ACCESS for Biosimilars Act of 2019

Medicare reimbursement issues. FDA regulations of biosimilars. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program. H.R. 133, Consolidating Appropriations Act, 2021. H.R. 925, HEROES Act.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Drug pricing legislation. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program. H.R. 133, Consolidating Appropriations Act, 2021. H.R. 925, HEROES Act.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug pricing and value Issues related to ICD-10 diagnosis codes Prescription drug manufacturing and supply chains Issues regarding the ongoing COVID-19 public health emergency Biosimilars S. 3466/H.R. 4597, and H.R. 6179/S. 4134

Client expense: $790,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Biosimilars S. 3466, H.R. 4597, and H.R. 6179, S. 4134

Client expense: $790,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D redesign, rebate reform, and international pricing index (no specific bills) 2021 Notice of Benefit and Payment Parameters and cost-sharing assistance Medicaid Drug Rebate Program (MDRP), including value-based purchasing (VBP) arrangements and line extensions Biosimilars S. 3466, H.R. 4597, and H.R. 6179, S. 4134

Client expense: $790,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to generic pharmaceuticals and biosimilars, including H. R. 928, the BLOCKING Act of 2019. Changes to the Risk Evaluation and Mitigation Strategies (REMS) program. Reimbursement rate for biosimilars. S. 1895, the Lower Health Care Costs Act, S.2543, The Prescription Drug Pricing Reduction Act, and H. R. 3,The Lower Drug Costs Now Act. H. R. 1865. Issues related to the implementation of H. R. 748, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including supply chain issues for generic medicines. Issues related to H.R.6395 and S.4049, National Defense Authorization Act for Fiscal Year 2021, including pharmaceutical supply chain provisions. Issues related to H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act, including domestic pharmaceutical manufacturing. Issues related to H.R. 133, Consolidated Appropriations Act for Fiscal Year 2021. Issues related to H.R. 6179, Increasing Access to Biosimilars Act of 2020, H.R. 4597, the ACCESS Act, and H.R. 4455, the Biosim Act.

Client expense: Not reported · Firm income: $60,000

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S.

Medicare related to biosimilars H.R. 4455 - The BIOSIM Act Passed the House as part of H.R. 3. Appropriations included in Committee report H.R. 2740; included also in FY 2021 Labor-H Committee report. H.R. 6179/S. 4134 - Increasing Access to Biosimilars Act of 2020 H.R. 4597/S. 3466 - The ACCESS Act H.R. 8624 - Protecting Access to Innovation during COVID-19 Act S. 4295 Public Health Emergency Pass-Through Payment Fairness Act Most Favored Nation Model for Medicare Part B Drugs and Biologicals Interim Final Rule

Client expense: $75,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S., White House Office

Medicare related to biosimilars H.R. 4455 - The BIOSIM Act Passed the House as part of H.R. 3. Appropriations included in Committee report H.R. 2740; included also in FY 2021 Labor-H Committee report. H.R. 6179/S. 4134 - Increasing Access to Biosimilars Act of 2020 H.R. 4597/S. 3466 - The ACCESS Act H.R. 8624 - Protecting Access to Innovation during COVID-19 Act S. 4295 Public Health Emergency Pass-Through Payment Fairness Act

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S., White House Office

H.R. 6800 - HEROES (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 8406 - The HEROES 2.0 (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 2693/S. 283 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019 2021 Notice of Benefit and Payment Parameters (NBPP) rule and cost-sharing assistance H.R. 7647 - Preserving Patient Savings on Drug Costs Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 Issues related to Most Favored Nation (MFN)/International Pricing Index (IPI) Executive Order, no specific bill H.R. 4597/S. 3466 - the ACCESS for Biosimilars Act of 2020 H.R. 3 - Lower Prescription Drug Costs Now Act H.R. 19/S. 3129 Lower Costs, More Cures Act S. 2543 Prescription Drug Pricing Reduction Act Issues related to the 340B program, no specific bill Medicare Part B coverage and reimbursement issues Home administration for Part B medicines due to COVID-19 Issues related to International Pricing Index (IPI), no specific bill Coding and reimbursement for biologics/biosimilars Issues related to Part D redesign Issues related to Part D rebate reform Medicare Part D access issues for plan year 2020 and 2021, no specific bill Issues related to Direct to Consumer Advertisement Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters Medicare End Stage Renal Disease Prospective Payment System (ESRD PPS) Proposed Rule (bundled payment for calcimimetics) Medicaid Value-Based Purchasing (VBP) Proposed Rule (Line Extensions & Manufacturer Co-pay Assistance)

Client expense: $2,920,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE

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

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

Medicare reimbursement issues. FDA regulations of biosimilars. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program. The Cares Act (P.L. 116-136). H.R. 925, HEROES Act.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Drug pricing legislation. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program. The Cares Act (P.L. 116-136). H.R. 925, HEROES Act.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. including provisions relating to Anti-microbial Resistance H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act H.R. 5076, Protecting Seniors Through Immunization Act of 2019 H.R. 6197, Increasing Access to Biosimilars Act of 2020 H.R. 8061, Community Immunity During COVID-19 Act of 2020 S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; 340B program integrity; 340B of the Public Health Services Act; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Vaccines; Adult vaccines and immunizations; Supply chain; Coronavirus stimulus funding; HIV; Rebate pass through; COVID-19 vaccines; Vaccines catch up; Proposed rule on Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products (79 Fed. Reg. 75,506-75,527, December 18, 2014); Coronavirus Aid Relief, and Economic Security (CARES) Act (P.L. 116-146)

Client expense: $980,000 · Firm income: Not reported

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

Issues related to Medicare Part D redesign, rebate reform, and international pricing index (no specific bills) 2021 Notice of Benefit and Payment Parameters and cost-sharing assistance Medicaid Drug Rebate Program (MDRP), including value-based purchasing (VBP) arrangements and line extensions Biosimilars S. 3466, H.R. 4597, and H.R. 6179, S. 4134

Client expense: $610,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug pricing and value Issues related to ICD-10 diagnosis codes Prescription drug manufacturing and supply chains Biosimilars S. 3466/H.R. 4597, and H.R. 6179/S. 4134

Client expense: $610,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Biosimilars S. 3466, H.R. 4597, and H.R. 6179, S. 4134

Client expense: $610,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Medicare Part A, B and D AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377 - Medicare Negotiation and Competitive Licensing Act of 2019 Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Drug Pricing Outcomes Based Contracts/value based arrangements Medicaid H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772 - The Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act S. 3129 - Lower Costs, More Cures Act of 2019 S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 3457 - Preserving Patient Access to Home Infusion Act H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Transparency policy issues Center for Medicare and Medicaid Innovation (CMMI) 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) Reimbursement for cell therapy products S. 3353/H.R. 5534 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act Patient Cost-Sharing and Smoothing S. 4134 - Increasing Access to Biosimilars Act of 2020 S. 102 - Prescription Drug Price Relief Act of 2019 CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)

Client expense: $1,190,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.

Client expense: $500,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office

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

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R. 6800 - HEROES (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 266 - Paycheck Protection Program and Health Care Enhancement Act and temporary access to Part B medicines at home H.R. 2693/S. 283 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019 2021 Notice of Benefit and Payment Parameters (NBPP) rule and cost-sharing assistance. H.R. 6179 - Increasing Access to Biosimilars Act of 2020 H.R. 4597/S. 3466 - the ACCESS for Biosimilars Act of 2020 H.R. 3 - Lower Prescription Drug Costs Now Act H.R. 19/S. 3129 Lower Costs, More Cures ActS. 2543 Prescription Drug Pricing Reduction Act Issues related to the 340B program, no specific bill Medicare Part B coverage and reimbursement issues Home administration for Part B medicines due to COVID-19 Issues related to International Pricing Index (IPI), no specific bill Coding and reimbursement for biologics/biosimilars Issues related to Part D redesign Issues related to Part D rebate reform Medicare Part D access issues for plan year 2020 and 2021, no specific bill Issues related to Direct to Consumer Advertisement patient affordability issues, including copay cards

Client expense: $2,970,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE

Medicare Part A, B and D AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Drug Pricing Outcomes Based Contracts/value based arrangements Medicaid H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act S. 3129: Lower Costs, More Cures Act of 2019 S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 3457: Preserving Patient Access to Home Infusion Act - Provisions related to Medicare and prescription drug access H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Transparency policy issues Center for Medicare and Medicaid Innovation (CMMI) 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) Reimbursement for cell therapy products S. 3353/H.R. 5534, Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act Patient Cost-Sharing and Smoothing S. 4134, Increasing Access to Biosimilars Act of 2020 S. 102, Prescription Drug Price Relief Act of 2019

Client expense: $780,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Discussions regarding Medicaid 340B drug discount program Support for legislation H.R.4597/S.3466 instituting 0$ co-pay for biosimilars under Medicare Discussions regarding pass-through status of Spinraza

Client expense: $760,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 748, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act H.R. 5076, Protecting Seniors Through Immunization Act of 2019 S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Vaccines; Supply chain; Coronavirus stimulus funding; HIV; Rebate pass through; Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-146)

Client expense: $2,620,000 · Firm income: Not reported

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

Drug pricing legislation. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Medicare reimbursement issues. FDA regulations of biosimilars. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.

Client expense: $580,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act Medicare Part A H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act Part D policy issues including non-interference and rebates policy issues 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 H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act 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 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) Reimbursement for cell therapy products

Client expense: $3,350,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Medicare reimbursement issues. FDA regulations of biosimilars. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Drug pricing legislation. H.R. 1520, Purple Book Continuity Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Vaccines; Supply chain; Coronavirus stimulus funding; HIV; Rebate pass through; Coronavirus Preparedness and response supplemental appropriations Act (P.L. 116-123); Families First Coronavirus Response Act (P.L. 116-127); Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-146).

Client expense: $2,170,000 · Firm income: Not reported

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

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

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Affordable Care Act; Vaccines; Women's Health; Average Manufacturer Price (AMP) CAP repeal; Ebola; Antibiotics.

Client expense: $1,020,000 · Firm income: Not reported

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

Drug pricing legislation. H.R. 1520, Purple Book Continuity Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare reimbursement issues. FDA regulations of biosimilars. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 99, Medicare Drug Price Negotiation Act (Sanders) - Part D price negotiations, formulary changes S. 205, Right Rebate Act (Wyden) - Medicaid drug rebate program S. 317, ACE Kids Act (Grassley) - health homes for children with medically complex conditions S. 377, Medicare Negotiation and Competitive Licensing Act (Brown) - Part D price negotiation S. 470, Medicare at 50 Act (Stabenow) - Medicare buy-in option S. 475, RxCAP Act (Wyden) - Part D cost-sharing S. 489, State Public Option Act (Schatz) - Medicaid buy-in option S. 516, Prescription Drug Monitoring Act (Klobuchar) - required use of PDMPs S. 548, EMPOWER Care Act (Portman) - MFP demonstration S. 640, Phair Pricing Act (Kennedy) -- Part D rebates at the point of sale S. 691, Medicare Extra Rx HELP Act (Casey) - Part D assistance for low-income seniors S. 709, Prescription Drug Pricing Dashboard Act (Casey) - interactive dashboard with drug price and utilization data for federal programs S. 773, Telehealth Innovation and Improvement Act (Gardner) - testing expanded coverage of telehealth services in Medicare S. 988, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - payments on clean claims S. 1114, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap S. 2081, Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 (Peters)- drugs in Part B S. 2252, Empowering States to Address Drug Costs Act (Van Hollen)- drug pricing S. 2446, Medicare Audiologist Access and Services Act of 2019 (Warren)-Medicare coverage of audiologist services S. 2650 - Medicare Prescription Drug Savings and Choice Act of 2019 (Durbin) - lowering prescription drug costs S. 2807, Hospice Care Improvement Act of 2019 (Portman) - Medicare hospice programs S. 2846, Protecting Patients Transportation to Care Act (Isakson) - Medicaid coverage of transportation S. 2911, Seniors Prescription Drug Relief Act of 2019 (Cassidy) - Part D smoothing S. 3000, Patient Shared Savings Act (Cassidy) - prescription drug plans S. 3001, Permanent Relief for Seniors and Medicare, Medicaid, Human Services Extension Act of 2019 (Toomey) - extensions S. 3029, Territories Medicare Prescription Drug Assistance Equity Act of 2019 (Menendez) - Territories, low-income Medicare part D beneficiaries S. 3078, Audit & Appeals Fairness, Integrity, and Reforms in Medicare Act of 2019 (Grassley) - Medicare appeals process S. 3129, Lower Costs, More Cures Act of 2019 (Crapo) - drug pricing H.R. 19, Lower Costs, More Cures Act of 2019 (Walden) - drug pricing H.R. 259, Medicaid Extenders Act (Pallone) - MFP demonstration, spousal impoverishment protections H.R. 448, Medicare Drug Price Negotiation Act (Cummings) - Part D price negotiations, formulary changes H.R. 789, Improving Transparency and Accuracy in Medicare Part D Spending Act (Welch) - payments on clean claims H.R. 937, Right Rebate Act (Schrader) - Medicaid drug rebate program H.R. 1034, Phair Pricing Act (Collins) - Part D rebates at the point of sale H.R. 1035, Prescription Drug Price Transparency Act (Collins) - Medicare PBM standards H.R. 1046, Medicare Negotiation and Competitive Licensing Act (Doggett) - Part D price negotiation H.R. 1226, ACE Kids Act (Castor) - health homes for children with medically complex conditions H.R. 1277, State Public Option Act (Lujan) - Medicaid buy-in option H.R. 1301, Mental Health Telemedicine Expansion Act (DelBene) - Medicare coverage of mental health telehealth services H.R. 1342, EMPOWER Care Act (Dingell) - MFP demonstration H.R. 1343, Protecting Married Seniors from Impoverishment Act (Dingell) - spousal impoverishment protections H.R. 1346, Medicare Buy-In and Health Care Stabilization Act (Higgins) - Medicare buy-in option H.R. 1375, PAID Act (Kind) - transparency of Medicare secondary payer information H.R. 1394, Medigap Consumer Protection Act (Doggett) - Medicare supplemental consumer protections H.R. 1551, Quality Care for Moms and Babies Act (Engel) - quality measures in Medicaid and CHIP H.R. 1781, Payment Commission Data Act (Carter) - MedPAC and MACPAC access to drug pricing and rebate data in Medicare and Medicaid H.R. 1839, Medicaid Services Investment and Accountability Act (Ruiz) - MFP demonstration, spousal impoverishment protections, ACE Kids Act, Medicaid drug rebate program, health homes for children with medically complex conditions H.R. 2131, Medicare Advantage Quality Payment Relief Act (Kind-Kelly) - MA benchmark cap H.R. 2757, Creating Lower Cost Alternatives for Your Prescription Drugs Act (Cunningham) - eliminate copay for generic drugs in Medicare Part D H.R. 3107, Improving Seniors' Timely Access to Care Act (DelBene) - Medicare Advantage prior authorization H.R. 3253, Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act (Dingell) - MFP demonstration, spousal impoverishment protections, Medicaid drug rebate program H.R. 3417, Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act (Neal) - funding for quality measurement initiatives, Medicare coverage of mental health telehealth services, real-time benefit tools in Medicare Part D, Medicare eligibility and enrollment notices H.R. 3461, Community-Based Independence for Seniors Act (Sanchez-Kelly) - Community-Based Institutional Special Needs Plan H.R. 3613, State Accountability, Flexibility, and Equity for Hospitals Act of 2019 (Bilirakis) -Medicaid DSH payments H.R. 3631, Territories Health Care Improvement Act (Soto) -Medicaid funding H.R. 3644, Independence at Home Demonstration Act of 2019 (Burgess)-Medicare demonstration program H.R. 3925, Reducing Barriers to Substance Use Treatment Act (Tonko)- Opioids H.R. 3935, Protecting Patients Transportation to Care Act (Carter)-Medicaid coverage for transportation H.R. 4378, Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (Lowey)-Health extenders H.R. 4453, Protecting Seniors from Health Care Fraud Act of 2019 (Ruiz)-Distributing information to Medicare beneficiaries to prevent fraud H.R. 4527, Expanding Health Care Options for Early Retirees Act (Malinowski)-Option for first responders to buy-in to Medicare H.R. 4529, Promoting Access to Broadband Act of 2019 (Maloney)-Medicaid H.R. 4583, Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 (Schneider) - prescription drug affordability H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 (Peters) - biosimilars, Part B H.R. 4618, Medicare Hearing Act of 2019 (McBath) - coverage for certain hearing items and services under part B H.R. 4619, Pharmaceutical Rebates for Excessive Pricing Above Inflation Act (Schakowsky) - drug rebates, Part D H.R. 4620, More Help for Seniors Act of 2019 (Rose) - expand eligibility for low-income subsidies under Part D of the Medicare program H.R. 4621, Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2019 (Blunt Rochester) - best practices re social determinants of health H.R. 4628, Better Tools to Lower Costs Act of 2019 (Scanlon) - resource requirements H.R. 4629, Star Rating for Biosimilars Act (Tonko) - biosimilars H.R. 4632, Better Transparency in Information for Medicare Beneficiaries Act of 2019 (Kind) - provides consumers information regarding premiums under LIS benchmark plans H.R. 4649, Capping Drug Costs for Seniors Act of 2019 (Horsford) - cap on beneficiary liability under part D of the Medicare program H.R. 4650, Medicare Dental Act of 2019 (Kelly) - Medicare dental coverage H.R. 4655, Enhancing Retirement Security for Medicare Beneficiaries Act of 2019 (Lee) - eligibility of individuals for premium and cost-sharing subsidies under part D H.R. 4661, Advancing Enrollment and Reducing Drug Costs Act of 2019 (Pappas) - Medicaid in territories H.R. 4663, Freedom from Price Gouging Act (Porter) - drug rebates, Part B H.R. 4665, Medicare Vision Act of 2019 (Schrier) - vision items and services under part B H.R. 4666, To amend title XVIII of the Social Security Act to provide certain low-income territorial residents with automatic eligibility for premium and cost-sharing subsidies under the Medicare program, and for other purposes (Shalala) - Medicare in territories H.R. 4669, Maximizing Drug Coverage for Low-Income Seniors Act of 2019 (Stevens) - auto enrollment and intelligent assignment H.R. 4671, Helping Seniors Afford Health Care Act (Kim) - Medicare affordability and low income beneficiaries H.R. 4676, Protecting Medicare Beneficiaries with Pre-Existing Conditions Act (Schneider) - Medigap H.R. 4699, To amend title XIX of the Social Security Act to remove the matching requirement for a territory to use specially allocated Federal funds for Medicare covered part D drugs for low-income individuals (Gonzales-Colon) - Part D, territories H.R. 4769, Medicare Prescription Drug Savings and Choice Act of 2019 (Schakowsky) - lowering prescription drug costs H.R. 4946, Ensuring Seniors Access to Local Pharmacies Act of 2019 (Welch) - equal access of Medicare beneficiaries to community pharmacies in underserved areas H.R. 4996, Helping Medicaid Offer Maternity Services Act of 2019 (Kelly) - State extension of Medicaid H.R. 5006, Expanding Access to Inpatient Mental Health Act (Emmer) - Medicaid coverage for SUD/mental health for institutionalized H.R. 5039, Life Sustaining Prescription Drug Price Relief Act of 2019 (Lipinski) - part D H.R. 5057, Pass- Through Technical Corrections Act (Tonko) - drug pass-through status under Medicare outpatient payment H.R. 5201, Telemental Health Expansion Act of 2019 (Matsui) - Medicare coverage of mental telehealth H.R. 5232, Road to Recovery Act (Fitzpatrick) - Medicaid and CHIP SUD treatment H.R. 5281, Drug Price Transparency in Medicaid Act of 2019 (Carter) - transparency and spread pricing affordability Discussion Draft, Medicare Part D Reform (Neal-Pallone-Brady-Walden) - maximum out-of-pocket limit, federal reinsurance payments Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues including proposed RADV regulation for MA; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2021 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; Part D reform, out of pocket limits; issues related to Medicare for All, Medicare buy-in and public option; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2021 Rate Notice and Call Letter; issues related to MLTSS; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); issues related to the international price index; issues related to child and maternal health; issues related to Medicaid supplemental and disproportionate share hospital (DSH) funding; issues related to Medicaid funding for territories; issues related to medical management; issues relating to MA supplemental benefits; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

Client expense: $2,340,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Affordable Care Act; Vaccines; Women's Health; Average Manufacturer Price (AMP) CAP repeal; Ebola; Antibiotics.

Client expense: $1,020,000 · Firm income: Not reported

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

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

Client expense: $1,580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 340B Reforms, Drug pricing, Anti-microbial Resistance, General Pharmaceutical issues transparency, formulary design, prescription drug coverage, Biosimiliars, Cost and value of medicines, Maternal Health, Affordable Care Act, Importation, Vaccines.

Client expense: $890,000 · Firm income: Not reported

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

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. Drug Compounding. Drug Shortages. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Proposed Anti-Kickback Statute (AKS) Rebates. FDA Citizen Petitions. Suitability Petitions. S.660: Efficiency and Transparency in Petitions Act. H.R.2387: STOP GAMES Act of 2019. H.R.985: FAST Generics Act of 2019. H.R.1506: FAIR Generics Act. H.R.2455/S.1169: Ensuring Timely Access to Generics Act of 2019. H.R.1503: Orange Book Transparency Act of 2019. H.R.1520: Purple Book Continuity Act of 2019. Drug Pricing. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.2374/S.1224: Stop STALLING Act. H.R.2376: Prescription Pricing for the People Act of 2019. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.1093/S.378: Stop Price Gouging Act. H.R.3: Lower Drug Costs Now Act of 2019. S.474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019. S.440: Preserving Access to Cost Effective Drugs (PACED) Act. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Orphan Drug Exclusivity. Biologic Exclusivity. H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Public Law 115-52: FDA Reauthorization Act of 2017.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Medicaid Extenders - Federally Qualified Health Centers alignment to HEDIS quality metrics; ER Utilization Report - requiring CMS to conduct a study that analyzes emergency room utilization by Medicaid beneficiaries; H.R. 3107, Improving Seniors Timely Access to Care Act of 2019 - provisions related to prior authorization for Medicare Advantage Plans; H.R. 3, Lower Drug Costs Now Act - provisions addressing prescription drug pricing; Prescription Drug Pricing Reduction Act (PDRPA) of 2019 - provisions addressing prescription drug pricing; The Star Rating for Biosimilars Act - provisions related to Medicare Advantage program star rating system; H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines Act - provisions related to payment for biosimilar drugs under Medicare program; H.R. 4597, Acting to Cancel Co-Pay and Ensure Substantial Savings (ACCESS) to Biosimilars Act - provisions related to payment for biosimilar drugs under Medicare program; H.R. 3461, Community-Based Independence for Seniors Act of 2019 (CBI-SNP) - provisions related to community-based long-term services and supports; H.R. 4004, Social Determinants Accelerator Act of 2019 - provisions addressing social determinants of health; Medicare Part D prescription drug pricing.

Client expense: $440,000 · Firm income: Not reported

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