Drug Shortages Shelf Life Extension Act

H.R. 5487 - Value in Health Care Act of 2021 S. 2652 / H.R. 5067 - Preserving Patient Access to Home Infusion Act S.308 / H.R.1436 - PPE in America Act S.1260 - United States Innovation and Competition Act of 2021 S. 936 / H.R. 5502 - INFORM Consumers Act S. 2648 - Rural ACO Improvement Act S. 1574 / H.R.5632 - Long-Term Care Pharmacy Definition Act S. 834 / H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 H.R.3173 / S 3018 - Improving Seniors Timely Access to Care Act of 2021 H.R. 3746 - Accountable Care in Rural America Act H.R. 959 / S. 364 - Black Maternal Health Momnibus Act of 2021 H.R. 4387 / S. 1675 - Maternal Health Quality Improvement Act of 2021 S. 168 / H.R. 708 - Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act S. 150 - Ensuring Parity in MA for Audio Only-Telehealth Act S. 3146 - The Protecting Patients from Counterfeit Medical Devices Act S. 3799 - The PREVENT Pandemics Act H.R. 6520 - The Medical and Health Stockpile Accountability Act of 2022, automated data collection infrastructure for healthcare supply chain S. 3416 - The Protecting Patients from Counterfeit Medical Devices Act S. 3493 - Drug Shortages Shelf Life Extension Act H.R. 4521 - America COMPETES Act of 2022 S.610 - Protecting Medicare and American Farmers from Sequester Cuts Act H.R.3684 - Infrastructure Investment and Jobs Act H.R. 4735 / S. 2493 - The Provider Relief Extension Act H.R. 3589 - Better Way for Providers To Repay Act of 2021 H.R. 3203 / S. 773 - To allow hospitals that were participating in or applied for the 340B drug discount program before the public health emergency to temporarily maintain eligibility H.R. 7961 - Safety from Violence for Healthcare Employees (SAVE) Act H.R. 7410 - The American Made Medicine Act H.R. 7053/S. 3792 - Hospital Inpatient Services Modernization Act H.R. 8747 - Assistance for Rural Community Hospitals (ARCH) Act H.R. 8800 - Supporting Medicare Providers Act of 2022 H.R. 4040 - Advancing Telehealth Beyond COVID-19 Act FY 2022 Omnibus Appropriations Bill S. 5249 - Preserving Patient Access to Value-Based Care Act 340B Drug Discount Program eligbility Incentivize Domestic Manufacturing Hospital Infrastructure Support FDA User Fee Reauthorization Bills Healthcare workforce (Graduate medical education , health professional training programs, recruitment and retension incentives) Medicare provider payment cuts (Medicare sequestration cuts, physician fee schedule 3.75% reduction due to evaluation & management code increases/budget neturality adjustment, Pay-as-You-Go reductions due to American Rescue Plan) Climate change healthcare impact HHS FY 2023 appropriations - Removal of a ban on using federal funds for implementing a unique patient identification system (Section 510) and fuding for Childrens Hospitals Graduate Medical Education (CHGME) Program ACO Assignment Bill NQF/Quality Measurement funding authorization Preparing for the next pandemic and supply chain resiliency

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

The Child Nutrition Reauthorization Act Precautionary Allergen Labels Labeling Medicine S. 3493, H.R. 7669, Drug Shortages Shelf Life Extension Act Appropriations requests for increased federal research and safer schools

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

Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Affordable prescription drugs; 340B Drug pricing program; Health care privacy; Patient privacy issues; Issues related to the American Rescue Plan Act, PL 117-2; Issues related to expanding health care coverage, including in non-Medicaid expansion states; Issues related to improving social determinants of health; Issues related to extending and expanding flexibilities for virtual care; Financial support for providers for diagnosis and treatment related to COVID-19, coverage of COVID-19 related conditions, access to PPE and other materials and equipment related to the treatment of patients with COVID-19, including funding for the Provider Relief Fund; Issues related to affordable health care coverage; H.R. 2228 - Rural Behavioral Health Access Act; Issues related to drug pricing; Issues related to Bipartisan Infrastructure Framework; Issues related to telehealth; Efforts to extend Medicare sequester delay, including H.R.1868; Issues related to Medicare policy on virtual care; Issues related to vaccine mandates; S. 168/H.R. 708 - Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S. 773/H.R. 3203 - Legislation related to 340B eligibility; S. 834/H.R. 2256 - Resident Physician Shortage Reduction Act; S. 834/H.R. 2256 - Healthcare Workforce Resilience Act; S. 368/H.R. 1332 - Telehealth Modernization Act ; S. 1512/H.R. 2903 - CONNECT for Health Act; S. 1988 - Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; S.773/H.R. 3203 - 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; H.R. 4943 - Childrens Mental Health Infrastructure Act; H.R. 4944 - Helping Kids Cope Act; H.R. 5376 - Build Back Better Act; H.R. 1667 - Dr. Lorna Breen Health Care Provider Protection Act; Issues related to workforce retention; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act; H.R. 7053/S. 3792 - Hospital Inpatient Services Modernization Act; issues related to the Acute Hospital Care at Home (AHCAH) waiver; H.R. 4407/S. 1568 - Technical Reset to Advance the Instruction of Nurses (TRAIN) Act; S. 3493 - Telehealth Extension and Evaluation Act; H.R. 6202 - Telehealth Extension Act; H.R. 5376 - Inflation Reduction Act (Public Law 117-169); H.R. 6833 - Continuing Resolution; Issues related to adequate financing for hospitals and providers; H.R. 4040 - Advancing Telehealth Beyond COVID-19 Act; Issues related to extending the Medicare Dependent Hospital and Low Volume Hospital programs; Issues related to extending bonus payments for Advanced Alternative Payment models; H.R. 4587 - Value in Health Care Act; Issues related to coding and coverage of spiritual care through chaplain services; Issues related to value-based care programs, including the Bundled Payments for Care Improvement (BPCI) Advanced Model

Issues related to Medicare and Medicaid coverage and Medicaid disproportionate share program; Financial support for providers for diagnosis and treatment related to COVID-19; coverage of COVID-19 related conditions; access to PPE and other materials and equipment related to the treatment of patients with COVID-19, including funding for the Provider Relief Fund; PL 117-2; Issues related to Bipartisan Infrastructure Framework; Issues related to telehealth; Efforts to extend Medicare sequester delay, including H.R.1868; Issues related to Medicare policy on virtual care; Childrens Health Graduate Medical Education; issues related to drug pricing; Issues related to hospital DSH eligibility; Issues related to Home and Community Based Services (HCBS); Medicaid waiver-related issues; Childrens transplant program issues; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S.773/H.R. 3203 - legislation 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; S. 834/H.R. 2256 - Resident Physician Shortage Reduction Act; S. 1024/H.R. 2255 - Healthcare Workforce Resilience Act; S. 368/H.R. 1332 - Telehealth Modernization Act; S. 1512/H.R. 2903 - CONNECT for Health Act ; S. 1988 - Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 5376 - Build Back Better Act; Efforts to delay statutory PAYGO payment reductions; Efforts to offset physician payment reductions; Efforts to improve hospital reimbursement; Issues related to cuts to Medicaid DSH; Issues related to cuts to uncompensated care pools; Issues related to hospital at home programs; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act; H.R. 7053/S. 3792 - Hospital Inpatient Services Modernization Act; issues related to the Acute Hospital Care at Home (AHCAH) waiver; S. 3493 - Telehealth Extension and Evaluation Act; H.R. 6202 - Telehealth Extension Act; H.R. 5376 - Inflation Reduction Act (Public Law 117-169); H.R. 6833 - Continuing Resolution; Issues related to adequate financing for hospitals and providers; H.R. 4040 - Advancing Telehealth Beyond COVID-19 Act; Issues related to extending the Medicare Dependent Hospital and Low Volume Hospital programs; Issues related to extending bonus payments for Advanced Alternative Payment models; H.R. 4587 - Value in Health Care Act; Issues related to coding and coverage of spiritual care through chaplain services; Issues related to value-based care programs, including the Bundled Payments for Care Improvement (BPCI) Advanced Model

Healthcare Supply Chain - Highlighted the important role played by hospital group purchasing organizations in promoting resiliency and value in healthcare purchasing. Provided information on ongoing efforts to reduce greenhouse gas emissions and support environmentally preferred sourcing for healthcare supplies. Engaged to support policies to ensure greater transparency and mitigate or limit shortages of prescription drugs. Supported policies that would expedite critical cargo, including cargo necessary for medical care, during a public health emergency or disaster. Food and Drug Administration User Fee Amendments - Supported passage of legislation to extend user-fee authorities ((S. 4348, H.R.7667, H.R. 6833). Advocated for greater transparency in the health care supply chain for drugs and medical devices. Supported updating language related to the Unapproved Drugs Initiative, and incorporating the PASTUER Act (S.2076) and the PATCH Act (H.R. 7084) in final passage. Inflation Reduction Act (H.R. 5376) - Supported extension of enhanced subsidies through the health insurance marketplace. Supported provisions that would increase reimbursement for biosimilar medications and monitored impact of other policies impacting prices of prescription drugs. Public Health Emergency - Advocated for HHS to further extend the declared Public Health Emergency. Telehealth - Supported efforts to make telehealth flexibilities offered during COVID-19 Public Health Emergency permanent. Supported CONNECT for Health Act (S. 1512/H.R. 2903) and the Extending Telehealth Beyond COVID-19 Act (H.R. 4040). Encouraged reimbursement parity for certain telehealth services and support for audio-only telehealth services. Health Care Workforce - Urged passage of the Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708; S. 168); The Health Care Workforce Resilience Act (S. 1024/H.R. 2255); The Resident Physician Shortage Reduction Act (S.834/H.R. 2256). The Opioid Workforce Act (S. 1438/H.R. 3441). Urged administration to examine practices of health care staffing agencies. Supported passage of the Travel Nursing Agency Transparency Study Act (S. 4352). Supported passage of the Safety from Violence for Healthcare Employees Act (H.R. 7961). Prepare for and Respond to Existing Viruses, Emerging New Threats, and (PREVENT) Pandemics Act (S. 3799) - monitored PREVENT Pandemics Act and supported inclusion of provisions to improve supply chain transparency and extend shelf life of prescription drugs. Supported passage of the Integrity, Notification, Fairness in Online Retail Marketplaces (INFORM) Consumers Act (S. 963/H.R. 5502). 340B Drug Pricing Program - Urged HHS to enforce guidance that would allow 340B Covered Entities to utilize contract pharmacies. Social Determinants of Health and Health Equity - Shared insights and offered suggestions to CMS regarding health equity measurement, indices and data collection. Supported the Social Determinants Accelerator Act (H.R. 2503; S. 3039); The LINC to Address Social Needs Act (S. 509). Antimicrobial resistance (S. 2076) - Supported passage of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. Supported passage of Opioid Treatment Access Act (S. 3629/H.R. 6279). Supported passage of Drug Shortage Shelf Life Extension Act (S. 3493). Supported passage of the Hospital Inpatient Services Modernization Act (S. 3792/H.R. 7053).

H.R. 5487 - Value in Health Care Act of 2021 S. 2652/H.R. 5067 - Preserving Patient Access to Home Infusion Act H.R. 6520 - The Medical and Health Stockpile Accountability Act of 2022, automated data collection infrastructure for healthcare supply chain S.308 / H.R.1436 - PPE in America Act S.1260 - United States Innovation and Competition Act of 2021 S. 936 / H.R. 5502 - INFORM Consumers Act S. 2648 - Rural ACO Improvement Act S. 1574/H.R.5632 - Long-Term Care Pharmacy Definition Act H.R. 7053/S. 3792 - Hospital Inpatient Services Modernization Act S. 834 / H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 H.R.3173 / S 3018 - Improving Seniors Timely Access to Care Act of 2021 H.R. 3746 - Accountable Care in Rural America Act H.R. 959 / S. 364 - Black Maternal Health Momnibus Act of 2021 H.R. 4387 / S. 1675 - Maternal Health Quality Improvement Act of 2021 S. 168 / H.R. 708 - Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act S. 150 - Ensuring Parity in MA for Audio Only-Telehealth Act S. 3799 - The PREVENT Pandemics Act S. 3416 - The Protecting Patients from Counterfeit Medical Devices Act S. 3493 - Drug Shortages Shelf Life Extension Act H.R. 4521 - America COMPETES Act of 2022 S.610 - Protecting Medicare and American Farmers from Sequester Cuts Act H.R.3684 - Infrastructure Investment and Jobs Act H.R. 4735/S. 2493 - The Provider Relief Extension Act H.R. 3589 - Better Way for Providers To Repay Act of 2021 H.R. 3203 / S. 773 - To allow hospitals that were participating in or applied for the 340B drug discount program before the public health emergency to temporarily maintain eligibility H.R. 7961 - Safety from Violence for Healthcare Employees (SAVE) Act H.R. 7410 - The American Made Medicine Act Hospital Infrastructure Support FDA User Fee Reauthorization Bills Healthcare workforce (Graduate medical education , health professional training programs, recruitment and retention incentives) Medicare provider payment cuts (Medicare sequestration cuts, physician fee schedule 3% reduction due to evaluation & management code increases/budget neutrality adjustment, Pay-as-You-Go reductions due to American Rescue Plan) HHS FY 2023 appropriations - Removal of a ban on using federal funds for implementing a unique patient identification system (Section 510) and funding for Childrens Hospitals Graduate Medical Education (CHGME) Program NQF/Quality Measurement funding authorization

The Child Nutrition Reauthorization Act Precautionary Allergen Labels Labeling Medicine S. 3493, H.R. 7669, Drug Shortages Shelf Life Extension Act Appropriations requests for increased federal research and safer schools The White House Conference on Nutrition and Hunger

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

Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office

Health Care Supply Chain - Advocated for the importance of hospital group purchasing organizations, and highlighted role in supporting supply chain resiliency to secure essential, authentic medical supplies for hospitals throughout the course of the COVID-19 pandemic. Supported adoption of effort to reduce greenhouse gas emissions and environmentally preferred sourcing for health care supplies. Engaged to support policies to limit shortages of prescription drugs. Advocated for greater transparency in the health care supply chain for drugs and medical devices. Build Back Better Act (H.R. 5376) - Supported policies to encourage health care coverage and close the Medicaid coverage gap. Public Health Emergency - Advocated for HHS to further extend the declared Public Health Emergency. Telehealth - Supported efforts to make telehealth flexibilities offered during COVID-19 Public Health Emergency permanent. Supported CONNECT for Health Act (S. 1512/H.R. 2903) and encouraged reimbursement parity for certain telehealth services and support for audio-only telehealth services. Health Care Workforce - Urged passage of the Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708; S. 168); The Health Care Workforce Resilience Act (S. 1024/H.R. 2255); The Dr. Lorna Breen Health Care Provider Protection Act (S.610/H.R. 1667); The Resident Physician Shortage Reduction Act (S.834/H.R. 2256). The Opioid Workforce Act (S. 1438/H.R. 3441). Urged administration to examine practices of health care staffing agencies. Supported passage of the Travel Nursing Agency Transparency Study Act (S. 4352). Supported passage of the Safety from Violence for Healthcare Employees Act (H.R. 7961). Prepare for and Respond to Existing Viruses, Emerging New Threats, and (PREVENT) Pandemics Act (S. 3799) - monitored Senate Committee adoption of PREVENT Pandemics Act. Supported inclusion of provisions to improve supply chain transparency and extend shelf life of prescription drugs. Supported passage of the Integrity, Notification, Fairness in Online Retail Marketplaces (INFORM) Consumers Act (S. 963/H.R. 5502). 340B Drug Pricing Program - Urged HHS to enforce guidance that would allow 340B Covered Entities to utilize contract pharmacies. Food and Drug Administration User Fees (S. 4348, H.R.7667) - Urged inclusion of provisions in FDA user fee legislation to provide greater authorities for the FDA to promote supply chain transparency, clarifying language related to the Unapproved Drugs Initiative, the PASTUER Act (S.2076) and the PATCH Act (H.R. 7084). Social Determinants of Health and Health Equity - Shared insights and offered suggestions to CMS regarding health equity measurement, indices and data collection. Supported the Social Determinants Accelerator Act (H.R. 2503; S. 3039); The LINC to Address Social Needs Act (S. 509). Antimicrobial resistance (S. 2076) - Supported passage of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. Supported passage of Opioid Treatment Access Act (S. 3629/H.R. 6279). Supported passage of Drug Shortage Shelf Life Extension Act (S. 3493).

H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) 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. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) 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. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 4127: DISARM Act - Provisions related to antimicrobial drug development 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. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies 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 and 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. 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. 7035: Biologics Market Transparency 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. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes 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. 912/H.R. 1978: Protecting Seniors Through Immunization Act 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. 1463: Modernizing Therapeutic Equivalence Rating Determination Act 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. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising 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 2938 - Bipartisan Safer Communities Act - budget offset provisions related to Rebate Rule S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications 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 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 High deductible health plans/HSA and FSA for dietary supplements policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization 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 Dietary Supplement Health and Education Act Reform 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 Veterans' Affairs issues related to product sampling Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022

H.R. 5: Equality Act H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments 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. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Projects 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. 7035: Biologics Market Transparency 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. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes 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. 1463: Modernizing Therapeutic Equivalence Rating Determination Act 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. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising 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. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications 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 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 High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization 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

Issues related to Medicare and Medicaid coverage and Medicaid disproportionate share program; Financial support for providers for diagnosis and treatment related to COVID-19; coverage of COVID-19 related conditions; access to PPE and other materials and equipment related to the treatment of patients with COVID-19, including funding for the Provider Relief Fund; PL 117-2; Issues related to Bipartisan Infrastructure Framework; Issues related to telehealth; Efforts to extend Medicare sequester delay, including H.R.1868; Issues related to Medicare policy on virtual care; Childrens Health Graduate Medical Education; issues related to drug pricing; Issues related to hospital DSH eligibility; Issues related to Home and Community Based Services (HCBS); Medicaid waiver-related issues; Childrens transplant program issues; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S.773/H.R. 3203 - legislation 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; S. 834/H.R. 2256 - Resident Physician Shortage Reduction Act; S. 1024/H.R. 2255 - Healthcare Workforce Resilience Act; S. 368/H.R. 1332 - Telehealth Modernization Act; S. 1512/H.R. 2903 - CONNECT for Health Act ; S. 1988 - Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 5376 - Build Back Better Act; Efforts to delay statutory PAYGO payment reductions; Efforts to offset physician payment reductions; Efforts to improve hospital reimbursement; Issues related to cuts to Medicaid DSH; Issues related to cuts to uncompensated care pools; Issues related to hospital at home programs; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act; H.R. 7053/S. 3792 - Hospital Inpatient Services Modernization Act; issues related to the Acute Hospital Care at Home (AHCAH) waiver; S. 3493 - Telehealth Extension and Evaluation Act; H.R. 6202 - Telehealth Extension Act; Issues related to coverage of spiritual care as a supplemental benefit under Medicare Advantage plans

Affordable prescription drugs; 340B Drug pricing program; Health care privacy; Patient privacy issues; Issues related to the American Rescue Plan Act, PL 117-2; Issues related to expanding health care coverage, including in non-Medicaid expansion states; Issues related to improving social determinants of health; Issues related to extending and expanding flexibilities for virtual care; Financial support for providers for diagnosis and treatment related to COVID-19, coverage of COVID-19 related conditions, access to PPE and other materials and equipment related to the treatment of patients with COVID-19, including funding for the Provider Relief Fund; Issues related to affordable health care coverage; H.R. 2228 - Rural Behavioral Health Access Act; Issues related to drug pricing; Issues related to Bipartisan Infrastructure Framework; Issues related to telehealth; Efforts to extend Medicare sequester delay, including H.R.1868; Issues related to Medicare policy on virtual care; Issues related to vaccine mandates; S. 168/H.R. 708 - Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S. 773/H.R. 3203 - Legislation related to 340B eligibility; S. 834/H.R. 2256 - Resident Physician Shortage Reduction Act; S. 834/H.R. 2256 - Healthcare Workforce Resilience Act; S. 368/H.R. 1332 - Telehealth Modernization Act ; S. 1512/H.R. 2903 - CONNECT for Health Act; S. 1988 - Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; S.773/H.R. 3203 - 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; H.R. 4943 - Childrens Mental Health Infrastructure Act; H.R. 4944 - Helping Kids Cope Act; H.R. 5376 - Build Back Better Act ; H.R. 1667 - Dr. Lorna Breen Health Care Provider Protection Act; Issues related to workforce retention; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act; H.R. 7053/S. 3792 - Hospital Inpatient Services Modernization Act; issues related to the Acute Hospital Care at Home (AHCAH) waiver; H.R. 4407/S. 1568 - Technical Reset to Advance the Instruction of Nurses (TRAIN) Act; S. 3493 - Telehealth Extension and Evaluation Act; H.R. 6202 - Telehealth Extension Act; Issues related to coverage of spiritual care as a supplemental benefit under Medicare Advantage plans

H.R. 5487 - Value in Health Care Act of 2021 S. 2652/H.R. 5067 - Preserving Patient Access to Home Infusion Act S.308 / H.R.1436 - PPE in America Act S.1260 - United States Innovation and Competition Act of 2021 S. 936 / H.R. 5502 - INFORM Consumers Act S. 2648 - Rural ACO Improvement Act S. 1574/H.R.5632 - Long-Term Care Pharmacy Definition Act S. 834 / H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 H.R.3173 / S 3018 - Improving Seniors Timely Access to Care Act of 2021 H.R. 3746 - Accountable Care in Rural America Act H.R. 959 / S. 364 - Black Maternal Health Momnibus Act of 2021 H.R. 4387 / S. 1675 - Maternal Health Quality Improvement Act of 2021 S. 168 / H.R. 708 - Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act S. 150 - Ensuring Parity in MA for Audio Only-Telehealth Act S. 3146 - The Protecting Patients from Counterfeit Medical Devices Act S. 3799 - The PREVENT Pandemics Act H.R. 6520 - The Medical and Health Stockpile Accountability Act of 2022, automated data collection infrastructure for healthcare supply chain S. 3416 - The Protecting Patients from Counterfeit Medical Devices Act S. 3493 - Drug Shortages Shelf Life Extension Act H.R. 4521 - America COMPETES Act of 2022 S.610 - Protecting Medicare and American Farmers from Sequester Cuts Act H.R.3684 - Infrastructure Investment and Jobs Act H.R. 4735/S. 2493 - The Provider Relief Extension Act H.R. 3589 - Better Way for Providers To Repay Act of 2021 H.R. 3203 / S. 773 - To allow hospitals that were participating in or applied for the 340B drug discount program before the public health emergency to temporarily maintain eligibility HHS FY 2023 appropriations - Removal of a ban on using federal funds for implementing a unique patient identification system (Section 510) and funding for Childrens Hospitals Graduate Medical Education (CHGME) Program 340B Drug Discount Program eligibility Incentivize Domestic Manufacturing Hospital Infrastructure Support FDA User Fee Reauthorization Bills Healthcare workforce (Graduate medical education , health professional training programs, recruitment and retention incentives) Medicare provider payment cuts (Medicare sequestration cuts, physician fee schedule 3.75% reduction due to evaluation & management code increases/budget neutrality adjustment, Pay-as-You-Go reductions due to American Rescue Plan)

The Child Nutrition Reauthorization Act Precautionary Allergen Labels Labeling Medicine S. 3493, H.R. 7669, Drug Shortages Shelf Life Extension Act Appropriations requests for increased federal research and safer schools

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

Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

The Child Nutrition Reauthorization Act Precautionary Allergen Labels Labeling Medicine S. 3493, Drug Shortages Shelf Life Extension Act Appropriations requests for increased federal research and safer schools

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

Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Issues related to Medicare and Medicaid coverage and Medicaid disproportionate share program; Financial support for providers for diagnosis and treatment related to COVID-19; coverage of COVID-19 related conditions; access to PPE and other materials and equipment related to the treatment of patients with COVID-19, including funding for the Provider Relief Fund; PL 117-2; Issues related to Bipartisan Infrastructure Framework; Issues related to telehealth; Efforts to extend Medicare sequester delay, including H.R.1868; Issues related to Medicare policy on virtual care; Childrens Health Graduate Medical Education; issues related to drug pricing; Issues related to hospital DSH eligibility; Issues related to Home and Community Based Services (HCBS); Medicaid waiver-related issues; Childrens transplant program issues; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S.773/H.R. 3203 - legislation 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; S. 834/H.R. 2256 - Resident Physician Shortage Reduction Act; S. 1024/H.R. 2255 - Healthcare Workforce Resilience Act; S. 368/H.R. 1332 - Telehealth Modernization Act; S. 1512/H.R. 2903 - CONNECT for Health Act ; S. 1988 - Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 5376 - Build Back Better Act Efforts to delay statutory PAYGO payment reductions; Efforts to offset physician payment reductions; Issues related to cuts to Medicaid DSH; Issues related to cuts to uncompensated care pools; Issues related to hospital at home programs; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act; H.R. 7053/S. 3792 - Hospital Inpatient Services Modernization Act; issues related to the Acute Hospital Care at Home (AHCAH) waiver; S. 3493 - Telehealth Extension and Evaluation Act; H.R. 6202 - Telehealth Extension Act; Issues related to coverage of spiritual care as a supplemental benefit under Medicare Advantage plans

Affordable prescription drugs; 340B Drug pricing program; Health care privacy; Patient privacy issues; Issues related to the American Rescue Plan Act, PL 117-2; Issues related to expanding health care coverage, including in non-Medicaid expansion states; Issues related to improving social determinants of health; Issues related to extending and expanding flexibilities for virtual care; Financial support for providers for diagnosis and treatment related to COVID-19, coverage of COVID-19 related conditions, access to PPE and other materials and equipment related to the treatment of patients with COVID-19, including funding for the Provider Relief Fund; Issues related to affordable health care coverage; H.R. 2228 - Rural Behavioral Health Access Act; Issues related to drug pricing; Issues related to Bipartisan Infrastructure Framework; Issues related to telehealth; Efforts to extend Medicare sequester delay, including H.R.1868; Issues related to Medicare policy on virtual care; Issues related to vaccine mandates; S. 168/H.R. 708 - Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S. 773/H.R. 3203 - Legislation related to 340B eligibility; S. 834/H.R. 2256 - Resident Physician Shortage Reduction Act; S. 834/H.R. 2256 - Healthcare Workforce Resilience Act; S. 368/H.R. 1332 - Telehealth Modernization Act ; S. 1512/H.R. 2903 - CONNECT for Health Act; S. 1988 - Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; S.773/H.R. 3203 - 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; H.R. 4943 - Childrens Mental Health Infrastructure Act; H.R. 4944 - Helping Kids Cope Act; H.R. 5376 - Build Back Better Act ; H.R. 1667 - Dr. Lorna Breen Health Care Provider Protection Act; Issues related to workforce retention; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act; H.R. 7053/S. 3792 - Hospital Inpatient Services Modernization Act; issues related to the Acute Hospital Care at Home (AHCAH) waiver; H.R. 4407/S. 1568 - Technical Reset to Advance the Instruction of Nurses (TRAIN) Act; S. 3493 - Telehealth Extension and Evaluation Act; H.R. 6202 - Telehealth Extension Act; Issues related to coverage of spiritual care as a supplemental benefit under Medicare Advantage plans

Build Back Better Act (H.R. 5376) - Supported policies to encourage health care coverage and close the Medicaid coverage gap. Urged additional pandemic financial support for hospitals. Advocated for investments for hospitals and health care providers, including physical structure improvements, workforce and graduate medical education support. Public Health Emergency - Advocated for HHS to further extend the declared Public Health Emergency. Telehealth -Supported provisions in the Consolidated Appropriations Act, 2022 (H.R. 2471) to temporarily extend certain flexibilities after the end of the public health emergency. Supported passage of the CONNECT for Health Act (S. 1512/H.R. 2903) to make telehealth flexibilities permanent. Encouraged reimbursement parity for certain telehealth services and support for audio-only telehealth services. Health Care Workforce - Urged passage of the Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708; S. 168); The Health Care Workforce Resilience Act (S. 1024/H.R. 2255); The Dr. Lorna Breen Health Care Provider Protection Act (S.610/H.R. 1667); The Resident Physician Shortage Reduction Act (S.834/H.R. 2256). The Opioid Workforce Act (S. 1438/H.R. 3441). Urged administration to examine practices of health care staffing agencies. Health Care Supply Chain - Advocated for the importance of hospital group purchasing organizations, and highlighted role in supporting supply chain resiliency to secure essential, authentic medical supplies for hospitals throughout the course of the COVID-19 pandemic. Engaged to support policies to limit shortages of prescription drugs. Advocated for greater transparency in the health care supply chain for drugs and medical devices. Prepare for and Respond to Existing Viruses, Emerging New Threats, and (PREVENT) Pandemics Act (S. 3799) - monitored introduction of PREVENT Pandemics Act. Supported inclusion of provisions to improve supply chain transparency and extend shelf life of prescription drugs. Supported passage of the Integrity, Notification, Fairness in Online Retail Marketplaces (INFORM) Consumers Act (S. 963/H.R. 5502). Provider Relief Fund - Urged HHS and Congress to offer greater flexibility and extend deadlines for hospitals to utilize PRF funding and provide clear guidance on reporting expectations. Supported Provider Relief Deadline Extension Act (S. 2493) and Provider Relief Fund Improvement Act (H.R. 5963/S.3611). Drug Pricing - Reviewed options to further support modifications to the unapproved drugs initiative that would prevent or limit price increases for older, unapproved drugs. Supported changes to the 340B program and urged HHS to enforce guidance that would allow 340B Covered Entities to utilize contract pharmacies. Advocated for HHS to offer additional 340B Drug Pricing Program eligibility flexibility for hospitals that have had patient mix changed during the COVID-19 public health emergency (S. 773). Supported inclusion of provisions in Consolidated Appropriations Act, 2022 (H.R. 2471) that would extend eligibility for covered entities that may have lost eligibility during the public health emergency. Medical Device User Fee Amendments - Urged greater authorities for the FDA to promote supply chain transparency. Generic Drug User Fee Amendments - Supported rapid adoption of generic drug user fee amendments, and urged inclusion of clarifying language related to the Unapproved Drugs Initiative and the PASTUER Act (S.2076). Social Determinants of Health and Health Equity - Shared insights and offered suggestions to CMS regarding health equity measurement, indices and data collection. Supported the Social Determinants Accelerator Act (H.R. 2503; S. 3039); The LINC to Address Social Needs Act (S. 509). Antimicrobial resistance (S. 2076) - Supported passage of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. Supported passage of Opioid Treatment Access Act (S. 3629/H.R. 6279). Supported passage of Drug Shortage Shelf Life Extension Act (S. 3493).

a. Incentivize Domestic Manufacturing b. Hospital Infrastructure Support c. H.R. 5487 - Value in health Care Act of 2021 d. S. 2652/H.R. 5067 - Preserving Patient Access to Home Infusion Act e. S.308/H.R.1436 - PPE in America Act f. S.1260 - United States Innovation and Competition Act of 2021 g. S. 936 / H.R. 5502 - INFORM Consumers Act h. S. 2648 - Rural ACO Improvement Act i. S. 1574/H.R.5632 - Long-Term Care Pharmacy Definition Act j. S. 834 / H.R. 2256 - Resident Physician Shortage Reduction Act of 2021 k. H.R.3173 S 3018 - Improving Seniors Timely Access to Care Act of 2021 l. H.R. 3746 - Accountable Care in Rural America Act m. H.R.1319 - American Rescue Plan Act of 2021 n. H.R. 959 / S. 364 - Black Maternal Health Momnibus Act of 2021 o. H.R. 4387 / S. 1675 - Maternal Health Quality Improvement Act of 2021 p. S. 168 / H.R. 708 - Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act q. S. 150 - Ensuring Parity in MA for Audio Only-Telehealth Act r. 340B Drug Discount Program eligbility t. Healthcare workforce (Graduate medical education , health professional training programs, recruitment and retension incentives) u. Medicare provider payment cuts (Medicare sequestration cuts, physician fee schedule 3.75% reduction due to evaluation & management code increases/budget neturality adjustment, Pay-as-You-Go reductions due to American Rescue Plan) v. Automated data collection infrastructure for healthcare supply chain w. S. 3146 - The Protecting Patients from Counterfeit Medical Devices Act x. S. 3799 - The PREVENT Pandemics Act y. H.R. 650 - The Medical and Health Stockpile Accountability Act of 2022 z. S. 3416 - The Protecting Patients from Counterfeit Medical Devices Act aa. S. 3493 - Drug Shortages Shelf Life Extension Act ab. H.R. 4521 - America COMPETES Act of 2022 ac. H.R.5376 - Build Back Better Act ad. S.610 - Protecting Medicare and American Farmers from Sequester Cuts Act ae. H.R.3684 - Infrastructure Investment and Jobs Act af. H.R. 4735/S. 2493 - The Provider Relief Extension Act ag. H.R. 3589 - Better Way for Providers To Repay Act of 2021 ah. H.R. 3203 / S. 773 - To allow hospitals that were participating in or applied for the 340B drug discount program before the public health emergency to temporarily maintain eligibility ai. HHS FY 2022 appropriations - Removal of a ban on using federal funds for implementing a unique patient identification system (Section 510) aj. ACO Assignment Bill ak. NQF/Quality Measurement funding authorization al. Preparing for the next pandemic and supply chain resiliency