Immunization Infrastructure Modernization Act of 2021

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

ARC Act of 2021 (H.R. 2631) Credit for Caring Act (S. 1670 / H.R. 3321) Easy Enrollment in Health Care Act (S. 3001) Ensuring Coverage in Public Health Emergencies Act of 2021 (H.R. 526) Healthcare Cybersecurity Act (S. 3904) Improving Social Determinants of Health Act (H.R. 379/S. 4440) Medical Nutrition Equity Act (S. 2013/H.R. 3783) The Protecting Americans with Pre-Existing Conditions Act of 2021 (S. 779) Safe Step Act of 2021 (H.R. 2163) Immunization Infrastructure Modernization Act (H.R. 550) Implementation of the Advancing Care for Exceptional Kids Act (ACE Kids, Pub. L. 116-16) Prescription Drug User Fee Act (PDUFA), provisions related to improving clinical trial diversity and equitable opportunities for trial participation Palliative Care and Hospice Education and Training Act (H.R. 647) A bill to provide for the publication by the Secretary of Health and Human Services of physical activity recommendations for Americans (H.R. 2094/S. 1301) Halt Obesity in America Act (H.R. 5625) Youth Sports Facilities Act (no bill number)

Client expense: $70,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of

HR 550, Immunization Information Systems Modernization Act HR 2170/S 581, Helping Adults Protect Immunity (HAPI) Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act PREVENT Pandemics Act HR 2347/S 2691, Strengthening the Vaccines for Children Program Act Federal funding for Section 317 Immunization Programs, infectious disease and public health funding Student loan forgiveness for public health workforce HR 3655, Vaccine Injury Compensation Modernization Act FY23 Omnibus Spending bill

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

For S.1654 - A bill to amend the Internal Revenue Code of 1986 to include certain over-the-counter dietary supplement products as qualified medical expenses; allowing HSA supplement deduction For S.4367 - A bill to amend the Internal Revenue Code of 1986 to eliminate limitations on contributions to health savings accounts; allowing HSA expansion ForS.3124 - National Patient ID Repeal Act; prohibiting the Patient Identification tracking Against H.R.550 - Immunization Infrastructure Modernization Act of 2021, nationalizing vaccine databases for easier tracking For Amending the Infrastructure Law (PL No: 117-58), to allow wired broadband, not just wireless For H.R.5816 - National Informed Consent Exemption (NICE) Act, allowing exemption for all federally-connected vaccines, and requiring government study of the unvaccinated (to restore Control Group science) Against S. 4090, Dietary Supplement Listing Act, to protect supplement manufacturers from bankruptcy

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies relating to: Adoption of recommendations of the National Academy of Medicine report, The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed for Kids (CARING for Kids) Act H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 485, Stronger Child Abuse Prevention and Treatment Act H.R. 550, Immunization Infrastructure Modernization Act of 2021 H.R. 909/S. 484, Moms Matter Act H.R. 959/S. 346, Black Maternal Health Momnibus Act of 2021 H.R. 1065/S. 1486, Pregnant Workers Fairness Act H.R. 1324/S/ 467, Effective Suicide Screening and Assessment in the Emergency Department Act of 2021 H.R. 1390, Childrens Health Insurance Program Pandemic Enhancement and Relief (CHIPPER) Act H.R. 1620, Violence Against Women Act Reauthorization Act of 2021 H.R. 1791, Childrens Health Insurance Program Permanency (CHIPP) Act H.R. 2094/S. 1301, Promoting Physical Activity for Americans Act H.R. 2347/S. 2691, Strengthening the Vaccines for Children Program Act of 2021 H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act of 2021 H.R. 3182, Safe Sleep for Babies Act of 2021 H.R. 3407/S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act H.R. 3655, Vaccine Injury Compensation Modernization Act of 2021 H.R. 4217/S. 2779, Taskforce Recommending Improvements for Unaddressed Mental Perinatal & Postpartum Health (TRIUMPH) for New Moms Act H.R. 5376, Inflation Reduction Act - provisions related to health equity and mental and behavioral health for patients and health care providers H.R. 5487/S. 3972, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2021 H.R. 5585, Advanced Research Projects Agency-Health (ARPA-H) Act H.R. 7076, Supporting Childrens Mental Health Care Access Act of 2022 H.R. 7236, Strengthen Kids Mental Health Now Act of 2022 H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022 H.R. 7780, Mental Health Matters Act H.R. 8296, Womens Health Protection Act of 2022 H.R. 8391, Continuity in Necessary Evaluative Crisis Treatment (CONNECT) Act of 2022 H.R. 8450, Healthy Meals, Healthy Kids Act S. 104/H.R. 379, Improving Social Determinants of Health Act of 2021 S. 248/H.R. 804, Family and Medical Insurance Leave (FAMILY) Act S. 499/H.R. 369, Improving Health Insurance Affordability Act of 2021 S. 674, Public Health Infrastructure Saves Lives Act S. 844/H.R. 3109, PHIT Act of 2021 S. 1259, Safe Cribs Act S. 1275/H.R. 2119, Family Violence Prevention and Services Improvement Act of 2021 S. 1658/H.R. 3110, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act S. 1675/H.R. 4387, Maternal Health Quality Improvement Act S. 2069/H.R. 4323, Excellence in Mental Health and Addiction Treatment Act S. 3479/H.R. 8151, Building a Sustainable Workforce for Healthy Communities Act S. 3623, Violence Against Women Act Reauthorization Act of 2022 S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) S. 4170, Mental Health Reform Reauthorization Act of 2022

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

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

H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 4348: FDASLA Act of 2022 - 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. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers HR 5605 PrEP Assistance Act H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - 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. 8152: American Data Privacy and Protection Act H.R. 5376 Inflation Reduction Act - provisions related to vaccines and pharmaceuticals H.R. 4127: DISARM Act Act Provisions related to antimicrobial drug development H.R. 3932/S. 2076: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. H.R. 3655: Vaccine Injury Compensation Modernization Act H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) S. 912/H.R. 1978: Protecting Seniors Through Immunization Act H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: 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, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - 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 S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Dietary Supplement Health and Education Act Reform Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Final Rule; Importation of Prescription Drugs Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022 Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property

Client expense: $1,390,000 · Firm income: Not reported

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

ARC Act of 2021 (H.R. 2631) Credit for Caring Act (S. 1670 / H.R. 3321) Easy Enrollment in Health Care Act (S. 3001) Ensuring Coverage in Public Health Emergencies Act of 2021 (H.R. 526) Healthcare Cybersecurity Act (S. 3904) Improving Social Determinants of Health Act (H.R. 379/S. 4440) Medical Nutrition Equity Act (S. 2013/H.R. 3783) The Protecting Americans with Pre-Existing Conditions Act of 2021 (S. 779) Safe Step Act of 2021 (H.R. 2163) Immunization Infrastructure Modernization Act (H.R. 550) Implementation of the Advancing Care for Exceptional Kids Act (ACE Kids, Pub. L. 116-16) Prescription Drug User Fee Act (PDUFA), provisions related to improving clinical trial diversity and equitable opportunities for trial participation Palliative Care and Hospice Education and Training Act (H.R. 647) A bill to provide for the publication by the Secretary of Health and Human Services of physical activity recommendations for Americans (H.R. 2094/S. 1301) Halt Obesity in America Act (H.R. 5625) Youth Sports Facilities Act (no bill number) Requirements related to No Surprises Act Final Rule

Client expense: $180,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022

Client expense: $3,220,000 · Firm income: Not reported

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities --- In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment (Discussion Draft) ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)

Client expense: $3,220,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic

Client expense: $3,220,000 · Firm income: Not reported

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

Issues related to program integrity, health insurance, Medicare, Medicaid, population health; Issues related to H.R. 5376, Inflation Reduction Act of 2022 (now PL 117-169) and implementation; S.3799, PREVENT Pandemics Act, with specific focus on Section 213 (public health data availability and access; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Bipartisan Safer Communities Act, P.L. 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to reauthorization of FDA user fee bills (H.R.7667, Food and Drug Amendments of 2022; S.4348 Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)); Issues related to the Public Health Emergency; H.R. 550, Immunization Infrastructure Modernization Act; H.R. 6000, Cures 2.0 Act; Issues related to modernizing Immunization Information Systems (IIS); H.R. 7007, COVID Supplemental Appropriations Act, 2022; Issues related to the FY 2023 Presidents Budget

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

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 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; S.581HAPI Act; 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; H.R.2170 HAPI 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.1978 Protecting Seniors Through Immunization Act of 2021; 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.912 Protecting Seniors Through Immunization 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; H.R.5376 Build Back Better Act/Inflation Reduction Act; 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; S. 3373 Honoring our PACT Act of 2022; H.R. 3967 Honoring our PACT Act of 2022; H.R. 6833 Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023; H.R. 8885 Better Health Care Directories Act

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

HR 550, Immunization Information Systems Modernization Act HR 2170/S 581, Helping Adults Protect Immunity (HAPI) Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act PREVENT Pandemics Act HR 2347/S 2691, Strengthening the Vaccines for Children Program Act Federal funding for Section 317 Immunization Programs, infectious disease and public health funding Student loan forgiveness for public health workforce HR 3655, Vaccine Injury Compensation Modernization Act

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

For S.1654 - A bill to amend the Internal Revenue Code of 1986 to include certain over-the-counter dietary supplement products as qualified medical expenses; allowing HSA supplement deduction For S.4367 - A bill to amend the Internal Revenue Code of 1986 to eliminate limitations on contributions to health savings accounts; allowing HSA expansion ForS.3124 - National Patient ID Repeal Act; prohibiting the Patient Identification tracking Against H.R.550 - Immunization Infrastructure Modernization Act of 2021, nationalizing vaccine databases for easier tracking For Amending the Infrastructure Law (PL No: 117-58), to allow wired broadband, not just wireless For H.R.5816 - National Informed Consent Exemption (NICE) Act, allowing exemption for all federally-connected vaccines, and requiring government study of the unvaccinated (to restore Control Group science) Against S. 4090, Dietary Supplement Listing Act, to protect supplement manufacturers from bankruptcy

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies relating to: Adoption of recommendations of the National Academy of Medicine report, The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention Implementation of the Dr. Lorna Breen Health Care Provider Protection Act (P.L. 117-105) H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed for Kids (CARING for Kids) Act H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 485, Stronger Child Abuse Prevention and Treatment Act H.R. 550, Immunization Infrastructure Modernization Act of 2021 H.R. 909/S. 484, Moms Matter Act H.R. 959/S. 346, Black Maternal Health Momnibus Act of 2021 H.R. 1065/S. 1486, Pregnant Workers Fairness Act H.R. 1324/S/ 467, Effective Suicide Screening and Assessment in the Emergency Department Act of 2021 H.R. 1390, Childrens Health Insurance Program Pandemic Enhancement and Relief (CHIPPER) Act H.R. 1620, Violence Against Women Act Reauthorization Act of 2021 H.R. 1791, Childrens Health Insurance Program Permanency (CHIPP) Act H.R. 2094/S. 1301, Promoting Physical Activity for Americans Act H.R. 2347/S. 2691, Strengthening the Vaccines for Children Program Act of 2021 H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act of 2021 H.R. 3182, Safe Sleep for Babies Act of 2021 H.R. 3407/S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act H.R. 4217/S. 2779, Taskforce Recommending Improvements for Unaddressed Mental Perinatal & Postpartum Health (TRIUMPH) for New Moms Act H.R. 5376, Build Back Better Act - provisions related to nursing education infrastructure, health equity, social determinants of health, mental and behavioral health for patients and health care providers, and child and maternal health H.R. 5487/S. 3972, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2021 H.R. 5585, Advanced Research Projects Agency-Health (ARPA-H) Act H.R. 7076, Supporting Childrens Mental Health Care Access Act of 2022 H.R. 7236, Strengthen Kids Mental Health Now Act of 2022 H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022 H.R. 7790, Infant Formula Supplemental Appropriations Act, 2022 S. 104/H.R. 379, Improving Social Determinants of Health Act of 2021 S. 248/H.R. 804, Family and Medical Insurance Leave (FAMILY) Act S. 499/H.R. 369, Improving Health Insurance Affordability Act of 2021 S. 674, Public Health Infrastructure Saves Lives Act S. 844/H.R. 3109, PHIT Act of 2021 S. 1259, Safe Cribs Act S. 1275/H.R. 2119, Family Violence Prevention and Services Improvement Act of 2021 S. 1658/H.R. 3110, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act S. 1675/H.R. 4387, Maternal Health Quality Improvement Act S. 1738, Hallways to Health Care Act S. 2069/H.R. 4323, Excellence in Mental Health and Addiction Treatment Act S. 3479, Building a Sustainable Workforce for Healthy Communities Act S. 3623, Violence Against Women Act Reauthorization Act of 2022 S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) S. 4170, Mental Health Reform Reauthorization Act of 2022

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

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

H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 4127: DISARM Act - Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing and patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - 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. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: 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, and for other purposes - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S 2938 - Bipartisan Safer Communities Act - budget offset provisions related to Rebate Rule S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - 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 S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Dietary Supplement Health and Education Act Reform Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022

Client expense: $1,110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), 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 FY23 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, House Labor HHS Appropriations bill; Senate 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 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; S.581HAPI Act; 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; H.R.2170 HAPI 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.1978 Protecting Seniors Through Immunization Act of 2021; 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.912 Protecting Seniors Through Immunization 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; H.R.5376 Build Back Better Act; 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

Client expense: $70,000 · 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 program integrity, health insurance, Medicare, Medicaid, population health; Monitor possible healthcare policies in upcoming reconciliation package including: making ACA tax credits/subsidies permanent, addressing Medicaid coverage gap, expanding home and community based services, prescription drug reform; H.R. 5376, Build Back Better Act; S.3799, PREVENT Pandemics Act, with specific focus on Section 213 (public health data availability and access; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Bipartisan Safer Communities Act, P.L. 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to reauthorization of FDA user fee bills (H.R.7667, Food and Drug Amendments of 2022; S.4348 Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)); Issues related to the Public Health Emergency; H.R. 550, Immunization Infrastructure Modernization Act; H.R. 6000, Cures 2.0 Act; Issues related to modernizing Immunization Information Systems (IIS); H.R. 7007, COVID Supplemental Appropriations Act, 2022; Issues related to the FY 2023 Presidents Budget

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.550: Immunization Information Systems ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---National Coverage Determination Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Implementation of Consolidated Appropriations Act for FY 2021 ---Pricing and Rebates Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---S.3018: Improving Seniors Timely Access to Care Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare 2023 IPPS Proposed Rule Comment Letter ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.4127: DISARM Act ---Separate Payment Mechanism for Innovative Antimicrobials Products

Client expense: $3,120,000 · Firm income: Not reported

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

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.550: Immunization Information Systems ---Implementation of Consolidated Appropriations Act for FY 2021 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Client expense: $3,120,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office

HR 550, Immunization Information Systems Modernization Act HR 2170/S 581, Helping Adults Protect Immunity (HAPI) Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act PREVENT Pandemics Act HR 2347/S 2691, Strengthening the Vaccines for Children Program Act Federal funding for Section 317 Immunization Programs, infectious disease and public health funding Student loan forgiveness for public health workforce

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

ARC Act of 2021 (H.R.2631) Credit for Caring Act (S.1670 / H.R. 3321) Easy Enrollment in Health Care Act (S.3001) Ensuring Coverage in Public Health Emergencies Act of 2021 (H.R. 526) Healthcare Cybersecurity Act (S.3904) Improving Social Determinants of Health Act (H.R. 379/S4440) Medical Nutrition Equity Act (S. 2013/H.R. 3783) The Protecting Americans with Pre-Existing Conditions Act of 2021 (S.779) Requirements related to No Surprises Act Final Rule Safe Step Act of 2021 (H.R. 2163) Immunization Infrastructure Modernization Act (H.R. 550) A bill to provide for the publication by the Secretary of Health and Human Services of physical activity recommendations for Americans (H.R. 2094/S. 1301)

Client expense: $220,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of

For S.1654 - A bill to amend the Internal Revenue Code of 1986 to include certain over-the-counter dietary supplement products as qualified medical expenses; allowing HSA supplement deduction For S.4367 - A bill to amend the Internal Revenue Code of 1986 to eliminate limitations on contributions to health savings accounts; allowing HSA expansion ForS.3124 - National Patient ID Repeal Act; prohibiting the Patient Identification tracking Against H.R.550 - Immunization Infrastructure Modernization Act of 2021, nationalizing vaccine databases for easier tracking For Amending the Infrastructure Law (PL No: 117-58), to allow wired broadband, not just wireless For H.R.5816 - National Informed Consent Exemption (NICE) Act, allowing exemption for all federally-connected vaccines, and requiring government study of the unvaccinated (to restore Control Group science) Against S. 4090, Dietary Supplement Listing Act, to protect supplement manufacturers from bankruptcy

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: 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, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform

Client expense: $1,100,000 · Firm income: Not reported

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

Legislation and policies relating to: Adoption of recommendations of the National Academy of Medicine report, The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention Provisions of the Infrastructure Investment and Jobs Act (P.L. 117-58) related to public health infrastructure improvements H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed for Kids (CARING for Kids) Act H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 485, Stronger Child Abuse Prevention and Treatment Act H.R. 550, Immunization Infrastructure Modernization Act of 2021 H.R. 909/S. 484, Moms Matter Act H.R. 959/S. 346, Black Maternal Health Momnibus Act of 2021 H.R. 1065/S. 1486, Pregnant Workers Fairness Act H.R. 1324/S/ 467, Effective Suicide Screening and Assessment in the Emergency Department Act of 2021 H.R. 1390, Childrens Health Insurance Program Pandemic Enhancement and Relief (CHIPPER) Act H.R. 1791, Childrens Health Insurance Program Permanency (CHIPP) Act H.R. 2094/S. 1301, Promoting Physical Activity for Americans Act H.R. 2347/S. 2691, Strengthening the Vaccines for Children Program Act of 2021 H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act of 2021 H.R. 3182, Safe Sleep for Babies Act of 2021 H.R. 3407/S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act H.R. 4217/S. 2779, Taskforce Recommending Improvements for Unaddressed Mental Perinatal & Postpartum Health (TRIUMPH) for New Moms Act H.R. 5376, Build Back Better Act - provisions related to nursing education infrastructure, health equity, social determinants of health, mental and behavioral health for patients and health care providers, and child and maternal health H.R. 5487/S. 3972, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2021 H.R. 7076, Supporting Childrens Mental Health Care Access Act of 2022 S. 104/H.R. 379, Improving Social Determinants of Health Act of 2021 S. 248/H.R. 804, Family and Medical Insurance Leave (FAMILY) Act S. 499/H.R. 369, Improving Health Insurance Affordability Act of 2021 S. 610/H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act S. 674, Public Health Infrastructure Saves Lives Act S. 844/H.R. 3109, PHIT Act of 2021 S. 1259, Safe Cribs Act S. 1275/H.R. 2119, Family Violence Prevention and Services Improvement Act of 2021 S. 1658/H.R. 3110, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act S. 1675/H.R. 4387, Maternal Health Quality Improvement Act S. 2069/H.R. 4323, Excellence in Mental Health and Addiction Treatment Act S. 3479, Building a Sustainable Workforce for Healthy Communities Act S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act)

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

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

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: 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, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform

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

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

Issues related to program integrity, health insurance, Medicare, Medicaid, population health; Implementation of American Rescue Plan Act of2021 (PL 117-2); Monitor possible healthcare policies in upcoming reconciliation package including: making ACA tax credits/subsidies permanent, addressing Medicaid coverage gap, expanding home and community based services, prescription drug reform; H.R. 5376, Build Back Better Act; Consolidated Appropriations Act, 2022 (PL 117-103); S.3799, PREVENT Pandemics Act; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Issues related to reauthorization of the FDA user fee bills; Issues related to the Public Health Emergency; H.R. 550, Immunization Infrastructure Modernization Act; H.R. 6000, Cures 2.0 Act; Issues related to modernizing Immunization Information Systems (IIS); H.R. 7007, COVID Supplemental Appropriations Act, 2022; Issues related to the FY 2023 Presidents Budget

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

ARC Act of 2021 (H.R.2631) Build Back Better Act (H.R.5376) Credit for Caring Act (S.1670 / H.R. 3321) Easy Enrollment in Health Care Act (S.3001) Ensuring Coverage in Public Health Emergencies Act of 2021 (H.R. 526) Healthcare Cybersecurity Act (S.3904) Improving Social Determinants of Health Act (H.R. 379/S4440) Medical Nutrition Equity Act (S. 2013/H.R. 3783) The Protecting Americans with Pre-Existing Conditions Act of 2021 (S.779) Public Health Infrastructure Saves Lives Act (S. 674) Public Health Funding Prevents Pandemics Act (S. 571) Requirements related to No Surprises Act, Parts I & II interim final rules Safe Step Act of 2021 (H.R. 2163) To Fund Prevention and Public Health Fund (H.R. 1583) Immunization Infrastructure Modernization Act (H.R. 550) A bill to provide for the publication by the Secretary of Health and Human Services of physical activity recommendations for Americans (H.R. 2094/S. 1301)

Client expense: $200,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of

Access to immunizations. H.R.951/S.345 - Maternal Vaccination Act, and and provisions from the act included in H.R.959/S.345, Black Maternal Health Momnibus Act of 2021. H.R.550 - Immunization Infrastructure Modernization Act of 2021. Implementation of vaccine infrastructure and confidence activities in the American Rescue Plan Act of 2021 (P.L. 117-2). S.3799 - Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act. H.R.6000 - Cures 2.0 Act.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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 FY23 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 TaskforceH.R.4502 House Labor HHS Appropriations bill; S.3062 Senate 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 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; S.581HAPI Act; 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; H.R.2170 HAPI 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.1978 Protecting Seniors Through Immunization Act of 2021; 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.912 Protecting Seniors Through Immunization 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; H.R.5376 Build Back Better Act; 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.2471 FY22 Consolidated Appropriations Act, 2022; 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.6617 Further Additional Extending Government Funding Act; H.R. 7055 Elijah E. Cummings Family Asthma Act; S. 3332 Let States Innovate Under Medicaid Act;

Client expense: $50,000 · 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

HR 550, Immunization Information Systems Modernization Act HR 2170/S 581, Helping Adults Protect Immunity (HAPI) Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act PREVENT Pandemics Act HR 2347/S 2691, Strengthening the Vaccines for Children Program Act Federal funding for Section 317 Immunization Programs, infectious disease and public health funding Student loan forgiveness for public health workforce

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

For S.1654 - A bill to amend the Internal Revenue Code of 1986 to include certain over-the-counter dietary supplement products as qualified medical expenses For S.4367 - A bill to amend the Internal Revenue Code of 1986 to eliminate limitations on contributions to health savings accounts. ForS.3124 - National Patient ID Repeal Act Against H.R.550 - Immunization Infrastructure Modernization Act of 2021 For Amending the Infrastructure Law (PL No: 117-58), to allow wired broadband, not just wireless For H.R.5816 - National Informed Consent Exemption (NICE) Act Against supplement mandatory product listing

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies relating to: Adoption of recommendations of the National Academy of Medicine report, The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention Provisions of the Infrastructure Investment and Jobs Act (H.R. 3684) related to public health infrastructure improvements Provisions of the draft Build Back Better Act related to health equity, social determinants of health, mental and behavioral health for patients and health care providers, and child and maternal health H.R. 66, Comprehensive Access to Robust Insurance Now Guaranteed for Kids (CARING for Kids) Act H.R. 482, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 485, Stronger Child Abuse Prevention and Treatment Act H.R. 550, Immunization Infrastructure Modernization Act of 2021 H.R. 909/S. 484, Moms Matter Act H.R. 959/S. 346, Black Maternal Health Momnibus Act of 2021 H.R. 1065/S. 1486, Pregnant Workers Fairness Act H.R. 1324/S/ 467, Effective Suicide Screening and Assessment in the Emergency Department Act of 2021 H.R. 1390, Childrens Health Insurance Program Pandemic Enhancement and Relief (CHIPPER) Act H.R. 1791, Childrens Health Insurance Program Permanency (CHIPP) Act H.R. 2094/S. 1301, Promoting Physical Activity for Americans Act H.R. 2347/S. 2691, Strengthening the Vaccines for Children Program Act of 2021 H.R. 3110, Providing Urgent Maternal Protections to Nursing Mothers (PUMP) Act H.R. 3182, Safe Sleep for Babies Act of 2021 H.R. 4217, Taskforce Recommending Improvements for Unaddressed Mental Perinatal & Postpartum Health (TRIUMPH) for New Moms Act H.R. 5235, Student Mental Health Helpline Act of 2021 H.R. 5487, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2021 S.J. Res. 29 - 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. 104/H.R. 379, Improving Social Determinants of Health Act of 2021 S. 248/H.R. 804, Family and Medical Insurance Leave (FAMILY) Act S. 499/H.R. 369, Improving Health Insurance Affordability Act of 2021 S. 610/H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act S. 674, Public Health Infrastructure Saves Lives Act S. 844/H.R. 3109, PHIT Act of 2021 S. 1259, Safe Cribs Act S. 1275/H.R. 2119, Family Violence Prevention and Services Improvement Act of 2021 S. 1301/H.R. 2094, Promoting Physical Activity for Americans Act S. 1658/H.R. 3110, Providing Urgent Maternal Protections for Nursing Mothers Act S. 1675, Maternal Health Quality Improvement Act S. 1902, Behavioral Health Crisis Services Expansion Act

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

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA)

12-Month Continuous Eligibility for Children in Medicaid/CHIP Easy Enrollment in Health Care Act of 2021 Provider Relief Fund Reporting Requirements Accelerating Kids Access to Care Act (H.R. 3089/S. 1544) Connect for Health Act of 2021 Medicaid Payment Parity Coronavirus Medicaid Response Act (S. 4108) H.R. 2347, Strengthening the Vaccines for Children Program Act HR 1025, the Kids Access to Primary Care Act S. 1833 The Ensuring Access to Primary Care for Women and Children Act of 2021 Medicaid Maintenance of Effort (MOE) Protections Comprehensive Access to Robust Insurance Now Guaranteed (CARING) for Kids Act (H.R.66) H.R. 1791 Childrens Health Insurance Program Permanency (CHIPP) Act Stabilize Medicaid and CHIP Coverage Act (H.R. 1738) Permanent CHIP Funding Extension Permanent Extension of Express Lane Eligibility Option Pediatrics Home and Community-Based Services (HCBS) in Medicaid Medicaid Reentry Act Accelerating Kids Access to Care Act Expanding Medicaid HCBS Services for Children Maternal Health H.R. 4996 Helping Moms Act H.R.4995 - Maternal Health Quality Improvement Act of 2020 Postpartum Medicaid Extension and Maternal Health Improvements Closing the Medicaid Coverage Gap Increased Funding for Childrens Hospitals Graduate Medical Education Allow for the home and other secure locations as originating (patient) and distant (provider) sites in telehealth Waive telehealth cost-sharing for patients in telehealth Pay for telehealth care visits at parity with that of in-person visits Allow telehealth care for both new and established patients Including Preventive Medicine Service Codes to be Eligible for Telehealth Increased Access To Broadband to Expand Telehealth Services Financial Relief to Medicaid Providers Financial Relief for Pediatricians Provider Relief Fund COVID-19 Response Medicaid/CHIP Eligibility Redeterminations post PHE Build Back Better Act Payment for COVID-19 Vaccine Counseling Coding Changes for COVID-19 Counseling Payment Standards in CBP Custody Standards in ICE Family Detention Standards in ORR Custody Licensure of ORR Shelters Emergency Intake Sites Public Charge Child Nutrition Reauthorization/WIC SNAP Mental Health for Children H.R. 6, DREAM Act Family Separation and Detention Medical Nutrition Equity Act Build Back Better Act Lift the Bar Act CARE for Families Act HR 3107 WIC Act Keep Families Together Act Breastfeeding Peer Counseling Program Public Health Preparedness and Response Research for Pregnant and Lactating Women Funding for Pediatric Device Consortia Funding for Emergency Medical Services for Children Program HRSA Pediatric Mental Health Care Access Program PUMP Act Dietary Guidelines Child Poverty Coronavirus Response Legislation Asylum Child Poverty Reduction Act Suicide Prevention Dr Lorna Breen Health Care Provider Protection Act S. 4349 CBP Medical Services Contract Child Nutrition Waivers School Meal Standards Universal School Meals Eviction Moratorium Equality Act Mental Health Services for Students Act Medicaid Bump Act Youth Mental Health and Suicide Prevention Act Child Tax Credit Comprehensive Mental Health in Schools Pilot Program Pediatric Subspecialty Loan Repayment Program Fiscal Year (FY) 2022 Appropriations Regulation of E-Cigarettes (premarket review) Kids PRIVCY Act (H.R. 4801) KIDS Act (H.R. 5439/S. 2918) Adolescent Health Federal cannabis regulation Primary Care Physician Reentry Act Gun violence prevention research funding Child passenger safety (H.R. 5736) Appropriations for the Indian Health Service Maternal, Infant, and Early Childhood Home Visiting Program funding Infant sleep product safety (S. 1259, H.R. 3182) Lead exposure prevention Food safety Paid family and medical leave, Build Back Better Act Climate change Vehicle emissions standards Button battery ingestions (H.R. 5313, S. 3278) Early childhood education Blood lead reference values Access to genetic sequencing Child product safety and injury prevention Federal Indian Boarding School Program (S. 2907, H.R. 5444) Furniture tip-overs (S. 441, H.R. 1314) Child Abuse Prevention and Treatment Act reauthorization, CAPTA Reauthorization Act of 2021 CAPTA Plans of safe care grants Family First Prevention Services Act implementation Issues related to the COVID-19 pandemic and providing supports for the child welfare community CAPTA Fatalities Prevention and Response Title IV-B Reauthorization Ensuring Medicaid continuity for Children in Foster Care Act (S. 2689/H.R. 5414) Congregate care reform Mental health supports for foster youth/former foster youth Appropriations - global child and youth-focused global health subaccounts (Vulnerable Children, Maternal and Child Health, Nutrition, WASH) Global Child Thrive Act Implementation Global Child Thrive Act Implementation Strengthening Efforts to End Violence Against Children Act of 2021 (not yet introduced) Reach Every Mother and Child Act of 2021 (S. 1451) FY22 National Defense Authorization Act: Stopping Proposals to Reduce Military Medical Personnel Billets Improvements to the Supplemental Security Income Program, including in the Build Back Better Act Immunizations: Strengthening the Vaccines for Children Program Act (H.R. 2347 / S. 2691), Authorization of a Pediatric COVID-19 Vaccine, and Promoting Pediatric Vaccination Against COVID-19 Newborn Screening Saves Lives Reauthorization Act (H.R. 482 / S. 350) FY22 Labor, Health and Human Services, and Education Appropriations Individuals with Disabilities Education Act (IDEA) Full Funding Act (S. 3213 / H.R. 5984) Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2021(H.R. 5487) Interim Final Rule Implementing Head Start Vaccine and Universal Masking Requirements Payment for Vaccine Counseling in Medicaid and CHIP Early Hearing Detection and Intervention Act of 2021 (H.R. 5561) Improving the Health of Children Act (H.R. 5551) Immunization infrastructure Modernization Act of 2021 (H.R. 550) Interagency Autism Coordinating Committee 2021-2022 Strategic Plan Comments Inclusion of the NURSE Act in the Build Back Better Act (S. 1602 / H.R. 3166)

Client expense: $230,000 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Indian Health Service, Interior, Dept of (DOI), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), White House Office

ARC Act of 2021 (H.R.2631) Build Back Better Act (H.R.5376) Credit for Caring Act (S.1670 / H.R. 3321) Easy Enrollment in Health Care Act (S.3001) Ensuring Coverage in Public Health Emergencies Act of 2021 (H.R. 526) Improving Social Determinants of Health Act (H.R. 379/S4440) Medical Nutrition Equity Act (S. 2013/H.R. 3783) The Protecting Americans with Pre-Existing Conditions Act of 2021 (S.779) Public Health Infrastructure Saves Lives Act (S. 674) Public Health Funding Prevents Pandemics Act (S. 571) Requirements related to No Surprises Act, Parts I & II interim final rules Safe Step Act of 2021 (H.R. 2163) To Fund Prevention and Public Health Fund (H.R. 1583) Immunization Infrastructure Modernization Act (H.R. 550) A bill to provide for the publication by the Secretary of Health and Human Services of physical activity recommendations for Americans (H.R. 2094/S. 1301)

Client expense: $120,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

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 FY23 budget; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; H.R.4502 House Labor HHS Appropriations bill; S.3062 Senate Labor HHS Appropriations bill; Elijah E. Cummings Family Asthma Act; 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 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; S.581HAPI Act; 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; H.R.2170 HAPI 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.1978 Protecting Seniors Through Immunization Act of 2021; 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.912 Protecting Seniors Through Immunization 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; H.R.5376 Build Back Better Act; 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

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), U.S. Postal Service (USPS), White House Office

Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions, and substance misuse/behavioral health issues. Specific Legislation: 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act and Pandemic and All-Hazards Preparedness and Advancing Innovation Act (Public Law 113-5, 116-22) 3.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 4.Implementation of Every Student Succeeds Act (Public Law 114-95) 5.Implementation of the Comprehensive Addition and Recovery Act (Public Law 114-98) 6.Tax Cuts and Jobs Act (Public Law 115-97) 7.Pandemic and All-Hazards Preparedness Advancing Innovation Act (P.L. 116-22) 8.Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136) 9.Implementation of the Amer 10.Strengthening the Vaccines for Children Program Act (H.R. 2347) 11.The Healthy Families Act (S. 1195/H.R. 2465) 12.FAMILY Act (H.R. 804/S. 248) 13.American Rescue Plan Act of 2021 (P.L. 117-2) 14.Pursuing Equity in Mental Health Act (H.R. 1475) 15.Public Health Infrastructure Saves Lives Act (S. 674) 16.Summer Meals Act of 2021 (H.R. 783) 17.The Mental Health Services for Students Act (H.R. 721) 18.Black Maternal Health Momnibus (H.R. 959/S. 346) 19.Immunization Information System Modernization Act (H.R. 550) 20.Protecting Seniors through Immunization Act (H.R. 1978) 21.Community Immunity During COVID-19 Act (H.R. 736/S. 167) 22.Parity Enforcement Act (H.R. 1364) 23.Improving Social Determinants of Health Act (S. 104/H.R 379) 24.FY 2022 Labor, HHS, Education and Related Agencies Appropriations 25.WIC Act of 2021 (S. 853) 26.Environmental Justice Legacy Pollution Cleanup Act (Bill number not yet available) 27.Transportation Alternatives Enhancement Act (H.R. 463/S. 614) 28.SAFE Streets Act (H.R. 508) 29.Safe Routes to School Expansion Act (H.R. 386) 30.Social Determinants Accelerator Act (H.R. 2503) 31.Strengthening the Vaccines for Children Act (H.R. 2347) 32.Tracking COVID-19 Variants Act (S. 236) 33.Tobacco Tax Equity Act (S. 1314/H.R. 2786) 34.NURSE Act (S. 1602) 35.Maternal Immunization Enhancement Act (S. 1114) 36.Maternal Immunization Coverage Act (S. 1117) 37.Equality Act (H.R. 5) 38.Climate Change Health Protection and Promotion Act (S. 1702/H.R. 3271) 39.RISE from Trauma Act (S. 2086) 40.Improving Data Collection for Adverse Childhood Experiences Act (H.R. 3467) 41.FY2022 Agriculture-FDA Appropriations Bill 42.Honoring the Centers for Disease Control and Prevention on the 75th anniversary of its establishment and expressing deep gratitude on behalf of the people of the United States to the scientists, disease detectives, career civil servants, and support staff at the Centers for Disease Control and Prevention for their dedication to protecting the health, safety, and security of the United States and to strengthening public health in the United States and abroad. (S Res. 332/H. Res. 618) 43.Build Back Better Act (H.R. 5376) 44.Behavioral Health Crisis Services Expansion Act (S. 1902) 45.Ensuring Understanding of COVID-19 to Protect Public Health Act (S. 176) 46.Protecting the Health of Americas Older Adults Act (H.R. 6302) 47.Cures 2.0 Act (H.R. 6000) 48.Helping Adults Protect Immunity Act (H.R. 2170) 49.Early Childhood Nutrition Improvement Act (H.R. 5919) 50.Public Health Workforce Loan Repayment Act (H.R. 3297) 51.Campus Prevention and Recovery Services for Students Act 52.Universal School Meals Program Act of 2021 (S. 1530) House(s) of Congress and Federal Agencies lobbied during the quarter: House, Senate, Exec Office of Pres, HHS, CDC, FDA, CMS, OMB, DOT, HUD, EPA, NIMH, ACF, Education, USDA, DHS, FEMA, and SAMHSA.

Client expense: $36,373 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

Access to immunizations; Maternal immunizations; Immunization infrastructure; Health information technology/immunization information systems (IIS); Vaccine equity; Vaccine education/confidence; Quality measures; Community Immunity During COVID-19 Act of 2021 (H.R. 736/S. 167); Immunization Infrastructure Modernization Act (H.R. 550); Maternal Vaccinations Act (H.R. 951/S. 345), and provisions from the act included in the Black Maternal Health Momnibus (H.R. 959/S. 345); Implementation of vaccine infrastructure and confidence activities in the American Rescue Plan Act of 2021 (P.L. 117-2); The PREVENT HPV Cancers Act of 2021 (H.R. 1550).

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

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

Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions, and substance misuse/behavioral health issues. Specific Legislation: 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act and Pandemic and All-Hazards Preparedness and Advancing Innovation Act (Public Law 113-5, 116-22) 3.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 4.Implementation of Every Student Succeeds Act (Public Law 114-95) 5.Implementation of the Comprehensive Addition and Recovery Act (Public Law 114-98) 6.Tax Cuts and Jobs Act (Public Law 115-97) 7.Pandemic and All-Hazards Preparedness Advancing Innovation Act (P.L. 116-22) 8.Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136) 9.Implementation of the Amer 10.Strengthening the Vaccines for Children Program Act (H.R. 2347) 11.The Healthy Families Act (S. 1195/H.R. 2465) 12.FAMILY Act (H.R. 804/S. 248) 13.American Rescue Plan Act of 2021 (P.L. 117-2) 14.Pursuing Equity in Mental Health Act (H.R. 1475) 15.Public Health Infrastructure Saves Lives Act (S. 674) 16.Summer Meals Act of 2021 (H.R. 783) 17.The Mental Health Services for Students Act (H.R. 721) 18.Black Maternal Health Momnibus (H.R. 959/S. 346) 19.Immunization Information System Modernization Act (H.R. 550) 20.Protecting Seniors through Immunization Act (H.R. 1978) 21.Community Immunity During COVID-19 Act (H.R. 736/S. 167) 22.Parity Enforcement Act (H.R. 1364) 23.Improving Social Determinants of Health Act (S. 104/H.R 379) 24.FY 2022 Labor, HHS, Education and Related Agencies Appropriations 25.WIC Act of 2021 (S. 853) 26.Environmental Justice Legacy Pollution Cleanup Act (Bill number not yet available) 27.Transportation Alternatives Enhancement Act (H.R. 463/S. 614) 28.SAFE Streets Act (H.R. 508) 29.Safe Routes to School Expansion Act (H.R. 386) 30.Social Determinants Accelerator Act (H.R. 2503) 31.Strengthening the Vaccines for Children Act (H.R. 2347) 32.Tracking COVID-19 Variants Act (S. 236) 33.Tobacco Tax Equity Act (S. 1314/H.R. 2786) 34.NURSE Act (S. 1602) 35.Maternal Immunization Enhancement Act (S. 1114) 36.Maternal Immunization Coverage Act (S. 1117) 37.Equality Act (H.R. 5) 38.Climate Change Health Protection and Promotion Act (S. 1702/H.R. 3271) 39.RISE from Trauma Act (S. 2086) 40.Improving Data Collection for Adverse Childhood Experiences Act (H.R. 3467) 41.FY2022 Agriculture-FDA Appropriations Bill 42.Honoring the Centers for Disease Control and Prevention on the 75th anniversary of its establishment and expressing deep gratitude on behalf of the people of the United States to the scientists, disease detectives, career civil servants, and support staff at the Centers for Disease Control and Prevention for their dedication to protecting the health, safety, and security of the United States and to strengthening public health in the United States and abroad. (S Res. 332/H. Res. 618) 43.Build Back Better Act (H.R. 5376) 44.Behavioral Health Crisis Services Expansion Act (S. 1902) 45.Ensuring Understanding of COVID-19 to Protect Public Health Act (S. 176) 46.Protecting the Health of Americas Older Adults Act (H.R. 6302) 47.Cures 2.0 Act (H.R. 6000) 48.Helping Adults Protect Immunity Act (H.R. 2170) 49.Early Childhood Nutrition Improvement Act (H.R. 5919) 50.Public Health Workforce Loan Repayment Act (H.R. 3297) 51.Campus Prevention and Recovery Services for Students Act 52.Universal School Meals Program Act of 2021 (S. 1530) House(s) of Congress and Federal Agencies lobbied during the quarter: House, Senate, Exec Office of Pres, HHS, CDC, FDA, CMS, OMB, DOT, HUD, EPA, NIMH, ACF, Education, USDA, DHS, FEMA, and SAMHSA.

Client expense: $33,586 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Rx Reform; Prescription Drugs; Prescription Drug Reform HR 3 (117th Congress), Elijah E. Cummings Lower Drug Costs Now Act, by Rep. Frank Pallone (D-NJ). Establishes a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees. HR 550 (117th Congress), Immunization Infrastructure Modernization Act of 2021, by Rep. Ann Kuster (D-NH). Amends the Public Health Service Act with respect to immunization system data modernization and expansion. HR 2355 (117th Congress), Opioid Prescription Verification Act of 2021, by Rep. Rodney David (R-IL). To facilitate responsible, informed dispensing of controlled substances and other prescribed medications. HR 3742 (117th Congress), Vaccine INFO Act, by Rep. Gus Bilirakis (R-FL). Requires the Secretary of Health and Human Services to issue revised regulations to require the dissemination of information on ACIP recommended immunizations to staff of nursing facilities.

Client expense: Not reported · 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, White House Office

Affordable Care Act(ACA); ACA Reform; ACA Coverage Improvement; Lower Health Care Costs; Transparency; Surprise Billing; Maternal Health;COVID-19 Response/Relief Packages; Telehealth; Health Equity Public Law 116-260 (H.R.133) COVID-19 Relief and Fiscal 2021 Omnibus HR 550 Immunization Infrastructure Act of 2021 HR 3 Lower Drug Costs Now Public Law 117-2 (H.R.1319) American Rescue Plan Act of 2021 HR 979 Vaccine Fairness Act, Rep Angie Craig (MN-02) HR 3 - Lower Drug Costs Act HR 1878 State Health Care premium Reduction Action (Repr. Angie Craig- MN)

Client expense: $28,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; Rx Reform; Prescription Drug Reform H.R. 550 Immunization Infrastructure Modernization Act of 2021 Sponsor: Rep. Annie Kuster (D-NH-02) H.R. 2347 Strengthening the Vaccines for Children Program Act of 2021 Sponsor: Rep. Kim Schrier (D-WA-08)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures Act (PL 114-255) implementation an oversight; SUPPORT for Patients and Communities Act (PL 115-271) implementation and oversight; issues related to health data privacy, unique patient identifier and patient matching, patient access to data, pharmacy real-time benefit transactions; standards to increase interoperability; Medicare coverage of telehealth services, S 368, the Telehealth Modernization Act; the COVID-19 pandemic response including CDC data infrastructure modernization, vaccine distribution and verification, HR 550, the Immunization Infrastructure Modernization Act, HR 318, the Safe Testing at Residence Telehealth Act, telemental and telebahavioral health, broadband access and infrastructure development, HR 1317, the American Rescue Plan Act; Telehealth Expansion Act, H.R. 5981; Telehealth Extension Act, H.R. 6202

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

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

Issues around vaccine distribution credentialing and public health surveillance; HR 550, the Immunization Infrastructure Modernization Act, Issues relating to immunization registry modernization

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

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

H.R. 550, the Immunization Infrastructure Modernization Act H.R. 1474, the Alzheimers Caregiver Support Act H.R. 1667, the Dr. Lorna Breen Health Care Provider Protection Act H.R. 2503 Social Determinants Accelerator Act S. 3039, the Social Determinants Accelerator Act H.R. 2554, the Opioid Prescription Verification Act H.R. 3320, the Allied Health Workforce Diversity Act of 2021 H.R. 3321, the Credit for Caring Act H.R. 4131, the Better Care Better Jobs Act H.R. 5376, the Build Back Better Act H.R. 5541, the Primary and Virtual Care Affordability Act H.R. 5583, the Helping Enable Access to Lifesaving Services Act H.R. 5981, the Telehealth Expansion Act H.R. 5594, the Enhancing Community Health Workforce Act H.R. 5924, A bill to amend the Public Health Service Act to authorize a loan repayment program to encourage specialty medicine physicians to serve in rural communities experiencing a shortage, and for other purposes. S. 2428, the False Claims Amendments Act S. 3021, the Comforting Our Military Families through On-base or Remote Treatment Act P.L. 117-43, the Extending Government Funding and Delivering Emergency Assistance Act P.L. 117-58, the Infrastructure Investment and Jobs Act

Client expense: $130,000 · Firm income: Not reported

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