Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

General issues related to Puerto Rico hurricane recovery. H.R. 6378, H.R. 7328, H.R. 269, & S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 and 2019

Client expense: $620,000 · Firm income: Not reported

Government targets: Federal Emergency Management Agency (FEMA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE

Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions, and substance misuse/behavioral health issues. Specific Legislation: 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act and Pandemic and All-Hazards Preparedness and Advancing Innovation Act (Public Law 113-5, 116-22) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Implementation of Child Care and Development Block Grant Act of 2014 (Public Law 113-186) 7.Implementation of Every Student Succeeds Act (Public Law 114-95) 8.Implementation of the Comprehensive Addition and Recovery Act (Public Law 114-98) 9.FY 2020 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations (H.R. 2740/Not Yet Introduced)) 10.FY 2020 Departments of Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations (H.R. 3164/Not yet introduced) 11.FY2020 Departments of Transportation, HUD and related agencies Appropriations (H.R. 3163/Not Yet Introduced) 12.Midnight Rules Relief Act (S.34/H.R. 21) 13.Regulations from the Executive in Need of Scrutiny Act (S. 21/H.R. 26) 14.Regulatory Accountability Act (S.951/H.R. 5/H.R. 45/H.Res.33) 15.Searching for and Cutting Regulations that are Unnecessarily Burdensome (SCRUB) Act (H.R. 998) 16.Regulatory Integrity Act (H.R. 1004) 17.OIRA Insight, Reform, and Accountability Act (S. 676/H.R. 1009) 18.A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (S.Con.Res. 3) 19.American Health Care Act (H.R. 1628/H.Res. 228) 20.Ozone Standards Implementation Act (S. 263/H.R. 806) 21.Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule of the Bureau of Land Management relating to "Waste Prevention, Production Subject to Royalties, and Resource Conservation" (S.J. Res. 11/H.J.Res.36) 22.Common Sense Nutrition Disclosure Act (S. 261/H.R. 772) 23.Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act (H.R. 1840) 24.Preservation of Antibiotics for Medical Treatment Act (H.R. 1587) 25.Preventing Antibiotic Resistance Act (S. 629) 26.Better Care Reconciliation Act (H.R. 1628) and related amendments 27.Public Health Emergency Response Act (S. 196) 28.Recognizing the importance of vaccinations and immunizations in the United States (H.Res.327) 29.Consolidated Appropriations Act, 2017 (Public Law 115-31) 30.Treat and Reduce Obesity Act (S. 830/H.R. 1953) 31.Community Health and Medical Professionals Improve Our Nation (CHAMPION) Act (H.R. 3922) 32.Community Health Investment, Modernization, and Excellence Act of 2017 (S. 1899) 33.Tobacco Tax Equity Act (S. 1837) 34.Healthy Kids Act (S. 1821/H.R. 3921) 35.Implementation of the Drug Quality and Security Act (P.S. 113-54) 36.Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017 (Public Law 115-56) 37.Friendly Airports for Mothers Act (S. 1110/H.R. 2375) 38.Lead-Safe Housing for Kids Act (S. 1845) 39.Supporting Working Moms Act (S. 2122/H.R. 3255) 40.Championing Healthy Kids Act (H.R. 3922) 41.Making further continuing appropriations for fiscal year 2018, and for other purposes (Public Law 115-90) 42.An Act to amend the Homeland Security Act of 2002 to require the Secretary of Homeland Security to issue Department of Homeland Security-wide guidance and develop training programs as part of the Department of Homeland Security Blue Campaign, and for other purposes (Public Law 115-96) 43.Tax Cuts and Jobs Act (Public Law 115-97) 44.Pandemic and All-Hazards Preparedness Advancing Innovation Act (S. 2852/H.R. 6378/H.R. 7328/S. 1379/H.R. 269) 45.Vaccine Access Improvement Act (H.R. 4993) 46.Relief from New Source Performance Standards Act (H.R. 453) 47.Strategies to Address Antimicrobial Resistance (S. 2469) 48.Opioid Quota Reform Act (S. 2535) 49.Hospital Preparedness Program Reauthorization Act (H.R. 4776) 50.Blocking Regulatory Interference from Closing Kilns Act (H.R. 1917) 51.Health Equity and Accountability Act (H.R. 5942) 52.Opioid Crisis Response Act of 2018 (S. 2680) 53.Agriculture and Nutrition Act (H.R. 2) 54.Agriculture Improvement Act (S. 3042) 55.SECURE Act (H.R. 5998) 56.Trauma-Informed Care for Children and Families Act (S. 774) 57.SUPPORT for Patients and Communities Act (H.R. 6) 58.Centers for Disease Control Emergency Response Act (S. 3161) 59.LABEL Opioids Act (S. 3428) 60.Relief from New Source Performance Standards Act (S. 1857) 61.Outdoors for All Act (S. 3499) 62.The MOMMA Act (H.R. 5977) 63.Preventing Maternal Deaths Act (H.R. 1318) 64.Medicare Access to Vaccines Equity Act (note yet introduced) 65.The Support Act (H.R. 6) 66.Climate Change Health Protection and Promotion Act (S. 529) 67.FY 2020 Departments of the Interior, Environment, and Related Agencies Appropriations Act (H.R. 3052/Not Yet Introduced) 68.NURSE Act (H.R. 1597) 69.Investing for the People Act (H.R. 2021) 70.Child Care for Working Families Act (H.R. 365/S. 568) 71.FAMILY Act (H.R. 1185/S. 463) 72.Transportation Alternatives Enhancement Act (S. 1098) 73.Lower Health Care Costs Act (S. 1895) 74.LIFT America Act (H.R 2479) 75.Public Health Funding Restoration Act (H.R. 3447/S. 1944) 76.Older Americans Act reauthorization (not yet introduced) 77.Campus Prevention and Recovery Services for Students Act (H.R. 3591) 78.Healthier Students for Stronger Campuses Act (S. 1281) 79.Saving Lives Through Better Data Act (S. 1793) 80.VACCINES Act (H.R. 2862) 81.DISARM Act (S. 1712/not yet introduced) 82.Community Access, Resources, and Education for Families Act (H.R. 3117) 83.Protecting Seniors Through Immunization Act (S. 1872) 84.Tobacco-Free Youth Act (S. 1541) 85.Tobacco to 21 Act (H.R. 2411/S. 1258) 86.Investing for People Act (H.R. 2021) 87.School Based Health Centers Reauthorization Act (H.R.2075/S.1013) 88.Reversing the Youth Tobacco Epidemic Act of 2019 (H.R. 2339) House(s) of Congress and Federal Agencies lobbied during the quarter: House, Senate, Exec Office of Pres, HHS, CDC, FDA, CMS, OMB, DOT, HUD, EPA, Education, USDA, DHS, FEMA, and SAMHSA.

Client expense: $38,304 · Firm income: Not reported

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

General issues related to Puerto Rico hurricane recovery. H.R. 6378, H.R. 7328, H.R. 269, & S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 and 2019

Client expense: $550,000 · Firm income: Not reported

Government targets: Federal Emergency Management Agency (FEMA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE

Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions, and substance misuse/behavioral health issues. Specific Legislation: 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2. Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3. Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4. Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5. Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6. Implementation of the Drug Quality and Security Act of 2013 (Public Law 113-54) 7. Implementation of Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 8. Implementation of Child Care and Development Block Grant Act of 2014 (Public Law 113-186) 9. Implementation of Every Student Succeeds Act (Public Law 114-95) 10. Implementation of the Comprehensive Addition and Recovery Act (Public Law 114-98) 11. FY 2018 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations (S. 1771/H.R. 3358) 12. FY 2018 Departments of Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations (S. 1603/H.R. 3268) 13. Consolidated Appropriations Act 2018 (Public Law 115-141) 14. Midnight Rules Relief Act (S.34/H.R. 21) 15. Regulations from the Executive in Need of Scrutiny Act (S. 21/H.R. 26) 16. Regulatory Accountability Act (S.951/H.R. 5/H.R. 45/H.Res.33) 17. Searching for and Cutting Regulations that are Unnecessarily Burdensome (SCRUB) Act (H.R. 998) 18. Regulatory Integrity Act (H.R. 1004) 19. OIRA Insight, Reform, and Accountability Act (S. 676/H.R. 1009) 20. A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (S.Con.Res. 3) 21. American Health Care Act (H.R. 1628/H.Res. 228) 22. Ozone Standards Implementation Act (S. 263/H.R. 806) 23. Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule of the Bureau of Land Management relating to "Waste Prevention, Production Subject to Royalties, and Resource Conservation" (S.J. Res. 11/H.J.Res.36) 24. Common Sense Nutrition Disclosure Act (S. 261/H.R. 772) 25. Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act (H.R. 1840) 26. Preservation of Antibiotics for Medical Treatment Act (H.R. 1587) 27. Preventing Antibiotic Resistance Act (S. 629) 28. Better Care Reconciliation Act (H.R. 1628) and related amendments 29. Public Health Emergency Response Act (S. 196) 30. Recognizing the importance of vaccinations and immunizations in the United States (H.Res.327) 31. Consolidated Appropriations Act, 2017 (Public Law 115-31) 32. Treat and Reduce Obesity Act (S. 830/H.R. 1953) 33. Community Health and Medical Professionals Improve Our Nation (CHAMPION) Act (H.R. 3922) 34. Community Health Investment, Modernization, and Excellence Act of 2017 (S. 1899) 35. Tobacco Tax Equity Act (S. 1837) 36. Healthy Kids Act (S. 1821/H.R. 3921) 37. Implementation of the Drug Quality and Security Act (P.S. 113-54) 38. Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017 (Public Law 115-56) 39. Friendly Airports for Mothers Act (S. 1110/H.R. 2375) 40. Lead-Safe Housing for Kids Act (S. 1845) 41. Supporting Working Moms Act (S. 2122/H.R. 3255) 42. Championing Healthy Kids Act (H.R. 3922) 43. Making further continuing appropriations for fiscal year 2018, and for other purposes (Public Law 115-90) 44. An Act to amend the Homeland Security Act of 2002 to require the Secretary of Homeland Security to issue Department of Homeland Security-wide guidance and develop training programs as part of the Department of Homeland Security Blue Campaign, and for other purposes (Public Law 115-96) 45. Tax Cuts and Jobs Act (Public Law 115-97) 46. Pandemic and All-Hazards Preparedness Advancing Innovation Act (S. 2852/H.R. 6378/H.R. 7328) 47. Vaccine Access Improvement Act (H.R. 4993) 48. Relief from New Source Performance Standards Act (H.R. 453) 49. Strategies to Address Antimicrobial Resistance (S. 2469) 50. Opioid Quota Reform Act (S. 2535) 51. Hospital Preparedness Program Reauthorization Act (H.R. 4776) 52. Blocking Regulatory Interference from Closing Kilns Act (H.R. 1917) 53. Health Equity and Accountability Act (H.R. 5942) 54. Opioid Crisis Response Act of 2018 (S. 2680) 55. Agriculture and Nutrition Act (H.R. 2) 56. Agriculture Improvement Act (S. 3042) 57. SECURE Act (H.R. 5998) 58. FY 2019 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations (S. 3158) 59. FY 2019 Departments of the Interior, Environment, and Related Agencies Appropriations Act (H.R. 6147/S. 3073) 60. FY 2019 Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations (H.R. 5961/ S. 2976) 61. Trauma-Informed Care for Children and Families Act (S. 774) 62. SUPPORT for Patients and Communities Act (H.R. 6) 63. Centers for Disease Control Emergency Response Act (S. 3161) 64. LABEL Opioids Act (S. 3428) 65. Relief from New Source Performance Standards Act (S. 1857) 66. Outdoors for All Act (S. 3499) 67. The MOMMA Act (H.R. 5977) 68. The WIC Act (not yet introduced) 69. Preventing Maternal Deaths Act (H.R. 1318) 70. Medicare Access to Vaccines Equity Act (note yet introduced) 71. The Support Act (H.R. 6) 72. Climate Change Health Protection and Promotion Act (S. 529) 73. FY 2020 Departments of the Interior, Environment, and Related Agencies Appropriations Act 74. NURSE Act (H.R. 1597) 75. Investing for the People Act (H.R. 2021) 76. Child Care for Working Families Act (H.R. 365/S. 568) 77. FAMILY Act (H.R. 1185/S. 463) 78. Transportation Alternatives Enhancement Act (S. 1098) House(s) of Congress and Federal Agencies lobbied during the quarter: House, Senate, Exec Office of Pres, HHS, CDC, FDA, CMS, OMB, DOT, HUD, EPA, Education, USDA, DHS, FEMA, and SAMHSA

Client expense: $33,373 · Firm income: Not reported

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

Issue: Educate Congress and the administration on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support the reauthorization of Health Resources and Services Administrations Title VII health professions workforce programs. S. 192, Community and Public Health Programs Extension Act S. 106, Community Health Investment, Modernization, and Excellence Act of 2019 S. 692, Community Health Center and Primary Care Workforce Expansion Act of 2019 Issue: Support the reauthorization of the National Health Service Corps, Community Health Centers, and Teaching Health Centers mandatory appropriation fund. Issue: Support initiatives of hospitals to promote affordable housing in local communities and eliminate other social determinants of health to improve health equity. Issue: Educate Congress and the administration about academic medicines response to the opioid epidemic. Support funding for training on substance use disorders, pain management, and safe prescribing practices. Issue: Support reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund Issue: Oppose restrictions on fetal tissue research. Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (H.R. 7328/ H.R. 6378/S.2852/H.R. 4776 of the 115th congress) Issue: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. Issue: Support continuation of high-quality affordable health insurance through preservation of current levels of health care coverage. Support programs and funds for safety-net providers. Issue: Support measures to preserve and strengthen the 340B Drug Pricing Program and oppose efforts to reduce the scope of the program, including instituting a moratorium, increasing reporting requirements on covered entities, and imposing user fees Draft, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2018 Draft, Diagnostic Accuracy and Innovation Act (DAIA) Issue: Oppose burdensome regulation of Laboratory Developed Tests Issue: Educate Congress on surprise medical bills and price transparency. Support general principles for surprise medical bills draft legislation.

Client expense: $1,081,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Education, Dept of, Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

General issues related to Puerto Rico hurricane recovery. H.R. 6378, H.R. 7328, H.R. 269, & S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 and 2019

Client expense: $780,000 · Firm income: Not reported

Government targets: Federal Emergency Management Agency (FEMA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE

Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions, and substance misuse/behavioral health issues. Specific Legislation: 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2. Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3. Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4. Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5. Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6. Implementation of the Drug Quality and Security Act of 2013 (Public Law 113-54) 7. Implementation of Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 8. Implementation of Child Care and Development Block Grant Act of 2014 (Public Law 113-186) 9. Implementation of Every Student Succeeds Act (Public Law 114-95) 10. Implementation of the Comprehensive Addition and Recovery Act (Public Law 114-98) 11. FY 2018 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations (S. 1771/H.R. 3358) 12. FY 2018 Departments of Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations (S. 1603/H.R. 3268) 13. Consolidated Appropriations Act 2018 (Public Law 115-141) 14. Midnight Rules Relief Act (S.34/H.R. 21) 15. Regulations from the Executive in Need of Scrutiny Act (S. 21/H.R. 26) 16. Regulatory Accountability Act (S.951/H.R. 5/H.R. 45/H.Res.33) 17. Searching for and Cutting Regulations that are Unnecessarily Burdensome (SCRUB) Act (H.R. 998) 18. Regulatory Integrity Act (H.R. 1004) 19. OIRA Insight, Reform, and Accountability Act (S. 676/H.R. 1009) 20. A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (S.Con.Res. 3) 21. American Health Care Act (H.R. 1628/H.Res. 228) 22. Ozone Standards Implementation Act (S. 263/H.R. 806) 23. Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule of the Bureau of Land Management relating to "Waste Prevention, Production Subject to Royalties, and Resource Conservation" (S.J. Res. 11/H.J.Res.36) 24. Common Sense Nutrition Disclosure Act (S. 261/H.R. 772) 25. Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act (H.R. 1840) 26. Preservation of Antibiotics for Medical Treatment Act (H.R. 1587) 27. Preventing Antibiotic Resistance Act (S. 629) 28. Better Care Reconciliation Act (H.R. 1628) and related amendments 29. Public Health Emergency Response Act (S. 196) 30. Recognizing the importance of vaccinations and immunizations in the United States (H.Res.327) 31. Consolidated Appropriations Act, 2017 (Public Law 115-31) 32. Treat and Reduce Obesity Act (S. 830/H.R. 1953) 33. Community Health and Medical Professionals Improve Our Nation (CHAMPION) Act (H.R. 3922) 34. Community Health Investment, Modernization, and Excellence Act of 2017 (S. 1899) 35. Tobacco Tax Equity Act (S. 1837) 36. Healthy Kids Act (S. 1821/H.R. 3921) 37. Implementation of the Drug Quality and Security Act (P.S. 113-54) 38. Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017 (Public Law 115-56) 39. Friendly Airports for Mothers Act (S. 1110/H.R. 2375) 40. Lead-Safe Housing for Kids Act (S. 1845) 41. Supporting Working Moms Act (S. 2122/H.R. 3255) 42. Championing Healthy Kids Act (H.R. 3922) 43. Making further continuing appropriations for fiscal year 2018, and for other purposes (Public Law 115-90) 44. An Act to amend the Homeland Security Act of 2002 to require the Secretary of Homeland Security to issue Department of Homeland Security-wide guidance and develop training programs as part of the Department of Homeland Security Blue Campaign, and for other purposes (Public Law 115-96) 45. Tax Cuts and Jobs Act (Public Law 115-97) 46. Pandemic and All-Hazards Preparedness Advancing Innovation Act (S. 2852/H.R. 6378/H.R. 7328) 47. Vaccine Access Improvement Act (H.R. 4993) 48. Relief from New Source Performance Standards Act (H.R. 453) 49. Strategies to Address Antimicrobial Resistance (S. 2469) 50. Opioid Quota Reform Act (S. 2535) 51. Hospital Preparedness Program Reauthorization Act (H.R. 4776) 52. Blocking Regulatory Interference from Closing Kilns Act (H.R. 1917) 53. Health Equity and Accountability Act (H.R. 5942) 54. Opioid Crisis Response Act of 2018 (S. 2680) 55. Agriculture and Nutrition Act (H.R. 2) 56. Agriculture Improvement Act (S. 3042) 57. SECURE Act (H.R. 5998) 58. FY 2019 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations (S. 3158) 59. FY 2019 Departments of the Interior, Environment, and Related Agencies Appropriations Act (H.R. 6147/S. 3073) 60. FY 2019 Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations (H.R. 5961/ S. 2976) 61. Trauma-Informed Care for Children and Families Act (S. 774) 62. SUPPORT for Patients and Communities Act (H.R. 6) 63. Centers for Disease Control Emergency Response Act (S. 3161) 64. LABEL Opioids Act (S. 3428) 65. Relief from New Source Performance Standards Act (S. 1857) 66. Outdoors for All Act (S. 3499) 67. The MOMMA Act (H.R. 5977) 68. The WIC Act (not yet introduced) 69. Preventing Maternal Deaths Act (H.R. 1318) 70. Medicare Access to Vaccines Equity Act (note yet introduced) 71. The Support Act (H.R. 6) House(s) of Congress and Federal Agencies lobbied during the quarter: House, Senate, Exec Office of Pres, HHS, CDC, FDA, CMS, OMB, DOT, HUD, EPA, Education, USDA, DHS, FEMA, and SAMHSA.

Client expense: $28,207 · Firm income: Not reported

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

Good Samaritan Health Professionals Act (regarding ensuring access to care by protecting certain medical volunteers from lawsuits), H.R. 1876, entire bill; Good Samaritan Health Professionals Act (regarding ensuring access to care by protecting certain medical volunteers from lawsuits), S. 781, entire bill; Pandemic and All-Hazards Preparedness and Advancing Innovation Act, H.R. 6378, Sec. 209 (regarding ensuring access to care by protecting certain medical volunteers from lawsuits); Pandemic and All-Hazards Preparedness Reauthorization Act, S. 2852, Sec. 207 (regarding healthcare volunteer registration systems) and Sec. 208 (liability related to healthcare volunteers); Pandemic and All-Hazards Preparedness and Advancing Innovation Act, H.R. 7328, Sec. 207 (regarding healthcare volunteer registration systems) and Sec. 208 (liability related to healthcare volunteers).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act HR 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 HR 394/S85 - Restoring Access to Medication Ac HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 Medicare Doughnjt hole -House/Senate Labor HHS AppropriationsHouse/Senate DoD AppropriationsDoggett bill Trump Administration IPI proposal, Trump Administration proposed changes to six protected classes. HR6378, Pandemic and All Hazards Preparedness and Advancing Innovation Act; HR4993/S3253, Vaccine Access Improvement Act; HR 4297/S2103, Protecting Seniors Through Immunization Act; H.R.4710 - 340B PAUSE ActH.R.4297 - Protecting Seniors Through Immunization Act of 2017 S. 3477 - Protecting Seniors through Immunization Act S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees -Know the Lowest Price Act of 2018Medicare Part D Six Protected Classes HHS Proposal on Medicare Part B International Pricing Index (IPI)340B Drug Discount Program S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $920,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

HR6378/HR7328/S2851 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

Client expense: $323,071 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Repeal of the Affordable Care Act H.R. 1628 The American Health Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program HR1628 Better Care Reconciliation Act ACA Cost Sharing Reduction Subsidies Graham-Cassidy Amendment to HR 1628 340B drug pricing program HR3545-Overdose, Prevention and Patient Advocacy Act HR4392 CMS OPPS 340b rule moratorium HR4710 340b PAUSE Act Bipartisan Healthcare Stabilization Act of 2017 Opioid Crisis Response Act of 2018 42 CFR Part 2 IMD Exclusion Prescription drug monitoring programs H.R. 5197, S. 2516, Alternatives to opioids in the emergency dept Act H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act H.R. 5261, Treatment, Education, and Community Help to Combat Opioid Addiction Act Poison Center Network Enhancement Act A Bill to support the peer support specialist workforce HR6 Support for Patients and Communities Act H.R. 4710 PAUSE Act HELP Act S. 2312 HR6378 Pandemic and All Hazards Preparedness and Advancing Innovation Act S.974 CREATES Act S.2843 Opioid Workforce Act HEAL Act S.3120 SERV Communities Act H. R. 6071 S.428, H.R. 3325 The Advancing Care for Exceptional (ACE) Kids Act Cassidy Surprise Billing Draft H.R.6 Support for Patients and Communities Act Protecting Patients from Surprise Medical Bills Hassan Surprise Billing-S. 3592, No more Surprise Medical Bills Act H.R. 7328, Pandemic and All-Hazards Preparedness and Advancing Innovation Act

Client expense: $460,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---H.R. 7328: Pandemic and All-Hazards Preparedness and Innovation Act of 2018 ---National Biodefense Strategy ---Gene Editing Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.771: Improving Access to Affordable Prescription Drugs ---General Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Funding for Antimicrobial Resistance Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate) Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act ---Incentives for Generic Drug Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations The United States-Mexico-Canada Agreement ---Pricing and Reimbursement Provisions ---IP Provisions ---Regulatory Harmonization US-UK Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-EU Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-Japan Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---Vaccine Quality Measure Diagnostic and Personalized Medicine Regulation and Oversight Precision Medicine Initiative

Client expense: $2,500,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) ---H.R. 7328: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 ---National Biodefense Strategy ---Gene Editing Funding for Antimicrobial Resistance Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate) Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019

Client expense: $2,500,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) ---H.R. 7328: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 ---National Biodefense Strategy ---Gene Editing Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate)

Client expense: $2,500,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support continuation of high-quality affordable health insurance through preservation of current levels of health care coverage. Support programs and funds for safety-net providers. H.R. 3728, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) Act of 2017 Issue: Support reauthorization of Title VII health professions programs P.L. 115-241, Childrens Hospital GME Support Reauthorization Act Issue: Support reauthorization of the Childrens Hospital GME program H.R. 959/S. 1109 Title VIII Nursing Workforce Reauthorization Act of 2017 Issue: Support reauthorization of Title VIII nursing workforce development programs S.3095 / H.R. 2574, Building a Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development S. 3660 / H.R. 5942, Health Equity and Accountability Act Issue: Support workforce grants to medical schools to improve health equity Issue: Oppose regulatory proposals to narrow the definition of sex Issue: Educate Congress and the administration, support training on substance use disorders, pain management, and safe prescribing practices. Strategies to prevent, identify, and treat opioid addiction Issue: Support reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund Issue: Promote resilience of health professionals Issue: Support policies to address IV fluid shortages exacerbated by hurricanes, and educate Congress on the shortage of IV saline fluid and injectable drug shortage. Issue: Oppose restrictions on fetal tissue and embryonic stem cell research. P.L. 115-176/H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act. Issue: Oppose Right to Try legislation that removes safety measures under FDAs current expanded access program. P.L. 115-271 SUPPORT for Patients and Communities Act H.R. 5261, Treatment, Education, and Community Help to Combat Addiction Act of 2018 S.2680, Opioid Crisis Response Act of 2018 S.2711, Enhancing Access to Addiction Treatment Act of 2018 Issue: Support policies to address the opioid epidemic including improving coverage and payment for non-opioid therapies, enhancing usability of PDMPs, addressing physician shortages, promoting medication assisted treatment, eliminating Medicare limits on in-patient psychiatric hospital treatment, eliminating Medicaid IMD exclusion, aligning privacy regulations, and investing in research and education, and reauthorizing the Patient Centered Outcomes Research Institute. Provide grants to regional Centers of Excellence in substance use disorder education. Support policy eliminating Medicaid IMD exclusion and revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). Issue: Amend Controlled Substances Act to improve MAT waiver process for qualified health professionals. H.R. 6082, the Overdose Prevention and Patient Safety Act Issue: Support legislation revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). H.R. 7328/ H.R. 6378/S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 Issue: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. H.R.4776 Hospital Preparedness Reauthorization Act of 2018. Issue: Support reauthorization of the Hospital Preparedness Program Issue: Support legislative solutions to fire arm related injuries and fatalities including research, public health surveillance, and firearm background checks. H.R. 4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes. Issue: Support rescission of Medicare cuts to hospitals that participate in 340B Drug Pricing Program H.R. 4710, 340B PAUSE Act Issue: Oppose bill that would impose a moratorium on 340B hospitals and other issues S. 2312, 340B HELP Act Issue: Oppose bill that would impose a moratorium and add additional reporting requirements for 340B hospitals S.2453, Ensuring the Value of the 340B Program Act of 2018 Issue: Oppose bill that would require hospitals to report total 340B acquisition costs H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act Issue: Support bill to rescind Medicare cuts to 340B hospitals and improve program integrity H.R. 5598: 340B Optimization Act Issue: Oppose bill that would change eligibility metrics in the 340B program H.R. 6240, Drug Discount Accountability Act Issue: Oppose bill that would impose a user fee on hospitals that participate in the 340B program S. 3366, Maternal CARE Act Issue: Support efforts to reduce preventable maternal mortality Issue: Support national preparedness infrastructure.

Client expense: $892,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), Vice President of the U.S., White House Office

340B Drug Pricing Program Opioid issues (S. 2680, the Opioid Crisis Response Act of 2018; H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act; H.R. 5009, Jessies Law; H.R. 5818 / S. 2843, the Opioid Workforce Act; H.R. 5797, the IMD CARE Act; H.R. 6082/H.R. 5795, the Overdose Prevention and Patient Safety Act; S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act; S. 2460, Every Prescription Conveyed Securely Act; S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act; H.R. 5582, the Abuse Deterrent Access Act; H.R. 5685, the Medicare Opioid Safety Education Act; Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018; H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; S. 2899, Caring Recovery for Infants and Babies Act; S. 2898, Medication-Assisted Treatment Improvement Act; S.2911, Enhancing Patient Access to Non-Opioid Treatment Options) Draft Protecting Patients from Surprise Medical Bills Act HIPAA policy in mental and behavioral health information sharing 21st Century Cures Act implementation Pandemic and All Hazards Preparedness Reauthorization, including Hospital Preparedness Program (S. 2852 / H.R. 6378, H.R. 7328, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2018) S.781/ HR 1876. Good Samaritan Health Professional Act of 2017 Health workforce reauthorizations (H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act; H.R. 1676, the Palliative Care and Hospice Education and Training Act Liver allocation policy S.2554, Patient Right to Know Drug Prices Act Consumer-directed health care proposals (Associations Health Plans, Short-term Limited Duration Insurance plans, Section 1332 waivers) Maternal health legislation (H.R. 315, Improving Access to Maternity Care Act and H.R. 1318, Preventing Maternal Deaths Act)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 906 (Furthering Asbestos Claims Transparency Act); amends title 11 of the United States Code to require the public disclosure by trusts established under section 524(g) of such title, of quarterly reports that contain detailed information regarding the receipt and disposition of claims for injuries based on exposure to asbestos. H.R. 1563 (Mary Jo Lawyer Spano Mesothelioma Patient Registry Act of 2017); amends the Public Health Service Act to provide for the establishment of a mesothelioma patient registry. H.R. 575 (Cosmetic Modernization Amendments of 2017); amends the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic manufacturing establishments, the submission of cosmetic and ingredient statements, and the reporting of serious cosmetic adverse events. S. 1113 (Personal Care Products Safety Act); amends the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. H.R. 832 (Arbitration Transparency Act); amends title 9 of the United States Code to require that arbitration proceedings in certain disputes involving consumer financial products and services be open to the public. S. 542 (Safety Over Arbitration Act of 2017); amends title 9, United States Code, with respect to arbitration where the claim or controversy alleges facts relevant to a hazard to public health or safety. S. 552/H.R. 1414 (Justice for Victims of Fraud Act); amends the Truth in Lending Act and the Electronic Fund Transfer Act to provide justice to victims of fraud. S. 550/H.R. 1396 (Restoring Statutory Rights Act); invalidates arbitration agreements between parties in certain commercial contracts or transactions if they require arbitration of a claim for damages or injunctive relief brought by an individual or small business arising from the alleged violation of a federal or state statute, the U.S. Constitution, or a state constitution. S. 646/H.R. 2631 (Justice for Servicemembers and Veterans Act); amends title 38, United States Code, to improve the enforcement of employment and reemployment rights of members of the uniformed services, to amend the Servicemembers Civil Relief Act to improve the protection of members of the uniformed services. S. 647 (Mandatory Arbitration Transparency Act); amends title 9, United States Code, with respect to arbitration. S. 537/H.R. 1374 (Arbitration Fairness Act); prohibits mandatory, pre-dispute arbitration in employment, consumer, antitrust, or civil rights disputes. S. 2203/H.R. 4734/H.R. 4570 (Ending Forced Arbitration of Sexual Harassment Act of 2017); prohibits a pre-dispute arbitration agreement from being valid or enforceable if it requires arbitration of a sex discrimination dispute. H.R. 3857 (PASS Act of 2017); amend the Securities Exchange Act of 1934 to lower standards of conduct for brokers and dealers that are in the best interest of their retail customers. S. 534/H.R. 1973 (Protecting Young Victims from Sexual Abuse Act of 2017); prevents the sexual abuse of minors and amateur athletes by requiring the prompt reporting of sexual abuse to law enforcement authorities S. 2564, (PROTECT Asbestos Victims Act of 2018); restricts claims against asbestos trusts and provides for criminal penalties for fraudulent claims. S. 1112, (Maternal Health Accountability Act of 2017); retricts the use of information reviewed by the maternal mortality review committee. Infomration is considered confidential and not subject to dioscvery at a civil trial. S. 2852 (Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018); regarding immunity provisions, and additional variations of the bill including: H.R. 7328 (Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018) and H.R. 6378 (Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018). H.R. 6022/ S. 3019 (Accurate Labels Act); regarding the broad preemption of state and local labeling laws for consumer products. H.R. 6903 (Safe Cosmetics and Personal Care Products Act of 2018); amends current law to ensure the safety of cosmetics and personal care products. H.R. 919 (Blitz Gas Can bill). H.R. 3850 (Made in America Act of 2017); directs the FTC to establish labels that may be used as a voluntary means of indicating to consumers the extent to which products are of US origin; more specifically about the FTC enforcement authority. General issues pertaining to Asbestos Bankruptcy Trusts. Cosmetic Regulation and Safety and realted preemption issues in Murray Alexander draft bill. General lobbying with regard to the Education Departments borrower defenses rule. General lobbying with regard to warranties of Energy Star-rated products and ability of consumers to bring a class action against manufacturers of Energy Star-rated products. General lobbying with regard to pesticide regulations. General lobbying with regard to amending Telephone Consumer Protection Act liability. General lobbying with regard to attorney advertising issues. General lobbying with regard to asbestos exposure and related health and environmental issues. General lobbying with regard to liability issues related to regulation of cosmetics products. General lobbying with regard to TSCA implementation. General lobbying with regard to asbestos in talc and talc generally. General lobbying with regard to nursing home arbitration. General lobbying with regard to issues relating to PFOA.

Client expense: $1,300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 1316, Prescription Drug Price Transparency Act Support S. 637, C-THRU Act. Support H.R. 5958, Phair Pricing Act Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act; provisions also included in H.R. 7328, Pandemic and All-Hazards Preparedness and Advancing Innovation Act.

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

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

S. 2852 & H.R.637/H.R.7328-The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

OTC Drug Review Monograph H.R. 5333/S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act. Legislation to update and modernize the Over-the-Counter Drug Review Monograph system, which regulates the manufacture, labeling, and marketing of specific over-the-counter (OTC) drugs. H.R. 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6903 - Safe Cosmetics and Personal Care Products Act of 2018

Client expense: $197,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

General education about federal policies impacting pharmaceutical development, approval, and reimbursement (including Medicare, Medicaid, Affordable Care Act issues). Policies impacting public health preparedness and prevention. Pandemic All Hazards Preparedness Authorization Act of 2018, H.R. 6378, S. 2851, H.R. 7328, S. 2852. Over-the-Counter Drug Safety Innovations and Reform Act, S. 2315, H.R. 7328. H.R. 6 Support for Patients and Communities Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6378, H.R. 7328, S.2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues related to Puerto Rico hurricane recovery HR 6378, HR 7328 & S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

Client expense: $970,000 · Firm income: Not reported

Government targets: Federal Emergency Management Agency (FEMA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE

H.R. 7328 - Pandemic and All Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2018 - SUpport of PAHPA reauthorization and OTC monograph reform. H.R. 6 - Support for Patients and Communities Act - Support for policies that help to fight the opioid epidemic with a focus on public health. S. 3120 - Helping to End Addiction and Lessen Substance Use Disorders Act - Support for policies that help to fight the opioid epidemic with a focus on public health. S. 2315 - The Over the Counter Drug Safety Innovation and Reform Act - Support for amending and improving OTC Monograph Reform. S. 2852 - the Pandemic and All Hazards Preparedness and Advancing Innovation Act of 2018 - Issues related to the continues attention required to antibiotic resistance as a public health threat and policies to ensure the adequacy and development of antibiotics to ward against threats to the common good. Trump Administration's Blueprint for lowering the price of prescription medications in the United States. CMS regulations related to Medicare Part D and promulgation of laws related to curbing substance use disorder among Medicare beneficiaries. H.R. 2871 - The Preserving Patient Access to Compounded Medications Act of 2017 - Concerns about how the bill could compromise safety protocols for compounded medications. Issues related to antibiotic innovation and advancement Issues related to health information technology, unique device identifiers on Medicare claims forms, and other critical policies to promote device safety. Issues related to over the counter medications and supplements. Issues related to HIT needs and capabilities within the Veteran's health care system.

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

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

H.R. 7328 - Pandemic and All Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2018 - SUpport of PAHPA reauthorization and OTC monograph reform. H.R. 6 - Support for Patients and Communities Act - Support for policies that help to fight the opioid epidemic with a focus on public health for Medicare and Medicaid beneficiaries. S. 3120 - Helping to End Addiction and Lessen Substance Use Disorders Act - Support for policies that help to fight the opioid epidemic with a focus on public health for Medicare and Medicaid beneficiaries. Trump Administration's Blueprint for lowering the price of prescription medications in the United States for Medicare and Medicaid beneficiaries. CMS regulations related to Medicare Part D and promulgation of laws related to curbing substance use disorder among Medicare beneficiaries. Issues related to interoperability and patient access in health care entitlement programs.

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

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

Food and Drug Administration and cleaning products (H.R. 5333, H.R. 7328, H.R. 695, S. 2315)

Client expense: $60,000 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to the study and approval of certain over the counter antimicrobial hand soaps. S. 2315, Over-the-Counter Drug Safety, Innovation, and Reform Act and H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. Issues related to cleaning product ingredients labeling,disclosure and transparency. H.R. 7328 Over-the-Counter Monograph Safety pandemic and all hazards preparedness and advancing innovation Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE