Federal Rulemaking: Selected EPA and HHS Regulatory Analyses Met Several Best Practices, but CMS Should Take Steps to Strengthen Its Analyses

What GAO Found

GAO reviewed 11 Executive Order (EO) 13771 rules—five significant Environmental Protection Agency (EPA) rules and six economically significant Department of Health and Human Services (HHS) rules. Seven of the 11 rules modified (i.e. repealed, amended, or delayed) existing rules (see table). GAO found that analyses for most of the seven rules monetized the same types of benefits and costs as analyses for the rules they modified, an indicator of consistency in the regulatory analyses. For example, one EPA rule modified an earlier rule that had established requirements for chemical risk management programs. EPA monetized anticipated changes to industry compliance costs for both rules. Where agencies monetized similar types of benefits and costs for both reviewed rules and modified rules, the value of some estimates differed, in part, because agencies had updated analytical assumptions, such as the number of entities subject to requirements or relevant wage data.

Topics and Characteristics of 11 Environmental Protection Agency (EPA) and Department of Health and Human Services (HHS) Rules Selected for Review

Agency

Topics

Modified existing rule(s)

Monetized costs exceeded benefits

EPA

Risk management programs

 

Railroad ties as non-waste fuels

 

Chemical data reporting

 

Mercury reporting

 

Effluent from dental offices

HHS, FDA

Food labeling

 

Agricultural water requirements

HHS, CMS

End-stage renal disease treatment

 

Home health quality reporting

 

Patient discharge planning

 

Diabetes prevention and appropriate use of imaging services

Legend: ● = Yes; ○ = No

Source: GAO analysis of EPA, Food and Drug Administration (FDA), and Centers for Medicare & Medicaid Services (CMS) data. | GAO-21-151

Regulatory analyses for eight of the 11 rules GAO reviewed projected that monetized costs would exceed monetized benefits, though each identified other factors that may have led decision makers to determine that the total benefits justified the total costs, such as important, non-quantified effects. These eight analyses met about half of the selected best practices for economic analysis. However, some analyses developed by HHS’s Centers for Medicare & Medicaid Services (CMS) did not fully meet best practices associated with analyzing regulatory alternatives, assessing important effects, and providing transparency. It is particularly important that agencies develop quality analyses for economically significant rules, such as those finalized by CMS. By meeting these best practices, CMS could help the public and other parts of government provide effective feedback and mitigate potential conflict with entities affected by rules. It could also help CMS assess whether a rule’s benefits justify the costs.

Why GAO Did This Study

EO 13771 generally requires executive agencies to identify two rules for repeal for each new rule issued. Since EO 13771 went into effect in 2017, executive agencies have taken regulatory actions expected to generate over $50 billion in savings to society. Quality regulatory analysis provides agency decision makers and the public with a thorough assessment of the benefits and costs of different regulatory options.

GAO was asked to review regulatory analyses for rules finalized under EO 13771. For selected agencies, this report examines (1) how the calculated economic effects of selected rules differed, if at all, from those of rules they modified; and (2) the extent to which agencies met best practices in analyzing the economic effects of selected rules for which monetized costs exceed monetized benefits.

GAO reviewed analyses for 11 rules—and the rules they modified— finalized by EPA and HHS, the two agencies that finalized the most economically significant EO 13771 rules through fiscal year 2019. GAO compared analyses to selected best practices in GAO’s Assessment Methodology for Economic Analysis .

What GAO Recommends

GAO recommends that CMS take steps to ensure its future regulatory analyses are consistent with best practices for analyzing alternatives, assessing important effects, and providing transparency. EPA said it appreciated GAO’s findings. HHS generally agreed with the report, and CMS agreed with the recommendation directed to it.

For more information, contact Yvonne D. Jones at (202) 512-6806 or jonesy@gao.gov.

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    This Capsule—named for its 2-page format—draws from a number of GAO reports to provide examples of how the federal government and states have used Medicaid during pandemics, economic recessions, natural disasters, and other crises. In this Capsule, GAO cites policy considerations and reiterates a recommendation to Congress. For more information, contact Carolyn L. Yocom at (202) 512-7114 or yocomc@gao.gov.
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  • Charges Unsealed Against Former Chadian Diplomats to the U.S. Charged in Connection with International Bribery and Money Laundering Scheme
    In Crime News
    An indictment returned by a federal grand jury in Washington, D.C. was unsealed on May 20, 2021, charging the Republic of Chad’s former Ambassador to the United States and Canada and Chad’s former Deputy Chief of Mission for the United States and Canada with soliciting and accepting a $2 million bribe from a Canadian start-up energy company, and conspiring to launder the bribe payment in order to conceal its true nature.
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  • Quantadyn Corporation And Owner Settle False Claims Act Allegations of Bribery To Obtain Government Contracts For Simulators
    In Crime News
    The Department of Justice announced today that QuantaDyn Corporation (QuantaDyn), headquartered in Ashburn, Virginia, has agreed to resolve civil claims arising from allegations that it engaged in a bribery scheme to steer government contracts for training simulators to the company, as part of a broader settlement that includes a guilty plea by the company.  As part of the plea agreement, QuantaDyn has agreed to pay $37,757,713.91 in restitution, which also will resolve the company’s civil False Claims Act liability for the scheme.  William T. Dunn Jr., the majority owner, President, and Chief Executive Officer of QuantaDyn, has separately paid $500,000 to resolve his personal False Claims Act liability. 
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  • Information Technology: DHS Directives Have Strengthened Federal Cybersecurity, but Improvements Are Needed
    In U.S GAO News
    What GAO Found The Department of Homeland Security (DHS) has established a five-step process for developing and overseeing the implementation of binding operational directives, as authorized by the Federal Information Security Modernization Act of 2014 (FISMA). The process includes DHS coordinating with stakeholders early in the directives' development process and validating agencies' actions on the directives. However, in implementing the process, DHS did not coordinate with stakeholders early in the process and did not consistently validate agencies' self-reported actions. In addition to being a required step in the directives process, FISMA requires DHS to coordinate with the National Institute of Standards and Technology (NIST) to ensure that the directives do not conflict with existing NIST guidance for federal agencies. However, NIST officials told GAO that DHS often did not reach out to NIST on directives until 1 to 2 weeks before the directives were to be issued, and then did not always incorporate the NIST technical comments. More recently, DHS and NIST have started regular coordination meetings to discuss directive-related issues earlier in the process. Regarding validation of agency actions, DHS has done so for selected directives, but not for others. DHS is not well-positioned to validate all directives because it lacks a risk-based approach as well as a strategy to check selected agency-reported actions to validate their completion. Directives' implementation often has been effective in strengthening federal cybersecurity. For example, a 2015 directive on critical vulnerability mitigation required agencies to address critical vulnerabilities discovered by DHS cyber scans of agencies' internet-accessible systems within 30 days. This was a new requirement for federal agencies. While agencies did not always meet the 30-day requirement, their mitigations were validated by DHS and reached 87 percent compliance by 2017 (see fig. 1). DHS officials attributed the recent decline in percentage completion to a 35-day partial government shutdown in late 2018/early 2019. Nevertheless, for the 4-year period shown in the figure below, agencies mitigated within 30 days about 2,500 of the 3,600 vulnerabilities identified. Figure 1: Critical Vulnerabilities Mitigated within 30 days, May 21, 2015 through May 20, 2019 Agencies also made reported improvements in securing or replacing vulnerable network infrastructure devices. Specifically, a 2016 directive on the Threat to Network Infrastructure Devices addressed, among other things, several urgent vulnerabilities in the targeting of firewalls across federal networks and provided technical mitigation solutions. As shown in figure 2, in response to the directive, agencies reported progress in mitigating risks to more than 11,000 devices as of October 2018. Figure 2: Federal Civilian Agency Vulnerable Network Infrastructure Devices That Had Not Been Mitigated, September 2016 through January 2019 Another key DHS directive is Securing High Value Assets, an initiative to protect the government's most critical information and system assets. According to this directive, DHS is to lead in-depth assessments of federal agencies' most essential identified high value assets. However, an important performance metric for addressing vulnerabilities identified by these assessments does not account for agencies submitting remediation plans in cases where weaknesses cannot be fully addressed within 30 days. Further, DHS only completed about half of the required assessments for the most recent 2 years (61 of 142 for fiscal year 2018, and 73 of 142 required assessments for fiscal year 2019 (see fig. 3)). In addition, DHS does not plan to finalize guidance to agencies and third parties, such as contractors or agency independent assessors, for conducting reviews of additional high value assets that are considered significant, but are not included in DHS's current review, until the end of fiscal year 2020. Given these shortcomings, DHS is now reassessing key aspects of the program. However, it does not have a schedule or plan for completing this reassessment, or to address outstanding issues on completing required assessments, identifying needed resources, and finalizing guidance to agencies and third parties. Figure 3: Department of Homeland Security Assessments of Agency High Value Assets, Fiscal Years (FY) 2018 through 2019 Why GAO Did This Study DHS plays a key role in federal cybersecurity. FISMA authorized DHS, in consultation with the Office of Management and Budget, to develop and oversee the implementation of compulsory directives—referred to as binding operational directives—covering executive branch civilian agencies. These directives require agencies to safeguard federal information and information systems from a known or reasonably suspected information security threat, vulnerability, or risk. Since 2015, DHS has issued eight directives that instructed agencies to, among other things, (1) mitigate critical vulnerabilities discovered by DHS through its scanning of agencies' internet-accessible systems; (2) address urgent vulnerabilities in network infrastructure devices identified by DHS; and (3) better secure the government's highest value and most critical information and system assets. GAO was requested to evaluate DHS's binding operational directives. This report addresses (1) DHS's process for developing and overseeing the implementation of binding operational directives and (2) the effectiveness of the directives, including agencies' implementation of the directive requirements. GAO selected for review the five directives that were in effect as of December 2018, and randomly selected for further in-depth review a sample of 12 agencies from the executive branch civilian agencies to which the directives apply. In addition, GAO reviewed DHS policies and processes related to the directives and assessed them against FISMA and Office of Management and Budget requirements; administered a data collection instrument to selected federal agencies; compared the agencies' responses and supporting documentation to the requirements outlined in the five directives; and collected and analyzed DHS's government-wide scanning data on government-wide implementation of the directives. GAO also interviewed DHS and selected agency officials.
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  • United States Sanctions Two Hizballah Officials
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • Former Raytheon Engineer Sentenced for Exporting Sensitive Military Related Technology to China
    In Crime News
    Today, Wei Sun, 49, a Chinese national and naturalized citizen of the United States, was sentenced to 38 months in prison by District Court Judge Rosemary Marquez. Sun previously pleaded guilty to one felony count of violating the Arms Export Control Act (AECA).
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  • Two Individuals Charged with Bribery Related to Iraq Contracts
    In Crime News
    Two individuals have been charged with bribery offenses in connection with Department of Defense contracts as part of the Fraud Section’s ongoing efforts to combat corruption and fraud in contracting on U.S. military installations overseas.
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  • Fake Title – Maintenance (4/18)
    In U.S GAO News
    GAO Email Notification Test We are testing our notification distribution process for GAO reports. If you are able to read this information the link contained in the email notification link worked. Please confirm that you received the email notification from GAOReports@gao.gov and used the link to access the prepublication site by contacting Andrea Thomas at thomasa@gao.gov (202) 512-3147 John Miller at millerj@gao.gov (202) 512-3672 Thank you
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  • This Week in Iran Policy
    In Crime Control and Security News
    Office of the [Read More…]
  • Tennessee Emergency Medical Doctor Sentenced to Prison for Unlawfully Distributing Controlled Substances
    In Crime News
    A Tennessee emergency medical doctor was sentenced today to serve 24 months in prison followed by three years of supervised release for his role in unlawfully distributing controlled substances.
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  • The Department of Justice Alleges Conditions at Cumberland County Jail Violate the Constitution
    In Crime News
    Today, the Justice Department’s Civil Rights Division and the U.S. Attorney’s Office for the District of New Jersey concluded that there is reasonable cause to believe that the conditions at the Cumberland County Jail in Bridgeton, New Jersey violate the Eighth and Fourteenth Amendments of the Constitution.
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  • California Man Charged with COVID-Relief Fraud Scheme
    In Crime News
    A federal grand jury in Los Angeles, California, returned an indictment on April 13, charging a California man with stealing hundreds of thousands of dollars from the Paycheck Protection Program (PPP).
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  • Pharmacist Charged in $4 Million Health Care Fraud and Kickback Scheme
    In Crime News
    A New York man was arrested today for his role in a conspiracy to commit health care fraud and to pay kickbacks and bribes to customers for expensive prescription orders in connection with more than $4 million in Medicare and Medicaid reimbursements.
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  • North Carolina Man Sentenced for Violating Fair Housing Act and Threatening a Family Because of Their Race
    In Crime News
    The Justice Department announced today that Douglas Matthew Gurkins, 34,was sentenced to 28 months in prison, followed by three years supervised release, for using threats of force against an African American family because of the family members’ race and because they were renting a dwelling.
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  • Federal Prison Industries: Actions Needed to Evaluate Program Effectiveness
    In U.S GAO News
    The First Step Act of 2018 made new, nonfederal markets and potential buyers available to Federal Prison Industries (FPI), a government corporation organized within the Bureau of Prisons (BOP); however, various challenges could limit FPI's ability to sell to customers in these markets. FPI makes apparel, personal protective equipment, and furniture, among other products. FPI may now sell to the District of Columbia government, including, for example, to its firefighters; nonfederal, governmental entities for use in correctional settings or in response to a disaster or emergency, such as local jails and first responders; and nonprofit organizations, such as universities. However, a lack of information makes it difficult to estimate the dollar value of these new markets. The following figure depicts the new markets made available to FPI. New Markets for Federal Prison Industries' Products under the First Step Act Data on the size of most of the new markets are very limited. For example, GAO found no existing national information to help estimate the size and scope of relevant spending by nonfederal entities on disaster relief and emergencies. Also, challenges related to state and local government operations, for example, could limit FPI's ability to sell products in the new markets made available under the First Step Act. Specifically, state-level prison industries and in-state vendors often have preferential access to many of the procurement markets now available to FPI. FPI and the private sector share some similar operating requirements, such as those related to keeping workers safe. They also face different requirements and business practices, such as those related to the legal framework, security, and costs. Available data indicate that buyers are generally satisfied with the delivery and quality of FPI products. GAO analyzed 231 performance reports on FPI in the federal government's database for contractor performance, as of August 2019. Customers rated FPI's performance in the delivery schedule and quality categories as exceptional, very good, or satisfactory on about 80 and 90 percent, respectively, of performance reports. There were too few ratings on cost to analyze them. FPI aims to assist inmates in their reentry into society by providing marketable job skills, but BOP has not reviewed FPI's impact on recidivism in over 2 decades. BOP relies on outdated studies that assessed the impact of FPI on inmates released in the 1980s. In January 2020, BOP cited a 1992 study as the basis for the Attorney General's designation of FPI as an Evidence-Based Recidivism Reduction Program under the First Step Act 0f 2018 . BOP made a plan to evaluate FPI but the plan's timeline passed and the BOP has not set a new one. Without an updated plan for evaluating FPI, BOP continues to rely on outdated evaluations of FPI and has limited information about FPI's effectiveness amidst changes to its inmate population Additionally, while BOP has reported some descriptive statistics on recidivism rates, it has not developed a goal. Without a timeline for evaluation and a goal for reducing recidivism, BOP's ability to assess the effectiveness of FPI will be limited. FPI is a government owned corporation that, as a national reentry program, manages, trains, and rehabilitates inmates through employment. FPI sells inmate-produced goods and services primarily to federal government agencies. The First Step Act of 2018 authorized FPI to sell its products to new markets. A provision in the First Step Act of 2018 required GAO to review various aspects of FPI. This report addresses (1) the potential size and scope of the additional markets made available to FPI under the First Step Act; (2) the similarities and differences in selected requirements and business practices of FPI and private sector sellers of products and services; (3) customers' satisfaction with FPI regarding quality, price, and timely delivery of its products and services; and (4) the extent to which BOP has evaluated the effectiveness of FPI and other vocational programs in reducing recidivism and the results. GAO examined recidivism studies and data, analyzed performance data, conducted fieldwork at four FPI facilities selected based on security level and type of products produced, met with industry associations, and interviewed agency officials and employed inmates. GAO is making two recommendations: (1) BOP should update its evaluation plan for FPI by setting a new timeline for evaluation and (2) BOP should set a goal to reduce recidivism. DOJ concurred with the recommendations. For more information, contact Gretta L. Goodwin at (202) 512-8777 or goodwing@gao.gov or William T. Woods at (202) 512-4841 or woodsw@gao.gov.
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  • Federal Contractor Agrees to Pay More Than $6 Million to Settle Overbilling Allegations
    In Crime News
    Virginia-based Information Innovators Inc. (Triple-I) has agreed to pay the United States $6.05 million to resolve allegations that a predecessor company, Creative Computing Solutions Inc. (CCSi), violated the False Claims Act by knowingly overbilling the U.S. Department of Homeland Security (DHS) for work performed by CCSi employees who lacked required job qualifications.
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  • Priority Open Recommendations: U.S. Agency for International Development
    In U.S GAO News
    What GAO Found In April 2020, GAO identified three priority recommendations for the U.S. Agency for International Development (USAID). Since then, USAID has implemented all three of those recommendations by taking actions to improve management and oversight of international food assistance projects, project performance data collection, and reform efforts. In May 2021, GAO identified three additional priority recommendations for USAID, bringing the total number to three. These recommendations involve the following areas: Complying with Equal Employment Opportunity requirements Improving financial information USAID's continued attention to these issues could lead to significant improvements in government operations. Why GAO Did This Study Priority open recommendations are the GAO recommendations that warrant priority attention from heads of key departments or agencies because their implementation could save large amounts of money; improve congressional and/or executive branch decision-making on major issues; eliminate mismanagement, fraud, and abuse; or ensure that programs comply with laws and funds are legally spent, among other benefits. Since 2015 GAO has sent letters to selected agencies to highlight the importance of implementing such recommendations. For more information, contact Thomas Melito at (202) 512-9601 or melitot@gao.gov.
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  • Missile Defense: Observations on Ground-based Midcourse Defense Acquisition Challenges and Potential Contract Strategy Changes
    In U.S GAO News
    The Missile Defense Agency (MDA) is developing a system to defend the U.S. from long-range missile attacks. As MDA continues to develop this system, called Ground-based Midcourse Defense (GMD), it has opportunities to incorporate into its approach lessons learned from over 2 decades of system development. MDA has made progress in developing and fielding elements of the GMD system. For example, MDA is constructing a new missile field to expand the fleet of interceptors. However, MDA has also experienced significant setbacks. Most recently, the Department of Defense canceled development of a key GMD element, the Redesigned Kill Vehicle, in 2019 because of fundamental problems with the system's design. Ongoing Construction of a New Ground-based Midcourse Defense Interceptor Field (July 16, 2019) Over the years, GAO has identified practices that MDA could apply to the GMD program to improve acquisition outcomes, such as: Using knowledge-based acquisition practices Involving stakeholders early and often Providing effective oversight Promoting competition Performing robust testing GAO has also made numerous recommendations to improve MDA's acquisition outcomes and reduce risk. As of July 2020, the department has concurred with most of the recommendations GAO made since MDA's inception in 2002. Although the department has implemented many of the recommendations, it has further opportunities to implement the remaining open recommendations and apply lessons learned on a major, new effort to develop a next-generation GMD interceptor. Since the late 1990s, DOD has executed the GMD program through a prime contractor responsible for developing and integrating the entire weapon system. MDA is considering taking over these responsibilities for GMD for the next phase of the program. GAO found that this approach offers potential benefits to the agency, such as more direct control over and greater insight into GMD's cost, schedule, and performance. However, the approach has some challenges that, if not addressed, could outweigh the benefits. For example, MDA may encounter challenges obtaining the technical data and staffing levels necessary to manage this complex weapon system, which could ultimately affect its availability or readiness. As of October 2020, MDA has not yet determined an acquisition strategy for the next phase of the GMD program. The GMD system aims to defend the U.S. against ballistic missile attacks from rogue states like North Korea or Iran. DOD has been developing this system since the 1990s and has spent $53 billion on the system so far. GMD is a complex system that includes interceptors and a ground system, and MDA has largely relied on a contractor, Boeing, to manage development and system integration. MDA is considering moving away from this approach as the program embarks on developing a key element of the GMD, a new interceptor. The House Armed Services Committee included a provision in a report for GAO to assess the GMD contract structure and identify potential opportunities to improve government management and contractor accountability. This report addresses (1) the lessons learned from challenges MDA encountered acquiring the GMD system and (2) the potential benefits and risks of MDA taking over system integration responsibilities for GMD. To conduct this work, GAO reviewed GMD program documentation, prior GAO reports on missile defense, GAO interviews with other DOD components, and expert panel reviews of GMD. GAO also spoke with officials from MDA and other DOD components. GAO has 17 open recommendations aimed at improving missile defense acquisition outcomes and reducing risk. Recently, DOD has taken steps to address some of these open recommendations, but further action is needed to fully implement the remaining recommendations. For more information, contact W. William Russell at (202) 512-4841 or russellw@gao.gov.
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  • Department of Justice Releases Report on its Efforts to Disrupt, Dismantle, and Destroy MS-13
    In Crime News
    Today, the Department of Justice released “Full Scale Response: A Report on the Department’s Efforts to Combat MS-13 from 2016-2020.”  This report describes the Department’s work to dismantle La Mara Salvatrucha (MS-13) in the United States and abroad.  The data show that since 2016, the Department has prosecuted approximately 749 MS-13 gang members.  So far, more than 500 of these MS-13 gang members have been convicted, including 37 who received life sentences.  Department prosecutors are using more than 20 federal criminal statutes to prosecute MS-13 members, including, for the first time, filing terrorism charges against MS-13’s leadership.  The data also show that for decades MS-13 has exploited weaknesses in border enforcement policies, as approximately 74 percent of the defendants prosecuted were unlawfully present in the United States.  The report also describes the Department’s efforts to combat MS-13 internationally through increased partnerships with law enforcement in Mexico and Central America.  Through international cooperation, hundreds of MS-13 members have been arrested abroad and more than 50 MS-13 members have been extradited to the United States.
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  • Secretary Blinken’s Call with Bruneian Foreign Minister II Erywan
    In Crime Control and Security News
    Office of the [Read More…]
  • Former Cancer Center President Indicted For Participation In Long-Running Antitrust Conspiracy
    In Crime News
    A federal grand jury returned an indictment against Dr. William Harwin, founder and former President of Florida Cancer Specialists & Research Institute LLC (FCS), for conspiring to allocate medical and radiation oncology treatments for patients in Southwest Florida, the Department of Justice announced today.
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