Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2020

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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)

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

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.

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

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

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

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

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

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.

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

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

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

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

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

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

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