Organ Transplants: Changes in Allocation Policies for Donated Livers and Lungs

What GAO Found

The Organ Procurement and Transplantation Network (OPTN) develops allocation policies in the United States to determine which transplant candidates receive offers for organs, such as livers or lungs, that are donated from deceased donors. In July 2018, the Department of Health and Human Services (HHS), which oversees OPTN, directed it to change the liver allocation policy to be more consistent with federal regulations. The liver allocation policy changed in February 2020 from a system that, in general, offered donated livers first to the sickest candidates within the fixed boundaries of a donation service area or region to a system based on a candidate’s level of illness and distance from the donor hospital. The current liver allocation policy offers livers first to the sickest candidates within 500 nautical miles of the donor hospital using a series of distance-based concentric circles, called acuity circles.

The processes used to develop the liver and lung allocation policies had various similarities and differences. For example, while the current liver allocation policy, the 2017 liver allocation policy, and the current lung allocation policy each had public comment periods, the length of these comment periods varied—25 days for the current liver allocation policy; two separate 62-day and 64-day periods for the 2017 liver allocation policy; and 61 days (retroactive) for the current lung allocation policy. In addition, the current lung allocation policy resulted in part from a federal district court order directing HHS to initiate emergency review of the policy. However, the 2017 liver allocation policy—that was approved but never implemented—resulted from a 2012 OPTN Board directive to reduce geographic disparities in organ allocation. HHS oversight of OPTN’s processes were similar for all three allocation policies and included reviewing the proposed changes to the policies to ensure compliance with federal regulations, according to HHS officials.

Timeline of Selected Events Related to Three Organ Allocation Policies

Why GAO Did This Study

Organ transplantation is the leading form of treatment for patients with severe organ failure. OPTN, a nonprofit entity that was established in 1984 under the National Organ Transplant Act, manages the nation’s organ allocation system. In 2019, 32,322 organs were transplanted from deceased donors in the United States. Nevertheless, as of July 2020, close to 110,000 individuals remained on waiting lists for donor organs. Previously, donated livers and lungs were generally offered first to the sickest candidates in donation service areas. However, livers and lungs are now generally offered first to the sickest candidates based on distance.

GAO was asked to review the changes to the liver and lung allocation policies. This report describes (1) changes to the liver allocation policy, and (2) similarities and differences in the processes OPTN used to change the liver and lung allocation policies, and federal oversight of these processes, among other things.

GAO reviewed documents, including those related to the current liver and lung allocation policies, and the 2017 liver allocation policy; interviewed HHS officials and OPTN members; reviewed the National Organ Transplant Act and its implementing regulations; and conducted a literature review of studies published from January 2017 through April 2020 in peer-reviewed and other publications.

HHS and the United Network for Organ Sharing (the contractor serving as OPTN) provided technical comments on a draft of this report, which GAO incorporated as appropriate.

For more information, contact James Cosgrove at (202) 512-7114 or cosgrovej@gao.gov.

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    In U.S GAO News
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Estimated Frequency with Which Criminal Investigators Who Reported Using BSA Reports Almost Always, Frequently, or Occasionally Found Relevant Reports for Various Activities, 2015–2018 Notes: GAO conducted a generalizable survey of 5,257 personnel responsible for investigations, analysis, and prosecutions at the Drug Enforcement Administration, Federal Bureau of Investigation, Homeland Security Investigations, Internal Revenue Service-Criminal Investigation, Offices of U.S. Attorneys, and U.S. Secret Service. The margin of error for all estimates is 3 percentage points or less at the 95 percent confidence interval. As of December 2018, GAO found that the Financial Crimes Enforcement Network (FinCEN) granted the majority of federal and state law enforcement agencies and some local agencies direct access to its BSA database, allowing them to conduct searches to find relevant BSA reports. FinCEN data show that these agencies searched the BSA database for about 133,000 cases in 2018—a 31 percent increase from 2014. FinCEN created procedures to allow law enforcement agencies without direct access to request BSA database searches. But, GAO estimated that relatively few local law enforcement agencies requested such searches in 2018, even though many are responsible for investigating financial crimes. GAO found that agencies without direct access may not know about BSA reports or may face other hurdles that limit their use of BSA reports. One of FinCEN's goals is for law enforcement to use BSA reports to the greatest extent possible. However, FinCEN lacks written policies and procedures for assessing which agencies without direct access could benefit from greater use of BSA reports, reaching out to such agencies, and distributing educational materials about BSA reports. By developing such policies and procedures, FinCEN would help ensure law enforcement agencies are using BSA reports to the greatest extent possible to combat money laundering and other crimes. GAO reviewed a nongeneralizable sample of 11 banks that varied in terms of their total assets and other factors, and estimated that their total direct costs for complying with the BSA ranged from about $14,000 to about $21 million in 2018. Under the BSA, banks are required to establish BSA/anti-money laundering compliance programs, file various reports, and keep certain records of transactions. GAO found that total direct BSA compliance costs generally tended to be proportionally greater for smaller banks than for larger banks. For example, such costs comprised about 2 percent of the operating expenses for each of the three smallest banks in 2018 but less than 1 percent for each of the three largest banks in GAO's review (see figure). At the same time, costs can differ between similarly sized banks (e.g., large credit union A and B), because of differences in their compliance processes, customer bases, and other factors. In addition, requirements to verify a customer's identity and report suspicious and other activity generally were the most costly areas—accounting for 29 and 28 percent, respectively, of total compliance costs, on average, for the 11 selected banks. Estimated Total Direct Costs for Complying with the Bank Secrecy Act as a Percentage of Operating Expenses and Estimated Total Direct Compliance Costs for Selected Banks in 2018 Notes: Estimated total direct compliance costs are in parentheses for each bank. Very large banks had $50 billion or more in assets. Small community banks had total of assets of $250 million or less and met the Federal Deposit Insurance Corporation's community bank definition. Small credit unions had total assets of $50 million or less. Federal banking agencies routinely examine banks for BSA compliance. FinCEN data indicate that the agencies collectively cited about 23 percent of their supervised banks for BSA violations each year in their fiscal year 2015–2018 examinations. A small percentage of these violations involved weaknesses in a bank's BSA/anti-money laundering compliance program, which could require the agencies by statute to issue a formal enforcement action. Stakeholders had mixed views on industry proposals to increase the BSA's dollar thresholds for filing currency transaction reports (CTR) and suspicious activity reports (SAR). For example, banks must generally file a CTR when a customer deposits more than $10,000 in cash and a SAR if they identify a suspicious transaction involving $5,000 or more. If both thresholds were doubled, the changes would have resulted in banks filing 65 percent and 21 percent fewer CTRs and SARs, respectively, in 2018, according to FinCEN analysis. Law enforcement agencies told GAO that they generally are concerned that the reduction would provide them with less financial intelligence and, in turn, harm their investigations. In contrast, some industry associations told GAO that they support the changes to help reduce BSA compliance costs for banks. Money laundering and terrorist financing pose threats to national security and the U.S. financial system's integrity. The BSA requires financial institutions to file suspicious activity and other reports to help law enforcement investigate these and other crimes. FinCEN administers the BSA and maintains BSA reports in an electronic database that can be searched to identify relevant reports. Some banks cite the BSA as one of their most significant compliance costs and question whether BSA costs outweigh its benefits in light of limited public information about law enforcement's use of BSA reports. GAO was asked to review the BSA's implementation. This report examines (1) the extent to which law enforcement uses BSA reports and FinCEN facilitates their use, (2) selected banks' BSA compliance costs, (3) oversight of banks' BSA compliance, and (4) stakeholder views of proposed changes to the BSA. GAO surveyed personnel at six federal law enforcement agencies, collected data on BSA compliance costs from 11 banks, reviewed FinCEN data on banking agencies' BSA examinations, and interviewed law enforcement and industry stakeholders on the effects of proposed changes. GAO is recommending that FinCEN develop written policies and procedures to promote greater use of BSA reports by law enforcement agencies without direct database access. FinCEN concurred with GAO's recommendation. For more information, contact Michael Clements at (202) 512-8678 or clementsm@gao.gov.
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    In U.S GAO News
    In fiscal year 2019, debt held by the public reached 79 percent of gross domestic product (GDP). The government's fiscal response to COVID-19 combined with the severe economic contraction from the pandemic will substantially increase federal debt. The Congressional Budget Office (CBO) projected that debt held by the public will reach 98 percent of GDP by the end of fiscal year 2020. The nation's fiscal challenges will require attention once the economy has substantially recovered and public health goals have been attained. GAO has previously reported that a long-term plan is needed to put the government on a sustainable fiscal path. Other countries have used well-designed fiscal rules and targets—which constrain fiscal policy by controlling factors like expenditures or revenue—to contain excessive deficits. For example, Germany's constitution places limits on its deficits. The U.S. federal government has previously enacted fiscal rules, such as those in the Budget Control Act of 2011. However, current fiscal rules have not effectively addressed the misalignment between spending and revenues over time. GAO identified key considerations to help Congress if it were to adopt new fiscal rules and targets, as part of a long-term plan for fiscal sustainability (see table). Key Considerations for Designing, Implementing, and Enforcing Fiscal Rules and Targets Setting clear goals and objectives can anchor a country's fiscal policy. Fiscal rules and targets can help ensure that spending and revenue decisions align with agreed-upon goals and objectives. The weight given to tradeoffs among simplicity, flexibility, and enforceability depends on the goals a country is trying to achieve with a fiscal rule. In addition, there are tradeoffs between the types and combinations of rules, and the time frames over which the rules apply. The degree to which fiscal rules and targets are binding, such as being supported through a country's constitution or nonbinding political agreements, can impact their permanence, as well as the extent to which ongoing political commitment is needed to uphold them. Integrating fiscal rules and targets into budget discussions can contribute to their ongoing use and provide for a built-in enforcement mechanism. The budget process can include reviews of fiscal rules and targets. Fiscal rules and targets with limited, well-defined exemptions, clear escape clauses for events such as national emergencies, and adjustments for the economic cycle can help a country address future crises. Institutions supporting fiscal rules and targets need clear roles and responsibilities for supporting their implementation and measuring their effectiveness. Independently analyzed data and assessments can help institutions monitor compliance with fiscal rules and targets. Having clear, transparent fiscal rules and targets that a government communicates to the public and that the public understands can contribute to a culture of fiscal transparency and promote fiscal sustainability for the country. Source: GAO analysis of literature review and interviews. | GAO-20-561 Our nation faces serious challenges at a time when the federal government is highly leveraged in debt by historical norms. The imbalance between revenue and spending built into current law and policy have placed the nation on an unsustainable long-term fiscal path. Fiscal rules and targets can be used to help frame and control the overall results of spending and revenue decisions that affect the debt. GAO was asked to review fiscal rules and targets. This report (1) assesses the extent to which the federal government has taken action to contribute to long-term fiscal sustainability through fiscal rules and targets, and (2) identifies key considerations for designing, implementing, and enforcing fiscal rules and targets in the U.S. GAO compared current and former U.S. fiscal rules to literature on the effective use of rules and targets; reviewed CBO reports and relevant laws; and interviewed experts. GAO conducted case studies of national fiscal rules in Australia, Germany, and the Netherlands. Congress should consider establishing a long-term fiscal plan that includes fiscal rules and targets, such as a debt-to-GDP target, and weigh GAO's key considerations to ensure proper design, implementation, and enforcement of these rules and targets. The Department of the Treasury and other entities provided technical comments, which GAO incorporated as appropriate. For more information, contact Jeff Arkin, at (202) 512-6806 or arkinj@gao.gov.
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    In U.S GAO News
    The federal government has long identified the financial services sector as a critical component of the nation's infrastructure. The sector includes commercial banks, securities brokers and dealers, and providers of the key financial systems and services that support these functions. Altogether, the sector holds about $108 trillion in assets and faces a variety of cybersecurity-related risks. Key risks include (1) an increase in access to financial data through information technology service providers and supply chain partners; (2) a growth in sophistication of malware—software meant to do harm—and (3) an increase in interconnectivity via networks, the cloud, and mobile applications. Cyberattacks that exploit risks can occur against either public or private components of the sector. For example, in February 2016, hackers were able to install malware on the Bangladesh Central Bank's system through a service provider, which then directed the Federal Reserve Bank of New York to transfer money to accounts in other Asian countries. This attack resulted in the theft of approximately $81 million. Several industry groups and firms are taking steps to enhance the security and resilience of the U.S. financial services sector through a broad range of cyber risk mitigation efforts. These efforts include coordinating within the sector through groups such as the Financial Services Sector Coordinating Council and the Financial Systemic Analysis and Resilience Center, conducting industrywide incident response exercises, sharing threat and vulnerability information, developing and providing guidance in conducting risk assessments, and offering cybersecurity-related training. The Departments of Homeland Security and the Treasury and federal financial regulators are also taking multiple steps to support cybersecurity and resilience through risk mitigation efforts. Among other things, federal agencies provide cybersecurity expertise and conduct simulation exercises related to cyber incident response and recovery. Treasury, as the designated lead agency for the financial sector, plays a key role in supporting many of the efforts to enhance the sector's cybersecurity and resiliency. For example, Treasury's Assistant Secretary for Financial Institutions serves as the chair of the committee of government agencies with sector responsibilities, and Treasury coordinates federal agency efforts to improve the sector's cybersecurity and related communications. However, Treasury does not track efforts or prioritize them according to goals established by the sector for enhancing cybersecurity and resiliency. Treasury also has not fully implemented GAO's previous recommendation to establish metrics related to the value and results of the sector's risk mitigation efforts. Further, the 2016 sector-specific plan, which is intended to direct sector activities, does not identify ways to measure sector progress and is out of date. Among other things, the sector-specific plan lacks information on sector-related requirements laid out in the 2019 National Cyber Strategy Implementation Plan . Unless more widespread and detailed tracking and prioritization of efforts occurs according to the goals laid out in the sector-specific plan, the sector could be insufficiently prepared to deal with cyber-related risks, such as those caused by increased access to data by third parties. For decades, the federal government has taken steps to protect the nation's critical infrastructures. The financial services sector's reliance on information technology makes it a leading target for cyber-based attacks. Recent high-profile breaches at commercial entities have heightened concerns that data are not being adequately protected. Under the Comptroller General's authority, GAO initiated this review to (1) describe the key cyber-related risks facing the financial sector; (2) describe steps the financial services industry is taking to share information on and address risks to its sector; and (3) assess steps federal agencies are taking to enhance the security and resilience of the sector. GAO analyzed relevant reports and information to determine risks and mitigation efforts and compared agency efforts against federal policies and guidance. GAO also interviewed officials at 16 private sector entities, two self-regulatory organizations, and eight federal agencies, including the Department of the Treasury. GAO is making recommendations to Treasury to track and prioritize the sector's cyber risk mitigation efforts, and to update the sector's plan with metrics for measuring progress and information on how sector efforts will meet sector goals and requirements, including those contained within the National Cyber Strategy Implementation Plan. Treasury generally agreed with the recommendations. For more information, contact Nick Marinos at (202) 512-9342 or marinosn@gao.gov or Michael Clements at (202) 512-7763 or ClementsM@gao.gov.
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    In Crime News
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    In U.S Courts
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    In Crime News
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    In U.S GAO News
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