Pharmaceutical Supply Chain Risk Assessment Act of 2023

S. 3565, Affordable Connectivity Program Extension Act of 2024, all provisions; Draft Bill, Sustain 340B Program Discussion Draft, Issues pertaining to 340B Program access; S. 1302/H.R. 2389, Resident Physician Shortage Reduction Act of 2023, all provisions; S. 3679/H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions; S.2415, Preventing Maternal Deaths Reauthorization Act, all provisions; H.R. 7931, Preserving Emergency Access in Key Sites Act (PEAKS) , all provisions; H.R. 8245, Rural Hospital Stabilization Act , all provisions; H.R. 8246, Second Chances for Rural Hospitals Act, all provisions; S.940/ H.R. 1711, Rural America Health Corps Act, all provisions; S.665 / H.R. 4942, Conrad State 30 and Physician Access Reauthorization Act, all provisions; S. 3211/ H.R. 6205, Healthcare Workforce Resilience Act, all provisions; S. 3765 / H.R. 6960, Emergency Medical Services for Children Reauthorization Act of 2024, all provisions; H.R. 7635, The 340B PATIENTS Act, all provisions; H.R.8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net (340B ACCESS) Act, Issues pertaining to 340B Program access; S. 2364, Mapping Americas Pharmaceutical Supply Act, all provisions; S. 1961, Pharmaceutical Supply Chain Risk Assessment Act of 2023, all provisions; S. 2510, RAPID Reserve Act, all provisions; S. 2362, Drug Shortage Prevention Act, all provisions; Draft Bill, the Drug Shortage Prevention and Mitigation Act, Issues pertaining to proposed solutions to address generic drug shortages; S. 862, Restoring America's Health Care Workforce and Readiness Act, all provisions; HR 2584/ S.2768, Safety From Violence for Healthcare Employees (SAVE) Act, all provisions; S.4079/H.R. 8383, Rural Obstetrics Readiness Act , all provisions; H.R. 8186, Healthy Affordable Housing Act, all provisions; S. 4289, Medical Debt Cancellation Act, all provisions; S. 4054, Health Care Cybersecurity Improvement Act of 2024, all provisions; S. 3770/ H.R. 7266, "The Future Advancement of Academic Nursing (FAAN Act)", all provisions; S. 1176 / H.R. 2663, Workplace Violence Prevention for Health Care and Social Service Workers Act, all provisions; H.R. 977/S. 470, Patient Access to Higher Quality Care Act, all provisions; Draft Bill, Family Health Affordability Act, all provisions; Draft Bill, HEALTH for MOM Act, all provisions; U.S. Department of Labor, Health Plan Accountability, health plan accountability; Office of the U.S. Trade Representative, Section 301 Tariffs, Issues related to tariffs on health care products manufactured in China; Federal Emergency Management Agency (FEMA), Public Assistance for COVID expenses, Issues related to distribution of public assistance funds to hospitals; Administration for Strategic Preparation & Response (ASPR / HHS), Pediatric Emergencies, Issues related to Pediatric Disaster Care Centers of Excellence; U.S. Department of State Immigration, Issues related to visas for foreign-trained health care workers; Immediate Office of the Secretary (IOS - HHS), Medical Debt, Issues related to how hospitals address medical debt; Cyber Security, Issues pertaining to Change Health Care cyber attack, breach notifications and ongoing cyber risks to the health care field; Lab Developed Tests (LDTs), Issues related to proposed regulatory oversight of Lab Developed Tests (LDTs); Employment Retirement Income Security Act (ERISA), ERISA improvements; Artificial Intelligence (AI), AI use in health care; Rural Health Care Access, Issues to protect access to rural health care; Prescription drug shortages, Issues pertaining to Drug shortages, supply chains; Hospital mergers and acquisitions, Issues pertaining to hospital consolidation, mergers an acquisition, community benefit, physician practice acquisition; Workforce nurse staffing mandate, workforce development programs; Maternal Health and Child Health, Access to maternal and child health care and addressing related workforce shortages; Behavioral Health, Related to expanding access to care and reducing regulatory barriers; Price Transparency, Issues related to hospital price transparency; Health Plan Accountability, Issues specific to prior authorization, patient access to care, adequate provider networks, inappropriate denials, reducing account receivables, prompt pay and cost-based reimbursement for critical access hospitals under Medicare Advantage; Medical Debt, Issues specific to medical debt incurred by patients and hospital billing and collection practices; Physician Owned Hospitals, Physician-owned hospitals; Tax-exempt status, not-for-profit hospitals' tax exempt status; Health Professions Diversity, Increasing health professionals of color, National health service corps; centers of excellence; health careers opportunity programs.

Client expense: $6,080,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

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

S. 3565, Affordable Connectivity Program Extension Act of 2024, all provisions; Draft Bill, Sustain 340B Program Discussion Draft, Issues pertaining to 340B Program access; S. 1302/H.R. 2389, Resident Physician Shortage Reduction Act of 2023, all provisions; S. 3679/H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions; S.2415, Preventing Maternal Deaths Reauthorization Act, all provisions; H.R. 7931, Preserving Emergency Access in Key Sites Act (PEAKS) , all provisions; H.R. 8245, Rural Hospital Stabilization Act , all provisions; H.R. 8246, Second Chances for Rural Hospitals Act, all provisions; S.940/ H.R. 1711, Rural America Health Corps Act, all provisions; S.665 / H.R. 4942, Conrad State 30 and Physician Access Reauthorization Act, all provisions; S. 3211/ H.R. 6205, Healthcare Workforce Resilience Act, all provisions; S. 3765 / H.R. 6960, Emergency Medical Services for Children Reauthorization Act of 2024, all provisions; H.R. 7635, The 340B PATIENTS Act, all provisions; H.R.8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net (340B ACCESS) Act, Issues pertaining to 340B Program access; S. 2364, Mapping Americas Pharmaceutical Supply Act, all provisions; S. 1961, Pharmaceutical Supply Chain Risk Assessment Act of 2023, all provisions; S. 2510, RAPID Reserve Act, all provisions; S. 2362, Drug Shortage Prevention Act, all provisions; Draft Bill, the Drug Shortage Prevention and Mitigation Act, Issues pertaining to proposed solutions to address generic drug shortages; S. 862, Restoring America's Health Care Workforce and Readiness Act, all provisions; HR 2584/ S.2768, Safety From Violence for Healthcare Employees (SAVE) Act, all provisions; S.4079/H.R. 8383, Rural Obstetrics Readiness Act , all provisions; H.R. 8186, Healthy Affordable Housing Act, all provisions; S. 4289, Medical Debt Cancellation Act, all provisions; S. 4054, Health Care Cybersecurity Improvement Act of 2024, all provisions; S. 3770/ H.R. 7266, "The Future Advancement of Academic Nursing (FAAN Act)", all provisions; S. 1176 / H.R. 2663, Workplace Violence Prevention for Health Care and Social Service Workers Act, all provisions; H.R. 977/S. 470, Patient Access to Higher Quality Care Act, all provisions; Draft Bill, Family Health Affordability Act, all provisions; Draft Bill, HEALTH for MOM Act, all provisions; U.S. Department of Labor, Health Plan Accountability, health plan accountability; Office of the U.S. Trade Representative, Section 301 Tariffs, Issues related to tariffs on health care products manufactured in China; Federal Emergency Management Agency (FEMA), Public Assistance for COVID expenses, Issues related to distribution of public assistance funds to hospitals; Administration for Strategic Preparation & Response (ASPR / HHS), Pediatric Emergencies, Issues related to Pediatric Disaster Care Centers of Excellence; U.S. Department of State Immigration, Issues related to visas for foreign-trained health care workers; Immediate Office of the Secretary (IOS - HHS), Medical Debt, Issues related to how hospitals address medical debt; Cyber Security, Issues pertaining to Change Health Care cyber attack, breach notifications and ongoing cyber risks to the health care field; Lab Developed Tests (LDTs), Issues related to proposed regulatory oversight of Lab Developed Tests (LDTs); Employment Retirement Income Security Act (ERISA), ERISA improvements; Artificial Intelligence (AI), AI use in health care; Rural Health Care Access, Issues to protect access to rural health care; Prescription drug shortages, Issues pertaining to Drug shortages, supply chains; Hospital mergers and acquisitions, Issues pertaining to hospital consolidation, mergers an acquisition, community benefit, physician practice acquisition; Workforce nurse staffing mandate, workforce development programs; Maternal Health and Child Health, Access to maternal and child health care and addressing related workforce shortages; Behavioral Health, Related to expanding access to care and reducing regulatory barriers; Price Transparency, Issues related to hospital price transparency; Health Plan Accountability, Issues specific to prior authorization, patient access to care, adequate provider networks, inappropriate denials, reducing account receivables, prompt pay and cost-based reimbursement for critical access hospitals under Medicare Advantage; Medical Debt, Issues specific to medical debt incurred by patients and hospital billing and collection practices; Physician Owned Hospitals, Physician-owned hospitals; Tax-exempt status, not-for-profit hospitals' tax exempt status; Health Professions Diversity, Increasing health professionals of color, National health service corps; centers of excellence; health careers opportunity programs.

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

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

Discussion with OMB/OIRA regarding OSHA Occupational Exposure to COVID-19 in Healthcare Settings Final Rule; Discussion with FDA Drug Shortage expert regarding Inflation Reduction Act Provisions that could impact duration of shortages; Discussion with ASPR Hospital Preparedness Program Staff about speaking at a meeting regarding HPP issues; Discussion with White House Office of Management & Budget, Centers for Medicare & Medicaid Services (CMS) - HHS FY 2024 Inpatient Prospective Payment System/Long Term Care Hospital Proposed Rule; Discussion with White House Office of Management & Budget, Centers for Medicare & Medicaid Services (CMS) - HHS FY 2024 Medicare Advantage Final Rule; Hill outreach about reducing hospital workplace violence; Hill outreach about the benefits of hospital mergers and acquisitions; Statement to the U.S. Senate Committee on Health, Education, Labor, and Pensions, Examining Health Care Workforce Shortages: Where Do We Go from Here?; Letter to the U.S. Senate Committee on Health, Education, Labor, and Pensions in response to an RFI on the drivers of health care workforce shortages; Support S.1110, Rural Hospitals Support Act, a bill to amend title XVIII of the Social Security Act to rebase the calculation of payments for sole community hospitals and Medicare-dependent hospitals, and for other purposes; Support H.R. 1110, Telehealth Option Act, a bill to direct the Secretary of Health and Human Services, the Medicare Payment Advisory Commission, and the Medicaid and CHIP Payment and Access Commission to conduct studies and report to Congress on actions taken to expand access to telehealth services under the Medicare, Medicaid, and Childrens Health Insurance programs during the COVID-19 emergency; Feedback on the Connect for Health Act; AHA provided feedback on the creating opportunities new for necessary and effective care technologies (CONNECT) Act; False Claims Act Case AHA Provides Statement for House Hearing on Price Transparency, Competition; Oppose H.R.977/S.470 Patient Access Higher Quality Health Care Act, a bill to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals, and for other purposes; Support S.940, The Rural America Health Corps Act A bill to establish a demonstration program to provide payments on eligible loans for individuals who are eligible for the National Health Service Corps Loan Repayment Program; Support the Conrad State 30 and Physician Access Reauthorization Act that would allow international doctors trained in the United States to remain in the country if they practice in areas experiencing medical shortages; Letter to CMS regarding intent to issue staffing mandates for nursing homes and urged CMS and policy makers to focus on efforts that will bolster our workforce; Support HR 2389/ S 1302, Resident Physician Shortage Reduction Act of 2023, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Support HR 2411/ S 1150, National Nursing Workforce Center Act of 2023, a bill to amend the Public Health Service Act to support and stabilize the existing nursing workforce, establish programs to increase the number of nurses; Support HR 2534, Preserving Rules Ordered for The Entities Covered Through 340B Act of 2023 or the PROTECT 340B Act of 2023, a bill to amend title XXVII of the Public Health Service Act to ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program; Support HR 2559, Strengthening Community Care Act of 2023, a bill to extend funding for community health centers and the National Health Service Corp; Statement to the House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing titled, Competition and Transparency: The Pathway Forward for a Stronger Health Care Market highlighting that mergers and acquisitions can be a helpful tool for many hospitals and pushing back against site-neutral payment policies; Letter urging Congress to continue to protect this critical program and oppose efforts to cut its benefits, which would result in reduced access to quality care for the patients and communities served by 340B hospitals; Statement to Subcommittee on Health of the Committee on Energy and Commerce on its hearing Examining Existing Federal Programs to Build a Stronger Health Workforce and Improve Primary Care; Support S 1447, Bipartisan Solution to Cyclical Violence Act of 2023, a bill to amend the Public Health Service Act to establish a grant program supporting trauma center violence intervention and violence prevention programs, and for other purposes; Support HR 3046/ S 1403, Medical Student Education Authorization Act of 2023, a bill to amend the Public Health Service Act to establish a grant program to award grants to accredited public institutions of higher education, and for other purposes; Concerns with HR 2691, Transparent Prices Required to Inform Consumer and Employers Act or the Transparent PRICE Act, a bill to promote hospital and insurer price transparency; Letter strongly opposing the draft bills, which would create additional site-neutral payment cuts and threaten access to care, especially in rural and other vulnerable communities; Comment letter to the Office of Civil Rights on its HIPAA Privacy Rule to Support Reproductive Health Care Privacy and concerns the guidance is too broad and will result in significant adverse consequences for hospitals, patients and the public at large; Statement to SFC for the hearing on Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs; Comment letters to CMS on their Inpatient and Long-term Care Facility Prospective Payment System FY 2024 proposed rule; Letter to reauthorize key programs within the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018, supporting policies that will reduce barriers to receiving and administering behavioral health care by improving payment policies, reducing unnecessary regulatory and administrative burden, and strengthening the behavioral health workforce; Comment letter on the Environmental Protection Agencys (EPA) proposed standards for the use of ethylene oxide (EtO) to sterilize medical devices urge caution and thoughtfulness in EPAs approach to avoid disrupting health care delivery through the unintentional fracturing of the already fragile medical device supply chain; Comment on Energy and Commerce Committee Chair Rodgers drug shortages discussion draft; Support S. 2364 Mapping Americas Pharmaceutical Supply Act A bill to map the United States pharmaceutical supply chain and use data analytics to identify supply chain vulnerabilities and other national security threats; Support S. 2510 RAPID Reserve Act A bill to improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies; Support S. 1961, Pharmaceutical Supply Chain Risk Assessment Act of 2023, A bill to require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks, and for other purposes; support the Drug Shortage Prevention Act that will help pave the way for additional improvements to the U.S. drug supply chain, which will, in turn, improve patient access and care; Support S.1636/H.R. 3440 Protecting Rural Telehealth Access Act A bill to amend title XVIII of the Social Security Act to protect access to telehealth services under the Medicare program. Drug Shortages RFI Letter to the U.S. Senate Committee on Finance in response to a Request For Information on drug shortages; Support H.R. 4713 Rural Hospital Technical Assistance Program Act A letter to support HR 4713, the Rural Hospital Technical Assistant Program Act. A bill to make permanent a program that provides technical assistance for rural hospitals to help prevent closures; Verbal Support Train More Nurse Act, It instructs HHS and DOL to conduct a joint review of all grant programs supporting the nursing workforce and coming up with recommendations to Congress within a year on how to change the programs to increase nurse faculty, provide pathways for those who want to become nurse faculty, and increase the nursing pipeline for both RNs and LPNs; Support H.R.2412 Helping Kids Cope Act To amend the Public Health Service Act to authorize grants to increase national capacity to provide pediatric behavioral health services at childrens hospitals and through community-based providers to improve childrens access to care; and to authorize grants to begin to address large numbers of children boarding in emergency departments, to support the pediatric behavioral health workforce, and for other purposes; Meeting with OMB to discuss Proposed Minimum Staffing Requirements for Long-term Care Facilities; Meeting with OMB to discuss FY 2024 IPPS and LTCH Final Rule; Meeting with Senate Finance Committee regarding the FY 2024 LTCH Final Rule; A letter to comment on ways to improve access to care in rural and underserved areas ensuring that Americans in these rural and underserved areas have high-quality, affordable health care; Support S. 2016/ H.R. 4189, CONNECT for Health Act of 2023, a bill to support to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; A letter to the Department of Veterans Affairs (VA) expressing significant concerns about Cotivitis audit and appeals process, including its inadequate appeals procedures, the scope of audits being performed and the untenable timelines that are being executed; Support S. 3211/ H.R. 6205, Healthcare Workforce Resilience Act, a bill to support Healthcare Workforce Resilience Act to enhance our Nations nurse and physician workforce by recapturing unused immigrant visas; Support for Reauthorization of PAPHA, The Pandemic and All-Hazards Preparedness Act (PAHPA), To amend the Public Health Service Act to reauthorize certain programs with respect to public health security and all-hazards preparedness and response related to the Administration for Strategic Preparedness and Response and certain programs with respect to public health security and all-hazards preparedness and response related to the Centers for Disease Control and Prevention, and for other purposes; Support H.R. 6430, Rural Community Hospitals (ARCH) Act, a bill to support the Assistance for Rural Community Hospitals (ARCH) Act; To support small rural hospitals for which Medicare patients make up a significant percentage of inpatient days or discharges, Congress established the Medicare- dependent Hospital (MDH) program in 1987, allowing eligible hospitals to receive the sum of their prospective payment system (PPS) payment rate, plus three- quarters of the amount by which their cost per discharge exceeds the PPS rate; Support H.R. 4531/ S.3393, Patients and Communities Reauthorization Act, a bill to reauthorize certain programs that provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; A letter to the FDA on its laboratory developed tests (LDTs) proposed rule urging the agency to not apply its device regulations to hospital and health system LDTs because they are not devices; rather, they are diagnostic tools developed and used in the context of patient care. Instead, we urged the FDA to continue to apply its enforcement discretion to hospital and health system LDTs; Submit Statement to the Committee on Energy and Commerce Subcommittee on Health hearing, Supporting Access to Long-Term Services and Supports: An Examination of the Impacts of Proposed Regulations on Workforce and Access to Care to share the hospital fields comments on proposed regulations for minimum staffing standards for LTC facilities and their potential impact on access to care; Concern H.R. 5378 Lower Costs, More Transparency Act, A bill to promotes price transparency in the health care sector, and for other purposes; Hill Briefing on SAVE Act, Support S. 2768 / H.R. 2584, The Safety from Violence for Healthcare Employees (SAVE) Act, A bill to protect hospital personnel from violence, and for other purposes; Health Care Spending in the United States: Unsustainable for Patients, Employers, and Taxpayers; Statement to the House Committee on Energy and Commerce Subcommittee on Health regarding the topic of national health expenditures, The Independent Dispute Resolution Process (IDR), To comment on the proposed rule related to the operations of the Independent Dispute Resolution Process (IDR) established by the No Surprises Act (NSA); Examining Chronic Drug Shortages in the United States, Statement to the House Committee on Ways and Means regarding the important topic of drug shortages in the United States; Support H.R. 6205 / S. 3211, Healthcare Workforce Resilience Act, A bill to reauthorize title II of the Higher Education Act of 1965, and for other purposes; H.R. 7513; Protecting Americas Seniors Access to Care, Statement to the House Committee on Ways and Means regarding Protecting Americas Seniors Access to Care to prohibit the Secretary of Health and Human Services from finalizing a proposed rule regarding minimum staffing for nursing facilities, and to establish an advisory panel on the skilled nursing facility workforce; Enhancing Access to Care at Home in Rural and Underserved Communities, Statement to the House Committee on Ways and Means on how telehealth flexibilities, the hospital-at-home (H@H) program and home health agencies have expanded access to care for patients in their homes and the need for these programs to continue; The recent cyberattack on Change Healthcare, Letter to House and Senate leadership requesting assistance for hospitals impacted by the cyberattack; The recent cyberattack on Change Healthcare, Letter to Senate Finance Committee leadership to share concerns regarding the Administrations proposal to penalize hospitals that do not meet certain cybersecurity requirements; Support S. 3779 / H.R. 7265, Child Suicide Prevention and Lethal Means Safety Act, A bill authorizing the Secretary of Health and Human Services to award grants to establish or expand programs to implement evidence-aligned practices in health care settings for the purpose of reducing the suicide rates of covered individuals, and for other purposes; Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDAs Proposed Rule.", Statement to the House Committee on Energy and Commerce Subcommittee on Health on the impact of the Food and Drug Administrations (FDA) proposed regulation of diagnostic tests; Senate RFI on the SUSTAIN 340B Act Draft, A letter to provide feedback on the Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of (SUSTAIN) 340B Act bipartisan discussion draft and accompanying request for information on the 340B Drug Pricing Program; Access to Health Care in America: Ensuring Resilient Emergency Medical Care, Statement to the House Committee on Ways and Means on access to emergency medical services in rural areas; Support H.R. 7623, Telehealth Modernization Act, A bill to amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program; House RFI on strengthening ERISA, A letter to provide feedback on an RFI from the House Education and Workforce Committee on ways to strengthen and improve ERISA, Addressing drug shortagesAHAs statement for record to Ways and Means committee hearing on Examining Chronic Drug Shortages in the United States, Statement commenting on the impact of the FDAs proposed regulation of laboratory developed tests (LDTs), AHAs statement for the record to Energy and Commerce Subcommittee on Health on "Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDAs Proposed Rule.", Response to RFI on oversight and regulation of LDTs, Response to Sen. Cassidy, Ranking Member of HELP Committee on his RFI seeking feedback on the FDAs proposed regulation of hospital LDTs, OMB meeting, including FDA officials, on the FDAs rulemaking on the regulation of hospital LDTs as medical devicesOMB/FDA; Support S 3679 / H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, A bill to reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes, Support S. 1110, the Rural Hospital Support Act, A bill to amend title XVIII of the Social Security Act to rebase the calculation of payments for sole community hospitals and Medicare-dependent hospitals, and for other purposes; Support HR 1565, Critical Access Hospital Relief Act of 2023, A bill to amend title XVIII of the Social Security Act to remove the 96-hour physician certification requirement for inpatient critical access hospital services.

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

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

Pharmaceutical Supply Chain Risk Assessment Act of 2023 (S. 1961); Drug Supply Chain Security Act (DSCSA); Block, Report, and Suspend Suspicious Shipments Act (H.R. 501); Education on supply chain issues, raw material shortages, drug shortages, ports and transportation issues, Buy America, domestic manufacturing, medical device sterilization.

Client expense: $200,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plans HR 830/S 1375: HELP Copays Act- copay accumulator programs S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile Regulating Laboratory Developed Tests (LDTs) and in vitro diagnostic tests (IVDs)

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