Kusserow on Compliance: DOJ moves against spine device manufacturer for paying kickbacks

The Department of Justice (DOJ) has intervened in a qui tam whistleblower case filed against SpineFrontier, Inc. and related entities and executives for alleging paying kickbacks to spine surgeons to induce use of their surgical devices. According to the complaint, spine surgeons were given over $8 million in sham “consulting” payments ostensibly for product evaluations, when in fact the payments were for use of SpineFrontier devices.

The defendants allegedly created Impartial Medical Experts LLC IME—a purported consulting company—as an entity intermediary to funnel kickbacks to spine surgeons. IME was designed to shield the defendants and spine surgeons from government scrutiny by creating a false impression that surgeons were consulting through an independent third-party entity. The Defendants generally paid “consulting” spine surgeons $500 for a cervical procedure, and $1,000 for a lumbar procedure—but only if the surgeon used SpineFrontier devices. The United States alleges that consulting spine surgeons often performed little or no work beyond implanting the devices—for which they were separately paid by insurers—and that the Defendants did not systematically collect or use feedback from consultants and paid them even when they had provided no feedback at all.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: FBI Reports on business email compromise scams

BEC Scams Accounted for 50% of cyber losses last year

The FBI once again reported on the increase in cyber-criminal activity related to ransomware and business email compromise (BEC) scams. During 2019, BEC accounted for almost a half million internet and cyber-crime complaints and caused losses of more than $3.5 billion. Approximately half of the reported loses were as result of BEC, sometime referred to as EAC (Email Account Compromise) crimes, which averaged $75,000 per incident reported. This was the most damaging and effective type of cyber-crime last year. The 23,775 BEC victims accounted for $1.77 billion in losses for victims, which was on average $75,000 per complaint.

These are sophisticated scams targeting business activities and individuals performing wire transfer payments. They normally come about as result of either a compromise or spoof an email account for a legitimate person/company. They use this email account to send fake invoices for business contractors. Sometimes they are sent to employees. They are designed to trick people into wiring money into the wrong bank accounts. An example of this relates to the diversion of payroll funds, wherein HR or payroll receives an email appearing to be from an employee requesting to update and change their direct deposit information for the current pay period, generally routing it to a pre-paid card account.

The most recent innovation has been scammers mimicking employee’s own CEO to steal funds from the payroll department. They hack into a company’s email server and identify which executives’ email addresses they can spoof to trick unsuspecting employees. The FBI also noted a decrease in the number of ransomware complaints, however a rise in the amount of losses per incident. Additionally, 764 health care providers reported being ransomware victims in 2019.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on LinkedIn.

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Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG Civil Monetary Penalties Law enforcement actions for the second half of 2019

Many remain unaware of the Civil Monetary Penalties Law (CMPL). It comes into action when the DOJ believes false claim cases don’t rise to a level sufficient for prosecution in the courts. The OIG is authorized under the CMPL to impose administrative penalties, assessments, and exclusions against a person who, among other things, submits, or causes to be submitted, claims to a federal health care program that the person knows, or should know, are false or fraudulent. The exclusions statute also authorizes OIG to exclude a person who violates the CMPL. Those who appeal the OIG imposed penalties can appeal to an HHS Administrative Law Judge (ALJ). It is rare that an ALJ has overturned the OIG. During this semiannual reporting period, the OIG concluded cases involving more than $30 million in CMPs and assessments.

THE CMPL can be thought of as the administrative version of the False Claims Act. This means that any person who submits, or causes to be submitted, to a federal health care program a claim for items and services that the person knows, or should know, is false or fraudulent is subject to a penalty of up to $15,270 for each item or service falsely or fraudulently claimed, an assessment of up to three times the amount falsely or fraudulently claimed, and exclusion.

For the purposes of the CMPL, “should know” is defined to mean that the person acted in reckless disregard or deliberate ignorance of the truth or falsity of the claim. The law and its implementing regulations also authorize actions for a variety of other violations, including submission of claims for items or services furnished by an excluded person; requests for payment in violation of an assignment agreement; violations of rules regarding the possession, use, and transfer of biological agents and toxins; and payment or receipt of remuneration in violation of the anti-kickback statute.

Additional authorities for the OIG use of CMPL have been added in recent years. The Patient Protection and Affordable Care Act (ACA) added more grounds for imposing CMPs. These include, among other types of conduct, knowingly making, or causing to be made, any false statements or omissions in any application, bid, or contract to participate as a provider in a federal health care program (including Medicare and Medicaid managed care programs and Medicare Part D). The ACA authorizes a penalty of up to $55,262 for each false statement, as well as activities relating to fraudulent marketing by MCOs, their employees, or their agents. The 21st Century Cures Act added more grounds for imposing CMPs, assessments, and exclusion from federal health care programs for fraudulent conduct in an HHS grant, contract, or other agreement. The OIG may assess CMPs of up to $10,000 per claim and assessments of up to three times the amount claimed for knowingly presenting a false or fraudulent claim. In addition, the OIG may impose a penalty of up to $50,000 and assessments of up to three times the amount of funds at issue: (1) for each instance of knowingly making a false statement in a document required to be submitted in order to receive funds under an HHS contract, grant, or other agreement; (2) for knowingly making or using a false record or statement that is material to a false or fraudulent claim; and (3) for knowingly making or using a false record or statement material to an obligation to pay or transmit funds or property owed to HHS. The OIG may impose a penalty of up to $10,000 per day and assessments of up to three times the amount at issue for knowingly concealing, or knowingly and improperly avoiding or decreasing, an obligation owed to HHS with respect to an HHS grant, contract, or other agreement. Finally, The OIG may impose a penalty of up to $15,000 per day for failing to grant timely access to OIG upon reasonable request for audits or to carry out other statutory functions in matters involving an HHS grant, contract, or other agreement.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 202o Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Is there no limit to fraud cases?

Doctor convicted in connection to a $325 million fraud case

Falsely diagnosing patients with lifelong illnesses

Needlessly subjected patients to unnecessary medications

A Texas rheumatologist was convicted in a jury trial in connection with a $325 million healthcare fraud case. He was found guilty of falsely diagnosing patients with lifelong illnesses and needlessly subjecting them to unnecessary medications such as chemotherapy drugs and then falsely billing insurers for millions of dollars. The DOJ saw this as an extremely egregious case because the doctor falsely diagnosed vulnerable patients—the young, elderly and disabled—with life-long diseases requiring invasive treatments that those patients did not in fact need.

The DOJ further noted that many of the patients, including one as young as 13, suffered physical and emotional harm as a result of the chemotherapy injections, hours’ long intravenous infusions, and other excessive, repetitive and profit-driven medical procedures. Also noted was that the evidence presented at trial showed that to obstruct and mislead a federal grand jury investigation, the doctor falsified medical records.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 202o Strategic Management Services, LLC. Published with permission.