Drug Pricing Program: HHS Uses Multiple Mechanisms to Help Ensure Compliance with 340B Requirements

What GAO Found

The 340B Drug Pricing Program (340B Program) requires drug manufacturers to sell outpatient drugs at a discount to covered entities—eligible hospitals and other entities participating in the program—in order for their drugs to be covered by Medicaid. Participation in the 340B Program has grown from nearly 9,700 covered entities in 2010 to 12,700 in 2020. The Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) administers the program and oversees covered entities’ compliance with 340B Program requirements through annual audits, among other efforts. If audits identify noncompliance with program requirements, HRSA issues findings to covered entities and requires them to take corrective action to continue participating in the 340B Program (see table).

Audit Findings Issued to Covered Entities by the Health Resources and Services Administration (HRSA) for Fiscal Years 2012-2019, as of September 2020

340B Program findings of noncompliance

Number

Eligibility of covered entities. Failure to maintain eligibility-related requirements (e.g., covered entities’ oversight of their contract pharmacies).

561

Diversion of 340B drugs to ineligible patients. 340B drugs distributed to individuals who are not eligible patients of a covered entity (e.g., patients’ health records are not maintained by the covered entity).

546

Duplicate discounts. Prescribed drugs that may have been subject to both the 340B price and a Medicaid rebate.

429

Total

1,536

Source: GAO analysis of information received from HRSA. | GAO-21-107

HRSA officials told GAO that, beginning in fall 2019, the agency started issuing findings only when audit information presents a clear and direct violation of the requirements outlined in the 340B Program statute. HRSA officials explained that guidance, which is used to interpret provisions of the 340B statute for the purposes of promoting program compliance among covered entities, does not provide the agency with appropriate enforcement capability. For example, HRSA officials reported that there were instances among fiscal year 2019 audits in which the agency did not issue findings for a failure to comply with guidance related to contract pharmacies in part because the 340B statute does not address contract pharmacy use and, therefore, there may not have been a clear statutory violation.

In addition to audits, HRSA provides education to covered entities about 340B Program requirements and has implemented other efforts to identify noncompliance. For example, HRSA

requires all covered entities to recertify their eligibility to participate in the 340B Program annually (e.g., self-attesting to compliance); and

uses a self-disclosure process through which covered entities can disclose and correct self-identified instances of noncompliance.

Why GAO Did This Study

Covered entities can realize substantial savings through 340B Program price discounts, enabling them to stretch federal resources to reach more eligible patients and provide more comprehensive services.

GAO was asked to provide information on HRSA’s efforts to oversee covered entities’ compliance with 340B Program requirements. This report describes (1) the audit findings that HRSA issued to address covered entity noncompliance with 340B Program requirements; and (2) other efforts HRSA uses to help ensure that covered entities comply with 340B Program requirements.

GAO reviewed documentation, including relevant federal laws and regulations and HRSA’s policies, procedures, and guidance, related to 340B Program oversight. GAO also reviewed HRSA data on the number and type of audit findings made from audits finalized during fiscal years 2012 through 2019 as of September 2020—the latest data available at the time of the audit. GAO also interviewed officials from HRSA, agency contractors, and 340B Program stakeholders.

GAO provided a draft of this report to HHS for review. The agency provided written and technical comments on the draft, both of which were incorporated as appropriate.

For more information, contact Debra A. Draper at (202) 512-7114 or draperd@gao.gov.

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    Pilgrim’s Pride Corporation (Pilgrim’s), a major broiler chicken producer based in Greeley, Colorado, has pleaded guilty and has been sentenced to pay approximately $107 million in criminal fines for its participation in a conspiracy to fix prices and rig bids for broiler chicken products, the Department of Justice announced today.
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  • Iraq Travel Advisory
    In Travel
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  • Secretary Pompeo’s Call with Iraqi Kurdistan Regional Government Prime Minister Barzani
    In Crime Control and Security News
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    In Travel
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  • Public Health: Federal Programs Provide Screening and Treatment for Breast and Cervical Cancer
    In U.S GAO News
    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, dickenj@gao.gov.
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  • Secretary Pompeo’s Call with Partners on COVID-19
    In Crime Control and Security News
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  • National Bio and Agro-defense Facility: DHS and USDA Are Working to Transfer Ownership and Prepare for Operations, but Critical Steps Remain
    In U.S GAO News
    The Department of Homeland Security (DHS) and U.S. Department of Agriculture (USDA) have taken steps to plan for and implement the successful transfer of the National Bio and Agro-Defense Facility (NBAF) from DHS to USDA for ownership and operation. (See figure.) The facility is to house state-of-the-art laboratories for research on foreign animal diseases—diseases not known to be present in the United States—that could infect U.S livestock and, in some cases, people. The departments' steps are consistent with selected key practices for implementation of government reforms. In addition, USDA has taken steps to prepare for NBAF's operation by identifying and addressing staffing needs; these steps are consistent with other selected key practices GAO examined for strategically managing the federal workforce during a government reorganization. However, critical steps remain to implement the transfer of ownershp of NBAF to USDA and prepare for the facility's operation, and some efforts have been delayed. Critical steps include obtaining approvals to work with high-consequence pathogens such as foot-and-mouth disease, and physically transferring pathogens to the facility. DHS estimates that construction of NBAF has been delayed by at least 2.5 months because of the effects of the COVID-19 pandemic. USDA officials stated that, until the full effects of delays to construction are known, USDA cannot fully assess the effects on its efforts to prepare for the facility's operation. In addition, USDA's planning efforts were delayed before the pandemic for the Biologics Development Module—a laboratory at NBAF intended to enhance and expedite the transition of vaccines and other countermeasures from research to commercial viability. A November 2018 schedule called for USDA to develop the business model and operating plan for the module in 2019. Officials stated in May 2020 that USDA intends to develop the business model and operating plan by fiscal year 2020's end. Construction Site of the National Bio and Agro-Defense Facility (NBAF) as of November 2019 and an Artist's Rendering of NBAF When Complete USDA's efforts to date to collaborate with DHS and other key federal or industry stakeholders on NBAF have included meeting regularly with DHS officials to define mission and research priorities, developing written agreements with DHS about DHS's roles and responsibilities before and after the transfer, and collaborating with the intelligence community, as well as with relevant international research groups and global alliances, on an ongoing basis. These efforts are consistent with selected key practices for interagency collaboration, such as including relevant participants and clarifying roles. Foreign animal diseases—some of which infect people—can pose threats to the United States. USDA and DHS have been developing NBAF to conduct research on and develop countermeasures (e.g., vaccines) for such diseases, as part of a national policy to defend U.S. agriculture against terrorist attacks and other emergencies. DHS is constructing NBAF in Manhattan, Kansas. DHS originally assumed responsibility for owning and operating NBAF. However, USDA will carry out this responsibility instead, following an executive order from 2017 to improve efficiency of government programs. Construction is expected to cost about $1.25 billion. GAO was asked to review issues related to development of NBAF and USDA's plans for operating it. This report examines (1) efforts to transfer ownership of NBAF from DHS to USDA and to prepare for the facility's operation and (2) USDA's efforts to collaborate with stakeholders. GAO reviewed DHS and USDA documents and interviewed key department officials and various stakeholders. GAO also compared the departments' efforts on NBAF with selected key practices for government reforms and collaboration. For more information, contact Steve D. Morris at (202) 512-3841 or morriss@gao.gov.
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  • Department of Justice Recognizes International Day of Zero Tolerance for Female Genital Mutilation
    In Crime News
    Female genital mutilation (FGM) has broad implications for the health and human rights of women and girls, as well as societies at large.
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  • Two Owners of New York Pharmacies Charged in a $30 Million COVID-19 Health Care Fraud and Money Laundering Case
    In Crime News
    The owners of over a dozen New York-area pharmacies were charged in an indictment unsealed today for their roles in a $30 million health care fraud and money laundering scheme, in which they exploited emergency codes and edits in the Medicare system that went into effect due to the COVID-19 pandemic in order to submit fraudulent claims for expensive cancer drugs that were never provided, ordered, or authorized by medical professionals.
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  • Judge Rya Zobel to Receive 2020 Devitt Award
    In U.S Courts
    Senior U.S. District Judge Rya Zobel, who grew up in Nazi Germany and later became the first woman to serve as director of the Federal Judicial Center, is the recipient of the 2020 Edward J. Devitt Distinguished Service to Justice Award.
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  • Justice Department Settles with a Car Rental Services Company to Resolve Immigration-Related Discrimination
    In Crime News
    The Justice Department announced today that it signed a settlement agreement with Fleetlogix Inc. (Fleetlogix) resolving claims that the company discriminated against work-authorized non-U.S. citizens by requiring them to provide specific and unnecessary work authorization documentation because of their citizenship or immigration status. Fleetlogix, based in San Diego, California, operates offices nationwide that provide cleaning and transportation services to rental car companies.
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  • Justice Department Files Lawsuit Against Tampa, Florida, Towing Company for Unlawfully Selling Car Belonging to Deployed Servicemember
    In Crime News
    The Justice Department today filed a lawsuit in the Middle District of Florida alleging that Target Recovery Towing Inc. and Target Recovery & Transport Inc. (together “Target”) violated the Servicemembers Civil Relief Act (SCRA), by failing to obtain a court order before auctioning off a car belonging to a U.s. Marine Corps Sergeant who was deployed overseas.  
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  • Recycling: Building on Existing Federal Efforts Could Help Address Cross-Cutting Challenges
    In U.S GAO News
    Based on GAO analysis of stakeholder views, five cross-cutting challenges affect the U.S. recycling system: (1) contamination of recyclables; (2) low collection of recyclables; (3) limited market demand for recyclables; (4) low profitability for operating recycling programs; and (5) limited information to support decision-making about recycling. For example, the Environmental Protection Agency's (EPA) most recent data show that less than a quarter of the waste generated in the United States is collected for recycling (69 million of 292 million tons) and is potentially available, along with new materials, to make new products (see fig.). Estimated Generation and Disposition of Waste in the United States, as of 2018 EPA, the Departments of Commerce (Commerce) and Energy, and the Federal Trade Commission have taken actions that advance recycling, such as collecting data and awarding grants for research on recycling technologies. However, EPA has not conducted studies or developed recommendations for administrative or legislative action on the effect of existing public policies on recycling, as the Resource Conservation and Recovery Act (RCRA) requires. Conducting these studies would provide Congress with information to better evaluate the effect of different policies on U.S. recycling efforts. In addition, Commerce is not fully meeting its RCRA requirement to stimulate the development of markets for recycled materials because it has not taken actions to stimulate domestic markets, as GAO recommended in 2006. Commerce officials stated that their work to stimulate international markets fulfills Commerce's obligations under RCRA. Congress may need to act to clarify Commerce's responsibilities under RCRA or assign responsibility for stimulating domestic markets to another agency. By taking action, Congress can ensure a federal response to the reduction in international demand for U.S. recyclables. EPA has taken several actions to plan and coordinate national efforts to advance recycling, such as releasing a draft national recycling strategy in October 2020. However, EPA has not incorporated some desirable characteristics for effective national strategies, identified in prior GAO work. By better incorporating such characteristics as it finalizes and implements its draft strategy, EPA will have greater assurance of the strategy's usefulness in making resource and policy decisions and will better ensure accountability for its implementation. In 1976, Congress sought to reduce solid waste and encourage recycling as part of RCRA, which gave primary responsibility for recycling to states and municipalities but requires EPA and Commerce to take specific actions. The United States generated almost 1,800 pounds of waste per capita in 2018. Recycling rates for common recyclables, such as paper, plastics, glass, and some metals, remain low. Furthermore, recent international import restrictions have reduced demand for U.S. exports of recyclables. GAO was asked to review federal efforts that advance recycling in the United States. This report examines (1) cross-cutting challenges affecting recycling in the United States, (2) actions that selected federal agencies have taken that advance recycling, and (3) actions EPA has taken to plan and coordinate national efforts to advance recycling. GAO reviewed laws and agency documents; and interviewed federal officials and nonfederal stakeholders, such as states, municipalities, and industry representatives, selected for their expertise and efforts to advance recycling. GAO is making one matter for congressional consideration to clarify a RCRA requirement for Commerce or to assign responsibility for stimulating domestic markets to another agency; and three recommendations to EPA, including that it take actions to fulfill certain RCRA requirements. EPA concurred with GAO's recommendations. For more information, contact J. Alfredo Gómez at (202) 512-3841 or gomezj@gao.gov.
    [Read More…]
  • Bolivia Travel Advisory
    In Travel
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  • Keynote Address of Deputy Attorney General Jeffrey A. Rosen on Combatting Fraud in the Age of COVID-19 at the BBB National Programs NAD 2020 Conference
    In Crime News
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  • Colorado Springs Agrees to Improve Stormwater Management in Settlement with the United States
    In Crime News
    The U.S. Department of Justice and the U.S. Environmental Protection Agency (EPA) today announced a settlement with the City of Colorado Springs, Colorado, to resolve violations of the Clean Water Act with respect to the City’s storm sewer system.
    [Read More…]
  • National Health Care Fraud and Opioid Takedown Results in Charges Against 345 Defendants Responsible for More than $6 Billion in Alleged Fraud Losses
    In Crime News
    Acting Assistant Attorney General Brian C. Rabbitt of the Justice Department’s Criminal Division, Assistant Director Calvin Shivers of the FBI’s Criminal Investigative Division, Deputy Inspector General Gary Cantrell of the Department of Health and Human Services Office of Inspector General (HHS-OIG) and Assistant Administrator Tim McDermott of the Drug Enforcement Administration (DEA) today announced a historic nationwide enforcement action involving 345 charged defendants across 51 federal districts, including more than 100 doctors, nurses and other licensed medical professionals. 
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  • Department Press Briefing – February 11, 2021
    In Crime Control and Security News
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  • Justice Department Again to Monitor Compliance with the Federal Voting Rights Laws on Election Day
    In Crime News
    The Justice Department today announced its plans for voting rights monitoring in jurisdictions around the country for the Nov. 3, 2020 general election. The Justice Department historically has monitored in jurisdictions in the field on election day, and is again doing so this year. The department will also take complaints from the public nationwide regarding possible violations of the federal voting rights laws through its call center.  
    [Read More…]
  • Former Resident of Stockton, California Sentenced to More Than 15 Years in Prison for Human Trafficking Convictions Related to Forced Labor of Foreign Nationals
    In Crime News
    Sharmistha Barai, 40, formerly of Stockton, California, was sentenced Friday, Oct. 2 to 15 years and eight months in prison for forced labor violations.
    [Read More…]
  • Former Rapides Parrish Corrections Officer Sentenced to 11 Months in Federal Prison for Assaulting Inmate
    In Crime News
    The Justice Department announced today that a former correctional officer with the Rapides Parish Sheriff’s Office (RPSO), Detention Center 1, in Alexandria, Louisiana, was sentenced today in federal court for assaulting an inmate detained at the facility.
    [Read More…]
  • Condemning ISIS-K Attack on a Kabul Gathering
    In Crime News
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