January 24, 2022

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Medtronic to Pay Over $9.2 Million To Settle Allegations of Improper Payments to South Dakota Neurosurgeon

15 min read
<div>Minnesota-based medical device maker Medtronic USA Inc. has agreed to pay $8.1 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce a South Dakota neurosurgeon to use certain Medtronic products, the Department of Justice announced today. Medtronic also agreed to pay an additional $1.11 million to resolve allegations that it violated the Open Payments Program by failing to accurately report payments it made to the neurosurgeon to the Centers for Medicare & Medicaid Services (CMS).</div>

Minnesota-based medical device maker Medtronic USA Inc. has agreed to pay $8.1 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce a South Dakota neurosurgeon to use certain Medtronic products, the Department of Justice announced today.

Medtronic also agreed to pay an additional $1.11 million to resolve allegations that it violated the Open Payments Program by failing to accurately report payments it made to the neurosurgeon to the Centers for Medicare & Medicaid Services (CMS).

“Kickbacks undermine the integrity of federal healthcare programs and increase costs borne by taxpayers,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Department of Justice’s Civil Division.  “This case demonstrates the Department of Justice’s commitment to ensure that medical device manufacturers do not use improper financial relationships to influence physician decision-making.”  

“We expect doctors to make medical decisions based on what is best for their patients, not what is best for their bank accounts,” said U.S. Attorney Ron Parsons for the District of South Dakota.  “The quality of medical care is eroded – and patients and their families suffer – when companies and physicians enter into these sorts of under the table schemes to create illegal financial incentives to increase the use of medical devices.”

“Allegations of kickbacks are taken very seriously. Such actions threaten the integrity of federal healthcare systems,” said Curt L. Muller, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services (HHS-OIG).  “We will continue working with our law enforcement partners to protect patients and taxpayers.”

“CMS’ Open Payments Program is intended to promote transparency and accountability in the healthcare system.  Manufacturers that misreport their financial relationships with healthcare providers erode the integrity of the Open Payments Program and will be held accountable,” said Brenna E. Jenny, HHS Deputy General Counsel and CMS Chief Legal Officer.  “CMS looks forward to continued partnership with the Department of Justice to resolve allegations of manufacturers skirting their Open Payments obligations.”

The Anti-Kickback Statute prohibits directly or indirectly offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid, TRICARE, and other federal healthcare programs. 

The settlement announced today resolves allegations that Medtronic agreed to the requests of South Dakota neurosurgeon, Wilson Asfora, M.D., to pay for social events at Carnaval Brazilian Grill, a restaurant Medtronic knew Asfora owned, including scores of expensive meals.  Medtronic allegedly made the payments to benefit Asfora and induce him to use Medtronic’s SynchroMed II intrathecal infusion pumps, which are implantable devices used to deliver medication to patients.  The United States alleged that Medtronic’s sponsored events at Asfora’s restaurant were social gatherings for which Asfora selected and invited his social acquaintances, business partners, favored colleagues, and potential and existing referral sources, while Medtronic paid for their meals and drinks.  Over a nine-year period, Medtronic allegedly paid for more than one hundred events at Asfora’s restaurant.  

This settlement also resolves Medtronic’s liability under CMS’ Open Payments Program, which was established by the Affordable Care Act and requires medical device manufacturers like Medtronic to disclose to CMS certain payments or other transfers of value to a physician like Asfora.  The United States alleged that Medtronic made payments to Asfora’s restaurant at his request, knowing that Asfora owned the restaurant, but underreported those payments to CMS.

Asfora and two of his other companies are defendants in a separate FCA lawsuit in which the United States filed a complaint in November 2019, alleging that Asfora received kickbacks to use certain implants in his spinal surgeries.  That pending case is captioned United States ex rel. Bechtold, et al. v. Asfora, et al., No. 4:16-cv-04115-LLP (D.S.D.). 

The government’s pursuit of these matters illustrates the government’s emphasis on combating healthcare fraud.  One of the most powerful tools in this effort is the False Claims Act.  Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the Department of Health and Human Services, at 800‑HHS‑TIPS (800-447-8477).

The settlement was the result of an investigation by the Department of Justice’s Civil Division, the U.S. Attorney’s Office for the District of South Dakota, and HHS-OIG.  As part of the settlement, Medtronic agreed to cooperate with the Department’s investigations of and litigation against other parties, and the device maker took remedial action once it learned of the wrongdoing, including terminating a sales representative and sales manager and disciplining twelve other employees involved in the alleged misconduct. 

The claims resolved by the settlement are allegations only, and there has been no determination of liability.

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    In U.S GAO News
    In 2004, the Department of State created the Office of the Coordinator for Reconstruction and Stabilization to coordinate U.S. planning and implementation of stabilization and reconstruction operations. In December 2005, President Bush issued National Security Presidential Directive 44 (NSPD-44), charging State with improving coordination, planning, and implementation of such operations and ensuring that the United States can respond quickly and effectively to overseas crises. GAO was asked to report on State's efforts to improve (1) interagency planning and coordination for stabilization and reconstruction operations, and (2) deployment of civilians to these operations. To address these objectives, we conducted interviews with officials and reviewed documents from U.S. agencies and government and private research centers.The office of the Coordinator for Reconstruction and Stabilization (S/CRS) is developing a framework for planning and coordinating U.S. reconstruction and stabilization operations. The National Security Council (NSC) has adopted two of three primary elements of the framework--the Interagency Management System and procedures for initiating the framework's use. However, the third element--a guide for planning stabilization and reconstruction operations--is still in progress. We cannot determine how effective the framework will be because it has not been fully applied to any stabilization and reconstruction operation. In addition, guidance on agencies' roles and responsibilities is unclear and inconsistent, and the lack of an agreed-upon definition for stabilization and reconstruction operations poses an obstacle to interagency collaboration. Moreover, some interagency partners stated that senior officials have shown limited support for the framework and S/CRS. Some partners described the new planning process, as presented in early versions of the planning guide, as cumbersome and too time consuming for the results it has produced. S/CRS has taken steps to strengthen the framework by addressing some interagency concerns and providing training to interagency partners. However, differences in the planning capacities and procedures of civilian agencies and the military pose obstacles to effective coordination. State has begun developing three civilian corps that can deploy rapidly to international crises, but key details for establishing and maintaining these units remain unresolved. First, State created the Active Response Corps (ARC) and the Standby Response Corps (SRC) comprised of U.S. government employees to act as first responders to international crises and has worked with several agencies to create similar units. However, these efforts are limited due to State's difficulty in achieving planned staffing levels for ARC, a lack of training available to SRC volunteers, other agencies' inability to secure resources for operations unrelated to their core domestic missions, and the possibility that deploying employees to such operations can leave units without sufficient staff. Second, in 2004, State began developing the Civilian Reserve Corps (CRC). CRC would be comprised of U.S. civilians who have skills and experiences useful for stabilization and reconstruction operations, such as police officers, civil engineers, public administrators, and judges that are not readily available within the U.S. government. If deployed, volunteers would become federal workers. S/CRS developed a plan to recruit the first 500 volunteers, and NSC has approved a plan to increase the roster to 2,000 volunteers in 2009. In May 2007, State received the authority to reallocate up to $50 million to support and maintain CRC, but it does not yet have the authority to obligate these funds. In addition, issues related to volunteers' compensation and benefits that could affect CRC recruitment and management would require congressional action. Furthermore, State has not clearly defined the types of missions for which CRC would be deployed. State has estimated the costs to establish and sustain CRC at home, but these costs do not include costs for deploying and sustaining volunteers overseas.
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  • Secretary Antony J. Blinken and Secretary Lloyd J. Austin at Top of Meeting with Afghan Interpreters
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Federal Prisons: Monitoring Efforts to Implement COVID-19 Recommendations and Examining First Step Act Implementation
    In U.S GAO News
    What GAO Found GAO's July 2021 report on the Bureau of Prison's (BOP) response to the COVID-19 pandemic found that, while BOP developed and updated COVID-19 guidance with input from the Centers for Disease Control and Prevention (CDC), BOP staff reported confusion about how to implement the guidance. In response, GAO recommended that BOP routinely evaluate how it communicates its COVID-19 guidance to facility staff and modify its approach, as needed, to ensure more clear communication about BOP protocols. Since GAO issued the report, BOP has developed two questions on its annual feedback survey to BOP staff about its COVID-19 guidance and deployed the survey in December 2021. This is a promising step; however, the recommendation remains only partially addressed, as BOP still needs to review and assess staff feedback to determine whether modifications to its guidance are needed. GAO will continue to monitor BOP's efforts. In addition, BOP has processes, such as teleconferences among BOP officials and facility inspections, to identify best practices and lessons learned related to BOP's COVID-19 response. However, BOP does not capture or share, bureau-wide, the lessons and practices discussed at its teleconferences, or have an approach for ensuring that facilities apply them, as appropriate. In response, GAO recommended that BOP develop and implement an approach to (1) capture and share best practices and lessons learned for responding to COVID-19 and future public health emergencies; and (2) ensure its facilities are applying, as appropriate, these best practices and lessons learned. At the time of GAO's report issuance, BOP indicated that it planned to conduct an after-action assessment of its pandemic response to help ensure preparedness for any future public health emergencies. BOP has yet to implement these two recommendations, and GAO will continue to coordinate with BOP for updates on BOP's progress. The First Step Act (FSA) requires the Attorney General, in consultation with an Independent Review Committee, to develop and release publicly on the Department of Justice (DOJ) website a risk and needs assessment system. This system is to be used to determine the recidivism risk of each federal inmate as part of the intake process. It is also to be used to help determine and assign the type and amount of evidence-based recidivism reduction (EBRR) programming—activities designed to help inmates succeed upon release from prison—appropriate for each inmate. Generally, eligible inmates who successfully complete EBRR programming may earn time credits that will allow them to be placed in prerelease custody or supervised release earlier than they were previously allowed. GAO is currently reviewing DOJ's and BOP's implementation of certain FSA requirements related to the risk and needs assessment and has a number of audit steps planned. These include examining BOP data and documentation on progress, and conducting interviews with DOJ and BOP officials, as well as selected stakeholders knowledgeable in the area of recidivism. GAO expects to publish the findings of its work, and any related recommendations that may stem from its findings, later in 2022. Why GAO Did This Study BOP is responsible not only for the supervision and custody of more than 157,000 federal inmates, but also for their health care, safety, and rehabilitation. The COVID-19 pandemic has strained BOP's institutions, yet BOP's obligation to provide inmates with programs to advance their education and development remains. Further, BOP has ongoing challenges with leadership instability and staff shortages. In response, GAO raised federal prison management as an emerging issue on its High-Risk List. This statement discusses (1) three recommendations GAO made in July 2021 to enhance BOP's COVID-19 response and efforts to date to address them, and (2) GAO's ongoing review of DOJ's and BOP's implementation of FSA requirements related to inmate assessments and programming. GAO updated information on BOP's activities in response to GAO recommendations, reviewed FSA requirements, and conducted preliminary research to design its audit work
    [Read More…]

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