The United States Officially Rejoins the Paris Agreement

Antony J. Blinken, Secretary of State

On January 20, on his first day in office, President Biden signed the instrument to bring the United States back into the Paris Agreement. Per the terms of the Agreement, the United States officially becomes a Party again today.

The Paris Agreement is an unprecedented framework for global action. We know because we helped design it and make it a reality. Its purpose is both simple and expansive: to help us all avoid catastrophic planetary warming and to build resilience around the world to the impacts from climate change we already see.

Now, as momentous as our joining the Agreement was in 2016 — and as momentous as our rejoining is today — what we do in the coming weeks, months, and years is even more important.

You have seen and will continue to see us weaving climate change into our most important bilateral and multilateral conversations at all levels. In these conversations, we’re asking other leaders: how can we do more together?

Climate change and science diplomacy can never again be “add-ons” in our foreign policy discussions. Addressing the real threats from climate change and listening to our scientists is at the center of our domestic and foreign policy priorities. It is vital in our discussions of national security, migration, international health efforts, and in our economic diplomacy and trade talks.

We are reengaging the world on all fronts, including at the President’s April 22nd Leaders’ Climate Summit. And further out, we very much looking forward to working with the United Kingdom and other nations around the world to make COP26 a success.

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    Through Operation Warp Speed—a partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DOD)—the federal government is accelerating efforts to develop vaccines and therapeutics for COVID-19. A typical vaccine development process can take approximately 10 years or longer, but efforts under Operation Warp Speed seek to greatly accelerate this process by completing key steps simultaneously (see figure). As of October 15, 2020, Operation Warp Speed publicly announced financial support for the development or manufacturing of six COVID-19 vaccine candidates totaling more than $10 billion in obligations. It has also announced financial support for the development of therapeutics, such as a $450 million award to manufacture a monoclonal antibody treatment (a treatment that uses laboratory-made antibodies, which also may be able to serve as a prevention option). Operation Warp Speed Timeline for a Potential Vaccine Candidate Note: An Emergency Use Authorization allows for emergency use of medical products without FDA approval or licensure during a declared emergency, provided certain statutory criteria are met. The Food and Drug Administration (FDA) may temporarily allow the use of unlicensed or unapproved COVID-19 vaccines and therapeutics through emergency use authorizations (EUA), provided there is evidence that the products may be effective and that known and potential benefits outweigh known and potential risks. For vaccines, FDA issued guidance in October 2020 to provide vaccine sponsors with recommendations regarding the evidence FDA needed to support issuance of an EUA. For therapeutics, FDA has issued four EUAs as of November 9, 2020. The evidence to support FDA's COVID-19 therapeutic authorization decisions has not always been transparent, in part because FDA does not uniformly disclose its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics. Given the gravity of the pandemic, it is important that FDA identify ways to uniformly disclose this information to the public. By doing so, FDA could help improve the transparency of, and ensure public trust in, its EUA decisions. The U.S. had about 10.3 million cumulative reported cases of COVID-19 and about 224,000 reported deaths as of November 12, 2020. Given this catastrophic loss of life as well as the pandemic's effects on the U.S. economy, effective and safe vaccines and therapeutics are more important than ever. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines, (1) efforts of Operation Warp Speed to accelerate COVID-19 vaccine and therapeutic development; and (2) FDA's use of EUAs for COVID-19 therapeutics and vaccines, among other objectives. GAO reviewed federal laws and agency documents, including HHS and DOD information on vaccine and therapeutic development and EUAs as of November 2020. GAO interviewed or received written responses from HHS and DOD officials, and interviewed representatives from vaccine developers and manufacturers, as well as select public health stakeholders and provider groups covering a range of provider types. FDA should identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines. HHS neither agreed nor disagreed with the recommendation, but said it shared GAO's goal of transparency and would explore approaches to achieve this goal. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov, or Alyssa M. Hundrup at (202) 512-7114 or hundrupa@gao.gov.
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  • Covid-19 In Nursing Homes: HHS Has Taken Steps in Response to Pandemic, but Several GAO Recommendations Have Not Been Implemented
    In U.S GAO News
    What GAO Found GAO's review of data from the Centers for Disease Control and Prevention (CDC) found that winter 2020 was marked by a significant surge in the number of COVID-19 cases and deaths in nursing homes. However, CDC data as of February 2021, show that both cases and deaths have declined by more than 80 percent since their peaks in December 2020. With the introduction of vaccines, observers are hopeful that nursing homes may be beginning to see a reprieve. Nevertheless, the emergence of more highly transmissible virus variants warrants the need for continued vigilance, according to public health officials. GAO's prior work has found that nursing homes have faced many difficult challenges battling COVID-19. While challenges related to staffing shortages have persisted through the pandemic, challenges related to obtaining Personal Protective Equipment (PPE) and conducting COVID-19 tests—although still notable—have generally shown signs of improvement since summer 2020. Further, with the decline in nursing homes cases, the Centers for Medicare and Medicaid Services (CMS) updated its guidance in March 2021 to expand resident visitation, an issue that has been an ongoing challenge during the pandemic. Some new challenges have also emerged as vaccinations began in nursing homes, such as reluctance among some staff to receive a COVID-19 vaccine. The Department of Health and Human Services (HHS), primarily through CMS and the CDC, has taken steps to address COVID-19 in nursing homes. However, HHS has not implemented several relevant GAO recommendations, including: HHS has not implemented GAO's recommendation related to the Nursing Home Commission report, which assessed the response to COVID-19 in nursing homes. CMS released the Nursing Home Commission's report and recommendations in September 2020. When the report was released, CMS broadly outlined the actions the agency had taken, but the agency did not provide a plan that would allow it to track its progress. GAO recommended in November 2020 that HHS develop an implementation plan. As of February 2021, this recommendation had not been implemented. HHS has not implemented GAO's recommendation to fill COVID-19 data voids. CMS required nursing homes to begin reporting the number of cases and deaths to the agency effective May 8, 2020. However, CMS made the reporting of the data prior to this date optional. GAO recommended in September 2020 that HHS develop a strategy to capture more complete COVID-19 data in nursing homes retroactively back to January 1, 2020. As of February 2021, this recommendation had not been implemented. Implementing GAO's recommendations could help address some of the challenges nursing homes continue to face and fill important gaps in the federal government's understanding of, and transparency around, data on COVID-19 in nursing homes. In addition to monitoring HHS's implementation of past recommendations, GAO has ongoing work related to COVID-19 outbreaks in nursing homes and CMS's oversight of infection control and emergency preparedness. Why GAO Did This Study The COVID-19 pandemic has had a disproportionate impact on the 1.4 million elderly or disabled residents in the nation's more than 15,000 Medicare- and Medicaid-certified nursing homes, who are often in frail health and living in close proximity to one another. HHS, primarily through CMS and CDC, has led the pandemic response in nursing homes. The CARES Act includes a provision for GAO to conduct monitoring and oversight of the federal government's efforts to prepare for, respond to, and recover from the COVID-19 pandemic. GAO has examined the government's response to COVID-19 in nursing homes through its CARES Act reporting (GAO-21-265, GAO-21-191, GAO-20-701, and GAO-20-625). This testimony will summarize the findings from these reports. Specifically, it describes COVID-19 trends in nursing homes and their experiences responding to the pandemic, and HHS's response to the pandemic in nursing homes. To conduct this previously reported work, GAO reviewed CDC data, agency guidance, and other relevant information on HHS's response to the COVID-19 pandemic. GAO interviewed agency officials and other knowledgeable stakeholders. In addition, GAO supplemented this information with updated data from CDC on COVID-19 cases and deaths reported by nursing homes as of February 2021. For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.
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    A Houston-area physician and anesthesiologist at two registered pain clinics, Texas Pain Solutions and Integra Medical Clinic, was sentenced today to seven years in prison for his role in fraudulently billing health care programs for at least $5 million dollars in medical tests and procedures, and for the role his fraud played in multiple patient deaths.
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  • Medicaid: CMS Needs More Information on States’ Financing and Payment Arrangements to Improve Oversight
    In U.S GAO News
    States and the federal government share in financing Medicaid, a health care program for low-income and medically needy individuals. States finance the nonfederal share with state general funds and other sources, such as taxes on health care providers and funds from local governments. GAO's analysis showed a change in how states finance their Medicaid programs. In particular, states relied on provider taxes and local government funds for about 28 percent, or $63 billion, of the estimated $224 billion total nonfederal share of Medicaid payments in state fiscal year 2018—7 percentage points more than state fiscal year 2008. Nonfederal Share of Medicaid Payments from Provider Taxes and Local Government Funds, State Fiscal Years 2008 and 2018 Note: Percentages do not add up due to rounding. Furthermore, GAO estimated that states' reliance on provider taxes and local government funds decreased states' share of net Medicaid payments (total state and federal payments) and effectively increased the federal share of net Medicaid payments by 5 percentage points in state fiscal year 2018. It also resulted in smaller net payments to some providers after the taxes and local government funds they contribute to their payments are taken into account. While net payments are smaller, the federal government's contribution does not change. This effectively shifts responsibility for a larger portion of Medicaid payments to the federal government and away from states. The Centers for Medicare & Medicaid Services (CMS)—which oversees Medicaid—collects some information on states' sources of funds and payments, but it is not complete, consistent, or sufficiently documented, which hinders the agency's oversight. For example, CMS does not require states to report on the source of the nonfederal share for all payments. Absent complete, consistent, and sufficiently documented information about all Medicaid payments, CMS cannot adequately determine whether payments are consistent with statutory requirements for economy and efficiency, and with permissible financing, such as the categories of services on which provider taxes may be imposed. Medicaid cost $668 billion in fiscal year 2019. GAO has previously reported on concerns about states' use of various funding sources for the nonfederal share. Although such financing arrangements are allowed under certain conditions, they can also result in increasing the share of net costs paid by the federal government and decreasing reliance on state general funds. GAO was asked to review the sources of funds states used for Medicaid and the types of payments made to providers. This report describes states' reliance on provider and local government funds for these arrangements; the estimated effect of these arrangements on the federal share of net Medicaid payments; and the extent to which CMS collects information on these arrangements. To do this work, GAO reviewed CMS information; administered a questionnaire to all state Medicaid agencies; analyzed the estimated effects of reliance on provider and local government funds; and interviewed CMS officials, as well as Medicaid officials in 11 states selected, in part, on Medicaid spending and geographic diversity. The Administrator of CMS should collect and document complete and consistent information about the sources of funding for the nonfederal share of payments to providers. CMS neither agreed nor disagreed with GAO's recommendation, but acknowledged the need for additional financing and payment data for Medicaid oversight. For more information, contact Carolyn L. Yocom at (202) 512-7114 or yocomc@gao.gov.
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  • Medicaid Information Technology: Effective CMS Oversight and States’ Sharing of Claims Processing and Information Retrieval Systems Can Reduce Costs
    In U.S GAO News
    The Centers for Medicare and Medicaid Services (CMS) has reimbursed billions of dollars to states for the development, operation, and maintenance of claims processing and information retrieval systems—the Medicaid Management Information Systems (MMIS) and Eligibility and Enrollment (E&E) systems. Specifically, from fiscal year 2008 through fiscal year 2018, states spent a total of $44.1 billion on their MMIS and E&E systems. CMS reimbursed the states $34.3 billion of that total amount (see figure). Money Spent by States and Reimbursed by CMS from 2008–2018 for Medicaid Management Information Systems (MMIS) and Eligibility and Enrollment (E&E) Systems For fiscal years 2016 through 2018, CMS approved 93 percent and disapproved 0.4 percent of MMIS funding requests, while for E&E it approved 81 percent and disapproved 1 percent of the requests. The remaining 6.6 percent of MMIS requests and 18 percent of E&E requests were either withdrawn by states or were pending. GAO estimates that CMS had some level of supporting evidence of its review for about 74 percent of MMIS requests and about 99 percent of E&E requests. However, GAO estimates that about 100 percent of E&E requests and 68 percent of MMIS requests lacked pertinent information that would be essential for indicating that a complete review had been performed. Among CMS requirements for system implementation funding is that states submit an alternatives analysis, feasibility study, and cost benefit analysis. However, GAO found that about 45 percent of such requests it sampled for fiscal years 2016 through 2018 did not include these required documents. The above weaknesses were due, in part, to a lack of formal, documented procedures for reviewing state funding requests. CMS also lacked a risk-based process for overseeing systems after federal funds were provided. CMS provided helpful comments and recommendations to states in selected cases, but in other instances it did not. In two states that had contractors struggling to deliver successful projects, state officials said they had not received recommendations or technical assistance from CMS. The states eventually terminated the projects after spending a combined $38.5 million in federal funds. According to CMS officials, they rely largely on states to oversee systems projects. This perspective is consistent with a 2018 Office of Management and Budget (OMB) decision that federal information technology (IT) grants totaling about $9 billion annually would no longer be tracked on OMB's public web site on IT investment performance. Accordingly, the CMS and Health and Human Services chief information officers (CIO) are not involved in overseeing MMIS or E&E projects. Similarly, 21 of 47 states responding to GAO's survey reported that their state CIO had little or no involvement in overseeing their MMISs. Such non-involvement of officials with duties that should be heavily focused on successful acquisition and operation of IT projects could be hindering states' ability to effectively implement systems. To improve oversight, CMS has begun a new outcome-based initiative that focuses the agency's review of state funding requests on the successful achievement of business outcomes. However, as of February 2020, CMS had not yet established a timeline for including MMIS and E&E systems in the new outcome-based process. CMS had various initiatives aimed at reducing duplication of Medicaid systems (see table). Description and Status of Centers for Medicare and Medicaid Services Initiatives Aimed at Reducing Duplication by Sharing, Leveraging, and Reusing Medicaid Information Technology Initiative Description Implementation status Number of surveyed states reporting use of the initiative Reuse Repository Used by states to collect and share reusable artifacts. Made available in August 2017. As of January 2020, CMS was no longer supporting this initiative. 25 of the 50 reporting states Poplin Project Was to provide free, open-source application program interfaces for states to use in developing their modular Medicaid systems. Initiative never fully implemented. As of January 2020, CMS was no longer supporting this initiative. Three of the 50 reporting states Open Source Provider Screening Module Open-source module for states to use at no charge. Made available in August 2018. As of January 2020, CMS was no longer supporting this initiative. One of the 50 states reported attempting to use the module. Medicaid Enterprise Cohort Meetings A forum where states can discuss sharing, leveraging, and/or reuse of Medicaid technologies. As of January 2020, Cohort meetings were being held on a monthly basis. 47 of the 50 states reported participating in the meetings. Source: GAO analysis of agency data. | GAO-20-179 However, as of January 2020, the agency was no longer supporting most of these initiatives because they failed to produce the desired results. CMS regulations and GAO's prior work have highlighted the importance of reducing duplication by sharing and reusing Medicaid IT. To illustrate the potential for reducing duplication, 53 percent of state Medicaid officials responding to our survey reported using the same contractor to develop their MMIS. Nevertheless, selected states are taking the initiative to share systems or modules. Further support by CMS could result in additional sharing initiatives and potential cost savings. The Medicaid program is the largest source of health care funding for America's most at-risk populations and is funded jointly by states and the federal government. GAO was asked to assess CMS's oversight of federal expenditures for MMIS and E&E systems used for Medicaid. This report examines (1) the amount of federal funds that CMS has provided to state Medicaid programs to support MMIS and E&E systems, (2) the extent to which CMS reviews and approves states' funding requests for the systems and oversees the use of these funds, and (3) CMS's and states' efforts to reduce potential duplication of Medicaid IT systems. GAO assessed information related to MMIS and E&E systems, such as state expenditure data, federal regulations, and CMS guidance to the states for submitting funding requests, states' system funding requests, and IT project management documents. GAO also evaluated a generalizable sample of approved state funding requests from fiscal years 2016 through 2018 to analyze, among other things, CMS's review and approval process and conducted interviews with agency and state Medicaid officials. GAO also reviewed relevant regulations and guidance on promoting, sharing, and reusing MMIS and E&E technologies; and surveyed 50 states and six territories (hereafter referred to as states) regarding the MMIS and E&E systems, and assessed the complete or partial responses received from 50 states. GAO is making nine recommendations to improve CMS's processes for approving and overseeing the federal funds for MMIS and E&E systems and for bolstering efforts to reduce potential duplication. Among these recommendations are that CMS should develop formal, documented procedures that include specific steps to be taken in the advanced planning document review process and instructions on how CMS will document the reviews; develop, in consultation with the HHS and CMS CIOs, a documented, comprehensive, and risk-based process for how CMS will select IT projects for technical assistance and provide recommendations to assist states that is aimed at improving the performance of the systems; encourage state Medicaid program officials to consider involving state CIOs in overseeing Medicaid IT projects; establish a timeline for implementing the outcome-based certification process for MMIS and E&E systems; and identify, prior to approving funding for systems, similar projects that other states are pursuing so that opportunities to share, leverage, or reuse systems or system modules are considered. In written comments on a draft of this report, the department concurred with eight of the nine recommendations, and described steps it had taken and/or planned to take to address them. The department did not state whether it concurred with GAO's recommendation to encourage state officials to consider involving state CIOs in Medicaid IT projects. HHS stated that it was unable to discern evidence as to whether a certain structure contributed to a specific outcome. GAO believes, consistent with federal law, that CIOs are critically important to the success of IT projects. For more information, contact Vijay D’Souza at (202) 512-6240 or dsouzav@gao.gov.
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    In Crime News
    On October 1, President Donald J. Trump signed into law a continuing resolution that contains the Antitrust Criminal Penalty Enhancement and Reform Permanent Extension Act (the “Act”).  The Act reauthorizes the Antitrust Criminal Penalty Enhancement and Reform Act (ACPERA) and repeals the sunset provision therein.
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