DTC Act of 2021

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

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

H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 4127: DISARM Act - Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing and patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S 2938 - Bipartisan Safer Communities Act - budget offset provisions related to Rebate Rule S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Dietary Supplement Health and Education Act Reform Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022

Client expense: $1,110,000 · Firm income: Not reported

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