Increasing Access to Biosimilars Act of 2020

Discussions regarding drug pricing and supply chain issues, rare diseases, gene therapy and value based arrangements; biosimilar support; Alzheimer's policy, PET scan coverage and reimbursement, and dementia care Appropriations on Alzheimers screening and diagnosis Support for H.R.1520/S.1895 codifying the Purple Book Discussions regarding S.2546/H.R.2279, the Safe Step Act, patient access issues Support for H.R.6179 directing CMS to implement a shared savings model for biosimilars

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

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

The BIOSIM Act (H.R. 4455); The Increasing Access to Biosimilars Act (H.R. 6179/S. 4134); Medicaids Consumer Price Index (CPI) penalty for generics; and Policies to incentivize biosimilars.

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

Government targets: 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) H.R. 8624 - Protecting Access to Innovation During COVID-19 Act H.R. 8702 - Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 S. 1895 - Lower Health Care Costs Act S. 4199 - Prescription Drug Pricing Reduction Act of 2020 S. 4274 - Legalizing Drug Discounts for Seniors Act of 2020 Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related issues ASP reporting policy issues Non-covered drugs policy issues Drug wastage rebates policy issues

Client expense: $660,000 · 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), Veterans Affairs, Dept of (VA), White House Office

H.R. 133 - Consolidated Appropriations Act, 2021 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 H.R. 7647 - Preserving Patient Savings on Drug Costs Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 Executive Order on Lowering Drug Prices by Putting America First and Most Favored Nation (MFN) model Interim Final Rule 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 Home administration for Part B medicines due to COVID-19 Reimbursement for biologics/biosimilars Issues related to Part D redesign Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Medicare Part D access issues for plan year 2020 and 2021, no specific bill 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) S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act of 2019

Client expense: $2,560,000 · 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), Office of Management & Budget (OMB), SENATE, Treasury, Dept of

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

Client expense: $1,260,000 · Firm income: Not reported

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

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 lowering health care costs with biosimilars: H.R.6179 (Cardenas) - Increasing Access to Biosimilars Act of 2020 IP/Patent Thickets Issues

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

Government targets: 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

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

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

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

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

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. 3107 - Improving Seniors' Timely Access to Care Act of 2019 - DelBene - prior authorization in Medicare Advantage 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. 4453 - Protecting Seniors from Health Care Fraud Act of 2019 - Ruiz -Distributing information to Medicare beneficiaries to prevent fraud 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. 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. 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. 4671 - Helping Seniors Afford Health Care Act - Kim - Medicare affordability and low income beneficiaries H.R. 4996 - Helping Medicaid Offer Maternity Services Act of 2020 - Kelly - extend Medicaid coverage post-partum H.R. 5006 - Expanding Access to Inpatient Mental Health Act - Emmer - Medicaid coverage for SUD/mental health for institutionalized 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. 5693 - Primary Health Services Enhancement Act - Kind - Medicare rural health H.R. 5808 - Save Rural Communities Act of 2020 - Arrington - rural emergency medical access services under Medicare H.R. 5833 - To amend title XVIII of the Social Security Act to permit the use of certain psychological evaluation via telehealth for Medicare coverage of neurostimulation services for the treatment of chronic pain - Latta - Medicare coverage in telehealth H.R. 5882 - GENE Therapy Payment Act - Schrader - value based care H.R. 6098 - To amend title XXI of the Social Security Act to allow States to expand income eligibility standards under the Children's Health Insurance Program -Barragan - CHIP eligibility H.R. 6151 - CARING for Kids Act - Fineknauer - CHIP H.R. 6179 - Increasing Access to Biosimilars Act of 2020 - Cardenas - payments to providers of biosimilars under Medicare H.R. 6209 - Reducing Unnecessary Senior Hospitalizations Act of 2020 or the RUSH Act of 2020 -Kuster - Medicare coverage for certain services in hospital emergency departments H.R. 6244 - To amend titles XVIII and XIX to provide for coverage at no cost sharing of COVID-19 testing under the Medicaid program and Children's Health Insurance Program - Kelly - Medicaid coverage of COVID-19 related visits and testing H.R. 6263 - To amend title XVIII of the Social Security Act to waive cost sharing under the Medicare program for certain visits relating to testing for COVID-19 -Sarbanes - Medicare coverage of COVID-19 related visits and testing H.R. 6273 - Protecting Vulnerable Americans in Times of Crisis Act of 2020 - Butterfield - FMAP H.R. 6311 - Care for COVID-19 Act - Ruiz - COVID-19 cost sharing H.R. 6336 - Increasing Hospital Capacity to Fight the Coronavirus Act of 2020 - Bishop - Medicare and Medicaid payments during COVID-19 emergency H.R. 6462 - Emergency Medicaid for Coronavirus Treatment Act - Gallego - Medicaid coverage H.R. 6511 - Ensuring Vaccination and Treatment Affordability Act - Pappas - COVID H.R. 6521 - To prohibit the Secretary of Health and Human Services from taking certain actions with respect to Medicaid supplemental payments reporting requirements, and for other purposes - Diaz Barragan - Medicaid, delays implementation of MFAR H.R. 6538 - Modernized Medicine Act - Kennedy - Medicaid, Telehealth H.R. 6539 - Coronavirus Medicaid Response Act - Lee - FMAP H.R. 6572 - To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to carry out a national campaign to increase awareness and knowledge of COVID-19. -Bilirakis - COVID H.R. 6583 - To amend title XVIII of the Social Security Act to establish a risk corridor program for Medicare Advantage plans during the COVID-19 emergency, and for other purposes. - Houlahan - COVID H.R. 6616 - Stronger Medicaid Response to the COVID-19 Pandemic Act -Cardenas - COVID H.R. 6640 - Medicare Advantage COVID Treatment Act - Mucarsel-Powell - COVID H.R. 6658 - Insular Area Medicaid Coronavirus Recovery Act - Sablan - FMAP H.R. 6727 - To hold Medicare beneficiaries harmless for specified COVID-19 treatment services furnished under part A or part B of the Medicare program - Schrier - COVID H.R. 6744 - Computer and Internet Equity Act - Davis - internet access for Lifeline program H.R. 6753 - Save Rural Hospitals Act of 2020 - Finkenauer - Medicare hospital payments H.R. 6792 - Improving Telehealth for Underserved Communities Act of 2020 - Smith - telehealth H.R. 6797 - CHIPPER Act - Wild - CHIP, COVID H.R. 6837 - Medicare Accelerated and Advance Payments Improvement Act of 2020 -Schneider - COVID H.R. 7154 - Outpatient Therapy Modernization and Stabilization Act -Boyle - outpatient therapy services H.R. 7187 - HEALTH Act of 2020 -Thompson -Smith - telehealth H.R. 7292 - To amend title XVIII of the Social Security Act to provide for forgiveness of certain accelerated and advance payments under parts A and B of the Medicare program. - Kaptur - advance payments H.R. 7338 - To amend title XVIII of the Social Security Act to permit the Secretary of Health and Human Services to waive requirements relating to the furnishing of telehealth services under the Medicare program, and for other purposes. - Cheney - Telehealth H.R. 7391 - To amend title XVIII of the Social Security Act to remove certain geographic and originating site restrictions on the furnishing of telehealth services under the Medicare program - Sherrill- Telehealth H.R. 7606 - MFAR Transparency Act - Williams - report on impact of MFAR to Congress H.R. 7627 - MORE Savings Act - Dean - Medicare access to opioid treatment and MAT H.R. 7663 - Protecting Access to Post-COVID-19 Telehealth Act of 2020 - Thompson - waive or modify application of Medicare requirements with respect to telehealth during PHE H.R. 7791 - Value in Health Care Act of 2020 - Welch - Medicare shared savings program and alternative payment arrangements H.R. 7877 - Lowering Drug Costs for Seniors Act of 2020 - Katko - Medicare Part D costs H.R. 7892 - Medicaid Expansion During Crisis Act - Coleman - extend eligibility period for Medicaid enrollment application H.R. 8177 - Renal Anemia Innovation Support and Expansion Act - OHalleran - Medicare prescription drug coverage for chronic kidney disease H.R. 8218 - Rural Ambulance Reimbursement Fairness Act - Gianforte - Medicare payment for rural ambulance services H.R. 8254 - Bringing Enhanced Treatments and Therapies to ESRD Recipients Kidney Care Act - Blumenauer - integrated care for Medicare beneficiaries with ESRD H.R. 8427 - To provide for certain reports on enrollment in the Lifeline program, and for other purposes - Luria - Lifeline program 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. 3013 - Encouraging Innovative Benefit Design to Lower Costs for Seniors Act - Crapo - offer additional prescription drugs under Part D S. 3220 - Ensuring Access to Direct Support Professionals Act - Portman - Medicaid coverage in acute care hospitals S. 3238 - Preventive Home Visit Act - King - preventative home visits S. 3277 - HCBS Infrastructure Improvement Act - Casey - access to community based services S. 3353 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020 - Cassidy - Medicare coverage of kidney transplant services S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - McSally - Medicare Part D drug pricing negotiation S. 3399 - FCHIP Extension Act - Tester - rural health S. 3442 - Care for COVID-19 Act - Booker - COVID-19 cost sharing S. 3443 - Improving Coverage and Care for Mothers Act - Casey - Medicaid coverage for all pregnant and postpartum women S. 3447 - RUSH Act of 2020 - Thune - Medicare coverage for certain services in hospital emergency departments S. 3466 - ACCESS for Biosimilars Act of 2020 - McSally - eliminates cost sharing for biosimilar biological products furnished under part B of the Medicare program S. 3615 - Rural Community Hospital Demonstration Extension Act of 2020 - Murkowski - rural community hospital demonstration program S. 3665 - Save Rural Hospitals Act of 2020 - Alexander - Medicare hospital payments S. 3750 - Medicare Accelerated and Advance Payments Improvement Act of 2020 - Shaheen - COVID S. 3881 - CHIPPER Act - Casey - CHIP, COVID S. 3998 - HEALTH Act of 2020 - Hyde-Smith - telehealth S. 3999 - Mental and Behavioral Health Connectivity Act - King - Mental Health S. 4108 - A bill to amend title XIX of the Social Security Act to increase Federal support to State Medicaid programs during economic downturns - Casey - FMAP S. 4151 - SOS: Sustaining Outpatient Services Act - Hoeven - Medicare OPPS coverage S. 4230 - Telehealth Expansion Act of 2020 - Wyden - Telehealth mental health services in Medicare S. 4274 - Legalizing Drug Discounts for Seniors Act of 2020 - Paul - exclude discounts for covered part D drugs from the anti-kickback prohibition S. 4295 - Public Health Emergency Pass-Through Payment Fairness Act of 2020 - Paul - access to drugs and devices under Medicare S. 4358 - Stronger Medicaid Response to the COVID-19 Pandemic Act - Bennet - Medicaid coverage for vaccines and treatment for COVID-19 for uninsured without cost-sharing S. 4375 - Telehealth Modernization Act - Alexander - make permanent Medicare telehealth flexibilities S. 4423 - COVID-19 Hospice Respite Care Relief Act of 2020 - Brown - Medicare hospice care S. 4448 - Fair Drug Prices for Kids Act - Warner - extend Medicaid drug rebate program to CHIP S. 4574 - Bringing Enhanced Treatments and Therapies to ESRD Recipients Kidney Care Act - Young - integrated care for Medicare beneficiaries with ESRD S. 4690 - A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes - Hassan - Medicaid and maternal health S. 4705 - A bill to amend title XIX requiring coverage under Medicaid of vaccines for pregnant women - Cassidy - Medicaid coverage S. 4717 - A bill to amend title XIX of the Social Security Act to streamline enrollment of certain Medicaid providers across State lines, and for other purposes - Grassley - Medicaid enrollment S. 4742 - A bill to amend title XIX of the Social Security Act to promote access to life-saving therapies for Medicaid enrollees by ensuring coverage of routine patient costs for items and services furnished in connection with participation in qualifying clinical trials, and for other purposes - Burr - Medicaid coverage 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 2022 Rate Notice; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to MLTSS; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to COVID-19, including testing; issues related to audio-only telehealth; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues related to Medicaid presumptive eligibility and continuous eligibility; issues relating to Medicaid best price; 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: $2,230,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

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

The BIOSIM Act (H.R. 4455); The Increasing Access to Biosimilars Act (H.R. 6179/S. 4134); Medicaids Consumer Price Index (CPI) penalty for generics; and Policies to incentivize biosimilars.

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

Government targets: 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: $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

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

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

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 Advantage; Medicaid Expansion; Medicare Data Sharing; Privacy; Medicare Prescription Drug Pricing; CMS; Generic drugs (CREATES); MACRA; Drug approval; Provider funding; Coronavirus Medicaid Response; Rate Notice and Call Letter; Prior Authorizations, COVID-19 Test Without Cost-Sharing. H.R. 3107 - 116th Congress (2019-2020) Improving Seniors' Timely Access to Care Act of 2019 Sponsor: Rep. Suzan DelBene (D-WA), Rep. Mike Kelly (R-PA), Roger Marshal (R-KS) and Ami Bera (D-CA) H.R. 5833 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to permit the use of certain psychological evaluation via telehealth for Medicare coverage of neurostimulation services for the treatment of chronic pain. Sponsor: Rep. Bob Latta (R-OK-05) H.R. 6179 - 116th Congress - Second Session Increasing Access to Biosimilars Act of 2020 Sponsor: Rep. Tony Cardenas (D-CA-29) H.R. 6218 - 116th Congress - Second Session Preserving Patient Access to Home INfusion Act Sponsor: Rep. Eliot Engel (D-NY-16) H.R. 6214 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to provide for coverage of testing for COVID-19 at no cost sharing under the Medicare Advantage program. Sponsor: Rep. Ron Kind (D-WI-03) H.R. 6484 - 116th Congress - Second Session Care for COVID-19 Act 2.0 Sponsor: Rep. Raul Ruiz (D-CA-36) H.R. 6674 - 116th Congress - Second Session Medicare Crisis Program Act of 2020 Sponsor: Rep. Pramila Hayapal. (D-WA-07) H.R. 6739 - 116th Congress - Second Session Ensuring Seniors' Access to COVID Treatments Act Sponsor: Rep. Sean Casten (D-IL-06) H.R. 7062 - 116th Congress - Second Session Affordable Insulin for the COVID-19 Emergency Act Sponsor: Rep. Maxine Waters (D-CA-43) H.R. 6583 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to establish a risk corridor program for Medicare Advantage plans during the COVID-19 emergency, and for other purposes. Sponsor: Rep. Chrissy Houlahan (D-PA-06) H.R. 6640 - 116th Congress - Second Session Medicare Advantage COVID Treatment Act Sponsor: Rep. Debbie Mucarsel-Powell (D-FL-26) H.R. 6837 - 116th Congress - Second Session Medicare Accelerated and Advance Payments IMprovement Act of 2020 Sponsor: Rep. Brad Schneider (D-IL-10) H.R. 7292 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to provide for forgiveness of certain accelerated and advance payments under parts A and B of the Medicare program. Sponsor: Repm. Marcy Kaptur (D-OH-09) H.R. 7323 - 116th Congress - Second Session Medicare Mental Health Inpatient Equity Act of 2019 Sponsor: Rep. Paul Tonko (D-NY-20) H.R. 7338 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to permit the Secretary of Health and Human Services to waive requirements relating to the furnishing of telehealth services under the Medicare program, and for other purposes. Sponsor: Rep. Liz Cheney (R-WY-At-Large) H.R. 5883 - 116th Congress - Second Session Generating Effective and Novel Evidence for Therapy Payment Act Sponsor: Rep. Kurt Schrader (D-OR-05) H.R. 6649 - 116th Congress - Second Session Lower Drug Costs for Seniors During COVID-19 Act of 2020 Sponsor: Rep. Jan Schakowsky (D-IL-09)

Client expense: Not reported · Firm income: Not reported

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

H.R. 3107 - Improving Seniors' Timely Access to Care Act of 2019 - DelBene - prior authorization in Medicare Advantage 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. 4453 - Protecting Seniors from Health Care Fraud Act of 2019 - Ruiz -Distributing information to Medicare beneficiaries to prevent fraud 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. 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. 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. 4671 - Helping Seniors Afford Health Care Act - Kim - Medicare affordability and low income beneficiaries H.R. 5006 - Expanding Access to Inpatient Mental Health Act - Emmer - Medicaid coverage for SUD/mental health for institutionalized 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. 5693 - Primary Health Services Enhancement Act - Kind - Medicare rural health H.R. 5808 - Save Rural Communities Act of 2020 - Jodey Arrington - rural emergency medical access services under Medicare H.R. 5833 - To amend title XVIII of the Social Security Act to permit the use of certain psychological evaluation via telehealth for Medicare coverage of neurostimulation services for the treatment of chronic pain - Latta - Medicare coverage in telehealth H.R. 5882 - GENE Therapy Payment Act - Schrader - value based care H.R. 6098 - To amend title XXI of the Social Security Act to allow States to expand income eligibility standards under the Children's Health Insurance Program - Barragan - CHIP eligibility H.R. 6151 - CARING for Kids Act - Abby Fineknauer - CHIP H.R. 6179 - Increasing Access to Biosimilars Act of 2020 - Cardenas - payments to providers of biosimilars under Medicare H.R. 6209 - Reducing Unnecessary Senior Hospitalizations Act of 2020 or the RUSH Act of 2020 -Kuster - Medicare coverage for certain services in hospital emergency departments H.R. 6244 - To amend titles XVIII and XIX to provide for coverage at no cost sharing of COVID-19 testing under the Medicaid program and Children's Health Insurance Program - Kelly - Medicaid coverage of COVID-19 related visits and testing H.R. 6263 - To amend title XVIII of the Social Security Act to waive cost sharing under the Medicare program for certain visits relating to testing for COVID-19 -Sarbanes - Medicare coverage of COVID-19 related visits and testing H.R. 6273 - Protecting Vulnerable Americans in Times of Crisis Act of 2020 - Butterfield - FMAP H.R. 6311 - Care for COVID-19 Act - Ruiz - COVID-19 cost sharing H.R. 6336 - Increasing Hospital Capacity to Fight the Coronavirus Act of 2020 - Bishop - Medicare and Medicaid payments during COVID-19 emergency H.R. 6462 - Emergency Medicaid for Coronavirus Treatment Act - Gallego - Medicaid coverage H.R. 6511 - Ensuring Vaccination and Treatment Affordability Act - Pappas - COVID H.R. 6521 - To prohibit the Secretary of Health and Human Services from taking certain actions with respect to Medicaid supplemental payments reporting requirements, and for other purposes - Diaz Barragan H.R. 6538 - Modernized Medicine Act - Kennedy - Medicaid, Telehealth H.R. 6539 - Coronavirus Medicaid Response Act - Lee - FMAP H.R. 6572 - To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to carry out a national campaign to increase awareness and knowledge of COVID-19. - Bilirakis - COVID H.R. 6583 - To amend title XVIII of the Social Security Act to establish a risk corridor program for Medicare Advantage plans during the COVID-19 emergency, and for other purposes. - Houlahan - COVID H.R. 6616 - Stronger Medicaid Response to the COVID-19 Pandemic Act - Cardenas - COVID H.R. 6640 - Medicare Advantage COVID Treatment Act - Mucarsel-Powell - COVID H.R. 6658 - Insular Area Medicaid Coronavirus Recovery Act - Sablan - FMAP H.R. 6727 - To hold Medicare beneficiaries harmless for specified COVID-19 treatment services furnished under part A or part B of the Medicare program - Schrier - COVID H.R. 6744 - Computer and Internet Equity Act - Davis - internet access for Lifeline program H.R. 6753 - Save Rural Hospitals Act of 2020 - Finkenauer - Medicare hospital payments H.R. 6792 - Improving Telehealth for Underserved Communities Act of 2020 - Smith - telehealth H.R. 6797 - CHIPPER Act - Wild - CHIP, COVID H.R. 6837 - Medicare Accelerated and Advance Payments Improvement Act of 2020 - Schneider - COVID H.R. 7154 - Outpatient Therapy Modernization and Stabilization Act - Boyle - outpatient therapy services H.R. 7187 - HEALTH Act of 2020 -Thompson -Smith - telehealth H.R. 7297 - To amend title XVIII of the Social Security Act to provide for forgiveness of certain accelerated and advance payments under parts A and B of the Medicare program. - Kaptur H.R. 7338 - To amend title XVIII of the Social Security Act to permit the Secretary of Health and Human Services to waive requirements relating to the furnishing of telehealth services under the Medicare program, and for other purposes. - Cheney - Telehealth H.R. 7391 - To amend title XVIII of the Social Security Act to remove certain geographic and originating site restrictions on the furnishing of telehealth services under the Medicare program - Sherrill - Telehealth 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. 3220 - Ensuring Access to Direct Support Professionals Act - Portman - Medicaid coverage in acute care hospitals S. 3238 - Preventive Home Visit Act - King - preventative home visits S. 3277 - HCBS Infrastructure Improvement Act - Casey - access to community based services S. 3353 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020 - Cassidy - Medicare coverage of kidney transplant services S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - McSally - Medicare Part D drug pricing negotiation S. 3399 - FCHIP Extension Act - Tester - rural health S. 3442 - Care for COVID-19 Act - Booker - COVID-19 cost sharing S. 3443 - Improving Coverage and Care for Mothers Act - Casey - Medicaid coverage for all pregnant and postpartum women S. 3447 - RUSH Act of 2020 - Thune - Medicare coverage for certain services in hospital emergency departments S. 3466 - ACCESS for Biosimilars Act of 2020 - McSally - eliminates cost sharing for biosimilar biological products furnished under part B of the Medicare program S. 3615 - Rural Community Hospital Demonstration Extension Act of 2020 - Murkowski - rural community hospital demonstration program S. 3665 - Save Rural Hospitals Act of 2020 - Alexander - Medicare hospital payments S. 3750 - Medicare Accelerated and Advance Payments Improvement Act of 2020 - Shaheen - COVID S. 3881 - CHIPPER Act - Casey - CHIP, COVID S. 3998 - HEALTH Act of 2020 - Hyde-Smith - telehealth S. 3999 - Mental and Behavioral Health Connectivity Act - King - Mental Health S. 4108 - A bill to amend title XIX of the Social Security Act to increase Federal support to State Medicaid programs during economic downturns - Casey - FMAP 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); issues relating to COVID-19; issues related to audio-only telehealth; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues related to Medicaid presumptive eligibility and continuous eligibility; issues relating to Medicaid best price; 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: $2,250,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

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

Client expense: $550,000 · 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, Transportation, Dept of (DOT), U.S. Trade Representative (USTR), White House Office

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 rare diseases, drug pricing and supply chain issues, rare diseases, gene therapy and value based arrangements; biosimilar support; Alzheimer's policy, PET scan coverage and reimbursement, and dementia care Support for H.R.3772, Alzheimers Diagnosis with PET Appropriations on Alzheimers screening and diagnosis H.R.748 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act), supported 90-day prescription drug supply (Sec.3714) H.R.1425, the Patient Protection and Affordable Care Enhancement Act, drug pricing provisions S.4049/H.R.6395, National Defense Authorization Act for Fiscal Year 2021 (Supply chain and Tricare pharmacy pilot program) Support for H.R.6179 directing CMS to implement a shared savings model for biosimilars

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

Medicare Advantage; Medicaid Expansion; Medicaid General; Medicare Data Sharing; Privacy; Medicare prescription drug prices, CMS; Generic drugs (CREATES); drug approval; HELP cost reduction package; CHIP; MACRA; Provider funding; Medicaid FMAP Increase; Coronvirus Medicaid Response; Rate Notice and Call Letter H.R.3107 - 116th Congress (2019-2020) Improving Seniors' Timely Access to Care Act of 2019 Sponsor: Rep. Suzan DelBene (D-WA-01) H.R. 5582 - 116th Congress - Second Session Parental Accessibility Rights for Emergency and Negligent Treatment Act Sponsor: Rep. Greg Murphy (R-NC-03) H.R. 5741 - 116th Congress - Second Session Strengthening Innovation in Medicare and Medicaid Act Sponsor: Rep. Terri Sewell (D-AL-07) H.R. 5897 - 116th Congress - Second Session Preventing Abuse and Neglect of Vulnerable Americans Act of 2020 Sponsor: Rep. Ruben Gallego (D-AZ-07) H.R. 5900 - 116th Congress - Second Session Accelerating Kids' Access to Care Act Sponsor: Rep. Joe Kennedy III (D-MA-04) H.R. 6098 - 116th Congress - Second Session To amend title XXI of the Social Security Act to allow States to expand income eligibility standards under the Children's Health Insurance Program, and for other purposes. Sponsor: Rep. Nanette Barragan (D-CA-44) H.R. 6273 - 116th Congress - Second Session Protecting Vulnerable Americans in Times of Crisis Act of 2020 Sponsor: Rep. G.K. Butterfield (D-NC-01) H.R. 5693 - 116th Congress - Second Session Primary Health Services Enhancement Act Sponsor: Rep. Ron Kind (D-WI-03) H.R. 5833 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to permit the use of certain psychological evaluation via telehealth for Medicare coverage of neurostimulation services for the treatment of chronic pain. Sponsor: Rep. Bob Latta (R-OH-05) H.R. 6147 - 116th Congress - Second Session Help Extend Auditory Relief (HEAR) Act of 2020 Sponsor: Rep. Matt Cartwright (D-PA-08) H.R. 6179 - 116th Congress - Second Session Increasing Access to Biosimilars Act of 2020 Sponsor: Rep. Tony Cardenas (D-CA-29) H.R. 6218 - 116th Congress - Second Session Preserving Patient Access to Home Infusion Act Sponsor: Rep. Eliot Engel (D-NY-16) H.R. 5534 116th Congress - First Session Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019 Sponsor: Rep. Ron Kind (D-WI-03) H.R. 6214 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to provide for coverage of testing for COVID-19 at no cost sharing under the Medicare Advantage program. Sponsor: Rep. Ron Kind (D-WI-03) H.R. 6282 - 116th Congress - Second Session Commission on America's Medical Security Act Sponsor: Rep. Raul Ruiz (D-CA-36) H.R. 6462 - 116th Congress - Second Session Emergency Medicaid for Coronavirus Treatment Act Sponsor: Rep. Ruben Gallego (D-AZ-07) H.R. 6486 - 116th Congress - Second Session Care for COVID-19 Act 2.0 Sponsor: Rep. Raul Ruiz (D-CA-36) H.R. 6495 - 116th Congress - Second Session Insular Area Medicaid Parity Act Sponsor: Del. Gregorio Kilili Camacho Sablan (D-MP At-Large) H.R. 6616 - 116th Congress - Second Session Stronger Medicaid Response to the COVID-19 Pandemic Act Sponsor: Rep. Tony Cardenas (D-CA-29) H.R. 6658 - 116th Congress - Second Session Insular Area Medicaid Coronavirus Recovery Act Sponsor: Del. Gregorio Kilili Camacho Sablan (D-MP At-Large) H.R. 6674 - 116th Congress - Second Session Medicare Crisis Program Act of 2020 Sponsor: Rep. Pramila Jayapal (D-WA-07) H.R. 6739 - 116th Congress - Second Session Ensuring Seniors' Access to COVID Treatments Act Sponsor: Rep. Sean Casten (D-IL-06) H.R. 7062 - 116th Congress - Second Session Affordable Insulin for the COVID-19 Emergency Act Sponsor: Rep. Maxine Waters (D-CA-43) H.R. 7127 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to make technical amendments to the separate payment under the Medicare program for disposable negative pressure wound therapy devices. Sponsor: Rep. G.K. Butterfield (D-NC-01) H.R. 7154 - 116th Congress - Second Session Outpatient Therapy Modernization and Stabilization Act Sponsor: Brendan Boyle (D-PA-02) H.R. 6583 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to establish a risk corridor program for Medicare Advantage plans during the COVID-19 emergency, and for other purposes. Sponsor: Rep. Chrissy Houlahan (D-PA-06) H.R. 6640 - 116th Congress - Second Session Medicare Advantage COVID Treatment Act Sponsor: Rep. Debbie Mucarsel-Powell (D-FL-26) H.R. 6837 - 116th Congress - Second Session Medicare Accelerated and Advance Payments Improvement Act of 2020 Sponsor: Rep. Brad Schneider (D-IL-10) H.R. 7292 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to provide for forgiveness of certain accelerated and advance payments under parts A and B of the Medicare program. Sponsor: Rep. Marcy Kaptur (D-OH-09) H.R. 7323 - 116th Congress - Second Session Medicare Mental Health Inpatient Equity Act of 2019 Sponsor: Rep. Paul Tonko (D-NY-20) H.R. 7338 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to permit the Secretary of Health and Human Services to waive requirements relating to the furnishing of telehealth services under the Medicare program, and for other purposes. Sponsor: Rep. Liz Cheney (R-WY-At-Large) H.R. 5882 - 116th Congress - Second Session Generating Effective and Novel Evidence for Therapy Payment Act Sponsor: Rep. Kurt Schrader (D-OR-05) H.R. 6159 - 116th Congress - Second Session Kids' Access to Primary Care Act of 2020 Sponsor: Rep. Kim Schrier (D-WA-08) H.R. 6281 - 116th Congress - Second Session Medicare Wage Index Parity Act of 2020 Sponsor: Rep. Bill Pascrell (D-NJ-09) H.R. 6649 - 116th Congress - Second Session Lower Drug Costs for Seniors During COVID-19 Act of 2020 Sponsor: Rep. Jan Schakowsky (D-IL-09)

Client expense: $1,690,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

Medicare Advantage; Medicaid Expansion; Medicaid General; Medicare Data Sharing; Privacy; Medicare prescription drug prices, CMS; Generic drugs (CREATES); drug approval; HELP cost reduction package; CHIP; MACRA; Provider funding; Medicaid FMAP Increase; Coronvirus Medicaid Response; Rate Notice and Call Letter H.R.3107 - 116th Congress (2019-2020) Improving Seniors' Timely Access to Care Act of 2019 Sponsor: Rep. Suzan DelBene (D-WA-01) H.R. 5741 - 116th Congress - Second Session Strengthening Innovation in Medicare and Medicaid Act Sponsor: Rep. Terri Sewell (D-AL-07) H.R. 5900 - 116th Congress - Second Session Accelerating Kids' Access to Care Act Sponsor: Rep. Joe Kennedy III (D-MA-04) H.R. 6098 - 116th Congress - Second Session To amend title XXI of the Social Security Act to allow States to expand income eligibility standards under the Children's Health Insurance Program, and for other purposes. Sponsor: Rep. Nanette Barragan (D-CA-44) H.R. 6273 - 116th Congress - Second Session Protecting Vulnerable Americans in Times of Crisis Act of 2020 Sponsor: Rep. G.K. Butterfield (D-NC-01) H.R. 5833 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to permit the use of certain psychological evaluation via telehealth for Medicare coverage of neurostimulation services for the treatment of chronic pain. Sponsor: Rep. Bob Latta (R-OH-05) H.R. 6179 - 116th Congress - Second Session Increasing Access to Biosimilars Act of 2020 Sponsor: Rep. Tony Cardenas (D-CA-29) H.R. 6218 - 116th Congress - Second Session Preserving Patient Access to Home Infusion Act Sponsor: Rep. Eliot Engel (D-NY-16) h.R. 6214 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to provide for coverage of testing for COVID-19 at no cost sharing under the Medicare Advantage program. Sponsor: Rep. Ron Kind (D-WI-03) H.R. 6282 - 116th Congress - Second Session Commission on America's Medical Security Act Sponsor: Rep. Raul Ruiz (D-CA-36) H.R. 6462 - 116th Congress - Second Session Emergency Medicaid for Coronavirus Treatment Act Sponsor: Rep. Ruben Gallego (D-AZ-07) H.R. 6486 - 116th Congress - Second Session Care for COVID-19 Act 2.0 Sponsor: Rep. Raul Ruiz (D-CA-36) H.R. 6616 - 116th Congress - Second Session Stronger Medicaid Response to the COVID-19 Pandemic Act Sponsor: Rep. Tony Cardenas (D-CA-29) H.R. 6658 - 116th Congress - Second Session Insular Area Medicaid Coronavirus Recovery Act Sponsor: Del. Gregorio Kilili Camacho Sablan (D-MP At-Large) H.R. 6674 - 116th Congress - Second Session Medicare Crisis Program Act of 2020 Sponsor: Rep. Pramila Jayapal (D-WA-07) H.R. 6739 - 116th Congress - Second Session Ensuring Seniors' Access to COVID Treatments Act Sponsor: Rep. Sean Casten (D-IL-06) H.R. 7062 - 116th Congress - Second Session Affordable Insulin for the COVID-19 Emergency Act Sponsor: Rep. Maxine Waters (D-CA-43) H.R. 7127 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to make technical amendments to the separate payment under the Medicare program for disposable negative pressure wound therapy devices. Sponsor: Rep. G.K. Butterfield (D-NC-01) H.R. 6640 - 116th Congress - Second Session Medicare Advantage COVID Treatment Act Sponsor: Rep. Debbie Mucarsel-Powell (D-FL-26) .R. 6837 - 116th Congress - Second Session Medicare Accelerated and Advance Payments Improvement Act of 2020 Sponsor: Rep. Brad Schneider (D-IL-10) H.R. 7292 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to provide for forgiveness of certain accelerated and advance payments under parts A and B of the Medicare program. Sponsor: Rep. Marcy Kaptur (D-OH-09) H.R. 7323 - 116th Congress - Second Session Medicare Mental Health Inpatient Equity Act of 2019 Sponsor: Rep. Paul Tonko (D-NY-20) H.R. 7338 - 116th Congress - Second Session To amend title XVIII of the Social Security Act to permit the Secretary of Health and Human Services to waive requirements relating to the furnishing of telehealth services under the Medicare program, and for other purposes. Sponsor: Rep. Liz Cheney (R-WY-At-Large) H.R. 5882 - 116th Congress - Second Session Generating Effective and Novel Evidence for Therapy Payment Act Sponsor: Rep. Kurt Schrader (D-OR-05) H.R. 6159 - 116th Congress - Second Session Kids' Access to Primary Care Act of 2020 Sponsor: Rep. Kim Schrier (D-WA-08) H.R. 6281 - 116th Congress - Second Session Medicare Wage Index Parity Act of 2020 Sponsor: Rep. Bill Pascrell (D-NJ-09) H.R. 6649 - 116th Congress - Second Session Lower Drug Costs for Seniors During COVID-19 Act of 2020 Sponsor: Rep. Jan Schakowsky (D-IL-09)

Client expense: $104,240 · Firm income: Not reported

Government targets: 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.

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

The BIOSIM Act (H.R. 4455); The Increasing Access to Biosimilars Act (H.R. 6179/S. 4134); Medicaids Consumer Price Index (CPI) penalty for generics; and Policies to incentivize biosimilars.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Advantage; Medicaid Expansion; Medicaid; Medicare Data Sharing; Privacy; Medicare Prescription Drug Prices; CMS; Generic Drugs (CREATES Act); Drug Approval; HELP Cost Reduction Package; CHIP, MACRA; Provider Funding; Medicaid FMAP Increase; Coronavirus Medicaid Response; Rate Notice and Call Letter HR 3107 (116th Congress), Improving Seniors Timely Access to Care Act of 2019, by Rep. Suzan DelBene (D-WA). Establish requirements with respect to the use of prior authorization under Medicare Advantage plans. HR 5534 (116th Congress), Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019, by Rep. Ron Kind (D-WI). Provide for extended months of Medicare coverage of immunosuppressive drugs for kidney transplant patients. HR 5582 (116th Congress), Parental Accessibility Rights for Emergency and Negligent Treatment Act, by Rep. Gregory Murphy (R-NC). Expands the scope of advance directive policies and related disclosures for providers under Medicaid and the Children's Health Insurance Program (CHIP). HR 5693 (116th Congress), Primary Health Services Enhancement Act, by Rep. Ron Kind (D-WI). Expand Medicare Rural Health Clinic Services and Federally Qualified Health Center Services to include physical therapy services. HR 5741 (116th Congress), Strengthening Innovation in Medicare and Medicaid Act, by Rep. Terri Sewell (D-AL). Clarify parameters for model testing and add accountability to model expansion under the Center for Medicare and Medicaid Innovation. HR 5833 (116th Congress), by Rep. Bob Latta (R-OH). Permit the use of certain psychological evaluation via telehealth for Medicare coverage of neurostimulation services for the treatment of chronic pain. HR 5882 (116th Congress), GENE Therapy Payment Act, by Rep. Kurt Schrader (D-OR). Provide States with the option under the Medicaid program to pay for covered outpatient drugs through risk-sharing value-based agreements. HR 5897 (116th Congress), Preventing Abuse and Neglect of Vulnerable Americans Act of 2020, by Rep. Ruben Gallego (D-AZ). Requires the Centers for Medicare & Medicaid Services (CMS) to publish specified information on its website relating to deficiencies of Medicaid intermediate care facilities for individuals with intellectual disabilities, including information regarding inspections, complaints, and administrative actions. HR 5900 (116th Congress), Accelerating Kids' Access to Care Act, by Rep. Joseph Kennedy (D-MA). Requires state Medicaid programs to establish a process through which qualifying out-of-state providers may enroll as participating providers without undergoing additional screening requirements. HR 6098 (116th Congress), by Rep. Nanette Diaz Barragan (D-CA). Allow States to expand income eligibility standards under the Childrens Health Insurance Program. HR 6147 (116th Congress), Help Extend Auditory Relief (HEAR) Act of 2020, by Rep. Matt Cartwright (D-PA). Provide coverage under the Medicare program of hearing aids and related hearing services. HR 6159 (116th Congress), Kids Access to Primary Care Act of 2020, by Rep. Kim Schrier (D-WA). Renew the application of the Medicare payment rate floor to primary care services furnished under the Medicaid program. HR 6179 (116th Congress), Increasing Access to Biosimilars Act of 2020, by Rep. Tony Cardenas (D-CA). Require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar biological products under the Medicare program. HR 6214 (116th Congress), by Rep. Ron Kind (D-WI). Provide for coverage of testing for COVID-19 at no cost sharing under the Medicare Advantage program. HR 6218 (116th Congress), Preserving Patient Access to Home Infusion Act, by Rep. Eliot Engel (D-NY). Clarify congressional intent and preserve patient access to home infusion therapy under the Medicare program. HR 6263 (116th Congress), by Rep. John Sarbanes (D-MD). Waive cost sharing under the Medicare program for certain visits relating to testing for COVID-19. HR 6273 (116th Congress), Protecting Vulnerable Americans in Times of Crisis Act of 2020, by Rep. G. K. Butterfield (D-NC). Increase allotments under the Medicaid program for territories of the United States, to provide for a temporary increase in the Federal medical assistance percentage for States under the Medicaid program. HR 6281 (116th Congress), Medicare Wage Index Parity Act of 2020, by Rep. Bill Pascrell (D-NJ). Provides statutory authority for, and extends, a specified methodology used to calculate the minimum Medicare hospital wage index for all-urban states. HR 6282 (116th Congress), Commission on America's Medical Security Act, by Rep. Raul Ruiz (D-CA). Establish a commission to assess, evaluate, and address the dependence of the United States on medications, devices, and medical equipment from foreign countries. HR 6336 (116th Congress), Increasing Hospital Capacity to Fight the Coronavirus Act of 2020, by Rep. Dan Bishop (R-NC). Provide a waiver of payment reductions under the Medicare and Medicaid programs for certain nonapproved capital expenditures undertaken by health care facilities during the COVID-19 emergency. HR 6486 (116th Congress), Care for COVID-19 Act 2.0, by Rep. Raul Ruiz (D-CA). Require the Secretary of Health and Human Services to establish a special enrollment period during the COVID-19 emergency period, to require the Secretary to carry out outreach and educational activities for such special enrollment period, to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage without any cost sharing for certain items and services furnished during any portion of such emergency period. HR 6487 (116th Congress), Advancing Connectivity during the Coronavirus to Ensure Support for Seniors Act, by Rep. Jan Schakowsky (D-IL). Increase the ability of nursing facilities to access telehealth services and obtain technologies to allow virtual visits during the public health emergency relating to an outbreak of coronavirus disease 2019 (COVID-19). HR 6583 (116th Congress), by Rep. Chrissy Houlahan (D-PA). Establish a risk corridor program for Medicare Advantage plans during the COVID-19 emergency. HR 6616 (116th Congress), Stronger Medicaid Response to the COVID-19 Pandemic Act, by Rep. Tony Cardenas (D-CA). Allows COVID-19 vaccines and treatment, as well as treatment for conditions that may complicate COVID-19 treatment, for uninsured individuals to be covered under Medicaid during the public health emergency. HR 6640 (116th Congress), Medicare Advantage COVID Treatment Act, by Rep. Debbie Mucarsel-Powell (D-FL). Requires Medicare Advantage (MA) plans to cover specified treatment services relating to COVID-19 without cost-sharing during the public health emergency. HR 6649 (116th Congress), Lower Drug Costs for Seniors During COVID-19 Act of 2020, by Rep. Janice Schakowsky (D-IL). Requires the Centers for Medicare & Medicaid Services to establish a process for prescription drug plans under Medicare and Medicare Advantage to allow enrollees to make coinsurance payments in periodic installments, if the enrollee chooses to obtain the entire prescribed supply of a covered drug in a single fill. HR 6674 (116th Congress), Medicare Crisis Program Act of 2020, by Rep. Pramila Jayapal (D-WA). Ensure access to affordable, comprehensive health insurance benefits for certain uninsured individuals during the COVID-19 emergency, and to ensure adequate coverage of treatments for COVID-19 under the Medicare and Medicaid programs and under group health plans and group or individual health insurance coverage. HR 6698 (116th Congress), Quality Care for Nursing Home Residents and Workers During COVID-19 Act of 2020, by Rep. Jan Schakowsky (D-IL). Improve the quality of care in skilled nursing facilities under the Medicare program and nursing facilities under the Medicare program during the COVID-19 emergency period. HR 6739 (116th Congress), Ensuring Seniors' Access to COVID Treatments Act, by Rep. Sean Casten (D-IL). Requires prescription drug plans under Medicare and Medicare Advantage to cover drugs that are approved to treat COVID-19 without cost-sharing during the public health emergency. HR 6753 (116th Congress), Rural Community Hospital Demonstration Extension Act of 2020, by Rep. Abby Finkenauer (D-IA). Amend the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to extend the rural community hospital demonstration program. HR 6837 (116th Congress), Medicare Accelerated and Advance Payments Improvement Act of 2020, by Rep. Bradley Scott Schneider (D-IL). Modify the accelerated and advance payment programs under parts A and B of the Medicare program during the COVID-19 emergency. HR 6971 (116th Congress), Medical Nutrition Therapy Act of 2020, by Rep. Eliot Engel (D-NY). Expand the availability of medical nutrition therapy services under the Medicare program. HR 7062 (116th Congress), Affordable Insulin for the COVID-19 Emergency Act, by Rep. Maxine Waters (D-CA). Eliminate cost-sharing with respect to coverage of insulin as a covered part D drug and associated medical supplies and to provide mail order access to insulin and such supplies under the Medicare program during the COVID-19 emergency period. HR 7127 (116th Congress), by Rep. G. K. Butterfield (D-NC). Makes technical amendments to the separate payment under the Medicare program for disposable negative pressure wound therapy devices. HR 7154 (116th Congress), Outpatient Therapy Modernization and Stabilization Act, by Rep. Brendan Boyle (D-PA). Improve and ensure ongoing Medicare beneficiary access to outpatient therapy services. HR 7292 (116th Congress), COVID-19 Hospital and Health Provider Loan Forgiveness Act of 2020, by Rep. Marcy Kaptur (D-OH). Provide for forgiveness of certain accelerated and advance payments under parts A and B of the Medicare program. HR 7323 (116th Congress), Medicare Mental Health Inpatient Equity Act of 2019, by Rep. Paul Tonko (D-NY). Eliminate the 190-day lifetime limit on inpatient psychiatric hospital services under the Medicare Program. HR 7338 (116th Congress), by Rep. Liz Cheney (R-WY). Permit the Secretary of Health and Human Services to waive requirements relating to the furnishing of telehealth services under the Medicare program. HR 7391 (116th Congress), by Rep. Mikie Sherrill (D-NJ). Remove certain geographic and originating site restrictions on the furnishing of telehealth services under the Medicare program.

Client expense: Not reported · Firm income: Not reported

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

Medicare Advantage; Medicaid Expansion; Medicaid; Medicare Data Sharing; Privacy; Medicare Prescription Drug Prices; CMS; Generic Drugs (CREATES Act); Drug Approval; HELP Cost Reduction Package; CHIP, MACRA; Provider Funding; Medicaid FMAP Increase; Coronavirus Medicaid Response; Rate Notice and Call Letter HR 3107 (116th Congress), Improving Seniors Timely Access to Care Act of 2019, by Rep. Suzan DelBene (D-WA). Establish requirements with respect to the use of prior authorization under Medicare Advantage plans. HR 5534 (116th Congress), Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019, by Rep. Ron Kind (D-WI). Provide for extended months of Medicare coverage of immunosuppressive drugs for kidney transplant patients. HR 5582 (116th Congress), Parental Accessibility Rights for Emergency and Negligent Treatment Act, by Rep. Gregory Murphy (R-NC). Expands the scope of advance directive policies and related disclosures for providers under Medicaid and the Children's Health Insurance Program (CHIP). HR 5693 (116th Congress), Primary Health Services Enhancement Act, by Rep. Ron Kind (D-WI). Expand Medicare Rural Health Clinic Services and Federally Qualified Health Center Services to include physical therapy services. HR 5741 (116th Congress), Strengthening Innovation in Medicare and Medicaid Act, by Rep. Terri Sewell (D-AL). Clarify parameters for model testing and add accountability to model expansion under the Center for Medicare and Medicaid Innovation. HR 5833 (116th Congress), by Rep. Bob Latta (R-OH). Permit the use of certain psychological evaluation via telehealth for Medicare coverage of neurostimulation services for the treatment of chronic pain. HR 5882 (116th Congress), GENE Therapy Payment Act, by Rep. Kurt Schrader (D-OR). Provide States with the option under the Medicaid program to pay for covered outpatient drugs through risk-sharing value-based agreements. HR 5897 (116th Congress), Preventing Abuse and Neglect of Vulnerable Americans Act of 2020, by Rep. Ruben Gallego (D-AZ). Requires the Centers for Medicare & Medicaid Services (CMS) to publish specified information on its website relating to deficiencies of Medicaid intermediate care facilities for individuals with intellectual disabilities, including information regarding inspections, complaints, and administrative actions. HR 5900 (116th Congress), Accelerating Kids' Access to Care Act, by Rep. Joseph Kennedy (D-MA). Requires state Medicaid programs to establish a process through which qualifying out-of-state providers may enroll as participating providers without undergoing additional screening requirements. HR 6098 (116th Congress), by Rep. Nanette Diaz Barragan (D-CA). Allow States to expand income eligibility standards under the Childrens Health Insurance Program. HR 6147 (116th Congress), Help Extend Auditory Relief (HEAR) Act of 2020, by Rep. Matt Cartwright (D-PA). Provide coverage under the Medicare program of hearing aids and related hearing services. HR 6159 (116th Congress), Kids Access to Primary Care Act of 2020, by Rep. Kim Schrier (D-WA). Renew the application of the Medicare payment rate floor to primary care services furnished under the Medicaid program. HR 6179 (116th Congress), Increasing Access to Biosimilars Act of 2020, by Rep. Tony Cardenas (D-CA). Require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar biological products under the Medicare program. HR 6214 (116th Congress), by Rep. Ron Kind (D-WI). Provide for coverage of testing for COVID-19 at no cost sharing under the Medicare Advantage program. HR 6218 (116th Congress), Preserving Patient Access to Home Infusion Act, by Rep. Eliot Engel (D-NY). Clarify congressional intent and preserve patient access to home infusion therapy under the Medicare program. HR 6263 (116th Congress), by Rep. John Sarbanes (D-MD). Waive cost sharing under the Medicare program for certain visits relating to testing for COVID-19. HR 6273 (116th Congress), Protecting Vulnerable Americans in Times of Crisis Act of 2020, by Rep. G. K. Butterfield (D-NC). Increase allotments under the Medicaid program for territories of the United States, to provide for a temporary increase in the Federal medical assistance percentage for States under the Medicaid program. HR 6281 (116th Congress), Medicare Wage Index Parity Act of 2020, by Rep. Bill Pascrell (D-NJ). Provides statutory authority for, and extends, a specified methodology used to calculate the minimum Medicare hospital wage index for all-urban states. HR 6282 (116th Congress), Commission on America's Medical Security Act, by Rep. Raul Ruiz (D-CA). Establish a commission to assess, evaluate, and address the dependence of the United States on medications, devices, and medical equipment from foreign countries. HR 6336 (116th Congress), Increasing Hospital Capacity to Fight the Coronavirus Act of 2020, by Rep. Dan Bishop (R-NC). Provide a waiver of payment reductions under the Medicare and Medicaid programs for certain nonapproved capital expenditures undertaken by health care facilities during the COVID-19 emergency. HR 6486 (116th Congress), Care for COVID-19 Act 2.0, by Rep. Raul Ruiz (D-CA). Require the Secretary of Health and Human Services to establish a special enrollment period during the COVID-19 emergency period, to require the Secretary to carry out outreach and educational activities for such special enrollment period, to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage without any cost sharing for certain items and services furnished during any portion of such emergency period. HR 6487 (116th Congress), Advancing Connectivity during the Coronavirus to Ensure Support for Seniors Act, by Rep. Jan Schakowsky (D-IL). Increase the ability of nursing facilities to access telehealth services and obtain technologies to allow virtual visits during the public health emergency relating to an outbreak of coronavirus disease 2019 (COVID-19). HR 6583 (116th Congress), by Rep. Chrissy Houlahan (D-PA). Establish a risk corridor program for Medicare Advantage plans during the COVID-19 emergency. HR 6616 (116th Congress), Stronger Medicaid Response to the COVID-19 Pandemic Act, by Rep. Tony Cardenas (D-CA). Allows COVID-19 vaccines and treatment, as well as treatment for conditions that may complicate COVID-19 treatment, for uninsured individuals to be covered under Medicaid during the public health emergency. HR 6640 (116th Congress), Medicare Advantage COVID Treatment Act, by Rep. Debbie Mucarsel-Powell (D-FL). Requires Medicare Advantage (MA) plans to cover specified treatment services relating to COVID-19 without cost-sharing during the public health emergency. HR 6649 (116th Congress), Lower Drug Costs for Seniors During COVID-19 Act of 2020, by Rep. Janice Schakowsky (D-IL). Requires the Centers for Medicare & Medicaid Services to establish a process for prescription drug plans under Medicare and Medicare Advantage to allow enrollees to make coinsurance payments in periodic installments, if the enrollee chooses to obtain the entire prescribed supply of a covered drug in a single fill. HR 6674 (116th Congress), Medicare Crisis Program Act of 2020, by Rep. Pramila Jayapal (D-WA). Ensure access to affordable, comprehensive health insurance benefits for certain uninsured individuals during the COVID-19 emergency, and to ensure adequate coverage of treatments for COVID-19 under the Medicare and Medicaid programs and under group health plans and group or individual health insurance coverage. HR 6698 (116th Congress), Quality Care for Nursing Home Residents and Workers During COVID-19 Act of 2020, by Rep. Jan Schakowsky (D-IL). Improve the quality of care in skilled nursing facilities under the Medicare program and nursing facilities under the Medicare program during the COVID-19 emergency period. HR 6739 (116th Congress), Ensuring Seniors' Access to COVID Treatments Act, by Rep. Sean Casten (D-IL). Requires prescription drug plans under Medicare and Medicare Advantage to cover drugs that are approved to treat COVID-19 without cost-sharing during the public health emergency. HR 6753 (116th Congress), Rural Community Hospital Demonstration Extension Act of 2020, by Rep. Abby Finkenauer (D-IA). Amend the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to extend the rural community hospital demonstration program. HR 6837 (116th Congress), Medicare Accelerated and Advance Payments Improvement Act of 2020, by Rep. Bradley Scott Schneider (D-IL). Modify the accelerated and advance payment programs under parts A and B of the Medicare program during the COVID-19 emergency. HR 6971 (116th Congress), Medical Nutrition Therapy Act of 2020, by Rep. Eliot Engel (D-NY). Expand the availability of medical nutrition therapy services under the Medicare program. HR 7062 (116th Congress), Affordable Insulin for the COVID-19 Emergency Act, by Rep. Maxine Waters (D-CA). Eliminate cost-sharing with respect to coverage of insulin as a covered part D drug and associated medical supplies and to provide mail order access to insulin and such supplies under the Medicare program during the COVID-19 emergency period. HR 7127 (116th Congress), by Rep. G. K. Butterfield (D-NC). Makes technical amendments to the separate payment under the Medicare program for disposable negative pressure wound therapy devices. HR 7154 (116th Congress), Outpatient Therapy Modernization and Stabilization Act, by Rep. Brendan Boyle (D-PA). Improve and ensure ongoing Medicare beneficiary access to outpatient therapy services. HR 7292 (116th Congress), COVID-19 Hospital and Health Provider Loan Forgiveness Act of 2020, by Rep. Marcy Kaptur (D-OH). Provide for forgiveness of certain accelerated and advance payments under parts A and B of the Medicare program. HR 7323 (116th Congress), Medicare Mental Health Inpatient Equity Act of 2019, by Rep. Paul Tonko (D-NY). Eliminate the 190-day lifetime limit on inpatient psychiatric hospital services under the Medicare Program. HR 7338 (116th Congress), by Rep. Liz Cheney (R-WY). Permit the Secretary of Health and Human Services to waive requirements relating to the furnishing of telehealth services under the Medicare program. HR 7391 (116th Congress), by Rep. Mikie Sherrill (D-NJ). Remove certain geographic and originating site restrictions on the furnishing of telehealth services under the Medicare program.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, 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: $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

H.R. 3107 - Improving Seniors' Timely Access to Care Act of 2019 - DelBene - prior authorization in Medicare Advantage 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. 4453 - Protecting Seniors from Health Care Fraud Act of 2019 - Ruiz -Distributing information to Medicare beneficiaries to prevent fraud 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. 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. 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. 4671 - Helping Seniors Afford Health Care Act - Kim - Medicare affordability and low income beneficiaries H.R. 5006 - Expanding Access to Inpatient Mental Health Act - Emmer - Medicaid coverage for SUD/mental health for institutionalized 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. 5693 - Primary Health Services Enhancement Act - Kind - Medicare rural health H.R. 5808 - Save Rural Communities Act of 2020 - Jodey Arrington - rural emergency medical access services under Medicare H.R. 5833 - To amend title XVIII of the Social Security Act to permit the use of certain psychological evaluation via telehealth for Medicare coverage of neurostimulation services for the treatment of chronic pain - Latta - Medicare coverage in telehealth H.R. 5882 - GENE Therapy Payment Act - Schrader - value based care H.R. 6098 - To amend title XXI of the Social Security Act to allow States to expand income eligibility standards under the Children's Health Insurance Program -Barragan - CHIP eligibility H.R. 6151 - CARING for Kids Act - Abby Fineknauer - CHIP H.R. 6179 - Increasing Access to Biosimilars Act of 2020 - Cardenas - payments to providers of biosimilars under Medicare H.R. 6209 - Reducing Unnecessary Senior Hospitalizations Act of 2020 or the RUSH Act of 2020 -Kuster - Medicare coverage for certain services in hospital emergency departments H.R. 6244 - To amend titles XVIII and XIX to provide for coverage at no cost sharing of COVID-19 testing under the Medicaid program and Children's Health Insurance Program - Kelly - Medicaid coverage of COVID-19 related visits and testing H.R. 6263 - To amend title XVIII of the Social Security Act to waive cost sharing under the Medicare program for certain visits relating to testing for COVID-19 -Sarbanes - Medicare coverage of COVID-19 related visits and testing H.R. 6273 - Protecting Vulnerable Americans in Times of Crisis Act of 2020 - Butterfield - FMAP H.R. 6311 - Care for COVID-19 Act - Ruiz - COVID-19 cost sharing H.R. 6336 - To amend title XI of the Social Security Act to provide for a waiver of payment reductions under the Medicare and Medicaid programs for certain nonapproved capital expenditures undertaken by health care facilities during the COVID-19 emergency - Bishop - Medicare and Medicaid payments during COVID-19 emergency 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. 3220 - Ensuring Access to Direct Support Professionals Act - Portman - Medicaid coverage in acute care hospitals S. 3238 - Preventive Home Visit Act - King - preventative home visits S. 3277 - HCBS Infrastructure Improvement Act - Casey - access to community based services S. 3353 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020 - Cassidy - Medicare coverage of kidney transplant services S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - McSally - Medicare Part D drug pricing negotiation S. 3399 - FCHIP Extension Act - Tester - rural health S. 3442 - Care for COVID-19 Act - Booker - COVID-19 cost sharing S. 3443 - Improving Coverage and Care for Mothers Act - Casey - Medicaid coverage for all pregnant and postpartum women S. 3447 - RUSH Act of 2020 - Thune - Medicare coverage for certain services in hospital emergency departments S. 3466 - ACCESS for Biosimilars Act of 2020 - McSally - eliminates cost sharing for biosimilar biological products furnished under part B of the Medicare program 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); issues relating to COVID-19; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; 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: $3,630,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), 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), Office of the Vice President of the United States, SENATE, Treasury, Dept of, White House Office

Medicare Advantage; Medicaid Rebates; Medicaid Expansion; Medicaid General; Rate Notice and Call Letter; Medicare Part D: NBPP, Part D Rx Rebates; Medicare Data Sharing Privacy Medicare prescription drug prices; CMS Program Integrity Rule, Generic Drugs (CREATES) drug approval; Help cost reduction package, CHIP, MACRA Provider funding. H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6] H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Act of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large] H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7] H.R.1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd [D-TX-35] H.R.4629 - 116th Congress (2019-2020) Star Rating for Biosimilars Act Sponsor: Rep. Tonko, Paul [D-NY-20] H.R. 3107 - 116th Congress Improving Seniors' Timely Access to Care Act of 2019 Rep. Suzan DelBene (D-WA-01) HR 4996 - 116th Congress First Session Helping MOMS Act of 2019 Rep. Robin Kelly (D-IL-02) HR 5882 - 116th Congress - Second Session Parental Accessibility Rights for Emergency and Negligent Treatment Act Rep. Greg Murphy (R=NC-03) HR 5741 - 116th Congress Second Session Strengthening Innovation in Medicare and Medicaid Act Rep. Terri Sewell (D-AL-07) HR 5900 - 116th Congress Second Session Accelerating Kids' Access to Care Act Rep. Joe Kennedy III (D-MA-04) HR 6098 - 116th Congress Second Session To amend title XXI of the Social Security Act to allow States to expand income eligibility standards under the Children's Health Insurance Program, and for other purposes. Rep. Nanette Barragan (D-CA-44) HR 6273 - 116th Congress Second Session Protecting Vulnerable Americans in Times of Crisis Act of 2020 Rep. GK Butterfield (D-NC-01) HR 5693 - 116th Congress Second Session Primary Health Services Enhancement Act Rep. Ron Kind (D-WI-03) HR 6147 - 116th Congress Second Session Help Extend Auditory Relieve (HEAR) Act of 2020 Rep. Matt Cartwright (D-PA-08) HR 6179 - 116th Congress Second Session Increasing Access to Biosimilars Act of 2020 Rep Tony Cardenas (D-Ca-29) HR 6218 - 116th Congress Second Session Preserving Patient Access to Home Infusion Act Rep. Eliot Engel (D-NY-16) HR 5534 - 116th Congress Second Session Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019 Rep. Ron Kind (D-WI-03)

Client expense: $102,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act 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