PROTECT 340B Act of 2021

340B Drug Reimbursement Program: to encourage Congress to pass a bill and/or work with the Administration to return the 340B program to its pre-2018 status. S. 773; H.R. 4390 (which was passed as part of H.R. 2471); H.R. 3203 (to recalibrate critical access hospitals' revenues due to PRF funds for the purpose of calculating reasonable 340b payments) Kansas Provider Assessment: to encourage CMS to approve the increase in Kansas' Medicaid provider assessment, and to encourage Congress to work with CMS to get it approved. H.R.4040 - Advancing Telehealth Beyond COVID-19 Act of 2021. Advocating for House passage and for the Senate to take it up and pass it. H.R.3684: Encouraging Congress to pay for this bill in ways other than extending Medicare sequestration by a year. Encouraging Congress to pass a bill to ensure that a PAYGO-related 4% cut is not added to Medicare sequestration at the end of 2022. Encouraging Congress to work with DHS to include nursing as a STEM-related field so that nursing graduates can remain in the United States to work legally in a much-needed field with labor shortages. H.R.8747/S.4009: Encouraging Congress to pass a bill to extend the low-volume hospital program at its current census levels and to extend the Medicare dependent hospital program; encouraging Congress to include these provisions in CRs or fiscal year 2023 appropriations bills. Opposing physician rate cuts in the 2023 Prospective Payment System and the 2023 OPPS and IPPS.

Client expense: Not reported · Firm income: $16,000

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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill H.R. 6000: Cures 2.0 Act; all healthcare provisions of the bill H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; all provisions of the bill H.R. 6833: Affordable Insulin Now Act; provisions related to the Prescription Drug User Fee Act Reauthorization H.R. 6963: Accelerated Approval Integrity Act of 2022; all provisions of the bill H.R. 6996: Accelerating Access for Patients Act of 2022; all provisions of the bill H.R. 7667: Food and Drug Amendments of 2022; provisions related to drug development user fees S. 2706: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill S. 4348: Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022; provisions related to drug development user fees S. 4535: Food and Drug Administration Simple Reauthorization (FDASRA) Act of 2022; provisions related to drug development user fees 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General discussions regarding drug cost and pricing policy issues General discussions related to the Cancer Moonshot Initiative and the Advanced Research Projects Agency for Health (ARPA-H) General discussion related to the Prescription Drug User Fee Act Reauthorization

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

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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 2163: Safe Step Act: all provisions of the bill H.R. 3173: Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill S. 464: Safe Step Act: all provisions of the bill S. 3108: Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General issues related to pharmaceutical pricing General issues related to drug development lifecycle

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

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

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, and private insurance Issues related to implementation of aspects of childrens health coverage under Medicaid, CHIP, the Exchanges, and private insurance Issues regarding the implementation of the ACE Kids Act S.1544/H.R. 3089 - Accelerating Kids Access to Care Act H.R. 7076/S. 3864, the Supporting Childrens Mental Health Care Access Act H.R. 7236 Strengthen Kids Mental Health Now Act S. 4472 Health Care Capacity for Pediatric Mental Health Act Issues regarding childrens and mothers health specifically continuous eligibility for children in Medicaid and CHIP, CHIP permanency, 12-months postpartum coverage for mothers and Medicaid coverage for children leaving the justice system. H.R. 4934, the Childrens Mental Health Infrastructure Act, H.R. 4944, the Helping Kids Cope Act, S.1902, the Behavioral Health Crisis Services Expansion Act Issues regarding childrens mental health, the national emergency in childrens mental health, and the Surgeon General Advisory on youth mental health. Issue regarding Medicaid supplemental payments HR. 3753/S. 1962 - Parity Implementation Act S.2762/H.R. 5131, the Pediatric Access to Critical Healthcare (PATCH) Act, and issues regarding pediatric health care infrastructure and capacity Issues regarding the importance of Medicaid to military and veteran families FY 2022 and FY 2023 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 appropriations Issues related to additional funding for CHGME Issues related to 340B Drug Pricing Program, prescription drug pricing, drug shortages, and pharmaceutical supply chain, including H.R. 4390, the PROTECT 340B Act of 2021 Issues related to Provider Relief Funding Issues related to pediatric nursing workforce Issues regarding the passage and implementation of COVID-19 relief packages, increased FMAP funding, and the impact of COVID-19 on childrens hospitals, the pediatric supply chain, and pediatric residency programs Issues regarding COVID-19 vaccination efforts for children Issues regarding surprise billing bad debt, and price transparency in health care H.R. 1397 - Telehealth Improvement for Kids Essential Services (TIKES) Act and broader telehealth policies Mental health funding provided in Consolidated Appropriations Act and ARPA Issues regarding the Public Health Emergency Issues regarding 340B drug program and other drug issues H.R. 7691, Safety from Violence for Healthcare Employees (SAVE) Act H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022 S.4170, The Mental Health Reform Reauthorization Act of 2022 Issues regarding infant formula shortage Issues regarding food security and nutrition Issues regarding drugs and medical device shortages Issues regarding climate change S. 4747, Investing in Kids Mental Health Now Act VALID Act Issues regarding the uptake of childhood vaccines Issues included in the FY2023 Omnibus bill

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

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Oceanic & Atmospheric Administration (NOAA), SENATE, Treasury, Dept of

H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products HR 1978 - Protecting Seniors Through Immunization Act H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing, patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Issues related to HFC's Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Veterans' Affairs issues related to product sampling Provisions related to the importation of HFCs, necessary for MDI production. P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)

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

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

Issue: Educate Congress and the administration on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Draft Graduate Medical Education Reform Act Issue: Support increased funding for the National Health Service Corps, Teaching Health Center GME, and National Disaster Medical Service (NDMS) demonstration pilot. Support increased Medicare support for Graduate Medical Education/physician training. Issues: Educate Congress and the administration about the role of academic medicine in the provision of mental and behavioral health care, including initiatives to respond to the opioid epidemic. Support measures to expand access to mental health care and substance use disorder treatment, including funding for training on substance use disorders, pain management, and safe prescribing practices, enhance enforcement of mental health parity laws, increased financial support for integrated behavioral health models. Support the provision of additional Medicare-supported graduate medical education slots for psychiatry and psychiatry sub-specialties. P.L. 117-328, Consolidated Appropriations Act, 2023 Support the provision of 200 additional Medicare-supported graduate medical education (GME) positions. Support the extension of COVID-related telehealth flexibilities. Support elimination or delay of Statutory Pay-As-You-Go (PAYGO) Medicare sequester and eliminating or reducing scheduled cuts to the Physician Fee Schedule. Support one-year of continuous Medicaid coverage for children. Support extension of postpartum Medicaid and CHIP coverage for 12 months. H.R. 1384/ S.445, Mainstreaming Addiction Treatment (MAT) Act of 2021 P.L. 117-328, Consolidated Appropriations Act, 2023, Division FF Issue: Support suspension of waiver requirement for certain providers to prescribe buprenorphine. H.R. 2067, Medication Access and Training Expansion (MATE) Act of 2021 P.L. 117-328, Consolidated Appropriations Act, 2023, Division FF Issue: Oppose legislative mandates dictating medical education curriculum on pain management and addiction. H.R. 7236, Strengthen Kids Mental Health Now Act/ S. 2727 Investing in Kids Mental Health Now Act Issue: Support increasing Medicaid reimbursement rates for pediatric mental health services through a 100% federal match. P.L. 116-22, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 Issues: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. Issue: Educate Congress on how the 340B Drug Pricing Program helps safety-net providers to fulfill their missions and care for patients and communities. Support measures to preserve and strengthen the 340B Drug Pricing Program and oppose efforts to reduce the scope of the program, including restrictions on covered entities use of contract pharmacy to distribute covered drugs. H.R. 4390, Preserving Rules Ordered for the Entities Covered Through 340B Act of 2021 (PROTECT 340B Act) Issue: Support measures to prevent pharmacy benefit managers and commercial insurers from discriminating against 340B covered entities. H.R. 3203/S. 773 Issue: Support policy to allow 340B DSH hospitals to remain eligible to participate in the program throughout the current public health emergency even if their DSH adjustment falls below the current threshold due to changes in payer mix as a result of the COVID-19 pandemic. Issue: Oppose insurance plans that do not meet Affordable Care Act requirements. Issue: Support increased interoperability and exchange of electronic health information and delayed enforcement of information blocking rule until comprehensive guidance is issued. Issue: Support the ongoing refinement of the two new mandatory alternative payment models, the Radiation Oncology Model and End-stage Renal Disease Treatment Choices Model, to better incentivize high-quality care for all patients. H.R. 4128/ S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 P.L. 117-328, Consolidated Appropriations Act, 2023 Issue: Educate Congress on development of Laboratory Developed Tests at academic medical centers and oppose policies that would increase burdensome regulations and negatively impact patients access to care by allowing Food and Drug Administration regulation of the development of Laboratory Developed Tests at academic medical centers. S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 H.R. 7667, Food and Drug Amendments of 2022 (FDA22) P.L. 117-328, Consolidated Appropriations Act, 2023 Issue: Support promotion of data sharing and clinical trials results reporting. Support increased clinical trials diversity. Issue: Development of Enhanced Primary Care Pilot Act proposal H.R. 2503 / S. 3039, Social Determinants Accelerator Act of 2021 Issue: Support grants to address social determinants of health H.R. 7585 / S. 4486, Health Equity and Accountability Act Issue: Support programs to improve health equity and address social determinants of health. Issue: Support incentives to encourage the inclusion of implicit bias training in medical education and residency training. Issue: Support congressional investment in the Centers for Medicare and Medicaid Innovation (CMMI) models to reduce maternal mortality and improve maternal health. Issue: Support maternal health initiatives to expand coverage during the postpartum period and expand demonstration project grants. H.R. 959, Black Maternal Health Momnibus Act of 2021 S. 1695 / H.R. 4387, Maternal Health Quality Improvement Act S. 1491/ H.R. 769, Rural MOMs Act H.R. 4387, Maternal Health Quality Improvement Act of 2021 H.R. 925 / S. 347, Data to Save Moms Act Issue: Support legislative efforts to improve maternal health and reduce rates of maternal mortality, including the Momnibus. Support legislative initiatives to improve data collection to improve maternal health equity. P.L. 117-159, Bipartisan Safer Communities Act Issue: Support policies to promote firearm safety, universal background checks, violence prevention programs, extreme risk protection orders, child access safety laws, reinstating assault weapons ban, data infrastructure, hospital based and community violence intervention programs, and programs to address mental and behavioral health impact of gun violence. Issue: Support funding for Community Violence Interventions / Hospital Based Violence Intervention Programs P.L. 117-105, Dr. Lorna Breen Health Care Provider Protection Act Issue: Support grants directed at improving clinician burnout and well-being. Issue: Provide feedback on implementation of the Provider Relief Fund. Support extension for use of PRF funds. Issue: Support improvements to the Medicare Accelerated and Advance Payment Programs, including delaying recoupment of MAAP loans. Issue: Support extension of public health emergency declaration. Issue: Provide feedback on COVID-19 and pandemic response. Provide feedback on monkeypox response including testing. S. 3799, PREVENT Pandemics Act P.L. 117-328, Consolidated Appropriations Act, 2023, Division FF Issue: Provide feedback on pandemic preparedness legislation, urge inclusion of provisions to support academic medical centers preparedness activities. Issue: Support establishment of regional pandemic response centers, stronger linkages between public health and academic medicine, and the role of medical students and academic medical centers in administering COVID vaccines. Issue: Support efforts of academic medical centers to respond to public health threats such as monkeypox and COVID-19. Urge establishment and implementation of robust national testing strategy; functional, redundant, and transparent supply chain; improved federal coordination; investments in public health and health care human and other resources; data modernization initiatives; and other actions to improve current and future pandemic response. H.R. 708, S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act Issue: Support for a temporary uniform licensing standard for all practitioners in all states throughout the COVID-19 public health emergency S. 674 Public Health Infrastructure Saves Lives Act Issue: Support investments in core public health infrastructure. Issue: Support ensuring patients are put first, that conscience protections align with medical professionalism standards, and oppose interference in the patient-physician relationship. Issue: Support increased interoperability and exchange of electronic health information. Support delay of enforcement beyond April 2021. H.R. 6000, Cures 2.0 Act Issue: Provide feedback on provisions related to public health, patients and caregivers, FDA, CMS, and research, and ARPA-H. Issue: Promote strategies to strengthen the health, public health, and research workforces. H.R. 3671, Doctors of Community Act Issue: Discuss authorization of the Teaching Health Center Graduate Medical Education program. H.R. 8131, Increasing Competition for Medical Residency Act Issue: Educate Congress on the medical education and training continuum, the annual residency Match, and the role of the National Resident Matching Program (NRMP) in medical education and residency. Issue: Provide guidance on the implementation of the No Surprises Act. Issue: Provide feedback on proposed modifications to the HIPAA privacy rule. H.R. 5035 / S. 2982, Child Suicide Prevention and Lethal Means Safety Act Issue: Support legislation to provide grants to improve suicide prevention and lethal means safety. Issue: Inform Congress and Administration about medical education on caring for older adults, nutrition, climate change, stigma around addiction, reproductive health, and accelerated medical education training programs. Issue: Provide feedback on efforts of the academic medicine community to address climate change and decarbonization. Issue: Support efforts of teaching hospitals to promote patient safety and high-quality care. H.R. 7152/ S.3534, The Tracking Pathogens Act P.L. 117-328, Consolidated Appropriations Act, 2023, Division FF Issue: Support expansion of CDC activities related to genomic sequencing of pathogens. Issue: Support reignition of Cancer Moonshot. H.R. 7961, Safety from Violence for Healthcare Employees (SAVE) Act Issue: Support statutory protections against violence and intimidation for health care workers and provide grants for hospital programs aimed at preventing violence in health care settings. P.L. 117-263, James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 Issue: Support a one year pause in military medical billet reductions in the Military Health System.

Client expense: $876,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Vice President of the U.S., White House Office

H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Client expense: $6,610,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE

The 340B Drug Pricing Program; H.R. 5376 - The Inflation Reduction Act; H.R.8295 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023; S.4659 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023; Fiscal Year 2023 Omnibus Appropriations Bill, H.R. 4390, The Protect 340B Act

Client expense: $203,296 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE

The 340B Drug Pricing Program; H.R. 5376 - The Inflation Reduction Act; H.R.8295 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023; S.4659 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023; Fiscal Year 2023 Omnibus Appropriations Bill, H.R. 4390, The Protect 340B Act

Client expense: $203,296 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE

HR 5- Equality Act HR 366- Protecting Access to Post-COVID-19 Telehealth Act of 2021 HR 1319- American Rescue Act of 2021 HR 1677- To Direct the Secretary of Health and Human Services, the Medicare Payment Advisory Commission... S 620 Keep Telehealth Options Act of 2021 HR 4502- Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act... S. 1544- Accelerating Kids' Access to Care Act HR 3089- Accelerating Kids' Access to Care Act HR 4943- The Children's Mental Health Infrastructure Act of 2021 HR 4944- The Helping Kids Cope Act of 2021 HR 4390- The PROTECT 340B Act HR 1916- Lasting Smiles Act HR 1397- The Telehealth Improvement for Kids' Essential Services HR 3783- Medical Nutrition Equity Act S 2013- Medical Nutrition Equity Act S 2691- Strengthening the Vaccines for Children Program Act of 2021 HR 2347- Strengthening the Vaccines for Children Program Act of 2021 HR 7236 Strengthen Kids' Mental Health Now Act HR 8295 Labor HHS FY23 Appropriations HR 6833 Continuing Appropriations Act of 2023 S 4747 Investing in Kids Mental Health Now Act S 4472 Health Care Capacity for Pediatric Mental Health HR 2617 Consolidated Appropriations Act of 2023 General issues regarding mental health, physical health, Medicaid, CHIP, and DSH.

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

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

HR 5- Equality Act HR 366- Protecting Access to Post-COVID-19 Telehealth Act of 2021 HR 1319- American Rescue Act of 2021 HR 1677- To Direct the Secretary of Health and Human Services, the Medicare Payment Advisory Commission... S 620 Keep Telehealth Options Act of 2021 HR 4502- Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act... S. 1544- Accelerating Kids' Access to Care Act HR 3089- Accelerating Kids' Access to Care Act HR 4943- The Children's Mental Health Infrastructure Act of 2021 HR 4944- The Helping Kids Cope Act of 2021 HR 4390- The PROTECT 340B Act HR 1916- Lasting Smiles Act HR 1397- The Telehealth Improvement for Kids' Essential Services HR 3783- Medical Nutrition Equity Act S 2013- Medical Nutrition Equity Act S 2691- Strengthening the Vaccines for Children Program Act of 2021 HR 2347- Strengthening the Vaccines for Children Program Act of 2021 HR 7236 Strengthen Kids' Mental Health Now Act HR 8295 Labor HHS FY23 Appropriations HR 6833 Continuing Appropriations Act of 2023 S 4747 Investing in Kids Mental Health Now Act S 4472 Health Care Capacity for Pediatric Mental Health HR 2617 Consolidated Appropriations Act of 2023 General issues regarding mental health, physical health, Medicaid, CHIP, and DSH.

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

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

Issues related to hemophilia treatments, specialty pharmacies and the 340B drug purchasing program Protect 340B Act (HR 4390) Prescription Drug User Fee Amendments Citizens Petition regarding gene therapy in hemophilia

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

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

Affordable Care Act implementation Coverage of hemophilia treatments and services in private insurance plans, including alternative funding model The HELP Copays Act (HR 5801) The Protect 340B Act (HR 4390) Private insurance policies that discriminate coverage for high cost drugs and use of patient assistance programs, also known as the (Alternative Payment Model)

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

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

COPE Act of 2019, H.R. 1528; American Rescue Plan, importance of 340B drug pricing program; Provider status for pharmacists; surprise medical billing in general; sustainability of safety net health systems; social determinants of health; promoting coordinated care; Coronavirus Preparedness and Response Supplemental Appropriations (CPRSA) Act; the Families First Coronavirus Response Act (14k CRA); the Coronavirus Aid, Relief, and Economic Security (CARES) Act - issues regarding patient care, Provider Relief Funds; and H.R. 266/P.L. 116-139, the Health Care Enhancement Act - provisions related to Public Health and Social Services Emergency Fund; and FCC's COVID-19 Telehealth Program; support of telehealth policies, including for audio-only telehealth services; Hill-Burton funding for front line safety net hospitals in H.R. 5376; within H.R. 5376 impact of pharmaceutical pricing policies on 340B drug discount program; S. 3799 PREVENT Pandemics Act - social determinants of health provisions; 340B Protect Act, H.R. 4390; and H.R. 2617, the Consolidated Appropriations Act of 2023.

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

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

Issues related to drug pricing reform Public law 117-1769 Inflation Reduction Act HR 2617 Consolidated Appropriations Act of 2023, --issues related to cardiovascular disease, --Issues related to FTC, --FDA issues (Food and Drug Omnibus Reforms Act) --Issues related to Pharmacy Benefit Manger transparency --Issues related to clinical trial diversity S1435 affordable prescriptions for patients act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to biodefense issues, S3799 PREVENT Pandemics Act Issues related to cardiovascular disease awareness, S. 3018/ HR 3173 Improving Seniors Timely Access to Care Act Issues related to 340B H.R. 5801 HELP Copays Act Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters HR 8588 Fair Care Act, 340B hospital reporting HR 4390 Protect 340B Act

Client expense: $2,140,000 · Firm income: Not reported

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

Advocated for: 1. Permanent telehealth expansion through the extension of emergency Medicare telehealth waiver allowing payment for tele-visits with patients in their home permanently. 2. Expand Medicare supported graduate medical education via the Resident Physician Shortage Act. 3. Reducing drug costs for patients and providers, providing the tools for providers to control drug costs such as through the 340B drug discount program flexibility and 340B program integrity. 4. Preserve 340B payments and maximize retroactive payments. Supporting the 340B Bill (the Preserving Rules Ordered for the Entities Covered Through ("PROTECT") 340B Act of 2022 -- H.R. 4390)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.4390 - PROTECT 340B Act of 2021 H.R.5963/S. 3611 - Provider Relief Fund Improvement Act H.R.7961 - SAVE Act HR 8576/S.4352 - Travel Nursing Agency Transparency Study Act Issues related to essential hospital designation Issues related to health equity Issues related to improving the provision of mental health care in the United States Issues related to reauthorizing the Hill-Burton program and allocating additional resources to essential hospitals Issues related to the 340B Drug Pricing program and contract pharmacies Issues related to the COVID-19 public health emergency Issues related to the health care workforce

Client expense: $490,000 · Firm income: Not reported

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

Issues related to FDA authority to manage drug shortages, regulation of pharmacy compounding, and implementation of the Drug Quality and Security Act (generally, no specific legislation or regulations). Issues related to COVID-19 response recommendations (generally, no specific legislation). The Protect 340B Act (H.R. 4390), and A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes (H.R. 3203/S. 773), provisions related to enforcement of the 340B Drug Pricing Program. Issues related to the rollout of Test to Treat Programs (generally, no specific legislation). Issues related to pharmacy residency funding (generally, no specific legislation).

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

Government targets: Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

HR 2547 Comprehensive Debt Collection Improvement Act (all sections of full text) S 3593 Telehealth Extension and Evaluation Act (all sections of full text) HR 4390 PROTECT 340B Act of 2021 (all sections of full text)(support) P.L. 117-169 Inflation Reduction Act of 2022; discussions involving the extension of ACA subsidies through 2025 Discussions involving 340B Drug Pricing Program Discussions involving Medicare sequestration Discussions involving CMS proposed Physician Fee Schedule Monitored HR 7776 James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 Monitored S 2428 False Claims Amendments Act of 2021 Monitored S 748 Medicare Sequester Relief Act Monitored S 2061 Telemental Health Care Access Act of 2021 Monitored HR 4058 Telemental Health Care Access Act of 2021 Monitored S 368 Telehealth Modernization Act Monitored HR 1332 Telehealth Modernization Act Monitored S 155 Equal Access to Care Act Monitored HR 688 Equal Access to Care Act Monitored discussions pertaining to CMS rulemaking on surprise billing ban Monitored discussions pertinent to health care group purchasing organizations (GPOs) Monitored nominations to executive branch agencies and federally authorized commissions Monitored CMS price transparency rule for hospitals, Public Health Service Act Section 2718(e)

Client expense: Not reported · Firm income: $100,000

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

HR1319; HR2547 (health related debt collection provisions); S1873; S1893; HR3671; S1024/HR2255; 340B general concerns; HR4390; HR5376; SAVE Act of 2022;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act; H.R. 6000, Cures 2.0 Act; H.R. 6519, Patients Right to Know Their Medication Act of 2022; Draft legislation, Pharmacy Price Transparency Protection Act; H.R. 7559, Prescription Information Modernization Act; Draft legislation, To ensure that private health insurers are able to provide appropriate oversight of entities providing pharmacy benefit manager services; Draft legislation, the PBM Transparency, Accountability, and Reform Act

Client expense: $320,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

340B Drug Reimbursement Program: to encourage Congress to pass a bill and/or work with the Administration to return the 340B program to its pre-2018 status. S. 773; H.R. 4390 (which was passed as part of H.R. 2471); H.R. 3203 (to recalibrate critical access hospitals' revenues due to PRF funds for the purpose of calculating reasonable 340b payments) Kansas Provider Assessment: to encourage CMS to approve the increase in Kansas' Medicaid provider assessment, and to encourage Congress to work with CMS to get it approved. H.R.4040 - Advancing Telehealth Beyond COVID-19 Act of 2021. Advocating for House passage and for the Senate to take it up and pass it. H.R.3684: Encouraging Congress to pay for this bill in ways other than extending Medicare sequestration by a year. Encouraging Congress to pass a bill to ensure that a PAYGO-related 4% cut is not added to Medicare sequestration at the end of 2022. Encouraging Congress to work with DHS to include nursing as a STEM-related field so that nursing graduates can remain in the United States to work legally in a much-needed field with labor shortages. H.R.8747/S.4009: Encouraging Congress to pass a bill to extend the low-volume hospital program at its current census levels and to extend the Medicare dependent hospital program; encouraging Congress to include these provisions in CRs or fiscal year 2023 appropriations bills. Opposing physician rate cuts in the 2023 Prospective Payment System and the 2023 OPPS and IPPS.

Client expense: Not reported · Firm income: $16,000

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

340B Drug Reimbursement Program: to encourage Congress to pass a bill and/or work with the Administration to return the 340B program to its pre-2018 status. S. 773; H.R. 4390; H.R. 3203 (to recalibrate critical access hospitals' revenues due to PRF funds for the purpose of calculating reasonable 340b payments). Kansas Provider Assessment: to encourage CMS to approve the increase in Kansas' Medicaid provider assessment, and to encourage Congress to work with CMS to get it approved. PRF Period 1 reporting: individual hospital needs. S. 2493; H.R. 4735 S. 1893: encouraging Congress to pass this bill that will help add additional physicians in rural areas. S. 1024: encouraging Congress to pass this bill that would encourage physicians to work in rural and out migrating areas. Encouraging Congress to end sequestration and allow PAYGO rules to enact a 4% cut to hospital Medicare reimbursement rates at the end of the year. Encouraging Congress to pass a bill that allows critical access hospitals to also be eligible for telehealth flexibilities afforded to other types of providers.

Client expense: Not reported · Firm income: $16,000

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

HR1319; HR2547 (health related debt collection provisions); S1873; S1893; HR3671; S1024/HR2255; 340B general concerns; HR4390; HR5376; SAVE Act of 2022;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Teaching Health Centers; Nurse Corps; National Health Service Corps; 340B Drug Discount Program; Community Health Center Program; Telehealth Reform; Healthcare Workforce Programs; H.R. 4390 PROTECT 340B Act; S.958/H.R.5141 MOBILE Health Care Act; S. 3569 HELP for Volunteers Act; S. 3799 PREVENT Pandemics Act; H.R. 8151 Building a Sustainable Workforce for Healthy Communities Act; H.R. 7666 Restoring Hope for Mental Health and Well-Being Act of 2022; H.R. 6833 Continuing Resolution legislation includes Federal Tort Claims Act Volunteer Malpractice Coverage; H.R. 5376 Inflation Reduction Act; and behavioral and mental health policy; and climate change policy.

Client expense: $280,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers HR 5605 PrEP Assistance Act H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act H.R. 5376 Inflation Reduction Act - provisions related to vaccines and pharmaceuticals H.R. 4127: DISARM Act Act Provisions related to antimicrobial drug development H.R. 3932/S. 2076: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. H.R. 3655: Vaccine Injury Compensation Modernization Act H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) S. 912/H.R. 1978: Protecting Seniors Through Immunization Act H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Dietary Supplement Health and Education Act Reform Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Final Rule; Importation of Prescription Drugs Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022 Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property

Client expense: $1,390,000 · Firm income: Not reported

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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 2163: Safe Step Act: all provisions of the bill H.R. 3173: Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill S. 464: Safe Step Act: all provisions of the bill S. 3108: Improving Seniors Timely Access to Care Act of 2021; all provisions of the bill P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General issues related to pharmaceutical pricing General issues related to drug development lifecycle

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

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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill H.R. 6000: Cures 2.0 Act; all healthcare provisions of the bill H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; all provisions of the bill H.R. 6833: Affordable Insulin Now Act; provisions related to the Prescription Drug User Fee Act Reauthorization H.R. 6963: Accelerated Approval Integrity Act of 2022; all provisions of the bill H.R. 6996: Accelerating Access for Patients Act of 2022; all provisions of the bill H.R. 7667: Food and Drug Amendments of 2022; provisions related to drug development user fees S. 2706: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill S. 4348: Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022; provisions related to drug development user fees S. 4535: Food and Drug Administration Simple Reauthorization (FDASRA) Act of 2022; provisions related to drug development user fees 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General discussions regarding drug cost and pricing policy issues General discussions related to the Cancer Moonshot Initiative and the Advanced Research Projects Agency for Health (ARPA-H) General discussion related to the Prescription Drug User Fee Act Reauthorization

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

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

Contact concerning FDA authority to manage drug shortages, regulation of pharmacy compounding, implementation of the Drug Quality and Security Act. Conversation with DEA regulation on Medication-Assisted Treatment and drug shortages. Discussed COVID-19 response recommendations with House and Senate Offices, White House Offices, and HHS and its sub-agencies, and DEA. Contact HHS, House and Senate Offices concerning rule enforcement of the 340B Drug Pricing Program. Met with House and Senate offices to discuss the Protect 340B Act (H.R. 4390) and bills S.773 and H.R. 3203, also related to the 340B program. Discussed role out of Test to Treat Program with HHS and its agencies.

Client expense: $355,000 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

Communication with Senate to pass insulin affordability legislation. Discussion with White House requesting response to drug contrast shortages. Contact concerning FDA authority to manage drug shortages, regulation of pharmacy compounding, implementation of the Drug Quality and Security Act. Conversation with DEA regulation on Medication-Assisted Treatment and drug shortages. Discussed COVID-19 response recommendations with House and Senate Offices, White House Offices, and HHS and its sub-agencies, and DEA. Contact HHS, House and Senate Offices concerning rule enforcement of the 340B Drug Pricing Program. Met with House and Senate offices to discuss the Protect 340B Act (H.R. 4390) and bills S.773 and H.R. 3203, also related to the 340B program. Discussed role out of Test to Treat Program with HHS and its agencies.

Client expense: $528,641 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

Contact concerning FDA authority to manage drug shortages, regulation of pharmacy compounding, implementation of the Drug Quality and Security Act. Discussed COVID-19 response recommendations with House and Senate Offices, White House Offices, and HHS and its sub-agencies, and DEA. Contact HHS, House and Senate Offices concerning rule enforcement of the 340B Drug Pricing Program. Met with House and Senate offices to discuss the Protect 340B Act (H.R. 4390) and bills S.773 and H.R. 3203, also related to the 340B program. Discussed role out of Test to Treat Program with HHS and its agencies. Advocated to protect pharmacy residency funding.

Client expense: $260,000 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

H.R.4390 - PROTECT 340B Act of 2021 H.R.5963/S. 3611 - Provider Relief Fund Improvement Act H.R.7961 - SAVE Act HR 8576/S.4352 - Travel Nursing Agency Transparency Study Act Issues related to essential hospital designation Issues related to health equity Issues related to improving the provision of mental health care in the United States Issues related to reauthorizing the Hill-Burton program and allocating additional resources to essential hospitals Issues related to the 340B Drug Pricing program and contract pharmacies Issues related to the COVID-19 public health emergency Issues related to the health care workforce

Client expense: $390,000 · Firm income: Not reported

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

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, and private insurance Issues related to implementation of aspects of childrens health coverage under Medicaid, CHIP, the Exchanges, and private insurance Issues regarding the implementation of the ACE Kids Act S.1544/H.R. 3089 - Accelerating Kids Access to Care Act H.R. 7076/S. 3864, the Supporting Childrens Mental Health Care Access Act H.R. 7236 Strengthen Kids Mental Health Now Act S. 4472 Health Care Capacity for Pediatric Mental Health Act Issues regarding childrens health included in Build Back Better Act/reconciliation H.R. 4934, the Childrens Mental Health Infrastructure Act, H.R. 4944, the Helping Kids Cope Act, S.1902, the Behavioral Health Crisis Services Expansion Act Issues regarding childrens mental health, the national emergency in childrens mental health, and the Surgeon General Advisory on youth mental health. Issue regarding Medicaid supplemental payments HR. 3753/S. 1962 - Parity Implementation Act S.2762/H.R. 5131, the Pediatric Access to Critical Healthcare (PATCH) Act, and issues regarding pediatric health care infrastructure and capacity Issues regarding the importance of Medicaid to military and veteran families FY 2022 and FY 2023 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 appropriations Issues related to 340B Drug Pricing Program, prescription drug pricing, drug shortages, and pharmaceutical supply chain, including H.R. 4390, the PROTECT 340B Act of 2021 Issues related to Provider Relief Funding Issues related to pediatric workforce Issues regarding the passage and implementation of COVID-19 relief packages, increased FMAP funding, and the impact of COVID-19 on childrens hospitals, the pediatric supply chain, and pediatric residency programs Issues regarding COVID-19 vaccination efforts for children Issues regarding surprise billing bad debt, and price transparency in health care H.R. 1397 - Telehealth Improvement for Kids Essential Services (TIKES) Act and broader telehealth policies Mental health funding provided in Consolidated Appropriations Act and ARPA Issues regarding the Public Health Emergency Issues regarding 340B drug program and other drug issues H.R. 7691, Safety from Violence for Healthcare Employees (SAVE) Act H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022 S.4170, The Mental Health Reform Reauthorization Act of 2022 Issues regarding infant formula shortage Issues regarding food security and nutrition Issues regarding medical device shortages Issues regarding climate change S. 4747, Investing in Kids Mental Health Now Act

Client expense: $565,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Oceanic & Atmospheric Administration (NOAA), SENATE, Treasury, Dept of

H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

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

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

HR 5- Equality Act HR 366- Protecting Access to Post-COVID-19 Telehealth Act of 2021 HR 1319- American Rescue Act of 2021 HR 1677- To Direct the Secretary of Health and Human Services, the Medicare Payment Advisory Commission... S 620 Keep Telehealth Options Act of 2021 HR 4502- Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act... S. 1544- Accelerating Kids' Access to Care Act HR 3089- Accelerating Kids' Access to Care Act HR 4943- The Children's Mental Health Infrastructure Act of 2021 HR 4944- The Helping Kids Cope Act of 2021 HR 4390- The PROTECT 340B Act HR 1916- Lasting Smiles Act HR 1397- The Telehealth Improvement for Kids' Essential Services HR 3783- Medical Nutrition Equity Act S 2013- Medical Nutrition Equity Act S 2691- Strengthening the Vaccines for Children Program Act of 2021 HR 2347- Strengthening the Vaccines for Children Program Act of 2021 HR 7236 Strengthen Kids' Mental Health Now Act HR 8295 Labor HHS FY23 Appropriations HR 6833 Continuing Appropriations Act of 2023 S 4747 Investing in Kids Mental Health Now Act S 4472 Health Care Capacity for Pediatric Mental Health General issues regarding mental health, physical health, Medicaid, CHIP, and DSH.

Client expense: $37,000 · Firm income: Not reported

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

HR 5- Equality Act HR 366- Protecting Access to Post-COVID-19 Telehealth Act of 2021 HR 1319- American Rescue Act of 2021 HR 1677- To Direct the Secretary of Health and Human Services, the Medicare Payment Advisory Commission... S 620 Keep Telehealth Options Act of 2021 HR 4502- Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act... S. 1544- Accelerating Kids' Access to Care Act HR 3089- Accelerating Kids' Access to Care Act HR 4943- The Children's Mental Health Infrastructure Act of 2021 HR 4944- The Helping Kids Cope Act of 2021 HR 4390- The PROTECT 340B Act HR 1916- Lasting Smiles Act HR 1397- The Telehealth Improvement for Kids' Essential Services HR 3783- Medical Nutrition Equity Act S 2013- Medical Nutrition Equity Act S 2691- Strengthening the Vaccines for Children Program Act of 2021 HR 2347- Strengthening the Vaccines for Children Program Act of 2021 HR 7236 Strengthen Kids' Mental Health Now Act HR 8295 Labor HHS FY23 Appropriations HR 6833 Continuing Appropriations Act of 2023 S 4747 Investing in Kids Mental Health Now Act S 4472 Health Care Capacity for Pediatric Mental Health General issues regarding mental health, physical health, Medicaid, CHIP, and DSH.

Client expense: $37,000 · Firm income: Not reported

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

Issue: Educate Congress and the administration on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Draft Graduate Medical Education Reform Act Issue: Support increased funding for the National Health Service Corps, Teaching Health Center GME, and National Disaster Medical Service (NDMS) demonstration pilot. Support increased Medicare support for Graduate Medical Education/physician training. Issues: Educate Congress and the administration about the role of academic medicine in the provision of mental and behavioral health care, including initiatives to respond to the opioid epidemic. Support measures to expand access to mental health care and substance use disorder treatment, including funding for training on substance use disorders, pain management, and safe prescribing practices, enhance enforcement of mental health parity laws, increased financial support for integrated behavioral health models, and the removal of regulatory barriers to telehealth-enabled mental health care, including electronic interprofessional consults (eConsults). Support Senate Finance Committee proposal to provide 400 additional Medicare-supported graduate medical education slots for psychiatry and psychiatry sub-specialties. H.R. 1384/ S.445 Mainstreaming Addiction Treatment (MAT) Act of 2021 Issue: Support suspension of waiver requirement for certain providers to prescribe buprenorphine. H.R. 2067 Medication Access and Training Expansion Act of 2021 Issue: Oppose legislative mandates dictating medical education curriculum on pain management and addiction. H.R. 7236 Strengthen Kids Mental Health Now Act Issue: Support increasing Medicaid reimbursement rates for pediatric mental health services through a 100% federal match. P.L. 116-22, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 Issues: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. Issue: Educate Congress on how the 340B Drug Pricing Program helps safety-net providers to fulfill their missions and care for patients and communities. Support measures to preserve and strengthen the 340B Drug Pricing Program and oppose efforts to reduce the scope of the program, including not providing 340B discounts on covered drugs purchased at community pharmacies. H.R. 4390 Preserving Rules Ordered for the Entities Covered Through 340B Act of 2021 (PROTECT 340B Act) Issue: Support measures to prevent pharmacy benefit managers and commercial insurers from discriminating against 340B covered entities. H.R. 3203/S. 773 Issue: Support policy to allow 340B DSH hospitals to remain eligible to participate in the program throughout the current public health emergency even if their DSH adjustment falls below the current threshold due to changes in payor mix as a result of the COVID-19 pandemic. Issue: Oppose insurance plans that do not meet Affordable Care Act requirements. Issue: Support increased interoperability and exchange of electronic health information and delayed enforcement of information blocking rule until comprehensive guidance is issued. Issue: Support the ongoing refinement of the two new mandatory alternative payment models, the Radiation Oncology Model and End-stage Renal Disease Treatment Choices Model, to better incentivize high-quality care for all patients. H.R. 4128/ S. 2209 Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 Issue: Educate Congress on development of Laboratory Developed Tests at academic medical centers and oppose policies that would increase burdensome regulations and negatively impact patients access to care by allowing Food and Drug Administration regulation of the development of Laboratory Developed Tests at academic medical centers. S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 H.R. 7667, Food and Drug Amendments of 2022 (FDA22) Issue: Support promotion of data sharing and clinical trials results reporting. Support increased clinical trials diversity. Issue: Development of Enhanced Primary Care Pilot Act proposal Issue: Support initiatives of hospitals to promote affordable housing in local communities and eliminate other social determinants of health to improve health equity. H.R. 2503 Social Determinants Accelerator Act of 2021 Issue: Support grants to address social determinants of health H.R. 7585 / S. 4486, Health Equity and Accountability Act Issue: Support programs to improve health equity and address social determinants of health. Issue: Support incentives to encourage the inclusion of implicit bias training in medical education and residency training. Issue: Support congressional investment in the Centers for Medicare and Medicaid Innovation (CMMI) models to reduce maternal mortality and improve maternal health. Issue: Support maternal health initiatives to expand coverage for postpartum women and expand demonstration project grants. H.R. 959 Black Maternal Health Momnibus Act of 2021 S. 1695 / H.R. 4387 Maternal Health Quality Improvement Act S. 1491/ H.R. 769 Rural MOMs Act H.R. 4387 Maternal Health Quality Improvement Act of 2021 H.R. 5376, Build Back Better Act H.R. 925 / S. 347 Data to Save Moms Act Issue: Support legislative efforts to improve maternal health and reduce rates of maternal mortality, including the Momnibus. Support legislative initiatives to improve data collection to improve maternal health equity. P.L. 117-159, Bipartisan Safer Communities Act Issue: Support policies to promote firearm safety, universal background checks, violence prevention programs, extreme risk protection orders, child access safety laws, reinstating assault weapons ban, data infrastructure, hospital based and community violence intervention programs, and programs to address mental and behavioral health impact of gun violence. Issue: Support funding for Community Violence Interventions/ Hospital Based Violence Intervention Programs P.L. 117-105, Dr. Lorna Breen Health Care Provider Protection Act Issue: Support grants directed at improving clinician burnout and well-being. Issue: Provide feedback on implementation of the Provider Relief Fund. Support extension for use of PRF funds. Issue: Support improvements to the Medicare Accelerated and Advance Payment Programs, including delaying recoupment of MAAP loans. Issue: Support extension of public health emergency declaration. Issue: Provide feedback on COVID-19 and pandemic response. Provide feedback on monkeypox response including testing. S. 3799, PREVENT Pandemics Act Issue: Provide feedback on pandemic preparedness legislation, urge inclusion of provisions to support academic medical centers preparedness activities. Issue: Support establishment of regional pandemic response centers, stronger linkages between public health and academic medicine, and the role of medical students and academic medical centers in administering COVID vaccines. H.R. 8131 Increasing Competition for Medical Residency Act Issue: Educate Congress on the medical education and training continuum, the annual residency Match, and the role of the National Resident Matching Program (NRMP) in medical education and residency. Issue: Support efforts of academic medical centers to respond to public health threats such as monkeypox and COVID-19. Urge establishment and implementation of robust national testing strategy; functional, redundant, and transparent supply chain; improved federal coordination; investments in public health and health care human and other resources; data modernization initiatives; and other actions to improve current and future pandemic response. H.R. 708, S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act Issue: Support for a temporary uniform licensing standard for all practitioners in all states throughout the COVID-19 public health emergency S. 674 Public Health Infrastructure Saves Lives Act Issue: Support investments in core public health infrastructure. Issue: Support ensuring patients are put first, that conscience protections align with medical professionalism standards, and oppose interference in the patient-physician relationship. Issue: Support increased interoperability and exchange of electronic health information. Support delay of enforcement beyond April 2021. H.R. 6000, Cures 2.0 Act Issue: Provide feedback on provisions related to public health, patients and caregivers, FDA, CMS, and research, and ARPA-H. Issue: Promote strategies to strengthen the health, public health, and research workforces. H.R. 3671, Doctors of Community Act Issue: Discuss authorization of the Teaching Health Center Graduate Medical Education program. Issue: Provide guidance on the implementation of the No Surprises Act. Issue: Provide feedback on proposed modifications to the HIPAA privacy rule. H.R. 5035, S. 2982 Child Suicide Prevention and Lethal Means Safety Act Issue: Support legislation to provide grants to improve suicide prevention and lethal means safety. Issue: Inform Congress and Administration about medical education on caring for older adults, nutrition, climate change, stigma around addiction, reproductive health, and accelerated medical education training programs. Issue: Provide feedback on efforts of the academic medicine community to address climate change and decarbonization. H.R. 7152/ S.3534, The Tracking Pathogens Act Issue: Support expansion of CDC activities related to genomic sequencing of pathogens. Issue: Support reignition of Cancer Moonshot. H.R. 7961 - Safety from Violence for Healthcare Employees (SAVE) Act Issue: Support statutory protections against violence and intimidation for healthcare workers and provide grants for hospital programs aimed at preventing violence in healthcare settings. Issue: Support a one-year pause in military medical billet reductions in the Military Health System.

Client expense: $912,077 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of the Vice President of the United States, SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot

Client expense: $850,000 · Firm income: Not reported

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

COPE Act of 2019, H.R. 1528; American Rescue Plan, importance of 340B drug pricing program; Provider status for pharmacists; surprise medical billing in general; sustainability of safety net health systems; social determinants of health; promoting coordinated care; Coronavirus Preparedness and Response Supplemental Appropriations (CPRSA) Act; The Consolidated Appropriations Act of 2021; the Families First Coronavirus Response Act (14k CRA); the Coronavirus Aid, Relief, and Economic Security (CARES) Act - issues regarding patient care, Provider Relief Funds; and H.R. 266/P.L. 116-139, the Health Care Enhancement Act - provisions related to Public Health and Social Services Emergency Fund; and FCC's COVID-19 Telehealth Program; support of telehealth policies, including for audio-only telehealth services; Hill-Burton funding for front line safety net hospitals in H.R. 5376; within H.R. 5376 impact of pharmaceutical pricing policies on 340B drug discount program; S. 3799 PREVENT Pandemics Act - social determinants of health provisions; 340B Protect Act, H.R. 4390.

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

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

Issues related to hemophilia treatments, specialty pharmacies and the 340B drug purchasing program Protect 340B Act (HR 4390) Prescription Drug User Fee Amendments Citizens Petition regarding gene therapy in hemophilia

Client expense: Not reported · Firm income: $51,000

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

Affordable Care Act implementation Coverage of hemophilia treatments and services in private insurance plans, including alternative funding model Comments on future rulemaking for the 2024 Notice on Benefit and Payment Parameters The HELP Copays Act (HR 5801) The Protect 340B Act (HR 4390) Private insurance policies that discriminate coverage for high cost drugs and use of patient assistance programs, also known as the (Alternative Payment Model)

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

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

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

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

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

S 2428 False Claims Amendments Act of 2021 (all sections of full text) Discussions involving Medicare sequestration Discussions pertaining to CMS rulemaking on surprise billing ban Discussions involving CMS proposed Physician Fee Schedule S 748 Medicare Sequester Relief Act (all sections of full text) HR 2547 Comprehensive Debt Collection Improvement Act (all sections of full text) S 3593 Telehealth Extension and Evaluation Act (all sections of full text) HR 4390 PROTECT 340B Act of 2021 (all sections of full text)(support) Discussions involving 340B Drug Pricing Program P.L. 117-169 Inflation Reduction Act of 2022; discussions involving the extension of ACA subsidies through 2025 Monitored CFPB actions that may limit providers ability to recoup patient medical debt Monitored S 2061 Telemental Health Care Access Act of 2021 Monitored HR 4058 Telemental Health Care Access Act of 2021 Monitored S 368 Telehealth Modernization Act Monitored HR 1332 Telehealth Modernization Act Monitored S 155 Equal Access to Care Act Monitored HR 688 Equal Access to Care Act Monitored discussions pertinent to health care group purchasing organizations (GPOs) Monitored Executive Branch action reports and consultations associated with Executive Order 14017 on America's supply chains Monitored nominations to executive branch agencies and federally authorized commissions Monitored CMS price transparency rule for hospitals, Public Health Service Act Section 2718(e)

Client expense: Not reported · Firm income: $100,000

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

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act; H.R. 6000, Cures 2.0 Act; H.R. 6519, Patients Right to Know Their Medication Act of 2022; Draft legislation, Pharmacy Price Transparency Protection Act; H.R. 7559, Prescription Information Modernization Act; Draft legislation, To ensure that private health insurers are able to provide appropriate oversight of entities providing pharmacy benefit manager services

Client expense: $400,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

Teaching Health Centers; Nurse Corps; National Health Service Corps; 340B Drug Discount Program; Community Health Center Program; Telehealth Reform; Healthcare Workforce Programs; Health center infrastructure funding; H.R. 4390 PROTECT 340B Act; S.958/H.R.5141 MOBILE Health Care Act; S. 3569 HELP for Volunteers Act; S. 3799 PREVENT Pandemics Act; H.R. 7383/S. 201 Improving Access to Health Care in Rural and Underserved Areas Act; H.R. 5365 Primary Health Services Enhancement Act; H.R. 8151 Building a Sustainable Workforce for Healthy Communities Act; H.R. 7876 Connecting Rural Telehealth To the Future Act; H.R. 7666 Restoring Hope for Mental Health and Well-Being Act of 2022; Federal Tort Claims Act Volunteer Malpractice Coverage; and behavioral and mental health policy; and climate change policy.

Client expense: $240,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office