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Erik Santos — Information

Summary

An Information in United States v. Erik Santos in the U.S. District Court for the District of New Jersey, filed after he waived prosecution by indictment by the Attorney for the United States acting under 28 U.S.C. § 515, and citing 18 U.S.C. § 371 and 18 U.S.C. § 1349. Count One charges conspiracy to violate the Anti-Kickback Statute, describing Santos as a Georgia resident who owned a holding company. It sets out Medicare reimbursement of approximately $7,700 per CGx Test, $51 per Coronavirus Test and $675 or $1,350 per RPP Test. The Information alleges that Laboratory-1 paid Santos kickbacks of approximately $33,250 for CGx Tests and leads, that he paid suppliers approximately $1,000 to $1,500 per test, and that he agreed to kickbacks of $100 and $225 per bundled COVID-19 and RPP test kit.

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SMS/2021R01107


                         UNITED STATES DISTRICT COURT
                            DISTRICT OF NEW JERSEY

 UNITED STATES OF AMERICA                        Hon.

                 V.                              Criminal No. 22-

 ERIK SANTOS                                      18 U.S.C. § 371
                                                  18 U.S.C. § 1349

                               INFORMATION

       The defendant having waived in open court prosecution by Indictment, the

Attorney for the United States, acting under authority conferred by 28 U.S.C. §

515, for the District of New Jersey charges:

                                    COUNT ONE
                  (Conspiracy to Violate the Anti-Kickback Statute)

       1. Unless otherwise indicated, at all times relevant to this Information:

                  The Defendant and Other Individuals and Entities

                 a.   Defendant ERIK SANTOS ("defendant SANTOS") was a

resident of Georgia. Defendant SANTOS owned and operated a holding company

("Santos Company-1") that conducted business with medical testing companies

controlled by Cooperating Witness-1 ("CW-1") and others.

                 b.   CW-1 was an owner of a clinical laboratory located m the

United States ("Laboratory-1") and companies that conducted or arranged for a

variety of medical tests (the "Testing Companies").
                    Background on the Medicare Program

            c.    The Department of Health and Human Services, Office of the

Inspector General ("HHS") and the Federal Bureau of Investigation ("FBI")

investigated a large-scale scheme to defraud the Medicare Program ("Medicare")

and other federal payors through the paying and receiving of kickbacks in return

for referrals of patients interested in certain medical services and products.

            d.     Medicare was a federally-funded program established by the

Social Security Act of 1965 (codified as amended in various sections of Title 42

of the United States Code) to provide medical insurance benefits for individuals

age 65 and older and certain disabled individuals who qualified under the Social

Security Act. Individuals who received benefits under Medicare were referred to

as "Medicare beneficiaries."    Medicare was administered by the Center for

Medicare and Medicaid Services ("CMS"), a federal agency under the United

States Department of Health and Human Services.

            e.     Medicare was a "health care benefit program," as defined by

18 U.S.C. § 24(b), and a "Federal health care program," as defined by 42 U.S.C.

§ 1320a-7b(f), that affected commerce.

            f.     Medicare was divided into four parts, which helped cover

specific services: Part A (hospital insurance), Part B (medical insurance), Part C

(Medicare Advantage), and Part D (prescription drug coverage).

             g.    Medicare Part B covered non-institutional care that included,

among other things, medical testing by clinical laboratories, where those services

were reasonable and necessary to diagnose or treat medical conditions and that


                                         2
met accepted standards of medical practice. Some examples of medical tests that

fell within the purview of Medicare Part B include:

                 i.     Genetic Cancer Screenings. A genetic cancer screening
(a "CGx Test") was a diagnostic tool that tested for a genetic predisposition to
cancer. Medicare reimbursed health care providers approximately $7,700 for
each qualifying CGx Test.

                11.      COVID-19 Testing. Several different laboratory tests
assessed whether an individual had the novel coronavirus disease 2019,
commonly referred to as "COVID-19" (collectively referred to herein as a
"Coronavirus Test"). Medicare reimbursed health care providers approximately
$51 for each qualifying Coronavirus Test.

                    111.                                          A Respiratory
                                Respiratory Pathogen Panel Testing.
Pathogen Panel test ("RPP Test") was used to detect certain respiratory viruses
and bacterial pathogens. The RPP Test did not and could not test for COVID-19.
The RPP Test could include a bacterial panel (which tested only for bacteria,
referred to herein as a "Partial RPP Test"), a viral panel (which tested only for
viruses), or both (referred to as a "Complete RPP Test"). Medicare offered
reimbursement of approximately $675 for each qualifying Partial RPP Test, and
approximately $1,350 for each qualifying Complete RPP Test.

               h.          In order to have one of the tests described above conducted,

an individual would complete a buccal or nasopharyngeal swab or a respiratory

sample to collect a specimen, which would then be transmitted to a laboratory

for testing.

               i.          Under Medicare regulations, any diagnostic laboratory test

had to be ordered by the physician treating the Medicare beneficiary; that is, the

physician who furnished a consultation or treated a beneficiary for a specific

medical problem and who used the results in the management of the

beneficiary's specific medical problem. For example, Medicare did not cover

preventative CGx Tests for beneficiaries who did not exhibit symptoms of cancer

or were not being treated for cancer. Moreover, any tests not ordered by the


                                               3
treating physician were not considered reasonable and necessary and were thus

not covered by Medicare.

            j.    In order for a health care provider to bill Medicare for services

rendered, it had to enroll with Medicare as a Medicare provider or "supplier." For

example, in order to bill Medicare for a CGx Test, Coronavirus Test, or RPP Test,

a clinical laboratory was first required to complete and submit a Form CMS-

855B, the Medicare Enrollment Application for "Clinics/Group Practices and

Certain Other Suppliers."

            k.    As provided in the Form CMS-855B, in order to enroll with

Medicare, a supplier of health care services such as a clinical laboratory had to,

among other things, certify the following: ( 1) the supplier understood that any

deliberate omission, misrepresentation, or falsification of any information on the

Form CMS-855B could be punished by criminal, civil, or administrative

penalties; (2) the supplier agreed to abide by applicable Medicare laws,

regulations and program instructions, such as, but not limited to, the federal

anti-kickback statute (42 U.S.C. § 1320a-1 b(b)) ("AKS"); (3) the supplier

understood that payment of a claim by Medicare was conditioned upon the claim

and the underlying transaction complying with such laws, regulations and

program instructions; and (4) the supplier had to refrain from knowingly

presenting or causing to present a false or fraudulent claim for payment by




                                        4
Medicare and submitting claims with deliberate ignorance or reckless disregard

of their truth or falsity.

              1.     Medicare-authorized suppliers of health care services, such as

clinical laboratories, could only submit claims to Medicare for reasonable and

medically necessary services. Medicare would not reimburse claims for services

that it knew were procured through kickbacks or bribes. Such claims were

deemed false and fraudulent because they violated Medicare laws, regulations,

and program instructions, and violated federal criminal law. For example, where

a CGx Test, a Coronavirus Test, or an RPP Test was procured through the

payment of a kickback in violation of the AKS, a claim to Medicare for

reimbursement for that test was fraudulent. By implementing these restrictions,

Medicare aimed to preserve its resources, which were largely funded by United

States taxpayers, for those elderly and other qualifying beneficiaries who had a

genuine need for medical services.

              m.     Laboratory- I was enrolled as a Medicare supplier and

authorized to bill Medicare for the medical tests described below. Laboratory- I

was also responsible for acknowledging that any claims made to Medicare

complied with the relevant laws, regulations, and program instructions.




                                          5
                                The Conspiracy

      2.    From in or around September 2019 through in or around

March 2020, in the District of New Jersey, and elsewhere, defendant

                                 ERIK SANTOS

did knowingly and intentionally conspire and agree with others to commit an

offense against the United States, that is, to knowingly and willfully solicit and

receive remuneration, directly and indirectly, overtly and covertly, in cash and

in kind, that is, kickbacks and bribes, from any person in return for purchasing,

ordering, and arranging for, and recommending purchasing and ordering, any

good, item, and service, namely, COVID-19 testing, respiratory pathogen panel

tests, and genetic cancer screening tests, for which payment may be made in

whole or in part under a Federal health care program, as defined in Title 18,

United States Code, Section 24(b), namely, Medicare, contrary to Title 42, United

States Code, Section 1320a-7b(b)(l)(B).

                            Goal of the Conspiracy

      3.    The goal of the conspiracy was for defendant SANTOS and his co-

conspirators to unlawfully enrich themselves by soliciting and receiving

kickbacks and bribes.




                                          6
                   Manner and Means of the Conspiracy

     4.    It was part of the conspiracy that:

            The CGx Test Scheme

           a.     In or around September 2019, defendant SANTOS, CW-1 and

others agreed to engage in a scheme to bill Medicare for CGx Tests obtained

through the payment of kickbacks and bribes.

            b.    Defendant SANTOS, CW-1 and others agreed that defendant

SANTOS and others would provide CW-1 's Testing Companies with qualified

patient leads, which identified individuals whose CGx Tests were eligible for

Medicare reimbursement.    In exchange, defendant SANTOS agreed to accept

kickbacks from the Testing Company of approximately $1,750 for each test that

resulted in a Medicare reimbursement. Defendant SANTOS would, in turn, pay

a kickback of approximately $1,000 to $1,500 to other individuals under his

management (collectively, the "Suppliers") for every processed CGx Test for

which CW-1 paid a kickback to defendant SANTOS.

            c.    In order to generate qualified patient leads, defendant

SANTOS and the Suppliers under his management used a variety of methods,

including making cold calls, using targeted Internet advertisements, and making

in-person solicitations for various medical services to elderly Medicare

beneficiaries across the United States. Once an eligible beneficiary was

identified, the Suppliers provided that individual's information to the Testing

Companies and others as part of a qualified patient lead. The Testing Companies



                                       7
operated an online portal (the "Portal") through which Suppliers uploaded

qualified patient leads directly to the Testing Companies.

             d.   After receiving qualified patient leads for likely candidates for

Medicare reimbursement, the Testing Companies had telemedicine health care

providers contact the Medicare beneficiaries identified in the qualified patient

leads. Those health care providers were not treating the beneficiaries for any

symptoms or conditions, but were instead operating with the objective of

providing those pre-screened beneficiaries with prescriptions for the relevant

tests, regardless of medical necessity. In other circumstances, defendant

SANTOS and his Suppliers had their own independent relationships or

arrangements with health care providers who followed up on qualified patient

leads to generate prescriptions that were then provided to the Testing

Companies.

             e.   Once the Testing Companies obtained prescriptions generated

through the qualified patient lead process, testing kits were sent to the

beneficiaries. Beneficiaries then completed the buccal swab or other testing

mechanism contained in the kits and returned them to Laboratory-1. Ultimately,

Laboratory-1 electronically submitted or caused the electronic submission of

claims to Medicare for payment for each of the tests. Laboratory-1 paid kickbacks

to defendant SANTOS and his co-conspirators for each test kit that was returned

to the lab and processed, and subsequently billed to Medicare.

             f.    Defendant SANTOS entered into a sham contract with

Laboratory-1 in order to make it appear that defendant SANTOS was engaged in,

                                        8
and being paid for, legitimate marketing and referral services for Laboratory-1

(the "CGx Agreement"). The CGx Agreement made it appear that Santos

Company-1 was engaged in referral services for Laboratory-1 and provided,

among other things, that Laboratory-1 would pay defendant SANTOS based on

the hours and expenses he incurred, rather than on a per-test basis.

            g.    In order to conceal the kickback arrangement, defendant

SANTOS generated false invoices for hourly referral services and sent them to

the Testing Companies, even though defendant SANTOS knew that the invoiced

payments were, in fact, pre-arranged kickbacks for each qualified patient lead

that had been processed by Laboratory-1.

            h.    From in or around November 2019 through in or around

March 2020, Laboratory-1 paid defendant SANTOS kickbacks of approximately

$33,250 in exchange for CGx Tests and qualified patient leads for CGx Tests.

The intended loss to Medicare associated with the leads and tests submitted by

SANTOS to the Testing Companies was approximately $1,193,709.00 in

reimbursements.

            The COVID-19 Test Scheme

            i.    In or around March 2020, during the early phase of the

COVID-19 pandemic, and at a time when many individuals reported difficulty

obtaining Coronavirus Tests to determine whether they were infected, defendant

SANTOS and CW-1 agreed that defendant SANTOS would be paid kickbacks on

a per-test basis for Coronavirus Tests submitted to Laboratory-1, provided that

those tests were bundled with a significantly more expensive RPP Test, which

                                       9
did not identify or treat COVID-19. Specifically, defendant SANTOS and CW-1

agreed that Laboratory-1 would pay defendant SANTOS a kickback of $100 per

bundled Coronavirus Test and Partial RPP Test kit processed by Laboratory-1,

and $225 per bundled Coronavirus Test and Complete RPP Test processed by

Laboratory-1.

            j.    Defendant SANTOS again entered into a sham contract with

Laboratory-1 in order to make it appear that defendant SANTOS was engaged in,

and being paid for, legitimate marketing and referral services for Laboratory-1

(the "COVID-19 Agreement"). The COVID-19 Agreement made it appear that

Santos Company-1 was engaged in referral services for Laboratory-1 and

provided, among other things, that Laboratory-1 would pay defendant SANTOS

based on the hours and expenses he incurred, rather than on a per-test basis.

            k.    Defendant SANTOS also agreed with CW-1 that defendant

SANTOS would generate false invoices for hourly referral services and send them

to the Testing Companies, even though defendant SANTOS knew that the

invoiced payments were, in fact, pre-arranged kickbacks for each bundled

Coronavirus Test and RPP Test that had been processed by Laboratory-1.

                                   Overt Acts

      5.    In furtherance of the conspiracy, and in order to effect the goal

thereof, defendant SANTOS and others committed or caused the commission of

the following overt acts in the District of New Jersey and elsewhere:

            a.    On or about December 18, 2019, defendant SANTOS caused

Santos Company-1 to submit to the Portal information identifying approximately

                                       10
4 Medicare beneficiaries located in New Jersey for whom defendant SANTOS

possessed CGx Tests that he sought to have processed by Laboratory-1 in

exchange for kickbacks.

           b.    On or about March 24, 2020, SANTOS emailed CW-1 an

executed version of the COVID-19 Agreement, which SANTOS signed on behalf

of Santos Company-1.

     All in violation of Title 18, United States Code, Section 371.




                                       11
                                COUNT TWO
                 (Conspiracy to Commit Health Care Fraud)

      1.    The allegations in Paragraphs 1 and 3 through 5 of Count One of

this Information are realleged here.

      2.    From in or around September 2019 through in or around March

2020, in the District of New Jersey, and elsewhere, defendant

                                 ERIK SANTOS

did knowingly and intentionally conspire and agree with others to knowingly and

willfully execute and attempt to execute a scheme and artifice to defraud a health

care benefit program and to obtain, by means of false and fraudulent pretenses,

representations, and promises, any of the money owned by, and under the

custody and control of, a health care benefit program, as defined by 18 U.S.C.

§ 24(b), in connection with the delivery of or payment for health care benefits,

items and services, contrary to Title 18, United States Code, Section 1347.

                            Goal of the Conspiracy

      3.    The goal of the conspiracy was for defendant SANTOS and others to

unlawfully enrich themselves by submitting or causing the submission of false

and fraudulent claims to Medicare.

                              Manner and Means

      4.    It was part of the conspiracy that:

            a.     As described in paragraphs 1 and 3 through 5 of Count One

of this Information, in exchange for kickbacks, defendant SANTOS and others

knowingly provided the Testing Companies with medically unnecessary CGx

Tests and qualified patient leads for CGx Tests, and agreed to provide the Testing
                                        12
Companies with medically unnecessary RPP Tests.

           b.    As   a   result,   Laboratory- I   submitted   and    caused   the

submission of false and fraudulent claims to Medicare for CGx Tests that were

procured through the payment of kickbacks and were not medically necessary.

     All in violation of Title 18, United States Code, Section 1349.




                                        13
                          FORFEITURE ALLEGATIONS

      1.     Upon conviction of the offenses alleged in Counts One and Two of

this Information, defendant SANTOS shall forfeit to the United States, pursuant

to 18 U.S.C. § 982(a)(7), all property, real or personal, that constitutes or is

derived, directly and indirectly, from gross proceeds traceable to the commission

of the offense (as defined in 18 U.S.C. § 24) alleged in this Information, including,

but not limited to, a sum of money equal to $33,250.

                      SUBSTITUTE ASSETS PROVISION
                   (Applicable to All Forfeiture Allegations)

      2.     If any of the above-described forfeitable property, as a result of any

act or omission of the defend ant:

             (a)   cannot be located upon the exercise of due diligence;

             (b)   has been transferred or sold to, or deposited with, a third

                   person;

             (c)   has been placed beyond the jurisdiction of the Court;

             (d)   has been substantially diminished in value; or

             (e)   has been commingled with other property which cannot be

                   subdivided without difficulty;

the United States shall be entitled to forfeiture of substitute property, pursuant

to 21 U.S.C. § 853(p), as incorporated by 18 U.S.C. § 982(b).



                                              VIKAS KHANNA
                                              Attorney for the United States,
                                              Acting Under Authority Conferred
                                              By 28 U.S.C. § 515

                                         14


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