Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, the House passed a bill that would raise the debt limit and CMS proposed rules designed to increase access to care for Medicaid beneficiaries and extend eligibility for federal health programs to DACA recipients. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On April 24, 2023, the National Institutes of Health (NIH) issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The technology available for licensing to achieve expeditious commercialization of results of federally-funded research and development is an engineered cell-penetrating monoclonal antibody for universal influenza immunotherapy. Many current influenza treatments rely on targeting surface viral glycoproteins. These glycoproteins are primary targets of the immune system, which results in increased selection pressure and mutational rate, leading to the well-known seasonal variation of influenza virus. In contrast, the nucleocapsid viral protein (NP), located in the interior of the virus, is more conserved and an ideal antibody target; however, NP is inaccessible to extracellular antibodies produced in response to infection. To circumvent the challenge of targeting NP, scientists at the National Institute of Allergy and Infectious Diseases (NIAID) have developed an antibody genetically fused with a cell penetrating peptide (CPP-mAb) that targets NP within infected cells to effectively inhibit viral replication. By targeting NP rather than the surface glycoproteins, this CPP-mAb can treat more influenza variants, potentially across flu seasons, and is an improvement upon current influenza treatments. Potential commercial applications for this technology could be as a clinical treatment that could be a viable alternative to the treatment of influenza when other treatments are ineffective, potentially lowering the mortality and morbidity rates in populations susceptible to influenza infection.
- On April 24, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Clarifying Eligibility for a Qualified Health Plan through an Exchange, Advance Payments of the Premium Tax Credit, Cost-Sharing Reductions, a Basic Health Program, and for Some Medicaid and Children’s Health Insurance Programs. This proposed rule would make several clarifications and update the definitions currently used to determine whether a consumer is eligible to enroll in a Qualified Health Plan (QHP) through an Exchange; a Basic Health Program (BHP), in states that elect to operate a BHP; and for some state Medicaid and Children’s Health Insurance Programs (CHIPs). The clarifications are specifically in reference to Deferred Action for Childhood Arrivals (DACA) recipients. CMS is proposing to remove an exception that excludes DACA recipients from the definitions of “lawfully present” used to determine eligibility to enroll in a QHP through an Exchange, a BHP, or Medicaid and CHIP under the Children's Health Insurance Program Reauthorization Act (CHIPRA) 214 option.
- On April 25, 2023, the Centers for Disease Control and Prevention (CDC) issued a request for information (RFI) entitled, World Trade Center Health Program; Youth Research Cohort; Request for Information. CDC, through its National Institute for Occupational Safety and Health (NIOSH), is announcing an opportunity for the public to provide information about approaches to establishing a new World Trade Center (WTC) Health Program research cohort of persons who were exposed to the September 11, 2001, terrorist attacks and were aged 21 years or younger at the time of their exposure. This research cohort will be designed to allow the WTC Health Program to conduct future research studies on the health and educational impacts in the population of persons aged 21 years or younger at the time of their exposures to airborne toxins, or any other hazard or adverse condition, resulting from the terrorist attacks on September 11, 2001. Once established, this new WTC Health Program “youth cohort” would serve as the basis for future WTC Health Program research into the health and educational impacts of this potentially vulnerable group.
- On April 25, 2023, CDC issued a notice entitled, Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Pregnant Healthcare Personnel Section. CDC is announcing the opening of a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Pregnant Healthcare Personnel Section. This updated recommendation will help facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who are pregnant or intend to become pregnant.
- On April 27, 2023, CMS issued a proposed rule entitled, Medicaid Program; Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality. This proposed rule would advance CMS’ efforts to improve access to care, quality and health outcomes, and better address health equity issues for Medicaid and CHIP managed care enrollees. The proposed rule would specifically address standards for timely access to care and states’ monitoring and enforcement efforts; reduce burden for some state directed payments and certain quality reporting requirements; add new standards that would apply when states use in lieu of services and settings (ILOSs) to promote effective utilization and specify the scope and nature of ILOS; specify medical loss ratio (MLR) requirements; and establish a quality rating system for Medicaid and CHIP managed care plans.
- On April 27, 2023, CMS issued a proposed rule entitled, Medicaid Program; Ensuring Access to Medicaid Services. This proposed rule intends to take a comprehensive approach to improving access to care and quality and health outcomes, as well as to better addressing health equity issues in the Medicaid program across fee-for-service (FFS), managed care delivery systems, and in home and community-based services (HCBS) programs. These proposed improvements seek to increase transparency and accountability, standardize data and monitoring, and create opportunities for states to promote active beneficiary engagement in their Medicaid programs, with the goal of improving access to care.
- On April 28, 2023, the Food and Drug Administration (FDA) issued final guidance entitled, S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; International Council for Harmonisation; Guidance for Industry; Availability. The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The final guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products. The recommendations in the guidance endeavor to facilitate the development of investigational GT products, while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/ replace) principles.
- On April 28, 2023, FDA issued a notice entitled, Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Elements and Terminologies; Establishment of a Public Docket; Request for Comments. FDA is requesting comment on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies for the electronic submission of PQ/CMC data. FDA is continuing to seek comment on the accuracy, suitability, and appropriateness of revised and/or new data elements and terminologies for submission of PQ/CMC data. In addition, the progress toward the establishment of standardized pharmaceutical data elements and terminologies will require further interactions between the Agency and interested parties and various stakeholders, including industry. Accordingly, FDA is planning to request comment on additional PQ/CMC data elements and terminologies over time.
- On April 28, 2023, CDC issued a notice entitled, Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee. CDC is seeking nominations for membership on the Healthcare Infection Control Practices Advisory Committee (HICPAC). The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. Nominations for membership on the HICPAC must be received no later than September 29, 2023.
- On April 28, 2023, CMS issued a notice entitled, Medicare Program; Extending the Medicare Diabetes Prevention Program’s (MDPP) Expanded Model Emergency Policy through CY 2023. This document is to alert Medicare Diabetes Prevention Program (MDPP) expanded model suppliers and interested parties that although current MDPP flexibilities permitted pursuant to regulations issued during the Public Health Emergency (PHE) for COVID-19 are scheduled to expire on May 11, 2023, CMS is specifying an effective date, for purposes of the regulations of December 31, 2023, through which in-person delivery of MDPP services can be suspended. This extended effective date applies for all MDPP suppliers to allow additional time to resume in-person services. MDPP suppliers may use all of or part of this period to extend the flexibilities described in the regulations. This document provides information to MDPP suppliers regarding the extension of the ability to suspend in-person services as the PHE for COVID-19 concludes.
- May 9, 2023: NIH announced a public meeting of the National Institute on Drug Abuse (NIDA) National Advisory Council on Drug Abuse (NACDA). The meeting agenda will include presentations and other NACDA business.
- May 16-17, 2023: NIH announced a public meeting of the National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB). The meeting agenda will include reports from the Director, NACBIB members, and other staff.
- May 16-17, 2023: NIH announced a public meeting of the National Institute of Mental Health (NIMH) National Advisory Mental Health Council (NAMHC). The meeting will include a presentation of the NIMH Director’s report and discussion of NIMH programs.
- May 23, 2023: NIH announced a public meeting of the National Advisory Council for Nursing Research (NACNR). The meeting agenda will include a call to order and opening remarks, the National Institute of Nursing Research (NINR) Director’s report, NINR strategy and program updates, and open discussion.
- May 24, 2023: CDC announced a public meeting of the Mine Safety and Health Research Advisory Committee (MSHRAC). The agenda will include presentations of and discussions on current NIOSH mining safety and health research projects, focusing on the Spokane Mining Research Division.
- May 25, 2023: The Department of Health and Human Services (HHS) announced a public meeting of the National Advisory Committee on Seniors and Disasters (NACSD). The NACSD shall evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS and the Administration for Strategic Preparedness and Response (ASPR) to support and enhance all-hazards public health and medical preparedness, response, and recovery aimed at meeting the needs of older adults. The NACSD will conduct a virtual public meeting to discuss, finalize, and vote on an initial set of recommendations to the HHS Secretary and ASPR.
- June 1, 2023: FDA announced a virtual listening session entitled, Good Manufacturing Practices for Cosmetic Products Listening Session. The purpose of the listening session is to consult cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts, to inform Agency efforts to develop regulations to establish good manufacturing practices for facilities that manufacture or process cosmetic products distributed in the U.S.
- June 8-9, 2023: CDC announced a public meeting of the HICPAC. The agenda will include updates on CDC’s activities for prevention of healthcare-associated infections (HAIs). It will also include updates from the following HICPAC workgroups: the Isolation Precautions Guideline workgroup, the Dental Unit Waterline Guideline Workgroup, the Healthcare Personnel Guideline Workgroup, the Neonatal Intensive Care Unit Guideline Workgroup, and the National Healthcare Safety Network Workgroup.
- June 13, 2023: CDC announced a public meeting of the NIOSH National Firefighter Registry Subcommittee (NFRS). The agenda for the meeting includes an overview of the National Firefighter Registry project including updates on its, status, national launch, communication strategies, targeted enrollment approach, follow-up questionnaire planning, and future planning applicable to stakeholders.
- June 13-14, 2023: FDA announced a public forum entitled, FDA Science Forum 2023. The purpose of the public workshop is to inform the public about the breadth of research underway at the Agency, and to show how cutting-edge science informs FDA’s regulatory decision-making to protect and promote public health.
- June 21, 2023: CDC announced a public meeting of the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH). The agenda will include discussions on the following: (1) ORAUT-OTIB-0052, DCAS-PER-049, DCAS-PER092, Peek Street; DCAS-PER-073 (Birdsboro), Battelle-TBD-5000, and examples of a “not suitable closeout for matrix” presentation; (2) newly issued Sandford Cohen & Associates reviews; (3) preparation for August 2023 full ABRWH meeting; and (4) newly issued guidance documents and supplemental topics.
II. Hearings & Markups
U.S House of Representatives
- On April 26, 2023, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Lowering Unaffordable Costs: Legislative Solutions to Increase Transparency and Competition in Health Care. Witnesses present included: The Honorable Chiquita Brooks-LaSure, Administrator, CMS; Ashley Thompson, Senior Vice President, Public Policy Analysis and Development, American Hospital Association (AHA); Kristin Bass, Chief Policy and External Affairs Officer, Pharmaceutical Care Management Association (PCMA); Brian Connell, Executive Director, Federal Affairs, The Leukemia and Lymphoma Society (LLS); Sean Cavanaugh, Chief Policy Officer, Aledade, Inc.; Ilyse Schuman, Senior Vice President, Health Policy, American Benefits Council (ABC); and Loren Adler, Fellow and Associate Director, USC-Brookings Initiative for Health Policy, Economic Studies Program, Brookings Institution.
- On April 26, 2023, the House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS-Ed) held an oversight hearing entitled, Provider Relief Fund and Health Care Workforce Shortages. The Honorable Carole Johnson, Administrator, Health Resources and Services Administration (HRSA), was the only witness.
- On April 26, 2023, the House Committee on Education & the Workforce Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, Reducing Health Care Costs for Working Americans and their Families. Witnesses present included: Tracy Watts, Senior Partner, Mercer; Marcie Strouse, Partner, Capitol Benefits Group; Sabrina Corlette, J.D., Senior Research Professor, Center on Health Insurance Reforms, Georgetown University’s Health Policy Institute; and Joel White, President, Council for Affordable Health Coverage (CAHC).
- On April 26, 2023, the House Committee on Ways and Means Subcommittee on Oversight held a hearing entitled, Tax-Exempt Hospitals and the Community Benefit Standard. Witnesses present included: Jessica Lucas-Judy, Director, Strategic Issues, Government Accountability Office (GAO); Dr. Ge Bai, Professor of Accounting and Health Policy, Johns Hopkins University; Dr. Zachary Levinson, Project Director, Kaiser Family Foundation (KFF); and Melinda Reid Hatton, General Counsel, AHA Secretary, AHA.
- On April 27, 2023, the House Committee on Energy and Commerce Subcommittee on Innovation, Data, and Commerce held a hearing entitled, Addressing America's Data Privacy Shortfalls: How a National Standard Fills Gaps to Protect Americans' Personal Information. Witnesses present included: Morgan Reed, President, ACT | The App Association; Donald Codling, Senior Advisor for Cybersecurity and Privacy, REGO Payment Architectures; Edward Britan, Head of Global Privacy, Salesforce; and Amelia Vance, Founder and President, Public Interest Privacy Center.
- On April 27, 2023, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Biosafety and Risky Research: Examining if Science is Outpacing Policy and Safety. Witnesses present included: Dr. Rocco Casagrande, Executive Chairman, Gryphon Scientific; Dr. Gregory Koblentz, Associate Professor & Director, Biodefense Graduate Programs, George Mason University; Dr. Andy Pekosz, Professor of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health; and Dr. Robert Hawley, Former Chief of Safety and Radiation Protection Division, U.S. Army Medical Research Institute, Fort Detrick.
- On April 28, 2023, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Antimicrobial Resistance: Examining an Emerging Public Health Threat. Witnesses present included: Amanda Jezek, Senior Vice President, Public Policy and Government Relations, Infectious Diseases Society of America; Kevin Outterson, Professor of Law and Executive Director of CARB-X, Boston University; Mary Denigan-Macauley, Director, Health Care, GAO; and Amy J. Mathers, Associate Professor, Medicine: Infectious Diseases and International Health, University of Virginia School of Medicine.
- On April 26, 2023, the Senate Committee on the Judiciary held a hearing entitled, The Assault on Reproductive Rights in a Post-Dobbs America. Witnesses present included: Michelle Goodwin, Chancellor’s Professor of Law, University of California; Dr. Nisha Verma, Board-certified OB/GYN Fellow, Physicians for Reproductive Health; Amanda Zurawski, Advocate; Dr. Ingrid Skop, Vice President and Director of Medical Affairs, Charlotte Lozier Institute; and Dr. Monique Wubbenhorst, Senior Research Associate, de Nicola Center for Ethics and Culture, University of Notre Dame.
- On April 26, 2023, the Senate Committee on the Budget held a hearing entitled, Under the Weather: Diagnosing the Health Costs of Climate Change. Witnesses present included: The Honorable Stephanie Smith, Member Of The House Of Delegates, District 45, Baltimore City, Maryland; Dr. Katelyn Moretti, Assistant Professor Of Emergency Medicine, Brown Emergency Medicine; Dr. Michael Greenstone, Milton Friedman Distinguished Service Professor in Economics & Director, Becker Friedman Institute & the Energy Policy Institute, University of Chicago; Dr. Carl Schramm, Professor, School of Information Studies, Syracuse University; and Mr. Michael Shellenberger, Founder & President, Environmental Progress.
III. Reports, Studies & Analyses
- On April 24, 2023, the HHS Office of the Inspector General (OIG) published a report entitled, Medicare Could Have Saved Up To $128 Million Over 5 Years if CMS Had Implemented Controls To Address Duplicate Payments for Services Provided to Individuals With Medicare and Veterans Health Administration Benefits. OIG conducted this report because over time, duplicative payments for medical services between Medicare and the Department of Veterans Affairs (VA) has been a persistent issue. OIG conducted an audit of $19.2 billion Medicare Parts A and B payments to determine whether Medicare paid providers for medical services that were authorized and paid for by VA’s community care programs. OIG found that Medicare did pay for services authorized by the VA, resulting in duplicate payments of up to $128 million. OIG determined that the duplicative payments occurred because CMS did not implement controls to prevent duplicate payments for services provided to individuals with both Medicare and Veterans Health Administration (VHA) benefits. OIG recommended that CMS take actions to better integrate data-sharing with VHA in order to identify potential fraud, waste, and abuse under the Medicare program. OIG also recommended that CMS create an internal process to address any duplicative payments going forward.
- On April 24, 2023, GAO published a report entitled, Medicaid: Characteristics of and Expenditures for Adults with Intellectual or Developmental Disabilities. Medicaid is the nation's primary payer of long-term services and supports (LTSS), including HCBS programs that are often utilized by those with intellectual and developmental disabilities (I/DD). HCBS programs provide a range of services that can help individuals with I/DD perform daily activities, such as eating and bathing. GAO’s analysis found that average per-beneficiary Medicaid expenditures in 2019 for beneficiaries with I/DD in selected states ranged from about $51,000 to $70,000, which is two to five times higher than the average expenditures for all Medicaid beneficiaries with disabilities. GAO also found that HCBS expenditures were lower than states’ estimated costs for serving beneficiaries with I/DD in institutional settings.
- On April 26, 2023, the Congressional Research Service (CRS) published a report entitled, Closed, Converted, Merged, and New Hospitals with Medicare Rural Designations: January 2018-November 2022. Hospital closures, conversions (or downsizes), and mergers are particularly relevant topics for hospitals located in rural areas. There are four Medicare hospital designations that aim to bolster the finances of rural hospitals through higher payment rates: critical access hospitals (CAH)s, low-volume hospitals (LVHs), Medicare dependent hospitals (MDHs), and sole community hospitals (SCHs). CRS’s analysis found that of the designated hospitals, only MDHs are overrepresented in the closed, converted, and merged categories. MDHs comprise 3.9 percent of all hospitals with a status change but comprise 10 percent of closed, 6.7 percent of converted and 7 percent of merged hospitals. CRS could not determine why MDHs were overrepresented in the closed, converted, and merged categories.
- On April 28, 2023, GAO published testimony entitled, Antibiotic Resistance: Federal Agencies Have Taken Steps to Combat the Threat, But Additional Actions Needed. Previous GAO analyses found that HHS had made progress expanding surveillance of antibiotic-resistant bacterial infections, but faced challenges in collecting and assessing data. GAO shared that experts warn the current pipeline of antibiotics in development is insufficient to meet the threat of resistance. This testimony provides an overview of GAO’s analysis of federal efforts and challenges related to: (1) the surveillance of antibiotic resistance; (2) diagnostic testing to identify resistant infections; and (3) the development of treatments for resistant infections. GAO also detailed eight recommendations for combatting the threat of antibiotic resistance. Recommendations included identifying leadership and clarifying roles and responsibilities among HHS agencies to assess the clinical outcomes of diagnostic testing for identifying antibiotic-resistant bacteria. GAO also recommended that HHS create a strategic framework to further incentivize the development of new treatments for antibiotic-resistant infections.
- On April 28, 2023, KFF published a report entitled, Mental Health and Substance Use Disorder Coverage in Medicare Advantage Plans. In February 2023, 20 percent of adults aged 65 and older reported symptoms of anxiety and/or depression, illustrating that mental health and substance use challenges face all populations. KFF provided an overview of Medicare’s coverage of mental health and substance use disorder (SUD) services, noting that Medicare Advantage (MA) plans are required to cover the same set of services as traditional Medicare. In its analysis, KFF found that only a small percentage of plans provided beneficiaries with extra benefits specifically for mental health and SUDs in 2022. Further, KFF found that 60 percent of MA enrollees were in plans that did not cover out-of-network mental health and SUD appointments, and that 98 percent of MA beneficiaries were enrolled in plans that required prior authorization for a subset of mental health and substance use services in 2022. KFF concluded that there are data limitations preventing a firm conclusion on whether MA plans are adequately serving mental health and SUD needs, but noted that the Consolidated Appropriations Act, 2023 (CAA, 2023) directs GAO to conduct a study comparing the provision of mental health and SUD services between MA and FFS Medicare.
IV. Other Health Policy News
- On April 24, 2023, HHS’s We Can Do This COVID-19 Public Education Campaign (PEC) collaborated with the Stay Well Community Health Initiative, which works to bring health-related resources to Black communities, to run the first-ever nationwide Vaccination Day. The event offered free COVID-19 vaccines and health resources in 21 cities with the aim of improving vaccination rates in Black communities that experience barriers to accessing health care. The We Can Do This campaign uses partnerships, digital outreach, influencers, and paid media to reach Americans where they are, with a focus on outreach around new HHS initiatives. HHS highlighted that across hundreds of events, the campaign has administered over 15,000 COVID-19 vaccinations. More information on this event can be found here.
- On April 26, 2023, the House of Representatives passed the Limit, Save, Grow Act of 2023 by a vote of 217-215 along party lines, except for four House Republicans who voted against the bill. The bill is not expected to pass in the Senate, which is controlled by Democrats, but is meant to increase the bargaining power of House Speaker Kevin McCarthy (R-CA-20) as the debt limit approaches this summer. The bill would suspend the debt ceiling through either March 31, 2024 or until the national debt increases by $1.5 trillion over the current $31.4 trillion ceiling. The bill would also return total discretionary spending to Fiscal Year (FY) 2022 levels for FY 2024 and restrict annual discretionary spending growth to one percent for the following decade. Further, the Limit, Save, Grow Act of 2023 would rescind unspent COVID-19 relief funds and repeal many of the energy and climate tax credits included in the Inflation Reduction Act (IRA). The Congressional Budget Office (CBO) scored the Limit, Save, Grow Act of 2023, estimating that if the bill is enacted and appropriations caps are met, federal deficits would be reduced by $4.8 trillion over the 2023–2033 period. More information on this bill can be found here.
- On April 26, 2023, CMS announced process updates it is making to increase compliance with the hospital price transparency requirements as implemented in the Hospital Price Transparency final rule. CMS’ existing hospital price transparency requirements direct each hospital operating in the U.S. to make its standard charges public. To date , CMS has issued more than 730 warning notices and 269 requests for corrective action plans (CAPs) and has imposed civil monetary penalties (CMPs) on four hospitals for noncompliance. In its update, CMS will now require hospitals that are out of compliance with the hospital price transparency regulation to submit a CAP within 45 days from when CMS issues the CAP request and be in full compliance within 90 days. The Agency will also now automatically impose a CMP on hospitals that fail to submit a CAP at the end of the 45-day CAP submission deadline. More information on this action can be found here.
- On April 27, 2023, HRSA awarded more than $147 million to 49 recipients to advance the Ending the HIV Epidemic in the U.S. (EHE) initiative, which is part of the Biden Administration’s efforts to lower new HIV infections in the U.S. by at least 90 percent by 2030. The funds will help states with the highest rates of HIV transmission connect individuals living with HIV to critical care, support, and treatment. Awards include nearly $139.1 million to metropolitan areas and states that can be used to implement strategies and initiatives designed to lower HIV transmission rates. The rest of the funding was awarded to two non-profit organizations to provide training and other resources to recipients of EHE funds. More information on this funding can be found here.
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