Improving Transparency to Lower Drug Costs Act of 2021

HR 3759 "Barriers to Suicide Act," all provisions. HR 3682 "Cady Housh and Gemesha Thomas Suicide Prevention Act," all provisions. S 1628 "Children and Teens Online Privacy Protection Act," all provisions. Issues pertaining to the reintroduction of the "American Data Privacy and Protection Act" (formerly HR 8152 - 117th Congress), all provisions. HR 2412 "Helping Kids Cope Act," all provisions. S 1409 "Kids Online Safety Act," all provisions. HR 3713 / S 1884 "Mental Health Services for Students Act," all provisions. Issues pertaining to legislation on secure storage of lethal means. S 1418 "Children and Teens Online Privacy Protection Act," all provisions.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Worker Shortage/Staffing Crisis S.1113, Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act Appropriations regarding but not limited to community violence intervention, the CDCs Office on Smoking and Health (OSH), School-Based Mental Health Services Professional Demonstration Grants/ School-Based Mental Health Services Grant Program, gun violence prevent and removing abortion prohibition language from future appropriations bills. H.R.3727 Teacher Health and Wellness Act S.1446, Nurse Corps Tax Parity Act H.R.3761/S.1774, Advancing Student Services in Schools Today Act H.R.3726, Student Mental Health Rights Act H.R.3305, Black Maternal Health Momnibus Act Funding for CDCs Social Determinants of Health program H.R.3646, Menstrual Equity For All Act of 2023, Incarceration related issues H.R.3682, Cady Housh and Gemesha Thomas Student Suicide Prevention Act of 2023, Entirety S.1409, Kids Online Safety Act, Entirety Monitor the following: Public Law 117-169, Inflation Reduction Act, Prescription drug reform Public Law 117-159, Bipartisan Safer Communities Act Medicaid DSH Payments, Hospital funding formula Abortion Access related issues Supporting Trauma Informed Education Practices Act Restoring Hope for Mental Health and Well‐Being Act Nurse Overtime and Patient Safety Act Health Force and Resilience Force Act, Black Maternal Health Momnibus Act Student Loan Forgiveness for Frontline Health Workers Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues The National Nurse Act, Entirety Telehealth issues Medicare X Choice Act Rural Healthcare related issues and initiatives H.R.12/S.701, the Women's Health Protection Act, Entirety Mental health supports for educators Closing Health Coverage Gaps for Public Servants Act Workplace Violence Prevention for Health Care and Social Service Worker Act Visas for international healthcare professionals Dobbs vs Jackson, United States Supreme Court decision Workplace violence related issues Green New Deal for Health, Entirety H.R.1485/S.727, Insulin for All Act H.R.1692, Health Care Affordability Act S.1139 A bill to apply prescription drug inflation rebates to drugs furnished in the commercial market Minimum staffing levels in skilled nursing facilities related issues

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; H.R. 5376, the Inflation Reduction Act of 2022; Draft legislation on pharmacy DIR fee reform

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

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; H.R. 5376, the Inflation Reduction Act of 2022

Client expense: $400,000 · Firm income: Not reported

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.799: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Proposed Rule (CMS-4192-P); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act

Client expense: $460,000 · Firm income: Not reported

H.R. 3554/S.1909 The Pharmacy DIR Reform To Reduce Senior Drug Costs Act, to amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes. H.R. 3662 -- The Patient Access to Urgent-Use Pharmacy Compounding Act of 2021, to amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes. H.R. 3682 --To amend title XI of the Social Security Act to provide greater transparency for discounts provided by manufacturers. H.R. 2608 --Ensuring Seniors Access to Local Pharmacies Act of 2021, a bill that establishes several requirements for prescription drug plans under the Medicare prescription drug benefit. H.R. 7213 - To amend title XVIII of the Social Security Act to provide pharmacy reimbursement for COVID-19-related and future emergency services.

Client expense: $35,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Proposed Rule (CMS-4192-P)

Client expense: $2,010,000 · Firm income: Not reported

H.R. 3554/S.1909 The Pharmacy DIR Reform To Reduce Senior Drug Costs Act, to amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes. H.R. 3662 -- The Patient Access to Urgent-Use Pharmacy Compounding Act of 2021, to amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes. H.R. 3682 --To amend title XI of the Social Security Act to provide greater transparency for discounts provided by manufacturers. H.R. 2608 --Ensuring Seniors Access to Local Pharmacies Act of 2021, a bill that establishes several requirements for prescription drug plans under the Medicare prescription drug benefit. H.R. 7213 - To amend title XVIII of the Social Security Act to provide pharmacy reimbursement for COVID-19-related and future emergency services.

Client expense: $35,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals

Client expense: $2,100,000 · Firm income: Not reported

H.R. 3554/S.1909 The Pharmacy DIR Reform To Reduce Senior Drug Costs Act, to amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes. H.R. 3662 -- The Patient Access to Urgent-Use Pharmacy Compounding Act of 2021, to amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes. H.R. 3682 --To amend title XI of the Social Security Act to provide greater transparency for discounts provided by manufacturers. H.R. 2608 --Ensuring Seniors Access to Local Pharmacies Act of 2021, a bill that establishes several requirements for prescription drug plans under the Medicare prescription drug benefit.

Client expense: $35,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals

Client expense: $430,000 · Firm income: Not reported

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

H.R. 1186: Supply Chain Security and Pharmaceutical Authentication Act of 2021 - Provisions related to medical supply chains H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3236: AMIGOS Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3682: Improving Transparency to Lower Drug Costs Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3694: To direct the Secretary of Health and Human Services, in consultation with the United States Trade Representative and other heads of Federal agencies, to submit to Congress a report the impact of a waiver of certain obligations of member nations under the Agreement on Trade-Related Aspects of Intellectual Property Rights on global COVID-19 vaccine access, and for other purposes - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3811: TRIPP Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3851: Continuous Manufacturing Research Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4295: Supply Chain Vulnerability Assessment Act of 2021 - Provisions related to medical supply chains H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4376: USTRx Act - Provisions related to international trade policy and manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1366: Pharmaceutical Supply Chain Defense and Enhancement Act - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains Trade Agreements including USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Draft drug pricing provisions for the FY2022 budget reconciliation legislation; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act

Client expense: $420,000 · Firm income: Not reported

H.R. 3554/S.1909 The Pharmacy DIR Reform To Reduce Senior Drug Costs Act, to amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes. H.R. 3662 -- The Patient Access to Urgent-Use Pharmacy Compounding Act of 2021, to amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes. H.R. 3682 --To amend title XI of the Social Security Act to provide greater transparency for discounts provided by manufacturers. H.R. 2608 --Ensuring Seniors Access to Local Pharmacies Act of 2021, a bill that establishes several requirements for prescription drug plans under the Medicare prescription drug benefit.

Client expense: $35,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act / Affordable Prescriptions for Patients Through Promoting Competition Act H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

Client expense: $1,601,681 · Firm income: Not reported

H.R. 3554/S.1909 The Pharmacy DIR Reform To Reduce Senior Drug Costs Act, to amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes. H.R. 3662 -- The Patient Access to Urgent-Use Pharmacy Compounding Act of 2021, to amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes. H.R. 3682 --To amend title XI of the Social Security Act to provide greater transparency for discounts provided by manufacturers. H.R. 2608 --Ensuring Seniors Access to Local Pharmacies Act of 2021, a bill that establishes several requirements for prescription drug plans under the Medicare prescription drug benefit.

Client expense: $35,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021

Client expense: $370,000 · Firm income: Not reported