HAPI Act

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

Client expense: Not reported · Firm income: Not reported

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

H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers HR 5605 PrEP Assistance Act H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act H.R. 5376 Inflation Reduction Act - provisions related to vaccines and pharmaceuticals H.R. 4127: DISARM Act Act Provisions related to antimicrobial drug development H.R. 3932/S. 2076: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. H.R. 3655: Vaccine Injury Compensation Modernization Act H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) S. 912/H.R. 1978: Protecting Seniors Through Immunization Act H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Dietary Supplement Health and Education Act Reform Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Final Rule; Importation of Prescription Drugs Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022 Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property

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

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

H.R. 66 - CARING for Kids Act - Rep. Buchanan, Vern - CHIP H.R. 265 - Insular Area Medicaid Parity Act - Rep. Sablan, Gregorio Kilili Camacho - Medicaid funding H.R. 315 - Medicare Sequester COVID Moratorium Act - Rep. Schneider, Bradley Scott - Medicare sequestration H.R. 340 - Incentivizing Medicaid Expansion Act of 2021 - Rep. Veasey, Marc - Medicaid expansion H.R. 432 - Mental Health Access Improvement Act of 2021 - Rep. Thompson, Mike -Medicare coverage of marriage and family therapist services and mental health counselor H.R. 502 - Medicare Dental Benefit Act of 2021 - Rep. Barragan, Nanette Diaz - Medicare coverage of dental and oral health services H.R. 525 - COVID HCBS Relief Act of 2021 - Rep. Dingell, Debbie - increased FMAP for HCBS H.R. 871 - Expand Medicaid Now Act - Rep. Fletcher, Lizzie - FMAP H.R. 918 - Stronger Medicaid Response to the COVID-19 Pandemic Act - Rep. Cardenas, Tony - COVID-19 coverage for the uninsured via Medicaid H.R. 955 - Medicaid Reentry Act of 2021 - Rep. Tonko, Paul -Medicaid coverage for incarcerated individuals H.R. 1167 - Advancing Enrollment and Reducing Drug Costs Act of 2021 - Rep. Pappas, Chris - Medicaid eligibility for low-income subsidies H.R. 1227 - Medicare-X Choice Act of 2021 - Rep. Delgado, Antonio - Medicare public option H.R. 1332 - Telehealth Modernization Act - Rep. Carter, Earl - telehealth services under Medicare H.R. 1349 - The COVID-19 Hospital and Health Provider Loan Conversion Act of 2021- Rep. Kaptur, Marcy - advance payments under parts A and B of Medicare H.R. 1353 - Coronavirus Medicaid Response Act - Rep. Lee, Susie - FMAP H.R. 1390 - CHIPPER Act - Rep. Wild, Susan - CHIP funding H.R. 1397 - TIKES Act - Rep. Blunt Rochester, Lisa - telehealth under Medicaid and CHIP H.R. 1609 - Treatment in Place Act - Rep. Axne, Cynthia - Medicare coverage of ambulance services H.R. 1676 - Jack Reynolds Memory Medigap Expansion Act - Rep. Axne, Cynthia - Medigap coverage for ESRD H.R. 1677 - KEEP Telehealth Options Act of 2021 - Rep. Balderson, Troy - telehealth expansion H.R. 1717 - Protecting Married Seniors from Impoverishment Act of 2021 - Rep. Upton, Fred - permanent protections against spousal impoverishment H.R. 1722 - Puerto Rico Health Care Fairness, Accountability, and Beneficiary Access Act of 2021 - Rep. Velazquez, Nydia - Medicaid in Puerto Rico H.R. 1738 - Stabilize Medicaid and CHIP Coverage Act - Rep. Dingell, Debbie - Medicaid and CHIP continuous enrollment H.R. 1784 - Medicaid REACH Act - Rep. Doggett, Lloyd - requirements for non-expansion H.R. 1791 - CHIPP Act - Rep. Barragan, Nanette Diaz - extending CHIP H.R. 1792 - Ensuring Kids Have Access to Medically Necessary Dental Care Act - Rep. Barragan, Nanette Diaz - dental coverage under CHIP H.R. 1793 - Immediate Coverage for Former Foster Youth Act - Rep. Bass, Karen - Medicaid coverage for foster youth H.R. 1794 - Foster Youth Dental Act of 2021 - Rep. Bass, Karen - Medicaid dental coverage for foster youth H.R. 1823 - To amend title XIX of the Social Security Act to remove the matching requirement for a territory to use specially allocated Federal funds for Medicare covered part D drugs for low-income individuals - Resident Commissioner Gonzalez-Colon, Jenniffer - Medicare covered part D H.R. 1825 - Territories Medicare Prescription Drug Assistance Equality Act of 2021 - Resident Commissioner Gonzalez-Colon, Jenniffer - Medicare Part D premium and cost-sharing subsidies H.R. 1826 - Fairness in Medicare Part B Enrollment Act of 2021 - Resident Commissioner Gonzalez-Colon, Jenniffer - late enrollment penalties under part B of the Medicare program H.R. 1880 - To amend the Deficit Reduction Act of 2005 to make permanent the Money Follows the Person Rebalancing Demonstration - Rep. Dingell, Debbie - Money Follows the Person Rebalancing Demonstration H.R. 1885 - RUSH Protection Act of 2021 - Rep. Kind, Ron - Medicare rural health clinic payments H.R. 1887 - Rural Hospital Support Act - Rep. Reed, Tom - Medicare payments for hospitals H.R. 1890 - Health Insurance Consumer Protection Act - Rep. Schakowsky, Janice D. - network adequacy standards and premium rates H.R. 1914 - CAHOOTS Act - Rep. DeFazio, Peter A. - Medicaid mobile crisis intervention services H.R. 1969 - Medicare Advantage Integrity Act - Resident Commissioner Gonzalez-Colon, Jenniffer - disparity in MA benchmark rates H.R. 2035 - Improving Access to Mental Health Act of 2021 - Rep. Lee, Barbara - mental health services under Medicare H.R. 2080 - SAVE Act - Rep. Bishop, Sanford D., Jr. - Medicare coverage of transportation services H.R. 2166 - Ensuring Parity in MA and PACE for Audio-Only Telehealth Act of 2021 - Rep. Sewell, Terri - Medicare Advantage payments for audio-only diagnoses H.R. 2168 - Expanded Telehealth Access Act - Rep. Sherrill, Mikie - Medicare payment for telehealth services H.R. 2170 - HAPI Act - Rep. Soto, Darren - access to vaccines and Medicaid H.R. 2179 - Affordable Insulin for the COVID-19 Emergency Act - Rep. Waters, Maxine - cost-sharing regarding insulin coverage H.R. 2217 - Territory Federal Matching Requirement Equity Act of 2021 - Resident Commissioner Gonzalez-Colon, Jenniffer - Medicaid FMAP for Territories H.R. 2228 - Rural Behavioral Health Access Act of 2021 - Rep. Kildee, Daniel - Medicare coverage of outpatient telehealth services H.R. 4074 - Addressing Social Determinants in Medicare Advantage Act of 2021 - Rep. Bilirakis, Gus M. - Medicare Advantage supplemental benefits H.R. 4640 - Close the Medigap Act of 2021 - Rep. Doggett, Lloyd - Medigap policies H.R. 6833 - Affordable Insulin Now Act - Rep. Craig, Angie - Insulin prices and cost sharing S. 150 - Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 - Sen. Cortez-Masto, Catherine - coverage of audio-only telehealth services in MA S. 151 - COVID HCBS Relief Act of 2021 - Sen. Casey, Robert - FMAP and HCBS S. 245 - SAME Act of 2021 - Sen. Warner, Mark - Medicaid expansion S. 274 - Stronger Medicaid Response to the COVID-19 Pandemic Act - Sen. Bennet, Michael - COVID-19 coverage for the uninsured via Medicaid S. 285 - Medicaid Reentry Act of 2021 - Sen. Baldwin, Tammy - Medicaid coverage for incarcerated individuals S. 368 - Telehealth Modernization Act - Sen. Scott, Tim - coverage of telehealth services under Medicare S. 386 - Medicare-X Choice Act of 2021 - Sen. Bennet, Michael - Medicare public option S. 439 - Coronavirus Medicaid Response Act - Sen. Casey, Robert - increases FMAP S. 440 - Continued Funding for Senior Services During COVID-19 Act - Sen. Casey, Robert - funding for services under the Older Americans Act of 1965 S. 453 - CHIPPER Act - Sen. Casey, Robert - CHIP funding S. 581 - HAPI Act -Sen. Brown, Sherrod - vaccines under Medicaid S. 620 - KEEP Telehealth Options Act of 2021 - Sen. Fischer, Deb - telehealth expansion S. 644 - Rural Hospital Closure Relief Act of 2021 - Sen. Durbin, Richard - Medicare coverage for critical access hospitals S. 646 - Stabilize Medicaid and CHIP Coverage Act of 2021 - Sen. Brown, Sherrod - Medicaid and CHIP enrollment S. 653 - COMP Act - Sen. Portman, Rob - Medicare secondary payer rules S. 712 - Dosha Joi Immediate Coverage for Former Foster Youth Act - Sen. Casey, Robert P., Jr. - Medicaid coverage for foster youth S. 748 - Medicare Sequester Relief Act - Sen. Shaheen, Jeanne - Medicare payment sequestration S. 764 - CAHOOTS Act - Sen. Wyden, Ron - Medicaid mobile crisis intervention services S. 826 - Medicare Patient Empowerment Act of 2021 - Sen. Paul, Rand - Medicaid payment options S. 870 - Improving Access to Mental Health Act of 2021 - Sen. Stabenow, Debbie - mental health services in Medicare S. 999 - Save Rural Hospitals Act of 2021 - Sen. Warner, Mark - Medicare hospital payments Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues including proposed RADV regulation for MA; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2023 policy and technical regulation for MA and Part D; issues related to Medicare for All, Medicare buy-in, reduced Medicare eligibility age, and public option; issues relating to 2023 Rate Notice; issues related to coverage in non-Medicaid Expansion States (e.g., Gap Population); issues related to expanded Medicare fee for service benefits (dental, hearing and vision); issues related to Medicaid coverage gap; issues related to specialty infant formula; issues related to the Inflation Reduction Act passage and implementation; contraceptive coverage and reproductive health; Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; issues related to Managed Long Term Services and Supports (MLTSS); issues related to removal of safe harbor protection for rebates; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to the end of the public health emergency; telehealth; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; issues related to health equity; issues related to vaccination; issues related to audio-only telehealth; issues related to addressing the social determinants of health, including housing, transportation, nutrition, educational opportunities, and MA supplemental benefits; issues related to Medicaid presumptive eligibility and continuous eligibility; issues relating to Medicaid best price; in-home health risk assessments; Medicare Medical Loss Ratio issues; issues related to changes to prior authorization regulations or legislation, electronic documentation, and related issues; issues relating to sequestration under the Medicare Advantage and Part D programs; implications of physician fee schedule on MA; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); issues related to the international price index; issues related to child and maternal health; issues related to Medicaid supplemental and disproportionate share hospital (DSH) funding; issues related to Medicaid funding for territories; issues related to medical management; issues relating to MA supplemental benefits; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value based payment models; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; issues relating to MACRA, including implications for MA and Part D plans; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); issues relating to potential Medicare mental health parity requirements; Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the Affordable Care Act (ACA) including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation. *Add MACPAC to Agency List.

Client expense: $3,230,000 · Firm income: Not reported

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

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

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

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

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

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

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related to tobacco cessation; Issues related to health inequities; Issues related to Medicaid waivers; Issues related to the Affordable Care Act; Issues related to supplemental oxygen; Issues related to access to healthcare; Issues related to COVID-19 Response; Issues related to Medicaid coverage for immigrants; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to health equity; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to FY23 appropriations bills; Issues relating to the Presidents FY24 budget H.R. 8295 Labor HHS Appropriations bill; S. 4659 Labor HHS Appropriations bill; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581 HAPI Act; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.2170 HAPI Act; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.5376 Build Back Better Act/Inflation Reduction Act; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021;; S. 3332 Let States Innovate Under Medicaid Act; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; H.R. 7845 NIH Clinical Trial Diversity Act of 2022; H.R. 6833 Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023

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

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues relating to the Presidents FY24 budget; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to FY23 appropriations bills; Issues related to Cancer Moonshot; Issues related to Implementation of ACA; Issues related to Short-Term Limited Duration Plans; Issues related to Healthy Future Taskforce, H.R. 8295 Labor HHS Appropriations bill; S. 4659 Labor HHS Appropriations bill; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581HAPI Act; H.R.379 Improving Social Determinants of Health Act of 2021; H.R.526 Ensuring Coverage in Public Health Emergencies Act of 2021; H.R.1872 To amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities, and for other purposes; H.R.1874 To amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; H.R.1875 To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage; H.R.1878 To amend the Patient Protection and Affordable Care Act to establish a health insurance affordability fund, and for other purposes; H.R.1888 To amend title XIX of the Social Security Act to require a Federal medical assistance percentage of 100 percent for Indian health care providers, and for other purposes; H.R.1890 To amend the Patient Protection and Affordable Care Act to require Exchanges to establish network adequacy standards for qualified health plans and amend the Public Health Service Act to provide protections for consumers against excessive, unjustified, or unfairly discriminatory increases in premium rates; S.104 Improving Social Determinants of Health Act of 2021; S.779 Protecting Americans with Pre-Existing Conditions Act of 2021; S.942 A bill to provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect; H.R.1790 To amend the Patient Protection and Affordable Care Act to require the Secretary of Health and Human Services to set forth a method of determining maximum out-of-pocket limits and annual updates to premium tax credit eligibility; H.R.550 Immunization Infrastructure Modernization Act of 2021; H.R.736 Community Immunity During COVID-19 Act of 202; H.R.791 Tracking COVID-19 Variants Act; H.R.1268 Building COVID-19 Vaccine Confidence Act of 2021; S.167 Community Immunity During COVID-19 Act of 2021; S.236 Tracking COVID-19 Variants Act; H.R.173 COVID-19 Prevention and Awareness Act of 2021;; H.R.959 Black Maternal Health Momnibus Act of 2021; H.R.3904 Reducing COVID-19 Disparities by Investing in Public Health Act; H.R.2170 HAPI Act; S.1314 Tobacco Tax Equity Act of 2021; H.R.2786 Tobacco Tax Equity Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.3749 Katherines Law for Lung Cancer Early Detection and Survival Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; S.1424 Chronic Disease Management Act of 2021; H.R.3883 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S.2043 A bill to amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; H.R.5376 Build Back Better Act/Inflation Reduction Act; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021; S.674 Public Health Infrastructure Saves Lives Act; Health Equity and Accountability Act; H.R.5030 DIVERSE Trials Act; S.2706 DIVERSE Trials Act; H.R.6302 Protecting the Health of Americas Older Adults Act; S.J.Res.29 A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to "COVID-19 Vaccination and Testing; Emergency Temporary Standard"; S.Res.462 A resolution designating November 2021 as "National Lung Cancer Awareness Month" and expressing support for early detection and treatment of lung cancer;; H.R.2909 To amend the Internal Revenue Code of 1986 to allow a one-time election for a qualified charitable distribution to a split-interest entity and to inflation adjust the limits for qualified charitable distributions.; H.R.2954 Securing a Strong Retirement Act of 2021; H.R. 7055 Elijah E. Cummings Family Asthma Act; S. 3332 Let States Innovate Under Medicaid Act; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; H.R. 7845 NIH Clinical Trial Diversity Act of 2022; S. 3373 Honoring our PACT Act of 2022; H.R. 3967 Honoring our PACT Act of 2022; H.R. 6833 Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023; H.R. 8885 Better Health Care Directories Act

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

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

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

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

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

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

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

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

Part D cost sharing. Eliminating costs sharing in Medicare and Medicaid through Budget reconciliation. H.R.1978/S.912 - Protecting Seniors Through Immunization Act of 2021. H.R.2170/S.581 - Helping Adults Protect Immunity (HAPI) Act.

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

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues relating to the Presidents FY23 budget; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to FY23 appropriations bills; Issues related to Cancer Moonshot; Issues related to Implementation of ACA; Issues related to Short-Term Limited Duration Plans; Issues related to Healthy Future Taskforce, House Labor HHS Appropriations bill; Senate Labor HHS Appropriations bill;; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581HAPI Act; H.R.379 Improving Social Determinants of Health Act of 2021; H.R.526 Ensuring Coverage in Public Health Emergencies Act of 2021; H.R.1872 To amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities, and for other purposes; H.R.1874 To amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; H.R.1875 To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage; H.R.1878 To amend the Patient Protection and Affordable Care Act to establish a health insurance affordability fund, and for other purposes; H.R.1888 To amend title XIX of the Social Security Act to require a Federal medical assistance percentage of 100 percent for Indian health care providers, and for other purposes; H.R.1890 To amend the Patient Protection and Affordable Care Act to require Exchanges to establish network adequacy standards for qualified health plans and amend the Public Health Service Act to provide protections for consumers against excessive, unjustified, or unfairly discriminatory increases in premium rates; S.104 Improving Social Determinants of Health Act of 2021; S.779 Protecting Americans with Pre-Existing Conditions Act of 2021; S.942 A bill to provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect; H.R.1790 To amend the Patient Protection and Affordable Care Act to require the Secretary of Health and Human Services to set forth a method of determining maximum out-of-pocket limits and annual updates to premium tax credit eligibility; H.R.550 Immunization Infrastructure Modernization Act of 2021; H.R.736 Community Immunity During COVID-19 Act of 202; H.R.791 Tracking COVID-19 Variants Act; H.R.1268 Building COVID-19 Vaccine Confidence Act of 2021; S.167 Community Immunity During COVID-19 Act of 2021; S.236 Tracking COVID-19 Variants Act; H.R.173 COVID-19 Prevention and Awareness Act of 2021;; H.R.959 Black Maternal Health Momnibus Act of 2021; H.R.3904 Reducing COVID-19 Disparities by Investing in Public Health Act; H.R.2170 HAPI Act; S.1314 Tobacco Tax Equity Act of 2021; H.R.2786 Tobacco Tax Equity Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.3749 Katherines Law for Lung Cancer Early Detection and Survival Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; S.1424 Chronic Disease Management Act of 2021; H.R.3883 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S.2043 A bill to amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; H.R.5376 Build Back Better Act; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021; S.674 Public Health Infrastructure Saves Lives Act; Health Equity and Accountability Act; H.R.5030 DIVERSE Trials Act; S.2706 DIVERSE Trials Act; H.R.6302 Protecting the Health of Americas Older Adults Act; S.J.Res.29 A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to "COVID-19 Vaccination and Testing; Emergency Temporary Standard"; S.Res.462 A resolution designating November 2021 as "National Lung Cancer Awareness Month" and expressing support for early detection and treatment of lung cancer;; H.R.2909 To amend the Internal Revenue Code of 1986 to allow a one-time election for a qualified charitable distribution to a split-interest entity and to inflation adjust the limits for qualified charitable distributions.; H.R.2954 Securing a Strong Retirement Act of 2021; H.R. 7055 Elijah E. Cummings Family Asthma Act; S. 3332 Let States Innovate Under Medicaid Act; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; H.R. 7845 NIH Clinical Trial Diversity Act of 2022

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

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related to tobacco cessation; Issues related to health inequities; Issues related to Medicaid waivers; Issues related to the Affordable Care Act; Issues related to supplemental oxygen; Issues related to access to healthcare; Issues related to COVID-19 Response; Issues related to Medicaid coverage for immigrants; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to health equity; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to FY23 appropriations bills; Issues relating to the Presidents FY23 budget; House Labor HHS Appropriations bill; Senate Labor HHS Appropriations bill; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581 HAPI Act; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.2170 HAPI Act; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.5376 Build Back Better Act; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021;; S. 3332 Let States Innovate Under Medicaid Act; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; H.R. 7845 NIH Clinical Trial Diversity Act of 2022

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

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

H.R. 66 - CARING for Kids Act - Rep. Buchanan, Vern - CHIP H.R. 265 - Insular Area Medicaid Parity Act - Rep. Sablan, Gregorio Kilili Camacho - Medicaid funding H.R. 315 - Medicare Sequester COVID Moratorium Act - Rep. Schneider, Bradley Scott - Medicare sequestration H.R. 340 - Incentivizing Medicaid Expansion Act of 2021 - Rep. Veasey, Marc - Medicaid expansion H.R. 432 - Mental Health Access Improvement Act of 2021 - Rep. Thompson, Mike -Medicare coverage of marriage and family therapist services and mental health counselor H.R. 502 - Medicare Dental Benefit Act of 2021 - Rep. Barragan, Nanette Diaz - Medicare coverage of dental and oral health services H.R. 525 - COVID HCBS Relief Act of 2021 - Rep. Dingell, Debbie - increased FMAP for HCBS H.R. 871 - Expand Medicaid Now Act - Rep. Fletcher, Lizzie - FMAP H.R. 918 - Stronger Medicaid Response to the COVID-19 Pandemic Act - Rep. Cardenas, Tony - COVID-19 coverage for the uninsured via Medicaid H.R. 955 - Medicaid Reentry Act of 2021 - Rep. Tonko, Paul -Medicaid coverage for incarcerated individuals H.R. 1167 - Advancing Enrollment and Reducing Drug Costs Act of 2021 - Rep. Pappas, Chris - Medicaid eligibility for low-income subsidies H.R. 1227 - Medicare-X Choice Act of 2021 - Rep. Delgado, Antonio - Medicare public option H.R. 1332 - Telehealth Modernization Act - Rep. Carter, Earl - telehealth services under Medicare H.R. 1349 - The COVID-19 Hospital and Health Provider Loan Conversion Act of 2021- Rep. Kaptur, Marcy - advance payments under parts A and B of Medicare H.R. 1353 - Coronavirus Medicaid Response Act - Rep. Lee, Susie - FMAP H.R. 1390 - CHIPPER Act - Rep. Wild, Susan - CHIP funding H.R. 1397 - TIKES Act - Rep. Blunt Rochester, Lisa - telehealth under Medicaid and CHIP H.R. 1609 - Treatment in Place Act - Rep. Axne, Cynthia - Medicare coverage of ambulance services H.R. 1676 - Jack Reynolds Memory Medigap Expansion Act - Rep. Axne, Cynthia - Medigap coverage for ESRD H.R. 1677 - KEEP Telehealth Options Act of 2021 - Rep. Balderson, Troy - telehealth expansion H.R. 1717 - Protecting Married Seniors from Impoverishment Act of 2021 - Rep. Upton, Fred - permanent protections against spousal impoverishment H.R. 1722 - Puerto Rico Health Care Fairness, Accountability, and Beneficiary Access Act of 2021 - Rep. Velazquez, Nydia - Medicaid in Puerto Rico H.R. 1738 - Stabilize Medicaid and CHIP Coverage Act - Rep. Dingell, Debbie - Medicaid and CHIP continuous enrollment H.R. 1784 - Medicaid REACH Act - Rep. Doggett, Lloyd - requirements for non-expansion H.R. 1791 - CHIPP Act - Rep. Barragan, Nanette Diaz - extending CHIP H.R. 1792 - Ensuring Kids Have Access to Medically Necessary Dental Care Act - Rep. Barragan, Nanette Diaz - dental coverage under CHIP H.R. 1793 - Immediate Coverage for Former Foster Youth Act - Rep. Bass, Karen - Medicaid coverage for foster youth H.R. 1794 - Foster Youth Dental Act of 2021 - Rep. Bass, Karen - Medicaid dental coverage for foster youth H.R. 1823 - To amend title XIX of the Social Security Act to remove the matching requirement for a territory to use specially allocated Federal funds for Medicare covered part D drugs for low-income individuals - Resident Commissioner Gonzalez-Colon, Jenniffer - Medicare covered part D H.R. 1825 - Territories Medicare Prescription Drug Assistance Equality Act of 2021 - Resident Commissioner Gonzalez-Colon, Jenniffer - Medicare Part D premium and cost-sharing subsidies H.R. 1826 - Fairness in Medicare Part B Enrollment Act of 2021 - Resident Commissioner Gonzalez-Colon, Jenniffer - late enrollment penalties under part B of the Medicare program H.R. 1880 - To amend the Deficit Reduction Act of 2005 to make permanent the Money Follows the Person Rebalancing Demonstration - Rep. Dingell, Debbie - Money Follows the Person Rebalancing Demonstration H.R. 1885 - RUSH Protection Act of 2021 - Rep. Kind, Ron - Medicare rural health clinic payments H.R. 1887 - Rural Hospital Support Act - Rep. Reed, Tom - Medicare payments for hospitals H.R. 1890 - Health Insurance Consumer Protection Act - Rep. Schakowsky, Janice D. - network adequacy standards and premium rates H.R. 1914 - CAHOOTS Act - Rep. DeFazio, Peter A. - Medicaid mobile crisis intervention services H.R. 1969 - Medicare Advantage Integrity Act - Resident Commissioner Gonzalez-Colon, Jenniffer - disparity in MA benchmark rates H.R. 2035 - Improving Access to Mental Health Act of 2021 - Rep. Lee, Barbara - mental health services under Medicare H.R. 2080 - SAVE Act - Rep. Bishop, Sanford D., Jr. - Medicare coverage of transportation services H.R. 2166 - Ensuring Parity in MA and PACE for Audio-Only Telehealth Act of 2021 - Rep. Sewell, Terri - Medicare Advantage payments for audio-only diagnoses H.R. 2168 - Expanded Telehealth Access Act - Rep. Sherrill, Mikie - Medicare payment for telehealth services H.R. 2170 - HAPI Act - Rep. Soto, Darren - access to vaccines and Medicaid H.R. 2179 - Affordable Insulin for the COVID-19 Emergency Act - Rep. Waters, Maxine - cost-sharing regarding insulin coverage H.R. 2217 - Territory Federal Matching Requirement Equity Act of 2021 - Resident Commissioner Gonzalez-Colon, Jenniffer - Medicaid FMAP for Territories H.R. 2228 - Rural Behavioral Health Access Act of 2021 - Rep. Kildee, Daniel - Medicare coverage of outpatient telehealth services H.R. 4074 - Addressing Social Determinants in Medicare Advantage Act of 2021 - Rep. Bilirakis, Gus M. - Medicare Advantage supplemental benefits H.R. 4640 - Close the Medigap Act of 2021 - Rep. Doggett, Lloyd - Medigap policies H.R. 6833 - Affordable Insulin Now Act - Rep. Craig, Angie - Insulin prices and cost sharing S. 150 - Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 - Sen. Cortez-Masto, Catherine - coverage of audio-only telehealth services in MA S. 151 - COVID HCBS Relief Act of 2021 - Sen. Casey, Robert - FMAP and HCBS S. 245 - SAME Act of 2021 - Sen. Warner, Mark - Medicaid expansion S. 274 - Stronger Medicaid Response to the COVID-19 Pandemic Act - Sen. Bennet, Michael - COVID-19 coverage for the uninsured via Medicaid S. 285 - Medicaid Reentry Act of 2021 - Sen. Baldwin, Tammy - Medicaid coverage for incarcerated individuals S. 368 - Telehealth Modernization Act - Sen. Scott, Tim - coverage of telehealth services under Medicare S. 386 - Medicare-X Choice Act of 2021 - Sen. Bennet, Michael - Medicare public option S. 439 - Coronavirus Medicaid Response Act - Sen. Casey, Robert - increases FMAP S. 440 - Continued Funding for Senior Services During COVID-19 Act - Sen. Casey, Robert - funding for services under the Older Americans Act of 1965 S. 453 - CHIPPER Act - Sen. Casey, Robert - CHIP funding S. 581 - HAPI Act -Sen. Brown, Sherrod - vaccines under Medicaid S. 620 - KEEP Telehealth Options Act of 2021 - Sen. Fischer, Deb - telehealth expansion S. 644 - Rural Hospital Closure Relief Act of 2021 - Sen. Durbin, Richard - Medicare coverage for critical access hospitals S. 646 - Stabilize Medicaid and CHIP Coverage Act of 2021 - Sen. Brown, Sherrod - Medicaid and CHIP enrollment S. 653 - COMP Act - Sen. Portman, Rob - Medicare secondary payer rules S. 712 - Dosha Joi Immediate Coverage for Former Foster Youth Act - Sen. Casey, Robert P., Jr. - Medicaid coverage for foster youth S. 748 - Medicare Sequester Relief Act - Sen. Shaheen, Jeanne - Medicare payment sequestration S. 764 - CAHOOTS Act - Sen. Wyden, Ron - Medicaid mobile crisis intervention services S. 826 - Medicare Patient Empowerment Act of 2021 - Sen. Paul, Rand - Medicaid payment options S. 870 - Improving Access to Mental Health Act of 2021 - Sen. Stabenow, Debbie - mental health services in Medicare S. 999 - Save Rural Hospitals Act of 2021 - Sen. Warner, Mark - Medicare hospital payments Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues including proposed RADV regulation for MA; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2023 policy and technical regulation for MA and Part D; Part D reform, out of pocket limits; issues related to Medicare for All, Medicare buy-in, reduced Medicare eligibility age, and public option; issues relating to 2023 Rate Notice; issues related to coverage in non-Medicaid Expansion States (e.g., Gap Population); issues related to expanded Medicare fee for service benefits (dental, hearing and vision); issues related to Medicaid coverage gap; contraceptive coverage and reproductive health; Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to MLTSS; issues related to removal of safe harbor protection for rebates; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to the end of the public health emergency; telehealth; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; issues related to health equity; issues related to vaccination; issues related to audio-only telehealth; issues related to addressing the social determinants of health, including housing, transportation, nutrition, educational opportunities, and MA supplemental benefits; issues related to Medicaid presumptive eligibility and continuous eligibility; issues relating to Medicaid best price; in-home health risk assessments; Medicare Medical Loss Ratio issues; issues related to changes to prior authorization regulations or legislation, electronic documentation, and related issues; issues relating to sequestration under the Medicare Advantage and Part D programs; implications of physician fee schedule on MA; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); issues related to the international price index; issues related to child and maternal health; issues related to Medicaid supplemental and disproportionate share hospital (DSH) funding; issues related to Medicaid funding for territories; issues related to medical management; issues relating to MA supplemental benefits; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value based payment models; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; issues relating to MACRA, including implications for MA and Part D plans; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); issues relating to potential Medicare mental health parity requirements; Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the Affordable Care Act (ACA) including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

Client expense: $2,890,000 · Firm income: Not reported

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 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

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

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

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

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

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

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

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

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

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

H.R. 66 - CARING for Kids Act - Rep. Buchanan, Vern - CHIP H.R. 265 - Insular Area Medicaid Parity Act - Rep. Sablan, Gregorio Kilili Camacho - Medicaid funding H.R. 315 - Medicare Sequester COVID Moratorium Act - Rep. Schneider, Bradley Scott - Medicare sequestration H.R. 340 - Incentivizing Medicaid Expansion Act of 2021 - Rep. Veasey, Marc - Medicaid expansion H.R. 432 - Mental Health Access Improvement Act of 2021 - Rep. Thompson, Mike -Medicare coverage of marriage and family therapist services and mental health counselor H.R. 502 - Medicare Dental Benefit Act of 2021 - Rep. Barragan, Nanette Diaz - Medicare coverage of dental and oral health services H.R. 525 - COVID HCBS Relief Act of 2021 - Rep. Dingell, Debbie - increased FMAP for HCBS H.R. 871 - Expand Medicaid Now Act - Rep. Fletcher, Lizzie - FMAP H.R. 918 - Stronger Medicaid Response to the COVID-19 Pandemic Act - Rep. Cardenas, Tony - COVID-19 coverage for the uninsured via Medicaid H.R. 955 - Medicaid Reentry Act of 2021 - Rep. Tonko, Paul -Medicaid coverage for incarcerated individuals H.R. 1167 - Advancing Enrollment and Reducing Drug Costs Act of 2021 - Rep. Pappas, Chris - Medicaid eligibility for low-income subsidies H.R. 1227 - Medicare-X Choice Act of 2021 - Rep. Delgado, Antonio - Medicare public option H.R. 1332 - Telehealth Modernization Act - Rep. Carter, Earl - telehealth services under Medicare H.R. 1349 - The COVID-19 Hospital and Health Provider Loan Conversion Act of 2021- Rep. Kaptur, Marcy - advance payments under parts A and B of Medicare H.R. 1353 - Coronavirus Medicaid Response Act - Rep. Lee, Susie - FMAP H.R. 1390 - CHIPPER Act - Rep. Wild, Susan - CHIP funding H.R. 1397 - TIKES Act - Rep. Blunt Rochester, Lisa - telehealth under Medicaid and CHIP H.R. 1609 - Treatment in Place Act - Rep. Axne, Cynthia - Medicare coverage of ambulance services H.R. 1676 - Jack Reynolds Memory Medigap Expansion Act - Rep. Axne, Cynthia - Medigap coverage for ESRD H.R. 1677 - KEEP Telehealth Options Act of 2021 - Rep. Balderson, Troy - telehealth expansion H.R. 1717 - Protecting Married Seniors from Impoverishment Act of 2021 - Rep. Upton, Fred - permanent protections against spousal impoverishment H.R. 1722 - Puerto Rico Health Care Fairness, Accountability, and Beneficiary Access Act of 2021 - Rep. Velazquez, Nydia - Medicaid in Puerto Rico H.R. 1738 - Stabilize Medicaid and CHIP Coverage Act - Rep. Dingell, Debbie - Medicaid and CHIP continuous enrollment H.R. 1784 - Medicaid REACH Act - Rep. Doggett, Lloyd - requirements for non-expansion H.R. 1791 - CHIPP Act - Rep. Barragan, Nanette Diaz - extending CHIP H.R. 1792 - Ensuring Kids Have Access to Medically Necessary Dental Care Act - Rep. Barragan, Nanette Diaz - dental coverage under CHIP H.R. 1793 - Immediate Coverage for Former Foster Youth Act - Rep. Bass, Karen - Medicaid coverage for foster youth H.R. 1794 - Foster Youth Dental Act of 2021 - Rep. Bass, Karen - Medicaid dental coverage for foster youth H.R. 1823 - To amend title XIX of the Social Security Act to remove the matching requirement for a territory to use specially allocated Federal funds for Medicare covered part D drugs for low-income individuals - Resident Commissioner Gonzalez-Colon, Jenniffer - Medicare covered part D H.R. 1825 - Territories Medicare Prescription Drug Assistance Equality Act of 2021 - Resident Commissioner Gonzalez-Colon, Jenniffer - Medicare Part D premium and cost-sharing subsidies H.R. 1826 - Fairness in Medicare Part B Enrollment Act of 2021 - Resident Commissioner Gonzalez-Colon, Jenniffer - late enrollment penalties under part B of the Medicare program H.R. 1880 - To amend the Deficit Reduction Act of 2005 to make permanent the Money Follows the Person Rebalancing Demonstration - Rep. Dingell, Debbie - Money Follows the Person Rebalancing Demonstration H.R. 1885 - RUSH Protection Act of 2021 - Rep. Kind, Ron - Medicare rural health clinic payments H.R. 1887 - Rural Hospital Support Act - Rep. Reed, Tom - Medicare payments for hospitals H.R. 1890 - Health Insurance Consumer Protection Act - Rep. Schakowsky, Janice D. - network adequacy standards and premium rates H.R. 1914 - CAHOOTS Act - Rep. DeFazio, Peter A. - Medicaid mobile crisis intervention services H.R. 1969 - Medicare Advantage Integrity Act - Resident Commissioner Gonzalez-Colon, Jenniffer - disparity in MA benchmark rates H.R. 2035 - Improving Access to Mental Health Act of 2021 - Rep. Lee, Barbara - mental health services under Medicare H.R. 2080 - SAVE Act - Rep. Bishop, Sanford D., Jr. - Medicare coverage of transportation services H.R. 2166 - Ensuring Parity in MA and PACE for Audio-Only Telehealth Act of 2021 - Rep. Sewell, Terri - Medicare Advantage payments for audio-only diagnoses H.R. 2168 - Expanded Telehealth Access Act - Rep. Sherrill, Mikie - Medicare payment for telehealth services H.R. 2170 - HAPI Act - Rep. Soto, Darren - access to vaccines and Medicaid H.R. 2179 - Affordable Insulin for the COVID-19 Emergency Act - Rep. Waters, Maxine - cost-sharing regarding insulin coverage H.R. 2217 - Territory Federal Matching Requirement Equity Act of 2021 - Resident Commissioner Gonzalez-Colon, Jenniffer - Medicaid FMAP for Territories H.R. 2228 - Rural Behavioral Health Access Act of 2021 - Rep. Kildee, Daniel - Medicare coverage of outpatient telehealth services H.R. 4074 - Addressing Social Determinants in Medicare Advantage Act of 2021 - Rep. Bilirakis, Gus M. - Medicare Advantage supplemental benefits H.R. 4640 - Close the Medigap Act of 2021 - Rep. Doggett, Lloyd -- Medigap policies H.R. 6833 - Affordable Insulin Now Act - Rep. Craig, Angie - Insulin prices and cost sharing S. 150 - Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 - Sen. Cortez-Masto, Catherine - coverage of audio-only telehealth services in MA S. 151 - COVID HCBS Relief Act of 2021 - Sen. Casey, Robert - FMAP and HCBS S. 245 - SAME Act of 2021 - Sen. Warner, Mark - Medicaid expansion S. 274 - Stronger Medicaid Response to the COVID-19 Pandemic Act - Sen. Bennet, Michael - COVID-19 coverage for the uninsured via Medicaid S. 285 - Medicaid Reentry Act of 2021 - Sen. Baldwin, Tammy - Medicaid coverage for incarcerated individuals S. 368 - Telehealth Modernization Act - Sen. Scott, Tim - coverage of telehealth services under Medicare S. 386 - Medicare-X Choice Act of 2021 - Sen. Bennet, Michael - Medicare public option S. 439 - Coronavirus Medicaid Response Act - Sen. Casey, Robert - increases FMAP S. 440 - Continued Funding for Senior Services During COVID-19 Act - Sen. Casey, Robert - funding for services under the Older Americans Act of 1965 S. 453 - CHIPPER Act - Sen. Casey, Robert - CHIP funding S. 581 - HAPI Act -Sen. Brown, Sherrod - vaccines under Medicaid S. 620 - KEEP Telehealth Options Act of 2021 - Sen. Fischer, Deb - telehealth expansion S. 644 - Rural Hospital Closure Relief Act of 2021 - Sen. Durbin, Richard - Medicare coverage for critical access hospitals S. 646 - Stabilize Medicaid and CHIP Coverage Act of 2021 - Sen. Brown, Sherrod - Medicaid and CHIP enrollment S. 653 - COMP Act - Sen. Portman, Rob - Medicare secondary payer rules S. 712 - Dosha Joi Immediate Coverage for Former Foster Youth Act - Sen. Casey, Robert P., Jr. - Medicaid coverage for foster youth S. 748 - Medicare Sequester Relief Act - Sen. Shaheen, Jeanne - Medicare payment sequestration S. 764 - CAHOOTS Act - Sen. Wyden, Ron - Medicaid mobile crisis intervention services S. 826 - Medicare Patient Empowerment Act of 2021 - Sen. Paul, Rand - Medicaid payment options S. 870 - Improving Access to Mental Health Act of 2021 - Sen. Stabenow, Debbie - mental health services in Medicare S. 999 - Save Rural Hospitals Act of 2021 - Sen. Warner, Mark - Medicare hospital payments Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues including proposed RADV regulation for MA; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2023 policy and technical regulation for MA and Part D; Part D reform, out of pocket limits; issues related to Medicare for All, Medicare buy-in, reduced Medicare eligibility age, and public option; issues relating to 2023 Rate Notice; issues related to coverage in non-Medicaid Expansion States (e.g., Gap Population); issues related to expanded Medicare fee for service benefits (dental, hearing and vision); issues related to Medicaid coverage gap; Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to MLTSS; issues related to removal of safe harbor protection for rebates; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to the end of the public health emergency; telehealth; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; issues related to health equity; issues related to vaccination; issues related to audio-only telehealth; issues related to addressing the social determinants of health, including housing, transportation, nutrition, educational opportunities, and MA supplemental benefits; issues related to Medicaid presumptive eligibility and continuous eligibility; issues relating to Medicaid best price; in-home health risk assessments; Medicare Medical Loss Ratio issues; issues related to changes to prior authorization regulations, electronic documentation, and related issues; issues relating to sequestration under the Medicare Advantage and Part D programs; implications of physician fee schedule on MA; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); issues related to the international price index; issues related to child and maternal health; issues related to Medicaid supplemental and disproportionate share hospital (DSH) funding; issues related to Medicaid funding for territories; issues related to medical management; issues relating to MA supplemental benefits; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value based payment models; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; issues relating to MACRA, including implications for MA and Part D plans; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the Affordable Care Act (ACA) including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

Client expense: $4,680,000 · Firm income: Not reported

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

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

Client expense: $3,170,000 · Firm income: Not reported

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing-Related Provisions ---Immunization Information Systems 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.133: Consolidated Appropriations Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions 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 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.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R3932/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.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations

Client expense: $3,170,000 · Firm income: Not reported

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

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

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

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

Part D cost sharing. Quality measures for vaccines. H.R.1978/S.912 - Protecting Seniors Through Immunization Act of 2021. H.R.2170/S.581 - Helping Adults Protect Immunity (HAPI) Act.

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

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related to tobacco cessation; Issues related to health inequities; Issues related to Medicaid waivers; Issues related to the Affordable Care Act; Issues related to supplemental oxygen; Issues related to access to healthcare; Issues related to COVID-19 Response; Issues related to Medicaid coverage for immigrants; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to health equity; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to FY23 appropriations bills; Issues relating to the Presidents FY23 budget;H.R.4502 House Labor HHS Appropriations bill; S.3062 Senate Labor HHS Appropriations bill; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581 HAPI Act; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.2170 HAPI Act; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.5376 Build Back Better Act; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021; H.R.2471 FY22 Consolidated Appropriations Act, 2022; H.R.6617 Further Additional Extending Government Funding Act; S. 3332 Let States Innovate Under Medicaid Act;

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

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues relating to the Presidents FY23 budget; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to FY23 appropriations bills; Issues related to Cancer Moonshot; Issues related to Implementation of ACA; Issues related to Short-Term Limited Duration Plans; Issues related to Healthy Future TaskforceH.R.4502 House Labor HHS Appropriations bill; S.3062 Senate Labor HHS Appropriations bill;; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581HAPI Act; H.R.379 Improving Social Determinants of Health Act of 2021; H.R.526 Ensuring Coverage in Public Health Emergencies Act of 2021; H.R.1872 To amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities, and for other purposes; H.R.1874 To amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; H.R.1875 To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage; H.R.1878 To amend the Patient Protection and Affordable Care Act to establish a health insurance affordability fund, and for other purposes; H.R.1888 To amend title XIX of the Social Security Act to require a Federal medical assistance percentage of 100 percent for Indian health care providers, and for other purposes; H.R.1890 To amend the Patient Protection and Affordable Care Act to require Exchanges to establish network adequacy standards for qualified health plans and amend the Public Health Service Act to provide protections for consumers against excessive, unjustified, or unfairly discriminatory increases in premium rates; S.104 Improving Social Determinants of Health Act of 2021; S.779 Protecting Americans with Pre-Existing Conditions Act of 2021; S.942 A bill to provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect; H.R.1790 To amend the Patient Protection and Affordable Care Act to require the Secretary of Health and Human Services to set forth a method of determining maximum out-of-pocket limits and annual updates to premium tax credit eligibility; H.R.550 Immunization Infrastructure Modernization Act of 2021; H.R.736 Community Immunity During COVID-19 Act of 202; H.R.791 Tracking COVID-19 Variants Act; H.R.1268 Building COVID-19 Vaccine Confidence Act of 2021; S.167 Community Immunity During COVID-19 Act of 2021; S.236 Tracking COVID-19 Variants Act; H.R.173 COVID-19 Prevention and Awareness Act of 2021;; H.R.959 Black Maternal Health Momnibus Act of 2021; H.R.3904 Reducing COVID-19 Disparities by Investing in Public Health Act; H.R.2170 HAPI Act; S.1314 Tobacco Tax Equity Act of 2021; H.R.2786 Tobacco Tax Equity Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.3749 Katherines Law for Lung Cancer Early Detection and Survival Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; S.1424 Chronic Disease Management Act of 2021; H.R.3883 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S.2043 A bill to amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; H.R.5376 Build Back Better Act; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021; S.674 Public Health Infrastructure Saves Lives Act; Health Equity and Accountability Act; H.R.5030 DIVERSE Trials Act; S.2706 DIVERSE Trials Act; H.R.6302 Protecting the Health of Americas Older Adults Act; S.J.Res.29 A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to "COVID-19 Vaccination and Testing; Emergency Temporary Standard"; S.Res.462 A resolution designating November 2021 as "National Lung Cancer Awareness Month" and expressing support for early detection and treatment of lung cancer; H.R.2471 FY22 Consolidated Appropriations Act, 2022; H.R.2909 To amend the Internal Revenue Code of 1986 to allow a one-time election for a qualified charitable distribution to a split-interest entity and to inflation adjust the limits for qualified charitable distributions.; H.R.2954 Securing a Strong Retirement Act of 2021; H.R.6617 Further Additional Extending Government Funding Act; H.R. 7055 Elijah E. Cummings Family Asthma Act; S. 3332 Let States Innovate Under Medicaid Act;

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

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

Capping Medicare Part D Out of Pocket Costs; Smoothing Medicare Part D Out of Pocket Costs; Broadening the Part D Low-Income Subsidy; Medicare Part B and Part D drug pricing; Part D appeals process and patient protections; Expanding Medicare coverage to include dental, vision, and hearing services; Reintroduction of the Seniors Prescription Drug Relief Act; H.R. 2170, S. 581 - HAPI Act; H.R. 1978, S. 91 - Protecting Seniors through Immunization Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; quality of care in skilled nursing homes.

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

Government targets: 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

Issues related to S.912 "Protecting Seniors through Immunization Act; issues related to H.R. 2170 "HAPI Act"; issues related to H.R. 1978 "Protecting Seniors through Immunization Act"; and issues related to Medicare Negotiation in the Build Back Better Act.

Client expense: $850,000 · Firm income: Not reported

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related to tobacco cessation; Issues related to health inequities; Issues related to Medicaid waivers; Issues related to the Affordable Care Act; Issues related to supplemental oxygen; Issues related to access to healthcare; Issues related to COVID-19 Response; Issues related to Medicaid coverage for immigrants; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to health equity; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; H.R.4502 House Labor HHS Appropriations bill; S.3062 Senate Labor HHS Appropriations bill; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581 HAPI Act; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.2170 HAPI Act; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.5376 Build Back Better Act; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021

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

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues relating to the Presidents FY23 budget; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; H.R.4502 House Labor HHS Appropriations bill; S.3062 Senate Labor HHS Appropriations bill; Elijah E. Cummings Family Asthma Act; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581HAPI Act; H.R.379 Improving Social Determinants of Health Act of 2021; H.R.526 Ensuring Coverage in Public Health Emergencies Act of 2021; H.R.1872 To amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities, and for other purposes; H.R.1874 To amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; H.R.1875 To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage; H.R.1878 To amend the Patient Protection and Affordable Care Act to establish a health insurance affordability fund, and for other purposes; H.R.1888 To amend title XIX of the Social Security Act to require a Federal medical assistance percentage of 100 percent for Indian health care providers, and for other purposes; H.R.1890 To amend the Patient Protection and Affordable Care Act to require Exchanges to establish network adequacy standards for qualified health plans and amend the Public Health Service Act to provide protections for consumers against excessive, unjustified, or unfairly discriminatory increases in premium rates; S.104 Improving Social Determinants of Health Act of 2021; S.779 Protecting Americans with Pre-Existing Conditions Act of 2021; S.942 A bill to provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect; H.R.1790 To amend the Patient Protection and Affordable Care Act to require the Secretary of Health and Human Services to set forth a method of determining maximum out-of-pocket limits and annual updates to premium tax credit eligibility; H.R.550 Immunization Infrastructure Modernization Act of 2021; H.R.736 Community Immunity During COVID-19 Act of 202; H.R.791 Tracking COVID-19 Variants Act; H.R.1268 Building COVID-19 Vaccine Confidence Act of 2021; S.167 Community Immunity During COVID-19 Act of 2021; S.236 Tracking COVID-19 Variants Act; H.R.173 COVID-19 Prevention and Awareness Act of 2021;; H.R.959 Black Maternal Health Momnibus Act of 2021; H.R.3904 Reducing COVID-19 Disparities by Investing in Public Health Act; H.R.2170 HAPI Act; S.1314 Tobacco Tax Equity Act of 2021; H.R.2786 Tobacco Tax Equity Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.3749 Katherines Law for Lung Cancer Early Detection and Survival Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; S.1424 Chronic Disease Management Act of 2021; H.R.3883 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S.2043 A bill to amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; H.R.5376 Build Back Better Act; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021; S.674 Public Health Infrastructure Saves Lives Act; Health Equity and Accountability Act; H.R.5030 DIVERSE Trials Act; S.2706 DIVERSE Trials Act; H.R.6302 Protecting the Health of Americas Older Adults Act; S.J.Res.29 A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to "COVID-19 Vaccination and Testing; Emergency Temporary Standard"; S.Res.462 A resolution designating November 2021 as "National Lung Cancer Awareness Month" and expressing support for early detection and treatment of lung cancer

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

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

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

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

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

Part D cost sharing; Quality measures for vaccines; Medicare reimbursement for vaccine education, counseling, and administration; Protecting Seniors Through Immunization Act (H.R. 1978/S. 912); Maternal Immunization Coverage Act (S. 1117); Maternal Immunization Enhancement Act (S. 1114); Helping Adults Protect Immunity (HAPI) Act (H.R. 2170/S. 581); Eliminating financial barriers to vaccines as part of the Build Back Better Act (H.R. 5376).

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

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

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

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

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

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

Client expense: $3,370,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

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 Coronavirus (COVID-19) Pandemic ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---S.2327: Seniors Prescription Drug Relief Act ---Patient Cost-Sharing and Smoothing 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.133: Consolidated Appropriations Act for FY 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 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions 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 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.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

Client expense: $3,370,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

Capping Medicare Part D Out of Pocket Costs; Smoothing Medicare Part D Out of Pocket Costs; Broadening the Part D Low-Income Subsidy; Medicare Part B and Part D drug pricing; Part D appeals process and patient protections; Expanding Medicare coverage to include dental, vision, and hearing services; Reintroduction of the Seniors Prescription Drug Relief Act; H.R. 2170, S. 581 - HAPI Act; H.R. 1978, S. 91 - Protecting Seniors through Immunization Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; quality of care in skilled nursing homes.

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

Government targets: HOUSE OF REPRESENTATIVES, President of the U.S., SENATE

Issues related to S.912 "Protecting Seniors through Immunization Act; issues related to H.R. 2170 "HAPI Act"; and issues related to H.R. 1978 "Protecting Seniors through Immunization Act".

Client expense: $1,310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Part D cost sharing; Quality measures for vaccines; Medicare reimbursement for vaccine education, counseling, and administration; S. 912/H.R. 1978, Protecting Seniors Through Immunization Act; S. 1117, Maternal Immunization Coverage Act; S. 1114, Maternal Immunization Enhancement Act; S. 581/H.R. 2170, Helping Adults Protect Immunity (HAPI) Act.

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

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related to tobacco cessation; Issues related to health inequities; Issues related to Medicaid waivers; Issues related to the Affordable Care Act; Issues related to supplemental oxygen; Issues related to access to healthcare; Issues related to COVID-19 Response; Issues related to Medicaid coverage for immigrants; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to health equity; Issues related to the implementation of the No Surprises Act; H.R.4502 House Labor HHS Appropriations bill; Senate Labor HHS Appropriations bill; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581 HAPI Act; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.2170 HAPI Act; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.5376 Build Back Better Act; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021

Client expense: $90,000 · Firm income: Not reported

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related asthma,; COPD,; influenza,; lung cancer,; pneumonia,; pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues relating to the Presidents FY23 budget; Issues related to the implementation of the No Surprises Act; H.R.4502 House Labor HHS Appropriations bill; Senate Labor HHS Appropriations bill; Elijah E. Cummings Family Asthma Act; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581HAPI Act; H.R.379 Improving Social Determinants of Health Act of 2021; H.R.526 Ensuring Coverage in Public Health Emergencies Act of 2021; H.R.1872 To amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities, and for other purposes; H.R.1874 To amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; H.R.1875 To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage; H.R.1878 To amend the Patient Protection and Affordable Care Act to establish a health insurance affordability fund, and for other purposes; H.R.1888 To amend title XIX of the Social Security Act to require a Federal medical assistance percentage of 100 percent for Indian health care providers, and for other purposes; H.R.1890 To amend the Patient Protection and Affordable Care Act to require Exchanges to establish network adequacy standards for qualified health plans and amend the Public Health Service Act to provide protections for consumers against excessive, unjustified, or unfairly discriminatory increases in premium rates; S.104 Improving Social Determinants of Health Act of 2021; S.779 Protecting Americans with Pre-Existing Conditions Act of 2021; S.942 A bill to provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect; H.R.1790 To amend the Patient Protection and Affordable Care Act to require the Secretary of Health and Human Services to set forth a method of determining maximum out-of-pocket limits and annual updates to premium tax credit eligibility; H.R.550 Immunization Infrastructure Modernization Act of 2021; H.R.736 Community Immunity During COVID-19 Act of 202; H.R.791 Tracking COVID-19 Variants Act; H.R.1268 Building COVID-19 Vaccine Confidence Act of 2021; S.167 Community Immunity During COVID-19 Act of 2021; S.236 Tracking COVID-19 Variants Act; H.R.173 COVID-19 Prevention and Awareness Act of 2021;; H.R.959 Black Maternal Health Momnibus Act of 2021; H.R.3904 Reducing COVID-19 Disparities by Investing in Public Health Act; H.R.2170 HAPI Act; S.1314 Tobacco Tax Equity Act of 2021; H.R.2786 Tobacco Tax Equity Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.3749 Katherines Law for Lung Cancer Early Detection and Survival Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; S.2622 Quit Because of COIVD-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; S.1424 Chronic Disease Management Act of 2021; H.R.3883 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S.2043 A bill to amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; H.R.5376 Build Back Better Act; S.2315 Medicaid Saves Lives Act; H.R.4595 Medicaid Saves Lives Act; S.Con.Res.14 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R.5227 LIFT the BAR Act of 2021; S.674 Public Health Infrastructure Saves Lives Act

Client expense: $90,000 · Firm income: Not reported

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

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

Client expense: $3,360,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), U.S. Trade Representative (USTR), White House Office

21st Century Cures Act 2.0 ---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 Coronavirus (COVID-19) Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing Related Provisions ---Immunization Information Systems 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) 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 ---H.R.5260: Reduced Costs and Continued Cures Act ---S.2327 - Seniors Prescription Drug Relief Act ---H.R. 5376: Build Back Better Act ---H.R.3684: Infrastructure Investment and Jobs Act ---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) 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 --- Alternative payment arrangements for gene therapies ---Drug Benefit Design ---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 ---Administration 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 ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Step Therapy ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---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.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.

Client expense: $3,360,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), U.S. Trade Representative (USTR), White House Office

Capping Medicare Part D Out of Pocket Costs; Smoothing Medicare Part D Out of Pocket Costs; Broadening the Part D Low-Income Subsidy; Medicare Part B and Part D drug pricing; Part D appeals process and patient protections; Expanding Medicare coverage to include dental, vision, and hearing services; Reintroduction of the Seniors Prescription Drug Relief Act; H.R. 2170, S. 581 - HAPI Act; H.R. 1978, S. 91 - Protecting Seniors through Immunization Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to HR 3 "Lower Drug Costs Now Act of 2019"; issues related to drug pricing; issues related to influenza vaccines; issues related to RSV Access; issues related to routine immunization rates; issues related to HR 1319 "American Rescue Plan"; general issues related to trade; general issues related to AMP CAP; general issues related to vaccines; issues related to 340B; issues related to insulin pricing; issues related to funding for Pandemic influenza; issues related to Flu Infrastructure Funding; issues related to HR 1978 "Protecting Seniors Through Immunization Act"; issues related to HR 2170 "Helping Adults Protect Immunity Act"; issues related to HR 550 "Immunization Infrastructure Modernization Act"; issues related to HR 2437 "Strengthening the Vaccines for Children Act of 2021"; issues related to HR 3655 "Vaccine Injury Compensation Modernization Act"; issues related to vaccine authorized for emergency use under HR 3705; issues related to RX to OTC switch; issues related to S.1132 "EPI Act"; issues related to S.2164 "Lower Costs, More Cures Act of 2021; and issues related to HR 19 "Lower Costs, More Cures Act of 2021".

Client expense: $980,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to lung disease treatment, prevention and research; public health; Issues related asthma; COPD; influenza; lung cancer; pneumonia; pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to the SUNSET Rule; Issues related to infrastructure; House Labor HHS Appropriations bill; Senate Labor HHS Appropriations bill; Elijah E. Cummings Family Asthma Act; H.R.3173 Improving Seniors Timely Access to Care Act; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1946 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; H.R.66 CARING for Kids Act; H.R.1390 CHIPPER Act; H.R.1583 To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States health care system; H.R.1738 To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children's Health Insurance Program, and for other purposes; H.R.1791 To amend title XXI of the Social Security Act to permanently extend the Children's Health Insurance Program, and for other purposes; S.245 SAME Act of 2021; S.1114 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes; H.R.2347 To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes; S.1117 A bill to amend title XIX of the Social Security Act to require Medicaid coverage of approved vaccines for pregnant women; S.368 Telehealth Modernization Act; H.R.2125 To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; H.R.1978 To amend title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare part D is consistent with the treatment of vaccines under Medicare part B, and for other purposes; H.R.2170 To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid; S.581HAPI Act; H.R.379 Improving Social Determinants of Health Act of 2021; H.R.526 Ensuring Coverage in Public Health Emergencies Act of 2021; H.R.1872 To amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities, and for other purposes; H.R.1874 To amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; H.R.1875 To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage; H.R.1878 To amend the Patient Protection and Affordable Care Act to establish a health insurance affordability fund, and for other purposes; H.R.1888 To amend title XIX of the Social Security Act to require a Federal medical assistance percentage of 100 percent for Indian health care providers, and for other purposes; H.R.1890 To amend the Patient Protection and Affordable Care Act to require Exchanges to establish network adequacy standards for qualified health plans and amend the Public Health Service Act to provide protections for consumers against excessive, unjustified, or unfairly discriminatory increases in premium rates; S.104 Improving Social Determinants of Health Act of 2021; S.779 Protecting Americans with Pre-Existing Conditions Act of 2021; S.942 A bill to provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect; H.R.1790 To amend the Patient Protection and Affordable Care Act to require the Secretary of Health and Human Services to set forth a method of determining maximum out-of-pocket limits and annual updates to premium tax credit eligibility; H.R.550 Immunization Infrastructure Modernization Act of 2021; H.R.736 Community Immunity During COVID-19 Act of 202; H.R.791 Tracking COVID-19 Variants Act; H.R.1268 Building COVID-19 Vaccine Confidence Act of 2021; S.167 Community Immunity During COVID-19 Act of 2021; S.236 Tracking COVID-19 Variants Act; H.R.173 COVID-19 Prevention and Awareness Act of 2021;; H.R.959 Black Maternal Health Momnibus Act of 2021; H.R.3904 Reducing COVID-19 Disparities by Investing in Public Health Act; H.R.2170 HAPI Act; S.1314 Tobacco Tax Equity Act of 2021; H.R.2786 Tobacco Tax Equity Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.1946 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.3749 Katherines Law for Lung Cancer Early Detection and Survival Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.1738 Stabilize Medicaid and CHIP Coverage Act; S.646 Stabilize Medicaid and CHIP Coverage Act of 2021; S.1114 Maternal Immunization Enhancement Act; S.1873 Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021; H.R.2125 Quit Because of COVID-19 Act; H.R.1978 Protecting Seniors Through Immunization Act of 2021; H.R.2347 Strengthening the Vaccines for Children Program Act of 2021; S.1117 Maternal Immunization Coverage Act; H.R.3149 HEAL for Immigrant Families Act of 2021; H.R.3961 To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; S.1660 HEAL for Immigrant Families Act of 2021; H.R.2903 CONNECT for Health Act of 2021; S.1512 CONNECT for Health Act of 2021; S.912 Protecting Seniors Through Immunization Act of 2021; S.1424 Chronic Disease Management Act of 2021; H.R.3883 To amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; S.2043 A bill to amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; No Surprises Act

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

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