Maternal Vaccination Act

Ensuring people are current on missed vaccines. 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. 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

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 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 Biosimilars ---H.R.7035: Biologics Market Transparency Act ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---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 ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Families First Coronavirus Response Act of 2020 ---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 ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---TRIPS IP 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 ---H.R.7667: The Food and Drug Amendments of 2022 ---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.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.4472: Better Empowerment Now To Enhance Framework and Improve Treatments (BENEFIT) Act ---H.R.4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---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 ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---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 ---S.4351: Enhanced Access to Affordable Medicines Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---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.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---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 ---Counterfeiting ---Drug Shortages ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: 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 ---Restrictions on Intellectual Property Rights Drug Pricing ---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.4418: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) 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.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---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 Foreign Drug Data Protection Laws ---Regulatory Harmonization 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 FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---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 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 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 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.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) 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 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 Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---S.4184 Retaining Access and Restoring Exclusivity (RARE) Act ---Build Back Better Act (Discussion Draft Senate) ---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 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Rare Disease Pilot Program 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 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---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.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 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of Consolidated Appropriations Act for FY 2021 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Recovery of Routine Immunizations ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy ---Tropical Disease Priority Review (PRV) Program Biosimilars ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R. 7035: Biologics Market Transparency Act ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---BSUFA III Discussion Draft ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---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 ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Draft Discussion) Diversity & Inclusion ---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 ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R. 4472: Better Empowerment Now To Enhance Framework and Improve Treatments Act ( BENEFIT Act) ---H.R. 4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R. 6963: Accelerated Approval Integrity Act ---H.R. 6996: Accelerating Approval for Patients Act ---H.R. 7008: The Pre-Approval Information Exchange Act ---S.1644 Promising Pathway Act ---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 ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---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 Drug Manufacturing, Quality & Distribution ---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. ---H.R. 3927: Manufacturing API, Drugs, & Excipients in America (MADE in America) Act ---H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies Act (INSPECTIONS Act) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: 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 ---Restrictions on Intellectual Property Rights Drug Pricing ---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.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---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 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Generic Drug Entry ---H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R. 5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R. 6888: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R. 1730: Speeding Therapy Access Today (STAT) Act ---Orphan Drug Act Reforms ---Tax Credit 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.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021

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

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

Vaccines, Public Health, Vaccine Confidence, Increased Funding for Immunization Programs HR 2437/S 2691, Strengthening the Vaccines for Children Act HR 2170/S 581, Helping Adults Protect Immunity Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act

Client expense: Not reported · Firm income: Not reported

H.R. 205 - Accelerating Broadband Connectivity Act of 2021 - Rep. Kelly, Trent [R-MS-1] - broadband H.R. 341 - Ensuring Telehealth Expansion Act of 2021 - Rep. Williams, Roger [R-TX-25] - telehealth H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - Rep. Thompson, Mike [D-CA-5] - telehealth H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz [D-CA-44] - SDOH H.R. 434 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Rep. Trone, David J. [D-MD-6] - mental health and SUD H.R. 596 - ACCESS Act - Rep. Schakowsky, Janice D. [D-IL-9] - telehealth H.R. 675 - COVID-19 Price Gouging Prevention Act - Rep. Schakowsky, Janice D. [D-IL-9] - price gouging H.R. 747 - Access to TESTs Act - Rep. DeGette, Diana [D-CO-1] - COVID-19 H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - maternal health H.R. 925 - Data to Save Moms Act - Rep. Davids, Sharice [D-KS-3] - maternal health H.R. 937 - Tech To Save Moms Act - Rep. Johnson, Eddie Bernice [D-TX-30] - maternal health H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy [D-GA-6] - maternal health H.R. 951 - Maternal Vaccination Act - Rep. Sewell, Terri A. [D-AL-7] - maternal health H.R. 959 - To end preventable maternal mortality and severe maternal morbidity in the United States and close disparities in maternal health outcomes, and for other purposes - Rep. Underwood, Lauren [D-IL-14] - maternal health H.R. 1046 - Federal Broadband Deployment in Unserved Areas Act - Rep. Curtis, John R. [R-UT-3] - broadband H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. [D-NC-1] - maternal health H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John A. [D-KY-3] - COVID-19 relief H.R. 1332 - Telehealth Modernization Act - Rep. Carter, Earl L. "Buddy" [R-GA-1] - telehealth H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse, and for other purposes - Rep. Veasey, Marc A. [D-TX-33] - broadband and telehealth H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - health education H.R. 1888 - Improving Access to Indian Health Services Act- Rep. Ruiz, Raul [D-CA-36] - FMAP for Indian health services H.R. 2010 - To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Rep. DeFazio, Peter A. [D-OR-4] - public option H.R. 3063 - MOMMIES Act - Rep. Pressley, Ayanna [D-MA-7] - maternal health H.R. 3126 - Healthy MOM Act - Rep. Watson Coleman, Bonnie [D-NJ-12] - maternal health H.R. 3407 - MOMMAs Act - Rep. Kelly, Robin L. [D-IL-2] - maternal health H.R. 3688 - To address maternal mortality and morbidity - Rep. Adams, Alma S. [D-NC-12] - maternal health H.R. 3753 - Parity Implementation Assistance Act - Rep. Cardenas, Tony [D-CA-29] - mental health and SUD H.R. 4026 - Social Determinants of Health Data Analysis Act of 2021 - Rep. Burgess, Michael C. [R-TX-26] - SDOH H.R. 4387 - Maternal Health Quality Improvement Act of 2021 - Rep. Kelly, Robin L. [D-IL-2] - maternal health H.R. 4502 - Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 - Rep. DeLauro, Rosa L. [D-CT-3] - health care funding H.R. 4918 - Rural Telehealth Expansion Act - Rep. Rosendale Sr., Matthew M. [R-MT-At Large] - telehealth and rural health H.R. 5376 - Build Back Better Act - Rep. Yarmuth, John A. [D-KY-3] - health care funding H.R. 5506 - Rural Telehealth Access Task Force Act - Rep. Pence, Greg [R-IN-6] - telehealth and rural health H.R. 5837 - To amend title XVIII of the Social Security Act to expand access to telehealth services relating to substance use disorder treatment - Rep. Curtis, John R. [R-UT-3] - telehealth SUD services S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina [D-MN] - SDOH S. 168 - TREAT Act - Sen. Murphy, Christopher [D-CT] - telehealth S. 287 - A bill to direct the Secretary of Health and Human Services to issue guidance to States to educate providers, managed care entities, and other insurers about the value and process of delivering respectful maternal health care through diverse and multidisciplinary care provider models, and for other purposes - Sen. Baldwin, Tammy [D-WI] - maternal health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert P., Jr. [D-PA] - maternal health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim [D-VA] - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory A. [D-NJ] - maternal health S. 347 - Data to Save Moms Act - Sen. Smith, Tina [D-MN] - maternal health S. 368 - Telehealth Modernization Act - Sen. Scott, Tim [R-SC] - telehealth S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat [R-PA] - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard J. [D-IL] - maternal health S. 851 - A bill to address social determinants of maternal health - Sen. Blumenthal, Richard [D-CT] - SDOH S. 983 - A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Sen. Whitehouse, Sheldon [D-RI] - public option S. 1333 - A bill to address maternal mortality and morbidity - Sen. Gillibrand, Kirsten E. [D-NY] - maternal health S. 1542 - MOMMIES Act - Sen. Booker, Cory A. [D-NJ] - maternal health S. 1622 - HEALTH for MOM Act of 2021 - Sen. Portman, Rob [R-OH] - maternal health S. 1704 - Telehealth Expansion Act of 2021 - Sen. Daines, Steve [R-MT] - telehealth S. 1804 - Mothers and Newborns Success Act - Sen. Kaine, Tim [D-VA] - maternal health S. 1833 - Ensuring Access to Primary Care for Women & Children Act - Sen. Brown, Sherrod [D-OH] - maternal health S. 1962 - Parity Implementation Assistance Act - Sen. Murphy, Christopher [D-CT] - mental health and SUD S. 1988 - Protecting Rural Telehealth Access Act - Sen. Manchin, Joe, III [D-WV] - telehealth S. 2061 - Telemental Health Care Access Act of 2021 - Sen. Cassidy, Bill [R-LA] - telehealth S. 2779 - TRIUMPH for New Moms Act of 2021 - Sen. Hassan, Maggie [D-NH] - maternal health and mental health S. 3039 - Social Determinants Accelerator Act of 2021 - Sen. Young, Todd [R-IN] - SDOH S. 3062 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2022 - Sen. Murray, Patty [D-WA] - HHS 2022 appropriations Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telemedicine; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy Biosimilars ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---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 ---Supply Chain Issues ---TRIPS IP Waiver 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 ---Clinical Trial Diversity ---Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (Discussion Draft) Drug Evaluation and Review ---S.1644: Promising Pathway Act ---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 ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Drug Manufacturing, Quality & Distribution ---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. ---Drug Shortages ---Executive Order on Buy American ---Inspections ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: 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 ---Restrictions on Intellectual Property Rights Drug Pricing ---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.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Principles Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---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 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Generic Drug Entry ---H.R.2883: Stop Stalling Access to Affordable Medications Act Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---Tax Credit 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.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---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.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 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.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020

H.R. 205 - Accelerating Broadband Connectivity Act of 2021 - Rep. Kelly, Trent [R-MS-1] - broadband H.R. 341 - Ensuring Telehealth Expansion Act of 2021 - Rep. Williams, Roger [R-TX-25] - telehealth H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - Rep. Thompson, Mike [D-CA-5] - telehealth H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz [D-CA-44] - SDOH H.R. 434 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Rep. Trone, David J. [D-MD-6] - mental health and SUD H.R. 596 - ACCESS Act - Rep. Schakowsky, Janice D. [D-IL-9] - telehealth H.R. 675 - COVID-19 Price Gouging Prevention Act - Rep. Schakowsky, Janice D. [D-IL-9] - price gouging H.R. 747 - Access to TESTs Act - Rep. DeGette, Diana [D-CO-1] - COVID-19 H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - maternal health H.R. 925 - Data to Save Moms Act - Rep. Davids, Sharice [D-KS-3] - maternal health H.R. 937 - Tech To Save Moms Act - Rep. Johnson, Eddie Bernice [D-TX-30] - maternal health H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy [D-GA-6] - maternal health H.R. 951 - Maternal Vaccination Act - Rep. Sewell, Terri A. [D-AL-7] - maternal health H.R. 959 - To end preventable maternal mortality and severe maternal morbidity in the United States and close disparities in maternal health outcomes, and for other purposes - Rep. Underwood, Lauren [D-IL-14] - maternal health H.R. 1046 - Federal Broadband Deployment in Unserved Areas Act - Rep. Curtis, John R. [R-UT-3] - broadband H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. [D-NC-1] - maternal health H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John A. [D-KY-3] - COVID-19 relief H.R. 1332 - Telehealth Modernization Act - Rep. Carter, Earl L. "Buddy" [R-GA-1] - telehealth H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse, and for other purposes - Rep. Veasey, Marc A. [D-TX-33] - broadband and telehealth H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - health education H.R. 1888 - Improving Access to Indian Health Services Act- Rep. Ruiz, Raul [D-CA-36] - FMAP for Indian health services H.R. 2010 - To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Rep. DeFazio, Peter A. [D-OR-4] - public option H.R. 3063 - MOMMIES Act - Rep. Pressley, Ayanna [D-MA-7] - maternal health H.R. 3126 - Healthy MOM Act - Rep. Watson Coleman, Bonnie [D-NJ-12] - maternal health H.R. 3407 - MOMMAs Act - Rep. Kelly, Robin L. [D-IL-2] - maternal health H.R. 3688 - To address maternal mortality and morbidity - Rep. Adams, Alma S. [D-NC-12] - maternal health H.R. 3753 - Parity Implementation Assistance Act - Rep. Cardenas, Tony [D-CA-29] - mental health and SUD H.R. 4026 - Social Determinants of Health Data Analysis Act of 2021 - Rep. Burgess, Michael C. [R-TX-26] - SDOH H.R. 4387 - Maternal Health Quality Improvement Act of 2021 - Rep. Kelly, Robin L. [D-IL-2] - maternal health H.R. 4502 - Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 - Rep. DeLauro, Rosa L. [D-CT-3] - health care funding H.R. 4918 - Rural Telehealth Expansion Act - Rep. Rosendale Sr., Matthew M. [R-MT-At Large] - telehealth and rural health H.R. 5376 - Build Back Better Act - Rep. Yarmuth, John A. [D-KY-3] - health care funding S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina [D-MN] - SDOH S. 168 - TREAT Act - Sen. Murphy, Christopher [D-CT] - telehealth S. 287 - A bill to direct the Secretary of Health and Human Services to issue guidance to States to educate providers, managed care entities, and other insurers about the value and process of delivering respectful maternal health care through diverse and multidisciplinary care provider models, and for other purposes - Sen. Baldwin, Tammy [D-WI] - maternal health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert P., Jr. [D-PA] - maternal health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim [D-VA] - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory A. [D-NJ] - maternal health S. 347 - Data to Save Moms Act - Sen. Smith, Tina [D-MN] - maternal health S. 368 - Telehealth Modernization Act - Sen. Scott, Tim [R-SC] - telehealth S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat [R-PA] - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard J. [D-IL] - maternal health S. 851 - A bill to address social determinants of maternal health - Sen. Blumenthal, Richard [D-CT] - SDOH S. 983 - A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Sen. Whitehouse, Sheldon [D-RI] - public option S. 1333 - A bill to address maternal mortality and morbidity - Sen. Gillibrand, Kirsten E. [D-NY] - maternal health S. 1542 - MOMMIES Act - Sen. Booker, Cory A. [D-NJ] - maternal health S. 1622 - HEALTH for MOM Act of 2021 - Sen. Portman, Rob [R-OH] - maternal health S. 1704 - Telehealth Expansion Act of 2021 - Sen. Daines, Steve [R-MT] - telehealth S. 1804 - Mothers and Newborns Success Act - Sen. Kaine, Tim [D-VA] - maternal health S. 1833 - Ensuring Access to Primary Care for Women & Children Act - Sen. Brown, Sherrod [D-OH] - maternal health S. 1962 - Parity Implementation Assistance Act - Sen. Murphy, Christopher [D-CT] - mental health and SUD S. 1988 - Protecting Rural Telehealth Access Act - Sen. Manchin, Joe, III [D-WV] - telehealth S. 2061 - Telemental Health Care Access Act of 2021 - Sen. Cassidy, Bill [R-LA] - telehealth S. 2779 - TRIUMPH for New Moms Act of 2021 - Sen. Hassan, Maggie [D-NH] - maternal health and mental health Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telemedicine; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

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

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

COVID- 19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; RX reform; Prescription drugs; Prescription Drug Reform HR 550 - Immunization Infrastructure Modernization Act of 2021 Sponsor: Rep. Annie Kuster (D-NH-02) HR 951 - Maternal Vaccination Act Sponsor: Rep. Terri Sewell (D-AL-07) HR 2347 - Strengthening the Vaccines for Children Program Act of 2021 Sponsor: Rep. Kim Schrier (D-WA-08) HR 3472 - Vaccine INFO Act Sponsor: Rep. Gus Bilrakis (R-FL-12) HR 3 - Lower Drug Costs Now Act Sponsor: Rep. Frank Pallone (D-NJ-06) HR 2355 - Opioid Prescription Verification Act of 2021 Sponsor: Rep. Rodney David (R-IL-13)

Client expense: $124,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; Rx Reform; Prescription 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 951 (117th Congress), Maternal Vaccination Act, by Rep. Terri Sewell (D-AL). Directs the Secretary of Health and Human Services to carry out a national campaign to increase awareness of the importance of maternal vaccinations for the health of pregnant and postpartum individuals and their children. HR 2347 (117th Congress), Strengthening the Vaccines for Children Program Act of 2021, by Rep. Kim Schrier (D- WA). Amends title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program. 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: $130,000 · Firm income: Not reported

21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the 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 the Families First Coronavirus Response Act of 2020, ---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 ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---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) ---Inspections Drug Patenting ---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.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---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 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the 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 the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---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.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit 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 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; Rx reform; Prescription drugs; Prescription Drug Reform; H.R. 550 - Immunization Infrastructure Modernization Act of 2021 Sponsor: Rep. Annie Kuster (D-NH-02) H.R. 951 - Maternal Vaccination Act Sponsor: Rep. Terri Sewell (D-AL-07) H.R. 2347 - Strengthening the Vaccines for Children Program Act of 2021 Sponsor: Rep. Kim Schrier (D-WA-08) H.R. 3742 - Vaccine INFO Act Sponsor: Rep. Gus Bilirakis (R-FL-12) H.R. 3 - Lower Drug Costs Now Act Sponsor: Rep. Frank Pallone (D-NJ-06) H.R. 2355 - Opioid Prescription Verification Act of 2021 Sponsor: Rep. Rodney David (R-IL-13)

Client expense: $1,350,000 · Firm income: Not reported

H.R. 205 - Accelerating Broadband Connectivity Act of 2021 - Rep. Kelly, Trent [R-MS-1] - broadband H.R. 341 - Ensuring Telehealth Expansion Act of 2021 - Rep. Williams, Roger [R-TX-25] - telehealth H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - Rep. Thompson, Mike [D-CA-5] - telehealth H.R. 379 - Improving Social Determinants of Health Act of 2021 - Rep. Barragan, Nanette Diaz [D-CA-44] - SDOH H.R. 434 - Preventing Mental Health and Substance Use Crises During Emergencies Act - Rep. Trone, David J. [D-MD-6] - mental health and SUD H.R. 596 - ACCESS Act - Rep. Schakowsky, Janice D. [D-IL-9] - telehealth H.R. 675 - COVID-19 Price Gouging Prevention Act - Rep. Schakowsky, Janice D. [D-IL-9] - price gouging H.R. 747 - Access to TESTs Act - Rep. DeGette, Diana [D-CO-1] - COVID-19 H.R. 909 - Moms Matter Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - maternal health H.R. 925 - Data to Save Moms Act - Rep. Davids, Sharice [D-KS-3] - maternal health H.R. 937 - Tech To Save Moms Act - Rep. Johnson, Eddie Bernice [D-TX-30] - maternal health H.R. 943 - Social Determinants for Moms Act - Rep. McBath, Lucy [D-GA-6] - maternal health H.R. 951 - Maternal Vaccination Act - Rep. Sewell, Terri A. [D-AL-7] - maternal health H.R. 959 - To end preventable maternal mortality and severe maternal morbidity in the United States and close disparities in maternal health outcomes, and for other purposes - Rep. Underwood, Lauren [D-IL-14] - maternal health H.R. 1046 - Federal Broadband Deployment in Unserved Areas Act - Rep. Curtis, John R. [R-UT-3] - broadband H.R. 1218 - Data Mapping to Save Moms Lives Act - Rep. Butterfield, G. K. [D-NC-1] - maternal health H.R. 1319 - American Rescue Plan Act of 2021 - Rep. Yarmuth, John A. [D-KY-3] - COVID-19 relief H.R. 1332 - Telehealth Modernization Act - Rep. Carter, Earl L. "Buddy" [R-GA-1] - telehealth H.R. 1721 - To amend the Consolidated Appropriations Act, 2021 to authorize additional funds for the Emergency Broadband Connectivity Fund, to provide grants to States and Tribal Entities to strengthen the National Lifeline Eligibility Verifier, to provide for Federal coordination between the National Lifeline Eligibility Verifier and the National Accuracy Clearinghouse, and for other purposes - Rep. Veasey, Marc A. [D-TX-33] - broadband and telehealth H.R. 1872 - MORE Health Education Act - Rep. Blunt Rochester, Lisa [D-DE-At Large] - health education H.R. 1888 - Improving Access to Indian Health Services Act- Rep. Ruiz, Raul [D-CA-36] - FMAP for Indian health services H.R. 2010 - To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Rep. DeFazio, Peter A. [D-OR-4] - public option H.R. 3063 - MOMMIES Act - Rep. Pressley, Ayanna [D-MA-7] - maternal health H.R. 3126 - Healthy MOM Act - Rep. Watson Coleman, Bonnie [D-NJ-12] - maternal health H.R. 3407 - MOMMAs Act - Rep. Kelly, Robin L. [D-IL-2] - maternal health H.R. 3688 - To address maternal mortality and morbidity - Rep. Adams, Alma S. [D-NC-12] - maternal health H.R. 3753 - Parity Implementation Assistance Act - Rep. Cardenas, Tony [D-CA-29] - mental health and SUD H.R. 4026 - To require the Comptroller General of the United States to submit to Congress a report on actions taken by the Secretary of Health and Human Services to address social determinants of health - Rep. Burgess, Michael C. [R-TX-26] - SDOH S. 104 - Improving Social Determinants of Health Act of 2021- Sen. Smith, Tina [D-MN] - SDOH S. 168 - TREAT Act - Sen. Murphy, Christopher [D-CT] - telehealth S. 287 - A bill to direct the Secretary of Health and Human Services to issue guidance to States to educate providers, managed care entities, and other insurers about the value and process of delivering respectful maternal health care through diverse and multidisciplinary care provider models, and for other purposes - Sen. Baldwin, Tammy [D-WI] - maternal health S. 334 - IMPACT to Save Moms Act - Sen. Casey, Robert P., Jr. [D-PA] - maternal health S. 345 - Maternal Vaccinations Act - Sen. Kaine, Tim [D-VA] - maternal health S. 346 - Black Maternal Health Momnibus Act of 2021 - Sen. Booker, Cory A. [D-NJ] - maternal health S. 347 - Data to Save Moms Act - Sen. Smith, Tina [D-MN] - maternal health S. 368 - Telehealth Modernization Act - Sen. Scott, Tim [R-SC] - telehealth S. 408 - Supporting Best Practices for Healthy Moms Act - Sen. Toomey, Pat [R-PA] - maternal health S. 411 - MOMMAs Act - Sen. Durbin, Richard J. [D-IL] - maternal health S. 851 - A bill to address social determinants of maternal health - Sen. Blumenthal, Richard [D-CT] - SDOH S. 983 - A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Sen. Whitehouse, Sheldon [D-RI] - public option S. 1333 - A bill to address maternal mortality and morbidity - Sen. Gillibrand, Kirsten E. [D-NY] - maternal health S. 1542 - MOMMIES Act - Sen. Booker, Cory A. [D-NJ] - maternal health S. 1622 - HEALTH for MOM Act of 2021 - Sen. Portman, Rob [R-OH] - maternal health S. 1704 - Telehealth Expansion Act of 2021 - Sen. Daines, Steve [R-MT] - telehealth S. 1804 - Mothers and Newborns Success Act - Sen. Kaine, Tim [D-VA] - maternal health S. 1833 - Ensuring Access to Primary Care for Women & Children Act - Sen. Brown, Sherrod [D-OH] - maternal health S. 1962 - Parity Implementation Assistance Act - Sen. Murphy, Christopher [D-CT] - mental health and SUD S. 1988 - Protecting Rural Telehealth Access Act - Sen. Manchin, Joe, III [D-WV] - telehealth S. 2061 - Telemental Health Care Access Act of 2021 - Sen. Cassidy, Bill [R-LA] - telehealth Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues related to Medicare Secondary Payer requirements; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health equity; issues related to vaccination; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; prescription drug pricing; telemedicine; rural health; issues related to behavioral health benefits; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues related to health insurance tax; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan and enhancements included in the American Rescue Plan Act (ARPA); issues related to Medicaid coverage gap; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; Rx reform; Prescription drugs; Prescription Drug Reform; H.R. 951 - Maternal Vaccination Act Sponsor: Rep. Terri Sewell (D-AL-07) H.R. 979 - Vaccine Fairness Act Sponsor: Rep. Angie Craig (D-MN-02) H.R. 1452 - To direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. Sponsor: Rep. Dan Crenshaw (R-TX-02) H.R. 1978 - Protecting Seniors Through Immunization 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) H.R. 3013 - COVID Vaccine Transportation Access Act Sponsor: Rep. Nanette Barragan (D-CA-44) H.R. 3655 - Vaccine Injury Compensation Modernization Act of 2021 Sponsor: Rep. Lloyd Doggett (D-TX-35) H.R. 3742 - Vaccine INFO Act Sponsor: Rep. Gus Bilirakis (R-FL-12) H.R. 3 - Lower Drug Costs Now Act Sponsor: Rep. Frank Pallone (D-NJ-06) H.R. 2831 - Prompt Approval of Safe Generic Drugs Act Sponsor: Rep. Nanette Barragan (D-CA-44)

Client expense: $124,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; Rx reform; Prescription drugs; Prescription Drug Reform; H.R. 550 - Immunization Infrastructure Modernization Act of 2021 Sponsor: Rep. Annie Kuster (D-NH-02) H.R. 3743 - Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act Sponsor: Rep. Richard Hudson (R-NC-08) H.R. 951 - Maternal Vaccination Act Sponsor: Rep. Terri Sewell (D-AL-07) H.R. 979 - Vaccine Fairness Act Sponsor: Rep. Angie Craig (D-MN-02) H.R. 1452 - To direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. Sponsor: Rep. Dan Crenshaw (R-TX-02) H.R. 1978 - Protecting Seniors Through Immunization 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) H.R. 3013 - COVID Vaccine Transportation Access Act Sponsor: Rep. Nanette Barragan (D-CA-44) H.R. 3655 - Vaccine Injury Compensation Modernization Act of 2021 Sponsor: Rep. Lloyd Doggett (D-TX-35) H.R. 3742 - Vaccine INFO Act Sponsor: Rep. Gus Bilirakis (R-FL-12) H.R. 3 - Lower Drug Costs Now Act Sponsor: Rep. Frank Pallone (D-NJ-06) H.R. 2831 - Prompt Approval of Safe Generic Drugs Act Sponsor: Rep. Nanette Barragan (D-CA-44)

Client expense: $1,650,000 · Firm income: Not reported

21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---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 ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---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) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---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.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---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 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the 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 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 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---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 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021

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

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

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; 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 951 (117th Congress), Maternal Vaccination Act, by Rep. Terri Sewell (D-AL). Directs the Secretary of Health and Human Services to carry out a national campaign to increase awareness of the importance of maternal vaccinations for the health of pregnant and postpartum individuals and their children. HR 979 (117th Congress), Vaccine Fairness Act, by Rep. Angie Craig (D-MN). Directs the Secretary of Health and Human Services to submit to Congress a weekly report on COVID-19 vaccine distribution. HR 1452 (117th Congress), by Rep. Dan Crenshaw (R-TX). Directs the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines. HR 1978 (117th Congress), Protecting Seniors Through Immunization Act of 2021, by Rep. Ann Kuster (D-NH). Amends 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. HR 2347 (117th Congress), Strengthening the Vaccines for Children Program Act of 2021, by Rep. Kim Schrier (D- WA). Amends title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program. HR 2831 (117th Congress), Prompt Approval of Safe Generic Drugs Act, by Rep. Nanette Diaz Barragan (D-CA). Amends the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling. HR 3013 (117th Congress), COVID Vaccine Transportation Access Act, by Rep. Nanette Diaz Barragan (D-CA). Authorizes the Secretary of Health and Human Services to award grants for removing transportation barriers to accessing vaccines for SARS-CoV-2, including booster vaccines, for individuals from low-income communities, minority communities, or other communities in which transportation poses a barrier to health care access. HR 3655 (117th Congress), Vaccine Injury Compensation Modernization Act of 2021, by Rep. Lloyd Doggett (D-TX). Amends the Public Health Service Act to make updates to the Vaccine Injury Compensation Program. 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. HR 3743 (117th Congress), Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act, by Rep. Richard Hudson (R-NC). Increases funding for the Reagan-Udall Foundation for the Food and Drug Administration and for the Foundation for the National Institutes of Health.

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; 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 951 (117th Congress), Maternal Vaccination Act, by Rep. Terri Sewell (D-AL). Directs the Secretary of Health and Human Services to carry out a national campaign to increase awareness of the importance of maternal vaccinations for the health of pregnant and postpartum individuals and their children. HR 979 (117th Congress), Vaccine Fairness Act, by Rep. Angie Craig (D-MN). Directs the Secretary of Health and Human Services to submit to Congress a weekly report on COVID-19 vaccine distribution. HR 1452 (117th Congress), by Rep. Dan Crenshaw (R-TX). Directs the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines. HR 1978 (117th Congress), Protecting Seniors Through Immunization Act of 2021, by Rep. Ann Kuster (D-NH). Amends 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. HR 2347 (117th Congress), Strengthening the Vaccines for Children Program Act of 2021, by Rep. Kim Schrier (D- WA). Amends title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program. HR 2831 (117th Congress), Prompt Approval of Safe Generic Drugs Act, by Rep. Nanette Diaz Barragan (D-CA). Amends the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling. HR 3013 (117th Congress), COVID Vaccine Transportation Access Act, by Rep. Nanette Diaz Barragan (D-CA). Authorizes the Secretary of Health and Human Services to award grants for removing transportation barriers to accessing vaccines for SARS-CoV-2, including booster vaccines, for individuals from low-income communities, minority communities, or other communities in which transportation poses a barrier to health care access. HR 3655 (117th Congress), Vaccine Injury Compensation Modernization Act of 2021, by Rep. Lloyd Doggett (D-TX). Amends the Public Health Service Act to make updates to the Vaccine Injury Compensation Program. 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. HR 3743 (117th Congress), Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act, by Rep. Richard Hudson (R-NC). Increases funding for the Reagan-Udall Foundation for the Food and Drug Administration and for the Foundation for the National Institutes of Health.