ENACT Act of 2021

H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 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. 3085: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 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 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. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) 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. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act 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. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 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. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias 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 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse 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 Final Rule; Importation of Prescription Drugs Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE

S.56/H.R. 1474 Alzheimer's Caregiver Support Act Americans Giving Care to Elders (AGE) Act of 2021 (H.R. 3689/S. 234) S.104 Improving Social Determinants of Health Act of 2021 National Coronavirus Commission Act of 2021 (H.R. 1306/S. 412) Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act (H.R. 596/ S. 57) NIH supplemental funding S.333 COVID-19 Nursing Home Protection Act of 2021 S.962 American Cures Act S.674 Public Health Infrastructure Saves Lives Act FDA Neuroscience Center of Excellence BRAIN Initiative funding PACE Plus Act (S. 1162) Nursing Home Reform Modernization Act (H.R. 1985/ S. 782) Homecare for Seniors Act (H.R. 2898/S. 1399) COVID HCBS Relief Act of 2021 (H.R. 525/S. 151) Long-term care provisions within H.R.1319 the American Rescue Plan Act of 2021 Credit for Caring Act (H.R. 3321/S. 1670) Comprehensive Care for Alzheimer's Act (H.R. 2517/S. 1125) Equity in Neuroscience & Alzheimer's Clinical Trials (ENACT) Act of 2021 (H.R. 3085/S. 1548) Elder Abuse Protection Act of 2021 (H.R. 2922) Reducing COVID-19 Disparities by Investing in Public Health Act (H.R. 3904) PROTECTS Act (S. 2214) Provider Training in Palliative Care Act (S. 2890) Choose Home Care Act of 2021 (S. 2562/H.R 5514) Direct Care Opportunity Act (H.R. 2999) Inflation Reduction Act of 2022 (H.R.5376) Cures 2.0 Act (H.R. 6000) Innovation in Aging Act (S. 3473) Revitalizing the Aging Network Act (S. 3431) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706/H.R. 5030) Stop the Wait Act of 2022 (S. 3575/H.R. 6583) Palliative Care and Hospice Education and Training Act (S. 4260) NAPA Reauthorization Act (H.R. 7775/S. 4203) Alzheimer's Accountability and Investment Act (H.R. 7773/S. 4202) IMPROVE Nursing Homes Act (H.R. 8677) Kevin and Avonte's Reauthorization Act of 2022 (H.R. 8907/S. 4885) Modernizing Accelerated Approval Pathway Act (S. 4446) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 9127) Access to Innovative Treatments Act of 2022 (H.R. 9358) Consolidated Appropriations Act, 2023 (H.R. 2617) National Concussion Surveillance System (NCSS) funding at the CDC Other matters related to COVID -19 and long COVID Other matters related to elder justice Other matters related to dementia care management models Other matters related to younger-onset Alzheimer's disease Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to home- and community-based services Other matters related to diversity in clinical trials Other matters related to caregiving Other matters related to biomedical research, Alzheimer's diagnostics, and patient-focused drug development Other matters related to Social Security Other matters related to related to user fee agreements and accelerated approval

S. 834/ H.R. 2256: Resident Physician Shortage Reduction Act S. 1024/H.R. 2255: Healthcare Workforce Resilience Act S. 1548/H.R. 3085: Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S. 1810/H.R. 3541: Conrad State 30 and Physician Access Reauthorization Act S. 3427: Neuroscience Center of Excellence Act of 2021 S.4348: FDASLA Act of 2022; section 506. S. 4906: National Neurological Conditions Surveillance System Reauthorization Act of 2022 H.R. 2754: COVID-19 Long Haulers Act H.R. 4122: Resident Education Deferred Interest Act of 2021 H.R. 5435: Bringing Regulatory Advances into Neuroscience (BRAIN) Act H.R. 5376: Inflation Reduction Act of 2022; Subtitle B Urging reforms to proposed surprise billing regulations to align with congressional intent for payment disputes. Support for creating a Neuroscience Center of Excellence at FDA. Supporting policies to address the COVID-19 public health emergency, including maintaining telemedicine coverage and ensuring access to affordable health coverage and medications. Medical research funding related to NIH including the BRAIN Initiative, AHRQ, HEAL Initiative, and the Congressionally Directed Medical Research Programs at the Department of Defense. Support for funding for the Pediatric Subspecialty Loan Repayment Program.

Client expense: $250,000 · Firm income: Not reported

H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 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: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act 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 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 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. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias 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 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse 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 Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.

S.56/H.R. 1474 Alzheimer's Caregiver Support Act Americans Giving Care to Elders (AGE) Act of 2021 (H.R. 3689/S. 234) S.104 Improving Social Determinants of Health Act of 2021 National Coronavirus Commission Act of 2021 (H.R. 1306/S. 412) Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act (H.R. 596/ S. 57) NIH supplemental funding S.333 COVID-19 Nursing Home Protection Act of 2021 S.962 American Cures Act S.674 Public Health Infrastructure Saves Lives Act FDA Neuroscience Center of Excellence BRAIN Intiative funding PACE Plus Act (S. 1162) Nursing Home Reform Modernization Act (H.R. 1985/ S. 782) Homecare for Seniors Act (H.R. 2898/S. 1399) COVID HCBS Relief Act of 2021 (H.R. 525/S. 151) Long-term care provisions within H.R.1319 the American Rescue Plan Act of 2021 Credit for Caring Act (H.R. 3321/S. 1670) Comprehensive Care for Alzheimer's Act (H.R. 2517/S. 1125) Equity in Neuroscience & Alzheimer's Clinical Trials (ENACT) Act of 2021 (H.R. 3085/S. 1548) Elder Abuse Protection Act of 2021 (H.R. 2922) Reducing COVID-19 Disparities by Investing in Public Health Act (H.R. 3904) PROTECTS Act (S. 2214) Provider Training in Palliative Care Act (S. 2890) Choose Home Care Act of 2021 (S. 2562/H.R 5514) Direct Care Opportunity Act (H.R. 2999) Inflation Reduction Act of 2022 (H.R.5376) Cures 2.0 Act (H.R. 6000) Innovation in Aging Act (S. 3473) Revitalizing the Aging Network Act (S. 3431) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706/H.R. 5030) Stop the Wait Act of 2022 (S. 3575/H.R. 6583) Palliative Care and Hospice Education and Training Act (S.4260) NAPA Reauthorization Act (H.R. 7775/S 4203) Alzheimer's Accountability and Investment Act (H.R. 7773/S 4202) IMPROVE Nursing Homes Act (H.R. 8677) Kevin and Avonte's Reauthorization Act of 2022 (H.R. 8907/S. 4885) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 9127) Other matters related to COVID -19 and long COVID Other matters related to elder justice Other matters related to dementia care management models Other matters related to younger-onset Alzheimer's disease Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to home- and community-based services Other matters related to diversity in clinical trials Other matters related to caregiving Other matters related to biomedical research, Alzheimer's diagnostics, and patient-focused drug development Other matters related to Social Security Other matters related to related to user fee agreements and accelerated approval

H.R. 2517/S. 1125: A bill to recommend that the Center for Medicare and Medicaid Innovation test the effect of a dementia care management model H.R.3085/S.1548, the Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S.1692/H.R.3354, the Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act S. 1125/H.R. 2517, recommends that the Center for Medicare and Medicaid Innovation (CMMI) test the effect of different dementia care management model and reimbursement strategies

Client expense: $43,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 834/ H.R. 2256: Resident Physician Shortage Reduction Act S. 1024/H.R. 2255: Healthcare Workforce Resilience Act S. 1548/H.R. 3085: Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S. 1810/H.R. 3541: Conrad State 30 and Physician Access Reauthorization Act S. 3427: Neuroscience Center of Excellence Act of 2021 S.4348: FDASLA Act of 2022; section 506. H.R. 2754: COVID-19 Long Haulers Act H.R. 4122: Resident Education Deferred Interest Act of 2021 H.R. 5435: Bringing Regulatory Advances into Neuroscience (BRAIN) Act H.R. 5376: Build Back Better Act; sections 139001-139003, 139101, 139102, 139201, 139202, 31060, 137402, 137405, 30601, 30602, 137301, and 30801 Urging reforms to proposed surprise billing regulations to align with congressional intent for payment disputes. Support for creating a Neuroscience Center of Excellence at FDA. Supporting policies to address the COVID-19 public health emergency, including maintaining telemedicine coverage and ensuring access to affordable health coverage and medications. Support for funding and the reauthorization of the CDC National Neurological Conditions Surveillance System. Medical research funding related to NIH including the BRAIN Initiative, AHRQ, HEAL Initiative, and the Congressionally Directed Medical Research Programs at the Department of Defense. Support for funding for the Pediatric Subspecialty Loan Repayment Program.

Client expense: $450,000 · Firm income: Not reported

S.56/H.R. 1474 Alzheimer's Caregiver Support Act Americans Giving Care to Elders (AGE) Act of 2021 (H.R. 3689/S. 234) S.104 Improving Social Determinants of Health Act of 2021 National Coronavirus Commission Act of 2021 (H.R. 1306/S. 412) Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act (H.R. 596/ S. 57) NIH supplemental funding S.333 COVID-19 Nursing Home Protection Act of 2021 S.962 American Cures Act S.674 Public Health Infrastructure Saves Lives Act FDA Neuroscience Center of Excellence BRAIN Intiative funding PACE Plus Act (S. 1162) Nursing Home Reform Modernization Act (H.R. 1985/ S. 782) Homecare for Seniors Act (H.R. 2898/S. 1399) COVID HCBS Relief Act of 2021 (H.R. 525/S. 151) Long-term care provisions within H.R.1319 the American Rescue Plan Act of 2021 Credit for Caring Act (H.R. 3321/S. 1670) Comprehensive Care for Alzheimer's Act (H.R. 2517/S. 1125) Equity in Neuroscience & Alzheimer's Clinical Trials (ENACT) Act of 2021 (H.R. 3085/S. 1548) Elder Abuse Protection Act of 2021 (H.R. 2922) Reducing COVID-19 Disparities by Investing in Public Health Act (H.R. 3904) PROTECTS Act (S. 2214) Provider Training in Palliative Care Act (S. 2890) Choose Home Care Act of 2021 (S. 2562/H.R 5514) Direct Care Opportunity Act (H.R. 2999) Build Back Better Act (H.R.5376) Cures 2.0 Act (H.R. 6000) Innovation in Aging Act (S. 3473) Revitalizing the Aging Network Act (S. 3431) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706/H.R. 5030) Stop the Wait Act (S. 3575/H.R. 6583) Palliative Care and Hospice Education and Training Act (S.4260) NAPA Reauthorization Act (H.R. 7775/S 4203) Alzheimer's Accountability and Investment Act (H.R. 7773/S 4202) Other matters related to COVID -19 and long COVID Other matters related to elder justice Other matters related to dementia care management models Other matters related to younger-onset Alzheimer's disease Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to home- and community-based services Other matters related to diversity in clinical trials Other matters related to caregiving Other matters related to biomedical research, Alzheimer's diagnostics, and patient-focused drug development Other matters related to Social Security Other matters related to related to user fee agreements and accelerated approval

H.R. 5: Equality Act H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 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: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Projects Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

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

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.

S.56/H.R. 1474 Alzheimer's Caregiver Support Act Americans Giving Care to Elders (AGE) Act of 2021 (H.R. 3689/S. 234) S.104 Improving Social Determinants of Health Act of 2021 National Coronavirus Commission Act of 2021 (H.R. 1306/S. 412) Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act (H.R. 596/ S. 57) NIH supplemental funding S.333 COVID-19 Nursing Home Protection Act of 2021 S.962 American Cures Act S.674 Public Health Infrastructure Saves Lives Act FDA Neuroscience Center of Excellence BRAIN Intiative funding PACE Plus Act (S. 1162) Nursing Home Reform Modernization Act (H.R. 1985/ S. 782) Homecare for Seniors Act (H.R. 2898/S. 1399) COVID HCBS Relief Act of 2021 (H.R. 525/S. 151) Long-term care provisions within H.R.1319 the American Rescue Plan Act of 2021 Credit for Caring Act (H.R. 3321/S. 1670) Comprehensive Care for Alzheimer's Act (H.R. 2517/S. 1125) Equity in Neuroscience & Alzheimer's Clinical Trials (ENACT) Act of 2021 (H.R. 3085/S. 1548) Elder Abuse Protection Act of 2021 (H.R. 2922) Reducing COVID-19 Disparities by Investing in Public Health Act (H.R. 3904) PROTECTS Act (S. 2214) Provider Training in Palliative Care Act (S. 2890) Choose Home Care Act of 2021 (S. 2562/H.R 5514) Direct Care Opportunity Act (H.R. 2999) Build Back Better Act (H.R.5376) Cures 2.0 Act (H.R. 6000) Innovation in Aging Act (S. 3473) Revitalizing the Aging Network Act (S. 3431) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706/H.R. 5030) Stop the Wait Act (S. 3575/H.R. 6583) Palliative Care and Hospice Education and Training Act (S.4260) NAPA Reauthorization Act (H.R. 7775/S 4203) Alzheimer's Accountability and Investment Act (H.R. 7773/S 4202) Other matters related to COVID -19 and long COVID Other matters related to elder justice Other matters related to dementia care management models Other matters related to younger-onset Alzheimer's disease Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to home- and community-based services Other matters related to diversity in clinical trials Other matters related to caregiving Other matters related to biomedical research, Alzheimer's diagnostics, and patient-focused drug development Other matters related to Social Security Other matters related to related to user fee agreements and accelerated approval

H.R. 2517/S. 1125: A bill to recommend that the Center for Medicare and Medicaid Innovation test the effect of a dementia care management model H.R.3085/S.1548, the Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S.1692/H.R.3354, the Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act S. 1125/H.R. 2517, recommends that the Center for Medicare and Medicaid Innovation (CMMI) test the effect of different dementia care management model and reimbursement strategies

Client expense: $45,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 289/ H.R. 869: Research Investment to Spark the Economy Act of 2021 S. 610/ H.R. 1667: Lorna Breen Health Care Provider Protection Act S. 834/ H.R. 2256: Resident Physician Shortage Reduction Act S. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 S. 1024/H.R. 2255: Healthcare Workforce Resilience Act S. 1548/H.R. 3085: Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S. 1810/H.R. 3541: Conrad State 30 and Physician Access Reauthorization Act S. 3427: Neuroscience Center of Excellence Act of 2021 H.R. 2754: COVID-19 Long Haulers Act H.R. 4122: Resident Education Deferred Interest Act of 2021 H.R. 5435: Bringing Regulatory Advances into Neuroscience (BRAIN) Act H.R. 5376: Build Back Better Act; sections 139001-139003, 139101, 139102, 139201, 139202, 31060, 137402, 137405, 30601, 30602, 137301, and 30801 Urging reforms to proposed surprise billing regulations to align with congressional intent for payment disputes. Support for creating a Neuroscience Center of Excellence at FDA. Support for eliminating the prohibition on national unique patient identifier. Supporting policies to address the COVID-19 public health emergency, including maintaining telemedicine coverage and ensuring access to affordable health coverage and medications. Support for funding and the reauthorization of the CDC National Neurological Conditions Surveillance System. Medical research funding related to NIH including the BRAIN Initiative, AHRQ, HEAL Initiative, and the Congressionally Directed Medical Research Programs at the Department of Defense. Support for funding for the Pediatric Subspecialty Loan Repayment Program.

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

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot S. 3799, the PREVENT Pandemics Act S. 3509 Creating Efficiency in Foreign Facility Inspections Act Prescription Drug User Fee Act (PDUFA)

Client expense: $1,480,000 · Firm income: Not reported

S.56/H.R. 1474 Alzheimer's Caregiver Support Act Americans Giving Care to Elders (AGE) Act of 2021 (H.R. 3689/S. 234) S.104 Improving Social Determinants of Health Act of 2021 National Coronavirus Commission Act of 2021 (H.R. 1306/S. 412) Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act (H.R. 596/ S. 57) NIH supplemental funding S.333 COVID-19 Nursing Home Protection Act of 2021 S.962 American Cures Act S.674 Public Health Infrastructure Saves Lives Act FDA Neuroscience Center of Excellence BRAIN Intiative funding PACE Plus Act (S. 1162) Nursing Home Reform Modernization Act (H.R. 1985/ S. 782) Homecare for Seniors Act (H.R. 2898/S. 1399) COVID HCBS Relief Act of 2021 (H.R. 525/S. 151) Long-term care provisions within H.R.1319 the American Rescue Plan Act of 2021 Credit for Caring Act (H.R. 3321/S. 1670) Comprehensive Care for Alzheimer's Act (H.R. 2517/S. 1125) Equity in Neuroscience & Alzheimer's Clinical Trials (ENACT) Act of 2021 (H.R. 3085/S. 1548) Elder Abuse Protection Act of 2021 (H.R. 2922) Reducing COVID-19 Disparities by Investing in Public Health Act (H.R. 3904) PROTECTS Act (S. 2214) Provider Training in Palliative Care Act (S. 2890) Choose Home Care Act of 2021 (S. 2562/H.R 5514) Direct Care Opportunity Act (H.R. 2999) Build Back Better Act (H.R.5376) Cures 2.0 Act (H.R. 6000) Innovation in Aging Act (S. 3473) Revitalizing the Aging Network Act (S. 3431) Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706/H.R. 5030) Stop the Wait Act (S. 3575/H.R. 6583) Other matters related to elder justice Other matters related to dementia care management models Other matters related to younger-onset Alzheimer's disease Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to home- and community-based services Other matters related to diversity in clinical trials Other matters related to caregiving Other matters related to biomedical research, Alzheimer's diagnostics, and patient-focused drug development Other matters related to Social Security Other matters related to related to user fee agreements and accelerated approval

H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - To amend the Public Health Service Act to improve the diversity of participants in research on Alzheimers disease, and for other purposes S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Nomination of Robert Califf to FDA Commissioner Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

H.R. 2517/S. 1125: A bill to recommend that the Center for Medicare and Medicaid Innovation test the effect of a dementia care management model H.R.3085/S.1548, the Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S.1692/H.R.3354, the Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act

Client expense: $45,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Parts B and D pricing reform, H.R. 3684, S. 2327, Senate S. 1971, the Chronic Kidney Disease Improvement in Research and Treatment Act. Issues related to CMS rulemaking [CMS-4190-F3, CMS-2482-P2]. S. 2614, the NOVEL Act Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 1946, S. 1873 H.R. 5030, S. 2706 DIVERSE Trails Act H.R. 3085, S. 1548 ENACT Act of 2021 H.R. 5260 - Reduced Costs and Continued Cures Act; Build Back Better Act General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to telemedicine Issues related to 340B

Client expense: $1,370,000 · Firm income: Not reported

S. 289/ H.R. 869: Research Investment to Spark the Economy Act of 2021 S. 610/ H.R. 1667: Lorna Breen Health Care Provider Protection Act S. 834/ H.R. 2256: Resident Physician Shortage Reduction Act S. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 S. 1024/H.R. 2255: Healthcare Workforce Resilience Act S. 1548/H.R. 3085: Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S. 1810/H.R. 3541: Conrad State 30 and Physician Access Reauthorization Act H.R. 2754: COVID-19 Long Haulers Act H.R. 4122: Resident Education Deferred Interest Act of 2021 H.R. 5435: Bringing Regulatory Advances into Neuroscience (BRAIN) Act S.1692/H.R.3354: Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act H.R. 5376: Build Back Better Act; sections 139001-139003, 139101, 139102, 139201, 139202, 31060, 137402, 137405, 30601, 30602, 137301, and 30801 H.R. 5657: Medical Marijuana Research Act Supporting vaccine requirements for health care workers. Urging reforms to proposed surprise billing regulations to align with congressional intent for payment disputes. Support for creating a Neuroscience Center of Excellence at FDA. Support for eliminating the prohibition on national unique patient identifier. Supporting policies to address the COVID-19 public health emergency, including maintaining telemedicine coverage and ensuring access to affordable health coverage and medications. Support for funding the CDC National Neurological Conditions Surveillance System. Medical research funding related to fetal tissue, AHRQ, Congressionally Directed Medical Research Programs at the Department of Defense, and the NIH including the BRAIN Initiative. Support for funding for the Pediatric Subspecialty Loan Repayment Program.

Client expense: $140,000 · Firm income: Not reported

S.56/H.R. 1474 Alzheimer's Caregiver Support Act Americans Giving Care to Elders (AGE) Act of 2021 (H.R. 3689/S. 234) S.104 Improving Social Determinants of Health Act of 2021 National Coronavirus Commission Act of 2021 (H.R. 1306/S. 412) Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act (H.R. 596/ S. 57) NIH supplemental funding S.333 COVID-19 Nursing Home Protection Act of 2021 S.962 American Cures Act S.674 Public Health Infrastructure Saves Lives Act FDA Neuroscience Center of Excellence BRAIN Intiative funding PACE Plus Act (S. 1162) Nursing Home Reform Modernization Act (H.R. 1895/ S. 782) Homecare for Seniors Act (H.R. 2898/S. 1399) COVID HCBS Relief Act of 2021 (H.R. 525/S. 151) Long-term care provisions within H.R.1319 the American Rescue Plan Act of 2021 Credit for Caring Act (H.R. 3321/S. 1670) Comprehensive Care for Alzheimer's Act (H.R. 2517/S. 1125) Equity in Neuroscience & Alzheimer's Clinical Trials (ENACT) Act of 2021 (H.R. 3085/S. 1548) Elder Abuse Protection Act of 2021 (H.R. 2922) Reducing COVID-19 Disparities by Investing in Public Health Act (H.R. 3904) PROTECTS Act (S. 2214) Provider Training in Palliative Care Act (S. 2890) Choose Home Care Act of 2021 (S. 2562/H.R 5514) Direct Care Opportunity Act (H.R. 2999) Build Back Better Act (H.R.5376) Cures 2.0 Act (H.R. 6000) other matters related to Alzheimer's diagnostics other matters related to elder justice other matters related to dementia care management models other matters related to younger-onset Alzheimer's disease other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease other matters related to home- and community-based services other matters related to diversity in clinical trials other matters related to caregiving other matters related to patient-focused drug development other matters related to biomedical research other matters related to Social Security

Issues related to Medicare Parts B and D pricing reform, H.R. 3684, S. 2327, Senate S. 1971, the Chronic Kidney Disease Improvement in Research and Treatment Act. Issues related to CMS rulemaking [CMS-4190-F3, CMS-2482-P2]. S. 2614, the NOVEL Act Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 1946, S. 1873 H.R. 5030, S. 2706 DIVERSE Trails Act H.R. 3085, S. 1548 ENACT Act of 2021 H.R. 5260 - Reduced Costs and Continued Cures Act; Build Back Better Act General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to telemedicine Issues related to 340B

Client expense: $1,400,000 · Firm income: Not reported

H.R. 2517/S. 1125: A bill to recommend that the Center for Medicare and Medicaid Innovation test the effect of a dementia care management model H.R.3085/S.1548, the Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S.1692/H.R.3354, the Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act

Client expense: $45,000 · Firm income: Not reported

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

S.56/H.R. 1474 Alzheimer's Caregiver Support Act Americans Giving Care to Elders (AGE) Act (H.R. 3689/S. 234) S.104 Improving Social Determinants of Health Act of 2021 National Coronavirus Commission Act (H.R. 1306/S. 412) Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act (H.R. 596/ S. 57) NIH supplemental funding S.333 COVID-19 Nursing Home Protection Act of 2021 S.962 American Cures Act S.674 Public Health Infrastructure Saves Lives Act FDA Neuroscience Center of Excellence BRAIN Intiative funding PACE Plus Act (S. 1162) Nursing Home Reform Modernization Act (H.R. 1895/ S. 782) Homecare for Seniors Act (H.R. 2898/S. 1399) COVID HCBS Relief Act of 2021 (H.R. 525/S. 151) Long-term care provisions within H.R.1319 the American Rescue Plan Act of 2021 Credit for Caring Act (H.R. 3321/S. 1670) Comprehensive Care for Alzheimer's Act (H.R. 2517/S. 1125) Equity in Neuroscience & Alzheimer's Clinical Trials (ENACT) Act (H.R. 3085/S. 1548) Elder Abuse Protection Act of 2021 (H.R. 2922) Reducing COVID-19 Disparities by Investing in Public Health Act (H.R. 3904) PROTECTS Act (S. 2214) Provider Training in Palliative Care Act (S. 2890) other matters related to Alzheimer's diagnostics other matters related to elder justice other matters related to dementia care management models other matters related to younger-onset Alzheimer's disease other matters related to aducanumab other matters related to home- and community-based services other matters related to diversity in clinical trials other matters related to caregiving

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

S. 289/ H.R. 869: Research Investment to Spark the Economy Act of 2021 S. 610/ H.R. 1667: Lorna Breen Health Care Provider Protection Act S. 834/ H.R. 2256: Resident Physician Shortage Reduction Act S. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 S. 1024/H.R. 2255: Healthcare Workforce Resilience Act S. 1548/H.R. 3085: Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S. 1810/H.R. 3541: Conrad State 30 and Physician Access Reauthorization Act H.R. 2754: COVID-19 Long Haulers Act H.R. 4122: Resident Education Deferred Interest Act of 2021 H.R. 5435: Bringing Regulatory Advances into Neuroscience (BRAIN) Act S. 1692/H.R.3354: Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act Support for creating a Neuroscience Center of Excellence at FDA. Support for eliminating the prohibition on national unique patient identifier. Supporting policies to address the COVID-19 public health emergency, including maintaining telemedicine coverage and ensuring access to affordable health coverage and medications. Support for funding the CDC National Neurological Conditions Surveillance System. Medical research funding related to fetal tissue, AHRQ, Congressionally Directed Medical Research Programs at the Department of Defense, and the NIH including the BRAIN Initiative. Support for funding for the Pediatric Subspecialty Loan Repayment Program.

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

HR 4502 - Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022; all provisions related to telehealth HR 5376 - Build Back Better Act; all provisions related to teleheath HR 769/S 1491 - Rural MOMS Act; all provisions of the bill HR 937/S 893 - Tech To Save Moms Act; all provisions of the bill HR 2903/S 1512 - CONNECT for Health Act of 2021; all provisions of the bill HR 3085/S 1548 - ENACT Act of 2021; all provisions of the bill S 1704 - Telehealth Expansion Act of 2021; all provisions of the bill S 2061 - Telemental Health Care Access Act of 2021; all provisions of the bill HR 2807 - PREVENT DIABETES Act; all provisions of the bill

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

H.R. 2517/S. 1125: A bill to recommend that the Center for Medicare and Medicaid Innovation test the effect of a dementia care management model H.R.3085/S.1548, the Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S.1692/H.R.3354, the Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act

Client expense: $45,000 · Firm income: Not reported

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

S.56/H.R. 1474 Alzheimer's Caregiver Support Act Americans Giving Care to Elders (AGE) Act S.104 Improving Social Determinants of Health Act National Coronavirus Commission Act Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act NIH supplemental funding S.333 COVID-19 Nursing Home Protection Act S.962 American Cures Act S.674 Public Health Infrastructure Saves Lives Act FDA Neuroscience Center of Excellence BRAIN Intiative funding PACE Plus Act Nursing Home Reform Modernization Act Homecare for Seniors Act COVID HCBS Relief Act of 2021 Long-term care provisions within H.R.1319 the American Rescue Plan Act of 2021 Credit for Caring Act (H.R. 3321/S. 1670) Comprehensive Care for Alzheimer's Act (H.R. 2517/S. 1125) Equity in Neuroscience & Alzheimer's Clinical Trials (ENACT) Act (H.R. 3085/S. 1548) Elder Abuse Protection Act of 2021 (H.R. 2922) Reducing COVID-19 Disparities by Investing in Public Health Act PROTECTS Act (S. 2214) other matters related to Alzheimer's diagnostics other matters related to elder justice other matters related to dementia care management models other matters related to younger-onset Alzheimer's disease other matters related to aducanumab other matters related to home- and community-based services other matters related to diversity in clinical trials

Client expense: $470,000 · Firm income: Not reported

H.R. 2517/S. 1125: A bill to recommend that the Center for Medicare and Medicaid Innovation test the effect of a dementia care management model H.R.3085/S.1548, the Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act S.1692/H.R.3354, the Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act

Client expense: $45,000 · Firm income: Not reported

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