Elijah E. Cummings Lower Drug Costs Now Act

H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill 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. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.

Client expense: $830,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Patient Protection and Affordable Care (P.L. 111-148) and Health Care Education Reconciliation Act of 2010 (P.L. 111-152); ACA reporting requirements; ERISA; tax treatment of employer-sponsored health coverage; employer-sponsored wellness programs; surprise medical billing reform; H.R 1319, the American Rescue Plan Act; COBRA Coverage Extension; H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act; S. 1704 - Telehealth Expansion Act of 2021; Build Back Better Act

Client expense: $720,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act This bill establishes several programs and requirements relating to the prices of prescription drugs. NSBA is monitoring. H.R.7 - Paycheck Fairness Act A bill to amend the Fair Labor Standards Act of 1938 to provide more effective remedies to victims of discrimination in the payment of wages based on sex, and for other purposes. NSBA opposes. H.R.25 - Fair Tax Act of 2021 To promote freedom, fairness, and economic opportunity by repealing the income tax and other taxes, abolishing the Internal Revenue Service, and enacting a national sales tax to be administered primarily by the states. NSBA supports H.R.603 - Raise the Wage Act of 2021 Bill would increase the federal minimum wage to $15 per hour over five years, allow for annual automatic increases without the consent of Congress, and eventually eliminate the tipped wage. NSBA opposes. H.R.842 - Protecting the Right to Organize Act of 2021 This bill expands various labor protections related to employees' rights to organize and collectively bargain in the workplace. NSBA opposes. H.R.971 - Small Business Succession Planning Act Bill directs the Small Business Administration (SBA) to create an online business succession planning toolkit that will assist small businesses through the process of creating business succession plans with the aid of SBA and its resource partners. NSBA supports. H.R.1319 - American Rescue Plan Act of 2021 This bill provides additional relief to address the continued impact of COVID-19 (i.e., coronavirus disease 2019) on the economy, public health, state and local governments, individuals, and businesses. NSBA supports. H.R.1381 - Main Street Tax Certainty Act This bill makes permanent the tax deduction for qualified business income. (Under current law, the deduction expires after December 31, 2025. NSBA supports. H.R. 1482 - 504 Credit Risk Management Improvement Act of 2021 The measure would increase and streamline oversight of the Small Business Administrations (SBA) 504 Loan Program, allowing small businesses to grow, modernize, and recover. NSBA supports. H.R. 1487 - Microloan Transparency and Accountability Act of 2021 The bill requires the SBA to perform an annual portfolio risk analysis of the Microloan Program, to ensure taxpayer money is safeguarded. NSBA supports. H.R.1490 - 504 Modernization and Small Manufacturer Enhancement Act of 2021 This bill modifies the SBA 504 Loan Program, which provides a small business with SBA financing--through a certified development company (CDC) intermediary-for expansion or modernization. NSBA supports. H.R.1502 - Microloan Improvement Act of 2021 The bill revises the microloan program through which the U.S. Small Business Administration (SBA) provides financial assistance to small businesses through designated intermediaries. NSBA supports. H.R.1507 - Providing Accountability through Transparency Act of 2021 Bill would require that each government agency provide a 100-word plain language summary of each proposed rule. NSBA supports. H.R.1508 - Guidance Clarity Act of 2021 Bill would require every federal agency to include text in guidance documents stating that guidance is not legally binding, making it easier for small businesses to understand which regulations apply to them. NSBA supports. H.R.1712 - Death Tax Repeal Act This bill repeals the estate and generation-skipping transfer taxes. It also makes conforming amendments related to the gift tax. NSBA supports. H.R.1799 - PPP Extension Act of 2021 This bill extends the Paycheck Protection Program, established to support small businesses in response to COVID-19 (i.e., coronavirus disease 2019), through June 30, 2021. NSBA supports. H.R. 1944 - Healthy Workplaces Act This bill allows tax credits for employer expenses for protecting employees from COVID-19 (i.e., coronavirus disease 2019). NSBA supports. H.R.1996 - SAFE Banking Act of 2021 This bill generally prohibits a federal banking regulator from penalizing a depository institution for providing banking services to a legitimate cannabis-related business. NSBA is monitoring. H.R. 3462 - SBA Cyber Awareness Act The bill expands cybersecurity operations at the Small Business Administration (SBA) by requiring them to issue a report assessing the agencys ability to combat cyber threats within six months of passage. The legislation requires the SBA to notify Congress of future breaches with information on those affected and how the breach occurred. NSBA supports. H.R. 3469 - Veteran Entrepreneurship Training Act of 2021 This bill authorizes the Boots to Business (B2B) program for five years to help transitioning service members start and grow their businesses. NSBA supports. H.R.3684 - Infrastructure Investment and Jobs Act This bill addresses provisions related to federal-aid highway, transit, highway safety, motor carrier, research, hazardous materials, and rail programs of the Department of Transportation (DOT). NSBA supports. H.R. 3807 -- Restaurant Revitalization Fund Replenishment Act of 2021 Congress provided $28.6 billion for the Restaurant Revitalization Fund (RRF), which provided relied to more than 100,000 restaurants and other food and beverage businesses. NSBA supports. H.R. 4037 - Trade Preferences and American Manufacturing Competitiveness Act To amend the Trade Act of 1974 to extend and modify the eligibility requirements for the Generalized System of Preferences, to amend the Harmonized Tariff Schedule of the United States to modify temporarily certain rates of duty, and for other purposes. NSBA is monitoring. H.R. 4256 - Investing in Main Street Act of 2021 It amends the Small Businesses Investment Act of 1958 to increase the percentage of capital and surplus that a bank or federal savings association may invest in Small Business Investment Companies (SBICs) to match current banking regulations. NSBA supports. H.R.4350 - National Defense Authorization Act for Fiscal Year 2022 This bill authorizes FY2022 appropriations for military activities and programs of the Department of Defense (e.g., personnel; research, development, test, and evaluation; and procurement of items such as aircraft, missiles, and ammunition). NSBA is monitoring. H.R. 4481 - Small Business 7(a) Loan Agent Transparency Act It provides oversight of 7(a) loan agents, including by requiring the Small Business Administration (SBA) to establish a registration system for such agents. NSBA supports. H.R.4513 - Small Business Advanced Cybersecurity Enhancements Act of 2021 The act aims to create proactive partnerships between small businesses and the government to help protect small businesses from criminal cyber-attacks. NSBA supports. H.R. 4521 -- the America COMPETES Act The bill is aimed at increasing U.S. competitiveness and boosting manufacturing, particularly in the semiconductor industry. NSBA supports. H.R. 4531 - 7(a) Loan Agent Oversight Act It requires the Small Business Administration (SBA) to submit an annual report containing specified information related to 7(a) loan agents. These agents provide fee-based referral and loan application services related to the SBA's 7(a) Program. NSBA supports. H.R.4515 - Small Business Development Center Cyber Training Act of 2021 The bill aims to establish a cyber counseling certification program at SBDCs to become better trained to assist small businesses with their cybersecurity and cyber strategy needs. NSBA supports. H.R.5065 - Prison to Proprietorship for Formerly Incarcerated Act This bill directs the Small Business Administration, in coordination with the Bureau of Prisons, to require the Service Corps of Retired Executives to provide entrepreneurship counseling and training services to formerly incarcerated individuals. NSBA supports. H.R.5078 - Prison to Proprietorship Act This bill directs the Small Business Administration, in coordination with the Bureau of Prisons, to require women's business centers and small-business development centers to provide entrepreneurship counseling and training services to individuals incarcerated in a minimum-, low-, or medium-security prison. NSBA supports. H.R.5376 - Build Back Better Act This bill provides funding, establishes programs, and otherwise modifies provisions relating to a broad array of areas, including education, labor, childcare, health care, taxes, immigration, and the environment. NSBA is monitoring. S.53 - Raise the Wage Act of 2021 Bill would increase the federal minimum wage to $15 per hour over five years, allow for annual automatic increases without the consent of Congress, and eventually eliminate the tipped wage. NSBA opposes. S.205 - Paycheck Fairness Act A bill to amend the Fair Labor Standards Act of 1938 to provide more effective remedies to victims of discrimination in the payment of wages based on sex, and for other purposes. NSBA opposes. S.420 - Protecting the Right to Organize Act of 2021 This bill expands various labor protections related to employees' rights to organize and collectively bargain in the workplace. NSBA opposes. S.480 - Main Street Tax Certainty Act This bill makes permanent the tax deduction for qualified business income. Under current law, the deduction expires after December 31, 2025. NSBA supports. S.522 - Providing Accountability through Transparency Act of 2021 Bill would require that each government agency provide a 100-word plain language summary of each proposed rule. NSBA supports. S.533 - Guidance Clarity Act of 2021 Bill would require every federal agency to include text in guidance documents stating that guidance is not legally binding, making it easier for small businesses to understand which regulations apply to them. NSBA supports. S.537 - Healthy Workplaces Ac This bill allows tax credits for employer expenses for protecting employees from COVID-19 (i.e., coronavirus disease 2019). NSBA supports. S. 617-the Death Tax Repeal Act of 2021 This bill repeals the estate and generation-skipping transfer taxes. It also makes conforming amendments related to the gift tax. NSBA supports. S.749 - American Innovation and Jobs Act This bill revises and expands the deductibility of research and experimental expenditures to allow immediate expensing of such expenditures. NSBA supports. S.936 - INFORM Consumers Act A bill to require online marketplaces to collect, verify, and disclose certain information regarding high-volume third-party sellers of consumer products to inform consumers. NSBA is monitoring. S.1605 - National Defense Authorization Act for Fiscal Year 2022 This bill authorizes Department of Defense (DOD) activities and programs for FY2022 and addresses various other issues. NSBA supports certain provisions. S.1687 - Small Business Cyber Training Act of 2021 This bill requires the Small Business Administration to establish a program for certifying at least 5 or 10% of the total number of employees of a small business development center to provide cybersecurity planning assistance to small businesses. NSBA supports. S. 1703 - Improving Access to Retirement Savings Act A bill to amend the Internal Revenue Code of 1986 to increase retirement savings, to improve retirement plan administration, and for other purposes. NSBA is monitoring. S. 1770 - Retirement Security and Savings Act of 2021 Bills amends the Internal Revenue Code of 1986 to reform retirement provisions, and for other purposes. NSBA is monitoring.

Client expense: $10,000 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Export-Import Bank of the United States (EXIM Bank), Federal Reserve System, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Intl Trade Administration (ITA), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Office of Personnel Management (OPM), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act This bill establishes several programs and requirements relating to the prices of prescription drugs. NSBA is monitoring. H.R.7 - Paycheck Fairness Act A bill to amend the Fair Labor Standards Act of 1938 to provide more effective remedies to victims of discrimination in the payment of wages based on sex, and for other purposes. NSBA opposes. H.R.25 - Fair Tax Act of 2021 To promote freedom, fairness, and economic opportunity by repealing the income tax and other taxes, abolishing the Internal Revenue Service, and enacting a national sales tax to be administered primarily by the states. NSBA supports H.R.603 - Raise the Wage Act of 2021 Bill would increase the federal minimum wage to $15 per hour over five years, allow for annual automatic increases without the consent of Congress, and eventually eliminate the tipped wage. NSBA opposes. H.R.842 - Protecting the Right to Organize Act of 2021 This bill expands various labor protections related to employees' rights to organize and collectively bargain in the workplace. NSBA opposes. H.R.971 - Small Business Succession Planning Act Bill directs the Small Business Administration (SBA) to create an online business succession planning toolkit that will assist small businesses through the process of creating business succession plans with the aid of SBA and its resource partners. NSBA supports. H.R.1319 - American Rescue Plan Act of 2021 This bill provides additional relief to address the continued impact of COVID-19 (i.e., coronavirus disease 2019) on the economy, public health, state and local governments, individuals, and businesses. NSBA supports. H.R.1381 - Main Street Tax Certainty Act This bill makes permanent the tax deduction for qualified business income. (Under current law, the deduction expires after December 31, 2025. NSBA supports. H.R. 1482 - 504 Credit Risk Management Improvement Act of 2021 The measure would increase and streamline oversight of the Small Business Administrations (SBA) 504 Loan Program, allowing small businesses to grow, modernize, and recover. NSBA supports. H.R. 1487 - Microloan Transparency and Accountability Act of 2021 The bill requires the SBA to perform an annual portfolio risk analysis of the Microloan Program, to ensure taxpayer money is safeguarded. NSBA supports. H.R.1490 - 504 Modernization and Small Manufacturer Enhancement Act of 2021 This bill modifies the SBA 504 Loan Program, which provides a small business with SBA financing--through a certified development company (CDC) intermediary-for expansion or modernization. NSBA supports. H.R.1502 - Microloan Improvement Act of 2021 The bill revises the microloan program through which the U.S. Small Business Administration (SBA) provides financial assistance to small businesses through designated intermediaries. NSBA supports. H.R.1507 - Providing Accountability through Transparency Act of 2021 Bill would require that each government agency provide a 100-word plain language summary of each proposed rule. NSBA supports. H.R.1508 - Guidance Clarity Act of 2021 Bill would require every federal agency to include text in guidance documents stating that guidance is not legally binding, making it easier for small businesses to understand which regulations apply to them. NSBA supports. H.R.1712 - Death Tax Repeal Act This bill repeals the estate and generation-skipping transfer taxes. It also makes conforming amendments related to the gift tax. NSBA supports. H.R.1799 - PPP Extension Act of 2021 This bill extends the Paycheck Protection Program, established to support small businesses in response to COVID-19 (i.e., coronavirus disease 2019), through June 30, 2021. NSBA supports. H.R. 1944 - Healthy Workplaces Act This bill allows tax credits for employer expenses for protecting employees from COVID-19 (i.e., coronavirus disease 2019). NSBA supports. H.R.1996 - SAFE Banking Act of 2021 This bill generally prohibits a federal banking regulator from penalizing a depository institution for providing banking services to a legitimate cannabis-related business. NSBA is monitoring. H.R. 3462 - SBA Cyber Awareness Act The bill expands cybersecurity operations at the Small Business Administration (SBA) by requiring them to issue a report assessing the agencys ability to combat cyber threats within six months of passage. The legislation requires the SBA to notify Congress of future breaches with information on those affected and how the breach occurred. NSBA supports. H.R. 3469 - Veteran Entrepreneurship Training Act of 2021 This bill authorizes the Boots to Business (B2B) program for five years to help transitioning service members start and grow their businesses. NSBA supports. H.R.3684 - Infrastructure Investment and Jobs Act This bill addresses provisions related to federal-aid highway, transit, highway safety, motor carrier, research, hazardous materials, and rail programs of the Department of Transportation (DOT). NSBA supports. H.R. 3807 -- Restaurant Revitalization Fund Replenishment Act of 2021 Congress provided $28.6 billion for the Restaurant Revitalization Fund (RRF), which provided relied to more than 100,000 restaurants and other food and beverage businesses. NSBA supports. H.R. 4037 - Trade Preferences and American Manufacturing Competitiveness Act To amend the Trade Act of 1974 to extend and modify the eligibility requirements for the Generalized System of Preferences, to amend the Harmonized Tariff Schedule of the United States to modify temporarily certain rates of duty, and for other purposes. NSBA is monitoring. H.R. 4256 - Investing in Main Street Act of 2021 It amends the Small Businesses Investment Act of 1958 to increase the percentage of capital and surplus that a bank or federal savings association may invest in Small Business Investment Companies (SBICs) to match current banking regulations. NSBA supports. H.R.4350 - National Defense Authorization Act for Fiscal Year 2022 This bill authorizes FY2022 appropriations for military activities and programs of the Department of Defense (e.g., personnel; research, development, test, and evaluation; and procurement of items such as aircraft, missiles, and ammunition). NSBA is monitoring. H.R. 4481 - Small Business 7(a) Loan Agent Transparency Act It provides oversight of 7(a) loan agents, including by requiring the Small Business Administration (SBA) to establish a registration system for such agents. NSBA supports. H.R.4513 - Small Business Advanced Cybersecurity Enhancements Act of 2021 The act aims to create proactive partnerships between small businesses and the government to help protect small businesses from criminal cyber-attacks. NSBA supports. H.R. 4521 -- the America COMPETES Act The bill is aimed at increasing U.S. competitiveness and boosting manufacturing, particularly in the semiconductor industry. NSBA supports. H.R. 4531 - 7(a) Loan Agent Oversight Act It requires the Small Business Administration (SBA) to submit an annual report containing specified information related to 7(a) loan agents. These agents provide fee-based referral and loan application services related to the SBA's 7(a) Program. NSBA supports. H.R.4515 - Small Business Development Center Cyber Training Act of 2021 The bill aims to establish a cyber counseling certification program at SBDCs to become better trained to assist small businesses with their cybersecurity and cyber strategy needs. NSBA supports. H.R.5065 - Prison to Proprietorship for Formerly Incarcerated Act This bill directs the Small Business Administration, in coordination with the Bureau of Prisons, to require the Service Corps of Retired Executives to provide entrepreneurship counseling and training services to formerly incarcerated individuals. NSBA supports. H.R.5078 - Prison to Proprietorship Act This bill directs the Small Business Administration, in coordination with the Bureau of Prisons, to require women's business centers and small-business development centers to provide entrepreneurship counseling and training services to individuals incarcerated in a minimum-, low-, or medium-security prison. NSBA supports. H.R.5376 - Build Back Better Act This bill provides funding, establishes programs, and otherwise modifies provisions relating to a broad array of areas, including education, labor, childcare, health care, taxes, immigration, and the environment. NSBA is monitoring. S.53 - Raise the Wage Act of 2021 Bill would increase the federal minimum wage to $15 per hour over five years, allow for annual automatic increases without the consent of Congress, and eventually eliminate the tipped wage. NSBA opposes. S.205 - Paycheck Fairness Act A bill to amend the Fair Labor Standards Act of 1938 to provide more effective remedies to victims of discrimination in the payment of wages based on sex, and for other purposes. NSBA opposes. S.420 - Protecting the Right to Organize Act of 2021 This bill expands various labor protections related to employees' rights to organize and collectively bargain in the workplace. NSBA opposes. S.480 - Main Street Tax Certainty Act This bill makes permanent the tax deduction for qualified business income. Under current law, the deduction expires after December 31, 2025. NSBA supports. S.522 - Providing Accountability through Transparency Act of 2021 Bill would require that each government agency provide a 100-word plain language summary of each proposed rule. NSBA supports. S.533 - Guidance Clarity Act of 2021 Bill would require every federal agency to include text in guidance documents stating that guidance is not legally binding, making it easier for small businesses to understand which regulations apply to them. NSBA supports. S.537 - Healthy Workplaces Ac This bill allows tax credits for employer expenses for protecting employees from COVID-19 (i.e., coronavirus disease 2019). NSBA supports. S. 617-the Death Tax Repeal Act of 2021 This bill repeals the estate and generation-skipping transfer taxes. It also makes conforming amendments related to the gift tax. NSBA supports. S.749 - American Innovation and Jobs Act This bill revises and expands the deductibility of research and experimental expenditures to allow immediate expensing of such expenditures. NSBA supports. S.936 - INFORM Consumers Act A bill to require online marketplaces to collect, verify, and disclose certain information regarding high-volume third-party sellers of consumer products to inform consumers. NSBA is monitoring. S.1605 - National Defense Authorization Act for Fiscal Year 2022 This bill authorizes Department of Defense (DOD) activities and programs for FY2022 and addresses various other issues. NSBA supports certain provisions. S.1687 - Small Business Cyber Training Act of 2021 This bill requires the Small Business Administration to establish a program for certifying at least 5 or 10% of the total number of employees of a small business development center to provide cybersecurity planning assistance to small businesses. NSBA supports. S. 1703 - Improving Access to Retirement Savings Act A bill to amend the Internal Revenue Code of 1986 to increase retirement savings, to improve retirement plan administration, and for other purposes. NSBA is monitoring. S. 1770 - Retirement Security and Savings Act of 2021 Bills amends the Internal Revenue Code of 1986 to reform retirement provisions, and for other purposes. NSBA is monitoring.

Client expense: $10,000 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Export-Import Bank of the United States (EXIM Bank), Federal Reserve System, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Intl Trade Administration (ITA), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Office of Personnel Management (OPM), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

1) Support increasing biosimilar adoption. No specific legislation. 2) Oppose importing foreign price controls through international reference pricing - H.R. 3

Client expense: Not reported · Firm income: Not reported

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

To promote Congressional awareness of the impact of healthcare policies on the research based biopharmaceutical and medical technology industry; monitor legislation related to drug prices, including H.R. 3; COVID-19 response and recovery; Inflation Reduction Act provisions related to pharmaceuticals

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies related to: APRN prescribing authority Development, testing and prescribing of pediatric pharmaceuticals Implementation of the Inflation Reduction Act (P.L. 117-169) provisions related to policies to lower prescription drug prices and improve vaccines for children H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 3932/S. 2076, Pioneering Antimicrobial Subscriptions to End Surging Resistance (PASTEUR) Act

Client expense: Not reported · Firm income: $24,000

Government targets: Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

COVID-19 Testing; Rx Reform; Prescription Drug Reform; OTC Covid Tests; Insulin H.R. 3 - Lower Drug Costs Now Act Sponsor: Rep. Frank Pallone (D-NJ-06)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill H.R. 6000: Cures 2.0 Act; all healthcare provisions of the bill H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; all provisions of the bill H.R. 6833: Affordable Insulin Now Act; provisions related to the Prescription Drug User Fee Act Reauthorization H.R. 6963: Accelerated Approval Integrity Act of 2022; all provisions of the bill H.R. 6996: Accelerating Access for Patients Act of 2022; all provisions of the bill H.R. 7667: Food and Drug Amendments of 2022; provisions related to drug development user fees S. 2706: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill S. 4348: Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022; provisions related to drug development user fees S. 4535: Food and Drug Administration Simple Reauthorization (FDASRA) Act of 2022; provisions related to drug development user fees 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General discussions regarding drug cost and pricing policy issues General discussions related to the Cancer Moonshot Initiative and the Advanced Research Projects Agency for Health (ARPA-H) General discussion related to the Prescription Drug User Fee Act Reauthorization

Client expense: $550,000 · Firm income: Not reported

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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 2163: Safe Step Act: all provisions of the bill H.R. 3173: Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill S. 464: Safe Step Act; all provisions of the bill S.3018 - Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues General healthcare issues surrounding the COVID-19 pandemic

Client expense: $550,000 · Firm income: Not reported

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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 2163: Safe Step Act: all provisions of the bill H.R. 3173: Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill S. 464: Safe Step Act: all provisions of the bill S. 3108: Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General issues related to pharmaceutical pricing General issues related to drug development lifecycle

Client expense: $550,000 · Firm income: Not reported

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

Legislation regarding drug pricing, value, and reimbursement; H.R.3, Elijah Cummings Lower Drug Costs Now Act, and related Senate legislation; H.R.19, Lower Costs, More Cures Act of 2021; H.R.5376 - Build Back Better Act and Inflation Reduction Act - P.L. 117-169, issues related to drug policies and access to therapies for patients with rare diseases; H.R.1629, Fairness in Orphan Drug Exclusivity Act; H.R.7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R.7667, the Food and Drug Amendments of 2022 - provisions concerning accelerated approval, orphan drugs; S.4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 - provisions concerning accelerated approval, orphan drugs; H.R.6963, Accelerated Approval Integrity Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for post-approval studies for drugs approved using accelerated approval, and for other purposes; H.R.2617, the Consolidated Appropriations Act, 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to copay assistance. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. Monitor legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to the Rare Pediatric Disease Priority Review Voucher Program. Monitor legislative and administrative action related to implementation of P.L. 116-136, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HSA/FSA provisions. Monitor legislative and administrative action related to telehealth expansion. Monitor legislative and administrative action related to a WTO IP waiver. S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. H.R. 2617, Consolidated Appropriations Act, 2023 (P.L. 117-328), including FDA provisions. H.R. 5376, Inflation Reduction Act of 2022. H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022. H.R. 7667, Food and Drug Amendments of 2022.

Client expense: $1,890,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Price of prescription drugs; antitrust issues; Prescription Drug Pricing Reduction Act Pharmacy Benefit Manager (PBM) operations and practices, Spread Pricing Direct and Indirect Remuneration (DIR) Drug Rebate Rule/Executive Order Senate Finance Committee Prescription Drug Pricing Reduction Act Lower Drug Costs Now Act (H.R. 3) Drug Patent Reform Robinson-Patman Reform Inflation Reduction Act of 2022 (H.R. 5376) Pharmacy Benefit Manager Transparency Act (S. 4293) PBM Transparency Language in the Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R.7666) 2023 Omnibus Appropriations Bill

Client expense: $1,270,000 · Firm income: Not reported

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

Affordable prescription drugs; 340B Drug pricing program; Health care privacy; Patient privacy issues; Issues related to the American Rescue Plan Act, PL 117-2; Issues related to expanding health care coverage, including in non-Medicaid expansion states; Issues related to improving social determinants of health; Issues related to extending and expanding flexibilities for virtual care; Financial support for providers for diagnosis and treatment related to COVID-19, coverage of COVID-19 related conditions, access to PPE and other materials and equipment related to the treatment of patients with COVID-19, including funding for the Provider Relief Fund; Issues related to affordable health care coverage; H.R. 2228 - Rural Behavioral Health Access Act; Issues related to drug pricing; Issues related to Bipartisan Infrastructure Framework; Issues related to telehealth; Efforts to extend Medicare sequester delay, including H.R.1868; Issues related to Medicare policy on virtual care; Issues related to vaccine mandates; S. 168/H.R. 708 - Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S. 773/H.R. 3203 - Legislation related to 340B eligibility; S. 834/H.R. 2256 - Resident Physician Shortage Reduction Act; S. 834/H.R. 2256 - Healthcare Workforce Resilience Act; S. 368/H.R. 1332 - Telehealth Modernization Act ; S. 1512/H.R. 2903 - CONNECT for Health Act; S. 1988 - Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; S.773/H.R. 3203 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program; H.R. 4943 - Childrens Mental Health Infrastructure Act; H.R. 4944 - Helping Kids Cope Act; H.R. 5376 - Build Back Better Act; H.R. 1667 - Dr. Lorna Breen Health Care Provider Protection Act; Issues related to workforce retention; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act; H.R. 7053/S. 3792 - Hospital Inpatient Services Modernization Act; issues related to the Acute Hospital Care at Home (AHCAH) waiver; H.R. 4407/S. 1568 - Technical Reset to Advance the Instruction of Nurses (TRAIN) Act; S. 3493 - Telehealth Extension and Evaluation Act; H.R. 6202 - Telehealth Extension Act; H.R. 5376 - Inflation Reduction Act (Public Law 117-169); H.R. 6833 - Continuing Resolution; H.R. 2617 - Consolidated Appropriations Act, 2023; Issues related to adequate financing for hospitals and providers; H.R. 4040 - Advancing Telehealth Beyond COVID-19 Act; Issues related to extending the Medicare Dependent Hospital and Low Volume Hospital programs; Issues related to extending bonus payments for Advanced Alternative Payment models; H.R. 4587 - Value in Health Care Act; Issues related to coding and coverage of spiritual care through chaplain services; Issues related to value-based care programs, including the Bundled Payments for Care Improvement (BPCI) Advanced Model; Issues related to data and quality measure reporting and eligibility for corresponding reimbursements; Issues related to prior authorization; H.R. 3173 - Improving Seniors Timely Access to Care Act; Issues related to Rural Emergency Hospital designation; Issues related to safety net hospital reimbursements.

Client expense: $310,000 · Firm income: Not reported

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

340B Drug Pricing Program; Issues related to 340B contract pharmacies; Financial support for providers for diagnosis and treatment related to COVID-19, including funding for the Provider Relief Fund; coverage of COVID-19 related conditions; S. 168/H.R. 708 - Temporary; Reciprocity to Ensure Access to Treatment (TREAT) Act; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S. 773/H.R. 3203 - Legislation related to 340B eligibility; S. 368/H.R. 1332 - Telehealth Modernization Act; S. 1512/H.R. 2903 - CONNECT for Health Act; S. 1988 -Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; S.773/H.R. 3203 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program; - S.773/H.R. 3203; H.R. 5376 - Build Back Better Act; H.R. 853 - Closing Loopholes for Orphan Drugs Act; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act; H.R. 5376 - Inflation Reduction Act (Public Law 117-169); H.R. 6833 - Continuing Resolution

Client expense: $310,000 · Firm income: Not reported

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

Issues related to Medicare and Medicaid coverage and Medicaid disproportionate share program; Financial support for providers for diagnosis and treatment related to COVID-19; coverage of COVID-19 related conditions; access to PPE and other materials and equipment related to the treatment of patients with COVID-19, including funding for the Provider Relief Fund; PL 117-2; Issues related to Bipartisan Infrastructure Framework; Issues related to telehealth; Efforts to extend Medicare sequester delay, including H.R.1868; Issues related to Medicare policy on virtual care; Childrens Health Graduate Medical Education; issues related to drug pricing; Issues related to hospital DSH eligibility; Issues related to Home and Community Based Services (HCBS); Medicaid waiver-related issues; Childrens transplant program issues; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S.773/H.R. 3203 - legislation to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program; S. 834/H.R. 2256 - Resident Physician Shortage Reduction Act; S. 1024/H.R. 2255 - Healthcare Workforce Resilience Act; S. 368/H.R. 1332 - Telehealth Modernization Act; S. 1512/H.R. 2903 - CONNECT for Health Act ; S. 1988 - Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 5376 - Build Back Better Act; H.R. 2617 - Consolidated Appropriations Act, 2023; Efforts to delay statutory PAYGO payment reductions; Efforts to offset physician payment reductions; Efforts to improve hospital reimbursement; Issues related to cuts to Medicaid DSH; Issues related to cuts to uncompensated care pools; Issues related to hospital at home programs; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act; H.R. 7053/S. 3792 - Hospital Inpatient Services Modernization Act; issues related to the Acute Hospital Care at Home (AHCAH) waiver; S. 3493 - Telehealth Extension and Evaluation Act; H.R. 6202 - Telehealth Extension Act; H.R. 5376 - Inflation Reduction Act (Public Law 117-169); H.R. 6833 - Continuing Resolution; Issues related to adequate financing for hospitals and providers; H.R. 4040 - Advancing Telehealth Beyond COVID-19 Act; Issues related to extending the Medicare Dependent Hospital and Low Volume Hospital programs; Issues related to extending bonus payments for Advanced Alternative Payment models; H.R. 4587 - Value in Health Care Act; Issues related to coding and coverage of spiritual care through chaplain services; Issues related to value-based care programs, including the Bundled Payments for Care Improvement (BPCI) Advanced Model; Issues related to data and quality measure reporting and eligibility for corresponding reimbursements; Issues related to prior authorization; H.R. 3173 - Improving Seniors Timely Access to Care Act; Issues related to Rural Emergency Hospital designation; Issues related to safety net hospital reimbursements.

Client expense: $310,000 · Firm income: Not reported

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

- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - HR 6007, "To amend title XVIII of the Social Security Act to provide for the expansion of coverage of vaccines under part B of the Medicare program, and for other purposes", regarding all provisions - H.Res. 446, Expressing support for the goals and ideals of National Stroke Awareness Month, regarding all provisions - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act", regarding all provisions - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - S 3394, "Emergency Use Transparency Act", regarding all provisions - HR 3990/S 2047, "No PFAS in Cosmetics Act", regarding all provisions - HR 8299/S 4386, "To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.", regarding all provisions - HR 7667/S 4348, "Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act", regarding provisions on accelerated approval and diversity in clinical studies - HR 5801, "HELP Copays Act", regarding all provisions - HR 3173/S 3018 - "Improving Seniors Timely Access to Care Act of 2021", regarding all provisions - S 3799 - "PREVENT Pandemics Act", regarding all provisions - HR 3932/S 2076 - "PASTEUR Act of 2021", regarding all provisions - HR 5376 - "Inflation Reduction Act", regarding provisions on drug pricing and provisions related to revenue - HR 7559 - Prescription Information Modernization Act of 2022, regarding all provisions - HR 2617 - "Consolidated Appropriations Act, 2023", regarding provisions related to pharmaceuticals, medical devices, mental health, and tax - Issues related to Dengue - Issues related to prescription drug pricing - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - Issues related to clinical research diversity - Issues related to international harmonization of medical device regulation

Client expense: $2,270,000 · Firm income: Not reported

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

H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 1946, S. 1873. Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 2617-accelerated approval in the Omnibus year end H.R. 4065, S. 1971 (section 101), P.L. 117-328, H.R. 2617 Kidney disease screening, Expanding Medicare annual wellness benefit to include kidney disease screening. H.R. 5260 - Reduced Costs and Continued Cures Act; HR. 5376- Inflation Reduction Act; Build Back Better Act; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Preventative healthcare services and screenings Issues related to preventative services and screenings for underrepresented communities IRA implementation, Pub. L. 117-169 Medicare Reform(s); Issues related to Medicare Part B and Part D pricing reform. General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding, coverage, and access for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to diagnostic reimbursement

Client expense: $1,170,000 · Firm income: Not reported

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

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification 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.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act 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.4293: Pharmacy Benefit Manager Transparency 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)

Client expense: $2,578,869 · Firm income: Not reported

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

Client expense: $2,578,869 · Firm income: Not reported

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

Client expense: $2,578,869 · Firm income: Not reported

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

Issues related to Medicare Part D redesign, rebate reform and international pricing index (including H.R. 3, H.R. 19) Medicaid Drug Rebate Program (MDRP), including value-based purchasing (VBP) arrangements and line extensions Issues related to Biosimilars

Client expense: $810,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues relating to the Presidents FY24 budget; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to FY23 appropriations bills; Issues related to Cancer Moonshot; Issues related to Implementation of ACA; Issues related to Short-Term Limited Duration Plans; Issues related to Healthy Future Taskforce, H.R. 8295 Labor HHS Appropriations bill; S. 4659 Labor HHS Appropriations bill; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Childrens Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Childrens Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; H.R.379 Improving Social Determinants of Health Act of 2021; H.R.526 Ensuring Coverage in Public Health Emergencies Act of 2021; H.R.1872 To amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities, and for other purposes; H.R.1874 To amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; H.R.1875 To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage; H.R.1878 To amend the Patient Protection and Affordable Care Act to establish a health insurance affordability fund, and for other purposes; H.R.1888 To amend title XIX of the Social Security Act to require a Federal medical assistance percentage of 100 percent for Indian health care providers, and for other purposes; H.R.1890 To amend the Patient Protection and Affordable Care Act to require Exchanges to establish network adequacy standards for qualified health plans and amend the Public Health Service Act to provide protections for consumers against excessive, unjustified, or unfairly discriminatory increases in premium rates; S.104 Improving Social Determinants of Health Act of 2021; S.779 Protecting Americans with Pre-Existing Conditions Act of 2021; S.942 A bill to provide that the rule entitled "Short-Term, Limited Duration Insurance shall have no force or effect; H.R.1790 To amend the Patient Protection and Affordable Care Act to require the Secretary of Health and Human Services to set forth a method of determining maximum out-of-pocket limits and annual updates to premium tax credit eligibility; H.R.550 Immunization Infrastructure Modernization Act of 2021; H.R.736 Community Immunity During COVID-19 Act of 202; H.R.791 Tracking COVID-19 Variants Act; H.R.1268 Building COVID-19 Vaccine Confidence Act of 2021; S.167 Community Immunity During COVID-19 Act of 2021; S.236 Tracking COVID-19 Variants Act; H.R.173 COVID-19 Prevention and Awareness Act of 2021;; H.R.959 Black Maternal Health Momnibus Act of 2021; H.R.3904 Reducing COVID-19 Disparities by Investing in Public Health Act; S.1314 Tobacco Tax Equity Act of 2021; H.R.2786 Tobacco Tax Equity Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.3749 Katherines Law for Lung Cancer Early Detection and Survival Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.1424 Chronic Disease Management Act of 2021; H.R.3883 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S.2043 A bill to amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021; S.674 Public Health Infrastructure Saves Lives Act; Health Equity and Accountability Act; H.R.5030 DIVERSE Trials Act; S.2706 DIVERSE Trials Act; H.R.6302 Protecting the Health of Americas Older Adults Act; S.J.Res.29 A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to COVID-19 Vaccination and Testing; Emergency Temporary Standard; S.Res.462 A resolution designating November 2021 as "National Lung Cancer Awareness Month and expressing support for early detection and treatment of lung cancer;; H.R.2909 To amend the Internal Revenue Code of 1986 to allow a one-time election for a qualified charitable distribution to a split-interest entity and to inflation adjust the limits for qualified charitable distributions.; H.R.2954 Securing a Strong retirement Act of 2021; H.R. 7055 Elijah E. Cummings Family Asthma Act; S. 3332 Let States Innovate Under Medicaid Act; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -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; H.R. 7845 NIH Clinical Trial Diversity Act of 2022; H.R. 8885 Better Health Care Directories Act; S.Res.863 A resolution designating November 2022 as National Lung Cancer Awareness Month and expressing support for early detection and treatment of lung cancer; H.R. 9336 Increasing Access to Lung Cancer Screening Act; H.R. 9565 Comprehensive Cancer Survivorship Act; S. 5295 Comprehensive Cancer Survivorship Act; H.R. 2617 Consolidated Appropriations Act, 2023; S. Amdt.6552 to H.R.2617

Client expense: $40,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related to tobacco cessation; Issues related to health inequities; Issues related to Medicaid waivers; Issues related to the Affordable Care Act; Issues related to supplemental oxygen; Issues related to access to healthcare; Issues related to COVID-19 Response; Issues related to Medicaid coverage for immigrants; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to health equity; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to FY23 appropriations bills; Issues relating to the Presidents FY24 budget;H.R. 8295 Labor HHS Appropriations bill; S. 4659 Labor HHS Appropriations bill; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021;; S. 3332 Let States Innovate Under Medicaid Act; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -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; H.R. 7845 NIH Clinical Trial Diversity Act of 2022; H.R. 9336 Increasing Access to Lung Cancer Screening Act;; H.R. 2617 Consolidated Appropriations Act, 2023; S. Amdt.6552 to H.R.2617

Client expense: $40,000 · Firm income: Not reported

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

Issues related to asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to lung disease treatment, prevention and research; Issues related to COVID-19 Response; Issues related to telehealth; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues related to health equity; Issues related to FY23 appropriations bills; Issues related to Cancer Moonshot; Issues relating to the Presidents FY24 budget; Issues related to CDC public health workforce and data modernization H.R. 8295 Labor HHS Appropriations bill; H.R.8236 Defense Appropriations bill; S. 4659 Labor HHS Appropriations bill; S. 4663 Defense Appropriations bill; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; ; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.5030 DIVERSE Trials Act; S.2706 DIVERSE Trials Act; S.Res.462 A resolution designating November 2021 as "National Lung Cancer Awareness Month" and expressing support for early detection and treatment of lung cancer; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -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; H.R. 7845 NIH Clinical Trial Diversity Act of 2022; S. 5251 Community Mental Wellness and Resilience Act; H.R. 9201 Community Mental Wellness and Resilience Act; S.Res.863 A resolution designating November 2022 as National Lung Cancer Awareness Month and expressing support for early detection and treatment of lung cancer; H.R. 9565 Comprehensive Cancer Survivorship Act; S. 5295 Comprehensive Cancer Survivorship Act; H.R. 2617 Consolidated Appropriations Act, 2023; S. Amdt.6552 to H.R.2617

Client expense: $40,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office

Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) 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 and drug pricing H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169); provisions related to drug pricing S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products 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 Pharmacy Benefit Manager reform and 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 Notice of Benefit and Payment Parameters (NBPP)

Client expense: $860,000 · Firm income: Not reported

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

Issues related to Biden infrastructure plan and associated tax increases Issues related to HHS nominations H.R.4123, Increasing Health Coverage through HRAs Act S.1784/H.R. 3353, the Contact Lens Prescription Verification Modernization Act H.R. 3, the Lower Drug Costs Now Act S. 4293, the Pharmacy Benefit Manager Transparency Act. H.R. _, the Fiscal Year 2023 Labor, Health and Human Services, Education, and Related Agencies Funding Bill Notice Of Proposed Rulemaking (NPRM) On The Affordability Of Employer Coverage For Family Members Of Employees H.R. 7504, the Start-ups for Cures Act H.R. 7505, the More Cures Act

Client expense: $40,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare payment issues including the Independent Payment Advisory Board (IPAB) and Medicaid issues. Medicare Part D. Drug pricing proposals including H.R. 3. Protecting Seniors Through Immunization Act. COVID-19 relief proposals. American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. Consolidated Appropriations Act, FY 23 (P.L. 117-328).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education about policies impacting pharmaceutical development, approval and reimbursement; Drug safety and drug counterfeiting; Medicare Part D; Federal preemption for prescription drugs; drug importation; and drug shortages. Drug pricing proposals including H.R. 3. Medicare rebate reform, the 340B program, and proposals to impose "most favored nation" pricing on Medicare Part B and D. COVID-19 relief proposals. American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. HR 3927. S. 2082. Consolidated Appropriations Act, FY 23 (P.L. 117-328). PASTEUR Act H.R. 3932, S. 2076.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education about policies impacting pharmaceutical development, approval and reimbursement; Non-interference. Rebates for Medicare Part D. Importation. 340B Program. CMMI Medicare Part B Demonstration. Drug pricing legislation including H.R. 3, Medicare rebate reform, "buy America" proposals, and proposals to impose "most favored nation" pricing on Medicare Part B and D. Policies impacting U.S. address to the Covid-19 pandemic, including American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. H.R. 4511. Provisions included in the Consolidated Appropriations Act, FY 23 (P.L. 117-328) related to the regulation of pharmaceuticals.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education about policies impacting pharmaceutical development, approval and reimbursement; Non-interference. Rebates for Medicare Part D. Importation. 340B Program. IPI drug pricing proposal, Medicare Rebate Rule. Drug pricing legislation including H.R. 3, Medicare rebate reform, "buy America" proposals, and proposals to impose "most favored nation" pricing on Medicare Part B and D. Policies impacting U.S. address to the Covid-19 pandemic, including American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. Provisions included in the Consolidated Appropriations Act, FY 23 (P.L. 117-328) related to the regulation of pharmaceuticals.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 1976, Medicare for All Act of 2021 H.R. 2471, Consolidated Appropriations Act, 2022 H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891, Preserve Access to Affordable Generics and Biosimilars Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 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. 5981/S.1704, Telehealth Expansion Act of 2021 H.R. 8295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 H.R. 8594/S. 4750, Restore Protections for Dialysis Patients Act S. 150, Ensuring Parity in Medicare Advantage for Audio-Only Telehealth Act S. 380, Health Savings Act of 2021 S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 Implementation of the Transparency in Coverage Final Rule; Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services (85 Fed. Reg. 72,158 - 72,310, November 12, 2020) Requirements Related to Surprise Billing; Internal Revenue Service; Employee Benefits Security Administration; Department of Health and Human Services (87 Fed. Reg. 52,618-52,655, August 26, 2022) Request for Information, Centers for Medicare & Medicaid Services; Medicare Program (87 Fed. Reg. 46,918-46,921, August 1, 2022) Notice of Proposed Rule, Employee Benefits Security Administration; Proposed Amendment to Prohibited Transaction Class Exemption 84-14 (the QPAM Exemption (87 Fed. Reg. 45,204-45,232, July 27, 2022) Affordability of Employer Coverage for Family Members of Employees (Family Glitch Regulation) (87 Fed. Reg. 20,354-20,364, April 7, 2022) Various issues relating to the employer-sponsored health care system, the "family glitch", implementation of regulatory process, provider network adequacy, health savings account (HSAs), health reimbursement account (HRAs), employer mandate; coronavirus pandemic; vaccine distribution, PPE, testing, medications and treatments, and vaccination incentives; digital health credentials; vaccine diplomacy; COVID-19 vaccine requirements, including a potential Emergency Temporary Standard from the Occupational Safety and Health Administration relating to employers with more than 100 employees; vaccine requirements for federal contractors; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; implementation of the American Rescue Plan Act (P.L. 117-2); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; comments on COVID-19 Telehealth Program Application Evaluation Metrics (WC Docket No. 20-89); efforts to reform the World Health Organizations (WHO) engagement with private sector; continued U.S. membership to the World Health Organization (WHO); support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health systems strengthening; greater harmonization of standards and investment in digital health internationally; role of private sector related pandemic prevention, preparedness and response

Client expense: $20,990,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR)

H.R. 3 - Lower Drug Costs Now Act; H.R. 2846 - Ensuring Access to Lower-Cost Medicines for Seniors Act; H.R. 5376 - the Inflation Reduction Act of 2022; S. 4348 - the Food and Drug Administration Safety and Landmark Advancements Act of 2022; Biosimilar interchangeability ; Part D Formulary Design and Generic Drug Tiering; H.R. 7667 - the Food and Drug Amendments of 2022; H.R. 8239 - Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2023, and for other purposes; S. 4338 - the Increasing Transparency in Generic Drug Applications Act S. 4351 - the Enhanced Access to Affordable Medicines Act H.R. 7559 - the Prescription Information Modernization Act of 2022; H.R. 2617 - Consolidated Appropriations Act of 2023

Client expense: $650,000 · Firm income: Not reported

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

Drug pricing proposals including HR 3, HR 5676 Build Back Better, Inflation Reduction Act (PL 117-169).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug pricing proposals including HR 3, HR 5676 Build Back Better, Inflation Reduction Act (PL 117-169).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education about policies impacting pharmaceutical development, approval and reimbursement. H.R. 3, Lower Drug Costs Now Act; Policies impacting pharmaceutical research, development, and approval. Policies impacting public health preparedness and prevention and U.S. address to the Covid-19 pandemic, including the American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. 340B Program. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. Accelerated Approval pathway; Alzheimers diagnostics policies. Consolidated Appropriations Act, FY 23 (P.L. 117-328).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Policies impacting Medicare Part D and Part B reimbursement policies. H.R. 3, Lower Drug Costs Now Act; Policies impacting pharmaceutical research, development, and approval. Policies impacting public health preparedness and prevention and U.S. address to the Covid-19 pandemic, including the American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R. 3. H.R. 19. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). Consolidated Appropriations Act, FY 23 (P.L. 117-328).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Policies impacting the national stockpile H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act Medicare sequestration Issues impacting drug pricing and reimbursement

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) 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. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) 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. 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 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products 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 Pharmacy Benefit Manager reform and 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 Notice of Benefit and Payment Parameters (NBPP)

Client expense: $6,610,000 · Firm income: Not reported

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

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and related Senate legislation. H.R. 19, Lower Costs More Cures Act. Legislative proposals regarding drug pricing, value, and reimbursement in H.R. 5376 Build Back Better Act/Inflation Reduction Act. H.R. 7667, the Food and Drug Amendments of 2022 and related Senate legislation. H.R.2471, Consolidated Appropriations Act, 2022 including the Food and Drug Omnibus Reform Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1676, Jack Reynolds Memorial Medigap Extension Act H.R. 1255/S. 377, The Living Donor Protection Act of 2021 H.R. 2617, Consolidated Appropriations Act, 2023, issues related to health care H.R. 4065, The Chronic Kidney Disease Improvement in Research and Treatment Act H.R. 5376, Build Back Better Act, provisions relating to health care H.R. 5585, Advanced Research Project Agency Health Act H.R. 6000, Cures 2.0 Act S. 1971, Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 Implementation of Executive Order 13879, Advancing American Kidney Health.

Client expense: $310,000 · Firm income: Not reported

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

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: $310,000 · Firm income: Not reported

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