GAO-21-40, Federal Buying Power: OMB Can Further Advance Category Management Initiative by Focusing on Requirements, Data, and Training, November 30, 2020


Category management is a government-wide initiative led by the Office of Management and Budget (OMB) that saves the federal government billions of dollars each year by improving how agencies buy common products and services. Defining requirements is a key first step agencies should take to understand what products and services they need before deciding how to buy them. However, OMB has primarily focused on the contracting aspects of the initiative, for example, in its guidance and implementation metrics. Leading practitioners of category management told GAO that agencies could save billions of additional dollars if OMB focused more on how agencies define requirements, which is consistent with GAO's previous findings (see figure). Office of Management and Budget's (OMB) Category Management Guidance and Metrics Agency officials told GAO that data challenges—particularly challenges in collecting, analyzing, and sharing data on their spending and the prices they pay—have hindered implementation of the category management initiative. OMB is aware of these government-wide challenges and has directed agencies to take certain steps on their own to address them. However, OMB's Fiscal Year 2020 Action Plan for managing government data states OMB should take a leadership role in addressing government-wide data challenges (see figure). Office of Management and Budget's (OMB) Approach to Category Management Data Challenges GAO found small businesses received 30 percent or more of annual category management obligations since 2016, but the number of small business vendors providing common products and services decreased each year, continuing a decade-long trend affecting both small and larger businesses. GAO also found that OMB should improve communication with small businesses by enhancing training for agency personnel responsible for small business matters (see figure). Office of Management and Budget's (OMB) Category Management Training for Agency Personnel Responsible for Small Business Matters In fiscal year 2019, federal agencies obligated over $350 billion to meet requirements for common products and services, such as medical supplies and computers. Since 2016, OMB has led efforts to improve how agencies buy these products and services through the category management initiative, which directs agencies across the government to buy more like a single enterprise. OMB has reported the federal government has saved $27.3 billion in 3 years through category management. GAO was asked to assess the initiative. This report assesses the extent to which: (1) OMB has focused on agencies' requirements definition, (2) agencies face challenges analyzing data, and (3) agencies bought common products and services from small businesses. GAO assessed data for all 28 agencies OMB tracks under the initiative, reviewed category management guidance from four selected agencies (with varying levels of implementation experience), and interviewed a broad range of officials from nine agencies as well as four small business advocacy groups. GAO is making 10 recommendations to OMB to increase emphasis on requirements, lead efforts to address data challenges, and improve training for small business personnel. OMB concurred with the substance of GAO's recommendations. For more information, contact Timothy DiNapoli at (202) 512-4841 or

GAO-21-7SP, Artificial Intelligence in Health Care: Benefits and Challenges of Technologies to Augment Patient Care, November 30, 2020


Artificial Intelligence (AI) tools have shown promise for augmenting patient care in the following two areas: Clinical AI tools have shown promise in predicting health trajectories of patients, recommending treatments, guiding surgical care, monitoring patients, and supporting population health management (i.e., efforts to improve the health outcomes of a community). These tools are at varying stages of maturity and adoption, but many we describe, with the exception of population health management tools, have not achieved widespread use. Administrative AI tools have shown promise in reducing provider burden and increasing efficiency by recording digital notes, optimizing operational processes, and automating laborious tasks. These tools are also at varying stages of maturity and adoption, ranging from emerging to widespread. GAO identified the following challenges surrounding AI tools, which may impede their widespread adoption: Data access. Developers experience difficulties obtaining the high-quality data needed to create effective AI tools. Bias. Limitations and bias in data used to develop AI tools can reduce their safety and effectiveness for different groups of patients, leading to treatment disparities. Scaling and integration. AI tools can be challenging to scale up and integrate into new settings because of differences among institutions and patient populations. Lack of transparency. AI tools sometimes lack transparency—in part because of the inherent difficulty of determining how some of them work, but also because of more controllable factors, such as the paucity of evaluations in clinical settings. Privacy. As more AI systems are developed, large quantities of data will be in the hands of more people and organizations, adding to privacy risks and concerns. Uncertainty over liability. The multiplicity of parties involved in developing, deploying, and using AI tools is one of several factors that have rendered liability associated with the use of AI tools uncertain. This may slow adoption and impede innovation. GAO developed six policy options that could help address these challenges or enhance the benefits of AI tools. The first five policy options identify possible new actions by policymakers, which include Congress, elected officials, federal agencies, state and local governments, academic and research institutions, and industry. The last is the status quo, whereby policymakers would not intervene with current efforts. See below for details of the policy options and relevant opportunities and considerations. Policy Options to Address Challenges or Enhance Benefits of AI to Augment Patient Care Policy Option Opportunities Considerations Collaboration (report p. 32) Policymakers could encourage interdisciplinary collaboration between developers and health care providers. Could result in AI tools that are easier to implement and use within a providers’ existing workflow. Could help implement tools on a larger scale. Approaches to encourage collaboration include agencies seeking input from innovators. For example, agencies have used a challenge format to encourage the public to develop innovative technologies. May result in the creation of tools that are specific to one hospital or provider. Providers may not have time to both collaborate and treat patients. Data Access (report p. 33) Policymakers could develop or expand high-quality data access mechanisms. A “data commons”–a cloud based-platform where users can store, share, access, and interact with data–could be one approach. More high-quality data could facilitate the development and testing of AI tools. Could help developers address bias concerns by ensuring data are representative, transparent and equitable. Cybersecurity and privacy risks could increase, and threats would likely require additional precautions. Would likely require large amounts of resources to successfully coordinate across different domains and help address interoperability issues. Organizations with proprietary data could be reluctant to participate. Best Practices (report p. 34) Policymakers could encourage relevant stakeholders and experts to establish best practices (such as standards) for development, implementation, and use of AI technologies. Could help providers deploy AI tools by providing guidance on data, interoperability, bias, and implementation, among other things. Could help improve scalability of AI tools by ensuring data are formatted to be interoperable. Could address concerns about bias by encouraging wider representation and transparency. Could require consensus from many public- and private-sector stakeholders, which can be time- and resource-intensive. Some best practices may not be widely applicable because of differences across institutions and patient populations. Interdisciplinary Education (report p. 35) Policymakers could create opportunities for more workers to develop interdisciplinary skills. Could help providers use tools effectively. Could be implemented in a variety of ways, including through changing academic curriculums or through grants. Employers and university leaders may have to modify their existing curriculums, potentially increasing the length of medical training. Oversight Clarity (report p. 36) Policymakers could collaborate with relevant stakeholders to clarify appropriate oversight mechanisms. Predictable oversight could help ensure that AI tools remain safe and effective after deployment and throughout their lifecycle. A forum consisting of relevant stakeholders could help recommend additional mechanisms to ensure appropriate oversight of AI tools. Soliciting input and coordinating among stakeholders, such as hospitals, professional organizations, and agencies, may be challenging. Excess regulation could slow the pace of innovation.   Status quo (report p. 37) Policymakers could maintain the status quo (i.e., allow current efforts to proceed without intervention). Challenges may be resolved through current efforts. Some hospitals and providers are already using AI to augment patient care and may not need policy-based solutions to continue expanding these efforts. Existing efforts may prove more beneficial than new options. The challenges described in this report may remain unresolved or be exacerbated. For example, fewer AI tools may be implemented at scale and disparities in use of AI tools may increase. Source: GAO. The U.S. health care system is under pressure from an aging population; rising disease prevalence, including from the current pandemic; and increasing costs. New technologies, such as AI, could augment patient care in health care facilities, including outpatient and inpatient care, emergency services, and preventative care. However, the use of AI-enabled tools in health care raises a variety of ethical, legal, economic, and social concerns. GAO was asked to conduct a technology assessment on the use of AI technologies to improve patient care, with an emphasis on foresight and policy implications. This report discusses (1) current and emerging AI tools available for augmenting patient care and their potential benefits, (2) challenges surrounding the use of these tools, and (3) policy options to address challenges or enhance benefits of the use of these tools. GAO assessed AI tools developed for or used in health care facilities; interviewed a range of stakeholder groups including government, health care, industry, academia, and a consumer group; convened a meeting of experts in collaboration with the National Academy of Medicine; and reviewed key reports and scientific literature. GAO is identifying policy options in this report. For more information, contact Karen L. Howard at (202) 512-6888 or

GAO-21-35, Public Health: Federal Programs Provide Screening and Treatment for Breast and Cervical Cancer, October 28, 2020


The Centers for Disease Control and Prevention (CDC) operates the National Breast and Cervical Cancer Early Detection Program (the Early Detection Program) to provide cancer screening and diagnostic services to people who are low-income and uninsured or underinsured. For those screened under the program who require treatment, the Breast and Cervical Cancer Prevention and Treatment Act of 2000 (the Treatment Act) allows states to extend Medicaid eligibility to individuals not otherwise eligible for Medicaid. GAO analysis of CDC data show that the Early Detection Program screened 296,225 people in 2018, a decrease from 550,390 in 2011 (about 46 percent). The largest decrease occurred from 2013 to 2014 (see figure). According to a CDC-funded study, the number of people eligible for the Early Detection Program decreased from 2011 through 2017, by about 48 percent for breast cancer and about 49 percent for cervical cancer. CDC officials attributed these declines in screening and eligibility, in part, to improved access to screening under the Patient Protection and Affordable Care Act (PPACA). For example, PPACA required health plans to cover certain women's preventive health care with no cost sharing. Number of People Screened by CDC's Early Detection Program, 2011-2018 GAO analysis of Centers for Medicare & Medicaid Services' (CMS) data found that, in 2019, 43,549 people were enrolled in Medicaid under the Treatment Act to receive treatment for breast or cervical cancer, a decrease from 50,219 in 2016 (13.3 percent). Thirty-seven states experienced a decrease in Medicaid enrollment under the Treatment Act during this time period, 13 states experienced an increase, and one state had no change. CMS officials noted that Medicaid expansion to adults with incomes at or below 133 percent of the federal poverty level under PPACA (the new adult group) is a key factor that contributed to these enrollment trends. CMS officials said that, in Medicaid expansion states, there were some people who previously would have enrolled in Medicaid based on eligibility under the Treatment Act who instead became eligible for Medicaid in the new adult group. The CMS data show that total enrollment under the Treatment Act in Medicaid expansion states decreased by 25.6 percent from 2016 to 2019. In contrast, total enrollment under the Treatment Act in non-expansion states increased by about 1 percent during this time period. According to the CDC, tens of thousands of people die each year from breast or cervical cancer. Early screening and detection, followed by prompt treatment, can improve outcomes and, ultimately, save lives. Federal programs, like CDC's Early Detection Program, are intended to improve access to these services. GAO was asked to examine the implementation of the Early Detection Program and the states' use of Medicaid under the Treatment Act. This report provides information on the number of people who were 1) screened through the Early Detection Program and 2) enrolled in Medicaid under the Treatment Act. GAO analyzed CDC data on the number of people screened by the Early Detection Program from calendar years 2011 through 2018—the most recent available. GAO also analyzed CMS Medicaid enrollment data from 2016 through 2019—the most recent available. Additionally, GAO reviewed a 2020 study funded by CDC that examines the number of people eligible for the Early Detection Program from 2011 through 2017. Finally, GAO interviewed CDC and CMS officials and reviewed relevant CDC and CMS documents. For more information, contact John E. Dicken, (202) 512-7114,

GAO-21-191, COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal Response, November 30, 2020


The COVID-19 pandemic has resulted in catastrophic loss of life and substantial damage to the global economy, stability, and security. According to federal data, the U.S. had an average of 116,000 new COVID-19 cases per day from November 1 through November 12, 2020. Between January 2020 and October 2020, at least 237,000 more deaths occurred from all causes, including COVID-19, than would normally be expected, according to data from the Centers for Disease Control and Prevention (CDC). Further, while the economy has improved since July 2020, many people remain unemployed, including both those temporarily laid off and those who have permanently lost their job (see figure). Also, more households have become seriously delinquent on mortgage payments during the pandemic. In addition, GAO’s review of academic studies suggests the pandemic will likely remain a significant obstacle to more robust economic activity. Number of Unemployed Workers Permanently Losing Jobs and on Temporary Layoff, January 2019 through October 2020 In response to the pandemic and its effects, Congress and the administration have taken a series of actions to protect the health and well-being of Americans. However, as the end of 2020 approaches, urgent actions are needed to help ensure an effective federal response on a range of public health and economic issues. Medical Supplies While the Department of Health and Human Services (HHS) and the Federal Emergency Management Agency (FEMA) have made numerous efforts to mitigate supply shortages and expand the medical supply chain, shortages of certain supplies persist. In September 2020, GAO reported that ongoing constraints with the availability of certain types of personal protective equipment (PPE) and testing supplies remain due to a supply chain with limited domestic production and high global demand. In October 2020, GAO surveyed public health and emergency management officials from all states, the District of Columbia, and U.S. territories (hereafter states) and found the following: Testing supplies. Most states reported no shortages of swabs or transport media, but about one-third to one-half reported shortages in other types of testing supplies (see figure). State-Reported Testing Supply Shortages, as of October 2020   GAO surveyed officials in the 50 states; Washington, D.C.; and the five U.S. territories and received responses from 47 of the 56 locations, representing 41 states; Washington, D.C.; and all five territories. Not all states responded to every question. PPE. The majority of states that responded were mainly able to fulfill requests for supplies from organizations and entities within their states. However, availability constraints continue with certain PPE, such as nitrile gloves. Supplies for future vaccine needs. About one-third of states that responded stated that they were “greatly” or “completely” concerned about having sufficient vaccine-related supplies to administer COVID-19 vaccines. An additional 21 states indicated that they were moderately concerned. In September 2020, GAO recommended that HHS, in coordination with FEMA, should further develop and communicate to stakeholders plans outlining specific actions the federal government will take to help mitigate supply chain shortages for the remainder of the pandemic; immediately document roles and responsibilities for supply chain management functions transitioning to HHS, including continued support from other federal partners, to ensure sufficient resources exist to sustain and make the necessary progress in stabilizing the supply chain; and devise interim solutions, such as systems and guidance and dissemination of best practices, to help states enhance their ability to track the status of supply requests and plan for supply needs for the remainder of the pandemic response. HHS and the Department of Homeland Security disagreed with these recommendations, noting, among other things, the work that they had done to manage the medical supply chain and increase supply availability. In November 2020, HHS repeated its disagreement with GAO’s recommendations and noted its efforts to meet the needs of states. In light of the surge in COVID-19 cases, along with reported shortages, including GAO’s nationwide survey findings, GAO underscores the critical imperative for HHS and FEMA to implement GAO’s September 2020 recommendations. Vaccines and Therapeutics In a recent GAO report (GAO-21-207), GAO found that there has been significant federal investment to accelerate vaccine and therapeutic development, such as through Operation Warp Speed, a partnership between the Department of Defense and HHS that aims to accelerate the development, manufacturing, and distribution of COVID-19 vaccines and therapeutics. Separately, Emergency Use Authorizations (EUA), which allow for the emergency use of medical products without Food and Drug Administration (FDA) approval or licensure provided certain statutory criteria are met, have also been used for therapeutics. As of November 9, 2020, FDA had made four therapeutics available to treat COVID-19 through EUAs. In that report, GAO recommended that FDA identify waysto uniformly discloseinformation from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines. By doing so, FDA could help improve the transparency of, and ensure public trust in, its EUA decisions. HHS neither agreed nor disagreed with the recommendation, but said it shared GAO’s goal of transparency. COVID-19 Testing Guidance HHS and its component agencies have taken several key actions to document a federal COVID-19 testing strategy and provide testing-related agency guidance. However, this guidance has not always been transparent, raising the risk of confusion and eroding trust in government. In particular, while it is expected that guidance will change as new information about the novel virus evolves, frequent changes to general CDC testing guidelines have not always been communicated with a scientific explanation. GAO recommends that HHS ensure that CDC clearly discloses the scientific rationale for any change to testing guidelines at the time the changeis made. HHS concurred with this recommendation. Types of COVID-19 Testing Approaches Nursing Home Care In September 2020, the Coronavirus Commission on Safety and Quality in Nursing Homes (established by the Centers for Medicare & Medicaid Services (CMS) in June 2020) made 27 recommendations to CMS on topics such as testing, PPE, and visitation. CMS released a response to the commission that broadly outlined the actions it has taken to date, but it has not fully addressed the commission’s recommendations or provided an implementation plan to track and report progress toward implementing them. While CMS is not obligated to implement all of the commission’s recommendations, the agency has not indicated any areas where it does not plan to take action. GAO recommends that CMS quickly develop a plan that further details how it intends to respond to and implement, as appropriate, the commission’s recommendations. HHS neither agreed nor disagreed with this recommendation and said it would refer to and act upon the commission’s recommendations, as appropriate. In addition, the Department of Veterans Affairs (VA) partners with state governments to provide nursing home care to more than 20,000 veterans in over 150 state veterans homes. In March 2020, VA instructed its contractor to stop in-person inspections due to concerns about COVID-19. As of September 2020, these inspections had not resumed, leaving veterans at risk of receiving poor quality care. Additionally, VA does not collect timely data on the number of COVID-19 cases and deaths occurring at each state veterans home, hindering its ability to monitor and take steps to mitigate the spread of COVID-19 in these homes. GAO recommends that VA (1) develop a plan to resume inspections of state veterans homes, which may include using in-person, a mix of virtual and in-person, or fully virtual inspections, and (2) collect timely data on COVID-19 cases and deaths in each state veterans home. VA concurred with both recommendations. Economic Impact Payments The CARES Act included economic impact payments (EIP) for eligible individuals to address financial stress due to the pandemic. As of September 30, 2020, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) had disbursed over 165.8 million payments to individuals, totaling $274.7 billion. According to IRS data, more than 26 million non-filers—individuals who do not normally file a tax return and may be hard to reach—received a payment (see figure). However, everyone that was supposed to receive a payment was not reached. Starting in September 2020, IRS sent notices to nearly 9 million individuals who had not yet received an EIP. Number of Filers and Non-Filers Issued an Economic Impact Payment, as of September 30, 2020 Treasury and IRS officials did not plan to track and analyze the outcomes of their EIP notice mailing effort until 2021. The lack of timely analysis deprives Treasury and IRS of data they could use to assess the effectiveness of their notice strategy and redirect resources as needed to other outreach and communication efforts. GAO recommends that Treasury, in coordination with IRS, should begin tracking and publicly reporting the number of individuals who were mailed an EIP notification letter and filed for and received an EIP, and use that information to inform ongoing outreach and communications efforts. Treasury agreed with this recommendation. Unemployment Insurance The CARES Act created three federally funded temporary programs for unemployment insurance (UI) that expanded benefit eligibility and enhanced benefits. In its weekly news releases, the Department of Labor (DOL) publishes the number of weeks of unemployment benefits claimed by individuals in each state during the period and reports the total count as the number of people claiming benefits nationwide. DOL officials told GAO that they have traditionally used this number as a proxy for the number of individuals claiming benefits because they were closely related. However, the number of claims has not been an accurate estimate of the number of individuals claiming benefits during the pandemic because of backlogs in processing a historic volume of claims, among other data issues. Without an accurate accounting of the number of individuals who are relying on these benefits in as close to real time as possible, policymakers may be challenged to respond to the crisis at hand. GAO recommends that DOL (1) revise its weekly news releases to clarify that in the current unemployment environment, the numbers it reports for weeks of unemployment claimed do not accurately estimate the number of unique individuals claiming benefits, and (2) pursue options to report the actual number of distinct individuals claiming benefits, such as by collecting these already available data from states. DOL agreed with the recommendation to revise its weekly news releases, and partially agreed with the recommendation to pursue options to report the actual number of distinct individuals claiming benefits. Tax Relief for Businesses To provide liquidity to businesses during the pandemic, the CARES Act included tax measures to help businesses receive cash refunds or other reductions to tax obligations. Some taxpayers need to file an amended income tax return to take advantage of these provisions; at the same time, IRS faces an increase in mail and paper processing delays due to the pandemic, which may delay the timely processing of this paperwork and issuance of these refunds. GAO recommends that IRS update its form instructions to include information on its electronic filing capability for tax year 2019. IRS agreed with this recommendation. Program Integrity Although the extent and significance of improper payments associated with COVID-19 relief funds have not yet been determined, the impact of these improper payments, including those that are the result of fraud, could be substantial. For example, numerous individuals are facing federal charges related to attempting to defraud the Paycheck Protection Program (PPP), UI program, or other federal programs, and many more investigations are underway. To address the risk of improper payments due to fraud and other causes, GAO previously recommended the following: The Small Business Administration (SBA) should develop and implement plans to identify and respond to risks in the PPP to ensure program integrity, achieve program effectiveness, and address potential fraud. The Office of Management and Budget (OMB), in consultation with Treasury, should issue timely guidance for auditing new and existing COVID-19-related programs, including Coronavirus Relief Fund payments, as soon as possible. Audits of entities that receive federal funds are critical to the federal government’s ability to help safeguard those funds.Also, Congress should amend the Social Security Act to explicitly allow the Social Security Administration to share its full death data with Treasury for data matching to prevent payments to ineligible individuals. GAO maintains that implementing these recommendations fully is critically important in order to protect federal funds from improper payments resulting from fraud and other risks. In this report, GAO also identifies new concerns about the timely reporting of improper payments for COVID-19 programs. The COVID-19 relief laws appropriated over a trillion dollars that may be spent through newly established programs to fund response and recovery efforts, such as SBA’s PPP. However, unlike the supplemental appropriations acts that provided for disaster relief related to the 2017 hurricanes and California wildfires, the COVID-19 relief laws did not require agencies to deem programs receiving these relief funds that expend more than a threshold amount as "susceptible to significant improper payments." In addition, based on OMB guidance, improper payment estimates associated with new COVID-19 programs established in March 2020 may not be reported until November 2022, in some instances. GAO is making two recommendations: OMB should develop and issueguidance directingagencies to include COVID-19 relief funding with associated key risks, such as changes to existing program eligibility rules, as part of their improper payment estimation methodologies, especially for existing programs that received COVID-19 relief funding. SBA should expeditiously estimate improper payments and report estimates and error rates for PPP due to concerns about the possibility that improper payments, including those resulting from fraudulent activity, could be widespread. GAO is also suggesting that Congress consider, in any future legislation appropriating COVID-19 relief funds, designating all executive agency programs and activities making more than $100 million in payments from COVID-19 relief funds as “susceptible to significant improper payments.” Aviation Assistance and Preparedness GAO identified concerns about efforts to monitor CARES Act financial assistance to the aviation sector. Treasury’s Payroll Support Program (PSP) provides $32 billion in payroll support payments and loans to help the aviation industry retain its employees. While recipients have begun submitting required compliance reports, Treasury has not yet finalized a monitoring system to identify and respond to the risk of noncompliance with PSP agreement terms, potentially hindering its ability to detect program misuse in a timely manner. GAO is recommending that Treasury finish developing and implement acompliance monitoringplan that identifies and responds to risks in the PSP. Treasury neither agreed nor disagreed with this recommendation, but committed to reviewing additional measures that may further enhance its compliance monitoring and ensure that PSP funds are used as intended. In June 2020, GAO suggested that Congress take legislative action to require the Secretary of Transportation to work with relevant agencies, such as HHS, the Department of Homeland Security, and other stakeholders, to develop a national aviation-preparedness plan to limit the spread of communicable diseasethreats and minimize traveland trade impacts. GAO originally made this recommendation to the Department of Transportation in December 2015. GAO urges Congress to take swift action to require such a plan, without which the U.S. will not be as prepared to minimize and quickly respond to ongoing and future communicable disease events. As of November 12, 2020, the U.S. had over 10.3 million cumulative reported cases of COVID-19 and about 224,000 reported deaths, according to federal agencies. The country also continues to experience serious economic repercussions. Four relief laws, including the CARES Act, were enacted as of November 2020 to provide appropriations to address the public health and economic threats posed by COVID-19. As of September 30, 2020, of the $2.6 trillion appropriated by these acts, the federal government had obligated a total of $1.8 trillion and expended $1.6 trillion of the COVID-19 relief funds, as reported by federal agencies. The CARES Act included a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines the federal government’s continued efforts to respond to and recover from the COVID-19 pandemic. GAO reviewed data, documents, and guidance from federal agencies about their activities and interviewed federal and state officials. GAO also sent a survey to public health and emergency management officials in the 50 states, Washington, D.C., and the five U.S. territories regarding medical supplies. GAO is making 11 new recommendations for agencies that are detailed in this Highlights and in the report. GAO is also raising one matter for congressional consideration. For more information, contact A. Nicole Clowers at (202)512-7114 or


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