Gabriella Miller Kids First Research Act 2.0

Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including Gabriella Miller Kids First Research Act 2.0 (HR 3391, S 1624); Accelerating Kids Access to Care Act(HR 3089, S 1544); Innovation in Pediatric Drugs Act of 2023 (HR 6664)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally H.R. 3884 and S. 1852 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Children's Hospital GME Support Reauthorization Act of2023), all provisions Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4758 (Accelerating Kids' Access to Care Act), all provisions H.R. 7213 (Autism Collaboration, Accountability, Research, Education, and Support Act of2024), all provisions H.R. 8260 and S. 4350 (Hospital Inpatient Services Modernization Act), all provisions H.R. I 0545 (American Relief Act, 2025), regarding HHS program funding and Medicaid program reform provisions National Institutes of Health program reforms generally S. 904 (Sickle Cell Disease Comprehensive Care Act), all provisions

Client expense: $190,000 · Firm income: Not reported

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

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes. HR 6992: Mapping America's Pharmaceutical Supply Act- require the Department of Health and Human Services to update its essential medicines list and create a database to help predict vulnerabilities in the U.S. pharmaceutical supply chain. S 3458: Seniors' Access to Critical Medications Act of 2023 - clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program. HR 8404/S 4330: ROCR Value Based Program Act of 2024 - To amend title XVIII of the Social Security Act to create a Radiation Oncology Case Rate Value Based Payment Program exempt from budget neutrality adjustment requirements, and to amend section 1128A of title XI of the Social Security Act to create a new statutory exception for the provision of free or discounted transportation for radiation oncology patients to receive radiation therapy services. HR 3633: Prevent HPV Cancers ACt of 2023 - To amend the Public Health Service Act to provide for a public awareness campaign with respect to human papillomavirus, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - To amend the Federal Food, Drug, and Cosmetic Act to provide for notification by manufacturers of critical essential medicines of increased demand of such drugs, and for other purposes. S 5368/HR 10239: End Drug Shortages Act - To amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, and for other purposes.

Childhood Cancer STAR Act (P.L. 115-180) Childhood Cancer STAR Reauthorization Act (P.L. 117-350) Fiscal Year 2024, Labor, Health, and Human Services Appropriation Fiscal Year 2024 Defense Appropriations H.R. 3391/S. 1624, the Gabriella Miller Kids First Research Act 2.0 H.R. 3663, the PREVENT HPV Cancers Act H.R. 4363/S. 2213, the Comprehensive Cancer Survivorship Act H.R. 4758/S. 2372, the Accelerating Kids' Access to Care Act

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE

Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including Gabriella Miller Kids First Research Act 2.0 (HR 3391, S 1624); Accelerating Kids Access to Care Act(HR 3089, S 1544); Innovation in Pediatric Drugs Act of 2023 (HR 6664)

Client expense: $56,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including Gabriella Miller Kids First Research Act 2.0 (HR 3391, S 1624); Accelerating Kids Access to Care Act(HR 3089, S 1544); Innovation in Pediatric Drugs Act of 2023 (HR 6664)

Client expense: $119,942 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including Gabriella Miller Kids First Research Act 2.0 (HR 3391, S 1624); Accelerating Kids Access to Care Act(HR 3089, S 1544); Innovation in Pediatric Drugs Act of 2023 (HR 6664)

Client expense: $46,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, and private insurance Issues regarding the annual Notice of Benefit and Payment Parameters for the Exchanges and private insurance Issues regarding childrens and mothers health specifically continuous eligibility for children in Medicaid and CHIP, CHIP permanency Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce and related access issues. Issue regarding Medicaid supplemental payments and directed payments Issues related to Health Information Technology, interoperability, information blocking, and cybersecurity Issues regarding the importance of Medicaid to children, including military and veteran families  Issues regarding Medicaid support for providers caring for children on Medicaid, including DSH payments Issues regarding Children's Hospitals Graduate Medical Education (CHGME) program and funding Issues related to 340B Drug Pricing Program, prescription drug pricing, drug shortages, high-cost drugs/therapies and pharmaceutical supply chain, including H.R. 3290 Issues related to pediatric workforce, Medicare GME, the Pediatric Specialty Loan Repayment Program, and Title VII and VIII Issues regarding Organ Procurement and Transplantation Network Issues regarding site neutrality and price transparency in health care  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness Issues regarding food security and nutrition Issues regarding drugs and medical device shortages and high costs Issues related to the regulation of laboratory-developed tests Issues regarding prescribing of drugs via telehealth Issues related to mental health services in schools Issues related to pediatric cancer and the Moonshot Issues regarding Artificial Intelligence (AI) Issues regarding oversight and implementation of EPSDT H.R. 2412 The Helping Kids Cope Act S.2372/HR. 4758 - Accelerating Kids Access to Care Act  H.R. 1397, Telehealth Improvement for Kids Essential Services (TIKES) Act H.R. 7623/ S. 3967, Telehealth Modernization Act Issues involving Site Neutral payment legislation, including H.R. 3281 and H.R. 3561 S. 1774/H.R. 3761 the Assist Act H.R. 2584/S.2768, Safety form Violence for Healthcare employees (Save) Act S. 1409, Kids Online Safety Act H.R. 6663/S. 3364, Kid PROOF Act of 2023 H.R. 6664 Innovation for Pediatric Drugs Act of 2023 H.R. 7808, the Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 6960 Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 3391 Gabriella Miller Kids First Research Act 2.0 H.R. 6963 Pediatric Cancer Drug Supply Act H.R. 3433/ S. 2897, Give Kids A Chance Act H.R. 7384, Creating Hope Reauthorization Act. H.R. 6664/S. 4905, Innovation in Pediatric Drugs Act H.R: 4714: Pediatricians Accelerate Childhood Therapies Act of 2023 S. 0251 340B PATIENTS Act of 2024 H.R. 9577 Stabilization to Prevent (STOP) Suicide Act.

Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including Gabriella Miller Kids First Research Act 2.0 (HR 3391, S 1624); Accelerating Kids Access to Care Act(HR 3089, S 1544); Innovation in Pediatric Drugs Act of 2023 (HR 6664)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Advanced Research Projects Agency-Health program generally H.R. 3884 and S. 1852 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Childrens Hospital GME Support Reauthorization Act of 2023), all provisions Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4758 (Accelerating Kids Access to Care Act), all provisions H.R. 7213 (Autism Collaboration, Accountability, Research, Education, and Support Act of 2024), all provisions H.R. 8260 and S. 4350 (Hospital Inpatient Services Modernization Act), all provisions

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

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Advanced Research Projects Agency-Health program generally H.R. 3884 and S. 1852 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Children's Hospital GME Support Reauthorization Act of2023), all provisions Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4758 (Accelerating Kids' Access to Care Act), all provisions H.R. 7213 (Autism Collaboration, Accountability, Research, Education, and Support Act of2024), all provisions H.R. 8260 and S. 4350 (Hospital Inpatient Services Modernization Act), all provisions Pediatric organ procurement and transplant policies generally Violence prevention programs generally

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

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes. HR 6992: Mapping America's Pharmaceutical Supply Act- require the Department of Health and Human Services to update its essential medicines list and create a database to help predict vulnerabilities in the U.S. pharmaceutical supply chain. S 3458: Seniors' Access to Critical Medications Act of 2023 - clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program. HR 8404/S 4330: ROCR Value Based Program Act of 2024 - To amend title XVIII of the Social Security Act to create a Radiation Oncology Case Rate Value Based Payment Program exempt from budget neutrality adjustment requirements, and to amend section 1128A of title XI of the Social Security Act to create a new statutory exception for the provision of free or discounted transportation for radiation oncology patients to receive radiation therapy services.

Childhood Cancer STAR Act (P.L. 115-180) Childhood Cancer STAR Reauthorization Act (P.L. 117-350) Fiscal Year 2024, Labor, Health, and Human Services Appropriation Fiscal Year 2024 Defense Appropriations H.R. 3391/S. 1624, the Gabriella Miller Kids First Research Act 2.0 H.R. 3663, the PREVENT HPV Cancers Act H.R. 4363/S. 2213, the Comprehensive Cancer Survivorship Act H.R. 4758/S. 2372, the Accelerating Kids' Access to Care Act

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes. HR 6992: Mapping America's Pharmaceutical Supply Act- require the Department of Health and Human Services to update its essential medicines list and create a database to help predict vulnerabilities in the U.S. pharmaceutical supply chain. S 3458 Seniors' Access to Critical Medications Act of 2023 - clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program.

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, and private insurance Issues regarding the annual Notice of Benefit and Payment Parameters for the Exchanges and private insurance H.R. 2412 The Helping Kids Cope Act S.2372/HR. 4758 - Accelerating Kids Access to Care Act  Issues regarding childrens and mothers health specifically continuous eligibility for children in Medicaid and CHIP, CHIP permanency Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce and related access issues. Issue regarding Medicaid supplemental payments and directed payments Issues related to Health Information Technology, interoperability, information blocking, and cybersecurity Pediatric Access to Critical Healthcare (PATCH) Act, and issues regarding pediatric health care infrastructure and capacity  Issues regarding the importance of Medicaid to children, including military and veteran families  Issues regarding Medicaid support for providers caring for children on Medicaid, including DSH payments Issues regarding Children's Hospitals Graduate Medical Education (CHGME) program and funding Issues related to 340B Drug Pricing Program, prescription drug pricing, drug shortages, high-cost drugs/therapies and pharmaceutical supply chain, including H.R. 3290 Issues related to pediatric workforce, Medicare GME, the Pediatric Specialty Loan Repayment Program, and Title VII and VIII Issues regarding Organ Procurement and Transplantation Network S. 3029/H.R. 6085 PREEMIE Reauthorization Act Issues regarding the Medicaid unwinding Issues regarding surprise billing, bad debt, and price transparency in health care  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness Issues regarding food security and nutrition Issues regarding drugs and medical device shortages and high costs Issues related to the regulation of laboratory developed tests Issues regarding prescribing of drugs via telehealth Issues related to mental health services in schools Issues related to pediatric cancer and the Moonshot Issues regarding Artificial Intelligence (AI) H.R. 1117, Advancing Safe Medications for Moms and Babies Act of 2023 H.R. 4189, CONNECT for Health Act H.R. 1110, KEEP Telehealth Options Act H.R. 5541, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act Issues regarding the Public Health Emergency Unwinding Issues involving Site Neutral payment legislation, including H.R. 3281 and H.R. 3561 S. 1884/H.R. 3713, Mental Health Services for Students Act H.R. 2389, The Resident Shortage Reduction Act S. 1774/H.R. 3761 the Assist Act H.R. 2665, Supporting Safety Net Hospitals Act H.R. 2584/S.2768, Safety form Violence for Healthcare employees (Save) Act H.R. 3046, Medical Student Education Authorization Act S. 2556, Improving CARE for Youth Act S. 2647/H.R. 5012, SHINE for Autumn Act of 2023 S. 923/H.R. 4933, Mental Health Professionals Workforce Shortage Loan Repayment Act of 2023 S. 2362/H.R. 3008, Drug Shortage Prevention Act of 2023 S. 1409, Kids Online Safety Act S. 1769/H.R. 3805, the Kickstarting Innovative Demonstrations Supporting (KIDS) Health Act. H.R. 5804, Mental Health Infrastructure Improvement Act H.R. 5976 /S. 3060 Youth Mental Health Research Act S. 3364, Kid PROOF Act of 2023 H.R. 6664 Innovation for Pediatric Drugs Act of 2023 H.R. 7808, the Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 7153/S. 3679 Dr. Lorna Breen Health Care Provider Protection Reauthorization Act S. 3757 Congenital Heart Futures Reauthorization Act of 2024 H.R. 6960 Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 3391 Gabriella Miller Kids First Research Act 2.0 H.R. 6963 Pediatric Cancer Drug Supply Act H.R. 3433/ S. 2897, Give Kids A Chance Act H.R. 7384, Creating Hope Reauthorization Act. H.R. 6664, Innovation in Pediatric Drugs Act S. 4298: Esthers Law Issues regarding oversight and implementation of EPSDT

Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including Gabriella Miller Kids First Research Act 2.0 (HR 3391, S 1624); Accelerating Kids Access to Care Act(HR 3089, S 1544); Innovation in Pediatric Drugs Act of 2023 (HR 6664)

Client expense: $56,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3391, Gabriella Miller Kids First Research Act 2.0: to expand the available funds to support research on pediatric diseases House and Senate Appropriations Legislation: Funding for firearm safety research, BRAIN initiative, Pediatric Specialty Loan Repayment Program, Pediatric Device Consortia (PDC) Grant Program at FDA, and NIH funding.

Client expense: $35,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3391, Gabriella Miller Kids First Research Act 2.0: to expand the available funds to support research on pediatric diseases House and Senate Appropriations Legislation: Funding for firearm safety research, BRAIN initiative, Pediatric Specialty Loan Repayment Program, Pediatric Device Consortia (PDC) Grant Program at FDA, and NIH funding.

Client expense: $35,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Advanced Research Projects Agency-Health program generally H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Childrens Hospital GME Support Reauthorization Act of 2023), all provisions Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4822 (Health Care Price Transparency Act of 2023), all provisions H.R. 7808 (EARLY Minds Act), regarding pediatric mental health H.R. 4758 (Accelerating Kids Access to Care Act), all provisions H.R. 7213 (Autism Collaboration, Accountability, Research, Education, and Support Act of 2024), all provisions

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

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally Gun violence prevention programs generally "Food as medicine" nutrition programs generally Advanced Research Projects Agency-Health program generally H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Children's Hospital GME Support Reauthorization Act of 2023), all provisions Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4822 (Health Care Price Transparency Act of 2023), all provisions H.R. 7808 (EARLY Minds Act), regarding pediatric mental health H.R. 4758 (Accelerating Kids Access to Care Act), all provisions Laboratory developed tests generally, including H.R. 2369 (Verifying Accurate Leading-edge IVCT Development Act of 2023), all provisions H.R. 7213 (Autism Collaboration, Accountability, Research, Education, and Support Act of 2024), all provisions

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

Childhood Cancer STAR Act (P.L. 115-180) Childhood Cancer STAR Reauthorization Act (P.L. 117-350) Fiscal Year 2024, Labor, Health, and Human Services Appropriation Fiscal Year 2024 Defense Appropriations H.R. 3391/S. 1624, the Gabriella Miller Kids First Research Act 2.0 H.R. 3663, the PREVENT HPV Cancers Act H.R. 4363/S. 2213, the Comprehensive Cancer Survivorship Act H.R. 4758/S. 2372, the Accelerating Kids' Access to Care Act

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - Require manufacturers to provide initial notification to the FDA no more than 48 hours after a sustained increase in demand for a drug S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes.

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - Require manufacturers to provide initial notification to the FDA no more than 48 hours after a sustained increase in demand for a drug S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes.

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, and private insurance Issues regarding the annual Notice of Benefit and Payment Parameters for the Exchanges and private insurance Issues regarding the implementation of the ACE Kids Act  H.R. 2412 The Helping Kids Cope Act S.2372/HR. 4758 - Accelerating Kids Access to Care Act  Issues regarding childrens and mothers health specifically continuous eligibility for children in Medicaid and CHIP, CHIP permanency Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce and related access issues. Issue regarding Medicaid supplemental payments and directed payments Issues related to Health Information Technology, interoperability, information blocking, and cybersecurity Pediatric Access to Critical Healthcare (PATCH) Act, and issues regarding pediatric health care infrastructure and capacity  Issues regarding the importance of Medicaid to children, including military and veteran families  Issues regarding Medicaid support for providers caring for children on Medicaid, including DSH payments FY 2024 and FY 2025 Senate and House Labor-HHS appropriations provisions - Children's Hospitals Graduate Medical Education (CHGME) program funding   Issues regarding Children's Hospitals Graduate Medical Education (CHGME) program reauthorization Issues related to 340B Drug Pricing Program, prescription drug pricing, drug shortages, high-cost drugs/therapies and pharmaceutical supply chain, including H.R. 3290 Issues related to pediatric workforce and the Pediatric Specialty Loan Repayment Program S. 3029/H.R. 6085 PREEMIE Reauthorization Act Issues regarding the Medicaid unwinding Issues regarding surprise billing, bad debt, and price transparency in health care  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness Issues regarding food security and nutrition Issues regarding drugs and medical device shortages and high costs Issues related to the regulation of laboratory-developed tests Issues regarding prescribing of drugs via telehealth Issues related to mental health services in schools Issues related to pediatric cancer and the Moonshot H.R. 1117, Advancing Safe Medications for Moms and Babies Act of 2023 H.R. 4189, CONNECT for Health Act H.R. 1110, KEEP Telehealth Options Act H.R. 5541, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act Issues regarding the Public Health Emergency Unwinding Issues involving Site Neutral payment legislation, including H.R. 3281 and H.R. 3561 S. 1884/H.R. 3713, Mental Health Services for Students Act The Pursuing Equity in Mental Health America Act H.R. 2389, The Resident Shortage Reduction Act S. 1774/H.R. 3761 the Assist Act H.R. 3633, the Prevent HPV Cancers Act H.R. 2665, Supporting Safety Net Hospitals Act H.R. 2584/S.2768, Safety form Violence for Healthcare employees (Save) Act S. 923, Better Mental Health Care for Americans Act H.R. 3046, Medical Student Education Authorization Act S. 2556, Improving CARE for Youth Act S. 2647/H.R. 5012, SHINE for Autumn Act of 2023 S. 923/H.R. 4933, Mental Health Professionals Workforce Shortage Loan Repayment Act of 2023 S.2476/H.R. 4884, Mental Health for Latinos Act of 2023 S. 2362/H.R. 3008, Drug Shortage Prevention Act of 2023 H.R. 3759, Barriers to Suicide Act of 2023 S. 1409, Kids Online Safety Act S. 1769/H.R. 3805, the Kickstarting Innovative Demonstrations Supporting (KIDS) Health Act. H.R. 5804, Mental Health Infrastructure Improvement Act H.R. 5976 /S. 3060 Youth Mental Health Research Act S. 3364, Kid PROOF Act of 2023 H.R. 6664 Innovation for Pediatric Drugs Act of 2023 H.R. 7808, the Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 7153/S. 3679 Dr. Lorna Breen Health Care Provider Protection Reauthorization Act S. 3757 Congenital Heart Futures Reauthorization Act of 2024 H.R. 6960 Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 3391 Gabriella Miller Kids First Research Act 2.0 H.R. 6963 Pediatric Cancer Drug Supply Act H.R. 3433/ S. 2897, Give Kids A Chance Act S. 2560 Long COVID Support Act H.R. 7384, Creating Hope Reauthorization Act. H.R. 6664, Innovation in Pediatric Drugs Act

Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including Gabriella Miller Kids First Research Act 2.0 (HR 3391, S 1624); Accelerating Kids Access to Care Act(HR 3089, S 1544); Innovation in Pediatric Drugs Act of 2023 (HR 6664)

Client expense: $169,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Medicaid Disproportionate Share Hospital payments Advanced Research Projects Agency-Health program generally H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Children's Hospital GME Support Reauthorization Act of 2023), all provisions Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4822 (Health Care Price Transparency Act of 2023), all provisions H.R. 7808 (EARLY Minds Act), regarding pediatric mental health Laboratory developed tests generally, including H.R. 2369 (Verifying Accurate Leading-edge IVCT Development Act of 2023), all provisions

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

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Medicaid Disproportionate Share Hospital payments Advanced Research Projects Agency-Health program generally H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Childrens Hospital GME Support Reauthorization Act of 2023), all provisions Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4822 (Health Care Price Transparency Act of 2023), all provisions H.R. 7808 (EARLY Minds Act), regarding pediatric mental health

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

H.R. 3391, Gabriella Miller Kids First Research Act 2.0: to expand the available funds to support research on pediatric diseases H.R. 4366, Consolidated Appropriations Act: Funding for the U.S. Centers for Disease Control and Prevention, the National Institutes of Health, and the National Institute of Justice to conduct public health research into firearm morbidity and mortality prevention; funding for the National Institutes of Health for biomedical research.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3391, Gabriella Miller Kids First Research Act 2.0: to expand the available funds to support research on pediatric diseases H.R. 4366, Consolidated Appropriations Act: Funding for the U.S. Centers for Disease Control and Prevention, the National Institutes of Health, and the National Institute of Justice to conduct public health research into firearm morbidity and mortality prevention; funding for the National Institutes of Health for biomedical research.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Childhood Cancer STAR Act (P.L. 115-180) Childhood Cancer STAR Reauthorization Act (P.L. 117-350) Fiscal Year 2024, Labor, Health, and Human Services Appropriation Fiscal Year 2024 Defense Appropriations H.R. 3391/S. 1624, the Gabriella Miller Kids First Research Act 2.0 H.R. 3663, the PREVENT HPV Cancers Act H.R. 4363/S. 2213, the Comprehensive Cancer Survivorship Act H.R. 4758/S. 2372, the Accelerating Kids' Access to Care Act

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE

Childhood Cancer STAR Act (P.L. 115-180) Childhood Cancer STAR Reauthorization Act (P.L. 117-350) Fiscal Year 2024, Labor, Health, and Human Services Appropriation Fiscal Year 2024 Defense Appropriations H.R. 3391/S. 1624, the Gabriella Miller Kids First Research Act 2.0 H.R. 3663, the PREVENT HPV Cancers Act H.R. 4363/S. 2213, the Comprehensive Cancer Survivorship Act H.R. 4758/S. 2372, the Accelerating Kids' Access to Care Act

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE

Childhood Cancer STAR Act (P.L. 115-180) Childhood Cancer STAR Reauthorization Act (P.L. 117-350) Fiscal Year 2024, Labor, Health, and Human Services Appropriation Fiscal Year 2024 Defense Appropriations H.R. 3391/S. 1624, the Gabriella Miller Kids First Research Act 2.0 H.R. 3663, the PREVENT HPV Cancers Act H.R. 4363/S. 2213, the Comprehensive Cancer Survivorship Act H.R. 4758/S. 2372, the Accelerating Kids' Access to Care Act

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Medicaid Disproportionate Share Hospital payments Advanced Research Projects Agency-Health program generally H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Children's Hospital GME Support Reauthorization Act of 2023), all provisions Implementation of Pediatric Specialty Loan Repayment Program Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4822 (Health Care Price Transparency Act of 2023), all provisions H.R. 4714 / S. 2345 (Pediatricians Accelerate Childhood Therapies (PACT) Act), all provisions H.R. 2412 (Helping Kids Cope Act), all provisions H.R. 5976 / S. 3060 (Youth Mental Health Research Act), all provisions S. 2556 (Improving Coordination and Access to Resources Equitably (CARE) for Youth Act), all provisions

Client expense: $180,000 · Firm income: Not reported

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Medicaid Disproportionate Share Hospital payments Advanced Research Projects Agency-Health program generally H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Childrens Hospital GME Support Reauthorization Act of 2023), all provisions Implementation of Pediatric Specialty Loan Repayment Program Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4822 (Health Care Price Transparency Act of 2023), all provisions

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

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Medicaid Disproportionate Share Hospital payments Advanced Research Projects Agency-Health program generally H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Children's Hospital GME Support Reauthorization Act of 2023), all provisions Implementation of Pediatric Specialty Loan Repayment Program Medicare "site neutral" payment policy generally, including H.R. 5378 (Lower Costs, More Transparency Act), Section 203 Pediatric cancer research generally Pediatric access to cell and gene therapies generally H.R. 4822 (Health Care Price Transparency Act of 2023), all provisions H.R. 4714 / S. 2345 (Pediatricians Accelerate Childhood Therapies (PACT) Act), all provisions H.R. 2412 (Helping Kids Cope Act), all provisions H.R. 5976 / S. 3060 (Youth Mental Health Research Act), all provisions S. 2556 (Improving Coordination and Access to Resources Equitably (CARE) for Youth Act), all provisions

Client expense: $180,000 · Firm income: Not reported

Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including Gabriella Miller Kids First Research Act 2.0 (HR 3391, S 1624); Accelerating Kids Access to Care Act(HR 3089, S 1544); Innovation in Pediatric Drugs Act of 2023 (HR 6664)

Client expense: $77,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - Require manufacturers to provide initial notification to the FDA no more than 48 hours after a sustained increase in demand for a drug S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes PN 649: Monica M. Bertagnolli, Department of Health and Human Services - Nomination of Monica Bertagnolli for the Director of the National Institutes of Health

Childhood Cancer STAR Act (P.L. 115-180) Childhood Cancer STAR Reauthorization Act (P.L. 117-350) Fiscal Year 2024, Labor, Health, and Human Services Appropriation Fiscal Year 2024 Defense Appropriations H.R. 3391/S. 1624, the Gabriella Miller Kids First Research Act 2.0 H.R. 3663, the PREVENT HPV Cancers Act H.R. 4363/S. 2213, the Comprehensive Cancer Survivorship Act H.R. 4758/S. 2372, the Accelerating Kids' Access to Care Act

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE

S.895/H.R. 902, Ellies Law: Funding for comprehensive research at the National Institute of Neurological Disorders and Stroke on unruptured intracranial aneurysms. S.1026/H.R. 2390, Gun Violence Prevention Research Act: To authorize the appropriation of funds to the Centers for Disease Control and Prevention for conducting or supporting research on firearms safety or gun violence prevention. S. 1624/H.R. 3391, Gabriella Miller Kids First Research Act 2.0: To require certain civil penalties to be transferred to a fund through which amounts are made available for the Gabriella Miller Kids First Pediatric Research Program at the National Institutes of Health. No Bill: Funding for the U.S. Centers for Disease Control and Prevention, the National Institutes of Health, and the National Institute of Justice to conduct public health research into firearm morbidity and mortality prevention. No Bill: Funding for MISSION ZERO military/civilian trauma preparedness program. No Bill: Funding for the Pediatric Subspecialty Loan Repayment Program. No Bill: Increased funding for the National Institutes of Health for biomedical research.

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

S.895/H.R. 902, Ellies Law: Funding for comprehensive research at the National Institute of Neurological Disorders and Stroke on unruptured intracranial aneurysms. S.1026/H.R. 2390, Gun Violence Prevention Research Act: To authorize the appropriation of funds to the Centers for Disease Control and Prevention for conducting or supporting research on firearms safety or gun violence prevention. S. 1624/H.R. 3391, Gabriella Miller Kids First Research Act 2.0: To require certain civil penalties to be transferred to a fund through which amounts are made available for the Gabriella Miller Kids First Pediatric Research Program at the National Institutes of Health. No Bill: Funding for the U.S. Centers for Disease Control and Prevention, the National Institutes of Health, and the National Institute of Justice to conduct public health research into firearm morbidity and mortality prevention. No Bill: Funding for MISSION ZERO military/civilian trauma preparedness program. No Bill: Funding for the Pediatric Subspecialty Loan Repayment Program. No Bill: Increased funding for the National Institutes of Health for biomedical research.

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

Support policies to remove barriers to clinical trials, promote research generally, address issues in childhood cancer research including Gabriella Miller Kids First Research Act 2.0 (HR 3391, S 1624); Accelerating Kids Access to Care Act(HR 3089, S 1544)

Client expense: $75,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Medicaid Disproportionate Share Hospital payments Advanced Research Projects Agency-Health program generally Public health data collection, including HHS Protect program H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Childrens Hospital GME Support Reauthorization Act of 2023), all provisions Implementation of Pediatric Specialty Loan Repayment Program

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

Medicaid program reforms, including telemedicine and prior authorization issues Section 340B Drug Pricing program, including H.R. 5378 (Lower Costs, More Transparency Act), Section 202 Drug pricing reforms generally Juvenile mental and behavioral health legislation generally "Food as medicine" nutrition programs generally Medicaid Disproportionate Share Hospital payments Advanced Research Projects Agency-Health program generally Public health data collection, including HHS Protect program H.R. 3884 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of2023), all provisions H.R. 3391 (Gabriella Miller Kids First Research Act 2.0), all provisions H.R. 3887 (Children's Hospital GME Support Reauthorization Act of 2023), all provisions Implementation of Pediatric Specialty Loan Repayment Program H.R. 2412, Helping Kids Cope Act, all provisions H.R. 4758/S. 2372, Accelerating Kids Access to Care Act, all provisions Pediatric access to cell and gene therapies generally

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

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - Require manufacturers to provide initial notification to the FDA no more than 48 hours after a sustained increase in demand for a drug S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions

H.R. 824 - Telehealth Benefit Expansion for Workers Act of 2023 H.R. 1202 / S. 704 - Resident Education Deferred Interest (REDI) Act H.R. 2389 - Resident Physician Shortage Reduction Act of 2023 H.R. 2400 / S. 1165 - Reentry Act of 2023 H.R. 3226 - Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act of 2023 H.R. 3305 / S. 1606 - Black Maternal Health Momnibus Act H.R. 3312 / S. 1602 - Moms Matter Act H.R. 3331 / S. 754 - Improving Mental Health and Wellness in School Act H.R. 3391 / S. 1624 - Gabriella Miller Kids First Research Act 2.0 H.R. 3432 - Telemental Health Care Access Act of 2023 H.R. 3805 - KIDS Health Act of 2023 H.R. 3813 - CDC Leadership Accountability Act of 2023 H.R. 3821 - Firefighter Cancer Registry Reauthorization Act of 2023 H.R. 3836 - Medicaid Primary Care Improvement Act H.R. 3838 - Preventing Maternal Deaths Reauthorization Act of 2023 H.R. 3841 - To amend title III of the Public Health Service Act to reauthorize the program of payments to children's hospitals that operate graduate medical education programs H.R. 3843 - Action for Dental Health Act of 2023 H.R. 3884 - Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023 H.R. 3887 - Childrens Hospital GME Support Reauthorization Act of 2023 H.R. 4189 / S. 2016 - CONNECT for Health Act of 2023 H.R. 4331 - Strengthening Medicaid for Serious Mental Illness Act H.R. 4381 - Public Health Emergency Congressional Review Act H.R. 4420 - Preparedness and Response Reauthorization Act H.R. 4421 - Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4529 - Public Health Guidance Transparency and Accountability Act of 2023 H.R. 4531 / S. 2433 - SUPPORT for Patients and Communities Reauthorization Act H.R. 4830 / S. 2444 - ATTAIN Mental Health Act H.R. 4837 - Building a Health Care Workforce for the Future Act H.R. 4851 - 988 Implementation Assistance Act H.R. 4884 / S. 2476 - Mental Health for Latinos Act H.R. 4892 - Medicaid Bump Act H.R. 4911 - Supporting the Health and Safety of Law Enforcement Act H.R. 4918 - Solutions Not Stigmas Act of 2023 H.R. 4933 / S. 462 - Mental Health Professionals Workforce Shortage Loan Repayment Act H.R. 4941 - PATH Act H.R. 4942 / S. 665 - Conrad State 30 and Physician Access Reauthorization Act H.R. 4950 / S. 2481 - IMPROVE Addictions Care Act H.R. 4968 - GOLD CARD Act of 2023 H.R. 5010 - Recognizing Gun Violence as a Public Health Emergency Act H.R. 5116 / S. 2688 - Behavioral Health Information Technology (BHIT) Coordination Act H.R. 5128 / S. 2137 - Preserving Access to Home Health Act of 2023 H.R. 5163 - Telehealth Response for E-prescribing Addiction Therapy Services Act H.R. 5312 - Supporting Healthy Mothers and Infants Act of 2023 H.R. 5414 / S. 1346 - Improving Mental Health Access for the Emergency Department Act of 2023 H.R. 5568 - CARE for Moms Act H.R. 5804 - Mental Health Infrastructure Improvement Act of 2023 H.R. 5819 / S. 1378 - COMPLETE Care Act H.R. 5976 / S. 3060 - Youth Mental Health Research Act S. 1291 - Protecting Kids on Social Media Act S. 2308 - Community Health Care Reauthorization Act S. 2840 - Bipartisan Primary Care and Health Workforce Expansion Act S. 2556 - Improving CARE for Youth Act S. 2511 - ADAPT Act S. 2733 - PEER Support Act S. 2966 - TEAMS Act

S.895/H.R. 902, Ellies Law: Funding for comprehensive research at the National Institute of Neurological Disorders and Stroke on unruptured intracranial aneurysms. S.1026/H.R. 2390, Gun Violence Prevention Research Act: To authorize the appropriation of funds to the Centers for Disease Control and Prevention for conducting or supporting research on firearms safety or gun violence prevention. S. 1624/H.R. 3391, Gabriella Miller Kids First Research Act 2.0: To require certain civil penalties to be transferred to a fund through which amounts are made available for the Gabriella Miller Kids First Pediatric Research Program at the National Institutes of Health. No Bill: Funding for Neglected Surgical Conditions within the State, Foreign Operations, and Related Programs (SFOPS) Appropriations Report for Fiscal Year (FY) 2024. No Bill: Funding for the U.S. Centers for Disease Control and Prevention, the National Institutes of Health, and National Institute of Justice to conduct public health research into firearm morbidity and mortality prevention. No Bill: Funding for MISSION ZERO military/civilian trauma preparedness program. No Bill: Funding for the Pediatric Subspecialty Loan Repayment Program. No Bill: Increased funding for the National Institutes of Health for biomedical research. No Bill: Funding for the Pediatric Device Consortia Grant Program at the Office of Orphan Products Development at the Food and Drug Administration.

Client expense: $35,000 · Firm income: Not reported