MERIT Act

NAPA Reauthorization Act (P.L. 118-92) Alzheimers Accountability and Investment Act (P.L. 118-93) Comprehensive Care for Alzheimers Act (S. 626 / H.R. 1637 118th Congress) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Reauthorization Act (P.L. 118-142) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (H.R. 3747) Elizabeth Dole Home Care Act, (S. 141 / H.R. 542 118th Congress) The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (H.R. 8371 118th Congress) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10 118th Congress) Access to Innovative Treatments Act of 2023 (H.R. 2408 118th Congress) Mandating Exclusive Review of Individual Treatments (MERIT) Act of 2023 (H.R. 133 118th Congress) Elder Justice Reauthorization and Modernization Act of 2023 (S. 1198/H.R. 2718 118th Congress) Expanding Veterans Options for Long-Term Care Act (S. 495/H.R.1815 118th Congress) Palliative Care and Hospice Education and Training Act of 2023 (S. 2287/H.R. 4425) Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 (S. 1544/H.R. 1199 118th Congress) Supporting Our Seniors Act (S. 2584 118th Congress) Alleviating Barriers for Caregiving Act (S. 3109 118th Congress) Credit for Caring Act (S. 925/H.R. 2036) Lifespan Respite Care Reauthorization Act (S. 4325/H.R. 6160 118th Congress) to amend the Public Health Service Act to reauthorize a lifespan respite care program Lifespan Respite Care Reauthorization Act (S.830/H.R.2560) DeOndra Dixon INvestigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2025 (H.R. 3491/S. 1838) Paid Family and Medical Leave Tax Credit Extension Act (S. 3680 118th Congress) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 400/H.R. 996) CONNECT for Health Act (S. 2016/H.R. 4189 118th Congress; S. 1261 119th Congress) PACE Part D Choice Act (S. 1703/H.R. 3549 118th Congress) Improving Seniors' Access to Timely Care Act (S. 1816/H.R. 3514) to amend Title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act (H.R. 9233) Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT) Act (S. 526/H.R. 1092) Essential Caregivers Act of 2024 (S. 4280/H.R. 8331) Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) Linking Seniors to Needed Legal Services Act (H.R. 8588) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Catching Up Family Caregivers Act (S. 5149 / H.R. 9764 118th Congress) Improving Retirement Security for Family Caregivers Act (S. 5148 / H.R. 9765 118th Congress) Charitable Act (S. 317/H.R. 801) Health Tech Investment Act (S.1399) One Big Beautiful Bill Act (H.R. 1) Older Americans Act Reauthorization Act (S. 2120) Alzheimers Screening and Prevention Act (H.R. 6130/S. 3267) Other matters related to disaster preparedness and older adults, public health emergencies, public health preparedness and response, telehealth, health disparities, and older Americans/people with disabilities in all phases of emergencies Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta-amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices other matters related to rural health other matters related to veterans' health other matters related to Tricare Other matters related to research Other matters related to biomarkers including blood based tests and cerebral spinal fluid (CSF) Other matters related to public health Other matters related to elder justice Other matters related to Medicaid Other matters related to nonprofit infrastructure and operations Other matters related to the National Plan to Address Alzheimer's Disease and the NAPA Advisory Council Other matters related to the Alzheimer's Screening and Prevention (ASAP) Act Other matters related to brain health, risk reduction, and the U.S. POINTER study and results

Client expense: $560,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

NAPA Reauthorization Act (P.L. 118-92) Alzheimers Accountability and Investment Act (P.L. 118-93) Comprehensive Care for Alzheimers Act (S. 626 / H.R. 1637 118th Congress) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Reauthorization Act (P.L. 118-142) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (H.R. 3747) Elizabeth Dole Home Care Act, (S. 141 / H.R. 542 118th Congress) The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (H.R. 8371 118th Congress) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10 118th Congress) Access to Innovative Treatments Act of 2023 (H.R. 2408 118th Congress) Mandating Exclusive Review of Individual Treatments (MERIT) Act of 2023 (H.R. 133 118th Congress) Elder Justice Reauthorization and Modernization Act of 2023 (S. 1198/H.R. 2718 118th Congress) Expanding Veterans Options for Long-Term Care Act (S. 495/H.R.1815 118th Congress) Palliative Care and Hospice Education and Training Act of 2023 (S. 2287/H.R. 4425) Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 (S. 1544/H.R. 1199 118th Congress) Supporting Our Seniors Act (S. 2584 118th Congress) Alleviating Barriers for Caregiving Act (S. 3109 118th Congress) Credit for Caring Act (S. 925/H.R. 2036) Lifespan Respite Care Reauthorization Act (S. 4325/H.R. 6160 118th Congress) to amend the Public Health Service Act to reauthorize a lifespan respite care program Lifespan Respite Care Reauthorization Act (S.830/H.R.2560) DeOndra Dixon INvestigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2025 (H.R. 3491/S. 1838) Paid Family and Medical Leave Tax Credit Extension Act (S. 3680 118th Congress) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 400/H.R. 996) CONNECT for Health Act (S. 2016/H.R. 4189 118th Congress; S. 1261 119th Congress) PACE Part D Choice Act (S. 1703/H.R. 3549 118th Congress) Improving Seniors' Access to Timely Care Act (S. 1816/H.R. 3514) to amend Title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act (H.R. 9233) Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT) Act (S. 526/H.R. 1092) Essential Caregivers Act of 2024 (S. 4280/H.R. 8331) Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) Linking Seniors to Needed Legal Services Act (H.R. 8588) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Catching Up Family Caregivers Act (S. 5149 / H.R. 9764 118th Congress) Improving Retirement Security for Family Caregivers Act (S. 5148 / H.R. 9765 118th Congress) Charitable Act (S. 317/H.R. 801) Health Tech Investment Act (S.1399) One Big Beautiful Bill Act (H.R. 1) Older Americans Act Reauthorization Act (S. 2120) Alzheimers Screening and Prevention Act (H.R. 6130/S. 3267) Other matters related to disaster preparedness and older adults, public health emergencies, public health preparedness and response, telehealth, health disparities, and older Americans/people with disabilities in all phases of emergencies Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta-amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices other matters related to rural health other matters related to veterans' health other matters related to Tricare Other matters related to research Other matters related to biomarkers including blood based tests and cerebral spinal fluid (CSF) Other matters related to public health Other matters related to elder justice Other matters related to Medicaid Other matters related to nonprofit infrastructure and operations Other matters related to the National Plan to Address Alzheimer's Disease and the NAPA Advisory Council Other matters related to the Alzheimer's Screening and Prevention (ASAP) Act Other matters related to brain health, risk reduction, and the U.S. POINTER study and results

Client expense: $520,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

NAPA Reauthorization Act (P.L. 118-92) Alzheimers Accountability and Investment Act (P.L. 118-93) Comprehensive Care for Alzheimers Act (S. 626 / H.R. 1637 118th Congress) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Reauthorization Act (P.L. 118-142) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (H.R. 3747) Elizabeth Dole Home Care Act, (S. 141 / H.R. 542 118th Congress) The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (H.R. 8371 118th Congress) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10 118th Congress) Access to Innovative Treatments Act of 2023 (H.R. 2408 118th Congress) Mandating Exclusive Review of Individual Treatments (MERIT) Act of 2023 (H.R. 133 118th Congress) Elder Justice Reauthorization and Modernization Act of 2023 (S. 1198/H.R. 2718 118th Congress) Expanding Veterans Options for Long-Term Care Act (S. 495/H.R.1815 118th Congress) Palliative Care and Hospice Education and Training Act of 2023 (S. 2243 118th Congress) Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 (S. 1544/H.R. 1199 118th Congress) Supporting Our Seniors Act (S. 2584 118th Congress) Alleviating Barriers for Caregiving Act (S. 3109 118th Congress) Credit for Caring Act of 2025 (S. 925/H.R. 2036) Lifespan Respite Care Reauthorization Act of 2024 (S. 4325/H.R. 6160) to amend the Public Health Service Act to reauthorize a lifespan respite care program Lifespan Respite Care Reauthorization Act of 2025 (S.830/H.R.2560) DeOndra Dixon INvestigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2025 (H.R. 3491/S. 1838) Paid Family and Medical Leave Tax Credit Extension Act (S. 3680 118th Congress) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 400/H.R. 996) CONNECT for Health Act of 2025 (S. 2016/H.R. 4189 118th Congress; S. 1261) PACE Part D Choice Act (S. 1703/H.R. 3549 118th Congress) Improving Seniors' Access to Timely Care Act (S. 4532/H.R. 8702 118th Congress) to amend Title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act (H.R. 9233) Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT) Act (S. 526/H.R. 1092) Essential Caregivers Act of 2024 (S. 4280/H.R. 8331, 118th Congress) Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691, 118th Congress) Linking Seniors to Needed Legal Services Act (H.R. 8588, 118th Congress) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Catching Up Family Caregivers Act (S. 5149 / H.R. 9764, 118th Congress) Improving Retirement Security for Family Caregivers Act (S. 5148 / H.R. 9765, 118th Congress) Charitable Act (S. 317/H.R. 801) Health Tech Investment Act (S.1399) One Big Beautiful Bill Act (H.R. 1) Older Americans Act Reauthorization Act of 2025 (S. 2120) Other matters related to disaster preparedness and older adults, public health emergencies, public health preparedness and response, telehealth, health disparities, and older Americans/people with disabilities in all phases of emergencies Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta-amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices other matters related to rural health other matters related to veterans' health other matters related to Tricare Other matters related to research Other matters related to biomarkers including blood based tests and cerebral spinal fluid (CSF) Other matters related to public health Other matters related to elder justice Other matters related to Medicaid Other matters related to the National Plan to Address Alzheimer's Disease and the NAPA Advisory Council Other matters related to nonprofit infrastructure and operations Other matters related to the Alzheimer's Screening and Prevention (ASAP) Act Other matters related to the National Plan to Address Alzheimer's Disease and the NAPA Advisory Council Other matters related to nonprofit infrastructure and operations Other matters related to the Alzheimer's Screening and Prevention (ASAP) Act Other matters related to brain health, risk reduction, and the U.S. POINTER study and results

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

NAPA Reauthorization Act (P.L. 118-92) Alzheimers Accountability and Investment Act (P.L. 118-93) Comprehensive Care for Alzheimers Act (S. 626 / H.R. 1637 118th Congress) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Reauthorization Act (P.L. 118-142) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (H.R. 3747) Elizabeth Dole Home Care Act, (S. 141 / H.R. 542 118th Congress) The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (H.R. 8371 118th Congress) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10 118th Congress) Access to Innovative Treatments Act of 2023 (H.R. 2408 118th Congress) Mandating Exclusive Review of Individual Treatments (MERIT) Act of 2023 (H.R. 133 118th Congress) Elder Justice Reauthorization and Modernization Act of 2023 (S. 1198/H.R. 2718 118th Congress) Expanding Veterans Options for Long-Term Care Act (S. 495/H.R.1815 118th Congress) Palliative Care and Hospice Education and Training Act of 2023 (S. 2243 118th Congress) Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 (S. 1544/H.R. 1199 118th Congress) Supporting Our Seniors Act (S. 2584 118th Congress) Alleviating Barriers for Caregiving Act (S. 3109 118th Congress) Credit for Caring Act (S. 925/H.R. 2036) Lifespan Respite Care Reauthorization Act (S. 4325/H.R. 6160) to amend the Public Health Service Act to reauthorize a lifespan respite care program Lifespan Respite Care Reauthorization Act (S.830/H.R.2560) DeOndra Dixon INvestigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2025 (H.R. 3491/S. 1838) Paid Family and Medical Leave Tax Credit Extension Act (S. 3680 118th Congress) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 400/H.R. 996) CONNECT for Health Act (S. 2016/H.R. 4189 118th Congress; S. 1261 119th Congress) PACE Part D Choice Act (S. 1703/H.R. 3549 118th Congress) Improving Seniors' Access to Timely Care Act (S. 4532/H.R. 8702 118th Congress) to amend Title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act (H.R. 9233) Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT) Act (S. 526/H.R. 1092) Essential Caregivers Act of 2024 (S. 4280/H.R. 8331) Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) Linking Seniors to Needed Legal Services Act (H.R. 8588) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Catching Up Family Caregivers Act (S. 5149 / H.R. 9764) Improving Retirement Security for Family Caregivers Act (S. 5148 / H.R. 9765) Charitable Act (S. 317/H.R. 801) Health Tech Investment Act (S.1399) One Big Beautiful Bill Act (H.R. 1) Older Americans Act Reauthorization Act (S. 2120) Other matters related to disaster preparedness and older adults, public health emergencies, public health preparedness and response, telehealth, health disparities, and older Americans/people with disabilities in all phases of emergencies Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta-amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices other matters related to rural health other matters related to veterans' health other matters related to Tricare Other matters related to research Other matters related to biomarkers including blood based tests and cerebral spinal fluid (CSF) Other matters related to public health Other matters related to elder justice Other matters related to Medicaid Other matters related to the National Plan to Address Alzheimer's Disease and the NAPA Advisory Council Other matters related to nonprofit infrastructure and operations Other matters related to the Alzheimer's Screening and Prevention (ASAP) Act

Client expense: $1,790,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

NAPA Reauthorization Act (S. 133 / H.R. 619 - P.L. 118-92) Alzheimers Accountability and Investment Act (S. 134 / H.R. 620 - P.L. 118-93) Comprehensive Care for Alzheimers Act (S. 626 / H.R. 1637) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Infrastructure for Alzheimer's Reauthorization Act of 2024 (S. 3775/ H.R. 7218 - P.L. 118-142) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (S. 4276/H.R. 7688) Elizabeth Dole Home Care Act, of 2023 (S. 141 / H.R. 542) Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (H.R. 8371) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10) Access to Innovative Treatments Act of 2023 (H.R. 2408) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 133) Elder Justice Reauthorization and Modernization Act of 2023 (S. 1198/H.R. 2718) Expanding Veterans Options for Long-Term Care Act (S. 495/H.R.1815) Palliative Care and Hospice Education and Training Act (S. 2243) Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 (S. 1544/H.R. 1199) Supporting Our Seniors Act (S. 2584) Alleviating Barriers for Caregiving Act (S. 3109) Credit for Caring Act of 2024 (S. 3702/H.R. 7165) Credit for Caring Act of 2025 (S. 925/H.R. 2036) Lifespan Respite Care Reauthorization Act of 2024 (S. 4325/H.R. 6160) Lifespan Respite Care Reauthorization Act of 2025 (S.830/H.R.2560) DeOndra Dixon INvestigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2024 (H.R. 7406) Paid Family and Medical Leave Tax Credit Extension Act (S. 3680) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 400/H.R. 996) CONNECT for Health Act of 2023 (S. 2016/H.R. 4189) PACE Part D Choice Act of 2023 (S. 1703/H.R. 3549) Improving Seniors' Access to Timely Care Act of 2024 (S. 4532/H.R. 8702) Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act of 2024 (H.R. 9233) Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT)(S. 526/H.R. 1092) Essential Caregivers Act of 2024 (S. 4280/H.R. 8331) Ensuring Patient Access to Critical Breakthrough Products Act of 2024 (H.R. 1691) Linking Seniors to Needed Legal Services Act of 2024 (H.R. 8588) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Catching Up Family Caregivers Act of 2024 (S. 5149 / H.R. 9764) Improving Retirement Security for Family Caregivers Act of 2024 (S. 5148 / H.R. 9765) Charitable Act (S. 317/H.R. 801) Other matters related to disaster preparedness and older adults, public health emergencies, public health preparedness and response, telehealth, health disparities, and older Americans/people with disabilities in all phases of emergencies Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta-amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices Other matters related to rural health Other matters related to veterans' health Other matters related to Tricare Other matters related to research Other matters related to biomarkers including blood based tests and cerebral spinal fluid (CSF) Other matters related to public health

Client expense: $530,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

Linking Seniors to Needed Legal Services Act (H.R. 8588) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (S. 4276/H.R. 7688) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Improving Seniors' Access to Timely Care Act (S. 4532/H.R. 8702) to amend Title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act (H.R. 9233) Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT) Act (S. 526/H.R. 1092) Essential Caregivers Act of 2024 (S. 4280/H.R. 8331) Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) PACE Part D Choice Act of 2023 (S. 1703/H.R. 3549) Credit for Caring Act of 2024 (S. 3702/H.R. 7165) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 3680) CONNECT for Health Act of 2023 (S. 2016 / H.R. 4189) Lifespan Respite Care Reauthorization Act (H.R. 6160) to amend the Public Health Service Act to reauthorize a lifespan respite care program DeOndra Dixon Investigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2024 (H.R. 7406) NAPA Reauthorization Act (S. 133/H.R. 619/P.L. 118-92) Alzheimers Accountability and Investment Act (S. 134/H.R. 620/P.L. 118-93) Comprehensive Care for Alzheimers Act (S. 626/H.R. 1637) Elizabeth Dole Home Care Act of 2023 (S. 141/H.R. 542) Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (H.R. 8371) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 133) Access to Innovative Treatments Act of 2023 (H.R. 2408) Elder Justice Reauthorization and Modernization Act of 2023 (H.R. 2718/S. 1198) Expanding Veterans Options for Long Term Care Act (H.R.1815/S. 495) Palliative Care and Hospice Education and Training Act (S.2243) Facilitating Innovative Nuclear Diagnostics Act of 2023 (H.R. 1199/S. 1544) Supporting Our Seniors Act (S. 2584) Alleviating Barriers for Caregiving Act (S. 3109) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Reauthorization Act (P.L.118-142) Catching Up Family Caregivers Act (S. 5149 / H.R. 9764) Improving Retirement Security for Family Caregivers Act (S. 5148 / H.R. 9765) Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices other matters related to rural health other matters related to veterans health other matters related to Tricare Other matters related to research Other matters related to biomarkers including blood based tests and cerebral spinal fluid (csf)

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), 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), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---H.R.6973: Generic Drug Application Review Reforms ---S.148: Stop STALLING Act ---S.4351: Enhanced Access to Affordable Medicines Act Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4758: Accelerating Kids Access to Care Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433: Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1067: Ensuring Timely Access to Generics ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART) Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

Economic development for City of Pittsburgh, including monitoring of Appropriations, specifically Nationally Significant Freight and Highway Projects Program. Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Economic development for City of Pittsburgh, including monitoring of Appropriations, specifically Nationally Significant Freight and Highway Projects Program within Transportation Approps. Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Economic development for City of Pittsburgh, including TIGER grants and transportation-related issues. Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Economic development for City of Pittsburgh, including TIGER grants and transportation-related issues; Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

1.SECURE 2.0 Technical Corrections Discussion Draft: Legislative language that will amend SECURE 2.0 to make technical changes to a variety of provisions. 2.H.R. 3063, S.4917 Retirement Fairness for Charities and Educational Institutions Act: Would allow 403(b) plans to invest in Collective Investment Trusts or Separate Accounts that establishes investment parity with other defined contribution plans, like 401(k)s. 3.H.R. 3942 Lifetime Income for Employees (LIFE) Act: Amends the current rules for qualified default investment alternatives to facilitate the use of an annuity component that will expand the availability of guaranteed returns and guaranteed lifetime income that help savers secure their retirement futures. 4.H.R. 4237, S. 2282 Ensuring Sound Guidance Act: Would require investment advisers and ERISA retirement plan sponsors to prioritize financial returns over non-pecuniary factors when making investment decisions on behalf of their clients. 5.H.R. 4924, S. 2517 Auto Reenroll Act of 2023: The bill allows plan sponsors to re-enroll non-participants at least once every three years, unless the individual affirmatively opts-out again. The bill also permits plans to sweep all eligible employees as a group for re-enrollment and does not change the automatic enrollment safe harbors. 6.H.R. 5060, S. 2627 Womens Retirement Protection Act (WRPA): The legislation would impose spousal consent requirements on nearly all distributions from defined contribution plans. The bill also seeks to enhance financial literacy through grants to community-based organizations and also offers grants to such organizations to help low-income women and survivors of domestic abuse obtain qualified domestic relations orders. 7.H.R. 5408, S. 2767 SSI Savings Penalty Elimination Act: The legislation would increase the asset limit from $2,000 to $10,000 for an individual, and from $3,000 to $20,000 for a married couple. Increasing the limit empowers people to prepare themselves for a financial emergency and allows them to enter the workforce without worrying theyll save lose their eligibility for SSI by saving too much. 8.H.R. 6007, S. 4398 Retirement Investment in Small Employers (RISE) Act: The legislation would create a new Micro Employer Pension Plan Startup Credit in IRC Section 45E for qualified micro employers. A qualified micro employer is defined as an employer with 10 or fewer employees. The credit amount is 100% of any retirement plan administrative costs up to $2,500 for the first three years after adoption of the retirement plan. 9.H.R. 6065, S.3102 Retirement Savings for Americans Act (RSAA) of 2023: Would create a federally run retirement plan, similar to the TSP, that would be available to all private sector workers whose employer signs up for the plan. 10.S. 3305 Helping Young Americans Save for Retirement Act: The legislation would lower the minimum participation age in ERISA-covered defined contribution plans from age 21 to age 18. 11.H.R. 6757 Roth IRA Rollovers: This legislation will allow retirement savers to roll over their Roth IRA savings into a Roth account within a workplace retirement plan. 12.H.R. 6772 Expanding Access to Retirement Savings for Caregivers Act: The bill would allow individuals that took at least one year out of the workforce without receiving an earned income, for the purposes of caring for a family member, to make catch-up contributions in years prior to age 50 to their 401(k) plans, individual retirement accounts (IRAs), and other eligible retirement accounts. 13.H.R. 7162, S. 3716 401Kids Savings Account Act of 2024: This bill would create childrens savings accounts (CSAs) for every child in America that would be managed by State Treasurers. Funds from the accounts could be used for post-secondary education, starting a business, buying a house, or retirement security. 14.H.R. 7293 Automatic IRA Act of 2024: Mandates employers with 10 or more employees to implement an automatic enrollment retirement plan in the workplace. 15.H.J. Res 142, S.J. Res 79 Fiduciary Rule Congressional Review Act: 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 "Retirement Security Rule: Definition of an Investment Advice Fiduciary" 16.H.R. 10467 Retirement Simplification and Clarity Act: This legislation: 1) permits an in-service plan distribution to an individual retirement annuity on or after attainment of age 50; and (2) includes a specific reference to an individual retirement annuity as a rollover option under a simplified 402(f) safe harbor notice. 17.General Accounts Product Corrections Act: Would clarify fiduciary responsibilities for life insurance companies as it relates to investments in their general accounts. Income Security S. 2415 and H.R. 7107, the Long-Term Care Affordability Act: Would allow for tax free distributions from retirement accounts to fund LTC contracts. H.R. 133, Both provisions are in the larger bill. H.R.1185 - FAMILY Act. Issue: paid family and medical leave proposal would offer paid leave benefits via a payroll tax for birth or adoption of a child or caring for a sick family member. H.R.1940 - New Parents Act of 2019. Issue: paid family and medical leave H.R.2163 - To amend the Internal Revenue Code of 1986 to allow for tax-advantaged distributions from health savings accounts during family or medical leave, and for other purposes. Issue: paid family and medical leave S.463 - FAMILY Act. Issue: paid family and medical leave- paid family and medical leave proposal would offer paid leave benefits via a payroll tax for birth or adoption of a child or caring for a sick family member S.920 - New Parents Act of 2019. Issue: paid family and medical leave Discussion draft - CRADLE Act. Issue: paid family and medical leave - allows for a deferment of retirement benefits for paid leave benefits. Proposed FY 2020 Budget proposal on paid family and medical leave. Issue: paid family and medical leave H.R. 2694 - Pregnant Workers Fairness Act. Issue: paid family and medical leave. Concurrent Resolution on the Budget, FY2022, S.Con.Res.14. The budget resolution calls for the $3.5 trillion in long-term investments to be fully offset by a combination of new tax revenues, health care savings, and long-term economic growth. In addition, the agreement would prohibit new taxes on families making less than $400,000 per year, and on small businesses and family farms. Issue: Medicare/Dental (Expanding Medicare to include dental, vision, hearing benefits and lowering the eligibility age). H.R. 5376- Build Back Better Act This bill provides funding, establishes programs, and otherwise modifies provisions relating to a broad array of areas, including education, labor, child-care, health care, taxes, immigration, and the environment. Excepted Benefits on Supplemental Benefits-proposed tri-agency rule through HHS, Treasury and Labor. S.3680 - Paid Family and Medical Leave Tax Credit Extension and Enhancement Act Diversity and Inclusion H.R. 5084 - Improving Corporate Governance Through Diversity Act. Issue: diversity and inclusion. H.R. 5360 - Closing the Racial Wealth Gap Act. Issue: diversity and inclusion. H.R. 281 - Ensuring Diverse Leadership Act. Issue: diversity and inclusion. H.R. 7946 and S. 4464 - Federal Reserve Racial and Economic Equity Act. Issue: diversity and inclusion.

Client expense: $1,419,462 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Linking Seniors to Needed Legal Services Act (H.R. 8588) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (S. 4276/H.R. 7688) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Improving Seniors' Access to Timely Care Act (S. 4532/H.R. 8702) to amend Title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act (H.R. 9233) Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT) Act (S. 526/H.R. 1092) Essential Caregivers Act of 2024 (S. 4280/H.R. 8331) Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) PACE Part D Choice Act of 2023 (S. 1703/H.R. 3549) Credit for Caring Act of 2024 (S. 3702/H.R. 7165) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 3680) CONNECT for Health Act of 2023 (S. 2016 / H.R. 4189) Lifespan Respite Care Reauthorization Act (H.R. 6160) to amend the Public Health Service Act to reauthorize a lifespan respite care program DeOndra Dixon Investigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2024 (H.R. 7406) NAPA Reauthorization Act (S. 133/H.R. 619/P.L. 118-92) Alzheimers Accountability and Investment Act (S. 134/H.R. 620/P.L. 118-93) Comprehensive Care for Alzheimers Act (S. 626/H.R. 1637) Elizabeth Dole Home Care Act of 2023 (S. 141/H.R. 542) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 133) Access to Innovative Treatments Act of 2023 (H.R. 2408) Elder Justice Reauthorization and Modernization Act of 2023 (H.R. 2718/S. 1198) Expanding Veterans Options for Long Term Care Act (H.R.1815/S. 495) Palliative Care and Hospice Education and Training Act (S.2243) Facilitating Innovative Nuclear Diagnostics Act of 2023 (H.R. 1199/S. 1544) Supporting Our Seniors Act (S. 2584) Alleviating Barriers for Caregiving Act (S. 3109) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Reauthorization Act (S. 3775/ H.R. 7218) Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices other matters related to rural health other matters related to veterans health other matters related to Tricare Other matters related to research Other matters related to biomarkers including blood based tests and cerebral spinal fluid (csf)

Client expense: $540,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), 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), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act H.R. 8261: Preserving Telehealth, Hospital, and Ambulance Access Act S. 1450: Cutting Medicare Prescription Drug Prices in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY 2026 and Maximum Fair Prices policy issues CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P) Medicaid Drug Rebate Program Final rule (CMS-2434-F)

Client expense: $1,540,000 · 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

1.SECURE 2.0 Technical Corrections Discussion Draft: Legislative language that will amend SECURE 2.0 to make technical changes to a variety of provisions. 2.H.R. 3063, S.4917 Retirement Fairness for Charities and Educational Institutions Act: Would allow 403(b) plans to invest in Collective Investment Trusts or Separate Accounts that establishes investment parity with other defined contribution plans, like 401(k)s. 3.H.R. 3942 Lifetime Income for Employees (LIFE) Act: Amends the current rules for qualified default investment alternatives to facilitate the use of an annuity component that will expand the availability of guaranteed returns and guaranteed lifetime income that help savers secure their retirement futures. 4.H.R. 4237, S. 2282 Ensuring Sound Guidance Act: Would require investment advisers and ERISA retirement plan sponsors to prioritize financial returns over non-pecuniary factors when making investment decisions on behalf of their clients. 5.H.R. 4924, S. 2517 Auto Reenroll Act of 2023: The bill allows plan sponsors to re-enroll non-participants at least once every three years, unless the individual affirmatively opts-out again. The bill also permits plans to sweep all eligible employees as a group for re-enrollment and does not change the automatic enrollment safe harbors. 6.H.R. 5060, S. 2627 Womens Retirement Protection Act (WRPA): The legislation would impose spousal consent requirements on nearly all distributions from defined contribution plans. The bill also seeks to enhance financial literacy through grants to community-based organizations and also offers grants to such organizations to help low-income women and survivors of domestic abuse obtain qualified domestic relations orders. 7.H.R. 5408, S. 2767 SSI Savings Penalty Elimination Act: The legislation would increase the asset limit from $2,000 to $10,000 for an individual, and from $3,000 to $20,000 for a married couple. Increasing the limit empowers people to prepare themselves for a financial emergency and allows them to enter the workforce without worrying theyll save lose their eligibility for SSI by saving too much. 8.H.R. 6007, S. 4398 Retirement Investment in Small Employers (RISE) Act: The legislation would create a new Micro Employer Pension Plan Startup Credit in IRC Section 45E for qualified micro employers. A qualified micro employer is defined as an employer with 10 or fewer employees. The credit amount is 100% of any retirement plan administrative costs up to $2,500 for the first three years after adoption of the retirement plan. 9.H.R. 6065, S.3102 Retirement Savings for Americans Act (RSAA) of 2023: Would create a federally run retirement plan, similar to the TSP, that would be available to all private sector workers whose employer signs up for the plan. 10.S. 3305 Helping Young Americans Save for Retirement Act: The legislation would lower the minimum participation age in ERISA-covered defined contribution plans from age 21 to age 18. 11.H.R. 6757 Roth IRA Rollovers: This legislation will allow retirement savers to roll over their Roth IRA savings into a Roth account within a workplace retirement plan. 12.H.R. 6772 Expanding Access to Retirement Savings for Caregivers Act: The bill would allow individuals that took at least one year out of the workforce without receiving an earned income, for the purposes of caring for a family member, to make catch-up contributions in years prior to age 50 to their 401(k) plans, individual retirement accounts (IRAs), and other eligible retirement accounts. 13.H.R. 7162, S. 3716 401Kids Savings Account Act of 2024: This bill would create childrens savings accounts (CSAs) for every child in America that would be managed by State Treasurers. Funds from the accounts could be used for post-secondary education, starting a business, buying a house, or retirement security. 14.H.R. 7293 Automatic IRA Act of 2024: Mandates employers with 10 or more employees to implement an automatic enrollment retirement plan in the workplace. 15.H.J. Res 142, S.J. Res 79 Fiduciary Rule Congressional Review Act: 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 "Retirement Security Rule: Definition of an Investment Advice Fiduciary" 16.General Accounts Product Corrections Act: Would clarify fiduciary responsibilities for life insurance companies as it relates to investments in their general accounts. Income Security S. 2415 and H.R. 7107, the Long-Term Care Affordability Act: Would allow for tax free distributions from retirement accounts to fund LTC contracts. H.R. 133, Both provisions are in the larger bill. H.R.1185 - FAMILY Act. Issue: paid family and medical leave proposal would offer paid leave benefits via a payroll tax for birth or adoption of a child or caring for a sick family member. H.R.1940 - New Parents Act of 2019. Issue: paid family and medical leave H.R.2163 - To amend the Internal Revenue Code of 1986 to allow for tax-advantaged distributions from health savings accounts during family or medical leave, and for other purposes. Issue: paid family and medical leave S.463 - FAMILY Act. Issue: paid family and medical leave- paid family and medical leave proposal would offer paid leave benefits via a payroll tax for birth or adoption of a child or caring for a sick family member S.920 - New Parents Act of 2019. Issue: paid family and medical leave Discussion draft - CRADLE Act. Issue: paid family and medical leave - allows for a deferment of retirement benefits for paid leave benefits. Proposed FY 2020 Budget proposal on paid family and medical leave. Issue: paid family and medical leave H.R. 2694 - Pregnant Workers Fairness Act. Issue: paid family and medical leave. Concurrent Resolution on the Budget, FY2022, S.Con.Res.14. The budget resolution calls for the $3.5 trillion in long-term investments to be fully offset by a combination of new tax revenues, health care savings, and long-term economic growth. In addition, the agreement would prohibit new taxes on families making less than $400,000 per year, and on small businesses and family farms. Issue: Medicare/Dental (Expanding Medicare to include dental, vision, hearing benefits and lowering the eligibility age). H.R. 5376- Build Back Better Act This bill provides funding, establishes programs, and otherwise modifies provisions relating to a broad array of areas, including education, labor, child-care, health care, taxes, immigration, and the environment. Excepted Benefits on Supplemental Benefits-proposed tri-agency rule through HHS, Treasury and Labor. S.3680 - Paid Family and Medical Leave Tax Credit Extension and Enhancement Act Diversity and Inclusion H.R. 5084 - Improving Corporate Governance Through Diversity Act. Issue: diversity and inclusion. H.R. 5360 - Closing the Racial Wealth Gap Act. Issue: diversity and inclusion. H.R. 281 - Ensuring Diverse Leadership Act. Issue: diversity and inclusion. H.R. 7946 and S. 4464 - Federal Reserve Racial and Economic Equity Act. Issue: diversity and inclusion.

Client expense: $809,027 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S. 4667 Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S. 2780 Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.4351: Enhanced Access to Affordable Medicines Act ---H.R 6973: Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433 - Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---American Pandemic Preparedness Plan (AP3) ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---HR 8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.2780 - Medication Affordability and Patent Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act H.R. 8261: Preserving Telehealth, Hospital, and Ambulance Access Act S. 1450: Cutting Medicare Prescription Drug Prices in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY 2026 and Maximum Fair Prices policy issues CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P) Medicaid Drug Rebate Program Final rule (CMS-2434-F)

Client expense: $6,880,000 · Firm income: Not reported

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

Retirement Security, Quarter 3 2024 1. H.J. Res 142, S.J. Res 79 Fiduciary Rule Congressional Review Act: 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 "Retirement Security Rule: Definition of an Investment Advice Fiduciary" Income Security S. 2415 and H.R. 7107, the Long-Term Care Affordability Act: Would allow for tax free distributions from retirement accounts to fund LTC contracts. H.R. 133, Both provisions are in the larger bill.

Client expense: $740,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Economic development for City of Pittsburgh, including TIGER grants and transportation-related issues. Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Economic development for City of Pittsburgh, including monitoring of Appropriations, specifically Nationally Significant Freight and Highway Projects Program within Transportation Approps. Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Economic development for City of Pittsburgh, including TIGER grants and transportation-related issues; Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Economic development for City of Pittsburgh, including monitoring of Appropriations, specifically Nationally Significant Freight and Highway Projects Program. Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 1691: Ensuring Patient Access to Critical Breakthrough Products Act of 2023 H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act H.R. 8261: Preserving Telehealth, Hospital, and Ambulance Access Act S. 1450: Cutting Medicare Prescription Drug Prices in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Drug rebate program Rebate policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)

Client expense: $1,510,000 · Firm income: Not reported

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

H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 1691: Ensuring Patient Access to Critical Breakthrough Products Act of 2023 H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act H.R. 8261: Preserving Telehealth, Hospital, and Ambulance Access Act S. 1450: Cutting Medicare Prescription Drug Prices in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)

Client expense: $6,960,000 · Firm income: Not reported

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

Issues related to energy efficiency in commercial and residential buildings, and advanced building controls Issues related to industrial technologies Issues related to carbon capture and sequestration technologies Issues related to nuclear energy Issues related to Department of Energy wind technology programs (no pending legislation) Issues related to renewable energy (no pending legislation) Issues related to Smart Grid (no pending legislation) Issues related to natural gas Issues related to energy savings performance contracts Department of Energy appropriations Issues related to energy storage Issues related to smart metering Pipeline Safety Act H.R.2, Investing in a New Vision for the Environment and Surface Transportation in America Act Executive Order 13920: Securing the United States Bulk-Power System H.R. 133, Omnibus and COVID Relief and Response Act, 2021 Issues relating to smart cities technologies Issues related to Hydrogen Issues related to biofuels, sustainable aviation fuels Issues related to energy storage Supply Chain Executive Order; DOE Industrial Base and Semiconductor Supply Chain DOE Bulk Power System Executive Order Cybersecurity Actions and Presidential National Security Memorandum

Client expense: $2,660,000 · Firm income: Not reported

Government targets: Defense Advanced Research Projects Agency (DARPA), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), SENATE

Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (S. 4276/H.R. 7688) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Improving Seniors' Access to Timely Care Act (S. 4532/H.R. 8702) to amend Title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans PACE Part D Choice Act of 2023 (S. 1703/H.R. 3549) Credit for Caring Act of 2024 (S. 3702/H.R. 7165) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 3680) CONNECT for Health Act of 2023 (S. 2016 / H.R. 4189) Lifespan Respite Care Reauthorization Act (H.R. 6160) to amend the Public Health Service Act to reauthorize a lifespan respite care program DeOndra Dixon Investigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2024 (H.R. 7406) NAPA Reauthorization Act (S. 133/H.R. 619) Alzheimers Accountability and Investment Act (S. 134/H.R. 620) Comprehensive Care for Alzheimers Act (S. 626/H.R. 1637) Elizabeth Dole Home Care Act of 2023 (S. 141/H.R. 542) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 133) Access to Innovative Treatments Act of 2023 (H.R. 2408) Elder Justice Reauthorization and Modernization Act of 2023 (H.R. 2718/S. 1198) Expanding Veterans Options for Long Term Care Act (H.R.1815/S. 495) Palliative Care and Hospice Education and Training Act (S.2243) Facilitating Innovative Nuclear Diagnostics Act of 2023 (H.R. 1199/S. 1544) Supporting Our Seniors Act (S. 2584) Alleviating Barriers for Caregiving Act (S. 3109) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Reauthorization Act (S. 3775/ H.R. 7218) Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices other matters related to rural health other matters related to veterans health other matters related to Tricare

Client expense: $2,033,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), 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), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

Retirement Security 1.SECURE 2.0 Technical Corrections Discussion Draft: Legislative language that will amend SECURE 2.0 to make technical changes to a variety of provisions. 2.H.R. 3063 Retirement Fairness for Charities and Educational Institutions Act of 2023: Would allow 403(b) plans to invest in Collective Investment Trusts or Separate Accounts that establishes investment parity with other defined contribution plans, like 401(k)s. 3.H.R. 3942, Lifetime Income for Employees (LIFE) Act: Amends the current rules for qualified default investment alternatives to facilitate the use of an annuity component that will expand the availability of guaranteed returns and guaranteed lifetime income that help savers secure their retirement futures. 4.H.R. 4237, S. 2282 Ensuring Sound Guidance Act: Would require investment advisers and ERISA retirement plan sponsors to prioritize financial returns over non-pecuniary factors when making investment decisions on behalf of their clients. 5.H.R. 4924, S. 2517 Auto Reenroll Act of 2023: The bill allows plan sponsors to re-enroll non-participants at least once every three years, unless the individual affirmatively opts-out again. The bill also permits plans to sweep all eligible employees as a group for re-enrollment and does not change the automatic enrollment safe harbors. 6.H.R. 5060, S. 2627 Womens Retirement Protection Act (WRPA): The legislation would impose spousal consent requirements on nearly all distributions from defined contribution plans. The bill also seeks to enhance financial literacy through grants to community-based organizations and also offers grants to such organizations to help low-income women and survivors of domestic abuse obtain qualified domestic relations orders. 7.H.R. 5408, S. 2767 SSI Savings Penalty Elimination Act: The legislation would increase the asset limit from $2,000 to $10,000 for an individual, and from $3,000 to $20,000 for a married couple. Increasing the limit empowers people to prepare themselves for a financial emergency and allows them to enter the workforce without worrying theyll save lose their eligibility for SSI by saving too much. 8.H.R. 6007, S. 4398 Retirement Investment in Small Employers (RISE) Act: The legislation would create a new Micro Employer Pension Plan Startup Credit in IRC Section 45E for qualified micro employers. A qualified micro employer is defined as an employer with 10 or fewer employees. The credit amount is 100% of any retirement plan administrative costs up to $2,500 for the first three years after adoption of the retirement plan. 9.H.R. 6065, S.3102 Retirement Savings for Americans Act (RSAA) of 2023: Would create a federally run retirement plan, similar to the TSP, that would be available to all private sector workers whose employer signs up for the plan. 10.S. 3305 Helping Young Americans Save for Retirement Act: The legislation would lower the minimum participation age in ERISA-covered defined contribution plans from age 21 to age 18. 11.H.R. 6757 Roth IRA Rollovers: This legislation will allow retirement savers to roll over their Roth IRA savings into a Roth account within a workplace retirement plan. 12.H.R. 6772 Expanding Access to Retirement Savings for Caregivers Act: The bill would allow individuals that took at least one year out of the workforce without receiving an earned income, for the purposes of caring for a family member, to make catch-up contributions in years prior to age 50 to their 401(k) plans, individual retirement accounts (IRAs), and other eligible retirement accounts. 13.H.R. 7162, S. 3716 401Kids Savings Account Act of 2024: This bill would create childrens savings accounts (CSAs) for every child in America that would be managed by State Treasurers. Funds from the accounts could be used for post-secondary education, starting a business, buying a house, or retirement security. 14.H.R. 7293 Automatic IRA Act of 2024: Mandates employers with 10 or more employees to implement an automatic enrollment retirement plan in the workplace. 15.H.J. Res 142, S.J. Res 79 Fiduciary Rule Congressional Review Act: 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 "Retirement Security Rule: Definition of an Investment Advice Fiduciary" 16.General Accounts Product Corrections Act: Would clarify fiduciary responsibilities for life insurance companies as it relates to investments in their general accounts. Income Security S. 2415 and H.R. 7107, the Long-Term Care Affordability Act: Would allow for tax free distributions from retirement accounts to fund LTC contracts. H.R. 133, Both provisions are in the larger bill. H.R.1185 - FAMILY Act. Issue: paid family and medical leave proposal would offer paid leave benefits via a payroll tax for birth or adoption of a child or caring for a sick family member. H.R.1940 - New Parents Act of 2019. Issue: paid family and medical leave H.R.2163 - To amend the Internal Revenue Code of 1986 to allow for tax-advantaged distributions from health savings accounts during family or medical leave, and for other purposes. Issue: paid family and medical leave S.463 - FAMILY Act. Issue: paid family and medical leave- paid family and medical leave proposal would offer paid leave benefits via a payroll tax for birth or adoption of a child or caring for a sick family member S.920 - New Parents Act of 2019. Issue: paid family and medical leave Discussion draft - CRADLE Act. Issue: paid family and medical leave - allows for a deferment of retirement benefits for paid leave benefits. Proposed FY 2020 Budget proposal on paid family and medical leave. Issue: paid family and medical leave H.R. 2694 - Pregnant Workers Fairness Act. Issue: paid family and medical leave. Concurrent Resolution on the Budget, FY2022, S.Con.Res.14. The budget resolution calls for the $3.5 trillion in long-term investments to be fully offset by a combination of new tax revenues, health care savings, and long-term economic growth. In addition, the agreement would prohibit new taxes on families making less than $400,000 per year, and on small businesses and family farms. Issue: Medicare/Dental (Expanding Medicare to include dental, vision, hearing benefits and lowering the eligibility age). H.R. 5376- Build Back Better Act This bill provides funding, establishes programs, and otherwise modifies provisions relating to a broad array of areas, including education, labor, child-care, health care, taxes, immigration, and the environment. Excepted Benefits on Supplemental Benefits-proposed tri-agency rule through HHS, Treasury and Labor. S.3680 - Paid Family and Medical Leave Tax Credit Extension and Enhancement Act Diversity and Inclusion H.R. 5084 - Improving Corporate Governance Through Diversity Act. Issue: diversity and inclusion. H.R. 5360 - Closing the Racial Wealth Gap Act. Issue: diversity and inclusion. H.R. 281 - Ensuring Diverse Leadership Act. Issue: diversity and inclusion. H.R. 7946 and S. 4464 - Federal Reserve Racial and Economic Equity Act. Issue: diversity and inclusion.

Client expense: $798,458 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---HR 8818: American Privacy Rights Act of 2024 ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,790,000 · Firm income: Not reported

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

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,790,000 · 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), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

Economic development for City of Pittsburgh, including monitoring of Appropriations, specifically Nationally Significant Freight and Highway Projects Program within Transportation Approps. Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Economic development for City of Pittsburgh, including TIGER grants and transportation-related issues; Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Economic development for City of Pittsburgh, including TIGER grants and transportation-related issues. Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Economic development for City of Pittsburgh, including monitoring of Appropriations, specifically Nationally Significant Freight and Highway Projects Program within Transportation Approps. Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Economic development for City of Pittsburgh, including monitoring of Appropriations, specifically Nationally Significant Freight and Highway Projects Program. Consolidated Appropriations Act, 2021 (Including Coronavirus Stimulus & Relief; H.R. 133; P.L. 116-260)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Coronavirus (COVID-19) Pandemic ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2630/S.652: SAFE STEP Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Client expense: $1,760,000 · Firm income: Not reported

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

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---Interchangeability and Pharmacy Substitution ---Reimbursement Coronavirus (COVID-19) Pandemic ---COVID-19 Lessons Learned ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Implementation of Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,760,000 · 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), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---Interchangeability and Pharmacy Substitution ---Reimbursement Coronavirus (COVID-19) Pandemic ---COVID-19 Lessons Learned ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Implementation of Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,760,000 · 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), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Coronavirus (COVID-19) Pandemic ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2630/S.652: SAFE STEP Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Client expense: $1,760,000 · Firm income: Not reported

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

Issues related to energy efficiency in commercial and residential buildings, and advanced building controls Issues related to industrial technologies Issues related to carbon capture and sequestration technologies Issues related to nuclear energy Issues related to Department of Energy wind technology programs (no pending legislation) Issues related to renewable energy (no pending legislation) Issues related to Smart Grid (no pending legislation) Issues related to natural gas Issues related to energy savings performance contracts Department of Energy appropriations Issues related to energy storage Issues related to smart metering Pipeline Safety Act H.R.2, Investing in a New Vision for the Environment and Surface Transportation in America Act Executive Order 13920: Securing the United States Bulk-Power System H.R. 133, Omnibus and COVID Relief and Response Act, 2021 Issues relating to smart cities technologies Issues related to Hydrogen Issues related to biofuels, sustainable aviation fuels Issues related to energy storage Supply Chain Executive Order; DOE Industrial Base and Semiconductor Supply Chain DOE Bulk Power System Executive Order Cybersecurity Actions and Presidential National Security Memorandum

Client expense: $2,370,000 · Firm income: Not reported

Government targets: Defense Advanced Research Projects Agency (DARPA), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), SENATE

H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act S. 1450: Cutting Medicare Prescription Drugs in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] ___ IPAY 2026 and Solicitation of Comments CMS Medicare Drug Price Negotiation Revised Guidance CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)

Client expense: $820,000 · Firm income: Not reported

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

H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act S. 1450: Cutting Medicare Prescription Drugs in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] ___ IPAY 2026 and Solicitation of Comments CMS Medicare Drug Price Negotiation Revised Guidance CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)

Client expense: $9,600,000 · Firm income: Not reported

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

Credit for Caring Act of 2024 (S. 3702/H.R. 7165) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 3680) CONNECT for Health Act (S. 2016 / H.R. 4189) Lifespan Respite Care Reauthorization Act (H.R. 6160) DeOndra Dixon INvestigation of Co-occurring Conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project Act of 2024 (H.R. 7406) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (H.R. 7688) NAPA Reauthorization Act (S. 133/H.R. 619) Alzheimers Accountability and Investment Act (S. 134/H.R. 620) Comprehensive Care for Alzheimers Act (S. 626/H.R. 1637) Elizabeth Dole Home Care Act of 2023 (S. 141/H.R. 542) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 133) Access to Innovative Treatments Act of 2023 (H.R. 2408) Elder Justice Reauthorization and Modernization Act of 2023 (H.R. 2718/S. 1198) Expanding Veterans Options for Long Term Care Act (H.R.1815/S. 495) Palliative Care and Hospice Education and Training Act of 2023 (S.2243) Facilitating Innovative Nuclear Diagnostics Act of 2023 (H.R. 1199/S. 1544) Supporting Our Seniors Act (S. 2584) Alleviating Barriers for Caregiving Act (S. 3109) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices

Client expense: $710,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), 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), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

Issues related to transportation infrastructure including funding; FAST Act (P.L.114-94) implementation; H.R.748, CARES Act (P.L.116-136) implementation; H.R.133; H.R.1319, American Rescue Plan Act of 2021 (P.L.117-2) implementation.

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

Government targets: HOUSE OF REPRESENTATIVES