Pediatric Cancer Drug Supply Act of 2024

HR 1692 / S 8, the Health Care Affordability Act; HR 2630 / S 652, the Safe Step Act; HR 3433 / S 2897, the Give Kids a Chance Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; HR 6003 / S 3103, the Medical Debt Relief Act; HR 6301 / S. 2039, The Cancer Drug Parity Act; HR 7383 / S 1214, the RARE Act; HR 8311 / S 4289, Medical Debt Cancellation Act; HR 824, the Telehealth Benefit Expansion for Workers Act; HR 1773, the Consumer Protection for Medical Debt Collections Act; HR 2813, Self-Insurance Protection Act; HR 2868, the Association Health Plans; HR 2880, the Protecting Patients Against PBM Abuses Act; HR 3799, CHOICE Arrangement Act; HR 3800, the Chronic Disease Flexible Coverage Act; HR 5609, the Advancing Health Savings Act; HR 5688, the Bipartisan HSA Improvement Act; HR 5687, the HSA Modernization Act; HR 6664, the Innovation in Pediatric Drugs Act; HR 6963, the Pediatric Cancer Drug Supply Chain Act; HR 7384, the Creating Hope Reauthorization Act; HR 8261, Preserving Telehealth, Hospital, and Ambulance Access Act; HR 8412, the Clinical Trial Modernization Act; HR 8574, the 340B ACCESS Act; HR 9129, Patient Debt Relief Act; S 113, the Prescription Pricing for the People Act; S 127, the Pharmacy Benefit Manager Transparency Act; S 1339, the Pharmacy Benefit Manager Reform Act; S 1542, the DRUG Act; S 1967 the Patients Before Middlemen Act; S 2243, the Palliative Care and Hospice Education and Training Act; S 2483, the Strengthening Consumer Protections and Medical Debt Transparency Act; S 2973, the Modernizing and Ensuring PBM Accountability Act; S 3167, Multiple Employer Welfare Arrangement (MEWA) Act; HR 9774 / S 5194, the Health Care Affordability Act; Legislation to protect insurance purchasers interacting with insurance brokers; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Efforts to extend and make permanent the current enhanced Advance Premium Tax Credits; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; FDA draft guidance related to dose optimization studies in clinical trials

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

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

H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl - spread-pricing by PBMs for Medicaid H.R. 2880 - Protecting Patients Against PBM Abuses Act - Rep. Carter, Earl - PBM transparency H.R. 4818 - Treat and Reduce Obesity Act - Rep. Wenstrup, Brad - weight loss coverage H.R. 5372 - Expanding Seniors Access to Lower Cost Medicines Act of 2023 - Rep. Joyce, John - generic drugs, biosimilars cost H.R. 5378 - Lower Costs, More Transparency Act - Rep. McMorris Rodgers, Cathy - PBM transparency H.R. 5385 - Medicare PBM Accountability Act - Rep. Landsman, Greg McMorris - PBM transparency H.R. 6283 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 6963 - Pediatric Cancer Drug Supply Act of 2024 - Rep. Eshoo, Anna - establishes agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs H.R. 7635 - The 340B PATIENTS Act of 2024- Rep. Matsui, Doris - ensures accessibility of drugs under 340B drug discount program S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - PBM transparency S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - PBM transparency S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices, prevent patent thickets S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - drug pricing transparency S. 1269 - INSULIN Act of 2023 - Sen. Shaheen, Jeanne - insulin pricing S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernie - PBM transparency S. 1542 - DRUG Act - Sen. Marshall, Roger - PBM regulation S. 2973 - Modernizing and Ensuring PBM Accountability Act - Sen. Wyden, Ron - Plan implementation S. 3934 - Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; coverage of weight loss drugs; high priced drugs; patent reforms; Pharmacy Benefit Managers; and copay coupons.

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.

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.

Medicare and Medicaid payment issues Health care workforce Drug Shortages Health Equity / Social determinants of health Maternal Health Behavioral and Mental Health MACRA reform Hospital consolidation Health care pricing transparency Tax Exempt Hospitals Primary Care and Health Workforce Expansion Act Lower Cost More Transparency Act Site Neutral 340B Drug Pricing MA prior authorization Medicare hospital wage index Telehealth and digital health Home health Rural health Pediatric drug shortages and the Pediatric Cancer Drug Supply Act of 2024 (H.R. 6963) COMPLETE Care Act (H.R. 5819) Artificial intelligence Lorna Breen Health Care Worker Safety Reauthorization Act (S. 3679 / H.R. 7153) and appropriations to same SAVE Act (S. 2768 / H.R. 2584) Lab developed tests Mobile stroke unit funding Connected MOM (S. 712) 340B Patients Act (H.R. 7635 / S. 3922) Improving Seniors' Timely Access to Care Act (H.R. 9702 / S. 4532) Connect Act (H.R. 4189 /S. 2016) MAPS Act (H.R. 6992) H. Res. 389 - In support of Healthcare workers TEAM Model implementation Physician Fee Schedule Medical Graduate Investment Act

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

Medicare and Medicaid payment issues Health care workforce Drug Shortages Health Equity / Social determinants of health Maternal Health Behavioral and Mental Health MACRA reform Hospital consolidation Health care pricing transparency Tax Exempt Hospitals Primary Care and Health Workforce Expansion Act Lower Cost More Transparency Act Site Neutral 340B Drug Pricing MA prior authorization Medicare hospital wage index Telehealth and digital health Home health, rural health Pediatric drug shortages and the Pediatric Cancer Drug Supply Act of 2024 (H.R. 6963) Centers for Medicare & Medicaid Services (CMS) direct contracting and the Global and Professional Direct Contracting (GPDC) Program MEDICAID Provider Assessment Program and prescription payment issues COMPLETE Care Act (H.R. 5819) Artificial intelligence Lorna Breen Health Care Worker Safety Reauthorization Act (S. 3679 / H.R. 7153) SAVE Act (S. 2768 / H.R. 2584) Lab developed tests Mobile stroke unit funding Connected MOM (S. 712) 340B Patients Act (H.R. 7635 / S. 3922) Improving Seniors' Timely Access to Care Act (H.R. 9702 / S. 4532) Connect Act (H.R. 4189 /S. 2016) MAPS Act (H.R. 6992)

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

Medicare and Medicaid payment issues Health care workforce Drug Shortages Health Equity Maternal Health Behavioral and Mental Health MACRA reform Hospital consolidation Health care pricing transparency PAHPA Reauthorization Tax Exempt Hospitals Primary Care and Health Workforce Expansion Act Lower Cost More Transparency Act Site Neutral 340B Drug Pricing MA prior authorization Medicare hospital wage index Telehealth Home health, rural health Pediatric Cancer Drug Supply Act of 2024 (H.R.6963) Centers for Medicare & Medicaid Services (CMS) direct contracting and the Global and Professional Direct Contracting (GPDC) Program MEDICAID Provider Assessment Program and prescription payment issues COMPLETE Care Act (H.R. 5819) Artificial intelligence Lorna Breen Health Care Worker Safety Reauthorization Act (S. 3679 / H.R. 7153) SAVE Act (S. 2768 / H.R. 2584) Lab developed tests Mobile stroke unit funding ASC policy issues

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

H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl - spread-pricing by PBMs for Medicaid H.R. 2880 - Protecting Patients Against PBM Abuses Act - Rep. Carter, Earl - PBM transparency H.R. 5372 - Expanding Seniors Access to Lower Cost Medicines Act of 2023 - Rep. Joyce, John - generic drugs, biosimilars cost H.R. 5378 - Lower Costs, More Transparency Act - Rep. McMorris Rodgers, Cathy - PBM transparency H.R. 5385 - Medicare PBM Accountability Act - Rep. Landsman, Greg McMorris - PBM transparency H.R. 6283 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 6963 - Pediatric Cancer Drug Supply Act of 2024 - Rep. Eshoo, Anna - establishes agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs H.R. 7635 - The 340B PATIENTS Act of 2024- Rep. Matsui, Doris - ensures accessibility of drugs under 340B drug discount program S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - PBM transparency S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - PBM transparency S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices, prevent patent thickets S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - drug pricing transparency S. 1269 - INSULIN Act of 2023 - Sen. Shaheen, Jeanne - insulin pricing S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernie - PBM transparency S. 2973 - Modernizing and Ensuring PBM Accountability Act - Sen. Wyden, Ron - Plan implementation S. 3934 - Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; coverage of weight loss drugs; patent reforms; Pharmacy Benefit Managers; and copay coupons.

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

HR 1692 / S 8, the Health Care Affordability Act; HR 2630 / S 652, the Safe Step Act; HR 3433 / S 2897, the Give Kids a Chance Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; HR 6003 / S 3103, the Medical Debt Relief Act; HR 6301 / S. 2039, The Cancer Drug Parity Act; HR 7383 / S 1214, the RARE Act; HR 824, the Telehealth Benefit Expansion for Workers Act; HR 1773, the Consumer Protection for Medical Debt Collections Act; HR 2813, Self-Insurance Protection Act; HR 2868, the Association Health Plans; HR 2880, the Protecting Patients Against PBM Abuses Act; HR 3799, CHOICE Arrangement Act; HR 3800, the Chronic Disease Flexible Coverage Act; HR 5609, the Advancing Health Savings Act; HR 5688, the Bipartisan HSA Improvement Act; HR 5687, the HSA Modernization Act; HR 6664, the Innovation in Pediatric Drugs Act; HR 6963, the Pediatric Cancer Drug Supply Chain Act; HR 7384, the Creating Hope Reauthorization Act; S 113, the Prescription Pricing for the People Act; S 127, the Pharmacy Benefit Manager Transparency Act; S 1339, the Pharmacy Benefit Manager Reform Act; S 1542, the DRUG Act; S 1967 the Patients Before Middlemen Act; S 2243, the Palliative Care and Hospice Education and Training Act; S 2483, the Strengthening Consumer Protections and Medical Debt Transparency Act; S 2973, the Modernizing and Ensuring PBM Accountability Act; S 3167, Multiple Employer Welfare Arrangement (MEWA) Act; Legislation to protect insurance purchasers interacting with insurance brokers; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; FDA draft guidance related to dose optimization studies in clinical trials

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.

HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; HR 6301 / S. 2039, The Cancer Drug Parity Act; HR 824, the Telehealth Benefit Expansion for Workers Act; HR 2868, the Association Health Plans; HR 2813, Self-Insurance Protection Act; HR 3799, CHOICE Arrangement Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; HR 2630 / S 652, the Safe Step Act; HR 7383 / S 1214, the RARE Act; S 2243, the Palliative Care and Hospice Education and Training Act; S 3167, Multiple Employer Welfare Arrangement (MEWA) Act; HR 1692 / S 8, the Health Care Affordability Act; HR 3800, the Chronic Disease Flexible Coverage Act; HR 5688 the Bipartisan HSA Improvement Act; HR 5687, the HSA Modernization Act; HR 5609, the Advancing Health Savings Act; HR 1773, the Consumer Protection for Medical Debt Collections Act; S 2483, the Strengthening Consumer Protections and Medical Debt Transparency Act; HR 6003 / S 3103, the Medical Debt Relief Act; HR 7384, the Creating Hope Reauthorization Act; HR 6664, the Innovation in Pediatric Drugs Act; HR 6963, the Pediatric Cancer Drug Supply Chain Act; HR 3433 / S 2897, the Give Kids a Chance Act; S 127, the Pharmacy Benefit Manager Transparency Act; S 113, the Prescription Pricing for the People Act; HR 2880, the Protecting Patients Against PBM Abuses Act; S 1967 the Patients Before Middlemen Act; S 2973, the Modernizing and Ensuring PBM Accountability Act; S 1339, the Pharmacy Benefit Manager Reform Act; S 1542, the DRUG Act; Implementation of the FY23 omnibus, specifically provisions related to increasing access to clinical trials; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; Legislation to increase federal investment in Consumer Assistance Programs; FDA draft guidance related to dose optimization studies in clinical trials

H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl - spread-pricing by PBMs for Medicaid H.R. 2880 - Protecting Patients Against PBM Abuses Act - Rep. Carter, Earl - PBM transparency H.R. 5372 - Expanding Seniors Access to Lower Cost Medicines Act of 2023 - Rep. Joyce, John - generic drugs, biosimilars cost H.R. 5378 - Lower Costs, More Transparency Act - Rep. McMorris Rodgers, Cathy - PBM transparency H.R. 5385 - Medicare PBM Accountability Act - Rep. Landsman, Greg McMorris - PBM transparency H.R. 6283 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 6963 - Pediatric Cancer Drug Supply Act of 2024 - Rep. Eshoo, Anna - establishes agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs H.R. 7635- The 340B PATIENTS Act of 2024- Rep. Matsui, Doris - ensures accessibility of drugs under 340B drug discount program S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - PBM transparency S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - PBM transparency S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - drug pricing transparency S. 1269 - INSULIN Act of 2023 - Sen. Shaheen, Jeanne - insulin pricing S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernie - PBM transparency S. 3934- Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; contraceptive coverage; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; issues related to coverage of EUA drugs under Medicare Part D; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; issues related to comparative effectiveness research and quality-adjusted life years; issues related to health plan step-therapy; and other issues relating to health care reform implementation.

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

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act - extension of expanded tax credits for ACA marketplaces; The Prevent HPV Cancers Act Women and Lung Cancer Research and Preventive Services Act of 2021 Gabriella Miller Kids First Research Act 2.0 (H.R. 623/S. 1523) The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Surprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act Modernization of Clinical Trials Act DEPICT Act NIH Clinical Trials Diversity Act Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act Retaining Access and Restoring Exclusivity (RARE) Act Health Equity and Accountability Act Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines Help CoPays Act Compact Fairness Act Nancy Gardner Sewell Multi-Cancer Early Detection Act PSA for HIM Act PC CARE Act Alan Reinstein Ban Asbestos Act Firefighter Cancer Registry Act DOD Directed Medical Research Program Childhood Cancer STAR Act H.R. 3810, the Drug Origin Transparency Act of 2023, H.R. 3008, the Drug Shortage Prevention Act, H.R. 2500, the Protecting Americans from Unsafe Drugs Act of 2023 H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3807, the Medical Device Shortage Reduction Act of 2023, H.R. 405, Essential Medicines Strategic Stockpile Act of 2023 Comprehensive Cancer Survivorship Act (S.2213 H bill number TBD): Safe Step Act Cancer Drug Parity Act (S.2039 - Cancer Drug Parity Act of 2023; H.R. 6301 Cancer Drug Parity Act of 2023) Equitable Community Access to Pharmacist Services Act PBM Reform 340B Reform Medical Nutrition Act Drug Shortages The Screening for Communities to Receive Early and Equitable Needed Services (SCREENS for Cancer) Act - H.R. 3916 - SCREENS for Cancer Act of 2023 Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers (PREVENT) Act - H.R. 3633 PREVENT HPV Cancers Act of 2023; Promotion Resources to Expand Vaccination, Education and New Treatment for HPV Cancers Act of 2023 Access to Breast Cancer Diagnosis Act of 2023 Find It Early Act - H.R. 3086 Henrietta Lacks Congressional Gold Medal Act Creating Opportunities Now for Necessary and Effective Technologies (CONNECT) for Health Act of 2023 Accelerating Kids Access to Care Act- S.2372; H.R. 4758 RAPID Reserve Act (S. 2510) Energy & Commerce Majority Drug Shortage RFI Energy & Commerce Majority/Finance Minority Drug Shortage RFI House Budget Committee RFI on how to reduce healthcare spending Telehealth Benefit Expansion for Workers Act (H.R. 824) Multi-Cancer Early Detection Act Women and Lunch Cancer Research and Preventative Services Act Lung Cancer Screening and Prevention Act Veterans Counting Cancer Act Harley Jacobsen Clinical Trial Participant Income Exemption Act (H.R. 7090) Creating Hope Reauthorization Act of 2024 (H.R. 7384) The Pediatric Cancer Drug Supply Act of 2024 (H.R. 6963) The Counting Veterans Cancer Act of 2023 (S. 1994) Lung Cancer Screening and Prevention Act (H.R. 6693) Health Equity Accountability Act

S. 3085, Preventing Adverse Childhood Experiences (PACE) Act S. 1409, Kids Online Safety Act (KOSA) H.R. 4714 & S. 2345, The Pediatricians Accelerate Childhood Therapies (PACT) Act H.R. 3226 & S.1573, The PREEMIE Reauthorization Act H.R. 3838 & S.2415, Preventing Maternal Deaths Reauthorization Act of 2023 S. 3393, SUPPORT for Patients and Communities Reauthorization Act - advocated for inclusion of Community Mental Health Services Block Grant (MHBG) Prevention & Early Intervention Set Aside & S. 3085, PACE Act provisions in reauthorization H.R. 5378, Lower Costs, More Transparency Act (hospital & 340B provisions) H.R. 7808, Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 2439 & S. 1135, Ally's Act H.R. 7379, Patient Matching and Transparency in Certified Health IT (MATCH IT) Act H.R. 6960 & S. 3765, Emergency Medical Services for Children (EMSC) Reauthorization Act of 2024 H.R. 6664, Innovation in Pediatric Drug Act of 2023 H.R. 6963, Pediatric Cancer Drug Supply Act of 2024 H.R. 3433, Give Kids a Chance Act SUSTAIN 340B Act - Senate discussion draft H.R. 4581 & S. 2231, Maternal and Child Health Stillbirth Prevention Act H.R. 5012 & S. 2647, SHINE for Autumn Act Pending telehealth legislation slated for end of 2024 H.R. 7542 & S. 3864, Stop CMV Act

Client expense: $211,059 · Firm income: Not reported

Issues related to drug pricing, drug shortages, drug importation plans, and the drug supply chain, including support for the following bills: Mapping Americas Pharmaceutical Supply (MAPS) Act (H.R. 6992), and the Pediatric Cancer Drug Supply Act of 2024 (H.R. 6963). Issues related to COVID-19 response and post-public health emergency recommendations, including telehealth and pharmacist provision of testing and vaccination (generally, no specific legislation). Issues related to combatting opioid addiction, including support for the following bills: the Fentanyl Safe Testing and Overdose Prevention Act (S. 2569) and the Test Strip Access Act of 2023 (H.R. 4106). Patient access to pharmacist provided vaccinations for COVID/flu/pediatric illnesses, COVID-19 testing, emergency HIV prophylaxis, initiation of oral antivirals for flu/COVID, buprenorphine, and other pharmacist services authorized under state law (generally, no specific legislation). Reauthorization of the Pandemic and All-Hazards Preparedness Act, including recommendations to leverage pharmacists as part of the care team. Patient access to comprehensive reproductive healthcare (generally, no specific legislation). Issues related to healthcare workforce shortages (generally, no specific legislation). The Lower Costs, More Transparency Act (H.R. 5378) and the Site-based Invoicing and Transparency Enhancement (SITE) Act (S. 1869), provisions related to site neutral payments. The Dr. Lorna Breen Health Care Provider Protection Reauthorization Act (H.R. 7153/S. 3679), provisions related to supporting health workers mental health and well-being. Issues related to the Change Healthcare cyberattack, including communications with the Department of Health and Human Services and the Centers for Medicare & Medicaid Services encouraging flexibility following the cyberattack (generally, no specific legislation).

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