Re-authorization Act of 2019 H.R. 2296 Fair Accountability and Innovative Research Drug Pricing (FAIR Drug Pricing) Act of 2019 H.R. 1607 Fairness to Pet Owners Act H.R. 3379 Priced Relief, Innovation, and Competition for Essential Drugs (PRICED) Act H.R. 478 Safe and Affordable Drugs from Canada Act of 2019 H.R. 3 Lower Drug Costs Now Act of 2019 H.R. 275 Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448 Medicare Drug Price Negotiation Act H.R. 1046 Medicare Negotiation and Competitive Licensing Act of 2019 H.R. 5304 PBM Transparency in Prescription Drug Costs Act H.R. 5172 NOPAIN Act S. 2543 Prescription Drug Pricing Reduction Act of 2019 S. Rept. 116-120 Prescription Drug Pricing Reduction Act of 2019 S. 2247 Phair Relief Act of 2019 S. 3070 Preventing Pill Mills Through Data Sharing Act H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 19 Lower Costs, More Cures Act on 2019 S. 3129 Lower Costs, More Cures Act on 2019 H.R. 748 Coronavirus Aid, Relief, and Economic Security Act or the CARES 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. 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)

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

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (Isakson) - regulations re nonprescription drugs that are marketed without an approved new drug application S. 3052, United States-Mexico-Canada Agreement Implementation Act (Grassley) - drug pricing S. 3067, Non-Opioids Prevent Addiction In the Nation Act (Capito) - non-opioid treatments S. 3092, Expanding Access to Low-Cost Generics Act of 2019 (Smith) - exclusivity period H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.R. 4640, Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (DeFazio) - direct negotiation H.R. 4712, Fairness in Orphan Drug Exclusivity Act (Dean) - limitations on exclusive approval of orphan drugs H.R. 4810, Opioid Prescription Verification Act of 2019 (David) - dispensing of controlled substances H.R. 4906, Insulin Price Reduction Act (Diana DeGette) - insulin costs H.R. 5304, PBM Transparency in Prescription Drug Costs Act (Schrader) - PBMs H.R. 5364, End Price Gouging for Insulin Act (Beatty) - annual reference price for insulin products H.R. 5430, United States-Mexico-Canada Agreement Implementation Act (Hoyer) - drug pricing H.R. 5442, Lowest Price for Patients Act (Porter) - pharmacies to disclose any differential between the cost of a prescription drug H.R. 5444, Lower Insulin Costs Now Act (Underwood) - lowering insulin costs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

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)

H.R. 1614 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S. 724 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S.340 CREATES Act of 2019 H.R. 985 FAST Generics Act of 2019 S.640 Phair Pricing Act of 2019 S. 97 Affordable and Safe Prescription Drug Importation Act S. 61 Safe and Affordable Drugs from Canada Act of 2019 H.R. 1034 Phair Pricing Act of 2019 H.R. 965 CREATES Act of 2019 H.R. 1478 Affordable Insulin Act of 2019 H.R. 447 Affordable and Safe Prescription Drug Importation Act H.R. 1499 Protecting Consumer Access to Generic Drugs Act H.R. 3417 The Beneficiary Education Tools, Telehealth, and Extenders Re-authorization Act of 2019 H.R. 2296 Fair Accountability and Innovative Research Drug Pricing (FAIR Drug Pricing) Act of 2019 H.R. 1607 Fairness to Pet Owners Act H.R. 3379 Priced Relief, Innovation, and Competition for Essential Drugs (PRICED) Act H.R. 478 Safe and Affordable Drugs from Canada Act of 2019 H.R. 3 Lower Drug Costs Now Act of 2019 H.R. 275 Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448 Medicare Drug Price Negotiation Act H.R. 1046 Medicare Negotiation and Competitive Licensing Act of 2019 H.R. 5304 PBM Transparency in Prescription Drug Costs Act H.R. 5172 NOPAIN Act S. 2543 Prescription Drug Pricing Reduction Act of 2019 S. Rept. 116-120 Prescription Drug Pricing Reduction Act of 2019 S. 2247 Phair Relief Act of 2019 S. 3070 Preventing Pill Mills Through Data Sharing Act H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 19 Lower Costs, More Cures Act on 2019 S. 3129 Lower Costs, More Cures Act on 2019

Medicare Direct and Indirect Remuneration H.R. 1034, S.640 Phair Pricing Act of 2019, S. 2247 Phair Relief Act

Client expense: Not reported · Firm income: $110,000

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

S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act, issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act, issues related to ensuring the continuity of MAC pricing. Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information--Provisions on Part D. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P as in proposed and final version CMS-4182-F, particularly issues related to pharmacy DIR and implementation of a real-time-benefit tool); provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare. Provisions related to opening the Medicare doughnut hole in P.L. 115-123. HR 803: Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, pharmacy payments & adjustments in Part D/ DIR. HR 789: To amend title XVIII of the Social Security Act to prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies." HR 1035: The Prescription Drug Price Transparency Act, requires greater transparency and accountability from PBMs. HR 1034/S 640: The Phair Pricing Act, lowers the cost of prescription medication for patients in the Medicare Part D program. HR 965/S 340: "The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act." Proposals to address pay-for-delay, orphan drug abuse and patent evergreening. Implementation of the e-prescribing provisions of controlled substances provisions of the SUPPORT Act, (P.L. 115-271). The Payment Commission Data Act, H.R. 1264, H.R. 1781 and S. 801: provisions allowing MACPAC and MedPAC access to certain drug price concession and rebate information. S. 64: Preserve Access to Affordable Generics and Biosimilars Act, bars pay-for-delay for generics and biosimilars. S. 1416: The Affordable Prescriptions for Patients Act of 2019, address product hopping and patent thickets by giving the FTC greater powers to investigate and bring legal actions. S. 1384: The Prescription Drug Rebate Reform Act, would require all patients coinsurance obligations be set as a percentage of net price, rather than list price, before or after a deductible is met. S. 1505: a bill to require prescription drug plans and MA-PD plans to report potential fraud, waste, and abuse to the Secretary of Health and Human Services under Medicare part D, and for other purposes. S. 1532: The Pharmacy Benefit Manager Accountability Study Act of 2019, (Provisions requiring GAO to submit a report on PBMs). Modernization and cost-sharing of the Part D drug benefit. H.R. 2115: the "Public Disclosure of Drug Discounts Act, requires PBMs to disclose the aggregate amount of rebates, discounts, and price concessions that PBMs negotiate with drug manufacturers, and make this information publicly available to allow the public to compare the aggregate rebates, discounts, and price concessions that PBMs receive. H.R. 2113: "The Prescription Drug STAR (Sunshine, Transparency, Accountability and Reporting) Act," provisions related to disclosure of PBM-pharmaceutical company negotiated rebates. H.R. 2376/S. 1227: Prescription Pricing for the People Act of 2019, FTC study of PBMs. S.2199: The Insulin Price Reduction Act, require private health insurance plans and Medicare Part D plans to eliminate rebates for insulin and limit out of pocket costs ($250 for individuals, and $500 for families) if manufacturers reduce insulin list prices to prices during plan year 2006 and do not raise insulin prices above inflation. S.2543: The Prescription Drug Pricing Reduction Act (PDPRA) of 2019, -Legislation to amend Medicare and Medicaid to lower prescription drug prices and strengthen safeguards related to prescription drugs. Provisions related to inflation protection provisions and PBM transparency. S.2247: Phair Relief Act, Provisions related to pharmacy DIR. H.R. 3: Lower Drug Costs Now Act of 2019, Provisions to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollment. CMS Proposed rule: "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses," (CMS-4180-P)-provisions related to pharmacy Direct and Indirect Negotiation.

___ 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. 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. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights ___ H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification ___ H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ 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. 3523: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing ___ H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models ___ S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation ___ S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification ___ S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing ___ S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing ___ S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation ___ 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. 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. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting ___ S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ S. 1261: Choose Medicare Act - 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. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency ___ S. 1895: Lowering Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues ___ S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling ___ 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. 2081: Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 - Provisions related to prescription drug pricing and manufacturer 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 ___ Anti-Kickback Statute policy issues ___ Center for Medicare and Medicaid Innovation (CMMI) policy issues ___ Medicaid rebates and waiver policy issues ___ 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) ___ Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) ___ Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) ___ Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Monograph Reform and HSA/FSAs

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. 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. 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. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation 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. 3523: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation 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. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - 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. 1801: Affordable Medications Act - Provisions related to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lowering Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling 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. 2081: Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 - Provisions related to prescription drug pricing and manufacturer 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 Policy issues related to patient medication information Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues 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) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Issues related to HHS OIG Proposed Rule 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 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 S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act

Client expense: $854,535 · 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 Issues related to HHS OIG Proposed Rule 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 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 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: $854,535 · Firm income: Not reported

Issues related to prescription drug coverage and pharmacy benefits Issues related to HHS OIG Proposed Rule 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 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 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.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act, issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act, issues related to ensuring the continuity of MAC pricing. Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information--Provisions on Part D. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P as in proposed and final version CMS-4182-F, particularly issues related to pharmacy DIR and implementation of a real-time-benefit tool); provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare. Provisions related to opening the Medicare doughnut hole in P.L. 115-123. HR 803: Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, pharmacy payments & adjustments in Part D/ DIR. HR 789: To amend title XVIII of the Social Security Act to prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies." HR 1035: The Prescription Drug Price Transparency Act, requires greater transparency and accountability from PBMs. HR 1034/S 640: The Phair Pricing Act, lowers the cost of prescription medication for patients in the Medicare Part D program. HR 965/S 340: "The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act." Proposals to address pay-for-delay, orphan drug abuse and patent evergreening. Implementation of the e-prescribing provisions of controlled substances provisions of the SUPPORT Act, (P.L. 115-271). The Payment Commission Data Act, H.R. 1264, H.R. 1781 and S. 801: provisions allowing MACPAC and MedPAC access to certain drug price concession and rebate information. S. 64: Preserve Access to Affordable Generics and Biosimilars Act, bars pay-for-delay for generics and biosimilars. S. 1416: The Affordable Prescriptions for Patients Act of 2019, address product hopping and patent thickets by giving the FTC greater powers to investigate and bring legal actions. S. 1384: The Prescription Drug Rebate Reform Act, would require all patients coinsurance obligations be set as a percentage of net price, rather than list price, before or after a deductible is met. S. 1505: a bill to require prescription drug plans and MA-PD plans to report potential fraud, waste, and abuse to the Secretary of Health and Human Services under Medicare part D, and for other purposes. S. 1532: The Pharmacy Benefit Manager Accountability Study Act of 2019, (Provisions requiring GAO to submit a report on PBMs). Modernization and cost-sharing of the Part D drug benefit. H.R. 2115: the "Public Disclosure of Drug Discounts Act, requires PBMs to disclose the aggregate amount of rebates, discounts, and price concessions that PBMs negotiate with drug manufacturers, and make this information publicly available to allow the public to compare the aggregate rebates, discounts, and price concessions that PBMs receive. H.R. 2087: "The STAR (Sunshine, Transparency, Accountability and Reporting) Act," provisions related to disclosure of PBM-pharmaceutical company negotiated rebates. H.R. 2376/S. 1227: Prescription Pricing for the People Act of 2019, FTC study of PBMs. S.2199: The Insulin Price Reduction Act, require private health insurance plans and Medicare Part D plans to eliminate rebates for insulin and limit out of pocket costs ($250 for individuals, and $500 for families) if manufacturers reduce insulin list prices to prices during plan year 2006 and do not raise insulin prices above inflation. S.2543: The Prescription Drug Pricing Reduction Act (PDPRA) of 2019, -Legislation to amend Medicare and Medicaid to lower prescription drug prices and strengthen safeguards related to prescription drugs. Provisions related to inflation protection provisions and PBM transparency. S.2247: Phair Relief Act, Provisions related to pharmacy DIR. H.R. 3: Lower Drug Costs Now Act of 2019, Provisions to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollment. CMS Proposed rule: "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses," (CMS-4180-P)-provisions related to pharmacy Direct and Indirect Negotiation.

Medicare Direct and Indirect Remuneration H.R. 1034, S.640 Phair Pricing Act of 2019, S. 2247 Phair Relief Act

Client expense: Not reported · Firm income: $80,000

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

Medicare Direct and Indirect Remuneration H.R. 1034, S. 640 Phair Pricing Act of 2019, S.2247 Phair Relief Act

Client expense: Not reported · Firm income: Not reported