NIH Clinical Trial Diversity Act of 2022

S. 253, Cannabidiol and Marihuana Research Expansion Act, all provisions H.R. 6087, Improving Access to Workers Compensation for Injured Federal Workers Act of 2022, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5030, Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, all provisions H.R. 1384, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions S. 445, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions H.R. 2067, Medication Access and Training Expansion (MATE) Act of 2021, all provisions S. 2235, Medication Access and Training Expansion (MATE) Act of 2021, all provisions H.R. 6072, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services S. 509, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services H.R. 379, Improving Social Determinants of Health Act of 2021, all provisions S. 104, Improving Social Determinants of Health Act of 2021, all provisions S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and (PREVENT) Pandemics Act, all provisions H.R. 8, Bipartisan Background Checks Act of 2021, all provisions H.R. 1446, Enhanced Background Checks Act of 2021, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 2163, Safe Step Act, all provisions S. 464, Safe Step Act, all provisions H.R. 666, Anti-Racism in Public Health Act of 2021, all provisions S. 162, Anti-Racism in Public Health Act of 2021, all provisions H.R. 5248, Temporary Responders for Immediate Aid in Grave Emergencies (TRIAGE) Act of 2021, all provisions H.R. 6311, Comprehensive Addiction Resources Emergency Act of 2021, all provisions S. 3418, Comprehensive Addiction Resources Emergency Act of 2021, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 3735, Parity Implementation Assistance Act, all provisions H.R. 7232, 9-8-8 and Parity Assistance Act of 2022, all provisions H.R. 7116, 9-8-8 Implementation Act of 2022, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions S. 4090, Dietary Supplement Listing Act of 2022, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act, all provisions S. 610, Dr. Lorna Breen Health Care Provider Protection Act, all provisions H.R. 3753, Parity Implementation Assistance Act, all provisions S. 1962, Parity Implementation Assistance Act, all provisions S. 3904, Healthcare Cybersecurity Act of 2022, all provisions H.R. 4128, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions H.R. 6000, Cures 2.0 Act, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 8152, To provide consumers with foundational data privacy rights, create strong oversight mechanisms, and establish meaningful enforcement, all provisions H.R. 2377, Federal Extreme Risk Protection Order Act of 2022, all provisions H.R. 7910, Protecting Our Kids Act, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions H.R. 7667, Food and Drug Amendments of 2022, all provisions H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022, all provisions H.R. 2503, Social Determinants Accelerator Act of 2021, all provisions S. 3039, Social Determinants Accelerator Act of 2021, all provisions H.R. 7192, Diagnostic Device Advisory Committee Act, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act, all provisions H.R. 7845, NIH Clinical Trial Diversity Act of 2022, all provisions H.R. 708, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions H.R. 4480, Telehealth Coverage and Payment Parity Act, all provisions H.R. 7573, Telehealth Extension and Evaluation Act, all provisions S. 3593, Telehealth Extension and Evaluation Act, all provisions H.R. 5541, Primary and Virtual Care Affordability Act, all provisions H.R. 1306, National Coronavirus Commission Act of 2021, all provisions S. 412, National Coronavirus Commission Act of 2021, all provisions H.R. 1843, COVID-19 Hate Crimes Act, all provisions S. 937, COVID-19 Hate Crimes Act, all provisions H.R. 3778, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions S. 1976, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions H.R. 6904, Patients Before Profits Act of 2022, all provisions H.R. 7053, Hospital Inpatient Services Modernization Act, all provisions S. 3792, Hospital Inpatient Services Modernization Act, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 5224, Preventing Overdoses and Saving Lives Act of 2021, all provisions H.R. 6279, Opioid Treatment Access Act of 2022, all provisions H.R. 7234, Summer Barrow Prevention, Treatment, and Recovery Act, all provisions H.R. 3352, Midwives for MOMS Act of 2021, all provisions H.R. 847, Promoting Digital Privacy Technologies Act, all provisions S. 224, Promoting Digital Privacy Technologies Act, all provisions H.R. 3771, South Asian Heart Health Awareness and Research Act of 2021, all provisions H.R. 7559, Prescription Information Modernization Act of 2022, all provisions H.R. 8289, Banning Misleading Drug Ads Act of 2022, all provisions H.R. 3614, Menstrual Equity For All Act of 2021, all provisions No Surprises Act/implementation Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions 21st Century Cures Act/implementation Maternal mortality Maternal health and inequities/FY 2023 funding Prior Authorization AMA Recovery Plan for Americas Physicians/telehealth/prior authorization/physician burnout/scope Section 2527(b) of the U.S. Innovation and Competition Act (USICA)/Open Access Language Retired Physician Re-entry COVID-19 telehealth flexibilities COVID-19/Vaccine distribution/Vaccines in physician offices Physician burnout and suicide COVID-19/Health Equity/vaccines COVID-19 response/testing/misinformation/therapeutics/Paxlovid Public Health Emergency COVID-19 Health Equity/Men who have sex with men/3-month blood donation use deferral Health Equity/Federally qualified health centers and clinical trials Womens Reproductive Health Medication Abortion Access Diabetes Provider Relief Fund/COVID-19 Electronic Health Records (EHR) Certification Data Privacy Hunger, Nutrition, and Health Digital Health/AI/Digital Therapeutics Monkeypox/testing/vaccination

Client expense: $4,550,000 · 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), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), President of the U.S., SENATE, Vice President of the U.S., White House Office

H.R. 8594/S. 4750, the Restore Protections for Dialysis Patients Act H.R. 7845/ the NIH Clinical Trial Diversity Act H.R. 1255/S. 377, the Living Donor Protection Act H.R. 1676, the Jack Reynold Medigap Expansion Act H.R. 526, Ensuring Coverage in Public Health Emergencies Act of 2021 Health disparities S. 1002, the Junk Plan Accountability and Disclosure Act of 2021 H.R. 4065/S. 1971, the Chronic Kidney Disease Improvement in Research and Treatment Act of 2021. H.R. 3893, the CARE for All Kidneys Act FY 2023, Labor-HHS-Education Appropriations Act H.R. 7585, the Health Equity and Accountability Act of 2022 (HEAA) H.R. 5801, the Help Ensure Lower Patient (HELP) Copays Act H.R. 7667, the Food and Drug Amendments of 2022 H.R. 7506, the New Era for Preventing End-Stage Kidney Disease Act of 2022 Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules Diversity Plans To Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry Request for Information on ways to strengthen and improve the Organ Procurement and Transplantation Network

Client expense: $160,000 · Firm income: Not reported

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

H.R. 379/S. 104 - Improving Social Determinants of Health Act; bill to require the Centers for Disease Control and Prevention (CDC) to establish a program to improve health outcomes and reduce health inequities by, for example, coordinating activities across the CDC. As part of the program, the CDC must award grants to eligible organizations to build capacity to address social determinants of health. H.R. 469 - Comprehensive Breast Reconstruction Act of 2021; bill provides for Medicare, Medicaid, and private health insurance coverage of certain tattooing services in connection with post-mastectomy breast reconstruction, and aligns the scope of Medicare and Medicaid coverage of such breast reconstruction with that of private health insurance. H.R. 5030/S.2706 - DIVERSE Trials Act; A bill to require FDA to issue guidance on decentralized clinical trials to promote meaningful demographic/geographic diversity in patient engagement, expand reporting by laboratories that test for and diagnose COVID-19, and require a study on data collection and data sharing during public health emergencies H.R. 6000 - Cures 2.0 Act; a comprehensive healthcare and biomedical research bill H.R. 4794/S. 2533 - Making Advances in Mammography and Medical Options for Veterans Act; a bill to improve mammography services furnished by the Department of Veterans Affairs H.R. 4571/S. 2102 - Supporting Expanded Review for Veterans in Combat Environments (SERVICE) Act of 2021; a bill to expand eligibility for Veterans Health Administration mammography screenings to veterans who served in certain locations during specified periods, including those who were exposed to toxic substances at such locations H.R. 6584 - Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes. S. 3799 - Prepare for and Respond to Existing Viruses, Emerging New Threats, (PREVENT) and Pandemics Act; a bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics. H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 S. 4260 - Palliative Care and Hospice Education and Training Act; a bill to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools, social work schools, and other programs, including physician assistant education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative medicine. H.R. 7667/S. 4348 - Food and Drug Amendments of 2022; a bill to reauthorize Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices. H.R. 9565/S. 5295- Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivors background, or forthcoming survivorship needs, and for other purposes. Policies related to telehealth Policies to increase clinical trial diversity and access for underrepresented populations Policies related to genetic counseling and testing Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to the reauthorization of FDA User Fee Agreements Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 Policies related to the implementation of the Mammography Quality Standards Act Policies related to administration actions necessary in breast imaging and breast cancer diagnosis Comments regarding a request for information on establishing a National Directory of Healthcare Providers and Services

Client expense: $50,000 · 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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act, HR 5376 - extension of expanded tax credits for ACA marketplaces; HR 1550, The Prevent HPV Cancers Act  S. 699, Women and Lung Cancer Research and Preventive Services Act of 2021 HR 623, Gabriella Miller Kids First Research Act 2.0 S. 4260, The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act, S 2890 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Suprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins H.R. 6638 - Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act - DeGette, Bennet, Burr, Buschon DIVERSE Trials Act - H.R.5030/ S.2706 DEPICT Act, HR 6584 Give Kids a Chance Act, H.R. 6972 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348 S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act Potential legislation on cancer survivorship being developed by Rep. Wasserman Schultz Health Equity and Accountability Act, HR 7585 Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines

Client expense: $1,990,000 · 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), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

DIVERSE Trials Act, HR 5030/S 2706 HR 623, Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act, HR 6584 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348

Client expense: $1,990,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office

Issues related to pharmacy provider status. H.R. 7213 Equitable Community Access to Pharmacist Services Act; issues related to access to pharmacist services. H.R. 7845 NIH Clinical Trial Diversity Act of 2022; issues related to access to pharmacist services.

Client expense: $420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 1730/S. 670- Speeding Therapy Access Today Act H.R. 1946, S. 1873. Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 5030/ S. 2706 DIVERSE Trials Act HR 5376, Inflation Reduction Act reconciliation bill; Medicare price negotiation provision and Part D redesign; Preventative healthcare services and screenings; Issues related to preventative services and screenings for underrepresented communities H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 Accelerating Access for Patients Act; H.R.7667 - Food and Drug Amendments of 2022; S. 1548, H.R. 3085/H.R. 7845. ENACT Act of 2021 S.4348 - FDASLA Act of 2022; 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; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases; general issues related to pharmacy benefit managers (PBMs); general issues related to insurance coverage of specialty treatments Issues related to clinical trial diversity COVID-19; COVID-19 vaccine and therapy development Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts. E-Labeling EVUSHELD Issues related to repeal of the Medicaid AMP Cap. Issues related to drug pricing, IRA Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees;

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

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

Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees; Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 6000-CURES Act 2.0 H.R. 5030/ S. 2706- DIVERSE Trials Act H.R. 6584- DEPICT Act H.R. 3085/S. 1548- ENACT Act of 2021 H.R. 7845- NIH Clinical Trial Diversity Act of 2022 H.R. 1946/, S. 1873- Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

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

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

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

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 HR 1978 - Protecting Seniors Through Immunization Act 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. 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, patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property 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. 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 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 Issues related to HFC's 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 Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Veterans' Affairs issues related to product sampling Provisions related to the importation of HFCs, necessary for MDI production. P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)

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

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

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

Health Insurance Coverage (general); Health Equity (general); Breastfeeding (general); Assisted Reproductive Technology (general); Substance Use Disorder (general); Gynecologic Cancer (general); Reproductive Health (general); Intimate Partner Violence (general); Gun Violence (general); Immunization (general); Breast Cancer (general); Medical Liability Reform (general); Health IT (general); Patient-Physician Relationship (general); Child Welfare (general); Maternal Mortality and Morbidity (general); Graduate Medical Education (general); Contraception (general); Abortion (general); Indian Health (general); Teaching Health Centers Graduate Medical Education (general); Community Health Centers (general); National Health Service Corps (general); Health care workforce (general; Sexually Transmitted Infections (general); Access and Provision of Medication for Opioid Use Disorder (HHS); Research in Pregnant and Breastfeeding Women (general); Health Care Reform (general); Title X Family Planning Program (general); Womens Preventive Services (general); Administrative Burden (general); COVID-19 Response (general); COVID-19 Vaccines (general); Pandemic Preparedness (general); Risk Evaluation and Mitigation Strategies (general); Data Collection (general); Health Insurance and Portability and Accountability Act (general); Social Determinants of Health (General); Maternal Mental Health (general); Online misinformation (general); EMTALA (general); Father Engagement (general); Care for Individuals with Disabilities (general); H.R. 3755/S. 1975, Womens Health Protection Act; implementation of P.L. 115-320, Improving Access to Maternity Care Act; implementation of Maternal Health Quality Improvement Act contained in P.L. 117-103; H.R. 959/ S. 346, Black Maternal Health Momnibus Act; H.R. 1065/S. 1486, Pregnant Workers Fairness Act; H.R. 1350/ S.408, Supporting Best Practices for Healthy Moms Act; H.R. 3407/S. 411, MOMMAs Act; implementation of P.L. 117-2, the American Rescue Plan Act of 2021; H.R. 2007/S. 2444, Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021; H.R. 3110/S. 1658, PUMP for Nursing Mothers Act; H.R. 2903/S.1515, CONNECT for Health Act; H.R. 3671/S.1958, Doctors of Community (DOC) Act; Implementation of P.L. 114-255, the 21st Century Cures Act; Implementation of the No Surprises Act contained in P.L. 116-260; H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act; H.R. 804/S. 248, FAMILY Act; H.R. 5/S. 393, Equality Act; Implementation of P.L. 117-168, Inflation Reduction Act of 2022; H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act; H.R. 5239/ S. 2941, Good Samaritan Health Professionals Act of 2021; H.R. 7073/S.3824, Into the Light for MMH and SUD Act of 2022; H.R.5487/S.3972, SHINE for Autumn Act of 2021; Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) (general); H.R.7011/S.3797, Maternal and Child Health Stillbirth Prevention Act of 2022; H.R. 2234/S. 1021, Equal Access to Abortion Coverage (EACH) Act; S. 4467, Protecting Access to Medication Abortion Act; S.Res.664, A resolution expressing opposition to the criminalization of essential healthcare, including the full range of sexual and reproductive healthcare such as abortion, gender-affirming care, and contraceptive care, and disapproving of the criminalization of pregnancy outcomes; H.Res.589, Expressing the sense of the House of Representatives that policies governing access to medication abortion care in the United States should be equitable and based on science; H.R. 7894/S. 4347, Affordability is Access Act; H.R. 6005/S. 3223, Access to Birth Control Act; H.R. 7845, NIH Clinical Trial Diversity Act of 2022; H.R. 4217/S. 2779, TRIUMPH for New Moms Act of 2021; H.R. 7974, Endometriosis CARE Act of 2022; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Safety and efficacy of noninvasive prenatal screening tests (FDA/CMS); COVID-19 public health emergency unwinding (general); Implementation of the Maternal Health Quality Improvement Act and Rural MOMS Act included in P.L. 117-103; Implementation of P.L. 117-103, Consolidated Appropriations Act, 2022;; health care provider conscience protections (general);; H.R. 9247, Abortion Care Awareness Act; H.R. 9220, Informing New Factors and Options for Reproductive Care Act; H.R. 8834, EQUIP Act; S. 4688, Reproductive Freedom for All Act; S. 4748, Protecting National Access to Reproductive Care Act; H.R. 4040, Advancing Telehealth Beyond COVID-19 Act of 2021; Reproductive health care workforce (general); S.4467, Protecting Access to Medication Abortion Act; S.4723, Let Doctors Provide Reproductive Health Care Act; H.R. 8373, Right to Contraception Act; S.4764, Reproductive Health Care Accessibility Act; H.R. 9487, Advancing Safe Medications for Moms and Babies Act of 2022; H.R. 9602, Maternal Health Pandemic Response Act of 2022; Reauthorization of P.L. 115-328, PREEMIE Reauthorization Act of 2018; H.R. __, Improving Access to Prenatal Telehealth Care Act of 2022; H.R. 9689, Know Your Body Act; S.5276, Right to Build Families Act of 2022; S.5227/H.R.8452, Reproductive Health Travel Fund Act of 2022; H.R. 6216/S. 3389, Sickle Cell Disease Comprehensive Care Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

Health disparities Access to clinical trials for underrepresented populations Improving Social Determinants of Health Act (S.104/H.R.379) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) DIVERSE Trials Act (H.R. 5030/S. 2706) Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (H.R.6584); a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes CURES 2.0 Act (H.R. 6000) Policies related to cancer survivorship Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people, including COVID-19 vaccination and monoclonal antibody distribution Policies related to reducing the cost of cancer treatment for patients Policies related to decline in breast cancer screenings during the COVID-19 pandemic Policies related to genetic counseling and screening Policies related to reauthorization of user fees at the Food and Drug Administration (H.R. 7667/ S. 4348) H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 Advanced Research Project Agency-Health Act (H.R.5585) Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act (S.3799) Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 H.R. 9565/S. 5295- Comprehensive Cancer Survivorship Act Policies related to the reauthorization of FDA User Fee Agreements Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 Policies related to the implementation of the Mammography Quality Standards Act Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to the regulation of diagnostic devices Section 1557, Nondiscrimination in Health Programs and Activities (RIN Number 0945-AA17) Request for Information on establishing a National Directory of Healthcare Providers and Services

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act, HR 5376 - extension of expanded tax credits for ACA marketplaces; HR 1550, The Prevent HPV Cancers Act  S. 699, Women and Lung Cancer Research and Preventive Services Act of 2021 HR 623, Gabriella Miller Kids First Research Act 2.0 S. 4260, The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act, S 2890 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Suprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins H.R. 6638 - Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act - DeGette, Bennet, Burr, Buschon DIVERSE Trials Act - H.R.5030/ S.2706 DEPICT Act, HR 6584 Give Kids a Chance Act, H.R. 6972 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348 S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act Potential legislation on cancer survivorship being developed by Rep. Wasserman Schultz Health Equity and Accountability Act, HR 7585 Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines

Client expense: $1,200,000 · 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), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

DIVERSE Trials Act, HR 5030/S 2706 HR 623, Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act, HR 6584 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348

Client expense: $1,200,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office

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; General issues related to drug pricing; 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. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; 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: $930,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

H.R. 379/S. 104 - Improving Social Determinants of Health Act; bill to require the Centers for Disease Control and Prevention (CDC) to establish a program to improve health outcomes and reduce health inequities by, for example, coordinating activities across the CDC. As part of the program, the CDC must award grants to eligible organizations to build capacity to address social determinants of health. H.R. 469 - Comprehensive Breast Reconstruction Act of 2021; bill provides for Medicare, Medicaid, and private health insurance coverage of certain tattooing services in connection with post-mastectomy breast reconstruction, and aligns the scope of Medicare and Medicaid coverage of such breast reconstruction with that of private health insurance. H.R. 5030/S.2706 - DIVERSE Trials Act; A bill to require FDA to issue guidance on decentralized clinical trials to promote meaningful demographic/geographic diversity in patient engagment, expand reporting by laboratories that test for and diagnose COVID-19, and require a study on data collection and data sharing during public health emergencies H.R. 6000 - Cures 2.0 Act; a comprehensive healthcare and biomedical research bill H.R. 4794/S. 2533 - Making Advances in Mammography and Medical Options for Veterans Act; a bill to improve mammography services furnished by the Department of Veterans Affairs H.R. 4571/S. 2102 - Supporting Expanded Review for Veterans in Combat Environments (SERVICE) Act of 2021; a bill to expand eligibility for Veterans Health Administration mammography screenings to veterans who served in certain locations during specified periods, including those who were exposed to toxic substances at such locations H.R. 6584 - Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes. S. 3799 - Prepare for and Respond to Existing Viruses, Emerging New Threats, (PREVENT) and Pandemics Act; a bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics. Efforts to introduce a bill regarding clinical trial diversity nicknamed the The Clinical Trial Diversity Act H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 S. 4260 - Palliative Care and Hospice Education and Training Act; a bill to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools, social work schools, and other programs, including physician assistant education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative medicine. H.R. 7667/S. 4348 - Food and Drug Amendments of 2022; a bill to reauthorize Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices. Policies related to telehealth Policies related to COVID-19 vaccination and monoclonal antibody distribution Policies to increase clinical trial diversity and access for underrepresented populations Policies related to genetic counseling and testing Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to the reauthorization of FDA User Fee Agreements Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017

Client expense: $50,000 · 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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

DIVERSE Trials Act, HR 5030/S 2706 HR 623, Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act, HR 6584 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348

Client expense: $1,200,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act, HR 5376 - extension of expanded tax credits for ACA marketplaces; HR 1550, The Prevent HPV Cancers Act  S. 699, Women and Lung Cancer Research and Preventive Services Act of 2021 HR 623, Gabriella Miller Kids First Research Act 2.0 S. 4260, The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act, S 2890 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Suprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins H.R. 6638 - Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act - DeGette, Bennet, Burr, Buschon DIVERSE Trials Act - H.R.5030/ S.2706 DEPICT Act, HR 6584 Give Kids a Chance Act, H.R. 6972 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348 S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act Potential legislation on cancer survivorship being developed by Rep. Wasserman Schultz Health Equity and Accountability Act, HR 7585 Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines

Client expense: $1,200,000 · 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), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

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

Health disparities Access to clinical trials for underrepresented populations Improving Social Determinants of Health Act (S.104/H.R.379) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) DIVERSE Trials Act (H.R. 5030/S. 2706) Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (H.R.6584); a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes CURES 2.0 Act (H.R. 6000) Policies related to cancer survivorship Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people, including COVID-19 vaccination and monoclonal antibody distribution Policies related to reducing the cost of cancer treatment for patients Policies related to decline in breast cancer screenings during the COVID-19 pandemic Policies related to genetic counseling and screening Policies related to reauthorization of user fees at the Food and Drug Administration (H.R. 7667/ S. 4348) H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 Advanced Research Project Agency-Health Act (H.R.5585) Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act (S.3799) Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017

Client expense: Not reported · Firm income: $42,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

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; General issues related to drug pricing; 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. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; 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: $910,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

H.R. 8594/S. 4750, the Restore Protections for Dialysis Patients Act H.R. 7845/ the NIH Clinical Trial Diversity Act H.R. 1255/S. 377, the Living Donor Protection Act H.R. 1676, the Jack Reynold Medigap Expansion Act H.R. 526, Ensuring Coverage in Public Health Emergencies Act of 2021 Health disparities S. 1002, the Junk Plan Accountability and Disclosure Act of 2021 H.R. 4065/S. 1971, the Chronic Kidney Disease Improvement in Research and Treatment Act of 2021. H.R. 3893, the CARE for All Kidneys Act FY 2023, Labor-HHS-Education Appropriations Act H.R. 7585, the Health Equity and Accountability Act of 2022 (HEAA) H.R. 5801, the Help Ensure Lower Patient (HELP) Copays Act H.R. 7667, the Food and Drug Amendments of 2022 H.R. 7506, the New Era for Preventing End-Stage Kidney Disease Act of 2022 Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules Diversity Plans To Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry Request for Information on ways to strengthen and improve the Organ Procurement and Transplantation Network

Client expense: $150,000 · Firm income: Not reported

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

Issues regarding the detection of SARS-CoV-2 in wastewater; H.R. 7845, NIH Clinical Trial Diversity Act of 2022

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $7,270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Health Insurance Coverage (general); Health Equity (general); Breastfeeding (general); Assisted Reproductive Technology (general); Substance Use Disorder (general); Gynecologic Cancer (general); Reproductive Health (general); Intimate Partner Violence (general); Gun Violence (general); Immunization (general); Breast Cancer (general); Medical Liability Reform (general); Health IT (general); Patient-Physician Relationship (general); Child Welfare (general); Maternal Mortality and Morbidity (general); Graduate Medical Education (general); Contraception (general); Abortion (general); Indian Health (general); Teaching Health Centers Graduate Medical Education (general); Community Health Centers (general); National Health Service Corps (general); Health care workforce (general); Title VII Health Workforce Programs (general); Title VIII Health Workforce Programs (general); Sexuality Education (general); Sexually Transmitted Infections (general); Access and Provision of Medication-based Opioid Use Disorder Treatment (HHS); Research in Pregnant and Breastfeeding Women (general); Health Care Reform (general); Title X Family Planning Program (general); Womens Preventive Services (general); Administrative Burden (general); COVID-19 Response (general); COVID-19 Vaccines (general); Pandemic Preparedness (general); Risk Evaluation and Mitigation Strategies (general); Data Collection (general); Social Determinants of Health (General); Maternal Mental Health (general); Online misinformation (general); EMTALA (general); H.R. 3755/S. 1975, Womens Health Protection Act; implementation of P.L. 115-320, Improving Access to Maternity Care Act; implementation of Maternal Health Quality Improvement Act contained in P.L. 117-103; H.R. 959/ S. 346, Black Maternal Health Momnibus Act; implementation of P.L. 116-123, the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020; implementation of P.L. 116-127, the Families First Coronavirus Response Act; implementation of P.L. 116-136, the Coronavirus Aid, Relief, and Economic Security Act; implementation of P.L. 116-139, Paycheck Protection Program and Health Care Enhancement Act; H.R. 1065/S. 1486, Pregnant Workers Fairness Act; implementation of P.L. 117-105, Lorna Breen Health Care Provider Protection Act H.R. 1350/ S.408, Supporting Best Practices for Healthy Moms Act; H.R. 3407/S. 411, MOMMAs Act; implementation of P.L. 117-2, the American Rescue Plan Act of 2021; H.R. 2007/S. 2444, Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021; H.R. 3110/S. 1658, PUMP for Nursing Mothers Act; H.R. 2903/S.1515, CONNECT for Health Act; H.R. 3671/S.1958, Doctors of Community (DOC) Act; Implementation of P.L. 114-255, the 21st Century Cures Act; Implementation of the No Surprises Act contained in P.L. 116-260H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act; H.R. 804/S. 248, FAMILY Act; H.R. 5/S. 393, Equality Act; H.R. 4151/S. 2238, FASD Respect Act; Advanced Research Projects Agency for Health (ARPA-H); H.R. 5376, Build Back Better Act, H.R. 5376, Inflation Reduction Act of 2022; H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act; H.R. 5239/ S. 2941, Good Samaritan Health Professionals Act of 2021; H.R. 7073/S.3824, Into the Light for MMH and SUD Act of 2022; H.R.5487/S.3972, SHINE for Autumn Act of 2021; Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) (general); Disclosure of Ingredients in Menstrual Products (general); H.R.7011/S.3797, Maternal and Child Health Stillbirth Prevention Act of 2022; H.R. 2234/S. 1021, Equal Access to Abortion Coverage (EACH) Act; S. 4467, Protecting Access to Medication Abortion Act; S.Res.664, A resolution expressing opposition to the criminalization of essential healthcare, including the full range of sexual and reproductive healthcare such as abortion, gender-affirming care, and contraceptive care, and disapproving of the criminalization of pregnancy outcomes; H.Res.589, Expressing the sense of the House of Representatives that policies governing access to medication abortion care in the United States should be equitable and based on science; H.R. 7894/S. 4347, Affordability is Access Act (AAA); H.R. 6005/S. 3223, Access to Birth Control Act; H.R. 7845, NIH Clinical Trial Diversity Act of 2022; H.R. 4217/S. 2779, TRIUMPH for New Moms Act of 2021; H.R. 7974, Endometriosis CARE Act of 2022; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; H.R. 8185/S. 4440 Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; H.R. 7617/S. 309, Preventive Care Awareness Act of 2022; Safety and efficacy of noninvasive prenatal screening tests (FDA/CMS); COVID-19 public health emergency unwinding (general); ; Implementation of the Maternal Health Quality Improvement Act and Rural MOMS Act included in P.L. 117-103; Implementation of P.L. 117-103, Consolidated Appropriations Act, 2022;; health care provider conscience protections (general); Access to prenatal telehealth services (general) ; H.R. ____, Abortion Care Awareness Act; Consent for use of human reproductive material in assisted reproductive technology or intrauterine insemination (general); H.R. ____, Informing New Factors and Options for Reproductive Care Act; H.R. 8834, EQUIP Act; S. 4688, Reproductive Freedom for All Act; S. 4748, Protecting National Access to Reproductive Care Act; H.R. 4040, Advancing Telehealth Beyond COVID-19 Act of 2021; Reproductive health care workforce (general); S.4467, Protecting Access to Medication Abortion Act; S.4723, Let Doctors Provide Reproductive Health Care Act; H.R. 8373, Right to Contraception Act; S.4764, Reproductive Health Care Accessibility Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), 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 asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to lung disease treatment, prevention and research; Issues related to COVID-19 Response; Issues related to telehealth; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues related to health equity; Issues related to FY23 appropriations bills; Issues related to Cancer Moonshot; Issues relating to the Presidents FY24 budget; Issues related to CDC public health workforce and data modernization H.R. 8295 Labor HHS Appropriations bill; H.R.8236 Defense Appropriations bill; S. 4659 Labor HHS Appropriations bill; S. 4663 Defense Appropriations bill; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; ; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.5030 DIVERSE Trials Act; S.2706 DIVERSE Trials Act; S.Res.462 A resolution designating November 2021 as "National Lung Cancer Awareness Month" and expressing support for early detection and treatment of lung cancer; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; H.R. 7845 NIH Clinical Trial Diversity Act of 2022;

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

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

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

Issues related to drug pricing reform H.R.5376, Build Back Better Act S2891 Restoring America Invents Act S1435 affordable prescriptions for patients act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to clinical trial diversity, HR 6584 DEPICT Act, HR5030 DIVERSE Trials Act, HR 7845 and S2706 NIH Clinical Trial Diversity Act of 2022 Issues related to biodefense issues, S3799 PREVENT Pandemics Act Issues related to cardiovascular disease awareness, S. 3018/ HR 3173 Improving Seniors Timely Access to Care Act, S.464 Safe Step Act and HR8295 Labor/HHS Appropriations bill H.R. 5801 HELP Copays Act Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters FDA Issues; User Fee Reauthorization HR7667 Food and Drug Amendments Act and S4348 FDA safety and landmark advancement act H.R. 6963, the Accelerated Approval Integrity Act of 2022 H.R. 7047, a bill to amend Title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R. 6000, the Cures 2.0 Act H.R. 7008, the Pre-Approval Information Exchange Act S4293 Pharmacy benefit managers transparency act HR 8588Fair Care Act, 340B hospital reporting HR 4390 Protect 340B Act

Client expense: $3,150,000 · Firm income: Not reported

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

H.R. 379/S. 104 - Improving Social Determinants of Health Act; bill to require the Centers for Disease Control and Prevention (CDC) to establish a program to improve health outcomes and reduce health inequities by, for example, coordinating activities across the CDC. As part of the program, the CDC must award grants to eligible organizations to build capacity to address social determinants of health. H.R. 469 - Comprehensive Breast Reconstruction Act of 2021; bill provides for Medicare, Medicaid, and private health insurance coverage of certain tattooing services in connection with post-mastectomy breast reconstruction, and aligns the scope of Medicare and Medicaid coverage of such breast reconstruction with that of private health insurance. H.R. 5030/S.2706 - DIVERSE Trials Act; A bill to require FDA to issue guidance on decentralized clinical trials to promote meaningful demographic/geographic diversity in patient engagment, expand reporting by laboratories that test for and diagnose COVID-19, and require a study on data collection and data sharing during public health emergencies H.R. 6000 - Cures 2.0 Act; a comprehensive healthcare and biomedical research bill H.R. 4794/S. 2533 - Making Advances in Mammography and Medical Options for Veterans Act; a bill to improve mammography services furnished by the Department of Veterans Affairs H.R. 4571/S. 2102 - Supporting Expanded Review for Veterans in Combat Environments (SERVICE) Act of 2021; a bill to expand eligibility for Veterans Health Administration mammography screenings to veterans who served in certain locations during specified periods, including those who were exposed to toxic substances at such locations H.R. 6584 - Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes. S. 3799 - Prepare for and Respond to Existing Viruses, Emerging New Threats, (PREVENT) and Pandemics Act; a bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics. Efforts to introduce a bill regarding clinical trial diversity nicknamed the The Clinical Trial Diversity Act H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 S. 4260 - Palliative Care and Hospice Education and Training Act; a bill to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools, social work schools, and other programs, including physician assistant education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative medicine. H.R. 7667/S. 4348 - Food and Drug Amendments of 2022; a bill to reauthorize Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices. Policies related to telehealth Policies related to COVID-19 vaccination and monoclonal antibody distribution Policies to increase clinical trial diversity and access for underrepresented populations Policies related to genetic counseling and testing Policies related to cancer survivorship Policies related to PBM and drug cost transparency Comments to FTC regarding a Request for Information on Pharmacy Benefit Managers practices (FTC-2022-0015) Comments to FDA on the Draft Guidance For Industry: Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (FDA-2021-D0789)

Client expense: $80,000 · 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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

H.R. 1255/S. 377, the Living Donor Protection Act H.R. 1676, the Jack Reynold Medigap Expansion Act H.R. 526, Ensuring Coverage in Public Health Emergencies Act of 2021 Health disparities S. 1002, the Junk Plan Accountability and Disclosure Act of 2021 H.R. 4065/S. 1971, the Chronic Kidney Disease Improvement in Research and Treatment Act of 2021. H.R. 3893, the CARE for All Kidneys Act FY 2023, Labor-HHS-Education Appropriations Act H.R. 7585, the Health Equity and Accountability Act of 2022 (HEAA) H.R. 5801, the Help Ensure Lower Patient (HELP) Copays Act H.R. 7845, NIH Clinical Trial Diversity Act of 2022 H.R. 7667, the Food and Drug Amendments of 2022 H.R. 7506, the New Era for Preventing End-Stage Kidney Disease Act of 2022 Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules Diversity Plans To Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry Request for Information on ways to strengthen and improve the Organ Procurement and Transplantation Network

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

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

Health disparities Access to clinical trials for underrepresented populations Improving Social Determinants of Health Act (S.104/H.R.379) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) DIVERSE Trials Act (H.R. 5030/S. 2706) Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (H.R.6584); a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes CURES 2.0 Act (H.R. 6000) Policies related to cancer survivorship Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people, including COVID-19 vaccination and monoclonal antibody distribution Policies related to reducing the cost of cancer treatment for patients Policies related to decline in breast cancer screenings during the COVID-19 pandemic Policies related to genetic counseling and screening Policies related to reauthorization of user fees at the Food and Drug Administration (H.R. 7667/ S. 4348)H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 Advanced Research Project Agency-Health Act (H.R.5585) Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act (S.3799) Comments to the FDA on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry (FDA-2021-D0789) Comments to the FTC on the Business Practices of Pharmacy Benefit Managers and Their Impact on Independent Pharmacies and Consumers (FTC-2022-0015)

Client expense: Not reported · Firm income: $42,000

Government targets: Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 4127: DISARM Act - Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing and patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S 2938 - Bipartisan Safer Communities Act - budget offset provisions related to Rebate Rule S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Dietary Supplement Health and Education Act Reform Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022

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

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

FDA Safety and Landmark Advancements Act (S. 4348)/Food and Drug Amendments of 2022 (HR 7667) -Support reauthorization of FDA User Fees -Clinical Trial Diversity -Accelerated Approval DIVERSE Trials Act (S. 2706, HR 5030) -Support Targeting Resources for Equitable Access to Treatment for Long COVID (TREAT Long COVID) Act (H.R. 7482/ S.4015 ) -Support CARE for Long COVID Act (S. 3726) NIH Clinical Trial Diversity Act of 2022 (H.R.7845) Budget Reconciliation Legislation -Support extension of ACA tax credits

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

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

Issues related to asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to lung disease treatment, prevention and research; Issues related to COVID-19 Response; Issues related to telehealth; Issues related to the SUNSET Rule; Issues related to infrastructure; Issues related to supplemental oxygen; Issues related to health equity; Issues related to FY23 appropriations bills; Issues related to Cancer Moonshot; Issues relating to the Presidents FY23 budget; Issues related to CDC public health workforce and data modernization House Labor HHS Appropriations bill; H.R.8236 House Defense Appropriations bill; Senate Labor HHS Appropriations bill; Senate Defense Appropriations bill; H.R.2140 To prioritize funding for an expanded and sustained national investment in basic science research; S.571 Public Health Funding Prevents Pandemics Act; S.961 A bill to prioritize funding for an expanded and sustained national investment in basic science research; S.962 A bill to prioritize funding for an expanded and sustained national investment in biomedical research; ; H.R.107 Lung Cancer Screening Registry and Quality Improvement Act of 2021; H.R.1800 Women and Lung Cancer Research and Preventive Services Act of 2021; S.699 Women and Lung Cancer Research and Preventive Services Act of 2021; H.R.3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.5030 DIVERSE Trials Act; S.2706 DIVERSE Trials Act; S.Res.462 A resolution designating November 2021 as "National Lung Cancer Awareness Month" and expressing support for early detection and treatment of lung cancer;; S.4348 -FDASLA Act of 2022; H.R.7667 - Food and Drug Amendments of 2022, S.4535 -A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; H.R. 7845 NIH Clinical Trial Diversity Act of 2022

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

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

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. 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

Client expense: $6,340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE

S. 253, Cannabidiol and Marihuana Research Expansion Act, all provisions H.R. 6087, Improving Access to Workers Compensation for Injured Federal Workers Act of 2022, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5030, Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, all provisions H.R. 1384, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions S. 445, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions H.R. 2067, Medication Access and Training Expansion (MATE) Act of 2021, all provisions S. 2235, Medication Access and Training Expansion (MATE) Act of 2021, all provisions H.R. 6072, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services S. 509, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services H.R. 379, Improving Social Determinants of Health Act of 2021, all provisions S. 104, Improving Social Determinants of Health Act of 2021, all provisions S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and (PREVENT) Pandemics Act, all provisions H.R. 8, Bipartisan Background Checks Act of 2021, all provisions H.R. 1446, Enhanced Background Checks Act of 2021, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 2163, Safe Step Act, all provisions S. 464, Safe Step Act, all provisions H.R. 666, Anti-Racism in Public Health Act of 2021, all provisions S. 162, Anti-Racism in Public Health Act of 2021, all provisions H.R. 5248, Temporary Responders for Immediate Aid in Grave Emergencies (TRIAGE) Act of 2021, all provisions H.R. 6311, Comprehensive Addiction Resources Emergency Act of 2021, all provisions S. 3418, Comprehensive Addiction Resources Emergency Act of 2021, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 3735, Parity Implementation Assistance Act, all provisions H.R. 7232, 9-8-8 and Parity Assistance Act of 2022, all provisions H.R. 7116, 9-8-8 Implementation Act of 2022, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions S. 4090, Dietary Supplement Listing Act of 2022, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act, all provisions S. 610, Dr. Lorna Breen Health Care Provider Protection Act, all provisions H.R. 3753, Parity Implementation Assistance Act, all provisions S. 1962, Parity Implementation Assistance Act, all provisions S. 3904, Healthcare Cybersecurity Act of 2022, all provisions H.R. 4128, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions H.R. 6000, Cures 2.0 Act, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 8152, To provide consumers with foundational data privacy rights, create strong oversight mechanisms, and establish meaningful enforcement, all provisions H.R. 2377, Federal Extreme Risk Protection Order Act of 2022, all provisions H.R. 7910, Protecting Our Kids Act, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions H.R. 7667, Food and Drug Amendments of 2022, all provisions H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022, all provisions H.R. 2503, Social Determinants Accelerator Act of 2021, all provisions S. 3039, Social Determinants Accelerator Act of 2021, all provisions H.R. 7192, Diagnostic Device Advisory Committee Act, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act, all provisions H.R. 7845, NIH Clinical Trial Diversity Act of 2022, all provisions H.R. 708, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions H.R. 4480, Telehealth Coverage and Payment Parity Act, all provisions H.R. 7573, Telehealth Extension and Evaluation Act, all provisions S. 3593, Telehealth Extension and Evaluation Act, all provisions H.R. 5541, Primary and Virtual Care Affordability Act, all provisions H.R. 1306, National Coronavirus Commission Act of 2021, all provisions S. 412, National Coronavirus Commission Act of 2021, all provisions H.R. 1843, COVID-19 Hate Crimes Act, all provisions S. 937, COVID-19 Hate Crimes Act, all provisions H.R. 3778, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions S. 1976, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions H.R. 6904, Patients Before Profits Act of 2022, all provisions H.R. 7053, Hospital Inpatient Services Modernization Act, all provisions S. 3792, Hospital Inpatient Services Modernization Act, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 5224, Preventing Overdoses and Saving Lives Act of 2021, all provisions H.R. 6279, Opioid Treatment Access Act of 2022, all provisions H.R. 7234, Summer Barrow Prevention, Treatment, and Recovery Act, all provisions H.R. 3352, Midwives for MOMS Act of 2021, all provisions H.R. 847, Promoting Digital Privacy Technologies Act, all provisions S. 224, Promoting Digital Privacy Technologies Act, all provisions H.R. 3771, South Asian Heart Health Awareness and Research Act of 2021, all provisions H.R. 7559, Prescription Information Modernization Act of 2022, all provisions H.R. 8289, Banning Misleading Drug Ads Act of 2022, all provisions H.R. 3614, Menstrual Equity For All Act of 2021, all provisions No Surprises Act/implementation Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions 21st Century Cures Act/implementation Maternal mortality Maternal health and inequities/FY 2023 funding Prior Authorization AMA Recovery Plan for Americas Physicians/telehealth/prior authorization/physician burnout/scope Section 2527(b) of the U.S. Innovation and Competition Act (USICA)/Open Access Language Retired Physician Re-entry COVID-19 telehealth flexibilities COVID-19/Vaccine distribution/Vaccines in physician offices Physician burnout and suicide COVID-19/Health Equity/vaccines COVID-19 response/testing/misinformation/therapeutics/Paxlovid Public Health Emergency COVID-19 Health Equity/Men who have sex with men/3-month blood donation use deferral Health Equity/Federally qualified health centers and clinical trials Womens Reproductive Health Medication Abortion Access Diabetes Provider Relief Fund/COVID-19 Electronic Health Records (EHR) Certification Data Privacy Hunger, Nutrition, and Health Digital Health/AI/Digital Therapeutics Monkeypox/testing/vaccination

Client expense: $4,550,000 · 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), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), President of the U.S., SENATE, Vice President of the U.S., White House Office

Issues related to drug pricing reform H.R.5376, Build Back Better Act S2891 Restoring America Invents Act S1435 affordable prescriptions for patients act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to clinical trial diversity, HR 6584 DEPICT Act, HR5030 DIVERSE Trials Act, HR 7845 and S2706 NIH Clinical Trial Diversity Act of 2022 Issues related to biodefense issues, S3799 PREVENT Pandemics Act Issues related to cardiovascular disease awareness, S. 3018/ HR 3173 Improving Seniors Timely Access to Care Act, S.464 Safe Step Act and HR8295 Labor/HHS Appropriations bill H.R. 5801 HELP Copays Act Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters FDA Issues; User Fee Reauthorization HR7667 Food and Drug Amendments Act and S4348 FDA safety and landmark advancement act H.R. 6963, the Accelerated Approval Integrity Act of 2022 H.R. 7047, a bill to amend Title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R. 6000, the Cures 2.0 Act H.R. 7008, the Pre-Approval Information Exchange Act S4293 Pharmacy benefit managers transparency act

Client expense: $2,070,000 · Firm income: Not reported

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

H.Res. 1141 - Educator Mental Health Awareness Week Resolution H.Res. 1191 - Providing for consideration of the bill (H.R. 4176) to improve Federal population surveys by requiring the collection of voluntary, self-disclosed information on sexual orientation and gender identity in certain surveys, and for other purposes; providing for consideration of the bill (H.R. 5585) to establish the Advanced Research Projects Agency-Health, and for other purposes; providing for consideration of the bill (H.R. 7666) to amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorders, and for other purposes; and for other purposes. H.R. 623 - Gabriella Miller Kids First Research Act 2.0 H.R. 909 / S. 484 - Moms Matter Act H.R. 1384 / S. 445 - Mainstreaming Addiction Treatment (MAT) Act H.R. 1475/ S. 1795 - Pursuing Equity in Mental Health Act H.R. 2067 - MATE Act H.R. 2256/ S. 834 - Resident Physician Shortage Reduction Act of 2021 H.R. 2377 - Federal Extreme Risk Protection Order Act of 2021 H.R. 2376 - Excellence in Recovery Housing Act H.R. 2929 - Virtual Peer Support Act H.R. 3173/ S. 3018 - Improving Seniors Timely Access to Care Act of 2021 H.R. 3407/ S. 411 - MOMMAS Act H.R. 3447 - Permanency for Audio-Only Telehealth Act H.R. 3450/ S. 1727 - Medicaid Bump Act H.R. 3753/ S. 1962 - Parity Implementation Assistance Act H.R. 3771 - South Asian Heart Health Awareness Act of 2021 H.R. 4058/ S. 2061 - Telemental Health Care Access Act. H.R. 4122 / S. 3658 - Resident Education Deferred Interest (REDI) Act H.R. 4217 / S. 2779 - TRIUMPH for New Moms Act H.R. 4770 - Evaluating Disparities and Outcomes of Telehealth (EDOT) Act of 2021 H.R. 4944 - Helping Kids Cope Act of 2021 H.R. 5218 - Collaborate in an Orderly and Cohesive Manner Act H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 6943 / S. 3635 - Public Safety Officer Support Act H.R. 7073 - Into the Light for Maternal Mental Health Act H.R. 7076 - Supporting Childrens Mental Health Care Access Act of 2022 H.R. 7116 - 988 Implementation Act of 2022 H.R. 7232 - 988 and Parity Assistance Act of 2022 H.R. 7233 - Keeping Incarceration Discharges Streamlined for Children and Accommodating Resources in Education Act or the KIDS CARES Act H.R. 7234 - Summer Barrow Prevention, Treatment, and Recovery Act H.R. 7235 / S.4301 - Substance Use Prevention, Treatment, and Recovery Services Block Grant Act of 2022 H.R. 7236 - Strengthen Kids Mental Health Now Act of 2022 H.R. 7237 - Reauthorizing Evidence-based and Crisis Help Initiatives Needed to Generate Improved Mental Health Outcomes for Patients Act of 2022 or the REACHING Improved Mental Health Outcomes for Patients Act of 2022 H.R. 7238 - Timely Treatment for Opioid Use Disorder Act of 2022 H.R. 7241 - Community Mental Health Services Block Grant Reauthorization Act H.R. 7248 - Continuing Systems of Care for Children Act H.R. 7249 / S. 3686 - Anna Westin Legacy Act of 2022 H.R. 7254 - Mental Health Justice and Parity Act of 2022 H.R. 7255 / S. 4271 - Garrett Lee Smith Memorial Reauthorization Act H.R. 7427 - To amend title XI of the Social Security Act to require CMI testing of incentive payments for behavioral health providers and certain other providers for adoption and use of certified electronic health record technology, and for other purposes. H.R. 7565 - NIH Improve Act H.R. 7649 - To direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes. H.R. 7666 - Restoring Hope for Mental Health and Well-Being Act of 2022 H.R. 7667 - Food and Drug Amendments of 2022 H.R. 7740 - Employee and Retiree Access to Justice Act of 2022 H.R. 7767 - Strengthening Behavioral Health Benefits Act H.R. 7845 - NIH Clinical Trial Diversity Act H.R. 7857 - Minority Fellowship Program Reauthorization Act of 2022 H.R. 7910 - Protecting Our Kids Act H.R. 8180 - Undertaking Needed Investments in Therapy, Education, and De-Escalation Act of 2022 H.R. 8229 - Telemental Health Parity Act S. 2938 - Bipartisan Safer Communities Act S. 4132 - Womens Health Protection Act S. 4170 - Mental Health Reform Reauthorization Act of 2022 S. 4306 - Improving Access to Behavioral Health Integration Act S. 4348 - Food and Drug Administration Safety and Landmark Advancements S. 4461 - Expanding Access to Mental Health Training Act S. 4448 - Suicide Prevention Act No legislation - Implementation of new REMS regulations

Client expense: $181,613 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE