Wisconsin Pain Management Companies To Settle False Claims Act Allegations

The Department of Justice announced today that Advanced Pain Management Holdings Inc. (APMH), its wholly-owned subsidiaries,  APM Wisconsin MSO (“APM MSO”) and Advanced Pain Management LLC (APM LLC); and Advanced Pain Management S.C. (APMSC) (collectively the “APM Entities”) have agreed to pay $885,452 to settle claims that they violated the False Claims Act by paying kickbacks and by performing medically unnecessary laboratory tests.  The APM Entities are headquartered in the Milwaukee, Wisconsin area. 

“Healthcare providers must make recommendations about their patients’ health without respect to their own financial interests,” said Acting Assistant Attorney General Jeffrey Bossert Clark for the Department of Justice’s Civil Division.  “We will continue to do our part to protect federal health care program beneficiaries and the American taxpayers from the corrupting influence of kickbacks designed to undermine the impartiality and integrity of physician decision making.”

“The financial arrangements pursued by APMH wrongly gave physicians an incentive to make medical decisions based on their own financial interests, rather than their patients’ interests,” said U.S. Attorney Matthew D. Krueger for the Eastern District of Wisconsin.  “Medicare and Medicaid only pay for procedures and tests that are medically necessary and untainted by kickbacks.  This settlement reflects our office’s continuing efforts to combat violations of the False Claims Act and improper arrangements under the Anti-Kickback Statute.”     

“It is imperative that the public has faith and trust that the decisions made by medical providers are based upon the best interests of their patients” said Lamont Pugh III, Special Agent in Charge, U.S. Department of Health & Human Services, Office of Inspector General – Chicago Region.  “The specter of a payment of a kickback in any form or fashion diminishes that faith and trust and can lead to the improper payment and wasting of limited taxpayer dollars. The OIG will continue to work with our investigative partners to ensure the continued integrity of federally funded health care programs.”

The United States alleged that APMH improperly gifted shares of incentive stock to non-employee APMSC physicians who performed pain management procedures at APMH’s ambulatory surgical centers.  The incentive stock was to be redeemed upon a sale of APMH and was dependent on the profitability of APMH, which was determined largely by referrals from the non-employee physicians.  The incentive stock was allegedly given as a reward for past and anticipated referrals to APMH’s ambulatory service centers. 

The United States further contended that APMH paid non-employee APMSC physicians to serve as medical directors in a manner that was tied to the volume of procedures at APMH’s ambulatory surgery centers.  There were no written agreements documenting the services the medical directors were to provide, and the medical directors were not required to record or report any medical director functions.

The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by federally funded programs.  The Anti-Kickback Statute is intended to ensure that a physician’s medical judgment is not compromised by improper financial incentives and is instead based on the best interests of the patient.

The United States alleged that the APM Entities performed confirmatory urine drug tests that were medically unnecessary.  For certain claims, providers allegedly failed to customize orders for confirmatory urine drug tests based on each patient’s individualized risk assessment and circumstances, resulting in a higher level of testing than supported by the medical record.  The APM Entities disclosed these improper urine drug test claims to the Department of Health and Human Services. 

The settlement resolves allegations originally brought in a lawsuit filed by a whistleblower under the qui tam provisions of the False Claims Act, which allow private parties to bring suit on behalf of the government and to share in any recovery.  The whistleblower will receive $142,152 as her share of the federal recovery in this case.

The APM Entities settlement with the United States is based on their ability to pay, and is part of a broader settlement that also resolves various state law claims.   

The case was handled by the U.S. Attorney’s Office for the Eastern District of Wisconsin with assistance from the Justice Department’s Civil Division, and the U.S. Department of Health and Human Services Office of Inspector General. 

The lawsuit is captioned United States, et al. ex rel. Hedstrom v. Advanced Pain Mgmt., et al., Case No. 13-C-556 (E.D. Wisc.). The claims settled by this agreement are allegations only, and there has been no determination of liability.

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    Most commercial aircraft undergo voluntary inspections to ensure that galleys and lavatories are constructed and assembled to meet the Food and Drug Administration's (FDA) sanitation standards, according to industry representatives. Twenty-seven percent of the inspections FDA conducted between fiscal years 2015 and 2019 found objectionable conditions. But in nearly all of these instances, the conditions identified, such as the need for additional sealant in areas where there was a gap or seam, were corrected by the airline or aircraft manufacturer during the inspection. However, some regional airline representatives told GAO that their aircraft do not receive these construction inspections, either because larger airlines with which they have contracts told them the inspections were unnecessary or because they did not believe the inspections were relevant to them. FDA provides these inspections free of charge, upon request of aircraft manufacturers or airlines, and aircraft passing inspection receive a certificate of sanitary construction. Representatives of one aircraft manufacturer said they view the certificate as beneficial because their customers see it as a guarantee that the aircraft was constructed in a way that decreases the likelihood of microbial contamination, pests, and insects. While the construction inspections are important, they are not required, and FDA does not proactively encourage airlines to request them. By developing a process for communicating directly to all U.S.-based commercial airlines, including regional airlines, to encourage them to receive construction inspections, FDA could better ensure that aircraft meet FDA sanitation standards to protect passenger health. An Airline Representative Applying Additional Sealant in Response to an FDA Inspection FDA faces several challenges in providing construction inspections and is taking steps to address these challenges. For example, the demand for inspections by manufacturers and airlines is unpredictable, and FDA inspectors are responsible for inspections at multiple locations. To help mitigate these challenges, officials we interviewed from four FDA field offices said they usually request advance notice from industry to allow the agency time to allocate the necessary resources for construction inspections. Voluntary construction inspections are the primary mechanism by which FDA oversees compliance with its required sanitation standards for the construction of aircraft galleys and lavatories. A report accompanying the House 2019 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill included a provision for GAO to review FDA's process for ensuring proper sanitation in aircraft galleys and lavatories. This report (1) examines the extent to which aircraft are inspected to ensure compliance with FDA's sanitation standards, and (2) discusses challenges FDA faces in providing aircraft inspections and how FDA is addressing such challenges. GAO reviewed FDA guidance, interviewed FDA officials in headquarters and four selected field offices with high volumes of construction inspections, conducted site visits to meet with FDA inspectors, and interviewed representatives of selected aircraft manufacturers and airlines. GAO recommends that FDA develop a process for communicating directly with all U.S.-based commercial airlines to encourage them to request construction inspections. FDA generally agreed with our recommendation. For more information, contact Steve Morris (202) 512-3841 MorrisS@gao.gov.
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  • Drinking Water: EPA Could Use Available Data to Better Identify Neighborhoods at Risk of Lead Exposure
    In U.S GAO News
    GAO's statistical analysis indicates that areas with older housing and vulnerable populations (e.g., families in poverty) have higher concentrations of lead service lines in the selected cities GAO examined. By using geospatial lead service line data from the selected water systems and geospatial data from the U.S. Census Bureau's American Community Survey (ACS), GAO identified characteristics of neighborhoods with higher concentrations of lead service lines. The Environmental Protection Agency's (EPA) guidance for water systems on how to identify the location of sites at high-risk of having lead service lines has not been updated since 1991 and many water systems face challenges identifying areas at risk of having lead service lines. By developing guidance for water systems that outlines methods for identifying high-risk locations using publicly available data, EPA could better ensure that public water systems test water samples from locations at greater risk of having lead service lines and identify areas with vulnerable populations to focus lead service line replacement efforts. (See figure for common sources of lead in home drinking water.) Common Sources of Lead in Drinking Water within Homes and Residences EPA has taken some actions to address the Water Infrastructure Improvements for the Nation (WIIN) Act requirement, which include developing a strategic plan regarding lead in public water systems. However, EPA's published plan did not satisfy the statutory requirement that the agency's strategic plan address targeted outreach, education, technical assistance, and risk communication undertaken by EPA, states, and public water systems. For example, the plan does not discuss public education, technical assistance or risk communication. Instead, EPA's plan focused solely on how to notify households when EPA learns of certain exceedances of lead in their drinking water. Moreover, EPA's plan is not consistent with leading practices for strategic planning. For example, EPA's plan does not set a mission statement or define long-term goals. Developing a strategic plan that meets the statutory requirement and fully reflects leading practices for strategic planning would give EPA greater assurance that it has effectively planned for how it will communicate the risks of lead in drinking water to the public. Lead in drinking water comes primarily from corrosion of service lines connecting the water main to a house or building, pipes inside a building, or plumbing fixtures. As GAO reported in September 2018, the total number of lead service lines in drinking water systems is unknown, and less than 20 of the 100 largest water systems have such data publicly available. GAO was asked to examine the actions EPA and water systems are taking to educate the public on the risks of lead in drinking water. This report examines, among other things: (1) the extent to which neighborhood data on cities served by lead service lines can be used to focus lead reduction efforts; and (2) actions EPA has taken to address WIIN Act requirements, and EPA's risk communication documents. GAO conducted a statistical analysis combining geospatial lead service line and ACS data to identify characteristics of selected communities; reviewed legal requirements and EPA documents; and interviewed EPA officials. GAO is making four recommendations, including that EPA develop (1) guidance for water systems on lead reduction efforts, and (2) a strategic plan that meets the WIIN Act requirement. EPA agreed with one recommendation and disagreed with the others. GAO continues to believe the recommendations are warranted, as discussed in the report. For more information, contact J. Alfredo Gómez at (202) 512-3841 or gomezj@gao.gov.
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  • Secretary Michael R. Pompeo With Tony Katz of The Morning News on WIBC Indianapolis
    In Crime Control and Security News
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    In Crime Control and Security News
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  • Three Individuals Charged with Arranging Adoptions from Uganda and Poland Through Bribery and Fraud
    In Crime News
    Three women were charged in a 13-count indictment filed on Aug. 14 in the Northern District of Ohio for their alleged roles in schemes to corruptly and fraudulently procure adoptions of Ugandan and Polish children through bribing Ugandan officials and defrauding U.S. adoptive parents, U.S. authorities, and a Polish regulatory authority.
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  • The United States Condemns the Kidnapping of Students in Kankara, Nigeria
    In Crime Control and Security News
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    In Travel
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    In Crime Control and Security News
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  • Jersey/Swiss Financial Services Firm Admits to Conspiring with U.S. Taxpayers to Hide Assets and Income in Offshore Accounts
    In Crime News
    Strachans SA in Liquidation pleaded guilty yesterday to conspiring with U.S. taxpayers and others to hide income and assets in offshore entities and bank accounts from the IRS, and was sentenced in accordance with the guilty plea, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division, U.S. Attorney Nicola T. Hanna, and Chief James Lee of the Internal Revenue Service, Criminal Investigation (IRS-CI).
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  • Over 500K Rapid Coronavirus Tests Being Distributed to HBCUs
    In Human Health, Resources and Services
    In yet another effort by [Read More…]