Pharmacy Owner Pleads Guilty to $6.5 million Health Care Fraud Schemes

A New York woman pleaded guilty today to perpetrating schemes to defraud health care programs, including obtaining more than $6.5 million from Medicare Part D Plans and Medicaid drug plans.

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  • Sexual Harassment and Assault: Guidance Needed to Ensure Consistent Tracking, Response, and Training for DOD Civilians
    In U.S GAO News
    The Department of Defense (DOD) has taken steps to track reports of sexual harassment and sexual assault involving its federal civilian employees, but its visibility over both types of incidents is hindered by guidance and information-sharing challenges. While employees may not report all incidents for a variety of reasons, DOD also lacks visibility over those incidents that have been reported. For example, from fiscal years 2015 through 2019, DOD recorded 370 civilian employees as victims of sexual assault and 199 civilian employees as alleged offenders. However, these data do not include all incidents of sexual assault reported over this time period. Specifically, based on DOD guidance, examples of incidents that could be excluded from these data include those involving civilian employee victims (1) occurring in the continental United States, (2) employed by DOD components other than the military services, such as defense agencies, and (3) who are also military dependents. Without guidance that addresses these areas, DOD does not know the extent to which its civilian workforce has reported work-related sexual assault worldwide. Number of Department of Defense Federal Civilian Employees Recorded as Victims or Alleged Offenders in Reported Sexual Assault Incidents, Fiscal Years 2015-2019 While DOD has developed policies and procedures to respond to and resolve sexual harassment and sexual assault incidents involving federal civilian employees, gaps exist. For example, DOD issued guidance in June 2020 directing components to establish anti-harassment programs, but it lacks details regarding how such programs should be structured. Without clarifying guidance, components can establish programs that do not align with U.S. Equal Employment Opportunity Commission guidance for model anti-harassment programs. Additionally, GAO found that DOD civilian employees' ability to make restricted reports of sexual assault—confidential disclosures that do not initiate official investigations, but allow the victim to receive DOD-provided sexual assault support services—varies across components. According to DOD officials, they have not taken action to resolve this variation due to conflicts with federal statute, among other things. By reporting to and requesting any needed actions from Congress to resolve any conflicts with statute, the department can alleviate such inconsistencies and minimize legal risks for DOD components. With nearly 900,000 federal civilian employees around the world, DOD has responsibilities for preventing and responding to sexual harassment and assault within its workforce. In fiscal year 2018, DOD estimated that about 49,700 civilian employees experienced sexual harassment and about 2,500 civilian employees experienced work-related sexual assault in the prior year. House Report 116-120 included a provision for GAO to review DOD's prevention of and response to sexual harassment and assault involving DOD federal civilian employees. GAO's report examines, among other things, the extent to which DOD has (1) visibility over such reported incidents, and (2) developed and implemented policies and procedures to respond to and resolve these incidents. GAO reviewed policies and guidance; analyzed program data from fiscal years 2015 through 2019; interviewed officials at a nongeneralizable sample of five military installations; evaluated DOD training materials; and interviewed DOD, service, and civilian officials. GAO is making 19 recommendations, including that DOD issue guidance for comprehensive tracking of civilian work-related sexual assaults, enhance guidance on the structure of anti-harassment programs for civilians, and report to and request any needed actions from Congress on the ability of civilian employees to make restricted reports of sexual assault. As discussed in the report, DOD generally concurred with the recommendations. For more information, contact Brenda S. Farrell at (202) 512-3604 or farrellb@gao.gov.
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  • Man Charged with $5 Million COVID-Relief Fraud
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    A Texas man has been charged in the Eastern District of Texas with allegedly filing bank loan applications fraudulently seeking more than $5 million dollars in forgivable loans guaranteed by the Small Business Administration (SBA) under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
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  • Economic Adjustment Assistance: Experts’ Proposed Reform Options to Better Serve Workers Experiencing Economic Disruption
    In U.S GAO News
    What GAO Found U.S. workers have faced considerable changes in how they work and in the skills they need because of economic changes created by emerging technologies, disruptive business models, and other economic forces. Federal economic adjustment assistance (EAA) programs were established, in part, to help workers adjust to these economic disruptions. Consistent with GAO's prior work on EAA programs, experts in GAO's roundtable identified a range of challenges to using EAA programs to effectively respond to economic disruptions workers might experience. In light of these challenges, experts identified reform actions that could better serve workers (see table). The actions fell into six interrelated reform areas. Examples of Potential Reform Actions That Could Better Serve Workers Who Experience Economic Disruption, as Identified by Experts in GAO's Roundtable Reform area Examples of potential reform actions identified by experts Proactive efforts to address disruption Establish lifelong learning accounts for workers through contributions of individual workers, employers, and government agencies to fund continuous education and training opportunities. Establish a tax credit to help incentivize employers to retrain rather than lay off employees. Access to Economic Adjustment Assistance (EAA) programs Use the existing unemployment insurance system to better inform dislocated workers about the availability of and their eligibility for EAA programs. Worker training Expand the number of short-term, high-demand skills-based training opportunities. Prompt employers to develop apprenticeship programs. For example, require employers to operate apprenticeship programs of their own or pay a tax to fund the creation of apprenticeship programs. Income and other supports Create more opportunities for workers to co-enroll in training and financial safety-net programs. Develop supportive services programs for dislocated workers at the community colleges in which they are enrolled. EAA service delivery Provide dislocated workers ready access to easy-to-navigate data on high-demand skills, earnings in various occupations, and the number of available jobs in those occupations in their area. Provide community colleges with additional state or federal resources to deliver more career guidance to dislocated workers. Structure of the EAA system Invest in training infrastructure, such as publicly funded regional universities, community colleges, and other institutions. Reduce barriers to accessing existing national datasets to facilitate the evaluation of EAA program effectiveness. Source: GAO analysis of expert statements. | GAO-21-324 Note: These potential reform actions are not listed in any specific rank or order and their inclusion in this report should not be interpreted as GAO endorsing any of them. GAO did not assess how effective the potential reform actions may be or the extent to which program design modifications, legal changes, and federal financial support would be needed to implement any given reform action or combination of reform actions. Why GAO Did This Study Various economic disruptions, such as policy changes that affect global trade or the defense or energy industries and shifts in immigration, globalization, or automation, can lead to widespread job loss among workers within an entire region, industry, or occupation. GAO was asked about options for reforming the current policies and programs for helping workers weather economic disruption. This report describes a range of options, identified by experts, to reform the current policies and programs for helping workers weather economic disruption. With the assistance of the National Academies of Sciences, Engineering, and Medicine, GAO convened a 2-day, virtual roundtable in August 2020 with 12 experts, selected to represent a broad spectrum of views and expertise and a variety of professional and academic fields. They included academic researchers, program evaluators, labor economists, former federal agency officials, and state and local practitioners. GAO also reviewed relevant federal laws, prior GAO reports, and other research. For more information, contact Cindy S. Brown Barnes at (202) 512-7215 or brownbarnesc@gao.gov.
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  • Farm Programs: USDA Should Take Additional Steps to Ensure Compliance with Wetland Conservation Provisions
    In U.S GAO News
    What GAO Found The U.S. Department of Agriculture's (USDA) Natural Resources Conservation Service (NRCS) has taken steps to increase the consistency of their determinations about where wetlands exist on farmers' lands. For example, NRCS state offices formed teams to make such determinations in the prairie pothole region (see fig.), which covers parts of Iowa, Minnesota, North Dakota, and South Dakota. These offices also standardized their wetland determination procedures and included more details, such as the types of data that can be used to identify wetland boundaries. Under wetland conservation provisions in federal law, to receive the benefits of certain USDA farm programs, farmers must not convert wetlands to cropland. Wetlands and Cropland in the Prairie Pothole Region NRCS's primary method to ensure compliance with wetland conservation provisions is conducting annual compliance checks of selected tracts of land for farmers in USDA programs. To select tracts, NRCS draws a national random sample. The sample is to include about 1 percent of tracts subject to wetland the provisions nationally, so many tracts are not sampled for years. For 2014 through 2018, NRCS identified fewer than five farmers with wetland conservation violations per year on the approximately 417,000 tracts in North Dakota and South Dakota—the states with the most wetland acres. Agency officials said NRCS has limited resources to conduct more checks. However, some USDA agencies emphasize risk-based criteria, rather than a random sample, in selecting tracts to check for compliance with other provisions. Doing so makes the checks more efficient by targeting the tracts most likely to have violations. If NRCS used a risk-based approach for its compliance checks (e.g., using information on acres cultivated annually on tracts), it could more efficiently ensure compliance with wetland conservation provisions. If NRCS finds violations, USDA's Farm Service Agency (FSA) may withhold program benefits from farmers, or it may grant waivers to farmers who acted in good faith, without intent to commit violations. FSA granted 243 of 301 requests for good-faith waivers from 2010 to 2018, according to FSA data. FSA relies on committees of fellow farmers to decide on waivers by considering factors such as prior violations. GAO found that some committees relied on weak justification to grant waivers even if farmers had prior violations and that FSA had not specified what is adequate justification. By specifying what constitutes adequate justification, FSA could better ensure it provides benefits only to eligible farmers. Why GAO Did This Study Wetlands perform vital ecological functions, and draining them can harm water quality and wildlife habitat. Many wetlands were drained for farming before enactment of wetland conservation provisions in 1985. However, millions of acres of wetlands, known as potholes, remain in the prairie pothole region. NRCS determines where wetlands exist on the land of farmers who participate in USDA farm programs, and it identifies violations of wetland provisions. FSA administers farm program benefits. In 2017, USDA's Office of Inspector General reported that NRCS had implemented wetland determination procedures in the prairie pothole region inconsistently. GAO was asked to review USDA's implementation of wetland conservation provisions in the prairie pothole region. This report examines, among other objectives, the steps NRCS has taken to increase the consistency of wetland determinations and the approaches NRCS and FSA use to ensure compliance with the provisions. GAO reviewed agency manuals, data, and files on wetland determinations and waivers, and interviewed agency officials and stakeholder groups.
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  • Oil and Gas: Onshore Competitive and Noncompetitive Lease Revenues
    In U.S GAO News
    Pursuant to federal law, the Department of the Interior's (Interior) Bureau of Land Management (BLM) offers leases competitively through auction or noncompetitively for a fee if an adequate bid is not received. Competitive leases for oil and gas development on federal lands produced greater revenues, on average, than noncompetitive leases for fiscal years 2003 through 2019, according to GAO's analysis of revenues reported by Interior's Office of Natural Resources Revenue (ONRR) and leases from BLM. For this period, about 72,800 competitive leases produced about $14.3 billion in revenues—while total of 100,300 leases produced $16.1 billion. Average revenues from competitive leases over this time period were nearly 3 times greater than revenues from noncompetitive leases; about $196,000 and $66,000, respectively. Based on GAO's analysis of leases that started in fiscal years 2003 through 2009, competitive leases produced oil and gas more often than noncompetitive leases during the leases' 10-year primary term. Further, competitive leases with high bonus bids (bids above $100 per acre) were more likely to produce oil and gas in their 10-year primary terms than both competitive leases with lower bonus bids and noncompetitive leases. Specifically, about 26 percent of competitive leases that sold with bonus bids above $100 per acre produced oil and gas and generated royalties in their primary term compared with about 2 percent for competitive leases that sold at the minimum bid of $2 per acre and about 1 percent for noncompetitive leases. GAO's analysis showed that competitive leases with high bonus bids generated over 3 times the amount of cumulative, or total, royalties by the end of their primary term than all other competitive and noncompetitive leases combined (see fig.). Cumulative Royalties from Competitive Leases, by Bonus Bid, and Noncompetitive Leases That Started in Fiscal Years 2003 through 2009 According to BLM, federal onshore oil and gas leases generate about $3 billion annually in federal revenues, including royalties, one-time bonus bid payments, and rents. The Federal Onshore Oil and Gas Leasing Reform Act of 1987 requires that public lands available for oil and gas leasing first be offered under a competitive bidding process. BLM offers leases with 10-year primary terms competitively through auction or, if the tract of land does not receive an adequate bid, noncompetitively for a fee. The minimum bid is $2 per acre, and bids at or above the minimum are called bonus bids. ONRR is to collect revenues from oil and gas leases in accordance with the specific terms and conditions outlined in the leases, including revenues from rents and royalties. Lessees are to pay rent annually until production begins on the leased land and then pay royalties as a percentage of oil and gas production. Lease terms may be extended beyond the primary term if, for example, the lease is producing oil or gas. GAO was asked to review oil and gas leasing on federal lands. This report describes oil and gas revenues from competitive and noncompetitive leases for fiscal years 2003 through 2019. GAO analyzed federal lease and revenue data and interviewed Interior officials and four experts knowledgeable about federal oil and gas leasing. To consistently compare leases over their lifecycle, GAO analyzed revenues that occurred within the leases' primary term (first 10 years) for leases that started in fiscal years 2003 through 2009. For more information, contact Frank Rusco at (202) 512-3841 or RuscoF@gao.gov.
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    The Justice Department today filed a statement of interest in federal district court in Kalamazoo, Michigan, arguing that the Free Exercise Clause of the Constitution requires the state of Michigan to justify why it cannot provide exemptions to its school closing order for in-person instruction at religious high schools when it provides exemptions for trade and technical instruction in person, college sports teams, and other educational activities.
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  • Medicaid: HHS’s Preliminary Analyses Offer Incomplete Picture of Behavioral Health Demonstration’s Effectiveness
    In U.S GAO News
    What GAO Found The Protecting Access to Medicare Act of 2014 (PAMA) established the Certified Community Behavioral Health Clinics (CCBHC) demonstration and tasked the Department of Health and Human Services (HHS) with its implementation. CCBHCs aim to improve the behavioral health services they provide, particularly for Medicaid beneficiaries. Initially established for a 2-year period, the demonstration has been extended by law a number of times; most recently, it was extended to September 2023. States participating in the demonstration can receive Medicaid payments, consistent with federal requirements, for CCBHC services provided to beneficiaries. PAMA also required HHS to assess the effect of the demonstration on service access, costs, and quality. HHS's preliminary assessments of the demonstration in eight states, with 66 participating CCBHCs, found the following: Access. CCBHCs commonly added services related to mental and behavioral health, such as medication-assisted treatment, and took actions to provide services outside the clinic setting, such as through telehealth. Costs. States' average payments to CCBHCs typically exceeded CCBHC costs for the first 2 years of the demonstration. CCBHC payments and costs were more closely aligned in the second year for most states, better reflecting the payment methods prescribed under the demonstration. Quality. States and CCBHCs took steps, such as implementing electronic health records systems, to report performance on 21 quality measures. GAO found data limitations complicated—and will continue to affect—HHS's efforts to assess the effectiveness of the demonstration. For example: Lack of baseline data. PAMA requires HHS to assess the quality of services provided by CCBHCs compared with non-participating areas or states. The demonstration marked the first time these clinics reported performance on quality measures, so no historical baseline data exist. HHS officials noted that with time, additional data may provide insight on the quality of services. Lack of comparison groups. PAMA requires HHS to compare CCBHCs' efforts to increase access and improve quality with non-participating clinics and states. HHS was unable to identify comparable clinics or states due to significant differences among the communities. Lack of detail on Medicaid encounters. PAMA requires HHS to assess the effect of the demonstration on federal and state costs and on Medicaid beneficiaries' access to services. HHS plans to use Medicaid claims and encounter data to assess such changes. However, GAO has previously identified concerns with the accuracy and completeness of Medicaid data and has made numerous recommendations aimed at improving their quality. HHS's decisions in implementing the demonstration also complicated its assessment efforts. HHS allowed states to identify different program goals and target populations, and to cover different services. HHS also did not require states to use standard billing codes and billing code modifiers it developed. The lack of standardization across states limited HHS's ability to assess changes in a uniform way. Why GAO Did This Study Behavioral health conditions—mental health issues and substance use disorders—affect millions of people. HHS estimates that 61 million adults had at least one behavioral health condition in 2019—41 million of whom did not receive any related treatment in the prior year. Many individuals with behavioral health conditions rely on community mental health centers for treatment, but the scope and quality of these services vary. To improve community-based behavioral health services, PAMA created the CCBHC demonstration and provided HHS with $25 million to support its implementation. PAMA directed HHS to assess the demonstration and to provide recommendations for its continuation, modification, or termination. To date, HHS has issued three annual reports assessing the initial demonstration period, which ran from 2017 to 2019. HHS plans to issue a fourth annual report and a final report by December 2021. This report describes HHS's assessment of the demonstration regarding access, costs, and quality. Under the CARES Act, GAO is to issue another report on states' experiences by September 2021. GAO reviewed federal laws and regulations; HHS guidance; and HHS's assessments of the demonstration, including three issued reports, interim reports, and the analysis plan for future reports. GAO also interviewed HHS officials and officials from organizations familiar with community health clinics. HHS provided technical comments, which GAO incorporated as appropriate. For more information, contact Carolyn L. Yocom (202) 512-7114 or yocomc@gao.gov.
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    Why this Matters Safe vaccines are critical to fighting diseases, from polio to COVID-19. Research shows that the protection provided by U.S. licensed vaccines outweighs their potential risks. However, misinformation and unjustified safety concerns can cause people to delay or refuse vaccination, which may increase preventable deaths and prolong negative social and economic impacts. The Science What is it? A vaccine is generally considered safe when the benefits of protecting an individual from disease outweigh the risks from potential side effects (fig. 1). The most common side effects stem from the body's immune reaction and include swelling at the injection site, fever, and aches. Figure 1. Symptoms of polio and side effects of the polio vaccine. A vaccine is generally considered safe if its benefits (preventing disease) outweigh its risks (side effects). In rare cases, some vaccines may cause more severe side effects. For example, the vaccine for rotavirus—a childhood illness that can cause severe diarrhea, dehydration, and even death—can cause intestinal blockage in one in 100,000 recipients. However, the vaccine is still administered because this very rare side effect is outweighed by the vaccine's benefits: it saves lives and prevents an estimated 40,000 to 50,000 childhood hospitalizations in the U.S. each year. The two messenger RNA (mRNA) vaccines authorized for COVID-19—a disease that contributed to more than 415,000 American deaths between January 2020 and January 2021—can cause severe allergic reactions. However, early safety reporting found that these reactions have been extremely rare, with only about five cases per 1 million recipients, according to data from January 2021 reports by the Centers for Disease Control and Prevention. In general, side effects from vaccines are less acceptable to the public than side effects from treatments given to people who already have a disease. What is known? Vaccine developers assess safety from early research, through laboratory and animal testing, and even after the vaccine is in use (fig. 2). Researchers may rely on previous studies to inform future vaccine trials. For example, safety information from preclinical trials of mRNA flu vaccine candidates in 2017 allowed for the acceleration of mRNA COVID-19 vaccine development. Vaccine candidates shown to be safe in these preclinical trials can proceed to clinical trials in humans. In the U.S., clinical trials generally proceed through three phases of testing involving increasing numbers of volunteers: dozens in phase 1 to thousands in phase 3. Although data may be collected over years, most common side effects are identified in the first 2 months after vaccination in clinical trials. After reviewing safety and other data from vaccine studies, the Food and Drug Administration (FDA) may license a vaccine to be marketed in the U.S. There are also programs to expedite—but not bypass—development and review processes, such as a priority review designation, which shortens FDA’s goal review time from 10 to 6 months. Safety monitoring continues after licensing. For example, health officials are required to report certain adverse events—such as heart problems—following vaccination, in order to help identify potential long-term or rare side effects that were not seen in clinical trials and may or may not be associated with the vaccine. Figure 2. Vaccine safety is assessed at every stage: development through post-licensure. Following a declared emergency, FDA can also issue emergency use authorizations (EUA) to allow temporary use of unlicensed vaccines if there is evidence that known and potential benefits of the vaccine outweigh known and potential risks, among other criteria. As of January 2021, two COVID-19 vaccines had received EUAs, after their efficacy and short-term safety were assessed through large clinical trials. However, developers must continue safety monitoring and meet other requirements if they intend to apply for FDA licensure to continue distribution of these vaccines after the emergency period has ended. What are the knowledge gaps? One knowledge gap that can remain after clinical trials is whether side effects or other adverse events may occur in certain groups. For example, because clinical trials usually exclude certain populations, such as people who are pregnant or have existing medical conditions, data on potential adverse events related to specific populations may not be understood until vaccines are widely administered. In addition, it can be difficult to determine the safety of new vaccines if outbreaks end suddenly. For example, vaccine safety studies were hindered during the 2014-2015 Ebola epidemic when a large increase in the number of cases was followed by a sharp decrease. This disrupted the clinical trials of Ebola vaccine candidates, because the trials require many infected and non-infected people. Furthermore, a lack of understanding and/or misinformation about the steps taken to ensure the safety of vaccines hinders accurate public knowledge about safety concerns, which may cause people to delay or refuse vaccination. This resulting hesitancy may, in turn, increase deaths, social harm, and economic damage. Opportunities Continuing and, where necessary, improving existing vaccine safety practices offers the following opportunities to society: Herd immunity. Widespread immunity in a population, acquired in large part through safe and effective vaccines, can slow the spread of infection and protect those most vulnerable. Health care improvements. Vaccinations can reduce the burden on the health care system by reducing severe symptoms that require individuals to seek treatment. Eradication. Safe vaccination programs, such as those combatting smallpox, may eliminate diseases to the point where transmission no longer occurs. Challenges There are a number of challenges to ensuring safe vaccines: Public confidence. Vaccine hesitancy, in part due to misinformation or historic unethical human experimentation, decreases participation in clinical trials, impeding identification of side effects across individuals with different racial, ethnic, and socioeconomic backgrounds. Mutating viruses. Some viruses, such as those that cause the flu or COVID-19, may mutate rapidly and thus may require new or updated vaccines, for which ongoing safety monitoring is important. Long-term and rare effects. Exceedingly rare or long-term effects may not be identified until after vaccines have been widely administered. Further study is needed to detect any such effects and confirm they are truly associated with the vaccine. Policy Context & Questions What steps can policymakers take to improve public trust and understanding of the process of assessing vaccine safety? How can policymakers convey the social importance of vaccines to protect the general public and those who are most vulnerable? How can policymakers leverage available resources to support ongoing vaccine development and post-licensure safety monitoring? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
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    In Crime News
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