November 28, 2022

Volume XII, Number 332

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A COVID-19 Laboratory Testing Conviction under EKRA

Mark Schena, the President of Arrayit Corporation, has been found guilty by a jury for violations of the Eliminating Kickbacks in Recovery Act (EKRA), healthcare fraud, wire fraud, and securities fraud.

On May 18, 2021, a superseding indictment was issued against Mark Schena for his role in promoting Arrayit online and publicly by making false and misleading statements to the public regarding Arrayit’s COVID-19 testing technology and requirements to bundle with allergy testing, among other false and misleading representations to investors.[1]  Schena was charged with violations of conspiracy to commit healthcare fraud and wire fraud (18 U.S.C. § 1349), healthcare fraud (18 U.S.C. § 1347 and 18 U.S.C. § 2), conspiracy to pay kickbacks (18 U.S.C. § 371), violations of EKRA (18 U.S.C. § 220) and various violations of security fraud (15 U.S.C. § 78j & 78ff; 17 C.F.R. 240.10b-5; and 18 U.S.C. § 2).[2]  The Government alleged that Schena had offered and paid, as well as conspired to pay, and paid, illegal kickbacks to physicians and marketers to induce the ordering of bundled COVID-19 testing and allergy testing, many of which were not medically necessary, not eligible for reimbursement, or not provided.[3]  It is further alleged that Schena, along with his VP of Marketing, Paul Haje, entered into sham contracts and agreements and maintained false invoices for payments with marketers.[4] 

Schena had also employed Marc Jablonski, the president of DxSolutions, a marketing organization based in Arizona.  The Government alleged that Jablonski solicited and received kickbacks and bribes from Schena in exchange for inducing orders for COVID-19 and allergy testing, many of which were not medically necessary.[5]  It was further alleged that Jablonski paid “illegal kickbacks and bribes to other marketers in exchange for arranging for medical practitioners to collect blood samples and order allergy testing.”[6]  Jablonski cooperated with the Government and pled guilty to one count of conspiracy to defraud the United States as well as pay and receive illegal kickbacks.[7] 

Earlier this year, Schena failed in his argument to dismiss the superseding indictment with respect to the violations of EKRA.  Schena attempted to argue that EKRA did not apply because the marketers worked with physicians and not patients directly.[8]  The Court did not agree with this proposition, instead finding that the act of marketing is an inducement to refer an individual and can violate EKRA when such marketers are paid on a per specimen, per person, or percentage of reimbursement.[9]

The case proceeded to trial.  Part of the trial focused on Arrayit’s relationships with consultants or “marketers” and whether Schena knew that the compensation structure paid by Arrayit violated EKRA.  Emails and texts were introduced at trial.[10]  On September 1, 2022, a jury found Schena guilty on all counts.  Sentencing is scheduled for January 2023.   As noted in the press release, Schena “faces a maximum penalty 20 years imprisonment for the conspiracy to commit health care fraud and conspiracy to commit wire fraud; 10 years of imprisonment for each count of health care fraud; five years imprisonment for conspiracy to pay kickbacks; 10 years imprisonment for each count of payment of kickbacks; and 20 years imprisonment for each count of securities fraud.”[11]


FOOTNOTES

[1] U.S. v. Schena, 5:20-cr-00425-EJD, DKT 53, Superseding Indictment at ¶¶ 29-32 (N.D. Cal. May 18, 2021)

[2] Id. at pp. 14-16 (the “Counts”)..

[3] Id. at ¶¶ 30, 32, 35, 41, 43, 45.

[4] U.S. v. Haje, 5:21-cr-00214-EJD, DKT 1, ¶ 32 (N.D. Cal. May 25, 2021). 

[5] United States v. Jablonski, 21-cr-00213-EJD, DKT 1 (May 25, 2021); DOJ N. Dist. Of CA, New Charges Filed Against Medical Technology Company President and Two Others in Alleged Fraudulent Covid-19 Testing Scheme (May 26, 2021), available at https://www.justice.gov/usao-ndca/pr/new-charges-filed-against-medical-technology-company-president-and-two-others-alleged 

[6] United States v. Jablonski, 21-cr-00213-EJD, DKT 1, ¶ 33 (N.D. Cal. May 25, 2021).

[7] United States v. Jablonski, 21-cr-00213-EJD, DKT 17 (N.D. Cal. July 6, 2022).

[8] U.S. v. Schena5:20-cr-00425-EJD DKT 106 (N.D. Cal. March 14, 2022).

[9] U.S. v. Schena,  2022 WL 1720083 (N.D. Cal. May 28, 2022).

[10] U.S. v. Schena, 5:20-cr-00425-EJD, DKT 217 (N.D. Cal. Sept. 6, 2022).

[11] Department of Justice Press Release, Medical Technology Company President Convicted in $77 Million COVID-19 and Allergy Testing Scheme (Sept. 2, 2022), available at https://www.justice.gov/opa/pr/medical-technology-company-president-convicted-77-million-covid-19-and-allergy-testing-scheme.

Copyright © 2022 Robinson & Cole LLP. All rights reserved.National Law Review, Volume XII, Number 256
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About this Author

Danielle H. Tangorre Attorney Health Law Robinson Cole Law Firm Albany
Partner

Danielle H. Tangorre represents and advises a broad range of health care providers, including clinical laboratories, long-term care facilities, behavioral health providers, substance abuse providers, physician group practices and licensed healthcare providers. She is a member of the Health Law Group. 

Regulatory

Danielle advises clients on operational and compliance issues, federal and state fraud and abuse laws, including the Stark law, Anti-Kickback Statute and the Eliminating Kickbacks in Recovery...

212-451-2964
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