Capping Drug Costs for Seniors Act of 2021

Expanding Medicare benefits to include dental, hearing, and vision Extending and making permanent COVID-19 telehealth flexibilities Increasing drug affordability and accessibility via drug pricing, Medicare Part D redesign and benefits, capping out-of-pocket costs and smoothing, and streamlining prior authorization processes Advocating for improvements to Medicare Part C and Part D proposed rule Inflation Reduction Act of 2022 H.R. 4417, the Capping Drug Costs for Seniors Act S. 2327, the Seniors Prescription Drug Relief Act S. 828/H.R. 432, the Mental Health Access Improvement Act of 2021 H.R. 2080, the Seniors Access to Vaccine Ensured Act of 2021 H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act H.R. 4011, the Capping Drug Costs for Seniors Act of 2022 H.R. 4479/S. 2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2021 S. 2061/H.R. 4058, the Telemental Health Care Access Act of 2021 S. 1512/H.R. 2903, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021 H.R. 1332/S. 368, the Telehealth Modernization Act H.R. 366, the Protecting Access to Post-COVID-19 Telehealth Act of 2021 H.R. 3733: Essential Caregivers Act of 2021 H.R. 6202, the Telehealth Extension Act of 2021 S. 3575, the Stop the Wait Act of 2022 S. 3593, the Telehealth Extension and Evaluation Act S. 3675, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) 2.0 Act H.R. 7051/S. 3791, the Access to Prescription Digital Therapeutics Act of 2022 H.R. 5375, the Inflation Reduction Act of 2022

Client expense: $31,190 · Firm income: Not reported

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

General education around pharmaceuticals related to Parkinson's disease Increasing drug affordability and accessibility via drug pricing, Medicare Part D redesign and benefits, and streamlining prior authorization processes and step therapy protocols Prescription Drug User Fee Act H.R. 4417, the Capping Drug Costs for Seniors Act H.R. 4479/S. 2609, the Facilitating Innovative Nuclear Diagnostics Act of 2021 S. 2327, the Seniors Prescription Drug Relief Act H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act of 2021 H.R. 2163, the Safe Step Act H.R. 5801, the Help Ensure Lower Patient (HELP) Copays Act H.R. 5376, the Inflation Reduction Act of 2022

Client expense: $31,190 · 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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues VA drug pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues Part B Discarded Units Refund policy issues Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements

CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues VA drug pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues Part B Discarded Units Refund policy issues Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1676, Jack Reynolds Memorial Medigap Extension Act H.R. 2934, Renal Anemia Innovation Support and Expansion (RAISE) Act S. 4011, Capping Drug Costs for Seniors Act of 2022 H.R. 4065, The Chronic Kidney Disease Improvement in Research and Treatment Act H.R. 4417, Capping Drug Costs for Seniors Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 6973, Enhanced Access to Affordable Medicines Act of 2022 H.R. 7634, Protecting Health Care for All Patients Act of 2022 S. 1971, Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 S. 2317, Seniors Prescription Drug Relief Act Issues related to Medicare Part D coverage for drugs indicated to treat patients with chronic kidney disease; Quality Improvement Program (QIP) in the End Stage Renal Disease (ESRD) prospective payment system; CY 2022 Medicare End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Improvement Program (QIP) rule making; CY 2022 policy and technical issues changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; Centers for Medicare and Medicaid Innovation (CMMI) ESRD Treatment Choices (ETC) model; Implementation of expanded Medicare immunosuppressive drug coverage for kidney transplant patients; Implementation of Executive Order 13879, Advancing American Kidney Health; Telehealth flexibilities for nephrologists and kidney patients on dialysis.

Client expense: $320,000 · Firm income: Not reported

General education around pharmaceuticals related to Parkinson's disease Increasing drug affordability and accessibility via drug pricing, Medicare Part D redesign and benefits, and streamlining prior authorization processes and step therapy protocols Prescription Drug User Fee Act H.R. 4417, the Capping Drug Costs for Seniors Act H.R. 4479/S. 2609, the Facilitating Innovative Nuclear Diagnostics Act of 2021 S. 2327, the Seniors Prescription Drug Relief Act H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act of 2021 H.R. 2163, the Safe Step Act H.R. 5801, the Help Ensure Lower Patient (HELP) Copays Act

Client expense: $61,153 · 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

Expanding Medicare benefits to include dental, hearing, and vision Extending and making permanent COVID-19 telehealth flexibilities Increasing drug affordability and accessibility via drug pricing, Medicare Part D redesign and benefits, capping out-of-pocket costs and smoothing, and streamlining prior authorization processes Advocating for improvements to Medicare Part C and Part D proposed rule H.R. 4417, the Capping Drug Costs for Seniors Act S. 2327, the Seniors Prescription Drug Relief Act S. 828/H.R. 432, the Mental Health Access Improvement Act of 2021 H.R. 2080, the Seniors Access to Vaccine Ensured Act of 2021 H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act H.R. 4011, the Capping Drug Costs for Seniors Act of 2022 H.R. 4479/S. 2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2021 S. 2061/H.R. 4058, the Telemental Health Care Access Act of 2021 S. 1512/H.R. 2903, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021 H.R. 1332/S. 368, the Telehealth Modernization Act H.R. 366, the Protecting Access to Post-COVID-19 Telehealth Act of 2021 H.R. 3733: Essential Caregivers Act of 2021 H.R. 6202, the Telehealth Extension Act of 2021 S. 3575, the Stop the Wait Act of 2022 S. 3593, the Telehealth Extension and Evaluation Act S. 3675, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) 2.0 Act H.R. 7051/S. 3791, the Access to Prescription Digital Therapeutics Act of 2022

Client expense: $61,153 · Firm income: Not reported

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, provisions related to patents H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5801 HELP Copays Act, provisions related to patient assistance H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, provisions related to patents H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5801 HELP Copays Act, provisions related to patient assistance H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1676, Jack Reynolds Memorial Medigap Extension Act H.R. 2934, Renal Anemia Innovation Support and Expansion (RAISE) Act S. 4011, Capping Drug Costs for Seniors Act of 2022 H.R. 4065, The Chronic Kidney Disease Improvement in Research and Treatment Act H.R. 4417, Capping Drug Costs for Seniors Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act S. 1971, Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 S. 2317, Seniors Prescription Drug Relief Act Issues related to Medicare Part D coverage for drugs indicated to treat patients with chronic kidney disease; Quality Improvement Program (QIP) in the End Stage Renal Disease (ESRD) prospective payment system; CY 2022 Medicare End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Improvement Program (QIP) rule making; CY 2022 policy and technical issues changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; Centers for Medicare and Medicaid Innovation (CMMI) ESRD Treatment Choices (ETC) model; Implementation of expanded Medicare immunosuppressive drug coverage for kidney transplant patients; Implementation of Executive Order 13879, Advancing American Kidney Health; Telehealth flexibilities for nephrologists and kidney patients on dialysis.

Client expense: $320,000 · Firm income: Not reported

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 2179: Affordable Insulin for the COVID-19 Emergency Act - Provisions related to Part D and insulin H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Insulin policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues

Expanding Medicare benefits to include dental, hearing, and vision Extending and making permanent COVID-19 telehealth flexibilities Increasing drug affordability and accessibility via drug pricing, Medicare Part D redesign and benefits, capping out-of-pocket costs and smoothing, and streamlining prior authorization processes Advocating for improvements to Medicare Part C and Part D proposed rule H.R. 4417, the Capping Drug Costs for Seniors Act S. 2327, the Seniors Prescription Drug Relief Act S. 828/H.R. 432, the Mental Health Access Improvement Act of 2021 H.R. 2080, the Seniors Access to Vaccine Ensured Act of 2021 H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act H.R. 4479/S. 2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2021 S. 2061/H.R. 4058, the Telemental Health Care Access Act of 2021 S. 1512/H.R. 2903, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021 S. 3593, the Telehealth Extension and Evaluation Act H.R. 6202, the Telehealth Extension Act of 2021 H.R. 1332/S. 368, the Telehealth Modernization Act H.R. 366, the Protecting Access to Post-COVID-19 Telehealth Act of 2021

Client expense: $57,949 · Firm income: Not reported

General education around pharmaceuticals related to Parkinson's disease Increasing drug affordability and accessibility via drug pricing, Medicare Part D redesign and benefits, and streamlining prior authorization processes and step therapy protocols Prescription Drug User Fee Act H.R. 4417, the Capping Drug Costs for Seniors Act H.R. 4479/S. 2609, the Facilitating Innovative Nuclear Diagnostics Act of 2021 S. 2327, the Seniors Prescription Drug Relief Act H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act of 2021 H.R. 2163, the Safe Step Act H.R. 5801, the Help Ensure Lower Patient (HELP) Copays Act

Client expense: $57,949 · 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

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act - Rep. Pallone, Frank, Jr. [D-NJ-6] - drug pricing H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021 - Rep. Rush, Bobby L. [D-IL-1] - generic drugs H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Rep. Harshbarger, Diana [R-TN-1] - PBMs H.R. 1873 - Advancing Education on Biosimilars Act of 2021 - Rep. Bucshon, Larry [R-IN-8] - drug education H.R. 2071 - Medicare Prescription Drug Price Negotiation Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - Part D price negotiation H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd [D-TX-35] - Part D price negotiation H.R. 2148 - Prescription Drug Price Relief Act of 2021 - Rep. Khanna, Ro [D-CA-17] - excessive drug pricing H.R. 2608 - Ensuring Seniors Access to Local Pharmacies Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - rural health H.R. 2829 - End Price Gouging for Medications Act - Rep. Welch, Peter [D-VT-At Large] - reference prices H.R. 2846 - Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021 - Rep. McKinley, David B. [R-WV-1] - biosimilar drugs H.R. 2855 - Star Rating for Biosimilars Act - Rep. Tonko, Paul [D-NY-20] - biosimilar drugs H.R. 2891 - Preserve Access to Affordable Generics and Biosimilars Act - Rep. Nadler, Jerrold [D-NY-10] - biosimilar drugs H.R. 3831 - Seniors Securing Access to Vital and Essential Prescription Drugs Act - Rep. Lee, Susie [D-NV-3] - Part D H.R. 4121 - PRO Seniors Act - Rep. Arrington, Jodey C. [R-TX-19] - drug rebates H.R. 4417 - Capping Drug Costs for Seniors Act of 2021 - Rep. Horsford, Steven [D-NV-4] - reduces out of pocket spending H.R. 4418 - SPIKE Act - Rep. Horsford, Steven [D-NV-4] - Medicare drug price threshold H.R. 5623 - The Insulin Cost Reduction Act - Rep. Grothman, Glenn [R-WI-6] - insulin prices under part D H.R. 6000 - Cures 2.0 Act - Rep. DeGette, Diana [D-CO-1] - drug development H.R. 6228 - To limit cost sharing for prescription drugs - Rep. Manning, Kathy E. [D-NC-6] - cost sharing S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha [R-TN] - PBMs S. 833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Sen. Klobuchar, Amy [D-MN] - Part D price negotiation S. 898 - Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Sen. Baldwin, Tammy [D-WI] - reporting price increases S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard [I-VT] - Part D price negotiation S. 1123 - PING Act - Sen. Blackburn, Marsha [R-TN] - Part D non-interference S. 1323 - End Price Gouging for Medications Act - Sen. Merkley, Jeff [D-OR] - reference prices S. 1428 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy [D-MN] - biosimilar drugs S. 2257 - Expanding Access to Affordable Prescription Drugs and Medical Devices Act - Sen. Rosen, Jacky [D-NV] - drug shortages and costs S. 2304 - DTC Act of 2021- Sen. Durbin, Richard J. [D-IL] - drug pricing S. 2327 - Seniors Prescription Drug Relief Act - Sen. Cassidy, Bill [R-LA] - Medicare part D modernization redesign and reduces out of pocket spending S. 2815 - Seniors Saving on Insulin Act - Sen. Kennedy, John [R-LA] - Part D Senior Savings model S. 3339 - A bill to limit cost sharing for prescription drugs - Sen. Warnock, Raphael G. [D-GA] - cost sharing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1676, Jack Reynolds Memorial Medigap Extension Act H.R. 2934, Renal Anemia Innovation Support and Expansion (RAISE) Act H.R. 4065, The Chronic Kidney Disease Improvement in Research and Treatment Act H.R. 4417, Capping Drug Costs for Seniors Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act S. 1971, Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 S. 2317, Seniors Prescription Drug Relief Act Issues related to Medicare Part D coverage for drugs indicated to treat patients with chronic kidney disease; Quality Improvement Program (QIP) in the End Stage Renal Disease (ESRD) prospective payment system; CY 2022 Medicare End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Improvement Program (QIP) rule making; CY 2022 policy and technical issues changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; Centers for Medicare and Medicaid Innovation (CMMI) ESRD Treatment Choices (ETC) model; Implementation of expanded Medicare immunosuppressive drug coverage for kidney transplant patients; Implementation of Executive Order 13879, Advancing American Kidney Health; Telehealth flexibilities for nephrologists and kidney patients on dialysis.

Client expense: $270,000 · Firm income: Not reported

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act - Rep. Pallone, Frank, Jr. [D-NJ-6] - drug pricing H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021 - Rep. Rush, Bobby L. [D-IL-1] - generic drugs H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Rep. Harshbarger, Diana [R-TN-1] - PBMs H.R. 1873 - Advancing Education on Biosimilars Act of 2021 - Rep. Bucshon, Larry [R-IN-8] - drug education H.R. 2071 - Medicare Prescription Drug Price Negotiation Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - Part D price negotiation H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd [D-TX-35] - Part D price negotiation H.R. 2148 - Prescription Drug Price Relief Act of 2021 - Rep. Khanna, Ro [D-CA-17] - excessive drug pricing H.R. 2608 - Ensuring Seniors Access to Local Pharmacies Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - rural health H.R. 2829 - End Price Gouging for Medications Act - Rep. Welch, Peter [D-VT-At Large] - reference prices H.R. 2846 - Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021 - Rep. McKinley, David B. [R-WV-1] - biosimilar drugs H.R. 2855 - Star Rating for Biosimilars Act - Rep. Tonko, Paul [D-NY-20] - biosimilar drugs H.R. 2891 - Preserve Access to Affordable Generics and Biosimilars Act - Rep. Nadler, Jerrold [D-NY-10] - biosimilar drugs H.R. 3831 - Seniors Securing Access to Vital and Essential Prescription Drugs Act - Rep. Lee, Susie [D-NV-3] - Part D H.R. 4121 - PRO Seniors Act - Rep. Arrington, Jodey C. [R-TX-19] - drug rebates H.R. 4417 - Capping Drug Costs for Seniors Act of 2021 - Rep. Horsford, Steven [D-NV-4] - reduces out of pocket spending H.R. 4418 - SPIKE Act - Rep. Horsford, Steven [D-NV-4] - Medicare drug price threshold S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha [R-TN] - PBMs S. 833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Sen. Klobuchar, Amy [D-MN] - Part D price negotiation S. 898 - Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Sen. Baldwin, Tammy [D-WI] - reporting price increases S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard [I-VT] - Part D price negotiation S. 1123 - PING Act - Sen. Blackburn, Marsha [R-TN] - Part D non-interference S. 1323 - End Price Gouging for Medications Act - Sen. Merkley, Jeff [D-OR] - reference prices S. 1428 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy [D-MN] - biosimilar drugs S. 2257 - Expanding Access to Affordable Prescription Drugs and Medical Devices Act - Sen. Rosen, Jacky [D-NV] - drug shortages and costs S. 2304 - DTC Act of 2021- Sen. Durbin, Richard J. [D-IL] - drug pricing S. 2327 - Seniors Prescription Drug Relief Act - Sen. Cassidy, Bill [R-LA] - Medicare part D modernization redesign and reduces out of pocket spending S. 2815 - Seniors Saving on Insulin Act - Sen. Kennedy, John [R-LA] - Part D Senior Savings model Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1676, Jack Reynolds Memorial Medigap Extension Act H.R. 2934, Renal Anemia Innovation Support and Expansion (RAISE) Act H.R. 4065, The Chronic Kidney Disease Improvement in Research and Treatment Act H.R. 4417, Capping Drug Costs for Seniors Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act S. 1971, Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 S. 2317, Seniors Prescription Drug Relief Act Issues related to Medicare Part D coverage for drugs indicated to treat patients with chronic kidney disease; Quality Improvement Program (QIP) in the End Stage Renal Disease (ESRD) prospective payment system; CY 2022 Medicare End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Improvement Program (QIP) rule making; CY 2022 policy and technical issues changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; Centers for Medicare and Medicaid Innovation (CMMI) ESRD Treatment Choices (ETC) model; Implementation of expanded Medicare immunosuppressive drug coverage for kidney transplant patients; Implementation of Executive Order 13879, Advancing American Kidney Health; Telehealth flexibilities for nephrologists and kidney patients on dialysis.

Client expense: $300,000 · Firm income: Not reported