PATCH Act of 2022

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing FDA device approval- 510(k) and PMA processes Connected care and remote patient monitoring Supply chain legislative proposals S.4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 (Title II, Rosen cybersecurity amendment adopted in Committee) H.R.7667 - Food and Drug Amendments of 2022 (Title II, Title VIII - Sec. 808) H.R.959 Momnibus Act of 2021, all provisions S.801 Connected MOM Act, all provisions H.R.6637 - Health Equity Accountability Act Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress H.R.5640 /S.3252 - Data Mapping to Save Moms Lives Act, in whole HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R.7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R.7084 - Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions S.3983 - PATCH Act (whole) H.R.8152, the American Data Privacy and Protection Act (whole)

Client expense: $870,000 · Firm income: Not reported

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

Support H.R. 526, Ensuring Coverage in Public Health Emergencies Act of 2021, a bill to provide for special enrollment periods during public health emergencies; Letter urging Congress to provide additional funds to the Provider Relief Fund and for vaccine distribution and administration, which will allow for continued support of hospitals' COVID-19-related lost revenues, as well as additional expenses incurred due to purchasing supplies and equipment, staffing, establishing emergency testing and vaccination centers and constructing and retrofitting facilities; Support H.R. 708 and S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, a bill to provide temporary licensing reciprocity for telehealth and interstate health care treatment; Support H.R. 1306 and S. 412, National Coronavirus Commission Act of 2021, a bill to establish the Commission on the Coronavirus Pandemic in the United States; Support S. 610/ H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act, a bill to address behavioral health and well-being among health care professionals; Support 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; Support S.834, Resident Physician Shortage Reduction Act of 2021, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan and urge the Committee on Education and Labor not to report it favorably; Support S.924 and H.R. 2130, 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; Discussions with ASPR about COVID-19 related medical supply and personnel shortages; Discussions with FEMA about COVID-19 public assistance funding policies; Letter asking Congress to consider an infrastructure proposal that you prioritize hospital and health system needs to ensure our nations health care system is well positioned to meet the opportunities and challenges that lie ahead; Support S.1512/H.R. 2903, CONNECT for Health Act of 2021, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services; Support H.R. 2255/ S 1024, Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Support S.1568, Technical Reset to Advance the Instruction of Nurses (TRAIN) Act, a bill to amend title XVIII of the Social Security Act to provide a waiver of the cap on annual payments for nursing and allied health education payments; Support 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, and for other purposes; Statement to Senate Committee on Homeland Security and Governmental Affairs hearing on "COVID-19 Part II: Evaluating the Medical Supply Chain and Pandemic Response Gaps" urges Congress to take steps to strengthen the nations medical supply chain; Statement to Senate Committee on Finance hearing on COVID-19 Health Care Flexibilities: Perspectives, Experiences, and Lessons Learned stating that these flexibilities can continue to drive significant improvements in patient care long after the public health emergency (PHE) ends and given the beneficial impact of those specific flexibilities urges Congress and the Administration to make them permanent. In addition, a second group of flexibilities will remain critically important for some time following the PHE and will require a carefully crafted phase-out plan to ensure enough time is provided for a necessary transition. Without action from Congress and the Administration prior to the termination of the PHE, we are concerned that much of the progress made because of the implementation of many of these flexibilities may be unnecessarily halted or even lost; Letter urges Senate HELP Committee to consider recommendations and prioritize programs that support the health care workforce needs of the country in the wake of the COVID-19 pandemic and into the future; Support H.R. 769/S. 1491, Rural Maternal and Obstetric Modernization of Services Act or the Rural MOMS Act, a bill to amend the Public Health Service Act to improve obstetric care in rural areas; Support for S.1675/ H.R. 4387, Maternal Health Quality Improvement Act, a bill to improve maternal health; Support 1438, Opioid Workforce Act of 2021, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Support HR 3441,Substance Use Disorder Workforce Act, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the substance use disorder crisis; Support S.1810 / H.R.3541, Conrad State 30 and Physician Access Reauthorization Act, a bill to provide incentives to physicians to practice in rural and medically underserved communities; Statement to the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights for the hearing on Antitrust Applied: Hospital Consolidation Concerns and Solutions expressing that integration helps to ensure every community, whether rural, urban or suburban, has access to the same high standard of affordable, evidenced based care; discussions to ensure that H.R. 2547s limits on unfair practice under FDCPA for debt collectors does not inappropriately interfere with or restrict the ability of hospitals to be able to obtain payment for care provided; Support for revising/repealing changes to the Rural Health Clinic (RHC) Program that reduced reimbursement for provider-based RHCs; Hill outreach expressing concerns with United Healths retroactive denial of coverage for emergency-level care in facilities; Hill outreach expressing concern about CMS mid-build audit denials; Senate outreach on prior authorization legislation; Urge support for legislation/administrative action to extend the deadline to use PRF money; Urged HRSA to ensure that the drug companies that denied 340B Statute appropriate discounts make the impacted hospitals whole for the benefit of the vulnerable communities they serve; Support S. 2304 Drug-Price Transparency for Competition Act of 2021 (DTC Act of 2021), a bill to amend title XI of the Social Security Act to require that direct-to-consumer advertisements for prescription drugs and biological products include an appropriate disclosure of pricing information; Support S.246/H.R.851 Future Advancement of Academic Nursing Act or the FAAN Act, a bill to amend the Public Health Service Act to authorize grants to support schools of nursing in program enhancement and infrastructure modernization, increasing the number of nursing faculty and students, and for other purposes; Support S. 1568/HR 4407Technical Reset to Advance the Instruction of Nurses Act or the TRAIN Act, a bill to amend title XVIII of the Social Security Act to provide a waiver of the cap on annual payments for nursing and allied health education payments; Comment letter to the Occupational Safety and Health Administration (OSHA) recommending the withdrawal of the COVID-19 Emergency Temporary Standard for occupational exposure to COVID-19; Meeting with Department of Labor staff to discuss our concerns about the OSHA COVID-19 Emergency Temporary Standard for occupational exposure to COVID-19; Discussion with ASPR staff overseeing the Strategic National Stockpile about their intent to procure supplies of surgical masks; Call with Senator Cassidys staff to discuss concerns about impact of FEMA COVID-19 funding of traveling nurse agencies on hospital nursing shortages; Oppose S 2428, False Claims Amendments Act of 2021A bill to amend title 31, United States Code, to modify False Claims Act procedures, and for other purposes; Discussions about Provider Relief Fund - reporting on past disbursements and urging HHS to disburse remaining PRF money; Discussions about the challenges that teaching hospitals have with training the physician workforce, residency caps that limit funding for training programs, a shortage of residents pursuing primary care specialties, a growing patient pool due to the newly insured and aging of the population; Discussions about the hospital and health system priorities for infrastructure and reconciliation bills; Letter urging Congress to maintain the current legal and regulatory framework for evaluating mergers and acquisitions; Hill outreach to discuss the benefits of health care integration; Hill outreach about the negative impact of potentially anticompetitive conduct by nurse-staffing agencies; Support HR 5035/ S 2982 Child Suicide Prevention and Lethal Means Safety Act, a bill to authorize 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; Support H.R.5376 Build Back Better Act, this bill provides funding, establishes programs, and otherwise modifies provisions relating to a broad array of areas, including education, labor, child care, health care, taxes, immigration, and the environment; Discussions with members of congress about the implementation of Rural Emergency Hospital payment designation; Discussions on the No Surprises Act Implementation (surprise billing) and urging federal regulators to restore the independence of the independent dispute resolution process in the No Surprises Act Part 2 regulations; Support HR 5699 Student Assisted Vaccination Effort (SAVE) Act, a bill to expand the definition of qualified persons for purposes of the Public Readiness and Emergency Preparedness Act to include health professional students; Support S 2873 Preventing and Addressing Trauma with Health Services Act (PATHS Act), a bill to require the Secretary of Health and Human Services to award grants to establish or expand programs and activities to increase access to high-quality culturally competent trauma support and mental health care; Letter urging HRSA to delay proposals to withdraw certain HPSAs; Support S 3497 and HR 6397, Medical Student Education Authorization Act of 2022, a bill to amend the Public Health Service Act to establish a grant program to award grants to public institutions of higher education located in a covered State; Support HR 6279 and S 3629, Opioid Treatment Access Act of 2022, a bill to authorize a study on certain exemptions for treatment of opioid use disorder through opioid treatment programs during the COVID-19 public health emergency; Support HR 5703 and S 3677, Post-Disaster Mental Health Response Act, a bill to amend the Robert T. Stafford Disaster Relief and Emergency Assistance Act to authorize the President to provide professional counseling services to victims of emergencies declared under such Act; Submitted a statement on the hearing for Pandemic Profiteers: Legislation to Stop Corporate Price Gouging regarding concerns about anticompetitive conduct on the part of health care staffing agencies, some of which have been exploiting the severe shortage of health care providers during the COVID-19 pandemic; Submitted a statement on the hearing for Americas Mental Health Crisis and supports additional approaches to help ensure improved access to needed comprehensive, affordable and quality behavioral health services; Provide comments to the Affordability Subcommittee of the Healthy Future Task Force expressing our shared focus with Congress on providing relief from the pandemic, ensuring a smooth recovery and rebuilding a better health care system for the future, all while continuing to support efforts to promote greater affordability and value to patients and the health care system; Submitted statement on the hearing for Recruiting, Revitalizing & Diversifying: Examining the Health Care Workforce Shortage about the challenges ahead and the need to examine Americas health care workforce shortage. We must work together to solve these issues so that our nations hospitals and health systems can continue to care for the patients and communities they serve; Submitted statement on the hearing for Protecting Youth Mental Health: Part II - Identifying and Addressing Barriers to Care examines ways to protect the mental health of our nations youth; Submitted statement on the hearing for Exploring Pathways to Affordable, Universal Health Coverage Care expressing the need to build upon and improve our existing system to increase access to coverage of comprehensive health benefits; Submitted a letter to provide information regarding the challenges facing Americas health care workforce as the country enters the third year of the COVID-19 pandemic; Provided comments to the Modernization Subcommittee of the Healthy Future Task Force urging Congress to consider how to ensure the telehealth flexibilities could remain in place for patients and health care providers beyond the PHE; Support HR 7053 and S 3792, Hospital Inpatient Services Modernization Act, a bill to amend title XVIII of the Social Security Act to extend acute hospital care at home waiver flexibilities; Support resolution, H. Res. 909, Expressing support for healthcare personnel and condemning assaults on healthcare personnel as the U.S. healthcare system faces unprecedented staffing shortages and increased workplace-related stressors; Letter urges Congress to provide immediate additional support for hospitals and health systems serving their communities during this unprecedented public health crisis. While the support Congress has provided during the last two years of the COVID-19 pandemic has helped hospitals care for their patients and communities, there is still a significant need for financial support and relief as COVID-19 challenges persist; Support S 3904, Healthcare Cybersecurity Act of 2022, a bill to enhance the cybersecurity of the Healthcare and Public Health Sector; Letter urging OSHA to extend the comment deadline for the rule making on the occupational exposure to COVID-19 in healthcare settings by at least an additional 30 days, through May 23; Meeting with the Office of the Assistant Secretary of Health (OASH) at HHS to discuss the widespread blood shortages in the U.S. and next steps; Stakeholder calls with HHS ASPR regarding the distribution/administration of COVID-19 therapeutics; Discussions on S 571, Public Health Funding Prevents Pandemics Act, a bill to fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States healthcare system; Regular calls with ASPR and other stakeholders participating in the Health Care and Public Health (HPH) Sector Joint Supply Chain Resilience Working Group (Joint SCRWG), a formal Working Group under the authority of the Critical Infrastructure Partnership Advisory Council (CIPAC) to support the Presidents vision for a resilient public health supply chain; Monthly calls with ASPRs Hospital Preparedness Program (HPP) to discuss updates on the hospital association COVID-19 funding program; Call with ASPR Healthcare and Public Health Government Coordinating Council leadership and other hospital associations to provide feedback on the COVID-19 hospital data guidance update; Provide comment letter to OSHA on the re-opening of comments on the Occupational Exposure to COVID-19 Rulemaking in which we urge OSHA not to finalize its rule for occupational exposure to COVID-19. In our comments, we indicate that we continue to oppose establishing new regulations that are not fully aligned with the Centers for Disease Control and Preventions evolving evidence-based guidance. With the constantly evolving, science-based CDC guidance and recommendations, CMS vaccination requirement and existing OSHA general standards, we strongly believe that an inconsistent and overly strict OSHA COVID-19 health care standard is not necessary, would cause confusion and will ultimately lower hospital employees morale and worsen unprecedented personnel shortages in hospitals. It is essential to a well-functioning health care system that only one set of science-based standards be applied to health care providers, and that these standards be aligned across federal agencies; Letter urging Congress to make the expanded tax credits permanent, ensuring millions of low- and middle-income families continue to have access to affordable coverage in 2023 and beyond; Express concerns with the letter to CMS from Congressman Murphy that makes a number of requests for data surrounding the COVID-19 add on payments for hospitals. We are concerned about the questions as they do not take into account the continued needs of the nations hospitals and health systems. Hospitals continue to face numerous challenges, including increased labor and supply costs and workforce shortages. These additional payments have helped to address some but not all of the high costs associated with COVID-19 patient care. The complexity of care is still higher than pre-pandemic levels as measured by length of stay, which further indicates that its still more resource intensive to treat COVID inpatients. In addition, the high costs associated personal protective equipment, isolation measures, and other additional resources are necessary when treating all patients, unless and until it is determined they do not have COVID-19; Submitted a letter to Ways and Means per their request for information on the health care industry and climate change. We support the sustainability efforts while acknowledging that for a variety of reasons, many hospitals and health systems face challenges and barriers to implementing this work, especially while responding to a pandemic; Letter urging HHS to maintain the COVID-19 public health emergency (PHE) until it is clear that the global pandemic has receded and the capabilities authorized by the PHE are no longer necessary. This will help prevent any future surges from threatening the health and safety of patients and the ability of health care professionals to care for them; Long COVID Best Clinical Practices Discussion with the White House Policy Advisor, Office of the COVID-19 Response; Submitted comment letter to the Federal Trade Commission outlining the impact pharmacy benefit managers (PBMs) practices have on the field. Specifically, urging the FTC to increase scrutiny on insured-mandated white bagging policies, as well as the impact of PBM-negotiated rebates and other business practices on the 340B drug discount pricing program and overall drug prices and drug price increases; Submit a comment letter to the Internal Revenue Service for their proposed rule amending how employer coverage affordability would be measured for family members of employees. We advocated for a fix to the current methodology for assessing affordability of employer coverage for family members, often referred to as the family glitch, which is estimated to affect about 5 million individuals. We commend the IRS on proposing to revise the regulation and improve access to health insurance coverage for millions of American families; Concerns S.4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022, a bill 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 product; Comment letter on CMS Radiation Oncology (RO) Model proposed rule. We strongly supports CMS efforts to transform the delivery of cancer care. We also support the original intent of the RO Model, which was to protect access to care by ensuring fair, predictable payment for radiation oncologists. However, this important goal of the original RO Model has been marred by the incorporation of significant payment cuts and substantial administrative burdens for those participating in this mandatory model. As such, the AHA supports CMSs proposal to delay the start date of the RO model from Jan. 1, 2023 to a date to be determined through future rulemaking; Support S. 4352,Travel Nursing Agency Transparency Study Act, a bill to require a study on the effects of travel nurse agencies on the health industry during the COVID-19 pandemic; Letter in response to CMS request for guidance on implementing the regulatory requirement for convening providers and facilities exchange information with co-providers and co-facilities to create a comprehensive good faith estimate as part of the implementation of the No Surprises Act. Due to the lack of currently available automated solutions, this process would require a significant manual effort by providers, which would undoubtedly result in the convening provider being unable to meet the short statutory timeframes for delivering good faith estimates to the patients and could also lead to inadvertent errors. AHA has requested an extension in enforcement direction until a technical solution has been identified and implemented; Support HR 7691, Safety From Violence for Healthcare Employees Act or the SAVE Act, a bill to protect hospital personnel from violence, and for other purposes; Letter requesting that HHS, HRSA, and OIG take immediate enforcement action against the now 17 companies that are refusing to honor their obligations under the 340B program; Letter sent to HHS Secretary to discuss how best to ensure prompt repayment to 340B hospitals without penalizing the rest of the hospital field after the U.S. Supreme Court unanimously agreed that HHS outpatient payment cuts to hospitals in the 340B Drug Pricing Program were unlawful. The Courts decision did not determine a remedy for the unlawful payment cuts, instead, it remanded the case to the lower courts to address the proper remedy; Support HR 7084/ S 3983, Protecting and Transforming Cyber Health Care Act of 2022 or the PATCH Act of 2022, a bill to amend the Federal Food, Drug, and Cosmetic Act to require, for purposes of ensuring cybersecurity, the inclusion in any premarket submission for a cyber device of information to demonstrate a reasonable assurance of safety and effectiveness throughout the lifecycle of the cyber device, and for other purposes; Submit Comment letter of support for CMS continued focus on strengthening health insurance coverage and ensuring ease of enrollment and limited gaps in coverage, including proposed updates to Medicare enrollment and eligibility rules; Submit letter for oversight hearing on Medicare Advantage (MA) plans expressing concerns about some MA plans inappropriate restrictions on beneficiary access to medically necessary care, including those highlighted in a recent report issued by the Department of Health and Human Services Office of Inspector General (HHS-OIG), and urge Congress to increase its oversight of these plans; Provided feedback on the Senate Finance Committees discussion draft addressing mental health care and telehealth. AHA supports allowing Medicare beneficiaries who seek treatment for mental health disorders to receive their care through audio-only services, removing the requirement for Medicare patients to receive an in-person visit prior to receiving mental health services through telehealth, and expanding beyond physicians and limited non-physician practitioners the types of providers who can deliver and bill for telehealth services; Support HR 8576/ S 4352 Travel Nursing Agency Transparency Study Act, a bill to require a study on the effects of travel nurse agencies on the health industry during the COVID-19 pandemic; Support HR 8806 Healthcare Cybersecurity Act of 2022, a bill to enhance the cybersecurity of the Healthcare and Public Health Sector; Submitted a statement for the record for the Senate Judiciary Subcommittee hearing on Flatlining Care: Why Immigrants Are Crucial to Bolstering Our Health Care Workforce. This hearing examines the importance of improving the immigration process in order to help alleviate Americas health care workforce shortage. We encourage Congress to help address domestic health care workforce shortage;

Client expense: $6,950,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), SENATE, White House Office

Healthcare Supply Chain - Highlighted the important role played by hospital group purchasing organizations in promoting resiliency and value in healthcare purchasing. 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. 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 omnibus legislation (H.R. 2617). Telehealth - Supported efforts to make telehealth flexibilities offered during COVID-19 Public Health Emergency permanent. Supported CONNECT for Health Act (H.R. 2617 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). Urged administration to examine practices of health care staffing agencies and 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; H.R 2617) - monitored PREVENT Pandemics Act and supported inclusion of provisions to improve supply chain transparency, enhance cybersecurity of medical devices and extend shelf life of prescription drugs in omnibus legislation. 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). Supported passage of Opioid Treatment Access Act (S. 3629/H.R. 6279). Supported passage of Drug Shortages Shelf Life Extension Act (S. 3493). Supported passage of the Biologics Competition Act (H.R. 8877).

Client expense: $250,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Health care quality; physician and hospital quality; health care innovation; Patient Protection and Affordable Care Act/health care reform implementation; unique device identifier policy and post-market surveillance for medical devices; clinical trial design; clinical data registries including HR 5394, Meaningful Access to Federal Health Plan Claims Data Act of 2021; HIPAA and registries; federal funding/appropriations for HHS, NIH, AHRQ, CDC, FDA, HRSA and the Childrens Hospital Graduate Medical Education payment program, the Prevention & Public Health Fund, medical research, and prevention; research and scholarly communication policy; implementation and oversight of 21st Century Cures Act; data blocking/interoperability of electronic data; health disparities; reduction/oversight of prior authorization and other administrative burdens; digital health; Sect. 1557 Nondiscrimination in Health Programs and Activities; cardiomyopathy education and awareness; peripheral arterial disease (PAD) education and awareness; research on valvular heart disease including the CAROL Act (HR 1193/ S 1133); VA Mission Act implementation; COVID-19 and implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act, the Families First Coronavirus Response Act , the Coronavirus Aid, Relief, and Economic Security Act, Coronavirus Provider Protection Act (HR 3021), and clinician mental health including the Dr. Lorna Breen Health Care Provider Protection Act (HR 1667/S 610); patient identification; the Protecting and Transforming Cyber Health Care Act (HR 7084); the Diagnostic Device Advisory Committee Act (HR 7192); the Innovation and Competition Act (S. 1260)

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

Issues related to H.R. 6000, Cures 2.0 Act Issues related to global medical supply chains Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021 Issues related to disparities of care Issues pertaining to FDA included in P.L. 117-328, the Consolidated Appropriations Act, 2023, including S.4348 - FDASLA Act of 2022, H.R.7667 - Food and Drug Amendments of 2022, S. 3799 - PREVENT Pandemics Act, S. 4391 - CLEAR Documentation Act - regarding certificates to foreign government, H.R. 8299/S. 4386 - regarding device change control plans, and H.R. 7084/A. 3983 -Patch Act of 2022, pertaining to cyber security of medical devices Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices Support for the Cardiovascular Advances in Research and Opportunity Legacy (CAROL) Act (H.R. 1193 and S. 1133) Issues related to Cancer Moonshot proposals

Client expense: $730,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to third party servicing of medical devices Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of COVID-19 diagnostic tests Issues related to the Valid Act of 2021 - H.R. 4128/S. 2209 Issues related to Health Equity Issues related to the PASTEUR Act of 2021 - S. 2076/HR 3932 Issues related to COVID-19 Clinical Testing & Testing Supplies Issues related to Public Health Emergency Preparedness Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to COVID-19 Clinical Testing and Testing Supplies Issues related to consumer and health data privacy Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to H.R. 7667, Food and Drug Amendments of 2022 Issues related to S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Issues related to S. 4386, A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan. Issues related to S. 3799, PREVENT Pandemics Act Issues related to S. 3700 Prevent Pandemics Act Issues related to H.R. 2617 Consolidated Appropriations Act Issues related to H.R. 6833 Continuing Appropriations and Ukraine Supplemental Appropriations Act Issues related to S. 4349 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices. Issues related to H.R. 7676 Emerging Signals Modernization Act of 2022 Issues related to cyber security including H.R. 7084/S. 3983, PATCH Act and S. 4336 Strengthening Cybersecurity for Medical Devices Act

Client expense: $750,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Issues related to Health Care Trade and Supply Chain Security. Issues related to AI in Health Care. Issues related to Department of Health and Human Services Appropriations. Issues related to research and development tax policy. HR 1846, To amend the Public Health Service Act with respect to hospital infrastructure, all provisions. HR 4479 / S 2609, Facilitating Innovative Nuclear Diagnostics Act of 2021, all provisions. S 2107, Facilitating American-Built Semiconductors Act, all provisions. HR 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions. HR 5585, Advanced Research Projects Agency - Health Act, all provisions. S 3983 / HR 7084, PATCH Act of 2022, all provisions. HR 7667, Food and Drug Amendments of 2022, all provisions. HR 4521 / S 1260, United States Innovation and Competition Act of 2021, all provisions. S 2533 / HR 4794, Making Advances in Mammography and Medical Options for Veterans Act, all provisions. S 2102, Dr. Kate Hendricks Thomas SERVICE Act, all provisions. HR 4571, Supporting Expanded Review for Veterans In Combat Environments Act of 2021, all provisions. HR 2617, Consolidated Appropriations Act, 2023, provisions pertaining to health care cyber security, medical contrast and diagnostic radiopharmaceutical regulation, and HHS ASPR Hospital Preparedness Program appropriations. S 3799, PREVENT Pandemics Act, provisions pertaining medical device shortage reporting.

Client expense: $1,440,000 · Firm income: Not reported

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

Provider relief fund. H.R. 7084/S. 3983 - PATCH Act of 2022. H.R. 2617 - Consolidated Appropriations Act, 2023. Laboratory test regulation.

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

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

S. 299, SAFE TECH Act. H.R. 1816, Information Transparency & Personal Data Control Act. H.R. 3816, the American Choice and Innovation Online Act. H.R. 3825, Ending Platform Monopolies Act. S. 2875, Cyber Incident Reporting Act of 2021. S. 2407, Cyber Incident Notification Act of 2021. H.R. 4513, Small Business Advanced Cybersecurity Enhancements Act of 2021. S. 120, Safe Connections Act of 2021. S. 3600, Strengthening American Cybersecurity Act of 2022. H.R. 7084, Protecting and Transforming Cyber Health Care Act of 2022. H.R. 6416, Banning Surveillance Advertising Act of 2022. S. 1260, United States Innovation and Competition Act of 2021. H.R. 6580, Algorithmic Accountability Act of 2022. H.R. 6769, Digital Services Oversight and Safety Act of 2022. H.R. 8152, the American Data Privacy and Protection Act. H.R. 8111/ S.4434, My Body, My Data Act of 2022, with specific regard to the enforcement provisions. S. 3103, Eliminating Limits to Justice for Child Sex Abuse Victims Act of 2022. S. 3538, Eliminating Abusive and Rampant Neglect of Interactive Technologies Act of 2022. S. 3888, Government Surveillance Transparency Act of 2022. H.R. 8946, Online Dating Safety Act of 2022 H.R. 8306, FINE Act H.R. 7132, Safe Connections Act of 2022. S. 4796: Local News and Broadcast Media Preservation Act of 2022 Draft legislation on Project Safe Childhood, with specific regard to liability provisions. Draft legislation on privacy. Draft legislation on data breach notification rules. Draft legislation on data privacy and security. Draft legislation on child privacy rules. General lobbying on Section 230 reform. General lobbying with regard to the use of forced arbitration by tech platforms and in terms of service.

Client expense: $1,170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing Connected care and remote patient monitoring Supply chain legislative proposals Right to Repair of medical devices H.R.7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R.7084 - Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions S.3983 - PATCH Act (whole) H.R.8152, the American Data Privacy and Protection Act (whole)

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

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

21st Century Cures 2.0. H.R.1193: Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act. S.4348: FDASLA Act of 2022 and H.R.7667: Food and Drug Amendments of 2022. H.R.7084: PATCH Act of 2022. H.R.9067: Better Interoperability for Devices (BID) Act. S.3799 - PREVENT Pandemics Act. S.4391 - CLEAR Documentation Act - regarding certificates to foreign government.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1. Cybersecurity resources for providers 2. Information blocking policies 3. Patient ID - removing congressional ban 4. Telehealth - retaining pandemic flexibilities 5. Broadband - more resources for providers 6. Privacy - reduce duplication with HIPAA 7. Digital Identity Remove Section 510 Labor-HHS Appropriations (patient ID) HR 1848 - LIFT America Act (cyber) - To rebuild and modernize the Nations infrastructure to expand access to broadband and Next Generation 9-1-1, rehabilitate drinking water infrastructure, modernize the electric grid and energy supply infrastructure, redevelop brownfields, strengthen health care infrastructure, create jobs, and protect public health and the environment, and for other purposes H.R.1332 - Telehealth Modernization Act S.1512 - CONNECT for Health Act of 2021 H.R. 6000, the Cures 2.0 Act. Patch Act, HR 7084 and S 3983 Mainstreaming Addiction Treatment Act (MAT Act, H.R. 1384 / S. 445) HR 8152 - American Data Privacy and Protection Act H.R.4040 - Advancing Telehealth Beyond COVID-19 Act of 2021 H.R. 8806 - Healthcare Cybersecurity Act of 2022 S 3904 - Healthcare Cybersecurity Act of 2022 e S. 4528 - Improving Digital Identity Act of 2022

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, Treasury, Dept of

1. Cybersecurity resources for providers 2. Information blocking policies 3. Patient ID - removing congressional ban 4. Telehealth - retaining pandemic flexibilities 5. Broadband - more resources for providers 6. Privacy - reduce duplication with HIPAA 7. Digital Identity Remove Section 510 Labor-HHS Appropriations (patient ID) HR 1848 - LIFT America Act (cyber) - To rebuild and modernize the Nations infrastructure to expand access to broadband and Next Generation 9-1-1, rehabilitate drinking water infrastructure, modernize the electric grid and energy supply infrastructure, redevelop brownfields, strengthen health care infrastructure, create jobs, and protect public health and the environment, and for other purposes H.R.1332 - Telehealth Modernization Act S.1512 - CONNECT for Health Act of 2021 H.R. 6000, the Cures 2.0 Act. Patch Act, HR 7084 and S 3983 Mainstreaming Addiction Treatment Act (MAT Act, H.R. 1384 / S. 445) HR 8152 - American Data Privacy and Protection Act H.R.4040 - Advancing Telehealth Beyond COVID-19 Act of 2021 H.R. 8806 - Healthcare Cybersecurity Act of 2022 S 3904 - Healthcare Cybersecurity Act of 2022 e S. 4528 - Improving Digital Identity Act of 2022

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, Treasury, Dept of

General issues related to medical device cybersecurity, including S.3983/H.R. 7084, PATCH Act, Artificial Intelligence, and the healthcare supply chain. Issues related to coverage for certain medical devices. Issues related to the thirty-party servicing of medical devices and remanufacturing of medical devices, including H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022. Issues related to S.2609/H.R. 4479, Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Cybersecurity and medical devices - policies on hospital incentives and H.R.7084/S.3983 Protecting and Transforming Cyber Health Care Act of 2022 or the PATCH Act of 2022 and HR 2617 - Consolidated Appropriations Act of 2023 - FDA section and inclusion of PATCH Act Language

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues related to medical device cybersecurity, including S.3983/H.R. 7084, PATCH Act, Artificial Intelligence, and the healthcare supply chain. Issues related to coverage for certain medical devices. Discussions related to medical device user fees in the user fees reauthorization legislation. Issues related to the thirty-party servicing of medical devices and remanufacturing of medical devices, including H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support H.R. 526, Ensuring Coverage in Public Health Emergencies Act of 2021, a bill to provide for special enrollment periods during public health emergencies; Letter urging Congress to provide additional funds to the Provider Relief Fund and for vaccine distribution and administration, which will allow for continued support of hospitals' COVID-19-related lost revenues, as well as additional expenses incurred due to purchasing supplies and equipment, staffing, establishing emergency testing and vaccination centers and constructing and retrofitting facilities; Support H.R. 708 and S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, a bill to provide temporary licensing reciprocity for telehealth and interstate health care treatment; Support H.R. 1306 and S. 412, National Coronavirus Commission Act of 2021, a bill to establish the Commission on the Coronavirus Pandemic in the United States; Support S. 610/ H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act, a bill to address behavioral health and well-being among health care professionals; Support 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; Support S.834, Resident Physician Shortage Reduction Act of 2021, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan and urge the Committee on Education and Labor not to report it favorably; Support S.924 and H.R. 2130, 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; Discussions with ASPR about COVID-19 related medical supply and personnel shortages; Discussions with FEMA about COVID-19 public assistance funding policies; Letter asking Congress to consider an infrastructure proposal that you prioritize hospital and health system needs to ensure our nations health care system is well positioned to meet the opportunities and challenges that lie ahead; Support S.1512/H.R. 2903, CONNECT for Health Act of 2021, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services; Support H.R. 2255/ S 1024, Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Support S.1568, Technical Reset to Advance the Instruction of Nurses (TRAIN) Act, a bill to amend title XVIII of the Social Security Act to provide a waiver of the cap on annual payments for nursing and allied health education payments; Support 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, and for other purposes; Statement to Senate Committee on Homeland Security and Governmental Affairs hearing on "COVID-19 Part II: Evaluating the Medical Supply Chain and Pandemic Response Gaps" urges Congress to take steps to strengthen the nations medical supply chain; Statement to Senate Committee on Finance hearing on COVID-19 Health Care Flexibilities: Perspectives, Experiences, and Lessons Learned stating that these flexibilities can continue to drive significant improvements in patient care long after the public health emergency (PHE) ends and given the beneficial impact of those specific flexibilities urges Congress and the Administration to make them permanent. In addition, a second group of flexibilities will remain critically important for some time following the PHE and will require a carefully crafted phase-out plan to ensure enough time is provided for a necessary transition. Without action from Congress and the Administration prior to the termination of the PHE, we are concerned that much of the progress made because of the implementation of many of these flexibilities may be unnecessarily halted or even lost; Letter urges Senate HELP Committee to consider recommendations and prioritize programs that support the health care workforce needs of the country in the wake of the COVID-19 pandemic and into the future; Support H.R. 769/S. 1491, Rural Maternal and Obstetric Modernization of Services Act or the Rural MOMS Act, a bill to amend the Public Health Service Act to improve obstetric care in rural areas; Support for S.1675/ H.R. 4387, Maternal Health Quality Improvement Act, a bill to improve maternal health; Support 1438, Opioid Workforce Act of 2021, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Support HR 3441,Substance Use Disorder Workforce Act, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the substance use disorder crisis; Support S.1810 / H.R.3541, Conrad State 30 and Physician Access Reauthorization Act, a bill to provide incentives to physicians to practice in rural and medically underserved communities; Statement to the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights for the hearing on Antitrust Applied: Hospital Consolidation Concerns and Solutions expressing that integration helps to ensure every community, whether rural, urban or suburban, has access to the same high standard of affordable, evidenced based care; discussions to ensure that H.R. 2547s limits on unfair practice under FDCPA for debt collectors does not inappropriately interfere with or restrict the ability of hospitals to be able to obtain payment for care provided; Support for revising/repealing changes to the Rural Health Clinic (RHC) Program that reduced reimbursement for provider-based RHCs; Hill outreach expressing concerns with United Healths retroactive denial of coverage for emergency-level care in facilities; Hill outreach expressing concern about CMS mid-build audit denials; Senate outreach on prior authorization legislation; Urge support for legislation/administrative action to extend the deadline to use PRF money; Urged HRSA to ensure that the drug companies that denied 340B Statute appropriate discounts make the impacted hospitals whole for the benefit of the vulnerable communities they serve; Support S. 2304 Drug-Price Transparency for Competition Act of 2021 (DTC Act of 2021), a bill to amend title XI of the Social Security Act to require that direct-to-consumer advertisements for prescription drugs and biological products include an appropriate disclosure of pricing information; Support S.246/H.R.851 Future Advancement of Academic Nursing Act or the FAAN Act, a bill to amend the Public Health Service Act to authorize grants to support schools of nursing in program enhancement and infrastructure modernization, increasing the number of nursing faculty and students, and for other purposes; Support S. 1568/HR 4407Technical Reset to Advance the Instruction of Nurses Act or the TRAIN Act, a bill to amend title XVIII of the Social Security Act to provide a waiver of the cap on annual payments for nursing and allied health education payments; Comment letter to the Occupational Safety and Health Administration (OSHA) recommending the withdrawal of the COVID-19 Emergency Temporary Standard for occupational exposure to COVID-19; Meeting with Department of Labor staff to discuss our concerns about the OSHA COVID-19 Emergency Temporary Standard for occupational exposure to COVID-19; Discussion with ASPR staff overseeing the Strategic National Stockpile about their intent to procure supplies of surgical masks; Call with Senator Cassidys staff to discuss concerns about impact of FEMA COVID-19 funding of traveling nurse agencies on hospital nursing shortages; Oppose S 2428, False Claims Amendments Act of 2021A bill to amend title 31, United States Code, to modify False Claims Act procedures, and for other purposes; Discussions about Provider Relief Fund - reporting on past disbursements and urging HHS to disburse remaining PRF money; Discussions about the challenges that teaching hospitals have with training the physician workforce, residency caps that limit funding for training programs, a shortage of residents pursuing primary care specialties, a growing patient pool due to the newly insured and aging of the population; Discussions about the hospital and health system priorities for infrastructure and reconciliation bills; Letter urging Congress to maintain the current legal and regulatory framework for evaluating mergers and acquisitions; Hill outreach to discuss the benefits of health care integration; Hill outreach about the negative impact of potentially anticompetitive conduct by nurse-staffing agencies; Support HR 5035/ S 2982 Child Suicide Prevention and Lethal Means Safety Act, a bill to authorize 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; Support H.R.5376 Build Back Better Act, this bill provides funding, establishes programs, and otherwise modifies provisions relating to a broad array of areas, including education, labor, child care, health care, taxes, immigration, and the environment; Discussions with members of congress about the implementation of Rural Emergency Hospital payment designation; Discussions on the No Surprises Act Implementation (surprise billing) and urging federal regulators to restore the independence of the independent dispute resolution process in the No Surprises Act Part 2 regulations; Support HR 5699 Student Assisted Vaccination Effort (SAVE) Act, a bill to expand the definition of qualified persons for purposes of the Public Readiness and Emergency Preparedness Act to include health professional students; Support S 2873 Preventing and Addressing Trauma with Health Services Act (PATHS Act), a bill to require the Secretary of Health and Human Services to award grants to establish or expand programs and activities to increase access to high-quality culturally competent trauma support and mental health care; Letter urging HRSA to delay proposals to withdraw certain HPSAs; Support S 3497 and HR 6397, Medical Student Education Authorization Act of 2022, a bill to amend the Public Health Service Act to establish a grant program to award grants to public institutions of higher education located in a covered State; Support HR 6279 and S 3629, Opioid Treatment Access Act of 2022, a bill to authorize a study on certain exemptions for treatment of opioid use disorder through opioid treatment programs during the COVID-19 public health emergency; Support HR 5703 and S 3677, Post-Disaster Mental Health Response Act, a bill to amend the Robert T. Stafford Disaster Relief and Emergency Assistance Act to authorize the President to provide professional counseling services to victims of emergencies declared under such Act; Submitted a statement on the hearing for Pandemic Profiteers: Legislation to Stop Corporate Price Gouging regarding concerns about anticompetitive conduct on the part of health care staffing agencies, some of which have been exploiting the severe shortage of health care providers during the COVID-19 pandemic; Submitted a statement on the hearing for Americas Mental Health Crisis and supports additional approaches to help ensure improved access to needed comprehensive, affordable and quality behavioral health services; Provide comments to the Affordability Subcommittee of the Healthy Future Task Force expressing our shared focus with Congress on providing relief from the pandemic, ensuring a smooth recovery and rebuilding a better health care system for the future, all while continuing to support efforts to promote greater affordability and value to patients and the health care system; Submitted statement on the hearing for Recruiting, Revitalizing & Diversifying: Examining the Health Care Workforce Shortage about the challenges ahead and the need to examine Americas health care workforce shortage. We must work together to solve these issues so that our nations hospitals and health systems can continue to care for the patients and communities they serve; Submitted statement on the hearing for Protecting Youth Mental Health: Part II - Identifying and Addressing Barriers to Care examines ways to protect the mental health of our nations youth; Submitted statement on the hearing for Exploring Pathways to Affordable, Universal Health Coverage Care expressing the need to build upon and improve our existing system to increase access to coverage of comprehensive health benefits; Submitted a letter to provide information regarding the challenges facing Americas health care workforce as the country enters the third year of the COVID-19 pandemic; Provided comments to the Modernization Subcommittee of the Healthy Future Task Force urging Congress to consider how to ensure the telehealth flexibilities could remain in place for patients and health care providers beyond the PHE; Support HR 7053 and S 3792, Hospital Inpatient Services Modernization Act, a bill to amend title XVIII of the Social Security Act to extend acute hospital care at home waiver flexibilities; Support resolution, H. Res. 909, Expressing support for healthcare personnel and condemning assaults on healthcare personnel as the U.S. healthcare system faces unprecedented staffing shortages and increased workplace-related stressors; Letter urges Congress to provide immediate additional support for hospitals and health systems serving their communities during this unprecedented public health crisis. While the support Congress has provided during the last two years of the COVID-19 pandemic has helped hospitals care for their patients and communities, there is still a significant need for financial support and relief as COVID-19 challenges persist; Support S 3904, Healthcare Cybersecurity Act of 2022, a bill to enhance the cybersecurity of the Healthcare and Public Health Sector; Letter urging OSHA to extend the comment deadline for the rule making on the occupational exposure to COVID-19 in healthcare settings by at least an additional 30 days, through May 23; Meeting with the Office of the Assistant Secretary of Health (OASH) at HHS to discuss the widespread blood shortages in the U.S. and next steps; Stakeholder calls with HHS ASPR regarding the distribution/administration of COVID-19 therapeutics; Discussions on S 571, Public Health Funding Prevents Pandemics Act, a bill to fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States healthcare system; Regular calls with ASPR and other stakeholders participating in the Health Care and Public Health (HPH) Sector Joint Supply Chain Resilience Working Group (Joint SCRWG), a formal Working Group under the authority of the Critical Infrastructure Partnership Advisory Council (CIPAC) to support the Presidents vision for a resilient public health supply chain; Monthly calls with ASPRs Hospital Preparedness Program (HPP) to discuss updates on the hospital association COVID-19 funding program; Call with ASPR Healthcare and Public Health Government Coordinating Council leadership and other hospital associations to provide feedback on the COVID-19 hospital data guidance update; Provide comment letter to OSHA on the re-opening of comments on the Occupational Exposure to COVID-19 Rulemaking in which we urge OSHA not to finalize its rule for occupational exposure to COVID-19. In our comments, we indicate that we continue to oppose establishing new regulations that are not fully aligned with the Centers for Disease Control and Preventions evolving evidence-based guidance. With the constantly evolving, science-based CDC guidance and recommendations, CMS vaccination requirement and existing OSHA general standards, we strongly believe that an inconsistent and overly strict OSHA COVID-19 health care standard is not necessary, would cause confusion and will ultimately lower hospital employees morale and worsen unprecedented personnel shortages in hospitals. It is essential to a well-functioning health care system that only one set of science-based standards be applied to health care providers, and that these standards be aligned across federal agencies; Letter urging Congress to make the expanded tax credits permanent, ensuring millions of low- and middle-income families continue to have access to affordable coverage in 2023 and beyond; Express concerns with the letter to CMS from Congressman Murphy that makes a number of requests for data surrounding the COVID-19 add on payments for hospitals. We are concerned about the questions as they do not take into account the continued needs of the nations hospitals and health systems. Hospitals continue to face numerous challenges, including increased labor and supply costs and workforce shortages. These additional payments have helped to address some but not all of the high costs associated with COVID-19 patient care. The complexity of care is still higher than pre-pandemic levels as measured by length of stay, which further indicates that its still more resource intensive to treat COVID inpatients. In addition, the high costs associated personal protective equipment, isolation measures, and other additional resources are necessary when treating all patients, unless and until it is determined they do not have COVID-19; Submitted a letter to Ways and Means per their request for information on the health care industry and climate change. We support the sustainability efforts while acknowledging that for a variety of reasons, many hospitals and health systems face challenges and barriers to implementing this work, especially while responding to a pandemic; Letter urging HHS to maintain the COVID-19 public health emergency (PHE) until it is clear that the global pandemic has receded and the capabilities authorized by the PHE are no longer necessary. This will help prevent any future surges from threatening the health and safety of patients and the ability of health care professionals to care for them; Long COVID Best Clinical Practices Discussion with the White House Policy Advisor, Office of the COVID-19 Response; Submitted comment letter to the Federal Trade Commission outlining the impact pharmacy benefit managers (PBMs) practices have on the field. Specifically, urging the FTC to increase scrutiny on insured-mandated white bagging policies, as well as the impact of PBM-negotiated rebates and other business practices on the 340B drug discount pricing program and overall drug prices and drug price increases; Submit a comment letter to the Internal Revenue Service for their proposed rule amending how employer coverage affordability would be measured for family members of employees. We advocated for a fix to the current methodology for assessing affordability of employer coverage for family members, often referred to as the family glitch, which is estimated to affect about 5 million individuals. We commend the IRS on proposing to revise the regulation and improve access to health insurance coverage for millions of American families; Concerns S.4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022, a bill 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 product; Comment letter on CMS Radiation Oncology (RO) Model proposed rule. We strongly supports CMS efforts to transform the delivery of cancer care. We also support the original intent of the RO Model, which was to protect access to care by ensuring fair, predictable payment for radiation oncologists. However, this important goal of the original RO Model has been marred by the incorporation of significant payment cuts and substantial administrative burdens for those participating in this mandatory model. As such, the AHA supports CMSs proposal to delay the start date of the RO model from Jan. 1, 2023 to a date to be determined through future rulemaking; Support S. 4352,Travel Nursing Agency Transparency Study Act, a bill to require a study on the effects of travel nurse agencies on the health industry during the COVID-19 pandemic; Letter in response to CMS request for guidance on implementing the regulatory requirement for convening providers and facilities exchange information with co-providers and co-facilities to create a comprehensive good faith estimate as part of the implementation of the No Surprises Act. Due to the lack of currently available automated solutions, this process would require a significant manual effort by providers, which would undoubtedly result in the convening provider being unable to meet the short statutory timeframes for delivering good faith estimates to the patients and could also lead to inadvertent errors. AHA has requested an extension in enforcement direction until a technical solution has been identified and implemented; Support HR 7691, Safety From Violence for Healthcare Employees Act or the SAVE Act, a bill to protect hospital personnel from violence, and for other purposes; Letter requesting that HHS, HRSA, and OIG take immediate enforcement action against the now 17 companies that are refusing to honor their obligations under the 340B program; Letter sent to HHS Secretary to discuss how best to ensure prompt repayment to 340B hospitals without penalizing the rest of the hospital field after the U.S. Supreme Court unanimously agreed that HHS outpatient payment cuts to hospitals in the 340B Drug Pricing Program were unlawful. The Courts decision did not determine a remedy for the unlawful payment cuts, instead, it remanded the case to the lower courts to address the proper remedy; Support HR 7084/ S 3983, Protecting and Transforming Cyber Health Care Act of 2022 or the PATCH Act of 2022, a bill to amend the Federal Food, Drug, and Cosmetic Act to require, for purposes of ensuring cybersecurity, the inclusion in any premarket submission for a cyber device of information to demonstrate a reasonable assurance of safety and effectiveness throughout the lifecycle of the cyber device, and for other purposes; Submit Comment letter of support for CMS continued focus on strengthening health insurance coverage and ensuring ease of enrollment and limited gaps in coverage, including proposed updates to Medicare enrollment and eligibility rules; Submit letter for oversight hearing on Medicare Advantage (MA) plans expressing concerns about some MA plans inappropriate restrictions on beneficiary access to medically necessary care, including those highlighted in a recent report issued by the Department of Health and Human Services Office of Inspector General (HHS-OIG), and urge Congress to increase its oversight of these plans; Provided feedback on the Senate Finance Committees discussion draft addressing mental health care and telehealth. AHA supports allowing Medicare beneficiaries who seek treatment for mental health disorders to receive their care through audio-only services, removing the requirement for Medicare patients to receive an in-person visit prior to receiving mental health services through telehealth, and expanding beyond physicians and limited non-physician practitioners the types of providers who can deliver and bill for telehealth services; Support HR 8576/ S 4352 Travel Nursing Agency Transparency Study Act, a bill to require a study on the effects of travel nurse agencies on the health industry during the COVID-19 pandemic; Support HR 8806 Healthcare Cybersecurity Act of 2022, a bill to enhance the cybersecurity of the Healthcare and Public Health Sector; Submitted a statement for the record for the Senate Judiciary Subcommittee hearing on Flatlining Care: Why Immigrants Are Crucial to Bolstering Our Health Care Workforce. This hearing examines the importance of improving the immigration process in order to help alleviate Americas health care workforce shortage. We encourage Congress to help address domestic health care workforce shortage.

Client expense: $5,120,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), SENATE, White House Office

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).

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

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

1. Cybersecurity resources for providers 2. Information blocking policies 3. Patient ID - removing congressional ban 4. Telehealth - retaining pandemic flexibilities 5. Broadband - more resources for providers 6. Privacy - reduce duplication with HIPAA Remove Section 510 Labor-HHS Appropriations (patient ID) HR 1848 - LIFT America Act (cyber) - To rebuild and modernize the Nations infrastructure to expand access to broadband and Next Generation 9-1-1, rehabilitate drinking water infrastructure, modernize the electric grid and energy supply infrastructure, redevelop brownfields, strengthen health care infrastructure, create jobs, and protect public health and the environment, and for other purposes H.R.1332 - Telehealth Modernization Act S.1512 - CONNECT for Health Act of 2021 H.R. 6000, the Cures 2.0 Act. Patch Act, HR 7084 and S 3983 Mainstreaming Addiction Treatment Act (MAT Act, H.R. 1384 / S. 445) HR 8152 - American Data Privacy and Protection Act H.R.4040 - Advancing Telehealth Beyond COVID-19 Act of 2021

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), SENATE

Health care quality; physician and hospital quality; health care innovation; Patient Protection and Affordable Care Act/health care reform implementation; unique device identifier policy and post-market surveillance for medical devices; clinical trial design; clinical data registries including HR 5394, Meaningful Access to Federal Health Plan Claims Data Act of 2021; HIPAA and registries; federal funding/appropriations for HHS, NIH, AHRQ, CDC, FDA, HRSA and the Childrens Hospital Graduate Medical Education payment program, the Prevention & Public Health Fund, medical research, and prevention; research and scholarly communication policy; implementation and oversight of 21st Century Cures Act; data blocking/interoperability of electronic data; health disparities; reduction/oversight of prior authorization and other administrative burdens; digital health; Sect. 1557 Nondiscrimination in Health Programs and Activities; cardiomyopathy education and awareness; peripheral arterial disease (PAD) education and awareness; research on valvular heart disease including the CAROL Act (HR 1193/ S 1133); VA Mission Act implementation; COVID-19 and implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act, the Families First Coronavirus Response Act , the Coronavirus Aid, Relief, and Economic Security Act, Coronavirus Provider Protection Act (HR 3021), and clinician mental health including the Dr. Lorna Breen Health Care Provider Protection Act (HR 1667/S 610); patient identification; the Protecting and Transforming Cyber Health Care Act (HR 7084); the Diagnostic Device Advisory Committee Act (HR 7192); the Innovation and Competition Act S. 1260

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

Provider relief fund. H.R. 7084/S. 3983 - PATCH Act of 2022. S. 4348 - Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. Inflation Reduction Act (H.R. 5376) Public Law No. 117-169. H.R. 6833 - Continuing Resolution.

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

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

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing Connected care and remote patient monitoring Supply chain legislative proposals S.4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 (Title II, Rosen cybersecurity amendment adopted in Committee) H.R.7667 - Food and Drug Amendments of 2022 (Title II, Title VIII - Sec. 808) Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R.7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R.7084 - Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions S.3983 - PATCH Act (whole) H.R.8152, the American Data Privacy and Protection Act (whole)

Client expense: $620,000 · Firm income: Not reported

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

Issues related to H.R. 6000, Cures 2.0 Act Issues related to global medical supply chains Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021 Issues related to disparities of care Issues pertaining to FDA, including S.4348 - FDASLA Act of 2022, H.R.7667 - Food and Drug Amendments of 2022, S. 3799 - PREVENT Pandemics Act, S. 4391 - CLEAR Documentation Act - regarding certificates to foreign government, H.R. 8299/S. 4386 - regarding device change control plans, and H.R. 7084/A. 3983 -Patch Act of 2022, pertaining to cyber security of medical devices Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices Support for the Cardiovascular Advances in Research and Opportunity Legacy (CAROL) Act (H.R. 1193 and S. 1133) Issues related to Cancer Moonshot proposals

Client expense: $1,463,550 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 299, SAFE TECH Act. H.R. 1816, Information Transparency & Personal Data Control Act. H.R. 3816, the American Choice and Innovation Online Act. H.R. 3825, Ending Platform Monopolies Act. S. 2875, Cyber Incident Reporting Act of 2021. S. 2407, Cyber Incident Notification Act of 2021. H.R. 4513, Small Business Advanced Cybersecurity Enhancements Act of 2021. S. 120, Safe Connections Act of 2021. S. 3600, Strengthening American Cybersecurity Act of 2022. H.R. 7084, Protecting and Transforming Cyber Health Care Act of 2022. H.R. 6416, Banning Surveillance Advertising Act of 2022. S. 1260, United States Innovation and Competition Act of 2021. H.R. 6580, Algorithmic Accountability Act of 2022. H.R. 6769, Digital Services Oversight and Safety Act of 2022. H.R. 8152, the American Data Privacy and Protection Act. H.R. 8111/ S.4434, My Body, My Data Act of 2022, with specific regard to the enforcement provisions. S. 3103, Eliminating Limits to Justice for Child Sex Abuse Victims Act of 2022. S. 3538, Eliminating Abusive and Rampant Neglect of Interactive Technologies Act of 2022. S. 3888, Government Surveillance Transparency Act of 2022. H.R. 8946, Online Dating Safety Act of 2022 H.R. 8306, FINE Act H.R. 7132, Safe Connections Act of 2022. S. 4796: Local News and Broadcast Media Preservation Act of 2022 Draft legislation on Project Safe Childhood, with specific regard to liability provisions. Draft legislation on privacy. Draft legislation on data breach notification rules. Draft legislation on data privacy and security. Draft legislation on child privacy rules. General lobbying on Section 230 reform. General lobbying with regard to the use of forced arbitration by tech platforms and in terms of service.

Client expense: $1,180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Health Care Trade and Supply Chain Security. Issues related to AI in Health Care. Issues related to Department of Health and Human Services Appropriations. Issues related to research and development tax policy. HR 1846, To amend the Public Health Service Act with respect to hospital infrastructure, all provisions. HR 4479 / S 2609, Facilitating Innovative Nuclear Diagnostics Act of 2021, all provisions. S 2107, Facilitating American-Built Semiconductors Act, all provisions. HR 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions. HR 5585, Advanced Research Projects Agency - Health Act, all provisions. S 3983 / HR 7084, PATCH Act of 2022, all provisions. HR 7667, Food and Drug Amendments of 2022, all provisions. HR 4521 / S 1260, United States Innovation and Competition Act of 2021, all provisions. S 2533 / HR 4794, Making Advances in Mammography and Medical Options for Veterans Act, all provisions. S 2102, Dr. Kate Hendricks Thomas SERVICE Act, all provisions. HR 4571, Supporting Expanded Review for Veterans In Combat Environments Act of 2021, all provisions.

Client expense: $820,000 · Firm income: Not reported

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

21st Century Cures 2.0. H.R.1193: Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act. S.4348: FDASLA Act of 2022 and H.R.7667: Food and Drug Amendments of 2022. H.R.7084 - PATCH Act of 2022.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Cybersecurity and medical devices - policies on hospital incentives and H.R. 7084/S. 3983 Protecting and Transforming Cyber Health Care Act of 2022 or the PATCH Act of 2022

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing FDA device approval- 510(k) and PMA processes Connected care and remote patient monitoring Supply chain legislative proposals S.4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 (Title II, Rosen cybersecurity amendment adopted in Committee) H.R.7667 - Food and Drug Amendments of 2022 (Title II, Title VIII - Sec. 808) H.R.959 Momnibus Act of 2021, all provisions S.801 Connected MOM Act, all provisions H.R.6637 - Health Equity Accountability Act Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress H.R.5640 /S.3252 - Data Mapping to Save Moms Lives Act, in whole HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R.7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R.7084 - Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions S.3983 - PATCH Act (whole) H.R.8152, the American Data Privacy and Protection Act (whole)

Client expense: $740,000 · Firm income: Not reported

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

Health care quality; physician and hospital quality; health care innovation; Patient Protection and Affordable Care Act/health care reform implementation; unique device identifier policy and post-market surveillance for medical devices; clinical trial design; clinical data registries including HR 5394, Meaningful Access to Federal Health Plan Claims Data Act of 2021; HIPAA and registries; federal funding/appropriations for HHS, NIH, AHRQ, CDC, FDA, HRSA and the Childrens Hospital Graduate Medical Education payment program, the Prevention & Public Health Fund, medical research, and prevention; research and scholarly communication policy; implementation and oversight of 21st Century Cures Act; data blocking/interoperability of electronic data; health disparities; reduction/oversight of prior authorization and other administrative burdens; digital health; cardiomyopathy education and awareness; peripheral arterial disease (PAD) education and awareness; research on valvular heart disease including the CAROL Act (HR 1193/ S 1133); VA Mission Act implementation; COVID-19 and implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act, the Families First Coronavirus Response Act , the Coronavirus Aid, Relief, and Economic Security Act, Coronavirus Provider Protection Act (HR 3021), and clinician mental health including the Dr. Lorna Breen Health Care Provider Protection Act (HR 1667/S 610); patient identification; the Protecting and Transforming Cyber Health Care Act (HR 7084); the Diagnostic Device Advisory Committee Act (HR 7192); the Innovation and Competition Act S. 1260

Client expense: $410,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), 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).

Client expense: $210,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA), White House Office

Support H.R. 526, Ensuring Coverage in Public Health Emergencies Act of 2021, a bill to provide for special enrollment periods during public health emergencies; Letter urging Congress to provide additional funds to the Provider Relief Fund and for vaccine distribution and administration, which will allow for continued support of hospitals' COVID-19-related lost revenues, as well as additional expenses incurred due to purchasing supplies and equipment, staffing, establishing emergency testing and vaccination centers and constructing and retrofitting facilities; Support H.R. 708 and S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, a bill to provide temporary licensing reciprocity for telehealth and interstate health care treatment; Support H.R. 1306 and S. 412, National Coronavirus Commission Act of 2021, a bill to establish the Commission on the Coronavirus Pandemic in the United States; Support S. 610/ H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act, a bill to address behavioral health and well-being among health care professionals; Support 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; Support S.834, Resident Physician Shortage Reduction Act of 2021, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan and urge the Committee on Education and Labor not to report it favorably; Support S.924 and H.R. 2130, 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; Discussions with ASPR about COVID-19 related medical supply and personnel shortages; Discussions with FEMA about COVID-19 public assistance funding policies; Letter asking Congress to consider an infrastructure proposal that you prioritize hospital and health system needs to ensure our nations health care system is well positioned to meet the opportunities and challenges that lie ahead; Support S.1512/H.R. 2903, CONNECT for Health Act of 2021, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services; Support H.R. 2255/ S 1024, Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Support S.1568, Technical Reset to Advance the Instruction of Nurses (TRAIN) Act, a bill to amend title XVIII of the Social Security Act to provide a waiver of the cap on annual payments for nursing and allied health education payments; Support 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, and for other purposes; Statement to Senate Committee on Homeland Security and Governmental Affairs hearing on "COVID-19 Part II: Evaluating the Medical Supply Chain and Pandemic Response Gaps" urges Congress to take steps to strengthen the nations medical supply chain; Statement to Senate Committee on Finance hearing on COVID-19 Health Care Flexibilities: Perspectives, Experiences, and Lessons Learned stating that these flexibilities can continue to drive significant improvements in patient care long after the public health emergency (PHE) ends and given the beneficial impact of those specific flexibilities urges Congress and the Administration to make them permanent. In addition, a second group of flexibilities will remain critically important for some time following the PHE and will require a carefully crafted phase-out plan to ensure enough time is provided for a necessary transition. Without action from Congress and the Administration prior to the termination of the PHE, we are concerned that much of the progress made because of the implementation of many of these flexibilities may be unnecessarily halted or even lost; Letter urges Senate HELP Committee to consider recommendations and prioritize programs that support the health care workforce needs of the country in the wake of the COVID-19 pandemic and into the future; Support H.R. 769/S. 1491, Rural Maternal and Obstetric Modernization of Services Act or the Rural MOMS Act, a bill to amend the Public Health Service Act to improve obstetric care in rural areas; Support for S.1675/ H.R. 4387, Maternal Health Quality Improvement Act, a bill to improve maternal health; Support 1438, Opioid Workforce Act of 2021, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Support HR 3441,Substance Use Disorder Workforce Act, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the substance use disorder crisis; Support S.1810 / H.R.3541, Conrad State 30 and Physician Access Reauthorization Act, a bill to provide incentives to physicians to practice in rural and medically underserved communities; Statement to the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights for the hearing on Antitrust Applied: Hospital Consolidation Concerns and Solutions expressing that integration helps to ensure every community, whether rural, urban or suburban, has access to the same high standard of affordable, evidenced based care; discussions to ensure that H.R. 2547s limits on unfair practice under FDCPA for debt collectors does not inappropriately interfere with or restrict the ability of hospitals to be able to obtain payment for care provided; Support for revising/repealing changes to the Rural Health Clinic (RHC) Program that reduced reimbursement for provider-based RHCs; Hill outreach expressing concerns with United Healths retroactive denial of coverage for emergency-level care in facilities; Hill outreach expressing concern about CMS mid-build audit denials; Senate outreach on prior authorization legislation; Urge support for legislation/administrative action to extend the deadline to use PRF money; Urged HRSA to ensure that the drug companies that denied 340B Statute appropriate discounts make the impacted hospitals whole for the benefit of the vulnerable communities they serve; Support S. 2304 Drug-Price Transparency for Competition Act of 2021 (DTC Act of 2021), a bill to amend title XI of the Social Security Act to require that direct-to-consumer advertisements for prescription drugs and biological products include an appropriate disclosure of pricing information; Support S.246/H.R.851 Future Advancement of Academic Nursing Act or the FAAN Act, a bill to amend the Public Health Service Act to authorize grants to support schools of nursing in program enhancement and infrastructure modernization, increasing the number of nursing faculty and students, and for other purposes; Support S. 1568/HR 4407Technical Reset to Advance the Instruction of Nurses Act or the TRAIN Act, a bill to amend title XVIII of the Social Security Act to provide a waiver of the cap on annual payments for nursing and allied health education payments; Comment letter to the Occupational Safety and Health Administration (OSHA) recommending the withdrawal of the COVID-19 Emergency Temporary Standard for occupational exposure to COVID-19; Meeting with Department of Labor staff to discuss our concerns about the OSHA COVID-19 Emergency Temporary Standard for occupational exposure to COVID-19; Discussion with ASPR staff overseeing the Strategic National Stockpile about their intent to procure supplies of surgical masks; Call with Senator Cassidys staff to discuss concerns about impact of FEMA COVID-19 funding of traveling nurse agencies on hospital nursing shortages; Oppose S 2428, False Claims Amendments Act of 2021A bill to amend title 31, United States Code, to modify False Claims Act procedures, and for other purposes; Discussions about Provider Relief Fund - reporting on past disbursements and urging HHS to disburse remaining PRF money; Discussions about the challenges that teaching hospitals have with training the physician workforce, residency caps that limit funding for training programs, a shortage of residents pursuing primary care specialties, a growing patient pool due to the newly insured and aging of the population; Discussions about the hospital and health system priorities for infrastructure and reconciliation bills; Letter urging Congress to maintain the current legal and regulatory framework for evaluating mergers and acquisitions; Hill outreach to discuss the benefits of health care integration; Hill outreach about the negative impact of potentially anticompetitive conduct by nurse-staffing agencies; Support HR 5035/ S 2982 Child Suicide Prevention and Lethal Means Safety Act, a bill to authorize 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; Support H.R.5376 Build Back Better Act, this bill provides funding, establishes programs, and otherwise modifies provisions relating to a broad array of areas, including education, labor, child care, health care, taxes, immigration, and the environment; Discussions with members of congress about the implementation of Rural Emergency Hospital payment designation; Discussions on the No Surprises Act Implementation (surprise billing) and urging federal regulators to restore the independence of the independent dispute resolution process in the No Surprises Act Part 2 regulations; Support HR 5699 Student Assisted Vaccination Effort (SAVE) Act, a bill to expand the definition of qualified persons for purposes of the Public Readiness and Emergency Preparedness Act to include health professional students; Support S 2873 Preventing and Addressing Trauma with Health Services Act (PATHS Act), a bill to require the Secretary of Health and Human Services to award grants to establish or expand programs and activities to increase access to high-quality culturally competent trauma support and mental health care; Letter urging HRSA to delay proposals to withdraw certain HPSAs; Support S 3497 and HR 6397, Medical Student Education Authorization Act of 2022, a bill to amend the Public Health Service Act to establish a grant program to award grants to public institutions of higher education located in a covered State; Support HR 6279 and S 3629, Opioid Treatment Access Act of 2022, a bill to authorize a study on certain exemptions for treatment of opioid use disorder through opioid treatment programs during the COVID-19 public health emergency; Support HR 5703 and S 3677, Post-Disaster Mental Health Response Act, a bill to amend the Robert T. Stafford Disaster Relief and Emergency Assistance Act to authorize the President to provide professional counseling services to victims of emergencies declared under such Act; Submitted a statement on the hearing for Pandemic Profiteers: Legislation to Stop Corporate Price Gouging regarding concerns about anticompetitive conduct on the part of health care staffing agencies, some of which have been exploiting the severe shortage of health care providers during the COVID-19 pandemic; Submitted a statement on the hearing for Americas Mental Health Crisis and supports additional approaches to help ensure improved access to needed comprehensive, affordable and quality behavioral health services; Provide comments to the Affordability Subcommittee of the Healthy Future Task Force expressing our shared focus with Congress on providing relief from the pandemic, ensuring a smooth recovery and rebuilding a better health care system for the future, all while continuing to support efforts to promote greater affordability and value to patients and the health care system; Submitted statement on the hearing for Recruiting, Revitalizing & Diversifying: Examining the Health Care Workforce Shortage about the challenges ahead and the need to examine Americas health care workforce shortage. We must work together to solve these issues so that our nations hospitals and health systems can continue to care for the patients and communities they serve; Submitted statement on the hearing for Protecting Youth Mental Health: Part II - Identifying and Addressing Barriers to Care examines ways to protect the mental health of our nations youth; Submitted statement on the hearing for Exploring Pathways to Affordable, Universal Health Coverage Care expressing the need to build upon and improve our existing system to increase access to coverage of comprehensive health benefits; Submitted a letter to provide information regarding the challenges facing Americas health care workforce as the country enters the third year of the COVID-19 pandemic; Provided comments to the Modernization Subcommittee of the Healthy Future Task Force urging Congress to consider how to ensure the telehealth flexibilities could remain in place for patients and health care providers beyond the PHE; Support HR 7053 and S 3792, Hospital Inpatient Services Modernization Act, a bill to amend title XVIII of the Social Security Act to extend acute hospital care at home waiver flexibilities; Support resolution, H. Res. 909, Expressing support for healthcare personnel and condemning assaults on healthcare personnel as the U.S. healthcare system faces unprecedented staffing shortages and increased workplace-related stressors; Letter urges Congress to provide immediate additional support for hospitals and health systems serving their communities during this unprecedented public health crisis. While the support Congress has provided during the last two years of the COVID-19 pandemic has helped hospitals care for their patients and communities, there is still a significant need for financial support and relief as COVID-19 challenges persist; Support S 3904, Healthcare Cybersecurity Act of 2022, a bill to enhance the cybersecurity of the Healthcare and Public Health Sector; Letter urging OSHA to extend the comment deadline for the rule making on the occupational exposure to COVID-19 in healthcare settings by at least an additional 30 days, through May 23; Meeting with the Office of the Assistant Secretary of Health (OASH) at HHS to discuss the widespread blood shortages in the U.S. and next steps; Stakeholder calls with HHS ASPR regarding the distribution/administration of COVID-19 therapeutics; Discussions on S 571, Public Health Funding Prevents Pandemics Act, a bill to fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States healthcare system; Regular calls with ASPR and other stakeholders participating in the Health Care and Public Health (HPH) Sector Joint Supply Chain Resilience Working Group (Joint SCRWG), a formal Working Group under the authority of the Critical Infrastructure Partnership Advisory Council (CIPAC) to support the Presidents vision for a resilient public health supply chain; Monthly calls with ASPRs Hospital Preparedness Program (HPP) to discuss updates on the hospital association COVID-19 funding program; Call with ASPR Healthcare and Public Health Government Coordinating Council leadership and other hospital associations to provide feedback on the COVID-19 hospital data guidance update; Provide comment letter to OSHA on the re-opening of comments on the Occupational Exposure to COVID-19 Rulemaking in which we urge OSHA not to finalize its rule for occupational exposure to COVID-19. In our comments, we indicate that we continue to oppose establishing new regulations that are not fully aligned with the Centers for Disease Control and Preventions evolving evidence-based guidance. With the constantly evolving, science-based CDC guidance and recommendations, CMS vaccination requirement and existing OSHA general standards, we strongly believe that an inconsistent and overly strict OSHA COVID-19 health care standard is not necessary, would cause confusion and will ultimately lower hospital employees morale and worsen unprecedented personnel shortages in hospitals. It is essential to a well-functioning health care system that only one set of science-based standards be applied to health care providers, and that these standards be aligned across federal agencies; Letter urging Congress to make the expanded tax credits permanent, ensuring millions of low- and middle-income families continue to have access to affordable coverage in 2023 and beyond; Express concerns with the letter to CMS from Congressman Murphy that makes a number of requests for data surrounding the COVID-19 add on payments for hospitals. We are concerned about the questions as they do not take into account the continued needs of the nations hospitals and health systems. Hospitals continue to face numerous challenges, including increased labor and supply costs and workforce shortages. These additional payments have helped to address some but not all of the high costs associated with COVID-19 patient care. The complexity of care is still higher than pre-pandemic levels as measured by length of stay, which further indicates that its still more resource intensive to treat COVID inpatients. In addition, the high costs associated personal protective equipment, isolation measures, and other additional resources are necessary when treating all patients, unless and until it is determined they do not have COVID-19; Submitted a letter to Ways and Means per their request for information on the health care industry and climate change. We support the sustainability efforts while acknowledging that for a variety of reasons, many hospitals and health systems face challenges and barriers to implementing this work, especially while responding to a pandemic; Letter urging HHS to maintain the COVID-19 public health emergency (PHE) until it is clear that the global pandemic has receded and the capabilities authorized by the PHE are no longer necessary. This will help prevent any future surges from threatening the health and safety of patients and the ability of health care professionals to care for them; Long COVID Best Clinical Practices Discussion with the White House Policy Advisor, Office of the COVID-19 Response; Submitted comment letter to the Federal Trade Commission outlining the impact pharmacy benefit managers (PBMs) practices have on the field. Specifically, urging the FTC to increase scrutiny on insured-mandated white bagging policies, as well as the impact of PBM-negotiated rebates and other business practices on the 340B drug discount pricing program and overall drug prices and drug price increases; Submit a comment letter to the Internal Revenue Service for their proposed rule amending how employer coverage affordability would be measured for family members of employees. We advocated for a fix to the current methodology for assessing affordability of employer coverage for family members, often referred to as the family glitch, which is estimated to affect about 5 million individuals. We commend the IRS on proposing to revise the regulation and improve access to health insurance coverage for millions of American families; Concerns S.4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022, a bill 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 product; Comment letter on CMS Radiation Oncology (RO) Model proposed rule. We strongly supports CMS efforts to transform the delivery of cancer care. We also support the original intent of the RO Model, which was to protect access to care by ensuring fair, predictable payment for radiation oncologists. However, this important goal of the original RO Model has been marred by the incorporation of significant payment cuts and substantial administrative burdens for those participating in this mandatory model. As such, the AHA supports CMSs proposal to delay the start date of the RO model from Jan. 1, 2023 to a date to be determined through future rulemaking; Support S. 4352,Travel Nursing Agency Transparency Study Act, a bill to require a study on the effects of travel nurse agencies on the health industry during the COVID-19 pandemic; Letter in response to CMS request for guidance on implementing the regulatory requirement for convening providers and facilities exchange information with co-providers and co-facilities to create a comprehensive good faith estimate as part of the implementation of the No Surprises Act. Due to the lack of currently available automated solutions, this process would require a significant manual effort by providers, which would undoubtedly result in the convening provider being unable to meet the short statutory timeframes for delivering good faith estimates to the patients and could also lead to inadvertent errors. AHA has requested an extension in enforcement direction until a technical solution has been identified and implemented; Support HR 7691, Safety From Violence for Healthcare Employees Act or the SAVE Act, a bill to protect hospital personnel from violence, and for other purposes; Letter requesting that HHS, HRSA, and OIG take immediate enforcement action against the now 17 companies that are refusing to honor their obligations under the 340B program; Letter sent to HHS Secretary to discuss how best to ensure prompt repayment to 340B hospitals without penalizing the rest of the hospital field after the U.S. Supreme Court unanimously agreed that HHS outpatient payment cuts to hospitals in the 340B Drug Pricing Program were unlawful. The Courts decision did not determine a remedy for the unlawful payment cuts, instead, it remanded the case to the lower courts to address the proper remedy; Support HR 7084/ S 3983, Protecting and Transforming Cyber Health Care Act of 2022 or the PATCH Act of 2022, a bill to amend the Federal Food, Drug, and Cosmetic Act to require, for purposes of ensuring cybersecurity, the inclusion in any premarket submission for a cyber device of information to demonstrate a reasonable assurance of safety and effectiveness throughout the lifecycle of the cyber device, and for other purposes; Submit Comment letter of support for CMS continued focus on strengthening health insurance coverage and ensuring ease of enrollment and limited gaps in coverage, including proposed updates to Medicare enrollment and eligibility rules; Submit letter for oversight hearing on Medicare Advantage (MA) plans expressing concerns about some MA plans inappropriate restrictions on beneficiary access to medically necessary care, including those highlighted in a recent report issued by the Department of Health and Human Services Office of Inspector General (HHS-OIG), and urge Congress to increase its oversight of these plans.

Client expense: $4,580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), SENATE, White House Office

Issues related to Health Care Trade and Supply Chain Security. Issues related to AI in Health Care. Issues related to Department of Health and Human Services Appropriations. Issues related to research and development tax policy. HR 1846, To amend the Public Health Service Act with respect to hospital infrastructure, all provisions. HR 4479 / S 2609, Facilitating Innovative Nuclear Diagnostics Act of 2021, all provisions. S 2107, Facilitating American-Built Semiconductors Act, all provisions. HR 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions. HR 5585, Advanced Research Projects Agency - Health Act, all provisions. S 3983 / HR 7084, PATCH Act of 2022, all provisions. HR 7667, Food and Drug Amendments of 2022, all provisions. HR 4521 / S 1260, United States Innovation and Competition Act of 2021, all provisions. S 2533 / HR 4794, Making Advances in Mammography and Medical Options for Veterans Act, all provisions. S 2102, Dr. Kate Hendricks Thomas SERVICE Act, all provisions. HR 4571, Supporting Expanded Review for Veterans In Combat Environments Act of 2021, all provisions.

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

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

S. 299, SAFE TECH Act. H.R. 1816, Information Transparency & Personal Data Control Act. H.R. 3816, the American Choice and Innovation Online Act. H.R. 3825, Ending Platform Monopolies Act. S. 2875, Cyber Incident Reporting Act of 2021. S. 2407, Cyber Incident Notification Act of 2021. H.R. 4513, Small Business Advanced Cybersecurity Enhancements Act of 2021. S. 120, Safe Connections Act of 2021. S. 3600, Strengthening American Cybersecurity Act of 2022. H.R. 7084, Protecting and Transforming Cyber Health Care Act of 2022. H.R. 6416, Banning Surveillance Advertising Act of 2022. S. 1260, United States Innovation and Competition Act of 2021. H.R. 6580, Algorithmic Accountability Act of 2022. H.R. 6769, Digital Services Oversight and Safety Act of 2022. H.R. 8152, the American Data Privacy and Protection Act. H.R. 8111/ S.4434, My Body, My Data Act of 2022, with specific regard to the enforcement provisions. S. 3103, Eliminating Limits to Justice for Child Sex Abuse Victims Act of 2022. S. 3538, Eliminating Abusive and Rampant Neglect of Interactive Technologies Act of 2022. S. 3888, Government Surveillance Transparency Act of 2022. Draft legislation on privacy. Draft legislation on data breach notification rules. Draft legislation on data privacy and security. Draft legislation on child privacy rules. General lobbying on Section 230 reform. General lobbying with regard to the use of forced arbitration by tech platforms and in terms of service.

Client expense: $1,010,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Provider relief fund. H.R. 5376 - Build Back Better Act. H.R. 7084/S. 3983 - PATCH Act of 2022. S. 4348 - Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act.

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

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

Issues related to H.R. 6000, Cures 2.0 Act Issues related to global medical supply chains Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021 Issues related to disparities of care Issues pertaining to FDA, including S.4348 - FDASLA Act of 2022, H.R.7667 - Food and Drug Amendments of 2022, S. 3799 - PREVENT Pandemics Act, S. 4391 - CLEAR Documentation Act, and S. 4386 - regarding device change control plans and H.R. 7084/A. 3983 -Patch Act of 2022, pertaining to cyber security of medical devices Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices Support for the Cardiovascular Advances in Research and Opportunity Legacy (CAROL) Act (H.R. 1193 and S. 1133) Issues related to Cancer Moonshot proposals

Client expense: $666,100 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Monitoring issues relating to medical device cybersecurity. H.R.7084 and S.3983-PATC Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376 - Build Back Better Act, H.R. 2471 - Consolidated Appropriations Act of 2022: Provisions related to Provider Relief Fund. S. 3983, H.R. 7084 - PATCH Act of 2022: Provisions related to cybersecurity. S. 2209 - VALID Act, S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA): Provisions related to laboratory developed tests.

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Cybersecurity and medical devices - policies on hospital incentives and HR 7084/S.3983 Protecting and Transforming Cyber Health Care Act of 2022 or the PATCH Act of 2022

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1. Cybersecurity resources for providers 2. Information blocking policies 3. Patient ID - removing congressional ban 4. Telehealth - retaining pandemic flexibilities 5. Broadband - more resources for providers Remove Section 510 Labor-HHS Appropriations (patient ID) HR 1848 - LIFT America Act (cyber) - To rebuild and modernize the Nations infrastructure to expand access to broadband and Next Generation 9-1-1, rehabilitate drinking water infrastructure, modernize the electric grid and energy supply infrastructure, redevelop brownfields, strengthen health care infrastructure, create jobs, and protect public health and the environment, and for other purposes H.R.1332 - Telehealth Modernization Act S.1512 - CONNECT for Health Act of 2021 H.R. 6000, the Cures 2.0 Act. Patch Act, HR 7084 and S 3983 Mainstreaming Addiction Treatment Act (MAT Act, H.R. 1384 / S. 445)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

1. Cybersecurity resources for providers 2. Information blocking policies 3. Patient ID - removing congressional ban 4. Telehealth - retaining pandemic flexibilities 5. Broadband - more resources for providers Remove Section 510 Labor-HHS Appropriations (patient ID) HR 1848 - LIFT America Act (cyber) - To rebuild and modernize the Nations infrastructure to expand access to broadband and Next Generation 9-1-1, rehabilitate drinking water infrastructure, modernize the electric grid and energy supply infrastructure, redevelop brownfields, strengthen health care infrastructure, create jobs, and protect public health and the environment, and for other purposes H.R.1332 - Telehealth Modernization Act S.1512 - CONNECT for Health Act of 2021 H.R. 6000, the Cures 2.0 Act. Patch Act, HR 7084 and S 3983 Mainstreaming Addiction Treatment Act (MAT Act, H.R. 1384 / S. 445)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Advocacy on HR 4479/S2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act, to fix policy packaging for radiopharmaceuticals; Advocacy with CMS on Beta Amyloid PET Medicare Coverage; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and S. 4333, the CLEAR Act, to allow FDA to continue regulating all imaging agents as drugs. Advocacy with Congress and FDA on H.R. 7084/S.3983 PATCH Act to seek improvements related to cybersecurity requirements of installed base devices; Advocacy on H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the definition of remanufacturing and have education and enforcement of remanufacturers; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and provisions related to remanufacturing of medical devices and medical device cybersecurity; Advocacy on H.R. 2007 The Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, to promote research and use of noninvasive treatment alternatives for uterine fibroids; Advocacy on Digital Millennium Copyright Act (DMCA) Section 1201 and Right to Repair issues broadly; Advocacy on focused ultrasound technology; advocacy on medical device cybersecurity.

Client expense: $570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

General issues related to medical device cybersecurity, including S.3983/H.R. 7084, PATCH Act, Artificial Intelligence, and the healthcare supply chain. Issues related to coverage for certain medical devices, including in H.R. 6000, Cures 2.0 Act. Discussions related to the medical device user fee reauthorization in H.R.7667, Food and Drug Amendments Act of 2022, as amended. Issues related to the thirty-party servicing of medical devices and remanufacturing of medical devices, including H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022, and H.R. 6566, Freedom to Repair Act of 2022.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing FDA device approval- 510(k) and PMA processes Connected care and remote patient monitoring Healthcare Data Privacy Supply chain legislative proposals Issues related to upcoming MDUFA V legislation H.R.959 Momnibus Act of 2021, all provisions S.801 Connected MOM Act, all provisions H.R.6637 - Health Equity Accountability Act Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress HR 5640 /S. 3252. Data Mapping to Save Moms Lives Act, in whole HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R. 7084, the Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions

Client expense: $580,000 · Firm income: Not reported

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

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing FDA device approval- 510(k) and PMA processes Connected care and remote patient monitoring Healthcare Data Privacy Supply chain legislative proposals Issues related to upcoming MDUFA V legislation H.R.959 Momnibus Act of 2021, all provisions S.801 Connected MOM Act, all provisions H.R.6637 - Health Equity Accountability Act Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress HR 5640 /S. 3252. Data Mapping to Save Moms Lives Act, in whole HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R. 7084, the Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions

Client expense: $590,000 · Firm income: Not reported

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

Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. Issues related to telemedicine and remote patient monitoring, including H.R.4670 - Advanced Safe Testing at Residence Telehealth Act of 2021. Issues related to global medical supply chains. Issues related to H.R. 6000, Cures 2.0 Act. Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021. H.R. 7084 / S. 3983 - PATCH Act of 2022 Issues related to disparities of care. Issues pertaining to FDA, including medical device user fee reauthorization, certificates to foreign government, change control protocols, emerging signals, electronic labeling, and shortage reporting. Issues related to the sterilization of medical devices. Issues related to digital health, data interoperability, and electronic health records. Issues related to servicing and repair of medical devices Issues related to ONC and CMS implementation of effective and efficient interoperability standards. Support for the Cardiovascular Advances in Research and Opportunity Legacy (CAROL) Act (H.R. 1193 and S. 1133).

Client expense: $870,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE